Intractable Pain Treatment Laws
and Regulations
California
Colorado
Florida
New Jersey
Texas
Virginia
Washington
As demand for better pain management grows in the United States, the public is taking an
interest in policies that
govern the medical use of opioid analgesics for people with chronic pain. Although the use of
opioids in acute
and cancer pain is well accepted, their use in chronic noncancer pain has been considered widely
to be
inappropriate due to concerns about efficacy, toxicity, and addiction (Portenoy, 1990; Turk &
Brody, 1991).
Indeed, some state medical boards have used their disciplinary authority to reject or discourage
the prescribing of
opioids for chronic noncancer pain (Oregon Board of Medical Examiners, 1991; Washington
State Medical
Disciplinary Board, 1987).
However, the assumptions behind the belief that opioids should not be used for patients
with chronic pain are
undergoing a critical reappraisal in an effort to clarify patient selection and appropriate
management strategies
(Portenoy, 1994). At the same time, state governments have begun to adopt laws that
specifically allow the use of
opioids for the treatment of intractable pain.
Definitions
Intractable pain is a term that is used and defined in the federal controlled
substances regulations
and now in some state laws. The term generally refers to a pain state 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). It includes pain due to cancer as well as to other chronic diseases.
Intractable pain treatment policy refers to laws, regulations, or other
government-issued policies
and guidelines that address the legitimacy of the medical use of opioid analgesics to treat patients
with intractable
pain. These policies vary in the degree to which opioid treatment for intractable pain is accepted
or rejected, and
they may include specific restrictions and conditions. The focus of this article is federal and state
laws and regulations, including the Federal Intractable Pain Regulation (1974); the state laws of Virginia (1988),
Texas (1989),
California (1990), Colorado (1992), Washington (1993), and Florida (1994); and the state
regulation of New
Jersey (1984).
Federal intractable pain policy
Federal regulations established in the early 1970s govern the prescribing of controlled
substances (Code of
Federal Regulations, 1988, Part 1300). As a general principle, the federal government
does not regulate
medical practice as this is a function of the states (Joranson, 1990). In 1974, however, Congress
adopted a law to
prohibit physicians from prescribing opioids to detoxify or maintain opioid addiction (unless
they are operating as
part of a separately registered narcotic treatment program). Subsequently, to clarify the critical
distinctions
between the treatment of opioid addiction and the use of opioids to treat pain, the Drug
Enforcement
Administration (DEA) issued a regulation in 1974 stating that the law was not intended to
interfere with
physicians who used opioids to treat intractable pain:
This section is not intended to impose any limitation on a physician or authorized hospital
staff...to administer
or dispense [including prescribe] narcotic drugs to persons with intractable pain in which
no relief or cure is
possible or none has been found after reasonable efforts. (Code of Federal Regulations,
1988, p. 72)
The DEA has reiterated and communicated this policy to U.S. physicians through its
Physician's Manual (Drug
Enforcement Administration, 1990) and its Pharmacist's Manual (Drug Enforcement
Administration,
1986).
State intractable pain treatment policies
In addition to federal regulations, physicians' prescribing is subject to the law and regulations of
each state, which
sometimes are more restrictive than federal law (Joranson & Gilson, 1994). A physician's
prescribing of
controlled substances may be reviewed by a number of agencies, including state justice
departments, triplicate
prescription programs, professional licensing boards, and local law enforcement agencies.
Typically, these
agencies want to identify physicians who are prescribing outside of legitimate medical practice.
Legitimate and
illegitimate medical practices are usually defined in state medical practice law and by the
regulations and
enforcement policies of state medical boards. There are no state laws or regulations that consider
the use of
opioids for intractable pain to be an illegitimate practice.
Indeed, the model for state medical practice laws recommends that state legislatures define the
practice of
medicine to include the use of drugs to treat pain (Federation of State Medical Boards of the
United States, 1988).
Further, the model for state controlled substances laws specifically recommends that prescribing
opioids for
intractable pain be considered legal under state law (National Conference of Commissioners on
Uniform State
Laws, 1990).
Physicians, however, have been investigated and prosecuted for prescribing opioids for
chronic pain (Angarola
& Joranson, 1993; Joranson & Gilson, 1994). According to a 1991 survey, most of the members
of state medical
boards of the United States said they would discourage a physician from prescribing opioids for
chronic noncancer
pain, and approximately one-third of state medical board members said they would investigate
the practice as a
potential violation of law (Joranson, Cleeland, Weissman, & Gilson, 1992).
