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7 Articles in Volume 4, Issue #5
A Case For Intractable Pain Centers: Part 1
Co-Existing Psychological Factors
Cold Lasers in Pain Management
Diagnosing Diffuse Aches and Pains
Occipital Nerve Block for Cervicogenic Headaches
Opioid Therapy in Chronic Non-cancer Pain Management
Reflex Sympathetic Dystrophy (RSD)

A Case For Intractable Pain Centers: Part 1

A crisis due to the scarcity of intractable pain (IP) centers is leaving suffering patients with no place to turn.

This is the first in a series of articles that address the need for accessible intractable pain centers in every community. The series will review existing legislation that permits extreme approaches to the relief of this deadly condition, outline the precautions that must be taken to safely operate an IP center, suggest the steps that must be taken to establish a functional IP center, and urge competent physicians to pursue this subspecialty. No greater opportunity exists to serve in the tradition of medicine while conducting a lucrative center.

There are several scenarios that must be addressed. At last count, there were thirteen states that have intractable pain laws and, before this series is over, we will indicate special cautions that exist in any of these states. Whether laws exist or not, there is a need for intractable pain centers and we will try to provide guidelines for physicians in states not having their own intractable pain laws.

We will be interviewing physicians who have been instrumental in establishing guidelines, legislators who have written the bills and attorneys who have represented intractable pain physicians.

A Case In Point

A short time ago, this author received an e-mail from a patient in Connecticut frantically seeking an intractable pain practice. His doctor, for one reason or another, had closed his practice and this patient was left high and dry. The procedure had been for him to periodically visit his physician for routine reevaluation and ongoing prescription of opioids so that he could function. He had long since exhausted all other remedies.

Without these prescriptions, he was incapacitated with pain and was desperately seeking assistance to find an a practice to continue his therapy. He was so desperate that he stated he would be willing to travel to New York, New Jersey, Pennsylvania, or Massachusetts. This author recommended an organization that might be able to refer him to an Intractable Pain practice and it is hoped that he was able to find relief.

There were a few things about this incident that surprised this author. First of all, Practical Pain Management is a professional publication not intended for patients and yet even our editor has received numerous other communications from desperate patients. These patients are either searching the internet or finding our publication in medical offices. There is no bureau or guide for a patient in need to find an IP center.

Desperate Pleas for Help

The following email was sent to Marv Rosenfeld, Publisher of Practical Pain Management on July 4, 2004.

“I am a 40-year-old IP patient who has been treated with narcotics for a cervical hernia at L5-6 and also 3 herniated discs in the lower lumbar area. Along with this there is moderate to severe spinal stenosis in the 3 disc area mentioned. The injuries are all found on MRI and some other tests that have slipped my mind. I also had a failed shoulder surgery that has only gotten worse. My dilemma is that my pain management doctor has lost his license for 5 years due to some fraudulent billing to Medicare in 1998-2000 so all his patients are in the same boat as me. There are no doctors that will treat me with the meds that he had been treating me within the 50 mile distance that I had been driving (3 hours) to see him every 4 months. With those meds I am able to workout, play with my children, and even think clearly without the pain I had been suffering and soon will be suffering again. Any kind of help or referrals to other doctors will be so much appreciated. Please get back to me with help. I don’t know where to turn or what to do, so help me. Thank you.”

The following email was sent to Forest Tennant, MD DrPH, Editor in Chief on August 8, 2004.

“I found your intractable pain articles this morning and sobbed. I have been praying and searching for a pain specialist who could understand. Your definition of Intractable Pain describes my life for the past 4 years to a “T.” I was in an airplane crash in March of 2000. My L5-S1 disc was split in half, L4 and L3 were weakened. Whiplash snapped the muscles in my neck so efficiently that the natural curvature of the spine has been gone ever since.

I had a spinal fusion one and a half years later, a second surgery eight months later, and more “stupid, doesn’t work, what the hell was I thinking” painful injections and procedures that I can’t even count anymore. The pain just kept getting worse and it was awful to begin with. Believe me when I tell you that it has been only by the love of God and my family that I have not lost my mind or taken my life because of this all-consuming pain.

