The Prescription Drug Epidemic: A Federal Judge S Perspective
Arnau Cyr
In addition, the Strategy directs federal agencies to expand efforts to prevent substance use among school-aged children and young adults, and support community-led coalitions implementing evidence-based prevention strategies across the country. It directs federal agencies to expand scientific understanding of the recovery process by establishing a federal recovery research agenda; adopt flexible, responsive approaches that help people with SUD find and follow a pathway to recovery or remission that works for them; and eliminate barriers and increase economic opportunities for people in recovery. And the Strategy includes specific actions to improve access to medication for opioid use disorder (MOUD) programs for jails and prisons; identify ways to advance racial equity in the investigation, arrest, and sentencing for drug related offenses without negatively impacting public safety; divert non-violent individuals from the criminal justice system and juvenile justice systems to treatment when appropriate; and remove barriers and expand supportive services to help reintegrate people into society after incarceration.
NIDA funded scientists are actively seeking solutions through the NIH HEAL (Helping to End Addiction Long-Term) initiative. In addition, to support those who work with juveniles and adults within the court system, including judges, counselors, social workers, case workers, and others, NIDA has created materials and has identified other helpful resources that can be used in educating offenders and those who work with them about the science related to drug use, misuse, and addiction.
The National Prescription Drug Take Back Day aims to provide a safe, convenient, and responsible means of disposing of prescription drugs, while also educating the general public about the potential for abuse of medications.
Late Friday, less than 10 months after the US Supreme Court overturned Roe v. Wade, a federal judge in Texas known for his strong anti-abortion views handed down a decision in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration that attempts to revoke FDA approval for mifepristone. Mifepristone is used, along with misoprostol, in the most common medication abortion regimen in the United States.
NIDA sponsors a virtual town hall meeting, bringing together representatives from key federal agencies involved in preventing and combating substance abuse in the United States. Participants were linked via satellite from Washington, DC, to Camden, Maine, where members of five local communities, as well as community leaders from Freeport, Illinois, and Quincy, Washington, talked about their success in implementing the Communities That Care (CTC) system aimed at keeping youth safe from drugs.
NIDA launches PEERx, an updated prescription drug section on its teen Web site for teens to find interactive videos and other tools that help them make decisions about abusing prescription drugs based on real life situations they encounter at school and in life.
The Division of Therapeutics and Medical Consequences (DTMC) plans and directs studies necessary to identify, evaluate, develop, and obtain FDA marketing approval for new medications and devices to treat Substance Use Disorders (SUDs) and related medical and psychiatric conditions. The Division develops and administers a program on basic and clinical research to (a) develop innovative pharmacological and non-pharmacological approaches to treat SUDs and related medical and psychiatric conditions and (b) investigate the medical consequences of drug abuse, including HIV/AIDS. DTMC supports research to identify valid and reliable outcome measures for clinical trials of therapeutics for SUDs. The Division also supports training in the pre-clinical and clinical research of therapeutics for SUDs. DTMC implements its research program through collaborations with (a) the pharmaceutical sector in both the United States and abroad, and (b) other federal therapeutic development programs. It also works closely with FDA in assuring that research designed to demonstrate the clinical efficacy of new compounds is evaluated and approved in an expeditious manner. Finally, the Division disseminates the knowledge acquired by the DTMC funded research.
In 2007, approximately 27,000 unintentional drug overdose deaths occurred in the United States, one death every 19 minutes. Prescription drug abuse is the fastest growing drug problem in the United States. The increase in unintentional drug overdose death rates in recent years (Figure 1) has been driven by increased use of a class of prescription drugs called opioid analgesics (1). Since 2003, more overdose deaths have involved opioid analgesics than heroin and cocaine combined (Figure 2) (1). In addition, for every unintentional overdose death related to an opioid analgesic, nine persons are admitted for substance abuse treatment (2), 35 visit emergency departments (3), 161 report drug abuse or dependence, and 461 report nonmedical uses of opioid analgesics (4). Implementing strategies that target those persons at greatest risk will require strong coordination and collaboration at the federal, state, local, and tribal levels, as well as engagement of parents, youth influencers, health-care professionals, and policy-makers.
