ADDITIONAL INFORMATION SUBMITTED BY THE AMERICAN MEDICAL ASSOCIATION TO THE SELECT COMMITTEE ON NARCOTICS ABUSE AND CONTROL, UNITED STATES HOUSE OF REPRESENTATIVES

RE: THE USE OF PSYCHOTROPIC DRUGS IN MEDICAL PRACTICE

The American Medical Association takes this opportunity to submit additional information for inclusion in the official record of the hearing held on September 19, 1978, by the Select Committee on Narcotics Abuse and Control, concerning the subject of the use of psychotropic drugs in medical practice.

AMA ORGANIZATION AND PURPOSES

The American Medical Association is a voluntary professional association with a current membership exceeding 200,000 Doctors of Medicine. The AMA was founded in 1846 and continues to operate for the purpose of promoting the science and art of medicine and the betterment of public health. To this end, AMA is basically an educational, scientific and information organization. Through a variety of endeavors including publication of the latest scientific information in medical journals and other publications, accreditation of undergraduate, graduate and continuing medical education programs, sponsorship of scientific symposia on important and current areas of medicine, and encouragement of continuing medical education, the AMA strives to keep the standards of American medicine the highest in the world. In fact, more than 60% of the AMA's annual budget is specifically directed toward those goals.

The American Medical Association is organized as a federation of 55 state, commonwealth, territorial and insular medical societies. The 55 "constituent associations" that make up the AMA are themselves made up of 1,931 county and metropolitan medical societies. Official AMA policy is established by a House of Delegates that meets twice yearly in order to consider resolutions, reports and other policy matters of the Association. A majority of House of Delegates members are selected by the constituent state societies. Certain medical specialty societies also have voting representation. While House of Delegates policy is binding upon the American Medical Association as a national organization, state and local medical societies are free to determine their own policy.

Membership by a physician in the AMA can be obtained in one of two ways. A vast majority of AMA members (approximately 170,000) belong to AMA through their state medical associations. In most cases, a physician to be a member of AMA first obtains membership in good standing in a state medical association. For physicians who are ineligible for membership in state medical associations (such as interns, residents, physicians in the Public Health Service, military and government service, etc.) direct membership is available (approximately 30,000).

AMA'S PROCEDURES FOR MEMBER DISCIPLINE

Responsibility for enforcement of the Principles of Medical Ethics is vested in the medical societies, with AMA's Judicial Council serving as an appellate body. The AMA's appellate review is limited to questions of law and procedure. The AMA's Judicial Council has limited original jurisdiction.

It was suggested at the Select Committee's hearing that the AMA should organize a national committee with staff and jurisdiction to investigate alleged aberrational prescribing practices. At this time, we would question the benefits that might be derived from such activity. First, the AMA has no authority to compel a physician to allow AMA investigation of his or her practice. Second, such activity would duplicate the efforts of state and local medical societies, state licensing boards, local law enforcement agencies, and the federal Drug Enforcement Administration.

It was also suggested, at the hearing, that AMA exert pressure on state and local societies to expel members who are reported to have aberrational prescribing practices. We believe that no member's rights of membership should be restricted unless appropriate "due process" is afforded initially at the local level and, therefore, when a complaint regarding a member is referred to the AMA the complaint is transmitted to the appropriate local society for an investigation of the facts.

The Judicial Council of the American Medical Association has stated that physician ownership of a retail pharmacy in and of itself does not violate the AMA Principles of Medical Ethics. Exploitation of the patient through over

utilization, overcharging, patient steering, etc. is unethical. The ethical issue concerns abuse of the patient-physician relationship, not ownership of a pharmacy. AMA has no data as to the number of pharmacies owned by physicians.

AMA'S ROLE IN PROVIDING INFORMATION ON PSYCHOTROPIC DRUGS

AMA will continue to exercise an appropriate leadership role concerning the use of psychotropic drugs and their potential for abuse by providing guidelines and recommendations to physicians concerning controlled substance abuse, including psychotropic drugs. Furthermore, the AMA will continue to publish current information regarding the use of psychotropic drugs in our periodically revised AMA Drug Evaluations and in its scientific publications, including the Journal of the American Medical Association and appropriate medical specialty journals.

