H. Westley Clark M.D., J.D., M.P.H.
Center for Substance Abuse Treatment
Substance Abuse and Mental Services Administration
U.S. Department of Health and Human Services
The Use and Utility of Prescription Drug Monitoring Programs
Energy and Commerce Committee
Subcommittee on Oversight and Investigations
United States House of Representatives
Wednesday October 24, 2007
Mr. Chairman and members of the Subcommittee, my name is Dr. H. Westley Clark, and I am the Director of the Center for Substance Abuse Treatment within the Substance Abuse and Mental Health Services Administration (SAMHSA), an agency of the Department of Health and Human Services (HHS). I am testifying on behalf of our Administrator, Terry Cline, Ph.D., who was not able to be here.
I am here to talk about electronic monitoring systems and how these systems have helped States and the Federal Government address non-medical use of prescription drugs.
Non-medical Prescription Drug Use
In February, John Walters, the Director of the White House’s Office of National Drug Control Policy (ONDCP) stated, “Millions of Americans benefit from the tremendous scientific achievements represented by modern pharmaceutical products. But, when abused, some prescription drugs can be as addictive and dangerous as illegal street drugs.”
Combined data from the Reports for 2002 to 2006 of SAMHSA’s National Survey on Drug Use and Health (NSDUH) indicate that an annual average of 4.7 percent of persons aged 12 or older (an estimated 12.6 million persons) used a prescription pain reliever non-medically in the 12 months prior to the survey. In 2006, 2.1 percent of persons aged 12 or older (about 5.2 million persons) used a prescription pain reliever non-medically in the month prior to the survey. Current non-medical use of pain relievers between 2005 and 2006 was statistically unchanged. In the survey, “non-medical use” of these drugs was defined as use without a prescription of the individual’s own or simply for the experience or feeling the drugs caused. The 2006 survey found that males were more likely than females to have used a prescription pain reliever non-medically in the past year (6.1 vs. 4.3 percent). Young adults aged 18 to 25 had the highest rate of past year non-medical use, at 12.4 percent, compared to 7.2 percent for ages 12 to 17, 7.4 percent for ages 26 to 34, and 2.7 percent for ages 35 and above.
In addition, the NSDUH reported that in 2006, among persons aged 12 or older, 2.2 million initiated non-medical use of prescription pain relievers within the past year. That is about the same as the estimated number of initiates for marijuana.
Where are People Obtaining Their Drugs?
The 2006 NSDUH also revealed where people were obtaining their prescription drugs. Nearly 56 percent of the past year non-medical users of prescription pain relievers obtained the drugs free of charge from a friend or relative, 19.1 percent from a single doctor, 14.8 percent bought or took them from a relative or friend, 3.9 percent bought them from a drug dealer or other stranger, 1.6 percent got them from more than one doctor, less than 1 percent reported getting them from the internet, and 4.9 percent got them from other sources, including a fake prescription, or stole them from a doctor’s office/clinic/hospital/pharmacy.
SAMHSA is responding, along with other agencies across the government, to address the non-medical use of prescription drugs, which now ranks second, only behind marijuana as the Nation’s most prevalent illegal drug.
According to SAMHSA’s Treatment Episode Data Set (TEDS), treatment admissions for abuse of opiates other than heroin, such as morphine, oxycodone, and hydrocodone, represented approximately 16,000 of all primary opiate admissions in 1995 and rose to about 68,000 in 2005. Opiates other than heroin represented 21 percent of all primary opiate admissions in 2005, up from 7 percent in 1995.
The emerging challenge of prescription drug abuse and misuse is a complex issue that requires epidemiological surveillance, distribution chain integrity, interventions, and more research by the private and public sectors. Thus, no organization or agency can address the problem alone; a coordinated response is required. The Federal Government, medical partners, public health administrators, State legislators, and international organizations all are needed to implement educational outreach and other strategies targeted to a wide swath of distinct populations, including physicians, pharmacists, patients (both intended and inadvertent), educators, parents, high school and college students, high risk adults, the elderly, and many others. Outreach to physicians and their patients and pharmacists needs to be complemented by education, screening, intervention, and treatment for those misusing or abusing prescription drugs.
