Medical Guidelines are not Prosecutorial Tools

What are the FSMB Model Guidelines for State Medical Boards and the WHO Pain Treatment Guidelines?; Alexander DeLuca, M.D., MPH; War on Doctors/Pain Crisis blog of the Pain Relief Network; 2007-11-09.

Table of Contents:
The FSMB Model Guidelines  //  The WHO Pain Guidelines  // 
Medical Guidelines are not Prosecutorial Tools  //  Footnotes

The FSMB Model Guidelines
Originally adopted in 1998 by the Federation of State Medical Boards (FSMB), the Model Guidelines for the Use of Controlled Substances for the treatment of pain have been widely disseminated to state medical boards and other healthcare organizations, and by 2004 twenty of seventy state medical boards had “policy, rules, regulations or statutes reflecting the Federation’s Model Guidelines and two states have formally endorsed them.”¹ The Model Guidelines were updated in 2003 to reflect mounting evidence that the treatment of chronic pain continued to be inadequate citing the “Barriers” literature (discussed in another essay in this series, “The Ethical Obligation of Physicians to Relieve Suffering“, to be published soon). It states:

“The undertreatment of pain is recognized as a serious public health problem that results in a decrease in patients’ functional status and quality of life and may be attributed to a myriad of social, economic, political, legal and educational factors, including inconsistencies and restrictions in state pain policies.²

State medical boards are encouraged, in cooperation with their state’s attorney general, to evaluate their state pain policies, rules, and regulations to identify any regulatory restrictions or barriers that may impede the effective use of opioids to relieve pain.”³

The WHO Pain Treatment Guidelines
The World Health Organization (WHO) guidelines are probably the most widely disseminated worldwide, and have formed the starting point for several similar, national efforts. They were developed to insure that adequate and proper supplies of narcotic-opioid medications be made available, primarily to third world countries, in order that proper management of pain be easily attainable without logistic supply difficulties.

In a paper entitled The WHO Analgesic Ladder for Cancer Pain Management, the authors performed systematic review (40 references) of MEDLINE and textbooks, direct contact of authors, and meeting proceedings, from 1982-1995, covering studies evaluating effectiveness of WHO analgesic ladder as an intervention for cancer pain management. They concluded that evidence provided was insufficient to estimate confidently the effectiveness of the WHO analgesic ladder for the management of cancer pain.

Some direct quotations from this paper:⁴

“The limited effectiveness of the ladder as a management tool is rarely, if ever, acknowledged.”

“Inadequate analgesia is a result of “real” myths that impede adequate provision of effective analgesic interventions.”

“The main problem then is not the lack of evidence as to whether the ladder can relieve pain in cancer patients (this is likely to be the case) but the lack of strong evidence to produce unbiased estimates of the proportion of patients in whom the ladder produces satisfactory results.”

“In our opinion - it would be inappropriate and unfair, and possibly harmful, if current estimates of the proportion of patients in whom the application of the ladder results in adequate analgesia are used to set treatment goals and to judge the performance of clinicians.”

“If that is ignored, we may be responsible for making yet another important contribution to the already long list of barriers and myths surrounding the management of cancer pain.”

Medical Guidelines are not Prosecutorial Tools
The WHO guidelines were never intended to be used as a prosecutorial tool. The invocation of the WHO “analgesic ladder” concept of progressive pharmacological treatment of pain, in state investigations of physicians, is sometimes unfair. On the one hand the guidelines are interpreted as rules and the physician is faulted for violating in some aspect. On the other hand, state rules and regulations are often at odds with the spirit and specifics of the WHO guidelines.

Zech et. al. attempted to validate the WHO guidelines in a 10 year prospective study of some 2118 patients over a period of 140,000 treatment days. While the study supports wide dissemination of WHO guidelines to effect a clear improvement in the treatment of the many patients suffering from cancer pain in the clinical and home setting, the study does not support the contention, often made by law enforcement agencies, that the use of the guidelines pre-supposes preclusion of the initial use of opioids, in favor of nonsteroidal analgesics, or that the initial use of medications other than the opioids is either required or clinically desirable within the therapeutic framework of the management of malignant or non malignant pain.⁵

In this study 76% of patients (Table VI, page 68) were given and required opioids within 6 days admission. The number of patients eventually requiring strong opioids was 70% (page 70) and most patients required adjuvants (page 72) in addition to opioids.⁶

Footnotes