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doi: 10.1097/01.NT.0000437157.40211.12
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Survey: One-Fifth of US Neurologists Unaware of Updated FDA Warnings on Antiepileptic Drugs: What Can Be Done to Improve Communication of Safety Risks?

Rukovets, Olga

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ARTICLE IN BRIEF

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Epileptologists discuss strategies to improve communication about adverse events associated with antiepileptic drugs in light of a survey finding that one fifth of US neurologists were unaware of updated drug safety risks and recommendations for antiepileptic drugs.

Are the updated safety warnings from the US Food and Drug Administration (FDA) for antiepileptic drugs (AEDs) and other therapies successfully reaching neurologists and clinicians who prescribe them? Not necessarily, according to a new study published in the Oct. 2013 edition of Epilepsy & Behavior. As many as one-fifth of US neurologists surveyed by e-mail said they were unaware of updated drug safety risks and recommendations for AEDs.

The investigators asked 4,627 AAN members — 13 percent of whom responded — about their awareness of the risk of suicidality with newer AEDs, increased birth defect risk from fetal exposure to divalproex, impaired cognitive development from fetal divalproex exposure, and a haplotype screening requirement for Asian patients starting carbamazepine. They found surprising gaps in knowledge and awareness of risks.

Most surveyed neurologists reported receiving safety notifications from specialty organizations (67 percent), published literature (67 percent), colleagues and/or peers (53 percent), and continuing medical education or other educational programs (53 percent). The responses represented all 50 states and Washington, DC.

The findings have potentially serious implications for patient care, said Gregory Krauss, MD, professor of neurology at Johns Hopkins Medical School in Baltimore, who led the study. “It just didn't seem like there had been good communication between the FDA and the neurology community when it comes to new drugs,” Dr. Krauss said, adding that he and his coauthors were surprised by the diversity of sources that people used. “There's no go-to source or systematic way that neurologists seem to be getting safety information.

“One result of our survey is that neurologists would appreciate getting more systematic notifications — they would like to receive information from their professional organizations and have FDA warnings be transmitted through [these organizations] with intermittent update emails — something that could be batched twice a year — or special risks can be transmitted immediately. That's something I would certainly endorse,” Dr. Krauss told Neurology Today.

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EPILEPTOLOGISTS WEIGH IN

Commenting on the survey, Sheryl Haut, MD, chair of the North American Commission of the International League Against Epilepsy, and director of adult epilepsy at Montefiore Medical Center at Albert Einstein College of Medicine in the Bronx, told Neurology Today, the study findings likely extend beyond epilepsy to other neurologic disorders.

The 13 percent survey response rate was “disappointing,” noted Dr. Haut, but the authors offered sufficient demographic data to reassure the generalizability of these findings to all US neurologists. She said she was surprised that, although most respondents were aware of a recommendation for haplotype screening, many did not routinely perform the safety screening.

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David G. Vossler, MD, clinical associate professor of neurology and medical director of the University of Washington Medicine Valley Medical Center Neuroscience Institute in Renton, WA, and vice chair of the Medications Workgroup at the American Epilepsy Society, said that among the survey findings, he was surprised that the “FDA website was utilized the least of all the items [16 percent] queried in this paper,” he said.

Dr. Vossler added that he was particularly concerned about the transmission of updated safety information for older AEDs that are now available in generic form. For the brand name, newer drugs on the market, he said, “we get letters from the pharmaceutical company, which are mandated by the FDA, called ‘Important Prescribing Information.’ But when there are new data on old drugs that are no longer being promoted by brand name pharmaceutical companies, what's the requirement by the FDA that the companies have to report this to providers? I think that's a gap,” he noted.

Interestingly, Dr. Vossler said, according to these data, there also seems to be differences in how academic neurologists and private practice neurologists accessed the information: 75 percent of the academics relied on journal articles and peers compared with 59 percent of the private practitioners; whereas 54.8 percent of private practice neurologists relied on pharmaceutical companies versus 23.4 percent of the academic neurologists.

Dr. Haut suggested to Neurology Today that a pilot study should be implemented in the future, “where a systematic warning is sent out and then patterns of delivery and impact are measured.”

“The majority of the neurologists in this study said they would prefer to receive this information from a structured, easily obtained source. And a large number actually endorsed the idea of having a formal warning process via specialty organizations or email that would provide them with updated medication warnings — and I think that that's really essential,” Dr. Vossler told Neurology Today. Having a “hodgepodge of sources,” he said, means some providers may simply not receive the updated safety information because they don't subscribe or have access to some of these channels.

As the largest specialty organization for neurology, the AAN might take the lead on developing a more systematic dissemination system, she said. “These organizations could send out an ‘e-mail blast’ based on preset criteria such as official FDA warnings, or even safety issues that do not reach the level of an official warning.” To avoid inundating neurologists with e-mails, Dr. Haut suggested a committee or task force from each organization to decide on essential notifications.

Agreeing, Dr. Vossler said, “I think it's really going to be necessary for specialty societies like the AAN to devise a strategy on behalf of our patients to reach out to the FDA to figure out how to effectively push new safety data to [neurologists] on a regular and reliable basis. Then, at the specialty society level, we will need to have people who are assigned, perhaps on a rotating basis, to review the literature and decide in groups what concerns rise to the level of requiring notifications, and then get that out to the members,” Dr. Vossler said. Still, not all neurologists are members of the AAN, so you are inevitably going to miss some people, he added.

Stephanie Yao, a press officer for the FDA's Center for Drug Evaluation and Research, told Neurology Today that they are open to working with specialty societies to improve drug safety communication: “We educate and share with organizations information like MedWatch Safety Alerts and Drug Safety Communications that could be useful for their audiences. In turn, the specialty groups decide whether to pass the information along to their members. Specialty organizations are our valued stakeholder, and we welcome opportunities to collaborate with specialty societies and improve the dissemination of information to reach busy health care professionals.”

In the meantime, until there is a systematic notification effort in place, Dr. Vossler said that neurologists need to be more proactive. “Neurologists who are prescribing medications in certain drug categories like anti-epileptics not only ought to visit the AAN website and become familiar with the AAN guidelines, but they also should visit some of the other specialty society pages, in addition to periodically monitoring the FDA website.”

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TUNE IN, LISTEN UP: According to a new study published in the Oct. 2013 edition of Epilepsy & Behavior, 20 percent of U.S. neurologists surveyed by e-mail said they were unaware of updated drug safety risks and recommendations for antiepileptic drugs. David G. Vossler, MD, clinical associate professor of neurology and medical director of the University of Washington Medicine Valley Medical Center Neuroscience Institute in Renton, WA, spoke with Neurology Today of some of the current challenges to communication, as well as potential strategies to improve the transmission of the FDA's safety warnings to neurologists: http://bit.ly/rCBryX.

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LINK UP FOR MORE INFORMATION:

•. Bella SG, Matsumotoa M, Krauss GL, et al. New antiepileptic drug safety information is not transmitted systematically and accepted by U.S. neurologists. Epilepsy Behav. 2013; 29:(1):36–40.

•. U.S. Food and Drug Administration's MedWatch: www.fda.gov/Safety/MedWatch.

•. Information from the American Academy of Neurology on drug and device safety: www.aan.com/practice/patient-safety/drug-and-device-safety.

Wolters Kluwer Health | Lippincott Williams & Wilkins

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