Some promising strategies exist for addressing these two high-risk groups. The first is use of prescription data combined with insurance restrictions to prevent "doctor shopping" and reduce inappropriate use of opioids. Users of multiple providers for the same drug, people routinely obtaining early refills, and persons engaged in other inappropriate behaviors can be tracked with state prescription drug monitoring programs or insurance claim information. Public and private insurers can limit the reimbursement of claims for opioid prescriptions to a designated doctor and a designated pharmacy. This action is especially important for public insurers because Medicaid recipients and other low-income populations are at high risk for prescription drug overdose. Insurers also can identify inappropriate use of certain opioids for certain diagnoses (e.g., the use of extended-release or long-acting opioids like transdermal fentanyl or methadone for short-term pain).
A second strategy is improving legislation and enforcement of existing laws. Most states now have laws against doctor shopping, but they are not enforced uniformly. In contrast, only a few states have laws regulating for-profit clinics that distribute controlled prescription drugs with minimal medical evaluation. Laws against such "pill mills" as well as laws that require physical examinations before prescribing might help reduce the diversion of these drugs for nonmedical use. In addition, a variety of other state controls on prescription fraud are being employed. For example, according to the National Alliance for Model State Drug Laws, 15 states required or permitted pharmacists to request identification from persons obtaining controlled substances as of March 2009.*
A public health approach to the problem of prescription drug overdose also should include secondary and tertiary prevention measures to improve emergency and long-term treatment. Overdose "harm reduction" programs emphasize broader distribution (to nonmedical users) of an opioid antidote, naloxone, that can be used in an emergency by anyone witnessing an overdose. Efforts also are under way to increase the ability of professionals responding to emergencies to administer optimum treatment for overdoses. Substance abuse treatment programs also reduce the risk for overdose death (15). Continued efforts are needed to remove barriers to shifting such programs from methadone clinics to office-based care using buprenorphine. Office-based care can be less stigmatizing and more accessible to all patients, especially those residing in rural areas.
When developing a national approach to address prescription drug overdose, any policy must balance the desire to minimize abuse with the need to ensure legitimate access to these medications, and its implementation must bring together a variety of federal, state, local, and tribal groups. The Administration's plan for addressing prescription drug abuse, Epidemic: Responding to America's Prescription Drug Abuse Crisis, which was released in April 2011, includes four components: education, tracking and monitoring, proper medication disposal, and enforcement.
The majority of health-care providers receive minimal education regarding addiction and might be at risk for prescribing an addictive medication without fully appreciating the potential risks. Therefore, the first component of the plan calls for mandatory prescriber education. This would require prescribers to be trained on appropriate prescribing of opioids before obtaining their controlled substance registration from the Drug Enforcement Administration (DEA). Parents and patients also must be educated about the dangers and prevalence of prescription drug abuse and how to use prescription drugs safely. To achieve this, the plan calls for a public/private partnership to develop an educational campaign directed at parents and patients.
The second component of the plan calls for prescription drug monitoring programs to be operational in all states and mechanisms to be in place for data sharing. As of May 2011, 35 states had operational monitoring programs, and 13 additional states had passed enacting legislation.
The fourth component calls on law enforcement agencies to help decrease prescription drug diversion and abuse. The majority of prescribers are responsible, but unscrupulous persons continue to operate outside of legitimate medical practice. These persons must be held accountable, and the plan outlines specific actions the federal government can take to help law enforcement agencies effectively address pill mills and doctor shopping.
Alternate Text: The figure above shows the percentage of patients and prescription drug overdoses, by risk group in the United States. Among patients who are prescribed opioids, an estimated 80% are prescribed low doses (
aa06259810