Opioid Rx Regulatory & Legal Issues
This section focuses on guidance and mandates coming from government agencies -- federal, state, or local -- or medical boards regarding the prescribing, dispensing, and administration of opioid medications.

NOTE: All URL links listed below were valid at the time of posting; however, the Internet is constantly changing and some linked sites may move or become inactive with time.  Please notify us of any broken links at: Info@Pain-Topics.org..

CONTENTS

• DEA — Notes & Announcements
• Increasing Patient Access to Pain Medicines Around the World
• Achieving Balance in Federal and State Pain Policy
• Practitioner’s Manual - Outline of Controlled Substances Act
• Model Policy for the Use of Controlled Substances
• Prescription Monitoring Programs (PMPs)

DEA — Notes & Announcements

From: US Department of Justice, Drug Enforcement Administration.

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.

For more information see: http://www.deadiversion.usdoj.gov/fed_regs/rules/2007/fr1119.htm.

Also see, DEA Policy Statement: Dispensing Controlled Substances for the Treatment of Pain (September 6, 2006) at: http://www.deadiversion.usdoj.gov/fed_regs/notices/2006/fr09062.htm.

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Increasing Patient Access to Pain Medicines Around the World:

A Framework to Improve National Policies that Govern Drug Distribution

From: Pain & Policy Studies Group. University of Wisconsin Paul P. Carbone Comprehensive Cancer Center; Madison, Wisconsin; 2008.

See details & register for course: http://www.painpolicy.wisc.edu/on-line_course/welcome.htm

(Free registration is required. Access checked 8/29/08.)

This free, non-credit course focuses on the relationships between government policies that affect the medical availability of opioid analgesics and patients who experience moderate to severe pain. It is critically important for healthcare professionals and government drug regulators, as well as advocates involved in the areas of palliative care and pain relief, to understand government policies controlling opioid analgesics and how they can impact medication availability and patient access to these drugs. The course has 7 lessons with required readings as follows:

• Understanding the relationship between pain and drug control policy.
• The role of international and national law and organizations.
• Barriers to opioid availability and access.
• WHO guidelines to evaluate national opioid control policies.
• National systems for estimating opioid requirements and reporting consumption.
• WHO guidelines on procurement and distribution systems for opioid analgesics.
• How to make a change in your country.
  

This is a self-paced course that can be taken at any time. On average, it takes between 10 and 12 hours to complete.

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Achieving Balance in Federal and State Pain Policy: A Guide to Evaluation (5th Edition)

From: Pain & Policy Studies Group; University of Wisconsin Paul P. Carbone Comprehensive Cancer Center; Madison, Wisconsin; UPDATED 2008 (July, 5th Edition).

PDF available for download at: http://www.painpolicy.wisc.edu/Achieving_Balance/EG2008.pdf (7 MB, 723 pp)

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.

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.

ALSO SEE: Achieving Balance in State Pain Policy: A Progress Report Card
From: Pain & Policy Studies Group; University of Wisconsin Paul P. Carbone Comprehensive Cancer Center; Madison, Wisconsin; UPDATED 2008 (July, 4th Edition).

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.

PDF available for download at: http://www.painpolicy.wisc.edu/Achieving_Balance/PRC2008.pdf  (36 pp)

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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.

 PDF available here for download: DEA_PractitionersManual2006.pdf (2 MB; 66 pp)

This manual has been prepared by the DEA, Office of Diversion Control, to assist practitioners (physicians, dentists, veterinarians, and other registrants authorized to prescribe, dispense, and administer controlled substances) in their understanding of the Federal Controlled Substances Act (CSA) and its implementing regulations as they pertain to the practitioner’s profession. Pertinent citations to the law and regulations are included in this manual.

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
From: US Department of Justice, Drug Enforcement Administration, Office of Diversion Control, April 2006.

 PDF available here for download: DEA_ControlledSubstList_2006.pdf (298 KB; 59 pp)

For Internet HTML verson, see: http://www.deadiversion.usdoj.gov/schedules/schedules.htm

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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).

PDF available for download at: http://www.fsmb.org/pdf/2004_grpol_Controlled_Substances.pdf (45 KB, 6 pp)

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.

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.

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Prescription Monitoring Programs (PMPs)

Prescription Monitoring Programs — from Pain & Policy Studies Group, University of Wisconsin Paul P. Carbone Comprehensive Cancer Center; Madison, Wisconsin; regularly updated.

Go to website: http://www.painpolicy.wisc.edu/domestic/diversion.htm

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.

Go to website: http://namsdl.org/presdrug.htm

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.

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