I am a strong free-market man in advertising but not in the medical field after seeing this. This is new to me, and I believe I am convinced now on which way I am going to go with this kind of advertising. Mr. EVANS. MS. Boe, do you want to answer that briefly? Ms. BOE. There are many elderly people who have insomnia, and it is a very debilitating condition for an older person. I think anything that would help them sleep is something the patient would want. And these ads are directed to the physicians. The one that says the drug that is in it that may be helping her depression may be causing her constipation is directed to the physician because the patient may come in and say, "I can't take this anymore. It's making me constipated." And the doctor may know something that might solve that problem. Mr. GILMAN. Ms. Boe, I notice you state in your testimony that the detailman is virtually inconspicuous in terms of making a final decision when a physician decides what medication. Ms. BOE. That was the finding of some studies that have been done. Mr. GILMAN. But the studies are 1966, 1964, and a 1963 study. Aren't there any more current studies you have undertaken to determine what the influence is of the detailman with regard to the amount of medication that is being peddled? Ms. BOE. These were not studies we conducted to begin with, and there may be others that have been conducted by companies, but the ones in the literature are referenced there and, in fact, were quoted earlier this morning. Mr. GILMAN. If we find that the psychotropic drug abuse has arisen only in the last few years, I am wondering if these studies are pertinent or not considering the amount of abuse and the amount of distribution of this type of drug today as compared to 10 years ago. Ms. BOE. The purpose of those particular questionnaires was to learn what influences the physician's prescribing decision. And I doubt whether that has changed that much over all the years. Mr. GILMAN. Have you taken any current studies? Ms. BOE. We haven't taken any studies of that in the past or currently, as I explained. Mr. GILMAN. Are you aware of any other current studies? Ms. BOE. No; I am not personally aware of it except as Mr. Lerner explained to you the investigation that Roche is currently undertaking to find out more about the usage of their products. Mr. GILMAN. Time is running and we will have to conclude our hearing in just a moment. And I'd like to address this to both Dr. Maronde and yourself, and we have addressed this issue before today. Do you feel that the detailmen are properly trained for the responsibility they have of providing the physician with all of the current information, and really educating the physician with regard to the utilization of important medications and drugs? Ms. BOE. Yes, I do, sir. I do believe they are adequately trained for the limited role that they have, since the physician has other means of getting information about the products, too. Mr. GILMAN. Dr. Maronde. And I can't help but remember the recent news articles where detailmen or equipment salesmen were in the operating room actually performing the operations along with the surgeon. Ms. BOE. But that should not be a criticism of those detail persons. Mr. GILMAN. This is indicative of the amount of reliance that the profession places on the representatives of the pharmaceutical companies and the other companies supplying them with information. Dr. Maronde. Dr. MARONDE. I believe that the qualifications have improved in the last 5 years of the pharmaceutical representatives, and the training is better. But I still think it has a long way to go. And, of course, there is a big problem with objectivity that is built into the system. I don't know how to get at that. Mr. GILMAN. I guess that is precisely the point. What we are talking about here is whether we are providing for or just pushing pills to meet sales goals. Ms. BOE. Could I make one final comment, Mr. Gilman. It is not in the company's best interest for the detail person to misrepresent his product or to push it for indications that are not appropriate. If that drug is misused and that physician doesn't get a good result from it, he has lost not only that particular physician's use of that drug but probably that physician's confidence for any other of the company's products. I have heard detailmen tell me personally that they tell doctors: Don't use our product. You are not doing it right, and if that is the way you are going to prescribe it, we'd rather you don't prescribe it. Mr. GILMAN. Mr. Chairman, I have no further questions. Thank you. Mr. EVANS. MS. Boe and Dr. Maronde, we appreciate very much your testimony, and I am particularly glad Mr. DORNAN. One more brief question-and I am glad you didn't have to take anything to come to this hearing. Ms. BOE. So am I. Mr. EVANS. We will conclude at the end of your question, Mr. Dornan. Mr. DORNAN. One of the staff has given me an interesting question. I have my own personal belief that we have about 75 percent more psychiatrists than we need in the profession. Again, I'll relate that to the southern California area. But I think that a psychiatrist is far more qualified to write a psychotropic drug prescription than any other doctor, because it is mood-altering. Yet, we find 85 percent of psychotropic drugs are prescribed by nonpsychiatric doctors; the treatment is symptomatic, not curative or etiologic. Is this going to continue this practice of nonpsychiatric M.D.'s continuing to write the overwhelming majority of prescriptions for mood-altering drugs? Ms. BOE. Mr. Dornan, these are not indicated as curative drugs. They are symptomatic drugs. That is what they are for. Furthermore, more than 50 percent of the prescriptions for the antianxiety agents are adjuncts to