A Descriptive Evaluation of Prescriber Perceptions and Experience With Risk Evaluation and Mitigation Strategy (REMS) Programs in an Integrated Health Care System.

OBJECTIVE: To assess prescriber perceptions and experience with risk evaluation and mitigation strategy (REMS) programs in an integrated health care delivery system. METHODS: A cross-sectional online survey was e-mailed to eligible health care prescribers if they prescribed at least 1 selected REMS-related product within 6 months spanning January 1 to June 30, 2013; were an active employee of Kaiser Permanente Southern California; and had an active " kp.org " e-mail address. Descriptive analyses were conducted on the survey responses. RESULTS: Three hundred sixty-four respondents (34%) completed the online survey. The majority were primary care prescribers (65%) versus nonprimary prescribers. The majority of primary care, oncologist, and specialist prescribers responded that REMS was meaningful, improved patient safety, and made an impact on their patient interactions. The majority of surgeons and pain management prescribers responded that REMS was not meaningful, did not improve safety for the patients, or did not impact their interactions with their patients. Over 50% of prescribers counseled their patients or had another health care team member discuss the risks and benefits of these REMS-related medications; medication guides or other printed literature was not provided as much. CONCLUSION: The results from the survey suggest that prescriber specialty has an impact on the perceived value of the REMS program and the perceived need to counsel patients regarding medications with REMS programs.

Ipilimumab administration for advanced melanoma in patients with pre-existing Hepatitis B or C infection: a multicenter, retrospective case series.

Ipilimumab is a fully human, monoclonal antibody directed against Cytotoxic T Lymphocyte Antigen-4 (CTLA-4) that has demonstrated a survival benefit and durable disease control in patients with advanced melanoma. Ipilimumab is associated with potentially serious immune-related adverse events, including autoimmune hepatitis. Because clinical trials of ipilimumab excluded patients with pre-existing hepatitis B or C infection, there is a paucity of data on the safety of ipilimumab administration to that patient population. Here, we report the largest case series to date of patients with hepatitis B or C who received ipilimumab for advanced melanoma. Two of the nine patients described in this case series experienced fluctuations in their liver function tests (LFTs) and were subsequently treated with corticosteroids. Although this is a small series, the rate of hepatotoxicity appears similar to what has been seen in the general population treated with ipilimumab, and the ability to administer ipilimumab did not appear to be affected by concomitant hepatitis B or C infection. The use of ipilimumab in patients with metastatic melanoma who have pre-existing hepatitis can be considered among other therapeutic options.