- State intractable pain laws provide provisions for aggressive pain treatment while protecting doctors from unwarranted prosecution—provided that strict guidelines are followed.
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It has been our contention, as we move forward in our campaign to establish intractable pain centers in every community, that laws exist — albeit with strict guidelines
— that permit aggressive treatment of intractable pain patients with opioids and other controlled substances. In our September/October 2004 issue we began this series of articles with “The California Model.” California’s Intractable Pain Law and Patient’s Bill of Rights provide safeguards for the patient and protection for the physician.
For this article, the fourth in the series, we researched the laws in other states that address intractable pain. Most of the information was obtained from the University of Wisconsin web site at URL http://www.medsch.wisc.edu/painpolicy. We encourage you to visit this site for more detailed information than is presented here.
A few introductory observations follow. Some sort of pain law exists in almost every state. We limited our research to those states whose laws contain the words “intractable pain.” While we consider guidelines for prescribing controlled substances important, it is our contention that intractable pain requires special attention and that its needs are different than those controlling chronic or acute pain treatment.
Going back to our research on California law, we found one aspect that, as far as our research revealed, is not contained in any other state law; namely, the physician cannot dismiss a patient being treated for intractable pain in California without providing alternative resources for the continuation of treatment. This is a very important point. California legislators, by their action, have shown recognition of the fact that intractable pain patients who are not adequately and aggressively treated are in great danger. Untreated severe pain, as stated in several articles in issues of this journal, can result in serious consequences such as suicide, dementia, cardiac problems, and hormonal deficiencies.
The following sections present only an overview of the nature of the laws that currently exist. We noticed that many of the state laws discussed contain guidelines that are very similar. These states used The Model Policy for The Use of Controlled Substance for the Treatment of Pain as issued by the Federation of State Medical Boards of The United States. The Federation was formed to assist state boards in developing codes and initiatives governing pain treatment. A key point is that the laws protect from prosecution the physician aggressively treating intractable pain patients — the caveat being that he or she must adhere to strict guidelines. The following states and California, covered previously, have laws for intractable pain treatment.
On April 16, 2003 the Arkansas code was amended to ad a section entitled “Chronic Intractable Pain Treatment Act” Here is a statement from that law:
“No disciplinary action by The State Medical Board solely for prescribing dangerous or controlled drugs for the relief of chronic intractable pain.”
Thus, physicians are immune from criminal action when legitimately treating intractable pain patients. The law then created a Pain Management Review Board. Complaints concerning the treatment of intractable pain patients are brought before this board. The review board ascertains whether or not the physician has violated the state guidelines and may take disciplinary action ranging from instruction and monitoring to license suspension.
In 1996 Colorado adopted “Guidelines for Prescribing Controlled Substances for Intractable Pain” and made the following statement:
“Physicians who prescribe opiates for intractable pain should not fear disciplinary action from any enforcement or regulatory agency in Colorado if they use sound clinical judgment and care for their patients according to the principles of sound professional practice.”
In the introduction to the guidelines it is quite clear that the legislators recognized the necessity for aggressive treatment and also were aware of the inhibitions of physicians who fear criminal action. They emphasized the responsibility of the medical profession to care for these patients.
The guidelines are very comprehensive and complete. They cover evaluation, treatment plan, informed consent, periodic review, consultation, records, compliance with controlled substance laws and regulations, and addiction vs. physical dependence.
They conclude with this statement:
“The Board hopes to replace practitioners’ perception of inappropriate regulatory scrutiny with recognition of the Board’s commitment to enhance the quality of life of patients by improving pain management while, at the same time, preventing the diversion and abuse of controlled substances.”
A section of the Florida code is entitled Intractable Pain; Authorized Treatment.
The statements in this code are not as comprehensive as most other states but the intent is the same. Here is the key statement:
“Intractable pain must be diagnosed by a physician licensed under this chapter and qualified by experience to render such diagnosis. Notwithstanding any other provision of law, a physician may prescribe or administer any controlled substance under Schedules II-V, as provided for in s. 893.03, to a person for the treatment of intractable pain, provided the physician does so in accordance with that level of care, skill, and treatment recognized by a reasonably prudent physician under similar conditions and circumstances.”
