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1995 Joranson DE, Medical board guidelines for intractable
pain treatment. APS Bulletin 1995
5(3):1-5.
State Medical Board Guidelines for
Treatment of Intractable Pain
David E. Joranson, MSSW
Department editors' note: This is the second of two articles concerning federal and state policy on
the use of
opioids to treat people who have intractable pain. In part 1 in the last issue of APS Bulletin, we
addressed federal
and state laws and regulations. Part 2 discusses state medical board guidelines. Also, please
note the second
article in this department (see page 5), which provides information on potential federal
legislation that would
significantly affect pain clinicians and patients.
The belief that opioids should not be used for patients with chronic noncancer pain is
undergoing a scientific and
clinical appraisal to clarify the criteria for patient selection and appropriate clinical management
(Portenoy, 1994).
Policy changes are also under way to correct overly restrictive regulatory policies and practices
that have
discouraged physicians from prescribing opioid analgesics to patients with intractable pain.
Intractable pain has
been defined as pain in which the cause cannot be removed or otherwise treated and no relief or
cure has been
found after reasonable efforts (Code of Federal Regulations, 1988; Medical
Practice Act of
Texas, 1989; California Business and Professions Code, 1990). The term
includes pain due to
cancer as well other diseases and chronic conditions.
The first article on this subject appeared in the last issue of APS Bulletin and
summarized the
current status of laws and regulations regarding intractable pain treatment. No laws or
regulations actually
prohibit the use of opioids for intractable pain (Joranson, 1995). Federal and state controlled
substances laws have
been silent on the use of opioids for pain; these laws are not intended to regulate medical
conduct, a matter left up
to state medical practice laws and regulations. However, a U.S. Drug Enforcement
Administration (DEA)
regulation was adopted specifically to recognize that use of opioids for the intractable pain is
legal under federal
law, compared to prescribing opioids to maintain narcotic addiction, which is not (Code of
Federal
Regulations, 1988).
In the last 6 years, five states (California, Colorado, Florida, Texas, and Washington) have
adopted laws that
recognize the legality of using opioids for intractable pain. The previous article (Joranson, 1995)
also discussed
the benefits and risks of using the force of law to make legitimate the use of opioid analgesics for
the treatment of
intractable pain. For example, a simple provision that has been recommended by legal and
medical experts can be
added to state law to establish that medical use of opioids for intractable pain is a legitimate
medical practice
(National Conference of Commissioners on Uniform State Laws, 1990).
There are concerns about enacting detailed laws or regulations that specify the conditions
under which
physicians can prescribe opioids. The legal route may seem an attractive way to address
inadequate prescribing of
opioids, particularly if access to the legislative or rulemaking process is close at hand. However,
it should be clear
that legislating the particulars of medical practice does not directly redress inadequate physician
education or
improve practice patterns - and can also have unforeseen consequences.
State medical board guidelines
In addition to laws and regulations, another method of policy development is used by states
to clarify the role of
opioids in medical treatment of chronic noncancer pain: state medical board guidelines or policy
statements. A
guideline is an official statement of a medical board's attitude or policy about a particular issue.
Guidelines do not
have the legal status of laws and regulations, but guidelines can explain what activities the
medical board
considers to be within the boundaries of professional practice. Guidelines alert licensees to
unprofessional
practices of concern to the board and give practitioners practical information about how to avoid
these
problems.
In the last 10 years, a number of state medical boards, including those of Alaska, Arizona,
California, Georgia,
Idaho, Massachusetts, Minnesota, North Carolina, Oregon, Texas, and Washington, have
published guidelines that
address the prescribing of opioids for intractable pain. In California, the pharmacy and nursing
boards have also
developed guidelines.
In some cases, boards have adopted these guidelines to address inappropriate uses of
opioids and unprofessional
prescriptive practices that they have identified. More recently, however, some boards have
begun using guidelines
to address physicians' fears of board investigation or discipline for prescribing opioids for
chronic noncancer pain.
