A Guide to State Opioid Prescribing Policies

Pain Policy and Regulation: Minnesota

Summary

Minnesota has a variety of laws, rules, and guidelines relating to the use of controlled medication, pain management, and palliative care. Minnesota licensees should consult with their licensing board and read all relevant material. Minnesota recently finished a pain management report, which Minnesota licensees should read, and which is available here.

This document contains general summaries of Minnesota's basic legal/regulatory material on the use of controlled medications to treat pain.

Guidelines for the Use of Controlled Substances for the Treatment of Pain

Physicians should not be afraid to prescribe controlled substances. Physicians have been reluctant to prescribe controlled substances because of fear of reprisals in the form of hostile scrutiny or regulatory action against their licenses. The Minnesota Board emphasizes that proper use of controlled substances will not result in any action against the physician. It is in the best interest of the patient to have proper pain control. Therefore, the Board wants to make physicians aware of the updated version of the Model Guidelines for pain control published by the Federation of Medical Boards. The Guidelines can be found at: http://www.fsmb.org/pdf/2004_grpol_Controlled_Substances.pdf.

Physicians should not avoid the prescribing of controlled substances provided they have done a thorough workup as well as the appropriate follow-up. The physician needs to have complete documentation of each step. The Federation guidelines for pain management are guidelines for physicians. They are not rules or laws. They should be used as a way to improve pain management for patients. In Minnesota, these guidelines are not used as part of an enforcement process.

Evaluation of the Patient. A complete medical history and physical examination must be conducted and documented in the medical record. The medical record should document the nature and intensity of the pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function, and history of substance abuse. The medical record also should document the presence of one or more recognized medical indications for the use of controlled substances.

Treatment Plan. The written treatment plan should state objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function, and should indicate whether any further diagnostic evaluations or other treatments are planned. After treatment begins, the physician should adjust drug therapy to the individual medical needs of each patient. Other treatment modalities or a rehabilitation program may be necessary depending on the cause of the pain and the extent to which the pain is associated with physical and psychosocial impairment.

Informed Consent and Agreement for Treatment. The physician should discuss the risks and benefits of the use of controlled substances with the patient or with a guardian or caregiver if the patient is incompetent. The patient should receive prescriptions from one physician and one pharmacy where possible. If the patient is determined to be at high risk for medication abuse or has a history of substance abuse, the physician should consider the use of a written agreement between physician and patient outlining patient responsibilities, including the following:

• Urine/serum medication levels screening when requested;
• Number and frequency of all prescription refills; and
• Reasons for which drug therapy may be discontinued (ie, violation of agreement).

Periodic Review. At reasonable intervals based on the individual circumstances of the patient, the physician should review the course of treatment and any new information about the cause of the pain. Continuation or modification of therapy should depend on the physician's evaluation of progress toward stated treatment objectives, such as improvement in the patient's pain intensity and improved physical and/or psychosocial function (ie, ability to work, need for healthcare resources, ability to carry out activities of daily living, and quality of social life). If treatment goals are not being achieved despite medication adjustments, the physician should reevaluate the appropriateness of continued treatment. The physician should monitor patient compliance with medication usage and related treatment plans.

Consultation. The physician should be willing to refer the patient as necessary for additional evaluation and treatment to achieve treatment objectives. Special attention should be given to those patients with pain who are at risk for misusing their medications and those whose living arrangements pose a risk for medication misuse or diversion. The management of pain in patients with a history of substance abuse or with a comorbid psychiatric disorder may require extra care, monitoring, documentation, and consultation with or referral to an expert in the management of such patients.

Medical Records. The physician should keep accurate records that include the following:

• Complete medical history and results of physical examination;
• Diagnostic, therapeutic, and laboratory results;
• Evaluations and consultations;
• Treatment objectives;
• Discussion of risks and benefits;
• Treatment history;
• Medications (including date, type, dosage, and quantity prescribed);
• Instructions and agreements; and
• Periodic reviews.

Records should remain current and should be accessible and readily available for review.

Compliance With Controlled Substances Laws and Regulations

To prescribe, dispense, or administer controlled substances, the physician must be licensed in the state and must comply with applicable federal and state regulations. Physicians should review the Drug Enforcement Administration's Practitioner's Manual for specific rules governing controlled substances as well as applicable state regulations. The Manual can be found at the Drug Enforcement Administration's Web site at: http://www.deadiversion.usdoj.gov.

Definitions

Acute Pain. Acute pain is the normal, predicted physiologic response to an adverse chemical, thermal, or mechanical stimulus and is associated with surgery, trauma, and acute illness. It is generally time-limited and is responsive to opioid therapy, among other therapies.

Addiction. Addiction is a neurobehavioral syndrome with genetic and environmental influences that results in psychological dependence on the use of substances for their psychic effects and is characterized by compulsive use despite harm. Addiction may also be referred to by terms such as "drug dependence" and "psychological dependence." Physical dependence and tolerance are normal physiologic consequences of extended opioid therapy for pain and should not be considered addiction.

Analgesic Tolerance. Analgesic tolerance is the need to increase the dose of opioid to achieve the same level of analgesia. Analgesic tolerance may or may not be evident during opioid treatment and does not equate with addiction.

Chronic Pain. A pain state that is persistent and in which the cause of the pain cannot be removed or otherwise treated. Chronic pain may be associated with a long-term incurable or intractable medical condition or disease.

Pain. An unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage.

Physical Dependence. Physical dependence on a controlled substance is a physiologic state of neuroadaptation characterized by the emergence of a withdrawal syndrome if drug use is stopped or decreased abruptly, or if an antagonist is administered. Physical dependence is an expected result of opioid use. Physical dependence, by itself, does not equate with addiction.

Pseudoaddiction. Pseudoaddiction is a pattern of drug-seeking behavior of patients with pain who are receiving inadequate pain management. Pseudoaddiction can be mistaken for addiction.

Substance Abuse. Substance abuse is the use of any substance(s) for nontherapeutic purposes or use of medication for purposes other than those for which it is prescribed.

Tolerance. Tolerance is a physiologic state resulting from regular use of a drug in which an increased dosage is needed to produce the same effect, or a reduced effect is observed with a constant dose.