Risk Evaluation and Mitigation Strategies (REMS), Pill Mills, and Responsible Opioid Prescribing

Abstract

Over the past 20 years, drug overdose deaths in the United States have tripled. More than 100 people die each day secondary to prescription drug use, whether related to drug abuse, misuse, or adverse events. In July 2012, the Drug Abuse Warning Network reported that of 4.8 million drug-related visits to US emergency departments in 2010, 46.8% were due to drug abuse or misuse. Prescription drugs had the highest representation of all abused drugs at a frequency of 435 per 100,000 population. Because Florida is the state with the greatest number of medications dispensed and the highest drug mortality, the actions of that state have a far-reaching impact because of the enormous volume of drugs diverted from Florida. Recognizing the problem, the US Food and Drug Administration (FDA) started Risk Evaluation and Mitigation Strategies (REMS) as a source of education. REMS require drug manufacturers to educate physicians who, in turn, will educate their patients about the proper use of high-risk medications, including opioids. This chapter addresses the problem of clinics that appear to operate as pain clinics but really exist to dispense prescriptions for medication, or ‘‘pill mills,’’ and their contribution to the national prescription drug epidemic. A template for responsible controlled substance prescribing, which includes complete history taking and physical examination with particular attention to comorbidities (including psychiatric disorders), is described. Finally, an overview of the available risk assessment and ongoing management tools is presented.