[Senate Hearing 111-711]
[From the U.S. Government Publishing Office]
S. Hrg. 111-711
DRUG WASTE AND DISPOSAL: WHEN PRESCRIPTIONS BECOME POISON
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HEARING
before the
SPECIAL COMMITTEE ON AGING
UNITED STATES SENATE
ONE HUNDRED ELEVENTH CONGRESS
SECOND SESSION
__________
WASHINGTON, DC
__________
JUNE 30, 2010
__________
Serial No. 111-20
Printed for the use of the Special Committee on Aging
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SPECIAL COMMITTEE ON AGING
HERB KOHL, Wisconsin, Chairman
RON WYDEN, Oregon BOB CORKER, Tennessee
BLANCHE L. LINCOLN, Arkansas RICHARD SHELBY, Alabama
EVAN BAYH, Indiana SUSAN COLLINS, Maine
BILL NELSON, Florida GEORGE LeMIEUX, FLORIDA
ROBERT P. CASEY, Jr., Pennsylvania ORRIN HATCH, Utah
CLAIRE McCASKILL, Missouri SAM BROWNBACK, Kansas
SHELDON WHITEHOUSE, Rhode Island LINDSEY GRAHAM, South Carolina
MARK UDALL, Colorado SAXBY CHAMBLISS, Georgia
KIRSTEN GILLIBRAND, New York
MICHAEL BENNET, Colorado
ARLEN SPECTER, Pennsylvania
AL FRANKEN, Minnesota
Debra Whitman, Majority Staff Director
Michael Bassett, Ranking Member Staff Director
(ii)
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C O N T E N T S
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Page
Opening Statement of Senator Herb Kohl........................... 1
Opening Statement of Senator Bob Corker.......................... 2
Opening Statement of Senator Susan Collins....................... 3
Panel I
Statement of Hon. R. Gil Kerlikowske, Director, White House
Office of National Drug Control Policy, Washington, DC......... 4
Panel II
Statement of Joseph Rannazzisi, Deputy Assistant Administrator,
Office of Diversion Control, Drug Enforcement Administration,
U.S. Department of Justice, Washington, DC..................... 21
Statement of Mary Hendrickson, Pharm.D., Director of Quality and
Regulatory Affairs, Genco Pharmaceutical Servicees, Milwaukee,
WI............................................................. 32
Statement of Bernard Strain, Father of Timothy Michael Strain,
Philadelphia, PA............................................... 41
Statement of Stevan Gressitt, M.D., Founding Director, Maine
Institute for Safe Medicine, Faculty Associate, University of
Maine, Center on Aging, Unity, ME.............................. 46
Statement of Bruce Behringer, Associate Vice President and
Executive Director, Office of Rural and Community Health and
Community Partnerships, East Tennessee State University,
Johnson City, TN............................................... 60
APPENDIX
Statement of the American Health Care Association (ahca) and the
National Center for Assisted Living (ncal)..................... 77
Statement of the Food and Drug Administration, Department of
Health and Human Services...................................... 81
Statement of The National Association of Chain Drug Stores
(NACDS)........................................................ 88
(iii)
DRUG WASTE AND DISPOSAL: WHEN PRESCRIPTIONS BECOME POISON
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WEDNESDAY, JUNE 30, 2010
U.S. Senate,
Special Committee on Aging,
Washington, DC.
The Committee met, pursuant to notice, at 2:03 p.m. in room
SD-106, Dirksen Senate Office Building, Hon. Herb Kohl
(chairman of the committee) presiding.
Present: Senators Kohl [presiding], Casey, Corker, and
Collins.
OPENING STATEMENT OF SENATOR HERB KOHL, CHAIRMAN
The Chairman. Good afternoon. We appreciate you all being
here today.
Our hearing today is about what happens to drugs that are
prescribed but never taken and how we can do a better job of
making sure that they do not cause unintended harm or even
death.
Odds are that many of us have half-empty bottles of
medicine lying around our houses. Some of us may have thought
we were doing the right thing by flushing them down the toilet
or throwing them away with our trash. But these disposal
methods can have a damaging effect on our environment.
A 2002 U.S. Geological Survey of 139 bodies of water across
the country found that over 80 percent of the water samples
were contaminated by prescription drugs, which have been shown
to harm fish and our wildlife. While we don't yet know what
impact this has on humans, we can all agree that it is
disturbing to think about leftover drugs tainting our drinking
water.
Environmental harm is only one side of the issue. Though
improper disposal of prescription drugs can be risky, lack of
disposal can be deadly. Prescription drugs from the medicine
cabinet may be just as harmful as illegal drugs purchased off
the street if they were not prescribed for you, for a
particular need, at a particular time, by a professional.
One of the best strategies to tackle the problem of drug
disposal is to make sure drugs are not wasted in the first
place. We need to explore innovative ways to improve patient
care and reduce waste through programs like medication therapy
management, improved compliance, and patient education.
For example, many doctors prescribe several months' supply
of a medication before it has been determined whether the
patient will respond well to it. A program in Maine aims to
reduce waste by limiting initial prescriptions for a list of
drugs that are known to provoke adverse reactions in some
individuals. Once the patient and their doctor decide to
continue with the medication, it is then dispensed in larger
quantities.
Not surprisingly, reducing waste also reduces costs. The
initiative also saves Maine's Medicaid program money--nearly a
quarter of a million dollars in projected savings for 2010.
Since we cannot eliminate all waste, we need to find better
ways to dispose of unwanted medications. We need to expand
programs such as the one in Wisconsin that collects leftover
drugs and incinerates them, turning them into an energy source;
or like the one that we will be hearing about from Senator
Collins in her home State of Maine, which has successfully
implemented a comprehensive drug mail-back program.
Unfortunately, current DEA guidelines concerning who can
handle the most dangerous types of drugs create a barrier for
many drug disposal initiatives. While we understand there is a
risk that drugs can fall into the wrong hands on their way to a
drug disposal collection point, the fact is that the risk of
that happening in the home is even greater. We need the DEA to
update its regulations to allow safe, comprehensive take-back
programs across our country.
We also need to provide Americans with better information
about what to do with their leftover medications. Contradicting
guidelines put forth by the DEA, FDA, EPA, and the U.S. Fish
and Wildlife Service need to be reconciled.
Americans deserve a safe and effective way to get drugs
away from their homes and keep them out of our drinking water.
I will be working with my colleagues to develop a comprehensive
package of legislative reforms that reduce waste and ensure
safe disposal.
We thank you again for your willingness to be here today,
and we will now turn to the ranking member, Senator Corker, for
his statement.
OPENING STATEMENT OF SENATOR BOB CORKER
Senator Corker. Mr. Chairman, thank you. I very much
appreciate you calling the hearing.
Prescription drug misuse in Tennessee is a big issue. So
not only am I concerned about this from the standpoint of
having appropriate national policy to deal with diversion
issues, to deal with disposal issues, knowing that prescription
drugs are expensive, and sometimes people are wary to let go of
them. So, they end up being around medicine cabinets and other
places far longer than they should.
So I look forward to hearing the testimony today, and I
thank you very much for calling this hearing and thank our
witnesses for being here.
The Chairman. Thank you, Senator Corker.
Now we will hear from Senator Collins.
STATEMENT OF SENATOR SUSAN COLLINS
Senator Collins. Thank you, Mr. Chairman.
First, let me thank you and the ranking member for calling
this hearing to examine the challenges associated with the safe
disposal of unused or expired prescription drugs.
An estimated 40 percent of drugs that are dispensed outside
of our Nation's hospitals go unused. That generates
approximately 200 million pounds of pharmaceutical waste each
year. These unused drugs, as the chairman has pointed out, are
prime candidates for diversion and also are a potential source
of both safety and environmental problems.
While many rural States, including Tennessee and Wisconsin,
are experiencing serious problems associated with diverted or
misused prescription drugs, no State has been harder hit than
mine, the State of Maine. Since 1997, when I first came to the
Senate, the number of the accidental deaths from drugs in Maine
has increased almost tenfold, jumping from 19 to 179 last year,
and most of these deaths were due to prescription drugs.
Moreover, prescription drug abuse is the second most-common
form of illicit drug abuse among our Nation's teenagers behind
only marijuana use. Nearly 1 in 5 of Maine's high school
seniors say that they have abused prescription drugs. Many of
these drugs were found in medicine cabinets, dresser drawers,
or trash cans of their unsuspecting parents or grandparents.
