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the National Institute of Allergy and Infectious Diseases. Extracts of the same substance, supplied by different manufacturers, may vary appreciably in strength, and furthermore, different batches of extracts supplied by the same company may vary in clinical potency. This would preclude the compounding of therapeutic allergenic extracts by pharmacies, upon prescription.
In order to render the best medical care and offer the best clinical results of therapy, as well as to best avoid undesirable effects of illformulated and ill-prepared allergenic treatment extracts, the physician, in the practice of allergy, with the knowledge of the degree of sensitivity of the patient, must supervise the formulation and preparation of such treatment extracts for clinical use in the specific treatment of patients with allergic diseases.
It is urged, therefore, that allergenic extracts be made an exception in section 5 of the Hart bill, S-1575.
Senator Moss. Thank you, Dr. Horstman. Now, an allergy is something—the treatment of something that breaks out the body-do I understand that, as a layman?
Dr. HORSTMAN. Allergenic extracts are used primarily in the treatment of severe hay fever and asthma. They are of relatively little value in other types of allergy, and of almost no value in dermatitis cases, or hives, which you may have implied.
Senator Moss. I see. So this would be mostly hay fever and asthma that you would be dealing with?
Dr. HORSTMAN. This would cover at least 90 percent of the use of allergenic extracts.
Senator Moss. Is it your testimony that a doctor-one who practices allergy-could not properly prepare a prescription that could be then filled by a practicing pharmacist, but that it ought to be really prepared in the office of the physician?
Dr. HORSTMAN. That is correct, sir.
Senator Moss. Is this the common practice now? Is this generally done now?
Dr. HORSTMAN. This is the procedure by which allergenic extracts are prepared and dispensed. These may be given in the doctor's office, and this I believe would be preferable under all circumstances. However, there are many patients who require desensitization who cannot make weekly trips to see a doctor. I might use as an example, Duke University, which has a very large allergy section.
Duke gets its referrals from all over the State of North Carolina, and perhaps from many of the other States. A patient comes there and resides either in some sort of a motel or even in the hospital. He is evaluated and a program is then established which the patient returns with to his family doctor or referring physician.
From this point on, the contact with the allergist is by some form of communication, either phone or mail, to regulate the dosage and follow the progress of the patient.
Senator Moss. Are these prescriptions—are they fluid or pills?
Dr. HORSTMAN. They are injection materials. Most of them are in solution. However, some of them are precipitates, and the type of vaccine or the type of extract which is chosen would depend upon a number of rather highly technical subjects.
Senator Moss. Well, a practicing allergist then would have stocked in his office, a number of fluids and drugs out of which he would compound what he was to use for a particular patient?
Dr. HORSTMAN. That is correct, sir.
Senator Moss. What I am trying to find is the distinction as to why it wouldn't be practical for the physician, in examining the patient, to write down what he thinks should be the combination and have the patient then get it filled and utilize that; then vary that prescription if it did seem to be tailored, as you indicate, to the specific problem of a given patient.
Dr. HORSTMAN. Mr. Chairman, I would like to explain that this is an extremely complex field. Each batch of material which I receive from a manufacturer, I evaluate its potency because, as my statement mentions, there is no standardization for these materials, and they vary from manufacturer to manufacturer and from batch to batch.
Therefore, I evaluate the potency of these materials on patients in whom I know the degree of sensitivity. I use my patients as a standardization for the materials that I then compound into extracts.
I might say, sir, that one would, from determining the degree of sensitivity, by history, by skin test, by physical examination, would decide approximately what dosage this patient might tolerate, where to start and to what level one might, over a period of several years, obtain a satisfactory result.
Having gone through this, a formula is set up, using material which only I understand the potency of. The patient follows a scheudle, and this schedule includes a reduction in dosage at a certain time of year; provided that this were a grass case, at the beginnig of the grass pollinating season, the dosage of this extract must be reduced appreciably or you will be subjecting the patient to an undue risk of having a serious systemic and possibly fatal reaction.
It would seem extremely difficult for a doctor-pharmacy-patient relationship to be established where such variables could be controlled.
Senator Moss. Well now, in judging the potency, as you say, of the materials you receive, you do that by giving some dosage to a patient and observing the results? Or, how do you judge the potency?
Dr. HORSTMAN. I make multiple dillutions of the material and use the skin of a known patient to determine its potency.
Senator Moss. I see. Section 5, subparagraph 2, of the bill provides an exception for the administration of a unit dose of a drug to the patient by or under the supervision of such medical practitioner. Isn't this enough of an exception to meet the situation you are talking about?
