Dear Friends in CIP or CI,

I am asked by many "does where I live make a difference" when
it comes to treatment of my pain?" Yes it does, and this statement
below (on several states not all) gives you an idea of what several
states do in regards to putting into writing protective devices for
physicians, clients, and all within that state to provide "reasonable"
care for those who have nonmalignant intractable pain (NIP). This
particular piece is dated 1995, however, it takes great credibility in
light of current DEA interventions to "criminalize" our physicians,
blaming them for "addicts, drug dealers and humane care" in short
"murder" when in fact this is not so.

Medical and scientific evidence supports the use of "opioids" as
a relatively safe method of treating noncurable pain that will persist
regardless of other interventions some of which we have learned
are deadly, cause further pain and disorders, and yet put the
physician outside the DEA witch hunt.

Neurontin has been one of the most impressive
never having been FDA approved for NIP, or
bipolar disorder, causing some irreversible side effects that can
cause life threatening outcomes; a 430 million dollar class action
suit never put off the manufacturer for a day for the PROFITS made
off of this medication exceed this by 20 or more times. It is at
best a "seizure" medication.

What can I do? SO many want an easy answer, and when you
hear of a fellow NIPer travelling to another state for treatment you
may shake your head, but ultimately this is what so many are
being forced to do, due to LE practicing pain management, forcing
the care of clients into the hands of drug enforcement workers, the
police, and unfortunately the "media" who given the wrong story, or
lacks research, IDOLIZES in "fabulous" tales those who died of
"Oxycontin OD's" when in fact the party who died likely obtained the
drug illegally; "broke the seal" "crushed and bumped it in a rig" the
list goes on and on. These medications are safe in the hands of
pain clients, and were created for them.

It is a never ending battle and if you, or someone you love suffer
NIP then it is your fight. I work closely with others like myself (Cyn
from OCPM for one) who continually feel the frustration for pain
clients feel isolated by mistreatment and tend to isolate once
treated. We need all to educate themselves, those in their support
groups, families and to push hard within your own states to let
legislators KNOW the true story.

I hope this piece below helps a few, if not many.

Peace, and a PFD to all,

Karen G.

http://www.medsch.wisc.edu/painpolicy/publicat/95apsip.htm#newjersey

1995 Joranson DE, Intractable pain treatment laws and regulations. APS
Bulletin 1995 5(2):1-3, 15-17.


Intractable Pain Treatment Laws and Regulations
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.

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' d
evelopment 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.


Acknowledgments
The author gratefully acknowledges comments on the manuscript from Albert M.
Brady, June L. Dahl, Kathleen M. Foley, Aaron M. Gilson, John D. Loeser,
William L. Marcus, Russell K. Portenoy, Harvey L. Rose, and Joel R. Saper.

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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Karen Hallenbeck~Sikorsky~George BS,RN,UM,QC
Interqual Certified
Published Psychiatric Researcher
Advocate for those in CIP, HIV, Psychologic Pain
http://hometown.aol.com/anewplanforyou
http://hometown.aol.com/anewplanforyou/sb.html



Owner-Moderator
http://groups.yahoo.com/group/ADayWithoutPain/
"ADayWithoutPain"
http://groups.yahoo.com/group/AnAnGeLInPain
"AnAnGeLInPain"

Ya'll are special you truly are, and to be the
catalyst for this group is a miracle for I know
in my heart that God's will created this group(s)
and each of you are very very special to me, always
no matter what I AM SO PROUD to a "part of" what
this family has become..AND WILL BE!!!!

"A Higher Power is necessary to find the ability to withstand self
destruction.."


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