You gave me so much hope…you really did. I barely know what to say. It has been so hard to convince anyone outside my family that the pain is so severe it takes my breath away. That my whole life has become something I can’t recognize. That because I can’t bring myself to writhe on the floor and scream in front of each new doctor then I CAN’T POSSIBLY BE IN AS MUCH PAIN AS I AM TELLING THEM I AM.

Could you recommend someone who understands INTRACTABLE pain and, if you could not help me with the above requests, then I just wanted to thank you. Thank you so much for researching and writing what you did. You gave me hope at just the moment I screamed out for it. That means so much, as I’m sure you know. Thank you and thank you again.”

The second surprise was the fact that this individual referred to intractable pain by the acronym ‘IP.’ Intractable pain is the severe, constant pain that can only be relieved through the use of drugs. That seems simple enough yet we very seldom see the term in the literature. Authors may refer to constant, severe pain but not ‘intractable pain’ or ‘IP.’ It is not clear why this is so, but perhaps there is a perception that this term is associated with some sort of abuse or, perhaps, there is a great reluctance to classify pain as incurable vs. curable and grade it as mild, moderate or severe.

Although the use of the term ‘IP’ in the U.S. has been promoted by intractable pain legislation, the term appears to have originated in the British medical literature several decades ago. If American pain physicians are to advance the specialty of pain management, management of the most extreme condition should be foremost on the agenda and recognized for what it is. Most physicians currently specializing in pain are either anesthesiologists or physical medicine physicians and yet they do not specialize in incurable medical conditions. Further, a cursory search could not find any family practice, psychiatry, or internal medicine residencies that offered fellowships in intractable pain.

State of the Art

It seems to this author that there is an atmosphere, at present, that ignores the difference between the various states of pain: acute, chronic, and intractable. A further complication is that society does not appear to make the critical distinction between ‘addiction’ and ‘physical dependence’ (the latter being the result of required high dosing). A main concern for some physicians has become “Will I be in trouble for over-prescribing strong, habit forming drugs?” What appears to be ignored in this troubling environment, is the difference between moderate pain, the pain of the terminally ill, and the patient with excruciating, intractable pain. And that poses the question, “Is it permissible to treat patients with life-ending and intractable pain conditions with higher doses than other patients?”

Research indicates that indeed there are states that have laws that authorize this special treatment for such patients but, unfortunately, there are states where the courts are either misinformed or are ignoring these protections in the mistaken assumptions of drug abuse or addiction. The courts should not fall into the trap of applying these drug abuse laws inappropriately. It is critical that the legal community understands that IP patients clearly require opioids in order to function and not to get ‘high.’ Indeed, opioids given to an IP patient balances out the intense, unremitting pain and allows the patient to achieve a semblance of normalcy and pursue normal activities, including work. Rather than a ‘high’ of a drug addict, the IP patient experiences a negation of the pain allowing fairly normal functioning. Often, functioning can be restored to a level where the individual can resume normal activities, including returning to work.

Federal Regulations

The Federal government has made it clear, through regulatory wording, that there is a distinction between the use of opioids to treat pain and laws dealing with opioid addiction. The distinction is spelled out in a the 1988 Code of Federal Regulations (pg. 72) concerning prescribing controlled substances and reads as follows:

“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)

This policy was reiterated by the DEA as part of its Physician’s Manual. However, control of medical practices is a state function and physicians in an IP center should follow their state regulations.

The Drug Enforcement Administration, in collaboration with leading pain physicians, has completed a document entitled “Prescription Pain Medications.” This document, released in August 2004, will be reviewed in a future issue of Practical Pain Management. Its purpose is — through a series of questions and answers — to address the problems, both legal and procedural, of prescribing opiods for the relief of chronic pain. It is a welcome educational resource that will assist in the fulfillment of our objectives.