Indeed, the 1991 national survey of medical board members supports the need for medical boards
to clarify their
policies; most medical board members across the country who were surveyed said (at that time)
that they would
discourage a physician from prescribing opioids for a patient with chronic noncancer pain, and
approximately
one-third said they would investigate the practice as a potential violation of law (Joranson,
Cleeland, Weissman, &
Gilson, 1992).
Recent progress in California
In 1993, the Medical Board of California (MBC) undertook a review of "malprescribing."
A special task force
on appropriate prescribing heard testimony that physicians avoid prescribing controlled
substances including
"triplicate" drugs for patients with intractable pain for fear of discipline by the MBC (Medical
Board of
California, 1994b). The MBC took several actions to emphasize to all California physicians that
it supports
appropriate prescribing of opioids for pain, including intractable pain.
Under the leadership of Board President Jacquelin Trestrail, MD, and Executive Director
Dixon Arnett, the
MBC provided information about the new Agency for Health Care Policy and Research
(AHCPR) clinical practice
guidelines on acute and cancer pain to all state physicians and encouraged them to apply these
guidelines in their
clinical practices. The MBC cosponsored the California Summit on Effective Pain Management
held in 1994
(Angarola & Joranson, 1994), which recommended that the triplicate prescription system be
replaced with a less
invasive and more efficient system. Further, the MBC adopted a proactive policy statement,
"Prescribing Controlled Substances for Pain" (Medical Board of California, 1994a) and announced that it would
publish guidelines
to help physicians avoid investigation when they used opioids for management of intractable
pain.
The MBC asked the University of Wisconsin Pain Research Group (PRG) to draft the new
guidelines. The PRG
reviewed existing law, regulations, and guidelines published in the United States as well as in
Canada (College of
Physicians and Surgeons of Alberta, 1993). The new California guidelines were constructed
around the
fundamental principles that guide professional medical practice, as generally recognized by
medical boards.
Drafts were reviewed by medical and legal experts before MBC approval.
The American Pain Society endorsed the California guidelines early in 1995, with the
exception of the provision
that restricts prescribing of opioids to substance abusers, even if they have pain ("APS OKs,"
1995). According to
a 1995 PRG telephone survey, other state medical boards have begun to consider adopting the
same or similar
guidelines (executive directors of state medical boards to D.E. Joranson & A.M. Gilson, personal
communications, January 1995). In early 1995, the president of the Minnesota Board of Medical
Practice
endorsed the "common sense" guidelines from California (Kidder, 1995, p. 3).
Review of medical board guidelines
Current state medical board guidelines vary
considerably in
several ways, including the extent to which they accept opioid therapy for patients with chronic
noncancer pain.
These guidelines are summarized below.
Minnesota: As Sigel (1988) described, guidelines from the Minnesota Board
of Medical
Examiners state that the diagnosis of intractable pain should be based on a history, physical
examination, and
appropriate empirical data, not simply on the assertion of the patient. The treatment plan should
reflect the use of
other treatment modalities, appropriate referrals, and documentation of why those modalities are
inappropriate or
ineffective. The patient should be monitored regularly. The physician should control the drug
supply, including
detailed records of each drug dosage, amount, and number of refills. The physician should be
aware of the
potential for habituation or addiction and provide a justification for maintaining an addictive
state, if appropriate.
Violations include prescribing to a patient who is an addict or is dependent.
Massachusetts: The Massachusetts Board of Registration in Medicine (1989)
guidelines indicate that treatment of chronic pain should be based on a carefully documented
medical condition
and a statement justifying the need for continued narcotic use and explaining why past modalities
have been
inappropriate or ineffective. The physician must identify and treat factors contributing to the
pain, use a
consulting specialist, document prescriptions, assess potential for narcotic diversion, and monitor
the
patient.
Idaho: The Idaho State Board of Medicine (1990) guidelines for controlled
substances prescriptions incorporate language from the federal regulation that recognizes the
legality of using
opioids to treat intractable pain.
