A Guide to State Opioid Prescribing Policies

Pain Policy and Regulation: Michigan

Public Health Code Background Legislation

The legislature finds that the treatment of pain is an appropriate issue for the legislature to consider, and that the citizens of this state would be well served by the enactment of legislation that accomplishes all of the following:

• Provides more and better information to healthcare consumers regarding the medical treatment of pain, healthcare coverage and benefits for the treatment of pain, and the education of health professionals in pain and symptom management.
• Provides for the appointment of an advisory body to study and make recommendations on model core curricula on pain and symptom management for the institutions in this state, providing healthcare education, continuing education for health professionals on pain and symptom management, and the integration of pain and symptom management into the customary practice of healthcare.
• Educates health professionals about the disciplinary process for state licensees and registrants, including but not limited to, how the department of consumer and industry services processes allegations of wrongdoing against licensees and registrants.
• The legislature finds that the use of controlled substances is appropriate in the medical treatment of certain forms of pain and that efforts to control diversion or improper administration of controlled substances should not interfere with the legitimate, medically recognized use of those controlled substances to relieve pain and suffering.
• The legislature finds that some patients in this state with pain are unable to obtain from their healthcare providers sufficient pain relief through the prescription of controlled substances, especially controlled substances included in schedule 2 under section 7214.
• It is the intent of the legislature to permit and facilitate adequate treatment for pain by licensed health professionals, including but not limited to, the prescription or dispensing of controlled substances included in schedule 2 under section 7214, when medically appropriate, and to enable regulatory and law enforcement agencies to prevent the abuse and diversion of controlled substances by creating an electronic monitoring system.

Michigan Board of Medicine and Board of Osteopathic Medicine Guidelines for the Use of Controlled Substances in the Treatment of Pain