The vast majority of Americans currently dispose of
unwanted medicines by throwing them in the trash or by flushing
them down the toilet or sink. This has raised concerns about
the potential environmental impact of these disposal methods
and in particular about the effect on our Nation's water
supply. These concerns have led a number of local communities
and States, including Maine, to initiate drug take-back
programs to collect unused or unwanted medications for
disposal.
Mr. Chairman, I am particularly grateful that you have
invited one of my constituents, Dr. Stevan Gressitt--and I
apologize if I have mispronounced his name--to testify about
the Safe Medicine Disposal for ME program, which I believe
could be used as a national model. Our mail-back program in
Maine uses prepaid mailing envelopes addressed to the Maine
Drug Enforcement Agency that individuals and families can use
for the disposal of unused medications.
These envelopes are available for pickup throughout the
State at pharmacies, doctor's offices, and post offices. All
the drugs collected by the program are disposed of through the
same high-heat incineration process that is used for Maine's
law enforcement drug seizures.
Since the program was established in 2007, it has prevented
more than a ton of unused, unneeded, or expired drugs from
falling into the hands of our children or being diverted to
criminals. At the same time, it has kept these medications out
of our water supply and landfills.
So, again, Mr. Chairman, thank you very much for focusing
the Senate's attention on this issue.
The Chairman. Thank you very much, Senator Collins.
At this time, we will turn to our witness on the first
panel, who is R. Gil Kerlikowske, the Director of National Drug
Control Policy. There, he oversees all Federal drug control
programs, as well as the President's national drug control
strategy. Previously, Mr. Kerlikowske served 9 years as the
chief of police for Seattle, WA.
We welcome you here, sir, and we look forward to your
testimony.
STATEMENT OF HON. R. GIL KERLIKOWSKE, DIRECTOR, WHITE HOUSE
OFFICE OF NATIONAL DRUG CONTROL POLICY, WASHINGTON, DC.
Mr. Kerlikowske. Chairman Kohl, Ranking Member Corker, and
Senator Collins, thank you very much for the opportunity to
address prescription drug abuse and disposal.
I am also very encouraged and very pleased about the
committee's focus on this topic. Prescription drug abuse,
proper methods of disposal have been a major factor for us at
ONDCP since my arrival, and I have directed the National Drug
Control Program agencies to address these vital issues in our
drug control efforts.
Let me begin by describing the growing problem--and Senator
Collins, you certainly elaborated on that also--of drug abuse
in this country, of prescription drug abuse. This abuse has
increased dramatically in the last several years. In recent
years, the number of individuals who, for the first time,
consumed prescription drugs for a nonmedical purpose exceeded
the number of first-time marijuana users. This increase has had
tragic consequences.
In 2006, more than 26,000 Americans died from unintentional
drug overdoses, and prescription drugs, particularly the opioid
painkillers, are considered a major contributor to the total
number of drug deaths. The extreme threat and abuse of
prescription drugs comes from their widespread availability.
Well, how are they obtained? Well, for instance, in 2007-
2008, among persons aged 12 or older who used these pain
relievers nonmedically in the last 12 months, about 70 percent
obtained the pain relievers from a friend or a relative.
Further troubling, an estimated 1.9 million adults, aged 50 or
older, or 2.1 percent of adults in that age range, used
pharmaceutical drugs nonmedically in the past year.
The problem doesn't lend itself to traditional
interventions. These drugs are originally dispensed for
legitimate purposes. Too often the public's perception is that
they are safe for uses other than for which they were
prescribed.
Well, we must change public perception so the societal norm
shifts to one where unused or expired medications are disposed
of in a timely, safe, and environmentally responsible manner.
To address the growing problem, the national drug control
strategy outlines specific steps to address prescription drug
abuse.
The first is to encourage individuals to dispose of expired
or unused drugs through increased prescription drug take-back
programs or disposal programs. We know that legitimate
prescriptions from the family medicine cabinet are most often
the source of the drugs that get abused.
To counter this, law enforcement professionals and
grassroots organizations have held take-back days where
residents can dispose of their unwanted prescriptions. These
events have already been a success in many States, but more can
be done.
It is important to remember that all take-back programs
must be conducted consistent with the regulations of the
Controlled Substances Act. Under current rules, the DEA special
agent-in-charge must approve the take-back events when
controlled substances are accepted. Therefore, if Congress were
to amend the CSA to ease restrictions on drug take-back
programs, it would be an important step in combating this
problem by decreasing the supply of prescription drugs that may
be misused.
Another step the strategy promotes is more training and
education for physicians about opiate painkiller prescribing.
Through the Physician Clinical Support System Program, the
Substance Abuse and Mental Health Services Administration will
train prescribers on how to instruct patients in the use and
proper disposal of painkillers, observe signs of dependence,
and use prescription monitoring programs to detect doctor
shopping. We are also working with our Federal partners to
identify other ways to increase prescriber education.
Our strategy promotes the expansion of prescription drug
monitoring programs and establishing the information sharing
between States. The strategy also calls for ONDCP, along with
the DEA, to continue to work with State, local, and tribal
officials to give more assistance to States that are targeting
doctor shopping and pill mills. This is an extremely difficult
problem for State-level law enforcement to handle and due to
resource constraints and difficulties navigating these cases
across multiple State, local, and tribal jurisdictions.
Lastly, the strategy focuses on driving illegal Internet
pharmacies out of business and also shutting down rogue pain
clinics that do not follow appropriate prescription practices.
ONDCP is working with the DEA, the FDA, and EPA, and Congress
to further refine Federal laws and regulations to foster an
expansion of comprehensive, cost-effective prescription drug
take-back programs across the country.
Unless take-back programs are consumer friendly, large
quantities of unneeded prescription drugs will remain in the
community, subject to diversion and misuse. I look forward to
continuing to work with this committee to address these
challenging important issues, and I know that we could not
accomplish what we all want to for the Nation from the
executive branch without the support of Congress.
Thank you for the opportunity to testify, and I look
forward to answering your questions.
[The prepared statement of Mr. Kerlikowske follows:]
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The Chairman. Thank you, Mr. Kerlikowske.
Mr. Kerlikowske, your Web site directs consumers to FDA in
order to obtain a list of flushable medications. Yet the EPA
and the U.S. Fish and Wildlife Service have expressed concerns
about flushing any medication. These conflicting
recommendations are confusing. Is there a straightforward,
comprehensive guide for Americans wishing to dispose of their
medications in a safe and environmentally responsible way?
Mr. Kerlikowske. Along with the information about what
should be disposed of, according to the FDA, through flushing
it down the drain, we have a series on our Web site of how
other drugs can be disposed of. The drugs--the small number of
drugs that are listed by the FDA are those that are clearly
deemed as absolutely the most dangerous kinds of drugs, drugs
that can be actually absorbed through skin contact and need to
be disposed of in a way that they never can be misused.
But I am in complete agreement that a simple,
straightforward set of guidelines is imperative, and we are
working very hard to do that, Senator.
The Chairman. What is your timetable on that?
Mr. Kerlikowske. The timetable has been that we are working
with two members on the Senate side, two members on the House
side for a drug take-back program. The other important thing
would be that the recommendation that the Attorney General be
given some latitude in administrative rulemaking when it comes
to this area. So I am very hopeful that some proposed
legislation will be forthcoming shortly, and we will do
everything we can to foster that through the administration.
The Chairman. All right. Thank you so much.
Senator Corker.
Senator Corker. Mr. Chairman, thank you.
I just have one question. Again, thank you for your
testimony.
I know that there has been concern about prescription drugs
and the water supply. I am just wondering if the guidance that
has been given is one that is based on scientific evidence, if
we know enough about it, if it is more of a cautionary kind of
issue?
But I know it is something that many citizens are concerned
about, and I just wondered if you could educate us as to
whether there has actually been enough evidence to know that it
is of concern? Or are we basically saying that its out of more
of caution until we find out more about the issue?
Mr. Kerlikowske. Senator, I think your question is an
excellent one, and I think there are two things, and
particularly having come from Seattle. I mean, the Nation is
becoming such an environmentally conscious nation, in so many
ways. So, there are two things that have come about, and one is
that the ability to test such minute amounts, to detect such
minute amounts of a substance in the water system or the sewer
system, those things have greatly increased.