Prescription drug monitoring programs (PDMPs) are among the most important components of government efforts to prevent and reduce controlled substance diversion and abuse. Prior to Fiscal Year (FY) 2002, there were 15 States operating PDMPs. Beginning in FY 2002, Congress appropriated funding to the Department of Justice (DOJ) to support PDMPs. Since the inception of the DOJ program, called the Harold Rogers Prescription Drug Monitoring Program, (Rogers PDMP or Rogers Program), this funding opportunity has resulted in 21 States receiving new program grants and 13 States netting planning grants. There are now 25 States operating PDMPs and 8 States with legislation in place to establish a program. Nearly all of the 33 States have received funding through the Rogers Program. (Rhode Island has never applied for funding.) Out of the States that have enacted PDMP legislation, 24 States have legislative authority to provide reports to physicians or prescribers, 26 to licensing boards, 21 to pharmacies, and 29 to law enforcement. Currently, six States have established agreements with other States. As these programs mature, the number of States who are sharing information with other States continues to grow. It should be noted that some States collect more than only controlled substances information, and some States have different substances in their schedules than those set out in the Controlled Substances Act.
Although PDMPs vary from State to State, the majority of these types of programs are administered by a law enforcement agency in conjunction with a state board of pharmacy or through professional licensing boards. All States receiving Rogers PDMP funding are encouraged to exchange data. Collaboration is an important aspect of these activities, and grantees must develop a team of law enforcement and health care professionals and collaborate with other public and private agencies and organizations.
The Bureau of Justice Assistance (BJA) within DOJ’s Office of Justice Programs administers the Rogers Program along with DEA’s Office of Diversion Control and ONDCP. The National Alliance for Model State Drug Laws provides technical assistance to states that either have a PDMP or intend to establish one. Every PDMP that receive funding through the Rogers Program must provide performance data on: reducing the rate of “inappropriate use of prescription drugs”; reducing the quantity of pharmaceutical controlled substances obtained by individuals attempting to engage in fraud and deceit (i.e., “doctor shopping”); and increasing coordination among PDMP partners (e.g., regulatory, health, law enforcement agencies).
All share the following common objectives:
- To educate and inform practitioners and the public;
- To develop and advance public health initiatives;
- To facilitate early identification and intervention in cases of drug misuse or abuse;
- To aid investigations and law enforcement; and
- To safeguard the integrity and access to the programs database.
Education and Information A major goal of many PDMPs is the provision of information and feedback to practitioners and the public. For example, data gathered through these systems is used to identify and analyze prescribing trends within geographic regions, medical specialties or drug classes permitting agencies to provide appropriate information or training at the right time.
Public Health Initiatives States use the information obtained from the review and analysis of monitoring data in the development of public health initiatives. Information on trends in prescribing and dispensing can be used to assist in addressing problems such as under- and over-utilization and inappropriate prescribing. Some States use monitoring information as the basis for initiation of education and prevention programs, formulation of laws and regulations, development of controlled substances policies, and establishment of practice and treatment guidelines. One advantage of prescription drug monitoring is that initiatives can be targeted to selected subsets of healthcare practitioners.
Early Intervention and Prevention Another goal of these monitoring programs is early intervention and prevention of drug misuse. PDMPs can help physicians detect patients who may be abusing prescriptions sooner than would be possible with other forms of information gathering.
Investigations and Enforcement Existing DOJ-funded State programs have demonstrated a strong track record of assisting law enforcement and regulatory agencies to identify and respond to some illegal activity associated with prescription drugs. The systems make prescription records accessible at a single site, often computerized database, and thereby facilitate the gathering of evidence with minimal or no intrusion on practitioners and pharmacies. Similar to public health agencies, law enforcement can use information on trends in prescribing and dispensing to assist addressing problems such as identifying online Internet sales or finding suspicious prescribing patterns which may merit further investigation.
