Spokesmen for organized pharmacy do not think on-site pharmacy service will benefit pharmacists

By Patricia J. Bush and Pharmacy Albert I. Wertheimer and the HMOThe British Experience

It is inevitable that there will be changes in the medical needs of a population as a result of medical advances and changing disease and demographic patterns. If the response to these changing medical needs is a gradual or minor change in health services, provider groups are rarely inconvenienced and their cooperation is usually assured. If the change in health services is rapid or major, however, as is the current move of British general practitioners to health centers (the British equivalent of the HMO), certain provider groups may feel themselves to be seriously threatened. Representatives of a threatened provider group , while seeking to maintain, if not to raise the status and income of the group 's members, will argue in public statements and in bargaining with the government that an arrangement of health services which maintains or relatively elevates the position of the group is in the best interests of consumers. Because the cooperation of providers is required for provision of medic al services , a strong case must be made by government, competing provider groups or aroused consumers to inspire substantial change in arrangements that members of a provider group believe not to be in their best interests. The pharmacy profession is an interesting case in point. Pharmacists in Britain have been forced to consider the implications of reorganization of the British National Health Service (NHS) with the general practitioner service in health centers. Seemingly, a health center would be a place where a modern pharmacist who has been " over-educated for what he does and under-utilized for what he knows" could employ his expertise and become a contributing member of a health team . It may be, however, that gains made by situating pharmacy service within health centers would not be worth the dysfunctional aspects of such an arrangement and that satisfactory trade-offs are not available. Although pharmacists can envision longterm benefits to the profeSSion, they are not likely to favor a change if they cannot personally expect to share in the benefits . At present, spokesmen for organized pharmacy do not believe that on-site pharmacy service in health centers will benefit pharmaCists. They have taken the position that there should be no on-site service if there are existing pharmacies (chemist shops) convenient to health centers, that access to NHS dispensing contracts should

be limited and that existing chemists should not be allowed to move or " leap-frog "· closer to health centers. Spokesmen argue that the neighborhood chemist shop must be preserved because it is convenient, an important source of health advice and a tradition in British life . Perhaps it is best to maintain the status quo; on the other hand, this may be too much of a luxury when resources are scarce and demands are high. This article examines the decisions to discourage onsite pharmacy service in the now rapidly burgeoning health centers in Britain .

--.--------_.._-_ .. __ .•. - --- _. --- ---- - _ .. ._Based on a paper presented be fore the Economics and Admini strative Science Section at the APh A Academy of Pharmaceutica l Sciences National Meeting in San Diego, Califor-

Health Center History Health centers, mandated in the 1946 National Health Service Act, were first mentioned as early as 1920 in the Dawson Report. The 1946 concept of a health center was a community center from which all general practitioner services, ambulatory specialist services and all services provided by local health authorities, including health education, would be provided. The duty to provide health center premises was conferred upon local authorities by Section 21 of the Act. Section 21 (1) ... It shall be the duty of every local health authority to provide, equip and maintain to the satisfaction of the Minister premises, which shall be called 'health centers ' at which facilities shall be available for all or any of the following purposes: (a) for the provision of general medical services under Part IV of this Act by medical practitioners; (b) for the provision of general dental services under Part IV of this Act by dental practitioners; (c) for the provision of pharmaceutical services under Part IV of this Act by registered pharmacists; (d) for the provision or organization of any of the services which the local authority are required or empowered to provide; (e) for the provision of the services of specialists or other services provided for out-patients under Part II of this Act. , . For Scotland, the main difference in the NHS (Scotland) Act of 1947 was that the responsibility for provision of health centers was conferred upon the Secretary of State instead of local authorities. At the inception of the NHS in 1948, only nine health centers existed and, despite the NHS Act, only 20 more were built between 1948 and 1963. Only two of these,

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nia. November 13, 1973.

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• A chemist shop is said to have " Ieap-frogged" if it " jumps " not only c loser to a health center but closer than all other chemists.

