[House Hearing, 112 Congress]
[From the U.S. Government Publishing Office]
PRESCRIPTION DRUG DIVERSION: COMBATING THE SCOURGE
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON COMMERCE, MANUFACTURING, AND TRADE
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED TWELFTH CONGRESS
SECOND SESSION
__________
MARCH 1, 2012
__________
Serial No. 112-122
Printed for the use of the Committee on Energy and Commerce
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COMMITTEE ON ENERGY AND COMMERCE
FRED UPTON, Michigan
Chairman
JOE BARTON, Texas HENRY A. WAXMAN, California
Chairman Emeritus Ranking Member
CLIFF STEARNS, Florida JOHN D. DINGELL, Michigan
ED WHITFIELD, Kentucky Chairman Emeritus
JOHN SHIMKUS, Illinois EDWARD J. MARKEY, Massachusetts
JOSEPH R. PITTS, Pennsylvania EDOLPHUS TOWNS, New York
MARY BONO MACK, California FRANK PALLONE, Jr., New Jersey
GREG WALDEN, Oregon BOBBY L. RUSH, Illinois
LEE TERRY, Nebraska ANNA G. ESHOO, California
MIKE ROGERS, Michigan ELIOT L. ENGEL, New York
SUE WILKINS MYRICK, North Carolina GENE GREEN, Texas
Vice Chairman DIANA DeGETTE, Colorado
JOHN SULLIVAN, Oklahoma LOIS CAPPS, California
TIM MURPHY, Pennsylvania MICHAEL F. DOYLE, Pennsylvania
MICHAEL C. BURGESS, Texas JANICE D. SCHAKOWSKY, Illinois
MARSHA BLACKBURN, Tennessee CHARLES A. GONZALEZ, Texas
BRIAN P. BILBRAY, California JAY INSLEE, Washington
CHARLES F. BASS, New Hampshire TAMMY BALDWIN, Wisconsin
PHIL GINGREY, Georgia MIKE ROSS, Arkansas
STEVE SCALISE, Louisiana JIM MATHESON, Utah
ROBERT E. LATTA, Ohio G.K. BUTTERFIELD, North Carolina
CATHY McMORRIS RODGERS, Washington JOHN BARROW, Georgia
GREGG HARPER, Mississippi DORIS O. MATSUI, California
LEONARD LANCE, New Jersey DONNA M. CHRISTENSEN, Virgin
BILL CASSIDY, Louisiana Islands
BRETT GUTHRIE, Kentucky KATHY CASTOR, Florida
PETE OLSON, Texas
DAVID B. McKINLEY, West Virginia
CORY GARDNER, Colorado
MIKE POMPEO, Kansas
ADAM KINZINGER, Illinois
H. MORGAN GRIFFITH, Virginia
_____
Subcommittee on Commerce, Manufacturing, and Trade
MARY BONO MACK, California
Chairman
MARSHA BLACKBURN, Tennessee G.K. BUTTERFIELD, North Carolina
Vice Chairman Ranking Member
CLIFF STEARNS, Florida CHARLES A. GONZALEZ, Texas
CHARLES F. BASS, New Hampshire JIM MATHESON, Utah
GREGG HARPER, Mississippi JOHN D. DINGELL, Michigan
LEONARD LANCE, New Jersey EDOLPHUS TOWNS, New York
BILL CASSIDY, Louisiana BOBBY L. RUSH, Illinois
BRETT GUTHRIE, Kentucky JANICE D. SCHAKOWSKY, Illinois
PETE OLSON, Texas MIKE ROSS, Arkansas
DAVID B. McKINLEY, West Virginia HENRY A. WAXMAN, California (ex
MIKE POMPEO, Kansas officio)
ADAM KINZINGER, Illinois
JOE BARTON, Texas
FRED UPTON, Michigan (ex officio)
(ii)
C O N T E N T S
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Page
Hon. Mary Bono Mack, a Representative in Congress from the State
of California, opening statement............................... 1
Prepared statement........................................... 4
Hon. G.K. Butterfield, a Representative in Congress from the
State of North Carolina, opening statement..................... 6
Prepared statement........................................... 8
Hon. Cliff Stearns, a Representative in Congress from the State
of Florida, opening statement.................................. 13
Hon. Edolphus Towns, a Representative in Congress from the State
of New York, prepared statement................................ 172
Witnesses
R. Gil Kerlikowski, Director, Office of National Drug Control
Policy......................................................... 13
Prepared statement........................................... 16
Answers to submitted questions............................... 175
Pamela Jo Bondi, Attorney General, State of Florida.............. 35
Prepared statement........................................... 37
Answers to submitted questions............................... 183
Jack Conway, Attorney General, Commonwealth of Kentucky.......... 44
Prepared statement........................................... 47
Answers to submitted questions............................... 189
Aaron E. Haslam, Senior Assistant Attorney General, State of Ohio 54
Prepared statement........................................... 56
Answers to submitted questions............................... 194
Joseph T. Rannazzasi, Deputy Assistant Administrator, Drug
Enforcement Administration..................................... 78
Prepared statement........................................... 80
Answers to submitted questions............................... 199
John M. Gray, President and Chief Executive Officer, Healthcare
Distribution Management Association............................ 105
Prepared statement........................................... 108
Answers to submitted questions............................... 210
Joseph H. Harmison, Owner, DFW Prescriptions, on Behalf of
National Community Pharmacists Association..................... 116
Prepared statement........................................... 118
Answers to submitted questions............................... 246
Kevin N. Nicholson, Vice President, National Association of Chain
Drug Stores.................................................... 125
Prepared statement........................................... 127
Answers to submitted questions............................... 249
Kendra A. Martello, Assistant General Counsel, Pharmaceutical
Research and Manufacturers of America.......................... 140
Prepared statement........................................... 142
Answers to submitted questions............................... 252
David R. Gaugh, Vice President for Regulatory Sciences, Generic
Pharmaceuticals Association.................................... 154
Prepared statement........................................... 156
Answers to submitted questions............................... 255
PRESCRIPTION DRUG DIVERSION: COMBATING THE SCOURGE
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THURSDAY, MARCH 1, 2012
House of Representatives,
Subcommittee on Commerce, Manufacturing, and Trade,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 11:10 a.m., in
room 2322 of the Rayburn House Office Building, Hon. Mary Bono
Mack (chairman of the subcommittee) presiding.
Members present: Representatives Bono Mack, Blackburn,
Stearns, Harper, Lance, Cassidy, McKinley, and Butterfield.
Staff present: Paige Anderson, Policy Coordinator,
Commerce, Manufacturing, and Trade; Charlotte Baker, Press
Secretary; Kirby Howard, Legislative Clerk; Brian McCullough,
Senior Professional Staff Member, Commerce, Manufacturing, and
Trade; Gib Mullan, Chief Counsel, Commerce, Manufacturing, and
Trade; Shannon Weinberg, Counsel, Commerce, Manufacturing, and
Trade; Michelle Ash, Democratic Chief Counsel, Commerce,
Manufacturing, and Trade; and Will Wallace, Democratic Policy
Analyst.
Mrs. Bono Mack. Good morning. If statistics hold true, by
the time this hearing is over 10 Americans will have tragically
and I believe needlessly died from prescription drug overdoses.
Today prescription drug abuse is a deadly, serious, and rapidly
escalating problem all across our Nation. We have a solemn
obligation to tackle this growing epidemic head on, and I am
going to keep beating the drums until Congress, the FDA, and
the DEA come up with a comprehensive plan for action.
The Chair now recognizes herself for an opening statement,
and the clock is not working. That is all right for me. It
won't be all right for you all, though, so don't get too
comfortable.
OPENING STATEMENT OF HON. MARY BONO MACK, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
As Americans we rally around efforts to fight breast
cancer, childhood diseases, and other serious health threats.
But for far too long there have been only hushed whispers about
prescription drug abuse, now the fastest-growing drug problem
in America according to the CDC.
Today as the death toll from prescription drug overdoses
continues to rise sharply, it is time to move the story from
the obituary page to the front page where it belongs. It is
time to realize that we can't simply wish this horrific problem
away, not with nearly 30,000 people a year dying from it. See
no evil, hear no evil often leads to a society's unspoken evil,
indifference.
We can do better than that, and we must. Just about
everyone knows someone who is affected by prescription drug
abuse, which impacts an estimated 12.5 million Americans and is
now considered a health epidemic by the CDC. According to a
recent, ``Monitoring the Future,'' national survey nearly one
in four twelfth-graders have abused prescription drugs.
Today two classes of medicines, painkillers and insomnia
and anxiety drugs, are responsible for about 70 deaths and
nearly 3,000 emergency room visits a day. These are stunning
numbers, but here is what is even more alarming. The death toll
from overdoses of these powerfully-addictive medicines is now
more than double the death toll from heroin, cocaine, and all
other illegal drugs combined. As a result, for the first time
ever drug deaths outnumber traffic fatalities and has become
the leading cause of accidental death in America.
So what is the answer? When it comes to prescription drug
abuse, where are the safety belts and the airbags that we need
to deploy? First, like anyone in recovery knows we have to
admit we have a serious problem. Americans today simply are
prescribed too many medicines. There is a pill for just about
every ache, pain, and malady.
So what is wrong with that? Well, consider this. Not long
ago the DEA conducted three national drug take-back days, and I
applaud them for that, and at those 3 take-back days they
collected an astonishing 995,815 pounds of unused and unneeded
medicines. That is 995,000 pounds, not pills, in just 3 days.
Today doctor shopping is a widespread problem which
contributes to our Nation's alarming prescription drug
addiction rate, increases costs to all of us through higher
insurance rates, and makes it extremely difficult for the DEA
to crack down on abusers. Compounding the problem is an
oftentimes false sense of security. ``If it is approved by the
FDA and prescribed by a doctor, then it must be OK.'' Wrong.
Too many pills taken at once or combining them with other drugs
and alcohol can have a serious and even deadly consequence.
But the issue confronting us today is much more complex and
involved than just what have you found lately in Grandma's
medicine cabinet. The black market sale of powerful and highly-
addictive narcotic painkillers such as OxyContin and Vicodin is
big business, prompting the DEA to attack the problem on
multiple fronts from street-level sales all the way to the top
of the supply chain. Targeted first were the so-called, ``pill
mills'' in Florida which were largely unregulated until last
year, and they routinely dispensed painkillers like they were
M&Ms from a gumball machine.
There is yet another, more insidious side of the story as
well. After becoming addicted to prescription painkillers, law
enforcement authorities say more and more people are now
switching to heroin. In San Diego County, which borders my
district, drug treatment experts say the use of heroin by young
adults has more than tripled since 2006. Much of this growth is
due to people who have switched to heroin as a cheaper
alternative to OxyContin, now going on the street for as much
as $80 for an 80-milligram tablet. By contrast, OxyContin sells
for about $6 a tablet in pharmacies.
Personally, I will never forget the very chilling phone
call I received one night from a constituent of mine who told
me that his son had had a gun put to his head because he
couldn't pay the street price any long for his OxyContin.
So what is the answer? I believe my legislation, the Ryan
Creedon Act, H.R. 2119, and the Stop Oxy Abuse Act, H.R. 1316,
are good starting points. My goal is to improve prescriber
education by getting doctors, dentists, nurse practitioners,
and other prescribers up to speed on the dangers of addiction
and to make certain that powerful and seductive narcotic
prescription drug such as OxyContin are used to treat severe
pain only, not moderate pain like a toothache or a sore knee.
In far too many cases addiction becomes a much greater health
threat than the original pain itself, and in far too many cases
death is the final result of a failed rehab.
So let us not continue to blame this on Grandma and her
medicine chest. She knows better, and in our hearts Americans
do, too.
[The prepared statement of Mrs. Bono Mack follows:]
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Mrs. Bono Mack. And I am happy to recognize the gentleman
from North Carolina, the ranking member of our subcommittee,
Mr. Butterfield, for his 5 minutes.
OPENING STATEMENT OF HON. G.K. BUTTERFIELD, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF NORTH CAROLINA
Mr. Butterfield. Thank you. Let me thank the chairman for
holding today's hearing on this very important subject of
prescription drug diversion, and I know that this issue is very
important to you, and I admire your work on it.
Prescription drug diversion is an ever-growing problem in
our country. In fact, a couple years ago in 2010, seven million
people, seven million, over the age of 12 were considered
current users of a prescription pain reliever; tranquilizers,
stimulant, or a sedative, that was not prescribed to them.
Sadly, it has become clear that as legitimate prescription drug
use rises, so, too, does the number of people who abuse these
drugs and so, too, does the number of people who accidentally
die from prescription drug overdose. It is unconscionable that
since 1990, a little over 20 years ago, the deaths resulting
from an overdose of prescription drugs have risen. It has risen
five-fold. Sometimes must be done, and I agree with that.
But the question is what and by whom. Some of the testimony
we will hear today comes from manufacturers and distributors of
prescription drugs. It seems to me that the security and
safeguards these entities employ is very impressive and goes
beyond what might be expected. The use, layers upon layers of--
they use layers upon layers of security. They hire third
parties to audit the processes and make immediate changes if a
vulnerability is indentified. They track shipments with GPS
precision and have built in a lot of redundancy in their
security procedures.
Understandably, though, the further down the supply chain a
particular drug travels the greater are the opportunities for
diversion. The National Survey on Drug Use and Health reported
that 76 percent, more than three-quarters of people who use
prescription drugs non-medically, gain access to them from
someone they know. I think this needs to be our focus as we go
forward.
To that end, we need to focus on anti-diversion efforts,
and I am pleased that the director from the White House Office
of National Drug Control Policy is here today to tell us about
their action plan.
In a perfect world the answer to this problem is personal
responsibility, but in the real world it is clear the Federal
Government does have a defined role to play. We need to provide
greater support for education programs for young people so they
can learn at an early age the dangers of misusing prescription
drugs. We need to provide greater support for rehabilitation
initiatives so those who are addicted to prescription drugs
have access to the help they medically need, and we need to
make sure DEA has access to the resources it needs to
scrutinize all the players involved and the manufacturer,
distribution, and dispensing of controlled substances. Most
involved in this process are good and honest people. DEA needs
to find the ones who are not.
And so I would like to personally on behalf of the
Democrats on this committee thank all of you for coming today,
and I look forward to your testimony. I stand ready to work
with each of you, Madam Chair, and our colleagues and witnesses
to curtail prescription drug abuse in the United States of
America.
Thank you so very much. I yield back.
[The prepared statement of Mr. Butterfield follows:]
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Mrs. Bono Mack. Thank you, Mr. Butterfield. Chairman Upton
has yielded his 5 minutes for an opening statement to me in
accordance with committee rules, and as his designee I now
recognize Mr. Stearns for 2 minutes for an opening statement.
OPENING STATEMENT OF HON. CLIFF STEARNS, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF FLORIDA
Mr. Stearns. Thank you, Madam Chair, and just wanted to
compliment you for this hearing on prescription drug diversion.
Very important and I am also very pleased to have and welcome
our attorney general, Florida's own attorney general, Pam
Bondi. She is here to testify on this important hearing. She is
Florida's 37th attorney general, sworn in in January of last
year. She is a native of Florida, and she graduated from the
University of Florida, which I represent, so I am proud to have
her as a so-called constituent. She also graduated from Stetson
Law School and was a prosecutor for almost 18 years.
Among her top priorities is strengthening penalties to stop
pill mills in the Sunshine State, which from our last hearing,
Madam Chair, on this issue was a prevalent problem in our
State, and with her dedication and leadership against
prescription drug abuse, Florida went from having 98 of the top
100 dispensing physicians for oxycodone pills to have 13
dispensing physicians residing in Florida.
So frankly her success in this effort resulted in
recognition from the National Association of Drug Diversion
Investigators, Florida Police Chiefs Association, and from the
Florida Board of Medicine. So I want to welcome her, and I
thank you, Madam Chair, for the opportunity to do so.
Mrs. Bono Mack. Thank you, and I just want to point out
that there is a hearing going on in the Health Subcommittee
with the Cabinet Secretary. So a lot of members are bouncing in
and out. If they are able to attend, I just want to thank the
members who are here.
Mr. Butterfield. Madam Chairman, that is where I was until
I figured out I was in the wrong place.
Mrs. Bono Mack. I am glad you figured it out. But we do
have three panels before us today. Each of our witnesses has
prepared an opening statement. They will be placed into the
record. Each of you will have 5 minutes to summarize that
statement in your remarks. The good news is the clock is
working, and there is a timer in front of you now.
On our first panel we have the Honorable Gil Kerlikowske,
Director of the Office of National Drug Control Policy. Good
morning, Director, and once again, thank you very much for
being here. I am happy to recognize you now for 5 minutes for
your statement.
STATEMENT OF R. GIL KERLIKOWSKE, DIRECTOR, OFFICE OF NATIONAL
DRUG CONTROL POLICY
Mr. Kerlikowske. Thank you, Chairman Bono Mack and Ranking
Member Butterfield and distinguished members of the
subcommittee. It is a great opportunity for us to update you on
this important issue of prescription drug abuse in the United
States.
Prescription drug abuse has been a major focus of the
Office of National Drug Control Policy since my confirmation. I
am particularly indebted to Chairman Bono Mack for calling me
up to her office in the first week that I was in the office to
really begin to educate me about an issue that, frankly, 3
years ago was not on the public's radar screen, but it is
clearly in front of the public today.
