As awareness grows about the dangers of prescription drug abuse, the government is following through on its promise to address the “nation’s fastest-growing drug problem.” The Food and Drug Administration (FDA) recently revealed its risk evaluation and mitigation strategy for extended-release and long-acting opioids to prevent misuse and abuse, starting with education for doctors who prescribe highly addictive painkillers as well as the patients who take them.
The FDA’s plan requires 20 makers of extended-release painkillers, such as Purdue Pharma, Johnson & Johnson and Pfizer, to fund courses for doctors and make them available for free or at a nominal cost. The goal is to teach doctors about proper opiate prescribing for pain patients to minimize the risks of diversion and addiction. The training will be provided by companies that provide continuing medical education for health professionals, not by the drug makers themselves, and will be audited by a third party to assess their impact.
All of this is good news. Doctors will learn the delicate balance between protecting patients from opiate addiction and providing relief to legitimate pain sufferers. They will be able to answer important questions like: When is opioid therapy appropriate? How many pills should be prescribed? How can doctors counsel patients on the safe use of these drugs? What are the signs of opioid misuse?
At the same time, patients will receive easy-to-read guidelines on the use, dangers and proper disposal of the drugs, as well as instructions for emergency care in the event of an overdose. For those who heed the guidelines, the information could prove invaluable, as many patients assume that any medication prescribed by their doctor must be safe.
Optional May Mean Low-Impact
Although many features of the FDA’s prescription drug plan hit the mark, there are also a few misses. Most notably, doctors are not required to take the classes, so the prescribers who are already aware of the challenges of prescribing opiates may become more aware, but those who are unaware will remain so.
In 2010, an expert panel assembled by the FDA advocated for the inclusion of mandatory rather than voluntary training, which was echoed by the Obama administration. However, the American Medical Association and other doctors’ groups have opposed mandatory training, calling the programs burdensome and warning they may discourage physicians from treating pain patients. Until Congress amends the Controlled Substances Act, no one can be forced to comply – prescribers can continue prescribing without training and, of course, patients are free to ignore the materials provided to them.
Since the continuing education courses will not be a requirement, compliance rates may be regrettably low. The FDA expects 60 percent of the 320,000 prescribers to be trained by 2016, though it acknowledges that educating just over half of doctors (if their estimations are correct) is not enough.
“We’d like to see a higher number,” said FDA commissioner Dr. Margaret Hamburg, “and we are working with Congress to explore a way of mandating training.”
Ideally, physicians would receive mandatory education in addiction and pain management as well as guidance on prescribing addictive medications as a prerequisite for licensure. This training wouldn’t be limited to a two or three hour session funded by drug companies and it would cover the full range of highly addictive medications, including stimulants and sedatives.
For now, the FDA’s plan focuses exclusively on extended-release opiate painkillers, such as oxycodone, fentanyl and morphine, which are among the most highly abused prescription drugs. Opioids accounted for nearly 15,000 overdose deaths in 2008 and nearly 16,000 deaths in 2009, according to the Centers for Disease Control and Prevention. More people are dying from prescription opiate overdoses than from heroin and cocaine overdoses combined. Despite the risks, physicians receive little to no training in medical school on prescribing addictive medications, and some prescribe painkillers for unapproved uses, such as migraine headaches.
So is the FDA’s plan a solution to the prescription drug epidemic? No, but it is a step in the right direction. Now if doctors and patients would do their part, we might see real progress.