The AMA also distributes pamphlets and brochures to physicians concerning the use of all drugs, including psychotropic drugs, and conducts scientific programs for physicians on drugs and their appropriate use. Courses will be offered by physicians concerning drug therapy and psychotropic drugs at the next AMA Winter Scientific Meeting in December, 1978. As an example, ore three-hour course is entitled "Practical, Rational Approach to Psychotropic Drugs: Antidepressants, Antipsychotics, Antianxieties." Another course is entitled "Clinical Aspects of Alcohol and Drug Abuse". These courses, along with other AMA educational programs, are designed to aid the physician in properly evaluating and prescribing the most appropriate treatment regimen to meet patient needs.

The AMA Council on Scientific Affairs will also continue to evaluate drug utilization and when appropriate make recommendations to the profession as necessary by way of the AMA House of Delegates.

MEDICAL EDUCATION AND PSYCHOTROPIC DRUGS

The American Medical Association also has a significant role in the development of requirements of undergraduate medical education.

The AMA Council on Medical Education appoints 6 members to the Liaison Committee on Medical Education (LCME). Along with AMA's representatives, 6 members of the LCME are appointed by the Executive Committee of the Association of American Medical Colleges, 2 members represent the public and one member represents the federal government. The LCME is recognized as the accrediting agency for medical schools by the United States Office of Education. The LCME works to insure that American medical schools meet the needs of society and the medical profession by insuring, through the establishment of guidelines and the conduct of regularly scheduled on-site inspections, that graduates from accredited institutions are competent to meet society's expectations for high standards and that the schools meet the expectations of students that a useful and valid medical education experience is provided.

However, the LCME does not require an explicit curriculum of courses for all medical schools. This policy is based upon a philosophy that all medical schools should be allowed to innovate in order to meet the needs of the communities and medical students that each school serves. The LCME has stated that: "Biochemistry, pharmacology, physiology, anatomy, pathology and microbiology are the traditional generic fields of biomedical sciences, which along with appropriate elements of the behavioral sciences are usually considered essential to the education of the physician. These should be taught in sufficient depth and breadth to insure that there is a fundamental knowledge for ongoing continuing medical education."

The depth and breadth of each school's curriculum, is ascertained by LCME through regular site visits of each medical school by teams of qualified medical educators who present, in writing, their findings for review and comment concerning the inspected institution to the members of the AMA Council on Medical Education, the Executive Council of the Association of American Medical Colleges, the Advisory Committee on Undergraduate Medical Education and to the Liaison Committee on Medical Education, which makes the final decision concerning status and term of the school's accreditation. Quantitative information is provided in advance of a site visit so that the survey team may assess from the data and by observation whether or not the educational program is consonant with the school's objectives and the LCME's educational guidelines. The curriculum directory of the Association of American Medical Colleges indicates that the averages required course offering in pharmacology is 100 class hours. In addition, after the formal basic course of study in an area such as pharmacology, the sub

ject matter is reiterated and reinforced during the clinical years as an integral part of diagnosis, therapy, and patient management.

The pharmacology of psychotropic agents is formally taught as a subsection of basic pharmacology. In recent years, as these agents have become a major part of psychiatric therapeutics, psychiatric faculties have become more involved in teaching at the basic science level. In the clinical years, psychotropic drugs are presented as part of the totality of psychiatric therapy as well as significant agents for use in primary care disciplines.

National proficiency tests that are required prior to licensure are designed to assure that those who are licensed to practice medicine obtain a sufficient level of competency in pharmacology as well as other components of the medical curriculum.