Table I

Health Centers in Great Britain

- 1948 1948-1963 196 4- 1968 1969 - 1971 Total ope n Und er co nstruct ion App roved Act ively pla nn ed Tota l ope n o r pla nned

9 20 74 185 288 140 100 192 720

Sou r ce - B l oomf i e ld , J. C " "H ea l t h Ce n ters , Gro u p Me di ca l Prac ti ces and Ph a r macy , " Ph arm. J. , T ab l e 1, 292 (1 971 )

one in England and one in Scotland, had pharmacy departments.2 There are two reasons why more health centers were not built-( 1) an historic reluctance of general practitioners to come under the control of local authorities which was believed to lead to a salaried service and consequent interference with clinical practice and (2) the cost of the centers was too great a burden on local taxes already strained to provide housing, education and other social services in post-war Britain . Pharmacists generally did not support the building of health centers , They shared a reluctance with general practitioners to come under the control of local authorities and felt that on-site health center pharmacy service would threaten the economic viability of established chemists , Furthermore, they considered a provision in the Act unfair which allowed the hiring of pharmaCists but not physicians or dentists , The reluctance of the primary providers of health services to work in health centers, along with the fund shortage and general lack of dissatisfaction with the general practitioner segment of the NHS effectively strangled the health center program until the 1960s. In that decade, several critical studies of the general practitioner service and facilities, lengthening patient lists and an increasing awareness of the psychosocial aspects of disease stimulated concern with the status of general practitioners and awakened interest in health centers 3 These factors, the financial advantages of group practice and the success of experimental attachments of auxiliary personnel to practices finally won general practitioners to an acceptance of health centers, From 1964 through 1968 local authorities built health centers at an average of 19 per year (Table I, above) , However, as pressures for grouping the primary health services mounted and financial pressures

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eased, an additional 50 health centers were opened in 1969. By the end of 1971 the total had increased to 288 with a further 240 in building stages and 192 in active planning stages. Current estimates project 1,300 health centers will be in operation by the end of 1980 4 Three thousand of the more than 20,000 general practitioners are expected to be practicing from health centers and hardly a chemist will be unaffected. Pharmacy and the Health Center Pharmacists mounted a long and successful campaign to rescind the provision in the 1946 Act which permitted local authorities to hire pharmacists but not physicians or dentists. The 1968 Health Services and Public Health Act made it clear that in new health centers in England and Wales, local authorities could not employ registered pharmacists to provide pharmaceutical services. In the few health centers where pharmacists were already employed by local authorities, no change was required but the number of pharmacists employed was not to be increased . Local authorities were empowered to provide pharmaceutical service in health centers on a contractor basis only . The Pharmaceutical SOCiety of Great Britain recommended the following guidelines-when a health center proposal is submitted to the Department of Health and Social Security (DHSS) for approval , the lOcal pharmaceutical committee, which is elected by and represents area pharmacists, is sent details of the proposal by the local authority's Executive Council listing the physicians who will be practicing from the proposed health center and the chemists who are within a one-half mile radius of the proposed site. The committee considers what effect the center will have on chemists' businesses and reports its views to the Council. If the committee determines that pharmacy service should be provided within the center, the chemists within the radius are invited to participate in a consortium to provide pharmacy service within the health center .2 The guidelines are not always followed. While most areas have an informed and actively involved pharmaceutical committee, not all committees are promptly advised by their Executive Councils when a health center is proposed 4 Nor is the information always available from the DHSS because local authorities do not always notify the Department until they are seeking approval of capital borrowing for construction of a health center .

