Special reports Physician drug dispensing Clifford W. Lober, M.D.,* Stephen D. Behlrner, M.D.,** Neal S. Penneys,M.D.,*** Jerome L. Shupack, M.D.,**** and Bruce H. Thiers, M.D.***** Tampa, FL,* Helena, MT, ** Miami, FL, *** New York, Ny'**** and Charleston, SC*****
United States Representative Ron Wyden (DOR) recentlyintrocluced legislation (RR. 2168) that would have drastically curtailed a physician's ability. to dispense medications. 1 Although the Wyden legislation is stalled at present, it is appropriate to review the issue of physician drug dispensing because it is likely that similar legislation seeking to deny physicians the right to dispense may be- reintroduced during the next session of Congress. ,The Federal Trade Commission recognizes that "the dispensing of medication by physicians is a traditional part of medical· practice."? Before the emergence of large retail pharmacies in the 1940s, many physicians dispensed medications in their ~ffiCeS. In 1947, almost 25% of all physicians dispensed pharmaceuticals' but by 1967 the percentage had declined to 10%.3 It is estimated that only 5o/~ of all physicians are currently dispensing pharmaceuticals in their offices." Physician dispensing is regulated in all fifty states.' State medical licensure boards have the statutory authority to regulate. physician dispensing through disciplinary. actions. Their responsibility is to prevent abusive or inappropriate drug dispensing. III the case of federal legislation, however, the issue of profit accruing to dispensing physicians has been the central issue. Our focus herein is strictly limited to determin-
From the Division of Dermatology. University of South Florida College of Medicine. Tampa," the Department of Dermatology, University of Miami School of Medicine. Miami,·" the Department of Dermatology, New York University Medical Center; New york.....• and the Department of Dermatology, Medical University of South Carolina, Charleston.....• Reprint requests to: Dr. Clifford W. Lober. 800 N. Central Ave., Kissimmee. FL 32741. "In private practice. Helena, MT.
ing if it is in the public interest (e.g., in the interest of patients) to have physicians legislatively stripped of the right to dispense medications. No attempt will be made to address the issue of whether a given physician should dispense. We will examine physician dispensing by exploring the areas of preeminent concern: quality of care, economics, drug availability, patient compliance, safety, and the merits of government regulation. QUALITY OF CARE
Pharmacists are "throwing a "public-interest" smoke screen over their legislative demands on physician drug dispensing" by suggesting that pharmacists serve as guarantors against possible physician error." There is absolutely no evidence presently available indicating any systematic or generalized problem in the area of physician dispensing. Norman F. Lent (R-NY) stated that based. upon testimony he heard on April 22, 1987, the physician dispensing problem "is highly conjectural and hypothetical."? Jeffrey L Zuckerman, director of the Bureau of Competition of the Federal Trade Commission, stated on Oct. 27, 1987, that there is an "absence of any reliable evidence that this practice is likely to harm consumers."! The Federal Trade Commission has stressed that pharmacists are "trying to peddle a solution when they haven't found a problem."? Pharmacists believe that they serve a vital function by reviewing prescriptions for errors, possible allergic reactions, and potential adverse interactions. Although this may be the case in ideal situations .or in academic medical centers, the Federal Trade Commission reports that "in practice, of course, pharmacists frequently do not conduct such reviews."? "In everyday practice, the
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916 Lober et al.
pharmacist's workload is often too heavy to deal directly with every patient." 10 It is not surprising, therefore, that pharmacists have been seeking permission in virtually all states to utilize assistants. The qualifications of such assistants, if indeed the state(s) enforce any educational qualifications, are often doubtful. The assistants may be given the responsibility to review prescriptions without the prerequisite knowledge of pharmaceuticals essential to this task. Are these often untrained assistants to be the guarantors against possible physician error? Pharmacists have also endeavored to expand the use of generic and therapeutic substitution. I I, ~2 Generic medications have only one advantage over name brands--
information. This essential patient information can only be obtained by a patient's attending physician. The attending physician, therefore, is uniquely suited to assume the professional and legal responsibility for determining a patient's drug therapy, taking into account patient quality of care as well as cost considerations." 16 Although "doctors can and do make mistakes, pharmacists probably make as many errors in interpreting thousands of prescriptions from hundreds of doctors."! The Federal Trade Commission recognizes that although physician dispensing eliminates the pharmacist from acting as a potential "check" on physician prescribing errors, "this loss is counterbalanced by a significant benefit: the elimination of medication errors that occur because of miscommunications between physicians and pharmaclsts such as misinterpretations of written
prescriptions."? ECONOMICS~COST
AND PROFIT
Physician dispensing presently accounts for no more than one tenth of one precent of the $20 billion prescription drug market.' Although there are little objective data comparing bottom line physician dispensing costs to those charged by pharmacists, information recently presented before the House Energy and Commerce Subcommittee on Health and the Environment and a recent Newsweek survey suggests that patients consistently get a better price from dispensing physicians than from pharmacists. 17.I' Newsweek determined that ampicillin, which could be obtained from a doctor's group practice for $5, varied in cost in pharmacies between si 1.30 . and $14.05. 1& Aithough pharmacists may not agree with this conclusion, one surmises that if pharmacy dispensing was a better economic deal for patients, the pharmacists would certainly not need to pursue legislation prohibiting physicians and others from disperisirtg. It is no surprise that physicians can successfully compete with pharmacists given that "the average druggist generally adds 100 percent to the cost of drugs before tacking on the dispensing fee.':" If, however, "pharmacists believe that the dispensing services they offer are superior to those offered by dispensing physicians," the chairman of the Federal Trade Commission suggests that "they