The second part of this is that a lot of what has been
disposed of or is now in the different systems isn't always as
a result of flushing the individual substance down the toilet.
It is also through human waste. I think that these are
questions that need to be answered.
On the other hand, we have a nation that is very concerned
about the environment, and figuring out a way to dispose of
these in a safe manner that doesn't have environmental effects
is part of our work with the EPA. By the way, we couldn't be
more pleased with the support that Lisa Jackson and EPA have
given us as we kind of work through this myriad of
difficulties.
Senator Corker. So, I guess, do we know? I mean, are we
doing things necessary to figure out, first of all, if those
levels are of concern and, secondarily, how they are actually
entering our drinking water today?
Mr. Kerlikowske. The testing is continuing on, and I would
be happy to provide information that I can obtain and others
from the EPA on some of the most recent. Unfortunately, I do
not have those specifics, but I think your point is right on
the mark.
Senator Corker. OK. So you don't really yet personally have
an opinion. Well, we look forward to following up and getting
additional information.
Thank you.
Mr. Kerlikowske. Thank you, Senator.
The Chairman. Senator Collins.
Senator Collins. Thank you, Mr. Chairman.
Director, I know that your office does recommend that
consumers take advantage of community take-back programs, such
as the very successful program that we have in Maine. I
described it during my opening statement. It has been very
popular. It has prevented more than a ton of unused or expired
drugs from being dumped into water supplies or diverted.
There are some organizations, however, including, I am
told, PhRMA, who have raised concerns about these kinds of
mail-back programs. They argue that they create a greater
potential for drug diversion because the mailer obviously
contains drugs. It is addressed to the Maine Drug Enforcement
Agency. It is clear what is inside.
But I will tell you that it is my understanding that in my
State at least, there have been no examples of a single package
even being diverted for criminal use. What is your judgment?
Since you come from a law enforcement background, do you see
any potential for diversion through these take-back, mail-back
programs?
Mr. Kerlikowske. You know, I am only slightly familiar with
the program in Maine, and I would tell you that I think by far
the greater danger is the drug staying in the medicine
cabinets, the potential for abuse or misuse while they are
there and no longer necessary for the patient that had them. So
I also clearly recognize that what may work in New Jersey,
which was a large take-back in perhaps more urban areas of that
State, is not particularly effective in a State like Maine that
we want people to dispose of these safely.
So I would tell you that I think that the potential for
diversion is minimal in the take-back program that you have
described in Maine and that by far the greater danger is
letting these things pile up in the medicine cabinets.
Senator Collins. I agree. Thank you.
The Chairman. Thank you so much, Mr. Kerlikowske.
Mr. Kerlikowske. Thanks.
The Chairman. At this point, we are happy to welcome our
second panel who will testify here today. Our first witness on
the second panel will be Joseph Rannazzisi, who is Deputy
Assistant Administrator for the Office of Diversion Control at
the U.S. Drug Enforcement Agency, where he oversees drug
investigations and serves as liaison to various outside
industries and agencies.
Next, we will hear from Mary Hendrickson, who is Director
of Quality and Regulatory Affairs for Genco Pharmaceutical
Services in Milwaukee, WI. At this position, Dr. Hendrickson is
responsible for the regulation of one of the largest reverse
pharmaceutical distribution sites in our country.
Next, we will be hearing from Bernard Strain. Mr. Strain
currently works for Pennsylvania State Treasurer Rob McCord,
and previously, he served as Deputy Finance Director for the
city of Philadelphia.
After that, we will be hearing from Dr. Steve Gressitt, who
is faculty associate at the University of Maine Center on Aging
and Founding Director of the Maine Institute for Safe Medicine.
In addition, he is Associate Professor of clinical psychiatry
at the University of New England College of Osteopathic
Medicine.
Our fifth witness is from Tennessee.
Senator Corker. Mr. Chairman, if it is OK, I will introduce
him. I first want to welcome all of you, but I especially
welcome a native of our State, Mr. Bruce Behringer from Johnson
City. He had been working as Executive Director of the Office
of Rural and Community Health and Community Partnerships at
East Tennessee State University for the better part of two
decades.
Through his work, East Tennessee has been helping to build
a curriculum to educate new pharmacists and practitioners
regarding prescription drug use in small mountain communities,
and his vast knowledge of the topic and firsthand experience
makes him amply qualified to share his expertise with us today.
It is also my pleasure to congratulate him and Dean Calhoun
and all of their colleagues at East Tennessee State University
Gatton College of Pharmacy for receiving full accreditation
this last Monday. I know they have worked hard. They have done
an excellent job also in educating primary physicians, No. 1 in
the country.
So, Mr. Behringer, I thank you for being here. I thank you
for your work and certainly for sharing your expertise here
today.
Thank you.
The Chairman. Thank you all.
We will start with Mr. Rannazzisi.
STATEMENT OF JOSEPH RANNAZZISI, DEPUTY ASSISTANT ADMINISTRATOR,
OFFICE OF DIVERSION CONTROL, DRUG ENFORCEMENT ADMINISTRATION,
U.S. DEPARTMENT OF JUSTICE, WASHINGTON, DC
Mr. Rannazzisi. Chairman Kohl, Ranking Member Corker,
Senator Collins, good afternoon. On behalf of Acting
Administrator Michele Leonhart and nearly 10,000 men and women
of the Drug Enforcement Administration, I am honored today to
appear before you and provide testimony concerning the disposal
of pharmaceutical controlled substances.
Let me begin by saying that the overwhelming majority of
dispensed pharmaceuticals in the United States are not
controlled substances. They are noncontrolled or legend drugs
that are not subject to the provisions of the Controlled
Substances Act. DEA's authority under the CSA is limited to
controlled substances.
So why is DEA concerned with collection and disposal
processes? In carrying out its enforcement and regulatory
obligations, DEA must monitor pharmaceutical take-back programs
because, in all likelihood, any organized collection of
unwanted or unused pharmaceuticals will also include the
collection of controlled substances.
The percentage of controlled substances collected during
take-back programs may be small, but DEA has a statutory
mandate to ensure that all controlled substances are collected
and disposed of in a manner that protects public health and
safety and prevents the reintroduction of these drugs into
illicit or the illicit market.
The diversion and abuse of pharmaceutical controlled
substances has reached alarming levels in the United States.
There are many contributing factors to this increase, but one
source for abused pharmaceuticals is right in our own home, the
medicine cabinet. Household medicine cabinets provide free and
easy access to controlled substance by drug seekers and
nonmedical users, such as teenagers, and increase the risk of
accidental ingestion and poisoning of children and the elderly.
Additionally, the improper disposal of medications may pose
risks to the environment. States, counties, and municipalities
have tried to develop pharmaceutical collection and disposal
programs to address the problems resulting from unwanted and
unused medications in household medicine cabinets. These
programs are beneficial in many ways, but the Controlled
Substances Act only provides for collection and disposal of
controlled substances under very limited circumstances.
Specifically, the Controlled Substances Act provides for a
closed system of distribution with stringent procedures on
procurement, distribution, and possession of controlled
substances. As part of this closed system, all persons who
possess a controlled substance must be registered with the Drug
Enforcement Administration or exempt from registration.
The Controlled Substances Act exempts ultimate users or
patients from the requirement of registration when they possess
a controlled substance for a legitimate medical purpose.
However, there is no exception that allows ultimate users or
long-term care facilities to distribute controlled substances
for any purpose, even to dispose of unwanted or unused drugs.
Simply stated, it is illegal for ultimate users to distribute
controlled substances.
Congress has proposed legislation in both chambers to
address this issue--specifically, in the House of
Representatives, H.R. 1359, the Secure and Responsible Drug
Disposal Act of 2009, and H.R. 1191, the Safe Drug Disposal Act
of 2009. In May 2009, the Department of Justice issued a views
letter in support of H.R. 1359. In May 2010, the National
Association of Attorneys General also issued a letter in
support of 1359.
H.R. 1359 and its companion measures, Senate 1292 and
Senate 3397, allows the Attorney General discretion to
promulgate regulations and provides the requisite flexibility
to address this important issue. It provides a means by which
ultimate users may distribute pharmaceutical controlled
substances to other persons for disposal.