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In February 1972, the DHSS approved in principle the provision of pharmacy service on a contractor basis in seven health centers in England and two in Wales. At that time there were applications for 13 more, in all cases by consortium 6 Planned consortia are reported to include up to 14 chemist contractors consisting of chain as well as independent chemists l .8 Present plans project that fewer than 50 of the 1,300 health centers either built or projected will have on-site pharmacy service . The provision of on-site pharmacy service is viewed as a threat to an already threatened sector of British business . In 1972 there were 12,202 pharmacies-one for every 4,000 persons using the NHS. The number of pharmacies had decreased from the 1955 number of 15,313 .9 The average number of closures has been 250 per year since 1966. The closures are in line with the generally decreasing viability of small independent retailers . The smallprescription volume chemist has the greatest risk of closing. All of the chemists who closed between 1963 and 1969 were dispensing less than 18,000 prescriptions per year. 10 .11 The average chemist contractor dispenses about 80 prescriptions per day in a six-day week which accounts for 40 percent of his turnover of £29,000 (about $75,000). His expenses are deducted from a gross profit margin of £ 3171 (about $8,200) .12.1 3 While NHS prescription volume increased in the sixties, it has leveled off in recent years and the move of physicians into health centers is not expected to increase the total prescription volume . Thus, it is clear that on-site health center pharmacy service would decrease prescription volume in existing area chemist shops, contribute to the closure of smallvolume chemists and reduce the income of others . The Butetown, Cardiff, story is widely repeated and strikes fear in chemist-owners 4 In 1966 when physiCians moved into the new health center and a pharmacy opened directly adjacent to the health center, one pharmacy lost 75 percent of its dispensing business " overnight" and two more closed within the year. Customer loyalty did not supersede convenience. There are no plans to change the traditional methods of reimbursement for health center prescription dispensing which includes an on-cost fee based on the average overhead costs of all chemist contractors. Such a system favors the larger volume dispenser who is likely to have a lower than average actual overhead cost

per prescription , while the small volume dispenser is likely to have a higher than average actual overhead cost per prescription. Because total area prescription volume will not increase, actual costs to members of an on-site consortium will increase with no compensating increase in volume. Thus, if the additional costs and income are apportioned in equal shares to members, the small volume store might gain on balance. However, if the shares are apportioned on the basis of the prescription volume in the existing community pharmacies, the smaller contractors will suffer increasing economic pressures . In the face of threats to the economic viability of many members, the Pharmaceutical SOCiety has asked the government to change its policy of unlimited entry into NHS dispensing contracts, at least within a prescribed area around a health center . To date, governments have largely accepted the principle that chemist shops are providing a valuable service in the health delivery system and that this service should be retained, but not to the extent of protecting a small volume dispenser by restricting entry into NHS contracts or by paying actual overheads in on-cost calculations instead of average overheads . Historically, the government's bargaining with representatives of community pharmacists has been over conditions of services such as renumeration and hours ; discussions of pharmacy service in health centers have followed this pattern as well. Position of Organized Pharmacy The request for limitation of entry into NHS contracts has not been granted by the government. However, a decision to let local pharmacy areas withhold on-site pharmacy service from their health centers has been made. The decision rests on two points which are rarely challenged, the first refers to the importance of the service performed by neighborhood chemists and the second to their present accessibility. The first assumption, that neighborhood chemists are performing an important service, rests not so much on their ability to dispense medicines but on their ability to dispense health advice . There is a further assumption that when pharmacists give advice on health they are not only qualified to give it, but they give advice which is significantly better than a layman would give. This further assumption has never been challenged . The government first officially recognized the advisor function of pharmacists in the Medicines Act of 1968. Part II Sec-

