A REMS for Long-Acting Opioid Analgesics: Anticipated Impact on the Dual Public Health Issues of Non-Medical Use and Patient Pain Care

Abstract

In September 2007, the Federal Food, Drug, and Cosmetic Act (FFDCA) was expanded to comprise active postmarket risk identification for approved drugs, including monitoring of drug safety data from disparate sources and adverse event surveillance using electronic data from government and the private sector. These legislative provisions became effective in March 2008, when the Food and Drug Administration (FDA) was charged with the legal mandate of establishing a Risk Evaluation and Mitigation Strategy (REMS) to address the public health issue of drug abuse and diversion for various medications to be approved, or already approved, for marketing. Conceptually, REMS can be considered a mechanism to achieve a post-marketing drug safety risk-benefit analysis. The enacting FFDCA legislation also emphasizes that the goal of a REMS is to minimize medication abuse and diversion while, at the same time, avoiding impeding patient access to medications essential to treat the health consequences of chronic diseases and conditions. The FDA’s initial effort to create a broad-based REMS program now is considering such elements as (i) covering 24 long-acting opioid analgesic products, each included in Schedule II under the Controlled Substances Act and indicated for the treatment of moderate to severe pain; (ii) establishing a registry for all patients using these medications; and (iii) requiring prescriber certification through the Drug Enforcement Administration’s registration process. It is anticipated that the FDA will begin implementing this REMS in December, 2009, so the program requirements will be finalized within the year. As a result, there will likely be a number of issues within the final REMS that demand further consideration. Not only must this REMS be proven to effectively control abuse and diversion, it also must be shown to avoid fostering unintended practitioner, pharmacy, and patient concerns that ultimately restrict opioid availability and hinder effective patient access to treatment.