Substitution Gets Limited kay From Science Group Drug Research Board says physician shouldn't specify brand unnecessarily A prestigious medical group has issued a statement which assigns to pharm rists a more important role in drug product seJection than medical inen have traditionally been willing to grant. In fact, the statement appears to endorse the pharinacist's right to substitute one brand for another under certain circumstances, without first consulting with the prescribing phy sician. The action was taken in the form of a resolution and accompanying "narrative", prepared by the Drug Research Board. DRB is part of the National Academy of Science, a quasigovernmental organization that advises Congress and federal agencies on scientific matters, (ÑAS was, for example, the organization to which the Food & Drug Administration turned over the job of evaluating all prescription drugs against the effectiveness standards imposed by the Kefauver-Harris Amendents of 1962.) The Drug Research Board prepared its statement following meetings with representatives of the American Pharmaceutical Association and the Pharmaceu tical Manufacturers Association on the subject of substitution and generic prescribing. The position taken by the 18man ding group will soon be considered by NAS itself. What ever stand is taken by NAS could influence Congressional action with regard to reimbursement for drugs under Medicare, Medicaid, or national health in surance. Good reason: What the DRB ,resolution says, in effect, is that a physician should not insist on ■ specific brand unless he has good reason based on his own Knowledge of product quality and/or cost. Similarly, the resolution says, a pharmacist should not sub. stitute unless he can defend his action on the basis of quality and cost. Full text of the resolution and accompanying narrative appears on this page. Breakthrough: Edward G. Feldmann, associate executive director for Scientific Affairs of APhA, said the DRB position is a lot closer to APhA's stand on substitution than any major medical group has previously been willing to take. In fact, Dr. Feldmann said, the statement is a "breakthrough" in APhA's campaign to enlist medical profession support for its ding (Continued on P. 241 TEXT OF DRB'S STATEMENTS RESOLUTION 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 responsibility 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 selection of particular drug prod ucts, and Whereas the pharmacist may, in some situations, have greater knowl edge of drug products than other health professionals, inclusting knowl edge of both quality and costs, and Whereas it is appropriate that deci sions with regard to the choice of drug products be made by the health profes sional possessing the greatest amount of information involved in the particu lar selection in question, with the at tendant accountability, therefore be it Resolved: That the physician, having selected the chemical entity to be used for therapy, stewild be required either to delegate to the pharmacist, or ex pictly to retain to himself, selection of the particular drug product to be dis pensed to and received by the patient. ACCOMPANYING The essential point of a prescription is that the patient receive the medica bon which his physician intends that he receive. The crux of the probik m is the physician's intent and the amount of understanding be, the physician, brings to that intent. If he understands sufficient about what he has prescribed to restart it narrowly (eg, to a single beard), then he must be able to defend his sele. tion, not only to the patient, to the pharmacist, and to third party payers, but also to a group of his peers in the practice of medicine (ie., physicians) should they later review his decrions and actions. If he prescribes a particular brand and, in fact, his understanding of what he has prescribed exteur's 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 phy sician, since he is the one ultimately -responsible for the care of the patient. There are three corollanies to this. First: The plgician's orders must be followed to whatever extent he speci fies. If he specifies, in writing on the prescription, that the prescription anst be filled exactly as written, the phar macist must do that and the patient should comply with those specific in structions from the physician. Second: If, however, the physician does not note such a restriction in writing on the prescription, the phar macist is free to substitute an equiva lent drug product (of the same generic drug). The pharmacist then assumes the responsibility (and the habit,) for this substitution and must defend his choice, should that defense be nices. sary. He has presumably made the substitution on knowledge of the drug product (including the cost) which is superior to the knowledge of the phys cian. Third: The knowledge of the individ. ual making the selection is paramount in his assumption of the responsability, 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 under standing; of the prescribest drung: product, and where the physicians knowl edge is Miriot, he should have the chance of the responsdality, Paul Calabresi, MD. Roge: Williams General Hospital Providence. J. Richard Crout, MD, director, FDA Bureau of Drugs. Victor A. Drill, MD, directo: of scientific and professional af fairs, G.D. Searle & Co. Robert M. Hidges, MD,. vict president, research and devel opment, Parke-Davis, Hugh H. Hussey, MD, editor emeritus, American Medical Association. Werner Kalow, MD, University of Toronto. Thomas D. Kinney, MD. Duke University Medical Center, Durham, NC. Kenneth G. Kohlstdt, MD. Indiana University Medical School. Emanuel M. Papper, MD. University of Miami medical school. James M. Price, MD, vice president, corporate research and experimental therapy, Abbott Labs. David P. Rall, MD, National Institute of Environmental Health Sciences, Researel Triangle Park, N.C. George W. Horn, MD, Pete Bent Brigham Hospital, Boston. AMERICAN DRUGGISI • Bwember 15, 1975 The attached Resolution was adopted by the Drug Research Board on The Resolution was forwarded for approval by the Assembly of Life The Resolution will now be distributed to the various encies of Enclosure Resolution (as originally forwarded to ALS) The National Research Council is the principal operating agency of the National Academy of Sciences and the National Academy of Engineering to serve government und other organizations The attached Resolution was adopted by the Drug Research Board at its The Resolution is being widely circulated to all groups concerned, Enclosure DCT: dem The National Research Council is the principal operating agency of the National Academy of Sciences and the National Academy of Engineering to serve government ... d other organizations news from the NATIONAL RESEARCH COUNCILS The National Research Council was organized by the National Academy of Sciences in 1916 in order to provide for a broader participation by Americum scientists and engineers in the work of the Academy. The Academy wax churtered by Congress in 1863 as u private organization with a responsibility for adrising the Federal Government in science and technology. Siner this responsibility is now shared with the National Academy of Engineering, organized in 1964 under the original NAS charter, the Research Commeil serves, in effect, as an operating agency for both academies, FOR RELEASE: P.M.'s, Tuesday, January 21, 1975 WASHINGTON--A physician should be required to give to, or explicitly withhold from, the pharmacist the option of substituting one brand of a drug he prescribes for another brand of the same drug--an option which could in many cases provide the same treatment at lower cost--according to a resolution of the National Research Council's Drug Research Board (DRB). This "substitution" option is allowed by law in only two states--Florida and Michigan. In all others it is illegal for a pharmacist, without checking with the prescribing physician, to replace one brand with another even if both brands are known by the pharmacist to have been made in the same laboratory and even if one costs substantially less than the other, the DRB said in a background statement accompanying its resolution. The DRB pointed out that "no inherent reason" exists for choosing the more expensive drug product simply because of brand-name familiarity. In the absence of any data indicating the substituted drug is not equivalent, then the pharmacist is "in the best position" to make the final choice, the Board said, with cost an element in the decision. Following are the resolution and the background statement: Resolution WHEREAS, The patient's welfare should be the ultimate goal of statutes and WHEREAS, The physician must have the ultimate responsibility and authority |