Prescription Drug Abuse

Federal policymakers are seeking to address prescription drug abuse, and have particularly focused on abuse and diversion of prescription opioids.  This page contains information on major activities that federal policymakers are taking to address this problem. 

Opioid Risk Evaluation and Mitigation Strategies

Prescription Drug Monitoring Programs (PMPs) 

Office of National Drug Control Policy's (ONDCP) 2011 Prescription Drug Abuse Prevention Plan

Centers for Disease Control and Prevention

Opioid Risk Evaluation and Mitigation Strategies

In April 2011, the Food and Drug Administration (FDA) announced the elements of REMS for long-acting and extended-release opioids.  According to the FDA, REMS is a "risk management plan that FDA can require a drug company to develop and implement to manage serious risks associated with a drug."  Under the Food and Drug Administration Amendments Act of 2007, the FDA may require a manufacturer to develop and implement REMS when the FDA finds it is necessary to ensure that the benefits of a drug outweigh its risks. REMS may include a Medication Guide, communication plan or other elements to supplement a drug's written prescribing information.  

The FDA will eventually require that all long-acting and extended-release opioids have REMS. For these opioids, the FDA requires drug manufacturers to develop an education program for prescribers and patients. Educational materials may be provided directly to prescribers or through CME providers.  Prescriber education will be voluntary and will include information on the risks and benefits of opioids, choosing and monitoring patients, counseling them on safe use of opioids and how to identify opioid misuse, abuse and addiction. Drug manufacturers will provide prescribers with educational materials to give to patients on safe use and storage of opioids. Patients will also receive Medication Guides on safe use of the drug when they pick up their prescriptions. 

• FDA Website on Opioid REMS
• ASA Comment Letter to FDA on Opioid REMS - 06/30/09
• ASA Comment Letter to FDA on Draft Blueprint for Prescriber Education Under Opioid REMS - 12/07/11

Prescription Drug Monitoring Program (PMPs)

PMPs are important clinical tools for our members delivering high quality care to acute and chronic pain patients.  PMPs are state databases that track patients' prescriptions, with the goal of detecting and preventing the diversion and abuse of prescription drugs.  These programs allow health care providers to access prescription history information to identify patients who are 'doctor shopping' and make more informed decisions about whether or not to prescribe controlled substances. 

There are two sources of federal funding of PMPs.  The National All Schedules Prescription Electronic Reporting Act (NASPER), enacted in 2005, is a program administered by the U.S. Department of Health and Human Services that awards grants to states to establish and improve PMPs.  NASPER also intended that state PMPs meet minimum criteria and be capable of exchanging information with other state PMPs.  Congress authorized $15 million each year for fiscal years 2006 and 2007, and $10 million each year for fiscal years 2008 through 2010.   In fiscal years 2009 and 2010, Congress appropriated $2 million in funds for NASPER. Congress has not yet authorized funds to support NASPER grants in FY 2012. 

The Harold Rogers Prescription Drug Monitoring Program (HRPDMP) is administered by the U.S. Department of Justice and provides grants in planning, implementation, and enhancement of PMPs.  The primary purpose of HRPDMP is to enhance the capacity of regulatory and law enforcement agencies to collect and analyze data on prescriptions for controlled substances.  Since its inception in 2002, HRPMDP has awarded grants to 47 states and 1 U.S. territory.  For FY 2011, the program received approximately $5.6 million in funding.                                                                                                
          

Learn more about state PMPs. 

• ASA Urges House Committee to Take Up H.R. 866, the NASPER Reauthorization Act of 2011 (11/7/11)

Office of National Drug Control Policy's (ONDCP) 2011 Prescription Drug Abuse Prevention Plan

In April, ONDCP released the Obama Administration's 2011 Prescription Drug Abuse Prevention Plan, entitled, Epidemic: Responding to America's Prescription Drug Abuse Crisis, which provides a comprehensive action plan to address prescription drug abuse, and particularly abuse and diversion of prescription opioids.  The plan recognizes that opioids are an important tool to relieve patient suffering, and any policy that aims to minimize prescription drug abuse must still assure patient access to the drugs they need. To achieve this goal, the action plan calls for federal departments and agencies to take action in four major areas:  education, monitoring, proper medication disposal, and enforcement. View the action plan. 

The National Center for Injury Prevention and Control at CDC works to prevent injury resulting from prescription drug abuse. Learn what CDC is doing to reduce injury and death from this epidemic.

CDC materials on prescription drug abuse:

• "Policy Impact: Prescription Painkiller Overdoses" - provides an overview of the problem and CDC's recommendations.
• "Vital Signs: Prescription Painkiller Overdoses in the US" - provides data on prescription drug overdoses and what health care providers can do to help.