Newspaper article Charleston Gazette Mail

FDA Reconsiders Required Painkiller Safety Training

Newspaper article Charleston Gazette Mail

FDA Reconsiders Required Painkiller Safety Training

Article excerpt

WASHINGTON - The Food and Drug Administration is reconsidering whether doctors who prescribe painkillers like OxyContin should be required to take safety training courses, according to federal documents. The review comes as regulators disclosed the number of doctors who completed voluntary training programs is less than half that targeted by the agency.

A panel of FDA advisers meets next week to review risk- management plans put in place nearly four years ago to reduce misuse and abuse of long-acting painkillers, powerful opioid drugs at the center of a national wave of abuse and death.

Under the current risk-management programs, drug makers fund voluntary training for physicians on how to safely prescribe their medications. However, many experts - including a previous panel of FDA advisers - said those measures don't go far enough and that physician training should be mandatory.

According to FDA figures, only 37,500 physicians had completed the voluntary training programs by March 2015, less than half of the targeted number of 80,000. In fact, surveys conducted by drug makers showed 40 percent of prescribers were unaware of the programs more than a half-year after they launched.

The FDA says its own findings "show mixed results that make it difficult to draw conclusions regarding the success of the program, according to briefing documents posted online.

The FDA will present its findings over a two-day meeting beginning next Tuesday, then ask its panel of outside safety experts what changes should be made to improve the plans. The panel's advice is not binding.

In the last year, government authorities have launched a number of steps intended to reduce painkiller deaths, including new federal prescribing guidelines from the Centers for Disease Control and Prevention and state measures that restrict and track opioid prescribing.

Prescription opioid overdoses have been rising steadily for well over a decade, reaching nearly 19,000 in 2014 - the highest number on record. …

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