[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]
IS THE U.S. DEPARTMENT OF
VETERANS AFFAIRS MEETING THE
PHARMACEUTICAL NEEDS OF VETERANS?
=======================================================================
HEARING
before the
SUBCOMMITTEE ON HEALTH
of the
COMMITTEE ON VETERANS' AFFAIRS
U.S. HOUSE OF REPRESENTATIVES
ONE HUNDRED ELEVENTH CONGRESS
FIRST SESSION
__________
SEPTEMBER 22, 2009
__________
Serial No. 111-42
__________
Printed for the use of the Committee on Veterans' Affairs
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53-427 WASHINGTON : 2009
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COMMITTEE ON VETERANS' AFFAIRS
BOB FILNER, California, Chairman
CORRINE BROWN, Florida STEVE BUYER, Indiana, Ranking
VIC SNYDER, Arkansas CLIFF STEARNS, Florida
MICHAEL H. MICHAUD, Maine JERRY MORAN, Kansas
STEPHANIE HERSETH SANDLIN, South HENRY E. BROWN, Jr., South
Dakota Carolina
HARRY E. MITCHELL, Arizona JEFF MILLER, Florida
JOHN J. HALL, New York JOHN BOOZMAN, Arkansas
DEBORAH L. HALVORSON, Illinois BRIAN P. BILBRAY, California
THOMAS S.P. PERRIELLO, Virginia DOUG LAMBORN, Colorado
HARRY TEAGUE, New Mexico GUS M. BILIRAKIS, Florida
CIRO D. RODRIGUEZ, Texas VERN BUCHANAN, Florida
JOE DONNELLY, Indiana DAVID P. ROE, Tennessee
JERRY McNERNEY, California
ZACHARY T. SPACE, Ohio
TIMOTHY J. WALZ, Minnesota
JOHN H. ADLER, New Jersey
ANN KIRKPATRICK, Arizona
GLENN C. NYE, Virginia
Malcom A. Shorter, Staff Director
______
SUBCOMMITTEE ON HEALTH
MICHAEL H. MICHAUD, Maine, Chairman
CORRINE BROWN, Florida HENRY E. BROWN, Jr., South
VIC SNYDER, Arkansas Carolina, Ranking
HARRY TEAGUE, New Mexico CLIFF STEARNS, Florida
CIRO D. RODRIGUEZ, Texas JERRY MORAN, Kansas
JOE DONNELLY, Indiana JOHN BOOZMAN, Arkansas
JERRY McNERNEY, California GUS M. BILIRAKIS, Florida
GLENN C. NYE, Virginia VERN BUCHANAN, Florida
DEBORAH L. HALVORSON, Illinois
THOMAS S.P. PERRIELLO, Virginia
Pursuant to clause 2(e)(4) of Rule XI of the Rules of the House, public
hearing records of the Committee on Veterans' Affairs are also
published in electronic form. The printed hearing record remains the
official version. Because electronic submissions are used to prepare
both printed and electronic versions of the hearing record, the process
of converting between various electronic formats may introduce
unintentional errors or omissions. Such occurrences are inherent in the
current publication process and should diminish as the process is
further refined.
C O N T E N T S
__________
September 22, 2009
Page
Is the U.S. Department of Veterans Affairs Meeting the
Pharmaceutical Needs of Veterans?.............................. 1
OPENING STATEMENTS
Chairman Michael Michaud......................................... 1
Prepared statement of Chairman Michaud....................... 31
Hon. Deborah L. Halvorson........................................ 2
WITNESSES
U.S. Department of Health and Human Services, Solomon Iyasu,
M.D., MPH, Director, Division of Epidemiology, Office of
Surveillance and Epidemiology, Center for Drug Evaluation and
Research, Food and Drug Administration......................... 16
Prepared statement of Dr. Iyasu.............................. 53
U.S. Department of Veterans Affairs:
Belinda J. Finn, Assistant Inspector General for Audits and
Evaluations, Office of Inspector General................... 18
Prepared statement of Ms. Finn........................... 58
Michael A. Valentino, R.Ph., MHSA, Chief Consultant, Pharmacy
Benefits Management Services, Veterans Health
Administration............................................. 23
Prepared statement of Mr. Valentino...................... 61
______
Hoadley, Jack, Ph.D., Research Professor, Health Policy
Institute, Georgetown University, Washington, DC............... 3
Prepared statement of Dr. Hoadley............................ 31
Lichtenberg, Frank R., Ph.D., Courtney C. Brown Professor of
Business, Columbia University, New York, NY, and Research
Associate, National Bureau of Economic Research................ 5
Prepared statement of Mr. Lichtenberg........................ 39
National Council on Patient Information and Education, Bethesda,
MD, William Ray Bullman, M.A.M., Executive Vice President...... 8
Prepared statement of Mr. Bullman............................ 46
Vietnam Veterans of America, Richard F. Weidman, Executive
Director for Policy and Government Affairs..................... 6
Prepared statement of Mr. Weidman............................ 42
SUBMISSIONS FOR THE RECORD
American Federation of Government Employees, AFL-CIO, statement.. 65
Stearns, Hon. Cliff, a Representative in Congress from the State
of Florida, statement.......................................... 67
MATERIAL SUBMITTED FOR THE RECORD
Jeanne Ireland, Assistant Commissioner for Legislation, Food and
Drug Administration, U.S. Department of Health and Human
Services, to Hon. Michael H. Michaud, Chairman, Subcommittee on
Health, Committee on Veterans' Affairs, letter dated November
6, 2009........................................................ 68
Post-Hearing Questions and Responses for the Record:
Hon. Michael H. Michaud, Chairman, Subcommittee on Health,
Committee on Veterans' Affairs, to Hon. George J. Opfer,
Inspector General, Office of Inspector General, U.S.
Department of Veterans Affairs, letter dated October 1,
2009, and response letter and attachment dated November 12,
2009 [An identical letter was sent to Hon. Henry E. Brown,
Jr., Ranking Republican Member, Subcommittee on Health,
Committee on Veterans' Affairs]............................ 71
Hon. Michael H. Michaud, Chairman, Subcommittee on Health,
Committee on Veterans' Affairs, to Hon. Eric K. Shinseki,
Secretary, U.S. Department of Veterans Affairs, letter
dated October 1, 2009, and VA responses.................... 73
IS THE U.S. DEPARTMENT OF
VETERANS AFFAIRS MEETING THE
PHARMACEUTICAL NEEDS OF VETERANS?
----------
TUESDAY, SEPTEMBER 22, 2009
U.S. House of Representatives,
Committee on Veterans' Affairs,
Subcommittee on Health,
Washington, DC.
The Subcommittee met, pursuant to notice, at 2:02 p.m., in
Room 334, Cannon House Office Building, Hon. Michael H. Michaud
[Chairman of the Subcommittee] presiding.
Present: Representatives Michaud, Snyder, Teague,
Halverson, and Perriello.
OPENING STATEMENT OF CHAIRMAN MICHAUD
Mr. Michaud. I would like to call the Subcommittee on
Health now to order, and I would like to thank everyone for
coming.
The goal of today's hearing is to determine whether the
U.S. Department of Veterans Affairs (VA) is meeting the
pharmaceutical needs of our veterans. We are conducting this
hearing because of the concerns that we have heard from our
veterans about proper access to nonformulary prescriptions,
concerns about adverse drug interaction and patient safety, and
recent reports by the Office of Inspector General (OIG) citing
the need to better manage certain aspects of the VA's pharmacy
benefit program.
When properly designed and implemented, formularies can
provide drug therapy that is rational, clinically appropriate,
safe and cost-effective. However, patients' care may be
compromised if the formulary system is not developed and
administered so that individuals can access drugs that they
need. I have heard from veterans who have voiced their
frustration with the VA National Formulary as being too
restrictive to the point that accessing appropriate drugs is a
barrier.
Some veterans have pointed to a flawed subjective system by
securing nonformulary drugs. For example, a veteran who was
denied access to a nonformulary drug at one VA medical center
may be approved by another medical center, which suggests that
the decision may not be based entirely on clinical factors.
I also have concerns about patient safety and whether we
are doing enough to prevent the adverse drug events. Among the
medication errors leading to adverse drug events are missed
doses, duplicate therapy, drug-to-drug interaction, inadequate
monitoring and preparation errors.
And finally, the recently released audit report from the
Office of the Inspector General raised concerns about the VA's
management of noncontrolled drugs and Consolidated Mail
Outpatient Pharmacy (CMOP) contracts. So we have panels here
today of experts to help us explore these issues. And I look
forward to hearing from them as well.
And I would now like to recognize Mrs. Halvorson if she has
an opening statement she would like to make.
[The prepared statement of Chairman Michaud appears on
p. 31.]
OPENING STATEMENT OF HON. DEBORAH L. HALVORSON
Mrs. Halvorson. Thank you, Mr. Chairman.
I appreciate all of you for being here. This is one of the
issues that is probably brought up more and more every time I
get together with my veterans, so I appreciate having the
opportunity to ask questions.
Many times, people will come to me and say, how come these
drugs are covered, and all of a sudden I get a notice saying
that this will no longer be covered any more? So, again, I
thank the Chairman for putting this together because this is
one of those important issues that we need to get to the bottom
of and make sure that we take care of our veterans. Our motto
here is, if you were there, we care. And we need to make sure
that we truly do care and don't just give it lip service
Mr. Michaud. Thank you very much, Mrs. Halvorson, and I
also want to thank you for your leadership and your advocacy
for veterans and their families during your short timeframe so
far here as a Member of Congress. So thank you.
I would like to ask the first panel to come up, please.
On our first panel we have Dr. Jack Hoadley; Dr. Frank
Lichtenberg; Rick Weidman from the Vietnam Veterans of America
(VVA); and William Bullman, who is the Executive Vice President
of the National Council on Patient Information and Education.
I would like to thank the four of you for coming forward
today to give us your thoughts and to help us deal with this
very important issue.
So, without any further adieu, I would like to begin by
asking Dr. Hoadley to begin.
STATEMENTS OF JACK HOADLEY, PH.D., RESEARCH PROFESSOR, HEALTH
POLICY INSTITUTE, GEORGETOWN UNIVERSITY, WASHINGTON, DC; FRANK
R. LICHTENBERG, PH.D., COURTNEY C. BROWN PROFESSOR OF BUSINESS,
COLUMBIA UNIVERSITY, NEW YORK, NY, AND RESEARCH ASSOCIATE,
NATIONAL BUREAU OF ECONOMIC RESEARCH; RICHARD F. WEIDMAN,
EXECUTIVE DIRECTOR FOR POLICY AND GOVERNMENT AFFAIRS, VIETNAM
VETERANS OF AMERICA; AND WILLIAM RAY BULLMAN, M.A.M., EXECUTIVE
VICE PRESIDENT, NATIONAL COUNCIL ON PATIENT INFORMATION AND
EDUCATION, BETHESDA, MD
STATEMENT OF JACK HOADLEY, PH.D.
Dr. Hoadley. Well, good afternoon, Mr. Chairman, and
Members of the Subcommittee.
My name is Jack Hoadley. I am a Research Professor at
Georgetown University's Health Policy Institute. And as a long-
time analyst of prescription drug issues, I have conducted
quite a few different research projects on formularies and
other approaches to managing the use of prescription drugs,
both in Medicare and Medicaid, in the VA and private-sector
health plans. And I appreciate the opportunity to speak to the
Subcommittee on these important issues.
In the Congressional debates over the Medicare Part D
benefit, the role of the VA National Formulary has been invoked
on a regular basis. Some point to it as a source of low prices
and an example that the Medicare Program might follow. And
others claim that access to drugs is more restrictive in the VA
system. And so, my colleagues and I took on a couple of years
ago the idea of conducting an objective comparison of the VA
National Formulary to the formularies that are used by some of
the Medicare Part D plans.
First, just a little bit of background. There is a long
history in the VA of using formularies. It really goes back
several decades culminating in the process of implementing a
national Formulary just a couple of years ago, and it is
important to note that the VA National Formulary really
functions differently than those in many of the private health
plans. The VA is an integrated system. Veterans go to VA
facilities to see VA doctors and fill prescriptions at a VA
pharmacy; whereas, in the private sector, they go get a
prescription, go to the pharmacy, and that is where they find
out that a drug is not covered. The VA pharmacy is more of a
clinical tool used by physicians rather than an enforcement
tool of the plan that is applied at the pharmacy.
So in our analysis we wanted to compare the VA formulary
with those used in some of the leading Medicare Part D plans,
and we used a sample of about 160 commonly prescribed drugs.
This was done in 2007. We wanted to look at the counts of drugs
in the VA formulary compared with counts of unrestricted drugs
on Medicare formularies, and by ``unrestricted,'' we mean a
drug that is not a nonpreferred drug at a higher copay and a
drug that does not require any kind of prior authorization or
other utilization management restriction.
In the straight count of drugs in the two formularies, we
found that of our 160 drugs, the typical Part D plan covered
about 104 of those drugs, and the VA covered about 82. The VA
was more comparable to the major integrated health system in
the Medicare system, Kaiser Permanente, which covered 77 and 79
drugs in 2 of its regions in California.
But the numerical comparison is really not the entire
story. There are a couple of differences between how the VA
formulary works and the perspective that Medicare plans use in
creating their formularies. One is how they treat generic
drugs. The VA covers about three-quarters of the generic drugs
in our sample on its formulary, whereas most of the Medicare
plans list all of them on formulary. And the VA is basically
going through and looking at the generic drugs and trying to
pick, based on clinical evidence and price, the most
appropriate of the generic drugs to be included on the
formulary.
By contrast, the Part D plans, because they don't have
relationships created with the physicians that are going to
prescribe medications, find it easier to simply list all the
generic drugs because, otherwise, they are going to spend time
with rejections at the pharmacy, make their enrollees unhappy
and, in the end, probably go ahead and approve that drug or get
somebody to switch to a different drug. And so, as a result,
they tend to put all the generic drugs on the list, whereas the
VA is making a judgment on clinical evidence and price and then
allowing an exceptions process to operate for other drugs.
There are also some program rules in Medicare that make a
difference there as well.
But the other part of our analysis was to look at the
prescribing and the frequency of prescribing of the drugs not
listed on the VA formulary. We took a number of examples, and
the one I will mention here today is cholesterol drugs, and
that is one of the most commonly prescribed drug classes and
one where some of the criticism of the VA formulary has been.
And the VA says in their guidelines that a high-potency
formulary statin for cholesterol, normally a generic, should be
the first line treatment for treating high cholesterol. But the
guidance goes on to say that physicians should consider a
second line therapy, for example, the nonformulary drug Zetia
or a nonformulary statin, such as Lipitor, if particular
patient circumstances warrant it.
And this is a guidance that is very consistent with other
evidence-based comparative-effectiveness reviews. And we took a
look at the prescribing of these nonformulary options, and we
found that, in 2006, the VA actually filled 700,000
prescriptions for Lipitor, a nonformulary statin, and 350,000
prescriptions for Zetia that year. And this is actually more
utilization than for some of the formulary drugs that treat
cholesterol. So, to us, that looked like evidence that where
drugs are not listed on the formulary, they really still are
very much accessible to beneficiaries.
So, in conclusion, our objective comparison does show that
the VA formulary is modestly smaller than that in the typical
Medicare plan, although similar to those used by integrated
healthcare systems like Kaiser Permanente. But since, as I
suggested, formulary size is not the only measure of access to
drugs, we think that the difference in the two systems, the
more integrated system where physicians had the ability to
prescribe from a formulary that they have worked with and get
exceptions made in what seems to us to be a pretty readily done
basis, that in the end, the veterans are getting access, good
access to drugs through the VA formulary.
So, with that, I will conclude my remarks.
[The prepared statement of Dr. Hoadley appears on p. 31.]
Mr. Michaud. Thank you very much, Dr. Hoadley.
Dr. Lichtenberg.
STATEMENT OF FRANK R. LICHTENBERG, PH.D.
Dr. Lichtenberg. Thank you, Mr. Chairman, and Members of
the Subcommittee. I have a PowerPoint which I will refer to.
Research that I and other economists have performed
indicates that access to medical innovations, that is new
drugs, medical procedures and devices, is one of the most
important determinants of longevity and health.
Four years ago, I performed a study that examined access to
new drugs under the Pharmacy Benefits Management System of the
Veterans Health Administration (VHA). And since 1997, the VA
National Formulary has played a key role in that system. And
some of the key findings of my report, the full text of which
there is a link at the end of my remarks, can be summarized by
several graphs.
So, figure one shows the percent of drugs on the 2005 VA
National Formulary by decade of Food and Drug Administration
(FDA) approval. And I guess the striking thing that we see here
is that if we look, for example, at drugs approved by the FDA
during the period 2000 to 2005, only 19 percent of those drugs
were on the VA National Formulary. And even if we look at so-
called priority review drugs, that is drugs that in the FDA's
opinion represent significant advances over existing treatment,
only a relatively small fraction of these drugs were on the VA
National Formulary. However, even if a drug is not on the
National Formulary, a VA patient may have access to a drug
through the local formulary or through a formulary exception.
And so it is important to look not just on what is on the
formulary, as Dr. Hoadley suggested, but at the drugs that are
actually being used by VA patients. And as a benchmark, I
compare them to non-VA patients. And so, to do this, I used
data from a government survey, the Medical Expenditure Panel
Survey, where we have data on a large number of prescriptions
consumed in both the VA system and non-VA patients. And what I
did was compare the average age of drugs used by VA and non-VA
patients. I define the age of a drug as how many years ago the
active ingredient of the drug was approved by the FDA. In other
words, Lipitor was approved by the FDA in 1996, so at this
point, it is a 13-year-old drug. And I have found very, I
think, compelling evidence that patients that use older drugs
on average tend to have worse outcomes than patients using
newer drugs.
So what I do in this comparison is compare the age of the
drugs used by VA and non-VA patients. And for example, if you
look at the right hand bar, what it shows is that 39 percent of
drugs used by non-VA patients are older than 15 years, whereas
for--I am sorry are less than 15 years old, whereas the
percentage that are less than 15 years old for VA patients is
31 percent. So, in other words, the drugs used in the VA health
system during the period 1999 to 2002 were older than the drugs
used in the rest of the U.S. healthcare system. And in fact,
the age of the drugs was, the relative gap was actually
increasing. That is consistent with the hypothesis that
implementation of the VA National Formulary beginning in 1997
reduced utilization of new drugs in the VA healthcare system.
But what we presumably all care about is outcomes; is
longevity, disability, quality of life and so forth. I have
done a number of studies and some other economists have as well
about the impact of medical innovation and pharmaceutical
innovation in particular on longevity and other health
outcomes. And in this paper, I present some new estimates that
suggest that the use of older drugs in the VA system may have
reduced the life expectancy or mean age of death of VA patients
by about 2 months. Now that doesn't sound like a very
significant number; however, there is other evidence that
suggests that people's willingness to pay, Americans'
willingness to pay to extend their lives is quite high, so the
per-patient value of that reduction in longevity may exceed
$25,000 per person.
I also use demographic data published by the VA to compute
the life expectancy of veterans both before and after the
National Formulary was implemented. And here the picture is the
following, that starting in 1991, from 1991 to 1997, the life
expectancy of American veterans increased by about 3 years.
However, it stopped increasing after 1997 and maybe even
declined a little bit, and that coincides pretty precisely with
the implementation of the VA Pharmacy Benefits Management
System. So I think that that is evidence that needs to be
considered further.
Thank you.
[The prepared statement of Dr. Lichtenberg appears on p.
39.]
Mr. Michaud. Thank you very much, Dr. Lichtenberg.
Mr. Weidman.
STATEMENT OF RICHARD F. WEIDMAN
Mr. Weidman. Mr. Chairman, first of all, I want to thank
you for your leadership in holding this hearing today.
There really are two levels of issues here on the table.
The first is, and the one which our written statement primarily
concerns itself with, is access to getting new medications on
the formulary to begin with. We believe that it is
inappropriate cost management at the cost of proper clinical
care. Many drugs are not making it on. That is a clinical
decision.
And that process by which things go on is a closed process.
In other words, it is not a transparent process. The advocates,
the veterans service organizations, the medical societies do
not have the opportunity to comment. There is no recipient
advisory group that has a chance to have the say for what the
veterans and their families have to say about this; what does
the medical community in general have to say about this?
Cutting to the chase, what we propose and urge you to
consider is moving to introduce legislation that will make the
VA formulary mirror that at U.S. Department of Defense (DoD).
The DoD formulary, everything, as soon as it is FDA approved,
as soon as practical, which is usually a short period of time,
it goes on the DoD formulary or the TRICARE formulary.
The veterans on active duty suddenly shouldn't feel the
pinch that those who are no longer on active duty, either
because they retired or because of longevity or because they
have ended their term of service because they got wounded,
should have the access to the full range of drugs that those on
active duty should have. That is also incidentally an open and
transparent process. It is warned. There are public meetings.
There are minutes, and there are a number of recommendations,
which actually Secretary Shinseki can take even without such
legislation, but we would encourage you to move ahead and to
develop comprehensive legislation in association with your
friends over at the House Armed Services Committee, who are
thoroughly familiar with that process, and move forward to do
it.
One of the fallacies of limiting the formulary is that we
are saving money. We would argue that it is penny wise and
pound foolish. Oftentimes the lack of the proper medication at
the proper time because it wasn't on the formulary leads to all
kinds of healthcare impact that results in sicker patients and
episodes that did not have to happen.
I will use, just as one example, diabetes. And you may
recall that a patient advocate leadership summit last year with
veterans service organizations came together in Washington, and
we focused on four diseases. One of those was diabetes, and
what stunned all of us in the veterans service organization
community is that, in fiscal year 2006, two-thirds of the cost
of care for diabetes went into acute inpatient stays.
Let me say that again: Two-thirds of the total cost of
treating the 1.2 million diabetics who go to the VA for their
healthcare was in inpatient treatment services. What that means
is, when you have to put somebody in the hospital who is under
a physician's care who has diabetes is that you failed. You
have failed big time.
And as a result of that, that is very expensive. It causes
secondary conditions, which leads to amputations of limbs. It
causes all kinds of secondary conditions which are then
themselves service-connected compensable. This is particularly
true for Vietnam veterans, where those of us who served in
Vietnam where diabetes is in fact service-connected
presumptive. That is one level.
I don't have much time to comment on the second level
except to say that the overall management, people are generally
happy with the timeliness of the medications, assuming that
they can get the medications that they need off of the
formulary. But by changing what goes on to the formulary, you
have competent people to manage the system.
But I cannot stress too strongly that while they say that
unions sometimes mirror the worst excesses of the business
industry in which they organize, in this case, the VA has
mirrored the worst in past decade or 15 years of the
pharmaceutical industry, which lost its way for a time and
seems to be finding its way again, where they forgot they were
in the health business. That is the business they are in, in
helping people get well, stay well as long as possible, and
they are not in the cost-containment or selling the most
widgets or having the highest cost reduction on the case of the
government side or their cost margin and profit margin on the
case of the private industry side.
Mr. Chairman, once again, thank you very much for holding
this hearing today. And I would be happy to answer any
questions sir.
[The prepared statement of Mr. Weidman appears on p. 42.]
Mr. Michaud. Thank you very much.
Mr. Bullman.
STATEMENT OF WILLIAM RAY BULLMAN, M.A.M.
Mr. Bullman. Good afternoon, Mr. Chairman, Members of the
Subcommittee.
I am Ray Bullman, Executive Vice President of the National
Council on Patient Information and Education, NCPIE. I have
been asked to testify this afternoon relative to three areas:
one, the broad range of patient medication safety issues; two,
best practices or innovative means that our coalition members
employ to enhance medication safety; and three, how NCPIE as a
multi-stakeholder coalition meets its mission to stimulate and
improve communication of information on appropriate use of
medicines to consumers and healthcare professionals.
I would note at the outset that while NCPIE does not focus
specifically on formulary issues, we recognize the impact that
formulary decision-making plays downstream on patient and
healthcare provider communication, informed decision-making
about therapy choice, and what medication is prescribed and
ultimately to what extent patients effectively self-manage
their medication therapy. NCPIE is, therefore, pleased to help
support the work of the Subcommittee.
In my written testimony, I have outlined specific safety
issues deriving or arising from each of nearly a dozen
medication-use and safety issues that impact medication safety.
If I may, I would address just one of these equally important
and much-entwined medication safety issues as a way of
demonstrating the magnitude of the problem and the vital role
that VA pharmacists can play in addressing it. That issue is
medication nonadherence, which just recently was estimated to
cost the U.S. economy over $290 billion annually or 13 percent
of total healthcare expenditures.
I hold out medication nonadherence by way of example
because it is so multifactoral in its cause and so emblematic
of a wide range of medication-use problems patients experience
beyond simply not being able or willing to follow prescribers'
directions on the vial, for example. For example, it embodies
the challenges of polypharmacy.
During the last decade, the number of medicines available
to treat many chronic diseases has increased. NCPIE supports
and promotes efforts to conduct medication reconciliation that
results in a more complete medication record for providers and
pharmacists, and applauds the Joint Commission for its
leadership and its members working to establish effective
medication reconciliation within the hospital setting and back
out to patients' healthcare providers in the ambulatory care
setting.
Medication nonadherence also brings to the fore issues like
the complexity of the medication regimen, multiple prescribers
who do not communicate amongst themselves, concerns about side
effects and concerns about costs, for example.
In my written testimony, I have described several best
practices programs or policy recommendations that several of
the NCPIE member organizations, mostly pharmacy and patient-
safety groups, advance to enhance medication and patient
safety. These range from collaboratively developed medication-
therapy-management guidelines for pharmacists such as the
American Pharmacists Association and the National Association
of Chain Drugs Stores has developed and produced, for example,
or the establishment of and roles and responsibilities of the
Medication Safety Officer within the hospital setting, or
online medication safety self-assessment tools designed to help
health organizations assess the medication safety practices in
their respective institutions.
Area three is how NCPIE works to meet its mission through
its broad membership. NCPIE works to meet its mission through
both in-house development and implementation of educational
products, programs and services, and through convening or
participating in collaborative programs with both member and
nonmember groups. Each of the following examples enables NCPIE
to promote and disseminate a wide range of educational
resources, including educational videos, medication wallet
cards, personal medication lists, and key questions that each
consumer and healthcare provider should discuss before any
medication therapy is initiated.
We also work through creation of a dedicated reoccurring
event, ``Talk About Prescriptions'' Month, each October, the
purpose of which is to enable high-quality medicine
communication to have its rightful place on the public health
landscape and agenda. This October will mark the 24th annual
``Talk About Prescriptions'' Month. We also work through key
external partnerships with our ``Be MedWise: Safe Use of Over-
the-Counter Medicines Campaign.'' We have collaborated and
partnered with the Food and Drug Administration, the American
Pharmacists Association and the Surgeon General's Office, then
Dr. Richard Carmona, to expand the scope of the campaign.
NCPIE also licenses content, for example, for its ``Be
MedWise'' campaign to two State universities through their
cooperative extension programs for Be MedWise Tennessee, a
statewide initiative, and Be MedWise Arkansas.
We also work through convening expert project advisory
teams. Our most recent product is ``Maximizing Your Role As a
Teen Influencer: What You Can Do to Help Prevent Prescription
Drug Abuse.'' We worked with 14 national expert organizations
on developing that program.
And last, we work with external coalitions. For example, we
are a member of the National Coordinating Council for
Medication Reporting and Prevention and the Safe Medication
Disposal for ME, or Maine, program; we are a member of that
advisory team.
I would thank the Subcommittee for inviting NCPIE to
testify, and I look forward to answering any questions you may
have. Thank you very much.
[The prepared statement of Mr. Bullman appears on p. 46.]
Mr. Michaud. Thank you very much, each of you, for your
testimony, and I do have a few questions.
I will start off with Dr. Hoadley. The Institute of
Medicine (IOM), over a decade ago, came out with a report that
found VA had a responsive process in place for assuring access
to medically necessary drugs to the formulary. Do you believe
that the Institute of Medicine's original findings still apply
today? And if not, do you think they should be updated?
Also, could you comment on Mr. Weidman's suggestion that
the VA should be very similar to what the DoD has in place when
they deal with the formulary?
Dr. Hoadley. To take the second question first, I have not
taken a look at the DoD formulary in my own research, so I
can't speak directly to that.
One question would need be raised in looking at how the DoD
formulary works. To the extent that the TRICARE program is like
the way Medicare drug program works and operates through a
number of private health plans, it is a somewhat different
environment than the VA system, which as an integrated health
system. That means a formulary really works differently.
I think that is an important point to emphasize. In an
integrated system, the idea, if things are working correctly,
is that the physicians have collectively bought into the
formulary. They have some role in helping to plan and have
input into the formulary, and then they are really committing
themselves to prescribing from the formulary where possible and
then getting exceptions where it is needed for particular
patient circumstances. So that is really part of the question
to ask.
In terms of your first question on the IOM study, I think
my findings are generally consistent with what that study found
several years ago, that the VA system does seem to be operating
well; the formulary does seem to be serving the needs of
veterans. And our findings of drugs that are on the formulary
itself and the relative ease with which exceptions seem to be
provided given the numbers of prescriptions for nonformulary
drugs that we identified seem to support that.
I know at the time of the IOM study, there were a couple of
different surveys done of physicians to ask physicians whether
they felt they were able to prescribe adequately from the
formulary and to get exceptions where needed. At the time,
those surveys generally supported that idea. It could always be
helpful to go back and conduct such surveys again to see
whether physicians in the VA system still feel they are able to
get the exceptions when needed and are able to prescribe well
from the formulary.
Mr. Michaud. Thank you.
Dr. Lichtenberg, in addition to your concern with the older
drugs on the VA formulary, do you believe that the current size
of the VA formulary is adequate? Should it be updated to
include newer drugs?
Dr. Lichtenberg. To be quite honest, I have not looked at
the current state of the VA formulary, so I couldn't really
comment on that.
But I would say it is my impression that there have not
been dramatic changes in policy since I did the study in 2005,
and therefore there is, for example, a policy that no drug will
be listed, only under extraordinary circumstances, perhaps
human immunodeficiency virus drugs, within, until 1 year after
it has been approved by the FDA. So there is a general
predisposition against listing new drugs on the formulary. I
think that that policy continues and that it is potentially
having adverse effects on the healthcare of veterans.
Mr. Michaud. Are you familiar at all with the DoD process
in getting drugs on the formulary?
Dr. Lichtenberg. I am afraid that I am not.
Mr. Michaud. Thank you.
Mr. Weidman, you brought up a very good suggestion about
looking at the DoD formulary and the process that they go
through, and reading your testimony I assume that that process
is more transparent than the VA process.
That being said, can you tell me what process a veteran or
someone would have to go through to get a physician to
prescribe a drug that is not on the formulary? Is it a
cumbersome process? Have you heard of any complaints about
counselors getting supervised or reprimanded by the supervisor
if they go off the formulary?
Mr. Weidman. The answer is, it is extraordinarily
difficult. It takes a lot of time. It is a cumbersome process
and deliberately so. And even incidentally for some expensive
drugs that are on the formulary, they will put them on fourth
or fifth screen back and make it difficult for people to access
the more expensive drugs at some stations. And nobody has
really looked at that, and nobody is policing that.
The issue over trying to get medications that are not on
the formulary, that is always VA's rejoinder, is that the
formulary is fine because people can get anything that is not
on the formulary when it is clinically indicated.
But that is just flat not true as a practical matter. We
hear from clinicians all the time both in physiological and in
neuropsychiatry that if they take things and make
recommendations for drugs that are not on the formulary, not
only does it take an enormous amount of time when they are
under pressure to see patients, face-to-face encounters with
patients, but also they get spoken to. They get spoken to
enough times, and they don't, and they are down the road; it is
as simple as that.
