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.
MATTHEW PERRONE - AP Health
Writer - Associated Press
No comments:
Post a Comment