APPENDIX D.-SECOBARBITAL SODIUM 100MG (2157F)

Recommended adult dose : 100mg at bedtime as needed for sleep.

Recommended 6-month limit: 250.

Description: A 6-month supply, if a recipient took one capsule every night (this is excessive in the judgment of experts) would be 186 capsules. The habituating dose of secobarbital is between 200 and 400mg daily.

These capsules are sold on the street as "reds" or "red devils" for $2.00 each. Distribution analysis: The number of recipients who received prescriptions for secobarbital 100mg within the consecutive 6 month period which made up this survey was 17,844. Of these 17,844 individuals, there were 1,624 or 9.1 percent who received in excess of 250 capsules. The largest number of capsules a recipient received was between 1,500-2,000 or approximately 10 capsules per day.

The 9.1 percent of the recipients who received in excess of 250 capsules over the 6 month period accounted for approximately 48 percent of the total number of secobarbital 100mg capsules dispensed.

State of California Department of Health, Medi-Cal Drug Claim

[Quantity distribution by beneficiary for 6 mo. period from June 1977 to December 1977]

ABUSE OF DANGEROUS LICIT AND ILLICIT

DRUGS-PSYCHOTROPICS

TUESDAY, SEPTEMBER 19, 1978

HOUSE OF REPRESENTATIVES,

SELECT COMMITTEE ON NARCOTICS ABUSE AND CONTROL,

Washington, D.C. The Select Committee met, pursuant to notice, at 1 p.m., in room 2212, Rayburn House Office Building, Hon. Lester L. Wolff (chairman of the Select Committee) presiding.

Present: Representatives Paul G. Rogers, James R. Mann, Charles B. Rangel, Benjamin A. Gilman, and Robert K. Dornan.

Staff present: Joseph L. Nellis, chief counsel; Howard Wallach, staff counsel; Michael Backenheimer, professional staff member; and Robert M. Orr, researcher.

Mr. WOLFF. The committee will come to order.

Mr. Dornan is inside on the phone. I must apologize to our witnesses for being late. We have had an extension of Camp David here in Congress for the last 2 days in that yesterday, having a dual responsibility, members of the International Relations Committee were called to the White House for the President to give his interpretation of the results of Camp David; and today we were privileged to have two meetings, one with President Sadat and the other with Mr. Begin, to give their interpretation. Although the three speak different languages, I'm happy to report that the languages seem to all say the same thing and and I think it's a very happy circumstance for all of us because although the problems that we face in this committee are extremely important, the universal problem of achieving peace in the world is an overriding desire and aim of the entire world. These are historic times. So I hope that you will excuse me for having been late in starting these hearings this afternoon.

On August 10, the committee held a hearing on the advertising and the detailing of psychotropic drugs. The committee heard testimony that suggested that the marketing practices of some of the major pharmaceutical firms have had a substantial impact on the prescribing habits of some physicians. The testimony also indicated that physicians in some cases may be overprescribing some categories of psychotropic drugs, particularly what are called the minor tranquilizers. There's a serious question whether many physicians are sufficiently trained in formal pharmacology to be adequately prepared to warn patients on the side effects and the utilization of these and other drugs with alcohol and other substances that create an interaction.

In the past, Congress has shown great concern over the potential abuses of psychotropic drugs by placing certain psychotropic drugs

under the Controlled Substances Act. The committee believes it is incumbent upon the medical profession to evidence equal concern in this

area.

Accordingly, the purpose of today's hearing is to focus in on the responsibilities of the members of the medical profession and to insure that they are not intentionally or unintentionally contributing to the creation of a chemical society or a drug-dependent nation. We do not accuse, indict, or criticize any segment of medicine. To the contrary, we seek testimony and answers to questions such as whether or not physicians are obtaining the proper psychopharmacological training in the medical schools or as part of their continuing education, what is the real true effect of drug advertising and the sales procedures that are used by detailmen on medical prescribing habits, and whether the Federal Government should be doing more to present objective information on the effects of the various mood-altering drugs to the public at large.

We are pleased to welcome this afternoon the following witnesses who will speak to these issues: Dr. T. Donald Rucker, chairman of the division of administrative and social sciences, College of Pharmacy, Ohio State University; Mr. John Pekkanen, independent writer, author of "American Connection." Our second panel will include Dr. Daniel X. Freedman, chairman of the department of psychiatry, University of Chicago, and member of the American Medical Association; and Dr. Joseph Boyle, member of the board of trustees of the American Medical Association.

And due to the Congress new advanced technologies and procedures, I have just been informed via this, which I carry in my hip and I think was borrowed from the doctors, a message that we are going to vote shortly. However, before we do that, I should like to swear our witnesses so we can proceed as expeditiously as possible and get in as much testimony as we possibly can before we do have to go over to

vote.

I would ask you gentlemen to stand and be sworn. Do you swear the testimony you will give before this committee will be the truth, the whole truth, and nothing but the truth, so help you God?

Dr. RUCKER. I do.