It also contains a provision authorizing the Attorney
General to promulgate regulations that authorize long-term care
facilities to dispose of pharmaceutical controlled substances
on behalf of their patients who are ultimate users. This
provision is necessary because nursing homes and other long-
term care facilities often come into possession of controlled
substances that are no longer needed or used by the patients
for whom they are prescribed.
1359 is straightforward and establishes the necessary
framework to address this issue through DEA's rulemaking
process. DEA regulations would be implemented uniformly
throughout the Nation and would allow a wide variety of
disposal methods that are consistent with effective controls
against diversion. 1359 would also give DEA the flexibility to
allow by regulation new methods of disposal if and when they
are developed in the future.
In conclusion, the collection, removal, and safe disposal
of unwanted or unused medications from households and long-term
care facilities will eliminate the potential avenue of drug
diversion, limit the availability of medications to drug
seekers and abusers, and decrease the potential for accidental
ingestion and poisoning.
We look forward to working with Congress to establish a
solid foundation for take-back disposal programs that minimize
any potential avenue for diversion while protecting the public
health and safety.
I thank the committee for the opportunity to appear today
and welcome any questions you may have.
[The prepared statement of Mr. Rannazzisi follows:]
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The Chairman. Thank you, Mr. Rannazzisi.
We will now hear from Ms. Hendrickson.
STATEMENT OF MARY HENDRICKSON, PHARM.D., DIRECTOR OF QUALITY
AND REGULATORY AFFAIRS, GENCO PHARMACEUTICAL SERVICES,
MILWAUKEE, WI
Dr. Hendrickson. Thank you, Chairman Kohl, Ranking Member
Corker, and Senator Collins for holding this important hearing
on prescription drug disposal. I appreciate the opportunity to
provide this testimony today representing Genco Pharmaceutical
Services.
As a pharmacist, I have been a witness to the surplus of
unused medications in long-term care facilities, as well as
witnessed the destruction method utilized. Many facilities have
limited resources to destroy product and may not be familiar
with the best standards of practice or environmental
regulations for discarding pharmaceuticals.
I have also observed unused medications in people's homes
within the general population. Unfortunately, as we know, in
some instances, these unused medications can fall into the
wrong hands, creating situations of misuse, abuse, and
accidental poisonings.
After working in reverse pharmaceutical distribution, I
have a very different perspective of how unused medications can
be managed. Currently, the reverse pharmaceutical industry
receives unused product, including controlled substances, from
other business entities such as pharmacies and drug
wholesalers.
After the product is processed, an environmentally
responsible destruction method is utilized. The product is
segregated into nonhazardous or hazardous waste and is sent to
incineration. Over 90 percent of the waste that we generate is
nonhazardous and is shipped to a waste energy facility. The
product combustion process generates steam, which spins
turbines, resulting in the generation of electricity.
Reverse pharmaceutical distribution is an extremely
regulated industry, inherently making the process not only more
complicated, but it also produces an industry with a high level
of safety, security, and accountability. Reverse distributors'
core business function is drug take-back, but primarily from
other business entities as opposed to consumers.
Our primary barrier to entry into consumer take-back is the
Controlled Substances Act, or CSA, as this act only allows for
transfer of controlled substances among DEA registrants. Since
patients are not DEA registrants, we cannot accept these
products from patients, with only a few exceptions, which I
will present.
The cost of consumer take-back has also been considered a
potential barrier to a successful program. However, we believe
that a resolution may exist, based on multiple customer
requests we have had for a program, including from large
pharmacy chains and manufacturers.
Consumer take-back is not new to us. In 2008, we conducted
a small feasibility pilot to determine if consumers in two
counties in Wisconsin would utilize a ship-back program for
their unused medications, except for controlled substances. We
ended the test program after 6 months but determined that
consumers would utilize this method, as we received over 15,000
medication returns during this time.
Despite the numerous requests we have received to manage
consumer take-back, we have not continued a program. While we
did our best to educate individuals on the definition of
controlled substances, we found that consumers still
incorrectly sent these products to us.
We reported receipt of that product to DEA, however ended
our program as a result to ensure that we were compliant with
the CSA. Our discontinuation of this program puts us at a
disadvantage to those operating other prescription take-back
programs that allow consumers to send back their unused or
expired medications.
Despite the challenges with the CSA for consumer returns,
the DEA has been very helpful in providing some clarifications
or variances to reverse distributors. First, a clarification
provided by the DEA to us for take-back of one particular
controlled substance with the trade name Actiq was questioned.
The dangerous--the appearance of the product, along with it
being a powerful narcotic, make it potentially dangerous to
children. In the clarification, we learned that we could accept
consumer returns for this product since we are the
manufacturer's agent.
The second clarification mentioned and currently used is
for reverse distributors and manufacturers to receive
controlled substances from non-DEA registrants in the event of
a patient-level recall.
Third, a variance was provided by the DEA, although not
widely used at the time it was issued, as an exemption for
reverse distributors to accept controlled substances from long-
term care facilities located in the State of Kentucky. As a
result of these clarifications, we are allowed to take back
controlled substances from non-DEA registrants, but only in a
very limited circumstance. We would welcome the opportunity to
expand our part in take- back of unused consumer product.
To finalize, our primary recommendation is a change to the
Controlled Substances Act to allow for take-back of controlled
substances from non-DEA registrants. Reverse distributors' core
business function essentially is drug take-back, and we have
systems in place to adhere to the highly regulated industry,
plus use an environmentally safe method to dispose of
medications.
To close, we recognize the significant problem of unused
consumer medications in the U.S. We believe with changes to the
Controlled Substances Act, Genco, along with our customers and
other reverse distributors, can have a significant impact on
reducing the unused medications in homes across the U.S. As a
result, we anticipate the occurrence and prevalence rates of
misuse, abuse, and accidental poisonings from prescription
products will decrease.
Finally, we also believe that it will minimize the
contribution of pharmaceutical contamination in our
environment.
Thank you for holding this hearing. I look forward to your
questions.
[The prepared statement of Dr. Hendrickson follows:]
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The Chairman. Thank you, Dr. Hendrickson.
Mr. Strain.
STATEMENT OF BERNARD STRAIN, FATHER OF TIMOTHY MICHAEL STRAIN,
PHILADELPHIA, PA
Mr. Strain. Yes. Good afternoon, Chairman Kohl, Senator
Corker, my friend and Senator Casey from Pennsylvania, Senator
Collins, and members of the committee.
My name is Bernie Strain. I am 52 years old, a lifelong
Philadelphian. For 28 years, I have been married to Beverly,
who is here today.
We had three wonderful sons together. Brian, 27, is serving
our country as a sergeant in the United States Air Force. He
has served several tours overseas, one in the sands of Iraq.
Andrew, 23, a recent Penn State grad who put himself through
that great school.
Our third son, Timothy Michael Strain, was 18 years of age
at his untimely and tragic death. Tim was soon to attend
college. Early in 2009, while working to put money away for
college, he severely burned his hand on a lawn mower, after
touching the muffler.
He was treated by a doctor and then seen at St.
Christopher's Hospital in the Philadelphia burn unit. He was
prescribed pain medication and scheduled for skin grafts.
Time went by, and while at his girlfriend's mother's home,
he complained of continuing severe pain in his hand. The
mother, who was arrested for this act, gave him medication--
methadone--from her own medicine cabinet.
The mixture of drugs that were in his system killed our son
that night. Timothy Michael Strain--charming, good-looking,
great athlete--was dead.
Months passed, and a news article was published in the
Philadelphia Daily News. The article was about the tragic way
our son Timmy died. After reading that newspaper article,
Beverly and I wondered how medications are routinely disposed
of, as well as the incidence of misuse of prescription drugs.
Our questioning led us to realize that there are drugs in
many of our homes that are unused and outdated. If we can
dispose of cans, bottles, batteries, paint, oil properly, why
can't we responsibly dispose of unused and outdated medication
that could be possibly lethal?
The same newspaper article caught the attention of an
environmental educator in Illinois. Paul Ritter, in my opinion,
should be teacher of the century. Paul and his students
developed the P2D2 program. This is a prescription drug give-
back program.
Paul called my wife and I on one of our darkest days
following the funeral of our youngest son. We never thought
that this could happen to us. It was always somebody else's
child pictured on that T-shirt with the words ``rest in
peace.'' Paul had the answers to all of our questions. He has
since become a dear friend following the night he called us and
offered his sympathy.