And it is clearly a conscious policy. Part of the problem
is the way in which we have misapplied comparative
effectiveness within the VA so that it becomes a race to the
bottom, so that the pharmacy is measured about cost avoidance
below the national mean average. Well, what happens if you have
all 152 stations doing that, of trying to get below the mean
average? Well, it continues to go down. And that is the wrong
measure. What chief pharmacists and all pharmacists ought to be
measured against is how much did you contribute to the overall
wellness of the individual patients at this medical center and
avoid inpatient stays and keep the patient more healthy and
contributing for those of working age to the overall economy.
Those should be the questions we should be asking. And it is
possible to develop metrics that way. People are going to do
what you measure them on. It is as simple as that. And we need
to change the way in which we think about pharmacy at the VA,
and we need to change the way in which VA measures it
internally.
And one last thing, if I may mention on that issue, you
asked about the IOM. We do need to revisit the IOM because what
the IOM said is, there are no good metrics inside the VA to
measure what is going on and to analyze it from the outside.
And that is still the case today. And if they have
measurements, they are refusing to share it with anybody. And
once again, stuff that happens in the back room is where bad
stuff happens. We are a democracy. This should be done out in
the sunshine. And the way in which the DoD process happens is
it is a totally public process with an advisory committee and
with minutes and people can attend, and it is warned in the
Federal Register, et cetera, et cetera. And we need the same
kind of process with the VA and that a lot of the problems, we
believe, if we adopt the DoD policy on formulary will come to,
will go away.
Just one last thing. The theory is that clinical stuff is
taken into account at the VA. And with all due respect, the way
you mentioned before about clinical evidence and it is
collaborative decision of the doctors; well, it is not. It is
not. The green-eyed boys always trump. The cost always trumps
clinical evidence when it comes to putting things on the VA
formulary. So that, even when they are looking through the
molecular entity process that they have set up, they can go all
the way through that and have strong evidence about cost
effectiveness as well as the efficacy of the drug, and then the
formulary people, the pharmacy people can still veto it just on
the basis of cost and impact on the pharmacy. And this is just
not right.
Clinical decisions need to predominate throughout the VA.
And if we can't do that, then we are certainly not delivering
care second to none. One could argue that then it is care
second to all. And that is not the way we should be doing
business, and frankly, we have so many wonderful clinicians in
the VA, if we can fix the system and let them do their job, we
will be care second to none.
Mr. Michaud. Thank you very much.
Mr. Weidman, you mentioned the DoD formulary. Since there
are more drugs on that formulary than on the VA formulary, have
you heard complaints where a servicemember may be using a
certain drug that is on the DoD formulary, moves to the VA
system, and is no longer able to get that medication?
Mr. Weidman. I have, and also our friends in modern warfare
have told me many of those problems as well where people are
kind of stunned because, particularly those that come out of
Walter Reed, and Walter Reed still has some problems
particularly with medical boards and with case management, but
it is overall, you know, a fabulous facility, and all of a
sudden, bang, they hit the VA system back home in Michigan or
Togus or wherever the case may be, and one of the things they
hit is the formulary and difficulties, particularly those who
have traumatic brain injury (TBI) and seizures. It is very
difficult because a lot of those things are not on the
formulary, and therefore, their doctors have to go through
circumlocutions. They can get it. Their VA doctors are willing
to do it, but it is not right that they should jump through
hoops.
Those are the kinds of things that should automatically be
presumed to be in, and we need to balance the system so we go
back to clinical input at every step of the way and achieve a
balance between cost and best clinical care, and currently, we
would argue that cost is trumped all the way down the line on
this one.
Mr. Michaud. Thank you very much.
Mrs. Halvorson.
Mrs. Halvorson. Thank you, Mr. Chairman, and thank you all
for being here.
I have got several questions, and I guess I am not sure
where to start.
First of all, again, the IOM study, actually is in quotes,
where it says that it has a responsive process in place where
assuring access to medically necessary prescription drugs. So--
oh, for exceptions to the formulary. So that actually is said
in the study that was done almost a decade ago, so obviously we
need to look. How do you feel about the fact that that is
actually written in this IOM study that obviously needs to be
taken a look at?
Now, Mr. Weidman, you have said that we need to take a look
at that again. So it is one thing to say we need to take a look
at it and another thing to do it. So what would you suggest,
because you say most of these things are done behind closed
doors, how do you profess that we take this out and do it in
the open? Do another study first? What would be your idea?
Mr. Weidman. Well, the IOM study, by the time you get it
going is going to take a year and a half, and I would suggest
that many of the things in the recommendation section of my
statement, Congresswoman, are things that the Secretary could
start doing right now to open up this process while the
Congress considers whether or not to change the statute and
mirror that which is used by DoD and TRICARE and TRICARE For
Life, that mandating or just requesting with this Secretary, I
think you can just request to him that he contract with the IOM
to do another study.
Now the way in which that RFP or that request for a
proposal is drawn, that contract with the Institute of Medicine
is something that, frankly, the committee should have direct
input in on as well as the veterans service organizations and
other advocates because sometimes those contracts are designed
to make sure that you don't get at what is the part of the
original intent.
And so that would be one way of doing it.
Second I think it would be useful to have the U.S.
Government Accountability Office (GAO) in the short term look
at some of the areas that we know are of concern. As an
example, Alzheimer's drugs, has it had a tremendous negative
impact on people not having the latest Alzheimer's drugs? As
many of you know, some of our older veterans, even some of the
older Vietnam veterans, but certainly the Korean and World War
II vets are subject to Alzheimer's. Nobody has come up with a
cure for Alzheimer's yet, and we are not suggesting that there
is. All you can do is slow it down. So when you slow down those
new medications that are coming on the market and have come on
the market in the last 3, 4, 5 years from being available to
those World War II and Korean veterans, they are never going to
get better after they have--by the time VA puts it on the
formulary, if indeed they ever do under existing circumstances.
So what I am saying is that you can look at that and point
to problem areas with the help of GAO at the same time that you
pursue a study with the Institute of Medicine, ma'am.
Mrs. Halvorson. Great. Thank you. I appreciate your
suggestion.
Mr. Bullman, I know that the VA is not a member of your
group. What kind of suggestions could you give us? Because it
sounds to me like it is a wonderful group to be able to help
our veterans maybe take their medications the right way,
because, first of all, we are talking about the fact that we
are having trouble getting them. But once we get them, we are
finding out that one of the major problems is following up and
making sure that they not only take it, but they take it in the
right doses and finish the medication.
Do you have any suggestions for all of us in order to help
the veterans in our system?
Mr. Bullman. That is a great question, and NCPIE would
certainly invite and encourage the VA to become a member of our
Council, but that said, we work oftentimes with representatives
from VA pharmacy on the various external coalitions, such as
the National Coordinating Council for Medication Error
Reporting and Prevention, for example.
The materials that NCPIE makes available, not just our
brochures and pamphlets and things like that, but reference-
based reports I think would certainly be conducive for helping
to at least raise the issue and the impact of nonadherence.
The best medicine in the world taken inappropriately or
incorrectly will have no impact and leads to the downstream
problems and sequelae that we are talking about here. Our
mantra has been for 25 years, ``Educate Before You Medicate.''
And we provide the educational tools and resources for both the
healthcare team, physician, pharmacist, nurse practitioner,
physician assistant, the questions to ask. But there needs to
be that commitment of a teachable moment at the point of not
just prescribing, dispensing but throughout the patient
pathway, when he or she has the opportunity to either ask
questions, recognizing the reluctance of consumers and patients
who are vulnerable and critically ill often to ask questions.
There needs to be the involved role of the caregiver as well.
So there are no magic bullets here, but there is a lot of
practical hands-on time and involvement.
The art of medicine needs to come back into this. And part
of the art of medicine is communication. So everything that we
do is about moving patient and healthcare providers to an
equally positioned discussion about medicines and safe medicine
use.
Mrs. Halvorson. Thank you.
And thank you, Mr. Chairman.
Mr. Michaud. Thank you very much.
Mr. Snyder.
Mr. Snyder. I just have one question, Dr. Hoadley.
Did you have any response to, there were some comments made
I think that referred to your previous testimony that I didn't
hear? Do you have any comments you want to make about the last
few minutes of discussion of question and answer?
Dr. Hoadley. I think some of the suggestions that Mr.
Bullman was just talking about are great suggestions in terms
of trying to improve adherence, making sure people are well-
informed about the medications they are taking.
On some of the other comments about the formulary and its
treatment of newer drugs, I think a couple of things should be
kept in mind. We really had a number of studies recently that
suggest, for at least some drug classes, some of the older
tried-and-true medications turn out to be just as effective or
even more effective than some of the newer medications. So it
is important to realize that newer does not necessarily equal
better drugs.
Beyond that, I think the question of the ability to get
exceptions from the formulary is really a critical one, and our
numbers suggest we are seeing three-quarters of a million
prescriptions for a nonformulary drug like Lipitor for
cholesterol. There are various numbers that can be looked at,
but in the end, the real question could be served by some kind
of additional study. A survey of physicians is one way to do
that, to simply find out whether the physicians that are
treating the veterans do feel themselves that they are able to
prescribe the drugs that they really want to prescribe and
whether they feel it is as difficult to get exceptions as Mr.
Weidman suggested in his comments or whether the numbers that I
see in terms of the actual number of prescriptions for some of
these nonformulary drugs suggest that they are able to get
prescription exceptions when needed. I think that that is
something that empirical evidence can be brought to, and we can
understand that question better.
Mr. Snyder. Mr. Weidman, what is your sense from veterans
that are in the system--I think you talked about this, too, but
if you would amplify on that. You and I are both Vietnam
veterans. If I were to go down to the VA clinic, I was there a
day or two ago, I mean at the hospital a day or two ago, what
is your sense of how quickly it would take to get a
nonformulary drug approved? I mean, if I am sitting there with
a primary care doctor, is it just a matter of him writing a
special prescription that says ``this drug only'' or----
Mr. Weidman. No, it is not.
Mr. Snyder. What is the length of the approval process and
the length of time? Is it cumbersome?
Mr. Weidman. It depends on the type of drug, and it depends
on how expensive it is, at least that is what I gather from the
outside and talking to clinicians and talking to veterans who
have been told this by their clinician, and some, in some
cases, it can take up to a week or 2 weeks about whether or not
to go with the off-formulary. Some things like the atypicals,
like schizophrenia, they say you have to go for 3 months on the
generics, and then, if it doesn't work, then we will try to use
the atypicals.
Well, you know, it is like what I was talking about before
with the misuse of comparative effectiveness. If you are part
of the 15 percent that the generic does not work as well for,
and your physician has some reason to believe that that is the
case, you are in duck soup, because you can't get this stuff
that you need.
And we have had that experience with diabetes medication
that people were seeing somebody on the outside, and then they
go to the VA because they, typically what happens is the
Vietnam vet who is in-country, finds out that it is service-
connected presumptive or he or she retires or loses their job,
and then they turn to the VA for their healthcare, and then
they discover that the diabetes medication they have been on
for 5 years or 3 years, you can't get at VA, and it is very
hard to get those exceptions.
It took us, I think it was 8 months, 9 months, pressing
hard to get the long-lasting insulins added last year to the VA
formulary, and we had to go with the white paper. And it was
through the good offices of this Committee that it finally got
added on to the formulary, because people couldn't get it,
virtually, by going off-formulary through the process.
Mr. Snyder. Thank you.
Thank you, Mr. Chairman.
Mr. Michaud. Thank you.
Once again, I would like to thank each of you for your
testimony today. There might be some additional questions that
we will ask in writing. Hopefully you will respond in a timely
manner. I really appreciate each of your testimonies here this
afternoon, so thank you.
I would like to ask the second panel to come forward. While
they are coming forward, we have Solomon Iyasu, who is a
Director of a Division within the FDA, U.S. Department of
Health and Human Services (HHS). We also have Belinda Finn who
is accompanied by Irene Barnett, who are both from the VA
Office of Inspector General.
I want to thank all three of you for coming here this
afternoon to give your testimony, and we will start off with
the good doctor.
STATEMENTS OF SOLOMON IYASU, M.D., MPH, DIRECTOR, DIVISION OF
EPIDEMIOLOGY, OFFICE OF SURVEILLANCE AND EPIDEMIOLOGY, CENTER
FOR DRUG EVALUATION AND RESEARCH, FOOD AND DRUG ADMINISTRATION,
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES; BELINDA J. FINN,
ASSISTANT INSPECTOR GENERAL FOR AUDITS AND EVALUATIONS, OFFICE
OF INSPECTOR GENERAL, U.S. DEPARTMENT OF VETERANS AFFAIRS;
ACCOMPANIED BY IRENE BARNETT, PH.D., AUDIT MANAGER, BEDFORD
OFFICE FOR AUDITS AND EVALUATIONS, OFFICE OF INSPECTOR GENERAL,
U.S. DEPARTMENT OF VETERANS AFFAIRS
STATEMENT OF SOLOMON IYASU, M.D., MPH
Dr. Iyasu. Thank you, Mr. Chairman.
Mr. Chairman, and Members of the Subcommittee, I am Dr.
Solomon Iyasu, Director of the Division of Epidemiology within
the Office of Surveillance and Epidemiology for Center for Drug
Evaluation and Research of the Food and Drug Administration.
I am pleased to be here today to discuss FDA's role in
identifying and communicating drug safety issues as well as our
collaboration with Veterans Affairs. FDA is charged by Congress
with the authority to review new drug applications for safety
and effectiveness. Adverse reactions reported during the
clinical trials of the drug are included in the labeling
information.
All drug products contain risks as well as benefits, and it
is often impossible to predict which individuals may have
increased sensitivity to particular drugs. No amount of
premarket study can provide all of the information about the
effectiveness or all the risks of a new drug when it is used by
the general population.
Once FDA approves a drug, the post-market monitoring stage
begins. A drug manufacturer is required to submit regular post-
market reports to FDA. Also, FDA receives adverse-event reports
directly from the public through our MedWatch Program. These
reports are reviewed and analyzed by FDA epidemiologists and
safety evaluators to assess the frequency and seriousness of
the adverse events and to determine their association with
medication usage.
As more becomes known about the potential risks or benefits
of a drug, often its FDA-approved labeling will be revised so
that it better reflects information on appropriate use. If
labeling alone is inadequate to manage risks, additional
actions may include revising drug name or packaging, issuing
``dear healthcare professionals'' letters, disseminating
educational special-risk communications, or requiring
restrictive distribution programs.
FDA uses a broad range of methods to communicate drug
safety information to the public. The different types of drug
safety communication includes labeling, early communications
about ongoing safety reviews, public health advisories,
healthcare professional sheets, and other methods of
communication, such as video broadcasts and conference calls.
Manufacturers also use various methods to communicate drug
safety information. A manufacturer may distribute a ``dear
healthcare professional'' letter to convey important
information regarding the marketed drug.
FDA's Drug Safety Oversight Board was established in 2005
to oversee the management of drug safety issues and
communication to the public about the risks and benefits of
medicines. The board is made up of FDA and medical experts from
other government health agencies and government departments,
including Veterans Affairs.
Along with other FDA colleagues, I am a primary participant
from the Office of Surveillance and Epidemiology (OSE) in
addition to the OSE Director and my counterpart in OSE's
Division of Pharmacovigilance.
Also, the FDA and Veterans Affairs have a memorandum of
understanding (MOU) for sharing information to enhance post-
market surveillance efforts and other drug and vaccine safety
projects. The goals of the collaboration are to explore ways to
promote efficient use of tools and expertise for product risk
identification, validation, and analysis, and to build
infrastructure and processes that meet shared needs for
evaluating the safety, efficacy and use of drugs, biologics and
medical devices.
In August 2008, the FDA and Veterans Affairs signed an
interagency agreement which allowed FDA to provide funding to
Veterans Affairs for work on safety issues of mutual interest.
This agreement allowed funding for personnel time and
programming costs associated with analysis of VA data to
explore questions of interest that were raised by FDA but also
of interest to Veterans Affairs. It is currently in the process
of being renewed for another year.
In September 2007, Congress passed the Food and Drug
Administration Amendments Act, which included new resources for
medical product safety that requires the HHS Secretary to
establish a post-market risk identification and analysis system
to link and analyze healthcare data from multiple sources. The
Sentinel Initiative is FDA's response to this mandate. Its goal
is to build and implement a new active surveillance system that
will eventually use electronic health information to monitor
the safety of all FDA-regulated products.
The Sentinel Initiative is a long-term effort that must
proceed in stages, and this effort is well under way. The FDA
is collaborating with the Federal and private sectors in
various activities that would inform the development of this
system.
In December 2008, the FDA held a public meeting on the
Sentinel Initiative to obtain input from stakeholders about the
structure, function, and scope of the project. The Director for
the Center for Medication Safety of the Department of Veterans
Affairs was among the participants at this day-long meeting,
presenting on the issue of risk communication.
After the initial step of creating the Sentinel System, the
FDA is initiating various pilot efforts to further the science
of medical product surveillance. One of these pilots, known as
Mini-Sentinel II, would include our Federal partners. We look
forward to the VA's participation in this effort. The effort
involves creating a distributed system that will focus on
developing methodologies to obtain more information on emerging
drug safety issues. The Sentinel System will augment the
Agency's current post-market surveillance tools to strengthen
FDA's ability to ensure that safe and effective new drugs are
available to the public, and that the risks of marketed drugs
are well understood.
The FDA has a critical role in the detection and management
of safety issues that are identified after a drug is approved,
including a critical role in communicating information to the
public. Our goal is to make the most up-to-date drug safety
information available to the public in a timely manner so that
healthcare professionals and patients can consider the
information when making decisions about medical treatment. Our
ability to fulfill our mission is enhanced by our partnerships
with patients, physicians, pharmacists, industry, State
regulators and other partners like Veterans Affairs. Together
we can help ensure the safe use of marketed drugs by providing
the best possible information to the American public.
Once again, thank you for the opportunity to testify to the
Subcommittee today.
[The prepared statement of Dr. Iyasu appears on p. 53.]
STATEMENT OF BELINDA J. FINN
Ms. Finn. Chairman Michaud and Members of the Subcommittee,
thank you for the opportunity to be here today and discuss
VHA's accountability for noncontrolled drugs. We have recently
issued two audit reports that address systemic weaknesses at
VHA's medical facilities and consolidated mail outpatient
pharmacies, commonly known as the CMOPs.
Joining me today is Irene Barnett, an audit manager from
our Bedford audit office.
In 2008, VHA medical facilities and the 7 CMOPs dispensed
about 126 million prescriptions and spent $3.7 billion on
pharmaceuticals. About 95 percent of those dollars went for
noncontrolled drugs. Although noncontrolled drugs are not
subject to the stringent inventory and oversight controls, they
are subject to diversion, since they are often expensive, have
a high street value, or contain active ingredients that can be
used to manufacture illicit drugs.
We reported VHA medical facilities and the CMOPs could not
adequately account for their noncontrolled drugs because of
inadequate inventory management practices, recordkeeping, and
inaccurate pharmacy data.
At the CMOPs, we found pill count differences ranging from
a negative of 3,100 pills to a positive 192,000 pills. At the
medical centers we also identified both positive and negative
variances. For example, 24 of 31 medical facilities reviewed
had a positive variance for at least 1 drug. These positive
differences in pill counts are significant because they
represent pills that are available to dispense or divert
without anyone knowing since they don't exist according to the
records.
Physical inventories act as a check on the effectiveness of
other inventory controls; however, the VHA's VistA system
cannot maintain a perpetual inventory that would provide
accurate information.
We also found problems with the recording of drug
transactions. For example, the local pharmacy personnel were
not consistently recording returns to stock from the pharmacy.
Physical security controls were in place at the CMOPs we
visited to prevent the unauthorized physical removal of
pharmaceuticals; however, the inventory systems contained 61
users who could order, receive, and adjust inventories without
any oversight.
Those same CMOP inventory systems contain generic user
accounts that allowed employees to anonymously order drugs,
reduce the inventory balance, and divert the drugs.
Finally, when the physical and the inventory counts don't
match, CMOP personnel simply adjust the inventory balance to
match the physical count.
In 2003, VHA initiated the Pharmacy Reengineering Project
to improve VistA's accountability for drugs. Although this
system development was originally slated for completion in
2005, it has experienced significant delays and is currently
halted for a review.
During our reviews, we recommended the Under Secretary for
Health improve accountability over noncontrolled drugs by
enforcing annual wall-to-wall inventories, establishing better
control over drug transactions, and correcting the CMOP
information security weaknesses.
The Under Secretary for Health agreed with all of our
recommendations and has provided acceptable plans to implement
our recommendations and correct the weaknesses.
That concludes my statement. We will be happy to answer any
questions you may have.
Mr. Michaud. Thank you very much. It has been very helpful.
[The prepared statement of Ms. Finn appears on p. 58.]
Mr. Michaud. Do you believe that the national CMOP remains
the preferred model for acquiring pharmaceutical supplies and
services, and are you aware of whether that is the same process
that the DoD goes through?
Ms. Finn. I can't speak to the DoD process. I know the CMOP
model and the VHA model of a prime vendor to centrally acquire
and distribute pharmaceuticals and supplies has been an
effective model for VHA. It is actually managed and operated
out of the National Acquisition Center, the contracts that
supply the pharmaceuticals and the supplies. And I believe VHA
gets effective pricing, probably about 26 percent better on
pharmaceuticals than other Federal customers.
Mr. Michaud. You mentioned the monitoring of inventorying
for noncontrolled drugs. Do you have a sense of whether this is
an issue in the private sector, and if not, do you think the VA
can learn something from the private sector as it relates to
monitoring their inventorying? Or do you think the
recommendation that you made to the VA would be sufficient to
take care of the problem that is out there?
Ms. Finn. During our review we did speak to pharmaceutical
managers in the private sector, and they did provide monitoring
over noncontrolled drugs that they considered subject to
diversion.
Also, during our review we found a number of VHA pharmacy
managers were monitoring drugs even before our work. And after
we conducted our work and noted the differences between the
physical inventories and the actual drugs on the shelf, many of
those managers took steps to monitor more drugs.
So I think at this point I would consider our
recommendations a good step forward. In a few years perhaps we
will go back and determine whether or not more action is
needed.
Mr. Michaud. Doctor, in your testimony you noted that the
FDA and VA signed an interagency agreement allowing FDA to
provide funds to the VA to work on safety issues of mutual
interest. Can you expand more on this point, and do you have
the same type of agreement with DoD?
Dr. Iyasu. The kind of work that we do under this
interagency agreement is--it comes under the greater umbrella
which is the MOU, the memorandum of understanding that we have
between the FDA, VA, and DoD. We specifically have this
interagency agreement with VA to work on emerging safety
issues, and some of the examples I have included in my written
testimony where rapid analysis can be done of safety
information that is available within the VA system either from
the adverse event reporting system or from their MedSafe
database.
So this is a unique collaboration in terms of having access
to electronic medical record data that VA is uniquely equipped
to sort of amplify on safety issues that we may have a concern
about, and it is also affecting the VA population.
So specific studies are agreed upon where the study
protocols that develop the hypotheses is developed, but the
work is actually done within the VA system while the part about
sharing of the information comes under the MOU, and the FDA may
get information on the aggregate results. And there are
specific examples like working on propoxyphene-containing
products where the VA databases have been very helpful in
informing the regulatory decisions pertaining to the actions
the FDA took.
Mr. Michaud. How does the FDA approve drugs? It is my
understanding you have a committee that looks at drugs and
makes a recommendation whether or not a drug should be approved
by FDA. Or how does that process work?
Dr. Iyasu. The approval process for new drugs is we have
the NDA process for new drug applications. So the companies
have to provide all of the information that has been collected
over the development period, and this starts from the
preclinical period and through the three stages of the clinical
studies.
And so all of the data are reviewed by FDA personnel,
medical officers in all disciplines. And most of the decisions
are based on whether there is adequate information to say that
the drug is safe and effective for its intended use. And this
is done by the collaboration of multiple disciplines, but the
lead responsibility is by the Office of New Drugs, and mostly
within the Center for Drug Evaluation and Research.
So when data are very controversial in terms of the
effectiveness data or the safety data that may be stemming from
the clinical trials, we may seek, also, advice from outside
experts. So we seek advice through the advisory committees that
we have set up for different therapeutic areas.
Mr. Michaud. My last question is, we do not deal with the
FDA in this Committee, but I have heard complaints about FDA's
progress for approving drugs and other issues that deal with
conflicts of interest. I think a couple of years ago a drug--I
think it was Prozac--was placed on the FDA approval list by the
Committee. They have a lot of veterans who are very supportive
of and encourage that; however, there is a concern about
conflict of interest with a certain doctor within FDA.
Recently I read an article dealing with the same issue with
amalgams in mercury and the potential conflict of interest
there as well. And when you look at prescription drugs, there
is big money involved.
How does FDA deal with complaints about conflict of
interest within the FDA, or do you just brush them off?
Dr. Iyasu. That is actually a good question. I am not an
expert in that area of conflict of interest, but I would be
very happy to take back the question and provide more detailed
answers to your concern.
Mr. Michaud. Thank you.
[The FDA subsequently provided the information in a follow-
up letter, dated November 6, 2009, which appears on p. 68.]
Mr. Michaud. Mr. Snyder.
Mr. Snyder. Thank you, Mr. Chairman.
I need you to educate me here. Ms. Finn, is this an
inventory problem, or is it a recordkeeping problem of the--at
the time drugs are prescribed? Where is the accuracy and the
inaccuracy? When you go in and count up the number of drugs and
pills in the storeroom, do we think that is accurate and that
the recordkeeping was wrong, or do we think the recordkeeping
is right, but somehow either too many pills were sent in, or
some were walking out the door in-house? Which is the problem,
or do you know?
Ms. Finn. The problem is we can't tell which is actually
accurate because the physical inventories are different from
the records. We know there are problems with the transactional
records, and we know there are problems with the actual taking
and recording of the physical inventories.
Mr. Snyder. Okay. The problem is on both ends.
Now, if somebody had asked me, you know, an hour ago when I
got to the airport do I think that somebody could make a phone
call to a VA hospital pharmacy and say, you know, how many
Lipitor 40 milligrams were prescribed last year, I would say,
yeah, they can probably do that in an hour. But apparently that
is not right. I thought because of the electronic
recordkeeping, there would be an ability to come up with those
numbers fairly quickly. Is that right or wrong?
Ms. Finn. They may be able to give you an answer. I can't
vouch for its accuracy.
Mr. Snyder. So let us suppose it was inaccurate. Where
would the inaccuracy come from? Prescriptions are written, and
they never get sent to a patient?
Ms. Finn. Part of the problem that we saw is the pharmacy
may dispense pills using a reprint function which may not
actually hit the pharmacy records, so there could be
prescriptions dispensed that aren't being recorded because they
are using an informal method.
Mr. Snyder. Now, in terms of the inventory, you had quite a
range of potential problems, right? Do we think at any time
that this interferes with veterans getting medications? Because
of the inaccuracies or inefficiencies, are sometimes veterans
getting prescriptions, they are told by the pharmacist, well,
this one isn't in, we didn't order it in a timely fashion, or
not?
Ms. Finn. No, sir. We didn't see any evidence of any harm
to veterans because the pills were not available.
Mr. Snyder. I don't mean harm. I just mean inconvenienced.
Ms. Finn. No. None of that either.
Mr. Snyder. So then it becomes an issue of cost.
Ms. Finn. It becomes an issue of cost and accountability.
Mr. Snyder. Thank you, Mr. Chairman.
Mr. Michaud. Once again, I would like to thank the
panelists. They have been very helpful. I look forward to
working with you as we move forward trying to address some of
the concerns that we have heard from the veterans community. So
once again, I thank each of you for coming today.
Our last panel is Mr. Valentino, who is the Chief
Consultant over at the Department of Veterans Affairs. He is
accompanied by Dr. Good and Dr. Tibbits.
I want to thank all three of you for coming forward this
afternoon. I look forward to your testimony.
Mr. Valentino, without any further ado, I would open it up
to you.
STATEMENT MICHAEL A. VALENTINO, R.PH., MHSA, CHIEF CONSULTANT,
PHARMACY BENEFITS MANAGEMENT SERVICES, VETERANS HEALTH
ADMINISTRATION, U.S. DEPARTMENT OF VETERANS AFFAIRS;
ACCOMPANIED BY CHESTER B. GOOD, M.D., MPH, CHAIR, VETERANS
AFFAIRS MEDICAL ADVISORY PANEL, VETERANS HEALTH ADMINISTRATION
U.S. DEPARTMENT OF VETERANS AFFAIRS; AND PAUL TIBBITS, M.D.,
DEPUTY CHIEF INFORMATION OFFICER FOR ENTERPRISE DEVELOPMENT,
OFFICE OF INFORMATION AND TECHNOLOGY, U.S. DEPARTMENT OF
VETERANS AFFAIRS
Mr. Valentino. Mr. Chairman, Ranking Member and Members of
the Subcommittee, thank you for providing me this opportunity
to discuss VA's Pharmacy Benefits Management Services program,
including our national Formulary and patient safety
initiatives.
I am accompanied today by Dr. Chester B. Good, Chair of the
Medical Advisory Panel, and Dr. Paul Tibbits, Deputy Chief
Information Officer for Enterprise Development.
Each veteran enrolled in the VA healthcare system is
eligible to receive prescription medications, over-the-counter
medications, and medical and surgical supplies under VA's
comprehensive medical benefits package.
In 2008, VA provided approximately 126 million outpatient
prescriptions to more than 4.4 million veterans. I can say with
confidence that VA is meeting the pharmaceutical needs of
veterans, and that we are striving every day to provide even
better care to more of America's heroes.
I have some very good news to share. Just last Thursday,
J.D. Powers and Associates, the widely recognized customer
satisfaction and quality analysis firm, released the results of
its third annual pharmacy customer satisfaction survey. This
survey evaluated both community and mail-order pharmacies,
including VA's consolidated mail outpatient pharmacies, or
CMOPs. VA CMOP program ranked third overall for the mail-order
pharmacy category, scoring 875 out of a possible 1,000 points.
Only Kaiser Permanente at 877 points and Prescription Solutions
at 876 points performed better than VA. All three organizations
received the same overall ranking of ``among the best,'' the
highest-ranking designation J.D. Powers and Associates offers.
This is exceptional news, and we thank this Committee and
Congress for making this success possible.
VA's pharmacy benefits program works to enhance the
clinical outcomes and improve the health of veterans through
the appropriate use of pharmaceuticals. This program consists
of six primary specialty areas: the Clinical Informatics
section; CMOPs; adverse drug event reporting; Emergency
Pharmacy Services; VA National Formulary management; and the VA
Center for Medication Safety, or VA MedSafe. I will briefly
explain how each of these programs provides better care to
veterans.
First, the Pharmacy Benefits Management (PBM) Clinical
Informatics section provides operational oversight to the
information systems used by PBM and all VA pharmacies. This
section is responsible for developing the functional
requirements for the Pharmacy Reengineering Project, which,
when completed, will provide a system to enhance patient safety
and encourage the appropriate use of pharmaceuticals by
providing integrated, streamlined decision-making to clinical
staff.
Second, VA operates seven CMOPs that provide prescription
fulfillment services to VA healthcare facilities. CMOPs support
VA's healthcare mission through advanced automated production
technologies to dispense and mail prescriptions to eligible
veterans. This ensures each veteran receives his or her
prescriptions in the most timely, accurate, and cost-effective
manner as possible. Three out of five CMOP performance metrics
currently exceed six sigma performance.
Third, by collecting and evaluating adverse drug events
through VA's Adverse Drug Event Reporting System, VA is able to
identify drug safety signals, assess significance of external
drug safety issues in our own patients, and track trends of
known drug safety issues almost instantaneously. This process
is facilitated by VA's electronic medical record, which links
prescription data to clinical outcomes at the patient level.