A portion of The Standards of Practice and Professional Ethics Code is entitled Standards of Practice — prescribing or administering controlled substances for the treatment of patients with chronic, nonmalignant or intractable pain. The stated purpose of the rule is to recognize the need to prescribe controlled substances to pain patients and contains basically the same guidelines as contained in other states (i.e Colorado) The only difference is that they do not make a clear distinction between intractable pain and chronic pain. We believe that permission for aggressive treatment with certain protections are necessary for intractable pain treatment to a greater degree than for other less severe pain cases.
A chapter of the Louisiana medical code is entitled Prescription, Dispensation and Administration of Medications. A subchapter of it is Medications Used in the Treatment of Noncancer-Related Chronic or Intractable Pain.
This state is very clear in its definitions and guidelines. For instance they define intractable pain as follows:
“Intractable Pain — a chronic pain state in which the cause of the pain cannot be eliminated or successfully treated without the use of controlled substance therapy and, which in the generally accepted course of medical practice, no cure of the cause of pain is possible or no cure has been achieved after reasonable efforts have been attempted and documented in the patient’s medical record.”
Here once again, state legislators address the needs of their constituents suffering from intractable pain. The guidelines are clear, comprehensive, and leave no doubt as to the necessity of prescribing aggressively and the protections offered by strict compliance with the guidelines.
Progress Report Card: Rating States On Their Pain Laws
Several years ago, the University of Wisconsin’s Pain & Policy Studies Group (PPSG) developed the Progress Report Card to meet the need for evaluating state pain policies.
The Progress Report Card is a tool that can be used by government and non-government organizations to achieve a more balanced and consistent state policy on the use of controlled substances for pain management, palliative care, and end-of-life care. Each state is assigned a grade according to an evaluation of policies in effect each year and is then compared to prior years to determine the extent of progress over time. A two-step method was used for this analysis: (1) identify the positive and negative policy provisions in each state, and (2) assign grades.
The PPSG developed 17 criteria — guided by a central principle of balance — to identify the presence of positive and negative provisions in all state statutes, regulations, and guidelines. The state grades are a measure of the quality of state pain policy in relation to the principle of balance, based on the frequency of provisions that meet the evaluation criteria; the higher the grade the more balanced are a state’s policies regarding opioid availability and pain management.
The Progress Report Card is the result of a systematic policy analysis, rather than a statement of a “position.” Although it is recognized that it is an oversimplification to use a single grade to characterize each state’s policy environment, the Progress Report Card is intended for use in conjunction with a detailed yearly evaluation guide to draw the attention of state policy-makers and healthcare professionals to potential opportunities for improving the quality and consistency of state pain policy and the regulatory environment for pain management. The complete text of state pain-specific policies is available on the PPSG website at www.medsch. wisc.edu/painpolicy.
It is recognized that a state’s policy environment also depends on clinicians’ perception of the policies and on how the policies are implemented by the relevant state and federal regulatory agencies. Such provisions will impact pain management to the extent that they are understood, strictly implemented and enforced.
—Pain & Policy Studies Group (PPSG),University of Wisconsin
Joranson DE, Gilson AM, Ryan KM, et al. Achieving Balance in Federal and State Pain Policy: A Guide to Evaluation. Madison, WI: Pain & Policy Studies Group, University of Wisconsin Comprehensive Cancer Center; 2000. Available at http://www.medsch.wisc.edu/painpol icy/eguide2000/index.html.
The state of Missouri, recognizing a need for guideline for treating intractable pain, added to the Physicians and Surgeons portion of the Occupation and Progress Title a section entitled “Intractable Pain Treatment Act.” As in many states, the legislators were diligent in providing for suffering constituents as evidenced by the following excerpt form the act:
“Notwithstanding any other provision of law to the contrary, a physician may prescribe, administer or dispense controlled substances for a therapeutic purpose to a person diagnosed and treated by a physician for a condition resulting in intractable pain, if such diagnosis and treatment has been documented in the physician’s medical records. No physician shall be subject to disciplinary action by the board solely for prescribing, administering or dispensing controlled substances when prescribed, administered or dispensed for a therapeutic purpose for a person diagnosed and treated by a physician for a condition resulting in intractable pain, if such diagnosis and treatment has been documented in the physician’s medical records.”