Volume 19 Number 5, Part 1 November 1988
should educate consumers about the price and quality of their services.?" The Federal Trade Commission has stated that it does "not believe that the public interest is served by restrictions on physician dispensing designed to protect the economic interests of specific groups or individuals.'? No issue is more disturbing in a discussion on physician dispensing than the allegation that physicians may dispense with monetary profit rather than the patient's best interest as the primary motivating factor. It is true that a small minority of physicians may act in an unethical manner. Similarly, a small percentage of pharmacists and other professionals may act unethically. The Federal Trade Commission has made it clear that the unethical acts of a few individuals do not justify "restraining an entire category of transactions by physicians. "2 Dispensing is viewed by physicians as a logical convenience that patients have come to expect from them." A recent study by the American Academy of Dermatology revealed that the primary reason dispensing physicians cited for their endeavors was patient compliance." It is obvious why the sick, elderly, disabled, or simply busy patient would want to obtain a prescription at or below pharmacy prices without having to travel to a pharmacy. A medical practice "already integrates several services under single ownership and management-it is a 'multi-product firm.' It diagnoses and treats patients, and in doing so, it maintains and improves health, reduces pain, certifies health conditions for insurers, employers and summer camps, and offers a variety of treatment, x-ray, and laboratory services. And now it dispenses drugs."! It would seem impossible to allocate the expenses a medical practice incurs, such as insurance, rent, utilities, and other costs, to each individual service that practice provides. Although the dispensing aspect of a physician's practice may be scrutinized, "other physician services, such as lab work, allergy shots, x-rays, or even follow-up visits have similar potential for conflict of interest."!' As Laurence McCullough stated, "If you want to get rid of conflict of interest, you have to outlaw the private practice of medicine.':"
Physician drug dispensing 917
AVAILABILITY Pharmacists often do not stock appropriate (and occasionally expensive) medications and may not have sufficiently trained personnel to compound complex multi-ingredient preparations. Because these compounds may not be profitable to prepare, pharmacists may refuse to :fill prescriptions for them and shuffle patients from one pharmacy to the next. Alternatively, they may charge quite hefty prices. In the interest of their patients many dermatologists have compounded and dispensed topical pharmaceuticals. COMPLIANCE
Physician dispensing can minimize the problem of patients never filling their prescriptions. 17 Newsweek reports that "about 20 percent of prescriptions don't get filled."18 In addition to not filling prescriptions, patients frequently fail to continue on medication or renew prescriptions. Peter T. Lamy, Ph.D., professor and director of the Center for the Study of Pharmacy and Therapeutics for the Elderly at the University of Maryland, reported that approximately 400/0 of elderly individuals discontinue antihypertensive medication on their own within 1 year after therapy is initiated. 22 In a study of 2,000 "representative consumers," it was found that 15% "admit to having stopped taking their medication prematurely" and 32% "didn't get refills, even though they need to do so.":" The cost of this lack of compliance is staggering, for «125,000 Americans die each year simply because they fail to take their medication as prescribed.?'? The economic cost of poor compliance is reflected in «20 million lost workdays a year, or about 1.5 billion dollars ill earnings.'?" Physician dispensing encourages both initial and continued patient compliance.
SAFETY Drugs sold by physicians are usually prepackaged in safety-sealed containers in clean rooms by wholesale or repacking firms under the direct supervision of pharmacists. Drug preparation can be safer than the traditional dispensing technique in which pharmacists handle pills, creams, or solutions by transferring them from large containers into unsealed vials, almost always with
Journal of the American Academy of Dermatology
918 Lober et al.
un gloved hands hidden behind open, unsterile store counters. "Most stores do not clean counting devices between prescriptions, including penicillin, which can contaminate other products.'?' Many pharmaceutical repackagers use "high density, opaque, polethylene containers with inner and outer tamper-evident safety seals and wrappers. This essentially inhibits water vapor, air, and light transmission that could contribute to drug degradation. These "extras" are not evident with the amber, plastic vials generally used by retail pharmacies.?" In addition, repackagers are held to strict accountability (including tracking of lot numbers) of all products moving through their systems. Although previously raised as issues under quality of care, the increased use of pharmacist assistants with little (or no) prerequisite training and the possibility of intentional drug substitution by a pharmacist pose potential safety hazards to patients.
dans. If they did, there would be no need to protect their incomes legislatively by restricting physician dispensing. Economic motivation per se is less important to a physician than providing a true conveniencefor his patients and thus encouraging a closer doctor-patient relationship. Physician dispensing adds to the availability of medication and may minimize the number of patients shuttling between pharmacies to obtain complex multiingredient preparations. Compliance is enhanced as availability increases. Prepackaged pharmaceuticals prepared under the auspices of pharmacists and dispensed by physicians are at least as safe as those prepared by the ungloved hands of a pharmacist hidden behind store counters. Thus, restricting the physician's right to dispense can negatively affect the quality of medical care, the cost of medications, safety, the availability of pharmaceuticals, and patient compliance. Such limitation is certainly not in the best interest of our patients.