Fourth, the Emergency Pharmacy Services section is
responsible for procuring, storing, and maintaining emergency
pharmaceutical and medical or surgical supply items for the
Department. This section works closely with other groups within
VA to ensure we are ready to respond to an emergency with
supplies at VA Medical Center storage sites nationwide. VA can
also deploy mobile pharmacies to provide targeted local
support.
Fifth, VA's National Formulary was consolidated into a
single formulary in 2009. VA experts monitor the medical
literature, scientific research and VA outcomes data to
identify evidence that may support adding drugs to or deleting
drugs from the formulary, and by drafting evidence-based
prescribing guidance. VA develops guidance on the pharmacologic
management of common and high-cost diseases and collaborates
with clinical experts within the Department to develop or
refine guidance when necessary.
Finally, VA MedSafe is a national comprehensive
pharmacovigilance program that emphasizes the safe and
appropriate use of medications. VA strives to ensure that
veterans receive the right medications in the right dose at the
right time. VA is frequently cited as a leader in the field of
pharmacovigilance by some of the leading experts in the field,
and currently has a formal collaboration agreement with the
Food and Drug Administration and the Department of Defense in
this important area.
Mr. Chairman, VA has developed a remarkable pharmacy
benefits management system that provides veterans safe and
effective medication to improve their healthcare. Our National
Formulary is based on the best clinical research and leverages
the size of our patient population and the Department to
procure medications at a low cost.
Thank you again for this opportunity to testify, and my
colleagues and I are prepared to answer your questions.
Mr. Michaud. Thank you very much, Mr. Valentino. I
appreciate your coming here today.
[The prepared statement of Mr. Valentino appears on p. 61.]
Mr. Michaud. You sat through the first panel and the second
panel, and you heard some of the concerns raised by both
panels. And one of the concerns is the fact that formulary
decisions are not conducted in a transparent process, they are
made behind closed doors. With the administration's commitment
to transparency, what are your comments on how you can make the
process more transparent? Are you familiar with the DoD
process? What is wrong with having the same system as the DoD
that is transparent compared to the VA system?
Mr. Valentino. I am familiar with the DoD process.
We do have a fair amount of transparency in our process. We
develop our evidence-based documents, literature reviews, drug
class reviews. We vet them internally. Everyone has a bite at
the apple in VA, frontline clinicians, physician managers. We
send them out far and wide for comment before we finalize those
documents which ultimately are posted on our Web site and then
are accessible by the public for further comment and feedback.
We use VA physicians and VA pharmacists to manage the
formulary process. Cost is really not considered until the very
end of the process. We spend a lot of time focusing on safety
primarily and efficacy of the products that we review. Cost is
certainly a consideration, but it is only considered at the
very end and certainly does not trump safety and efficacy.
In regards to getting input, there are a lot of meetings
that are held at the local and regional level with veteran
service organizations regarding the formulary. I think there is
a lot of collaboration and a lot of communication that takes
place at that level which does filter up to our level.
So we are always ready to receive comments, to work with
folks about the formulary issues. We don't seem to get that
many comments about the decisions that we have made. As Dr.
Hoadley testified, our physicians seem to be fairly happy with
the process and their access to nonformulary drugs. If we
believe that J.D. Powers survey, our patients appear to be
pretty happy as well. VA pharmacy usually scores pretty high in
our internal customer surveys, so we believe we do have a
fairly open process.
Mr. Michaud. Do you think the reason why you don't get very
many comments, from what I heard from earlier panels, is
because it is a secretive process? I don't know the DoD
formulary process, but would you be opposed to having VA go
through that same process, because that appears to be more
transparent than what VA is going through. If not, what are
your objections to the DoD process?
Mr. Valentino. I have not studied the DoD process in
detail. I know they have a Beneficiary Advisory Panel that is
advised of the decisions after the executive committee makes
their decisions.
I would be very happy to consider such a proposal for VA.
Mr. Michaud. When you look at what our soldiers are
currently going through today in Iraq and Afghanistan, TBI. We
heard from Mr. Weidman earlier that seizure medications are not
part of the formulary. I find that astonishing since this is a
signature wound of the war in Iraq and Afghanistan. Is that
correct, and if so, why wouldn't that be on the formulary since
we are hearing so much about TBI and post-traumatic stress
disorder?
Mr. Valentino. We do have a large number of seizure
medications on the formulary. We review all new drugs as they
are approved by the FDA. Frequently it takes a little bit of
time before we get published information in the literature so
we can make a better assessment of the safety and efficacy. But
we do--I believe that we do have a very good selection of drugs
for seizures on our formulary currently; and importantly, if we
don't have one that somebody needs, it is available through the
nonformulary process. Our policy requires that we adjudicate
those nonformulary requests within 96 hours. And we have our
various sites report that information to us quarterly. So we do
have a fairly rapid way of doing that.
Our policy also says if you need the drug urgently, the
time period to get it is immediately. We don't rely on the 96
hours. So typically that would occur in the inpatient setting.
But for out-patient drugs where someone needs to switch from
one drug to another, that typically happens rather quickly.
I would ask my colleague to comment further on the
antiseizure medications.
Dr. Good. I think also was mentioned atypical
antipsychotics, that they weren't on the formulary, and I
believe most of the atypical antipsychotics are on the
formulary and are used in these patients with TBI. And we have
a wide variety of antiseizure medications.
Mr. Michaud. I believe in Mr. Weidman's testimony, though,
he mentioned how difficult it is to get drugs off the
formulary. That is a big concern that I have, plus the fact
that there are a lot more drugs on the DoD formulary. For
instance, you may have a soldier at Walter Reed who is on
medication, on drugs that are not on the VA formulary, then
they get transferred over to the VA system. Have you run into
problems in that particular area as well?
Mr. Valentino. Early on we heard of some issues with
veterans who are on convalescent leave. They are still on
Active Duty, and they were receiving care at a VA close to
their residence. They were coming to us on very sophisticated
pain medications that were given by a pump with special tubing,
special concentrations of medications. It did take us just a
small bit of time to become accustomed to that equipment, get
the necessary supplies in.
At that time we did communicate with the field, and we
advised them that patients who fit into this category, they are
on convalescent leave; they are just getting their care at the
VA; they need to get whatever they are on regardless of whether
it is on the formulary or not on the formulary, no questions
asked. And I have not heard of any problems in that area since
that time.
Mr. Michaud. Mr. Perriello?
Mr. Periello. Thank you, Mr. Chairman.
Congratulations on the J.D. Powers and Associates ranking,
and I think there are some signs of progress and success that
are encouraging, but also obviously some concerns. One of
particular interest to my heavily rural district is access to
care. I wanted to hear a little more about the policy rationale
for the VA not filling prescriptions by non-VA doctors and what
some of the rules are for that. This is especially burdensome
for rural veterans who have to travel a long way to get these
prescriptions signed.
Mr. Valentino. Thank you.
There are a small number of prescriptions that we can fill
for--written by non-VA doctors, the CHAMPVA program is one
example, Aid and Attendance is another example, fee basis is
another example. But by and large, it has to do with the makeup
of our process.
As Dr. Hoadley testified, we offer a prescription benefit
as part of an integrated comprehensive medical care model. Our
prescription benefit is not an add-on, it is not a stand-alone
program, and that is a clear difference between some other
programs where you can just send in your prescriptions. We
believe that to do so, to provide prescriptions in that manner,
would possibly compromise the quality of care, because we don't
have the complete picture in regards to what that patient might
be getting from various sources; not just from our pharmacies,
but from other pharmacies.
We do have programs with some of our contracted CBOCs in
the rural areas so that patients can get their prescriptions
filled at a community pharmacy under contract at VA expense,
and then refills are sent to them via mail through our
Consolidated Mail Outpatient Pharmacy program.
Mr. Periello. Is there room to expand on any of those or
otherwise improve? I mean, while protecting the quality of care
arguments and wanting the comprehensive sense of a medical home
and all of the factors for a VA patient, isn't there something
between where we are now and those concerns where we could see
greater expansion of non-VA filling of prescriptions and the
like?
Mr. Valentino. I am sure anything is possible. We did have
a program for a few years called the Transitional Pharmacy
Benefit Program, and it was designed to ease the out-of-pocket
cost for patients who were waiting more than 30 days for their
initial primary care appointment. We found that it was
extremely difficult to administer our program under that model
because of the unfamiliarity of the prescribers with our
formulary. We also found that the number of eligible patients
who could participate as compared to those who actually did
participate was low. In other words, not very many people took
advantage of that program.
So to answer your question, yes, I think that there are
lots of alternatives that we could consider.
Mr. Periello. Are there particular barriers to doing it
that are ones where we would need to be involved, or is this a
matter of piloting some of these potential other ideas?
Mr. Valentino. Well, one of the big issues has to do with
the electronic medical records. That is really a huge safety
tool for us. Our prescribers are able to order medications
electronically. They are reviewed by a pharmacist. We check to
make sure the right dose is there, that the patient isn't on
other medications.
So if we were to start to fill a lot of prescriptions from
non-VA providers, we would lose that important safety
mechanism. That would cause us concern over the safety of the
product that we are dispensing. In other words, is it the right
drug for that person, is it going to interfere with other drugs
that he may be getting?
Mr. Michaud. Thank you very much, Mr. Perriello, and also
for your leadership on veterans issues. We really appreciate
your tenacity in making sure we take care of our veterans. So
thank you.
Just a couple more questions, Mr. Valentino.
I don't know if you had a chance to read the Inspector
General's report issued in June of 2009, the audit report. What
steps has the VA taken to address the issue that was addressed
in that report regarding the noncontrolled drugs and the CMOP
contract?
Mr. Valentino. We looked at each of the six
recommendations. We concurred with the recommendations. We have
drafted a policy regarding the inventory controls over
noncontrolled medications. We have communicated our
expectations verbally on a number of conference calls, a number
of e-mail bulletins that we sent out. So we have told people
what we want them to do.
We have developed a policy that is currently under review
in the concurrence process. That is, our short-term or our
interim solution is to just try to do more education, try to
develop the policy. We also are working with the network office
to have the System-wide Ongoing Assessment and Review Strategy
(SOARS) teams that go out and do assessments and take a look at
this particular area, make sure all of the policies are being
followed.
Our long-term solution has to do with the pharmacy
reengineering effort and some of the requirements that we have
developed for inventory management.
So that is really where we think we are going to make the
most gains. We have a lot of remote dispensing cabinets within
VA. We want to be able to get the inventories in those cabinets
rolled up along with the outpatient inventories, the
intravenous inventories, the unit dose inventories, into a
single place, and that will give us the ability then to match
what we purchase with what we dispense.
And as we heard earlier, you really need to monitor
everything basically. You need to have a perpetual inventory
system if you want to have more confidence in the process.
Mr. Michaud. You heard Dr. Lichtenberg's testimony, in
which he explained that older drugs on the VA formulary result
in shorter lives for our veterans. Any comment on that?
Mr. Valentino. Yes, I do have some comments. And if I may,
I have a couple of posters that I would like to share that
helps illustrate that.
This is a graph from the report that was mentioned, and it
shows the veteran's life expectancy versus life expectancy at
birth of all U.S. males. And when you look, everybody I have
showed this to says, Oh, my word, veterans are not living as
long as their counterparts. Well, there are a couple of
problems with that.
You will notice there are two Y axes here. So we have
corrected this chart to show what it would actually look like
if you put everything on the same axis.
I would also point out that the veterans used in this study
are all U.S. veterans; not veterans that get care at VA, not
veterans that are enrolled in VA, all veterans. So we have some
concerns.
This is actually what we believe is the true picture. In
fact, veterans--and again, these are not veterans that receive
care in VA. This is the same data. They actually live longer
than their counterparts. So I wanted to show this to illustrate
some of the concerns that we have with the report.
There are a number of issues. We have not had a 1-year
moratorium on drugs since 2000. And also, as Dr. Hoadley
pointed out, formulary status does not imply access. We have a
large number of drugs that we dispense on a nonformulary basis.
I ran a list of drugs where we have more than 100,000 30-day
equivalent prescriptions. Looked at a 12-month period, we
filled almost 9 million nonformulary, 30-day prescriptions.
That is out of 237 million 30-day equivalent prescriptions. So
roughly 4 percent of our utilization is for nonformulary drugs,
and that represents about 9 percent of our total cost. So
formulary status does not equal access.
Our nonformulary status is very similar to prior
authorization or step therapy that you see on other formularies
where these drugs are in the second or third tiers.
There are also drugs listed as examples in the report that
were withdrawn from the market for safety reasons prior to the
report being written. There are also drugs listed that were
listed as nonformulary that were on formulary.
So we do not agree with the conclusions in the paper
whatsoever.
Mr. Michaud. The VVA actually came up with several
recommendations in their testimony. I do not know if you had a
chance to review those recommendations. If so, would you care
to tell the Committee whether you agree or disagree, and, if
you disagree, why? And if you can't do it today----
Mr. Valentino. A couple of points.
We certainly appreciate the comments, and we truly are
interested in anything that can make our system better.
A couple of points that I would point out is regarding the
diabetes care, actually in VA diabetes care is very, very good.
There are some articles by Kerr that point out that VA care is
cost-effective and high-quality as compared to other systems.
The only other thing that I would point out is that we do
have some performance metrics, as was mentioned, that are
pharmacy related. So we have got performance metrics on
diabetes; we have got performance metrics on cholesterol, on
hypertension, and in these, when compared to Medicare,
Medicaid, and private programs, VA is often the leader in those
areas. So we do believe in performance metrics. We absolutely
agree that people will perform when you ask them to do
something and they know they are measuring it.
The other point is that in regards to the cholinesterase
inhibitors, which is the primary drug class used for dementia,
Alzheimer's, we currently have two of the three drugs available
on the National Formulary, and as with all drugs, if the third
one is needed, is medically necessary, there is a process to go
through to obtain that.
One example that I think is really--really illustrates
quite nicely how cost can be a factor or cannot be a factor is
drug treatments for wet AMD, and this is a condition where the
macula in the eye--I should probably let Bernie talk about it.
You get a proliferation of blood vessels, and it causes you not
to be able to see. There are some anticancer drugs that work
very well. One is approved by the FDA for this indication, very
expensive; the other is not approved by the FDA for this
indication, but seems to work well, seems to be safe. It is
pennies compared to thousands.
In VA we have made the decision that we are going to go
with the FDA drug which costs--go ahead. You talk about it.
Dr. Good. The drug is FDA-approved for treatment of macular
degeneration, which is a leading cause of blindness in the
elderly.
So we made the decision because evidence--the evidence
supported use of Lucentis, and even though we were getting
calls to use Avastin instead, because it was quite a bit
cheaper, because the evidence supported--in the literature
supported--and that is our approach, to live and die by the
evidence, what we think will best help the veteran. And in this
case we thought that by far the more expensive drug for the
same indication was what was in the best interest of the
veteran.
So this decision made several years ago, which stands
today, was to mandate use of Lucentis rather than the far, far
cheaper Avastin.
Mr. Michaud. My very last question. Why did the VA allow
the directive on drug accountability software to lapse in 2003?
Mr. Valentino. We have incorporated a lot of our directives
into handbooks that are based on themes, National Formulary
handbooks, different kinds of handbooks.
We looked at that particular requirement, and we found that
although it may seem like it really adds to the security, in
fact all it does is tell you about those drugs that you are
looking at, as we heard from the OIG. If folks tend to know
where you are looking, they go other places.
So we had fully anticipated that we would have the
perpetual inventory process in place by now, And so we didn't
feel that that requirement should be continued in policy.
Mr. Michaud. Thank you.
Any additional questions?
Once again, Mr. Valentino, I want to thank you and Dr.
Tibbits and Dr. Good for coming today, as well as the previous
two panels with us. It has been very helpful, and we really
appreciate it and look forward to working with you to try to
address some of the concerns that I heard.
We will adjourn the Subcommittee hearing.
[Whereupon, at 3:45 p.m., the Subcommittee was adjourned.]
A P P E N D I X
----------
Prepared Statement of Hon. Michael H. Michaud,
Chairman, Subcommittee on Health
The Subcommittee on Health will now come to order. I would like to
thank everyone for attending this hearing.
The goal of today's hearing is to determine whether the VA is
meeting the pharmaceutical needs of our veterans. We are conducting
this hearing because of the concerns that I have heard from our
veterans about proper access to non-formulary prescription drugs,
concerns about adverse drug interactions and patient safety, and recent
reports by the Office of Inspector General citing the need to better
manage certain aspects of the VA's pharmacy benefits program.
When properly designed and implemented, formularies can promote
drug therapy that is rational, clinically appropriate, safe, and cost-
effective. However, patient care may be compromised if a formulary
system is not developed and administered so that individuals can access
the drugs that they need. I have heard from veterans who have voiced
their frustration with the VA national formulary as being too
restrictive to the point that accessing appropriate drugs is a barrier.
Some veterans have pointed to a flawed, subjective system for securing
non-formulary drugs. For example, a veteran who is denied access to a
non-formulary drug at one VA medical center may be approved in another
medical center, which suggests that the decision may not be based
entirely on clinical factors.
I also have concerns about patient safety and whether we are doing
enough to prevent adverse drug events. Among the medication errors
leading to adverse drug events are missed doses, duplicate therapy,
drug to drug interaction, inadequate monitoring, and preparation error.
For example, what is the VA doing to prevent adverse drug events and
are they coordinating well with the FDA? What steps is the VA taking to
ensure that veterans do not accidentally take their prescribed medicine
in wrong doses or do not forget to take their medicine at the right
times? Also, how does the VA make sure that they catch potentially
adverse drug interactions when veterans get their prescriptions filled
both at the VA and at private pharmacies?
Finally, the recently released audit reports from the Office of
Inspector General raise concerns about the VA's management of non-
controlled drugs and the Consolidated Mail Outpatient Pharmacy (CMOP)
contract. Efficient management of the CMOP contract is critical because
almost 80 percent of all VA pharmaceuticals are dispensed using the
CMOP.
We have our panels of expert witnesses to help us explore these
issues today. I look forward to hearing their testimonies.
Prepared Statement of Jack Hoadley, Ph.D., Research Professor,
Health Policy Institute, Georgetown University, Washington, DC
Good morning Mr. Chairman and Members of the Subcommittee. My name
is Jack Hoadley, and I am a Research Professor at Georgetown
University's Health Policy Institute. As a long-time analyst of issues
surrounding prescription drug coverage, I have conducted a variety of
research projects with regard to formularies and other approaches to
managing the use of prescription drugs in Medicare, Medicaid, the VA,
and private-sector health plans. I appreciate the opportunity to speak
to the Subcommittee on these important issues.
During congressional debates over the Medicare Part D prescription
drug benefit, the role of the VA National Formulary has been commonly
invoked. Some have pointed to the role of the VA Formulary in helping
to achieve low prices for the VA, whereas others have made the claim
that access to drugs is more restricted in the VA system compared to
private plans, especially the private plans offering drug coverage
through Medicare Part D.
A report prepared in December 2006 for the Pharmaceutical Research
and Manufacturers of America (PhRMA) concluded that ``the application
of a VA-style formulary process to the Medicare prescription drug
program would significantly reduce physician and patient choice of
drugs,'' and that ``a reduction in choice of prescription drugs could
be of special concern for the Medicare population.''\1\ In an April
2007 memo, Greg D'Angelo of the Heritage Foundation wrote that ``if
Congress fixes prices in Medicare and establishes a restrictive
national formulary, the program would be less responsive to the diverse
and ever-changing needs of beneficiaries.''\2\ As a result of those
statements, my colleagues and I decided to shed further light on these
issues by conducting an objective comparison of the VA National
Formulary to formularies used by Part D plans.
---------------------------------------------------------------------------
\1\ ``Comparison of Compounds on the Formularies of Medicare
Prescription Drug Plans (PDPs) and the Department of Veterans Affairs
Veterans Health Administration (VA) National and Regional
Formularies,'' prepared for the Pharmaceutical Research and
Manufacturers of America by Covance Market Access Services Inc.,
December 2006.
\2\ Greg D'Angelo, ``The VA Drug Pricing Model,'' The Heritage
Foundation, 11 April 2007.
---------------------------------------------------------------------------
We examined a sample of 160 commonly prescribed drugs and compared
their status on the VA National Formulary to comparable unrestricted
coverage for a variety of Medicare Part D plans. In general, we found
that the VA listed fewer drugs on formulary, but our analysis of off-
formulary prescribing at the VA suggests that this does not translate
into less access to the drugs than exists under Medicare Part D.
Background
Formularies were used by veterans' medical centers as early as 1955
to help manage pharmacy inventories. In 1995, the VA took steps to
consolidate its bargaining power with drug makers and thus reduce
spending. It combined the formularies of local VA medical centers to
create a single formulary in each of 21 Veterans Integrated Service
Networks (VISNs). Two years later, it implemented a national formulary,
and by 2007 the VA had completed the process of phasing out the VISN
drug lists, making the national formulary the definitive and only VA
drug list.\3\
---------------------------------------------------------------------------
\3\ GAO, ``VA Drug Formulary: Better Oversight is Required, but
Veterans Are Getting Needed Drugs,'' Report to the Ranking Member,
Senate Committee on Veteran's Affairs, January 2001. Donna Young,
``VA's 10-Year Journey to One Formulary Concludes,'' American Journal
of Health-System Pharmacy, 64 (15 March 2007): 578-580.
---------------------------------------------------------------------------
The VA National Formulary functions somewhat differently than most
formularies maintained by private organizations. Since the VA is an
integrated system - meaning that veterans go to VA facilities to see VA
doctors and fill prescriptions at a VA formulary - the VA has a great
deal of leverage to promote the use of a single formulary within its
facilities and patient pool. This distinguishes the VA formulary from
those used by most private insurers. In most private plans, a drug's
formulary status might not be known by a physician when a prescription
is written, but instead only determined at the point of sale by the
pharmacist, when the patient brings a prescription to be filled at the
local pharmacy. In those cases, the prescribing physician has no
particular relationship with the insurer or health plan. The VA system
is more like group and staff model HMOs such as Kaiser Permanente,
where the formulary is viewed as a clinical tool to be used by
physicians, rather than an enforcement tool of the plan applied at the
pharmacy.
The VA National Formulary is managed by practicing VA physicians
and regional formulary managers and takes into account safety,
efficacy, and cost in deciding what drugs to list on the formulary. As
part of the process, VA clinicians have an opportunity to provide input
on the decisions, which helps to create a sense of buy-in for them. In
addition, VA physicians and pharmacists prepare comprehensive written
reviews that summarize recent published research on the safety and
efficacy of drugs in specific drug classes. These reviews may be used
to make recommendations on a drug's status within the formulary. For
example, a 2003 review of oral bisphosphonates (typically used to treat
osteoporosis) concluded that since Fosamax and Actonel ``produce
similar results . . . the VHA should consider these two drugs
equivalent clinically, and choose one for use based on best value.''\4\
---------------------------------------------------------------------------
\4\ Marc C. Geraci, ``Drug Class Review Oral Bisphosphonates in the
Treatment of Osteoporosis,'' VHA Pharmacy Benefits Management Strategic
Health care Group and the Medical Advisory Panel, September 2003.
---------------------------------------------------------------------------
The VA considers some classes ``closed,'' that is, drugs in that
class are only covered if they are listed on the formulary. Generally,
only a few drugs in a ``closed'' class are listed on the national
formulary. The VA justifies the exclusion of others on the grounds that
they are therapeutically interchangeable - ``equivalent in terms of
efficacy, safety and outcomes'' - to the drugs on the formulary. The VA
can then obtain lower prices for on-formulary drugs through competitive
contracts by committing to use them whenever clinically appropriate.\5\
Most often, these are classes where multiple brand-name drugs are
available, but few or no generic alternatives. Drugs in other classes
may have restrictions, meaning that physicians are encouraged to
prescribe certain ``preferred'' drugs in that class over others.\6\
Such restrictions are used both to create leverage in negotiating
prices and to restrict inappropriate use of certain drugs.
---------------------------------------------------------------------------
\5\ GAO, ``VA Drug Formulary: Better Oversight is Required, but
Veterans Are Getting Needed Drugs.''
\6\ Institute of Medicine, Description and Analysis of the VA
National Formulary (Washington: National Academic Press, June 2000).
---------------------------------------------------------------------------
According to the VHA, drugs not listed on the national formulary
may be prescribed through a non-formulary request process designed to
ensure timely, evidence-based decisions. Non-formulary drugs may be
approved for use by a patient if:
1. Formulary agents are contraindicated;
2. Formulary agents have caused adverse reactions;
3. All formulary alternatives have demonstrated therapeutic
failure;
4. No formulary alternative exists; or
5. ``The patient has previously responded to a non-formulary
agent and risk is associated with a change to a formulary agent.''
Through this process, drugs not listed on the VA formulary can be
prescribed. An informal survey by the VA pharmacy benefit manager in
1998 found that ``88 percent of waiver requests [for non-formulary
medications] were approved.''\7\ Nevertheless, VA formulary compliance
is very high. The VA estimates that overall use of drugs not on the
formulary is about 5 percent. This high compliance, especially for the
closed classes, is aided by the sense of buy-in by VA clinicians and
the reliance on clinical evidence as a key component of the decision-
making process. Adherence for a closed class sometimes reaches 90
percent within 3 months of a formulary change and over 98 percent
within 6 months.\8\
---------------------------------------------------------------------------
\7\ IOM, Description and Analysis of the VA National Formulary.
\8\ Michael Valentino, ``Overview of the VA Pharmacy Benefits
Management Strategic Health Care Group (PBM),'' presentation to the
American Enterprise Institute, 19 January 2007.
---------------------------------------------------------------------------
Several studies over the past decade have asked whether the VA
National Formulary too strictly limits the prescription drugs available
to veterans. After a 1999 report by the House Committee on
Appropriations raised such concerns, a mandated report by the Institute
of Medicine, released in 2000, concluded that ``the VA National
Formulary is not overly restrictive, and the limited available evidence
suggests that it has probably meaningfully reduced drug expenditures
without demonstrable adverse effects on quality.'' The reviewers also
found, however, that the National Formulary lacked ``essential systems
to assure that new drugs are expeditiously reviewed'' and that more
needed to be done to ensure ``that a responsive process for assuring
access to medically necessary exceptions to the formulary is
consistently in place.''\9\
---------------------------------------------------------------------------
\9\ IOM, Description and Analysis of the VA National Formulary.
---------------------------------------------------------------------------
In 1999 and 2000, the VA commissioned two independent surveys of VA
prescribers' perceptions of the VA National Formulary. The first survey
identified a subset of physicians who believed this formulary was more
restrictive than most in the private sector or that it impinged on
providing quality care to their patients. But nearly two-thirds thought
they were able to prescribe needed drugs and that their patients could
obtain nonformulary drugs when needed.\10\ Respondents to the second
survey also indicated general satisfaction with the formulary and
agreed that it was important for containing costs and ensuring good
value. Although they reported that roughly 90 percent of waiver
requests for off-formulary drugs were approved, about one-third of the
physicians indicated that approvals took 3 days or longer.\11\ In 2001
the Government Accountability Office told the Congress that
``prescribers reported that the national formulary generally contains
the drugs their patients need or, when necessary, prescribers can
usually get non-formulary drugs.''\12\
---------------------------------------------------------------------------
\10\ Peter A. Glassman et al., ``Physician Perceptions of a
National Formulary,'' American Journal of Managed Care 7:3 (March
2001), pp. 241-251.
\11\ Peter A. Glassman et al., ``Physician Satisfaction with
Formulary Policies: Is It Access to Formulary or Nonformulary Drugs
that Matters Most?'' American Journal of Managed Care 10:3 (March
2004), pp. 209-216.
\12\ ``VA Drug Formulary: Better Oversight is Required, but
Veterans are Getting Needed Drugs.''
---------------------------------------------------------------------------
In a 2005 report, economist Frank Lichtenberg concluded that the VA
was tardy in its addition of newly FDA-approved drugs to the VHA
formulary, and noted ``that only 19 percent of the drugs approved since
2000 were on the VHA formulary.''\13\ Lichtenberg attributed the use of
older drugs in the VA formulary to a reduction in veterans' mean age of
death, by 2.04 months. But Lichtenberg's report was rebutted by the
VA's Michael Valentino in a 2007 presentation.\14\ He offered evidence
that veterans experienced greater life expectancies at birth than other
populations. Arguing that ``newer is not always better,'' he pointed
out that ``many `new' drugs are actually `me too' drugs'' that are
essentially the same as - and not necessarily more effective than -
treatments already on the market. Valentino also noted that 23 new
drugs (including some that Lichtenberg lists as not covered by the VA)
were taken off the market for safety reasons between 1980 and 2005, and
concluded, ``what is the rationale for exposing patients to drugs with
unknown risks, when there is little or no clinical advantage?''
Valentino insisted that the ``VA reviews all new molecular entities for
consideration for national formulary listing in a timely fashion,'' and
that it based its decisions on cost and efficacy data.
---------------------------------------------------------------------------
\13\ Frank R. Lichtenberg, ``Older Drugs, Shorter Lives? An
Examination of the Health Effects of the Veterans Health Administration
Formulary,'' Center for Medical Progress at the Manhattan Institute,
October 2005.
\14\ Michael Valentino, ``Overview of the VA Pharmacy Benefits
Management Strategic Health Care Group.''
---------------------------------------------------------------------------
Comparing VA and Medicare Part D Plan Formularies
To compare the VA National Formulary with those offered by the
Medicare Part D prescription drug plans, my colleagues and I focused on
a pre-selected sample of 160 drugs representing more than half the
prescription volume for Medicare beneficiaries. The sample includes all
drugs in 14 drug classes, as well as other commonly prescribed drugs,
and has nearly equal numbers of generic (n=76) and brand-name (n=84)
medications.\15\ For Medicare, our analysis covers 47 standalone
prescription drug plans offered on a national or near-national basis in
2007, as well as two formularies offered in different regions by a
group model HMO participating in the Medicare Advantage program. We
considered the number of plans that listed a drug, whether the drug was
placed on a generic, preferred, or specialty tier, and whether the drug
was restricted through any utilization management tools (prior
authorization, step therapy, or quantity limits). For the VA, the
analysis considered whether a drug was listed on formulary and the
yearly volume of prescriptions written for that drug.\16\
---------------------------------------------------------------------------
\15\ For more details on our sample of drugs, see Jack Hoadley et
al., ``An In-Depth Examination of Formularies and Other Features of
Medicare Drug Plans,'' Henry J. Kaiser Family Foundation, April 2006,
and Jack Hoadley et al., ``Benefit Design and Formularies of Medicare
Drug Plans: A Comparison of 2006 and 2007 Offerings - A First Look,''
Henry J. Kaiser Family Foundation, November 2006.
\16\ Data on whether a drug is on the VA National Formulary and its
restrictions were obtained from the VA's Web site (January 2007
version). Information on the prescription volume was provided to the
authors by the VA. The VA's formulary lists all drugs by chemical name;
thus we assumed that when both a generic and a brand-name version of a
particular chemical exist, only the generic version is listed.
---------------------------------------------------------------------------
A simple count of the 160 sample drugs on the VA formulary suggests
that it lists fewer drugs (82 drugs) than any of the national or near-
national Part D plans (median number of drugs listed = 136; minimum =
99). However, there are key reasons that make this simple accounting
misleading. First, veterans have unrestricted access to all drugs
listed on the VA formulary and access to additional drugs if they seek
authorization. By contrast, Part D plans include drugs on their
formularies that may only be available to beneficiaries subject to
utilization restrictions, such as prior authorization, step therapy, or
quantity limits. In the VA system, patients only need to seek prior
authorization or undergo step therapy for drugs not listed on the VA
National Formulary.
