32 Practical PAIN MANAGEMENT, July/August 2009 ©2009 PPM Communications, Inc. Reprinted with permission. Earlier this year, the U.S. Food andDrug Administration (FDA)announced its intent to require

Abstract

manufacturers of two dozen opioid formulations to construct detailed Risk Evaluation and Mitigation Strategies (REMS) for their products in order to verify that their benefits to pain manage-ment continue to outweigh the potential risks associated with abuse and misuse. In addition to individualized REMS for certain branded and generic drugs, the FDA also plans to issue a formal REMS for the opioid drug class as a whole, which may take up to a year to develop.1 However, the FDA’s Amendment Act of 2007 paints a reasonable picture of what the pain management industry can expect from this type of REMS, including six general elements that can be used to assure safe use and with two of those elements calling for a more rigorous approach in documenting patient care:2 • Dispensing to patients with evidence or other documentation of safe use conditions such as laboratory test results; • Each patient receiving the drug is subject to certain monitoring. Drug developers are not the only constituents that stand to be affected. Physicians prescribing natural, semi-synthetic, and synthetic opioids to relieve chronic pain symptoms will also be held to more stringent guidelines in regards to determining whether or not patients are following treatment regimens as directed.3 Testing patients to prove compliance will play a critical role in satisfying the FDA’s desire for more stringent risk management. And for physicians with patients taking high doses of opiates, compliance monitoring within a labora-tory environment is the most appropriate way to do so. Compliance monitoring is recognized as a mechanism to minimize drug diversion, avoid overmedication, and evaluate if a patient is using illicit or non-prescribed drugs that may put the patient’s safety at risk while taking medication prescribed by their physician