Prices, Patients, and Drug Substitution

AMERICAN JOURNAL OF OPHTHALMOLOGY FRANK

W.

NEWELL,

Editor-in-Chief

233 East Ontario St., Chicago, Illinois 60611 EDITORIAL BOARD Mathea R. Allansmith, Boston Douglas R. Anderson, Miami Crowell Beard, San Jose Bernard Becker, St. Louis Benjamin F. Boyd, Panama Charles J. Campbell, New York Ronald E. Carr, New York Thomas Chalkley, Chicago Claes H. Dohlman, Boston Fred Ederer, Bethesda

Published

G. Richard O'Connor, San Francisco DuPont Guerry III, Richmond Arnall Patz, Baltimore Paul Henkind, Bronx Robert W. Hollenhorst, Rochester Steven M. Podos, New York Herbert E. Kaufman, New Orleans Albert M. Potts, Louisville Arthur H. Keeney, Louisville Algernon B. Reese, New York Bertha A. Klien, Tucson Robert D. Reinecke, Albany Carl Kupfer, Bethesda Marvin L. Sears, New Haven James E. Lebensohn, Chicago David Shoch, Chicago Irving H. Leopold, Irvine Bruce E. Spivey, San Francisco A. Edward Maumenee, Baltimore Bradley R. Straatsma, Los Angeles Irene H. Maumenee, Baltimore Gunter K. von Noorden, Houston Edward W. D. Norton, Miami

monthly by the Ophthalmic

Publishing

233 East Ontario St., Chicago, Illinois

Company

60611

Directors: A. E D W A R D M A U M E N E E , President; D A V I D S H O C H , Vice President; F R A N K W. N E W E L L , Secretary and Treasurer; E D W A R D W. D. N O R T O N , B R U C E E . S P I V E Y , B R A D L E Y R. S T R A A T S M A

PRICES, PATIENTS, AND DRUG SUBSTITUTION In view of the rising costs of prescrip­ tion medicines and other health care ser­ vices, many politicians, federal health planners, and consumer groups have sought programs or regulations to stabi­ lize drug prices. These groups have tried to convince state legislators to repeal or amend antisubstitution laws, which pro­ vide that when a physician writes a pre­ scription for a brand-name drug, the pharmacist is required to fill the prescrip­ tion with the specified company's prod­ uct. These laws originated in the 1950s fol­ lowing the development of many n e w prescription drugs that resulted in the phenomenal growth of the pharmaceuti­ cal industry. During this immediate post-war period, there was widespread counterfeiting and mislabeling of pre­ scription drugs, outright forgery of prod­ ucts and packaging, and uncontrolled iAf>

substitution of medicines regardless of therapeutic equivalence. In 1952 California became the first state to pass antisubstitution legislation, a n d eventually, all the states followed suit. In the last few years, over half the states have repealed or amended these laws to permit at least some form of substitution. Other states have similar laws under con­ sideration. The aim of these antisubstitu­ tion law repeal movements is to allow the pharmacist, with the consumer's consent, to substitute a less expensive generic equivalent drug when the physician has prescribed a more expensive brand-name product. Price is not the sole consideration in prescribing medication. Less expensive substitutes may not work the same way in the body as more expensive brand-name products, even though they have identical chemical structures. Studies in biopharmaceutics, an in­ creasingly important branch of therapeu-

VOL. 86, NO. 1 tics, try to determine the ability of a drug to reach the involved body cells in effec­ tive concentration. The preparation of a drug for use may influence its distribution in the body, the eye, and the particular involved cells. Therefore, considerable attention must be paid to bioavailability and therapeutic equivalence. Groups opposing substitution argue that existing standards are not sufficient to guarantee that only quality products reach the consumer. The effects of antisubstitution law re­ peal are now being evaluated in several states. Florida does not merely allow, but requires substitution unless the physician writes "medically necessary" on the pre­ scription. The pharmacist is required b y law to inform the patient when he substi­ tutes and to tell the patient the exact amount of money saved. The patient has the right to refuse the substitute. Substi­ tution appears to be making large inroads in Florida, a state that also has a negative and a positive formulary. The negative formulary lists those ge­ neric substitutes that are not biologic or therapeutic equivalents, and the positive one lists acceptable substitutes. Saskatch­ ewan, Canada, has had a freedom of sub­ stitution law since 1971, and in one year, the reduction of average prescription prices was barely 3 % . A substitution law that went into effect in Michigan in April 1975 caused initial dissatisfaction and confusion among phy­ sicians and pharmacists. The doctors did not use the dispense as written provision, and the pharmacists hesitated to substi­ tute without permission of the prescrib­ ing physician. Also the pharmacist appar­ ently needed an incentive to substitute because the profit margin on cheaper drugs is generally lower. Liability is another potential problem. The state of California, in amending the

