[Senate Hearing 111-711]
[From the U.S. Government Publishing Office]



                                                        S. Hrg. 111-711
 
       DRUG WASTE AND DISPOSAL: WHEN PRESCRIPTIONS BECOME POISON

=======================================================================

                                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



  Available via the World Wide Web: http://www.gpoaccess.gov/congress/
                               index.html
?

                  U.S. GOVERNMENT PRINTING OFFICE
61-708                    WASHINGTON : 2010
-----------------------------------------------------------------------
For sale by the Superintendent of Documents, U.S. Government Printing Office, 
http://bookstore.gpo.gov. For more information, contact the GPO Customer Contact Center, U.S. Government Printing Office. Phone 202ï¿½09512ï¿½091800, or 866ï¿½09512ï¿½091800 (toll-free). E-mail, [email protected].  

                       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)

  
?

                            C O N T E N T S

                              ----------                              
                                                                   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

                              ----------                              --



                        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:]

    [GRAPHIC] [TIFF OMITTED] T1708.001
    
    [GRAPHIC] [TIFF OMITTED] T1708.002
    
    [GRAPHIC] [TIFF OMITTED] T1708.003
    
    [GRAPHIC] [TIFF OMITTED] T1708.004
    
    [GRAPHIC] [TIFF OMITTED] T1708.005
    
    [GRAPHIC] [TIFF OMITTED] T1708.006
    
    [GRAPHIC] [TIFF OMITTED] T1708.007
    
    [GRAPHIC] [TIFF OMITTED] T1708.008
    
    [GRAPHIC] [TIFF OMITTED] T1708.009
    
    [GRAPHIC] [TIFF OMITTED] T1708.010
    
    [GRAPHIC] [TIFF OMITTED] T1708.011
    
    [GRAPHIC] [TIFF OMITTED] T1708.012
    
    [GRAPHIC] [TIFF OMITTED] T1708.013
    
    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:]

    [GRAPHIC] [TIFF OMITTED] T1708.014
    
    [GRAPHIC] [TIFF OMITTED] T1708.015
    
    [GRAPHIC] [TIFF OMITTED] T1708.016
    
    [GRAPHIC] [TIFF OMITTED] T1708.017
    
    [GRAPHIC] [TIFF OMITTED] T1708.018
    
    [GRAPHIC] [TIFF OMITTED] T1708.019
    
    [GRAPHIC] [TIFF OMITTED] T1708.020
    
    [GRAPHIC] [TIFF OMITTED] T1708.021
    
    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:]

    [GRAPHIC] [TIFF OMITTED] T1708.022
    
    [GRAPHIC] [TIFF OMITTED] T1708.023
    
    [GRAPHIC] [TIFF OMITTED] T1708.024
    
    [GRAPHIC] [TIFF OMITTED] T1708.025
    
    [GRAPHIC] [TIFF OMITTED] T1708.026
    
    [GRAPHIC] [TIFF OMITTED] T1708.027
    
    [GRAPHIC] [TIFF OMITTED] T1708.028
    
    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:]

    [GRAPHIC] [TIFF OMITTED] T1708.029
    
    [GRAPHIC] [TIFF OMITTED] T1708.030
    
    [GRAPHIC] [TIFF OMITTED] T1708.031
    
    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:]

    [GRAPHIC] [TIFF OMITTED] T1708.032
    
    [GRAPHIC] [TIFF OMITTED] T1708.033
    
    [GRAPHIC] [TIFF OMITTED] T1708.034
    
    [GRAPHIC] [TIFF OMITTED] T1708.035
    
    [GRAPHIC] [TIFF OMITTED] T1708.036
    
    [GRAPHIC] [TIFF OMITTED] T1708.037
    
    [GRAPHIC] [TIFF OMITTED] T1708.038
    
    [GRAPHIC] [TIFF OMITTED] T1708.039
    
    [GRAPHIC] [TIFF OMITTED] T1708.040
    
    [GRAPHIC] [TIFF OMITTED] T1708.041
    
    [GRAPHIC] [TIFF OMITTED] T1708.042
    
    [GRAPHIC] [TIFF OMITTED] T1708.043
    
    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:]

    [GRAPHIC] [TIFF OMITTED] T1708.044
    
    [GRAPHIC] [TIFF OMITTED] T1708.045
    
    [GRAPHIC] [TIFF OMITTED] T1708.046
    
    [GRAPHIC] [TIFF OMITTED] T1708.047
    
    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

                              ----------                              


[GRAPHIC] [TIFF OMITTED] T1708.048

[GRAPHIC] [TIFF OMITTED] T1708.049

[GRAPHIC] [TIFF OMITTED] T1708.050

[GRAPHIC] [TIFF OMITTED] T1708.051

[GRAPHIC] [TIFF OMITTED] T1708.052

[GRAPHIC] [TIFF OMITTED] T1708.053

[GRAPHIC] [TIFF OMITTED] T1708.054

[GRAPHIC] [TIFF OMITTED] T1708.055

[GRAPHIC] [TIFF OMITTED] T1708.056

[GRAPHIC] [TIFF OMITTED] T1708.057

[GRAPHIC] [TIFF OMITTED] T1708.058

[GRAPHIC] [TIFF OMITTED] T1708.059

[GRAPHIC] [TIFF OMITTED] T1708.060

[GRAPHIC] [TIFF OMITTED] T1708.061

[GRAPHIC] [TIFF OMITTED] T1708.062

[GRAPHIC] [TIFF OMITTED] T1708.063

[GRAPHIC] [TIFF OMITTED] T1708.064

[GRAPHIC] [TIFF OMITTED] T1708.065

[GRAPHIC] [TIFF OMITTED] T1708.066

[GRAPHIC] [TIFF OMITTED] T1708.067

                                 
