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S. HRG. 112–175 

RESPONDING TO THE PRESCRIPTION DRUG 

EPIDEMIC: STRATEGIES FOR REDUCING ABUSE, 

MISUSE, DIVERSION, AND FRAUD 

HEARING 

BEFORE THE

SUBCOMMITTEE ON CRIME AND TERRORISM 

OF THE

COMMITTEE ON THE JUDICIARY 

UNITED STATES SENATE 

ONE HUNDRED TWELFTH CONGRESS 

FIRST SESSION 

MAY 24, 2011 

Serial No. J–112–23 

Printed for the use of the Committee on the Judiciary 

( 

(II) 

COMMITTEE ON THE JUDICIARY 

PATRICK J. LEAHY, Vermont, Chairman 

HERB KOHL, Wisconsin 

DIANNE FEINSTEIN, California 

CHUCK SCHUMER, New York 

DICK DURBIN, Illinois 

SHELDON WHITEHOUSE, Rhode Island 

AMY KLOBUCHAR, Minnesota 

AL FRANKEN, Minnesota 

CHRISTOPHER A. COONS, Delaware 

RICHARD BLUMENTHAL, Connecticut 

CHUCK GRASSLEY, Iowa 

ORRIN G. HATCH, Utah 

JON KYL, Arizona 

JEFF SESSIONS, Alabama 

LINDSEY GRAHAM, South Carolina 

JOHN CORNYN, Texas 

MICHAEL S. LEE, Utah 

TOM COBURN, Oklahoma 

BRUCE A. COHEN, Chief Counsel and Staff Director 

KOLAN DAVIS, Republican Chief Counsel and Staff Director 

SUBCOMMITTEE ON CRIME AND TERRORISM

SHELDON WHITEHOUSE, Rhode Island, Chairman 

HERB KOHL, Wisconsin 

DIANNE FEINSTEIN, California 

DICK DURBIN, Illinois 

AMY KLOBUCHAR, Minnesota 

CHRISTOPHER A. COONS, Delaware 

JON KYL, Arizona 

ORRIN G. HATCH, Utah 

JEFF SESSIONS, Alabama 

LINDSEY GRAHAM, South Carolina 

STEPHEN LILLEY, Democratic Chief Counsel 

STEPHEN HIGGINS, Republican Chief Counsel 

(III) 

C O N T E N T S 

STATEMENTS OF COMMITTEE MEMBERS 

Page 

Leahy, Hon. Patrick J., a U.S. Senator from the State of Vermont .................... 176 

Whitehouse, Hon. Sheldon, a U.S. Senator from the State of Rhode Island ...... 1 

WITNESSES 

Brown, Hon. Sherrod, a U.S. Senator from the State of Ohio ............................. 3 

Eadie, John L., Director, Prescription Monitoring Program Center of Excellence, Brandeis University, Waltham, Massaschusetts .................................... 18 

Hosley, Laura, Manager, Community Prevention, Rhode Island Student Assistance Services, Warwick, Rhode Island ......................................................... 16 

Kerlikowske, R. Gil, Director, White House, Office of National Drug Control 

Policy, Washington, DC ....................................................................................... 5 

Leonhart, Michele M., Administrator, Drug Enforcement Administration, 

Washington, DC ................................................................................................... 7 

QUESTIONS AND ANSWERS 

Responses of R. Gil Kerlikowske to questions submitted by Senator Schumer . 27 

Responses of Michele M. Leonhart to questions submitted by Senator Schumer ........................................................................................................................ 32 

SUBMISSIONS FOR THE RECORD 

American Academy of Pain Medicine (AAPM), Perry G. Fine, President, Glenview, Illinois, May 20, 2011 letter ...................................................................... 36 

American Pain Foundation, Scott M. Fishman, President and Chair, Baltimore, MD, May 23, 2011, letter .......................................................................... 39 

American Society of Interventional Pain Physicians (ASIPP), Paducah, Kentucky, statement ................................................................................................... 41 

Casey, Hon. Robert P., Jr., a U.S. Senator from the State of Pennsylvania, 

statement .............................................................................................................. 112 

Chaudhry, Humayun J., President and Chief Executive Officer, Federation 

of State Medical Boards, statement .................................................................... 113 

Dean, General Arthur T., U.S. Army, (retired), Chairman and CEO, Community Anti-Drug Coalitions of America, Alexandria, Virginia, statement ......... 118 

Eadie, John L., Director, Prescription Monitoring Program Center of Excellence, Brandeis University, Waltham, Massaschusetts, statement ................. 137 

Gressitt, Stevan, Founding Director, International Institute for Pharmaceutical Safety, Portland, Maine, statement ...................................................... 146 

Hosley, Laura, Manager, Community Prevention, Rhode Island Student Assistance Services, Warwick, Rhode Island, statement ...................................... 159 

Kerlikowske, R. Gil, Director, White House, Office of National Drug Control 

Policy, Washington, DC, statement .................................................................... 169 

Leonhart, Michele M., Administrator, Drug Enforcement Administration, 

Washington, DC, statement ................................................................................ 177 

National Community Pharmacists Association (NCPA), Alexandria, Virginia, 

statement .............................................................................................................. 190 

Pain Care Coalition, Edward Michna, Chair, Washington, DC, May 20, 2011, 

letter ...................................................................................................................... 193 

Pasierb, Steve, President and CEO, The Partnership at Drugfree.org, New 

York, New York, statement ................................................................................. 201 

Page

IV 

Rockefeller, Hon. Jay, a U.S. Senator from the State of West Virginia, statement ...................................................................................................................... 208 

Kimberly Walsh, Deputy Commissioner, State of West Virginia, Department 

of Health and Human Resources, Charleston, West Virginia, May 24, 2011, 

letter ...................................................................................................................... 210 

(1) 

RESPONDING TO THE PRESCRIPTION DRUG 

EPIDEMIC: STRATEGIES FOR REDUCING 

ABUSE, MISUSE, DIVERSION, AND FRAUD 

TUESDAY, MAY 24, 2011 

U.S. SENATE, 

SUBCOMMITTEE ON CRIME AND TERRORISM, 

COMMITTEE ON THE JUDICIARY, 

Washington, DC. 

The Committee met, pursuant to notice, at 9:04 a.m., in room 

SD–226, Dirksen Senate Office Building, Hon. Sheldon Whitehouse, Chairman of the Subcommittee, presiding. 

Present: Senators Whitehouse, Klobuchar, and Blumenthal. 

OPENING STATEMENT OF HON. SHELDON WHITEHOUSE, A U.S. 

SENATOR FROM THE STATE OF RHODE ISLAND 

Chairman WHITEHOUSE. The hearing will come to order. This 

morning’s hearing considers a topic that is extremely important to 

the health and safety of our kids, of our families, and of our communities, and that is, ‘‘Responding to the Prescription Drug Epidemic: Strategies for Reducing Abuse, Misuse, Diversion, and 

Fraud.’’ 

Used properly, under a physician’s direction, pain relievers and 

other prescription drugs bring much-needed comfort to Americans. 

But their abuse poses a serious and growing threat to our communities and young people. In 2009, approximately 7 million Americans reported misuse of prescription drugs. The problem is particularly acute among teenagers. Prescription drugs are the second 

most abused category of drugs among our Nation’s young people, 

and six of the top ten abused substances among high school seniors 

are prescription drugs. 

Prescription drug abuse is extremely dangerous. Over the last 5 

years, emergency room visits involving improper use of pharmaceuticals more than doubled. Too often, the consequences were 

deadly. According to the CDC, drug-related poisonings are now the 

leading cause of death due to unintentional injuries in my home 

State of Rhode Island and in 16 other States, greater even than 

motor vehicle accidents. 

Diversion and abuse of prescription drugs can also impose significant financial costs on our health care system through emergency 

room visits and treatment of medical complications. We pay for 

that through higher private insurance premiums and higher Medicare and other public health costs. 

2 

The ever-growing epidemic of prescription drug abuse demands 

sustained attention from law enforcement, health care professionals, and Congress. It poses challenges similar to those faced 

from other illegal drugs. As with illegal drugs, for instance, largescale criminal networks have developed for the diversion and distribution of prescription drugs. 

However, there are unique challenges in the prescription drug 

context. These drugs can be readily available in our homes, giving 

teens easy and direct access. Approximately 70 percent of people 

aged 12 or older who used prescription pain relievers non-medically 

in 2009 got them from a friend or relative. 

Furthermore, education about the threat of prescription drugs is 

more difficult because these legal drugs have an important medical 

purpose, are prescribed by physicians, and come from pharmacies. 

Teens are too often unaware of the dangers of misuse and abuse. 

The special characteristics of prescription drugs demand a multipronged strategy for reducing wrongful use. This strategy should 

include educating prescribers and patients about responsible uses 

of these drugs, recognizing signs of abuse, providing appropriate 

treatments and interventions, and deploying appropriate law enforcement resources. 