I included prescription drug abuse as a signature
initiative as part of the administration's National Drug
Control Strategy. As been mentioned, it has been categorized as
a public health epidemic by the Centers for Disease Control and
Prevention.
The scope of non-medical use of pharmaceuticals is
striking. CBC found in 2008, that the opioid pain relievers
were involved in 14,800 deaths, and opioid pain relievers are
now involved in more overdose deaths as has been mentioned in
heroin and cocaine combined. The vast majority of abused
pharmaceutical drugs originally enter into circulation through
a prescription. The quantity of prescription painkillers sold
to pharmacies, hospitals, and doctors' offices has quadrupled
from 1999, to 2010.
When I testified last year before this subcommittee in
April, the administration had just released that month its
Comprehensive Prescription Drug Abuse Prevention Plan. The plan
focuses on four major pillars.
The first pillar is education. Most prescription
painkillers are prescribed by primary care doctors, internists,
and dentists, not pain specialists. The FDA is requiring
manufacturers of these opioids to develop educational materials
and training for prescribers. The administration is working
with Congress to amend the Federal law to require mandatory
education and training for prescribers, and we are also working
very hard to educate the general public about the risks and the
prevalence of prescription drug abuse and about the safe use
and proper storage and disposal of these medications.
The second pillar, monitoring. We focused on expanding and
improving State prescription drug-monitoring programs. Forty-
eight states have those laws. Despite the progress, some states
lack operational programs. Many states operate PDMPs that lack
interoperability with other states. But I am pleased to report
the administration worked with Congress to secure legislative
language to allow the Department of Veterans' Affairs to share
prescription drug data with these PDMPs.
Our third pillar focuses on safe disposal of unused and
expired medications and through the National Prescription Drug
Take Back Days that the DEA has collected and was talked about
by the chair. The administration also recognizes the
significant role that pill mills and rogue prescribers play in
this issue. Our surveys and research show that with chronic
addiction to prescription drug they are more likely to obtain
their drugs from the pill mills than the recent initiates.
And final pillar of the administration's plan focuses on
improving law enforcement capabilities to address diversion.
Across the country law enforcement regulatory and legislative
actions are forcing doctors and shoppers and doctor shoppers
and others seeking these sources of prescription drugs to be
apprehended.
The problem, of course, was highlighted in the State of
Florida, which was in 2010, the epicenter of the Nation's pill
mill epidemic, but I have to tell you that working with the
attorney general in the State of Florida has led to marked
changes in that State, and I couldn't be more pleased that not
only she, but Attorney General Conway are also here.
In 2011, ONDCP, our office, supported training events
because we know if you are going to do the enforcement, it
can't be just at the Federal level. It has to be at the State
and local level also, and experts in law enforcement need that
kind of training in order to investigate these complex cases.
We are undertaking a data analysis project right now to
examine the ways that prescription drugs are purchased,
purchasing behaviors, and whether those patterns are indicative
of suspicious behavior. We held a round table with members of
the pharmacy community and law enforcement to discuss pharmacy
robberies and burglaries. We called in the heads of
organizations that worked on the security of the manufacturers
and distributors to make sure that we were knowledgeable about
what they were doing to secure these very potent
pharmaceuticals.
In closing just let me thank the members of Congress for
their support on the ONDCP and my Executive Branch colleagues
who know that without your efforts and without your support we
would not make a difference in this very important area.
Thank you.
[The prepared statement of Mr. Kerlikowske follows:]
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Mrs. Bono Mack. Thank you very much, Director. I will
recognize myself now for 5 minutes for questioning.
And just ask you with everything that your office is doing
together, the DEA and the FDA, why are we losing this battle
against the prescription drug epidemic, and you have mentioned
a lot of progress we have made, but you do live in Florida, but
prescription drug abuse has not decreased. What is the next
step?
Mr. Kerlikowske. I think the fact that all of these things
are coming together, that we actually are starting to see some
fruition to all of the work that has been going on. For
instance, in the most recent Monitoring the Future Survey,
eighth, tenth, and twelfth graders have actually reduced their
level of use of prescription drugs, but I couldn't agree with
the chair more that it is an epidemic, that it is so wide
spread and that people still don't get it. They don't
understand that these are dangerous, they can be deadly, and
they can certainly be addictive.
I think that one of the greatest hopes will be in the next
step forward, and that is mandatory prescriber education.
Physicians must be told and must have unequivocal information
about the dangers of addiction, pain management, tolerance,
dependence, and they really don't get that in medical school.
The second part I know you will hear form the Drug Enforcement
administration as non-enforcement. The laws have to be
enforced, and people have to be prosecuted.
Mrs. Bono Mack. I appreciate that and especially your
viewpoint on prescriber education, but a problem for me, too,
is we examined this problem. There are clearly gaps in the
data, and we don't really know the extent of the problem.
What are the gaps, and how can they be filled?
Mr. Kerlikowske. Well, quite often we rely, for instance,
on fatality data to come from the individual states, and we
know that depending on the particular State, whether it is a
medical examiner system or others, those states can often be
delayed.
We also know that at times, whether it is from fatalities
from driving accidents or others, that the level of
examinations to determine what the cause and whether or not
that person had the drugs in their system is not always as
thorough as it can and should be. There are data gaps, but I
will be happy at another time to tell you about this new
initiative to take some of the data and really identify and
drill down into it.
Mrs. Bono Mack. I would be happy to work with you on that.
I think they are critical even for policymakers. We need that
data critically.
The DEA is going to testify that there are 1.4 million DEA
registrants. That seems awfully high. Do you think that 1.4
million registrants is about right for America, or is that kind
of a crazy number?
Mr. Kerlikowske. Chairman, I actually wouldn't know what
the right number would be, but I think when you look at nurse
practitioners, physicians, and all of the other people that
hold those DEA registration licenses across the country in the
healthcare field, that the number doesn't seem completely out
of line to me. I think more importantly is how they are
policed.
Mrs. Bono Mack. Thank you, and lastly, should we be
thinking about creating new classification schedules under the
Controlled Substance Act with stricter regimes for the drugs
that are clearly the biggest problems?
Mr. Kerlikowske. I know that issue has come up before to
put those into the higher schedule. I think the more important
part is to try and keep them out of the hands of the abusers
but not at the same time they get so restrictive that the
issues that led us to where we are today 15 years ago, which
was the clear indication that pain was not being adequately
treated in the United States, I think the pendulum was too far
over there. Clearly today the pendulum is too far over here
when it comes to the availability of these.
I am not sure scheduling would be the right answer, but we
have to bring this back to some equilibrium.
Mrs. Bono Mack. Are you working with the physicians who are
saying that pain shouldn't always be treated solely with
opioids and that there have to be other ways of treating pain,
that this is creating an epidemic that is hurting more people
than it is saving?
Mr. Kerlikowske. I have. I have heard from a number of
physicians that want to be much more flexible and understanding
and treating pain rather than writing prescriptions for 30, 60,
or 90 days worth of very powerful painkillers. They also want
to make sure that there are systems in place where they can be
adequately reimbursed for treatments other than what right now
seems to be a very simple and quick method but not always
particularly effective in treating pain by writing a script.
Mrs. Bono Mack. In the last 22 more seconds that I do have
something Attorney General Bondi cares deeply about are the
opiate babies. Can you speak briefly to what you have learned
about opiate babies?
Mr. Kerlikowske. I can. I can tell you that in the past and
having visited in one of the centers for newborns in Seattle
the issue always centered around newborns and the addiction
through heroin. Today when I met and saw all of those infants
and actually held one of those infants, the issue was all about
prescription drugs, and there was very little discussion about
mothers using heroin.
And so we are building some tremendous healthcare costs as
a result of not treating this adequately.
Mrs. Bono Mack. Thank you very much, Director, and happy to
recognize Mr. Butterfield for 5 minutes.
Mr. Butterfield. Thank you. Again, thank you very much for
coming forward today with your testimony. We have heard your
testimony, and we appreciate so much what you do.
I have a question that I would like to ask, and I may even
ask it of the other panels as well, but I believe it is very
critical, and it is central to the problem that we are dealing
with.
Efforts in one state may yield declines in the number of
pills dispensed, hospitalizations, or deaths, any of which are
very commendable achievements within that state's border, but
how can we be sure that addicted individuals simply don't go to
another state?
Mr. Kerlikowske. I think the key would be on the example
would be the fact that Florida had become such as has been
talked about, so publicly an epicenter for not only the use of
these very powerful, misuse and abuse of these very powerful
prescription drugs for people within the State of Florida but
for people traveling all the way through Appalachia and
actually New York, Connecticut, and other places.
The regulation of medicine is done at the state level. It
is not done at the Federal level, and we have to provide the
training, the technical assistance, the start-up money for the
computer systems, and the assistance to law enforcement,
particularly state and local law enforcement to understand how
to investigate these complex cases.
I would tell you that greater use of the PDMPs is
necessary. Not as many physicians or people in the healthcare
industry utilize them as should and that they need to be real
time and that they need to be interoperable across states.
When those things come together and I think we are seeing
some of this in the number of states that are sharing the
information, I think that that way we can stop that balloon
effect that you were talking about, Congressman.
Mr. Butterfield. We have been looking at the data in our
office, and the data seems to suggest that the total number of
elicit drug users was constant for 2 years, even though we have
seen great strides in states like Kentucky and Florida and even
Ohio.
Are we on the right path with this?
Mr. Kerlikowske. I think we are on the right path with this
with what I believe is a very balanced way and a very
comprehensive way of looking at this. I think that if I go back
and look at where we were, and believe me, I am the first one
to tell you that a lot more has to be done, particularly in
redoubling our efforts in some of these areas, but I look at
where we were 3 years ago. As a chief of police of a city of
almost 700,000 people, I was really unaware of this
prescription drug problem. I think that my colleagues who were
sworn to protect people in the city and learn about what are
the dangers when you don't realize it, when we didn't realize
it and prosecutors and judges and many others did not realize
it, we weren't paying attention to it because after all, it is
a prescription, it is coming out of the medicine cabinet. It
was a huge mistake.
This is on the front page of every major newspaper on a
regular basis. It is on television. We are moving in the right
direction.
Mr. Butterfield. Let me talk about tribal communities for a
minute, and I only have a minute 50 left. As the National Drug
Control Strategy points out, tribal communities have been
particularly hard hit by unemployment and combined with
problems accessing healthcare, education, and other services,
tribal communities can be disproportionately vulnerable to
prescription drug abuse.
A 2009, study by the Substance Abuse and Mental Health
Administration found that American Indians are more than twice
as likely as whites to abuse prescription drugs. What is the
administration doing to help tribal communities address these
unique challenges?
Mr. Kerlikowske. We started looking at that almost
immediately and a couple things that are done. First Assistant
Secretary Echo Hawk from the Department of Interior has been a
great partner, along with the Indian Health Service and along
with the Bureau of Indian Affairs. We have made trips to a
number of the tribal lands, for example, the Tohono O'odham
Nation in Arizona, and the issues around dietary issues,
alcohol issues, and illegal drugs was significant, but the
growing problem that was pointed out to us is exactly as you
said, and that is around the prescription drug issues.
Mr. Butterfield. But are you working with them to set up
databases?
Mr. Kerlikowske. Education, so the education and prevention
and working through the Indian Health Service and the Treatment
Service, and let me just mention on the enforcement side for
the first time one of our high-intensity drug trafficking
groups, HIDTA, in Portland includes a member of--a tribal chief
to help direct those needed enforcement resources back onto
tribal lands.
Mr. Butterfield. That includes databases and other
resources?
Mr. Kerlikowske. I don't know about the database in
particular. I would think that the health service would
probably be more knowledgeable about that.
Mr. Butterfield. All right. Thank you. You have been very
kind.
Mr. Kerlikowske. Thank you.
Mrs. Bono Mack. Thank you, Mr. Butterfield.
The Chair recognizes Mr. Stearns for 5 minutes.
Mr. Stearns. Thank you, Madam Chair.
Is it true that prescription drug overdose deaths now
surpass our car-related fatalities?
Mr. Kerlikowske. It is true that all overdose deaths are
now the leading, from drugs, misuse and abuse, not accidental,
are the number one cause of accidental death in this country,
ahead of gunshot wounds and ahead of car crash deaths, driven
by prescription drugs.
Mr. Stearns. That is a startling fact, don't you think?
Mr. Kerlikowske. Yes.
Mr. Stearns. Do you think based upon that that we should
have a radical change in our approach?
Mr. Kerlikowske. I think that we haven't gotten anywhere
near the attention or near the traction to something that is
killing more people in this country than car----
Mr. Stearns. And, in fact, 10 or 20 years ago I wouldn't
find the statistics like it is today?
Mr. Kerlikowske. Not at all.
Mr. Stearns. And why do you think that occurred?
Mr. Kerlikowske. One, I think that the driver of the
prescription drugs as we have been, as has been mentioned a
little bit, people don't see them as addictive, they don't see
them as dangerous, and they don't see them as deadly, because
they are, after all, a prescription.
Mr. Stearns. I think in your opening statement you were
talking about opiates were sold in 2010, to medicate every
American adult six times a day for a month. That was in your
statement.
Mr. Kerlikowske. Yes.
Mr. Stearns. Doesn't that put a line to the claim that we
are just getting better at pain management?
Mr. Kerlikowske. When I have spoken with the physicians who
looked at and were instrumental in the early days of under-
treating and the recognition of under-treating pain, I think
that a clear recognition, and as I mentioned a minute ago I
think that the pendulum was there and that in very good faith
ways they worked very hard to make sure that people actually
were adequately treated for pain.
A few things were missing. One is the amount of education
that a physician would need to clearly understand and recognize
some of the dangers of these. The other is that as many people
have mentioned, we have become kind of an overmedicated
society.
Mr. Stearns. How would we educate Americans to not be an
overly medicated society?
Mr. Kerlikowske. It is a pretty tough issue. It is kind of
like dealing with the obesity issue.
Mr. Stearns. Do you think it is something to do with our
culture today that----
Mr. Kerlikowske. I think that the more important part is to
educate the physicians around this, as physicians are so much
more knowledgeable about dietary issues and the causes, I don't
see the same level of knowledge among them and among healthcare
practitioners when it comes to the addictive properties of
these drugs.
Mr. Stearns. Could you from your department make it more
difficult for the doctors to provide prescription drugs in the
areas that are causing the overdoses? Is there something that
you could do?
Mr. Kerlikowske. I--we are kind of a small policy shop
that----
Mr. Stearns. You couldn't make any recommendations?
Mr. Kerlikowske [continuing]. We bring all of these folks
together. I think the key will be education and then making
sure that they follow the rules, and I think that we are well
on the way to hopefully getting that done.
Mr. Stearns. You mentioned in your opening statement the
actual cost to society is estimated at $56 billion in 2007, and
maybe likely higher today. Do you have any idea what the cost
in terms of devastating affects on families and communities--so
if it is $56 million [sic] in 2007, what do you think it is
today?
Mr. Kerlikowske. Well, and I think that the most recent
study on the costs to the United States taxpayer on drug abuse
is well around $190 billion that----
Mr. Stearns. One hundred and ninety billion.
Mr. Kerlikowske. For--and that includes all types of
heroin, cocaine, marijuana issues, et cetera, but I think that
you couldn't be more correct in putting forward the fact that
it is not only a huge cost in our healthcare system, it is a
huge personal cost and a huge personal tragedy the child that
doesn't graduate from high school, the employer that wants to
start a new business and can't find people that are drug free
so that they will have less accidents and be more productive.
All of these things play a huge part, and so the dollar cost is
one thing. The tragedy to this country is another important
part.
Mr. Stearns. Lots of times all of us talk about the legal
war on drugs, but we are also--I think we have to consider a
war on prescription drugs, and so I guess the question is where
does the current prescription drug war rank compared to our war
on illegal drugs?
Mr. Kerlikowske. I think my colleagues, particularly in the
Drug Enforcement Administration, when they set their goals and
they move forward each year in recognizing what the drug threat
is, several years ago they recognized this issue much more
quickly and actually changed their direction and focus. I think
you will hear about the number of what are called tactical
diversion squads, the number of investigations, the number of
local law enforcement and prosecutors that have been trained in
how to investigate these complex cases, because these are
actually legal drugs that are manufactured and often through
prescriptions or pill mills. So those are important steps
forward.
Mr. Stearns. Are we winning or losing?
Mr. Kerlikowske. We are moving ahead. I am encouraged by a
couple of things. One, the number of dispensed opioid
prescriptions has flattened, and if you looked at the charts in
a number of years, it looked like the space shuttle taking off.
The amount of opioids manufactured has flattened, and the fact
that in this most recent monitor in the future, eighth, tenth,
and twelfth graders actually decreased in their use of one of
the very powerful painkillers, Vicodin.
I think we are moving there, but as the chair and others
know so well, it is not enough, and it is not fast enough.
Mrs. Bono Mack. Thank you very much, Mr. Stearns, and I am
pleased to recognize Mr. McKinley for 5 minutes for his
questions.
Mr. McKinley. Thank you, Madam Chairman.
