Guidelines for the Use of Controlled Substances
for the Treatment of Pain
Section I: Preamble
The Kansas State Board of Healing Arts recognizes that principles
of quality medical practice dictate that the people of the State
of Kansas 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.
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. 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 Kansas State Board of Healing Arts is obligated under the laws
of the State of Kansas 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 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 sound
clinical grounds. All such prescribing must be based on clear documentation
of unrelieved pain and in compliance with these guidelines. If such
prescribing meets these criteria, the Board will support physicians
whose use of controlled substances has been questioned by another
regulatory or enforcement agency.
Allegations of improper prescribing of controlled substances for
pain will be evaluated on a case- by-case 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:
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Evaluation of the Patient
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.
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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.
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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
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urine/serum medication levels screening when requested;
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number and frequency of all prescription refills; and
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reasons for which drug therapy may be discontinued (i.e.,
violation of agreement).
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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.
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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 co-morbid psychiatric
disorder may require extra care, monitoring, documentation and
consultation with or referral to an expert in the management
of such patients.
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Medical Records
The physician should comply with and meet the requirements of
K.A.R. 100-24-1 in the maintenance of an adequate record for
each patient.
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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.
Section III: Definitions
For the purposes of these guidelines, the following terms are defined
as follows:
"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" is a neuro-behavioral 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" 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 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" 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 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" is a pattern of drug-seeking behavior
of pain patients who are receiving inadequate pain management that
can be mistaken for addiction.
"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" 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.
APPROVED by the Kansas State Board of Healing Arts this 17th
day of October, 1998.
Lawrence T. Buening, Jr.
Executive Director
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