The U.S. Food and Drug Administration (FDA) recognizes the five-fold increase in unintentional drug overdose deaths noted by the Centers for Disease Control and Prevention between 1990 and 2006 as a serious public health concern. Much of this increase follows from increases in the deaths from the use of opioid drugs, which in 2006 accounted for more overdose deaths than heroin and cocaine combined. The agency is also concerned about misuse of benzodiazepines (e.g., Valium and Xanax), which accounted for 272,000 emergency department visits in 2008 (compared to 306,000 for opioids).
FDA is pursuing a variety of programs and initiatives in an effort to strike the right balance between ensuring patients access to important pain medications and mitigating the risks. These efforts include:
* The Safe Use Initiative: The mission of the Safe Use Initiative is to create and facilitate public and private collaborations within the healthcare community. Its goal is to reduce preventable harm by identifying specific, preventable medication risks and developing, implementing and evaluating cross-sector interventions with partners who are committed to safe medication use (see http://www.fda.gov/Drugs/DrugSafety/ucm187806.htm1). Collaborations of this kind are essential for drugs like opioids, given the diverse factors that influence their use (e.g., legal, social, medical) and the many stakeholders working to assure they are used safely and effectively.
* Risk Evaluation and Mitigation Strategies (REMS) for Opioid Drugs: In 2007, Congress provided FDA with the authority to require REMS if that was necessary to ensure that the benefits of a drug outweigh its risks. These can include, for example, requirements for prescriber, pharmacist, and patient education about the risks and appropriate use of a drug, or other tools to better manage a drug’s risks On February 6, 2009, FDA sent letters to manufacturers of certain opioid drug products, indicating that these drugs will be required to have a REMS. The affected opioid drugs include long-acting and extended-release brand name and generic products that contain the active ingredients fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone (see http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163647.htm2). FDA held a series of public stakeholder meetings in 2009 and opened a docket to receive public comments. FDA continues to accept public comments on the Agency’s approach to opioid REMS and plans to hold a public advisory committee meeting in the summer of 2010 to discuss proposals for this important safety program.
* Efforts on Acetaminophen: Every year in the United States, about 30,000 people are hospitalized with overdoses associated with acetaminophen – approximately half of which are unintentional. In June 2009, FDA convened an advisory committee meeting to provide expert input on options to reduce harm while maintaining access to this effective medication for pain. Potential strategies are currently under review.
* Strategies for the safe disposal of drugs: Certain medicines may be especially harmful and, in some cases, fatal in a single dose if they are accidentally taken. For this reason, FDA lists 26 drugs, including a number of potent opioids, that have special disposal directions indicating they should be flushed down the sink or toilet after the medicine is no longer needed. If disposed of down the sink or toilet, they cannot be accidently used by children, pets, or anybody else (Learn More: Disposal by Flushing of Certain Unused Medicines: What You Should Know3).
* Evaluating the abuse potential of drugs: FDA has entered into a research collaboration with the National Institute on Drug Abuse (NIDA) to assess particular drugs for their abuse potential. The results of this research are provided to the Drug Enforcement Administration (DEA).
* Supporting efforts to identify safer pain medications. Janet Woodcock, MD, Director of the Center for Drug Evaluation and Research recently reviewed this area in the New England Journal of Medicine. See http://content.nejm.org/cgi/content/full/361/22/21054.Exit Disclaimer5
Through these efforts and others, FDA will join with sister agencies, medical professionals, health care institutions, patient organizations and others to reduce the number of overdose deaths.
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