Briefly, I think you and I had a little conversation
beforehand, before we began, and we were concerned about
privacy. I still would, I would like you to expand a little bit
about that. What--to me from an engineering for small business
perspective, I am a little concerned about, very concerned
about the privacy, but I know and I think you would recognize
that if there were a national registry of all the prescription
drug used in America, the pharmacies would be held responsible
to check that registry to find out that they just got OxyContin
just one day earlier for a 3-months' supply, and they would be
able to say no.
Isn't there something, some form, I know we don't want to
have FDA, because as we have had other hearings here, someone
being able to hack into that information.
Mr. Kerlikowske. Right.
Mr. McKinley. There were penalties according--that are
related to that, but we all know if we had a list, if someone
had a list, we could go hold those people responsible more so
than the distributors that are doing the best they can to
curtail that.
Tell me a little bit about what efforts we can do in
security privatizing those names so that individuals can't be
identified but yet we--a pharmacy would be able to know that
they have now, this is their third prescription for the same
medicine in the last 2 weeks. Isn't there something you are
doing on that?
Mr. Kerlikowske. I think----
Mr. McKinley. I saw this the other night. I just think that
is just great, education. It works so well with teenage
pregnancies and everything else, hasn't it? Sanctions against
governments that they continue to--so I really want something
with more substance to it that is going to solve the problem.
Mr. Kerlikowske. Sure. I think the answer is the
prescription drug monitoring plans that are done by the state.
Since the Federal Government doesn't regulate the practice of
medicine and the state does, having the PDMP, that electronic
database that would be used by all physicians and healthcare
professionals that would be real time and that in states,
particularly neighboring states, that information could be
shared across the states.
When it is led and directed and the start-up money comes
from the Federal Government but led and directed by the state
government, they can put in the protections about patient
confidentiality and privacy. I think in the best of all worlds
that national database would be a wonderful thing. I think it
would be difficult to implement because of the protections that
would be needed to prevent exactly as you said hacking, and I
think that part of that national database would be the fact
that it would be 5 or 6 or 7 years in the making. Right now we
have all but two states that have PDMPs, and as they become
more well used and more well robust, it will actually make a
difference with their use.
Mr. McKinley. So are you suggesting, and I think I
understand, something that would not work with mail orders
because they are ordered someplace else other than just in the
state, but tell me again, you think that if pharmacists knew by
looking at computer screen that that person got--would he or
she still fill that prescription if he knew it was being
violated?
Mr. Kerlikowske. When I speak with all of the different
groups and the individual pharmacists, and you look at their
ethical standards and their patient safety practices and the
number of pharmacists that have picked up the phone and either
said, either called the physician saying something isn't right
or the ones that have told that patient, you know what, I am
not going to fill that because I have that information, I am
pretty heartened by where the pharmacists are.
But I think going upstream a little bit, that doctor that
realizes that that patient that has come into his or her office
has been to two or three other physicians or that patient that
walks in on Friday evening to an emergency department and says,
gee, I am traveling or I have lost my prescription or I need
something like that, when that frontline, upstream person can
take a look at that system and say, well, this is the third
hospital you have been to this weekend or you are seeing two
other doctors with a similar complaint, I am not going to be
dealing with this, I think that is a help also.
Mr. McKinley. So what do we do with that individual when
they come in? Are they held?
Mr. Kerlikowske. They are not held because I think that
unless they actually get, unless there is a law violation, they
are not going to be charged or they are not going to be held,
but I think the other important part of this education piece is
that they need to get into the treatment. I have met so many
people now across this country on these travels that have
become addicted to prescription drugs, have received proper
quality treatment, and they are back. I mean, they are back
taking care of their families, they are back paying taxes, they
are back working, and I think that this is the entry point to
get them the help that they are needed, because we are talking
about a disease. We are talking about addiction.
Mr. McKinley. OK. I guess we have run out of time. Thank
you very much.
Mr. Kerlikowske. Thank you, Congressman.
Mrs. Bono Mack. Thank you. Mr. Harper, you are recognized
for 5 minutes.
Mr. Harper. Thank you, Madam Chair.
Director Kerlikowske, thank you for your time here and all
that you are trying to do in a very serious situation. You
know, with regard to the PDMPs, what do you think the biggest
barrier is in the implementation of a drug-monitoring program
for states whose programs have yet to go online?
Mr. Kerlikowske. One of the barriers is the fact that it
needs to be real time, and it needs to be ease of use.
Physicians have about, as I have been told, about 16 minutes
with a new patient to assess everything. These are busy
practices and busy offices, and they need to be given a tool
that is easy, that is accessible in order to use it and of
course, once they do and they become schooled in it and rely on
it, the physicians that I have spoken with tell me that it is a
patient safety tool.
Mr. Harper. OK. Now, we have 48 states that have authorized
programs, 40, I understand, have operational programs. Are all
of these state PDMPs created equal?
Mr. Kerlikowske. No.
Mr. Harper. OK.
Mr. Kerlikowske. They are not, but we are fortunate at Rice
University to have a center of excellence that takes the best
practices that helps those that are--and of course, the heads
of each of these agencies come together several times a year
for us to be able to speak with them. We want to be able to
make them as robust and helpful as possible, but I would be the
first to tell you that some are better than others.
Mr. Harper. Well, are there some that you would hold out as
a role model for the other states or for those that have yet to
go operational?
Mr. Kerlikowske. I think you will hear from Attorney
General Conway, and I think Kentucky is clearly one of those
states that has addressed this not just with a very robust and
smart PDMP and some pending changes that they have planned in
their laws to make it an even better system. I would tell you
that from what I have looked at in California, the CURES
System, is another one. The Center for Excellence, they have
done a very good job of putting in the hands of the people that
use these, develop these systems, information that is
necessary.
Mr. Harper. What are you seeing as strengths and weaknesses
as communication between the various states with their
monitoring programs? Is that a weak link? Do you feel like that
the communication between those states can be improved, and if
so, what would you suggest?
Mr. Kerlikowske. Now, you ask the million-dollar question,
and I think you are exactly right. Some states are easier to
get along with amongst each other on this particular issue and
to work together. Some states when you look at these systems
and it is not a huge amount of money but every state is facing
difficult budget times, how much of a priority is it. But when
I talked to these physicians or listen to these physicians in
all these states, I said, look. If I am in eastern Kentucky, I
really don't want to spend the time to check Ohio, West
Virginia. I need to get to a system that is already linked to
those neighboring states.
Mr. Harper. Uh-huh. Do you--are the PDMPs the only option
out there for states to implement the sharing of this
information?
Mr. Kerlikowske. Right now on the prescription drug abuse
issue, those are the options. I think the healthcare technology
in the future, e-prescribing, all of these other things will
play a big role in the future and make it easier and more
helpful.
Mr. Harper. We want to thank you for your work on this very
important topic, and with that I yield back, Madam Chair.
Mrs. Bono Mack. Thank you, Mr. Harper.
Director Kerlikowske, thank you so much for being here
today and all of your hard work. You have been generous not
only today but every day in working with me on these issues. I
applaud you for raising the profile for many years and
especially coming from somebody who said you didn't know 3
years ago, you certainly know now. I don't know that we have
all the answers, but at least we are finally starting to
confront it, and I look forward to working with you.
Thank you, again, very much for being here today. Is there
anything you would like to close--rather than a second round of
questions, something you just need to say that you didn't get
to say?
Mr. Kerlikowske. Madam Chair, one--I am indebted to the
committee and the members of Congress that take this issue on.
You have so many issues in front of you, and yet as I mentioned
to the President on the drug issue, when we think about keeping
our kids in school and we think about who is going to be the
workforce that we are all going to depend on in the future, I
think about healthcare costs, I think about law enforcement
issues.
The more that we can do on the drug prevention side and the
more that we can do to get people adequate treatment and get
them back into the--into being productive members of society,
none of that could happen without the will and the support and
the help of members like you all.
Thank you.
Mrs. Bono Mack. Thank you very much.
And with that we are going to take a very, very brief
recess just while we seat the second panel. Hopefully it is 30
seconds or so, and we ask the second panel to join the table.
[Recess]
Mrs. Bono Mack. All right. On our second panel we have four
very distinguished witnesses who are very deeply involved in
the issues of prescription drug abuse and prescription drug
diversion, which clearly go hand in hand. We are honored today
to have with us the Honorable Pamela Jo Bondi, attorney general
for the State of Florida, the Honorable Jack Conway, attorney
general for the State of Kentucky. Also joining us are Aaron
Haslam, Senior Assistant attorney general for the State of
Ohio, and Joseph Rannazzisi, Deputy Administrator for the Drug
Enforcement Administration.
Thank you all, again, for being with us this morning. To
help you keep track of time there is a timer light on your
table. When it turns yellow, you have a minute to wrap up. So,
again, you don't have to come to a screeching halt when it
turns red, but if you can wrap up your comments, we would
appreciate it.
So with that we are happy to recognize Attorney General
Bondi for her 5 minutes, and please just remember to turn your
microphones on, and you may begin.
STATEMENTS OF PAMELA JO BONDI, ATTORNEY GENERAL, STATE OF
FLORIDA; JACK CONWAY, ATTORNEY GENERAL, COMMONWEALTH OF
KENTUCKY; AARON E. HASLAM, SENIOR ASSISTANT ATTORNEY GENERAL,
STATE OF OHIO; AND JOSEPH T. RANNAZZISI, DEPUTY ASSISTANT
ADMINISTRATOR, DRUG ENFORCEMENT ADMINISTRATION
STATEMENT OF PAMELA JO BONDI
Ms. Bondi. Thank you, Congresswoman Bono Mack, and thank
you for championing this cause on behalf of our country, and
thank you as well, Ranking Member Butterfield, for having us
here today and also to Congressman Stearns from Florida and to
all the committee members. We truly appreciate this.
I am here to tell you about what Florida is doing to try to
stop prescription drug abuse. As Congressman Stearns told you,
just to put it in perspective, of the top 100 oxycodone dealers
in the entire country, 98 of them were in Florida. Now we have
13, and that is with legislation that has been in effect barely
a year. So last year we had over 900 pain management clinics
registered within our state. Today we have 580, and I guarantee
you that number is going to continue to plummet.
I want to outline now briefly our comprehensive legislation
and what we have done in our state. As you know, we have become
the Oxy Express, and that is why I worked so closely with
General Conway, with General DeWine in Ohio because what was
happening, people were buying their drugs in Florida, taking
them to Kentucky. I had to hug a mother in Kentucky when I was
with General Conway who lost her daughter 2 years ago to
prescription drugs that were bought in Florida, and that had to
stop.
So we passed, with that we passed tough new legislation in
our state, and we are very proud of that legislation. Long,
long overdue, let me tell you that.
The common characteristics of a pill mill in Florida were
cash business, $200 to $300 cash, armed guards at the door,
little to no medical equipment at all. Just shelves and shelves
of pills. These doctors who we call drug dealers wearing white
coats are sitting in a back room just signing prescription
pads, and it was legal, and it was killing our kids.
So we had very weak regulatory oversight of the pain
management clinics. We had limited oversights of the physicians
who were dispensing, which was very important, and we had a
non-operational prescription drug monitoring program.
So with that we have now passed some very tough
legislation, and we are very proud of that. One of the most
important things to me was that we banned doctors from
dispensing most abused narcotics, and we made that a violation
of the ban, both a third degree felony and how do you hurt a
bad doctor? Take their license away. So with that dispensing
ban we feel that we have been very successful as well.
We also have--we created a standard of care for physicians
prescribing controlled substances. We require these doctors to
either electronically prescribe or to use counterfeit-proof
prescription pads, none of which had been done in our state. We
also added, as I said, enhanced criminal penalties, which were
very important and required all of these pharmacies to be re-
permitted by the State of Florida.
We did great things. We now have the PDMP up and running,
which if you have any questions, I can discuss that with you as
well, and with that, you know, we can always create tough new
laws and onto something else, but what we did in Florida with
Governor Scott's help, we started a strike force, and that is
joint with Federal, state, and local officials all working
together. You can pass these laws and move on, and it is not
going to work. We are targeting these guys, and we are putting
them out of business.
And with that just--we have seven strike forces throughout
our state, and if you have questions about the strike force, I
can explain that in greater detail, but what we have done,
since we have had the strike force is we have truly gone in and
started putting these guys out of business. We are targeting
them, and we are not letting up on them.
We also have an educational component of this legislation,
and that involves narcotics overdose prevention education,
NOPE, and this task force, these remarkable people have done an
amazing job of going into our schools and educating our
children about this.
We have also instituted along with DEA state drug take back
days. I have participated personally in as many of those as I
could. You would not believe the drugs that are being turned
in, and it has gotten so successful that we plan on putting
permanent drop boxes up at our police stations and our
sheriff's offices as well. At two drug take back days alone we
seized over five tons of prescription drugs. Unbelievable.
So and we are very pleased to announce that as of February,
2012, our strike force efforts have resulted in 2,040 arrests,
34 of those are doctors. We have seized 390 weapons, almost $5
million, but there is one other problem. I have run out of
time, but that is the babies being born addicted to
prescription drugs, and that is our newest fight this session,
and we are not going to give up on that as well.
Thank you for all of your efforts, and we do know we have a
long way to go, but I don't think any of us in this room are
going to stop.
Thank you.
[The prepared statement of Ms. Bondi follows:]
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Mrs. Bono Mack. Thank you very much.
And General Conway, you are recognized for 5 minutes.
STATEMENT OF JACK CONWAY
Mr. Conway. Well, thank you, Chairwoman Bono Mack and
Representative Butterfield for your commitment to this issue. I
also want to recognize Congressman Guthrie, who is not here,
but who is a fellow Kentuckian who works with our drug task
forces on this very important issue.
Prescription pill abuse is a reality that has touched the
lives of just about every Kentucky family. It has touch my
family's life in a very personal way. It has ravaged our
communities, it has shattered families, and it has fueled
crime.
Depending on which study you believe, Kentucky is either
the most third- or fourth-most medicated State in the entire
country, and the four you always hear at the top of the list
are Kentucky, West Virginia, Tennessee, and Oklahoma. Last year
in Kentucky we had over 1,000 people that we documented died
from prescription painkiller overdoses. That is more than we
lost to auto accidents.
And Madam Chairman, we actually think that is
underreported, because our estimates are that only about half
the people that actually die from overdoses autopsied by a
medical examiner's offices. And when you take a look at the
unnatural deaths in the Commonwealth of Kentucky, what you see
over and over is not heroin or not cocaine, not even alcohol as
much as you see Xanax, oxycodone, Methadone, and hydrocodone.
Last year, Kentucky hospitals treated over 5,000 overdose
patients.
Now, this is an epidemic we first started to see in the
1990s in eastern Kentucky. Eastern Kentucky is a region of
heavy industry, of laborers, of coal mines. We have more
injury-prone jobs, but it is also an area of economic
depression, and we have too many doctors who overprescribed and
too many people became hooked. And because of the economic
depression, people figured out they could sell their pills on
the street, and a black market was born. And today when you go
through eastern Kentucky, which I do on a regular basis, you
will find that about 80 percent of the crime according to law
enforcement and prosecutors is fueled by the abuse and the
insidious addiction to prescription painkillers.
The problem has spread across the Commonwealth. It is not
just in eastern Kentucky. According to a ``Lexington Herald''
leader study not too long ago in 120 of our counties which we
have total, 118 were up in the number of schedule two and three
narcotics prescribed, and I am sad to report that estimates
from law enforcement and those in the healthcare community say
that we have only about 10 percent of the treatment beds that
we actually need in the Commonwealth of Kentucky.
You know, I am sick and tired of hearing about losing an
entire generation to prescription pill abuse in the
Commonwealth of Kentucky, so we have started a public education
program for doctors and also for school children in Kentucky. I
actually travel across the Commonwealth with two mothers from
Morehead, Kentucky, who lost their daughters to prescription
pill abuse, and it is really important to get people like that
who look like the mothers of these kids to tell them their
story, because they will listen to an elected official for 5
minutes or so, but when the mothers talk, they really listen.
And here is what is disheartening. You can look at these
kids, middle schoolers, high schoolers, and say, OK, you know,
tell the truth. Just because I am the attorney general, tell
the truth. How many of you have used a prescription pill or
your best friend has used it for an off-label purpose. I am sad
to report 70 or 80 percent of the hands go up. I ask them how
many think that prescription pills are easy to get. Seventy or
80 percent of the hands will stay up. Then I will ask them how
many of their parents lock up their medicine cabinets. All the
hands will go down. I realize it is not a problem that starts
with Grandma, but in some instances, particularly in Kentucky,
it is an addiction that is starting in our homes.
I have tried to do all I can. I have created the State's
first prescription pill task force. That is my drug
investigators working with local law enforcement. We are trying
to collaborate and share resources in a time of dwindling law
enforcement resources. We participated in Operation Flamingo
Road, where we partnered with the DEA and the Kentucky State
Police to round up 500 individuals who were vanning pills up
from Florida in 2009.
At that point we thought about 60 percent of our pills in
our streets were coming from Florida. Pam Bondi told me a story
one time that they executed a search warrant on a pain
management clinic in Broward County, Florida, and they seized
1,700 patient records. Of those 1,700 individuals they seized
the records 1,100 of them are from the Commonwealth of
Kentucky. That is what we in law enforcement call ``a clue.''