Although most state laws and regulations still do not specifically recognize the legality of
opioids for intractable
pain, this is changing. In the last several years, some legislatures have begun to adopt laws to
affirm the use of
controlled substances for intractable pain. Typically, legislators have been responding to (a) the
undertreatment of
patients with pain, (b) inappropriate medical board discipline of some physicians, and (c)
proposed legalization of
physician-assisted suicide. Media coverage of physician-assisted suicide and inadequate pain
management as well
as the efforts of patients and physicians who are advocating for legislative action to improve pain
management are
fueling state legislative interest in intractable pain treatment policy.
Washington
In the state of Washington, the use of opioids for intractable pain became an issue in 1987
when the Washington
State Medical Disciplinary Board opposed prescribing opioids for chronic pain:
Many cases reviewed by the Washington State Medical Disciplinary Board involve
inappropriate prescribing
of controlled substances. A significant number of these are related to the use of narcotics as a
method to manage chronic pain. During fiscal year 1987 the Board experienced nearly a 100%
increase in disciplinary actions related to prescribing of controlled drugs for chronic pain.
The Board does not recognize repeated
prescribing of controlled drugs as appropriate therapy for chronic pain [italics added]. (p.
1)
The subsequent outcry from physicians resulted in additional policy statements in 1989 and
1992 explaining that
the board had not wanted "to interfere with a physician's exercise of appropriate clinical
judgment" (State of
Washington Department of Health, 1989, p. 1), and that chronic pain is "best not treated with
opiates" (State of
Washington Department of Health, 1992, p. 1). Concern about the board's position continued,
and in 1993, the
state legislature enacted a statute that borrowed a provision from a recently developed model for
state drug laws
developed by medical and legal experts (National Conference of Commissioners on Uniform
State Laws,
1990):
A practitioner may dispense or deliver a controlled substance to or for an individual or
animal only for medical
treatment or authorized research in the ordinary course of that practitioner's profession.
Medical treatment includes dispensing or administering a narcotic drug for pain, including
intractable pain. (Washington Uniform
Controlled Substances Act, 1993)
Colorado
In 1992, the Colorado legislature adopted an intractable pain treatment policy as part of
revisions to its
controlled substances act. Colorado's approach is similar to that used in Washington
state.
Virginia
In 1988, Virginia enacted a law allowing physicians to prescribe heroin for treatment of
terminally ill cancer
patients ("Virginia Enacts Law," 1988). (Note: This occurred despite the fact that legislation at
the federal level
was necessary to make heroin actually available and that Congress had already soundly defeated
such a bill.) The
Virginia legislature adopted an additional measure to allow prescription of pain medications "in
excess of
recommended dosage" for patients with intractable pain ("Relieving Intractable Pain," 1988, p.
C5;
Commonwealth of Virginia, 1988). Both laws exemplify how drug laws can reflect common
misconceptions, that
is, that heroin has significant analgesic advantages over currently available opioids, and that a
physician's
prescription cannot legally exceed the dosage recommended in FDA-approved product labeling
(Angarola &
Joranson, 1995).
Texas: The first intractable pain treatment act
The first intractable pain treatment act (IPTA) was approved by the Texas legislature in 1989
and has received
considerable publicity (Hill, 1992). Physicians in Texas were concerned about board
investigations of physicians
and ambiguous language regarding opioid prescribing in the state's Medical Practice Act and
went to the
legislature for relief (Hill, 1992). The purposes of the new act were to clarify legal ambiguities,
bring Texas law
into conformity with the federal intractable pain regulation, and
assure that no Texan requiring narcotics for pain relief, for whatever reason, was denied
them because of a
physician's real or perceived fear that the state regulatory agency would take disciplinary
measures against the
physician for prescribing narcotics to relieve pain. (Hill, 1992, p.
70)
The Texas IPTA (a) provides a definition of intractable pain that is similar to that of the federal
regulation, (b)
autliorizes physicians to use controlled substances (not only opioids) for treatment of intractable
pain, (c) prohibits
healthcare facilities from restricting the use of such drugs for intractable pain, and (d) prohibits
the Texas State
Board of Medical Examiners from disciplining a physician for using such drugs in the legitimate
treatment of
intractable pain (Medical Practice Act of Texas, 1989).
The Texas IPTA also contains important exclusions. For example, the act does not protect a
physician if the
pain patient is also being treated for chemical dependency or when the physician should have
known that the
patient was using drugs in a nontherapeutic manner.
Several years after adoption of the IPTA, the Texas State Board of Medical Examiners issued a
policy statement
in its official newsletter that was drafted by a board member, C. Richard Stasney, MD, and by C.
Stratton Hill,
MD (1993). The statement endorsed the federal intractable pain regulation and the IPTA and
stated that the board
would use treatment outcome and not quantity or duration of prescribing as a standard for
evaluating cases against
doctors. In 1995, Hill, David Rallston, and colleagues are seeking further clarification of Texas
policy and have
submitted to the Board of Medical Examiners a proposed regulation for the treatment of
intractable pain in Texas
(C.S. Hill, personal communication).
