A panel of the US Food and Drug Administration (FDA) has voted to switch to electronic prescribing for alosetron hydrochloride in addition to retaining
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A panel of the US Food and Drug Administration (FDA) has voted to switch to electronic prescribing for alosetron hydrochloride in addition to retaining and refining other aspects of the current risk management system that restricts its availability.
Alosetron hydrochloride (LOTRONEX), manufactured by Prometheus Laboratories, Inc, is the only drug that is currently available for the treatment of women with severe diarrhea-predominant irritable bowel syndrome (IBS-D) who have not responded well to conventional therapies. Significant risks are associated with the use of this drug including ischemic colitis (inflammation and injury to large intestine resulting from inadequate blood supply), bowel perforation and ileus (bowel obstruction).
Members of the FDA’s Drug Safety and Risk Management Advisory Committee reiterated the importance of provider-patient communication about both the risks and benefits of the drug. 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 improvements.
In the current REMS/ETASU, only certified physicians are able to write prescriptions for alosetron. These certified individuals must write the prescription on paper then affix a sticker to it to attest that they are certified and the patient follows under the appropriate criteria. These criteria ensure that alosetron is used only in severely affected patients where the benefits would exceed the risks. For the pharmacy, REMS/ETASU for alosetron stipulates that only paper prescriptions with the sticker be filed. Fax, phone and computer prescriptions are not allowed.
The advisory panel discussed a variety of options for revising REMS/ETASU. All members were in favor of eliminating the sticker requirement and beginning e-prescribing as soon as possible. In addition, most of the panel favored keeping the requirement where patients sign a form attesting that the physician discussed the benefits and risks of the drug and that they fully understood the information. Some of the panel also endorsed the idea of an electronic registry.
Dr. Woods, clinical coordinator and residency program director in the Pharmacy Department at Saint Luke’s Hospital, Kansas City, Missouri, noted that it is necessary to ensure that any new electronic system implemented must still portray the special circumstances and conditions for which this drug is prescribed. “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.”
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