Dr. Horstman. Well, this would help somewhat. However, it would extremely complicate the management of the patient as the dosages are frequently as low as one one-hundredth of a cubic centimeter. Now I don't know whether you realize how small a volume that is. But it is almost impossible to dispense one one-hundredth of a cubic centimeter in a sterile vial. Therefore I think that a special exemption is necessary for allergenic extracts.
I might say, sir, I am not sure that this would qualify as a drug, as defined. There was some question in my mind when I read the bill that perhaps these were not drugs in the sense that you were defining them, but they certainly are materials which are used in the desensitization of patients, and the treatment therefore of allergic diseases, and in view of this possibility, the Academy of Allergy felt that a special exemption was necessary.
Senator Moss. The testimony you have given us today is the position of the American Academy of Allergy?
Dr. HORSTMAN. Yes, sir; and I am sure there will be additional testimony from other groups which will include the section on allergy of the American Medical Association, and also the American College of Allergists, which is another national group.
Senator Moss. I am advised that we have a telegram from that group, and it will be included in our record.
Dr. HORSTMAN. Sir, if they mentioned section 4, I do wish that the correction will be made to section 5,
Senator Moss. We will examine it closely to make sure that that correction is made if that is necessary.
Well, thank you, Dr. Horstman. We appreciate having you come to testify and give us the position of the American Academy of Allergy. Dr. HORSTMAN. Thank you, Mr. Chairman.
. Senator Moss. That completes the list of witnesses that we had scheduled for today. We do appreciate those who have come and testified before us. If there is any oversight, any one we missed, we would be glad to have them come forward now.
Apparently that completes it. So the committee is now adjourned. (Whereupon, at 11:30 a.m., the subcommittee was adjourned.)
ADDITIONAL ARTICLES, LETTERS, AND STATEMENTS
(Voice of the Pharmacist vol. 2 No. 29, Apr. 29, 1959 (Supplement)]
Iowa PhysiCIAN-PHARMACIST CODE OF UNDERSTANDING The purpose of this Code of Understanding is to improve relations between Doctors of Medicine and Pharmacists. Its provisions are intended as guides for physicians and pharmacists in their inter-related practices in the areas covered by it.
This Code of Understanding is not a pronouncement of law, but constitutes suggested rules of conduct for the members of these two health professions subject to the principles of ethics governing the members of the respective organizations and rules of law prescribed for their individual conduct.
This Code constitutes the recognition that Doctors of Medicine and Pharmacists are inter-dependent upon one another in serving the patient.
It is the hope of the parties who have participated in the development of this Code of Understanding that by an improved and closed relationship between the professions of medicine and pharmacy, that the public will be better served.
According to the American Medical Association Code of Ethics “It is not unethical for a physician to prescribe or supply drugs, remedies or appliances as long as there is no exploitation of the patient.
The Iowa Medical Society is cognizant of this provision in medical ethics but believes drug dispensing by physicians should be discouraged if adequate
pharmaceutical service is readily available. Physicians are trained to diagnose and treat disease while pharmacists are trained to compound prescriptions on the precise orders of physicians. Physicians should recognize the specialized training of pharmacists and utilize their services whenever it serves the best interests of the patient. Each of these professions should be respected and their areas of training and practice acknowledged of the fullest extent possible. The free choice of pharmacists should be permitted on the same basis as free choice of physicians.
The physician has a responsibility to make clear to the patient that even though a specific drug may be expensive, it is the best therapeutic agent he feels can be administered in treating the condition of the patient. Physicians should not advise a patient as to the exact price of a prescription, anymore than a pharmacist should attempt to establish a fee for a physician's service.
A physician should cooperate with pharmacists, first, by specifying the number of times a prescription is to be refilled and second, by making himself available to the pharmacist to determine whether or not his original orders should be altered after the original number of refills have been obtained.
Physicians and phamacists should work together as a team in seeing to it that a patient is properly medicated. Only through this teamwork is the patient properly served.
The pharmacist should never diagnose or prescribe even at the insistance of the patient but should refer those needing medical attention to a Doctor of Medicine of the patient's choice.
The sale of proprietary products and home remedies that have been released by the Federal Food and Drug Administration for over-the-counter sale which the patient may request for self-medication shall not be considered counter prescribing by the pharmacist.
In an emergency or preceding arrival of the physician, the pharmacist will render such first-aid treatment as is indicated by scientific knowledge and good judgement.
If there is any question in the pharmacist's mind regarding the ingredients of a prescription, possible error or safety of the drug, he should privately and tactfully