The Obama Administration has released a comprehensive action plan to address the national prescription drug abuse epidemic and announced new Federal requirements aimed at educating the medical community about proper prescribing practices.
The Administration's Epidemic: Responding to America's Prescription Drug Abuse Crisis provides a national framework for reducing prescription drug diversion and abuse by:
The plan is the culmination of six months of collaboration across the Federal government, with agencies including the Departments of Justice, Health and Human Services, Veterans Affairs, the Department of Defense, and others.
In support of the action plan, the Food and Drug Administration (FDA) today announced that it is requiring an Opioids Risk Evaluation and Mitigation Strategy (REMS). The new program will require manufacturers of long-acting and extended-release opioids to provide educational programs to prescribers of these medications, as well as materials prescribers can use when counseling patients about the risks and benefits of opioid use. The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require manufacturers to develop and implement a REMS to ensure the benefits of a drug or biological product outweigh its risks.
"Long-acting and extended-release opioid drugs have benefit when used properly and are a necessary component of pain management for certain patients, but we know that they pose serious risks when used improperly, with serious negative consequences for individuals, families, and communities," said FDA Commissioner Margaret A. Hamburg, M.D. "The prescriber education component of this Opioid REMS balances the need for continued access to these medications with stronger measures to reduce their risks."
Prescription drug abuse is our Nation's fastest-growing drug problem. The number of people who have unintentionally overdosed on prescription drugs now exceeds the number who overdosed during the crack cocaine epidemic of the 1980's and the black tar heroin epidemic of the 1970's combined.
In 2007, approximately 27,000 people died from unintentional drug overdoses, driven mostly by prescription drugs. Additionally, a ccording to the Substance Abuse and Mental Health Services Administration, the number of Americans in 2009 aged 12 and older currently abusing pain relievers has increased by 20 percent since 2002. Further, visits by individuals to hospital emergency rooms involving the misuse or abuse of pharmaceutical drugs have doubled over the past five years.
The Office of the National Drug Control Prolicy (ONDCP) is coordinating an unprecedented government-wide public health approach to reduce drug use and its consequences in the United States . This effort includes requesting an increase in funding for drug prevention by $123 million and treatment programs by $99 million dollars for Fiscal Year 2012, to train and engage primary health care to intervene in emerging cases of drug abuse, expand and improve specialty care for addiction—including care for families and veterans, and to better manage drug-related offenders in community corrections.
To read the full Action Plan, click here.
To read the FDA's Opioids Risk Evaluation and Mitigation Strategies (REMS), click here.
To get involved in DEA's National Prescription Drug Take-Back Initiative, click here.
For more information on National efforts to reduce drug use and its consequences visit: www.WhiteHouseDrugPolicy.gov