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653—13.2(148,150,150A,272C) Standards of practice—prescribing
or administering controlled substances for the treatment of patients with chronic,
nonmalignant pain. This rule establishes standards of practice for
the management of chronic, nonmalignant pain. The purpose of the rule is to
assist physicians who prescribe and administer drugs to provide relief and eliminate
suffering in patients with chronic, nonmalignant pain as defined in this rule.
13.2(1) Definitions. As used in this rule:
“Agency for Healthcare Research and Quality” or “AHRQ”
means the agency within the U.S. Department of Health and Human Services which
is responsible for establishing Clinical Practice Guidelines on various aspects
of medical practice.
“American Academy of Pain Medicine” or “AAPM”
means the American Medical Association recognized specialty society of physicians
who practice pain medicine in the United States. The mission of the AAPM is
to enhance pain medicine practice by promoting a climate conducive to the effective
and efficient practice of pain medicine.
“American Pain Society” or “APS” means
the national chapter of the International Association for the Study of Pain,
an organization composed of physicians, nurses, psychologists, scientists and
other professionals who have an interest in the study and treatment of pain.
The mission of the APS is to serve people in pain by advancing research, education,
treatment and professional practice.
“Chronic, nonmalignant pain (i.e., not caused by cancer)” means
persistent or episodic pain of a duration or intensity that adversely affects
the functioning or well-being of a patient when (1) no relief or cure for the
cause of pain is possible; (2) no relief or cure for the cause of pain has been
found; or (3) relief or cure for the cause of pain through other medical procedures
would adversely affect the wellbeing of the patient.
13.2(2) General provisions. Various controlled drugs, particularly
opioid analgesics, can be safely and effectively utilized to control pain in
certain patients. However, inappropriate prescribing of controlled substances
can lead to, or accelerate, drug abuse and diversion. Therefore, the medical
management of pain shall be based on a thorough knowledge of pain assessment,
pain treatment, and concern for the patient.
a. Treatment of acute pain and cancer pain. Physicians may refer to the
Clinical Practice Guidelines published by the AHRQ for counsel on the proper
treatment of acute pain and chronic pain associated with cancer. The AHRQ Clinical
Practice Guidelines provide a sound, compassionate, and flexible approach to
the management of pain in these patients.
b. Treatment of chronic, nonmalignant pain. The basic premise underlying
this rule is that various drugs, particularly opioid analgesics, may be useful
for treating patients with chronic, nonmalignant pain in a safe, effective,
and efficient manner when other efforts, including those by other practitioners
or the patient, have failed to remove or effectively treat the pain. The board
strongly recommends that physicians who have reservations about the use of drugs
in the treatment of chronic, nonmalignant pain consult: Definitions Related
to the Use of Opioids for the Treatment of Pain, a consensus document from the
American Academy of Pain Medicine (AAPM), the American Pain Society (APS), and
the American Society of Addiction Medicine (ASAM) (2001). Copies of the document
are available from the AAPM (http://www.painmed.org), the APS (http://www.ampainsoc.org),
the ASAM (http://www.asam.org), and the office of the board at 400 S.W. 8th
Street, Suite C, Des Moines, Iowa 50309-4686.
13.2(3) Effective chronic, nonmalignant pain management. To
ensure that pain is properly and promptly assessed and treated, a physician
who prescribes or administers controlled substances to a patient for the treatment
of chronic, nonmalignant pain shall exercise sound clinical judgment by establishing
an effective pain management plan in accordance with the following:
a. Patient evaluation. A patient evaluation that includes a physical examination
and a comprehensive medical history shall be conducted prior to the initiation
of treatment. The evaluation shall also include an assessment of the pain, physical
and psychological function, diagnostic studies, previous interventions, including
medication history, substance abuse history and any underlying or coexisting
conditions. Consultation/referral to a physician with expertise in pain medicine,
addiction medicine or substance abuse counseling or a physician who specializes
in the treatment of the area, system, or organ perceived to be the source of
the pain may be warranted depending upon the expertise of the physician and
the complexity of the presenting patient. Interdisciplinary evaluation is strongly
encouraged.
b. Treatment plan. The physician shall establish a comprehensive treatment
plan that tailors drug therapy to the individual needs of the patient. To ensure
proper evaluation of the success of the treatment, the plan shall clearly state
the objectives of the treatment, for example, pain relief, or improved physical
or psychosocial functioning. The treatment plan shall also indicate if any further
diagnostic evaluations or treatments are planned and their purposes. The treatment
plan shall also identify any other treatment modalities and rehabilitation programs
utilized.
c. Informed consent. The physician shall document discussion of the risks
and benefits of controlled substances with the patient or person representing
the patient.
d. Periodic review. The physician shall periodically review the course
of drug treatment of the patient and the etiology of the pain. Modification
or continuation of drug therapy by the physician shall be dependent upon evaluation
of the patient’s progress toward the objectives established in the treatment
plan. The physician shall consider the appropriateness of continuing drug therapy
and the use of other treatment modalities if periodic reviews indicate the objectives
of the treatment plan are not being met or there is evidence of diversion or
a pattern of substance abuse.
e. Consultation/referral. The physician shall consider consultation with,
or referral to, a physician with expertise in pain medicine, addiction medicine
or substance abuse counseling, if the objectives of the treatment plan are not
being met or there is evidence of diversion or a pattern of substance abuse.
f. Documentation. The physician shall keep accurate, timely, and complete
records that detail compliance with this subrule, including patient evaluation,
diagnostic studies, treatment modalities, treatment plan, informed consent,
periodic review, consultation, and any other relevant information about the
patient’s condition and treatment.
g. Physician-patient agreements. Physicians treating patients at risk for
substance abuse shall consider establishing physician-patient agreements that
specify the rules for medication use and the consequences for misuse. In preparing
agreements, a physician shall evaluate the case of each patient on its own merits,
taking into account the nature of the risks to the patient and the potential
benefits of treatment.
h. Termination of care. The physician shall consider termination of patient
care if there is evidence of diversion or a repeated pattern of substance abuse.