One phone call initiated a new direction in our lives, to
try to turn lemons into lemonade. With his experience and
knowledge, he introduced us to Gail and David Katz. They, too,
lost a son to prescription drug medication. Gail and David
started Save a Star Foundation in honor of their son Daniel.
Soon we were on our way to see how we were going to try to save
a child, a senior citizen, or one other potential victim.
Mr. Chairman, you are aware that on May 24th, our Tim's
birthday, a resolution was passed in the U.S. Senate, calling
on all 50 States to start thinking about the issue regarding
how properly to dispose of unused medications. Last week, in
the city of Philadelphia, through a resolution that was passed
in the City Council, called on our city of the first class.
Councilwoman Blondell Reynolds Brown introduced the
resolution and cosponsored by council members Tasco, Green, and
Jones. Through the District Attorney Seth Williams and Mayor
Michael Nutter, we will soon have a program in place. We will
develop a give-back program where our citizens can properly
dispose of our medication and not dump them into the water,
which is common practice, or simply throw them in the trash.
According to our water department, there are 50 plus
pharmaceuticals in our drinking water. More people die in the
United States from legal prescription drugs than from illegal
drug use. It is our intent to save another life. It may be a
member of your family.
If this legislation is passed, I respectfully ask you to
consider naming this ``Timmy's Law'' in honor of our wonderful
son.
In closing, I would ask all of the members of this
committee to tell your children and family members that you
love them before you leave each day to serve our great Nation.
As I left that fateful day to serve the citizens of
Pennsylvania, I received that devastating phone call on my way
to work that Timmy was dead. You just never know.
My wife and I are most sincere and dedicated to this cause,
as you can see by us driving here today. Our two other sons,
Brian and Andrew, are helping us with this effort as well and
hoping to make a positive difference in our neighborhoods,
city, and the Nation while preserving the memory of our beloved
son, Timothy Michael Strain, as well as trying to save just one
other life.
Thank you.
[The prepared statement of Mr. Strain follows:]
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The Chairman. Thank you very much, Mr. Strain.
Mr. Strain. Thank you.
The Chairman. Dr. Gressitt?
STATEMENT OF STEVAN GRESSITT, M.D., FOUNDING DIRECTOR, MAINE
INSTITUTE FOR SAFE MEDICINE, FACULTY ASSOCIATE, UNIVERSITY OF
MAINE, CENTER ON AGING, UNITY, ME AND ASSOCIATE PROFESSOR OF
CLINICAL PSYCHIATRY, UNIVERSITY OF NEW ENGLAND COLLEGE OF
OSTEOPATHIC MEDICINE
Dr. Gressitt. Good afternoon, Senator Kohl, Senator Corker,
Senator Collins, and members of the Special Committee on Aging.
I am Dr. Stevan Gressitt, Founding Director of the Maine
Institute for Safe Medicine. I am the co-principal investigator
on a U.S. EPA grant that tested the concept of using the U.S.
mail to remove unused and unwanted medication from the
community. Our final report is attached to my written
testimony.
Thank you for the opportunity to outline what we
accomplished and sketch some of our findings and proposals.
Today, virtually every home in America has unused medicine
like OxyContin, Valium, and antibiotics in the medicine
cabinet, and they are a hazard. After reviewing a number of
drug abuse prevention programs, we realized none of them were
actually removing a single tablet from harm's way.
We researched Federal agency rules and regulations and
found that if our Maine Drug Enforcement Agency was explicitly
responsible in State law that we might be able to use the mail
to have consumers dispose of their medication directly. We
wanted the easiest, simplest, 24-7 process, and mailboxes are
always open for deposit.
State legislation passed in 2005 included facilitation of
consumer unused medication into the scope of our Maine Drug
Enforcement Agency. Special agreements were made between the
Maine DEA, the U.S. DEA, and the United States Postal Service.
We are unaware of any other State that has taken this one
crucial step. We received the U.S. EPA grant in 2007.
The mail-back program is simple for the consumer, who can
request an approved, prepaid mailer from any of over 100
pharmacy sites across the State. The mailer includes
instructions and an utterly elective survey form. Unused
medication is put into the envelope and dropped in the mail.
The mailer is delivered to a post office box owned by the
Maine Drug Enforcement Agency. I have brought a few mailers for
your inspection. We have achieved a 43 percent return rate on
these mailers. Demand for mailers is escalating as more is
written about the problem of unused drug disposal.
The three most commonly returned types are central nervous
system drugs, which include the opiates; cardiovascular drugs,
hypertension medications; and then psychotherapeutics, which
include benzodiazepines, antidepressants, antipsychotics.
Seventeen percent of the returns are controlled drugs.
We have received drugs over 50 years old, old tonics
containing chloroform, completely unused 1,000-milligram
morphine pump cartridges. Approximately 50 percent of what was
returned had little environmental impact data available for us
to use. A review of waste in Maine resulted in a limit to 15-
day first prescriptions for three groups of drugs for Medicaid
recipients.
Adherence and compliance are up as a direct result of this
policy, which not only reduces waste, but brings more attention
to adherence or unacceptable side effects. We have removed over
a ton of drugs from harm's way, whether that is defined as harm
from abuse, diversion, resale, or environmental impact.
There are several additional immediate needed contributions
that Congress can make beside funding that would enhance a drug
disposal process or processes. One, enabling legislation for
the United States Drug Enforcement Administration to promulgate
regulations or rules to facilitate more drug return programs
safely and of various different formats, as ONDCP has
recommended.
No. 2, enabling legislation for the United States Postal
Service to more readily expand availability of their services
to the consumers of the country.
Three, support for a national resource and research center
on drug disposal. One is needed for the dissemination of best
practices, evaluation of evidence, policy, and to help advise
on further pilots based on what has become a significant and
substantial amount of work done to date all across the country
and frequently without much support.
Thank you for this opportunity, to describe our efforts and
I will try and answer any questions that you may have.
[The prepared statement of Dr. Gressitt follows:]
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The Chairman. Thank you very much, Dr. Gressitt.
Mr. Behringer.
STATEMENT OF BRUCE BEHRINGER, ASSOCIATE VICE PRESIDENT AND
EXECUTIVE DIRECTOR, OFFICE OF RURAL AND COMMUNITY HEALTH AND
COMMUNITY PARTNERSHIPS, EAST TENNESSEE STATE UNIVERSITY,
JOHNSON CITY, TN
Mr. Behringer. Thank you, Senators, and thank you, Senator
Corker, for the kind comments about our E.T.S.U. College of
Pharmacy.
I don't want to read the testimony, but I would like to
make a few comments that would reinforce, Senator Kohl, the
themes that you identified. I do not want to say anything that
would denigrate the area in which I live. I think, though, that
the State of Tennessee has the unfortunate ranking of being
first or second among all States over the course of the last
four years in the number of prescriptions per person dispensed.
I think that part of the issue that we are dealing with is a
volume issue, so many prescription medications, including
controlled substances, being in the hands and on the streets
and in the medicine cabinets all across the State.
Substance abuse has been explained to me as having an
amoeba- like characteristics and is very complicated. It keeps
moving and changing form. Unfortunately, it has moved in the
direction of controlled substances and medications in our area.
One of the true indicators of the movement was from a group of
communities that we pulled together from rural Appalachia, and
we asked them to talk to us about what their issues were. We
thought it was methamphetamine, and this is back in 2006 when
you will remember there was a huge campaign against
methamphetamine.
They started by saying, yes, that is a problem. But we need
to think about substance abuse as the broader problem. Then, by
the end of this conference sponsored by the Appalachian
Regional Commission, they said, no, that is not it. The real
issue is the culture of substance use that we have in our
country. It is not just in the mountains. It is not just in
Tennessee. It is all across the country.
Patients expect prescriptions in order to have a successful
encounter with a health professional. There is a pill for every
ill nowadays, and the pharmaceutical companies have gotten so
much better and effective in giving relief in a better, a
stronger, and a faster way. So there are many legally
prescribed medications that are sitting, unfortunately, unused
because, as you have said, people have a tendency to horde
things. They are very expensive, and they would rather save
them for another day if, in fact, they are needed.
