FDA Endorses Opioid Painkiller Safety Measures

The FDA wants manufacturers of opioid pankillers to underwrite training and educational programs for physicians who prescribe them.

The agency is requiring manufacturers to underwrite voluntary physician training as part of their risk evaluation and mitigation strategy (REMS) program. The three key components of this program will be:

1. Education and training for prescribers
2. An updated medication guide and patient counseling document
3. An auditing and assessment process

Opioid painkillers have been linked to increased falls and fractures in the elderly as well as drug abuse and overdose-related deaths.

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