EDITORIALS

141

antisubstitution law of May 1, 1976, stat­ ed that the prescribing physician would not be liable for the substitution judg­ ment of the pharmacist. In states where repeal of the antisubstitution law has oc­ curred but substitution is not mandatory (most states), the pharmacist, aware of potential liability resulting from dispens­ ing inefficacious cheaper generic equiva­ lents, may play it safe and not substitute. However, a statutory exemption that would absolve the pharmacist from liabil­ ity would not be in the best interest of the consumer who then might not be protect­ ed from inferior generic drugs. Elsewhere in this issue are the results of a recent study of the retail cost of antiglaucoma drugs in two cities. Drugs cost more in New York than in St. Louis. New York has a substitution law and Missouri does not. However, generic sub­ stitution was not significantly greater in New York. Actually, little generic substi­ tution occurred in either city. The price range in each city varied greatly, and the price of a drug was influenced by the style and appearance of the buyer, the neigh­ borhood, type of store, and type of ser­ vices offered by the pharmacy. These fac­ tors far outweighed the generic question in determining the cost of a prescription drug. Since 1970, 31 states (including the District of Columbia) have enacted legis­ lation permitting some form of prescrip­ tion drug substitution to reduce the cost of drugs to the consumer. These changes do not seem to have saved the consumer a significant quantity of money. They have increased the work load slightly for the physician who must now decide whether to protect his pre­ scription by writing additional orders, for example, "do not substitute" (New Jersey, New York, Pennsylvania), "medically necessary" (Florida), or "substitution prohibited" (Kentucky); for the pharma­ cist who now may have to comply with

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AMERICAN JOURNAL OF OPHTHALMOLOGY

fellow pharmacists and keep records of all substitutions, and for lawyers, both those in the Congress and Senate from states where such laws are made and amended and those who deal with liabili­ ty.

JULY, 1978

R.N., President, American Society of Ophthalmic Registered Nurses, 271 Bellefontaine, B-33, Houston, Texas 77025.

IRVING H. L E O P O L D

WELCOME: T H E AMERICAN SOCIETY O F OPHTHALMIC REGISTERED NURSES The American Society of Ophthalmic Registered Nurses first met in Las Vegas October 7, 1976, in order to establish an organization dedicated to excellence in ophthalmic nursing. The founders be­ lieved that such a society would further continuing education through study, dis­ cussion, and exchange of information in

the field.

In 1977, the theme of the meeting was "Insight Into Eyesight." Ophthalmolo­ gists spoke on a variety of topics: glauco­ ma, ocular emergencies, anesthesias used in ophthalmic surgery, and indications for vitrectomy. Members of the group spoke of the care of microinstruments, and a panel discussed preoperative, intraoperative and postoperative care of the eye pa­ tient. Approximately 100 ophthalmic nurses attended this second meeting. A. Edward Maumenee, M.D., was guest of honor at the annual luncheon meeting. The first officers are: president, Edna Ashy, Baylor University and Veterans Ad­ ministration Hospital, Houston, Texas; vice-president, Marlene Croce, Wills Eye Institute, Philadelphia; and secretarytreasurer, Corene Peacock, Johns Hopkins Hospital, Wilmer Eye Institute, Balti­ more, Maryland. The Society plans to meet at Kansas City Oct. 24 and 25, 1978, at the Ramada Central, during the American Academy of Ophthalmology meeting. Further infor­ mation is available from Edna Ashy,

Letters to the Editor must be typed double-spaced on 8V2 x 11-inch bond paper, with lV2-inch margins on all four sides, and limited in length to two man­ uscript pages. CORRESPONDENCE Metastatic Adenocarcinoma Editor: We read with interest the article, "Met­ astatic adenocarcinoma to the anterior uvea and increased carcinoembryonic an­ tigen levels" (Am. J. Ophthalmol. 85:363, 1978) by Gary Denslow and Richard Kielar, which described a patient with chronic unilateral iridocyclitis, compli­ cated by secondary glaucoma, that masked a metastatic cancer to the anterior uveal tract. The increased plasma carci­ noembryonic antigen level suggested the correct diagnosis. We have now had the opportunity to study 35 patients with metastatic cancer to the choroid (Table). In ten patients the site of the primary tumor was not located on routine clinical and laboratory exami­ nation. On ocular examination, the plas­ ma carcinoembryonic antigen level sug­ gested the correct diagnosis in 27 patients (77%). We have also noted that when gamma glutamyl transpeptidase, a liver enzyme, is screened carcinoembryonic antigen, with 92% of patients with meta­ static cancer of the uvea have either an increased carcinoembryonic antigen or gamma glutamyl transpeptidase level, 1 whereas routine liver enzymes may be normal, as noted in the case presented by Drs. Denslow and Kielar. Of our ten pa-