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What to Know About the U.S. FDA’s Opioid-REMS (Risk Evaluation and Mitigation Strategy)
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From: US Department of Justice, Drug Enforcement Administration.
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A Pharmacist’s Guide to Prescription Fraud The DEA Office of Diversion Control issued this brief guide for pharmacists outlining their responsibilities regarding controlled substances, types of fraudulent prescriptions, characteristics of forged prescriptions, prevention techniques, and proper controls in the pharmacy setting. Issue date February 2000.
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Achieving Balance in Federal and State Pain Policy These documents are undergoing updating and are expected to be reissued in 2013. Achieving Balance in Federal and State Pain Policy: A Guide to Evaluation From: Pain & Policy Studies Group; University of Wisconsin Paul P. Carbone Comprehensive Cancer Center; Madison, Wisconsin; UPDATED 2008 (July, 5th Edition).
The Evaluation Guide 2008: (1) provides updated background information about federal and state pain policy; (2) explains the central principle of balance in either positively or negatively affecting pain management, (3) presents the results of a criteria-based evaluation of federal and state policies that were current as of 2008, and (4) offers examples of language that can be used to achieve more balanced policies. Achieving Balance in State Pain Policy: A Progress Report Card The Progress Report Card quantifies state pain policies, and tracks progress to promote pain management and reduce policy barriers by comparing 2008 state policy grades with those from 2000, 2003, 2006, and 2007.
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Practitioner’s Manual — An Informational Outline of the Controlled Substances Act From: US Department of Justice, Drug Enforcement Administration, Office of Diversion Control, August 2006.
This manual is intended to help answer questions that practitioners may encounter and to provide guidance in complying with federal requirements. DEA remains committed to the 2001 Balanced Policy of promoting pain relief and preventing abuse of pain medications. In enforcing the CSA, it is DEA’s responsibility to ensure drugs are not diverted for illicit purposes. See note above regarding DEA changes to opioid prescribing. For additional information, see the DEA website at: http://www.deadiversion.usdoj.gov/pubs/manuals/pract/index.html. Reference Lists of Controlled Substances
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Model Policy for the Use of Controlled Substances for the Treatment of Pain From: Federation of State Medical Boards of the United States, Inc.; 2004 (May).
Circumstances that contribute to the prevalence of undertreated pain include: (1) lack of knowledge of medical standards, current research, and clinical guidelines for appropriate pain treatment; (2) the perception that prescribing adequate amounts of controlled substances will result in unnecessary scrutiny by regulatory authorities; (3) misunderstandings of addiction and dependence; and (4) lack of understanding of regulatory policies and processes. Adding to this problem is the reality that the successful implementation of state medical board pain policy varies among jurisdictions. As of January 2004, 22 of 70 state medical boards had policy, rules, regulations, or statutes reflecting the Federation’s Model Policy guidelines and two (2) states had formally endorsed the guidelines. < Back to Top >
Prescription Monitoring Programs (PMPs)
This website provides updated information about the status and trends of PMPs in the United States. As of late 2006, 27 states had adopted PMPs to monitor the prescribing of certain controlled substances and detect illicit prescribing and dispensing. Typically, PMPs collect prescribing and dispensing data from pharmacies, conduct reviews and analyses of the data, and make it available under certain circumstances to regulatory and law enforcement agencies, as well as practitioners. Prescription Drug Monitoring Project — from National Association for Model State Drug Laws (NAMSDL), updated periodically. Since its inception, NAMSDL has assisted states with efforts to address prescription drug diversion, abuse, misuse, and addiction. This website provides links to NAMSDL resources related to prescription monitoring programs (PMPs), including state-by-state summaries of ongoing monitoring efforts. < Back to Top >
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In spring 2011, the U.S. FDA announced requirements of their Risk Evaluation and Mitigation Strategy, or REMS, focusing on reducing the misprescribing, misuse, and abuse of certain opioid analgesics. What does this mean for healthcare providers? See the Pain-Topics UPDATES series discussing the past, present, and future of REMS.
Access UPDATES here: 
Effective December 19, 2007 the DEA's Notice of Proposed Rulemaking to permit an individual practitioner to issue multiple prescriptions to be filled sequentially and authorizing a patient to receive a total of up to a 90-day supply of a Schedule II controlled substance (eg, opioids) became finalized.
From the DEA Office of Diversion Control, this helpful and brief bulletin for healthcare providers outlines responsibilities of controlled substance prescribers, tips for recognizing potential drug abusers at the office or clinic, and what you should do when encountering a suspected drug abuser. Issue date December 1999.
This document promotes more balanced and consistent US federal and state policy relating to the use of controlled substances for the medical management of pain. It helps to provide a framework for deciding which policies should be removed, as well as recommended language to guide the development of new and more balanced policies.
PDF available here for download: 
These Model Policy guidelines have been widely distributed and endorsed by the Drug Enforcement Administration, American Academy of Pain Medicine, American Pain Society, and National Association of State Controlled Substances Authorities. Many states have adopted pain policies using all or part of the Model Policy. Despite increasing concern in recent years regarding the abuse and diversion of controlled substances, pain policies have improved due to the efforts of medical, pharmacy, and nursing regulatory boards committed to improving the quality of and access to appropriate pain care.
Prescription Monitoring Programs — from Pain & Policy Studies Group, University of Wisconsin Paul P. Carbone Comprehensive Cancer Center; Madison, Wisconsin; regularly updated.