Electronic information-sharing systems, such as the prescription 

drug monitoring programs authorized in 43 States, are promising 

tools for identifying pill mills and doctor shoppers. I was pleased 

to get bipartisan legislation passed last year allowing the Government to perform sophisticated analyses of Medicare data in order 

to avoid paying fraudulent claims and to give law enforcement tools 

for investigating criminal fraud. There are analogous ways to 

strengthen prescription monitoring programs so that they have 

more complete prescription data, use advanced analysis to identify 

diversion or abuse, and better allow prescribers, law enforcement, 

and others to address these problems. 

E-prescribing can also play a valuable role, limiting diversion, 

fraud, and medical mistakes by reducing opportunities for forgery 

and error. I am pleased that Rhode Island is a national leader in 

e-prescribing. We can combine the advantages of e-prescribing and 

of prescription monitoring programs to help physicians recognize 

early patterns of abuse. 

Today’s hearing seeks to advance these goals. I welcome our witnesses from the Office of National Drug Control Policy and the 

Drug Enforcement Agency, as well as from Brandeis University 

and my home State of Rhode Island. 

I congratulate the Obama administration on the release of their 

proposals for responding to America’s prescription drug abuse crisis. I look forward to working with the administration, Chairman 

Leahy, Ranking Member Kyl, and other Senators from both sides 

of the aisle on legislation to protect against prescription drug 

abuse. 

I saw Senator Kyl this morning, and he indicated that he may 

not be able to attend the hearing today. His schedule has been, I 

guess, a little bit tumultuous, and if he can, of course, I will recognize him. But if he does not, I have been instructed to proceed. 

3 

We have Senator Sherrod Brown of Ohio here to kick off the 

hearing. Senator Brown has taken a keen interest in this issue, 

and we look forward to his statement. Thank you, Senator Brown. 

STATEMENT OF HON. SHERROD BROWN, A U.S. SENATOR 

FROM THE STATE OF OHIO 

Senator BROWN. Thank you, Chairman Whitehouse, for allowing 

me to testify today and for your leadership on this important Subcommittee on Crime and Terrorism. 

Chairman Whitehouse and I served together on the Health, Education, Labor, and Pension Committee where we worked closely together on the Patient Protection and Affordable Care Act, and 

throughout our time in the Senate, I valued his expertise on the 

connections between our health care and our legal systems. 

Today’s hearing is an example of that connection, how the rampant abuse and trafficking of prescription drugs pose both a public 

health threat and a law enforcement threat. In recent years, more 

Ohioans have died from prescription drug overdoses than from car 

accidents. In 2008, statistics show that oxycodone and Percocet and 

other prescription drugs caused more overdoses in Ohio that year 

than heroin and cocaine combined. Prescription pain medications 

such as OxyContin are largely responsible for increasing overdoses 

and deaths in my State and across the country. Simply put, prescription drug abuse, as the Chairman said, is the fastest-growing 

drug problem in the Nation. 

Almost every day in Ohio, there is a reported story of a child lost 

to prescription drug abuse or neighborhoods harboring its illicit 

trade. In southeast Ohio, the most rural part of the State, it is particularly tragic. Old factory towns and rural communities have become havens for prescription drug abuse. These stories, of course, 

are not limited to Ohio and Rhode Island. Across the country communities are struggling to find ways to respond and to develop 

strategies to reduce the diversion and abuse of prescription drugs. 

Last year, I convened a first of its kind roundtable in southern 

Ohio with Federal and local law enforcement, community activists, 

elected officials, drug treatment leaders, and members from the 

medical community. They raised a concern with criminal manipulation of Ohio’s Medicaid program, which spends upwards of $820 

million on prescription medicines. While most prescription pain 

medicines are used as prescribed, as the Chairman pointed out, 

and they are valuable, some criminals defraud the Medicaid system 

and fleece Ohio taxpayers by acquiring multiple prescriptions and 

filling them at multiple pharmacies. 

A case of criminals defrauding taxpayers in the Medicaid system 

to sell and divert prescription drugs becomes a one-two punch in 

the stomach to the system. That is why last month I introduced the 

Stop Trafficking of Pills Act, which would establish a Medicaid 

lock-in program for Ohio and nationwide to crack down on the use 

of Medicaid cards to obtain and illegally resell prescription drugs. 

The bill would prevent prescription drug abusers from acquiring 

excess prescription drugs which they may abuse or illegally resell 

by barring them from visiting multiple doctors and pharmacies. 

Nearly 20 States already have something similar to the Medicaid 

lock-in program. South Carolina’s Medicaid lock-in pilot program 

4 

targeted at high-use beneficiaries spurred a 43-percent decrease in 

the total number of prescribed prescription pain medications. 

Consider Scioto County on the Ohio River in southern Ohio. In 

this Ohio River town, prescription drugs cause nine of every ten 

fatal drug overdoses. In nearly two-thirds of these cases, the individuals involved did not have prescriptions themselves, indicating, 

of course, they in all likelihood obtained the drugs illegally. An investigation by the GAO, which audited the Medicaid program of 

the five largest States, found 65,000 cases in which Medicaid beneficiaries visited six or more doctors and up to 46 different pharmacies to acquire these prescriptions. This same report found approximately 800 prescriptions written for dead patients and 1,200 

prescriptions written by dead physicians. 

Under a Medicaid lock-in program, States would identify highrisk prescription users, those who are receiving an excessive 

amount of prescription drugs or those who have been convicted of 

a drug-related offense. These high-risk prescription drug users 

would be placed in the program and assigned one physician and 

one pharmacy. It would mean no more doctor shopping, no more 

pharmacy hopping. 

States would identify prescription drugs that are dispensed 

under Medicaid and that present a high risk of overutilization. The 

legislation requires the Federal Government to set up a similar 

lock-in program for Medicare, where the abuse is there but obviously not as high. Prescription drug abuse in Ohio and our Nation 

needs to be treated like the epidemic it is. 

Chairman Whitehouse has been a leader on this issue, urging the 

DEA to implement electronic prescribing for controlled substances 

and calling for strong prescription drug monitoring systems. 

Today’s witnesses will describe the administration’s comprehensive prescription drug strategy and ways FDA can crack down on 

the abuse, and community activists will describe the victims and 

families whom they represent, offering the stories behind the statistics and policies being discussed. 

From the policies to the stories, it is clear prescription drug 

abuse knows no party lines. It is clear it is an issue of life or death 

in too many parts of our Nation, at least in my State especially in 

rural areas, which have experienced terrible job loss and economic 

hardship for hundreds of thousands of families. 

I will stop there. I thank the Chairman for allowing me to testify. 

Chairman WHITEHOUSE. Senator Brown, I appreciate very much 

your energy and your leadership on this issue, both here in Washington and in your home State of Ohio. It seems that Ohio and 

Rhode Island have a lot in common on this issue, and I look forward to continuing to work with you as you go forward. I particularly appreciate that, as busy as your schedule is, you took the time 

out this morning to come to this Committee, of which you are not 

a member, to make sure that your voice was heard here, and I am 

very grateful to you for that. 

I know your schedule commands you to be elsewhere, so thank 

you very much for taking the trouble. 

Chairman WHITEHOUSE. Now I will ask our first panel, Hon. Gil 

Kerlikowske and Hon. Michele Leonhart, to come forward. Let me 

ask you to stand and be sworn. Do you affirm that the testimony 

5 

you are about to give before the Committee will be the truth, the 

whole truth, and nothing but the truth? 

Mr. KERLIKOWSKE. I do. 

Ms. LEONHART. I do. 

Chairman WHITEHOUSE. Thank you. Please be seated. 

Thank you both for being here. It is an impressive turnout. And 

for those of you who do not know our witnesses, Gil Kerlikowske 

is the Director of the White House Office of National Drug Control 

Policy. Director Kerlikowske served as the chief of police for Seattle, Washington; was Deputy Director for the U.S. Department of 

Justice Office of Community-Oriented Policing Services; was police 

commissioner of Buffalo, New York; and served in the St. Petersburg, Florida, police department. He has been elected twice to be 

president of the Major Cities Chief, and he has received numerous 

awards and recognition for leadership, innovation, and community 

service. 

He is joined by Michele Leonhart, who is Administrator of the 

Drug Enforcement Administration. Confirmed in December 2010, 

she had been the Acting Administrator since 2007 and Deputy Administrator since 2004. As a career DEA special agent, Ms. 

Leonhart held several key positions as she moved through the 

ranks of DEA, including as assistant special agent in charge of the 

Los Angeles Field Division. She has received numerous awards, including the Rank of Distinguished Executive in 2004, and the Presidential Rank Award for Meritorious Service in 2005 and 2000. 

It is truly our privilege to have these two witnesses here, and 

why don’t we go across the table. We will start with Mr. 

Kerlikowske. Please proceed with your statements. 

STATEMENT OF HON. R. GIL KERLIKOWSKE, DIRECTOR, 

WHITE HOUSE OFFICE OF NATIONAL DRUG CONTROL POLICY, WASHINGTON, DC 

Mr. KERLIKOWSKE. Chairman Whitehouse, thank you very much 

for this opportunity to address the important issue of prescription 

drug abuse in our country, and I am very grateful for the Committee’s attention to this topic. Prescription drug abuse has been a 

major focus at ONDCP since my confirmation, and I have directed 

the National Drug Control Program agencies to address this epidemic in our country. 

