FDA Urges Mandatory Training for Doctors Prescribing Opioids
A Food and Drug Administration (FDA) advisory panel has recommended mandatory training for all doctors prescribing opioids as medication, in order to curb prescription drug abuse, addiction and overdoses.
The panel – Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee – consists of independent medical experts and is led by Chairman Almut Winterstein, MD, of the College of Pharmacy at the University of Florida. According to him, the panel voted overwhelmingly in favor of requiring doctors to attend mandatory training.
In an article posted by MedScape, the panel held a two-day meeting to modify the extended-release and long-acting (ER/LA) drugs opioid analgesic Risk Evaluation and Mitigation Strategies (REMS), which was approved in July 2012.
Major FDA Policy Shift on Prescribing Opioids
For years now, the main policy at the FDA has been to allow doctors to decide whether they will take the training courses on proper opioid prescribing practices.
Unfortunately, this has led to lower participation from physicians than the number expected by the FDA. The Associated Press (AP) reports that a review of federal documents shows that the shortfall of doctors in the voluntary program is “less than half that targeted by the agency.” The administration’s figures are at 37,500 doctors against a target of 80,000.
One explanation for this shortfall in participating doctors is a lack of information. According to an AP report, a recent survey by drug companies showed that “40 percent” of prescribers did not know about the voluntary training programs these companies offer as part of the opioid risk-management programs.
This lack of information can partly be blamed on REMS, which failed to have mandatory certification for doctors included. The American Medical Association (AMA) posted strong opposition to any plan by the administration to impose mandatory regulations on doctors.
Another problem the FDA has faced is how to implement its training programs to the large number of prescribers in the nation. NBC News reports that there are about 1.5 million prescribers. Aside from that, drug companies and pain specialty groups were quoted by AP arguing that certification would be “too burdensome for doctors.”
But as Michael Fry, a pharmacist with Providence Health system in Oregon, was quoted by NBC News, “If we keep [the risk-management training programs] voluntary we’re never going to get many people trained.”
The FDA can therefore push for a legal change through Congress in order to tie a prescriber’s license under the Drug Enforcement Administration (DEA) to the completion of the training requirements set out.
Recently appointed FDA administrator Dr. Robert Califf promised Congressmen during his confirmation hearing that the agency will take measures to address the opioid crisis in America. Even though he has avoided setting any requirements for doctors thus far, he will now have to make a bold decision in order to confront the opioid abuse epidemic.
The FDA can no longer sit idly by while Americans are calling for a response to the epidemic. This new recommendation by the expert panel – if approved – will go a long way in helping to reduce the rates of prescription pill addictions and abuse due to poor prescribing practices.
