ARTICLE IN BRIEF
An FDA initiative calls for manufacturers to pay for education outreach on prescribing long-term opioid analgesics, rejecting a panel's recommendation to make a training program mandatory for physicians.
The US Food and Drug Administration (FDA) on July 9 rejected the recommendations of an internal review panel to adopt mandatory education for prescribers of extended-release/long-acting opioid medications in favor of a voluntary program to be underwritten by pharmaceutical manufacturers but developed independently by privately contracted continuing education companies.
The unexpected decision came after several years of debate over whether or not the FDA risk evaluation and mitigation strategy (REMS) should be voluntary or mandatory. About 20 pharmaceutical companies and more than 30 name brand and generic extended-release/long-acting (ER/LA) opioid products will be affected by the final REMS.
An estimated 22.9 million prescriptions for ER/LA opioid analgesics were dispensed in 2011, and at least 320,000 physicians currently registered with the DEA (Drug Enforcement Agency) wrote at least one prescription, according to the FDA.
THE NEW REMS POLICY
The new REMS will put in place a structured safety education program for physicians and their patients, highlighting the risks of ER/LA overuse and potential for dependence and addiction, in an effort to address the pronounced increase in the illegal use and abuse of the newer pain medications.
According to the Centers for Disease Control and Prevention, 14,800 Americans died from overdoses involving opioids in 2008. In 2009, there were 15,597 deaths involving these medications, almost four times more than just ten years earlier.
However, the FDA emphasized that for many patients with acute and chronic pain, such products must remain available.
The initiative calls for manufacturers to pay for the education outreach program, and a number of major drug companies who manufacture such opioid analgesics shared input with the FDA during the REMS development process.
Under the new REMS, companies will be required to make education programs available to prescribers based on an FDA Blueprint. It is expected that most companies will meet this obligation by providing educational grants to continuing education (CE) providers, who will develop and deliver the training.
An information handout for patients prescribed ER/LA medications will also be developed and sent to all prescribers, as well as a one-page Medication Guide (MedGuide) for pharmacists who dispense such medications. There will also be ongoing audits of the continuing education program's content.
Currently there is no mandatory requirement that physicians prescribing ER/LA medications participate in any training program, nor are there any preconditions to prescribing them. The Obama Administration is seeking legislative changes that would establish a mandatory training program linked to DEA registration by prescribers.
The first CE classes under the new program will be offered to doctors by March 1, 2013, according to the FDA. The agency has also set up a website explaining the final REMS Blueprint, a list of included drugs, as well as a question and answer page at http://1.usa.gov/T6wCDZ.
Education is an integral part of any effort to change medical practice, something that the REMS should help address in a balanced way, according to Russell K. Portenoy, MD, professor of neurology and anesthesiology at Albert Einstein College of Medicine, and chairman of the department of pain medicine and palliative care at Beth Israel Medical Center.
“What is needed is systemic improvements, and that requires having all the piece in place, including education that includes best practices,” he told Neurology Today in a telephone interview.
“I am very supportive of the FDA REMS. The agency took a long time and included all stakeholders in its development.”
However, it is important to avoid any unintended consequences from education requirements that might limit access by patients who benefit from these medications.
“Some call it balance at the bedside. We need to address all risks associated with these medications more proactively — not just diversion and abuse.”
A systemic approach would require physicians to have two different skill sets, he noted. These include careful patient selection and individualized prescribing to optimize therapy, while at the same time identifying and minimizing potential risks.
“Not just abuse, diversion and addiction, but also potential side effects including lesser-known ones such as the potential for breathing problems during sleep,” he told Neurology Today.
“The take-home message is to stratify patients according to potential risks prior to therapy, and this includes any history of drug or alcohol abuse in the patient or their family. Second, physicians need to determine whether they have the skills to treat a patient alone or with help, and this takes education and training.”
This is especially true when prescribing narcotic pain medications for long-term problems. “It is like treating hypertension. You start therapy with a trial of a medication, selectively done for each individual and monitor his or her response. If you cannot determine a benefit, you stop the trial.”
Next, he said, therapy should be structured commiserate with risk.
“Treating an 85-year-old teetotaler who has never abused drugs is not the same as treating a 25-year-old with a back injury who admits occasionally using marijuana and who drinking beer on weekends,” he noted. “Urine screening, pill counts, and searching state databases for evidence of doctor shopping is probably unnecessary in the older patient, but not the younger one.”