• Section I: Preamble
  • The Michigan Boards of Medicine and Osteopathic Medicine & Surgery recognize that principles of quality medical practice dictate that the people of the State of Michigan have access to appropriate and effective pain relief. The appropriate application of up-to-date knowledge and treatment modalities can serve to improve the quality of life for patients with pain as well as reduce the morbidity and costs associated with untreated or inappropriately treated pain. The Board encourages physicians to view effective pain management as a part of quality medical practice for all patients with pain, acute or chronic, and it is especially important for patients who experience pain as a result of terminal illness. All physicians should become knowledgeable about effective methods of pain treatment and statutory requirements for prescribing controlled substances.
  • Inadequate pain control may result from physicians' lack of knowledge about pain management or from an inadequate understanding of addiction. Fears of investigation or sanction by federal, state, and local regulatory agencies may also result in inappropriate or inadequate treatment of patients with chronic pain. Accordingly, these guidelines have been developed to clarify the Boards' position on pain control, specifically as related to the use of controlled substances, to alleviate physician uncertainty and to encourage better pain management.
  • The Boards recognize that controlled substances, including opioid analgesics, may be essential in the treatment of acute pain resulting from trauma or surgery and chronic pain, whether from cancer or noncancer origins. Physicians are referred to the US Agency for Health Care and Research Clinical Practice Guidelines for a sound approach to the management of acute^[1] and cancer-related pain.^[2] The medical management of pain should be based on current knowledge and research and should include the use of both pharmacologic and nonpharmacologic modalities. Pain should be assessed and treated promptly, and the quantity and frequency of doses should be adjusted according to the intensity and duration of the pain. Physicians should recognize that tolerance and physical dependence are normal consequences of the sustained use of opioid analgesics and are not synonymous with addiction.
  • The Boards are obligated under the laws of the State of Michigan to protect the public health and safety. The Boards recognize that inappropriate prescribing of controlled substances, including opioid analgesics, may lead to drug diversion and abuse by individuals who seek them for other than legitimate medical use. Physicians should be diligent in preventing the diversion of drugs for illegitimate purposes.
  • Physicians should not fear disciplinary action from the Board or other state regulatory or enforcement agency for prescribing, dispensing, or administering controlled substances, including opioid analgesics, for a legitimate medical purpose and in the usual course of professional practice. The Board will consider prescribing, ordering, administering, or dispensing controlled substances for pain to be for a legitimate medical purpose if based on accepted scientific knowledge of the treatment of pain or if based on sound clinical grounds. All such prescribing must be based on clear documentation of unrelieved pain and in compliance with applicable state or federal law.
  • Each case of prescribing for pain will be evaluated on an individual basis. The Board will not take disciplinary action against a physician for failing to adhere strictly to the provisions of these guidelines if good cause is shown for such deviation. The physician's conduct will be evaluated to a great extent by the treatment outcome, taking into account whether the drug used is medically and/or pharmacologically recognized to be appropriate for the diagnosis, the patient's individual needs -- including any improvement in functioning -- and recognizing that some types of pain cannot be completely relieved. The Boards will judge the validity of prescribing based on the physician's treatment of the patient and on available documentation rather than on the quantity and chronicity of prescribing. The goal is to control the patient's pain for its duration while effectively addressing other aspects of the patient's functioning, including physical, psychological, social, and work-related factors. The following guidelines are not intended to define complete or best practice but rather to communicate what the Boards consider to be within the boundaries of professional practice.
• Section II: Guidelines
  The Boards have adopted the following guidelines when evaluating the use of controlled substances for pain control:
  1. 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 a controlled substance.
  2. 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.
  3. Informed Consent and Agreement for Treatment
     The physician should discuss the risks and benefits of the use of controlled substances with the patient, persons designated by the patient, or with the patient's surrogate or guardian 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 may employ the use of a written agreement between physician and patient outlining patient responsibilities, including:
     • 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).
  4. 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 patient’s pain intensity and improved physical and/or psychosocial function (ie, ability to work, need for healthcare resources, 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 in medication usage and related treatment plans.
  5. 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 being treated for 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.
  6. Medical Records
     The physician should keep accurate and complete records that include the following:
     • The medical history and physical examination;
     • Diagnostic, therapeutic, and laboratory results;
     • Evaluations and consultations;
     • Treatment objectives;
     • Discussion of risks and benefits;
     • Treatments;
     • Medications (including date, type, dosage, and quantity prescribed);
     • Instructions and agreements; and
     • Periodic reviews.

     Records should remain current and should be maintained in an accessible manner readily available for review.

  7. Compliance With Controlled Substances Laws and Regulations
     To prescribe, dispense, or administer controlled substances, the physician must be licensed in the state and comply with applicable federal and state regulations. Physicians are referred to the Physicians' Manual of the U.S. Drug Enforcement Administration and (any relevant documents issued by the state medical board) for specific rules governing controlled substances as well as applicable state regulations.
• Section III: Definitions

  For the purposes of these guidelines, terms are defined as follows:

  • 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 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 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 is 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 is an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage.
  • Physical dependence on a controlled substance is a physiologic state of neuroadaptation that is 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 is a pattern of drug-seeking behavior of patients being treated for pain who are receiving inadequate pain management and can be mistaken for addiction.
  • 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 is a physiologic state resulting from regular use of a drug in which an increased dosage is needed to produce the same effect, or in which a reduced effect is observed with a constant dose.

Michigan Board of Pharmacy Guidelines for the Use of Controlled Substances in the Treatment of Pain

The following guidelines are not intended to define complete or best practices, but rather to communicate what the Board considers to be minimum standards of practice for pharmacists caring for patients requiring pain control and presenting with prescriptions for controlled substances.