I have the responsibility to raise public awareness, coordinate 

Federal activities, and take action on drug issues that affect our 

Nation. The efforts that we have taken are balanced. They incorporate new research and evidence-based approaches to address 

drug use and its consequences. 

Prescription drug abuse is the fastest-growing drug problem in 

the United States. It is categorized as a public health epidemic by 

the Centers for Disease Control and Prevention. The number of individuals who for the first time consumed prescription drugs for a 

non-medical purpose was similar to the number of first-time marijuana users. We have also seen a fourfold increase in addiction 

treatment admissions for individuals primarily abusing prescription painkillers from 1997 to 2007. 

Even more alarming is the fact that about 28,000 Americans 

have died from unintentional drug overdoses in 2007, and prescripVerDate Nov 24 2008 12:33 Jan 09, 2012 Jkt 071663 PO 00000 Frm 00009 Fmt 6633 Sfmt 6633 S:\GPO\HEARINGS\71663.TXT SJUD1 PsN: CMORC
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tion drugs, particularly the opioid painkillers, are considered major 

contributors to the total number of drug deaths. And we believe 

there are two unique reasons for the growth in prescription drug 

abuse: easy accessibility to the drugs and the diminished perception of risk. A comprehensive approach is required to address this 

epidemic. It is important to balance prevention, education, and enforcement with the need for legitimate access to controlled substances. 

The administration has created an inclusive Prescription Drug 

Abuse Prevention Plan that brings together Federal, State, local, 

and tribal groups to reduce prescription drug diversion and abuse. 

The plan expands upon the administration’s National Drug Control 

Strategy and has four major areas. 

The first is education. Mandatory prescriber education as well as 

patient and parent education is essential. Sixty-nine percent of narcotic analgesics are distributed in primary care offices and emergency departments. In addition, we want to make sure that patients and parents are fully aware of the dangers and the prevalence of prescription drug abuse and that they are educated about 

the safe use and proper storage and disposal of these medications. 

The FDA is implementing a Risk Evaluation and Mitigation Strategy plan that requires manufacturers of long-acting and extendedrelease opioids to ensure that training is provided to prescribers. 

The second part of our plan includes that each State have a Prescription Drug Monitoring Program (PDMP), and Senator Brown 

mentioned the importance of those, and I know you have another 

witness that will be talking about those. But we are strongly supportive of those and that they have interoperability and that they 

be used by all of the prescribers. 

We have also made significant investments in health information 

technology and continue to work with HHS particularly on health 

information exchanges. Opportunities include identifying ways to 

incorporate real-time PDMP data at the point of care and dispensing. 

The third part of the plan calls for proper medication disposal. 

Unused medications that sit in our medicine cabinets are falling 

into the wrong hands, and by creating a method for proper disposal 

of expired or unused prescription drugs, we will benefit public 

health, public safety, and the environment. Passage of the Secure 

and Responsible Drug Disposal Act in 2010 was an important step 

forward in our efforts to make prescription drug disposal more accessible to individuals and to reduce the supply of drugs available. 

A drug disposal program has to be easily accessible to the public, 

environmentally friendly, cost-effective, and the cost burden should 

not be placed on consumers. 

The last part of the plan is smart law enforcement. You have the 

expert sitting to my left to talk about that, but our main effort will 

be, as they have already done with the DEA’s comprehensive work 

on pill mills, to address the issue of doctors who overprescribe, and 

of course, PDMPs help with doctor shopping. Our office, ONDCP, 

supports the HIDTAs, the High-Intensity Drug-Trafficking Areas, 

and we want to make sure that local law enforcement, with the cooperation of DEA, have the support that they need to understand 

7 

these complex investigations and do a better job of bringing drug 

dealers to justice. 

In closing, I want to thank all of my colleagues in the executive 

branch, but particularly we could not be effective in any of these 

areas without the support of Congress. 

[The prepared statement of Mr. Kerlikowske appears as a submission for the record.] 

Chairman WHITEHOUSE. Thank you, Director Kerlikowske. 

Director Leonhart. 

STATEMENT OF HON. MICHELE M. LEONHART, ADMINISTRATOR, DRUG ENFORCEMENT ADMINISTRATION, WASHINGTON, DC 

Ms. LEONHART. Chairman Whitehouse, Senator Klobuchar, thank 

you for the opportunity to discuss the growing epidemic of prescription drug abuse and the critical role of the Drug Enforcement Administration in the enforcement of our Nation’s drug laws and regulations. 

The diversion and abuse of pharmaceutical controlled substances 

is a significant and growing problem in the United States. Every 

leading indicator shows increases over relatively short periods of 

time in the use and abuse of these drugs. Pain clinics have 

emerged as a major source of controlled substances for non-legitimate medical purposes. DEA and other Federal, State, and local 

law enforcement agencies have developed great working relationships and continuously coordinate efforts to combat this emerging 

threat. 

Federal administrative and criminal actions against a physician 

with controlled substance privileges is rare. However, such actions 

are warranted when a physician is issuing controlled substance 

prescriptions for an illegitimate purpose and operating outside the 

usual course of professional practice. And as Administrator, I have 

made prescription drug abuse a top priority. 

I am especially alarmed that another contributing factor to the 

increase in prescription drug abuse is the availability of these 

drugs in the household. In many cases, prescription drugs remain 

in household medicine cabinets well after medication therapy has 

been completed, thus providing easy access to non-medical users for 

abuse, accidental ingestion, or illegal distribution for profit. And 

the 2010 Partnership Attitude Tracking Study, which we call 

PATS, noted that 51 percent of those surveyed believe that most 

teens get prescription drugs from their own family’s medicine cabinets. 

DEA manages a robust regulatory program aimed at preventing 

and curbing diversion, all the way from the manufacturing level to 

the dispensing of these medications to patients. In working with 

Congress, DEA also obtained new authority last year to regulate 

the disposal of unused medications by ultimate users, thereby getting unused medications out of the household medicine cabinets in 

a lawful manner. 

DEA is working diligently to promulgate disposal regulations. In 

the interim, DEA launched a nationwide take-back initiative in 

September of last year and again in April of this year, resulting in 

the combined collection of 309 tons of unwanted or expired medicaVerDate Nov 24 2008 12:33 Jan 09, 2012 Jkt 071663 PO 00000 Frm 00011 Fmt 6633 Sfmt 6633 S:\GPO\HEARINGS\71663.TXT SJUD1 PsN: CMORC
8 

tions. And DEA will continue to hold periodic take-back events 

until regulations are in place. 

DEA’s obligation under the law and to the public is to ensure 

that pharmaceutical controlled substances are prescribed and dispensed only for legitimate medical purposes in accordance with the 

Controlled Substances Act. And by carrying out this obligation, 

DEA strives to minimize the diversion of pharmaceutical controlled 

substances for abuse while ensuring that such medications are 

fully available to patients in accordance with the sound medical 

judgments of their doctors. In this manner, DEA is committed to 

balancing the need for diversion control and enforcement with the 

need for legitimate access to these drugs. 

DEA closely monitors the closed system through recordkeeping 

requirements and mandatory reporting at all levels of the supply 

chain. Due to enhancements to our regulatory resources, controlled 

substance manufacturers, distributors, importers, exporters, and 

narcotic treatment programs are receiving more inspections and 

audits than ever before. A key component to our enhanced investigative resources are tactical diversion squads. These unique 

groups combine the skills of special agents, diversion investigators, 

and task force officers. These TDS groups, as we call them, are 

dedicated solely toward investigating, disrupting, and dismantling 

those individuals or organizations involved in diversion schemes, 

and as of today, DEA has 37 operational TDS groups. DEA plans 

to add 27 more over the next few years. 

One example of the effectiveness of these tactical diversion 

squads is Operation Pill Nation, which has targeted rogue pain 

clinics in South Florida since February of 2010 and culminated in 

a series of major takedowns this past February. This led to 32 arrests, including 12 doctors and 5 pain clinic owners, and DEA also 

immediately suspended 63 DEA registration numbers and issued 

orders to show cause on 6 DEA registrations, which resulted in the 

surrender of 29 DEA registration numbers. And this caused a ripple effect throughout South Florida and resulted in 54 more registration numbers being surrendered. 

DEA recognizes that it cannot solve this problem alone, and DEA 

is working with our Federal, State and local, and private sector 

partners as a part of this administration’s comprehensive approach 

to combating prescription drug abuse. 

Many States also have adopted prescription drug monitoring programs, which are deemed to be a valuable tool in curbing diversion. 

The administration supports establishment of these programs in 

every State because PDMPs help cut down on prescription fraud 

and doctor shopping by giving physicians and pharmacists more 

complete information about a patient’s prescriptions for controlled 

substances. 

In closing, prescription drug abuse is a dangerous threat, and 

DEA is determined to be a part of the solution. And with your support and that of our partners, I know we will continue to make a 

positive difference in the lives of millions of Americans and communities across the Nation. So I thank you for the opportunity to appear here today, and I look forward to answering your questions. 