However, it must be noted that the Missouri legislators were just as diligent in providing restrictions against improper interpretation of this statement. The gist of their prohibitions alerts the physician to the danger and penalties associated with prescribing without careful consideration of addiction. Attention is given to the necessity of maintaining accurate records but guidelines — so common in other states — are not included although federal law and control substance definitions in other Missouri laws are referenced.
On March 15, 1996 the following was added to the medical code: Statement on The Use of Controlled Substances In The Treatment of Intractable Pain. In this statement, the legislators of Montana begin by expressing their concern of the illegal use of controlled substances. They then go on to say that just as great a concern is their belief that severe pain is untreated. A key point in the statement follows:
“The Board seeks to assure that no Montanan requiring narcotics for pain relief is denied them because of a physician’s real or perceived fear that the Board of Medical Examiners will take disciplinary action based solely on the use of narcotics to relieve pain.”
The rest of the statement deals with guidelines that must be followed to safely prescribe controlled substances.
The state of Nevada law has a simple statement:
“A physician is not subject to disciplinary action solely for prescribing or administering to a patient under his care…”
It then goes on to state that this includes Amygdalin, Procaine, and controlled substances listed elsewhere in their laws.
The above is repeated for osteopaths. While recognizing the need for physician protections, the statement doesn’t provide sufficient guidance to relieve a physician’s concerns.
In 1995, North Dakota released the following as part of the Controlled Substances for Care & Treatment:
“Notwithstanding any other provision of law, a physician may prescribe or administer controlled substances to a patient in the course of the physician’s treatment of the patient for intractable pain. A physician shall keep records of purchases and disposals of controlled substances prescribed or administered under this section. The records must include the date of purchase, the date of sale or administration by the physician, the name and address of the patient, and the reason for the prescribing or the administering of the substances to the patient.”
They also state that a hospital or any care facility can limit the use of controlled substances for intractable pain patients. As is some other states, the law does not contain guidelines for evaluation and treatment.
The Ohio legislature passed an act directing the medical board to establish rules governing the treatment of intractable pain while stating the following:
“...a physician who treats intractable pain by managing it with dangerous drugs is not subject to disciplinary action by the board under section 4731.22 of the revised code solely because the physician treated the intractable pain with dangerous drugs. The physician is subject to disciplinary action only if the dangerous drugs are not prescribed, administered, or dispensed in accordance with this section and the rules adopted under it.”
As a result, the Ohio medical board adopted very exacting guidelines that we believe are a prime example of the rules necessary to relieve concerns. They deal with everything from the physical examination to record keeping.
The State of Oklahoma provides physicians with very detailed guidelines for the prescribing of controlled substances for intractable pain treatment. However, somewhat disquieting is the fact that there are no prohibitions against prosecution so common in other states. While a physician may feel that adherence to the guidelines are his or her protection, some may fear that they are open to interpretation beyond control.
The state of Oregon offers the physician treating intractable pain protection against prosecution.
“A physician shall not be subject to disciplinary action by the Board of Medical Examiners for prescribing or administering controlled substances in the course of treatment of a person for intractable pain with the goal of controlling the patient’s pain for the duration of the pain.”
However, they go on to state that the medical board can exact penalties if guidelines that are provided are not adhered to.
The state of Rhode Island clearly protects the intractable pain physician.
“A physician may prescribe, administer or dispense controlled substances, not otherwise prohibited by law, for a therapeutic purpose to a person diagnosed and treated by a physician for a condition resulting in intractable pain, if such diagnosis and treatment has been documented in the physician’s medical records. No physician shall be subject to disciplinary action by the board solely for prescribing, administering or dispensing controlled substances when prescribed, administered or dispensed for a therapeutic purpose for a person diagnosed and treated by a physician for a condition resulting in intractable pain, if such diagnosis and treatment has been documented in the physician’s medical records.”