We had people by the vanload going to Kentucky to bring pills
back.
And that is why I am not only happy to a friendship with
Pam or General Bondi I should say, I am grateful that she came
along at this time. She has done a tremendous job of taking on
these pill pushers in her State. As she said, Florida was home
to 97 or 98 of the Nation's top 100 prescribers of oxycodone.
Now they are down to 13.
This issue knows no party. It is an American tragedy. We
are doing all we can. We have new legislation in the
Commonwealth of Kentucky to reregulate our pill mills. We have
entrepreneurs getting in the pill mill business. We need to
stop them. We have the issue of the mail order forms cease
shipping 90-day supplies of schedule two and three narcotics. I
understand the issue of efficiency in our healthcare system,
but that needs to be 30 days, and we need to make certain that
we get doctors using these systems. Yes, we have KASPER, our
PDMP. It is a good system, but only about 25 percent of our
doctors are using it, and on top of that those of us in law
enforcement can't see the data to do the investigations that we
need to do, and I would be happy to talk with you a little bit
more about that.
I have heard the questioning here today, and I am out of
time, so I am going to wrap up, but if you want to know what
you can do to help, help us get all 50 states up with PDMPs and
with systems that talk to one another. We can do our jobs if we
can get those systems up and running and if we can get the
doctors to use them.
Thank you very much for the opportunity to appear.
[The prepared statement of Mr. Conway follows:]
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Mrs. Bono Mack. Thank you very much, General Conway.
Mr. Haslam, you are recognized for 5 minutes.
STATEMENT OF AARON E. HASLAM
Mr. Haslam. Thank you Chairman Bono Mack, Ranking Member
Butterfield, and distinguished members of this committee. I
thank you on behalf of Ohio attorney general Mike DeWine and
all of Ohio for the opportunity to address you today.
As the Chief Assistant Prosecutor and later the elected
Prosecutor in Adams County, Ohio, I had a front row seat for
the devastation that this scourge can cause on a community. In
February, 2011, Ohio attorney general Mike DeWine recruited me
to lead his prescription drug task force. Attorney General
DeWine has been committed to using every resource Ohio has to
fight this scourge.
In Ohio we have taken nationwide--a nationwide stance in
fighting back through changes in legislation, proactive law
enforcement actions, partnering with prescribers and dispensers
and being proactive with awareness, education, and treatment.
Through this effort Ohio has raised public awareness,
increased public education, and improved Ohio's investigations
and prosecutions in both criminal and regulatory cases.
However, to make a real difference we must limit the
availability of prescription drugs to those individuals in
actual need and in the proper quantities. In Ohio unintentional
fatal and non-fatal drug poisoning has cost Ohioans $3.6
billion annually. Between the years of 1999, and 2007, Ohio's
rate of opioid distribution increased 325 percent. During that
same time period Ohio's unintentional drug overdose death rate
increased 305 percent. If you will look to my left, you can see
this remarkable correlation on the graph located closest to the
back of the room.
In 1997, Ohio averaged seven doses of opioids per capita.
In 2010, our average dose of opioid per capita increased to 67.
In less than 15 years Ohio watched that average dose of opioids
per capital increase almost 900 percent.
The chart to my left, the closest to the front of the room,
will illustrate that the death rates during the current
prescription drug scourge is much higher in Ohio than the death
rates in Ohio during the heroin epidemic in the '70s and the
crack cocaine epidemic in the 1990s.
Ohio's leaders recognize the seriousness of Ohio's
prescription drug problem. On February 8, 2011, Representatives
Terry Johnson and Dave Burke, a physician and a pharmacist,
introduced what is known as House Bill 93 in Ohio. The bill
passed through the House and the Senate unanimously. With the
support of the attorney general, Governor John Kasich signed
the bill into effect on May 20, 2011, and it became law.
Much like Florida, our pain clinics, our pill mills were
not regulated. House Bill 93 for the first time regulated pain
clinics in Ohio. It required physician ownership of pain
clinics. It required prescribers to review our PMDP--sorry, our
Prescription Drug Monitoring Program, which is known as OARRS
in Ohio, and they had to do that when they were treating
chronic pain patients.
Attorney General DeWine has worked tirelessly to create a
multidisciplinary approach to the investigation and prosecution
of prescription drug cases. Attorney General DeWine has worked
with law enforcement at the local, State, and Federal levels in
Ohio to investigate prescription drug cases. We are currently
working with county prosecutors and Federal prosecutors all
across Ohio to prosecute these cases. He is proud to be a part
of the State-wide team in an effort to protect Ohio's families.
Our next step the attorney general believes is to build a
bridge with State and Federal officials across the Nation. To
have a true impact we must collaborate on a multi-State
approach to combat this scourge. Ohio and the Nation must be
proactive working with all the stakeholders to tackle this
epidemic. When this happens you will see success.
For example, in Scioto County, one of Ohio's hardest hit
counties, also a border county to Kentucky, the last pill mill
was closed this past December. Scioto County has a population
of approximately 78,000 residents. At one time it housed 12
pill mills prior to Ohio's efforts. Today it houses zero pill
mills. Just last week Scioto County learned that accidental
overdoses decreased 17 percent and drug-related deaths
decreased 42 percent in 2011. This was the first decrease
Scioto County had seen in the past decade in these numbers. It
had been a steady increase prior to 2011.
I will end with a quote from Reverend Martin Luther King
Jr., who said, ``We may have all come on different ships, but
we are in the same boat now.'' Each of us may have arrived at
the prescription drug scourge on a different ship, but today we
are all in the same boat, and more importantly, people will die
if we continue to ignore the scourge.
Thank you.
[The prepared statement of Mr. Haslam follows:]
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Mrs. Bono Mack. Thank you very much.
Mr. Rannazzisi, you are recognized for 5 minutes.
STATEMENT OF JOSEPH T. RANNAZZISI
Mr. Rannazzisi. Thank you. Chairman Bono Mack, Ranking
Member Butterfield, distinguished members, on behalf of
Administrator Michele Leonhart and the men and women of the
Drug Enforcement Administration, I would like to thank you for
the opportunity to appear today to discuss prescription drug
diversion and the critical role the DEA plays in securing the
integrity of the controlled substance supply chain and delivery
system.
Before I get going I would just like to thank the chairman
and this committee for their leadership on this problem, and I
also want to thank you for promoting the National Take Back
Program. If I may throw in a plug, we will doing it again April
28, Saturday, State, Federal, local agencies with community
groups working together to collect those drugs, and I want to
thank you again for that.
Also, I would like to thank the leadership of Director
Kerlikowske, who has gone out of his way to ensure that we get
the--all of the resources that we need to do our job.
The abuse of pharmaceuticals continues to be a significant
problem in the United States, and it is based on pharmaceutical
diversion from the supply chain and the medication delivery
system, and we believe that is the major reason. There is just
holes in the system. Over the last few years individuals and
organizations have created schemes within the healthcare
delivery system that appear legitimate but are nothing more
than illegal operations to facilitate the illegal distribution
of pharmaceuticals. Pharmaceutical diversion facilitated by
these operations can be prevented if DEA registrants would just
fulfill their obligations under the Controlled Substances Act.
The act was designed so that each DEA registrant is a link
in the closed system of distribution. Each registrant,
manufacturers, wholesalers, distributors, practitioners, and
pharmacies have a critical role to play in keeping the
distribution chain closed.
Two major schemes have emerged to divert millions of
dosigents, powerful addictive drugs. The first one a few years
back was the internet pharmacy scheme. You could go online, and
you could purchase pretty much any schedule three, four, or
five controlled substance you would like. hydrocodone was the
drug of choice, and it came out of the distribution chain, and
really no one fulfilled their obligations to the chain. You had
distributors that weren't doing due diligence on pharmacies
that were ordering huge amounts of hydrocodone. The pharmacists
weren't checking those prescriptions to ensure they were valid,
that is they were issued for legitimate medical purposes in the
usual course of professional practice, and the doctors weren't
doing the same thing. They were just prescribing without a
legitimate reason for prescribing. There was no medical
determination made. It was a major breech in the system.
But because of law enforcement's focus on that problem and
then Congress coming in and passing the Ryan Haight Act, we
basically shut down that system. Unfortunately, that system
moved back to Florida and turned into pain clinics, and pain
clinics grew.
Now, these pain clinics, besides the fact that they are
operating illegally, they were doing the same thing that the
internet pharmacies did. The only difference is on the internet
pharmacies there was no face-to-face visit. In pain clinics
they actually see patients, but, again, the doctors are moving
huge amounts of prescriptions out the door. Pharmacists are not
checking the validity of those prescriptions. They are not
ensuring they are valid prescriptions, and the wholesalers and
distributors just continue to ship large amounts of drugs to
those pharmacies without doing due diligence, without knowing
their customer, without saying, well, why are you ordering? Why
are you ordering this amount of drug when every other average
pharmacy in the U.S. only orders this, and you are ten, 12, 14
times more than that? They have a responsibility under the act.
They choose not to comply with that obligation.
We are fighting this problem through education and
regulatory control and enforcement. Since 2005, we have a
distributor initiative that has educated distributors of their
obligations under the act. When distributors fail to adhere to
their obligations, DEA takes administrative or civil action
against their registration. From mid 2010, through the end of
2011, we took action against five wholesaler distributors for
unlawfully supplying Florida-based pain clinics or associated
pharmacies with controlled substances. These actions included
the issuance of immediate suspension orders and result in the
restriction and loss of DEA registrations.
We also focus our resources on practitioners that issue
those prescriptions not for legitimate medical purpose. These
practitioners feed the addiction of drug seekers and allow
drugs to enter the elicit market and facilitate overdose and
death. Rogue practitioner activity is not limited to Florida.
In fact, rogue pain clinics are moving northward, and they
operate in Georgia, Tennessee, Kentucky, and southern Ohio now
in addition to out west. A DEA investigation with State and
local and Federal agencies of a pain clinic doctor operating in
Portsmouth, Ohio, culminated this February with the doctor
being sentenced to four life terms for overdose deaths of four
individuals.
I have to wrap it up here, but we are making progress. DEA
is using its regulatory authority to ensure compliance with the
CSA and its implementing regulations. These measures that we
are taking are beginning to show promise. We are strengthening
the integrity of the system through registrant compliance.
In closing I want to assure you that DEA is working closely
with all of our counterparts; Federal, State, and local, and
our regulatory counterparts as part of the Administrator's
comprehensive approach to combating prescription drug abuse. We
are committed to balancing the need for diversion control
enforcement with the need for access to these important
medications by legitimate users.
Thank you for this opportunity to appear, and I look
forward to answering any questions.
[The prepared statement of Mr. Rannazzisi follows:]
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Mrs. Bono Mack. Thank you very much.
I am going to recognize myself for 5 minutes of
questioning, and I would like to begin with General, Attorney
General Bondi, and I know you care passionately and you and I
have spoken about the opiate babies, and it is my belief that
when people dabble with heroin or cocaine, they understand they
are dabbling with a potential addiction. They don't necessarily
think that when they start playing around with pharmaceuticals.
Can you speak to why you are so focused on the opiate
babies? I mean, you really are passionate about it. I would
love for you to--you ran out of time, so please talk about it
for a little bit if you could.
Ms. Bondi. Absolutely. You know, right after we passed our
legislation last session I started getting calls from neonatal
intensive care nurses, neonatologists, and said there is
another problem, and you have got to come see this. I went to
Saint Joseph's Hospital in Tampa. Twenty percent of the babies
going through the neonatal intensive care unit are born
addicted to prescription drugs.
Now, imagine the worst addict you can see on TV going
through those withdrawals, that is how these babies are born
into this world. Their incubators have to be covered with
blankets. They are sensitive to light, to sound, to touch.
Instead of milk, they are getting morphine or methadone. That
is how these kids are coming into this world.
All Children's Hospital in St. Petersburg, that is a
premiere hospital for children, 30 percent of the babies going
through the neonatal intensive care unit born addicted to
prescription drugs, and it has to stop. Take it from a cost
perspective. I take it from a life, babies' lives, but if you
look at it from a cost perspective, Saint Joe's had to expand
their NICU just to accommodate these babies. So it is costing
taxpayers a fortune, and I think a lot of it really has to do
with education, and that is why we have legislation proposed
this session. I have talked to adoption lawyers, I have talked
to nurses, we brought in the Board of Health, we brought in the
Board of Medicine. It is all about working together to educate
these women, because unfortunately, I think some of these women
will say I have stopped drinking alcohol, I have stopped
smoking marijuana, but because it is the word prescription
drugs, they don't realize the harm that it is doing to their
unborn child.
What scared me to death, Chairman Bono Mack, was when I
asked a doctor, I said, we can't let this become the next crack
baby epidemic, and he said, we have already surpassed it.
Mrs. Bono Mack. Thank you. I just wanted to say we don't
even know the long-term consequences for these opiate babies,
and I just want to turn with my limited time to Mr.--and
hopefully we will have a second round of questioning, but Mr.
Rannazzisi, you and I have had multiple discussions, and we are
not always on the same page, but I applaud some of your efforts
recently.
You and I have talked about quotas. If Florida is having
success at shutting down their pill mills, wouldn't the quotas
show a correlating reduction in the quotas that you do allow
the manufacturing of these drugs? Are you seeing that?
Mr. Rannazzisi. Actually, we are seeing a decrease somewhat
in Florida, but we are seeing the expansion of these pill mills
throughout the country. If you go to Tennessee, Kentucky,
southern Ohio, and most of those in southern Ohio were shut
down, but we still continue to see those flow out, and I just
right now, even though Florida is on the going downhill, states
north of Florida are starting on the rise. This problem is
just, again, just moving north and west.
Mrs. Bono Mack. Well, I am just glad you hear you admit
that and to say that. That is encouraging to me, but can you
speak briefly about the Cardinal Case? Now that the district
court has dissolved the temporary restraining order, what are
the next steps in the Cardinal Case, and apparently Cardinal
plans to appeal. If the district court's order is upheld, what
is the next step?
Mr. Rannazzisi. Because that case is in active litigation,
I am not allowed to answer questions, however, I can tell you
we have had cases similar to Cardinal in the case in the last 2
or 3 years. They are exercising their appeal rights, and we
respect that. We will continue on with this program. Looking at
our distributors, making sure that they meet their obligations
under the act, and if they don't meet their obligations under
the act, we will take the same action that we have taken.
Mrs. Bono Mack. I am just encouraged because long ago you
and I argued that it was all coming out of Grandma's medicine
chest. Correct?
Mr. Rannazzisi. Yes, ma'am, and not that I don't still
believe it is coming out of the medicine chest, but I believe
that we are handling it upstream now to prevent it from getting
down to that level.
Mrs. Bono Mack. Thank you for that.
Mr. Haslam, you talk about shipments, whole cargo
containers that go missing but they are unreported. Do you want
to speak to that?
Mr. Haslam. Anecdotally, law enforcement throughout Ohio
has told us that they, that cargo shipments are falling off the
trucks. We have heard----
Mrs. Bono Mack. Just magically.
Mr. Haslam. Just magically. We have heard----
Mrs. Bono Mack. Yes.
Mr. Haslam [continuing]. Through conversations with
manufacturers about their security measures, and they do seem
to be very good security measures as Director Kerlikowske
alluded to earlier.
However, there seems to be a point as it gets further down
the chain that the security measures either weaken or are not
as efficient, and once it gets to the distributors and then
they send it to their distributors who send it out, there
appear to be security measures that aren't in place that allow
shipments to fall off of trucks.
Mrs. Bono Mack. Thank you very much. My time is up, and I
would like to recognize Mr. Butterfield for 5 minutes.
Mr. Butterfield. Thank you. Let me go to the gentleman from
the DEA. How do you pronounce your name? Is it Rannazzisi?
Mr. Rannazzisi. Rannazzisi. Yes.
Mr. Butterfield. Yes. All right. Thank you. Let me talk
with you about the security procedures followed by the
prescription drug manufacturers, specifically how the drug
moves from raw materials to usable medicine, then to
distributors, and then down to the wholesalers. Are you
comfortable, sir, with the security mechanisms employed by
these companies?
Mr. Rannazzisi. The physical securities for the most, the
physical security systems for the most part I am. We do onsite
inspections every 3 years or so for manufacturers, importers,
exporters, any other raw material holders, and if there is
problems in physical security, we handle it onsite. We make
suggestions, and generally it is corrected.
Mr. Butterfield. All right. What kind of relationship does
the DEA have with the prescription drug industry? Specifically,
what programs does DEA employ to educate DEA manufacturers and
distributors? How closely, if at all, does DEA audit or approve
security measures employed by the manufacturers and
distributors, and is there a difference in procedure for
authorized distributors versus secondary distributors?
Mr. Rannazzisi. Well, first of all, we are on site for
these distribution and manufacturing facilities every 3 years.
In addition, for instance, the wholesalers and the
distributors, we have a program called the Distributor
Initiative where we sit down, not as a group, but individually
with each company, and we go over their distributions, and we
talk to them about what to look for when they are sending their
drugs downstream. We offer them assistance to help them
identify what diversion is and where it is, and that is done
individually by company.
The manufacturers, we have an open door as far as the
manufacturers go. I don't think we have ever had a problem with
the manufacturers where we haven't rectified that problem.