It is important to point out that the American Medical Association is not alone in exercising a leadership role in the practice of medicine. Along with the AMA and state, county and local medical societies, there are a growing number of medical specialty organizations that, along with AMA, develop guidelines for medical practice and disseminate significant amounts of current information. In the area of psychotropic drugs, the American Psychiatric Association has been very active and has just recently developed a screening criteria for the use of drugs in psychiatric practice. These criteria were developed under contract to the National Institute of Mental Health and AMA participated actively in reviewing these criteria.

CONCLUSION

The development of new knowledge in medical practice techniques in America is dynamic. With each new publication and each new discovery, physicians have an ever increasing base of information to use in making proper medical judgments. It is the purpose of AMA, its constituent associations, and other medical professional organizations to insure that such information is made available to physicians to the end that in exercising their professional judgments the most appropriate treatment choice can be made for patients. However, the American public will not be well served if the practice of medicine is reduced to following standard procedures for standard diagnosis promulgated by a central federal agency without appropriate consideration for the individual needs of each patient being treated.

PREPARED STATEMENTS

PREPARED STATEMENT OF T. DONALD RUCKER, PROFESSOR OF PHARMACY ADMINISTRATION, COLLEGE OF PHARMACY, OHIO STATE UNIVERSITY, COLUMBUS, OHIO Mr. Chairman, I am T. Donald Rucker, Professor of Pharmacy Administration at the College of Pharmacy, The Ohio State University, which is located in Columbus, Ohio. My professional training is in the field of economics and for the past 16 years I have specialized as a health care economist. During the last 12 years, though, my research and teaching activities have focused on the areas of drug insurance and prescription drug use with particular emphasis on matters involving quality assurance and public policy.

GENERAL ASPECTS OF THE PROBLEM

Our interest in the prescribing patterns of psychoactive drugs is based upon two points of reference. The first concerns the ability of these chemical agents to maximize patient response when drug therapy may be indicated. The second pertains to the sub-optimum results that are likely to ensue when medication orders do not conform to accepted standards regarding appropriate use. (The fact that this goal may be more elusive than specific for many psychoactive products should not preclude the development of criteria (1) to measure instances that are grossly irrational.) In considering this benefit-harm continuum, it seems apparent that methods which minimize irrational drug use should lead to gains for both individual patients and society.

Pursuit of rational drug therapy, however, involves the behavior not only of prescribers, but patients, manufacturers,1 regulatory bodies, dispensers, and

1 In evaluating new single-entity compounds introduced between 1950-73, the FDA found that 74 percent of the central nervous system drugs could bé classified as representing "little or no" therapeutic gain.

even health insurance programs. Further, the availability of community resources in the form of employment opportunities and counseling services represents a critical supportive factor when mental patients are released from institutional confinement. Moreover, in considering the multitude of patient-related variables, we should note, among others, non-compliance where instructions for ingestion are negated, pressure placed on prescribers-both postive and negative concerning the proper role of prescription therapy, shopping for physicians whose philosophical posture conforms to predetermined ends, and the discretion exercised by individuals which permits them to escape or contravene the medical model by seeking illicit substances where abuse is a primary objective. Because of the limitation of time, it is necesary to by-pass many of these forces that affect patient outcome since they are not central to our interest in the particular issue of prescribing practices.

Nevertheless, the ordering of psychoactive products often represents the primary modality by which both mental illness as a recognized condition and anxiety as a personal problem are treated within our society. Therefore, I shall present selected data related to this form of professional intervention. In addition, I'll offer several recommendations that warrant consideration of optimum benefits are to be realized when psychoactive drugs are prescribed.

QUANTITATIVE DIMENSIONS

An ideal data base covering the use of psychoactive substances would include detailed information on prescriptions classified by prescriber, dispenser, patient and type of drug. Unfortunately, society has not made the investment necessary to collect and analyze records of this kind. In order to summarize our use of these agents, we are forced to rely on a proxy measure of prescribing, the value of shipments as indicated in Table 1. This tabulation reveals that domestic shipments of Central Nervous System products rose from $518 million to $986 million during the ten-year period ending in 1975. Although the value of amphetamines, barbiturates and phenothiazine derivatives fell during this interval, the overall percentage change, even after adjustment for the gain in population, still registered an increased" of nearly 75 percent.3

While these economic indicators suggest an increasing reliance on psychoactive preparations, the extent of over prescribing (ordering quantities in excess of the patient's legitimate medical needs) or mal prescribing (neglecting valid non-drug therapies, selecting drugs with a sub-optimum therapeutic index or even those that are contra-indicated, ordering quantities in sub-clinical amounts, etc.) requires the application of normative criteria.

