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trolled Substances Act. Implied in both these statutes is the proper requirement that physicians are to prescribe drugs based upon the exercise of good medical judgment. The decision to prescribe a drug and then to select the drug for the particular patient must be based on an evaluation of the patient's needs and the risks and benefits of all treatment modes available. This assessment should be performed for each patient, male or female, regardless of whether the individual is elderly, in a hospital, other health care institution or incarcerated.

It is undeniable that there are certain problems in the prescribing of certain psychotropic drugs. These problems include any blatant misuse of the trust granted to physicians by a small group of physicians who prescribe these drugs solely for profit. When it can be established that a physician or other prescriber is prescribing or dispensing

a drugs for nonmedical uses, appropriate actions should be taken to halt such activity. We support strict enforcement of the law.

AMA has been especially active in working to improve medical discipline at the State level and in this regard we have developed model State legislation on the subject of physician discipline. This model legislation would provide for a variety of disciplinary actions against physicians found guilty of specified infractions. One of the specified infractions is "unprofessional conduct” as defined in the State medical practice act. Most State medical practice acts, many through recent amendments, include within the definition of unprofessional conduct the prescription and/or administration of certain types of drugs in a nontherapeutic or unprofessional manner.

The AMA model legislation, and a number of recently enacted State laws, require hospitals, medical societies, and other physician groups to report designated actions taken against physicians to the State medical boards, so that disciplinary action can be taken against such physicians if appropriate.

It should be pointed out that the development of medical practice is dynamic and constantly being refined. What may be characterized as poor prescribing may be done by a physician who does not yet know of or accept the "latest” scientific innovation. When poor prescribing practices are a problem, we believe corrective measures can be taken through information distribution and continuing medical education. However, it cannot be emphasized enough that statistics regarding the amount of a drug prescribed or the number of prescriptions written cannot be used to document so-called misprescribing or overprescribing of drugs in medical practice. Furthermore, it should be pointed out that in making therapeutic decisions, different physicians can appropriately reach different conclusions as to appropriate treatment for the same patient.

The American Medical Association supports efforts designed to eliminate improper prescribing, and we believe the principal means for achieving such a result is to provide unbiased, valid, and current information to physicians on the risks and benefits of particular drugs in various treatment situations. This information reaches physicians from many sources, including peer review and medical care evaluation studies as well as the scientific literature. We will continue to inform the medical profession regarding the risks and benefits of the use of psychotropic drugs.

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We caution against any Federal action that could, in effect, reduce the availability of patient treatment by restricting the physician's armamentarium to treat illness and injury in order to correct the abuses of a few.

Mr. Chairman, Dr. Freedman will now continue our presentation.

TESTIMONY OF DANIEL X. FREEDMAN, M.D., CHAIRMAN OF THE

DEPARTMENT OF PSYCHIATRY, UNIVERSITY OF CHICAGO Dr. FREEDMAN. Mr. Chairman and members of the committee: At this point it may be beneficial if I briefly review some characteristics of the various classes of drugs that you may be considering. At the outset, of course, we recognize that a large number of drugs with widely diverse actions are included in the category of psychotropic drugs, so it wouldn't be proper scientifically to generalize about all of them as a group. Psychotropic drugs are used in a variety of medical conditions ranging from transient situational anxiety or insomnia to physical pain, to the major psychoses. The specific indications, benefits, and risks for each class of psychotropic drugs are quite different. The major classes of psychotropic drugs include the narcotic analgesics, the antipsychotics, the antidepressants, the central nervous system stimulants, and the sedative-hypnotic-antianxiety drugs.

NARCOTIC ANALGESICS

These drugs have a long history of effective use in alleviating severe pain. Your committee, Mr. Chairman, is of course well aware of the problems of drug dependence and societal abuse associated with these drugs, all of which are covered by the Controlled Substances Act.

