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 WHEREAS, It is appropriate that decisions with regard to the choice of drug products be made by the health professional possessing the greatest amount of information involved in the particular selection in question, with the attendant accountability, therefore be it RESOLVER, That the physician, having selected the chemical entity to he used for therapy, should be required to delegate to the pharmacist, or explicitly to retain to himself, selection of the particular drug product to be dispensed and received by the patient. Background Statement Early in 1973, the DRB became interested in the question of the appropriateness of existing drug antisubstitution legislation and its relation to the final application of knowledge concerning drugs. Initially, the DRB considered that the antisubstitution laws which have existed in almost all of the states for several decades remain appropriate at the present time and protect the consumer from inferior products.. At that time (early 1973), a resolution strongly endorsing continuation of antisubstitution legislation was considered by the DRB. However, subsequent meetings with representatives of various groups, especially the American Pharmaceutical Association (Albá), brought out important facts with which the DRB had not previously been familiar and which it believes most of the American public and American physicians are not aware of. Perhaps most important is the fact that it is currently illegal for a pharmacist, often the last health professional to have contact with a patient prior to the latter's taking a prescribed drug, to substitute one brand of a given chemical entity for another (e.g., on the basis of lesser cost to the patient) even if both brands were manufactured in the same laboratory, when only the former brand is specified by the physician on the prescription. The DRB discussions concentrated on the knowledge or information, which goes into such decisions; and many of the discussions focused on how one is to deal with an absence of data on bioavailability and bioequivalence. The DRB did not consider that the cheaper of two drug products of the same chemical entity is necessarily the more desirable, However, in the absence of information to the contrary, it is unreasonable to assume that the less expensive is less desirable. In essence, the resolution finally adopted unanimously by the DRB asserts that, in the absence of data to the contrary, there is no inherent reason for choosing the more expensive drug product simply because of the familiarity of the physician or pharmacist with the brand name. It further asserts that the pharmacist may be the health professional most familiar with the details of cost, the one who has to deal with inventory and similar problems, and because of these, the physician should either delegate to the pharmacist the right to make the choice or explicitly reserve that right for himself. The DRB resolution, in addition, emphasizes accountability of the health professionals Involved--the physician and the pharmacist--for their decisions. For the physician, he must be prepared to defend his decision to restrict the dispensed drug product to the specific brand named in his prescription, should he choose to require such a restriction. For the pharmacist, he must be prepared to defend his substitution of a cheaper drug product than a brand named in the prescription, should substitution be permitted by the physician. The DRB is aware that it changed its position during the calendar year 1973, so that the final position is almost exactly opposite to that it initially considered taking on this issue. The main reasons for this change were (1) learning that amendment of antisubstitution laws does not mean removing from the physician the prerogative of requiring a particular brand; (2) becoming aware of the data on source manufacturer of a number of different brands of some chemical entities (e.g., tetracycline and chloral hydrate, as recorded in the "Hearings before the Subcommittee on Small Business of the U.S. Senate, 93rd Congress, Second Session, etc., etc.," Part 24, February 20, 21, March 5, and 6, 1974); (3) examining the relative laws recently passed by the states of Florida and Michigan. An important unstated aspect of this issue, however, is the conspicuous absence of data or information of any sort for use by the health professionals in making such decisions, other than cost data. As stated above, however, the DRB decided that, in the absence of data indicating incquivalence, cost would often be the deciding factor; and the pharmacist is often in the best position to make this final choice. The resolution was passed unanimously by the members of the DRD with one abstention, that of J. Richard Crout, director, Bureau of Drugs, Food and Drug Administration, whose agency has not taken an