[The prepared statement of Ms. Leonhart appears as a submission for the record.] 

9 

Chairman WHITEHOUSE. Thank you, Ms. Leonhart. 

Chairman Leahy could not be here today, but he has offered a 

statement for the record reflecting, among other things, observations we got, Director Kerlikowske and I, with the Chairman at the 

hearing that he held up in Vermont last year with all of us together. And without objection, I will add that to the record of this 

hearing. 

[The prepared statement of Chairman Leahy appears as a submission for the record.] 

Chairman WHITEHOUSE. I have a couple of questions. I think I 

will probably pass on the drug disposal questions because we are 

joined by Senator Klobuchar, who was the author of the Secure and 

Responsible Drug Disposal Act of 2010 that was mentioned in the 

testimony. But I do want to mention on that that I was in Rhode 

Island the other day at the Narragansett Bay Commission’s 

Bucklin Point Treatment Facility, and they are actually seeing effects from pharmaceuticals that are discarded down the drain out 

in the environment as they come through the treatment system 

and go out in that case into the river and then on down to the bay. 

So it is not a solution necessarily to have people dispose of this by 

throwing it down the drain. We really have to improve on that, and 

I suspect she will urge you to move those regulations with some degree of dispatch. 

As you know, we have had a long battle over the e-prescribing 

regulations. I think that has been 3 years from when we had the 

first hearing, and your predecessors at DEA sat next to people from 

HHS and had completely different views of the world, and in the 

same administration. And I gather that that has all been worked 

through, but if you could bring me up to date on where we are 

under the interim final rule in terms of actual deployment and the 

ability to certify contractors and actually have e-prescribing take 

place in the field. 

I am assuming that you view e-prescribing as an investigative 

and awareness asset in the drug diversion problem, and in that 

frame, I would like you to let me know where we stand. 

Ms. LEONHART. Yes, Chairman. We do view e-prescribing as an 

important tool—a tool for law enforcement, actually. We have 

worked very hard, especially since last March when I signed the interim rule, which went into effect almost a year ago. June 1st will 

be a year. We have been in contact with the people that are putting 

together the systems. They are moving forward. And we understand the first ones may be ready this summer for audit and then 

come online and be available by the end of the year. 

We have looked at a number of the comments that came in. The 

interim rule is in effect now. We believe the final rule will be ready 

to go early next year, and there should be no reason that people 

should not be moving forward to implement e-prescribing, which 

will help in many ways to include the diversion problem of prescription drugs, as well as help with fraud and enhance health for 

patients. 

Chairman WHITEHOUSE. Is there actually e-prescribing of controlled pharmaceuticals under the interim final rule happening 

now? Or are people still waiting for the contractors to be certified 

so that it can actually happen? I mean, it is one thing to have the 

10 

rule be in operation. It is another thing to actually have something 

happen in the real world. And I am not sure that this has actually 

hit the real world yet. Could you let me know what the status is 

in terms of actual flow of data across e-prescribing networks of controlled pharmaceuticals? 

Ms. LEONHART. Well, I can tell you it has not hit the real world 

yet, but the systems are being put in place. They first need to be 

audited. We understand one has announced called ‘‘Doctor First.’’ 

It has announced that it is DEA compliant and is ready to move 

forward, and I believe it is in the auditing stages now and has 

identified over 150 different customers, and that will be the first 

one that we have heard of that will come online probably by the 

end of the year. 

Chairman WHITEHOUSE. I am not going to remember the exact 

numbers that Senator Brown used, but he described individuals 

who had multiple prescriptions from multiple doctors and were 

using multiple pharmacies, and that is the type of thing that this 

sort of system can flag so that it does not happen, correct? 

Ms. LEONHART. That is correct—that with the prescription drug 

monitoring programs, we will be able to identify people that are 

doctor shopping, as you just explained. 

Chairman WHITEHOUSE. I will now recognize Senator Klobuchar, 

author of the Secure and Responsible Drug Disposal Act of 2010. 

Senator KLOBUCHAR. Thank you. You remember that name better than I do. That is pretty good. 

Thank you to both of our witnesses. Director Kerlikowske and I 

worked together back when he was police chief and I was county 

attorney. And then, of course, Ms. Leonhart, we have worked together as well, and you are from Minnesota so you can do no harm, 

as far as I am concerned. 

[Laughter.] 

Senator KLOBUCHAR. I wanted to go through—as Senator Whitehouse mentioned, we passed into law the Secure and Responsible 

Drug Disposal Act, something that Senator Cornyn and I authored, 

and got it through the House, and thank you for your help in doing 

that, Director Kerlikowske. And I wanted to find out the status of 

the rules. You know what this bill does, acknowledging that prescription drugs are the No. 2 way that kids can get addicted to 

drugs, the drugs sitting around in their parents’ medicine cabinets. 

And this allows pharmacies to do take-back programs, more than 

just police departments; clarifies some of the details; also for longterm care facilities, which it turned out were flushing a lot of these 

pills down the toilet because they did not know what they could do 

legally. And I know that the regulations were included as part of 

the plan released by the White House. 

Can you give us an update on the drafting of the regulations? 

And what are some of the key issues you will be looking at? And 

what do you think the timetable will be? 

Mr. KERLIKOWSKE. Senator, since it is in the design of the rulemaking, and the White House is not influencing the rulemaking, I 

would defer and ask that maybe Administrator Leonhart answer 

that question. Thank you. 

Senator KLOBUCHAR. OK. Very good. Thank you. 

11 

Ms. LEONHART. Senator, I want to thank you for your support. 

I am not sure that bill would have passed without your fine support and the support of your colleagues. It is very important to us. 

I am pleased to say that we are on track and hope to have a final 

rule by the end of the year or early next year. In the meantime, 

we have held our second take-back just last month, which was even 

more successful than the first take-back in September. 

We held a hearing, an open forum hearing, in January and had 

over 100 witnesses provide comments and submit comments that 

we are looking at very closely. And the good news is we are on 

track to have a final rule hopefully by the end of the year or January or February of next year. 

Senator KLOBUCHAR. OK. Very good. And are you working with 

various stakeholders on the rules and getting input? 

Ms. LEONHART. Absolutely. The public forum had stakeholders 

from all entities, and we have a wide range of recommendations 

and suggestions from them. And all options are on the table to 

come up with the best final rule we can get that allows for that 

safe and regular disposal. 

Senator KLOBUCHAR. Very good, because I think that we know 

the take-back programs are great. They are becoming more and 

more popular. But to have something that would be just commonplace in pharmacies would be the best, and certainly helping all 

these long-term care facilities would be good as well. 

I had a different kind of question, and it is about the use of synthetic drugs, including synthetic hallucinogens. And as you know, 

these drugs are not prescription medications, but I think it is clear 

that the abuse of these illegal drugs and prescription drugs are 

closely related. And I have a bill—Senators Grassley and Schumer 

have one, on certain types of synthetics, and I have one based on— 

it is called 2C–E, something that actually killed a young man in 

Minnesota and almost killed a number of others at a party. And 

I just wondered if you were aware of this problem, either of you, 

and if we have your support in moving forward on this legislation. 

Ms. LEONHART. We are absolutely aware of the synthetics, and 

especially of the young man who lost his life in Minnesota with the 

use of the 2C-E compound. These are synthetics that are the drugs 

of the future. Whether it is synthetic cannabis or a synthetic stimulant or hallucinogen, young people are attracted to that, so it concerns us. 

So we support any legislation, any tools that Congress can put 

forward that will help us combat that, and know that in Minnesota 

as well as the other States where these synthetics have shown up, 

we are working with State and local law enforcement. We are providing technical assistance, training, to do whatever we can to put 

a stop to that. 

Senator KLOBUCHAR. OK. Director Kerlikowske. 

Mr. KERLIKOWSKE. And, Senator, while the process is going on, 

the legislative process, we have used the bully pulpit of the White 

House to be able to bring to a lot of people’s attention the problems 

of the things such as bath salts, synthetic drugs, et cetera. So that 

has been helpful in alerting people to the problem, and thank you. 

Senator KLOBUCHAR. Very good. I just think the more we can list 

some of these as clearly illegal, that helps you with your education 

12 

process, makes parents aware of this new phenomenon with these 

drugs that I do not think anyone ever anticipated a decade ago. 

My last question along the lines of the tools for all of you to use 

is that the administration’s plan on prescription drugs makes reference to the role of Congress, and if you could touch further on 

the role of Congress. Can you talk about the potential need for further legislation in the area of illegal prescription drugs? Director 

Kerlikowske. 

Mr. KERLIKOWSKE. Senator, we think one of the most important 

parts of the comprehensive prescription drug plan will be in mandatory prescriber education. When we developed President Obama’s 

National Drug Control Strategy, his direction to me was to make 

sure that the voices of people across the country were heard, and 

we did that and included discussion around prescription drugs and 

information. 

The actual prescription drug plan is more comprehensive, more 

specific, and we developed it very much in the same way—by listening to people all over the country, particularly a number of prescribing physicians, whether they were in emergency departments 

or whether they were in a number of other locations, for instance, 

pain management or primary care. And overwhelmingly the information that was provided to me by them was that additional information and education about addiction, about dependence, about 

prescribing pain medications was important and vitally needed. 

