Pharmacy Update

FTC decision, and the staff is preparing that appeal now.

Survey of Pharmacy Law Available

FTC Raps Anacin Maker's Claims The manufacturer of Anacin and Arthritis Pain Formula would have to stop making claims that Anacin is a more effective painkiller than other aTC products and that it relieves tension, if an initial decision by a Federal Trade Commission administrative law judge holds. The decision, which may be appealed, stayed or docketed for review, contains an order requiring American Home Products Corporation to take corrective steps in its advertising campaign. Every Anacin ad would have to state that" Anacin is not a tension reliever. The company would be required to carry the notice until it had spent about $24 million to advertise Anacin. That sum is the approximate Anacin advertising budget for the five-year period ending in April 1973, when the tension relief ads ceased, accord\ ing to the FTC. Judge Montgomery K. Hyun found it "unfair" and "false" for II

American Home to claim that Anacin is more effective for relieving pain than any other aTC analgesic. The claim, he said, "is not only unfair to consumers but also false since the grea ter effectiveness of Anacin has not been scientifically established." Judge Hyun also rapped American Home's claim that Arthritis Pain Formula will cause · gastric discomfort less frequently than any other aTC analgesic. His order on this product would prohibit claims of comparative efficacy or safety unless they are established. The FTC judge said that Anacin's analgesic ingredient is not stronger than aspirin, since its main ingredient is aspirin. Hyun also noted that Anacin's only other ingredient, caffeine, is not an analgesic, but the judge ruled that caffeine disclosure statements in advertisements for Anacin are not required. A spokesman in the legal department of Anacin's manufacturer said the company intends to appeal the

The National Association of Boards of Pharmacy has completed its 1978-79 Survey of Pharmacy Law, which includes all 50 states, the District of Columbia and Puerto Rico. The guide, which covers state board organizational laws, licensure and reciprocal licensure laws, internships and state drug laws, is available for $5 from the NABP publications desk, ane East Wacker Drive, Suite 2210, Chicago, IL 6060l.

Study Will Evaluate Reimbursement by Capitation The National Center for Health Services Research has awarded a twoyear grant to G. Joseph Norwood, PhD, and his collaborators at the University of Iowa, to evaluate the savings potential of a capitation system for reimbursement of pharmacists. Norwood and his team will review the cost and impact on quality of care of the capitation system now used in two Iowa counties to reimburse pharmacists for drugs and services provided Medicaid patients. This system encourages pharmacists to reduce their costs through

Califano Ousts HCF A Head

Leona rd D. Sc haeffer

American PharmacyVol.NS18, No.12, Nov. 1978/675

Robert A. Derzon, the hospital administrator HEW secretary Joseph A. Califano Jr. hired to reform Medicare/Medicaid, was fired in September as director of HEW's Health Care Financing Administration (HCFA) . Califano named Leonard D. Schaeffer, an assistant secretary for management and budget, to succeed Derzon. According to published reports, Califano and Derzon were at odds on how fast the Medicare/Medicaid reform should move . The HEW secretary-who has vociferously advocated mandatory hospital cost controls-wanted to move faster than Derzon, who refused to blast the private health care sector, according to sources. Schaeffer is a former Citibank of New York financial vice president.

Robert A. Derzon

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such means as choosing generic equivalents when appropriate, and increasing the quantity of the drug dispensed to reduce the frequency of dispensing. Under the capitation system, Medicaid recipients choose a pharmacist to go to regularly. Those pharmacis ts then receive a monthly capitation fee based on the number of recipients on their rolls-equal to 85 perc en t of the estimated per capita cost for drugs and dispensing services. Incentive payments are awarded if the pharmacists' drug and management costs are less than the monthly fee; a differ en tial is paid if their cos ts exceed the capitation fee. The Norwood study is slated for completion in 1980. Drug Firms Are Spending More for Continuing Education According to a study of 13 pharmaceutical firms done by the Systema Corporation of Chicago, Illinois, marketing executives are spending more for continuing education (CE) programs. CE budgets of these firms are expected to rise 22 percent during 1978 over 1977 expenditures, according to