people who have had heart attacks and so on. So you will have a large percentage like that. I don't think they are overused on that score at all. They are useful products for a variety of reasons, and because most people go to internists or general practitioners rather than psychiatrists, those persons play an important role in providing medical care to those people. I'm afraid there are a great many people who share your belief about the overutilization of psychiatrists, so that is why they go to the general practitioner or the family practitioner. Mr. DORNAN. Thank you very much. Mr. EVANS. Thank you for your testimony. SUBMISSIONS FOR THE RECORD AMERICAN OSTEOPATHIC ASSOCIATION, Hon. LESTER L. WOLFF, Select Committee on Narcotics Abuse and Control, DEAR MR. CHAIRMAN: On behalf of the American Osteopathic Association, I would like to address the subject of prescribing practices of controlled substances. The abuse potential of controlled substances has long been a serious concern of the AOA. Since July of 1973, the Association has been on record, through a resolution passed by the Board of Trustees and the House of Delegates, urging members to use caution and discretion in prescribing these useful, but potentially harmful drugs. In July of this year, the AOA House of Delegates met and revised their earlier resolution concerned with prescribing practices to emphasize the importance of the physician's role in this very serious national problem. This resolution entitled, "Substance Abuse Policy Statement", is attached for your reference. In addition to urging its membership to exercise caution in the prescribing of such drugs, through the above cited resolution, the Association has actively participated in a Committee developed by the Drug Enforcement Administration to deal with controlled substances. This "Practitioner's Working Committee” is composed of both staff and practitioners from the American Osteopathic Association, American Medical Association, American Dental Association, American Veterinarian Medical Association, American Nurses Association, and the American Podiatry Association. As well as representatives from the Office of Compliance and Regulatory Affairs of the Drug Enforcement Administration. The Committee meets quarterly to discuss issues surrounding the prescribing of controlled substances and is presently finalizing "Guidelines for Prescribing Controlled Substances". These guidelines, in draft form, are addressed to the prescribing practitioner. When published, these guidelines, endorsed by the participating Associations, will be broadly distributed to the professions. Although the above Guidelines have not yet been published, in 1977 the American Osteopathic Association took the initiative to publish an article in "The D.O.", our profession's magazine, listing its own guidelines for prescribing controlled drugs. This is also attached for your reference. This Association will continue to monitor its membership, to ensure that all osteopathic physicians are fully aware of the abuse potential of such substances, and to emphasize their role as physicians in the prevention of diversion of licit drugs into illicit channels. While this is a summary of our major efforts in this area, the members of the AOA recognize the dimensions of the problem of substance abuse. It is our sincere intention to prevent abuse in prescribing practices and AOA emphasizes this priority to its members. If I can provide assistance or information to you, please let me know. Sincerely, Enclosures. JOHN P. PERRIN, [From The D.O., September 1977] WASHINGTON REPORT The Drug Enforcement Administration (DEA), an agency of the U.S. Department of Justice, has the responsibility of enforcing the Controlled Substances Act. Recently, the DEA has been increasingly active in surveillance and prosecution of those found in violation of provisions of the act. Because instances of noncompliance by some physicians may be due to limited knowledge of the law and its ramifications, the AOA Council on Federal Health Programs has developed the following basic information on the requirements of the Controlled Substances Act. The council also wishes to remind all osteopathic physicians of good prescribing practices. REGISTRATION Every physician who administers, prescribes, or dispenses controlled substances must be registered with the Drug Enforcement Administration. According to the DEA, "administer" means to instill a drug into the body of the patient, "prescribe" means to issue a prescription to the patient, and "dispense" means to give drugs which are in some type of bottle, box, or other container to the patient. If a physician has more than one office in which he administers, prescribes, or dispenses controlled substances, he is required to register at each office. However, if a physician only administers and/or dispenses at his principal office and only writes prescription orders at his other office, he is only required to register at his principal office, provided that each office is located in the same state. Interns and residents may dispense, administer, and prescribe controlled drugs under the registration of a hospital or other institution which is registered and by which such physician is employed, provided the following conditions are met. 1. The dispensing, administering, or prescribing is in the usual course of his professional practice. 2. The physician is authorized or permitted to do so by the jurisdiction in which he is practicing. 3. The hospital or institution has verified that the physician is permitted to dispense, administer, or prescribe drugs within the jurisdiction. 4. The physician acts only within the scope of his employment in the hospital or institution. 