FDA opioid safety plan focuses on physician education

The effort requires manufacturers of certain painkillers to make available updated medication guides and patient-counseling documents approved by the FDA.

By Christine S. Moyer — Posted July 23, 2012

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Educating health professionals on how to prescribe extended-release and long-acting opioids is among the federal government’s latest efforts to slow the rise in overdose deaths involving prescription painkillers.

Manufacturers of the powerful drugs will have to fund continuing education programs for physicians and others who prescribe the medications, according to a safety measure issued July 9 by the Food and Drug Administration. The training sessions will begin in March 2013, and participation will be voluntary for health professionals. At this article’s deadline, the FDA was looking into how the training will be offered.

Drugmakers also will have to make available FDA-approved medication guides and patient-counseling documents. The information will include details on the safe use, storage and disposal of extended-release and long-acting painkillers.

“Educating health care professionals on how to safely prescribe the drugs is essential to address this critical public health issue,” said FDA Commissioner Margaret A. Hamburg, MD. “Equally important, patients must know how to use these drugs safely.”

In 2011, an estimated 22.9 million prescriptions for extended-release and long-acting opioids were dispensed in the U.S., according to the FDA. Use of those painkillers have contributed to the increasing number of opioid-related overdose deaths, the FDA said.

In 2008, about 14,800 Americans died of overdoses involving opioids. There were 15,597 such deaths in 2009, according to the Centers for Disease Control and Prevention.

The recent FDA action, referred to as a risk evaluation and mitigation strategy, is part of a broader national initiative led by the White House to curb prescription drug abuse, misuse and overdose. In April 2011, the Obama administration launched a plan to cut nonmedical use of prescription drugs and opioid-related overdose deaths by 15% during the next five years.

The administration’s plan calls for expanding prescription-monitoring programs to all 50 states and making environmentally safe disposal of prescription drugs easier. The plan also supports linking Drug Enforcement Administration registration to mandatory training on controlled-substances prescribing, which the American Medical Association opposes. Legislation calling for such mandatory training has not been approved by Congress.

The AMA supports state prescription drug monitoring program data to help physicians make prescribing decisions and favors environmentally safe disposal of prescription drugs.

Teaching doctors about opioid prescribing

Although misuse of all prescription painkillers is serious, the FDA said extended-release and long-acting opioids have unique properties that can make them more harmful. Such properties include being able to crush the pills or alter them in other ways to increase the amount of drug immediately released.

The FDA’s risk evaluation and mitigation strategy will affect more than 20 manufacturers that produce extended-release and long-acting painkillers, Dr. Hamburg said. The companies will be required to provide grants to continuing education providers, such as hospitals and medical schools, that fund training on proper prescribing and management of painkillers.

The education providers will develop and deliver the training, said John Jenkins, MD, director of the Office of New Drugs at the FDA’s Center for Drug Evaluation and Research.

Physicians will take two to three hours to complete the course, he said. A knowledge assessment at the end of the training will ensure that the key messages were communicated to the health professional.

“The [manufacturers] are not permitted to be involved in the actual course design or curriculum,” Dr. Jenkins said.

The FDA estimates that within three years of implementing the education program, at least 60% of the 32,000 U.S. health professionals who prescribe the drugs will have received opioid training.

“We’d like to see the number even higher, in terms of the training received,” Dr. Hamburg said. But she said the FDA is optimistic that “as physicians start to receive this education, they will welcome it and it will benefit them and we will see it paying off.”

Pain organizations, including the American Academy of Pain Medicine and the American Pain Society, have come out in favor of the FDA’s latest action.

This is “a huge leap forward,” the academy said. “Increased education and training of practitioners and patients can reduce adverse outcomes that are often associated with opioids.”

But both organizations disagree with limiting the education to extended-release, long-acting painkillers.

“We cannot ignore the problems associated with immediate-release or rapid-onset opioids,” said Lynn Webster, MD, pain medicine specialist and president-elect of the American Academy of Pain Medicine. “All [painkillers] need to be safely prescribed, and that means we need education programs for all opioids.”

The FDA plans to monitor its opioid safety program to track the number of educational grants issued by manufacturers and how many health professionals complete training. The agency also will look for reports of difficulty accessing painkillers among patients who need the medication.

“The problem of prescription drug abuse and misuse is very real,” Dr. Hamburg said. “Nevertheless, patients in pain must have continued and appropriate access to the medications they need.”

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Goals of physician opioid training

The Food and Drug Administration issued new safety measures for extended-release and long-acting opioids. A critical component of the plan is a voluntary training program for physicians and other health professionals on how to properly prescribe and manage the painkillers. The FDA hopes to achieve five key outcomes with the program.

  • Understand how to assess patients for treatment with extended-release and long-acting opioids.
  • Be familiar with how to initiate therapy, modify dose and discontinue use of the drugs.
  • Be knowledgeable about managing ongoing therapy with the medications.
  • Know how to counsel patients and caregivers about the safe use of the drugs, including proper storage and disposal.
  • Be familiar with general and product-specific drug information.

Source: “FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics,” Food and Drug Administration, July 9 (link)

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External links

“Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting Opioids,” Food and Drug Administration, July 9 (link)

“FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics,” Food and Drug Administration, July 9 (link)

“List of Extended-Release and Long-Acting Opioid Products Required to have an Opioid REMS,” FDA (link)

“Epidemic: Responding to America’s Prescription Drug Abuse Crisis,” White House Office of National Drug Control Policy, April 19, 2011 (link)

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