FDA, CDC scrutiny follows surge in accidental opioid overdoses

Federal agencies are collaborating to address a deadly aspect of the use of opioids to treat pain -- the growing number of unintentional overdoses linked to this class of medications.

"We know that these drugs have important therapeutic uses," said Douglas Throckmorton, MD, deputy director of the Food and Drug Administration's Center for Drug Evaluation and Research. "We also know that there's abuse. There are overdoses. There's diversion that we don't want to happen."

Action has taken place at the state level, such as establishing prescription monitoring programs. Medical societies also have been involved. In November 2008, the American Medical Association Council on Science and Public Health issued a report on the nonmedical use of prescription drugs. It urged the development of continuing medical education, practice guidelines and performance measures. The AMA also intends to consult with involved agencies to ensure physicians are part of the solution.

"Physicians need a practice environment that allows for the appropriate use of controlled substances, including those used for pain management, while minimizing inappropriate use and diversion," said Edward L. Langston, MD, immediate past chair of the AMA Board of Trustees.

According to an FDA statement, the agency will work with the Centers for Disease Control and Prevention to support research into new efforts to prevent adults' unintentional drug overdoses. Though research was not limited to opioid-related events, agency officials predict this area will be the focus. The CDC will provide $350,000 a year for two years to be split between a pair of grantees. Officials said money also would come from the FDA, though the amount isn't yet set.

"These grants will help us identify promising strategies to combat this epidemic of prescription drug overdoses," said Len Paulozzi, MD, MPH, a medical epidemiologist in the unintentional injury prevention division of the CDC's National Center for Injury Prevention and Control.

The use of opioids to treat non-cancer chronic pain started to increase in the 1990s, but misuse and related ill effects grew as well. The number of accidental overdose deaths from narcotics or hallucinogens among those 15-64 years old, the target age group of this research, increased 83% from 5,921 in 1999 to 10,829 in 2005. Non-fatal unintentional poisonings from any cause for those 15-64 rose 44% from 376,611 incidents in 2001 to 542,372 in 2007. Research indicates that opioids are driving these trends.

"The prescription drug abuse problem is enormous and ... it seems to be getting worse," said Scott Fishman, MD, past president of the American Academy of Pain Medicine. "There's a substantial role that doctors have in this, and we have got to understand that we have a responsibility to our patients but also to society."

Doctors praised the agencies' efforts in hopes that they will help turn the tide. But a desire was expressed that possible solutions not be so onerous as to interfere with drugs' appropriate use. "We need something that is very practical and that can be implemented by physicians, but we still want to be able to manage pain. We don't want to take these drugs off the market," said Michael J. Mello, MD, MPH, a spokesman for the American College of Emergency Physicians.

Applications for the FDA/CDC grant were due Feb. 2, and projects should start in September. They will investigate risk-management strategies used by drug firms once a drug is available and the response if trouble develops. Research also may examine actions the FDA could take besides removing a drug from the market.

One idea is to enlist poison control centers, because these groups already deal with many calls on medication mishaps. According to a Jan. 22 statement by the Washington Poison Center in Seattle, seven out of the 10 most common calls to the group's hotline involve prescription or over-the-counter medications. Opioids are not currently on the list.

"Those overdosing on opioids are just showing up in the medical examiner's office dead, but a piece of solving this problem is figuring out how to get poison centers involved," said William Hurley, MD, the WPC's medical director. His organization is applying for one of FDA/CDC grants.

Until other interventions are available, physicians suggest determining pain treatment strategies by assessing patient function rather than subjective reports of pain, and taking advantage of various state and clinical resources when available.

Paul Chelminski, MD, MPH, an internist and associate professor of medicine at the University of North Carolina at Chapel Hill, routinely takes such steps. To prevent "doctor shopping," he checks his state drug registry to see if patients are getting controlled medicines from other doctors. He looks at online records from the North Carolina Dept. of Correction for past drug misuse. He also drug-tests patients to ensure they're taking the meds he prescribed.

"We want to believe the best about our patients, but we have to be more vigilant about monitoring for substance misuse and not just accepting the patients' statements," he said.

In a related development, a pair of FDA advisory committees recommended Jan. 30 that medications containing propoxyphene, or Darvon, a common painkiller, no longer should be marketed because of the significant potential for addiction and deliberate or accidental overdoses.