Model Guidelines for
the Use of Controlled
Substances for the Treatment of Pain |
| The recommendations contained herein were
adopted as policy by the House of Delegates of the Federation of State Medical Boards of the United States, Inc., May
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 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 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 (name of 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 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:
- urine/serum medication levels screening when requested;
- number and frequency of all prescription refills; and
- reasons for which drug therapy may be discontinued (i.e.,
violation of agreement).
|
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:
- the medical history and physical examination;
- diagnostic, therapeutic and laboratory results;
- evaluations and consultations;
- treatment objectives;
- discussion of risks and benefits;
- treatments;
- medications (including date, type, dosage and quantity
prescribed);
- instructions and agreements; and
- 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. |
|
|
