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Executive Summary

OTC drug educational programs should be aimed at the medical community and health professionals as well as consumers, ex-FDA Commissioner Arthur Hull Hayes urged in a presentation to the 8th General Assembly of the World Federation of Proprietary Medicine Manufacturers (WFPMM) in Washington, D.C. on Sept. 22. "It is important," Hayes declared, "for health professionals to understand non-Rx drugs, to understand that they are based on the same cutting-edge science, on the same high-technology" as Rx medicines. Hayes noted that "physicians and their extenders in this country and elsewhere -- whether they be the country practitioner, the nurse, the nurse/midwife, the physician assistant -- all are involved in the total care of the patient and that may very well involve a non-Rx drug." Hayes, who left FDA in September 1983 to head the New York Medical College, is now the president of EM Pharmaceuticals, the U.S. subsidiary of E. Merck. He warned the OTC manufacturers and marketers that "to say that physicians are in charge of Rx drugs and patients are in charge of non-Rx drugs is to deny the reality and to set the stage for disaster." WHO/PAHO representative Enrique Fefer also urged the OTC industry to undertake, on a worldwide basis, educational programs for health professionals. Noting that the OTC industry is skilled in "the preparation and dissemination of information," Fefer challenged the industry to "promote and support the development of teaching materials for health personnel and the public." He continued: "We know inappropriate products are being dispensed for self-medication by untrained pharmacy assistants whose white jackets give them an air of authority and professionalism." Fefer maintained that a recent study in a "relatively developed" South American country showed that benzodiazepines were dispensed without Rxs 61% of the time, with the diazepam subclass dispensed without Rx 75% of the time. WHO Asks For Industry Projects To Train Professionals About Rational Self-Medication Fefer asked: "Why not develop for [health professionals] appropriate training programs on rational drug dispensing that examines the benefits and risks of self-medication?" Similarly, Fefer suggested developing joint projects with universities, health departments, or professional organizations in the Third World to "produce popular information on health care and the proper place and use of OTC drugs." The WHO official said the international organization would "be a willing partner" in educational efforts. The increased communication to health professionals called for by Hayes and Fefer appears to be occurring in the U.S. through a shift in promotional priorities. Marketing consultant Charles Kline (Charles H. Kline & Co.) told the WFPMM meeting that OTC companies in the U.S. are already moving promotional resources away from the mass market toward a "hybrid" approach aimed at both the medical community and consumers. Kline reported that the percentage of U.S. OTC sales attributed to direct promotion to the consumer dropped from 78% in 1980 to 63% in 1985. Simultaneously, products promoted to both the health professional and consumer increased in share of total OTC sales from 7% in 1980 to 27% in 1985. OTC products promoted "ethically" (exclusively to the health professionals) dipped from 15% of total sales in 1980 to 10% in 1985. "We see a great many products that have benefitted by this" change to "hybrid" promotion, Kline observed, "cough/cold remedies in particular." Yale public health professor Lowell Levin told the WFPMM meeting that a recent WHO study in Europe "revealed the non-surprise that, with the exception of pharmacists, precious little attention in the education of health professionals was given to OTC or to self-medication in general." Levin urged the proprietary industry to "ensure that quality social research on the use of OTCs and research on the specific properties of OTC products are made available to academic departments of social medicine, pharmacology, and appropriate counterpart nursing and dental schools; support OTC research in schools of health professions and departments of social sciences (anthropology, sociology, economics and psychology); and provide continuing education resources to health care practitioners at point-of-practice and scientific meetings." Fefer and Hayes also encouraged the OTC companies to increase their efforts to educate segments of the general population. Hayes, for example, pointed out that there are specific subgroups of the population, such as the functionally illiterate or elderly, who have difficulty understanding OTC self-medication instructions. No matter what the economic system, Hayes said, "the non-prescription drug industry . . . ultimately must serve the consumer . . . But there are special problems: some consumers are illiterate, some consumers are elderly and cannot read well." Hayes asked, "how are you going to deal with them short of denying them the ability to self-medicate?" He urged the OTC firms to "be creative and find ways to bring your products . . . to those in need whatever their problems, whatever their capacities." OTC Use Information Is Essential "Software"; Non-Product Education Urged By Yale Professor Hayes maintained that the OTC industry has a duty to "educate those whom you serve . . . physicians cannot do it in the same way or as effectively as you can." Without suggesting specific educational programs, Hayes said, "it can't all be done on the label." Fefer compared OTC drug use information to essential computer "software." The product alone ("hardware"), Fefer said, "is of little use without the appropriate software (accurate information) for rational use." If increased use of OTCs is to be encouraged as a way to free resources in the health care segment, Fefer said, "we must provide [individuals] with accurate information, information that is culturally relevant and clearly understood. Just as OTC products are available in remote villages and towns, so should accurate information." The WHO request for commercially sponsored education programs is similar to projects undertaken by the Pharmaceutical Manufacturers Association earlier in this decade to help develop drug delivery infrastructures for Rx products in several African countries. PMA and Rx companies supported projects in Sierra Leone and Kenya. Yale's Levin urged an "industry-wide consortium" to work with national health departments "to develop and pool at each national level a non-product specific publication effort that is aimed at strengthening self medication knowledge and skills." Levin noted that WHO has "struggled" for almost 30 years to "modernize school health education," but Levin maintained that there "are still too fee examples of approaches that help the child practice health decision-making skills." Fefer maintained that OTC promotion in developing nations is not addressing primary health problems. He noted that government and WHO efforts to encourage use of oral rehydration products in Peru, "where diarrheal diseases constitute a major cause of infant mortality," are not succeeding. Those products are not among the top 15 leading OTCs. "But whoever is promoting topical mentholated rubs," he added, "is doing a superb job -- two such products are among the top five OTC sellers" in Peru.

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