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5 Articles in Volume 3, Issue #2
Balancing Pain Management and Professional Risk
Chronic Opioid Rules
Distraction Techniques for Lumbar Pain
Legal Landscape of Pain Treatment
National Pain Data Bank Minimizes Professional Risk

Legal Landscape of Pain Treatment

On overview of the legal, regulatory, and ethical issues relating to pain treatment.

Pain is the reason most people seek health care. The cost in lost productivity is in the billions of dollars annually. Over the years there have been major changes in the way pain is analyzed and treated. Thanks to the efforts of dedicated health care professionals, researchers, and legislators, there now exists a more compassionate and scientifically-based approach to pain management. Cooperative progress between law and medicine has opened up more freedom for legitimate prescribing. Organizations such as the Joint Commission of Accreditation of Hospitals Organization, the International Association for the Study of Pain and the Drug Enforcement Agency have incited changes in both federal and state laws.

In prior years, physicians were restricted in their prescribing practices of controlled substances — there was always the implied threat of disciplinary action if they prescribed “too much." As a result, many people had to learn to live — or die — with their pain.

Many barriers still exist to adequate pain management. Prominent among the barriers is the continued lack of knowledge on the part of many health care providers, as well as the lay public. Consequently, pain continues to be inadequately treated. As options to treat pain expand, there must be continuing education of health care professionals; ethical practice demands it and the legal environment may dictate it.

Definitions

The International Association for the Study of Pain defines pain and some of its varying forms as follows:1

  • Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage.
  • Central Pain is pain initiated or caused by a primary lesion or dysfunc- tion in the central nervous system.
  • Neuralgia is pain in the distribution of a nerve or nerves.
  • Neuritis is inflammation of a nerve or nerves.
  • Neurogenic pain is pain initiated or caused by a primary lesion, dysfunc- tion or transitory perturbation in the peripheral or central nervous system.
  • Neuropathic pain is pain initiated or caused by a primary lesion or dys- function in the nervous system.
  • Nociceptive pain results when a nox- ious stimulus (one which is damaging to normal tissue) stimulates a prefer- entially sensitive receptor.

Pain can be acute or chronic. Chronic pain is pain that generally lasts more than six months and, if untreated, it can of itself become a disease state. The Agency for Health Care Policy and Research (AHCPR) and the American Pain Society (APS) have developed recommendations for acute pain management. Acute pain management typically occurs in health care institutions or offices, although not restricted to these settings. Table 1 presents the AHCPR recommendations for treating acute pain:2

The AHCPR, in addressing cancer pain, published the ABC’s of pain management.3 It simplifies a philosophy of treatment as indicated in Table 2.

Organizational Initiatives

Several years ago, the late John Bonica, MD, dedicated himself to the relief of pain. Dr. Bonica, an Italian immigrant to the U.S., suffered debilitating pain resulting from sports injuries and subsequently wrote volumes about various pain treatments. Dr. Bonica left a legacy in the form of the ever-expanding International Association for the Study of Pain (IASP). The International Association is now in 60+ countries and holds a World Congress, convening to exchange research results and reports of specialty groups. The 2001 Congress passed the Patient’s Bill of Rights.

The American Pain Society (APS) is the U.S. arm of the IASP. Many regional and local societies have formed throughout the U.S. and the world. The focus is to relieve the many types of pain common to mankind. In 2002, the APS produced a guideline for the management of the pain of osteo-arthritis, rheumatoid arthritis and juvenile chronic arthritis.

AHCPR Recommendations for Treating Acute Pain
p Implement a valid and reliable pain assessment tool in clinical practice.
p Inform patients that treatment of their pain is important.
p Tell patients to notify someone if they are in pain.
p Set a goal with the patient for an acceptable level of pain intensity.
p Systematically document the pain experience. This should include factors influencing perception, evaluation of pain and pain responses, as appropriate.
p Assess pain at regular intervals — after initiation of treatment, at each new report of pain, and at suitable intervals after treatment.
p Treat the pain within 15 minutes.
p Use both drug and non-drug therapies to treat pain as appropriate.
p Determine if pain relief is acceptable to the patient.
p Institute a formal and collaborative institutional approach to pain management with clear lines of responsibility.

State Laws

There is currently a patchwork of state laws governing the prescribing of controlled substances for pain. It is crucial that physicians be familiar with both applicable state and federal regulations to avoid legal complications. Following are samples of state laws that impact on prescribing for pain.

In Texas, the Intractable Pain Treatment Act was approved in 1989. The purpose of the Act was to develop some degree of immunity from state medical boards for physicians who prescribe controlled substances for pain. The Intractable Pain Treatment Act Texas has helped physicians to treat unrelenting pain in a more benign environment.

Table 1.

