Teach Prescribers About Dangers of Long-Acting Pain Meds: FDA

MONDAY, July 9 (HealthDay News) — As part of its efforts to curb
the abuse of narcotic painkillers, the U.S. Food and Drug Administration
is requiring drug makers to educate doctors about the risks of long-acting
and extended-release forms of the drugs.

“Prescription-drug abuse is our nation’s fastest-growing drug problem,”
FDA commissioner Dr. Margaret Hamburg said during a Monday afternoon press
conference.

Commonly prescribed drugs that come in longer-acting forms include
oxycodone, morphine and fentanyl.

The continuing-education programs will be based on FDA-created
blueprints. The agency expects the more than 20 companies that make these
drugs to provide grants to firms that specialize in medical continuing
education. These firms will, in turn, develop and administer the programs
under FDA supervision and provide them to doctors for free.

Although all opioid painkillers carry risk of abuse, overdose and
death, the extended-release and time-release forms of the drugs are
particularly risky. Because they act in the body over longer periods, they
are more likely to cause problems, Hamburg said.

“The number of people harmed by these long-acting or extended-release
opioids due to misprescribing, misuse and abuse … continues to increase
dramatically,” Hamburg said.

In 2008, nearly 15,000 Americans died from overdoses of these drugs. In
2009, there were more than 15,500 deaths from opioid painkillers — almost
four times as many as in 1999, according to the U.S. Centers for Disease
Control and Prevention.

In addition, more than 2 million emergency-room visits in 2010 involved
abuse or misuse of prescription drugs — almost half of all drug-related
visits. Of these visits, more than 15 percent involved opioid medications,
Hamburg said.

The drugs are widely prescribed. It is estimated that nearly 23 million
prescriptions for extended-release and long-acting opioids were issued in
2011, Hamburg said. It is estimated that more than 320,000 prescribers
listed with the U.S. Drug Enforcement Administration wrote at least one
prescription for opioid painkillers in 2011, according to the FDA.

Despite these problems, Hamburg said, patients who need these drugs
must have access to them.

“Educating health care professionals on how to safely prescribe
extended-release and long-acting opioids is essential to address this
critical public health issue,” she said.

The FDA hopes that over the next three years, 60 percent of the 320,000
prescribing doctors will have been trained, Hamburg said.

Along with the programs for doctors, the FDA also is mandating that
manufacturers provide FDA-approved patient-education materials on the safe
use of these drugs. The material appears on a single page in
consumer-friendly language, and will be given to patients every time they
fill a prescription.

Both the drug companies and the FDA will review the progress and
success of these programs. Based on the reviews, the agency may require
the companies to provide additional elements to ensure success.

The first programs under the FDA’s new requirement are expected to be
launched by March 1. Although no doctor currently is required to take the
two- to three-hour continuing-education program, the Obama administration
is urging Congress to make such programs mandatory.

More information

For more about narcotic painkillers, visit the U.S. National Library of Medicine.

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