The timely article by Murray et al1 prompts me to write. We have produced nearly 30 risk minimization plans to permit the safer use of medicines by patients and to enhance the benefit to risk ratio.2 A key part of such plans, which are now enshrined in the United States under the Food and Drug Administration Amendments Act of 2007 (Pub L No. 110-85), within Risk Evaluation and Mitigation Strategies (REMS) and Risk Minimisation Action Plans, and also the Risk Management Plan of the European Medical Evaluation Agency (EMEA) in the European Union, are measures to minimize the effect of any identified and potential risks.
Banerjee AK. Pharmacists Are Key to Enhancing Benefit Risk for Medicines. Arch Intern Med. 2009;169(18):1718–1725. doi:10.1001/archinternmed.2009.345