The TNF Inhibitor class, which includes three expensive specialty
drugs primarily used for treating rheumatoid arthritis (Enbrel, Humira,
and Remicade), illustrates this dynamic. Neither the VA nor the median
Part D plan covers any of these drugs outright. In the VA, the drugs
are considered off formulary, but they are available when patients or
their doctors request authorization. Most Medicare drug plans list
these three drugs on formulary, but require prior authorization before
the drug is actually covered. In these two situations, patients face a
similar level of restricted access, but the formulary status is
different.
Second, many Part D plans list drugs on a ``non-preferred'' tier
with a higher level of cost sharing. This system creates a financial
incentive for beneficiaries to adhere to their plan's formulary, even
when their doctor may not know which drugs are preferred or not
preferred. By contrast, the VA does not use tiers; cost sharing for any
drug is limited to $8 for a month's supply for those patients subject
to the copayment. Because VA doctors use only the VA formulary, they
can become familiar with its coverage; financial incentives are not
needed to steer use.
Because of these system differences, it is most relevant to compare
the VA's formulary to the list of drugs that are on a preferred tier in
a Part D plan's formulary, without designations for either prior
authorization or step therapy.\17\ For the national and near-national
plans, the median number of unrestricted on-formulary drugs is 104,
compared to 136 when restricted drugs are included. By this criterion
the typical Medicare plan formulary comes closer to the 82 drugs listed
on the VA National Formulary (Table 1).
---------------------------------------------------------------------------
\17\ When a drug has a quantity limit, we do not treat that as a
restriction. Some plans designate large numbers of drugs with quantity
limits, apparently to restrict the dispensing of prescriptions of more
than 30 days.
Table 1. Number of Drugs with Unrestricted Coverage, VA Formulary and
Selected Medicare Plans, 2007
------------------------------------------------------------------------
Brand
All Drugs Generic Drugs
(N=160) Drugs (N=76) (N=84)
------------------------------------------------------------------------
On VA Formulary 82 56 26
------------------------------------------------------------------------
Median, 47 national Part D plans 104* 72 37
------------------------------------------------------------------------
Minimum, 47 national Part D 80* 48 20
plans
------------------------------------------------------------------------
Maximum, 47 national Part D 149 76 73
plans
------------------------------------------------------------------------
Top 10 Part D plans, by 2006
enrollment
------------------------------------------------------------------------
AARP Medicare Rx Basic 112 75 37
------------------------------------------------------------------------
Community Care Rx Basic 98 70 28
------------------------------------------------------------------------
Humana/Complete 121 76 45
------------------------------------------------------------------------
Humana/Enhanced 121 76 45
------------------------------------------------------------------------
Humana/Standard 149 76 73
------------------------------------------------------------------------
Medicare RX Rewards Value 117 76 41
------------------------------------------------------------------------
Prescription Pathway Bronze 118 74 44
------------------------------------------------------------------------
Silverscript (Caremark) 102 63 39
------------------------------------------------------------------------
United Healthcare Rx Basic 97 73 24
------------------------------------------------------------------------
Wellcare/Signature 94 74 20
------------------------------------------------------------------------
Group Model Medicare Advantage
Plans
------------------------------------------------------------------------
Kaiser Permanente, Northern 77 45 32
California
------------------------------------------------------------------------
Kaiser Permanente, Southern 79 50 29
California
------------------------------------------------------------------------
* Median and minimum for ``all drugs'' are measured directly and not the
sum of the brands and generics values.
* Note: Unrestricted coverage is defined as coverage on a preferred tier
with no prior authorization or step therapy requirements.
One view of the difference between the VA's formulary and those
used by Part D plans is how they treat the generic drugs in our sample
(Table 1). The typical Part D plan lists over 90 percent of generic
drugs, and several of the ten most popular plans list all of the
generics we studied. By contrast, the VA lists only 56 of 76 sample
generic drugs. This reflects the different perspective of those
designing these formularies. The VA chooses preferred drugs among
competing generics based on a combination of clinical evidence and
price. By contrast, Part D plans have incentives to list on formulary
most or all of the generics in a particular class. Lacking any close
relationships with prescribing physicians, they must rely on
enforcement at the pharmacy to encourage use of one particular generic
over another. Doing so risks alienating their enrollees for minimal
financial gain and may discourage enrollment if drugs are listed as
off-formulary on the Medicare's online Drug Plan Finder.
As noted above, the approach to formulary design in an integrated
health plan is more like the VA system than other Part D plans. It is
not surprising, therefore, that Kaiser Permanente formularies were
similar in scope to the VA formulary (Table 1). In both of its
California regions, Kaiser Permanente listed slightly fewer sample
drugs on formulary (77 and 79) than the VA National Formulary. Like the
VA, the Kaiser plans are more likely than other Part D plans to omit
generic drugs from their formularies.
Comparisons at the Drug Class Level
Comparisons between the VA National Formulary and the Part D plan
formularies vary considerably by drug class (Table 2). One reason for
the variation is that some drug classes (e.g. beta blockers) consist
mostly of generic drugs. Most Part D plans list nearly all generics on
formulary, whereas the VA is more likely to omit generic drugs from its
formulary for such classes. Specific program rules also affect the
comparisons. For example, Part D plans include more anti-depressants at
least partly because Medicare guidelines require that nearly all unique
anti-depressants be listed on formulary, although the guidelines do not
require that coverage be unrestricted.
Table 2. Formulary Listings by Class, VA and Part D Formularies, 2007
--------------------------------------------------------------------------------------------------------------------------------------------------------
VA National Formulary Median, 47 KP Northern CA KP Southern CA
Drug Class Drugs National
Studied Plans*
--------------------------------------------------------------------------------------------------------------------------------------------------------
Anti-Dementia Agents 6 5 4 3 3
--------------------------------------------------------------------------------------------------------------------------------------------------------
Anti-Depressants 30 18 23 24 24
--------------------------------------------------------------------------------------------------------------------------------------------------------
Beta Blockers 15 7 14 6 9
--------------------------------------------------------------------------------------------------------------------------------------------------------
Calcuim Channel Blockers 9 5 6 4 3
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cholesterol Agents 18 7 11 4 5
--------------------------------------------------------------------------------------------------------------------------------------------------------
Diabetes Agents 16 5 12 6 8
--------------------------------------------------------------------------------------------------------------------------------------------------------
Proton Pump Inhibitors 6 1 2 2 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hormonal Agents 12 6 4 7 6
--------------------------------------------------------------------------------------------------------------------------------------------------------
Renin-Angiotensin 18 8 10 3 3
--------------------------------------------------------------------------------------------------------------------------------------------------------
TNF Inhibitors 3 0 0 3 3
--------------------------------------------------------------------------------------------------------------------------------------------------------
Other Common Drugs 27 20 22 14 12
--------------------------------------------------------------------------------------------------------------------------------------------------------
TOTAL, SELECTED DRUGS 160 82 104 77 79
--------------------------------------------------------------------------------------------------------------------------------------------------------
*Drugs listed on a generic or preferred tier and without prior authorization or step therapy restrictions. Note that the median value for the total is
not the total of the class medians.
The pattern is similar for the Kaiser Permanente formularies, but
the details are different. Kaiser's formularies, for example, list
fewer drugs in categories such as anti-cholesterol agents or the renin-
angiotensin drugs used to treat hypertension. But Kaiser lists more
anti-depressants than the typical Part D plan. Kaiser also lists more
drugs without restriction in the TNF inhibitor class than either the VA
or the typical Part D plan, because they do not require prior
authorization for these drugs.
The Class of Cholesterol Drugs
The contrasting ways that formularies work in the VA compared to
the standalone Part D plans can be illustrated with the class of
cholesterol drugs. The VA's coverage of cholesterol agents has been
criticized because the formulary does not list some popular anti-
cholesterol drugs such as Crestor and Lipitor, while the majority of
national Part D plans list them without restrictions.\18\ As shown in
Table 2, the typical Part D plan lists 11 of the anti-cholesterol
agents in our sample, whereas the VA lists 7 drugs and Kaiser
Permanente lists just 4 in one region and 5 in another.
---------------------------------------------------------------------------
\18\ Deroy Murdock, ``VA Program No Model for Helping Americans Buy
Medications,'' Deseret News, 31 December 2006.
---------------------------------------------------------------------------
Whenever possible, the VA suggests that a ``high potency''
formulary statin should be the first-line treatment prescribed for the
patient. If he or she fails to meet clinical goals on that drug,
physicians are advised to consider a second-line therapy (such as
niacin or non-formulary Zetia) or a switch to a non-formulary statin,
such as Lipitor.\19\ These guidelines mean that non-preferred or even
non-formulary drugs are recommended and accessible to veterans, and
they may be prescribed in greater numbers than their on-formulary or
unrestricted counterparts. In fact, as Table 3 shows, there is more
utilization of Zetia, considered a second-line therapy not listed on
formulary, than the two on-formulary drugs in the Bile Acid
Sequestrants group. Similarly, prescribing of Lipitor, another second-
line therapy that is not on formulary, is higher than for Lescol, one
of the on-formulary statins.\20\
---------------------------------------------------------------------------
\19\ ``Ezetimibe (Zetia) for Nonformulary Use,'' VHA Pharmacy
Benefits Management Strategic Healthcare Group and the Medical Advisory
Panel, updated January 2007.
\20\ After this analysis was completed, changes were made to the VA
National Formulary's treatment of statins in response to FDA approval
of generic versions of Pravachol and Zocor.
Table 3. Formulary Listing of Cholesterol Agents, 2007
----------------------------------------------------------------------------------------------------------------
# of 47 Part
On VA D plans with VA
Drug* Generic Name Formulary? unrestricted Utilization
coverage FY 2006
----------------------------------------------------------------------------------------------------------------
Bile Acid Sequestrants
----------------------------------------------------------------------------------------------------------------
CHOLESTRYAMINE CHOLESTRYAMINEY 46 52,249
----------------------------------------------------------------------------------------------------------------
Welchol COLESVELAM N 20 4,714
----------------------------------------------------------------------------------------------------------------
Colestid COLESTIPOL Y 18 168,976
----------------------------------------------------------------------------------------------------------------
Cholesterol Absorption Inhibitors
----------------------------------------------------------------------------------------------------------------
Zetia EZETIMIBE N 36 369,783
----------------------------------------------------------------------------------------------------------------
Fibrates
----------------------------------------------------------------------------------------------------------------
Tricor FENOFIBRATE N 37 130,181
----------------------------------------------------------------------------------------------------------------
GEMFIBROZIL GEMFIBROZIL Y 47 1,771,658
----------------------------------------------------------------------------------------------------------------
Nicotinic Acid
----------------------------------------------------------------------------------------------------------------
Niaspan ER NIACIN Y 41 1,258,306
----------------------------------------------------------------------------------------------------------------
Omega-3 Fatty Acids
----------------------------------------------------------------------------------------------------------------
Omacor OMEGA-3 ACID N 13 827
----------------------------------------------------------------------------------------------------------------
Statins
----------------------------------------------------------------------------------------------------------------
Lipitor ATORVASTATIN N 34 711,138
----------------------------------------------------------------------------------------------------------------
Lescol FLUVASTATIN Y 8 500,954
----------------------------------------------------------------------------------------------------------------
Altoprev ER LOVASTATIN N 9 12
----------------------------------------------------------------------------------------------------------------
LOVASTATIN LOVASTATIN Y 47 1,424,081
----------------------------------------------------------------------------------------------------------------
Mevacor LOVASTATIN N 4 376,688
----------------------------------------------------------------------------------------------------------------
Pravachol PRAVASTATIN N 1 56,255
----------------------------------------------------------------------------------------------------------------
PRAVASTATIN PRAVASTATIN N 33 **
----------------------------------------------------------------------------------------------------------------
Crestor ROSUVASTATIN N 33 144,341
----------------------------------------------------------------------------------------------------------------
SIMVASTATIN SIMVASTATIN Y 45 **
----------------------------------------------------------------------------------------------------------------
Zocor SIMVASTATIN N 5 16,487,514
----------------------------------------------------------------------------------------------------------------
*Drug names in all capital letters are generic drugs.
**Data are not available for the newly approved generic versions of pravastatin and simvastatin. Previously,
the brand version of Zocor was on formulary.
Comparative effectiveness reviews of clinical evidence have led to
a similar conclusion to that of the VA. The Consumer Reports ``Best Buy
Drugs'' report, based on research by the Drug Effectiveness Review
Project, recommends use of one of three generic statins, with Lipitor
as an alternative for patients who have had a heart attack or acute
coronary syndrome together with highly elevated LDL.\21\ Among the 47
national and near-national Part D plans, 34 list Lipitor and 33 list
Crestor, while nearly all list generic drugs lovastatin and
simvastatin.
---------------------------------------------------------------------------
\21\ http://www.bestbuydrugs.org/drugreport_DR_Statins.shtml
---------------------------------------------------------------------------
Another factor that affects the formulary comparisons is the
Medicare Program's guidance requiring that Part D plans list on
formulary at least one drug in each subgroup of cholesterol drugs,
although plans may use coverage restrictions. The VA has no such
mandatory coverage requirement. Because Zetia and Omacor are the only
drugs in their subgroups, Part D plans must list them, whereas the VA
formulary does not. Nevertheless, shown in Table 3, not all Part D
plans have unrestricted coverage of these drugs. The VA, which
recommends Zetia as a second-line therapy, filled about 370,000
prescriptions for the drug.
Conclusions
An objective comparison of unrestricted coverage by Medicare Part D
plans to the VA National Formulary shows that the VA formulary is
modestly smaller than the typical Part D plan formulary and about the
same as formularies used by Kaiser Permanente. But formulary size is
not the same as access to drugs. This small gap largely reflects the
difference between integrated and non-integrated health systems and the
resulting approaches to ensuring access.
The VA National Formulary is closely tied to its prescribing
system. Like a staff-model or group-model HMO, physicians in the VA
system participate in creating the formulary and commit to prescribing
from it when it meets their patients' needs. Patients in both of these
integrated healthcare systems are less likely than other types of Part
D or private health plans to receive a prescription, only to be told
later that it is not covered or covered at a much higher price than a
more preferred drug. The incentive in integrated systems is for
physicians to prescribe from the formulary when they can, but it is a
relatively straightforward process to obtain authorization for any drug
that is not on the formulary. By contrast, physicians treating patients
in non-integrated systems face a variety of formularies for the
different plans in which their patients are enrolled, and they are
unlikely to prescribe according to each patient's formulary unless the
plan or patient points out which drugs are preferred. It is essential
when making comparisons with regard to access to drugs between the VA
and other plans to keep these differences in mind.
A full comparison of access to prescription drugs between the VA
system and other health systems would require more extensive studies,
such as surveys or clinical outcome studies. Nevertheless, this
comparison of Medicare Part D plan formularies to the VA formulary
lends support to the conclusion that veterans maintain good access to
prescription drugs through the VA National Formulary.
Prepared Statement of Frank R. Lichtenberg, Ph.D.,
Courtney C. Brown Professor of Business,
Columbia University, New York, NY, and Research Associate,
National Bureau of Economic Research
Access to new drugs in the Veterans Health Administration
Access to medical innovations T longevity and health
Research that I and other economists have performed
indicates that access to medical innovations--new drugs, medical
procedures, and devices--is one of the most important determinants of
longevity and health.
Four years ago I performed a study that examined access
to new drugs under the pharmacy benefits management system of the
Veterans Health Administration. Since 1997, the VA National Formulary
has played a key role in that system.
The fractions of drugs approved in the 1950s, 1960s,
1970s, and 1980s that were on the 2005 VA National Formulary were
almost identical: 52-53 percent.
However, only 38 percent of the drugs approved in the
1990s, and 19 percent of the drugs approved since 2000, were on the VA
National Formulary. Only 22 percent (17) of the 77 priority-review
drugs approved since 1997 were on the 2005 National Formulary. (Figure
1)
[GRAPHIC] [TIFF OMITTED] 53427A.001
Older drugs used by VA patients
The drugs used in the VA health system during 1999-2002
were older than the drugs used in the rest of the U.S. healthcare
system. For example, the percentages of VA and non-VA prescriptions for
drugs less than 5 years old were 5.6 percent and 8.6 percent,
respectively, and the percentages for drugs less than fifteen years old
were 31.4 percent and 39.0 percent. (Figure 2)
[GRAPHIC] [TIFF OMITTED] 53427A.002
The percent of drugs less than 10 years old increased by
1.4 percentage points per year in the non-VA sector, and by 0.6
percentage points per year in the VA sector. The percent of drugs less
than 15 years old increased by 1.9 percentage points per year in the
non-VA sector, and had virtually no increase in the VA sector.
These estimates are consistent with the hypothesis that
implementation of the VA National Formulary beginning in 1997 reduced
utilization of new drugs in the VA healthcare system.
Older drugs T reduced longevity, higher utilization of hospitals and
nursing homes
I present estimates of the impact of utilization of new
drugs on longevity, based on annual data on Medicaid drug utilization
and mortality by State, disease, and year, for all 50 States during the
period 1991-2001.
The estimates imply that use of older drugs in the VA
system reduced mean age at death of its patients by 0.17 years, or 2.04
months. The per-patient value of this reduction in longevity may exceed
$25,000.
I use demographic data published by the VA to compute the
life expectancy of veterans before and after the National Formulary was
implemented. Veterans' life expectancy increased substantially before
the National Formulary was introduced (during 1991-1997), but did not
increase, and may have even declined, after it was introduced (1997-
2002). (Figure 3)
[GRAPHIC] [TIFF OMITTED] 53427A.003
The life expectancy at birth of all U.S. males increased
after as well as before 1997, although the rate of growth declined by
about a third. (Figure 4)
[GRAPHIC] [TIFF OMITTED] 53427A.004
Implementation of the VA National Formulary is likely to
have increased utilization of hospitals and nursing homes. I estimate
that if the age of the drugs used by the Medicare population were
increased to match that used in the VA health system, the increase in
hospital, home healthcare, office-visit, and nursing-home expenditure
among the elderly would be about $5.1 billion per year.
Bibliography
Lichtenberg, Frank R., ``Older Drugs, Shorter Lives? An
Examination of the Health Effects of the Veterans Health Administration
Formulary,'' Medical Progress Report No. 2, October 2005, http://
www.manhattan-institute.org/html/mpr_02.htm
Lichtenberg, Frank R., Paul Grootendorst, Marc Van
Audenrode, Dominick Latremouille-Viau, and Patrick Lefebvre, ``The
impact of drug vintage on patient survival: a patient-level analysis
using Quebec's provincial health plan data,'' Value in Health 12 (6),
2009, pp. 847-856.
Lichtenberg, Frank R., ``Have newer cardiovascular drugs
reduced hospitalization? Evidence from longitudinal country-level data
on 20 OECD countries, 1995-2003,'' Health Economics 18 (5), 2009, pp.
519-534.
Lichtenberg, Frank R., and Gautier Duflos,
``Pharmaceutical innovation and the longevity of Australians: a first
look,'' Advances in Health Economics and Health Services Research 19,
2008, pp. 95-117.
Lichtenberg, Frank R., ``The Impact of New Drugs on U.S.
Longevity and Medical Expenditure, 1990-2003,''American Economic Review
97 (2), May 2007, pp. 438-443.
Lichtenberg, Frank R., ``Pharmaceutical Innovation and
U.S. Cancer Survival, 1992-2003: Evidence from Linked SEER-MEDSTAT
Data,'' Forum for Health Economics & Policy: Vol. 10: Iss. 1 (Frontiers
in Health Policy Research), Article 1. http://www.bepress.com/fhep/10/
1/1
Prepared Statement of Richard F. Weidman, Executive Director for
Policy and Government Affairs, Vietnam Veterans of America
Chairman Michaud, Ranking Member Brown and distinguished Members of
the Subcommittee, on behalf of National President John Rowan, our Board
of Directors and Members, I thank you for giving Vietnam Veterans of
America (VVA) the opportunity to testify today regarding the ``Is the
VA Meeting the Pharmaceutical Needs of Veterans? An Examination of the
VA National Formulary, Issues of Patient Safety, and Management of the
Pharmacy Benefits Program.''
In May of this year VVA wrote to Chairman Filner as part of VVA's
answer to his question about issues that need to be addressed by the
House Veterans Affairs Committee VVA responded with five issues, one of
which is described below:
Pharmacy Service--the formulary is much too restrictive (and
much more restrictive than either DoD or Medicare) on the
theory that they are going to save a lot of money on
medications. However, they often save pennies and spend big
dollars because they scrimp on medications that could have
prevented very costly acute care in-patient stays. The method
of evaluating pharmacists needs to be dramatically changed from
how much in ``savings'' they produce in comparison with the
national average (which becomes a ``race to the bottom'') to
how much did what they do in cooperation with the medical staff
at a given VA Medical Center to promote healing and wellness,
and reduce in-patient acute care stays in the hospital, and/or
to prevent secondary conditions from developing.
The crux of this issue remains the same some 5 months later.
In lay terms, VVA believes that what we have at the Veterans Health
Administration (VHA) of the U.S. Department of Veterans Affairs (VA) is
a mentality that tries to reduce front end costs (e.g., pharmaceutical
costs) which they call ``cost avoidance,'' without regard to overall
impact either on the health of the individuals concerned or the overall
cost impact on the system. In other words, they save some money by
artificially limiting the number and type of pharmaceuticals that are
generally available to clinicians at the VHA facilities, regardless of
whether that in the medium to long-run it causes veterans to have
secondary conditions. This practice is justified on the basis of ``cost
effectiveness'' within the context of just pharmaceuticals alone,
without regard for the rest of the medical setting.
It is ironic that the Research & Development section of VA is
holding a conference tomorrow in Washington to look at ``comparative
effectiveness'' in research and in other applications. While models
such as evidence based medicine has a real place, and has been of
significant use especially in treating psychiatric problems, it has all
too often been misapplied to practical allocation of resources, such as
the way in which VHA has implemented the formulary at VHA. VVA would
suggest that ``comparative effectiveness'' be applied to the overall
healthcare system, in such a way as to focus on ``comprehensive
effectiveness.''
Frankly, ``comparative effectiveness'' has been misapplied to the
VA formulary in such a way that it is a ``race to the bottom.''
Furthermore, when you are sick, Mr. Chairman, you are not necessarily
in the majority part of the group that inexpensive ``drug A'' worked
for just as well as the more expensive (usually copyright/patent
protected) ``drug B'' when the two were tested for efficacy against
each other. The decision of which to offer should be a clinical
decision by the physician in concert with the patient, as to what is
going to work the best for the individual patient. The practical tools
available to a veterans' physician should not be artificially limited
by what is listed on the VA formulary.
We know if something is not on the formulary, it is very difficult,
if not impossible, for most patients of that physician to get it. When
we raise this issue, VA retorts that any physician can order any Food &
Drug Administration (FDA) approved medication, whether it is on the
formulary or not. While theoretically a physician can secure
medications not on the formulary, as a practical matter it is
inordinately difficult and time consuming to do so, and if a physician
does it too often, they are ``counseled'' by their supervisor.
VVA has made the point to three of the most recent Undersecretaries
for Health at VA, and to Secretary Peake when he was in office, that
the VA National Formulary decision-making process lacks transparency
and public input that would cause them to have to justify keeping
something off of the formulary as opposed to putting something on the
formulary. This is just not right, and no way to make public ``life or
death'' policy decisions. This entire process needs to play out in the
open, in the sunshine, where it can clearly be seen by the public and
by clinicians what is being done and why it is being done. That is not
the case at VHA today.
The VA formulary has just over 1,300 drugs while the average
Medicare Part D formulary has more than 2,000 drugs. Only 38 percent of
the drugs approved by the FDA in the 1990s, and 19 percent of the drugs
approved since 2000, are on the VA National Formulary. It is clear to
us that the VA has a policy bias toward generics and those drugs whose
patents have expired, making them cheaper. This is despite the fact
that the VA has the best price in the world on pharmacy medications.
While we do not believe that ``newer'' is always better, that is a
clinical decision that the veteran's individual physician should be
making, and not ``the green eye shade'' fiscal guys in a back room
somewhere.
The restrictive VA formulary could have a deleterious effect on the
longevity and quality of life of veterans. Just one example of this is
how slow VHA was to add the long-lasting insulin to the VHA formulary
(and then only after significant pressure from VVA and from this
Committee), and the fact that many of the most effective treatments for
diabetes, many of which have appeared on the market since 2000, are
still not available on the VA formulary. The average beneficiary has
better access to newer diabetes and heart disease drugs through
Medicare Part D and Medicaid than does the average veteran through the
VA. This is just wrong, and needs to be fixed by broadening the VA
formulary, and by opening up this whole process.
The toughest things to get on the VA formulary of all are the most
innovative ``new molecular entities'' almost all of which are still
under patent, and therefore avoided by the VA decisionmakers. In this
instance there is apparently an evidence based process, but it can be
(and often it is) vetoed by the pharmacy people strictly on the basis
of the cost of the medication, and not by any part of an overall
decision as to what is best for the veteran's overall health, nor the
like total cost to the medical system of NOT providing this medications
to veterans who would be helped by it.
By restricting access to innovative drug therapy for chronically
ill veterans, VVA believes that the overly restrictive VA formulary may
result in less than optimal health outcomes. Said another way, it is
our belief that many of the VA Medical Centers are not doing such a
great job of controlling the measures of diabetes A1C, partly because
of the restrictive policies on medications. This results in ``spikes''
that are what cause the secondary conditions and/or very costly
inpatient hospitalization stays in some of the more than a million
diabetics being treated by VA. For this reason, it also results in the
veteran developing secondary conditions, which are also service
connected and result in higher monthly payments. But, obviously, the
key thing here is the diminishment of the quality of life for the
individual veteran.
While the 2000 Institute of Medicine (IOM) study of the then newly
implemented (1997) VA National Formulary . . . ``found that the VA
National Formulary is not overly restrictive, and the limited available
evidence suggests that it has probably meaningfully reduced drug
expenditures without demonstrable adverse effects on quality.''
However, the IOM report findings continue: ``The (IOM VA Formulary
Study) Committee also concluded that there are manifold opportunities
to improve the management of the formulary system used by the VHA. The
National Formulary lacks essential systems to assure that new drugs are
expeditiously reviewed for inclusion, and that a responsive process for
assuring access to medically necessary exceptions to the formulary is
consistently in place system-wide, that therapeutic interchange is
accomplished in a flexible and consistent way, sensitive to patient
risk, across the far-flung VHA system, and that views of critical
constituencies of both providers and patients are represented in the
management of the National Formulary . . .''
Perhaps most troubling, the (IOM) Committee found ``a dearth of
information to evaluate the full impact of the National Formulary on
veterans health and satisfaction, and on the VHA.'' That remains the
case today because the VA process takes place in the back room, out of
public view.
Since the time of the IOM Study of the VA National Formulary, the
VA Formulary and Formulary process has only grown more restrictive and
little has been done to address the concerns expressed in the IOM
study. Individual Veterans Integrated Services Network (VISN)
formularies have been eliminated in favor of only a consolidated VA
National Formulary.
The VA Formulary process involves internal Pharmacy and Medical
expertise through its own Medical Advisory Panel (MAP) and is cross
connected to the Department of Defense Pharmacoeconomic Center (DoD
PEC) and Indian Health but does not have outside professional or
beneficiary interest represented, such as the Veteran Service
Organizations, or professional pharmacy and pharmacists organizations,
or advocacy groups like the American Diabetes Association. Appropriate
national level professional organizations that would best represent the
patient as relates to safe and appropriate medication use, could
include representation from professional organizations such as the
American Pharmacists Association (APhA), American Society of Health-
System Pharmacists (ASHP), Academy of Managed Care Pharmacy (AMCP), and
American Society of Consultant Pharmacists (ASCP), as well as other
professional medical societies.
The lack of transparency and insular nature of the VA formulary
decision-making process is problematic and leaves unanswered questions
about access to care, chronic disease care, criteria use in reaching
decisions (e.g., costs versus long-term clinical effectiveness). VA
should publish specific drug decision-making criteria, including the
therapeutic category review schedule, decision-making process, Pharmacy
and Therapeutics Committee and Medical Advisory Panel members, meeting
schedules, and discussions of specific decisions. In addition, the
public should have an opportunity to submit information to the VA
Pharmacy and Therapeutics Committee in preparation for each decision
meeting.
The VA formulary decision-making process should also include a VA
Pharmacy Beneficiary Advisory Committee as does the Department of
Defense TRICARE Uniform Formulary process. For example, the Department
of Defense/TRICARE publically announces in advance its therapeutic
class review schedule, the specific drugs for review, and the criteria
for comparing different drugs. The DoD Pharmacoeconomic Center (PEC)
receives pricing and clinical data from the public including
pharmaceutical companies which are considered by the DoD Pharmacy and
Therapeutics (P&T) Committee. The DoD publishes on its Web site (http:/
/www.pec.ha.osd.mil/) the recommendation of the P&T Committee, the
rationale, and summary of the data considered.
These recommendations are then reviewed by a DoD Beneficiary
Advisory Panel (BAP; http://www.tricare.mil/pharmacy/bap/) composed of
non-government beneficiary, professional and patient advocacy
organization representatives, TRICARE contractors, and others. These
meetings are also announced in advance, open to the public, and the
results are published on the PEC Web site. The P&T Committee and the
BAP recommendations are then forwarded to the Director of the TRICARE
Management Activity for final decision. In most cases, newly FDA-
approved prescription medications are available from TRICARE network
pharmacies and the mail-order pharmacy program shortly after they
become commercially available. Furthermore, the public has the
opportunity for input at each step in the decision-making process, and
it is transparent.
Conversely, the Department of Veterans Affairs National Formulary
decision-making process lacks transparency and opportunity for public
input. This results in major disadvantages for VA patients and the
quality of VA healthcare. It can be argued that the overly restrictive
VA formulary as it stands today is significantly distorting the
practice of medicine at the VA, to the detriment of the health of
veterans who seek care there.
Recommendations:
Optimally, the Congress will pass a law mandating an open and
transparent process that is modeled on the law for DoD/TRICARE, and is
at least as open and transparent a process (if not more so) than the
DoD procedure. The DoD process automatically includes all medications
approved by the FDA. It is up to managers to justify restricting access
to a medication by removing it from the formulary, and this has to play
out in a public setting with significant input from advocacy groups,
medical societies, and other interested parties. VA should do no less
for our veterans once they take off the uniform.
Short of this much needed comprehensive overhaul or transformation
of the VA formulary, or perhaps while the Committee is working to draft
and secure passage of this legislation, VVA recommends the following
steps be taken immediately by Secretary Shinseki:
Change the performance evaluation criteria for Chief pharmacists to
measure his or her contribution toward the overall wellness of the
patients at a particular Medical Center. There are currently no such
metrics in place, but they can be developed and these contributions
measured, just like almost anything else. (Currently the pharmacists
are rewarded by how much ``cost avoidance'' they can achieve in
comparison with the national mean. This, of course, means that it is a
``race to the bottom.'' It is a testimony to the professionalism and
commitment to good medicine by the pharmacists that, given the way the
system is set up, with the emphasis on cost containment/cost reduction,
that so many veterans do get the right medication in the right amount
when they need it.)
The VA P&T Committee meeting schedule, therapeutic categories to be
reviewed, and review criteria should be publically announced well in
advance of P&T meetings.
The VA P&T Committee should establish a procedure to accept and
consider public input for these Formulary meetings.
The VA P&T Committee should publish its recommendations made in the
last decade with rationale for the conclusions and recommendations of
the Committee.
The Secretary of Veterans Affairs should establish a Beneficiary
Advisory Committee (BAC) of representatives from a representative
sampling of major veterans, patient advocacy, and healthcare
professional groups with the responsibility and authority to make
recommendations on the decisions of the VA P&T Committee including
addition, deletions, clinical use criteria, and preauthorization
requirements on drugs on the VA National Formulary.
Meetings of the VA Formulary Beneficiary Advisory Committee should
be open to the public and the minutes and considerations of all BAC
recommendations published on the VA P&T Committee Web site in a timely
manner.