Arizona: The Arizona Board of Medical Examiners' (I 990) guidelines
follow
the basic principles of professional practice: a history and medical examination sufficient to
establish a diagnosis,
a treatment plan, and contraindications to drug therapy. The physician should establish a
working diagnosis
including the presence of an accepted medical indication for the drug therapy. The risk of
iatrogenic dependence
should be minimized. The treatment plan should have clear, measurable objectives and include a
record of the
further evaluations that are planned, the alternative treatments that are contemplated, and the
expected dosing and
duration of the treatment with medications. The physician should discuss with the patient the
risks and benefits of
treatment and periodically review all aspects of the treatment plan. For patients who have not
improved despite
controlled substance treatment, the physician should document the appropriateness of a less
dangerous treatment.
The physician should discuss the patient's compliance, abuse, and diversion with other
caregivers. If treatment is
not producing the desired result, the physician should obtain consultation or refer the patient to
specialists. The
physician should keep accurate and complete records. In addition, the physician must remain
alert for any
indications of patient manipulation and should stay current with new developments, approaches,
and
recommendations in prescribing.
North Carolina: The Board of Medical Examiners of the State of North
Carolina (1991)
issued a nine-step set of guidelines to its licensees in 1991. These guidelines are patterned after
the Minnesota
guidelines.
Georgia: The Georgia Composite State Board of Medical Examiners (1991)
stated that the diagnosis should be based on the patient's history and a physical examination, not
simply on the
assertion of the patient. The treatment plan should reflect the use of other modalities of
treatment, including
appropriate referrals and their results, and documentation of the reasons that past modalities have
been inappropriate or ineffective. The physician should determine that the patient is not taking opioids for
nontherapeutic
purposes and should obtain the informed consent of the patient before using opioids. The patient
should be
monitored regularly, and the physician should have adequate control of the drug supply,
including detailed records
of each drug dosage, amount, and number of refills. The physician should maintain regular
contact with the
patient's family to assess treatment effectiveness. Adequate records should be
maintained.
Oregon: The guidelines from the Oregon Board of Medical Examiners (1991) state that it is not "generally accepted in current medical therapy" to treat nonmalignant pain
with narcotics on a
routine basis (p. 1); for those rare patients for whom chronic administration of opioids is
appropriate, there must
be a clear diagnosis and close monitoring of the effectiveness of the treatment regime.
Washington: The Washington State Medical Disciplinary Board (1992)
stated
that chronic pain conditions are "best not treated with opioids" (p. 1). If alternate strategies are
unsuccessful,
however, a documented working diagnosis must be based on history and physical examination,
not simply on the
assertion of the patient. A treatment plan should be written with measurable objectives, further
planned diagnostic
evaluation, and alternative treatments. The physician should determine that the patient is not
obtaining drugs from
other physicians or from illicit sources, and caution should be taken with long-term prescribing
of controlled
substances to patients with a history of abuse. The informed consent of the patient should be
obtained before
using opioids. The appropriateness of treatment should be reviewed periodically, and
consultation should be used
to determine the appropriate treatment plan. Adequate records must be maintained.
Texas: According to Stasney and Hill (1993), the Texas State Board of
Medical Examiners developed a policy statement in response to physician reluctance to use
opioids for fear of
discipline by the board. It states that controlled substances are indispensable for the treatment of
pain. The
diagnosis should be based on the patient's history and a physical examination, not simply on the
assertion of the
patient. The treatment standard will be determined largely by the treatment outcome, taking into
account that the
drug used is recognized to be appropriate for the diagnosis as determined by medical consensus.
The
appropriateness of the quantity and chronicity of prescribing will be judged on the basis of the
diagnosis and
treatment of the targeted symptoms, as opposed to the quality or duration of prescribing. The
physician should
determine that the patient is not taking narcotics for nontherapeutic purposes, according to state
law.
