The Food and Drug Administration is mandating that all companies that make long-acting or extended-release opioid medicines - including painkillers like oxycodone and methadone - fund training programs for doctors and distribute info sheets for patients that promote proper use of the pills.
The requirement would affect over 20 companies that make such medications, including Pfizer Inc, Johnson & Johnson and Endo Health Solutions Inc. The FDA first announced the requirement for educational materials last year.
Opioids are synthetic versions of opium that are used to treat moderate or severe pain, but they are also highly addictive.
Overdose from prescription drugs is now the leading cause of accidental death in the country, eclipsing car crashes and the combined impact of cocaine and heroin.
"The problem of prescription drug abuse and misuse is very real," said Dr. Margaret Hamburg, the head of the FDA. "Educating healthcare professionals on how to safely prescribe (the medicines) is essential to address this critical public health issue."
But the FDA cannot actually force doctors to take the classes without a change in the law, meaning the impact of the new requirements may be muted.
Hamburg said she expects half of the nation's 320,000 prescribers of painkillers to get the training by the program's third year. Classes are scheduled to begin by March of 2013.
"We of course would like to see the number even higher in terms of the training received," Hamburg said, adding that the FDA and the Obama administration is working with Congress to find a way to amend the law.
The new classes will be funded by drugmakers, but taught through existing continuing education programs in hospitals or universities using an FDA-developed outline. The FDA said the classes should take about two to three hours, and be free for doctors or of nominal cost.
It is unclear exactly how much the lack of information about painkillers contributes to abuse. The FDA said it has gotten reports from patients who say doctors may misprescribe the pills. And journal articles have highlighted the limited training doctors receive in medical school about prescribing and monitoring the use of painkillers long-term.
Patient advocates also worry harsher rules may affect access for those who actually need the drugs for chronic pain.
The FDA said it plans to assess the program periodically to make sure it is not harming patients' access.
(Reporting by Anna Yukhananov; Editing by Bob Burgdorfer and Sofina Mirza-Reid)
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