REMS Programs: Trends and Opportunities for Pharmacists

Minneapolis—The drug safety initiatives known as risk evaluation and mitigation strategies (REMS) have evolved over the past 30 years. From 1970 to 2005, drug safety measures largely focused on premarketing and risk assessment. From 2005 to 2008, risk minimization action plans (RiskMAP), good pharmacovigilance practices, and pharmacoepidemiologic assessment tools were developed; those tools then expanded to REMS in use today. At a contemporary issues session at the AMCP meeting, presenters provided an overview of REMS at a session titled Risk Evaluation and Mitigation Strategy Programs: Current Trend and Opportunities for Pharmacy Practice. Charlie Bell, director, pharma channel management, HealthBridge Parma & Biotech, opened the session with a brief history of REMS, noting that REMS allow the US Food and Drug Administration (FDA) to “enforce steps to ensure that the risk of using a drug is outweighed by the benefits.” REMS include physician training, patient selection, verification of laboratory results, patient awareness of possible risks, and ongoing monitoring. Core components of REMS include a medication guide (FDA-approved patient information pamphlet), a communication plan (process to give healthcare providers and patients specific safety information), elements to assure safe use (provider/patient training and education and patient monitoring), and program assessments (measures of efficacy). Recent updates include REMS on long-acting opioids, Mr. Bell said. He concluded his portion of the session with a discussion on a REMS coordinating center that links the key constituencies involved in the process, including stakeholders (prescribers, patients, pharmacies, dispensing facilities, and wholesalers/distributors). The session continued with a presentation from Gaurang Gandhi, PharmD, MHA, senior director of specialty pharmacy, Express Scripts, Inc. Dr. Gandhi focused on the role of pharmacy in REMS. Describing the pharmacist as the last healthcare professional to touch a patient’s medication, Dr. Gandhi noted that pharmacists communicate with the REMS coordination center, ensure that REMS requirements have been satisfied prior to dispensing the medication, collect and report adverse drug events, and inform the physician and patient when the prescription does not meet all REMS requirements. The pharmacist in charge typically assumes responsibility for training pharmacy staff on REMS requirements. He continued by outlining the benefits and burdens of REMS: the pros include systematic promotion of safe drug use, patient awareness of the benefits and risk of medications, increased collaboration among healthcare practitioners, availability of medications despite some associated risks, and better postmarketing surveillance. The cons include the administrative burden, some possibly confusing requirements, the possibility of insufficient input from the stakeholders (pharmacists, physicians, and patients), and lack of reimbursement for healthcare practitioners for activities required by REMS. Dr. Gandhi cited data from the American Society of Health-System Pharmacists on the challenges faced by pharmacists to be in compliance with REMS. Of pharmacists surveyed, 38% described the degree of difficulty in REMS compliances as very difficult, followed by 36% who said it was extremely difficult, 16% who said it was fairly difficult, and 4% who said it was moderately difficult. Only 2% said there was no challenge involved in REMS compliance. When asked about delay in patient care due to REMS requirements, 30% described the possibility of delay as fair, followed by 22% who said there was a very good chance of delay, 18% who said there was a moderate chance, 13% who said it was extremely likely there would be a delay, and 14% who described the effect of REMS on delay in patient care as negligible, Dr. Gandhi added. The next speaker was Jean Paul Nicandro, PharmD, medical scientist, Prometheus Laboratories, Inc. He focused his remarks on the evolution of alosetron hydrochloride (Lotronex®) risk management. He began by noting that the 2 primary objectives of REMS are the safe use of medications and the assurance that drug benefits outweigh risks. Programs need to balance 3 key elements: drug safety, patient/prescriber access, and the burden on the healthcare system, he added. Alosetron received FDA approval in February 2000 as in indication for female patients with diarrhea-predominant irritable bowel syndrome (IBS-D). It is a potent, selective serotonin type 3 receptor antagonist; the drug’s pharmacologic actions modulate the processes related to the pathophysiology of IBS. It reduces visceral hypersensitivity (pain), slows colonic transit, and decreases gastrointestinal (GI) secretions. In November 2000, the makers of alosetron enacted a voluntary withdrawal based on postmarketing reports of serious GI adverse events, including ischemic colitis, complications of constipation, hospitalizations, and death. Over the course of the next 11 years, the REMS for alosetron evolved. In June 2002, alosetron was reintroduced with a prescribing program (RiskMAP) and restricted indication for women with severe IBS-D. In 2004, a 0.5-mg dose was introduced, followed in April of that year by a modification to the prescribing program allowing refills. In January 2008, Prometheus Laboratories acquired the drug, and in 2010, the company received approval of the REMS for alosetron, Dr. Nicandro added.