And overwhelmingly they had told me that it should be mandatory. 

Although voluntary education is certainly something that people 

appreciate, and I know that these are physicians who are very 

overworked, mandatory prescriber education is, in my opinion, very 

important. 

Senator KLOBUCHAR. All right. Thank you very much. 

Thank you, Mr. Chair. 

Chairman WHITEHOUSE. And now we will turn to the distinguished Senator from Connecticut, whose many years of exemplary 

service as the Attorney General in Connecticut make him keenly 

aware of this issue. Senator Blumenthal. 

Senator BLUMENTHAL. Thank you, Senator Whitehouse, and 

thank you for holding this hearing, and thank you especially for 

being attuned to this very, very difficult and profoundly important 

topic. And I thank you both for your great work on this issue. 

I want to thank you also for the recommendation from the White 

House Office of National Drug Control Policy in its plan to combat 

prescription drug abuse to recommend that the Secretary of Veterans Affairs share patient information on controlled substance 

prescriptions with State prescription drug monitoring programs, 

which I think is very, very important. As you know, the VA also 

supports this request. And I will be introducing legislation within 

the coming days as part of a comprehensive program on veterans 

issues to support providing that tool in the toolbox, so to speak. 

So I wonder if you or Director Leonhart could perhaps share with 

us and put on the record your views as to why this recommendation is important. 

Mr. KERLIKOWSKE. Senator, thank you very much. I could not 

have a stronger partner than General Shinseki and the VA on this 

issue. I do not think there is anyone in this country that is not supVerDate Nov 24 2008 12:33 Jan 09, 2012 Jkt 071663 PO 00000 Frm 00016 Fmt 6633 Sfmt 6633 S:\GPO\HEARINGS\71663.TXT SJUD1 PsN: CMORC
13 

portive of our active-duty military and our returning veterans and 

how they can be helped. But we also know very correctly that selfmedication, the use of prescription drugs in both the active-duty 

military—it has been well documented—and also returning veterans, is a significant problem. It is a problem for combat readiness 

and force readiness. It is a problem for local jurisdictions, particularly jurisdictions where National Guard returns and there may 

not be as large a military base or presence. 

Prescription drug monitoring programs that are now in almost 

every State—and not all of them active, but we are working to help 

them to become more robust—are only as effective as how they are 

used. And if you can go into a VA hospital and obtain prescription 

drugs and then go down the street to a private physician, and the 

two systems do not talk to each other, that is dangerous for the patient. It puts the physicians in a difficult position because they do 

not know about what prescriptions are being offered to that patient 

by a different physician in a different facility. And so the support 

of the VA and the support of the Department of Defense on that 

issue, so that one system can clarify and talk to each other, is good 

for our veterans and our active-duty military. And it is clearly a 

patient safety issue, and I thank you for that support. 

Senator BLUMENTHAL. Would you have anything to add, Ms. 

Leonhart? 

Ms. LEONHART. I would add that it is a very serious problem: 5.3 

million Americans are abusing painkillers, and among those 5.3 

million are our veterans, especially returning veterans. And the 

leadership of Director Kerlikowske bringing the VA to the table has 

been significant and I think will in the end benefit all of our efforts, especially those that will most affect veterans. And thank you 

for your interest in that topic. 

Senator BLUMENTHAL. It almost enables or encourages doctor 

shopping and abuse to have these two separate systems that are 

completely unlinked and simply do not communicate with each 

other. 

How well—and I realize this is kind of an open-ended question, 

but how well are the State systems working? And do you note wide 

variation in their effectiveness? If you could give us a general assessment. 

Mr. KERLIKOWSKE. There are a number of people that have 

looked at these. The CDC just recently released a report, although 

the data that they used was a bit dated. I have examined them and 

looked at them. There are some States—particularly what is called 

the KASPER system in Kentucky, which is very forward leaning in 

this area, but there are several problems, and we have addressed 

those in the prescription drug plan. One is that they should be 

interoperable and talk to each other. 

During our 4-day trip to eastern Kentucky and also West Virginia, we learned that doctors would have to access multiple systems—those in Ohio, those in West Virginia, those in Kentucky— 

when it came to checking on patients and making sure that they 

were not overprescribing for patients who were seeing, in fact, 

other physicians. So the interoperability is key. The fact that it 

should be easy, that the information should be readily accessible 

14 

and should be in as close to real time as possible, are all important 

efforts. 

So this is a great first step, all of the States, including the State 

of Florida, passing that legislation, moving forward, now making 

them more robust, making them used, and making them interoperable, are all key components of the prescription drug plan. 

Ms. LEONHART. I would add that we have seen some promising 

information coming from the States that actually share that PDMP 

information with law enforcement. For instance, a recent study 

showed that there were lower death rates in States that were sharing with law enforcement, specifically in California, Texas, and 

New York. So it is a promising tool. Good to see that soon there 

are only two States that will be without PDMPs or without legislation pending. 

Senator BLUMENTHAL. Thank you very much. Thank you both for 

your great work in this area. 

Chairman WHITEHOUSE. Just to follow up on Senator 

Blumenthal’s question, have you been alerted to any desire for Federal legislative changes to support the State initiatives in prescription drug monitoring? As I understand it, the Medicare and Medicaid billing information, for instance, access to that for purposes 

of identifying prescription drug abuse and diversion is being accomplished primarily at the State level. Are they running into common 

problems that we should attend to? Or is the State-based process, 

do you think, a successful one in terms of something that can go 

forward and continue to make progress on its own without further 

Federal legislation? 

Mr. KERLIKOWSKE. Senator, we have widely discussed at the different hearings and the different visits that we have had around 

the country, the issue of a national PDMP. A couple things came 

into play. 

One, the experts that have developed those systems say they 

would be very difficult to implement because of, for instance, just 

the difficulty of personal identification when it comes to common 

names across an entire Nation, an entire data base. That would be 

a problem. 

Second, that the States design these and operate these themselves and, therefore, they can put into place the patient privacy, 

the confidentiality guidelines that they would like, and also who 

has access to it. I think there are a number of best practices, and 

I think as the evaluation continues on, I am pretty hopeful that the 

individual States by working together—and, of course, your next 

witness is certainly another subject matter expert in this—can be 

very helpful. But right now I am quite satisfied with what I am 

seeing at the State level. 

Chairman WHITEHOUSE. Do you agree, Ms. Leonhart? 

Ms. LEONHART. I do agree. I do believe that Congress could help, 

however, in the area of interoperability. And, of course, funding is 

an issue for the States moving forward with these systems. 

Chairman WHITEHOUSE. Well, thank you both very much. This 

has been—do you have any further questions, Senator Blumenthal? 

Are you ready for the next panel? Should we go on? If you would 

like another round, I—— 

15 

Senator BLUMENTHAL. I wanted to follow up on Senator 

Whitehouse’s excellent question about encouraging the effectiveness of the drug monitoring programs, and I know that there is 

some reluctance to make it more national and impose kind of national requirements. But I wonder where you see the resistance to 

increasing the interoperability, which I think is really key. As it is 

in so many criminal justice information programs, the failure to 

link State systems is a major barrier. So I am wondering either 

now or if you want to think further about it and respond in writing 

or have a conversation about it, I would be very interested in following up on that issue. 

Mr. KERLIKOWSKE. I know that the State of Ohio and the State 

of Kentucky have signed an interoperability agreement to begin 

sharing information. I think that shows some promise, and I would 

be happy to follow up to that question. 

Senator BLUMENTHAL. Great. Thank you very much. 

Thank you, Mr. Chairman. 

Chairman WHITEHOUSE. Let me thank the witnesses. Let me reference back to a statement that Director Kerlikowske made about 

his role as the bully pulpit at the White House on some of these 

issues, which is a role we obviously encourage. But I would hope 

that you might also be a bit of a bully pulpit within the White 

House with our friends at the Office of Management and Budget 

as these relevant rulemakings proceed. It has been astounding to 

me as a newly elected Senator to see the pace at which Federal 

rulemaking slugs forward. And while I think the agencies themselves are not always absolved of responsibility, it does seem that 

there is a common thread that things do seem to bog down at 

OMB. And if there is anything you can do to move some of these 

along and get OMB to expedite to the extent that they can, I think 

that would be helpful. 

I cannot tell you how long it took to get through the controlled 

pharmaceutical e-prescribing situation, and that was in theory with 

pretty much everybody on board as to the direction it should go. 

So I have become—I do not know what you would call it, but impatient, I guess, with the pace of Federal rulemaking. And you may 

be in a position to expedite it a bit, and if you can, I would urge 

you to do so. But I thank you for your dedicated efforts over many 

years in this area, and you, too, Ms. Leonhart. As Attorney General 

Blumenthal and I both know, you have people out in our streets 

and in the streets of foreign countries every day who are resourceful and brave, who take extraordinary risks to protect us. We have 

both had the pleasure and privilege of working with DEA agents 

who have been really among the finest Americans I have ever had 

the chance to work with. And so, I thank you for being here on 

their behalf. 

