FDA mandates drugmakers to provide more painkiller education for doctors, patients
(CBS/AP) Manufacturers of powerful prescription painkillers will be required by the government to train U.S. doctors, nurses and other health professionals in the safe use of the drugs.
Prescribers will not be required to attend the sessions because making them mandatory would require a new law by Congress. However, medical professionals who take the sessions will be able to complete some continuing education credits - which are often funded by prescription drug companies - through this program.
The new FDA plan covers about 30 opioid drugs, including Purdue Pharma's OxyContin, Johnson and 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 to people already taking pain medications, including cancer patients, to treat severe pain flare-ups.
Such opioid drugs are blamed for thousands of fatal overdoses each year. The safety measures, released by the Food and Drug Administration on Monday, are 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 products targeted by the FDA feature extended-release formulations designed to give long-lasting effects. 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 of the drug.
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 expects companies will meet the requirement by providing education grants to continuing education (CE) providers, who will develop and deliver the training. The two to three-hour training sessions must be provided to prescribers 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 1, 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.
Some health care experts stressed that training should be required for all prescribers, but FDA officials said the programs will be optional for now.
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.
White House Drug Czar Gil Kerlikowske joined FDA Commissioner Dr. Margaret Hamburg to announce the new plan. Kerilikowske said overdose deaths in the U.S. from opioids now outnumber overdose deaths from heroin and cocaine combined, and added the Obama administration is "laser-focused" on stopping these rates.
A Drug Enforcement Administration study in April found increases in prescription painkiller distribution across the U.S. has also coincided with increases in overdose deaths and pharmacy robberies across the country.
Another study published last week from the U.S. Centers for Disease Control and Prevention found deaths from opioid overdose have increased four-fold between 1999 and 2010, with methadone accounting for nearly one-third of opioid-associated deaths.
The Mayo Clinic has more on prescription drug abuse.
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