5. The hospital or institution authorizes the physician to dispense or prescribe under its registration and assigns him a specific code number. PRESCRIPTIONS All prescription orders for controlled substances must be signed on and bear the date when issued; they must also bear the full name and address of the patient and the name, address, and registration number of the physician. If an oral prescription order is not permitted, prescription orders must be written in ink or on a typewriter and must be signed by the practitioner by his own hand. Prescription order for drugs in schedules III, IV, and V may be issued either orally or in writing and may be refilled if so authorized on the prescription. However, the prescription order may only be renewed up to five times within six months after the date of issue. After five renewals or after six months, a new prescription order either oral or written is required. OTHER REQUIREMENTS If a physician discontinues his practice, he must return his registration certificate and any unused order forms to the nearest office of the DEA. If at that time he has any controlled substances in his possession, he should obtain information from the DEA regional office on how to dispose of the drugs. RESOLUTION No. 246 Whereas, the abuse of substances is a significant health problem in the United States today, and Whereas, the availability of addictive drugs distributed through illegal channels has created an increasingly large number of drug dependents, and Whereas, Physicians are ultimately responsible for the medical management of substance abusers who seek, or are referred for, medical treatment, and Whereas, total community education relative to substance abuse is essential to the alleviation of the problem; therefore, be it Resolved, that the American Osteopathic Association encourages its members, through continuing medical education, to have current knowledge of substances with a high potential for abuse, and of appropriate treatment techniques, and be it further Resolved, that the AOA encourages its members to participate in the education of their communities relative to substance abuse, and be it further Resolved, that the AOA pledges its support to law enforcement agencies, in their efforts to control substance abuse, and be it further Resolved, that the AOA urges all members of the osteopathic profession and osteopathic hospitals to participate in the care and rehabilitation of persons suffering from substance abuse. PRESCRIPTION PRACTICES OF PSYCHOTROPIC DRUGS LEADING TO POSSIBLE MISUSE AND ABUSE (By Jane E. Prather Ph. D., Sociologist, California State University, Northridge) INTRODUCTION: PREVALENCE OF DRUGS During the past decade the use of prescription psychotropics (sedative-hypnotics, stimulants and minor tranquilizers) by Americans has increased. (Shapiro and Baron, 1961; Mellinger, Balter and Manheimer, 1971). The use of stimulants and sedatives for the past five years appears to have stabilized and slightly decreased according to the last National Survey on Drug Abuse prepared for the National Institute on Drug Abuse (1977, 70–74). Americans' use of minor tranquilizers has not decreased during the past five years; in fact, the number of Americans (adults 18 and over) reporting ever having used minor tranquilizers for medical purposes increased from 24% in 1972 to 35% in 1977 (National Survey, 103). Over one-third of Americans report having used a minor tranquilizer sometime during their life and 18% of Americans reporting use of minor tranquilizers during the past year, 1977 (National Survey, 106). The use of one kind of minor tranquilizer, diazepam or Valium, is so popular that this drug has become the most widely prescribed drug in the United States (Backenheimer, 1976). The National Institute on Drug Abuse estimates approximately 57 million prescriptions of diazepam are filled per year in the U.S. for a total estimate of over 3 billion pills (NIDA, 1978). Women report more extensive use of psychotropics than do men. Twice as many women as men use psychotropic medications. For example, 42% of women in the national survey reported have ever used prescription tranquilizers while 27% of the men reported usage. More than one in every five women in the U.S. report using a prescription tranquilizer in the past year as contrasted to one in ten of American men. Twice as many women as men have been found to be frequent users of psychotropics: that is, taking a psychotropic drug daily for at least two months (Manheimer, Mellinger and Balter, 1968). Several scientists propose explanations for the higher use of psychotropics by women than men (Cooperstock, 1974; Mellinger et al., 1974; Prather and Fidell, 1978; Stimson, 1975). Not surprising, women more frequently then men are found to be the victims of prescription psychotropic misuse and of suicide attempts involving a psychotropic prescribed by their physician (Ianzito, 1970). Whether or not these patterns of use represent misuse, abuse, over-use or effective medical treatment is difficult to ascertain. The traditional distinction between legitimate and illegitimate psychotropic drug use based upon source (medical or non-medical) is invalid because a prescription may be mis-used or over-used depending upon such factors as purpose, dosage, quantity and frequency. Moreover, the physician, often unwittingly, can become the regular source for psychotropics used and sold for "street purposes." One study estimates that the general practitioner is the primary source of barbiturates and other sedatives abused by approximately 50% of all narcotic addicts (Chambers, Brill and Inciardi, 1972). Scientists differ in their interpretation of psychotropic drug use as being cause for concern. One group of scientists view American society as "overmedicated" while the other group considers American society as "undermedi |