We also need to recognize that the State of Tennessee is
bordered by eight other States. We have a number of people who
may be seeking medications across State borders. Right now, we
have very limited ways of knowing about that. We also have
people who, unfortunately, find pill mills in other States and
get on airplanes, go there, bring the pills back.
We have had a series of very unfortunate circumstances in
our region that are on the front page of the paper on a regular
basis about people who have had pills confiscated or they have
been arrested, or actually have been involved in murders. It
has been a very, very dangerous situation.
What I did want to say is I had the honor of teaching a
Health Disparities in Appalachia course in our College of
Pharmacy. These pharmacy students, are the next generation of
people who are going to be on the front line. They came up with
a set of three recommendations after they looked at the
prescription medication problem.
The first one is that we need a balanced educational
program, one which helps to teach physicians not just what the
right drug is to prescribe, but also the signs of addiction.
Pharmacists need to be taught about medication management and
counseling. Patients need to be taught about not misusing pills
and never, ever giving pills to somebody else.
General public needs to understand how dangerous this
situation really is, that it affects everybody. The elderly are
petrified in many communities if they have prescription drugs,
and they are thinking that somebody may come to get them.
Secondly, the pharmacy students found out that not all
prescribers and not all dispensers are actually using the
prescription medication monitoring programs in the different
States. I think that you, from this committee, could make a
very strong moral case that this is a horrible issue in this
country. You have put money forth to help States to create
those registries, and you should encourage all physicians,
encourage all organizations and all pharmacists to use those
registries because they will help to save lives.
Finally, our pharmacy students went out into the community
as part of take-back programs, and they learned how communities
really do want to be helpful. What they really need is
something to pull them together to make them aware of the
situation, and the take-back programs that have been sponsored
in northeast Tennessee have done that. They have found pill
bottles going back 35 years ago that people will turn back if
given the opportunity.
So I do encourage the committee as strongly as possible to
take the high road in encouraging all of us to consider that
this is a problem for the Nation, and it is a problem in our
communities, and it is a problem in our families. To encourage
us to think about it as something that we should all contribute
to the solution of.
[The prepared statement of Mr. Behringer follows:]
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The Chairman. Thank you very much, Mr. Behringer.
Mr. Rannazzisi, we understand that there is going to be a
nationwide day of disposal later this year for Americans who
want to do away with their leftover drugs. Can you tell us
something about that plan that you are putting together and
what you hope to achieve and how it is going to be publicized?
Mr. Rannazzisi. Yes, sir. Well, we are planning a
nationwide take-back day. We are working out the details. Right
now, it would be premature for me to announce it, but we will
have a nationwide take-back day.
It will be done in cooperation and in coordination with our
law enforcement partners, community groups, coalitions. It will
be--we should have media play throughout the country and
locally for this day, and we would like a very strong turnout.
But at this point in time, I can't give you any more detail
than that.
The Chairman. Mr. Rannazzisi, I would like to digress for
just a minute to take up a single question, no more than that.
In an appearance that you made before our committee in March on
dispensing of prescription drugs in nursing homes, at that
time, you heard testimony about the problem of identifying and
treating nursing home residents who are in extreme pain and
treating them with their needed drugs in a timely manner.
According to other witnesses, your agency's stepped-up
enforcement policies were causing serious documented problems
in the delivery of these pain-relieving drugs to elderly
patients who were badly in need of them. By the end of that
hearing, it seemed that we were well on our way to a compromise
between DEA and the nursing home industry.
However, it wasn't until just yesterday that DEA issued a
solicitation in the Federal Register asking for information
from interested parties concerning this pain medication issue.
This is the first that we have heard from DEA since your
testimony back in March.
So I was hopeful that our hearing back then and the urgency
of the issue as it played out in that hearing was going to
result in some rather immediate kind of dialog and compromise
between you and the nursing home industry. Can you tell us
where we are and how we are going to get where I believe we all
want to get and as soon as possible?
Mr. Rannazzisi. Yes, sir. I believe when we left that
hearing, the National Association of Boards of Pharmacy had
recommended that the nursing homes obtain State registration,
State controlled substance registration and authority. At that
point in time, DEA would look to providing them or authorizing
them with a controlled substance registration so they could
change the way they are doing their business right now.
We have been in contact with the Ohio Board of Pharmacy on
numerous occasions, providing technical assistance. Ohio Board
of Pharmacy is taking the lead in creating regulations. They
are working with other States in the National Association of
Boards of Pharmacy to create pattern regulations for the other
States to move forward with State authorization for controlled
substances.
That advance notice that was sent out yesterday is to
provide more information to us so when the time comes and when
we do start receiving the State authorizations for long-term
care facilities, we will be prepared to issue their
registrations. It is just background information on what the
long-term care facilities are doing and how changes within
their structure of how they are doing business we can
incorporate into what we are trying to do.
The Chairman. How long will this process be playing itself
out?
Mr. Rannazzisi. Well, again, I could only move as quickly
as the States do. The authority that I could provide is based
on the State controlled substance authority. Now I know that
the State of Ohio is moving forward very quickly but cautiously
because they want to make sure if their regulations are being
used as a pattern regulation for other States, they want to
make sure it is correct.
But I could assure you that we are providing all the
technical information necessary to help them create those regs.
As soon as we have that first reg in place, we will move
forward quickly.
The Chairman. Of course, there is always the danger in a
situation like this that 6 months from now and a year from now
we will still be talking about it. As you could imagine, we are
trying to move as quickly as we can to alleviate a serious
problem. Can you say anything by way of aid and comfort today?
Mr. Rannazzisi. I would like to tell you that the Ohio
Board of Pharmacy is moving as fast as they can, and I believe
that the individuals who are working on that reg in the Ohio
Board of Pharmacy are reaching out to the other States, and
they want to get a reg in place as quickly as possible because,
let us face it, Ohio especially, there are many problems in
Ohio. I believe Ohio is what kind of triggered a lot of the
problems throughout the United States.
So they are trying to move forward. The Ohio board
president, William Winsley, has taken a personal active role in
creating these regs. So knowing Mr. Winsley the way I know him,
I am sure that they will move forward as quickly as possible. I
could assure you that once we get the regs, we will move
forward as quickly as possible.
The Chairman. All right. If it is all right with you, we
will be in contact with you on a regular basis to see how we
are doing?
Mr. Rannazzisi. Yes, sir.
The Chairman. Thank you so much.
Dr. Hendrickson, you mentioned in your testimony that
people wishing to dispose of prescription drugs find the
process of separating controlled or noncontrolled products to
be confusing. Except for a change in the law, how can we better
educate people about the existing rules and how to properly
separate their medications?
Dr. Hendrickson. I think that could be through multiple
different efforts. When we conducted our program, we educated
people through having them call a 1-800 number. So that allowed
us to provide feedback to them on the definition of a
controlled substance, but then also what types of categories
were within the controlled substance. So we said pain
medications, sleep medications.
We also had someone available to answer questions, if they
had a specific question about alprazolam a controlled
substance? In addition to that, we followed up with written
information when we sent out the mailer or the shipping
materials for the product to be sent back to us.
So I think in general, through multiple different media
methods--verbal, as well as written--would be helpful.
The Chairman. All right. Senator Corker?
Senator Corker. Thank you, Mr. Chairman.
First, I want to tell Mr. Strain that his testimony was
very moving. I thank him and his wife for having the courage to
be here today and taking the time and effort to be here. I
thank you very much.
Dr. Hendrickson, just to follow up on the last question, I
mean, wouldn't it be simple just to label these things when
they were prescribed so people don't have to go to the effort
of making calls and doing all of that?
Dr. Hendrickson. They are actually labeled. There is a
label that says Federal law prohibits transferring this to
someone else other than who it is written for. That actually is
labeled on prescription medications.
In my experience as a pharmacist, people struggle even with
the directions on how to take their medication in the right
times or the right dosage. They especially don't seem to read
some of the warnings that are also on the prescription
container.
Senator Corker. So them calling is even more difficult,
right?
Dr. Hendrickson. I think it provides added education to
them. It is an additional reinforcement method that we
utilized.
Senator Corker. Yes.
Dr. Hendrickson. I think it certainly prevented medications
from coming back based on the questions that we had. So when we
educated people, we found that they were asking questions and
understood that they couldn't take things back. So it did
certainly prevent instances of controlled substances coming
back, that additional education.
Senator Corker. Thank you.
