The Food and Drug Administration has unveiled a long awaited plan to address prescription drug abuse – a plan that focuses on educating doctors about the benefits and risks of prescribing powerful opioid painkillers. The initiative was applauded by drug makers and medical organizations, but critics point out the pain education for physicians will be voluntary, not mandatory, as an expert panel recommended.
The final version of the agency’s risk evaluation and mitigation strategy (REMS) calls on 20 companies that manufacture painkillers to fund training courses for doctors that will be taught by medical education companies. The goal is to reduce the risk of addiction and other health problems associated with opioids, while ensuring access to the drugs for patients in pain.
One page educational brochures on the safe use, storage and disposal of opioids will also be created for patients.
“Misprescribing, misuse, and abuse of extended-release and long-acting opioids are a critical and growing public health challenge,” said FDA Commissioner Margaret A. Hamburg, MD. “The FDA’s goal with this REMS approval is to ensure that health care professionals are educated on how to safely prescribe opioids and that patients know how to safely use these drugs.”
The FDA initiative came after several years of deliberations by the agency about how to address an epidemic of painkiller abuse. In 2010, a panel of outside experts assembled by the FDA rejected the agency’s proposal that training of doctors be voluntary. The panel said mandatory training was needed to make up for a lack of pain education in medical schools.
The Obama administration has also endorsed mandatory training programs, but is trying to do it through legislation. However, it has not yet made an effort in Congress to amend the Controlled Substances Act.
While drug makers will underwrite the physician education programs, the FDA said they will not control their content. Groups that specialize in training programs for doctors will teach the courses, designed under an FDA blueprint, and periodic audits will be conducted to make sure they are effective. The agency’s goal is to have 60 percent of the doctors who prescribe opioids take the courses within three years. Training classes will begin in March, 2013.
The American Academy of Pain Medicine (AAPM), which represents 2,600 pain physicians, quickly endorsed the FDA plan, calling it a “huge leap forward.”
“We know that increased education and training of practitioners and patients can reduce adverse outcomes that are often associated with opioids. Through proper education and training, opioids can be administered safely to patients and continue to be an important option in the treatment of chronic and debilitating pain that is suffered by millions of Americans,” the AAPM said in a statement.
The AAPM said a “Safe Opioid Prescribing Course” it already offers to physicians could serve as a model for the FDA’s education program.
The AAPM is one of several medical organizations under investigation by the Senate Finance Committee for its financial ties to the pharmaceutical industry. In May, Senators Max Baucus (D-Montana) and Sen. Chuck Grassley (R-Iowa) sent letters to Purdue Pharma, Endo Pharmaceuticals and Johnson & Johnson accusing them of promoting “misleading information” about the safety and effectiveness of opioids. The letters also accused the AAPM and other pain organizations of playing a major role in spreading that misinformation.
Purdue Pharma, which makes the widely prescribed painkiller OxyContin, released a statement endorsing the FDA’s opioid training plan.
“Purdue supports the goals of enhanced prescriber and patient education as part of a comprehensive approach necessary to address the misuse, abuse, and diversion of prescription medicines, while ensuring these medications remain accessible for people with chronic, moderate to severe pain,” the company said.