The Federation of State Medical Board

This organization is dedicated to assisting medical boards in assuring high quality medical care throughout The United states. In 1998, the Federation adopted the Model Guidelines For The Use of Controlled Substances For The Treatment of Pain. The Federation realized that there was a reluctance to prescribe these drugs because of the controlled substance prohibitions, as well as inadequate legal distinctions between addiction and pain as a reason for prescribing. The Guideline can be found by visiting http://www.fsmb.org.

The work of the Federation has been extremely useful to the pain management specialty. Many states have adopted the guidelines and it certainly has encouraged better treatment for pain suffers. However, it does not address the subject of treating intractable pain sufferers. One might ask, “Isn’t intractable pain just a degree of chronic pain?” In a sense that may be true but it is necessary to separate intractable pain from lesser forms of chronic pain. Just examining the semantics makes the point. Chronic pain is pain that persists beyond the usual course of healing acute pain or a disease. The definition does not define the degree of pain. It need not be severe, just chronic.

Intractable pain, however, is not only chronic, but of a severity and persistence that is incapacitating and does not allow the patient to function without very aggressive treatment. At least thirteen state legislatures believe that IP treatment deserves special legislation and protections. It is the author’s hope that the Federation will adopt a comprehensive model regulation to guarantee patients adequate treatment and to protect the IP physician. The California initiatives, described below, are a step in the right direction and may serve as a starting point.

The California Model

There are two laws in California that enter into this discussion. The first is The Intractable Pain Law, part of the Business and Professional Code, that was passed in 1990 (Appendix A) through the efforts of the late State Senator Leroy Greene, Harvey Rose, MD and Forest Tennant, MD, the editor of this journal; and The Pain Patients Bill of Rights, part of The Health and Safety Code, passed in 1997. (Appendix B)

The Intractable Pain Law (refer to Appendix A) defines intractable pain and gives physicians the right to administer controlled substance to an intractable pain patient (paragraph a) without fear of disciplinary action by the medical board (paragraph c). Most important is the legal classification of the patient as being in a state of intractable pain. It is very important to note that, in this California model, the intractable pain physician is not given the right to make that judgment. At a minimum, the patient must be examined by a specialist in the area of pathology from which the pain originates and, if meeting the qualifying conditions as stated in paragraph b, declared to be in ‘a state of intractable pain.’ Documentation is very important and an intractable pain practice should require the referring doctor to sign a form that:

  • assigns the patient to the IP center,
  • states that the patient’s condition meets the above-mentioned requirements in being classified as an IP patient, and
  • states that the patient, to the best of the physician’s knowledge, is not addicted to any drug covered by controlled substance regulations.

Corroboration by an independent medical expert is highly recommended.

The remainder of California’s Intractable Pain Law deals with precautions against violations of controlled substance regulations and deals primarily with non-therapeutic prescribing and warns that the Intractable Pain Law offers no protection for violations in this area, a fact that should be obvious. However, it does pose a yet unanswered question that we will continue to investigate: how does an intractable pain physician deal with a drug-addicted patient who is also in severe pain? As of now, we suggest that the patient be referred first to a drug addiction specialist recognizing that this condition is not protected in California.

From 1990 until 1997, The Intractable Pain Law governed treatment but did not cover the rights of a patient to determine the course of action. In 1997, through the efforts of many of the same advocates, The Patients Bill of Rights was established giving these suffering citizens a stronger say in decisions affecting the course their lives.

The Patients Bill of Rights (refer to Appendix B) should be viewed as an important legislation that not only puts the patient in control of his or her future but also affords the IP physician the legal protection required to bring aid to patients without fear of frivolous litigation as long as the requirements are adhered to and documented. The Patients Bill of Rights, along with The Intractable Pain Law, makes California an exemplary model to follow. While, physicians sometimes assume that a regulation or law is inhibiting, it must be noted that, quite to the contrary when carefully followed, these laws should be the basis of encouraging California physicians to open much needed IP centers.

