Managing the Risks of Medicines: An Examination of FDA's Application of Criteria for Requiring a REMS.

Background: In September 2016, the Food and Drug Administration (FDA) published a draft guidance for industry, , that detailed the factors the Agency considers in determining when a Risk Evaluation and Mitigation Strategy (REMS) is necessary. The objective of this study was to determine how the FDA has applied these criteria for newly approved drugs.

Methods: For the 3-year period, 2015-2017, which included a full year of FDA approvals both before and after the issuance of the draft guidance, publicly available FDA reviews were analyzed for all 113 approved products using the criteria outlined in the guidance.

Implementation of a New Clinic-Based, Pharmacist-Managed PCSK9 Inhibitor Consultation Service.

Background: The proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors alirocumab and evolocumab were approved by the FDA in 2015. In anticipation of provider interest and a potential increase in referrals to the on-site specialty pharmacy, we created a pharmacist-managed consultation service.

Program Description: The development of a clinic-based pharmacist-managed consultation service for the management of the PCSK9 inhibitor agents alirocumab and evolocumab is described.

Hepatitis C Virus Resistance Testing in Genotype 1: The Changing Role in Clinical Utility.

Objective: To review the role and utility of baseline resistance testing with currently available and pipeline genotype 1 hepatitis C virus (HCV) treatment.

Data Sources: Authors reviewed liver meeting abstracts for data on currently-available and pipeline genotype 1 retreatment regimens from January 1, 2015, to March 23, 2017. Additional trials were identified from a review of clinicaltrials.