Drug makers offer ideas on stopping misuse of painkillers
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Prodded by federal regulators intent on curbing the misuse of potent prescription painkillers, drug makers on Friday proposed that all doctors prescribing the medicines be trained and certified by the Drug Enforcement Administration.
The proposal, however, would require Congress to broaden the DEA’s mission from enforcing drug laws to include certifying doctors. That could be a long process, easily bogged down in the bureaucracy — and with no guarantee of success.
Dr. John Jenkins, head of the Food and Drug Administration’s Office of New Drugs, said that if the requirements were too burdensome, doctors would opt out and their patients would be denied access to the drugs, which, though dangerous in certain circumstances, are important tools in pain management.
The proposal came in response to an FDA order this year to 16 drug manufacturers requiring them to devise a way of cutting misuse of so-called long-acting opioids, a category of narcotics that includes fentanyl, morphine, oxycodone and methadone.
“I think the challenge for us is there are serious ongoing safety issues with the use of these products that we have to address,†Jenkins said during a conference call after the meeting with pharmaceutical makers.
The long-acting opioids are responsible for hundreds of deaths annually through accidental or deliberate overdosing or inappropriate prescribing.
One problem is that the drugs contain relatively high levels of narcotics intended to be absorbed slowly via a sustained release mechanism.
Accidentally or intentionally chewing the drug can defeat the timed-release attribute of the medication, resulting in a dangerous infusion that can lead to fatal overdoses.
The drug makers also proposed stepping up educational efforts aimed at patients. But Jenkins said that would tax the resources of the FDA by requiring it to conduct detailed reviews of at least 18 versions of the drugs.
Jenkins said the FDA would consider the industry proposals and submit its safety guidelines for public comment and review by an advisory committee of experts in the spring.
-- Andrew Zajac, reporting from Washington