Although educating prescribers about the risks of ER/LA is vital, even mandatory education is unlikely to have much impact on abuse and diversion, said Miles Belgrade, MD, adjunct professor of neurology at the University of Minnesota Medical Center and a member of the AAN Section on Pain and Palliative Medicine. Moreover, requiring additional or mandatory CE classes might have unintended consequences, he told Neurology Today in a telephone interview.
“I think education is nice, but I'm not sure this is going to accomplish much,” said Dr. Belgrade, who also serves as medical director of the medical center's palliative care clinic. “My concern is that any effort in this direction will have a chilling effect on prescribing these long-acting drugs for patients that really need them, and doctors will revert to shorter-acting versions, which carry the same risks and abuse concerns.”
There is also little hard evidence that prior education-only initiatives like REMS, even when mandatory, have much impact on reducing medication risks, he added.
Charles Brock, MD, associate professor of neurology and director of the Pain Medicine Fellowship Program at the University of South Florida Morsani College of Medicine in Tampa, said he was surprised that the FDA rejected the panel's recommendations, although provider perception of a strict education program may have played a part. He too agreed that placing additional burdens on doctors might drive many back to shorter-acting drugs.
“We need to be mindful of the recommendations and how these are going to help our patients in the long term,” Dr. Brock, who also is a member of the AAN Section on Pain and Palliative Medicine, told Neurology Today.
The use of the word “education” might be misleading, he said. Mandatory education implies that all learners have been exposed through some means to an information set about a condition, but this does not imply that they will diagnose, prescribe, or treat any differently, he noted.
The desired outcome is to enhance providers' ability to provide excellent care and have that demonstrated through outcomes, according to Dr. Brock. In addition, a maintenance of certification module for pain management in each specialty might work better because such outcome data would be part of the learning experience. Improving pain education for medical students might also have more of a long-term impact, Dr. Brock said.
Although a few “bad apples” get the most attention because they have resulted in the high volume of inappropriate opioid prescriptions and pain treatment, most clinicians are doing their best when prescribing ER/LA opioids, based on the pain education they have received, according to Dr. Brock.
“That said, these providers are not going to improve their practice through any educational tools. Providers and patients need to know what is legitimate use of these medications. Opioid mitigation strategies by providers will help, as will prescription monitoring programs, given that any provider found to be inappropriate in prescribing these medications is addressed formally by their respective Board of Medicine.”
But the leadership of specialty organizations has to respond to the issue. AAN President Bruce Sigsbee, MD, told Neurology Today: “We are taking steps to educate our membership about the issue. Where appropriate, course directors will be encouraged to include comments about the problem.”
Dr. Sigsbee, medical director of Penobscot Bay Neurology in Rockport, ME, said voluntary education can be bolstered using two additional tools — patient contracts and an online prescription record keeping system.
“I practice in Maine, which has the one of the highest rates of opioid diversion in the US, and there has been a big push in the state to address the problem through education and other steps. I believe that education will be important not only for pain specialists, but also for primary care physicians because they write most of these prescriptions,” he told Neurology Today in a telephone interview.
One method that helps is making patients who receive such medications sign a contract that includes agreeing to blood tests for levels of their medication when they want a refill. In Dr. Sigsbee's medical group, 80 percent of member physicians are now using these contracts.
If a patient has no evidence of the prescribed medication in their system it is cause for concern that they might be diverting it, he explained.
“We say, no drug level, no pills.”
Physician groups in the state and elsewhere are currently voluntarily using similar model contracts, and several are available from various sources. Maine is considering making them mandatory for all patients who receive opioid scripts, Dr. Sigsbee told Neurology Today.
Another promising tool is establishing a website documenting every prescription a patient has had filled, he said. In Maine, physicians and pharmacists can log onto a special monitoring website to reduce the incidence of patients seeing multiple doctors to get pain medications.
“Although the system still has some bugs, all a physician or pharmacist has to do is enter the patient's name online and they can see every prescription they have filled for the past several years,” he explained. “I know emergency room doctors use it all the time.”
While education is an important factor — for physicians and patients — many doctors will likely resist any national mandate requiring more education, especially if it is linked to DEA oversight, according to Dr. Sigsbee.
“I think there is still a chance that Congress might approve the pending legislation just to show that they are trying to do something about the problem, but I'm not sure it will make any difference or not. I do think most doctors would see this as just another hassle though.”