So we are regulators. We have a relationship between
regulators and the industry, and we oversee them and make sure
that they are operating under the act, in compliance with the
act.
Mr. Butterfield. All right. Technology advances have
enabled new abuse deterrent drugs to take the place of
conventional pills. I am encouraged by the addition of abuse-
deterrent drugs into the marketplace, and while it is not a
silver or magic bullet in completely stopping prescription drug
abuse, it seems to be a tool that can greatly help.
Some medications have been reformulated to be extremely
difficult to crush and dissolve. These are what we call abuse
deterrent drugs and new additions to the prescription drug
marketplace and have not yet been widely adopted. But things
are moving in the right direction.
Question. How do you think abuse-deterrent formulations
will have an impact on reducing opiate abuse, and how do we
ensure that those who are addicted do not just switch to a new
drug such as Fentanyl or heroin?
Mr. Rannazzisi. I think that the abuse, well, first of all,
we are very supportive of these assistance formulations. We
think that is the future that will curb drug abuse.
However, we also know that abuse-resistance formulations
tend to stop drug abusers from ingesting the drug in certain
manners, for instance, injection or snorting the drug. When
they need to, they take it orally, and abuse-resistant
medication generally does not affect how you take it orally.
What we are seeing in the field is they are taking the drug
orally with an agent that will give it a synergistic property
to enhance the, for instance, for a drug like oxycodone, they
will take it with an Alprazolam product or Carisoprodol, which
is a muscle relaxant to enhance the product, the effects of the
product.
Mr. Butterfield. Thank you. I yield back.
Mrs. Bono Mack. Thank you, Mr. Butterfield.
Mr. Harper, you are recognized for 5 minutes.
Mr. Harper. Thank you, Madam Chair, and if I could, Mr.
Rannazzisi, if you I could ask you a few questions.
First, what regulation does DEA have that specifically
outlined the legal requirements that pharmacies, distributors,
and manufacturers are required to take to avoid drug diversion?
Mr. Rannazzisi. Well, for starters, pharmacists are held
pretty much to the same standard that doctors are under
1306.04, 1306.04 says a prescription is not valid unless it is
issued for legitimate medical purpose and use, of course, a
professional practice. It also goes on to say that a
corresponding responsibility exists with the pharmacist to
ensure that the prescription is valid.
Mr. Harper. OK.
Mr. Rannazzisi. The manufacturers under 1301.71 and 1301.74
have to maintain a system that stops diversion or the diversion
of controlled substances into other than a legitimate
marketplace. And it also goes on to say that you also have to
maintain a system of suspicious ordering monitoring, and they
leave it up to the manufacturers and distributors to determine
how to set up that system of suspicious ordering and
monitoring.
Mr. Harper. You know, I know the DEA has the ability to see
unusual ordering patterns. Are there certain thresholds or
levels that you pass on to the distributors to look for? Are
you giving them guidelines to--that you pass off?
Mr. Rannazzisi. No. I think what distributors have to do is
look at their customers. They know their customers. I don't
know all of their customers. They do. If they went onsite and
looked at their customers, they could make a determination of
what thresholds should be maintained for those individual
registrant customers.
The problem is is I don't believe that the distributors and
the wholesalers are actually looking at their customers as
closely as they should. If you have customers that on the
average purchase, I don't know, 70,000 oxycodone tablets a year
and you have customers purchasing well in excess of a million a
year, I think that would trigger something where you should go
onsite and find out why that is the issue.
Mr. Harper. Does the DEA have those volume parameters that
it uses but are not shared with manufacturers or distributors?
Mr. Rannazzisi. No. We--no, we don't share, we don't give
them volume parameters. That is up to them. It is their system
that they are setting up.
Mr. Harper. All right. Well, what guidance has DEA provided
to the manufacturers, distributors, pharmacies, or whatever on
the specific steps that they should be taking to identify
fraudulent prescriptions? What advice are you giving them to
look for or suggestions?
Mr. Rannazzisi. Well, there are certain red flags.
Mr. Harper. OK.
Mr. Rannazzisi. For instance, a pharmacy. If you have, if
you are sitting in we will say Portsmouth, Ohio, and all of
your customers are coming from, I don't know, 80 or 100 miles
away, and the doctor you are filling for is 100 miles the
opposite way, and it is all cash transactions, and you are
seeing this over and over again, you know, I am not the
smartest guy, but red flags pop up in my mind when that
happens.
Mr. Harper. Yes.
Mr. Rannazzisi. And I think those are typical red flags,
and Attorney General Bondi I am sure, or any one of these
distinguished gentlemen could tell they are seeing the same
thing that I am seeing. So over and over again we see these red
flags. The pharmacists should see them, too.
Mr. Harper. Would you favor under the Controlled Substance
Act to create a stricter requirement, legal requirement for the
most problematic drugs?
Mr. Rannazzisi. I think the requirements that are in place
right now for these drugs are fine if the individuals within
the supply chain and healthcare delivery system would follow
them. The problem is that the doctors continue, not all
doctors, 99 percent of the doctors are perfect. It is that
small percentage of doctors that just don't want to fulfill
their obligation. What they do is prescribe for illegitimate
purposes, or they don't make a medical determination. They just
go with patient-directed prescribing, which is just wrong. I
think that if everybody within that supply chain would just
police each other, we wouldn't have the problem that we have
right now.
Mr. Harper. I thank each of the witnesses for being here
today and for your insight, and with that I yield back.
Mrs. Bono Mack. Thank you, Mr. Harper.
Mr. McKinley, you are recognized for 5 minutes.
Mr. McKinley. Thank you again.
Let us go back to Florida or maybe Kentucky, but let us
start with Florida. When you have your program, your PDMP, do
you have an identification system? Is that how--is that
included in it?
Ms. Bondi. We, as I am sure you are aware, we had some very
difficult problems getting our PDMP in place, our Prescription
Drug Monitoring Program. It was, you know, 48 states have a
PDMP but many weren't up and running, and ours was one of them.
We received some resistance. What we have done now is that
it is up and running. We had some issues with getting it
funded. Do you know who came forward?
Mr. McKinley. Wait a minute. Do you have an identification
so when someone comes in, is this--do they enter their name or
something into----
Ms. Bondi. Yes.
Mr. McKinley [continuing]. A file?
Ms. Bondi. Yes, and it used----
Mr. McKinley. It is available for everyone in the State of
Florida?
Ms. Bondi. Absolutely, and it used to be 15-day reporting,
and now we have limited that down to 7-day reporting.
Mr. McKinley. OK. So----
Ms. Bondi. So we have shortened the reporting period.
Mr. McKinley [continuing]. If it works in your State, why
wouldn't that work nationally?
Ms. Bondi. Well, and this is, like I said, brand new in our
State because it had never been funded. So now it is funded by
forfeiture funds from our sheriff for the next few years.
Mr. McKinley. What about Kentucky? What are you doing in
Kentucky? Do you have the database or names?
Mr. Conway. We have the database, and what happens in
Kentucky, we were one of the first states to bring a PDMP
online, Congressman, but our doctors will go in and enter a
patient name to see if that particular patient is doctor
shopping. The problem we have in Kentucky is, it is a pretty
good system, but only about 25 percent of our doctors are using
it. It is not mandatory. It is not mandatory that ER docs, for
example----
Mr. McKinley. OK. Thank you.
What concerns me some is you have done a great job in
Florida. You just chased them to another State. That is what I
am hearing from the other testimony here, and what we are
hearing from around the country is that you did a great job. It
happens in law enforcement when you start performing your
duties, they go someplace else because they are not going to
change their behavior. They just transfer to another State.
I am looking to see how we can capture them nationally.
Ms. Bondi. And we still have a long way to go in Florida,
but I think what we are doing is we are working together, and
as long as I can tell you the two of us are still alive, we are
going to put this, we are going to put these guys out of
business. I mean, we work together constantly, we share ideas,
we share thoughts, and we frankly in Florida we work great with
the DEA. We--you have to work as a team, and I don't know if
you were here earlier for that part of it, but you have to
bring State, local, and Federal authorities and now wrap all of
our states into this, because this is a national crisis, and I
mean, we are in a war with drugs, and just the drug has
changed.
Mr. Conway. If I may address that point, Congressman, not
to take up too much of your time, but Kentucky borders seven
states, and the pharmacists when they fill a script, enter the
data that goes into the system that doctors later check.
The problem for us has been that the docs feel like it is
too time consuming. The docs don't want to be forced to do
this, and they don't have a system that they think is user
friendly that they can type in, takes 30 seconds or less, and
tells you if you are in eastern Kentucky whether or not this
patient has been to West Virginia, Ohio, or Virginia or
Tennessee.
And that is what we don't have, and really a State like
Kentucky can't get to where we need to be. We can't get 50
states with a good system that is interoperable unless we have
the help of the Federal Government.
Mr. McKinley. And Ohio, do you have the names up on--do you
have with your program, do you have the names, the individual,
so they know, we know what prescription drug they are
acquiring?
Mr. Haslam. We do, Congressman, and our program has been up
and running for many years as well just as Kentucky's has.
Mr. McKinley. Do you see a problem with that going
nationally?
Mr. Haslam. I don't. I think it is one of the necessary
tools that we are going to need to fight this epidemic.
Mr. McKinley. How do you deal with the privacy matter,
because that seems to be the hang up, the confidentiality of
people to access. What--how did you get around that for the
State of Ohio?
Mr. Haslam. Well, it is very protected by--our Ohio State
Pharmacy Board houses that program, and they are very
protective over the information and who it goes to and how it
is distributed, and that is how they get around it. They make
sure that it is protected, but it is, it is a necessary tool in
this battle as we move forward.
Mr. McKinley. So you are saying some states, in your three
states, you all have that. You are doing something along that
line.
Mr. Conway. The information is protected. Only the doctor
is going to see it, and if we have a designated case open on a
specific target, we can ask to see the KASPER data, but one of
the problems we have seen is that the Board of Medical
Licensure when they see disturbing trends are not forwarding
onto law enforcement. We have that problem in Kentucky.
Mr. Haslam. That is the same issue in Ohio, Congressman. It
is a great tool. It is under-utilized by our physicians. House
Bill 93 required physicians that are treating pain management
to utilize it, but as, exactly as you have alluded to, as we
have success in law enforcement, we are squeezing the balloon
and people are just moving to other states.
And what has happened, the three states represented here
today have all worked wonderfully together to tackle this issue
and to share that information and investigations.
Mr. McKinley. I know the time. I think you are great
models. I just want to see it replicated in all 50 states so we
can protect this thing. We can't have you operating in the
middle. So thank you. I yield back my time.
Mrs. Bono Mack. Thank you, and Dr. Cassidy, you are
recognized for 5 minutes.
Mr. Cassidy. Thank you, Madam Chair. First I will say that
we are introducing Mike Ross and I from the other side of the
aisle, H.R. 4095, which is the Stop Online Pharmacy Safety Act,
which attempts to close down or at least prevent the
publicizing of these rogue pharmacies. So hopefully we will get
some cosponsors on this.
Secondly, Mr. Rannazzisi, man, I keep on thinking with the
databases you all have, if we gave them to Google, I have no
doubt that Google knows what color dress my daughter has on
today. And so it seems like data mining could really go a long
way to pinpointing these problems for a specific intervention.
I am told by industry that you all have lots of data forwarded
to you regularly.
My question is why not?
Mr. Rannazzisi. I think the data they are referring to is
our ARCOS System.
Mr. Cassidy. Yes.
Mr. Rannazzisi. Yes. Under 827(D) they are required to send
all narcotic control substance transactions to us to be put in
a database, and we do have that information, and quite frankly,
we use that information to assist us in investigations.
However, that information is proprietary. It is protected
information. I can't release that information to industry, and
they have asked----
Mr. Cassidy. But you could release it to local law
enforcement.
Mr. Rannazzisi. If local law enforcement is involved in
investigation and they request the information, yes, we can.
Mr. Cassidy. Let me ask because as I go through the
testimony you have rank ordered states in which there is the
highest prescriptions per capita of controlled substances, you
have related it to over 65 how many people on Medicare Part D
are getting X amount per, in a certain region. I also see other
statistics where you speak about three or four physicians
moving from one State to another, so you have physician level,
and I am sure you also have a pharmacy level. It just seems,
again, if Google had that or some other data miner had that, we
could have a specific intervention here. Boom. And then there
and then there. I seems like there is missed opportunities.
What am I missing on this?
Mr. Rannazzisi. I don't believe there is missed
opportunities. The data that we have is very narrow. It is for
the narcotic controlled substances. For instance, I am dealing
with a pharmacy or a group of pharmacies and manufacturers or
distributors that are selling Fentermine or Alprazolam or drugs
like that. I have no way of tracking because it is not entered
into the system.
Mr. Cassidy. But if we just took those which are narcotics,
I mean, probably there is going to be a correlation between
somebody getting an illegal prescription for Ativan as well as
an illegal prescription for OxyContin. So I am not saying you
have to do the breath, but, again, if you have reported to you
the narcotics for OxyContin----
Mr. Rannazzisi. Uh-huh.
Mr. Cassidy [continuing]. Again, knowing that you just from
here have a heck of a lot of data----
Mr. Rannazzisi. Uh-huh.
Mr. Cassidy [continuing]. Why aren't we doing every week
another intervention at another pharmacy, because it seems like
it is a target-rich environment.
Mr. Rannazzisi. We are. We have active investigations
across the country based on complaints and our ARCOS data. Now,
sometimes the ARCOS data might show up with a pharmacy that is,
indeed, a legitimate pharmacy that does have a high volume, and
the reason they have a high volume is because they are next to
a hospital or oncology----
Mr. Cassidy. And that is a fair statement. I can imagine a
cross tab which would say, OK, here are the variables that we
find associated with, you know, again, I can see Google with an
algorithm that you give them.
Mr. Rannazzisi. Right.
Mr. Cassidy. Which would data mine. Are you all data mining
on that, formally data mining?
Mr. Rannazzisi. Yes. We look at that, we look at ARCOS data
on a regular basis. We look at the top 50, top 100 in different
areas of the country. We make sure that, you know, we do
background and make sure those pharmacies and wholesalers are
operating within the confines of the law, and if we have
further information on it, we open investigations. Yes. That is
what ARCOS is for. ARCOS is a targeting tool.
Mr. Cassidy. How many active investigations do you all have
right now?
Mr. Rannazzisi. I would have to get back. I don't want to
throw out a number.
Mr. Cassidy. Ballpark, 50, 100, or 1,000?
Mr. Rannazzisi. Oh, we have a lot. Many more than 1,000.
Mr. Cassidy. Now, kind of a recurring theme from these
folks is that people go from one State, they go to another. I
live in Louisiana, my pain doc is legitimate and tell me that
illegitimate patients, if you will, go to Mississippi or
Houston and then back again.
So is Federal, in your mind is Federal legislation required
that would almost mandate some sort of standard so that Texas,
Louisiana, Mississippi, Arkansas, or Kentucky with every State
bordering it would be in some sort of interchangeable
information?
Mr. Rannazzisi. I think--my personal opinion is, yes, I
would love to see that because I think doctors need that
additional tool. I think there as a practitioner you would
agree that I want to know what my patient is doing and who my
patient is seeing, whether it is in Kentucky, Ohio, or, you
know, four states over.
The problem is interconnectivity, and the problem is is a
lot of these states have different State laws and different
laws regarding the information and how it could be distributed.
So I don't think it is--I think the problem lies within the
states. They have to work it out. This is not a Federal
Government system, and while we support the states and we want
the states to get that interconnectivity, that is a question
better asked to the states. It is their decisions.
Mr. Cassidy. Just if I may have a few more seconds, I will
say that after Hurricane Katrina and all my patients were
displaced to other states, I found that those, there is
something that happened, a switch was turned, and a doctor in
Oklahoma could find out the drugs I was prescribing for my
patients in Louisiana, and so it does seem as if that
interoperability could occur in a fairly straightforward
fashion if we had, you know, a little direction.
Mr. Rannazzisi. I remember that, and that State boards were
working extremely well together, and I don't know how that
information was passed because we don't have dispensing
information, but I do know that we were working with the----
Mr. Cassidy. I think it was through E-scripts. I think that
there was something like that.
Mr. Rannazzisi. But the State boards really came together,
and they did a fine job getting everybody in line.
Mr. Cassidy. So there is a chance we just need those folks
to talk to their State boards.
Thank you. I yield back.
Mrs. Bono Mack. Thank you, Dr. Cassidy.
The chair recognizes Ms. Blackburn for 5 minutes.
Mrs. Blackburn. Thank you so much, and I want to thank you
all for your patience today. As you know, we have had other
hearings downstairs. We had Secretary Sebelius and looking at
the budget that is there, and I know that those of you at the
State level are quite concerned about the Obama Care impact
that is coming to a State near you very quickly.
Mr. Rannazzisi, am I saying your name correctly?
Mr. Rannazzisi. Yes, ma'am.
Mrs. Blackburn. I am close enough.
Mr. Rannazzisi. Perfect.
Mrs. Blackburn. OK. On the Ryan Haight Act how many online
pharmacies have registered under that act? What is--how is that
being built out?