Summary

The combination of California’s Intractable Pain Law and Patient’s Bill of Rights provides a good start in protecting both IP patients and their doctors from legal and regulatory issues. Following are some highlights of these laws:

  • the patient is independently certified to be in a state of intractable pain and is not addicted
  • the patient has the right to reject or accept any form of treatment
  • all patient/physician transactions are documented and signed (including any refusals)
  • if the physician decides to terminate a treatment, the patient may insist on its continuance or be given the names of other physicians who might continue the therapy
  • the physician may prescribe any drugs and dosage that is therapeutically necessary

These two laws in California afford options to the patient and protection to the IP physician. However, the laws assume an adequate number of facilities to deal with the severe condition of intractable pain. As an example, the necessity to recommend a physician who will continue opioid therapy as covered in The Patients Bill of Rights is difficult to enforce because of the very few IP centers.

Therein lies the biggest problem this series of articles will address: Why aren’t there more IP centers? A preliminary observation is that physicians fear litigation and consider the judicial system unfriendly to their positions, some practicing physicians do not understand the function and usefulness of IP centers and physicians have not adequately interpreted the governing regulations. It is important to address these concerns to promote the needed growth of IP centers in the United States. n

Appendix A
Business and Professions Code “Intractable Pain Law”

2241.5 Administration of controlled substances to person experiencing “intractable pain”

  1. Notwithstanding any other provision of law, a physician and surgeon may prescribe or administer controlled substances to a person in the course of the physician and surgeon’s treatment of that person for a diagnosed condition causing intractable pain.
  2. “Intractable pain,” as used in this section, means a pain state in which the cause of pain cannot be removed or otherwise treated and which in the generally accepted course of medical practice no relief or cure of the cause of the pain is possible or none has been found after reasonable efforts including, but not limited to, evaluation by the attending physician and surgeon and one or more physicians or surgeons specializing in the treatment of the area, system, or organ of the body perceived as the source of the pain.
  3. No physician or surgeon shall be subject to disciplinary action by the board for prescribing or administering controlled substances in the course of treatment of a person for intractable pain.
  4. This section shall not apply to those persons being treated by a physician and surgeon for chemical dependency because of their use of drugs or controlled substances.
  5. This section shall not authorize a physician and surgeon to prescribe or administer controlled substances to a person the physician and surgeon knows to be using drugs or substances for nontherapeutic purposes.
  6. This section shall not affect the power of the board to deny, revoke, or suspend the license of any physician and surgeon who does any of the following:
    1. Prescribes or administers a controlled substance or treatment that is nontherapeutic in nature or nontherapeutic in the manner the controlled substance or treatment is administered or prescribed or is for a nontherapeutic purpose in a nontherapeutic manner.
    2. Fails to keep complete and accurate records of purchases and disposals of substances listed in the California Controlled Substances Act, or of controlled substances scheduled in, or pursuant to, the federal Comprehensive Drug Abuse Prevention and Control Act of 1970. A physician and surgeon shall keep records of his or her purchases and disposals of these drugs, including the date of purchase, the date and records of the sale or disposal of the drugs by the physician and surgeon, the name and address of the person receiving the drugs, and the reason for the disposal of or the dispensing of the drugs to the person and shall otherwise comply with all state record keeping requirements for controlled substances.
    3. Writes false or fictitious prescriptions for controlled substances listed in the California Controlled Substances Act scheduled in the federal Comprehensive Drug Abuse Prevention and Control Act of 1970.
    4. Prescribes, administers, or dispenses in a manner not consistent with public health and welfare controlled substances listed in the California Controlled Substances Act or scheduled in the the federal Comprehensive Drug Abuse Prevention and Control Act of 1970.
    5. Prescribes, administers or dispenses in violation of either Chapter 4 (commencing with Section 11150) or Chapter 5 (commencing with Section 11210) of Division 10 of the Health and Safety Code or this chapter.
  7. (g) Nothing in this section shall be construed to prohibit the governing body of a hospital from taking disciplinary actions against a physician or surgeon, as authorized pursuant to Sections 809.05, 809.4, and 809.5.

