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61708– PDF 2010

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 

SPECIAL COMMITTEE ON AGING 

HERB KOHL, Wisconsin, Chairman 

RON WYDEN, Oregon 

BLANCHE L. LINCOLN, Arkansas 

EVAN BAYH, Indiana 

BILL NELSON, Florida 

ROBERT P. CASEY, Jr., Pennsylvania 

CLAIRE McCASKILL, Missouri 

SHELDON WHITEHOUSE, Rhode Island 

MARK UDALL, Colorado 

KIRSTEN GILLIBRAND, New York 

MICHAEL BENNET, Colorado 

ARLEN SPECTER, Pennsylvania 

AL FRANKEN, Minnesota 

BOB CORKER, Tennessee 

RICHARD SHELBY, Alabama 

SUSAN COLLINS, Maine 

GEORGE LeMIEUX, FLORIDA 

ORRIN HATCH, Utah 

SAM BROWNBACK, Kansas 

LINDSEY GRAHAM, South Carolina 

SAXBY CHAMBLISS, Georgia 

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) 

(1) 

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 

2 

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. 

3 

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. 

4 

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 

5 

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. 

20 

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. 

21 

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. 

22 

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 takeback 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 imporVerDate Nov 24 2008 14:03 Nov 18, 2010 Jkt 000000 PO 00000 Frm 00026 Fmt 6633 Sfmt 6633 H:\DOCS\61708.TXT SAG PsN: JOYCE
23 

tant 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 utiVerDate Nov 24 2008 14:03 Nov 18, 2010 Jkt 000000 PO 00000 Frm 00036 Fmt 6633 Sfmt 6633 H:\DOCS\61708.TXT SAG PsN: JOYCE
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lize 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 nonDEA 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 preVerDate Nov 24 2008 14:03 Nov 18, 2010 Jkt 000000 PO 00000 Frm 00045 Fmt 6633 Sfmt 6633 H:\DOCS\61708.TXT SAG PsN: JOYCE
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scription 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 litVerDate Nov 24 2008 14:03 Nov 18, 2010 Jkt 000000 PO 00000 Frm 00050 Fmt 6633 Sfmt 6633 H:\DOCS\61708.TXT SAG PsN: JOYCE
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tle 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 amoebalike 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 arVerDate Nov 24 2008 14:03 Nov 18, 2010 Jkt 000000 PO 00000 Frm 00064 Fmt 6633 Sfmt 6633 H:\DOCS\61708.TXT SAG PsN: JOYCE
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rested, 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 

67 

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. 

68 

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. 

69 

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 

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nies 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 

71 

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 

72 

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? 

73 

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 secondgeneration 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 steamgenerated. 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 

74 

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 

75 

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.] 

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