Like the DoD Beneficiary Advisory Panel, the VA Formulary
Beneficiary Advisory Committee should include at least 12-15 members
and have the opportunity to make Recommendations prior to final
decision on VA National Formulary changes and other pharmaceutical
issues. At least two of the following organizations should be included
in the membership of the VA Beneficiary Advisory Committee, the
American Pharmacists Association (APhA), American Society of Health-
System Pharmacists (ASHP), Academy of Managed Care Pharmacy (AMCP), and
American Society of Consultant Pharmacists (ASCP).
The VA Formulary Beneficiary Advisory Committee should have the
authority to recommend to the VA drug categories and new drugs to be
reviewed, changes to the criteria for use, clinical guidelines,
restrictions on use, etc.
The Veterans Health Administration should be required to consider
the recommendations of the VA Formulary Beneficiary Advisory Committee
prior to making final decisions on VA Uniform Formulary including
addition, deletions, clinical use criteria, and preauthorization
requirements.
Conclusion
The Secretary of Veterans Affairs could do some, all, or most of
the nine steps outlined here above within the scope of his authority.
However, there will be stiff resistance on the part of VHA officials
who like the status quo. All too often, some seemingly do not believe
that they should be answerable to anyone outside of that closed system,
much less individual veterans or veterans' service organizations. These
folks will have millions of reasons not to change, and perhaps so will
some at the Office of Management & Budget (OMB). They also have their
own constituencies around Washington who will tell the Secretary that
it is ``just too expensive'' to provide expensive drugs to veterans.
These individuals have had years of practice in ``push back'' to
prevent any significant change being accomplished without legislation
passing the Congress.
It is our belief that the time is right for this Subcommittee to
take the lead in creating a statutorily directed formulary that is
inclusive as a starting point, that is totally transparent, and that
has to take into account input from stakeholders, both medical
professionals and advocates outside of government. The VA continues to
have great ``bargaining power'' to secure the best possible prices on
each and every medication, and we believe that the private sector will
be reasonable in this regard. In any case, it is impossible to say
``Care Second to None'' until we clean up this major problem with the
VA formulary.
If we are going to assist the President to achieve transformation
of the VA for the 21st century, then there is no better place to start
than ensuring full transparency in the VA formulary, and a presumption
of inclusion of all FDA approved medications. And, for that, we need
bi-partisan legislation and the strong leadership from this
Subcommittee on this issue.
Thank you for your leadership in holding this hearing on a crucial
subject, Mr. Chairman. I will be pleased to answer any questions, and
look forward to working with you and your colleagues to greatly improve
this vital service to veterans.
Prepared Statement of William Ray Bullman, M.A.M.,
Executive Vice President, National Council on Patient Information
and Education, Bethesda, MD
Good afternoon Mr. Chairman and Members of the Subcommittee. I am
Ray Bullman, Executive Vice President of the National Council on
Patient Information and Education (NCPIE). I've been asked to testify
this afternoon relative to NCPIE patient medication safety efforts and
best practices or innovative means that NCPIE coalition Members utilize
to enhance medication safety.
I would note at the outset that NCPIE does not focus specifically
on formulary issues. Yet, recognizing the role and impact that
formulary decision-making ultimately plays downstream on patient--
healthcare provider communication, informed decision-making about
therapy choice and what medication is prescribed or recommended and
why, and ultimately--to what extent patients effectively self manage
their medication therapy, NCPIE is pleased to help support the work of
the Subcommittee this afternoon and moving forward. Additionally, I
would point out that NCPIE educational messages and materials are
motivated by what we refer to as the ``3Rs'' for Safe Medicine Use.
They are:
Risk-recognize that all medicines (prescription and
nonprescription) have risks as well as benefits; and you need to weigh
these risks and benefits carefully for every medicine you take.
Respect-respect the power of your medicine and the value
of medicines properly used.
Responsibility-take responsibility for learning about how
to take each medication safely. Being responsible also means following
this important rule: when in doubt, ask first. Your healthcare
professional can help you get the facts you need to use medicines
correctly.
These ``3 Rs'' are likely similar to motivators for healthcare
providers within the VA as they make evidence-based formulary decisions
and VA pharmacists, as they collaborate with members of the VA's
interdisciplinary healthcare team, and as they counsel patients about
safe and appropriate medicine use. As such, NCPIE is pleased to help
support VA pharmacists, a subset of the Nation's medication experts, as
they work collaboratively within the VA pharmacy system on what NCPIE
refers to as the ``Medicine Education Team,'' to help optimize
medication therapy and to minimize patient risks.
About NCPIE
NCPIE was established in October 1982 as a non-profit organization.
Its founding Chair was Congressman Paul G. Rogers (who served 24 years
in the U.S. House of Representatives representing West Palm Beach, FL,
and during his tenure was referred to as ``Mr. Health'' for his leading
role in passing dozens of measures promoting healthcare and the
environment). The late Honorable Congressman Rogers served as NCPIE's
Chair for 16 years.
NCPIE is a diverse coalition of organizations working to stimulate
and improve communication of information on the appropriate use of
medicines to consumers and healthcare professionals. NCPIE develops
programs, provides educational resources, issues research reports,
conducts special issues meetings and multi-media campaigns, such as our
annual ``Talk About Prescriptions'' Month every October. As such,
NCPIE's activities are guided by three common values: 1) to represent a
wide spectrum of organizations serving the public health through
educational and advocacy programs; 2) to empower consumers to be more
informed about and active in decisions affecting their use of
medicines; and 3) to be a catalyst and convener for the development of
new, useful, and scientifically accurate information about medicine use
that is disseminated in multiple formats to a wide range of audiences.
What makes NCPIE unique, besides its long-term focus on the
appropriate use of medicines, is the depth and breadth of its national
coalition of nearly 100 organizations committed to providing patients
with useful and appropriate medicine information. The NCPIE coalition
includes: consumer organizations; patient advocacy groups, and
voluntary health agencies; organizations representing healthcare
professionals and health educators; schools of pharmacy; State and
Federal Government agencies; health-related trade associations;
national and international private sector companies including
pharmaceutical manufacturers, patient information/database companies,
and managed care organizations.
NCPIE is based in Bethesda, Maryland. J. Leonard Lichtenfeld, M.D.,
representing the American Cancer Society, currently serves as NCPIE's
Chairperson.
Patient Medication Safety Issues/Current and Ongoing NCPIE Programs
NCPIE is one of the original patient safety organizations,
addressing safe and appropriate medicine use through the
identification, development, and dissemination of educational messages
and resources to promote safe and appropriate medicine use. NCPIE also
convenes and participates in ongoing and ad-hoc external collaborations
and issues-driven project partnerships, striving to address a wide
range of potential medication safety (safe use) issues, as described
below:
Safety Issues Related to Communicating Risk via Written Consumer
Medicine Information--NCPIE, in 1996, at the request of then HHS
Secretary Shalala, participated in the development of a 10-Year Action
Plan for the Provision of Useful Prescription Medicine Information. The
Action Plan, which included criteria for quality improvements for both
clinical content and the design, layout, and readability of written
medicine information leaflets conveyed by community pharmacies with
every retail prescription, sunset in December 2006. The Food and Drug
Administration as the lead agency responsible for assessing to what
extent Action Plan quality improvements were achieved by the private
sector during this 10-year period, is conducting a 2-day workshop later
this week to obtain key stakeholder input on proposed new prototypes
for such useful written information and to seek input on a research
agenda to ensure consumer input on the development, design, and testing
of such written information. NCPIE is participating in the workshop as
a reactor panelist.
Safety Issues Related to Medication Nonadherence--Although the
challenge of poor adherence has been discussed and debated for at least
three decades, these problems have, until recently, generally been
overlooked as a major healthcare priority. NCPIE has since 1995 called
for national action to address this major public health problem that
has recently been estimated to cost the U.S. economy over $290 billion
annually--or 13 percent of total healthcare expenditures (New England
Health Care Institute, July 2009). Consider:
Nearly 3/4 of Americans report they don't take their
medications as directed;
One in three never fill their prescriptions;
For common chronic conditions such as diabetes and
hypertension, proper adherence averages only 50-65 percent;
Three-69 percent of medication-related hospital
admissions are linked to poor adherence.
Failure to follow medication regimes is especially harmful to
people with chronic health conditions. When those with chronic
conditions fail to follow their medication regimen, they risk decreased
productivity, a lesser quality of life, a more rapid progression of
their condition, complications, hospitalization, and even death.
Employers are seeing billions of dollars lost to chronic condition-
related absenteeism and presenteeism (when employees report for work,
but do not function at full capacity). It is estimated that diabetes
accounts for 120 million work days lost every year to presenteeism.
In 1995, NCPIE released the referenced report, ``Prescription
Medicine Compliance: A Review of the Baseline of Knowledge,'' which
outlined the health consequences of nonadherence and defined key
factors contributing to poor medication adherence. The report included
an overview of strategies to enhance adherence, along with
implementation tools and materials.
In August 2007, NCPIE released its second report, ``Enhancing
Prescription Medicine Adherence: A National Action Plan.'' This
referenced report was released as a renewed nationwide call to action
for improving medication adherence through patient information and
education, health professional intervention, expanded research, and
supportive government policies. The report includes 10 recommendations
for action that cross-cut the continuum of care--from diagnosis through
treatment and follow-up patient care and monitoring. The report is
available for download at www.talkaboutrx.org.
1. Elevate patient adherence as a critical healthcare issue.
2. Agree on a common adherence terminology that will unite all
stakeholders.
3. Create a public/private partnership to mount a unified
national education campaign to make patient adherence a national health
priority.
4. Establish a multidisciplinary approach to compliance education
and management.
5. Immediately implement professional training and increase the
funding for professional education on patient medication adherence.
6. Address the barriers to patient adherence for patients with
low health literacy.
7. Create the means to share information about best practices in
adherence education and management.
8. Develop a curriculum on medication adherence for use in
medical schools and allied healthcare institutions.
9. Seek regulatory changes to remove roadblocks for adherence
assistance programs.
10. Increase the Federal budget and stimulate rigorous research on
medication adherence.
Safety Issues Related to Prevention of Medication Abuse Among
Teens--While the use of tobacco, alcohol and illicit drugs is declining
overall, a new threat is emerging; more teens are abusing prescription
drugs than any illicit drug, except marijuana. The misuse and abuse of
prescription medications--the very same drugs used to legitimately
relieve pain, and treat conditions like anxiety, depression, sleep
disorders, or ADHD in some people--is a growing and under-recognized
problem that puts young lives at risk.
One in 5 teens (or 4.5 million) has deliberately abused
these drugs.
One in 3 teens surveyed says there is ``nothing wrong''
when using prescription drugs ``every once and a while.''
Every day, 2,500 youth (12-17) abuse a prescription pain
reliever for the very first time.
NCPIE, with contract support from the Substance Abuse and Mental
Health Services Administration (SAMHSA), and input from a project
advisory team of over a dozen national organizations involved in drug
abuse prevention and teen health, has developed two collaborative
educational campaigns to promote prevention of prescription medicine
abuse among teenagers:
``Not Worth the Risk_Even If It's Legal,'' consisting of
English and Spanish language television and radio spots, a newspaper
article (English and Spanish distributions) and two educational
brochures, one targeting teens and one targeting parents. All of the
campaign elements are posted for viewing on www.talkaboutrx.org.
``Maximizing Your Role as a Teen Influencer: What You Can
Do To Help Prevent Teen Prescription Drug Abuse,''--turn-key
educational workshop materials (Power Point presentation with
presenter's notes and a comprehensive Presenter's Guide) to equip teen
influencers (e.g., parents, teachers, school administrators, coaches,
community leaders, physicians and pharmacists) with the knowledge and
skills to communicate with teens and help curb prescription drug abuse.
NCPIE has begun development of a third resource, an
online ``Tool Kit for Curbing Prescription Medicine Abuse on America's
College Campuses,'' in October 2009.
Safety Issues Related to Proper Disposal of Pharmaceuticals--Proper
disposal of unused medications has become a visible and sensitive
public health and environmental issue. Goals of proper disposal
programs include: 1) Prevent environmental exposures and impacts from
improper pharmaceutical disposal, especially to the aquatic ecosystem;
2) Minimize accidental overdoses by people, pets and wildlife; 3) Limit
opportunities for drug-related crime and subsequent abuse; 4) Provide a
safe alternative to drug stockpiling in homes; 5) Preclude outdated
drug donations; and 6) Facilitate pharmacoeconomic assessments of waste
and prescriptions, insurance, and reimbursement and dispensing policies
and practices.
NCPIE distributes a handout for consumers on proper disposal
entitled, ``Tips on Safe Storage and Disposal of Your Prescription
Medicines.'' (www.talkaboutrx.org). NCPIE is also a collaborative
partner and participant in The Safe Medicine Disposal for Maine. NCPIE
is represented on the project advisory team for this statewide pilot
disposal program developed in Maine with grant support from the U.S.
Environmental Protection Agency (EPA). The program provides a safe and
anonymous method of drug disposal for Maine residents and is the first
of its kind in the country. For additional information see: http://
www.safemeddisposal.com/.
Safety Issues Related to the Prevention of Medication Errors--NCPIE
is a member of the National Coordinating Council for Medication Error
Reporting and Prevention (NCC MERP), a coalition of over two dozen
leading national healthcare organizations who work collaboratively to
address the interdisciplinary causes of medication errors and to
promote the safe use of medications. The U.S. Pharmacopeia spearheaded
the formation of NCC MERP and is a founding member and Secretariat for
NCC MERP. The Department of Veterans Affairs is also a member of NCC
MERP. Currently, 14 NCC MERP Recommendations reside on the NCC MERP Web
site at: http://www.nccmerp.org/councilRecs.html. Select sample titles
include: Recommendations to Enhance Accuracy of Prescription Writing;
Recommendations for Health Care Organizations to Reduce Medication
Errors Associated with the Label, Labeling, and Packaging of
Pharmaceutical (Drug) Products and Related Devices; and Reducing
Medication Errors Associated with At-risk Behaviors by Healthcare
Professionals.
Safety Issues Related to Safe and Appropriate Use of Acetaminophen
Products--NCPIE is currently participating in two coalitions (Maryland
Acetaminophen Coalition and the American Pharmacists Multi-Stakeholder
Coalition) addressing the safe use of OTC and prescription medicines
containing the active ingredient acetaminophen. Acetaminophen is sold
under several brand names and is also available in over 600 cough and
cold products, sleep aids, and prescription pain relievers.
The wide spread utilization of acetaminophen by patients may
increase the incidence and prevalence of misuse, which can lead to
severe healthcare outcomes. Many cases of overdose are caused by
patients inadvertently taking more than the current recommended dose of
a particular product, or by taking more than one product containing
acetaminophen (e.g., an over-the-counter product and a prescription
drug containing acetaminophen).
Safety Issues Related to Older Adults and Medication Use/Misuse--
NCPIE, in 2007, developed and launched The Medication Use Safety
Training for Seniors TM program (MUST for Seniors
TM). This turn-key, online educational program for older
adult medicine users, caregivers, and community-based programs that
address older adult health and wellness includes a complete menu of
video vignettes, Power Point presentations with accompanying scripts
and a range of supporting educational handouts for individuals or group
participants. See: www.mustforseniors.org.
The following patient medication safety issues were first described
by NCPIE in a forward-looking October 1987 referenced report,
``Priorities and Approaches for Improving Prescription Medicine Use by
Older Americans.'' The report summarized the problem of improper
medication use among older adults, its consequences, and factors
contributing to the problem; identified priorities for resolving
factors leading to medication misuse; and suggested practical
approaches to program developers for taking action in the following key
priority areas: 1) Poor Communication Between Older Patients And Health
Professionals; 2) Polypharmacy (the use of multiple medicines); 3)
Multiple Health Care Providers 4) Altered Drug Action and Response With
Advancing Age; 5) Inability To Take The Medication As Prescribed, and
6) Deliberate Nonadherence.
Safety Issues Related to Children and Improper Medicine Use--In
1989 NCPIE produced a referenced report entitled, ``Children and
America's Other Drug Problem: Guidelines for Improving Prescription
Medicine Use Among Children and Teenagers.'' Key findings from the
report included the finding that improper medicine use among children
is a widespread problem. Adolescents are even more likely not to take
medicine as prescribed than children under age 13. Four types of
improper medicine misuse commonly occur: 1) Stopping a medicine too
soon; 2) Not taking enough of a medicine; 3) Refusing to take a
medicine; 4) Taking too much of a medicine. The consequences of such
improper medicine use are serious: 1) Dangerous health outcomes; 2)
Inadvertent treatment errors; 3) Life-threatening adverse effects; 4)
Unpleasant side effects; 5) Unnecessary diagnostic and treatment costs;
and 6) Greater risk of accidental poisoning.
Select Best Practices, Programs or Policies that NCPIE Member
Organizations Employ to Enhance Medication and Patient Safety
NCPIE is pleased to share best practices, programs, or policies
that select member organizations employ to enhance safe and appropriate
medicine use and patient safety. The following represents only a
partial list of such members' work products:
American Pharmacists Association
American Society of Health System Pharmacists
Academy of Managed Care Pharmacy
Health Resources and Services Administration, Office of
Pharmacy Affairs
Institute of Safe Medication Use (ISMP)
Pharmacy Coalition Work Product
American Pharmacists Association (APhA)
--Medication Therapy Management (MTM) Central--APhA Web content;
comprehensive information about MTM including links to:
MTM Certificate Program
MTM Services Continuing Education Programs
APhA MTM Digest
100 MTM Tips for the Pharmacist
http://www.pharmacist.com/AM/Template.cfm?Section=MTM&Template=/
TaggedPage/TaggedPageDisplay.cfm&TPLID=87&ContentID=19154
--``Pharmacist Clinical Services Improve Health Care Quality, Lower
Health Care Costs--Potential Medication Therapy Management Impact: $30
Billion in Savings''
Information presented by APhA to demonstrate possible savings if
pharmacist clinical services were more widely available for the
following diseases: Diabetes, Cardiovascular Disease, and Asthma.
Includes the following data from the Department of Veterans Affairs
(VA): By extrapolating the average salary data for a pharmacist, the VA
expects to see an annual $368,000 in savings from each pharmacist by
providing clinical pharmacy services. (Schumock OT, Butler MC, Meek PD,
Vermeulen LC, Arondeker BV, Bauman JL. Evidence of the Economic Benefit
of Clinical Pharmacy Services: 1996-2000 Pharmacotherapy 2003;
23(1):113-132)
American Society of Health-System Pharmacists (ASHP)
ASHP supports all pharmacists being able to play a leadership role
in medication-use safety. In larger hospitals, a dedicated position is
necessary to oversee the management of medication safety initiatives.
This new position has emerged to provide leadership in medication-use
quality and safety: the Medication Safety Officer (MSO). The MSO is a
practitioner who serves as an authoritative leader within the
organization on safe medication use. While an MSO can be a nurse or
physician, this role is usually filled by a pharmacist or pharmacy
manager in the Department of Pharmacy. To become an MSO, requirements
include formal training in medication safety and quality best
practices. Pharmacists who choose to specialize in medication-use
safety undergo 10 years of educational training, including an
accredited postdoctoral residency training program. Job
responsibilities of an MSO include, but are not limited to, the
following:
1. Managing information on patients and medication
2. Overseeing processes for prescribing and monitoring use of
medication
3. Optimizing communication methods to minimize risk for errors
4. Minimizing potential for error in medication labeling,
packaging, and nomenclature
5. Standardizing administration, dosing, and storage of
medication
6. Overseeing preparation, distribution, dispensing, and
administration of medication
7. Evaluating and oversee acquisition, use, and monitoring of
medication delivery devices
8. Maintaining safe environmental conditions for patients and
staff
9. Ensuring healthcare staff competence, education, and
proficiency
10. Ensuring patient education
11. Maintaining quality processes and oversee risk management
12. Ensuring legal and regulatory compliance
13. Serving as a liaison to the public for the organization and
management
14. Evaluating integration of technology, automation, and clinical
information systems
15. Promoting Best Practices for safe medication use
16. Collaborating with other healthcare disciplines and hospital
leadership to coordinate system-wide medication safety initiatives.
ASHP compiles its policy positions, statements, guidelines,
technical assistance bulletins, therapeutic position statements,
therapeutic guidelines, and selected ASHP-endorsed documents in ASHP's
Best Practices for Hospital & Health-System Pharmacy. This compilation
is updated annually, and provides guidance and direction to ASHP
members and pharmacy practitioners and to other audiences who affect
pharmacy practice.
Academy of Managed Care Pharmacy (AMCP)
The Framework for Quality Drug Therapy (http://www.fmcpnet.org/
index.cfm?p=132D8447)
This uniquely designed self-assessment tool is intended to be used
by individual pharmacists and other healthcare practitioners and by
organizations of virtually any size, from a physician's office to a
large corporate health plan. The interactive tool provides individual
practitioners and organizations with an online step-by-step process to
identify, evaluate and improve upon specific task, skills and functions
that contribute to effective medication therapy management. By
answering a series of questions contained in the interactive self-
assessment tool, the program helps identify drug therapy management
areas ripe for improvement. The program then populates any one of three
action plan templates chosen by the user. The action plan template
provides a format for defining measurable goals, assigning
responsibilities, identifying available resources, and tracking
progress, thus beginning a continuous quality improvement process.
Health Resources and Services Administration, Office of Pharmacy
Affairs
``Patient Safety and Clinical Pharmacy Services Collaborative
Change Package,'' (PSCS; version 11, August 1, 2008). The ``Patient
Safety and Clinical Pharmacy Services Collaborative Change Package,''
is organized into strategies. Each strategy includes change concepts,
each of which is accompanied by action items (e.g., ``assess
organizational needs for quality . . .''). The Change Package also
denotes links to current corresponding national initiatives, helpful
tools and resources, and definitions relevant to the proposed material.
The following is one illustrative strategy:
Strategies to Achieve Accountability for Results
IV. Safe Medication Use Systems: Develop and operate by safe
medication-use practices
Key Change Concepts for Improved Patient Safety and Clinical Pharmacy
Systems
J. Systematically introduce and institutionalize safe
medication-use practices and monitoring procedures.
Suggested Action Items (Range from J1.-J11; Representative sample
below).
J1. Eliminate the practice of providing free samples, or
establish a strict set of guidelines for acceptance and monitoring of
samples based on a rational formula for the organization.
J2. Require double-checking, especially during the times when
pharmacist is unavailable (e.g., develop and utilize policies requiring
two nurses to verify the right drug when nurses access medication
storage).
J3. Write notes in a standardized way based on locally developed
guidelines shared among providers; for example, list ``do not use''
abbreviations on the medication form
Institute for Safe Medication Practices (ISMP)
ISMP Self-Assessments
The Institute for Safe Medication Practices (ISMP) makes available
to healthcare organizations several ISMP Medication Safety Self
Assessments. These tools are designed to help healthcare organizations
assess the medication safety practices in their respective institution
surrounding the use of medication therapy, identify opportunities for
improvement, and compare individual organizational experience with the
aggregate experience of demographically similar organizations.
The self-assessments contain items that address the use of
medications in the clinical setting, many of which are on the ISMP list
of high-alert medications. Many of the items included represent system
improvements and safeguards that ISMP has recommended in response to
analysis of medication errors reported to the USP-ISMP Medication
Errors Reporting Program, problems identified during on-site
consultations with healthcare organizations, and guidelines in the
medical literature. Available Self Assessments include:
Acute Care--ISMP Medication Safety Self Assessment for
Hospitals
2004 Self-assessment
2000 Self-assessment
Antithrombotic Therapy
Bar Coding Assessment
Community/Ambulatory Pharmacy
Physician Practices
ISMP Medication Safety Self Assessment for Automated
Dispensing Cabinets
Pharmacy Coalition Work Product
1. Principles of a Sound Drug Formulary System
A coalition of national organizations representing healthcare
professionals, government, and business leaders formed a working group
(Including the Department of Veterans Affairs. See Appendix III) to
develop a set of principles specifying the essential components that
contribute to a sound drug formulary system. The Coalition was formed
in September 1999 in response to the widespread use of drug formularies
in both inpatient and outpatient settings and the lack of understanding
about formularies among the public. The passage of Federal legislation
providing a prescription drug benefit for Medicare beneficiaries also
brought increased attention to the appropriate role and management of
drug formulary systems within drug benefit programs. This document
contains ``Guiding Principles'' that the Coalition believes must be
present for a drug formulary system to appropriately serve the patients
it covers. See: http://www.amcp.org/amcp.ark?p=AA8CD7EC
How The NCPIE Coalition Works to Meet its Mission
NCPIE works to meet its mission to ``stimulate and improve
communication of information on the appropriate use of medicines to
consumers and healthcare professionals,'' through both in-house
development and implementation of educational products or programs and
through convening or participating in collaborative programs with both
member and non-member organizations. Examples of both approaches
include:
Dedicated/Recurring Event of Observance
In October 1986, NCPIE conducted its first annual ``Talk
About Prescriptions'' Month. The purpose of ``Talk About
Prescriptions'' Month (TAP Month) is to help ensure that safe and
appropriate medicine use through high-quality medicine communication is
positioned as an important public health issue. TAP Month also provides
NCPIE a regularly-scheduled platform for announcing new educational
products, programs or services to promote its organizational mission.
The theme for NCPIE's upcoming, 24th annual TAP Month, October 2009 is,
Talk About Prescriptions: ``Communication is Key.''
Establish Key Partnerships
In-house development, January 2002 launch, and ongoing
implementation of ``Be MedWise'' to Promote Safe Use of Over-the-
Counter Medicines (www.bemedwise.org). NCPIE conceptualized this
ongoing, Web-based public education campaign and invited the Food and
Drug Administration and the American Pharmacists Association to
participate in its launch at a national Press Club media briefing. Dr.
Richard Carmona, M.D., MPH, FACS, U.S. Surgeon General, participated in
a subsequent media briefing in September 2003 to expand the scope of
the campaign. NCPIE also licenses content from the campaign to support
two statewide collaborative programs, ``Be MedWise'' Tennessee, and
``Be MedWise'' Arkansas. Lead State organizations are the Universities
of Tennessee and Arkansas' Cooperative Extension Services, the
University of TN College of Pharmacy and the Univ. of Arkansas College
of Pharmacy.
Convene Expert Project Advisory Team
Formulation of an external Project Advisory Team (PAT) to
assist in the development, promotion, and dissemination of a turn-key
educational workshop kit, ``Maximizing Your Role as a Teen Influencer:
What You Can Do To Help Prevent Teen Prescription Drug Abuse.''. The
PAT for this project, which will launch in October 2009 in conjunction
with NCPIE's annual ``Talk About Prescriptions'' Month campaign
includes representatives from 14 organizations.
NCPIE also convened an external Project Advisory Team for the
development, promotion, and 2007 launch of its ongoing online NCPIE
program, ``Medication Use Safety Training for SeniorsTM
(MUST for SeniorsTM).''
Participate in External Coalitions
NCPIE currently participates in the following external
coalitions or special projects:
National Coordinating Council for Medication
Reporting and Prevention (NCC MERP)
National Consumers League/Agency for Health Care
Research and Quality National Medication Adherence Public
Awareness Campaign
Safe Medication Disposal for ME (Maine) Program--
Member of project advisory team
``Follow Directions: How to Use Methadone Safely''
Campaign Partner
New England Health Care Institute (NEHI) medication
adherence improvement project
Maryland State Board of Pharmacy Acetaminophen
Safety Campaign
American Pharmacists Association Safe Use of
Acetaminophen Products Coalition
Use the Internet and (Pending) Use of Social Media
NCPIE currently maintains or promotes four educational
Web sites:
www.talkaboutrx.org--primary site; home for ``Talk About
Prescriptions'' Month;
www.bemedwise.org--safe use of over-the-counter (OTC) medicines;
www.mustforseniors.org--targeting older adults and caregivers;
www.learnaboutrxsafety.org--targeting families, including older
adults, caregivers, parents and children; developed collaboratively for
The Center for Improving Medication Management (SureScripts) who own/
maintain the site.
Upcoming campaign (online Tool Kit to address medicine
abuse on college campuses) will include outreach via social media,
including Facebook and Twitter).
I would once again like to thank you for inviting me to testify
before this Subcommittee. I appreciate the work of this Subcommittee on
Oversight and Investigations of the House Committee on Veterans'
Affairs. On behalf of all NCPIE member organizations I thank you for
your trust in our ability to assist you with this important work. I
look forward to answering any questions you might have.
Prepared Statement of Solomon Iyasu, M.D., MPH, Director,
Division of Epidemiology, Office of Surveillance and Epidemiology,
Center for Drug Evaluation and Research, Food and Drug Administration,
U.S. Department of Health and Human Services
INTRODUCTION
Mr. Chairman and Members of the Committee, I am Dr. Solomon Iyasu,
Director, Division of Epidemiology, within the Office of Surveillance
and Epidemiology in the Center for Drug Evaluation and Research (CDER)
at the Food and Drug Administration (FDA or the Agency), which is part
of the Department of Health and Human Services (HHS). I am pleased to
be here today to discuss FDA's role in identifying and communicating
drug safety issues, as well as our collaboration with the Department of
Veterans Affairs (VA). We will first discuss the importance of FDA drug
regulation, including how the Agency manages drug safety issues and
informs the public when drug safety concerns arise. We will also
discuss some specific examples of how FDA and the VA have collaborated
in furthering our mission to protect the public health and keep our
drug supply safe.
FDA DRUG REGULATION
FDA promotes public health through the regulation of prescription
and over-the-counter drugs, which are an increasingly critical
component in improving the health of many Americans. FDA is charged by
Congress with the authority to review new drug applications for safety
and effectiveness. FDA's drug review process is recognized worldwide as
the gold standard, and we actively monitor the scientific bases for our
processes to ensure that they reflect advances in medical science.
Approval of a drug product is based on FDA's acceptance and review
of data collected during the course of the drug's development,
including the results of clinical trials, demonstrating that the drug
is safe and effective for its intended use. At least half of the effort
by FDA's premarket reviewers is dedicated to the assessment of safety.
Major changes have taken place in how drugs are evaluated, including a
complete evaluation of their metabolism, their interactions with other
drugs, and potential differences of effectiveness or safety in people
of different genders, ages, and races. In addition, FDA staff perform
systematic assessments of safety that yield comprehensive reviews,
focusing on the potential problems with the greatest clinical
importance. Adverse reactions reported during the clinical trials of
the drug are included in the labeling information, even if they
occurred in a small number of individuals, so that health professionals
are aware of the scope of the potential reactions and can advise their
patients accordingly.
All drug products contain risks as well as benefits, and it is
often impossible to predict which individuals may have increased
sensitivity to particular drugs. Before approving a drug, FDA takes
into account the known risks associated with the drug, along with the
benefits the drug will provide. FDA's responsibilities for oversight of
the entire life cycle of drugs--from premarket drug testing and
development through drug approval, postmarket surveillance, and risk
management--have never been more important. No amount of premarket
study can provide all of the information about effectiveness or all the
risks of a new drug when it is used by the general population in the
myriad ways not studied during clinical trials. As a result, FDA's
postmarket drug safety program plays an essential role by collecting
and assessing information about adverse events and medication errors
identified after approval. A key role of our postmarket safety system
is to detect serious unexpected adverse events and take definitive
action when needed.
Health professionals may observe differences from clinical trial
results in both the incidence and/or types of adverse drug experiences.
FDA is committed to improving the ability of healthcare professionals
to predict which patients might experience adverse events with a given
drug. FDA continuously seeks to provide the means for translating new
scientific advances into benefits for patients (for example, biomarkers
and pharmacogenomics) to take advantage of new ways to monitor the
performance of marketed drugs, and to communicate this information to
healthcare professionals and patients to help ensure the safe use of
drugs.
