FDA Panel: Alosetron REMS Should Include e-Prescribing

Miriam E. Tucker

July 10, 2013

Silver Spring, Maryland — A US Food and Drug Administration (FDA) advisory panel has voted to switch to electronic prescribing for alosetron hydrochloride, while retaining and refining other aspects of the current risk management system that restricts its availability.

Alosetron hydrochloride (Lotronex, Prometheus Laboratories, Inc) is the only drug currently available for the treatment of women with severe diarrhea‐predominant irritable bowel syndrome (IBS-d) who have failed conventional therapy. It is associated with significant risks for both ischemic colitis and serious complications of constipation such as bowel perforation and ileus.

At a hearing, members of the FDA's Drug Safety and Risk Management Advisory Committee emphasized the importance of provider-patient communication about the risks and benefits of the drug, and many expressed a desire to collect electronic data within the current Risk Evaluation and Mitigation Strategy (REMS) with elements to assure safe use (ETASU) to assure compliance and monitor patient outcomes.

REMS/ETASU is intended to ensure that alosetron is used only in severely affected patients for whom benefits exceed the risks and that those risks are communicated to prescribers, pharmacists, and patients. The program requires that healthcare providers who prescribe the drug are specially certified. Patients are given a medicine guide, and must sign a form attesting that they understand the risks.

In the current REMS/ETASU, certified physicians are required to write prescriptions on paper and to affix a sticker to the paper to attest that they are certified and the patient has fulfilled the requirements. On the pharmacy end, REMS/ETASU stipulates that only paper prescriptions with the sticker be filled. Prescriptions by fax, phone, and computer are not allowed.

However, Igor Cerny, PharmD, a REMS analyst at the FDA, told the panel that although the FDA agreed with Prometheus that the alosetron REMS/ETASU is generally meeting its 2 stated goals, compliance isn't 100%. About 10% of prescriptions for the drug are still being written by noncertified physicians, and 14% of the drug's prescribers are not enrolled in REMS. Moreover, a survey of pharmacists found that only 63% of the prescribers knew not to accept nonpaper prescriptions.

In 2012, 41,349 alosetron prescriptions were dispensed in outpatient US retail pharmacies.

"Assessment report data suggest that some REMS processes may need refinement to improve compliance and potentially decrease burden," Dr. Cerny said.

The advisory panel discussed a variety of options for revising REMS/ETASU. All members agreed that the sticker requirement be eliminated right away and e-prescribing begin as soon as possible. Most also opted to retain the requirement that patients sign a form attesting that the physician has discussed the risks and benefits of the drug with them and that they understood the information. Some panel members also endorsed the idea of an electronic registry.

Panel member Brian Sauer, PhD, said he would prefer to preserve the signature. "I think there's value in that," he noted. "I think it does solidify the patient–doctor relationship and activates the patient. But I think the sticker is outdated."

However, added Dr. Sauer, who is assistant professor of epidemiology at the University of Utah, Salt Lake City, "I think an electronic system that has to be developed by the sponsor is probably a little burdensome to the sponsor, so I think FDA has to take some initiative to help organize it."

Panelist T. Mark Woods, PharmD, pointed out that "[d]rugs with REMS have serious, serious problems. Yet, we hear about all the workarounds people are able to use to get around these REMS. We need to make sure that when we require a REMS that it is done on every patient every time. There probably needs to be built-in redundancy to make sure the patient education and monitoring are done appropriately."

Dr. Woods, clinical coordinator and residency program director in the Pharmacy Department at Saint Luke's Hospital, Kansas City, Missouri, said it is important to make sure any new electronic system is designed to accomplish what the paper-only rule was meant to do. "The sticker did serve a purpose. It communicates to the pharmacist that this is not the usual prescription. We have to have mechanisms so that everybody who's taking care of that patient knows that this is a special circumstance."

Several members also said that they would like to see the REMS/ETASU system standardized overall. Approximately 50 drugs are now subject to the process, each with unique requirements.


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