(Adopted May 2, 1998)
Section I: Preamble
The (name of board) recognizes that principles of
quality medical practice dictate that the people of the State of (name of
state) 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 to 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
Board's position on pain control, specifically as related to the use of
controlled substances, to alleviate physician uncertainty and to encourage
better pain management.
The Board recognizes 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
Research Clinical Practice Guidelines for a sound approach to the management of
acute1
and cancer-related pain.2
The medical management of pain should be based upon current
knowledge and research and includes 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 (state medical board) is obligated under the
laws of the State of (name of state) to protect the public health and
safety. The Board recognizes 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 Board 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 Board considers to
be within the boundaries of professional practice.
Section II: Guidelines
The Board has 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 should also 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 (1) urine/serum medication levels screening when
requested (2) number and frequency of all prescription refills and (3) reasons
for which drug therapy may be discontinued (i.e. violation of
agreement).
4. Periodic Review
At reasonable intervals based upon the individual
circumstance 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, such as 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 re-evaluate 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 (1) the medical history and physical examination (2) diagnostic,
therapeutic and laboratory results (3) evaluations and consultations (4)
treatment objectives (5) discussion of risks and benefits (6) treatments (7)
medications [including date, type, dosage, and quantity prescribed] (8)
instructions and agreements and (9) 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 neuroadaptation 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.
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1Acute 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.
2Jacox 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.