Another critical aspect to drug regulation is the safety of
products imported into the United States. On July 1, 2008, FDA issued
the ``Import Safety-Action Plan Update.'' The update outlines the
significant progress FDA has made and the key steps that are planned
for the future to enhance the safety of imported goods. FDA has taken
strong enforcement actions, signed agreements with key trading
partners, hosted bilateral and multilateral discussions, shared
critical information on safety and best practices, and begun a process
to improve safety practices, both inside and outside of government. FDA
has increased its presence abroad by establishing offices in China,
India, Europe, and Latin America at present. FDA is seeking to ensure
that imported drug products are safe and effective prior to reaching
U.S. ports of entry. Among other things, FDA is pursuing this goal by
maximizing foreign product preapproval inspections, increasing FDA
inspections, increasing the sharing and use of foreign competent
authority inspection reports and other information, developing plans to
use third-party certification, and providing technical assistance to
countries that have less developed regulatory systems to ensure product
safety.
Below we will discuss how FDA manages drug safety issues in
general, and we will highlight initiatives in place to further enhance
FDA's postmarket drug safety monitoring program.
HOW FDA MANAGES DRUG SAFETY ISSUES
Once FDA approves a drug, the postmarket monitoring stage begins. A
drug manufacturer is required to submit regular postmarketing reports
to FDA on its drug. These reports include critical information about
adverse events associated with the use of one or more drugs. Reports
are submitted in an expedited fashion for serious and unexpected
adverse events, and periodically for other adverse events.
Manufacturers submit several other types of postmarketing reports,
including new clinical trial results. Also during this period, we
continuously receive adverse event reports directly from the public,
such as healthcare professionals and patients through our MedWatch
program. Stored in a computerized database, these reports are reviewed
and analyzed by FDA epidemiologists and safety evaluators to assess the
frequency and seriousness of the adverse events and to determine their
association, if any, with medication usage. An adverse event may occur
because of simple or complex reasons, including drug exposure, an
interaction between one or more drugs, other therapies, environmental
factors, an individual's characteristics, and underlying diseases. Our
response to information from this ongoing surveillance depends on an
evaluation of the aggregate public health benefits of the product
compared to its evolving risk profile.
Decisions about regulatory action in response to evidence of a drug
safety risk are complex, taking into account many factors. The actions
taken depend on the characteristics of the adverse events, the
frequency of the reports, the seriousness of the diseases or conditions
for which the drug provides a benefit, the availability of alternative
therapies, and the consequences of not treating the disease. As more
becomes known about the potential risks or benefits of a drug, often
its FDA-approved labeling will be revised so that it better reflects
information on appropriate use. If labeling alone is inadequate to
manage risks, additional actions may include revising drug names or
packaging, issuing ``Dear Health Care Professional'' letters (sometimes
referred to as ``Dear Doctor'' letters), disseminating educational/
special risk communications, requiring restricted distribution
programs, or withdrawing a drug's approval.
HOW FDA COMMUNICATES ABOUT DRUG SAFETY ISSUES
FDA uses a broad range of methods to communicate drug safety
information to the public. Certain forms of communication are targeted
to specific audiences (e.g., healthcare professionals or patients).
Others are directed at more than one group to ensure widespread
dissemination of information about important drug safety issues,
including emerging drug safety issues. FDA continuously evaluates its
communication efforts and modifies them to enhance their accessibility
and effectiveness. We welcome public comment at any time, suggesting
ways to improve our safety communications. The different types of drug
safety communications are described in more detail below.
Labeling. FDA-approved drug product labeling is the primary source
of information about a drug's safety and effectiveness, and it
summarizes the essential scientific information needed for the safe and
effective use of the drug. Labeling for prescription drug products is
directed to healthcare professionals but may include patient counseling
information as well. For some prescription drugs, such as oral
contraceptives and estrogens, FDA determined several years ago that the
safe and effective use of these drugs required that additional labeling
in nontechnical language be distributed directly to patients by their
healthcare professional or pharmacist (Title 21 of the Code of Federal
Regulations (CFR) 310.501 and 310.515). In addition, FDA may require
Medication Guides, a type of patient-directed labeling, for products it
determines pose a serious and significant public health concern (21 CFR
208) as part of a risk evaluation and mitigation strategy (REMS). FDA-
approved patient labeling also may be provided by manufacturers for
other drugs.
Early Communications about Ongoing Safety Reviews. Since August
2007, FDA has issued Early Communications about Ongoing Safety Reviews
to keep healthcare professionals and the general public informed of
postmarket safety issues that are currently being evaluated by FDA.
Early Communications are issued at the beginning of FDA's assessment,
prior to conclusive determination of the clinical or public health
significance of the information under evaluation, and before a decision
has been made about what regulatory actions, if any, should be taken.
They reflect FDA's current analysis of available data concerning these
drugs; posting the information as an Early Communication does not mean
that FDA has concluded there is a causal relationship between the drug
and the emerging safety issue. It also does not mean that FDA is
advising healthcare professionals to discontinue prescribing these
products. In general, Early Communications have included a time frame
for when FDA anticipates completing the safety review and providing
followup.
Public Health Advisories (PHAs). FDA issues PHAs to provide
information regarding important public health issues to the general
public, including patients and healthcare professionals. For example,
PHAs may highlight important safety information, inform the public
about the completion of FDA's evaluation of an emerging drug safety
issue, announce the implementation of methods to manage the risks
identified for a marketed drug, or provide other important public
health information.
PHAs regularly include recommendations to mitigate a potential risk
and often are issued in conjunction with other drug safety
communications, such as Health Care Professional Sheets. PHAs related
to drugs are available through CDER's Web site and disseminated via the
MedWatch Partners Program.
Health Care Professional Sheets. FDA issues Health Care
Professional Sheets, which provide a summary of important and often
emerging drug safety information for a particular drug or drug class.
Health Care Professional Sheets begin with a summary ``Alert''
paragraph, followed by more detailed sections explaining the Alert,
including clinical considerations or recommendations for the healthcare
professional, information that patients should be made aware of and
discuss with their healthcare professional, a summary of the data that
were the basis for the recommendations, and, when applicable,
implications of the Alert. Health Care Professional Sheets are intended
to provide adequate factual information to address potential questions
from patients and facilitate a healthcare professional's consideration
of the drug safety issue.
Other Methods of Communication. FDA continues to explore other
methods of making its written communications more effective, as well as
the use of other media such as podcasts, video broadcasts and
conference calls, to disseminate drug safety information.
Manufacturers also use various methods to communicate drug safety
information. For example, a sponsor may distribute a ``Dear Health Care
Professional'' letter to convey important information regarding a
marketed drug. ``Dear Health Care Professional'' letters may be used to
disseminate information regarding a significant hazard to health,
announce important changes in product labeling, or emphasize
corrections to prescription drug advertising or labeling.
INITIATIVES TO IMPROVE DRUG SAFETY
Drug Safety Oversight Board
The Drug Safety Oversight Board (DSB or the Board) was established
in 2005 to oversee the management of drug safety issues and
communication to the public about the risks and benefits of medicines.
The Board's responsibilities include conducting timely and
comprehensive evaluations of emerging drug safety issues for healthcare
professionals and patients, and ensuring that experts both inside and
outside of FDA give their perspectives to the Agency. The DSB also
makes recommendations regarding disputes over scientific data and
implements drug safety policies. In addition to making FDA's decisions
on drug safety more transparent, the Board is a means to assure the
public and medical profession that guidance has not been unduly
influenced by the pharmaceutical industry.
The DSB oversees drug safety issues within FDA's CDER, and is made
up of FDA and medical experts from other government health agencies and
government departments, including the VA. Along with other FDA
colleagues, I am a primary participant from the Office of Surveillance
and Epidemiology (OSE), in addition to the OSE Director and my
counterpart in OSE's Division of Pharmacovigilance. In addition to the
VA, other Federal agency Board members include representatives from the
National Institutes of Health, the Centers for Disease Control and
Prevention, the Agency for Health Care Research and Quality, and the
Department of Defense.
As a result of its partnership with FDA on the DSB, the VA shared
the results of its own analysis involving the pain reliever
propoxyphene with FDA. Based on these data as well as other data, in
July 2009, FDA took action to require manufacturers of propoxyphene-
containing products to strengthen the label emphasizing the potential
for overdose when using these products, and to provide a medication
guide to patients stressing the importance of using the drugs as
directed. Among other things FDA is doing to further assess the safety
of this product, the Agency is working with the VA to explore whether
we can study how often the elderly are prescribed propoxyphene instead
of other pain relievers and the difference in the safety profiles of
propoxyphene compared to other drugs.
Other FDA/VA Collaborations
Collaborations between the VA and CDER's Office of Surveillance and
Epidemiology, as well as with other FDA Centers, enhance our
understanding of postmarket safety issues occurring in FDA-regulated
products.
In January 2007, and again in 2008, FDA and the VA signed a
Memorandum of Understanding (MOU) for sharing information to enhance
postmarket surveillance efforts and other drug and vaccine safety
projects. The goals of the collaboration are to explore ways to promote
efficient use of tools and expertise for product risk identification,
validation, and analysis and to build infrastructure and processes that
meet shared needs for evaluating the safety, efficacy, and use of
drugs, biologics, and medical devices.
Also, in August 2008, FDA and the VA signed an InterAgency
Agreement (IAA), which allowed FDA to provide funding to the VA for
work on safety issues of mutual interest. The IAA allowed funding for
personnel time and programming costs associated with analysis of VA
data to explore questions of interest that were raised by FDA, but also
of interest to VA. This agreement is currently in the process of being
renewed for another year.
In addition, CBER and the VA continue collaboration on the Vaccine
Safety Adverse Event Tracking and Safety Pilot Project. The focus of
this initiative is the influenza immunization pilot study in the
Central Veterans Health Administration (VHA) Database which will track
adverse events after administration of influenza vaccine in a cohort of
approximately 1 million VHA patients. It is anticipated that an
additional 900,000 more persons will be added to the Central Database
(bringing the total number of persons in the cohort to 2 million) in
October 2009.
Also, the VA and FDA's CDRH are working together to better
understand adverse events related to cardiac catheterization
procedures. The VA has developed a workflow system that allows for the
integration of adverse event data reporting for review and discussion
at a later date. This information is then shared with CDRH at regular
intervals. The VA and CDRH are developing ways to share information in
a similar fashion for endoscopes.
Food and Drug Administration Amendments Act of 2007 (FDAAA)
As you know, in September 2007, Congress passed FDAAA, which
included new resources for medical product safety and new regulatory
tools and authorities to ensure the safe and appropriate use of drugs.
For example, under FDAAA, FDA can require drug sponsors to make certain
safety-related labeling changes and conduct postmarketing studies and
clinical trials instead of relying on voluntary actions. In addition,
if FDA determines that a REMS--risk evaluation and mitigation
strategy--is necessary to ensure that the benefits of a drug outweigh
the risks of the drug, FDA can require manufacturers to submit a REMS
when a drug comes on the market, or later if FDA becomes aware of new
safety information.
Sentinel Initiative
FDAAA requires the HHS Secretary to develop methods to obtain
access to disparate data sources and to establish a postmarket risk
identification and analysis system to link and analyze healthcare data
from multiple sources. The Sentinel Initiative is FDA's response to
this mandate. Its goal is to build and implement a new active
surveillance system that will eventually use electronic health
information to monitor the safety of all FDA-regulated products. On May
22, 2008, FDA launched the Sentinel Initiative with the ultimate goal
of creating and implanting the Sentinel System--a national, integrated,
electronic system for monitoring medical product safety. The Sentinel
Initiative is a long-term effort that must proceed in stages, and this
effort is well under way. FDA is collaborating with the Federal and
private sector in various activities that will inform the development
of this system.
In December 2008, FDA held a public meeting on the Sentinel
Initiative to obtain input from stakeholders about the structure,
function, and scope of the project. The Director for the Center of
Medication Safety at the VA was among the participants at this day-long
meeting, presenting on the issue of risk communication.
As an initial step to creating the Sentinel System, FDA is
initiating various pilot efforts to further the science of medical
product surveillance. One of these pilots, known as Mini-Sentinel II,
will include our Federal partners. We look forward to the VA's
participation in this effort. The effort involves creating a
distributed system that will focus on developing methodologies to
obtain more information on emerging drug safety issues. Mini-Sentinel
II is a small-scale effort to conduct the types of safety evaluations
that FDA envisions doing on a larger scale with the Sentinel System.
Medical product-adverse event pairs will be selected based on
identification of priority safety issues from FDA's medical product
Centers. Then a protocol for a query will be developed and agreed to by
participating Federal partners. Subsequently, each participating
Federal partner will perform the analysis in their database. The query
will be translated into analytical code by the partner specifically
developed and suited for the partner's database structure. Summary
results of each Federal partner's analysis will be submitted to FDA for
further consideration. Lessons learned from this pilot will inform the
development of the Sentinel System.
The Sentinel System will augment the Agency's current postmarketing
surveillance tools and strengthen FDA's ability to ensure that safe and
effective new drugs are available to the public and that the risks of
marketed drugs are well understood.
CONCLUSION
FDA has a critical role in the detection and management of safety
issues that are identified after a drug is approved, including a
critical role in communicating information to the public. Our goal,
regardless of the communication tool employed, is to make the most up-
to-date drug safety information available to the public in a timely
manner so that healthcare professionals and patients can consider the
information when making decisions about medical treatment and be aware
of uncertainties in the data. Our ability to fulfill our mission is
enhanced by our partnerships with patients, physicians, pharmacists,
industry, State regulators, and other Federal partners like the VA.
Together we can help ensure the safe use of marketed drugs by providing
the best possible information to the American public.
Once again, thank you for the opportunity to testify before the
Committee today. We are happy to respond to questions.
Prepared Statement of Belinda J. Finn, Assistant Inspector General
for Audits and Evaluations, Office of Inspector General,
U.S. Department of Veterans Affairs
INTRODUCTION
Mr. Chairman and Members of the Subcommittee, thank you for the
opportunity to discuss systemic weaknesses impacting the Veterans
Health Administration's (VHA) ability to accurately account for its
inventories of non-controlled drugs in VHA medical facilities and
consolidated mail outpatient pharmacies (CMOPs). We issued two recent
Office of Inspector General (OIG) reports, Audit of VA Consolidated
Mail Outpatient Pharmacy Inventory Accountability and Audit of Veterans
Health Administration's Management of Non-Controlled Drugs, related to
this issue. I am accompanied by Irene Barnett, Ph.D., Audit Manager,
Bedford Office for Audits and Evaluations, OIG.
BACKGROUND
VHA medical facilities and CMOPs dispensed about 126 million
prescriptions for VA patients and spent $3.7 billion on pharmaceuticals
in fiscal year (FY) 2008. Prescription drugs are generally categorized
as controlled or non-controlled. Non-controlled drugs are not regulated
under the Controlled Substances Act 1970 due to the reduced risk for
abuse and addiction. Approximately 95 percent of the pharmaceutical
spending was on non-controlled drugs. Also, non-controlled drugs are
not subject to the same stringent inventory and oversight controls that
controlled drugs are subject to, yet some non-controlled drugs are
expensive, others contain active ingredients that can be used to
manufacture illicit drugs, and some are considered to be at high risk
of diversion given the high street value of the specific drug. Within
VHA, prescription medications are generally dispensed directly to
veterans by facility inpatient or outpatient pharmacies or by mail from
a medical facility's pharmacy or a CMOP. The CMOPs spend about twice as
much money on pharmaceuticals than VHA medical facilities. As part of
our recent oversight of pharmaceutical inventories, we visited two of
VHA's seven CMOP operations in Charleston, SC, and Dallas, TX, and six
of VHA's medical facilities in Fayetteville, NC, New York, NY, Long
Beach, CA, Wichita, KS, Seattle, WA, and Spokane, WA. In addition, we
also analyzed the inventory records of over 30 VA medical centers.
We reported VHA medical facilities and CMOPs could not accurately
account for non-controlled drug inventories because of inadequate
inventory management practices, recordkeeping, and inaccurate pharmacy
data. VHA needs to improve its ability to account for non-controlled
drugs to reduce the risk of diversion and standardize its pharmacy
inventory practices among its medical facilities and CMOPs. Without
improved controls, VHA cannot ensure its non-controlled drug
inventories are appropriately safeguarded, nor can VHA accurately
account for these expensive inventories.
FINDINGS
VHA cannot accurately account for its non-controlled drug
inventories because it has neither implemented nor enforced sufficient
controls to ensure pharmacy inventory practices are standardized and
pharmacy data is accurate. Furthermore, VHA does not currently require
its facilities to monitor any non-controlled drugs on an ongoing basis.
We found that both CMOPs and VHA medical facilities maintain
inventory management controls and use systems of inventory control that
rely upon annual physical counts of drugs. However, we identified
significant weaknesses in how well the facilities perform physical
counts and adjust inventory records.
Inadequate Inventory Controls Led to Significant Inventory Variances
VHA Handbook 1761.2, VHA Inventory Management, requires that an
annual wall-to-wall physical inventory be performed for all items. In
addition, VHA's Pharmacy Inventory Guidelines state that inventory
quantities of an open product should be estimated to the nearest tenth
of a bottle. The CMOPs did not perform complete annual physical counts
for all items, as required and inconsistently estimated their inventory
quantities of open products. Additionally, the inventory management
system used by most CMOPs does not always track drug dispensing. CMOP
personnel physically count all drugs that are manually dispensed, but
they do not count all drugs dispensed from individual pill dispensers
because they considered the physical count of open products to be too
labor intensive.
We performed inventory analyses at two of VA's seven CMOPs
supporting operations nationwide and identified pill variances ranging
from a negative variance of 3,092 pills to a positive variance 192,498
pills. The existence of these variances demonstrated the unreliability
and inaccuracy of the CMOPs' inventory records. Further, 14 of 18
pharmaceutical items that we reviewed had positive variances. These
variances can enable and mask a deliberate diversion and loss of drugs.
CMOP personnel were unable to explain the positive or negative pill
variances between the actual pill counts and the amounts we computed as
the ending inventory. However, they indicated the variances might be
the result of the inventory management system inaccurately tracking
dispensed pills and because annual wall-to-wall physical inventories
were not completed for all drugs.
Physical inventories performed within VA medical facilities did not
provide adequate accountability for non-controlled drugs. VHA requires
pharmacy managers to verify that physical inventories are conducted
completely and accurately by conducting random checks of at least 25
items. None of the pharmacy managers at the six VHA medical facilities
we visited were able to demonstrate compliance with this requirement.
In fact, we also found that three VHA facilities had not conducted
annual physical inventories in 2007 and one did not complete the annual
physical inventory in 2008 by the deadline.
VHA pharmacy managers at 9 of the 31 facilities reported that
pharmacy personnel are not consistently entering information on
quantities of drugs transferred to secondary locations, such as an
emergency room or inpatient ward, into the Veterans Health Information
System and Technology Architecture (VistA). This results in incomplete
information and may explain the negative inventory discrepancies we
calculated for selected drug items at many facilities. Dispensing data
on non-controlled drug inventories will be understated at facilities
where pharmacy personnel are not consistently and accurately entering
information on drug transfers in VistA.
We were particularly concerned about negative inventory
discrepancies we identified for at least one drug of the five selected
for testing at all 31 VHA medical facilities. Negative inventory
discrepancies reflect an ending inventory that was lower than it should
have been given the quantities of drugs purchased and dispensed by the
facility. We estimated that the 31 medical facilities were unable to
account for about 380,000 pills, or 8 percent of their total available
inventory. We considered the inventory variances to be significant.
Physical inventories act as a check on the effectiveness of other
inventory controls. While VHA requires its facilities to conduct annual
physical inventories of non-controlled drugs, it does not ensure
inventory data is accurate or use the data as a tool to identify drug
loss or possible drug diversion. We identified multiple weaknesses in
VHA's annual physical inventories of non-controlled drugs. For example,
VHA does not require facilities to maintain their annual physical
inventory reports for a certain time or record inventory results in a
standardized electronic format that could enable a centralized analysis
of inventory information. According to VHA officials, the current VistA
system cannot provide information to account for a facility's inventory
accurately because it lacks the capability to maintain a perpetual
inventory.
Other inventory management practices were also reducing the
integrity of available inventory management information. For example,
CMOPs did not have a policy for controlling and monitoring adjustments
to drug inventory records. When CMOPs conduct a physical count for a
particular drug and a variance exists between the physical count and
the system balance, CMOP personnel simply adjust the inventory system
balance so that the inventory balances correspond to actual physical
counts. Individuals can make an unlimited number of adjustments in any
quantities. Further, CMOP management was not verifying adjustments made
to drug inventory balances.
CMOPs did not adequately secure, track, and monitor non-controlled
drugs being held for return credit or consistently comply with existing
VHA policies. We identified instances where CMOP staff did not maintain
a record of non-controlled drugs held for return, or reconcile credits
received to the list of non-controlled drugs returned. VHA Directive
2008-021, Monitoring of Non-Controlled Substance Medication Returns,
requires non-controlled drugs held for return credit to be secured,
tracked, and monitored to reduce the possibility of fraud and maximize
revenues received through drug returns.
We found that physical security controls were in place to prevent
the unauthorized physical removal of pharmaceuticals at the two CMOPs
we visited. However, we identified security weaknesses in CMOP
inventory information systems. For example, we identified 61 users at
the two CMOPs we visited whose inventory management system access
allowed them to order, receive, and adjust non-controlled drug
inventories. Inventory management system controls were not effectively
tracking system user activity to determine if an employee had used all
three permissions that allowed users to order, receive, and adjust
against the same drug.
Further, CMOP inventory information systems were also at increased
risk of inappropriate alterations because generic user accounts enabled
employees to order a drug through the ordering system without being
identified as a specific user. The same employee could then use their
unique ID and password to reduce the inventory balance and divert the
drug.
Drug Transactions Not Accurately and Consistently Recorded
VHA has established some procedures regarding the use of VistA to
record drug transactions; however, controls are not in place to ensure
that accurate and complete information on drug transactions is
captured. For example, we found that local pharmacy personnel are not
consistently recording information in VistA on transactions such as
pharmacy stock transfers and drug returns. Prescription labels can be
reprinted when an original label is damaged although the reprint
function in VistA should not generally be used to dispense drugs. Some
dispensing data may be incomplete because pharmacy personnel are
inappropriately using the label reprint function in VistA to dispense
drugs. These practices negatively impacted the reliability of inventory
information.
Pharmacy personnel from six medical facilities we visited are using
the reprint function to dispense drugs to patients, which can affect
the accuracy of drug dispensing captured in VistA. The VistA
application lacks adequate controls to track why a reprint label is
being generated or to ensure that the function is being appropriately
used. Further, VistA captures the quantity of drugs dispensed using the
reprint function only if the original prescription was not released to
the patient. Without procedures to standardize the use of the reprint
function and to capture data on drug transfers, accountability of drug
inventories is compromised.
VHA facilities are not consistently capturing information on the
quantities of drugs originally dispensed and then returned to inventory
for reuse. Pharmacy managers at VHA facilities told us some personnel
are returning drugs to inventory without adjusting inventory records in
VistA, which inflates a facility's dispensing data. We calculated a
positive inventory discrepancy for at least one drug at 24 of 31 VHA
medical facilities where we specifically analyzed inventory
information. We estimated that these facilities had an excess of about
87,000 pills--or 10 percent--available to dispense. These pills are
available to dispense or divert since they do not exist according to
the inventory records.
The VHA Directive 98-020, Drug Accountability Software, which
required facilities to monitor at least 20 non-controlled drugs for
possible diversion, expired in 2003. At the time of our audits, VHA had
not provided facilities with technical guidance on how to monitor non-
controlled drugs on an ongoing basis to detect diversion, or taken
steps to improve the usefulness of its annual physical inventory
information.
Most pharmacy managers in VHA medical facilities reported that they
monitor at least one non-controlled drug for diversion on an ongoing
basis, with most monitoring one to five drugs. Typical action includes
comparing data on drug purchasing and dispensing to identify
unaccounted for drugs. The willingness to monitor certain non-
controlled drugs in the absence of VHA policy is a positive action.
However, over one-third of pharmacy managers reported that they lack
adequate information to monitor non-controlled drugs for diversion.
Given the number of high-risk non-controlled drugs medical facilities
maintain in stock, VHA needs to identify certain high-risk drugs that
should be monitored and provide facilities with guidance on how to
monitor and safeguard these drugs on an ongoing basis.
Overall, both VHA's VistA and CMOP inventory management software
require improvements to allow medical facilities and CMOPs to better
account for pharmacy inventory. In 2003, VHA initiated the Pharmacy Re-
engineering project to make improvements to VistA. The project was
slated for completion in 2005, but this project has experienced
significant delays. Current schedule projections are that the project
may not be completed until 2014. Since needed upgrades may take years
to be fully implemented, it is vital that VHA take more immediate
action to improve accountability over non-controlled drug inventories.
CONCLUSION
With pharmaceutical expenditures exceeding $3.7 billion in FY 2008
and future costs expected to increase, VHA needs accurate inventories
and strong recordkeeping to account for non-controlled drug
inventories. OIG audits reported large variances in the amount of non-
controlled drugs at VHA medical facilities and CMOPs and concluded that
VHA does not have reliable inventory information that could detect the
loss or unauthorized diversion of drugs. The implementation and
enforcement of inventory controls to provide accurate and complete
information is imperative to VHA's ability to account for, manage, and
safeguard non-controlled drugs.
We recommended the Under Secretary for Health take actions to
improve accountability over non-controlled drugs, including:
Enforcing requirements for conducting annual wall-to wall
inventories.
Ensuring annual physical inventory reports are reasonably
accurate and pharmacy managers are held accountable for the accuracy of
annual inventories.
Developing policy and establishing controls to monitor
and control adjustments to drug inventory records.
Enforcing compliance with the policy for returned drugs.
Establishing procedures that restrict a single user from
ordering, receiving, and adjusting against the same drug and removing
generic user IDs and passwords.
Developing procedures to identify high-risk non-
controlled drugs and requiring pharmacy managers to monitor those
drugs.
Developing appropriate internal controls to ensure
information on drug dispensing, drug transfers, and drug returns is
accurately and consistently recorded in VistA.
Limiting access to the VistA label reprint function to
appropriate pharmacy personnel.
The Under Secretary for Health agreed with our findings and
recommendations to improve accountability over non-controlled drug
inventories. VHA provided acceptable implementation plans to address
the recommendations. We will followup on the implementation of actions
to address the report recommendations.
Mr. Chairman, thank you for the opportunity to discuss these
important issues. We would be pleased to answer any questions that you
or other Members of the Subcommittee may have.
Prepared Statement of Michael A. Valentino, R.Ph., MHSA,
Chief Consultant, Pharmacy Benefits Management Services, Veterans
Health Administration, U.S. Department of Veterans Affairs
Mr. Chairman, Ranking Member, and Members of the Committee: thank
you for providing me this opportunity to discuss the Department of
Veterans Affairs' (VA) Pharmacy Benefits Management Services (PBM)
program, including our national Formulary and patient safety
initiatives. I am accompanied today by Dr. Chester B. Good, Chair of
the VA Medical Advisory Panel and Dr. Paul Tibbits, Deputy Chief
Information Officer for Enterprise Development.
Drug therapy is an essential component to quality preventative,
curative, and post-operative healthcare. Each Veteran enrolled in the
VA healthcare system is eligible to receive prescription medications,
over-the-counter medications, and medical and surgical supplies under
VA's comprehensive medical benefits package. Generally, these
pharmaceuticals must be prescribed by a VA provider and are made
available via the VA National Formulary process. In 2008, VA provided
approximately 126 million outpatient prescriptions to more than 4.4
million patients. Our error rate for these prescriptions is very low;
less than 1 in every 294,000. I can confidently say that VA is meeting
the pharmaceutical needs of Veterans and that we are striving every day
to provide even better care to more of America's heroes. My testimony
will describe how VA manages pharmacy benefits, the offices and
procedures we have in place to ensure Veterans receive safe and quality
care, and discuss VA's National Formulary. Before concluding, my
statement will also provide information on VA's recently initiated
Medication Reconciliation program.
Pharmacy Benefits Management
VA's Pharmacy Benefits Management (PBM) program works to enhance
the clinical outcomes and improve the health of Veterans through the
appropriate use of pharmaceuticals. PBM provides leadership and
governance for pharmaceutical activities and professional pharmacy
practice in the Veterans Health Administration (VHA) and provides
advice and support regarding pharmaceutical issues to Veterans, the
Under Secretary for Health, field directors, and pharmacy staff across
the system. The PBM organization consists of six primary specialty
areas: the Clinical Informatics section; the Consolidated Mail
Outpatient Pharmacy (CMOP) program; Adverse Drug Event Reporting (VA
ADERS); Emergency Pharmacy Services (EPS); VA National Formulary (VANF)
management; and the VA Center for Medication Safety (VA MedSAFE).
Clinical Informatics
The PBM Clinical Informatics section provides operational oversight
to the information systems used by PBM and all pharmacy operations
nationwide. This section plans and establishes the mechanisms by which
VA meets general program goals for developing and maintaining a
nationwide pharmacy information system--the Pharmacy Re-Engineering
(PRE) project. The VA PRE project being executed by the VA Office of
Information and Technology will provide a system to enhance patient
safety and encourage the appropriate use of pharmaceuticals by
providing streamlined decision-making information to clinical staff in
an integrated fashion.
PRE will provide a flexible technical environment to adjust to and
standardize future business conditions while meeting the dynamic needs
of the clinical environment. This system will improve major
functionalities, including medication order checks, and will provide
prescribers with access to pharmacy knowledge systems that can reduce
the potential for adverse drug events, improve efficiency by
streamlining order processing and dispensing, reduce inventory costs
and improve inventory accountability by providing automated tools to
track inventory, and improve patient outcomes through medication
utilization reporting and monitoring. Our focus, as always, is on the
Veteran, and this PBM program provides robust decision support and
patient safety features.
An example of how PRE will be used to improve operations is
demonstrated by the finding of the Department of Veterans Affairs
Office of the Inspector General (OIG) report 08-01322-114 dated June
23, 2009, that reviewed VHA's management of non-controlled drugs. The
report states that, ``VHA cannot accurately account for its non-
controlled drug inventories because it lacks effective controls and
reliable information to do so.'' PRE would assist VA in providing more
effective controls. Until automated inventory management tools are made
available through PRE, PBM is addressing the OIG findings by educating
field staff and developing guidance specific to OIG's recommendations.
These interim measures include conducting training on existing
requirements, implementing tracking requirements for a sample of high
cost/high risk drugs as recommended by OIG, and establishing triggers
that warrant focused reviews.
Consolidated Mail Outpatient Pharmacy
There are seven VA CMOP facilities in the National VA CMOP system.
These facilities are located in Charleston, SC; Dallas, TX; Hines, IL;
Leavenworth, KS; Murfreesboro, TN; Chelmsford, MA; and Tucson, AZ.
Together, they interactively provide pharmaceutical support services to
VA healthcare facilities located within defined respective CMOP service
areas throughout the United States. These service areas include the 21
Veterans Integrated Service Networks (VISN's) in the VA healthcare
system, the Civilian Health and Medical Program for the Department of
Veterans Affairs (CHAMPVA), and the Department of Defense's (DoD's)
Naval Medical Center in San Diego, CA. CMOPs support VA's healthcare
mission through advanced automated production technologies to dispense
and mail prescriptions to eligible Veterans. This ensures each Veteran
receives his or her prescriptions in the most timely, accurate and cost
effective manner as possible. Three of five CMOP performance metrics
currently exceed six sigma performance.
