Drug Updates

In order to strike a balance between reducing the risk of opioid abuse and maintain patient access for those that need these agents, pharmaceutical industry representatives plan to meet and develop a phased-in approach to discuss these issues. They are speculating that it could include a voluntary physician training program to better educate them about appropriate use of pain medications, and perhaps government certification for prescribing controlled substances.¹⁹ In early 2009, the FDA convened a meeting to discuss REMS for the opioid compounds, specifically fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone, citing an increase in abuse, misuse, and overdose rates within the last 10 years.²⁰ At that time, the FDA’s Office of New Drugs was focusing on extended-release versions of older drugs which contain high doses of opioids which need to be carefully prescribed by physicians properly trained in their safety. At the latest meeting of the Office of New Drugs, the pharmaceutical industry had proposed that the federal Drug Enforcement Administration (DEA) offer voluntary training to prescribers but acknowledged that congressional action would be needed to allow this to happen because it is outside of the DEA agency’s current duties. A public meeting will be held sometime this year to help finalize a plan.

Michele Kaufman is a freelance medical writer based in New York.

References

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