The panel is excused, and we will take a 2-minute break while 

the next panel assembles itself. Thank you both for your testimony. 

[Pause.] 

Chairman WHITEHOUSE. All right. If the hearing room will come 

back to order, my first order of business is to add to the record of 

this proceeding a number of items: 

First, a letter from our colleague, Senator Casey, and then statements from the Partnership at Drugfree.org; from the Community 

16 

Anti-Drug Coalitions of America; from the American Pain Foundation; from the American Academy of Pain Medicine; from the International Institute of Pharmaceutical Safety; from the Federation of 

State Medical Boards; and from the American Society of Interventional Pain Physicians. I appreciate all of their statements, and 

they will be, without objection, added to the record of these proceedings. 

[The statement appears as a submission for the record.] 

Chairman WHITEHOUSE. We now have our next panel. Our two 

witnesses are: 

First, Laura Hosley. She is manager of community prevention for 

Rhode Island Student Assistance Services. She also serves as coordinator of the Jamestown, Rhode Island, Prevention Coalition and 

oversees the North Kingstown, Rhode Island, drug-free communities grant. She previously served as project manager at the University of Rhode Island’s Cancer Prevention Research Center, 

worked as a student assistance counselor in Rhode Island middle 

and high schools, and directed a group home, serving individuals 

with mental illness and substance abuse problems. She has an undergraduate degree in education and psychology from the University of Rhode Island and a master’s in management from Lesley 

University. 

She is joined on our panel today by John Eadie, who is the director of the Prescription Monitoring Program Center of Excellence at 

Brandeis University. He previously served as director of the Division of Public Health Protection in the New York State Department 

of Health from 1985 to 1995, where he directed the State’s pharmaceutical diversion program, including the prescription monitoring 

program. He was co-founder and president of both the Alliance of 

State with Prescription Monitoring Programs and the National Association of State Controlled Substances Authorities. 

If I could ask you to stand while we administer the oath. Do you 

affirm that the testimony you are about to give before the Committee will be the truth, the whole truth, and nothing but the 

truth, so help you God? 

Ms. HOSLEY. I do. 

Mr. EADIE. I do. 

Chairman WHITEHOUSE. Please be seated. 

Ms. Hosley, welcome. Thank you for coming down from Rhode Island. Please present your statement. 

STATEMENT OF LAURA HOSLEY, MANAGER, COMMUNITY PREVENTION, RHODE ISLAND STUDENT ASSISTANCE SERVICES, 

WARWICK, RHODE ISLAND 

Ms. HOSLEY. Chairman Whitehouse, Senator Blumenthal, thank 

you for the opportunity to testify before you today on behalf of 

Rhode Island Student Assistance Services and the Jamestown and 

North Kingstown Substance Abuse Prevention Coalitions. I am 

pleased to provide you with our perspective on effective strategies 

for reducing the abuse, misuse diversion and fraud of prescription 

drugs. 

Rhode Island is a small State, but we seem to show up in the 

top of the national statistics when it comes to substance abuse. In 

2004, the last year the National Survey on Drug Use and Health 

17 

asked about the non-medical use of prescription drugs, Rhode Island was tied for fifth with two other States. In 2008, when the 

same survey asked about the use of pain relievers non-medically, 

Rhode Island came in seventh. It did not matter which of the five 

counties you looked at. They were all similar. The last Rhode Island SurveyWorks data showed that 1 percent of high school students have tried painkillers without a doctor’s prescription. 

I manage a drug-free communities grant in North Kingstown. 

Prior to this, I oversaw strategic prevention framework State incentive grants. In my 20 years of working in prevention, I had never 

seen such well-organized efforts as with these grants. After the 

first 3 years, we saw a drop in 30-day alcohol use of 14 percent and 

a 4-percent decrease in marijuana use among high school students. 

We had focused our efforts on underage drinking. 

We have cooperative relationships with multiple key partners 

which make it relatively easy to work on media campaigns, policy 

changes, law enforcement efforts, and more. The national prescription drug take-back program was held on April 30th in conjunction 

with the DEA. In North Kingstown, the local police department 

and the State police filled five boxes. When I received the list of 

how many pounds of drugs were collected, I saw that the top eight 

communities were either drug-free communities grantees or had 

the strategic prevention framework grant, or both. Together they 

had collected over 75 percent of the 1,716 pounds of drugs. Cities 

and towns that have the funding can get citizens educated and involved. They get results. 

I used to be a student assistance counselor. Student assistance 

counselors are on the front lines. Unfortunately, Federal and State 

funding no longer covers the cost to ensure that minimum programs are funded, especially since the safe and drug-free schools 

and communities funding was eliminated. The Rhode Island Student Assistance Program is a key element in the prevention infrastructure since the counselors are insiders. Along with providing 

early intervention, they can also assist with evaluation, policy, and 

enforcement efforts in the schools. 

Last month, I heard the story of a student who barged into a student assistance counselor’s office acting confused and incoherent. 

The counselor found out that she had taken prescription drugs that 

were not prescribed to her, along with LSD, and determined that 

she was in a drug-induced psychosis. The girl was taken to a hospital by ambulance where she stayed for 3 weeks. She is now back 

in school but needs to take lithium, which is usually prescribed for 

people with bipolar disorder, to remain stable enough to stay in 

school. She is still having crying bouts and difficulty handling 

stress. The boy who gave her the drugs has been released from 

prison and is allowed to attend school with an ankle monitor. Two 

lives connected by prescription drug abuse resulted in both having 

diminished chances for future success. 

While Rhode Island is just beginning to address the complex 

issues related to prescription drug abuse among teens, I believe one 

of our more effective prevention mechanisms will be the student assistance program. These highly trained counselors are onsite where 

access for students is easy and confidential. Collectively, the student assistance program, working in tandem with community coaliVerDate Nov 24 2008 12:33 Jan 09, 2012 Jkt 071663 PO 00000 Frm 00021 Fmt 6633 Sfmt 6633 S:\GPO\HEARINGS\71663.TXT SJUD1 PsN: CMORC
18 

tions, has been successful in reducing the use and abuse of alcohol 

and tobacco. I have every reason to believe that continuing and expanding the student assistance program, along with coalitions 

through the drug-free communities program, will help communities 

handle the complexity of prescription drug abuse among teens. 

I have provided more comprehensive recommendations in my 

written statement, but in the interest of time, I would like to focus 

on the one that is the most critical. I believe that with drug use 

on the rise and the elimination of the safe and drug-free schools 

and communities program, the Federal Government should focus 

more emphasis and funding on community and school-based substance abuse prevention and intervention strategies and programs 

by explicitly requiring that drug prevention and intervention programming be adequately included in the reauthorization of the Elementary and Secondary Education Act and by fully funding the 

drug-free communities program. 

We have the potential to reduce the abuse of prescription drugs 

among youth in schools and communities throughout Rhode Island 

as well as nationwide. 

Thank you for the opportunity to testify. I would be happy to answer any questions you may have. 

[The prepared statement of Ms. Hosley appears as a submission 

for the record.] 

Chairman WHITEHOUSE. Thank you, Ms. Hosley. 

We will take Mr. Eadie’s statement first, and then we can ask 

questions as a panel. But I wanted to thank you for the quality of 

your testimony. For those who have not read it but have just listened to you, you gave a summary today, but your full statement 

will be a part of the record, and it will be extremely helpful. 

I wanted to also mention, specifically with respect to the recommendation that this be protected in the reauthorization of the 

ESEA, Senator Brown, who was here, has a very keen interest in 

all of this and has—I guess he has rotated off the HELP Committee now. I am not on the HELP Committee. We will be doing 

that bill in that Committee. And Senator Blumenthal is on that 

Committee as well. So Senators who have been here today—I guess 

Senator Klobuchar is not, but you have very good representation of 

that Committee here by, I guess, fortuity. So it was a good recommendation for you to make at this moment. 

Mr. Eadie, please proceed. 

STATEMENT OF JOHN L. EADIE, DIRECTOR, PRESCRIPTION 

MONITORING PROGRAM CENTER OF EXCELLENCE, BRANDEIS UNIVERSITY, WALTHAM, MASSACHUSETTS 

Mr. EADIE. Good morning, Chairman Whitehouse and Senator 

Blumenthal. Thank you for the opportunity to appear before you on 

behalf of the Center of Excellence for Prescription Monitoring Programs at Brandeis University. We thank you for the honor of testifying on this critical matter. 

The Center of Excellence seeks to help end the prescription drug 

abuse epidemic without compromising pain management or the legitimate prescribing of controlled substances. In collaboration with 

the Alliance of States with Prescription Monitoring Programs, the 

Center provides academically sound and practice-relevant informaVerDate Nov 24 2008 12:33 Jan 09, 2012 Jkt 071663 PO 00000 Frm 00022 Fmt 6633 Sfmt 6633 S:\GPO\HEARINGS\71663.TXT SJUD1 PsN: CMORC
19 

tion, evaluation, and expertise to prescription monitoring programs 

and other stakeholders. The center is funded by a grant from the 

Department of Justice Bureau of Justice Assistance. 