VA's OIG Report 09-00026-143, dated June 10, 2009, reviewed CMOP
contract management. The report found that, ``. . . the National CMOP
Office generally complied with Federal and VA acquisition requirements
when developing, competing, and monitoring contracts . . .'' In
addition, the OIG auditors ``. . . found no evidence of contract
overpayments through (their) review of contract charges where
documentation was available . . .'' However, opportunities for
improvement exist in a number of areas.
Until 2007, each CMOP director was responsible for acquiring the
services and supplies the CMOP needed. CMOPs obtained contracting
support primarily from local VISNs or VA medical centers. In 2007, PBM
initiated significant changes in CMOP acquisition management. The
National CMOP Office added a contracting and logistics section and
centralized contracting. Each CMOP also hired a logistics manager to
strengthen purchasing and inventory controls at the CMOP level. In
December 2008, under the terms of a Memorandum of Understanding (MOU)
between PBM and the VA Office of Acquisition and Logistics' National
Acquisition Center (NAC), the National CMOP Office transferred the
responsibility and staff for all CMOP contracting to the NAC.
The National CMOP Office has established a management review
process for determining CMOP contract needs and evaluating the cost-
effectiveness of procurement alternatives. A process and policy have
been issued and the PBM Associate Deputy Chief Consultant for CMOP
oversees the process. The NAC has procedures to assure compliance with
the Federal Acquisitions and VA Acquisition Regulations. The CMOP has
increased the number of trained Contracting Officers Technical
Representatives (COTRs) from 37 to 75 to provide better contract
oversight and ensure contractor performance. These changes will
strengthen CMOP contract management and oversight functions and address
findings in the OIG report.
Adverse Drug Event Reporting
Post-marketing drug surveillance is vital to reporting adverse drug
events (ADEs) to the Food and Drug Administration (FDA) and VHA. A
cornerstone of this approach is collecting and evaluating reports of
ADEs through voluntary reporting by healthcare professionals. The
safety profile of any drug or pharmaceutical evolves over time as new
information is discovered when healthcare providers offer it to larger
populations and sub-groups not previously studied during clinical
trials. Because the electronic medical record is able to link
prescription data to clinical outcomes at the patient level, VA is
uniquely able to identify and track drug safety issues. VA has the only
national system for electronic reporting of ADEs through its innovative
VA Adverse Drug Event Reporting System (VA ADERS). By analyzing this
computerized database, VA is able to identify drug safety signals,
assess significance of external drug safety issues in our own patients,
and track trends of known drug safety issues almost instantaneously.
Emergency Pharmacy Services
The Emergency Pharmacy Services section is responsible for
procuring, storing, and maintaining emergency pharmaceutical and
medical or surgical supply items for the VA Pharmaceutical Cache
Program. This section works closely with the VA Office of Public Health
and Environmental Hazards' Emergency Management Strategic Healthcare
Group to ensure activation readiness of emergency supplies at VA
Medical Center storage sites nationwide. In addition to maintaining
VA's emergency pharmaceutical capabilities, Emergency Pharmacy Services
staff can deploy VA's Mobile Pharmacies to provide local support in
cases of national emergencies, such as a hurricane or other event, or
in response to a pandemic disease, under the guidelines of VA's
emergency response plan to ensure continuity of care and supplies to
Veterans, no matter the circumstances.
National Formulary Management
In 2009, VA consolidated all of its formularies into a single VA
National Formulary (VANF). The PBM office in Hines, Illinois, is the
organizational entity responsible for coordinating the development,
maintenance, and implementation of the VANF. Two groups, the VA Medical
Advisory Panel (MAP) and the VISN Pharmacist Executives (VPE) Committee
actively manage the VANF. The MAP provides clinical oversight of the
formulary process and is comprised of practicing VA physicians, PBM
clinical pharmacists and a physician from DoD. The VPE Committee is
comprised of senior VISN pharmacists who represent each VISN Formulary
Committee, a pharmacist from the Indian Health Service, and pharmacists
from DoD; it provides both clinical and operational oversight of the
formulary process.
PBM pharmacists support the MAP and VPEs by monitoring the medical
literature, scientific research and VA outcomes data to identify
evidence that may support adding drugs to or deleting drugs from the
VANF and by drafting evidence-based prescribing guidance. VA develops
guidance on the pharmacologic management of common and high-cost
diseases and collaborates with clinical experts within the Department
to develop or refine guidance when necessary. VA disseminates the
guidance throughout the Department for peer-review prior to being
presented to the MAP and VPEs for consideration. PBM has also developed
mechanisms for system-wide collection, analysis, trending and reporting
of ADEs.
PBM is also responsible for developing strategies for including a
drug class under a National Contract and monitoring trends regarding
product utilization with Pharmaceutical Prime Vendor purchases.
Pharmacists from DoD, VA, the Indian Health Service, and the Bureau of
Prisons discuss drug classes with potential for joint national
contracting. VA representatives meet with manufacturers for selected
drug classes and develop solicitation requirements for use by VA's NAC.
PBM reviews manufacturer incentive proposals, coordinates price and
clinical information as well as contractor performance when considering
renewal options for multiyear contracts, and collaborates with VA
contracting officers, counsel, acquisition review, and VA field
personnel regarding contract issues.
VA's Formulary Management Process is stipulated in VHA Handbook
1108.08, ``VHA Formulary Management Process,'' which was last updated
on February 26, 2009. This document provides guidance to the Deputy
Under Secretary for Health for Operations and Management, VA's MAP, the
PBM Chief Consultant, VISN Directors, VISN Pharmacist Executives,
Facility Directors, Facility Pharmacists, and VA prescribers.
VA Center for Medication Safety (VA MedSAFE)
PBM strives to ensure that Veterans receive the right medication,
in the right dose, at the right time. VA's efforts for safe medication
use are supported by the Computerized Patient Record System (CPRS),
electronic medication order entry, automated prescription fulfillment,
and the Bar Code Medication Administration (BCMA) system. The
electronic health record (EHR) currently provides automated checks for
allergies and possible drug interactions, further improving patient
safety and care. VA's Center for Medication Safety (VA MedSAFE) is a
national, comprehensive pharmaco-vigilance program that emphasizes the
safe and appropriate use of medications. VA MedSAFE utilizes different
methods and tools, including passive and active surveillance, to
continuously monitor for potential ADEs, including the use of VA ADERS
as previously described.
An ADE is defined as an unintended effect of a drug that occurs
secondary to drug administration. In many instances, VA MedSAFE
directly and promptly notifies providers across VA's healthcare system
if patients are at risk through its Risk Reduction efforts. VA, DoD and
FDA have a MOU that allows close collaboration on specific post-
marketing surveillance efforts and other drug and vaccine safety
projects. These efforts are conducted through FDA's newly established
Sentinel Initiative and its Office of Surveillance and Epidemiology's
Center for Drug Safety and Epidemiology Research. Medications and
prescriptions are essential to effective healthcare management, but
inaccuracies can have severe repercussions.
Evaluating preventable ADEs, providing interventions to decrease
preventable ADEs, and educating the field on best practices reduce the
likelihood of ADEs occurring. By conducting and promoting medication
safety projects at the regional and national levels, VA provides safe
and effective pharmaceutical care to Veterans. Through the national
roll-up system and data analysis provided by VA MedSAFE, each facility
and VISN can benchmark themselves against national trends. We are
unaware of any other healthcare system with as robust and well-
developed a system for tracking, assessing and acting on drug-related
safety issues within their patient population.
VA provides consumer medication information sheets on each new and
renewed prescription. VA is highly engaged with patient education on
medications, with local medical centers developing policy for teams of
clinicians to provide medication education, involving physicians, nurse
practitioners, physician assistants, clinical pharmacy specialists,
pharmacists, nurses, and other allied healthcare providers. Clinical
Pharmacy Specialists and clinical pharmacists are key members of the
healthcare team and can assist in optimizing drug therapy and improving
medication safety for outpatients.
Medication Reconciliation, a Joint Commission National Patient
Safety Goal, is a process which mitigates the risk of ADEs that occur
at transitions of care. It does this by addressing discrepancies
between a patient's accounting of his or her medication use and the
medication lists in the medical record every time a medication is
dispensed, changed, or added to the medication regiment. There are many
barriers to implementation including interoperability, software
development, staff and organization adoption, and a changing Joint
Commission National Patient Safety Goal.
The VA Medication Reconciliation Initiative, launched in December
2008, is tasked with facilitating safe, high quality, effective, and
above all, Veteran-centered medication reconciliation throughout the VA
system. This multidisciplinary effort includes a VA Medication
Reconciliation Toolkit, Educational Video, Facility Monitor, External
Peer Review Process, and patient informational Web site called
``Medications: Play it Safe!'' on the My HealtheVet Web site. This
initiative's workgroups continue to improve patient and staff resources
and tools to improve documentation and monitoring of this process. In
the coming months, we will continue to bring together VA innovators
with those in DoD and the private sector to establish a world-class
medication reconciliation program for Veterans and to provide guidance
for this challenging endeavor.
Conclusion
Mr. Chairman, VA has developed a remarkable pharmacy benefits
management system that provides Veterans safe and effective medication
to improve their healthcare. Our National Formulary is based on the
best clinical research and leverages the size of our patient population
and Department to procure medications at a low cost. Thank you again
for the opportunity to testify. My colleagues and I are prepared to
answer your questions.
Statement of American Federation of Government Employees, AFL-CIO
The American Federation of Government Employees (AFGE) appreciates
the opportunity to present its views on veterans' pharmaceutical needs.
AFGE represents approximately 180,000 employees in the Department of
Veterans Affairs (VA), more than two-thirds of whom are Veterans Health
Administration (VHA) professionals on the frontlines treating the
physical and mental health needs of our veteran population.
Recruitment and Retention of VA Pharmacy Workforce
VHA ranks pharmacists third among the top ten occupations as
national priorities for recruitment and retention. (See VHA's Workforce
Succession Strategic Plan for FY 2008-2012, page 30). According to the
VA's exit survey (page 34), career advancement is the most common
reason for pharmacists to leave the VA, followed by compensation.
VHA, the Bureau of Labor Statistics and other public and private
sources project a growing shortage of pharmacists nationwide due to
employment growth, resignations and retirements. In order for VHA to
effectively compete with other employers in the face of this worsening
pharmacist shortage, it needs to ensure that all local facilities
properly use special salary rates and other recruitment and retention
incentives.
AFGE commends VHA for recent efforts by some medical center
directors to address advancement and compensation barriers with
national salary surveys, bonuses and other recruitment and retention
incentives. However, whether any benefits of these national initiatives
accrue to the individual pharmacist depends largely on the discretion
of the local facility director. As a result, in a number of facilities,
VA pharmacist salaries are significantly below salaries offered by
other local employers.
Therefore, each facility should be required to align pharmacist
salaries closely with national surveys and third party data, and update
these salaries at least annually.
To retain older, experienced pharmacists, VHA should reevaluate its
current policy of appointing new pharmacists with limited or no
experience at a GS-12 level. These appointments are not supported by
the Hybrid Title 38 qualification standards for pharmacists and hurt
morale among more experienced pharmacists. VHA policy makes clear that
qualification standards are not intended to address salary issues.
Rather, VHA has various pay authorities, such as retention incentives,
special salary rates and bonuses; because VHA is slow to utilize these
pay authorities to react to community practice, chiefs of pharmacy are
forced to upgrade pharmacists instead.
VHA should also evaluate the widespread practice of restricting
certain positions to Doctors of Pharmacy (``PharmDs''). The pharmacist
qualification standards give equal credit for education and experience.
Unfortunately, some managers are unwilling to adequately credit
experience despite these clear standards. The justification that
managers rely on to require PharmDs is flawed, i.e. they contend that
the VA Clinical Pharmacist position is comparable to positions in
private sector retail establishments. However, they are not comparable;
private sector clinical pharmacists more typically work ``24/7'' and
weekend schedules.
With regard to Pharmacy Technicians, VA needs to increase the
number of GS-6 positions for certified employees. Currently, management
is not required to promote to a GS-6 because under the Pharmacy
Technician qualifications standards, a GS-6 is above the ``full
performance'' level.
VA should consider adding a requirement that all Pharmacy
Technicians pass the Technician Certification (PTCB) test to be
promoted to the GS-6 level. Certification requirements are prevalent in
the private sector. Certification was part of the original intent of
the Subject Matter Experts who developed the Pharmacy Technician
qualification standard, and certification was also the understanding of
the Hybrid Title 38 Collaboration Team and many of the members of the
Professional Standard Boards. In addition, VA needs to republish the
qualification standards allowing those who attain certification to be
at the journeyman level. Having employees attain certification status
and not be rewarded for this achievement is disheartening to say the
least.
Pharmacy Staffing
Many AFGE members report inadequate staffing at their pharmacies.
As a result, both pharmacists and pharmacy technicians are requested to
work overtime on a regular basis. Pressure to work overtime on a
prolonged basis can hurt workplace morale, increase risks to patients
and is more costly to the taxpayer than expanding the workforce.
Understaffing can also have wider ramifications. For example, the
Minneapolis VAMC has one of the busiest VA chemotherapy departments in
the country. The facility recently built a chemotherapy satellite
pharmacy that complies with new OSHA/NIOSH ``negative pressure''
regulations for preparing chemotherapy that were intended to reduce the
risk of harmful exposure of IV room staff to hazardous substances. Even
though the satellite was completed over a year ago, management has not
filled the pharmacy department's request for an additional technician
who is needed to work in the satellite, citing budget constraints. As a
result, the facility has still not moved chemotherapy preparation to
this satellite, and staff continues to prepare chemotherapy in a
positive pressure room in violation of the new regulations.
Short staffing also limits the ability of the pharmacy workforce to
comply with the large number of VA directives that are issued on a
regular basis to improve patient care.
Another AFGE member reported that at her facility, the pharmacy
does not have a triage pharmacist on staff that could extend
maintenance medications until the next primary care appointment if the
patient runs short.
AFGE members also expressed concern about the large number of
pharmacists who only have clinical duties. In contrast, pharmacy
production and verification functions, which involve extensive
requirements for providing medications to patients, remain short
staffed.
Other Comments
CMOPs
AFGE urges this Subcommittee to encourage the replication of best
practices of ergonomic interventions in place at some Consolidated Mail
Outpatient Pharmacies (CMOP's) to other CMOPs and hospital outpatient
verification high production areas.
Formularies
AFGE pharmacist members expressed concern about the unintended
impact of performance measures related to cost savings. In order to
meet Performance Measures, facilities often switch medications from a
drug in one class to another drug in the same class or a similar class.
Frequent switching frustrates and confuses our veterans. It is also
perplexing to staff why VHA allows so many deviations to the formulary
by pharmacy benefit managers at the VISN level.
Members also pointed out problems that result from other hospital
units using different products than the pharmacy. For example, the
pharmacy formulary allows the use of one type of nutritional supplement
for veterans who are outpatient, while the dietetic service has a
separate contracting process and therefore uses another product for
inpatient care. As a result, when a veteran changes from inpatient to
outpatient status, there are continuity of care problems. Similarly,
many of the wound care/dressing supplies provided by Supplies,
Processing and Delivery (SPD) on an inpatient basis are different than
those supplied by the pharmacy for outpatients. This also leads to
confusion and coordination problems for clinicians and patients.
Information Technology
Members indicated a need for a number of IT upgrades; for example,
it would be helpful to upgrade the VA intravenous (IV) package/IV
labeling, and also to have IV pumps that could download infusion data
into the computerized patient record system.
Patient Safety
AFGE urges increased oversight of the medication reconciliation
process. The Center for Patient Safety should look closely at VHA's
difficulties in complying with Joint Commission (JCAHO) performance
criteria in this area, and the adverse impact of noncompliance on other
inpatient staff members.
A pharmacist on another facility expressed concern about the
practice of allowing contract nurses from the state nursing homes,
rather than the veteran's treating physician, to make requests for
medication refills without any accountability.
AFGE thanks the Subcommittee for the opportunity to provide input
into this issue.
Statement of Hon. Cliff Stearns,
a Representative in Congress from the State of Florida
Thank you Mr. Chairman. I appreciate your holding this hearing to
examine the management of the Department of Veterans Affairs (VA)
pharmacy program.
The development of prescription medications that relieve suffering,
prevent, cure, and help manage illnesses has revolutionized modern
medicine and is improving the quality of life for many of our ill,
injured and elderly veterans.
Last year, VA filled over 125 million prescriptions for veteran
patients and expects that amount to double in 2010 to more than 254
million prescriptions.
In 1997, with the increased use of pharmaceuticals and concerns
over rising drug costs and geographic variability, VA was prompted to
establish a single National Formulary to help manage costs and improve
consistency across the VA healthcare system. The National Formulary
provides VA with leverage to purchase in bulk and increase the cost-
effectiveness of VA's pharmacy program.
A formulary system has the potential to also help educate
physicians and patients about drugs, ensure the use of quality drug
products and promote evidence-based management of disease.
However, it can also generate serious concerns about quality of
care because formularies restrict the different classes of drugs
available. For instance, a drug on the list may not be effective for
100 percent of the patients or it could be unexpectedly discontinued.
Additionally there is a lengthy process for the inclusion of a new or
breakthrough drug, and there are questions about the fairness and
responsiveness for the approval of the use of a non-formulary drug to
meet the specific needs of a veteran patient.
VA's proper management of the formulary system is vital to ensuring
our veterans receive the highest quality of care and access to the most
up-to-date medications they deserve.
Today's hearing will explore these important issues, and I would
like to thank all of our witnesses today for their testimony and I look
forward to the hearing.
Thank you Mr. Chairman. I yield back the balance of my time.
MATERIAL SUBMITTED FOR THE RECORD
U.S. Department of Health and Human Services
Food and Drug Administration
Rockville MD.
November 6, 2009
Hon. Michael H. Michaud
Chairman
Subcommittee on Health
Committee on Veterans' Affairs
House of Representatives
Washington, D.C. 20515
Dear Mr. Chairman:
This letter is in follow-up to the September 22, 2009, hearing
entitled ``Is the U.S. Department of Veterans Affairs (VA) Meeting the
Pharmaceutical Needs of Veterans? An Examination of the VA National
Formulary Issues of Patient Safety, and Management of the Pharmacy
Benefits Program.'' During that hearing you asked how the Food and Drug
Administration (FDA or the Agency) deals with complaints about conflict
of interest. After receiving further clarification from your staff,
below is our response your question, as it specifically pertains to
potential conflicts of interest and FDA advisory committee panels.
FDA's advisory committees provide independent expert advice to the
Agency on scientific, technical, and policy matter related to the
development and evaluation of FDA-regulated products. Advisory
committees enhance FDA's ability to protect and promote public health
by ensuring it has access to advice, in a public manner, as permitted
by existing laws and regulations. Although advisory committees provide
recommendations to FDA, FDA makes the final decisions.
FDA's advisory committee program is governed by a number of Federal
laws and regulations that set forth standards for convening advisory
committees and reviewing potential conflicts of interest, among other
things. FDA also has developed guidance documents that describe the
Agency's recommendations and policy related to our advisory committees.
FDA is committed to strictly adhering to the laws and regulations
governing the process for selecting advisory committee members. In
August 2008, FDA implemented several improved policies and procedures
to strengthen its management of advisory committees. These policies and
procedures are detailed in the form of guidance documents and their
goal is to make the process of seeking advice from independent experts
as open, public and transparent as possible.
One guidance, Procedures for Determining Conflict of Interest and
Eligibility for Participation in FDA Advisory Committees, describes how
FDA determines whether an individual invited to participate in an FDA
advisory committee has a potential conflict of interest and whether he/
she is eligible to participate in an advisory meeting. The approach set
forth in this guidance makes the Agency's review of potential conflicts
of interest more stringent than current legal requirements and previous
FDA guidance. For example, according to the new guidance:
If an individual, their spouse, or minor child has
potentially conflicting financial interests totaling more than $50,000,
they would not ordinarily be allowed to participate in that meeting.
Four specific scenarios are outlined where the conflict
is significant and FDA does not intend to issue a waiver, even if the
potential personal conflict is below $50,000.
Before a waiver is issued, FDA will require a showing
that the waiver is necessary to afford the committee essential
expertise.
FDA will limit the number of waivers that are granted, as
is now required by law.
Another guidance, Public Availability of Advisory Committee
Members' Financial Interest Information and Waivers, focuses on
ensuring that when FDA grants a waiver, the circumstances of that
waiver are made clear and transparent to the public. Therefore, all
waivers and advisors' disclosures of potentially conflicting interests
are posted to the FDA Web site. In most cases, FDA posts these
documents at least 15 days prior to the relevant advisory committee
meeting. These changes help to make the basis for FDA's decision to
grant a waiver clearer to the public.
A fact sheet providing a detailed summary of each guidance is
enclosed and can also be found on FDA's Web site at http://www.fda.gov/
ociadvisory/factsheet 080408.html. These guidances enable FDA to
improve consistency in the handling of potential conflicts of interest
and to provide greater clarity to the public. FDA makes the laws,
regulations, and guidance documents pertaining to advisory committees
available through our Web site at www.fda.gov/advisorycommittees to
provide ready access to the statutory aid regulatory framework that FDA
advisory committees operate within, and to describe the steps that FDA
has taken to enhance decision-making, increase transparency, and
strengthen public confidence in our advisory committee program.
Thank you for your interest in this matter. If you have further
concerns, please let us know.
Sincerely,
Jeanne Ireland
Assistant Commissioner for Legislation
Enclosure:
Fact Sheet: ``Improved Policies and Procedures Regarding
Transparency, Public Disclosure for FDA Advisory Committees''
0_________
U.S. Food and Drug Administration
U.S. Department of Health and Human Services
Fact Sheet
Improved Policies and Procedures Regarding Transparency,
Public Disclosure for FDA Advisory Committees
The Food and Drug Administration today announced several improved
policies and procedures to strengthen its management of FDA advisory
committees. They are detailed in four final guidance documents and one
draft guidance outlined below. Our goal is to make the our process for
seeking advice from independent experts as open, public, and
transparent as possible, so that we maintain the highest public
confidence in that process.
Final Guidance on Procedures For Determining Conflict of Interest and
Eligibility for Participation in FDA Advisory Committees
This guidance describes how FDA will determine whether an
individual invited to participate in an FDA advisory committee has a
potential conflict of interest and, accordingly, whether he or she is
eligible to participate in an advisory committee meeting. FDA has for
many years screened prospective advisory committee participants to
determine whether the potential for a financial conflict of interest
exists. When an advisor has a potential conflict, FDA may grant a
waiver to allow participation.
The approach set forth in FDA's guidance makes the agency's review
of potential conflicts more stringent than the legal requirements
recently put in place by Congress. It is more stringent than FDA's
Waiver Criteria 2000 guidance in four ways:
First, if an individual, his spouse, or minor child has
potentially conflicting financial interests totaling more than $50,000,
he or she would not be allowed to participate in that meeting.
Second, the guidance specifies four scenarios where the
conflict is significant and FDA does not intend to issue a waiver, even
if the potential personal conflict is below $50,000. (For example, if
the advisor is the principal investigator of a clinical trial of a
product about which the committee will be providing advice, the advisor
will not be allowed to participate in that meeting.)
Third, before we issue any waiver, we will require a
showing that the waiver is necessary to afford the committee essential
expertise.
Fourth, as now required by law, we will limit the number
of waivers we grant.
The guidance will improve consistency in the agency's handling of
potential conflicts of interest and provide greater clarity to the
public.
Final Guidance on Public Availability of Advisory Committee Members'
Financial Interest Information and Waivers
This guidance will ensure that when FDA grants a waiver, the
circumstances of that waiver will be made clear and transparent to the
public. All waivers and advisors' disclosures of potentially
conflicting interests will be posted to the FDA Web site. In most
cases, FDA will post these documents at least 15 days prior to the
relevant advisory committee meeting. New templates for waivers and
financial interest disclosure will make them clearer and more
consistent. These changes will make the basis for FDA's decision to
grant a waiver clearer to the public.
Final Guidance on Voting Procedures at Advisory Committee Meetings
This guidance is intended to ensure integrity of the voting process
at advisory committee meetings. It recommends that any question put to
a vote be clearly and collectively understood by those voting, and it
urges that there be a robust discussion of the issues at the heart of
the question before voting takes place. The guidance also recommends
that votes be cast simultaneously rather than sequentially. This is
intended to avoid ``voting momentum,'' in which voters may be
influenced, even subconsciously, by the votes of those who precede
them.
Final Guidance on Preparation and Public Availability of Information
Given to Advisory Committee Members
This guidance is intended to help sponsors develop, prepare and
submit to FDA briefing materials that will be given to advisory
committee members as background information before an open FDA advisory
committee meeting. It sets out timelines for preparing and submitting
the briefing materials to FDA. The guidance also describes when FDA
intends to make the briefing materials available to the public.
As described in the guidance, FDA intends to notify a sponsor about
an open meeting that will involve its product approximately 55 business
days before the meeting. The guidance then includes information on how
to prepare its briefing materials, and sets out timelines for the
submission, review, and public availability of the briefing materials.
The timelines vary depending on whether the sponsor's briefing
materials may include information that, under certain circumstances,
could be considered to be exempt from public disclosure, or whether the
sponsor is stating that its briefing materials are fully releasable to
the public.
The guidance states that FDA intends to post the publicly available
version of the briefing materials on its Web site no later than two
full business days before the day the meeting is scheduled to occur.
Draft Guidance on When FDA Convenes an Advisory Committee
This draft guidance proposes to clarify when FDA should refer a
matter to an advisory committee. It is being issued for consideration
and public comment.
In some instances, FDA is required by law to refer an issue to an
advisory committee. In others, it has discretion to consider whether to
refer a matter to an advisory committee. The guidance proposes that FDA
consider three factors when deciding whether to voluntarily refer a
matter to an advisory committee. It proposes that when one of these
factors is met, FDA should refer the matter to an advisory committee.
Conversely, if none of the factors is met, FDA should not refer the
matter.
The guidance also proposes that, for all first-of-a-kind or first-
in-class products for human use, FDA either refer the product to an
advisory committee or provide in the action letter for that product a
summary of the reasons why it did not refer the product to an advisory
committee before approval.
Web Site Improvements
FDA has enhanced the transparency of its advisory committee program
by overhauling its advisory committee Web site. We began by engaging
various stakeholder groups--including consumers, patients, healthcare
professionals, and industry representatives--to help us assess the Web
site's strengths and weaknesses.
Based on this assessment, we redesigned the Web site and
streamlined access to the information that appears to be of greatest
interest to users. We then performed usability testing to evaluate the
changes and to further refine our improvements.
The most significant improvements include the following:
Meeting announcements will be posted in an easy to read
format that provides prominent information on the page and allows for
quick access to other meeting information in an organized fashion.
Past meeting information, which was difficult to find on
the original site, is easily accessible from the main page.
Meeting materials are now posted in one location,
removing the previously difficult process of finding, or not finding,
information via a multitude of ill-defined links.
Each committee will have one location that provides full
information on that committee--its Charter, Roster, steps for
nominating candidates for committee vacancies, past meeting
information, and who to contact with questions about the committee.
A new section titled ``Most Popular'' links will
highlight significant areas of public interest.
The page offers an opportunity for consumers to provide
feedback on the site our advisory Committees--and we'll post summaries
of that feedback.
http://www.fda.gov/oc/advisory/factsheet080408.html
Committee on Veterans' Affairs
Subcommittee on Health
Washington, DC.
October 1, 2009
Honorable George J. Opfer
Inspector General
Office of Inspector General
U.S Department of Veterans Affairs
801 I Street, NW
Washington, DC 20001
Dear Inspector General Opfer:
Thank you for the testimony of Belinda J. Finn, Assistant Inspector
General for Audits and Investigations at the U.S. House of
Representatives Committee on Veterans' Affairs, Subcommittee on Health
Oversight Hearing on ``Is the VA Meeting the Pharmaceutical Needs of
Veterans? An Examination of the VA National Formulary, Issues of
Patient Safety, and Management of the Pharmacy Benefits Program.'' that
took place on September 22, 2009.
Please provide answers to the following questions by November 12,
2009, to Jeff Burdette, Legislative Assistant to the Subcommittee on
Health.
1. Do you believe that the VA has derived sufficient benefit from
the centralizing of contracting responsibilities at the National CMOP
office? In other words, does the national CMOP remain the preferred
model for acquiring pharmaceutical supplies and services?
2. In addition to the VA issuing and enforcing policies to
improve accountability of non-controlled drugs, what additional tools
does the VA need for effective enforcement of the new policies? For
example, Ms. Finn's testimony noted the need to improve IT. Are there
other tools that the VA needs to acquire?
Thank you again for taking the time to answer these questions. The
Committee looks forward to receiving your answers by November 12, 2009.
Sincerely,
MICHAEL H. MICHAUD
Chairman
0_________
U.S. Department of Veterans Affairs
Office of Inspector General
Washington, DC.
November 12, 2009
Hon. Michael H. Michaud
Chairman
Subcommittee on Health
Committee on Veterans' Affairs
United States House of Representatives
Washington, DC 20515
Dear Mr. Chairman:
This is in response to your October 1, 2009, letter following the
September 22, 2009, hearing on Is the VA Meeting the Pharmaceutical
Needs of Veterans? An Examination of the VA National Formulary, Issues
of Patient Safety, and Management of the Pharmacy Benefits Program.
Enclosed is our response to the additional hearing questions. This
information has also been provided to Congressman Henry E. Brown, Jr.,
Ranking Republican Member, Subcommittee on Health.
Thank you for your interest in the Department of Veterans Affairs.
Sincerely,
GEORGE J. OPFER
Inspector General
Enclosure
[An identical letter was sent to Hon. Henry E. Brown, Jr., Ranking
Republican Member, Subcommittee on Health, Committee on Veterans'
Affairs.]
0_________
Questions for the Honorable George J. Opfer, Inspector General,
U.S. Department of Veterans Affairs, Before the Subcommittee on Health,
Committee on Veterans' Affairs, United States House of Representatives
Hearing on Is the VA Meeting the Pharmaceutical Needs of Veterans?
Question 1: Do you believe that the VA has derived sufficient
benefit from the centralizing of contracting responsibilities at the
National CMOP Office? In other words, does the national CMOP remain the
preferred model for acquiring pharmaceutical supplies and services?
Response: The VA's National Acquisition Center (NAC) is responsible
for purchasing pharmaceuticals, supplies, and services dispensed by the
national community mail outpatient pharmacies (CMOPs). Centralizing
this function provides VA the following benefits:
Opportunities to leverage buying power to obtain lower
prices and volume discounts.
Decrease in the potential for conflict of interest
situations by having independent contracting actions.
Creation of a professional acquisition staff dedicated to
supporting pharmaceutical contract initiatives.
Improvement in the compliance with the Federal
Acquisition Regulation and VA Acquisition Regulation.
The CMOP is a preferred model for dispensing pharmaceutical
supplies and services because automation allows for safety in the
dispensing of pharmaceuticals and it is less expensive due to better
drug pricing and greater efficiencies realized by relying on seven
CMOPs as opposed to individual VA medical centers and clinics.
Question 2: In addition to the VA issuing and enforcing policies to
improve accountability of non-controlled drugs, what additional tools
does the VA need for effective enforcement of the new policies? For
example, Ms. Finn's testimony noted the need to improve IT. Are there
other tools that the VA needs to acquire?
Response: In our report, Audit of the Veterans Health
Administration's Management of Non-Controlled Drugs (June 23, 2009), we
identified several weaknesses in the Veterans Health Information System
and Technology Architecture (VistA)--the information system the
Veterans Health Administration (VHA) uses to manage pharmacy services
at its medical facilities. The current VistA system cannot provide
information to accurately account for a facility's on-hand drug
inventory.