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tion 10 provided exemptions from the requirement to · obtain a manufacturing license when the procedure consisted of the ... preparation or dispensing of a medicinal product for administration to a person where the pharmacist is requested by or on behalf of that person to do so in accordance with the pharmacist's own judgment as to the treatment required and that person is present in the pharmacy at the time of the request . .. In the words of the White Paper (Cmnd. 3395) preceding the Medicines Act, the pharmacist is ... specially qualified to exercise proper professional discretion over the sale and supply of drugs to the public . .. References to the advice function are frequently found in pharmaceutical publications; for instance, from the Pharmaceutical Journal published by the Pharmaceutical Society of Great BritainApart from his very important role in dispensing and giving advice to the public and the medical profession in connection with dispensed medicines, he often acts as the friend and confident of the whole community which he serves. No other professional person is so readily accessible as is the pharmacist, and during business hours he is always there to give his customers the benefit of his knowledge and experience, should it be required. With the growth of the appointment system in medical practice, I find that the public are turning more and more to the pharmacist for guidance and help. He has always provided this service but it is now being requested with greater emphasis, and his responsibilities in this direction were officially recognized in the Medicines Act, 1968. By undertaking the treatment of minor ailments, he relieves the medical practitioner of a considerable work load and in appropriate cases, by giving firm advice, encourages patients to seek early medical treatment. None can deny the importance of this work to the NHS.14 A Medical Officer of Health in an address before the Royal Society of Health in 1963 saidI am concerned with the role of the smaller pharmacy as a centre for information on matters of health; the small pharmacy is a unit of the local community-part of the neighborhood-people seek advice on a host of health matters. 15 In a 98-page report published by a subcommittee of the standing medical advisory committee of the Central Health Ser-

Vol. NS 15, No. 12, December 1975

vices Council the section on pharmacy referred to the role of the pharmacist as health advisor statingWe know that many people who feel ill do consult their pharmacist a long time before they consult their doctor, and this has been shown by a survey in London by Butterfield. 16 A document, "Pharmacies in Health Centre Areas," published in May 1971 by the Pharmaceutical Society contains the following section2. Is Advice Sought from a Pharmacy? The use made of the advisory service available from a pharmacy varies according to the location of the business and is influenced by several factors, not the least important of which is the time a particular pharmacist has been in practice in an area and hence how well he is known. The general practice pharmacist in a large village, a housing estate or a residential suburb, who is well-known to residents in the area, will certainly expect to be asked for advice much oftener than the pharmacist whose business is situated in a city or town centre and who depends on 'passing trade' for much of the turnover from counter sales. There are well-defined groups who tend to seek advice from a pharmacist, more often than average. In particular, the mothers of young children, especially the mother of a very young first child, will tend to develop the 'baby care ' section of the business, the policy being to some extent encouraged by the fact that a higher than average proportion of customers want help and advice on baby care products . ..

A second group tha t tends to seek advice from the pharmacist more often than normal is, of course, the elderly, and the pharmacy with a higher than average proportion of elderly people in the surrounding population is certainly used widely as a source of information on health matters . .. 3. Specific Requests for Advice Naturally the pharmacist is presented with his best opportunity of advising a customer when he is specifically asked for help. Such requests come in several different forms. A customer, after asking for a particular medicine may ask 'Is this preparation good for . .. ?'; or the customer may ask the pharmacist to recommend a preparation for the treatment of a particular ailment. In such cases, the pharmacist has to decide whether a customer should be advised to visit a medical practitioner without delay or whether a preparation can safely be supplied and the customer advised to use it for several days, visiting the medical practitioner only if the symptoms are not relieved. The fact that the pharmacist is asked to provide this kind of advice many times every working day was illustrated in the survey conducted by Dr. M. Whitfield . .. Professor W. J. M. Butterfield (1968 Priorities in Medicine, the Nuffield Provincial Hospitals Trust) also illustrated the role of the pharmacist in this field. The value of advice from the pharmacist that the medical practitioner should be consulted at once should not be underestimated . .. The customer is

Patricia J. Bush

Patricia J . Bush, MSc, is an instructor in the department of community medicine and international health, Georgetown University school of medicine . She received her BS in pharmacy from the University of Michigan and her MSc in medical sociology from the University of London. Having worked in both hospital pharmacy and college of pharmacy faculty positions, her current interests are in medicine use and prescribing quality. She is a member of APhA, the American Sociology Association and the American Public Health Association.