The urgency of our work is based upon our knowledge that: daily, 

50 people in our Nation die from unintentional prescription opioid 

overdoses; and, daily, 20 times that number are admitted to hospital emergency departments for opioid overdoses. 

At the Center of Excellence, we believe that we must improve our 

methods for identifying and interdicting prescription opioid abuse 

in order to slow down and reverse this epidemic’s ever rising toll. 

The rapid growth in States with prescription monitoring programs—and I am delighted to say that the number is now 48 

States. Five have just passed legislation in the last few weeks, and 

it has been signed. And we just have the District of Columbia and 

two States left—is a very hopeful accomplishment. The majority of 

these States have been authorized since 2003, when the Harold 

Rogers Prescription Drug Monitoring Programs Grant funding 

began—a program administered by the Department of Justice’s Bureau of Justice Assistance. Through that program, competitive 

grants have stimulated growth and enhancements among the 

PMPs. Important additional funding has been provided by the 

NASPER program until this new budget. That program, administered by the Substance Abuse and Mental Health Services Administration, is a formula grant program that has been important in 

assisting States’ prescription monitoring programs by supporting 

their operations. 

The continued operation of PMPs and the significant enhancements called for to address the prescription drug abuse epidemic 

appear to call for continuation and expansion of both unique programs. 

In addition to Federal funding support, we need a rapid evolution 

of the prescription monitoring programs into a new generation of 

even more effective systems, a new generation whose hallmark 

must become proactivity. The new generation will take advantage 

of technological advances and integrate them into the fabric of 

PMP operations. Many characteristics of the new generation are 

highlighted in the White House Office of National Drug Control 

Policy’s new Prescription Drug Abuse Prevention Plan, which you 

have discussed previously. 

In addition, interstate PMP data sharing is essential. This must 

be completed in order to create a national network of State prescription monitoring programs that are interoperable through the 

Prescription Monitoring Information Exchange Hub, known as the 

PMIX Hub, which BJA, the IJSI Institute, and the Alliance of 

States with Prescription Monitoring Programs have been working 

to establish for 6 years with support from our center. The Hub is 

operational today, and several States are in process of interconnecting. 

In addition, we need to work on the following issues: 

We must increase the proactive reporting to prescribers across 

the Nation where PMPs analyze the data within their databases 

and send it out when they identify potential problems and let prescribers and, for that matter, pharmacists know what is going on. 

20 

We also have other changes to make within the systems. You 

have touched on some of them already. 

Making data more timely. Oklahoma is pioneering such an effort 

today. Starting in April, they have got point-of-sale data going into 

their systems. 

Making access seamless, using electronic health records as a way 

of doing that. 

Combining prescription monitoring programs and e-prescribing, 

which you have discussed, is an important element and a new element. 

Considering with public and private third-party payers the value 

of mandating prescribers to assess PMP data prior to issuing the 

first controlled substance prescription and periodically thereafter 

as a condition of payment. 

In addition, we need to increase the requested reports and 

proactive use of the data for pharmacies. We need to also develop 

a verification system that PMPs would carry out to tie to dispensing, to make sure that the requirements—for example, if there 

is mandatory physician education, the prescription monitoring program should assure that that is being accomplished, that prescribers who are not trained are not going to prescribe, or if they 

do, report effectively. 

We need to also—and I cannot emphasize this enough. We need 

to increase and improve the access that law enforcement agencies 

have to prescription monitoring program data, both in terms of solicited reports where they request reports and in terms of unsolicited reports where the PMPs proactively identify problems and 

send them out. The same thing is true for health professional licensing agencies. 

There are other users of PMP data who need to be involved that 

are not currently involved. Just as an example, the Indian Health 

Services, Veterans Administration, and Department of Defense 

health care systems need to be integrated. And I know you have 

talked about that already, but this system has to be beyond that 

because it is not just the integration of VA and Department of Defense. It is the access to the other prescriptions issued for the same 

individuals in those systems who may be going outside to get cash 

paid prescriptions, which compounds and confounds what is going 

on within the VA system or the Department of Defense, and they 

are blind to it at the moment. 

We need to develop an early warning system, and PMPs have the 

capability of doing just that. 

We need to develop greater concern for youth. Our initial analysis identified significant concerns there. 

And we need to talk about mandatory prescriber education. It is 

from my perspective exactly important, and I recommend it highly 

to you. 

[The prepared statement of Mr. Eadie appears as a submission 

for the record.] 

Chairman WHITEHOUSE. Thank you, Mr. Eadie. I appreciate it. 

And thank you, Ms. Hosley. 

Your work in Rhode Island must have exposed you to some pretty well informed views about where it is that youngsters, in particular teenagers, are getting access to these prescription drugs. 

21 

And if you could comment a little bit about that and particularly 

how some of the earlier testimony about the need to improve on the 

regime of disposal could help this, because as I understand it, 

throwing them down the drain risks creating environmental problems, leaving them in the cabinet risks creating abuse or encouraging abuse, and there really is no clear third option that most 

Rhode Islanders are aware of. 

Ms. HOSLEY. Well, as I wrote in my statement of record, students 

seem to know who are getting their wisdom teeth pulled and who 

might have access to painkillers especially. We hear that in schools 

kids have access to Adderall. So it seems to be something where 

the students may share the medications that they are prescribed, 

but also are getting it from medicine cabinets, from their parents 

and grandparents. I think just the fact that these prescriptions are 

overprescribed, they do tend to be sitting in people’s homes. 

So I think that increasing awareness is huge, and when we had 

the take-back program, we made sure that we publicized it in the 

papers and that we put it on the list serves to go to home to all 

the parents so that they were aware that there was a way for them 

to get the medications to a place to properly dispose of them. 

I think the fact that they cannot just go at any time is a little 

difficult. I know I missed that date and still have some prescriptions sitting at home. But I heard that next year it might be twice 

in the next year. So at least if we had some type of mechanism in 

place for the disposal, that would help, but we really do need to increase the awareness. 

You know, with funding such as the drug-free communities, we 

can put a multi-pronged strategy in place for whichever drug we 

are focusing on, and I do not think we have really done that yet 

as far as prescription drugs go. It is something we need to do, but 

I think that all the communities need to do it and not just certain 

ones who are able to get additional funding. 

Chairman WHITEHOUSE. We have the good fortune in Rhode Island to have one of the largest pharmacy companies in the country 

headquartered right in Woonsocket—CVS—and perhaps you and I 

could work together with them once the regulations are finally 

through their Federal administrative rulemaking process, either at 

the end of the year or early next year, as DEA Director Leonhart 

suggested, and work with them on perhaps taking a leadership role 

in this area. So I look forward to working with you on that. 

Mr. Eadie, the States tend to manage these prescription drug 

monitoring programs. There has been a relatively limited Federal 

role other than the grantmaking role. Interoperability has come up 

as an area where it might be suitable for the Federal Government 

to provide some support and some guidance to these State-based 

programs. 

It appears that their State base actually is an asset in terms of 

awareness of local conditions, comfort about privacy and security 

issues, and things like that. Without taking those elements away, 

without making this something other than the State-based program that it is and has been, are there other ways than the interoperability where you think that the Federal Government could 

have a helpful role in supporting and guiding what would remain 

22 

under this model a State-driven prescription drug monitoring program? 

Mr. EADIE. Chairman Whitehouse, I think there is a role. I think 

that things we—in mandatory education, for example, if that is required, then it should be a corollary that prescription monitoring 

programs should build into their system an ability to track that 

and make sure that the trained physicians are the ones who are— 

and dentists, for that matter, and other prescribers, are the ones 

who are actually prescribing. That is a simple thing. 

Now, the larger question is how to involve the Federal Government without disrupting the value of the State-based systems, and 

the responsiveness that you have indicated is extremely important. 

Innovation is also important. Without State-run programs, we 

would not have the electronic prescription systems available to doctors today. That was an innovation that started with the State of 

Nevada just a little over a dozen years ago, and it is now widespread across the Nation. I mentioned Oklahoma as an example. 

They are starting point of sale. They are pioneering that effort. 

Massachusetts is pioneering efforts today for electronic health 

records integration. They also have an electronic-prescribing system testing in western Massachusetts, which you may or may not 

be aware of, but it was approved with a waiver by the Drug Enforcement Administration. It is funded by the Administration for 

Health Research and Quality. It is a small-scale project, but it has 

demonstrated that electronic prescribing by physicians can be operational and is effective, and that is ongoing today. It is actually 

operational at the moment. And we have been party to that and 

supporting that as it goes forward, and I think there is a major role 

for the future for that. 

I think that electronic prescribing should be integrated with 

PMPs. At the moment that is not possible because it does not exist. 

But it should be integrated as quickly as possible, and I think that 

Federal funding support, which indicates support for that initiative, is important. 

In short, I think that broad guidelines of criteria or of guidance 

are valuable. Being too specific at the Federal level, which is a 

tendency to anchor into Federal law or regulations specific things 

that States should do, will ossify the systems at a point today 

where the technology is rapidly evolving. We cannot afford to have 

anything that is rigid. But there can certainly be guidelines. There 

can certainly be statements of encouragement. There can be, in effect, minimal guidance such as States that are receiving Federal 

funding for PMPs should have built into them interoperability with 

them and other States. There should be or could be—the same 

thing as it relates to e-prescribing and other things—broad categories of requirements without specifics so that we can innovate, 

we can create, we can go forward. 