Maine enacted a comprehensive law effective March 22, 1999 entitled “Chapter 11, The Use of Controlled Substances for Treatment of Pain."12 The law emanates from The Department of Professional and Financial Regulation. It is comprehensive and inclusive and encourages physicians to practice effective pain management as part of quality medical practice.

The Massachusetts Board of Registration in Medicine published Prescribing Practices, Policy and Guidelines effective May 3, 1989 and amended December 12, 2001. The Board specifically endorsed the Federation of State Medical Board’s Model Guidelines for the Use of Controlled Substances in the treatment of pain (see the section following titled ‘Model Guidelines’).

Oregon’s statute Chapter 677, titled Regulation of Medicine, Podiatry and Related Medical Services implemented October 10, 1995 and amended July 6, 1999 specifically states (among other provisions) that a physician shall not be subject to disciplinary action by the Medical Examiners for prescribing or administering controlled substances in the course of treatment of a person for intractable pain. On the other hand, the law also makes provisions for disciplinary action to limit or suspend a physician’s license for inappropriate prescribing or inadequate record keeping. Oregon, in Chapter 847 Division 015 Board of Medical Examiners, also dictates that written notice of risks and benefits be provided to patients with intractable pain. The material risk consent form must be maintained as a permanent part of both a patient’s record and the dispensing record.

Federal Regulations & Enforcement

In treating pain, the practitioner must provide appropriate levels of pain relief while preventing patients from abusing pain medications.8 The Drug Enforcement Administration reminds the medical community of the abuse potential of controlled substances. Working together, law enforcement and health care professionals aim to provide legitimate pain relief while educating the public on the dangers of diversion.

The prescribing of controlled substances is addressed in Federal Regulation Title 21: Food and Drugs (see Table 3 for an excerpt of the applicable regulations).

In the recent past, the DEA aggressively scrutinized, investigated, and disciplined physicians for writing “too many" prescriptions for controlled substances. However, through medical and scientific advances, it is now recognized that effective treatment of pain with controlled medication not only improves the patient’s physical and psychosocial health and comfort, but also saves billions in health care dollars. The model guidelines (see the next section) provide a framework that is acceptable to the Drug Enforcement Agency in meeting requirements for establishing legitimate use.

Model Guidelines

The adoption of model guidelines for the use of controlled substances in the treatment of pain by the Federation of State Medical boards of the United States, Inc. in 1998, represented an essential step in legitimizing pain medication prescribing.9 Model guidelines assert that “ controlled substances, including opioid analgesics, may be essential in the treatment of acute pain due to trauma or surgery and chronic pain — whether due to cancer or non-cancer origins."

The model guidelines dictate the necessity of conducting a thorough history and physical in order to assess the indications for the use of a controlled substance to treat pain. Further diagnostic and treatment measures may need to be taken to determine the cause of pain. The physician must look for factors that place a patient at high risk for abuse (e.g. a history of prior substance abuse). Key requirements include continual medical review and a complete documentation trail.

In adopting these guidelines, the Federation of State Medical Boards of the United States Inc. achieved agreement with the Drug Enforcement Agency. In promulgating these model guidelines, the states of California, Oregon and West Virginia have mandated pain management education for physicians. Maryland, Massachusetts, Michigan, New Jersey, New Mexico and North Carolina are expected to do so in 2003.

Pain Control Standards

In January 2001, the Joint Commission of Accreditation of Hospitals Organization (JCAHO) published standards for pain control.5 JCAHO is a private national accreditation agency that has deemed status by the Federal Government to conduct accreditation surveys on behalf of Medicare. Most third party insurance reimbursement for physicians is tied to a prerequisite of affiliation with an accredited hospital.6 JCAHO surveys and accredits some 19,000 hospitals, health care plans and networks, outpatient service centers, home care organizations, nursing homes, long term care facilities, assisted living residences, and behavioral and mental health care organizations.

JCAHO requires that every health care facility must periodically assess and treat pain. In hospitals it is a requirement to assess pain when vital signs are taken. As a result, the pain assessment is now referred to as the “fifth vital sign." When temperature, pulse, blood pressure and respirations are assessed in the hospital, pain is now also assessed.

JCAHO believes that all patients have a right to pain relief. The result is that — especially in hospitals — patients are more likely to receive adequate pain treatment. In other settings, such as nursing homes, the approach, of necessity, must be more creative.

In February 2001, a Veteran’s Administration (VA) initiative was launched in compliance with JCAHO requirements.7 The national coordinator of the VA pain management strategy, Dr. Jane Tollett, lauded the concept of making the patient feel better. The VA is producing a web- based physician education program concerned with pain management and end-of-life care. The VA news release stated: “the message is clear: all those in pain have the right to systematic assessment and ongoing management of pain by health care professionals."

The VA is developing guidelines in collaboration with the Department of Defense to develop clinical guidelines for treatment of pain associated with chronic conditions, cancer and surgery. Veteran’s problems may differ somewhat from the general non-veteran population. Post traumatic stress disorder, homelessness and war-related factors complicate pain treatment options in this population.