Albert I. Wertheimer

Albert I. Wertheimer, PhD, is associate professor and director, graduate program in pharmacy administration, University of Minnesota college of pharmacy. He holds a BS and MBA from the University of Buffalo and the State University of New York at Buffalo, respectively, and a PhD from Purdue University. Prior to moving to Minnesota, he was on the SUNY IBuffalo faculty and on leave from there served as acting chief, Pharmacy Branch, National Center for Health Services Research and Development, HEW. Wertheimer is on the editorial boards of Medical Care and Drugs in Health Care, and is a contributing editor to International Pharmaceutical Abstracts. He is a member of APhA , American Marketing Association, American Public Health Association and FIP.

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probably much more likely to accept and act upon such advice given by a pharmacist than on a similar suggestion made by members of his family or by friends . Evidence in support of the claim that pharmacists are valuable as drug advisors rests on the survey by Whitfield 17 and the survey by Butterfield et al., 18 both published in 1968. The Whitfield survey was based on a sample of 20 pharmacists in eight towns over two days. There is no evidence that these samples were randomly selected . Of the 21,807 persons who were served, 616 asked some medically related question. Of these, 431 were women, 165 were men and 20 were not ascertained. The average advice seeker per store per day was 11 in 545, customers , or two percent. Of those asking advice 35, or less than si x percent, were referred to the physician . For those who purchased o-t-c medication, one in 35 (less than three percent) asked advice . In the only attempt to assess the quality of advice given by a community pharmacist, Whitfield's report is remarkable . 1? In all 616 instances of advice giving, Whitfield judged the advice to be appropriate . The use of the Butterfield survey to support an argument for the value to the community of the chemist shop is an error. The survey was done in 1963 in a statistically selected 2,500-person sample of the Bermondsley and Southwark low-income areas in Southeast London. Of those interviewed 95 percent had suffered one or more incidents of ill health in the previous two weeks and 12 percent of these had visited their physicians . The majority had taken some o-t-c medicines of which two were taken to everyone prescribed by a physician. The report statesPeople use the chemist far more than we might care to acknowledge because it is easier to make a self-diagnosis of a symptom or select from goods on the counter than to submit to waiting time . 18 However, only one percent of those who reporten buying o-t-c medication reported they had sought the pharmacist's advice . The Butterfield survey is critical of the public 's general knowledge of disease therapy . The researchers cite numerous examples of medicine misuse such as the ingestion of aspirin or antacid to relieve respiratory difficulties. Thus, while the need for advice is apparent, the role of the pharmacist as an advice giver is negligible . While granting there is a large reservoir of relatively minor and transient morbidity in the community which is probably not exac-

694

erbated by self-medication, the Butterfield study is more of an indictment of community pharmacy than a justification for government support. A third survey in 1969 of 1,412 adults by Dunnell and Cartwright also challenges the idea that pharmacists are frequent advisors . While an average of 1. 1 o-t-c medicines per household was purchased in the month prior to interview, for only about six percent was the chemist the first person who suggested the particular medicine. 19 Several reasons suggest why British pharmacists (like their American counterparts, 20.2 1) are infrequent dispensers of advice- ( 1) pharmacists are not expected to give advice, (2) the remuneration system does not encourage it, and (3) they are not educated for the task . Since the public rarely asks pharmacists for advice, it may be there is little recognition by the public that this is the pharmacist' s proper function . Nor has the advicegiving function been supported by most physiCians . Dunnell and Cartwright found that while 75 percent of general practitioners thought the public should be encouraged to ask nurses about health and medicines, only 31 percent thought the public should be encouraged to ask pharmacists.1 9 While the 1968 Medicines Act recognized the pharmacist' s advice-in-product selection function following a patron 's selfdiagnosis, he has not been recogni zed as performing or having a duty to perform the fun ction of warning patients about side effects, contraindications , or risks or hazards associated with taking the medicine . When it has been suggested that pharmacists assume this function , British Medical Association spokesmen generally have not approved .22 .23 However, in the absence of any study assessing the quality of advice, or the ability of pharmacists to give advice, such abilities must remain in doubt. Physi-. cians ' statements saying they desire to retain a monopoly in health information are thus not unreasonable. The remuneration system which depends on a fee for each prescription rewards those who dispense the most in the least time . There is no evidence that time spent in giving advice to patrons will increase sales volume. Indeed, the physical arrangements of traditional chemist shops are rarely an inducement to conversation with the pharmacist, nor is the self-service arrangement which is increasingly found in chemist shops . Patrons are encouraged to shop and to buy while waiting for prescriptions to be dispensed.