Chairman WHITEHOUSE. OK. Well, we are certainly interested in 

that in Rhode Island because, as you know, we are one of the top 

e-prescribing States in the country. 

Mr. EADIE. Yes. 

Chairman WHITEHOUSE. We sort of go back and forth with Massachusetts as to who claims to be No. 1. 

Mr. EADIE. Exactly. 

23 

Chairman WHITEHOUSE. And we are advanced enough in electronic health records that we are actually looking at a statutory 

health information exchange. And as we speak, data is actually 

flowing through something called Current Care in Rhode Island so 

that it is being populated automatically into electronic health 

records outside of a single corporation but across entities. So we 

look forward to working with you on those ideas, and I think if we 

can do that, then people who are at the front lines working with 

kids like Ms. Hosley will have an additional, as Senator 

Blumenthal said, tool in their toolbox. 

And with that, Senator Blumenthal. 

Senator BLUMENTHAL. Thank you, Mr. Chairman, and thank you 

both for being here from Massachusetts and Rhode Island, and 

thank you both for your work in this area. And I hope that folks 

in Rhode Island know how active and aggressive Senator Whitehouse has been with his background in law enforcement, but also 

his leadership in really moving the Judiciary Committee to take 

cognizance and take action in this area. 

I want to ask you about some of the potential actions that drug 

companies themselves could take in the area of discouraging or 

stopping drug abuse, apart from improving the monitoring programs that exist in many States, particularly with respect to painkillers, whether there are actions that can be taken to provide for 

greater safeguards in these areas. 

As you well know, OxyContin has been a continuing problem, 

oxycodone. There was an action by the Department of Justice and 

States, including Connecticut while I was Attorney General, relating to OxyContin. And the failure of the company that produces it 

to really follow perhaps more responsible measures in the marketing and selling of the pills that were subject to pain release 

mechanisms. And I do not want to single out, because it would be 

unfair to do so, any one company, but I wonder if you could give 

us your observations as folks who are dealing firsthand, on the 

ground, in the trenches, with this problem about actions that you 

see the pharmaceutical drug companies themselves potentially taking to reduce this problem. 

Ms. HOSLEY. I am not sure whose responsibility it would be, but 

perhaps if a shorter timeframe was given when those prescriptions 

were prescribed so that they did not get a 30-day prescription for 

having their wisdom teeth removed and maybe had a 3-day with 

the option to renew. I think there is too much medication out there, 

and I think it is way beyond what needs to be out there, and that 

just invites the misuse and abuse of the drugs. 

Mr. EADIE. I would recommend great care in the way in which 

funding from the manufacturers might be considered. Perhaps in 

the prevention area, the substance abuse prevention area, it would 

be helpful for having funding available. It certainly is an area 

where they have a need to share responsibility for what has happened with the use of their drugs. 

When it comes to issues closer to regulatory activities and things 

like the prescription monitoring programs, I think that one has to 

be very careful about considering funding that is perhaps voluntary 

or so-called voluntary. I can give the example of our own situation 

at the Center of Excellence. We were approached by a major drug 

24 

manufacturer in our first month of existence and asked if we would 

be willing to collect data from prescription monitoring programs 

and provide it to them for their RIMS obligation as it related to 

a new product they were bringing on the market, a new controlled 

substance product. And we thought about it carefully and decided 

that we could not do that in good faith because, No. 1, there would 

be the appearance perhaps of conflict of interest on our part to do 

that; and second would be the potential reality of it—that is, there 

would be no way we could look at the data without knowing somewhere in the back of our minds that how we analyzed the data, the 

way we presented it, the kinds of charts we produced, the analysis 

we stated, all could be inadvertently influenced by our knowledge 

that future funding would rest on how happy that manufacturer 

would be with the reports we produced. 

When we said no, thanked them, they came back with a counter 

proposal that we then serve in that capacity with 21 drug manufacturers, the ones working with the FDA on the RIMS project for the 

class-wide RIMS for the extended-release opioids. And we thought 

about that again. There was great value in collecting the data from 

the States. We still want to do that. It is very important to collect 

the data and analyze it. We know that from experience. But once 

again, the two caveats that I mentioned a moment ago came back 

to our cognitive function as we thought about it very carefully, and 

we thought about how easily a word change can be made in a document from a word that is choice of phrase, choice of how things are 

presented, there would be no way that we could protect ourselves 

against the thought in the back of our minds that next year’s 

money would be dependent on how happy these manufacturers are 

with what we produce. And so we ultimately thanked them but 

said no. 

Having said that, I think that applies generally across the board 

to any of the prescription monitoring program activities that States 

are involved with. I honor what the Florida State Legislature has 

just done in passing a law that refuses to allow their prescription 

monitoring program to accept funds from drug manufacturers, either directly or indirectly. I think that was a major step forward. 

As you probably know, there was $1 million offered to them by a 

drug manufacturer. But let me give you examples. 

We know that there are drug manufacturers that have been very 

active in supporting prescription monitoring programs for the last 

decade. But if you read their materials very carefully, there is no 

provision within that for the kind of proactive analysis of data and 

distribution of that data that is absolutely essential for prescription 

monitoring programs to go forward, particularly as it relates to law 

enforcement. And there is also—there has been in recent years a 

number of States that have enacted laws that have provided restrictions on law enforcement that extend to requiring court orders, 

requiring subpoenas, requiring a variety of what amount to, in our 

view, inappropriate restrictions on law enforcement’s access to the 

data. 

And so I think that there is room for manufacturers on the other 

hand to contribute to a fund that might be Congressionally mandated like the Food and Drug Administration establishes a fund 

that pays for its costs and which manufacturers are mandated to 

25 

contribute to that fund, and the fund is then used to cover the costs 

of the FDA in reviewing and approving their drugs. 

Why couldn’t, why shouldn’t there be an equivalent fund established by mandate of the Federal Congress to drug manufacturers 

to contribute significantly to the funds necessary to operate these 

prescription monitoring programs? They benefit by it extraordinarily. There is no reason why they cannot and should not contribute to the solution to the problems created by their drugs. 

Senator BLUMENTHAL. Well, I thank you for that answer. My 

time is up, but I look forward to working with both of you, and I 

want to say that the maker of OxyContin, by the way, has taken 

some very responsible steps. Purdue Pharma has taken some very 

important leadership steps in reason to these problems. And one 

area where I was thinking more could be done is in providing 

warnings, perhaps in restricting the length or amount of prescriptions as you have suggested, Ms. Hosley. But I look forward to 

working with you, and, again, thank you, Mr. Chairman, for your 

work in this area. 

Chairman WHITEHOUSE. Thank you, Senator Blumenthal. 

Let me thank my colleagues Senator Brown, Senator Klobuchar, 

and Senator Blumenthal all for participating in this hearing and, 

I guess, wrap up by saying how impressed I think we all have been 

by the information that we’ve heard today about the epidemic nature of the prescription drug problem and the rapid rate at which 

it is growing and affecting our emergency rooms, affecting our families, affecting our schools, affecting our communities. The areas 

that appear to need further attention and effort include public 

awareness, and I was glad that the Director of the Office of National Drug Control Policy, Director Kerlikowske, was here to talk 

about his efforts in that regard. 

We appear to need to better coordinate our law enforcement resources, although it does appear that the prescription drug monitoring programs stand out as a growing and effective State-based 

vehicle for addressing this problem, but one that could be strengthened with further integration with electronic prescribing, further 

integration with electronic health records, some integration, beginning integration with the VA, Department of Defense, and Indian 

Affairs health systems, and improved interoperability State to 

State. So those seem to be worthy goals that come out of this hearing. 

The last is that we do not seem to be in a very good place yet 

with respect to the disposal of unused controlled pharmaceuticals, 

that throwing them down the drain creates one set of problems, 

leaving them in the cabinet creates another set of problems. And 

we have not really developed a robust system for finding other 

ways to dispose of them, and we look forward to working particularly with the pharmacy and pharmaceutical industry to come up 

with solutions since it is their product that ultimately is at the 

heart of this problem. 

So I appreciate Director Kerlikowske and Director Leonhart for 

taking their time and sharing with us their expertise this morning. 

I appreciate very much Ms. Hosley’s testimony and her work in 

Rhode Island on the ground with the kids who are at the center 

of our attention really today, and Mr. Eadie for your many years 

26 

of service. I think that you are sort of the father or uncle, or whatever you would call it, of the PDMP movement, and clearly it is one 

of the success stories that we want to build on as we continue to 

move forward and address this epidemic. 

We will keep the record of this hearing open for an additional 7 

days, an additional week, if anybody wishes to add anything to the 

record. And other than that, the hearing will adjourn, and thank 

you very much for your testimony. 

[Whereupon, at 10:31 a.m., the Subcommittee was adjourned.] 

[Questions and answers and submissions follow.] 

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