the University of Alabama in Birmingham/UNIVERSITY STATION / BE(MINGHAM, ALABAMA 36294 the Medical Center/ SCHOOL OF MEDICINE / OFFICE OF THE DEAN / September 4, 1974 Hugh Hussey, M.D., Director Dear Hugh: Enclosed is a draft of a narrative I would like to submit to the full DRB at the September 25 meeting for its consideration. In the interest of time, I am sending copies of this to Duke Trexler and Fred Shideman. DRAFT OF NARRATIVE TO ATTACH TO DRB STATEMENT ON ANTISUBSTITUTION LAWS The essential point of a prescription is that the patient receive the medication which his physician intends that he receive. The crux of the problem is the physician's intent and the amount of understanding he, the physician, brings to that intent. If he understands sufficient about what he has prescribed to restrict it narrowly (e.g., to a single brand), then he will be able to defend his selection not only to the patient, to the pharmacist, and to third-party payors, but also to a group of his peers in the practice of medicine (i.e., physicians) should they later review his decisions and actions. If he prescribes a particular brand and, in fact, his understanding of what he has prescribed extends only to the level of its generic nature, then his narrow restriction to that particular brand will be indefensible to his peers, and substitution by the pharmacist (on the basis of product equivalence and lesser cost, to the best of his, the pharmacist's, knowledge) is justified. However, the prerogative of restricting the prescription remains with the physician, since he is the one ultimately responsible for the care of the patient. There are three corollaries to this. First: the physician's orders must be followed to whatever extent he specifies. If he specifies, in writing on the prescription, that the prescription must be filled exactly as written, the pharmacist must do that, and the patient should comply with those specific instructions from the physician. Second: if, however, the physician does not note such a restriction in writing on the prescription, the pharmacist is free to substitute an equivalent drug product (of the same generic drug). The pharmacist then assumes the respon sibility (and the liability) for this substitution and must defend his choice, should that defense be necessary. He has presumably made the substitution on knowledge of the drug product (including the cost) which is superior to the knowledge of the physician. Third: the knowledge of the individual making the selection is paramount in his assumption of the responsibility. This includes knowledge of the patient, his disease, and the ramifications of the pathology of that disease. This is the reason for ultimate delegation of that responsibility to the physician. However, it also includes to a very large extent knowledge and understanding of the prescribed drug product, and where the pharmacist's knowledge is superior, he should have the choice and the responsibility. Withman. James A.Pittman, Jr., M.D. the University of Alabama in Birmingham/ UNIVERSITY STATION/ BIRMINGHAM, ALABAMA 35294 the Medical Center/ SCHOOL OF MEDICINE / OFFICE OF THE DEAN / September 11, 1974 Duke C. Trexler, Executive Secretary Drug Research Board Division of Medical Sciences Dear Duke: I think Hugh Hussey's revision of the resolution to be presented to the DRB at the next meeting, which substitutes the word "provided" for the first five words of the one I drafted, is fine; and I suggest that we proceed to use that one in our further discussions. PROPOSED RESOLUTION OF THE DRUG RESEARCH BOARD WITH REGARD TO DRUG PRODUCT ANTISUBSTITUTION LAWS 1. WHEREAS the patient's best welfare should be the ultimate goal of state statutes and regulations concerning drug product selection, which in operational terms means the best product for the lowest cost; and 2. WHEREAS the physician must have the ultimate responsibility and authority in drug product selection, since he alone has intimate knowledge of the patient and his pathology (with the attendant obligation to be held accountable for his selection of particular drug products to peer reviewers, for cost as well as the quality, which the first concern); and 3. WHEREAS the pharmacist may, in some situations, have greater knowledge of drug products than other health professionals, including knowledge of both quality and costs; and 4. WHEREAS it is appropriate that decisions with regard to choice of drug product be made by the health professional possessing the greatest amount of information involved in the particular selection in question, with the attendant accountability, 5. BE IT THEREFORE RESOLVED that the physician, having selected the chemical entity to be used for therapy, may explicitly delegate to the pharmacist or retain to himself selection of the particular drug product to be dispensed and received by the patient; 6. AND FURTHER THAT any cost reduction thus achieved should be passed on, in full, to the patient. furied revolution to be presented to full > DRB. Washington, D.C. |