The third reason pharmacists do not assume the advice-giving role is related to their education. A pharmacy student is trained in one of 16 degree courses approved by the Pharmaceutical Society as fulfilling the academic requirements for registration as a pharmacist. 24 Although these degrees vary somewhat in emphasis , approval is conditional upon subjects being broadly based in three areaschemistry of drugs, pharmaceutical action of drugs , and actions and uses of drugs and medicines. Although the third area might be thought to include psychological and social factors in the taking of medicines, health-seeking behavior, or the responsibility of the pharmacist as a health advisor, a careful reading of the curriculum clarifies the intent- "Actions and uses of drugs and medicines" includes " microbiology, plant biology ... " The social sciences are not in evidence . Nor are refresher courses or post-graduate training ever related to the advice function. It can be argued that while pharmacists are neither encouraged nor trained in the advice function, their highly technical education prepares them to answer health-related questions. If the advice function is not encouraged or fulfilled in education or in actual practice, the possibility remains that the pharmacist fills an important function as a drug expert and advisor to physiCians . The following statements are typical of those found in almost any professional pharmacy publica tion . They are reiterated at professional gath ering s and in graduation addresses. If the simple act of dispensing did not justify professional status what did? ... the pharma cist should develop his advisory role to the medical profession . .. 22 .. . the general practice pharmacist would advise the general medical practitioner on the composition and form of drugs and their pharmacologic action . . .25 . .. it is he (the pharmacist) who has the specialized knowledge to advise both the physician and the patient . .. 26 However, in a government sampling ' of general practitioners designed to find out where they obtained information on existence and efficacy of new drug products, pharmacists were not included in the list of 11 named sources . For new products , 34 percent of physicians reported they obtained information from manufacturers ' representatives , and 10 percent from literature. For efficacy , journal articles, consultants, other general practitioners, drug firm

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representatives, and the literature were the most often cited sources.27 If the pharmacist wishes to be a drug advisor to physicians interaction is required . As long as the dispensing function is performed at a distance from physicians, the physical division is likely to be counter-productive to the pharmacist-to-physician advice function . The second point in support of retaining and/or protecting the neighborhood chemist is his convenience and accessibility to the public. However, there are no renewal prescriptions in the NHS; patients must return to the physician for each prescription . Therefore, locating the dispensing of prescriptions beside their origin would actually increase convenience . The charge that a health center pharmacy would be inconvenient must be in regard to the purchase of non prescribed medicines. But o-t-c medicines are available in other types of shops and would be increasingly so if local chemists shops closed because of on-site health center dispensing . Thus neither the performance of an important service nor convenience to the public argue strongly for protecting neighborhood chemists and limiting on-site health center pharmacy service. Nevertheless, these arguments were used by witnesses before the Working Party on National Health Service General Pharmaceutical Service of August 1972, a committee appointed by the Council of the Pharmaceutical Society , the Executive Committee of the National Pharmaceutical Union and the Central NHS Chemist Contractors Committee to consider aspects of pharmacists ' involvement in the NHS .2B Lay witnesses were satisfied with the nation 's pharmaceutical service and considered convenience to the public of paramount importance . On the other hand , written and oral testimony of some pharma-