Alaska: The Alaska State Medical Licensing Board (1993) developed
guidelines to
respond to complaints from patients and physicians that licensees were uncomfortable about
prescribing opioids
for fear of disciplinary action. The Alaska board borrowed the Minnesota guidelines. In
addition, the Alaska
board recommended "drug holidays" to evaluate for symptom recurrence or withdrawal (Alaska
State Medical
Licensing Board, p. 1).
California: The Medical Board of California (1994a) guidelines state that
the
prescribing of opioid analgesics for patients with intractable noncancer pain may be beneficial,
especially when
efforts to remove the cause of pain or treat it have been unsuccessful. Physicians should not fear
disciplinary
action from any enforcement or regulatory agency in California if they adhere to the following
principles of
professional practice.
A physician's diagnosis should be based on a history and physical examination and on
evaluation by one or more
specialists. A treatment plan should be written that includes measurable objectives and
alternative treatments.
The physician should discuss risks and benefits with the patient. New information about the
etiology of the pain
should be sought in periodic reviews of treatment. Continuation of treatment depends on the
physician's
evaluation of the patient's progress toward treatment objectives. Physicians are encouraged to
use consultation to
determine an appropriate treatment plan. Special attention is required for patients who are at risk
for diverting or
misusing medications. Management of pain in substance abusers requires extra care, including
consultation with
addiction medicine specialists and medication-use agreements with patients. Physicians should
document
treatment, maintain adequate records, and comply with controlled substances laws and
regulations.
It should be noted that California law requires that two physicians make the diagnosis of
intractable pain and
restricts prescribing of controlled substances to an individual using drugs for nontherapeutic
purposes.
Discussion and conclusions
Medical board guidelines vary considerably. The attitude taken by medical boards toward
the use of opioids
ranges from "It is generally accepted in current medical therapy that it is inappropriate to treat
nonmalignant pain
with narcotics on a routine basis" (Oregon Board of Medical Examiners, 1991, p. 1) to "The
Board recognizes that
opioid analgesics can also be useful in the treatment of patients with intractable nonmalignant
pain especially
where efforts to remove the cause of pain or to treat it with other modalities have failed"
(Medical Board of
California, 1994b, p. 5).
The conditions and qualifications for opioid use also vary considerably. The pain
management community may
not support some provisions, such as the requirement of two physicians to diagnose intractable
pain, the
recommendation for "drug holidays," the use of undefined terms such as addict and dependent, or
restrictions on
prescribing to the entire class of people who are substances abusers, even if they have
pain.
In my experience, most medical and other professional licensing boards are keenly interested in
improving
public health. As the demand for better pain management increases and medical boards become
aware of the
advances in medical knowledge about the use of opioids, they will likely want to revise their
prescribing policies.
But these revisions should take place in a systematic manner and in consultation with members
of the pain
community. One effective forum for discussing the appropriate use of opioid analgesics is the
pain seminars that
have been conducted for medical boards during 1994 and 1995. These seminars have been
sponsored by the
Federation of State Medical Boards of the United States in cooperation with the Pain Research
Group, and with
the participation of members of the American Pain Society who serve as faculty.
Medical board guidelines, like intractable pain treatment laws and regulations, can
encourage better treatment of
intractable pain. Guidelines vary from state to state and may also restrict appropriate prescribing.
Before medical
boards issue new guidelines for prescribing opioids for intractable pain, they should evaluate the
situation in their
state and systematically review the issues with experts. New guidelines, if they are needed,
should reflect current
knowledge about pain management and addiction and recognize the need for flexibility in the
management of
patients with intractable pain.
The current positive dialogue that is developing among medical boards, pain clinicians, and
addiction specialists
should be increased in order to ensure the development of rational and consistent intractable pain
treatment
guidelines at the state level.
Acknowledgment
The assistance of Aaron M. Gilson and Amy Harmon is greatly appreciated.
David Joranson is associate director for policy studies with the Pain Research Group at
the University of
Wisconsin Medical School in Madison, WI.
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