Drugmakers Plan to Prevent Misuse of Prescription Painkillers through Education
Under pressure from regulators trying to prevent hundreds of fatal overdoses each year, pharmaceutical executives are laying out plans to prevent the misuse of prescription painkillers.
The Associated Press reports that Johnson & Johnson, King Pharmaceuticals, and other drugmakers want to use patient medication guides, letters to doctors, and additional physician training materials to curb inappropriate use and prescribing of painkillers.
The Food and Drug Administration sent letters to 16 drugmakers in February ordering them to design risk management plans for their drugs. The FDA has required risk management plans for individual drugs before, but never for an entire class of drugs.
The companies produce 24 opioid drugs—including morphine, oxycodone, and methadone—which are often abused for their euphoric effect.
Industry consultant Sidney Schnoll said the requirement is "unprecedented in the history of pharmaceutical medicine and in the history of the FDA." Risk management plans can include safety labeling, educational campaigns, and even certification requirements for physicians.
Schnoll and others warned that mandatory certification standards could cause some physicians to stop prescribing the medications altogether, limiting access to patients.
"The bottom line here is that the 'risk management plans' should not impede important medication from reaching appropriate patients," said Schnoll, a paid consultant for the companies with Pinney Associates.
In place of mandatory certification, the drug industry said the federal Drug Enforcement Agency could offer voluntary training to prescribers. However, executives acknowledged that congressional action would be needed to allow the DEA to provide such training. Currently, the agency's mission is to enforce laws governing highly addictive medications.
The products targeted by the FDA, which come in both pill and patch forms, generally feature extended-release formulas designed to give long-lasting effects. But that potency carries serious risks when patients abuse them as stimulants.
The FDA has issued a number of warnings on prescription pain relievers in recent years but with little success. A federal survey conducted in 2007 found that 5.2 million people in the U.S. reported using prescription pain drugs inappropriately.
Companies attending the meeting include makers of generic pills as well as brand-name products, like Johnson & Johnson's Duragesic patch, King Pharmaceuticals' extended-releases Avinza and Embeda pills, and Purdue Pharma's extended-release OxyContin.
There are other problems with opioids besides deliberate abuse. The FDA has documented many cases of physicians prescribing the potent painkillers for patients with migraine headaches, which is an unapproved use. The FDA said patients also sometimes chew extended-release pills that are designed to be swallowed, leading to overdose.