ANTIPSYCHOTIC DRUGS

These drugs have revolutionized the treatment of schizophrenia in the past 25 years. Although they are not curative, maintenance therapy offers many patients an opportunity to forgo institutionalization and resume function in the community. Fortunately, drug tolerance and dependence do not occur, and hence abuse is rare indeed with thesu drugs. While these potent and effective agents—as most such agents ir medicine—have a potential for certain adverse reactions and drug interactions, guidelines for prescribing to optimize efficacy and to assure safety are quite well developed and accepted by the medical profession, while intensive research on improved use and avoidance of undesirable effects continues.

ANTIDEPRESSANT DRUGS

These drugs have earned a similar successful reputation for cor trolling the signs and symptoms of severe depression. Clinical research continues to identify different subsets of depression which respond best to certain antidepressants. Tolerance and dependence are not problems with use of these drugs. Nevertheless, since some of these drugs also possess sedative activity, it is not surprising that some cases of antidepressant abuse have been reported in the medical literature, thus alerting physicians to this hazard. This occasional hazard is with a few scattered subgroups of polydrug abusers. For manic depressiva psychosis the salt, lithium, is effective and as with the antidepressanı appears to prevent relapse.

CENTRAL NERVOUS SYSTEM STIMULANT DRUGS

The amphetamines have a strong potential for abuse and psycho logical dependence. This dependence is particularly prominent in individuals prone to drug abuse. There has been a change in medical practice to restrict the adjunctive use of amphetamines as anorexiants in the control of obesity, because they are seldom more effective than techniques of behavior control and other adjunctive anorexiant drugs that do not have as high a potential for dependence and abuse.

It should be pointed out, however, that long-term use of amphetamines in low total daily doses has been effective in the specific treatment of idiopathic edema without evidence of drug tolerance or abuse. The amphetamines and amphetamine-like drugs are also useful in selected cases of minimal brain dysfunction and, when so used, studies show no tolerance or abuse. They are the only available medicines effective for narcolepsy and may have occasional adjunctive use as an analeptic in endogenous depression and drug induced hypotension. Development of tolerance has been a problem in narcolepsy because of the large doses required to treat this disorder.

Now we turn to the drugs that occasion the most comment today, the sedative-hypnotic-antianxiety drugs. The two major groups comprising this class of drugs are the barbiturates (including the pharmacologically related nonbarbiturates] and the benzodiazepines. Anxiety and insomnia represent two of the major medical indications for these drugs. A 1977 report of the National Institute on Drug Abuse—“Sedative-Hypnotic Drugs: Risks and Benefits”- concludes that the benzodiazepines appear to be the drug of choice for most cases of insomnia as well as anxiety. This conclusion is based principally on the relative superior safety, less rapid tolerance development, and less potential for drug interaction, of the benzodiazepines. Although the benzodiazepines do have a potential for abuse and dependence differing from that of the antipsychotic and antidepressant drugs, their relative safety in terms of therapeutic doses and toxic effects provides an advantage over the barbiturates.

The number of prescriptions for all benzodiazepines has plateaued while prescriptions for barbiturates and related drugs have decreased. However, the benzodiazepines also have actions other than anti-insomnia and anti-anxiety, which account for their use in selective amnesia and intravenous anesthesia, spasticity, local skeletal muscle spasm, cer. tain dyskinesias, and treatment of seizures. These uses are responsible for a substantial amount of prescribing for these drugs. Moreover, a substantial percentage of the prescriptions for benzodiazepines are not for a primary complaint of anxiety or insomnia but for these conditions in conjunction with episodes of other illnesses. The wider use of these drugs by women is a transnational trend and may in part be explained by their greater utilization of the health care system and their willingness to seek help sooner than men for all primary care problems, although their changing role in society, which likely heightens anxiety, may also be a contributing factor.

Mr. Chairman, it should be recognized that there are continuous changes in the patterns of drug prescribing initiated by research and clinical experience. While physician practices change in light of undisputed data, established practice patterns are generally adhered to until new consensus is established. This is an interim period when medical experts often will and should disagree. Traditionally, information in the medical literature, continuing postgraduate education, and audit procedures are the primary mechanism for recognizing change and arriving at a consensus.

The AMA “Archives of General Psychiatry” over the past decade has published major controlled studies relating to the efficacy and side effects of psychotropic drugs. In addition, major national surveys of prescription drug use have also been published in order to more reliably inform physicians concerning drug use. If any of these selective references would be of use to the committee, we would be pleased to supply them.