INCREASED GOVERNMENT INTERVENTION
The Federal Trade Commission has clearly stated that "physician dispensing is in the public interest."? More clearly, the chairman of the Federal Trade Commission stated that "a Federal law prohibiting physician dispensing would be a prime example of unnecessary, heavy-handed, anti-consumer government regulation. It would be harmful to consumers because it would limit choice, restrain competition among physicians and pharmacists, and reduce the incentives for physicians and pharmacists to offer better combinations of prices, quality and service.''" Restraining competition and free trade is "rarely in the public's interest.'?'
REFERENCES 1. Wyden R. Amendment to H. R. 2168 (in the form of a
2. 3.
4, 5, 6.
SUMMARY 7.
We have reviewed the issue of physician drug dispensing by focusing upon quality of care, economic considerations, drug availability, patient compliance, safety, and increased governmental regulation. From a quality of care perspective, the increased use of pharmacist assistants, the tendency toward generic and therapeutic drug substitution, and the less specialized clinical education of pharmacists all pose hazards rather than safety checks upon physician prescribing. There is no evidence that pharmacists charge less than physi-
8. 9, 10. 11. 12,
13.
substitute). Committee on Energy and Commerce, U.S. House of Representatives. Washington, May 6, 1987. Zuckerman JI. Letter to C. Earl Hill, M.D., president, Maryland State Board of Medical Examiners, Dec. 31, 1986. Dickey MW. Statement of the AMA regarding physician drug dispensing and pharmacist prescribing to the subcommittee on Health and Environment, Committee on Energy and Commerce, U.S. House of Representatives. Washington: American Medical Association, April 22, 1987. Greenhouse L. Selling drugs. The role of doctors. New York Times, June 11, 1987, P B14. American Medical Association: State Health Legislation Report 13:3, 1987. Aronson P. Doctors as druggists. Good Rx for consumers. Wall Street Journal, June 25, 1987. Gianelli DM. Vote postponed on bill banning M.D. dispensing. Am Med News, May 15, 1987, p. 7. Zuckerman JI. The future of prescribing in America. Science, law and policy.Abstract of presentation. Presented at Princeton University, Oct. 27, 1987. Gianelli DM. Panel a.K.s bill curbing dispensing. Am Med News. June 19, 1987. p. 2. Shering Laboratories. The forgetful patient. The high cost of improper patient compliance. Shering Report IX, Kenilworth, NJ, 1987. Strom BL. General drug substitution revisited. N Engl J Med 1987;316:1456. Schwartz LL. The debate over substitution policy, its evolution and scientific basis. Am J Med 1985;79:38. Stoughton RB. Are generic formulations equivalent to
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14. 15. 16.
17. 18. 19.
trade name topical glucocorticoids? Arch Dermatol 1987;123:1312. Doering PA, Araujo OE, Flowers FP. Generic equivalence of dermatologic products. J AM ACAD DERMATOL 1987;16:1068-70. Ulrich CA. M.D. dispensing: two views. Am Moo News, June 26, 1987, p. 7. Grezlak C. Abstract prepared for panel discussion at the Future of Prescribing in American Science, Law and Policy, Health Policy International. Princeton University, Oct. 27, 1987. American Society of Internal Medicine: a focus on state health legislation, physician drug dispensing. Washington, Aug. 21, 1987. Schwartz J, Hager M. Now, one-stop medicine? Newsweek, May 25, 1987, p. 32. Oliver D. Preserving competition, FTC Chairman supports physician dispensing. Private Practice, June 1987, p.24.
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20. Taylor RH. Testimony of the American Academy of Family Physicians before the Subcommittee on Health and Environment, House Committee on Energy and Commerce, concerning physician dispensing of prescription drugs. Washington; American Academy of Family Physicians, April 22, 1987. 21. American Academy of Dermatology. Dermarketing and practice management, vel, I, p. 2, 1987. 22. Lamy PP. Medicaljclinical issues. The future of prescribing in America; science, law and policy. Health Policy International, Princeton University, Oct. 26, 1987. 23. Tabak MH. The word is out: physician dispensing. The future of prescribing in America: science, law and policy. Health Policy International, Princeton University, Oct. 27, 1987. 24. ReIman AS. Doctors and the dispensing of drugs. N Engl J Med 1987;317:311.
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