They lay out rules for record keeping, provide prohibition concerning abuses but do not have comprehensive guidelines.
“Legislators...have recognized that there are a sufficient number of constituents with intractable pain in their states to warrant their attention. Further, and most interestingly, they are aware of the inhibitions and fears of physicians to prescribe.”
The Texas Intractable Pain Treatment Act grants physicians the right to prescribe controlled substances and presents the following guidelines:
“Notwithstanding any other provision of law, a physician may prescribe or administer dangerous drugs or controlled substances to a person in the course of the physician’s treatment of a person for intractable pain.
“ No hospital or health care facility may forbid or restrict the use of dangerous drugs or controlled substances when prescribed or administered by a physician having staff privileges at that hospital or health care facility for a person diagnosed and treated by a physician for intractable pain.
“ No physician may be subject to disciplinary action by the board for prescribing or administering dangerous drugs or controlled substances in the course of treatment of a person for intractable pain.”
That said, they list strict requirements for record keeping and reporting and cite conditions under which drugs cannot be administered. This law would be improved if guidelines of examination, consultation, etc. were included.
In 1998, West Virginia amended a long standing code with a section titled ‘Management of Intractable Pain.’ They gave the physician protection against unwarranted disciplinary action as follows:
“A physician shall not be subject to disciplinary sanctions by a licensing board or criminal punishment by the state for prescribing, administering or dispensing pain-relieving controlled substances for the purpose of alleviating or controlling intractable pain.” Inappropriate prescribing is mentioned and they gave recognition of the need for guidelines but did not list any. Instead, they stated that the physician should use the guidelines of a recognized pain management organization. One wonders if this does not result in ambiguity and confusion.
We chose to mention only those states whose law has the words ‘intractable pain’ in them. Needless to say, there are states with pain management laws not entitled intractable pain management that have valuable information in this regard. If you are from one of those states we suggest that you investigate the state laws presented at the University of Wisconsin Medical School web site previously mentioned. There are, however, states that have no pain laws. If you are practicing in one of them, it behooves you and your colleagues to contact legislators and point out this discrepancy compared to other states. Those states are Alaska, Connecticut, Delaware, District of Columbia, Illinois and Indiana.
Legislators who, for political, altruistic, or humanitarian reasons have recognized that there are a sufficient number of constituents with intractable pain in their states to warrant their attention. Further, and most interestingly, they are aware of the inhibitions and fears of physicians to prescribe. I know, using California as an example, that this enlightenment came about through the efforts of lobbying physicians such as California’s Harvey Rose and Forest Tennant.
Without a doubt, these laws include prohibitions aimed at improper aggressive opioid and other controlled substances prescribing. In many of these states, well thought out guidelines are written in the laws and afford a degree of comfort to the physician that he or she will not be prosecuted if the guidelines are followed.
And yet — despite all the progress and enlightenment about pain — the medical profession and the suffering patients face a dilemma because of the fear of prescribing. In our humble opinion, here are some of the reasons:
The Role of the Physician. We do not believe that a sufficient number of physicians understand the safeguards that have been established for them. All pain physicians should have a clear understanding what laws govern prescribing in his or her state and in the federal regulations. Further, guidelines are just that and it is worthwhile, particularly if you reside in a state that has not published concise information, to investigate guidelines from professional organizations, other states and the federal government. They are all designed to keep you free from penalties.
Educating The Nay-Sayers. Recently, Vioxx was removed from the market because of the potential for cardiac conditions. It appears that some patients may have experienced cardiac conditions from it’s use. What does not seem to be considered in this calculus is the effects of untreated pain. Removing Vioxx from the market may result in far more cardiac cases than the use of it. Removing intractable pain patients from life-sustaining drugs can be detrimental. You can’t do it in California.
Public Relations. This journal is dedicated to the improvement of intractable pain treatment and we fervently hope that all pain journals and websites take on the cause.
There is no question that states legislators throughout the country have heard the call of the public and passed laws to relieve the suffering of intractable pain. Unfortunately, these laws are erratically implemented and enforced by non-elected regulators, bureaucrats, licensing boards, and the courts. We call upon all parties to not only follow the letter but also the spirit of the law.