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Berton Winograd, the market researcher who did the study. Projected spending for CE among the 13 companies surveyed is about .002 percent of sales. The study shows that most of the CE programs sponsored by pharmaceutical firms during 1977 concentrated on major treatment areas, such as hypertension and rheumatoid arthritis. While the majority of such CE programs are aimed at primary care physicians, a number are developed for use by medical specialists and other health professionals, including pharmacists. FDA Cites Connection Among Retinoic Acid, Sun and Skin Cancer The Food and Drug Administration (FDA) has recommended that physicians warn their patients that retinoic acid (tretinoin) may enhance the cancer-causing effects of sunlight on the skin. Retinoic acid is a widely used topical medication for acne vulgaris. The FDA based its recommendation on studies with hairless mice at Temple University. The studies showed that mice given retinoic acid and exposed to simulated sunlight had a significantly higher incidence of malignant tumors than controls. The tumors con tin ued to grow even after the sunlight-plus-retinoic acid treatments were stopped. In an August 23, 1978, "Dear Doctor" letter to prescribers, tretinoin manufacturer Johnson & Johnson issued this new package insert warning: "Recent studies in hairless albino mice suggest that tretinoin may accelerate the tumorigenic potential of ultraviolet radiation. Although the significance to man is not clear, patien ts should avoid or minimize exposure to sun." Johnson & Johnson makes RETIN-A brand tretinoin and ABEREL brand tretinoin (sold by the J & J affiliate McNeil Laboratories). FDA to Sponsor Unif-of-Use Conference The FDA will hold a conference on unit-of-use packaging January 24-26, 1979, at the Dulles Marriott hotel outside Washington, DC. Speakers will include a hospital pharmacist discussing the reaction of the pharmacy profession to unit-of-

use packaging, a wholesaler, a physician and a consumer representative. Attendance is limited to 125. For registration information, contact Dr. Linda M. Strand, Unit-of-Use Packaging Conference Chairman, Office of Health Affairs, FDA, HFY -22, Room 11-42, 5600 Fishers Lane, Rockville, MD 20857. Lashof Gets Key OT A Health Position Joyce C. Lashof, MD, the high-ranking HEW official who resigned her post in May, charging that secretary Califano "bypassed" her, has been, appointed assistant director of the Congressional Office of Technology Assessment. Lashof became head of the OT A division responsible for programs in health and human resources on September 8, according to OT A director Russell W. Peterson. FDA Will Remove 'Convenience' Indication for Oxytocin The FDA intends to require labeling changes for oxytocin, a drug used to induce labor, that would delete the indication for elective induction of labor, according to an FDA spokesman. He said the agency is against the use of oxytocin merely "for the convenience" of the physician delivering the baby. The use of oxytocin in delivery is a controversial issue, especially among some consumer groups. The drug's possible toxic effects are summed up in Martindale's The Extra Pharmacopoeia: "Excess oxytocin may cause violent uterine contractions leading to uterine rupture and extensive laceration of the soft tissues, foetal bradycardia and arrhythmias, and perhaps foetal or maternal death." Chemists' Society Seeks Award Nominations December 1, 1978, is the deadline for making nominations to the American Oil Chemists' Society for the group's Award in Lipid Chemistry. Letters of nomination together with supporting documents-including a summary of the nominee's research accomplishments, publications, positions held and degreesshould be submitted with eight copies to Earl C. Hammond, Dept. of

American PharmacyVol.NS18, No.12, Nov. 1978/676

Food Technology, Iowa State University, Ames, IA 50010 before December 1 . Letters from at least three other scientists supporting the nomination must also be submitted with eight copies. Neither the nominator nor the nominee need be a member of the American Oil Chemists' Society.