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statement that " .. . a commercially oriented pharmaCist is as zealous in guarding professional standards .. . " is seriously in doubt. It appears the status quo is. maintained to avoid undermining the economic viability of existing neighborhood chemists. Those few health centers planning pharmaceutical service will have as little impact on existing chemists as possible, e .g., the Kirkcaldy health center pharmacy will be dispensing only, "so it won 't undermine the economic viability of existing business." 9 No health center pharmacy service is expected to give patients or physicians any services beyond what is being given now by community pharmacies . There will be no on-site pharmacy service where the local chemists feel the service they are providing is adequate. Pharmacy appears to be faced with a dilemma . In its struggle to gain status and power as a health profession as well as to retain control over licensure, pharmacy has increased educational requirements, limited entry to the profession and has argued that pharmaCists should be represented in health planning. It has argued that pharmaCists have an expertise that is largely wasted, and that they should become valued health team members with a career structure, shorter and more flexible hours , and the oportunity for colleague interaction . Fulfillment of these goals might be attained best in a health center pharmacy, but also that on-site pharmacy service is likely to bankrupt some present members of the profession. With planning, the dysfunctional aspects of the move of pharmaCists to health centers need not be severe. By imagining that all dispensing were done in health centers,

(Continued on page 704)

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References 1. Ministry of Health , Con sultative Council on Medical and Allied Services. HMSO (Cmnd . 693). London (1920) 2. Bloom field , J . C., " Health Ce nters, Group Medical Practise s and Pharmacy" · Pharm. J .. 207, 292 (1971) 3. Central Health Services Counc il, Standing Medica l Advisory Committee. " The Field Work of the Family Doctor," HMSO. London (1963) 4 . Maddock, D . H., " Studies on the Distribution o f Health Centers and Their Impa ct upon Pharmacy and the Community ," unpublished master 's thesis, University of Wales (1970) 5. ·· 500 Hea lth Cen tres by 197 4 ,,· Pharm. J. 208, 173 (1972) 6. " Health Centre Consortia : Interest Grows." Pharm. J.. 208 , 12B (1972) 7. " Swindon Pharmacy Consortium ," Pharm. J., 208, 2 15 (197 2) B. ··Kirk ca ldy Health Centre Pharmacy,,· Pharm. J . 207 , 441 (1971) 9 . " London: Health Centre s and Pharmacy, " Pharm. J. , 208, 11 2 (1972) 10. Ministry of Health. 1963 Annua l Report. HMSO: London (1964)

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cists showed considerable dissatisfaction with conditions of pharmacy practice . They testified that pharmacy failed "to provide a career that is either economically or professionally satisfying." The report of the Working Party sided with the lay witnesses, suggesting that pharmaCists should not be unhappy with the present organization of general practice. In pointing out the advantages of the diversified chemist shop the report stated(1) the public is satisfied, (2) concentration into professional work would result in fewer pharmacies and therefore more inconvenience to the public, (3) there are not serious grounds to charge that those overseas countries (United States , Australia, New Zealand) which have followed the British model are poorly served pharmaceutically, (4) there is no evidence to show that commercially oriented pharmaCists are less zealous in maintaining professional standards than are more professionally oriented pharmaCists . The report goes on to sayWe think that at this moment in its history, the courageous thing for it (Pharmacy) to do is to face the circumstances that in fact exist and, without apology or excuse, to regard as a challenge and an opportunity the need to fuse a professional with a commercial outlook. Experience suggests it need lose no public esteem by doing so. Noticeably lacking are statements on whether the public would receive better health care under a different service arrangement. On point four alone, in an analysis of prescription violators in the U.S., Quinney showed that of 16 percent of pharmaCists classed as professionally oriented, none were violators .29 Of the 20 percent of business-oriented pharmacists, however, 75 percent were violators . The 11 . Department of Health and Social Security, Annua l Report for 1970. HMSO, London (1971) 12. " The Pharmacist, the Industry and the Health Service, " Pharm. J .. 208, 42 (1972) 13. ··NPU and Voluntary Trading .. · Pharm . J, 208, 207 ( 1972) 14. Bloom field . op. cit. 15. Sprowls, J . B ., " The Role of th e Pharma cist as a Public Health Consultant, " National Congre ss o f Medicines and Pharmacy. Chicago. lit. ( 1964) 16. Sta nding Medica l Advisory Committee," The Organization o f Group Pra ctice. HMSO, London (1971) 17 . Whitfield , M., " The Pharma cist' s Contribution to Medical Care .. · Practitioner. 200, 434 (196B) 18. Butterfield, W . J . H., Priorities in Medicine, Nuffield Provincia t Hospitals Trust. London (196B) 19. Dunnell, K., and Cartwright, A., Medicine Takers. Prescribers a nd Hoarders, Routledge & Kegan Paul, London and Boston (1972) 20 . Pharmacy and the Poor, America n Pharma ceutica l Associa tion. Wa shington , D .C. (1971) 2 1. Knapp. D. A., Wol f. H. H .. Knapp . D. E.. and Rudy. T. A ., ··The Pharma cist as Drug Advisor .. · JAPhA. NS9( 10) 502 ( 1969)