Chapter II D.E.A.Department of Justice section 1306.03
Persons Entitled to Issue Prescriptions:
  1. prescription for a controlled substance may be issued only by an individual practitioner who is:
    1. authorized to prescribe controlled substances by the jurisdiction in which he is licensed to practice his profession and
    2. either registered or exempt from registration pursuant to secs. 1301.22© and 1301.23 of this chapter.
  2. as amended at 62 FR 13966 Mar. 24, 1997.
Part 1306.04 Purpose of issue of Prescription:
  1. a prescription of a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper pre- scribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and au- thorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S. C. 829) and the person knowingly filling such a purported prescription as well as the person issuing it, shall be sub- ject to the penalties provided for violations of the provisions of law related to controlled substances.
  2. A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients.
  3. A prescription may not be issued for the dispensing of narcotic drugs listed in any schedule for “detoxification treatment" or “maintenance treatment" as defined in section 102 of the Act (21 U.S.C. 802) amended at 39 FR 37986 Oct. 25, 1974.
  4. Physician organizations advise diligence in prescribing, recognizing the po tential for diversion for illegitimate use.

Informed Consent

Informed consent is a another medical legal issue.10 The physician must explain the risks and benefits of controlled substances to the patient before initiating treatment with such medications. If the patient is incompetent, the physician may confer with the patient’s designated health care proxy or guardian. The physician may enter into a written agreement with the patient or surrogate. The agreement limits the patient to:

dealings with one physician,
one pharmacy where possible,
advises the patient that selling or
sharing medication is not allowed,
advises that communication between
the physician and pharmacy may be
necessary,
advises against abrupt stoppage and
tells the patient unannounced blood
or urine tests may be requested, and
l if unauthorized substances are found,
the patient will be referred for an
addiction disorder.

The goals of treatment generally include finding and treating the cause(s) of pain, improvement of comfort, activities, work and social activities. Once the plan is implemented, it is essential to conduct evaluation at appropriate intervals to monitor progress and re-adjust the treatment plan as indicated by patient response and circumstances. Medical documentation should be accurate and completely describe the entire process of assessment, treatment agreements and periodic review.

The Patient Self-Determination Act of 1990 relegates pain management under mitigation and treatment of disease. The Act deals with aspects of informed consent and posits that patients need to be informed of their options. Health care professionals have a duty to inform.

Ethical Issues

The American Academy of Pain Medicine published a position statement on the Basic Principles of Ethics for the Practice of Pain Medicine.13The position statement affirms the Code of Medical Ethics of the American Medical Association. The position statement “declares that its members shall continually strive for" ethical application of principles, clinical judgments based on what is best for the person in pain, adhere to principles of patient confidentiality and informed consent, practice beneficence, autonomy, nonmalficence and justice. Further, it advocates practicing, as an integral part of medicine, palliative and end-of-life care with knowledge and skill while informing patients and the public about what they hold as ethical practice.

Scientific evidence has shown that early intervention and treatment of pain is effective in returning people to a functional way of living. More importantly, early pain treatment may effectively relieve pain that may otherwise become chronic. Physicians must treat pain as an urgent condition. If the patient does not respond to treatment by the primary care physician, a referral to a Pain Specialist is indicated.4 The American Academy of Pain Medicine warns that effective pain evaluation and control must occur within a few weeks or months of onset “in order to prevent progressive pain, associated morbidity and increased costs."

A multidisciplinary treatment plan—especially in the case of chronic pain— should be prepared and implemented. Many major hospitals have multidisciplinary Pain Management Centers and there are also free-standing specialty pain clinics to which pain patients may be referred. Without prompt treatment, pain can become chronic, creating its own disease state in the form of defects in immunity and depression secondary to serotonin changes. The patient’s quality of life may deteriorate, complaints may proliferate and the person may become irritable and unpleasant to be around. Social isolation can result and become progressive—further compounding the problem.

Summary and Recommendations

Thanks to the dedication of people like Dr. John Bonica, Dr. Janet Travell, Dr. John Loesser, Dr. Daniel Carr, Dr. Richard Weiner and the myriad other pioneers and scientists from various health and consumer groups, much progress has been made. While the federal government has given a boost to the effort of pain relief, prescription drug coverage — with a provision for pain medicines — is still sorely needed for many people, especially the elderly.

Medical schools must lead in providing the necessary pain prescribing education to our physicians and nurse practitioners. Regulatory boards need to alleviate the fears of legitimate prescribing. Lawyers need to advise clients to discuss pain relief issues and desires with their health care proxies. Guardians and conservators need knowledge of pain relief availability if they are to take on the surrogate role of the incapacitated. No one should have to live or die in constant pain. n

Last updated on: May 16, 2011
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