Group Seeks Help to Survey Girls' Science Education The National Science Foundation has asked the American Association for the Advancemen t of Science (AAAS) to survey programs in science for women and girls. The results will appear in a publication that describes all efforts made between 1966 and the present to improve the science, mathematics and engineering education of girls and women in the United States and to increase their participation in science-related careers . Programs directed at any age level will be eligible for inclusion, as will work conducted by any type of orga:pization or agency. Projects of direct benefit to women and girls and research on the topic will be surveyed. People who know of projects which might be within the sc\ope of this inventory are asked to contact Dr. Michele L. Aldrich, OOS-AAAS, 1776 Massachusetts Ave., NW, Washington, DC 20036, (202) 467-5431 .

HEW Acts to Aid Disadvantaged, Needy Students The Department of Health, Education and Welfare (HEW) has taken two steps to aid students in a number of health professions, including pharmacy. In the first action, HEW issued "interim-final" regulations for administering $15 million to help attract disadvantaged students into careers in health. This program, authorized by a 1976 act, provides grants and contracts to schools and groups to recruit disadvantaged students. Grantees may provide counseling and/or financial help to these students . The "interim-final" designation means that the provisions are effective immediately, but may be modified after public comments are received. In the second. action, HEW an-

Am erican Pharmacy Vol. NS1 8, No .12, Nov. 1978/ 677

nounced "interim-final" rules for a new scholarship program for firstyear health professions students with "exceptional" financial need. While pharmacy is included in the $5 million program (FY 1978), priority will be given to schools of medicine, osteopathy and dentistry, according to HEW. Approximately 450 students will receive aid under the program in the 1978-79 school year.

PMA Sues New York on Substitution Law The Pharmaceutical Manufacturers Association (PMA) filed suit against the New York state departments of health and education on September 11, 1978, charging that the state's drug substitution law promotes unfair competition. PMA president C . Joseph Stetler said that the association will try to have the law declared unconstitutional and void. Stetler cited the following three major PMA objections to the law: • By mandating the dispensing of lower priced drugs, the law" actively promotes one element of the market over another," which PMA said handicaps research-intensive firms. • Drug manufacturers were denied their "constitutional right to comment in hearings" on the list of drugs from which New York state pharmacists must substitute. • When physicians do not prevent drug product selection (by so noting on the prescription form), the law "forces the dispensing of a different, lower priced product even if pharmacists and patients prefer otherwise." In late July, New York State Assembly speaker Stanley Steingut charged that a "drug industry propaganda campaign" was the main reason for "the failure of pharmacists and physicians to cooperate in lowering drug prices." Steingut said that the drug manufacturers' campaign was designed to frighten physicians and pharmacists by persuading them that their liability would increase if they selected lower priced generic drugs in place of higher priced brandname products. Steingut said that a speaker's office survey showed that in 25 years "there had not been one single law

suit based on substitution of a generic drug for a trade-name product."

Consumer Group Presses for Patient Access to Medical Records The Public Citizen Health Research Group (HRG) has published a guide called Getting Yours which is aimed at helping consumers gain access to their medical records. The Washington, DC, based group led by Sidney Wolfe, MD, wants consumers to pressure both Congress and their state legislatures to pass laws which would guarantee patients " unrestricted access to see, copy, and make corrections to their medical records." Wolfe, in a letter to Health, Education and Welfare secretary Joseph A. Califano Jr., chastises the HEW official for concentrating on waste in the health care system and neglecting other health care system reforms-e.g., access to medical records. "Guaranteeing patients a right of access to their medical records would

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empower citizens to improve their health and make better use of the health care dollar," said Wolfe. In a letter to Wolfe on access to medical records, Sen. Gaylord Nelson (D-Wn noted that Wisconsin was one of the first states to enact legislation guar-

anteeing consumers a right to see their medical records. "I believe that our statute has worked well," said Nelson. A congressional bill, H .R.I0076, based on recommendations of the Federal Privacy Protection Study

Commission, provides that patients served by institutions participating in Medicare-Medicaid may see, copy and correct their medical records. The bill, introduced on November II, 1977, is still pending in committee. 0

