Prescription opioids: Managing the risks while maintaining appropriate patient access
Authors: J. Henningfield, R. Fant, S. Schnoll, M. Sembower
Meeting: The College on Problems of Drug Dependence 72nd Annual Meeting
Date: June 14, 2010
Aims: The 2007 FDA Authorization Amendment (FDAAA) codified a new approach to risk management termed Risk Evaluation and Mitigation Strategies (REMS). In February, 2009, FDA announced that REMS would be required for 16 categories of extended release and long acting opioids. This presentation addresses challenges in risk management that are particularly relevant to opioid analgesics.
Conclusions: For most drugs, the primary risks are to the patient, and education-based risk management tools may provide adequate control. For opioid analgesics, use by non patients is a major risk and is less effectively addressed by education. Furthermore strategies to reduce ease of diversion and abuse might prevent appropriate patient access. The first step in risk management is "evaluation" to determine the nature and extent o f the risks and benefits to thereby guide risk mitigation development and implementation. Our analysis of the 2007 National Survey on Drug Use and Health indicated that among respondents who reported nonmedical use of a prescription opioid within the past 30 days (N=1,113), 77% obtained the drug from a friend or relative, 13.4% reported stealing the drug from a friend or relative, 20% received a prescription from a single physician, and 5% reported receiving prescriptions from more than one physician (potential "doctor shopping"). About 13% purchased the drug from an illicit dealer. Other evidence indicates that many persons using without a prescription used for analgesic benefit and not to get high, confirming that there are multiple routes of abuse, diversion, and motivation for use. This presentation will discuss the use of surveillance data in a premarket risk evaluation to provide the foundation for potential risk mitigation strategies. It will also describe how surveillance data can then be used to evaluate the potential benefits and unintended consequences of the REMS, thus providing a foundation for interventions and for modification of the REMS to improve its effectiveness without posing undue barriers to patient access.