Mr. Rannazzisi. Currently I--we have no registered
pharmacies under the act. We have I think four or five
applications pending but no pharmacies have been registered.
Now, remember there are a lot of provisions in the act that
allow you to do certain things online that is not, that you
don't--the Act was written so it would prevent the rogue
pharmacies from jumping online and continuing practice, and it
has done that. There is no domestic pharmacies currently there
operational that are under----
Mrs. Blackburn. OK. Then let me ask you this another way.
How many enforcement actions has DEA taken against online
pharmacies or rogue pharmacies under the act?
Mr. Rannazzisi. I would have to get back to you, ma'am.
Very few because the act pretty much shut down the domestic
online pharmacy problem, and the problem moved overseas.
Mrs. Blackburn. OK. Are you having difficulty in sorting
and finding out which are the rouge foreign-based pharmacies
or--I would like to visit with you more about that. I think
that it is an issue that is of concern to us and being able to
see where we have these online pharmacies, find out who is
registering or not. That would be helpful and instructive to
us.
So let us look at that a little bit and then if you could
quantify the kind of actions that have been taken against some
of these rogue pharmacies, just--it allows us to do a little
bit of due diligence and see if decisions we are making are
working or having an impact or not. So I would appreciate
having that time with you.
I want to talk with you for just a little bit, if you can
answer this within the allotted time, that is great, and if you
need to get back to me, that would be great. I am no
cheerleader for the FDA, but I understand their philosophy and
approach that, in that an agency as it applies to controlled
substances seems much more measured than that of the DEA at
times, and my understanding is I want to talk about this post-
inspection feedback in the form of what is known as the FDA
form 483, Inspection Report.
And my understanding on this FDA form 83 [sic] is that it
sets out with specificity the agency's concerns and the parties
have the opportunity to meet with the FDA and discuss any
issues that may be before them, that companies are given the
opportunity to address issues and solve problems in a
collaborative dialogue.
And if the company were to choose not to address the
issues, the agency then typically takes further action in the
form of a warning letter and proceeds with prosecution and
consent decrees as appropriate. And I think that that FDA-type
approach is different from the DEA approach when there are
problems, which his just enforcement and not the opportunity to
address concerns.
So it seems like DEA there is no post-inspection give and
take or dialogue that may be there and no information sharing
or the opportunity to address issues or--that are out there. So
my question to you is this, and you mentioned Tennessee as one
of the states with the pill mills, and you know, we all are
concerned about patients that are in pain that need medication,
companies that are trying to meet those needs, and here, again,
want companies to do the right thing, want them to spend the
money wisely, want individuals to be safe, want there to be
protections that are in place.
So my question is is there a more surgical approach? Should
we be thinking of a more surgical approach to addressing the
issue of prescription drug abuse rather than just looking at
suspension of licenses? You know, where is the right balance in
a vetting process? Is there a more proportional approach to
take rather than just going to an immediate suspension?
Mr. Rannazzisi. Yes. I would love to answer that question.
First of all, the FDA deals mostly with legend drugs, and they
do have manufacturing processes they do with controlled
substances, but the vast majority of their authority is over
legend drugs and prescription drugs, making sure they have good
manufacturing processes, maybe making sure that labeling is
correct, putting the drug through the appropriate validation
process.
My responsibility under the act is to ensure that there is
no diversion of highly-addictive medications into an elicit
marketplace. We do give chances to companies. If you look at
our history, we went onsite on many of these companies that we
have taken action against and pharmacies and explained to them
what their obligations were. We sat down with them and talked
to them of what their obligations were. They just----
Mrs. Blackburn. OK. So your response then would be that you
all are carrying out that dialogue?
Mr. Rannazzisi. Yes.
Mrs. Blackburn. OK. All right.
Mr. Rannazzisi. Yes. I look at Florida and the millions of
tablets that are going into the elicit marketplace in Florida,
not only from the pharmacies but also from the distributors and
the doctors. And I think we have to hold the line somewhere.
These are drugs that are killing people. It is not Amoxicillin,
and you know, we have to take a stand.
Mrs. Blackburn. OK. Do any of the others of you want to
make a response to that? No? OK.
Madam Chairman, I will yield back.
Mrs. Bono Mack. Thank you, and I am going to recognize
myself for 5 minutes for a second round and any other member
who wants to ask a second round, I will yield to you for your
own 5, and then we will move to the third panel.
My, first of all, my comment on what Dr. Cassidy had to
say, I think he brought up a good point, and I think it is fair
to ask if the DEA data mining capabilities are as robust and
clever as you would suspect. Googles are and perhaps we can
visit that in the days ahead, but this is a, sort of a general
question to each of you, and thank you, Mr. Rannazzisi, for
mentioning my support of your take back days, but 995,000
pounds of drugs in 3 days.
The question I want to ask each of you if you would care to
comment or weigh in is who is paying for those pills? Are we
paying for them in the form of healthcare premiums? Are we
paying for them through diversion out of Medicare Part D and
Medicaid? Who is paying for all of those pills? Why are there
995,000 pounds of extra pills being turned back in? What is the
overall toll in healthcare in our country just from this
problem?
Anybody?
Ms. Bondi. I can tell you from our local take back days
these are good, solid citizens who are coming in with brown
paper bags filled with prescriptions that they have had and
that they are concerned because they know you cannot flush
prescription drugs down your toilet, and they don't know what
to do with them, and they don't want their grandkids to get a
hold of them, and you know, when I speak to people, I say, no
one ever wants to believe it is their kids, so I say, your
kid's friends can get into your medicine cabinet.
So people--it is our citizens, and I think a lot of them
are getting them from their doctors, their dentists for
legitimate purposes. They are taking one or two of them, and
they are just stockpiling them because they don't know what to
do with them, but we have had remarkable results with good
citizens turning them in to have them properly disposed of.
Mrs. Bono Mack. But the question is is why is there so many
left over in the medicine chest to turn back in? Who is paying
for--what is the cost, and General Conway, you mentioned this
is an American tragedy, and I couldn't agree with you more.
There is no question our doctors are working too hard, and
ultimately this comes out of their patient visit, they are
scrambling because healthcare is squeezed more and more and
more, and this is a part of the problem. But $148 million
diverted out of Medicare Part D in 2008, alone.
So are we really, I mean, General Conway, do you want to
weigh in on----
Mr. Conway. Well, I don't know that I can quantify the
cost. I mean, sitting here as the attorney general of Kentucky
I can't quantify the cost, but my experience is similar to
General Bondi's. When I go to one of our drug take back days
and sit there with my plastic gloves on, it is the concerned
mother who doesn't want her kids and realized she saw something
on TV and her hydrocodone she got for a broken arm is expired.
The cost comes in crime. People are committing thefts to
get access to resources to buy pills. The cost comes in cash. A
lot of these pill mills deal on a purely cash basis. When you
have healthcare companies that are trying to get more efficient
in mandating 90-day supplies of some of these mail order pills,
a 90-day supply in Kentucky of hydrocodone or oxycodone,
chances are about 50 percent of that is hitting the streets.
That is what my law enforcement officials are telling me. That
is something that we need to quantify.
And certainly Medicare and Medicaid are paying some of
that.
Ms. Bondi. And Chair Bono Mack, I think what you are saying
is if you go in for a routine dental surgery, why do you need
60 oxycodone pills.
Mrs. Bono Mack. Exactly.
Ms. Bondi. You don't.
Mrs. Bono Mack. Thank you. Thank you, and Mr. Haslam, you
speak on this, to this in your testimony, too. You suggest that
maybe they have sort of a tiered approach into needing the
drugs. Do you want to speak a little bit about your beliefs on
this, too?
Mr. Haslam. Absolutely, Madam Chairman. The--what we see in
Ohio we see--to answer your original question, the taxpayers at
some level is paying for the problem. No matter how you look at
it when you boil it down to the common denominator, it is the
taxpayer that is paying for it, whether it is Medicaid costs in
Ohio, especially in southern Ohio, which is economically
depressed, it borders eastern Kentucky as we have heard
Attorney General Conway elude to is an economically-depressed
area. That--it is a huge burden on the Medicaid System there,
and as you move across the State of Ohio, though, it is not
limited to that socioeconomic class. It goes all through all
the way to the middle class up to the upper class, and whether
it is a company that has to pay increased healthcare premiums
that is I providing for its employees because of the number of
pills their employees are receiving as part of a prescription
or the insurance companies, the cost to those folks. The
insurance companies in Ohio have recently reached out to the
attorney general's office to talk with us and say what role do
we play in this? This is a huge cost to our bottom line. It
touches everybody.
So at the end of the day it is the taxpayer that is footing
the bill for this prescription drug problem and for those large
amounts of pills that are on the street.
Mrs. Bono Mack. Thank you. So when we win the day with the
arguments of the human suffering of the budgetary tolls, there
is no rhyme or reason why we wouldn't be tackling this head on
as a Nation, and again, Mr. Rannazzisi, one last question to
you.
This committee has been investigating nano encryption,
intagence, and other technologies coming out. Can you speak
briefly about future technologies that you might be exploring
like this on tracking drugs?
Mr. Rannazzisi. Ma'am, I can't take that question for the
record. I am not an expert on----
Mrs. Bono Mack. OK.
Mr. Rannazzisi. But I do have experts on staff.
Mrs. Bono Mack. That is fair. You know we will be
submitting plenty of questions to each of you for the record.
Mr. Butterfield, did you have----
Mr. Butterfield. I have one.
Mrs. Bono Mack. All right. I will yield to you----
Mr. Butterfield. Thank you.
Mrs. Bono Mack [continuing]. For 5 minutes.
Mr. Butterfield. Thank you. Under the careful supervision
of a doctor, prescription drugs can alleviate severe pain or
help those suffering from mental disorders like psychosis or
depression or anxiety or insomnia or attention deficit
disorder. Unfortunately, there are true stories of these drugs
being prescribed inappropriately or not for their intended use.
Only 54 percent of physicians ask about prescription drug
abuse when taking a patient's medical history, and only 55
percent regularly contact their patients' previous doctor
before prescribing controlled pain medication.
Question. State entities certify and regulate both doctors
and pharmacies. Through this role, General Conway, what do you
think State authorities can do to educate medical
practitioners?
Mr. Conway. Well, the thing about the medical community,
Congressman, is that it is not a one-size-fits-all approach,
and we have a piece of legislation we are considering right now
in the general assembly that I am supportive of that would
require anyone who wants to prescribe a schedule two or three
narcotic to mandatorily register with our PDMP.
But I think that the education component for the medical
community is important. The Chairwoman talked about what needs
to happen with short-term prescriptions. Our ER docs need to
have standards for how much should they prescribe if someone
shows up at the ER. They ought to do mandatory PDMP checks.
The problem for us in law enforcement and in Kentucky, and
I can't speak to it in other states, but in Kentucky we have a
little bit of a battle with our medical community in that the
KASPER System, our PDMP, is housed over in a cabinet of Health
and Family Services. They have the data. They observe the
trends that are problematic. They are supposed to take actions
against licenses if they spot problematic trends and then refer
them to law enforcement if necessary.
Until this issue received increased scrutiny here in the
last couple of months, in my first 4 years as attorney general,
I didn't have a single law enforcement referral from the Board
of Medical Licensure.
So the doctors, if they are going to be prescribing, you
know, there are different standards for an oncologist or pain
management doctor from a podiatrist and an allergist. But the
doctors that are going to be prescribing have an obligation to
use the system, to check their patients, and to help us police
their profession, because they are under-utilizing the system
right now, and they need to work with us so that we can see the
data.
I cannot ask who are the two largest prescribers of
schedule two and three narcotics in Pike County. I would love
to, but the law prohibits me from doing it, and the Board of
Medical Licensure is not sending me the data. So I am using
old-fashioned surveillance and talking to people about where
are they getting the pills in order to figure it out, and we
have a great system, and all the data is right there. We are
just under-utilizing it, and we are under-utilizing it because
we don't have the partnership we need with the medical
community to make certain that that is getting addressed in
Kentucky.
Mr. Butterfield. Would it be helpful to work with some of
the medical schools, the dental schools to develop a curricula
in this area?
Mr. Conway. Oh, absolutely. I speak to the pharmacy
students, and I speak to a lot of medical students on an annual
basis to tell them how big the problem is and to look out for
this. You know, it is a balance here. The medical community
gets nervous whenever an attorney general or a lawmaker gets in
the middle of the doctor, patient relationship, and I respect
that. I respect that, but there ought to be some way for us to
see the disturbing trends so that we can do our job in law
enforcement, and right now in Kentucky our data monitoring law
says I have to have a designated case, a bona fide case open on
a designated target. I can't look at trends. I can't see where
the problems are. I have to ask about Mr. Smith, and the data
is all there, and I can't use it, and I can't tell you how
incredibly frustrating that is.
Mr. Butterfield. Do you believe the Federal Government
should consider certain minimum standards for doctors, for
doctor education or training in the area of addiction
medications?
Mr. Conway. I don't think it is a bad idea. Traditionally
the regulation of the practice in medicine has been left to the
states. I respect that. I think we are doing all we can in the
Commonwealth of Kentucky to educate doctor. A lot of the
healthcare organizations are starting to set up--some of our
larger hospital companies are starting to set up standards for
their ER docs. I think that is great. I think it is something
probably best left to the states, but I would welcome some
Federal guidance on that.
Mr. Butterfield. All right. Thank you. I understand you may
have spent some time at Duke University.
Mr. Conway. I did, sir. I did, sir, and I don't know your
allegiance. One of the toughest things I have to do is get
elected statewide in the Commonwealth of Kentucky being a
graduate of Duke University. It is--basketball passions being
what they are.
Mr. Butterfield. The State legislature has just added Duke
University to my district.
Mr. Conway. Well, Roy Cooper and I have a running argument
every time we see each other, and I am going to see him this
weekend. I am sure we will be arguing over that little game
this weekend.
Mr. Butterfield. All right. Thank you.
Mrs. Bono Mack. Thank you. Mr. McKinley? No?
OK. Well, we--the next panel. OK. We want to thank you all
very, very much for your expertise and your hard work on this.
We look forward to working with you. Please anticipate further
questions in writing. We look forward to getting your
responses.
Again, thank you for fighting this battle, and we look
forward to partnering with you in the future. Safe travels
home.
Ms. Bondi. Thank you, Chair.
Mr. Conway. Thank you.
Mrs. Bono Mack. We will take quick 30-second break while we
seat the next panel.
[Recess]
Mrs. Bono Mack. On our third panel we have five witnesses.
First is John Gray, President and CEO of Healthcare
Distribution Management Association. Our next witness is Joseph
Harmison, a Pharmacist and Owner of DFW, it sounds like Dallas
Fort Worth Airport--oh, it is. OK. Of DFW Prescriptions, who is
testifying on behalf of the National Community Pharmacists
Association. Hopefully I will be flying through DFW later
today.
We also have another pharmacist joining us, Kevin
Nicholson, Vice President of the National Association of Chain
Drug Stores. Next is Kendra Martello, Assistant General
Counsel, Pharmaceutical Research and Manufacturers of America,
and our final witness is David Gaugh, Vice President for
Regulatory Science of the Generic Pharmaceuticals Association.
Welcome everyone. I think you know the drill. The 5
minutes. There is the timer, and with that we will be happy to
turn to you, Mr. Gray, for your 5 minutes. Please make sure
your microphone is on.
STATEMENTS OF JOHN M. GRAY, PRESIDENT AND CHIEF EXECUTIVE
OFFICER, HEALTHCARE DISTRIBUTION MANAGEMENT ASSOCIATION; JOSEPH
H. HARMISON, OWNER, DFW PRESCRIPTIONS, ON BEHALF OF NATIONAL
COMMUNITY PHARMACISTS ASSOCIATION; KEVIN N. NICHOLSON, VICE
PRESIDENT, NATIONAL ASSOCIATION OF CHAIN DRUG STORES; KENDRA A.
MARTELLO, ASSISTANT GENERAL COUNSEL, PHARMACEUTICAL RESEARCH
AND MANUFACTURERS OF AMERICA; AND DAVID R. GAUGH, VICE
PRESIDENT FOR REGULATORY SCIENCES, GENERIC PHARMACEUTICALS
ASSOCIATION
STATEMENT OF JOHN M. GRAY
Mr. Gray. Now it is greener. Thank you. Good afternoon,
Chairman Bono Mack and Ranking Member Butterfield and members
of the Energy and Commerce Subcommittee on Commerce,
Manufacturing, and Trade. I am John Gray, President and CEO of
the Healthcare Distribution Management Association, and I want
to thank you all for the opportunity to come here today and
talk about this critically important problem of prescription
drug abuse and diversion, and most importantly, what my members
are doing to combat that problem.
The pharmaceutical distribution industry's primary mission
is operate the safest, most secure, and efficient supply chain
in the world. As part of this mission HDMA and its members are
committed to addressing the serious national problem of
prescription drug abuse and to being a part of the solution.
HDMA members have not only statutory and regulatory
responsibilities to detect and prevent diversion and control
prescription drugs, but to undertake such efforts as
responsible members of our society.
To address the issue of prescription drug abuse,
distributors have developed complex systems to help prevent
diversion of medicines and to comply with the DEA's expanded
expectation for suspicious order in monitoring and reporting.
