Getting Informed Consent and Agreement for Treatment right: A legal perspective on key obligations for practitioners who use controlled substances to treat chronic pain

Jennifer Bolen, JD

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The terms “Narcotic Contract” and “Opioid Contract” are not really appropriate in a legal/regulatory context, even though these terms may sound more official. Most state legal/regulatory materials on prescribing controlled substances for the treatment of pain refer to a written agreement between the physician and patient as an “Agreement for Treatment.” Once you learn what your state says about the use of such a document, you should call it what your state calls it and use language similar to your state’s language. However, if you live in a state that refers to the agreement as a contract, consult with your legal counsel or a legal expert on the matter to decide whether you increase your legal exposure by using the term “contract.” The rationale for using your state’s terminology (unless it says “contract”) is obvious— you signal your knowledge of your state’s materials and, hopefully, you demonstrate your compliance with the same by the manner in which you document and use your Agreement for Treatment. Once again, the exception to the term “contract” relates to the potential increase in legal exposure or obligations.

The University of Wisconsin’s Pain & Policies Studies Group Web site contains an index of state materials and may be accessed at www.medsch.wisc.edu/painpolicy/index.htm. The Legal Side of Pain Web site contains a comprehensive set of quick reference materials for all states related to the use of controlled substances to treat pain and related ethical and professional obligations and may be accessed at www.legalsideofpain.com.

Federation of State Medical Boards: Model Policy for the Use of Controlled Substances for the Treatment of Pain (May 2004). Federation of State Medical Boards Web site. Available at www.fsmb.org/pdf/2004_grpol_controlled_substances.pdf. Accessed June 23, 2006.

Federation of State Medical Boards: White Paper on Model Guideline for the Use of Controlled Substances for the Treatment of Pain (1998). Federation of State Medical Boards Web site. Available at www.fsmb.org/pdf/1998_grpol_Pain_Management_Guidelines.pdf. Accessed June 23, 2006.

Remember, in some states, like Arizona, the directive language is “must,” and case law often sees informed consent as a “must” as well.

Arnold RM, Han KJ, Seltzer D: Opioid contracts in chronic nonmalignant pain management: Objectives and uncertainties. Am J Med. 2006; 119: 292-296.

Berg JW, Appelbaum PS, Lidz CW, et al.: Informed Consent: Legal Theory and Clinical Practice. New York: Oxford University Press; 2001.

Bolen J: Pain & the law: Back to basics, Part I—Informed Consent facilitates use of controlled substances. Pain Medicine News. 2005; 3(4): 10. Available at www.painmedicinenews.com.

Title 21, Code of Federal Regulations, Section 1306.04.

US Drug Enforcement Administration: Interim policy statement on dispensing controlled substances for the treatment of pain. Fed Regist. 2004; 69(220): 67170-67172. US Government Printing Office Access Web site. Available at www.gpoaccess.gov/fr/index.html. Accessed January 10, 2006.

US Drug Enforcement Administration: Clarification of existing requirements under the Controlled Substances Act for Prescribing Schedule II Controlled Substances. Fed Regist. 2005; 70(165): 50408-50409. US Government Printing Office Access Web site. Available at www.gpoaccess.gov/fr/index.html. Accessed January 10, 2006.

Arizona Board of Medical Examiners: Guidelines for the treatment of chronic pain. Arizona Board of Medical Examiners Web site. Available at azmdboard.org/pain_management/Guidelines.pdf. Accessed June 10, 2006.

Bolen J: Pain & the law: Back to basics, Part II—a treatment agreement establishes boundaries with patients. Pain Medicine News. 2005; 3(4): 20, 35. Available at www.painmedicine news.com.

Boswell MA, Cole BE: Weiner’s Pain Management: A Practical Guide for Clinicians, Seventh Edition.Boca Raton: Taylor & Francis Group, 2005.

Bolen J: Pain & the law: Ten common documentation errors and ways to fix them. Pain Medicine News. 2004; 2(4): 13, 21-22. Available at www.painmedicinenews.com.

Most states’ legal/regulatory materials likewise overlook the last two elements of a legal Informed Consent. One exception is Arizona’s relatively new Guidelines for the Treatment of Chronic Pain, adopted in early 2006. If you want your Informed Consent to help you minimize liability and risk potentials, then use all four elements and review this issue with qualified legal counsel.

See example Informed Consent and Agreement for Treatment located on www.legalsideofpain.com. The American Academy of Pain Medicine also splits the concepts of Informed Consent and Agreement for Treatment into separate forms, and readers can find samples on the Academy’s website at www.painmed.org.

American Academy of Pain Medicine: Position Statement on Opioid Therapy, Consent for Chronic Opioid Therapy. American Academy of Pain Medicine Web site. Available at www.painmed.org/productpub/statements/sample.html.

Title 21, Code of Federal Regulations, Section 1306.04.

North Carolina Board of Medicine: Policy for the Use of Controlled Substances for the Treatment of Pain. (Adopted September 1996 as Management of Chronic Non-Malignant Pain; redone July 2005 based on the Federation of State Medical Board’s Model Policy for the Use of Controlled Substances for the Treatment of Pain, as amended by the FSMB in 2004.) North Caroline Board of Medicine Web site. Available at http://www.ncmedboard.org/. Accessed June 10, 2006.

Fishman S, Mahajan G, Jung SW, et al.: The trilateral opioid contract. Bridging the pain clinic and the primary care physician through the opioid contract. J Pain Symptom Manage. 2002; 24(3): 335-344.

The DAST-20 is available at www.chronicpainnetwork.com.

The SOAPP® Tool is available at www.painedu.org/soap.asp.

The Opioid Risk Tool is available at www.emergingsolutionsinpain.com.

Colorado State Board of Medical Examiners: Policy for the Use of Controlled Substances for the Treatment of Pain (as revised November 18, 2004). State of Colorado Department of Regulatory Agencies Web site. Available at www.dora.state.co.us/medical/Policy10-14.htm. Accessed June 10, 2006. Accompanying sample patient contract, “Using Opioid Pain Medication in Chronic Pain,” available at www.dora.state.co.us/medical/Policy10-14SampleContract.doc. Accessed June 10, 2006.

The American Medical Association: Code of Medical Ethics: Current Opinions of the Council on Ethical and Judicial Affairs of the American Medical Association, 2004-2005 Edition. Opinion 8.08 implicates Ethics Principles I, II, III, IV, and V. American Medical Association Web site. Available at www.ama-assn.org/ama/pub/category/8488.html. Accessed June 10, 2006; Informed Consent available at www.ama-assn.org/ama/pub/category/4608.html. Accessed June 10, 2006.

Fishman SM, Bandman TB, Edwards A, et al.: The opioid contract in the management of chronic pain. J Pain Symptom Manage. 1999; 18: 27-37.

Heit H: Creating and Implementing Opioid Agreements. CareManagement Web site. Available at www.jcaremanagement.com/html/pain__creating_and_implementin.html. Accessed June 22, 2006.

Check your state law to make sure there is no requirement in pain management to implement “random” urine or serum drug testing. Usually, the randomness requirement is limited to employment or workplace drug testing, the nature of which is very different from that of urine drug testing in pain management.




DOI: https://doi.org/10.5055/jom.2006.0030

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