In closing, Mr. Chairman, it should be noted that a drug does not always have the same effect in different patients, nor for that matter, in the same patient at different times. The response of the patient is highly dependent on the status of his disease or illness. Because of these individual differences, the right of the patient to have available to him the best medication for his specific condition and situation makes it essential that physicians be accorded wide discretion in determining appropriate drug therapy.

At this time we will be happy to respond to any questions which the committee may have.

Mr. WOLFF. Thank you very much.

I just noticed your last statement. It prompted a question because it has come up in a variety of areas that perhaps do not deal specifically with the particular one that we are talking about now. It relates to the different effects upon different people of the same drug, depending not only on their physical condition but their size, their weight, their degree of maturity, and the like. I think this is not very well understood.

Dr. FREEDMAN. That's absolutely correct.
Mr. WOLFF. Dr. Boyle, at one point in your statement you say-

The decision to prescribe a drug and then to select a drug for a particular patient must be based on an evaluation of the patient's needs and the risks and benefits of all treatment modes available.

We have had, in a study that staff has conducted here, a statement that the typical"doctor visit” to one internist or family practice physician lasts in the neighborhood of 11 minutes. The physician will often end a visit by writing a prescription for the patient and the physician is often influenced to write that prescription by the patients.

Now the point made is the length of the patient's visit. First of all, is the length of visit sufficient to really do that which is intended or are physicians today being overtaxed by the number of patients that they see and therefore do not have sufficient time to make the complete analysis of the requirements of the patient?

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Dr. BOYLE. There were several questions in that, Mr. Chairman. With respect to the average amount of time that's involved in the visit, we believe that the use of an average length of visit could be totally misleading. In some instances a visit may take quite a long period of time if the problem is a complex one or a short period of time if the problem is not complex. Also, you're talking about, in the majority of instances, the continuation of an established relationship. The first time that a physician may see a patient it may take an hour or an hour and a half. Subsequently, it may take no more than a few minutes for the patient to communicate to the physician precisely what that patient's perceived problem is and it may take no more than a similar period of time for the physician to ask such questions as to ascertain what the problem really is and to instigate or initiate those procedures which are going to resolve the problem.

So the average length of time per visit really does not have a great deal of relevancy:

Also, I think time spent relates to the kinds of physicians taking care of the kinds of patients. It is a fact that patients and doctors tend to gravitate together so their personalities are somehow compatible. We see some patients who gravitate only to doctors who will take and have the time to sit and listen over a prolonged period of time, whereas other patients, of their own volition, gravitate to doctors who are much more abrupt and much more to the point and much more businesslike and not as persistent in trying to dig into some of the background matters involved. I don't think that it has anything to do with the pressures on the physician for time at the present time. I think that the average doctor is busy but not over busy. The average doctor does spend sufficient time to determine what the problem is and then to get at how to resolve it.

In some conversations we had about this sometime back, made the observation that it's dealing with your children. Sometimes it only takes you 5 minutes to figure out what it is that they really want and what to do about it. With others it may take you a long, long time and, in fact, sometimes you're never sure that you've gotten to it. The same thing is true with doctors and continuing patients. It is a close relationship over a long period of time.

Mr. WOLFF. That gets me to another point. Perhaps either you or Dr. Freedman can answer this.

In prescribing a psychotropic drug, the patient most times is told to take the drug on a specific basis and then was needed.” Are you shifting the responsibility over to the patient from the doctor in that case?

Dr. Boyle. First of all, “as needed” is usually in response to fairly specific directions to the patient as to when this need should arise. For example, a person who has a serious problem with hyperventilation can be instructed to control his or her breathing at the time and they can be told to use a paper bag to blow in it in order to cut down the problems related to getting rid of too much carbon monoxide, but the anxiety state that precipitates the hyperventilation may require the use of some antianxiety drug. You would instruct the patient that "as needed” means when you first begin to feel this process building up, take the drug, rather than taking this drug at some unneeded time. So "as needed” is something that's usually defined by the doctor.

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