Confidentiality It is imperative that confidentiality protections are strictly enforced, so as to protect the patient, and that the systems work in conjunction with Health Insurance Portability and Accountability Act security and privacy provisions.
In recognition of the importance of the systems and the need for education and information, recently, the BJA within DOJ collaborates with SAMHSA through a multi-year grant to the SAMHSA-funded National Addiction Technology Transfer Center for an Educational Collaborative for Prescription Drug Monitoring Program Initiative. This initiative was created to enhance the linkages between the DOJ Prescription Drug Monitoring Programs and State-funded and -licensed addiction treatment systems. The goal of the project is to:
- create electronic profiles between the PDMPs and the State-funded treatment system;
- develop a guide for family practice physicians and pharmacists describing the signs and symptoms of prescription drug abuse;
- develop a guide for family practice physicians outlining the skills for screening, intervening and referring individuals to treatment for prescription drug use disorders; and
- develop a marketing plan to assure dissemination of these products and resources.
Although we do not yet have results from this grant, we are hopeful that the goals of the project will be met and will help with future efforts around establishing and enhancing PDMPs. Recognizing the fact that electronic monitoring systems are not the only answer, focus has expanded to the proper use of prescription drugs. Many individuals who receive prescriptions for pain because of surgeries, dental work, or back pain leave the drugs in their medicine cabinets or other places in the house for extended periods of time. The Federal Government in February of this year issued guidelines for proper disposal of prescription drugs. These guidelines urge Americans to:
- Take unused, unneeded, or expired prescription drugs out of their original containers;
- Mix the prescription drugs with an undesirable substance, like used coffee grounds or kitty litter, and put them in impermeable, nondescript containers, such as empty cans or sealable bags, further ensuring that the drugs are not diverted or accidentally ingested by children and pets;
- Throw these containers in the trash;
- Flush prescription drugs down the toilet only if the accompanying patient information specifically instructs it is safe to do so; and
- Return unused, unneeded or expired prescription drugs to pharmaceutical take-back locations that allow the public to bring unused drugs to a central location for safe disposal.
The President’s Fiscal Year (FY) 2008 budget request for SAMHSA includes $1.76 billion for the Substance Abuse Prevention and Treatment Block Grant, of which 20 percent is a mandatory set-aside for substance abuse prevention. These funds are directed to specialty treatment providers, many of whom provide treatment for abuse and dependence of prescription drugs. The President’s FY 2008 budget also includes nearly $504 million in prevention and treatment discretionary grants, including Access to Recovery (ATR) and Screening, Brief Intervention, Referral and Treatment (SBIRT) programs.
The Access to Recovery program was launched in August 2004 with the announcement of grants to 14 States and one tribal organization. Since then, more than 170,000 people with substance abuse problems have received treatment and/or recovery support services, exceeding the three-year target of 125,000 people. In September 2007, 24 new Access to Recovery grants were awarded to 18 States, five tribal organizations, and the District of Columbia to increase access to clinical treatment and recovery support services for an estimated 160,000 individuals over the three-year grant period.
As I stated earlier in my testimony, the emerging challenge of prescription drug abuse and misuse is a complex issue that requires epidemiological surveillance, distribution chain integrity, interventions, and more research by private and public sectors. It requires a concerted effort by many, and electronic monitoring systems are a key part of the response along with treatment and prevention programs that include outreach and education. SAMHSA is committed to allowing its programs to give States and local authorities flexibility in meeting drug-related challenges their communities face, including the mounting problem of prescription drug abuse. Our strategies in prevention and treatment of prescription drug abuse are both targeted specifically to the prescription drugs themselves and to programs that enable prevention, intervention, and treatment of addictions, which can have a significant long-term impact on prescription drug abuse and misuse.
Thank you for this opportunity to present this information to you. I would be pleased to answer any questions you may have.
Last revised: April 19, 2011