• Review of the Prescription
  The pharmacist should exercise due diligence to verify that each prescription for a controlled substance has been issued for a legitimate medical purpose. The review should include, but not necessarily be limited to, a careful review of the prescription document for evidence of forgery or alteration, a discussion with the patient regarding the signs and symptoms of the disorder or disease and the diagnosis, a review of the patient's prescription records, and/or a discussion with the prescriber. The pharmacist may also determine that a query to the Michigan Automated Prescription System (MAPS) is warranted if fraud is suspected. Each of these and/or other steps taken to assure the validity of a prescription should be documented and filed in a readily retrievable manner.
• Fictitious or Possibly Fictitious Prescriptions
  When a pharmacist is reasonably certain that a prescription is fictitious, he or she should contact the appropriate law enforcement agency. In cases where the pharmacist suspects, but cannot be certain, that a prescription is fictitious, he or she should take necessary steps to help assure that a patient's symptoms are managed during the time it takes to confirm the validity of the prescription. In these cases, the pharmacist should also be certain to obtain positive patient identification in case the event must later be reported to enforcement agencies. The pharmacist may also determine that a query to the Michigan Automated Prescription System (MAPS) is warranted.
• Prescription Refills
  • The pharmacist should evaluate the patient at each refill of a controlled substance to help assure that positive, intended outcomes are achieved and that the patient is not experiencing untoward effects. This evaluation should include but not necessarily be limited to, a discussion with the patient regarding signs and symptoms of the condition being treated, a review of signs and symptoms of untoward effects, a review of the patient's prescription records, and/or a discussion with the prescriber regarding the need for continuation or modification of therapy.
  • Special attention should be given to those patients who are at risk for misusing their medications. 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.
  • The steps undertaken in the process of evaluation should be documented and filed in a readily retrievable manner.
• Patient Referral
  • When a patient presents with a prescription for a controlled substance that is not stocked in the pharmacy, the pharmacist should make every effort to refer the patient to another proper source of care to help assure that the patient finds access to medication required for symptom relief.
  • For the purposes of these guidelines, terms are defined as follows:
  • Dispense means to deliver or issue a controlled substance to an ultimate user or research subject by or pursuant to the lawful order of a practitioner, including prescribing, administering, or compounding necessary to prepare the substance for the delivery or issuance.
  • Dispenser means a practitioner that dispenses.
  • Good faith: The prescribing or dispensing of a controlled substance by a practitioner licensed under section 333.7303 of the Michigan Public Health Code, in the regular course of professional treatment to, or for, an individual who is under treatment by a practitioner for a pathology or condition other than that individual’s physical or psychological dependence upon or addiction to a controlled substance, except as provided in this article. Application of good faith to a pharmacist is the dispensing of a controlled substance pursuant to a prescriber's order which, in the professional judgment of the pharmacist, is lawful. In making the judgment, the pharmacist shall be guided by nationally accepted professional standards including, but not limited to, all of the following:
    • Lack of consistency in the doctor-patient relationship
    • Frequency of prescriptions for the same drug by one prescriber for larger numbers of patients
    • Quantities beyond those normally prescribed for the same drug
    • Unusual dosages
    • Unusual geographic distances between patient, pharmacist, and prescriber.
  • Pharmacy practice means a health service, the clinical application of which includes the encouragement of safety and efficacy in the prescribing, dispensing, administering, and use of drugs and related articles for the prevention of illness and the maintenance and management of health. Professional functions associated with the practice of pharmacy include:
    • The interpretation and evaluation of the prescription
    • Drug product selection
  • Positive identification means identification that includes a photograph of an individual in addition to his or her date of birth. Positive identification shall include an identification card issued by a governmental agency provided the identification card meets these requirements.

References

1. Acute Pain Management Guideline Panel. Acute Pain Management: Operative or Medical Procedures and Trauma. Clinical Practice Guideline. AHCPR Publication No. 92-0032. Rockville, Md: Agency for Health Care Policy and Research; February 1992.
2. Jacox A, Carr DB, Payne R, et al. Management of Cancer Pain. Clinical Practice Guideline No. 9. AHCPR Publication No. 94-0592. Rockville, Md: Agency for Health Care Policy and Research; March 1994.

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Author Information

David Brushwood, RPh, JD, Professor, University of Florida College of Pharmacy, Gainesville

Disclosure: David B. Brushwood, RPh, JD, has disclosed no relevant financial relationships.