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Michigan Guidelines for the Use of Controlled Substances for 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 those patients who suffer from
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 as well as statutory requirements
for prescribing controlled substances.
Inadequate pain control may result from physicians’ lack of knowledge
about pain management or 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 chronic pain patients.
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 due to trauma or surgery and
chronic pain, whether due to cancer or non-cancer origins. Physicians are referred
to the U.S. Agency for Health Care and Reseach 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 include the use of both pharmacologic and non-pharmacologic 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 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.
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. U.S. Department of Health and Human Resources, Public Health Service. 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. U.S. Department of Health and Human Resources, Public Health Service. March 1994.
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 if 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 etiology
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 have a history of substance
abuse, the physician may employ the use of a written agreement between physician
and patient outlining patient responsibilities, including
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 etiology 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, i.e., ability to work, need of health
care 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 in order to achieve treatment objectives. Special attention
should be given to those pain patients who are at risk for misusing their medications
and those whose living arrangement 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 to include
o the medical history and physical examination;
o diagnostic, therapeutic and laboratory results;
o evaluations and consultations;
o treatment objectives;
o discussion of risks and benefits;
o treatments;
o medications (including date, type, dosage and quantity prescribed);
o instructions and agreements; and
o periodic reviews.
Records should remain current and be maintained in an accessible manner and
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, the following terms are defined as follows:
Acute Pain
Acute pain is the normal, predicted physiological 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 physiological
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 which 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 neuro-adaptation
which 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
Pattern of drug-seeking behavior of pain patients who are receiving inadequate
pain management that can be mistaken for addiction.
Substance Abuse
Substance abuse is the use of any substance(s) for non-therapeutic 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.