PCP Update: Can Demand Be 'Legislated Away?' An unusual recommendation by Paul Luisada, MD / depu ty medical director for St. Elizabeth's community mental health facility in Washington, DC, livened up an August congressional hearing on the continuing saga of PCP abuse. "I don't think the PCP (phencyclidine) problem is so much dependence as it is recreational," Luisada told the House Select Committee on Narcotics Abuse and Control. "There will always be' a demand in this country for substances that change the ,way people feel. The demand for mood-altering substances cannot be legislated away.:' Luisada explained that PCP is the first in a series of synthetic drugs that he expects to see reach the "unregulated marketplace." "Examine what present mood-altering drugs there are, decide upon a list of them that can be available to satisfy the demand and perhaps then the black market will disappear-and the incentive to develop new, maybe worse, drugs will end," he advised. Luisada's testimony was coolly reo:' ceived, for committee members felt such action would condone drug abuse.

Approach Low-Key At White House Level During the morning session of the day-long hearing, associate director of the White House Domestic Policy Staff Lee Dogoloff took a more traditional stand by reiterating the lowkey approach toward PCP advocated by the interagency PCP Action Coordinating Committee. Dogoloff inherited his position on the PCP committee following the July resignation of Dr. Peter Bourne from the White House staff; Dogoloff also inherited some of the criticism leveled at White House handling of PCP policy. "Why haven't you moved before

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this 7" committee chairman Lester Wolff (D-NY) demanded after Dogoloff described the national PCP abuse problem. "You know all of this; if this information is available it requires action, not merely an exposition before a committee of Congress." The hearing bogged down over the legal definition of Schedule I drugs; Dogoloff and representatives from the National Institute on Drug Abuse (NIDA) indicated that PCP's legitimate use in veterinary medicine might prevent it from being rescheduled as a substance with no approved medical use . "I don't want to hear any cockamamie excuse about veterinarians," Rep. Charles B. Rangel (D-NY) said angrily. IIWe are not going to protect the veterinarians at the expense of our children." Dogoloff promised to "look into" the rescheduling question and also promised Wolff a White House action report on PCP. He told the committee he had no specific recommendations to make about PCP policy other than a low-keyed educational effort aimed at encouraging "attitude changes" rather than using scare tactics. He also said he and other PCP comittee members would rather design programs against polydrug abuse rather than just against PCP.

Bentsen's PCP Legislation The PCP committee also does not support legislation to control the chemical piperidine because it "isn't going to do what we want it to do," Dogoloff said. "There are another 29 or 30 ingredients (for PCP) that could be substituted .f or piperidine," he told the committee. Senator Lloyd Bentsen (D-TX), who made a brief appearance to drum up House support for the legislation in question, took issue with Dogoloff's testimony, saying

his advisers told him piperidine was essential to the production of PCP. None of the other witnesses could verify or refute the claim. Bentsen's legislation, an amendment to the Psychotropic Substances Act, has passed the Senate, and House approval was imminent as this article went to press. The Carter administration supports it. Peter Bensinger, administrator of the Drug Enforcement Administration, and two NIDA researchers told the select committee about their · agencies' responses to PCP abuse.

DEA Looks to Rescheduling DEA is concentrating on controlling illegal PCP manufacturing operations and rescheduling the drug's analogs and precursors, Bensinger said. He announced that two more PCP analogs are being placed on Schedule I; the rescheduling process is expected to be completed by the time you read this article. One problem highlighted by Bensinger is the light sentences many PCP traffickers receive when brough t to trial. "Heroin traffickers are moving to PCP because it involves a small investment with great return at little risk/' he said. NIDA has been collecting data on PCP abuse, and the researchers admit that there is still scanty information about the drug's effect on the human mind and the actual amount of abuse going on across the.country. NIDA efforts to deal with PCP abuse' have included the formation of a task force and development of general drug abuse educational materials. "NIDA educational efforts leave a lot to be desired," said one committee member. - Lilah Lohr

American Pharmacy VoI.NS18, No.12 , Nov. 1978/678