Ameet Sarpatwari1, Mayookha Mitra-Majumdar2, Katsiaryna Bykov2, Jerry Avorn2, Steven Woloshin2,3, Gita A Toyserkani4, Cynthia LaCivita4, Claudia Manzo4, Esther H Zhou4, Ellen Pinnow4, Gerald J Dal Pan4, Joshua J Gagne2, Krista F Huybrechts2, William B Feldman2,5, Kristyn Chin2, Aaron S Kesselheim2. 1. Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. asarpatwari@bwh.harvard.edu. 2. Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. 3. Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, NH, USA. 4. Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA. 5. Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Abstract
INTRODUCTION: Since 2007, the US Food and Drug Administration has had the authority to require risk evaluation and mitigation strategy (REMS) programs for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. Such programs can include requirements for patient monitoring, restrictions on dispensing or administration, and physician and pharmacy training and certification. However, there has been only scattered evidence on the impact of REMS programs on informed decision making, medication access, or patient outcomes. OBJECTIVE: The objective of this article was to describe a study that researchers at Brigham and Women's Hospital and Harvard Medical School will conduct in partnership with the Food and Drug Administration's Office of Surveillance and Epidemiology to investigate systematically how REMS programs have operated in practice. METHODS: Investigations include health insurance claims-based analyses to understand patterns of drug use, adherence to safety requirements, and patient outcomes under REMS programs; surveys and interviews to understand physician and patient experiences with REMS; and REMS program material-based and interview-based analyses to understand the effectiveness of risk communication in REMS programs. CONCLUSIONS: These research activities will evaluate the performance of REMS programs, provide information on the benefits and burdens to patients and healthcare providers, and generate recommendations for actionable steps to improve REMS programs overall.
INTRODUCTION: Since 2007, the US Food and Drug Administration has had the authority to require risk evaluation and mitigation strategy (REMS) programs for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. Such programs can include requirements for patient monitoring, restrictions on dispensing or administration, and physician and pharmacy training and certification. However, there has been only scattered evidence on the impact of REMS programs on informed decision making, medication access, or patient outcomes. OBJECTIVE: The objective of this article was to describe a study that researchers at Brigham and Women's Hospital and Harvard Medical School will conduct in partnership with the Food and Drug Administration's Office of Surveillance and Epidemiology to investigate systematically how REMS programs have operated in practice. METHODS: Investigations include health insurance claims-based analyses to understand patterns of drug use, adherence to safety requirements, and patient outcomes under REMS programs; surveys and interviews to understand physician and patient experiences with REMS; and REMS program material-based and interview-based analyses to understand the effectiveness of risk communication in REMS programs. CONCLUSIONS: These research activities will evaluate the performance of REMS programs, provide information on the benefits and burdens to patients and healthcare providers, and generate recommendations for actionable steps to improve REMS programs overall.
Authors: Christopher M Blanchette; Anthony P Nunes; Nancy D Lin; Kathleen M Mortimer; Joshua Noone; Krishna Tangirala; Stephen Johnston; Benjamin Gutierrez Journal: Drugs Context Date: 2015-02-10
Authors: Ameet Sarpatwari; Beatrice L Brown; Sarah A McGraw; Sara Z Dejene; Abdurrahman Abdurrob; Adrian J Santiago Ortiz; Aaron S Kesselheim Journal: JAMA Netw Open Date: 2022-01-04