Mr. PEKKANEN. I do.

Mr. WOLFF. Thank you very much.

Dr. Rucker, I wonder if you would proceed first and then we can come to Mr. Pekkanen.

TESTIMONY OF DR. T. DONALD RUCKER, CHAIRMAN OF THE DIVISION OF ADMINISTRATIVE AND SOCIAL SCIENCES, COLLEGE OF PHARMACY, OHIO STATE UNIVERSITY

Dr. RUCKER. Thank you, Mr. Chairman.

I am Donald Rucker, professor of pharmacy administration at the College of Pharmacy, Ohio State University. 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.

In order to begin my presentation I'd like to focus on one of the most critical elements in the entire professional decisionmaking process which is the problem of an ideal data base. An ideal data base for the area 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 the table which I will summarize for you. This tabulation reveals that the domestic shipments of central nervous system drugs, largely encompassing psychoactive preparations rose from $518 million to $986 million during the 10-year period ending in 1975. These figures are adjusted for changes in population but not for price changes. Although the value of amphetamines, barbiturates and phenothiazine derivatives fell during this interval, the overall percentage change still registered an increase of some 75 percent.

In looking at these data pertaining to utilization, we want to raise the question about the extent of overprescribing or possibly malprescribing. By overprescribing, I mean the ordering of quantities in excess of the patient's legitimate needs, and by malprescribing we include a number of different variables, including neglecting nondrug therapies, selecting drugs with a suboptimum therapeutic index or even those that are contraindicated, ordering quantities in subclinical amounts, et cetera.

In order to interpret these data, however, we need to have access to information on standards of appropriate prescribing. In that respect, it's difficult to interpret the data just cited with respect to whether the problem is genuinely one of overprescribing, malprescribing, or possibly underprescribing. However, I would like to focus on some elements concerning possibility of malprescribing as derived from a study recently completed at Ohio State University.

This hypothesis of malprescribing is suggested by the data in the appendix which summarizes the existence of 187 drug entities and some 282 corresponding dosage forms that appeared during the survey of hospital formularies. This survey covered 52 of the largest hospitals in the United States. In order to evaluate the prescribing of psychoactive preparations we developed five independent measures of negative therapeutic discrimination or, in essence, drugs that would not be recommended as a drug of choice. Thus, they can probably be regarded as inferior products. If you examine table 2, we have listed some 21 preparations that were found to be especially inappropriate for prescribing purposes. In fact, we contend that the therapeutic utility of these agents is so obscure that some question should be raised about the authorization for marketing in the first place. This judgment is corroborated by the fact that 10 or 12 of the agents have already been withdrawn from the marketplace. This situation seems to be somewhat incongruent with the theory of formulary promulgation which assumes that only those products which are well accepted and well tested will ultimately receive formulary listing. Within a period

of less than 2 years, however, we find that these products were withdrawn from the marketplace because the therapeutic characteristics of such agents were so inferior.

What relationship do these findings have to 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, that is, the local pharmacy and therapeutics committee, in each institution, is usually dominated by physicians. In fact, I do not know of a single instance where indeed the physicians do not have the majority vote. Third, it is assumed that these drugs were admitted at their respective institutions to accommodate the requirements of practitioners who wanted to order such agents for their paients. Fourth, the discrimination process in these examples did not give heavy weight to the factors of relative safety and efficacy, which seems to be the primary justification of an implementation of a formulary in the first place. Consequently, an indeterminate number of patients were exposed to inferior drugs.

I would like to stress that our data referred only to published sources. We do not have information on prescribing practices, the dispensing practices or the actual consumption of drugs by these patients.

This pattern involving the use of inferior drugs was replicated in 12 medicaid formularies where formularies were used for purposes of controlling prescribing for patients treated on an ambulatory basis. Most of the items that appear in table 3 are sedative-hypnotic combinations, but in all cases their pharmacologic credentials were insufficient to warrant enumeration on a single hospital formulary. In other words, we are talking about products so inferior that they never were recognized by a single hospital formulary among 52 large institutions. While administrative/economic criteria apparently dominated the construction of medicaid formularies, I am unaware of protests filed by practitioners who objected to the bypassing of therapeutic standards in the listing of these products on medicaid formularies.

Since a majority of the inferior products cited 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. You will recognize this product as Librium. 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. In short, the practitioner was often unaware of the active ingredients in a combination product.

The above data indicate that some and perhaps many practitioners have considerable difficulty in obtaining adequate information to effectively discriminate in the drug selection process. Part of this problem, though, may be traced to the tendency of certain prescribers to rely upon an excessive number of different products.

Mr. WOLFF. Dr. Rucker, can I ask you to suspend for a moment? I'm going to ask counsel to continue to get these statements on the record and we will withhold questions until our return, but in order to compensate for the time situation, we are going to go to vote while you're making your statements which we have in front of us. We are going to read some of these statements en route, so we accomplish two things at the same time, and the statements will be included in the record. We will return shortly.