The US government on Tuesday unveiled a new national strategy designed to cut misuse of prescription drugs, and primarily opioids, by 15 percent within five years. The FDA will require that 16 companies that make 25 pain patches and drugs provide a risk evaluation and mitigation strategy (REMS) to determine that an opioid's benefits outweigh its risks.
The plan focuses on four main areas: Providing education for prescribing physicians and the public; efforts to add prescription tracking databases in all 50 states; improving methods of disposing with unused or expired prescriptions; and more intense training and focus by law enforcement on illegal "pill mills" where addicts can receive illegal prescriptions.
FDA commissioner Margaret Hamburg commented that "the prescriber education component of the [REMS] balances the need for continued access to these medications with stronger measures to reduce their risks." She said that letters have been sent to manufacturers of long-acting and extended-release opioids describing the medication guides and tools for physician training that are now required. The companies will have 120 days to propose a plan for their drugs, which will then be reviewed by the agency, as well as professional physician-education providers to prevent bias in the materials, she explained.
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