The Board is obligated by statute to receive and investigate complaints alleging that a licensee is prescribing or administering what could be excessive quantities of drugs to persons who may be addicted to the medications.

Then, in 1992, without referencing the adoption of the Pain Act, TSBME placed the following pertinent statements on the front page of its newsletter:

The Board does not wish to inhibit the proper treatment of pain. However, the Board will continue to be concerned about the inappropriate use of narcotics in non-malignant conditions in which physical therapy measures, exercise techniques, or relaxation and stress control techniques have not been utilized.

At this point in 1992, it appeared as if TSBME not only focused on "excessive quantities of drugs to persons who may be addicted to the medications," but also required "physical therapy measures, exercise techniques, or relaxation and stress control techniques" to be used first with patients with nonmalignant conditions. In the last TSBME pronouncement before the adoption of the Pain Rules, TSBME no longer focused on "excessive quantities of drugs" as a sole indicator of inappropriate prescribing, nor did it require different treatment modalities for malignant and nonmalignant pain. Instead, referencing the International Narcotic Control Board, Section 21 of the Code of Federal Regulations, and the Pain Act, TSBME stated that

opioids (narcotics) and other Scheduled Controlled substances are indispensable for the treatment of pain; and, are useful for relieving and controlling many other distressing symptoms patients may suffer. It is the position of the Board that these drugs be prescribed for the treatment of these symptoms in appropriate and adequate doses after an appropriate diagnosis is made.

Additionally, this time TSBME stated the "[q]uantity and chronicity of prescribing will be judged on the basis of the diagnosis and treatment of the targeted symptoms and neither of these factors are prima facie evidence of inappropriate or excessive prescribing." After the publication of these three policy statements, the need for a simple, straightforward, and binding administrative rule became apparent.

Physicians also had a specific need for the Pain Rules. The incidence of pain is high, yet inferior pain relief occurs due to Texas physicians' perceived regulatory barriers to treating pain adequately. Specifically, 68 percent of those physicians responding to a statewide survey of licensed Texas physicians conducted in 1995 stated that they believed TSBME influences pain treatment some or even quite a lot. Yet, 61 percent of these same physicians did not know TSBME standards for opioid prescribing and 68 percent of them did not believe these standards could easily be determined.

Why the Texas Medical Practice Act is insufficient

The Texas Medical Practice Act (MPA) currently does not adequately address the discipline of physicians for prescribing practices. The stated purposes of MPA include "eliminating ... ineffective provisions ... and restating the law in more modern language where possible." Currently, MPA provides for disciplinary action relating to the inappropriate prescribing of controlled substances. Specifically, physicians in Texas have been disciplined by TSBME under various provisions of MPA relevant to prescribing practices. First, physicians have been disciplined for prescribing or practicing medicine in a manner not consistent with public health and welfare. Second, physicians have been disciplined by TSBME for "prescribing or administering a drug or treatment that is nontherapeutic in nature or nontherapeutic in the manner the drug or treatment is administered or prescribed." Unfortunately, none of these MPA provisions is defined in the Texas MPA.

The Pain Rules provide more guidance in referencing the definitions used in the Code of Federal Regulations (CFR). CFR requires prescriptions by a physician for a controlled substance to be issued for "a legitimate medical purpose in the usual course of professional practice." That requirement originated in the regulations implementing the Harrison Narcotic Act of 1914. It is used in the federal regulations implementing the Controlled Substance Act (CSA) and in interpretations of CSA by the Department of Justice. These three usages are explained below.

Regulatory usage

The original Harrison Narcotic Act regulations

The Harrison Narcotic Act of 1914 (the Act) established a registration and taxation system to control the use of narcotics. The regulations implementing this Act required all dispositions of opioids to be accompanied by an order form unless the disposition was (1) by a duly qualified and registered practitioner in the course of his professional practice, or (2) pursuant to a properly executed prescription for a legitimate medical purpose. Additionally, all prescriptions under the Act had to be issued for a legitimate medical purpose.

The U.S. Senate floor debate reveals the care with which Congress drafted the Act. A senator from the then rural state of Ohio asked to exempt physicians from the bill because of the hardships it imposed on the rural practice of medicine. He compromised on requiring the licensing of physicians to distribute narcotics, but exempted physicians from the record-keeping requirements of the bill. He pleaded:

We must have a cure for the drug habitue, but we must not forget the innocent sufferer on his or her bed of sickness and pain. Let us protect the country from the physician or druggist who is encouraging the drug habit for purely commercial purposes; but let us not by too much red tape hinder the physician in the proper practice of his profession. We can prevent the abuse of the drugs without unduly hampering its proper use.