New Jersey
The only state of which we are aware that currently has a regulation on intractable pain treatment
is New Jersey.
The regulation mirrors the federal intractable pain regulation in part. The New Jersey regulation,
however, has
several conditions that delimit the boundaries of intractable pain treatment:
When protracted prescribing [of narcotic drugs] is utilized for the alleviation of intractable
pain, practitioners
shall remain alert to the availability of new or alternative types of treatment. The
practitioner should attempt
periodically to either cease the medication or taper down the dosage, or try other
medication or treatment
modalities in a regular and vigilant effort to reduce the addiction propensity for the patient.
(New Jersey Board
of Medical Examiners, 1993, p. 64)
Regulations have the force of law, and compliance with specified conditions becomes the
responsibility of the
practicing physician. Indeed, failure to comply with such conditions might constitute a violation.
Thus, a New
Jersey physician who prescribes opioids for intractable pain should document compliance with the
additional
conditions in the patient's chart.
California
In 1990, California became the second state to adopt an IPTA due to the efforts of State
Sen. Leroy Greene and
Harvey Rose, MD. This legislation was the consequence of professional and public concerns
about inadequate
pain management, the harsh effects on patients, and physicians' concern about investigations by
the state medical
board. California's law is essentially identical to the Texas IPTA, although it requires evaluation
of the patient by
a specialist in addition to the attending physician (California Business and Professions
Code,
1990).
The adoption of the California IPTA has also served as a catalyst for a number of
governmental and professional
actions to identify and remove barriers to pain management. For example, other new legislation
required
examination of alternatives to the triplicate prescription program, distribution of information on
pain management
and the California intractable pain treatment policy to all physicians by the medical board, and a
medical board
survey of state medical schools' curricula on pain management. In March 1994, the governor
sponsored the
Summit on Effective Pain Management: Removing Impediments to Appropriate Prescribing to
prepare a strategy
for a statewide effort to improve pain management (Angarola & Joranson, 1994; State of
California Department of
Consumer Affairs, 1994). The licensing and disciplinary boards for medicine, pharmacy, and
nursing developed
positive guidelines for the appropriate use of opioids in intractable pain. The American Pain
Society Board of
Directors endorsed the medical board's guidelines (correspondence of APS President J. Campbell
to D. Arnett,
Executive Director, California Medical Board, January 11, 1995; see page 20 of this newsletter
for details). The
State of California's actions to make pain management a priority are exemplary.
Florida
In 1994, following an intense debate on euthanasia and physician-assisted suicide, the Florida
legislature instead
approved an intractable pain treatment provision. Intractable pain is defined as "pain for which,
in the generally
accepted course of medical practice, the cause cannot be removed and otherwise treated" (Florida
Statutes, 1994,
p. 2). A licensed and qualified physician must diagnose intractable pain. The new provision
permits use of any
controlled substance in Schedules II-V, not only opioids, to treat a person with intractable pain,
provided the
physician conforms to a standard of care that would be recognized by reasonably prudent
physicians under
similar circumstances [italics added] (Florida Statutes). (One might ask what
this means,
given the prevalence of inadequate pain management and the history of discouragement of
extended use of strong
opioids for chronic noncancer pain.) Florida's intractable pain provision also recognizes that the
state does not
condone euthanasia and bans the use of intractable pain treatment for such a purpose.
Discussion
The development of intractable pain treatment laws gives much-needed recognition to the
necessity for better
treatment of intractable pain and can help to correct past policy, which discouraged any use of
opioids. However,
the opportunity to develop new legislation merits our careful consideration of both benefits and
risks.
For example, could there be unintended consequences from making opioid therapy for
intractable pain a
"treatment of last resort"? Is it medically appropriate to require physicians to demonstrate that
every chronic pain
problem - whether due to terminal illness or any other chronic condition-is refractory to other
therapies before
prescribing opioid analgesics? How much time must elapse? How many therapies must be tried,
and at what
expense to the patient and the healthcare system? Although these questions should be answered
by the physician
and patient, they may also become legal questions once intractable pain treatment laws and
regulations are
enacted.
Are state intractable pain treatment laws really needed? Although the states
have the
power to regulate medical practice, the results can be unpredictable when state legislators and
other interest groups
start writing new laws, especially when the subject is drugs and medical practice - witness, for
example, Virginia's
approval of heroin in an effort to treat cancer pain. Moreover, after a new law is passed, a state
agency may adopt
regulations to codify, and perhaps restrict, the treatment of intractable pain, potentially leading to
new issues. For
example, if intractable pain regulations include conditions and restrictions, as in New Jersey,
these may expand
recordkeeping requirements and, thus, increase instead of decrease the potential for violations
when controlled
substances are prescribed for pain.