To aid in the development and implementation of these
systems, in 2008, HDMA and its member companies developed the
Industry Compliance Guidelines to support the distribution
industry practices on the evaluation of customer orders for
controlled substances and the reporting of so-called suspicious
orders to the DEA. The ICGs, as we call them, were vetted with
the DEA in advance to their publication.
These guidelines emphasize the concept of ``know your
customer.'' That is obtaining and reviewing thorough background
information about a perspective healthcare provider prior to
doing business with them. Therefore, in many cases potential
problems can be avoided even before an order is placed.
Because the advanced systems now in place and the
industry's proactive efforts, the DEA reported last year that
since 2006, and 2011, distributors in this country stopped
shipping controlled substances to more than 1,500 customers
that could have posed an unreasonable risk of diversion.
Let me add it is critical that the anti-diversion efforts
of our industry, as well as the enforcement actions of DEA,
should always carefully balance the need to cut of supply to
any customer engaged in diversion while not limiting access to
appropriately-prescribed and legally-dispensed medicines for
seriously ill patients or potentially putting legitimate
pharmacies out of the business.
Despite the best efforts of our industry, we find ourselves
today in a conundrum. Pharmaceutical distributors do not
manufacture legal controlled substances. We do not license
pharmacies or healthcare providers. We do not write
prescriptions for patients. We do not dispense these products
to patients. We do not see the prescription a patient presents
for filling at a pharmacy. A single pharmaceutical distributor
does not know and has no way of knowing if a pharmacy customer
is purchasing prescription drugs from other distributors.
Furthermore, we do not determine or set prescription drug
fill rates.
However, the DEA receives information from each distributor
that sells controlled substances to a particular pharmacy or
prescriber. The agency also sets annual allowable production
quotas for manufacturers of these controlled substances.
Distributors are often held accountable with incomplete
information for diversion from parts of the supply chain they
simply do not control.
To comply with DEA's expectations, distributors are being
asked to judge the diagnosis, intent, medical knowledge,
experience of doctors and pharmacists.
Furthermore, the DEA's emphasis on volumes and national
averages to determine suspicious orders may simply over
simplify the problem for schedule two controlled prescription
drugs. Our members have found the analysis of a single
pharmacy's controlled substance ordering pattern is simply far
more complex and includes critical factors such as the size of
the pharmacy, the patient demographics, the geographic
proximity to the hospitals or surgery centers, nursing homes,
cancer clinics, hospice providers, and other major urban areas.
Now, as was stated earlier today, I need to correct that.
We do not choose not to comply with these laws of suspicious
ordering. The fact is our members have many questions about the
compliance. You have heard this is a relatively new process, a
new procedure, and unfortunately, today with the questions we
have remaining each distributor essentially operates in an
information silo. We are unaware if a new pharmacy customer may
have been cut off by another distributor who had concern about
potential diversion at the pharmacy, or we are unaware that an
existing pharmacy customer is ordering controlled substances
from multiple distributors. Or we are also unaware that
specific pharmacies may be dispensing controlled substances for
physicians who are writing prescriptions for patients when
there is no legitimate medical need.
So in an effort to break down these walls and get this new
program going, HDMA has asked DEA in face-to-face meetings over
the last several years as well as in written communications to
provide some clarification and guidance on the agency's
expanded expectations of an anti-diversion program for
wholesale distributors, and we have sought greater information
sharing in the process between the agency and our industry.
Throughout these communications HDMA and its members have
also asked DEA to provide aggregated and critically-important
blinded data from the ARCOS System that could be used to
further assess product orders and provide supportive
information for the agency and for the members.
A distributor does not have the independent ability to
determine whether a pharmacy or a physician customer is
ordering from multiple distributors. Only the DEA possesses
that information.
In closing, we strongly believe that all stakeholders,
doctors, pharmacists, distributors, manufacturers, and indeed,
the government must work together to achieve this shared goal
to ensure a sufficient, safe supply of medicines for legitimate
patients while keeping those same drugs out of the hands of
individuals who will abuse them.
Ms. Chairman, thank you for your time.
[The prepared statement of Mr. Gray follows:]
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Mrs. Bono Mack. Thank you, Mr. Gray.
Mr. Harmison, you are recognized for 5 minutes.
STATEMENT OF JOSEPH H. HARMISON
Mr. Harmison. Thank you, Madam Chairwoman.
Mrs. Bono Mack. Turn the mic on and pull it close to you,
please.
Mr. Harmison. Does it help if I get it closer?
Mrs. Bono Mack. Yes. Thank you.
Mr. Harmison. I am sorry. I have a hearing deficit, and
people say I talk too softly. Sorry. Good afternoon, Madam
Chairwoman Bono Mack, Ranking Member Butterfield, and Members
of the subcommittee. I am Joe Harmison. I am a practicing
pharmacist. I am a pharmacy owner and past President of the
National Community Pharmacists Association. NCPA is a national
organization representing the owners and pharmacists of the
non-publically traded community pharmacies.
Everyone here today is in agreement that the United States
has a problem with drugs abuse, misuse, and diversion. I hope
we will also acknowledge that the drugs we are discussing today
when used appropriately are extremely beneficial. When they are
not used as intended, they are destructive in many ways.
As has been stated over and over, the majority of people
that abuse prescription drugs get them from the family medicine
cabinet or friends. This shines a very bright light on how we
need to destroy these drugs. The community pharmacists in the
United States have been excited, willing participants in the
Drug Take Back Program for Destruction.
The problem we have, we are not allowed to take back the
controlled substances of what--those are the drugs we really
want to get off the street. We can't handle that. We are
anxiously awaiting the rules we have been told with DEA they
are promulgating to allow us to participate in this process.
The pharmacists of America interact with millions of
patients every day and advises them on how to use their
medicine correctly and what can happen if they don't. We cannot
cure the problem we are addressing today by ourselves. We use
the tools we have, but we need more tools.
There have been many suggestions on how you can get more or
people can get more information to us. I am very much in
agreement that the most readily-implementable procedure we have
out now is the PDMPs. Every pharmacist in I believe it has been
stated 48 states has to submit on a regular basis the
information on the controlled substances they dispense. This
goes into some giant computer somewhere.
The problem the pharmacists have with it is most of us
don't have access to that information. It is certainly not in
real time, and it is not able to be incorporated into our
workflow systems. If you can find a way to get that to us, we
will be your greatest advocates in using it. We do not want to
be the drug police. We would be very willing to work with all
parties to prevent abuse, misuse, and diversion.
Another thing with this computer database, it must not be
the deciding factor on whether a patient gets their medicine.
That decision must be left to the responsible parties, the
prescribers and the pharmacists. We are the ones that know the
patients best. We know their conditions.
Another very important part of this equation is pharmacy
burglaries and robberies. In 2010, there were 686 armed
robberies of pharmacies in the United States, and
unfortunately, some of these end up with murders involved with
them. Unfortunately, I have way too much experience first hand
with pharmacy burglaries. One of my pharmacies has been
burglarized three times since December 1, 2011. This is one
small pharmacy, and from what I can determine the street value
of the drugs taken from my pharmacy is in excess of $575,000.
And more onerous than that, there were almost 10,000 doses of
controlled substances potentially put on the street.
I would like to make a few recommendations for your
consideration. One, require mandatory minimum sentences for
robberies and burglaries involving controlled substances. Find
some way to give Federal, State, and local law enforcement and
prosecutors the ability to better communicate and coordinate
their efforts to do their work.
Third, shut down the pill mills. Get the back actors out of
the process. Leave those of us that are trying to do the best
we know how, what we are trained to do, care for patients, to
do our job. Another is consider a change to the tax code to
allow those of us that have put out the money to have different
security systems, to depreciate those in 1 year. Don't make us
depreciate it over 7, 10, or more years.
And also we would hope that you might reconsider allocating
some of the money taken from forfeiture from crimes related to
controlled substance, put that in a pot somewhere and let
pharmacists apply for some of that money. If they can't afford
security systems, let them apply to use some of that forfeiture
money.
NCPA and the Community Pharmacists of the United States
will--are committed to working with Congress and law
enforcement to combat drug use, abuse, and diversion, but we
need your help.
Thank you for the ability to be here today and your
attention.
[The prepared statement of Mr. Harmison follows:]
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Mrs. Bono Mack. Thank you, and Mr. Nicholson, you are
recognized for 5 minutes.
STATEMENT OF KEVIN N. NICHOLSON
Mr. Nicholson. Chairman Bono Mack, Ranking Member
Butterfield, and subcommittee members, thank you for the
opportunity to testify. My name is Kevin Nicholson. I am a
pharmacist and Vice President of Government Affairs and Public
Policy for the Nationals Association of Chain Drug Stores.
NACDS represents traditional drug stores, supermarkets, and
mass merchants with pharmacies. Our members operate more than
40,000 pharmacies and employ more than 3.5 million employees,
including 130,000 pharmacists.
Our members are deeply committed to serving the healthcare
needs of Americans. We are serious about the trust our patients
impart upon us and about our responsibilities to provide the
highest quality care. We are keenly aware of the scourge of
prescription drug diversion, and our members actively work on
numerous solutions. We also support a number of new and
Federal-State policy initiatives.
DEA has implemented comprehensive regulations for a closed
system to minimize the diversion of controlled drugs. Our
members have developed extensive policies and procedures to
comply with DEA's regulatory regime and similar requirements
from State agencies such as board's pharmacy and narcotic drug
agencies. A complex regulatory and policy matrix of checks and
balances protects Americans.
Chain pharmacies have zero tolerance for prescription drug
diversion. We have implemented a variety of extensive and
robust loss prevention and internal security systems from our
prescription drug distribution centers to the point of
dispensing to patients. Examples include that we conduct
background checks and random drug testing, extensive DEA
training within 30 days of hire, maintaining electronic
inventories of controlled substances with random auditing, use
of camera surveillance closer to television, heavy-duty safes,
and complete alarm systems, training employees on how to handle
suspicious prescriptions, and internally investigating
unusually large drug orders.
Chain pharmacies support and comply with State prescription
drug monitoring programs. We support policies to prevent
illegitimate internet drug sellers from illegally selling
prescription drugs to consumers, and we support efforts to
provide consumers with the means for proper disposal of
unwanted medications in ways authorized by law enforcement.
NACDS is pleased to offer our support for the Online
Pharmacy Safety Act, which would take important steps to shut
down the illegitimate internet sellers that prey on consumers.
We applaud subcommittee members Bill Cassidy and Mike Ross for
their strong commitment to protecting the American public.
Approximately 36 million Americans have purchased prescription
medications online without a prescription. Americans are being
harmed by these rouge internet sites daily.
We also look forward to DEA's upcoming regulations to allow
consumers to safely dispose their unwanted controlled
prescription drugs. DEA recognizes that consumers' inability to
safely dispose of controlled prescription drugs contributes to
prescription drug diversion.
NACDS routinely meets with DEA officials to learn about
diversion trends and to develop strategies to mitigate and
reduce problems, and although we support the mission and
objectives of DEA, we do have concerns with DEA's recent
policies surrounding the volumes of controlled substances
ordered by pharmacies.
Every pharmacy environment is different, and enforcement
action should not be brought against a pharmacy merely based on
the number of controlled substances ordered or dispensed.
Certain pharmacy locations will have higher-than-average
volumes of controlled substances. For the ultimate good of
patients who rely on access to controlled substances for
legitimate purposes such as pain management, we urge DEA to
take a holistic approach when developing policies to pursue
enforcement actions.
We have worked over the past few years to develop
prescription drug risk management programs with FDA called REMS
to reduce the potential for addiction and abuse of prescription
drugs, and we will continue to work with FDA on future similar
risk management programs. We also meet routinely with the White
House Office of National Drug Control Policy on trends and
solutions.
We are proud of the comprehensive approach that our chain
pharmacies have taken and look forward to continuing our work
with Federal and State policymakers to implement solutions,
including expanding prescription drug monitoring programs,
shutting down illegitimate internet sites, and providing
consumers with the ability to safety dispose unwanted
prescription drugs.
I thank you for the opportunity to appear and welcome your
questions.
[The prepared statement of Mr. Nicholson follows:]
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Mrs. Bono Mack. Thank you, Mr. Nicholson.
Ms. Martello, you are recognized.
STATEMENT OF KENDRA A. MARTELLO
Ms. Martello. Thank you. Chairman Bono Mack, Ranking Member
Butterfield, and distinguished members of the subcommittee, my
name is Kendra Martello, and I am pleased to offer this
testimony today on behalf of the Pharmaceutical Research and
Manufacturers of America or PhRMA. Our members represent
America's leading pharmaceutical research and biotechnology
companies.
Our prescription drug distribution system is a closed
system. This means that all entities engaged in the
manufacture, distribution, and dispensing of pharmaceutical
products, including controlled substances, must be licensed,
registered, or approved by FDA, DEA, or the states. Thus, each
entity has a shared responsibility to prevent diversion of
pharmaceutical products.
When an authentic product is diverted, it could be
mishandled and potentially cause patient harm if reintroduced
into the legitimate supply chain. Additionally, the diverted
medicine can be misused or abused.
The Controlled Substances Act and DEA regulations require
entities handling these products to register and to have in
place effective controls and security measures to protect
against theft, loss, or diversion of controlled substances. The
DEA also has authority over Web sites dispensing controlled
substances and recent additional authority to supervise return
of unused controlled substances for disposal.
PhRMA member companies engage in a variety of activities to
help prevent diversion of their products from the regulated
supply chain. Our companies take these efforts seriously
because fundamentally patient safety and the public health
demand no less. Our members employ a range of measures to
prevent diversion from facility security including uniformed
guards, fences, and extensive access control and video
surveillance systems to strict controls over in-process
manufacturing operations to in-transit security measures such
as the use of GPS tracking devices on 18 wheelers that carry
medicines across the country to enhancing enforcement by
information sharing with law enforcement officials and to
helping educate other on best practices. Our companies work to
help secure the products we manufacture in the regulated supply
chain.
Because of the number of independent actors in the drug
distribution chain, preventing diversion of medicines from the
regulated supply chain is a shared responsibility. Recognizing
this PhRMA members participate in broad-based coalitions to
help address specific aspects of prescription drug diversion.
These include coalitions to increase penalties for cargo theft,
groups to facilitate information sharing and best practices,
and participation in stakeholder coalitions that are pursuing
new authorities in a variety of related and significant areas.
These activities are detailed further in my written testimony
submitted for the record.
We do believe that there are additional authorities that
could also have a significant impact on reducing diversion as
well as reducing the non-medical use of prescription drugs.
These include, first, increase the use of and improvements to
State prescription drug monitoring programs, which can be an
important tool to prevent and detect abusers and refer them for
treatment.
Second, reauthorize NASPER, which provides grants for these
State's monitoring tools and which is legislation we have
supported. Third, increase penalties for and enforcement
against criminal cargo theft, Rogan mine drug sellers, and
criminal counterfeiters. Fourth, fully implement DEA
authorities over online sales of controlled substances and
responsible secure disposal of unused controlled substances.
And finally, increase licensure requirements for wholesale
distributors to prevent unscrupulous actors from moving their
operations across State lines.
In conclusion, PhRMA and its member companies are dedicated
to improving the lives of patients. This emphasis on the
patient extends throughout the product life cycle, from
researching and developing new medicines, including abuse-
resistant formulations, to helping ensure medicines are used
appropriately, to helping prevent diversion from the regulated
supply chain.
At the same time addressing the growing problem of
prescription drug abuse is also a shared responsibility, and
patients need continued access to the medicines they need to
allow them to live longer, healthier lives. We remain committed
to addressing the issues surrounding prescription drug
diversion and inappropriate use of prescription medicines, and
we look forward to continuing to work with the subcommittee,
members of Congress, and other stakeholders on these important
issues. Thank you.
[The prepared statement of Ms. Martello follows:]
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Mrs. Bono Mack. Thank you, Ms. Martello.
Mr. Gaugh, you are recognized.
STATEMENT OF DAVID R. GAUGH
Mr. Gaugh. Thank you. Good afternoon, Chairman Bono Mack,
Ranking Member Butterfield, and members of the Energy and
Commerce Subcommittee on Commerce, Manufacturing, and Trade. I
am David Gaugh, Vice President of Regulatory Sciences at the
Generic Pharmaceutical Association and a licensed pharmacist.
GPhA represents the manufacturers, distributors, the
finished dose generic pharmaceuticals bulk chemicals, and also
suppliers of other goods and services to the generic
pharmaceutical industry. Generic pharmaceuticals now fill about
80 percent of all prescriptions dispensed in the United States
but consume just 25 percent of the total drugs spent for the
prescriptions. GPhA's member companies manufacture FDA-approved
generic versions of brand-name drugs in all therapeutic
classes, including prescription painkillers. We share the
concern of the members of the committee when medications that
are made to improve the quality of life and alleviate pain are
abused. We believe that addressing this issue will require
continued coordination among Federal agencies, State, local,
and Federal law enforcement, healthcare professionals, drug
manufacturers, patients, and even the caregivers. And we will
work together to shape policy.
To control the misuse of pain medications we must recognize
that the overwhelming majority of individuals, including
millions of senior and cancer patients, rely on these important
medications to help treat their pain. In our collective efforts
to curb drug diversion, we must carefully but not inadvertently
punish the patients who need these medications. Rather we
should punish the criminals who illegally acquire and sell
these products outside the normal chains of distribution.