official stand on the issue. Chairman of the DRB is Frederick E. Shideman, head, department of pharmacology, University of Minnesota. Other members are Daniel L. Azarnoff, professor of medicine and pharmacology, University of Kansas Medical Center; James A. Bain, director, division of basic health sciences, Emory University; Mitchell B. Balter, chief, special studies section, psychopharmacology research branch, National Institute of Mental Health; Allan D. Bass, associate dean for biomedical sciences, Vanderbilt University School of Medicine; Paul Calabresi, physician-in-chief, Roger Williams General Hospital, Brown University; J. Richard Crout, director, Bureau of Drugs, Food and Drug Administration; Victor A. Drill, director, scientific and professional affairs, C.D. Searle & Co., Skokie, Illinois; Robert M. Hodges, vice president, research and development, Parke, Davis & Company, Ann Arbor, Michigan; Hugh H. Hussey, editor emeritus, American Medical Association, Chicago, Illinois; Werner Kalow, chairman, department of pharmacology, University of Toronto; Thomas D. Kinney, professor of pathology, Duke University Medical Center; Kenneth G. Kohlstaedt, professor of medicine, Indiana University; Emanuel M. Papper, dean, University of Miami School of Medicine; James A. Pittain, Jr., dean, School of Medicine, University of Alabama; James M. Price, vice president, corporate research and experimental therapy, Abbott Laboratories, North Chicago, 111inois; David P. Rall, director, National Institute of Environmental Health Sciences, Research Triangle Park, North Carolina; and George W. Thorn, physician-inchief, emeritus, Peter Bent Erigham Hospital, Boston, Massachusetts. hw: 1,6, E 1/16/75 Comment on Hyperhole: Statement of the Drug Research Board ? At the risk of being repetitious, we feel obliged to return to a theme explored repeatedly in past issues of The JourNAL. This situation reminds me (R.11.M.) of an expe rience that occurred during my army years. I was attend. ing the Army Command and General Staff College at Fort Leavenworth. On the first day in our nervously chattering class of Military Map Reading, in strode an impressive full colonel: elegant, beribboned, and ramrod erect. He stared sternly at the large group. Then he spoke in measured words, "Gentlemen, I am Colonel Jones, your instructor in map reading. I wish to state at the outset of this course, that at all times, I reserve the right to use the terms north and south interchangeably!" This ice-breaking introduction is reminiscent of the ambiguous, mad-hatterish resolution of the Drug Research Board of the National Research Council (NB: the final paragraph): WHEREAS, The patient's welfare should be the ultimate goal of statutes and regulations concerning drug product selection, which in operational terms means the best product for the lowest cost, and WHEREAS, The physician must have the ultimate responsi bility and authority in drug product selection, since he has the fullest knowledge of the patient's needs and responses with attendant obligation to be held accountable for his selec tion of particular drug products, and 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 WHEREAS, It is appropriate that decisions with regard to the choice of drug products be made by the health professional possessing the greatest amount of information involved in the particular selection in question, with the attendant accountability, therefore be it Resolved, That the physician, having selected the chemical entity to be used for therapy, (a) should be required to delegate to the pharmacist, or (b) explicitly retain to himself, selection of the particular drug product to be dispensed and received by the patient. (Letters (a) and (b) and italics are added to lend some semblance of organization to this statement.) One interpretation of part (b) could be that a physician who wants a prescription filled as he has written it would, in effect, be required to specify a second time, "Yes, I really meant what I wrote." Part (a) means the reverse: a pharmacist can choose any brand or generically labeled substitute at his own dis cretion! Rather than repeat the tiresome hyperbole that is cmbraced by the notion that a pharmacist should be granted such latitude, we shall list the minimum requirements that must be met before a physician could properly delegate his responsibility for product selection. First, the physician would have to know exactly in which pharmacy the prescription would be filled—a tall order in any fair-sized city. Otherwise, if more than one brand of a product is marketed, he would be authorizing any pharmacist anywhere to decide what the patient should receive. The chaos that such a practice could wreak is illus trated concretely in "The Plea of a Jacksonville Druggist." If we assume the rare circumstance in which the physician does know where the prescription is