Mr. Behringer, you mentioned registries. Would you mind
explaining to me how that works exactly?
Mr. Behringer. The prescription monitoring programs that
have been established across the country in each State would
enable a prescriber--a physician, nurse practitioner, a
dentist--as well as the dispenser, the pharmacist, to check
through a database whether or not that same type of medication
had been prescribed sometime in the past.
Those registries are there to enable two things. No. 1,
they would enable a physician to figure out whether or not some
other physician had prescribed something that would be either
the same or something that might counteract with the
pharmaceutical which he or she would want to prescribe. So it
is a safety measure to enable a physician to know everything
that that patient is taking.
The second thing it would do, obviously, is if a physician
or a prescriber were to check the database and find out
somebody had just been to another physician last week or the
week before and got the same medication, it might give an
indication that they probably would not want to write that
prescription.
Senator Corker. What is the status of registries right now?
Mr. Behringer. I believe there are registries in all 50
States now and that not everybody is using them, which is the
problem.
Senator Corker. Right.
Mr. Rannazzisi. If I may jump in, sir?
Senator Corker. Sure.
Mr. Rannazzisi. I think what Mr. Behringer is referring to
is the prescription drug monitoring programs. I believe there
are about 38 States currently either in process or have
programs up and operational. They are exactly what he said. The
doctor could go to the monitoring program database and look and
see if a patient has visited any doctor, any other doctor for
the same ailment, requesting the same drugs.
Kentucky, Tennessee, Indiana, many States have up and
operational programs--Ohio--that are very, very good when
utilized. If they are not utilized, though, it is a waste of
time.
Senator Corker. So, based on your own experience, Mr.
Behringer, the registry use in Tennessee and surrounding
States, is it high? Is it not high? So, basically, today it
doesn't work. So how do you make the registry be robust and
used by people on a daily basis so it is effective?
Mr. Behringer. No. 1, physicians and--prescribers and
dispensers need to be assured that it is legal to do so, and I
believe that it is legal. Perhaps the associations can help
them, the professional associations help them to understand
that this is something that is legal to do within the framework
of the law.
No. 2, the registries have to be made timely so that if a
prescriber were to want to check on it, that they would be able
to get the most up to date information necessary for that
prescription--for them to write the prescription.
No. 3, there have to be either company, corporate or
organizational policies that not only encourage, but require
prescribers and dispensers to use them. There are some
companies that are just saying it is too timely. It is not
efficient. We can't afford to do this at this point in time.
I think that if this is a national issue, your attention to
ensuring that all States are participating in this and that
funding for these prescription monitoring programs that you
have provided in the past may be able to be expanded to ensure
that all those who would use them feel comfortable that they
are getting the right information at the right time, that they
are helping from a safety standpoint with some patients, and
they are helping to deter other patients from receiving the
medications they shouldn't get.
Senator Corker. How much effort is there for companies to
actually use these, and how does that bump up against all the
HIPAA regulations regarding privacy and that kind of thing?
Mr. Behringer. I believe the HIPAA regulations have been
taken care of. It is basically an additional step that someone
would take, just as if you were to have an electronic medical
record, and you would go into that person's record. This is a
much broader record, and it takes some time to access it
through the computer. It takes some time for the response in
the computer. Things need to be made in a more timely fashion
in order to be efficient.
But I think the intention should be that we as patients and
we as the public need some degree of protection. As long as--we
can check anything on the Internet nowadays. As long as it is
made efficient and as long as there is an intention that that
should be used and the expectation is that it should be used,
then all those companies that are involved or those prescribers
should pick this up as part of their policy.
Senator Corker. Mr. Chairman, thank you.
If you don't mind, I might let the gentleman go ahead.
Mr. Rannazzisi. There are two funding mechanisms for
prescription drug monitoring programs. One is the Harold Rogers
grant program out of the Appropriations Committee. The other
one is the NASPA program. Both fund, continue to fund
prescription drug monitoring programs throughout the country.
As Mr. Behringer said, it is getting the doctors to use it.
Now every State has a program tailored to their specific
needs. There is not a uniform method of creating these
programs. Every State does something different, and I believe
the States try and tailor their programs to what is happening
within their State. Some States don't have all controlled
substances, but most of the States, the requirement is for the
pharmacies, once the prescription has been dispensed, to send
that prescription information into the State whatever
regulatory agency or law enforcement agency is controlling it.
So they could submit it into the overall database.
It works very well when utilized. But as Mr. Behringer
said, it must be utilized in order for us to reap the benefits
of it. Thus far, I don't believe it is widely utilized.
Senator Corker. I guess if you are in a State like
Tennessee with eight bordering States and each State having its
own protocol, that is semi-problematic, right?
Mr. Rannazzisi. Yes, sir. But Tennessee, Ohio, Kentucky,
and Indiana have very aggressive programs, and the regulatory
boards and law enforcement agencies work very closely in those
States to ensure that information obtained by the doctors--from
the doctors and from the pharmacies, when necessary, is acted
upon.
Senator Corker. I thank all of you for your testimony and
for being here and, Mr. Chairman, for having this hearing.
Thank you.
The Chairman. Thank you, Senator Corker.
Senator Casey.
Senator Casey. Mr. Chairman, thank you.
I want to thank you, first of all, for your leadership on
this issue and for convening this hearing because every day of
the week, both Chairman Kohl and Senator Corker and I know that
we can have hearings on lots of subjects, and they are all
important in one way or another, but often they tend to be
broader and more general. They give us information, but they
don't necessarily lead to a strategy to create and develop
legislation.
Today is an exception to that. Chairman Kohl has called a
hearing where we have a very specific and urgent problem, and
we are getting very specific and detailed advice not based upon
theory, but based upon trial and error and practice and,
unfortunately, springing in many cases from tragedy.
That leads me to, first of all, apologize for being late. I
was going to give a more formal introduction of Bernie Strain,
who is an old friend of mine. But it probably worked out better
because he speaks very well for himself, as he always has. I am
grateful, Bernie, you are here, grateful for your witness.
We know that in Washington, we often have, as we do today,
all of our witnesses bring experience and learning and passion
to these issues. It is especially significant when someone
brings their own personal story, as Bernie Strain did today. So
we are grateful that he is here. We are grateful that he shared
this story, Timothy's story.
But he is worthy of special commendation that he is willing
to put his own story on the record and from his own tragedy to
give us information and I think inspiration to solve this
problem.
I wanted to start with Bernie, and I want to get to
everyone, each of our five witnesses. But I wanted to ask
Bernie Strain about, as you have learned about this problem in
the aftermath of Timmy's death--and you and I have spoken about
this somewhat, but not at length--about the strategies or the
programs that you have seen in practice or that you have read
about or learned about that you think work particularly well. I
know we have examples here, and I want to hear from other
witnesses.
But what is your sense of how this would work best,
especially on a national scale?
Mr. Strain. Senator, thank you for the kind words. Once
again, I would like to thank my wife, Beverly, for joining me
as well.
Senator, this problem, as well as a lot of the problems in
the United States, will not be solved with one program. This
problem will be solved with a mix of Senator Collins's program
in Maine, Senator Corker's program in Maine, and many of the
other programs that were spoken about here today. But in this
case and in my case, engaging the youth in a program, and that
is why I often say the P2D2 program.
It is rare we bring our youth into the decisionmaking
process. Until the youth take ownership of this problem and/or
problems, being on the environmental side, as well as the drug
problem side, the law enforcement side, until our youth take
ownership in this program and when our youth take ownership in
this program, they will help mold that program that will work.
When I mention the P2D2 program, and you can check it on
their Web site, but it is a program where the youth is involved
in the creation of this program, as well as the implementation
of this program. So when they take ownership in their studies
and their environmental impact--and it is a twofold problem,
where it is environmental as well as drugs. But until they take
ownership and when they take ownership, Senator, I think the
world and our country will be a better place.
So with the program that I often mention, like I said,
there are other programs that are out there. It is a program
that is a drug give-back program. But it is also in September,
we, as in the school that Timmy attended, will bring the P2D2
program on an educational side of things into the school.
Timmy attended a Philadelphia school that was environmental
friendly. The school is the Walter B. Saul school, and they
call it the ``farm school.'' Yes, Senator, there is a farm
school in the city of Philadelphia, and they often win prizes
in the State farm show, as you know.