States do not now directly prohibit by law or regulation the use of opioids for intractable
pain. If a state
medical, pharmacy, or nursing board discourages the use of opioids for intractable pain, this is
informal policy and
it should be changed. Such a change can occur without legislation-for example, through a
cooperative effort of
regulatory boards and pain experts to develop and communicate new guidelines (Commonwealth
of Massachusetts
Board of Registration in Medicine, 1989; Medical Board of California, 1994).
If the voluntary development of positive guidelines by a board proves unsuccessful,
political action, including
lobbying for intractable pain treatment legislation, merits consideration. In Idaho, an intractable
pain treatment act
was introduced to protect physicians who prescribed opioids for intractable pain from the
medical board.
Although the bill was not adopted, the medical board has undertaken a review of its policy on
prescribing for
intractable pain (Idaho State Board of Medicine, 1994).
Which language should be used? The Texas and California IPTAs might be
useful if the
primary goal is to protect physicians from a medical board when, in fact, that threat exists or
when the board is
reluctant to clarify and communicate its policy. The Texas and California IPTAS, however, also
appear to restrict
prescribing of opioids to substance abusers, even if they have pain. The laws in Washington and
Colorado do not
exclude substance abusers and are consistent with the nationally approved model for drug control
laws in the
United States. On the other hand, they do not establish a legal protection for physicians from
their medical
boards.
Can legislation be an opportunity to initiate action? A new intractable pain
law, by itself,
probably will do little directly to change practice patterns or improve the management of
patients' pain. In California, however, the legislative sponsor and key supporters of the new IPTA have served as
powerful catalysts for
other positive actions to improve pain management in the state.
In addition, either a legislature or a governor can establish a pain commission to study the
problem and make
recommendations for action. Study commissions can, however, also waste time and energy and
actually delay real
progress unless there is (a) strong support for implementation of the recommendations; (b) a
clear mission focused
on better and more cost-effective pain management; (c) willingness to identify and address
common myths and
barriers; (d) competent and adequate staff resources; and (e) a membership that is balanced,
knowledgeable, and
committed to the mission.
Conclusions
Long-held medical beliefs and regulatory traditions have rejected the use of opioids for chronic
noncancer pain
but are now undergoing reassessment in light of new knowledge, recent clinical experience, and
the public
attention being given to better pain management. The ultimate goal of a balanced public policy
should be to
harmonize medical and drug regulation with clinical practice so that physicians are free to use
this treatment
according to good medical judgment. This harmony can sometimes be promoted through laws
and certainly
through the development of medical, pharmacy, and nursing guidelines. Such guidelines should
encourage pain
management and help clinicians select and manage patients and avoid investigation. Guidelines
should also
continue sanctions against sloppy and unprofessional practices that can contribute to drug abuse.
Such guidelines
as those issued in Texas and California give medical boards unique opportunity to encourage
quality care while at
the same time allowing them to focus limited resources on cases in which there is harm to public
health.
(Note: The second article in this series will discuss state medical boards' development of
intractable pain
guidelines.)
As the development of intractable pain policy proceeds in the United States, we should take
care not to
oversimplify the complexity of chronic pain and its treatment. We should avoid creating the
impression that all
prescribing of opioids is appropriate or that any person with chronic pain has a right to opioids.
We should also
avoid creating the impression that new policies will correct deficits in practitioners' knowledge
and attitudes.
The appropriate use of a range of therapeutic options, including nonpharmacologic
treatments, opioids, and
other drugs, depends on careful evaluation and monitoring of results by knowledgeable
professionals supported by
regulatory policy and practice. Opioids and other individual therapeutic modalities should
neither be prescribed
nor proscribed by laws, regulations, or policies.
Do the differences in today's state intractable pain laws and regulations suggest we are
moving toward a
balkanized approach to the use of opioids for chronic pain? How can we uniformly raise the
quality of pain care if
policies differ from state to state? The quality of intractable pain treatment policy at the state
level would benefit
from a dialogue aimed at acheiving consensus among healthcare professional, regulatory, and
patient interests in
the United States. One aim of such a dialogue should be to achieve reasonable uniformity of
policy among the
states; another would be to address the needs of individual patients who have fallen through the
cracks. The
author would appreciate having readers' perspectives and any additional information about state
policies.
David E Joranson, MSSW
Department editors' note: This first of two articles discusses current federal policy and new state
laws regarding
the use of opioids to treat people with intractable pain. The second article in the series will
discuss state medical
boards' recent progress in developing intractable pain treatment guidelines.
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