2.) Model Guidelines: Controlled Substances for the Treatment of Pain
From: Helen Dynda (olddad66@runestone.net)
Wed Aug 1 01:22:31 2001
[]] Model Guidelines for the Use of Controlled Substances for the
Treatment of Pain...The Federation of State Medical Boards of the United
States, Inc. (Adopted May 2, 1998)
http://www.medsch.wisc.edu/painpolicy/domestic/model.htm
Section l: 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 acute and cancer-related pain.
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 ll: 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 lll: 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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