But it is with bringing that program into those schools,
where Saul can Skype the school in Illinois, and it is the
continuing education process that will make this program and
other programs take effect and give them a responsibility to
get involved in this program or a program.
Senator Casey. I think that education part of this is
vitally important because this is not a problem that you see on
the front page every day, as you all know. So that part of it
is going to be a challenge.
I guess one of the challenges that I am trying to wrestle
with here is how best to do this if we can do something at the
national level. Sometimes the Federal Government does too much.
We try to have one program, one-size-fits-all, too prescriptive
where States and even jurisdictions smaller than a State
already have a strategy figured out, and they basically say
don't get in our way. Just give us some help, and we have it
pretty well taken care of.
I guess I wanted to get some guidance. I noticed in the
testimony, Dr. Gressitt, that you gave on page 4, when you
highlighted the goals for the Maine program, you said--and I
will read them quickly--``devise, implement, and evaluate a
mail-back plan.'' That is obviously central to it. ``Dispose of
the medications in compliance with the law.'' Then, third, ``to
test the educational campaign.'' What I am wondering about from
you, and I will start with you--and I know I am a little over
time; I will be quick--as well as others, how do you see this
playing out on the national level? Do you think it is best to
have State programs in place as they see fit or with Federal
help? Or do you think there needs to be a more national
standard or, at a minimum, national goals?
Dr. Gressitt. Thank you, Mr. Casey.
I believe that if the DEA can set some national standards
and regulations and rules which help stop the diversion, stop
the resale, and maintain a safe system, both States and
commercial entities or DEA or ONDCP can lead forward. I don't
believe there--as Mr. Strain has said, I don't believe there is
going to be one size that fits all. But at this point, we need
at least some authorization and ability across the country in
order to move forward, at all.
If the mail-back program--the mail-back program that we did
was originally designed to be replicable, and we have held
that. So that replication, done with due regard to DEA
concerns, I think can stand on its own. But that is not the
only way.
Community take-backs and some drop boxes are certainly
available. I know Mary Hendrickson may have some thoughts on
that as well.
Senator Casey. I won't ask another question. Maybe one
more, and then I want to make sure Chairman Kohl has his time
for questions. Anybody else on this issue before we move on?
Dr. Hendrickson. I would also like to add obviously or add
upon what Dr. Gressitt said. So federally, obviously, the
changes with the Controlled Substances Act, but also the one
other item would be at a State level, as federally funded RCRA,
Resource Conservation Recovery Act, household waste would be
exempt. However, there are State agencies that regulate this
potentially a little bit more strict.
So I think it would need to be a combination. Our biggest--
or the biggest issue for us is obviously the Controlled
Substances Act also federally.
Dr. Gressitt. If I could add a footnote to mine?
Senator Casey. Sure.
Dr. Gressitt. What Mary just said brought strikingly back,
the cost of disposal can be very different in different states
because of state variability in control. If the Federal
Government could help with ensuring that those costs don't
skyrocket, that would be another element that would be helpful.
Senator Casey. Thank you very much.
The Chairman. Thank you.
Dr. Gressitt, Maine's medication program, as you know so
well, has instituted a policy limiting initial prescriptions of
certain drugs to 15 days as a way to combat waste. How is this
program working?
Dr. Gressitt. Three classes of drugs were selected by
MaineCare--opiates, second-generation antipsychotics, and
second-generation antidepressants. The information was
announced to the providers in the State, and although there was
some trepidation, the feedback I got--at that time I was the
medical director for the State for the office of Adult Mental
Health. The feedback I got from the other physicians in the
State was, you know what, this is just good common sense.
Then one of the members of the Maine Psych Association came
up to me and said, ``you know, it is such a good idea. This
isn't just going to be for MaineCare. It is every insurer.'' So
regardless of who the insurer was, she made a personal decision
that she would adhere to a shorter first prescription as a
general good clinical practice.
I would say that is where the success is. I would say that
having a check at 15 days to look at adherence and side effects
is important, unless--aware I am a doctor, I am not an
accountant--what the actual dollars are as far as savings.
The Chairman. All right. Dr. Hendrickson, what is the
environmental impact of drug incineration?
Dr. Hendrickson. It would depend on whether it is hazardous
or nonhazardous product. Ultimately, both products end up to be
incinerated. There is out of all methods of destruction,
incineration would be the most environmentally friendly.
I could not speak to the specifics of the outcome of the
steam-generated. Ultimately, the environmental impact, though,
of our product that is nonhazardous that is incinerated is
actually generation of electricity and a reduction in the need
for the use of coal or other energy sources in that instance.
The Chairman. Mm-hmm. Mr. Strain, is there some advice or
counsel you would offer parents around the country with respect
to attempting to prevent the tragedy that occurred in your
family?
Mr. Strain. Senator, if you have about 4 hours today and
this committee has 4 hours, I would love to go over steps from
raising a child. Like I said, I have a son in the United States
Air Force. I have had a son who put himself through Penn State
University. There is no book on raising a child. I don't claim
to have ever read that book or I might not ever claim to write
that book.
But accidents happen. If we could just--there is no--if I
could put it into 5 minutes, it is an event that happened. He
was misadvised on what he was given. He was of age. He was 18
years of age when it did happen. But he was just misadvised, as
well as a lot of these young people are.
They all think he was a weightlifter. He had a football
scholarship. He was the kid next door. These things happen.
Like I said in my testimony that I am trying to make lemons
from lemonade, and it is just a terrible tragic thing that
happened. We will never forget it.
But I will scream to the highest mountain or I will scream
across the deepest sea that every teenager and/or person or
senior citizen, if you put something the size of a dime in your
mouth, it could possibly kill you.
The Chairman. All right.
Bob, do you have anything more?
Senator Casey. Maybe just one. I wanted to get a sense from
those who have a more complete understanding than I do about
what are the barriers to making this an effective national
policy? I mean, obviously, we have got rules on disposal, and
we know how difficult some of those are to navigate and to
surmount or overcome.
But give me a sense of what the biggest and most difficult
barriers are right now.
Mr. Rannazzisi. Yes, sir. If I may start?
Senator Casey. Sure.
Mr. Rannazzisi. The Drug Enforcement Administration's hands
are tied right now because we cannot promulgate a regulation
because the statute is prohibiting us from doing so. 1359 and
the companion bill, 1292 and 3397 in the Senate, will give us
the regulatory flexibility to create a baseline infrastructure
so the States could then fill in, and the municipalities and
the counties, how they want to set up their program.
But we need that statutory authority in order to do that.
That will give us the authority to write regs based on ultimate
users transferring drugs and long-term care facilities
transferring drugs. It will give us the opportunity to create
that baseline infrastructure. But without that, our hands are
tied.
Senator Casey. Anybody else on that specific question?
Dr. Gressitt. Very much so. I would like to simply say I
agree with everything he said. We have bumped into every word
he said several times.
Senator Casey. When you were----
Dr. Gressitt. Many times. It would certainly be helpful
across the country if what he has asked for is, indeed,
implemented sooner than later because regs take time. That time
is a delay, and in that delay will be more deaths.
Senator Casey. Yes, Bernie?
Mr. Strain. Senator, if I might ask, through that
resolution that was passed in the Philadelphia City Council
last week if when they have the hearings, if you could come to
testify at that hearing, we would love to have your expertise
and your testimony with that hearing. But we also would like to
put together a program model after various programs--Senator
Collins's program, mail-back programs.
If we could use that program that we are putting together
in the city of the first class and the city of Philadelphia,
you are aware that the District Attorney in Montgomery County
in Pennsylvania, Risa Ferman, put together a drug give-back
program. So if we can use putting together that model in the
city of Philadelphia, maybe we can carry it across the State of
Pennsylvania.
Senator Casey. Well, thank you. I hope I can be there. I
will check with the schedulers. We always love being in your
great hometown.
Mr. Strain. If you can have your people call our people, we
would appreciate it.
Senator Casey. Thank you. Thanks, Bernie.
Mr. Strain. Thank you.
Senator Casey. Thank you very much, Chairman Kohl.
The Chairman. Thanks, Senator Casey.
We thank you all for being here today. It has been a very
good hearing, informative and important with respect to this
issue that we are dealing with.
Thank you.
[Whereupon, at 3:30 p.m., the hearing was adjourned.]
A P P E N D I X
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