TABLE 1.-DOMESTIC SHIPMENTS OF PSYCHOTHERAPEUTIC AGENTS, USA, 1966 AND 1975 1

Source: Current Industrial Reports, Pharmaceutical Preparations Except Biologicals, U.S. Bureau of Census, series MA-28G. 1966 and 1975.

1 The expert assistance of Stephen W. Schondelmeyer, Pharm. D., in compiling the tabular material merits special commendation.

This figure would fall slightly if adjusted for price changes that occurred during the period. 3 The comparable figure for 1965-74 was nearly 78 percent.

Standards of rational drug therapy may be derived from guidelines such as the package insert, reports of experts that appear in the Medical Letter, therapeutic interpretations issued by the FDA, as well as published studies conducted by scientific/professional bodies and independent investigators. While a diligent detective may be able to accumulate and evaluate evidence from these diverse sources, the typical practitioner is likely to find this task too complex. It seems improbable, therefore, that the average prescriber will be able to establish a systematic basis for assessing both therapeutic options and the nature of his or her prescribing decisions.

Rather than confront this primary objective, some investigators have attempted to appraise the prescribing of psychoactive agents largely from the perspective of patient attitudes (2) and drug use. (3) These studies, which feature careful design and analysis, have produced a general conclusion that "usage patterns appear to be cautious and appropriate to level of distress or life crisis, and prevailing attitudes toward the use of drugs are predominantly conservative." (4) On the other hand, if we examine the type of psychoactive drugs on the market and selected for listing on important formularies, a different interpretation seems evident. Moreover, when prescribing and dispensing patterns are reviewed against previously determined norms, the tranquilizing effect engendered by household utilization surveys tends to evaporate.

This hypothesis may be tested by reviewing the some 187 drug entities and their 282 corresponding dosage forms enumerated in the Appendix. These psychoactive agents appeared on the formularies of the largest hospitals in the United States. In each instance, however, one or more of five indices of negative therapeutic discrimination suggested that such items were inferior to alternative choices. (5) Further, Table 2 lists 21 preparations from the same source that were judged by the project staff to be especially questionable for use on any formulary. In fact, their therapeutic utility is so marginal that the justification for marketing in the first place seems obscure.

What relationship do these findings have with the prescribing patterns of physicians? First, of the 52 hospitals in the survey, 44 were affiliated with medical schools. Second, the certification mechanism for formulary approval, the local pharmacy and therapeutics committee, is dominated by physicians. (6) Third, it is assumed that these drugs were admitted at their respective institutions to accommodate the requirements of practitioners who wanted to order them for their patients. Fourth, the discrimination process in these examples did not give heavy weight to the factors of relative safety and efficacy. Consequently, an indeterminate number of patients were exposed to inferior drugs.

This pattern is replicated in Table 3 which furnishes a list of selected psychoactive products that appeared in a sample of 12 Medicaid formularies. Most of these items are sedative-hypnotic combinations but in all cases their pharmacologic credentials were insufficient to warrant enumeration on a single hospital formulary. (7) While administrative/economic criteria apparently dominated the construction of Medicaid formularies, I am unaware of protests filed by practitioners who objected to the by-passing of therapeutic standards.

Since a majority of the inferior products cited above are combination items, it is disturbing to contemplate the results of one study covering two combination products that included the very popular chlordiazepoxide as a major ingredient. When the sample of practitioners was requested to identify the active components of these preparations, a failure rate of 55 and 44 percent was recorded. (8)