Appendix B
Division of Health & Safety Code Part 4.5: Pain Patient’s Bill of Rights

124690. The Legislature finds and declares all of the following:

  1. The state has a right and a duty to control the illegal use of opiate drugs.
  2. (Inadequate treatment of acute and chronic pain originating from cancer or noncancerous conditions is a significant health problem.
  3. For some patients, pain management is the single most important treatment a physician can provide.
  4. A patient suffering from severe chronic intractable pain should have access to proper treatment for his or her pain.
  5. Due to the complexity of their problems, many patients suffering from severe chronic intractable pain may require referral to a physician with expertise in the treatment of severe chronic intractable pain. In some cases, severe chronic intractable pain is best treated by a team of practiceians in order to address the associated physical, psychological, social, and vocational issues.
  6. In the hands of knowledgeable, ethical, and experienced pain management practitioners, opiates administered for severe acute and severe chronic intractable pain can be safe.
  7. (g) Opiates can be an accepted treatment for patients in severe intractable pain who have not obtained relief from any other means of treatment.
  8. A patient suffering from severe chronic intractable pain has the option to request or reject the use of any or all modalities to relieve his or her severe chronic intractable pain.
  9. A physician treating a patient who suffers from severe chronic intractable pain may prescribe a dosage deemed medically necessary to relieve severe chronic intractable pain as long as the prescribing is in conformance with the provisions of the California Intractable Pain Treatment Act, Section 2241.5, of the Business & Professions Code.
  10. A patient who suffers from severe chronic intractable pain has the option to choose opiate medication for the treatment of the severe chronic intractable pain as long as the prescribing is in conformance with the provisions of the California Intractable Pain Treatment Act, Section 2241.5, of the Business & Professions Code.
  11. The patient’s physician may refuse to prescribe opiate medications for a patient who requests the treatment for severe chronic intractable pain. However, that physician shall inform the patient that there are physicians who specialize in the treatment of severe chronic intractable pain with methods that include the use of opiates.

124961. Nothing in this section shall be construed to alter any of the provisions set forth in the California Intractable Pain Treatment Act, Section 2241.5, of the Business & Professions Code. This section shall be known as the Pain Patient’s Bill of Rights.

  1. A patient suffering from severe chronic intractable pain has the option to request or reject the use of any or all modalities in order to relieve his or her severe chronic intractable pain.
  2. A patient who suffers from severe chronic intractable pain has the option to choose opiate medications to relieve severe chronic intractable pain without first having to submit to an invasive medical procedure, which is defined as surgery, destruction of a nerve or other body tissue by manipulation, or the implantation of a drug delivery system or device, as long as the prescribing physician acts in conformance with the provisions of the California Intractable Pain Treatment Act, Section 2241.5, of the Business & Professions Code.
  3. The patient’s physician may refuse to prescribe opiate medication for the patient who requests a treatment for severe chronic intractable pain. However, that physician shall inform the patient that there are physicians who specialize in the treatment of severe chronic intractable pain with methods that include the use of opiates.
  4. A physician who uses opiate therapy to relieve severe chronic intractable pain may prescribe a dosage deemed medically necessary to relieve severe chronic intractable pain, as long as that prescribing is in conformance with the California Intractable Pain Treatment Act, Section 2241.5, of the Business & Professions Code.
  5. A patient may voluntarily request that his or her physician provide an identifying notice of the prescription for purposes of emergency treatment or law enforcement identification.
  6. Nothing in this section shall do the following:
    1. Limit any reporting or disciplinary provisions applicable to licensed physicians and surgeons who violate prescribing practices or other provisions set forth in the Medical Practice Act, Chapter 5 (commencing with Section 2000) of Division 2 of the Business and Professions Code, or the regulations adopted thereunder.
    2. Limit the applicability of any federal statute or federal statue or any other statues or regulations of this state that regulate dangerous drugs or controlled substances.
Last updated on: December 20, 2011
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