Therefore, the original intent of the language was to balance the needs of law enforcement with adequate pain relief for patients. The intent of the Pain Rules is to carry this balance forward.

Drug Enforcement Administration manual

The Diversion Control Division of the Drug Enforcement Administration issued a manual in 1990 to assist physicians' understanding of CSA. The manual states:

Controlled substances and, in particular, narcotic analgesics, may be used in the treatment of pain experienced by a patient with a terminal illness or chronic disorder. These drugs have a legitimate clinical use and the physician should not hesitate to prescribe, dispense or administer them when they are indicated for a legitimate medical purpose. It is the position of the Drug Enforcement Administration that these controlled substances should be prescribed, dispensed or administered when there is a legitimate medical need.

It is my opinion that the difference between permitting prescribing for legitimate medical purpose, as used here, and restricting prescribing for a nontherapeutic use or prescribing not consistent with public health and welfare, as used in the Texas MPA, is twofold. First, a positive statement of the law allows for the changes in medical practice as more research is done. The negative statements nontherapeutic use and not consistent with public health and welfare do not. Second, cultural and societal biases can be used to interpret nontherapeutic use and public health and welfare. This may lead to underprescribing of opioids. For instance, when opioids are prescribed for certain chronic nonmalignant painful conditions, many people do not believe this is culturally and socially acceptable. Further, the phrase nontherapeutic use and efficacy might be confused. For example, certain chronic painful conditions (neuropathic pain) may respond poorly to opioids. However, is relieving only some aspects of neuropathic pain a nontherapeutic use? Restating the law in this area replaces a vague provision with language that more appropriately addresses the issue of adequate pain relief.

Controlled Substance Act and the Code of Federal Regulations

Congress states in the legislative findings section of CSA that "many of the drugs included within this title have a useful and legitimate medical purpose and are necessary to maintain the health and general welfare of the American people." Indeed, the regulation implementing CSA states that "for a controlled substance to be effective [a prescription] must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. " Texas law now conforms to these established standards. It is hoped this improved legal standard will provide guidance to Texas physicians prescribing opioids and lead to improved prescribing practices.

Federal and state case law usage

Federal case law

Requiring all prescriptions to be issued for a "legitimate medical purpose in the usual course of professional practice" has a long and well defined history in the area of narcotics regulation. In fact, as described below, review of the federal case law reveals that three factors determine whether a physician is prescribing for a legitimate medical purpose in the usual course of professional practice. In many cases, the "facts ... were so blatant that a statement of clear cut criteria in a form useful in other cases would have been superfluous to the decision." However, within the case law, several factors repeat with regularity. The following factors, therefore, can be characterized as determining that a physician is not prescribing for a "legitimate medical purpose in the usual course of professional practice."

(1) Lack of medical treatment by the physician--
(a) no medical history and no physical exam;
(b) physician ignores results of tests made; and
(c) no charge for medical services, but instead a graduated fee according to the number of pills desired.

Lack of medical judgment by the physician--
(a) inordinately large number of drugs given or prescriptions issued;
(b) excessive frequency of prescriptions;
(c) no logical relation between drugs prescribed and treatment of alleged condition;
(d) physician allows patient to request a specific drug, rather than prescribing a drug based on a medical history and diagnosis;
(e) prescriptions issued in exchange for sexual relations with the patient; and
(f) physician ignores presence of track marks on patient for whom injectable drugs are prescribed.

(2) Awareness of a nonlegitimate purpose on the part of the physician--
(a) physician tells patient to fill prescriptions at different pharmacies;
(b) physician writes more than one prescription at a time, then post-dates some of them to avoid the appearance of overprescribing;
(c) physician erases names in record book to avoid scrutiny;
(d) physician asks patient to use a fictitious name for prescription or agrees to write prescription in the name of someone who is not the patient;
(e) physician uses street slang rather than medical terminology for drugs prescribed;
f) prescriptions issued to patient known to be distributing them to others or to be using them for other than legitimate medical purposes; and
(g) physician tells patient names of disease he/she can claim to suffer if pharmacist questions him/her.