GPhA member companies are absolutely committed to the safe
and reliable manufacturing and delivery of generic drugs. As an
industry we have invested millions of dollars in technologies
and delivery systems to help assure that our products reach
their destinations safely and securely.
For example, our industry works with the DEA through the
closed system that you have heard about before of distribution
to prevent a diversion and also to assure that these products
do not fall in the hands of abusers.
The DEA also administers drug allotment and accountability
systems to ensure against lost and diversion of controlled
substances. While some have questioned whether the quota system
needs to be reevaluated, we do not believe that doing so is an
appropriate way to address concerns with prescription drug
abuse. Further restrictions of the quota system could actually
hinder access to important medical therapies for the patients
who rely on them.
For example, there are drugs specifically designed for
attention deficit disorder and attention deficit hyperactive
disorder in the quota system that are currently on the FDA's
drug shortage list. Thus we are concerned that if Congress
starts to tip the balance in the quota system, it could
actually have unintended consequences on the patients who need
these medications.
GPhA has also been participating in the Pharmaceutical
Distribution Security Alliance or the PDSA to develop a
consensus technology model for increasing the security of the
drug supply chain in the United States. As part of this model
manufacturers have committed to maintaining a database that
would associate unit level data and lot number association.
GPhA believes this model will deliver greater safety to the
patients and help to achieve FDA's stated goals of enhancing
the identification of suspect products.
But no matter how secure we make the supply chain for
prescription drugs, ensuring safe use of these drugs is a
responsibility that rests on all of us. In fact, recent studies
suggest that the problem with prescription drug abuse in the
United States today primarily stems not from drugs that are
outside the legitimate supply chain or have been obtained
illegally through the black market, but instead from those who
legally prescribe and are available in the homes.
According to a 2010, national survey of health more than 70
percent of people abusing prescription drugs are doing so with
products that were obtained either from friends or relatives.
The general drug industry has been a leader in addressing
the problem on drug diversion. We believe that education is the
key component to addressing this issue and as such support
efforts such as the American Medicine Chest Challenge, Smart
Rx, and the National Council on Prescription Information and
Education.
In addition, our industry has focused its efforts in the
area by joining the brand industry, patient groups, and the FDA
to develop the REMS Program, which addresses long-acting and
extended-release opioid medications. REMS, which is short for
Risk Evaluation and Medication Strategies, are special programs
that are used by the FDA to help prevent adverse outcomes for
the patients and through the education of key participants
about the risks that are associated with the medications and
the proper and legitimate use of these medications.
Madam Chairman, thank you for the tireless efforts to
combat the problems of the prescription drug abuse in this
country. You know more than anyone that this is very much a
multi-faceted issue that will require multi-stakeholders to
solution.
Thank you, and I will be happy to answer any questions.
[The prepared statement of Mr. Gaugh follows:]
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Mrs. Bono Mack. Thank you, Mr. Gaugh, and I recognize
myself for 5 minutes for questioning, and I just want to say I
get very frustrated anytime I hear denial from anybody in front
of this committee, as if they don't have a role in this. I
think that there is plenty of blame to go around. There is no
doubt, and in the private sector if anybody was analyzing
statistics and looking at the number of overdose deaths
screaming upward, I mean, Donald Trump would say, ``You are
fired.''
These statistics are staggering. The attorney general
pointed that out. They did a fantastic job. I, you know,
something that really struck me to the pharmacy, the two
pharmacy representatives, the murders of the four people in New
York, how the bad guy, the assailant, whatever you want to call
him, was an addict, too. Correct? And it seems that--are these
robberies, are these crimes on the uptick because of the
prescription drug epidemic? Are they addicts themselves, and
are they actually--which is worse? Are they, you know, I have
seen people trying to go through withdrawal. They will do
anything to get the drug, anything at all. So are you seeing it
because they are addicts or just people who are trying to
divert it to the black market?
Mr. Harmison. I can't speak with a great deal of authority
here. I think that it is a combination. To the best of my
knowledge I have never seen a patient come in that I could say
this person is in withdrawal. I think that there is so much
money involved with the black market of this, I think there are
so many people that enjoy the euphoria. There is a demand, and
somebody is going to meet that demand. Some of them are evil
enough they will do whatever it takes to get it.
Mrs. Bono Mack. But it is not the euphoria. They need a
basic level to sustain themselves, so let us make it clear that
it is not to sustain the euphoria. At any point in time it
becomes so that they can live. Correct?
Mr. Harmison. Yes, ma'am, but what I mean by euphoria, it
has been proven over and over people in true organic pain do
not get euphoria from the pain-relieving drugs. If they are an
addict, they do--the threshold to keep down the withdrawal
syndromes does keep rising. They do have to have more and more,
probably more often and more often.
Mrs. Bono Mack. Right.
Mr. Harmison. But I don't know the people committing the
crimes are addicts or salespeople.
Mrs. Bono Mack. Mr. Nicholson, do you want to weigh in on
that?
Mr. Nicholson. Thank you, Madam Chairwoman. First I would
add that I start off by saying that nothing is more important
to our members than the safety of their patients and their
employees, and I would also add that the incidents that you are
talking about with respect to deaths from pharmacy robberies,
the pharmacy robbery problem is, in fact, not, from what we are
hearing is not at a nationwide spike, but it is spiking in
certain geographic areas such as in the greater, in the
northeast and in the New York metropolitan area.
To help address these issues, you know, we work on a number
of initiatives. We have been recently meeting with the
officials at the HIDTA Office in that area to develop solutions
that would help pharmacies to prevent these types of
circumstances in the future.
Mrs. Bono Mack. Do you all flag and identify willingly if
an addict is willing to disclose to you he is addicted to
opiates and I just want to know in my record that I am asking
for these, I know it presents a whole host of other problems,
but there are these sorts of things that pharmacies are not
addressing right now currently. Correct? Are you able to say, I
know you can say you have an allergy to iodine, and you can put
that on a patient's record. Correct? But can you say none
addiction to a substance with a patient's willingness to
provide that kind of information? Do you track that data?
Mr. Nicholson. Well, we, I mean, the information that goes
to a patient profile is provided either by the patient
themselves----
Mrs. Bono Mack. That is what I am asking you. Do you, but
do you specifically if a patient says to you, I am in recovery
for an opiate addiction, if I come to you with a prescription
for Opana, Opana, whatever----
Mr. Nicholson. Right.
Mrs. Bono Mack [continuing]. Or Vicodin, whatever opiates--
--
Mr. Nicholson. I mean----
Mrs. Bono Mack [continuing]. Please talk to me, counsel me
first, call my doctor and say, ``Doc, I want you to know.'' Do
you do that now? I mean, that is a basic, simple step.
Mr. Nicholson. The basic practice would be in a situation
where a patient comes to you and says they are an addict, you
would--the ultimate goal would be to refer them to treatment.
Mrs. Bono Mack. Do you keep it on their record? It is a yes
or no question.
Mr. Nicholson. I can't answer. I mean----
Mrs. Bono Mack. Yes, because the answer is no, but let me
just move on because my time is limited. I just want to go down
the line if I might and get a yes or no answer out of each of
you.
Do you agree with me that there is, is there an epidemic on
prescription drug abuse?
Mr. Gray. Yes.
Mr. Harmison. Absolutely yes.
Mr. Nicholson. Yes.
Ms. Martello. Yes.
Mr. Gaugh. Yes.
Mrs. Bono Mack. Do you agree each of you have a
responsibility in finding a solution to this problem?
Mr. Harmison. Yes.
Mr. Nicholson. Yes.
Ms. Martello. Yes.
Mr. Gaugh. Yes.
Mrs. Bono Mack. Thank you. Lastly I am just going to close
with this one thought that I am a little bit frustrated by the
notion that a prescription drug monitoring program is punitive.
It shouldn't be. My daughter was a professor of, I mean, excuse
me, my father was a professor of medicine, and I really hold in
very high regard doctors and understand their limited time.
Same with pharmacists.
But when we are thinking this is a cumulative measure
rather than a holistic approach, the ability for each of you to
see a patient in their entirety, perhaps if we changed the
language, it is not punitive but it is supposed to be an added
tool that will actually help you provide better healthcare to
your patients, your consumers, your customers. I think that
that would help if we could change the feeling and the
language, and I am happy to work with all of you on that.
My time has expired. I am happy to yield to Mr. Butterfield
for 5 minutes.
Mr. Butterfield. Thank you. I am happy that the chairman
went a little bit over time because that kept me from having to
ask each of you the question about whether or not you feel some
shared responsibility in curving the abuse of drugs, and each
one of you answered the question as I thought you would. I
don't get the sense for 1 minute that any of you are not
sensitive to what we are talking about today, and so I thank
you for coming. I thank you for what you do in your industry
and just encourage you to--let us work together to try to solve
this huge problem that we are facing.
I asked this question of the first panel, and I am going to
try it again, and then I will close it out and head to the
airport. Law enforcement efforts in one State may certainly
yield reductions in the number of pills dispensed or
hospitalizations or deaths. All of this is commendable if it
happens within the State's border, but how can we be sure that
addicted individuals simply don't go to another State and
continue to commit the crime? We have asked other panels about
that, and it is the elephant in the room. I mean, that is the
big problem. If we fix the problem in one State, it is very
simple for the addict to go to a neighboring State.
Now, help us with some of your ideas on that very quickly.
Mr. Gray.
Mrs. Bono Mack. Please make sure your microphone is on.
Mr. Gray. All they have to do is get in a car and go, and I
think ultimately the solution is going to be the ability to
link up these PDMP Systems and what other health IT record
systems can be done across the country, and where doctors in
Florida or doctors in Michigan can look at, you know, can go
online and see what each individual patient is doing, I mean,
that is the only way to kind of link up the information flow so
a pharmacist in Tennessee can look up and understand that this
patient was also just recently at a pharmacy in Florida, and
now they are up here.
But right now as you heard the earlier panel, these systems
are discreet by their states. They are not connected, so the
information flow isn't there.
Mr. Butterfield. Thank you.
Mr. Harmison. Is it on?
Mr. Butterfield. Yes.
Mr. Harmison. I don't know why they can't be connected.
There are nationwide systems right now that we deal with every
day with insurance that will feed back to us in a matter of
seconds. There is drug allergy on record to this. They have had
it refilled too soon. It is not on our formulary. There is all
sorts of information that comes back in seconds. I don't know
why something like this--but I am the most technologically
illiterate person in this room, but I don't know why it can't
be done.
Mr. Nicholson. I would agree with, you know, my--Mr. Gray
and Mr. Harmison that, yes, I mean, we definitely need, you
know, the mater solution is to connect the prescription drug
monitoring programs. At NACDS we support appropriations for
NASPER and for the Harold Rogers Prescription Drug Monitoring
Program to provide funding to the states so that they can
upgrade and better maintain their prescription drug monitoring
programs and work on programs to interconnect them with each
other.
I also would add that we are hopeful that as the healthcare
delivery system becomes more interoperable that pharmacies and
prescribers and hospitals and you know, other entities will
have better access to patient's full, the patient's full record
so that there won't be gaps that would allow a patient to go
from prescriber to prescriber or from State to State.
Mr. Butterfield. OK. Counsel.
Ms. Martello. Similarly prescription drug monitoring
programs, we think that they can be an efficient and effective
tool in helping to identify folks for treatment as well, and
some of the solutions that have been talked about today include
making sure that information is provided to these State
prescription drug-monitoring programs in real time but also
enhancing their interoperability across State lines so that you
can utilize this data to its maximum effect.
Mr. Butterfield. All right. Fifty seconds.
Mr. Gaugh. I would concur with my colleagues on the panel
that PDMP is a system that is in place, but it does not cross
borders at this point in time, and as Mr. Harmison said, the
reimbursements are instantaneously, why can't this be
instantaneously.
Mr. Butterfield. Very well. Thank you.
Mrs. Bono Mack. Thank you.
Mr. McKinley, you are recognized for 5 minutes.
Mr. McKinley. Thank you. Mr. Gray, I think you started in a
direction, and I want to follow back up again. Maybe--but then
you stopped short of going that direction.
Question. When we have spoken with the DEA, they claim for
the distribution groups they give you very specific suggestions
for improvements or otherwise how to--I have a feeling that
there is a breakdown from what they say they are doing and what
you in the distribution business--are the distributors getting
good advice, good direction when they go to the DEA and ask for
improvements to their delivery system before they pull the
registration?
Mr. Gray. That is the big debate, and if you talk to my
members, they would tell you that those meetings, particularly
at the regional level, tend to be deficient in solid advice at
the end of the day as to whether or not a particular pharmacy
should be--have a stop order as far as delivery.
You know, our members started in this process with the DEA
4 years ago as they said. This is a relatively new program. It
was certainly a novel idea to consider the distributor as a
choke point. I think that is kind of a pejorative term for what
we are trying to do as a team as Attorney General Bondi said.
We should be working in cooperation and collaboration with the
DEA, and we shouldn't be in an adversarial posture, which these
things, when you issue an ISO, that is where you end up as was
stated earlier.
So what happens then, and I have heard, I have talked to
most of my members about this, and a common situation that will
occur is that there will be a discussion, the distributor will
sit down and say, we have reason to believe, we see some
spikes, something is wrong with the ordering of this particular
pharmacy. We think maybe they should be cut off. What do you
think? And the common refrain, I have heard this more than once
so there has got to be some element of truth to it, the common
refrain is, that is a business decision for the distributor to
make.
Well, sure it is, but then that business decision can be
used against you if you decide not to, and the questions that
we submitted to the DEA last June 1 to Administrator Leonhart
attempted to get to answer some of those specific questions
within the confines of these meetings. A question the
distributor would obviously have about a pharmacy practice, and
this all stems to the data discussion earlier.
They have data we cannot see. We cannot see that a pharmacy
may be delivering, may be receiving deliveries from more than
one wholesaler. All we see is our numbers, and it--that has
been a source of frustration. I am hoping today we can turn the
dialogue into a constructive one. It is not us versus them, but
how can we work together. I think we can make a lot of progress
working together.
Mr. McKinley. Let me stay on that question. If the--there
are two other issues with it. First, are the pharmaceuticals
that distributors, are they compensated for doing this police
work for the DEA?
Mr. Gray. Oh, no. This is all out of the distributor's
pocketbook. We have--our companies have invested tens of
millions of dollars in doing this.
Mr. McKinley. Thank you. So a smaller distribution firm,
how do they do that?
Mr. Gray. Very expensive. If you want to talk to some of
them, I can make that happen.
Mr. McKinley. Well, I just wonder----
Mr. Gray. Yes.
Mr. McKinley [continuing]. Is the long and the short of
this with the DEA trying to put the smaller distributors out of
business?
Mr. Gray. I wouldn't want to speculate on that. I can't
imagine that that would be the case. I think the DEA is
absolutely, you know, fervent and correctly so in attempting to
stop this problem, but I think like any new initiative, we are
in our dating period trying to figure out how to get along.
Mr. McKinley. Is this an--is this one of those unfunded
mandates that we are passing onto the companies to do, and we
are not going to compensate them. Then we are going to turn
around and criticize them for the cost of pharmaceuticals?
Mr. Gray. Well, that is an interesting way to put it, but,
well, I mean, as I say, the hardcore fact is when we put in
these monitoring systems, it is at the company's expense to do
so.
Mr. McKinley. I want to see this in a most robust way to
try to correct the problem, but I just have, I have this
nagging feeling here that there are parts of the chain that are
not being treated equally, and I hope that the DEA will revisit
how they work with each----
Mr. Gray. Well, we do, too, because we have a long history
since I have been onboard in '04, we have worked more than--we
were the first responders in Katrina, our companies are the
ones that got in there and got--we were the only ones that got
in and got medicines to the people stranded in New Orleans. We
were the ones that set up the vaccine tracking system with the
CDC in a cooperative effort. We worked cooperatively with the
Secretary of HHS to develop the system for bird flu maintenance
and stockpiling around the country. We have a long track record
in the last 5 years of working hugely cooperatively with
Federal agencies and the government. I would love to see that
same level of participation and cooperation with the DEA,
because I believe they are correct. Together we can solve a lot
of this problem. If they help us help them, we can make a lot
of strides to solving this problem, but we are working in a
vacuum.
Mrs. Bono Mack. Thank you very much, and I would like to
begin wrapping things up, and I thank all of our panelists very
much for being here today, for your time, and for your
commitment to this critically-important issue. If 30,000
Americans died every year from food poisoning, Congress would
take action. If 30,000 Americans died from pesticide exposure,
Congress would take action. For that matter, if 30,000 dolphins
died and washed up on our beaches every year, Congress would
take action.
So why are the victims of prescription drug abuse treated
any differently? But working together as we have all said I
know that we can come up with some good answers, and we can
save lives.
So I again thank you all very much for being here and
especially for weathering the delay that we had this morning. I
would like to remind members they have 10 business days to
submit questions for the record. I know we will have one
specifically about undosed marking, and so we will submit
questions to you, and I would ask the witnesses to please
respond promptly to any questions you might receive.
Again, thank you, and the hearing is now adjourned.
[Whereupon, at 1:50 p.m., the subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]
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