The FDA scheduled a meeting for March 3 with the manufacturers of opioid drugs to discuss risk evaluation and mitigation strategies (REMS) for the compounds, citing an increase in rates of abuse, misuse and overdose with such products over the last decade, the agency announced.

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The affected drugs often have extended-release versions and John Jenkins, the director of the FDA’s Office of New Drugs, commented that “we’re focusing on these products because they generally contain very high doses of the drugs and need to be used very carefully.” He added: “What we’re talking about is putting in place a programme to try to ensure that physicians prescribing these products are properly trained in their safe use, and that only those physicians are prescribing those products.”

A new control programme to prevent abuse could result in new restrictions on the prescribing, dispensing and distribution of extended-release products such as methadone and some morphine tablets as well as fentanyl patches and Purdue Pharma’s OxyContin. Regulators noted that some doctors could lose their authority to prescribe medicines in an effort to cut the number of deaths and injuries resulting from inappropriate use.

The US regulator noted that the products to be addressed at the meeting are 24 brand name and generic opioid drugs that contain fentanyl, hydromorphone, methadone, morphine, oxycodone and oxymorphone. The agency explained that it hopes to gain information in this process “that will lead to practical and effective solutions for development of a REMS and for appropriate use of these opioid drug products.”

Source: FirstWord

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