The standard used in United States v. Rosen to analyze whether a physician distributed or dispensed a controlled substance for other than legitimate medical purposes in the usual course of professional practice is as follows:

A physician is restricted to dispensing or prescribing drugs in the bona fide treatment of a patient's disease, including a dispensing of a moderate amount of drugs to a known addict in a good-faith attempt to treat the addiction or to relieve conditions or suffering incident to addiction. However, under the guise of treatment a physician cannot sell drugs to a dealer nor distribute drugs intended to cater to cravings of an addict. Congress did not intend for doctors to become drug "pushers." In making a medical judgment concerning the right treatment for an individual patient, physicians require a certain latitude of available options. Hence, what constitutes bona fide medical practice must be determined upon consideration of evidence and attending circumstances.

This standard clearly reveals flexibility in the law, which is important when dealing with unsettled medical issues such as treatment of nonmalignant pain with opioids. Physicians are given the latitude of "available options" and are judged based on the "evidence and attending circumstances."

Texas case law definitions

An additional basis for the change from the Texas standard, which restricts prescribing for nontherapeutic use or prescribing not consistent with public health and welfare, to the federal standard, which requires the prescription to be for a legitimate medical purpose in the usual course of professional practice, is the paucity of Texas case law providing clarification to the terms nontherapeutic use or consistent with public health and welfare. The Texas MPA states: "Any term, word, word of art, or phrase that is used in this [MPA] and not otherwise defined in this [MPA] has the meaning as is consistent with the common law." However, only four applicable cases exist in Texas. Only one reported case can initially be found where the defendant lost his license due to a "professional failure to practice medicine in an acceptable manner consistent with public health and welfare." In Balla v. Texas State Board of Medical Examiners, an appellate court upheld the revocation of Dr. George Balla's medical license for issuing "patient prescription orders for amphetamine and amphetamine-like drugs through the mail ... without 'a proper medical examination to determine if such drugs were medically necessary or medically indicated for treatment of any illness or medical condition.'" Although Dr. Balla's actions were clearly not acceptable, one case does not provide direction for physicians who want to practice medicine that is consistent with both accepted scientific and medical standards and the less well defined standard of "public health and welfare."

The common law definition of "prescribing or administering a drug that is nontherapeutic in nature or nontherapeutic in the manner the drug or treatment is administered or prescribed" is also very limited. Only three reported cases rely on this section of MPA and only one of them resulted in the revocation of a physician's license. In the other two cases, the courts overruled the Texas Board of Medical Examiners because it lacked the expert testimony necessary to uphold the license revocation.

Finally, no cases in Texas have relied on "prescribing, administering or dispensing in a manner not consistent with public health and welfare dangerous drugs ... or controlled substances...." Therefore, Texas common law has not provided adequate assistance in defining these three phrases in the Texas MPA.

How Texas regulations might have changed a recent Florida disciplinary action

Sometimes having case law that addresses the issues of pain management can initially create the worst possible outcome. Indeed, the reason for drafting clear guidelines regarding the treatment of pain rather than leaving it up to the courts to decide is best demonstrated in a recent physician disciplinary action in Florida, Hoover v. Agency for Health Care Administration. On June 26, 1996, a Florida district court reversed the Florida Board of Medicine's reprimand and civil fine of a physician alleged to have "inappropriately and excessively" prescribed various Schedule II controlled substances. The court's reversal turned on the fact that the Florida Board of Medicine substituted its own judgment for a hearing officer's findings of fact and conclusions of law without proving a violation of the Florida Medical Practice Act by clear and convincing evidence.

At a formal hearing requested by the physician, Board of Medicine experts testified that "the doctor had prescribed excessive, perhaps lethal amounts of narcotics, and practiced below the standard of care." One of these physicians also stated that "the amounts prescribed constituted a 'tremendous number of pills.'" However, the expert physicians did not treat patients with chronic pain and

'candidly testified that without being provided with copies of the medical records for those patients, they could not evaluate [the physician's] diagnosis of what alternative modalities were attempted or what testing was done to support the use of medication chosen by [the physician] to treat [her patients].'

The physician under investigation, on the other hand, testified in great detail

concerning the condition of each of the patients, her diagnoses and courses of treatment, alternatives attempted, the patients' need for medication, the uniformly improved function of the patients with the amount of medication prescribed, and her frequency of writing prescriptions to allow her close monitoring of the patients. She presented corroborating physician testimony regarding the appropriateness of the particular medications and the amounts prescribed and her office-setting response to the patients' requests for relief from intractable pain.