FDA Unveils Safety Measures for Opioid Painkillers

By MATTHEW PERRONE | July 11, 2012

Drugmakers that market powerful painkiller medications will be required to train U.S. doctors, nurses and other health professionals in the safe use of the drugs, which are blamed for thousands of fatal overdoses each year.

The safety plan released by the Food and Drug Administration on Monday is designed to reduce misuse and abuse of long-acting opioid pain relievers, which include forms of morphine, methadone and oxycodone. The agency’s plan mainly involves educating doctors and patients about appropriate use of the drugs.

The FDA has issued a number of warnings on prescription pain relievers in recent years but with little effect. Inappropriate use of the drugs caused nearly 342,000 emergency department visits in 2009, according to government figures. The drugs were blamed for 16,000 deaths that year, up from 14,800 in 2008.

The FDA said drug companies that sell the drugs must provide two to three hours of training to prescribers, either for free or for a small fee. The agency wants companies to train at least 60 percent of the 320,000 U.S. prescribers of the drugs within three years of launching the education programs.

The programs, which will be vetted by FDA regulators, must be available by March 2013.

In addition to training, drugmakers will be required to distribute safety brochures to patients explaining the risks of the drugs and instructions to seek emergency care in event of an overdose.

The FDA spent more than three years developing the so-called risk management plans for the drugs, with input from industry and health care professionals.

Some health care experts stressed that training should be required for all prescribers. But FDA officials said the programs will be optional for now because making them mandatory would require a new law by Congress.

The new FDA plan covers about 30 opioid drugs, including Purdue Pharma’s OxyContin, Johnson & Johnson’s Duragesic patch and Pfizer’s Embeda. Opioids are drugs that simulate the effects of natural narcotics, such as the opium poppy. They are typically prescribed for people already taking pain medications, including cancer patients, to treat severe pain flare-ups.

The products targeted by the FDA feature extended-release formulations designed to give long-lasting effects. But that potency carries serious risks when doctors prescribe them inappropriately, and when patients abuse them as stimulants.

The FDA reports that many physicians prescribe the painkillers for patients with migraine headaches, an unapproved use. Patients will also sometimes chew extended-release pills that are designed to be swallowed, causing an overdose.

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