In 2003, VHA launched the Pharmacy Re-Engineering (PRE) project to
make improvements to VistA. We did not evaluate the design of the
project or results of system tests, but Pharmacy Benefits Management
officials told us that this new system is expected to address VistA
deficiencies. The PRE project was halted as part of VA's Office of
Information and Technology's review of VA system development projects,
and has not yet fully restarted. Other IT systems or tools that would
improve accountability over inventories include centralization of
billing and drug file management, and Radio Frequency Identification
(RFID) labeling for pharmaceuticals.
During our recent audits, the Pharmacy Benefits Management Services
indicated that they would like to see the creation of specialty CMOPs.
Currently, each CMOP manages many low volume products. By centralizing
the low volume products, a specialty CMOP can bring the volume of those
products up to a higher level and eliminate the distribution of those
products at other CMOPs; potentially enabling CMOPs to manage inventory
better. To recognize these improvements, CMOPs also need more robust
software for billing customers. A system is needed where the CMOP that
fills and bills for the prescription is transparent to the medical
center.
For drug file management, there is currently little standardization
of stock across the system. Improvements could be realized by
standardizing stock lists and prices. Currently, CMOPs attempt to
maintain prices on several thousand line items of inventory and
predictably inventory information is not accurate at given points in
time. Managing the CMOP stock list centrally would enable CMOPs to
vastly improve their drug file management and allow them to follow the
private industry model where prices are pushed out to each CMOP from a
central location.
The use of a RFID chip inside labels would enable CMOPs to
electronically track stock from the time it came into their facilities
until the time it left. If CMOP suppliers and United States Postal
Service used this same technology, CMOPs could track drugs through the
entire supply chain right up to the point where they reach the patient.
Currently, costs appear prohibitive, but RFID pricing technology seems
to be decreasing rapidly and VA should leverage future inventory
management tools that enable the tracking and accountability for drugs
through the entire supply chain.
Committee on Veterans' Affairs
Subcommittee on Health
Washington, DC.
October 1, 2009
Honorable Eric K. Shinseki
Secretary
U.S. Department of Veterans Affairs
810 Vermont Avenue, NW
Washington, DC 20240
Dear Secretary Shinseki:
Thank you for the testimony of Michael Valentino, Chief Consultant
to the Pharmacy Benefits Management Service at the U.S. House of
Representatives Committee on Veterans' Affairs, Subcommittee on Health
Oversight Hearing on ``Is the VA Meeting the Pharmaceutical Needs of
Veterans? An Examination of the VA National Formulary, Issues of
Patient Safety, and Management of the Pharmacy Benefits Program.'' that
took place on September 22, 2009.
Please provide answers to the following questions by November 12,
2009, to Jeff Burdette, Legislative Assistant to the Subcommittee on
Health.
1. How are new drugs added to the VA national formulary? How are
requests from VISNs and local facilities to add new drugs to the
formulary handled? How often is the national formulary updated and when
was the last update?
2. It is our understanding that each VA facility must institute a
process to review requests for drugs that are not on the formulary.
What are the respective roles of the VA medical center, VISN, and the
VA central office in ensuring that the review process for non-formulary
drug requests are not subjective and based on objective criteria?
3. What percent of non-formulary drug requests are approved? If
such requests for non-formulary drugs are not approved, what are some
typical reasons for the non-approval? Does the VA track and store data
on non-formulary drug requests?
4. In 2000, a report by the Institute of Medicine found that the
VA's national formulary lacked ``essential systems to assure that new
drugs are expeditiously reviewed.'' Please discuss the steps that the
VA has taken to address this deficiency.
5. How does the VA handle issues of patient safety and prevent
adverse drug interactions for veterans who fill their prescriptions
through the VA and private pharmacies?
6. What is the VA doing to encourage medication compliance among
veterans to maximize the results of the drug therapy?
7. The VA's November 2002 directive on ``VA National Dual Care
Policy'' expired in July 2007. Have there been any updates to the
directive? If not, are there plans to issue an updated directive?
8. Since the VA developed an integrated Web-based application
that fully automates the VA's adverse drug event reporting process, has
the reporting increased? If so, by how much? What does the VA do with
this data? Who reviews the reports and what action, if any, is taken?
For example, are there a certain number of adverse drug events that are
reported before the VA releases guidance?
9. Please describe the work and role of the VA Center for
Medication Safety. For example, what are some examples of the
medication safety projects that this Center implements? How does the
Center educate the field on safe and best practices to minimize adverse
drug events? What are some examples of the research that the Center has
translated into national policy?
10. Please describe the VA's interactions with FDA on drug
recalls. Does the VA follow the FDA's lead? Or, does the VA have the
authority to halt the use of the prescription drugs by the veterans
before FDA officially initiates the recall?
11. As you know, off-labeling is use of drugs outside of the
approved indications by FDA. How prevalent are off-label prescriptions
at the VA? And how does the VA deal with off-label drug use in cases
where there is little or not supportive evidence of benefit or safety
in a population or for a medical condition?
12. It is our understanding that some VA facility directors confer
prescribing authority to certain nurses, pharmacists, and physician
assistants if the state provides this authority and if it is cosigned
by a medical doctor. What guidance and oversight is provided by the
central VA office?
13. Based on the findings of the Inspector General's June 2009
audit reports, what steps has the VA taken to address issues identified
with the management of non-controlled drugs and the CMOP contract?
14. Why did the VA allow the directive on Drug Accountability
Software to lapse in 2003? Are there plans for an updated directive?
Thank you again for taking the time to answer these questions. The
Committee looks forward to receiving your answers by November 12, 2009.
Sincerely,
MICHAEL H. MICHAUD
Chairman
0_________
Questions for the Record
The Honorable Michael H. Michaud, Chairman
House Committee Veterans' Affairs, Subcommittee on Health
Is the U.S. Department of Veterans' Affairs (VA) Meeting
the Pharmaceutical Needs of Veterans? An Examination of
the VA National Formulary, Issues of Patient Safety, and
Management of the Pharmacy Benefits Program
September 22, 2009
Question 1: How are new drugs added to the VA national formulary?
How are requests from VISNs and local facilities to add new drugs to
the formulary handled? How often is the national formulary updated and
when was the last update?
Response: The Department of Veterans' Affairs (VA) policy (http://
vaww1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1834) requires
that drugs newly approved by the Food and Drug Administration (FDA) be
automatically reviewed for VA National Formulary (VANF) as soon as
sufficient safety and efficacy information becomes available. In
addition, requests for changes in a VANF drug status may be submitted
to the pharmacy benefits manager (PBM) by a Veterans Integrated Service
Network (VISN) formulary committee, the VISN pharmacist executive
committee (VPE), the Medical Advisory Panel (MAP), a Veterans Health
Administration (VHA) Chief Medical Consultant, or a VHA Chief Medical
Officer. An individual or group of physicians may submit a request for
VANF addition through its VISN Formulary Committee(s). Decisions for
VANF listing are evidence-based and made by consensus of the MAP and
VPE Committees. The VANF is updated monthly, provided that there are
changes to be posted. The last two formulary updates occurred on July
1, 2009, and October 7, 2009.
Question 2: It is our understanding that each VA facility must
institute a process to review requests for drugs that are not on the
formulary. What are the respective roles of the VA medical center,
VISN, and the VA central office in ensuring that the review process for
non-formulary drug requests are not subjective and based on objective
criteria?
Response: VA policy requires that a non-formulary request process
exist at each VA medical center (http://vaww1.va.gov/vhapublications/
ViewPublication.asp?pub_ ID=1834).
This policy is intended to assure that decisions are evidence-based
and timely. Routine requests for non-formulary agents are reviewed and
the requestor is notified of the decision within 96 hours of receipt of
a completed non-formulary request. Emergency requests for non-formulary
agents are immediately addressed by individual(s) identified in local
VA medical center policy. If the degree of urgency or emergency is in
question, the drug is provided immediately and the nature of the
urgency or emergency is reviewed afterward.
Non-formulary drugs that have received FDA approval are only to be
approved when:
1. A documented contraindication exists to the formulary agent(s)
2. A documented adverse reaction occurred to the formulary
agent(s)
3. A documented therapeutic failure to formulary therapeutic
alternatives exists
4. No formulary alternative exists
5. The patient has previously responded to a non-formulary agent
and serious risk is associated with a change to a formulary agent; or
6. Other circumstances having compelling evidence-based clinical
reasons
All physician-initiated appeals of a non-formulary drug request are
received and adjudicated by the facility chief of staff.
Medical center management, VISN pharmacist executives (VPE) and VA
Central Office Pharmacy Benefits Management (PBM) Service staff have
the responsibility to assure the intent of the VA policy is followed.
Quarterly reports from VPEs are sent to the PBM Service. These reports
show the number of non-formulary requests received, approved and
denied, and the average processing time. Evidence-based prescribing
guidance documents, when applicable, are the objective criteria used to
assist clinicians in the non-formulary review process.
Question 3: What percent of non-formulary drug requests are
approved? If such requests for non-formulary drugs are not approved,
what are some typical reasons for the non-approval? Does the VA track
and store data on non-formulary drug requests?
Response: Approximately 81 percent of non-formulary drug requests
are approved. PBM does not track reasons for the non-approval of
requests, however, a typical reason is due to clinicians not being
aware of a suitable formulary alternative, particularly in the
situation of medical trainees. Other common reasons include requests
for off-label indications where there is no evidence to support safety
and efficacy for the intended indication, and indications falling
outside of VHA's evidence-based clinical criteria for use. Clinicians
are able to ask for adjudication of any denial, if they disagree with
the initial non-approval of the drug. PBM does track and store data
regarding the number of non-formulary drug requests received, approved
and denied, and the average process time for adjudicating the requests.
Question 4: In 2000, a report by the Institute of Medicine found
that the VA's national formulary lacked ``essential systems to assure
that new drugs are expeditiously reviewed.'' Please discuss the steps
that the VA has taken to address this deficiency.
Response: At the time the Institute of Medicine (IOM) conducted its
review of the VA National Formulary, the addition of new drugs to the
VANF was governed by VHA Directive 97-047 ``VA National Formulary
Policy.'' Paragraph 2.d. of this policy stated, ``PBM Formulary
recommendations will be based on a review of new drug products approved
by the Food and Drug Administration (FDA) and recommendations by VISN
formulary committees. For a new drug product to be considered for
addition to the Formulary, it must be on the market for a minimum of 1
year. Exceptions can be made if the FDA designates the product as a
unique therapeutic entity (FDA designation of `1P').'' This policy was
instituted as a safety precaution because many new drugs were being
fast tracked through the review process and adequate clinical trials,
in our patient population, were not always available. This 1 year
period allowed for adequate evaluation of these agents in our patient
population.
Directive 97-047 did not preclude VHA from reviewing new drugs
expeditiously; it only prevented VHA from adding them to the VA
National Formulary for 1-year after they reached the market unless they
were approved by the FDA with a 1P designation. It is important to note
that individual VISNs and facilities were not held to this policy for
drug formularies managed at the local and VISN levels. They could, and
did, add new drugs to VISN and facility formularies before the 1-year
waiting period. It is also important to note that not all newly
approved drugs are relevant to the VA population and would not be
expected to be reviewed nor added to the formulary. Drugs used
exclusively in the pediatric population are one example where the drugs
would be neither extensively reviewed nor added to the formulary.
VHA advised IOM staff at the time they began their analysis that
based on PBM's own review of existing formulary policy, it had decided
to change the 1-year moratorium and eliminate that requirement from PBM
policy. Although one of the hearing panelists stated that VA's 1-year
moratorium policy is still in effect, that is not the case; it was
eliminated in July 2001.
From 2001 through 2009 all policy governing VA Formulary practice
was contained in VA Manuals, VHA Directives and PBM Policies; modified
to accommodate changes. The National Formulary was a ``core formulary''
to which each VISN was permitted to supplement with local additions.
In an effort to ensure that a travelling veteran could obtain a
needed refill or renewal of a scheduled medication at any VA location,
the VISN Pharmacist Executives and the Medical Advisory Panel decided
to do away with VISN variation and establish a comprehensive National
Formulary; to which additions at the local level are no longer
permitted. Therefore, on February 26, 2009, VHA published a Handbook
(VHA Handbook 1108.08, ``VHA Formulary Management Process'') which
provided a comprehensive document encompassing all prior policy;
including changes implemented subsequent to the IOM analysis. Note:
Under each formulary process the ability of the provider to request a
medication via a Non-formulary Request (with an approval rate of 80
percent) was available. This accounts for approximately 4 percent of
total prescriptions dispensed by VHA.
Question 5: How does the VA handle issues of patient safety and
prevent adverse drug interactions for veterans who fill their
prescriptions through the VA and private pharmacies?
Response: VHA's current drug-drug interaction (DDI) software
package is available at the point of care to warn against potential
critical and significant drug-drug interactions when a provider enters
an outpatient prescription to be filled in a VA pharmacy. Potential
interactions are communicated to prescribers as an Alert. Prescriptions
obtained outside VA are recorded in the ``non-VA medication'' field in
the computerized patient record system (CPRS) as part of the medication
reconciliation process or when at the patient's request, a VA
prescriber writes a prescription for the patient to fill at his or her
expense at a non-VA pharmacy. The CPRS can provide order checks for
medications dispensed by a VA pharmacy, or those documented as
dispensed from a non-VA pharmacy when the drug is matched to VA's
national drug file. Prescribers are required to state an ``override
reason'' when submitting an order containing a critical drug-drug
interaction for which they receive an Alert. Drug-drug interactions for
non-VA medications are subject to additional manual screening by a
pharmacist during the final order review. Any potential interactions
identified during the final manual review are communicated to the
prescriber.
Question 6: What is the VA doing to encourage medication compliance
among veterans to maximize the results of the drug therapy?
Response: Medication compliance and monitoring is performed by
clinical pharmacists, nurses and providers and discussed with patients
during outpatient visits. These reviews evaluate the dose and schedule
of each medication the patient is currently taking and are performed by
clinicians throughout VA. Compliance is assessed by asking the patient
about their medications through a series of questions and evaluating
prescription refill patterns. It is always important to ask patients if
they are having difficulty remembering to take their medications and VA
believes clinical pharmacists are integral to the healthcare team to
identify these types of barriers to compliance. For some patients,
there may be an opportunity to reduce the medication burden (i.e.
polypharmacy) to increase compliance. For others with a significant
number of prescriptions, compliance may be increased through the use of
assistive devices such as pill boxes, personalized medication schedules
etc., which VA can provide.
CPRS version 26, released in May 2006, introduced new graphing
features that are available to providers. Medication compliance can be
charted in a graph with indications of prescription dispensing events,
prescription days supply, and any relevant corresponding laboratory
results for the patient. This allows a visual representation of when a
patient can be reliably expected to have or have had a supply of
medication on-hand.
Overall, medication compliance and monitoring is assessed and
monitored on an ongoing case-by-case basis via numerous mechanisms
(patient interviews, chart reviews and refill record reviews).
Medication education and adherence is a shared responsibility among
patients and their healthcare providers. Clinical pharmacists are
extensively trained to assist patients with medication adherence and
are available throughout VA's facilities to provide this service.
Question 7: The VA's November 2002 directive on ``VA National Dual
Care Policy'' expired in July 2007. Have there been any updates to the
directive? If not, are there plans to issue an updated directive?
Response: VA reissued the directive entitled, ``VHA National Dual
Care Policy'' on August 25, 2009 (http://vaww1.va.gov/vhapublications/
ViewPublication.asp?pub_ ID=2058).
Question 8: Since the VA developed an integrated Web-based
application that fully automates the VA's adverse drug event reporting
process, has the reporting increased? If so, by how much? What does the
VA do with this data? Who reviews the reports and what action, if any,
is taken? For example, are there a certain number of adverse drug
events that are reported before the VA releases guidance?
Response: VHA implemented its Web-based Veterans adverse drug event
reporting system (VA ADERS) in March 2007. The legacy adverse drug
event (ADE) system was used for reporting all serious ADEs prior to the
implementation of VA ADERS. The increased reporting provides a more
comprehensive assessment of adverse effects within the ``veteran
population.'' This in turn allows for increased vigilance and a more
rapid response when concerns about therapy in this specific population
are evidenced.
Due to the labor intensive process involved in coding ADE reports
in the legacy system, only serious ADEs were required to be reported.
The Web-based system automates coding of ADEs which allows for both
non-serious and serious ADEs to be reported. The total number of ADEs
reported in the legacy ADE database, which was in place from Fiscal
Year 2001-2006, was 21,357. Since the implementation of VA ADERS in the
3rd quarter of FY 07 to the present, there have been 115,398 ADEs
reported. This is 5 times more ADE reports in approximately half the
time. The number increases to 9 times more ADE reports if an equal
timeframe is used (FY 2004-2006: 12,855 reports) for a more direct
comparison of ADE reports in VA ADERS to the number of ADE reports in
the legacy ADE system. It is evident that the number of reported ADEs
increased significantly as a result of the Web-based ADE system. This
does not imply that more ADEs are occurring; it is only proof that the
number of reports has increased, presumably due to ease of entry and
staff education.
The data reported in VA ADERS is used for benchmarking reportable
ADEs, assessing preventable ADEs, delineating between ADEs caused by
the inherent pharmacology of a drug, drug-drug interactions, or
idiosyncratic mechanisms. Standard reports such as the top 10 ADEs, top
10 drugs related to ADEs, the number of ADEs reported for new drugs,
and ADEs reported to the FDA's MedWATCH program are tracked daily and
reported nationally on a quarterly basis. In addition to the standard
reports conducted by the VA ADERS team, ad hoc evaluations and reports
are conducted as requested and placed on a predetermined reporting
schedule (i.e. influenza ADEs are identified and reported weekly). The
ad-hoc ADE reports are often conducted in response to a Risk
Communication released by the FDA, a therapeutic or generic conversion
taking place across the system, a cluster of ADEs reported in a given
facility or VISN, an unexpected ADE report from a given site or in
response to national safety campaign (i.e. influenza and antiviral
use).
The reports are reviewed at the facility, VISN, and national
levels. The national standard reports are reviewed by the VA ADERS
team, the VA ADERS Advisory Committee and the Directors of VAMedSAFE.
This information is assessed by the VA ADERS team and other staff from
VAMedSAFE on a quarterly basis, or more frequently if needed. The VISN
and facility reports are reviewed and assessed monthly by the facility
Pharmacy & Therapeutics Committee (P&T) and the VISN Formulary
Committees. The actions taken are in direct association with the
problem identified. Examples include:
Facility example: In response to an ADE resulting in an
interaction between an anticoagulation drug that requires frequent
therapeutic monitoring and another drug, the facility instituted a
process to notify anticoagulation providers when patients are
prescribed critically interacting drugs by another provider.
VISN example: Dermatology staff identified that ADEs were
occurring when topical steroid products were applied liberally. The
term ``liberally'' was removed from the ordering process and replaced
with ``sparingly'' and ``lightly''. By removing liberally as an option,
providers can no longer inadvertently order the inappropriate
directions that were contributing to the ADEs.
National example: A review of a few serious ADEs related
to intravenous iron dextran products led to the removal of one of the
iron dextran formulations from the National VA Formulary.
The three examples above illustrate how actions taken in response
to ADE reports occur at the facility, VISN, and national levels. The VA
ADERS system is a dynamic system used for benchmarking, surveillance
and process system improvements, all of which require different types
and degrees of actions depending on the level and seriousness of the
event. There is no ``threshold'' or ``preset ADE number'' that dictates
a guidance release; however, medication safety is inherent in the VA
pharmacy culture and results and reports from this system are used on a
regular basis to aid in process improvements that enhance patient
safety at the facility or VISN level, add to information at a national
level to assist in Drug Safety Risk Communications and informed
decisions, and lastly, serve as a foundation for developing national
safety based Medication Use Evaluations (MUE).
Question 9: Please describe the work and role of the VA Center for
Medication Safety. For example, what are some examples of the
medication safety projects that this Center implements? How does the
Center educate the field on safe and best practices to minimize adverse
drug events? What are some examples of the research that the Center has
translated into national policy?
Response: The VA Center for Medication Safety (VAMedSAFE) is a
world-class comprehensive pharmacovigilance program. Pharmacovigilance
is defined as the science of the detection, assessment, understanding
and prevention of the adverse effects of drugs. VAMedSAFE has
implemented many national projects to improve drug safety in the
Veteran population. VAMedSAFE is recognized nationally for its efforts
in drug safety and as a result has entered into a collaborative
agreement with the FDA to evaluate the significance of known ADEs, and
to identify and track new and emerging drug safety issues. As such,
VAMedSAFE conducts drug safety and monitoring efforts with the rigor of
a regulatory body, while maintaining the access and utilization
required for a healthcare delivery system to take necessary action. The
work of VAMedSAFE not only informs VA policy at the national level, but
has been influential in many FDA decisions, hence affecting the U.S.
population as a whole.
VAMedSAFE accomplishes its goals by evaluating preventable ADEs
through the use of active and passive surveillance techniques,
providing interventions to decrease preventable ADEs through Risk
Reduction programs, educating clinical staff about medication safety
best practices, advising clinical staff about emerging safety issues
through Medication Safety/Risk Communications, and conducting and
promoting medication safety research. Examples of VAMedSAFE projects
include:
Rapid Cycle Evaluations--This method uses integrated
clinical and administrative databases and mining of spontaneously
reported ADEs (through VA ADERS) to identify and assess the rate and
risk of ADEs for specific medications. Selected examples include:
Flouroquinolones and dysglycemia
Safety of non-steroidal anti-inflammatory drugs
(NSAIDs) in VA System in regard to the risk of myocardial infarction
Risk of thiazolidinediones and cardiovascular disease
Long-acting opioids and all cause mortality (focus on
methadone)
Risk Reduction Projects--Risk Reduction is the method
used by VAMedSAFE to identify and intervene on potential ADEs. Selected
examples include:
Nifedipine IR for hypertension
High dose vitamin E for cardiovascular disease
prophylaxis
Glyburide use in elderly patients with renal
insufficiency
Use of high dose zolpidem IR
National Medication Use Evaluations (MUEs)--VAMedSAFE
conducts national MUEs to evaluate and monitor the safe and appropriate
use of agents across the VA system. Selected examples include:
Pravastatin vs Fluvastatin--Evaluation of safety and
appropriate use following therapeutic interchange
Travoprost--Evaluation of safety following a
therapeutic interchange
Erythropoesis--Stimulating Agents (ESAs)--Evaluation of
appropriate monitoring to assure safe and cost-effective use of ESAs.
To minimize adverse drug events, VAMedSAFE educates the field on
safe and best practices through safety bulletins, safety information
documents attached to risk reduction efforts and continuing education
programs. In FY 2009, thirty Safety Bulletins were disseminated to the
field. VAMedSAFE develops many bulletins elaborating on or clarifying
early warning communications and other warnings from FDA; however, many
safety bulletins are developed secondary to ADE signals identified
through VAMedSAFE's surveillance efforts or through direct reports and
concerns from the field. Selected examples include:
Safety Bulletins
Risk of Severe Hypoglycemia with Glyburide in Patients
with Renal Insufficiency
Iron Dextran and the ADEs associated with the high
molecular weight formulation
Concentrated opioid solutions and concentration/
confusion problems
Oxybutynin and oxycodone Look-Alike Sound-Alike (LASA)
errors
VAMedSAFE promotes, conducts and assists other researchers with
medication safety research projects designed to evaluate safety signals
or confirm suspected ADE signals. These studies often give VA needed
information to make informed formulary management decisions. Selected
examples of VAMedSAFE research projects that have been translated into
national policy or resulted in formulary management decisions include:
Thiazolidinediones and risk of myocardial infarction--
This full study resulted from a Rapid Cycle Evaluation which was
conducted in response to an FDA warning. The results of the study led
to removal of a drug from the VANF and a revision of VA's prescribing
criteria for this drug class.
Fluoroquinolones and risk of dysglycemias--This study was
conducted in response to a Rapid Cycle Evaluation that identified an
ADE signal for severe dysglycemias with fluoroquinolones. The results
of the study confirmed the suspected severe dysglycemia associated with
some of the agents in the drug class. VA modified its prescribing
criteria due to this study. Gatifloxacin utilization decreased
substantially secondary to evaluations and recommendations in the
prescribing criteria. VA's actions occurred 2 years prior to FDA
recommending removal of the drug from the U.S. market.
NSAIDs and the risk of myocardial infarction (MI)--This
study resulted from a Rapid Cycle Evaluation that confirmed a
cardiovascular ADE signal for the Cox-2 inhibitor drug class (a known
ADE) and identified the absence of an ADE signal for some of the other
NSAIDs. The results of the study further confirmed the risk of MI's
with the Cox-2s and supported the safety of etodolac, the agent chosen
as the recommended replacement for Cox-2s in VA.
Question 10: Please describe the VA's interactions with FDA on drug
recalls. Does the VA follow the FDA's lead? Or, does the VA have the
authority to halt the use of the prescription drugs by the veterans
before FDA officially initiates the recall?
Response: The VA National Center for Patient Safety (NCPS) Product
Recall Office (PRO) has organizational responsibility for all product
recalls (including drug recalls) which involves identifying and
removing recalled products from inventory. The PBM Services office has
responsibility for reviewing all drug safety information including drug
recalls, and developing Drug Safety Alerts when appropriate. PBM
Services collaborates with NCPS PRO when drug recalls require
contacting patients and replacing their supply of medication. NCPS PRO
and PBM generally follow FDA's lead; however, PBM may determine that a
drug recall should be considered ``patient level'' when the
manufacturer and FDA have only recalled a drug to the ``retail'' level.
VHA is not averse to initiating action ahead of or separate from FDA in
order to provide enhanced drug safety for Veterans.
VHA frequently has advance notice on planned announcements by FDA
concerning drug safety. As part of the VA-FDA MOU, PBM is given the
opportunity to review and comment on FDA announcements days in advance.
In addition to providing input to FDA, VA has the opportunity for
advance planning to respond to drug safety issues, including drug
recalls. In FDA's testimony, they highlighted one example
(propoxyphene) where a drug recall was being considered, and VA
provided important clinical information that was used in their
regulatory decision-making process. Another example where VA worked
closely with FDA on a drug recall was with contaminated un-fractionated
heparin.
Question 11: As you know, off-labeling is the use of drugs outside
of the approved indications by FDA. How prevalent are off-label
prescriptions at the VA? And how does the VA deal with off-label drug
use in cases where there is little or no supportive evidence of benefit
or safety in a population or for a medical condition?
Response: VA PBM has provided guidance for the off-label use of
medications (http://www.pbm.va.gov/directive/
Guidance%20Off%20Label%20Prescribing.pdf). PBM uses evidence-based
medicine to inform formulary and coverage decisions. Thus, if there is
adequate evidence of sufficient quality for the safe and effective use
of a medication for an off-label indication, VA may support use of that
drug for that particular indication. It should be noted that other
factors play a part in this decision, most important being the
consideration of other therapeutic interventions or medications that
are available to treat the same condition.
When there is little or no evidence to support safety and efficacy
for an off-label indication, decisions of coverage need to be decided
on a case-by-case basis. In most circumstances, this requires
consultation with the local Pharmacy and Therapeutics Committee, which
can review the unique circumstances involved in the request. While
there may be many situations where off-label use of medications is
likely to benefit an individual patient, it should also be understood
that there are many other examples where off-label use of medications
has been associated with patient harm. VA's guidance document gives
direction for making those difficult decisions.
Question 12: It is our understanding that some VA facility
directors confer prescribing authority to certain nurses, pharmacists,
and physician assistants if the state provides this authority and if it
is cosigned by a medical doctor. What guidance and oversight is
provided by the central VA office?
Response: Under the principle of Federal Supremacy, VHA grants the
authority to prescribe non-controlled substances to Advanced Practice
Nurses, Clinical Pharmacy Specialists, and Pharmacists with direct
patient care responsibilities and Physician Assistants. VHA grants the
authority to prescribe controlled substances only to those providers
whose State licensure permits this practice. This may take the form of
a clinical privilege statement or a Scope of Practice, as appropriate.
Privileging or scope of practice for every individual is reviewed by
the relevant facility service chief, whose recommendation is submitted
to the appropriate facility-based body. For privileges, the
recommendation, along with the appointment recommendation of the
Professional Standards Board (PSB) or credentialing committee (if
applicable), is submitted to the medical staff's Executive Committee
for review. The medical staff's Executive Committee evaluates the
applicant's credentials to determine if clinical competence is
adequately demonstrated to support the granting of the requested
privileges. A final recommendation is then submitted to the facility
Director for approval. For scope of practice statements, the service
chief's recommendation is submitted for final approval to the facility-
based authorizing body appropriate to each profession.
VHA has issued Directives on each of the professional groups
identified in the question that outline the approval process for
prescriptive authority. These include VHA Directive 2009-014,
Establishing Medication Prescribing Authority for Clinical Pharmacy
Specialists; VHA Directive 2008-049, Establishing Medication
Prescribing Authority for Advanced Practice Nurses; VHA Directive 2004-
029, Utilization Of Physician Assistants (PAs); and VHA Directive 2008-
043, Scope Of Practice For Pharmacists With Direct Patient Care
(responsibilities).
All practitioners are required to complete the standardized VHA
credentialing. Advanced Practice Nurses and Clinical Pharmacy
Specialists may be granted either clinical privileges or a Scope of
Practice, as determined by their licensure and the facility.
Pharmacists with direct patient care responsibilities and Physician
Assistants are granted a Scope of Practice.
Question 13: Based on the findings of the Inspector General's June
2009 audit reports, what steps has the VA taken to address issues
identified with the management of non-controlled drugs and the CMOP
contract?
Response: VHA has taken several steps to address the deficiencies
identified in the Office of the Inspector General (OIG) reports. In
regard to inventory management, VHA has developed a draft directive
outlining the selective monitoring of high cost, high risk non-
controlled substances at VA medical centers and it is undergoing review
and concurrence to become VHA policy. PBM has communicated all the
current dispensing requirements under the draft policy to VA Chiefs of
Pharmacy on several conference calls and through e-mail notifications.
VA is pursuing Information Technology solutions regarding the use of
label reprints and other OIG findings/recommendations and is exploring
the ability of its Pharmaceutical Prime Vendor to provide standardized
national inventory management tools.
VA's long-term plan to address all of OIG's findings is dependent
on the use of enhanced software capabilities to support a comprehensive
inventory management system. The specifications for the enhancements
were developed and submitted in 2005 to the VA's Office of Information
and Technology as part of the Pharmacy Re-Engineering (PRE) project.
The current plan is for this functionality to be available sometime in
2011, depending on funding and development priorities.
All CMOP contracting recommendations have been addressed. With the
exception of rewriting the CMOP software to improve inventory
accountability which is expected to be completed near the end of FY
2010, all proposed actions to meet the OIG recommendations have been
completed.
Question 14: Why did the VA allow the directive on Drug
Accountability Software to lapse in 2003? Are there plans for an
updated directive?
Response: VHA's directive on Drug Accountability was allowed to
expire primarily due to the lack of standardized automated national
tools to accomplish the requirements. Facilities reported difficulties
trying to audit high cost drugs manually. They were unable to
accurately reconcile inventories due to dispensing software
limitations. It is PBM's belief that a policy which cannot be
implemented in the field is not a good management practice; therefore,
PBM allowed the directive to expire with the understanding that
enhanced software development was due to be implemented in 2008 as part
of the PRE project.
After the Drug Accountability policy expired, VA's Chiefs of
Pharmacy were advised that although it was no longer in effect, it
would be prudent for them to continue some form of drug accountability
oversight, using locally developed processes to aid in the detection of
diversion of non-controlled substances. PBM recommended that sites take
steps to limit the number of storage areas for high cost drugs and
reduce inventory levels when possible.
Though VHA still lacks the tools planned for PRE, PBM supports
issuing a new directive with monitoring that can be accomplished using
currently available tools. A draft policy has been developed and is
currently undergoing review for concurrence. Once PRE inventory modules
are developed and implemented, VHA will revise the policy to take
advantage of the enhanced software capability.