destined to be filled, he would need intimate knowledge of that pharmacy. He would be obliged to know (1) what brands (or "generic equivalents") are being stocked currently; (2) that convincing evidence exists that all the different products are indeed equivalent therapeutically; (3) the cost of the drugs (is one product cheaper than the other?); (4) how he can be assured, if all the foregoing is known, that the most economical one will indeed be dispensed; and finally (5) whether any saring will be passed on to the patient. In the event that a substitution is made, will the patient be confused by receiving a drug with an unfamiliar name on the label or with an unfamiliar appearance and think that he has been given the wrong drug? Will he wonder who is really managing his treatment? If these crucial questions can be answered, all the rhet oric about "substitution" will be meaningless. The physi cian simply will prescribe the most economical therapeutic equivalent product in the pharmacy. But felicitous theory is a long way from practical reality. If the physician does not have the necessary information about the product available in a pharmacy that his patient may patronize, we might pose one additional rhetorical question (to illustrate another dimension of the need to know the destination of the prescription): does the phar macist have the financial assets to hear his share of the malpractice judgment, if he happens to cause harm to a patient through an improper substitution? (One may assess a toxic reaction, but how does one measure lack of efficacy in an individual patient?) Thus the remarkable, through-the-looking-glass resolu Address editorial communications to the Editor, 635 N Dearborn St, Chicago 60610 380 JAMA, Apill 28, 1975 Vol 232, No 4 Editorials During 1974, the Drug Research Board (DRB) of the National Research Council/National Academy of Sciences (NRC/NAS) held a special meeting with representatives of the Pharmaceutical Manufacturers Association. One outcome of the meeting was a statement supporting the state drug antisubstitution laws and opposing their repeal. When that statement was reviewed at the next regular meeting of the DRB, a representative of the American Pharmaceutical Association (APhA) made a plea for deferral of action at least until representatives of APhA.should have had an opportunity to be heard. Accordingly, Dr. Shideman, chairman of the DRB, appointed Dr. James Pittman (chairman) and me as a com mittee of two to meet with APhA representatives. At the meeting that ensued, the APhA representatives announced that their association had no desire to have the antisubstitution laws repealed--only modified. The arguments were persuasive, and Dr. Pittman presented a report at the next regular meeting of the DRB on Oct 25, 1974. The report was not accepted as written, was rewritten that day, and re-presented to the DRB where discussion and debate led finally to adoption of the following resolu tion: Resolved, That the physician, baving selected the chemical entity to be used for therapy, should be required to delegate to the pharmacist, or explicitly to retain to himself, selectina of the particular drug product to be dispensed and received by the patient. Following the October meeting of the DR, Dr. Piltman wrote what he told me by telephone he intended solely as a "think piece”—a basis for discussion of the foregoing resolution of the DRB at its meeting on March 11 1975. However, Dr. Pittman's writing was somehow used, at least in part, by NRC/NAS as a press release, Jan 21, 1975, to accompany the resolution, which by then had received the endorsement of the Assembly of Life Sciences The press release was headlined "Drug Board Urgis Changes in Drug Substitution Laws"—something I cannot find as the intent of the DRB; at least the DRB never stated it so, and I never believed it so. Confusion and perplexity have ensued. The APhA has seized on the press release for use in strong efforts to up grade the role of the pharmacist, perhaps to the point where he will be the therapist while the physician is a diagnostician only. In other words, the honorable DRB is in danger of being used against its own best interests. Therefore, I recommended (1) that reconsideration of the resolution be a prime order of business at the March 14 meeting of the DRB; (2) that the DRB rescind for now the confusing resolution; (3) that the resolution be restudied by an ad hoc committee of the DRB, the study to iaclude a search for the reasons for misunderstanding of the resolution. I did not believe that the resolution demanded a repeal or modification of the state drug antisubstitution laws; other wise I would not have supported it by vote. Obvioush, ! was naïve. The various interpretations placed on the reso lution by various parties indicate that the resolution is unclear in its intent. Clarification is of paramount impor |