Early this year the Centers for Disease Control and Prevention issued a report quantifying the epidemic of drug overdoses and adverse events from the use of opioids, otherwise known as narcotics. The report, “Grand Rounds: Prescription Drug Overdoses – a U.S. Epidemic,” pointed out that too many doctors prescribe powerful painkillers such as OxyContin without completely understanding the complexity of alleviating chronic pain and without having the necessary information about the risks and often exaggerated benefits of narcotics.
So a lot of interested parties looked forward to last week, when the FDA issued guidelines for prescribing the dangerous drugs. A lot of interested parties were disappointed.
Known as the risk evaluation and mitigation strategy (REMS), the process requires 20 drug manufacturers to sponsor physician education programs about how to prescribe their products, 30 of which are affected. The material will be created by medical education companies, and will include patient-education brochures.
That’s nice, but a story on FDA Law Blog was clear about the program’s deficits: “[M]ore than three years after beginning the opioid REM process, the final REMS … amounts to essentially a mere education and monitoring program. …[D] espite FDA’s statement in 2009 that “voluntary programs have not been successful in getting us where we need to go with maintaining access to legitimate patients and dramatically decreasing the serious adverse event reports,” the healthcare professional education provided by the REMS is in fact voluntary.”
And, as noted on MedPage Today, the guidelines were criticized not only because doctors aren’t required to educate themselves about the drugs, but for empowering the industry that produces the problematic products to sponsor education about them and for not including powerful short-acting narcotics such as Vicodin.
The new REMS sound like a language course that teaches students all about nouns, pronouns and adverbs, but lacks lesson plans for conjugating verbs.
As Dr. Andrew Kolodny, chair of psychiatry at Maimonides Medical Center in New York, told MedPage, “These educational programs are likely going to do more harm than good. Nowhere does it say that prescribers should tell patients these drugs are addictive. And these programs give the implied message that there’s evidence for using opioids in long-term, noncancer chronic pain.”
We addressed some of these issues a few months ago in our post about the demise of American Pain Foundation, which had demonstrated a shocking conflict of interest between its information campaign and its pharmaceutical sponsors.
Kolodny said that the new, unimproved REMS offers the same version that the FDA’s own advisory committee deep-sixed two years ago. He said the REMS is a windfall for the medical education companies retained by the drug manufacturers, about five of which already generate much of the industry-sponsored education for opioids.
A better approach ties a practitioner’s DEA license or certification to his or her mastery of opiate indications, risks and benefits. For example, Kolodny noted, is a drug called buprenorphine (Suboxone), an opiate that also treats addiction. Before a doctor may prescribe it, he or she must complete an eight-hour class.
It’s not a lot to ask when you consider that:
- Prescription drug abuse is the fastest growing drug problem in the U.S.
- Approximately 23 million prescriptions for extended-release and long-acting opioids were written in 2011.
- In one recent year in the U.S. one death due to drug overdose occurred every 19 minutes.
- The recent increase in unintentional drug overdose deaths has been driven by the increased use of prescription narcotics.
- In one recent year, for every unintentional overdose death related to narcotics, nine patients were admitted for substance abuse treatment, 35 visited emergency departments, 161 reported drug abuse or dependence and 461 reported nonmedical uses of these drugs.
- In the 10 years between 1997 and 2007, the distribution of morphine per person increased more than 600 percent. According to the CDC, that’s enough morphine for everyone in the U.S. to take a typical, 5 mg dose of Vicodin every four hours for three weeks.
The physician education courses under the new REMS would last about 2 to 3 hours and cover how to weigh the risks and benefits of opioid therapy and how to recognize the potential for abuse and addiction. The first courses are to be scheduled by March next year.
The FDA estimates that there are 320,000 prescribers of long-acting narcotics in the U.S.; 1 in 4 is expected to be trained by the end of the program’s first year. The goal is to have 6 in 10 trained by the third year.
But doctor education programs alone can’t reduce the terrible toll of narcotic abuse and industry-wide ignorance of best pharmaceutical intervention practice. Practices such as “doctor shopping,” in which consumers go from doctor to doctor in search of prescriptions for illegal pharmaceuticals, or seek out multiple practitioners who each prescribe the desired drug, even for a legitimate condition, have to be addressed. There are state laws against such behavior, but their routine enforcement is wanting.
“[O] nly a few states,” according to the CDC, “have laws regulating for-profit clinics that distribute controlled prescription drugs with minimal medical evaluation. Laws against such ‘pill mills’ as well as laws that require physical examinations before prescribing might help reduce the diversion of these drugs for nonmedical use.” (We recently retold the story of one pill-pushing doctor who did get busted for murder related to fatal overdoses.)
The CDC also says the plug can be pulled on doctor shopping by tracking prescriptions in a database, and by insurance companies paying attention to claims processing and limiting reimbursements for narcotic prescriptions to designated doctors and pharmacies.
A meatier set of guidelines by the FDA also would be nice.