22 . Teeling-Smith. G.. Pharm. J., 206, 468 (1970) 23 . British Medica l Association . Young Pra c tit ioners Subcommittee Proceedi ngs ( 197 1) 2 4. ·'The Schools o f Pharmacy.'· Pharm. J. 207,1 3 (1971) 25. Attributed to Turner P., in " Future of Medicine and Pharmacy ." Pharm. J . 207 , 549 (1971) 26. Attributed to Darling W . W ., in ·· The Pharmacist's Responsibitity" · Pharm. J., 208 , 252 ( 1972) 27 . Sainsbury Report of the Committee o f Enquiry into the Relation o f the Pharmaceutical Industry with the NHS, HMSO. London (1967) 2B. ·-Working Party on National Health Service Generat Pharmaceutical Services," Report to the Central NHS (Chemist Contractors) Committee. Pharm. J , 209, 145 ( 197 2) 29 . Quinney. E. R. . " Occupational Structure and Criminal Behavior: Prescription Violations of Retail Pharmacists," Soc. Prob .. 11, 179 ( 1963) 30. ·· Survey of Pharmacies 1970.'· Pharm. J, 207, 191 (19 71) 31 . National Health Service Reorganization: England, HMSO (Cmnd 5055), London (1972) 32 . Department of Health and Social Security, Management Arrangements for the Reorganized NHS, HMSO, London (1972)

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The United States and International Drug Regulatory Approaches

national formulas regarding the end-market sales price of pharmaceutical products. These varying governmental formulas make it virtually impossible for a manufacturer to sell his product at the wholesale level on a uniform basis. Thus, the varying transfer prices of imitators and varying end prices mandated by government controls offer a field day for doctrinaire critics who obviously feel no obligation to reconcile their allegations of flagrant pricing malpractice with a much less exotic figurethe companies' actual profits. In the U.S. we have not yet accustomed ourselves to thinking in terms of price regulation. And our approach to safety and efficacy regulation has been rather ethnocentric . In common with Japan and France, our regulatory authorities have tended to insist that only clinical work done in this country could be used as a basis of product approval. Paradoxically, FDA would consider adverse foreign reports on products so that the manufacturer was placed in an absolute " no win" situation in conducting foreign trials. Fortunately, the FDA leadership has come around to the welcome position that good science is good science, and that it will therefore accept foreign studies that have the right controls and protocols . Ironically, this liberalization comes at a moment when the agency itself seems partially paralyzed from intense Congressional and consumer scrutiny, salted liberally with second-guessing . Add the impact of the new "Freedom of Information" Act and it is difficult to foresee how FDA can escape from its tormentors and become the decisive and effective agency that both the public and the pharmaceutical industry want and need it to be . In essence, these developments demonstrate that scientific judgments cannot be made in a political setting. Currently there is a tendency in some

quarters abroad to watch and emulate FDA . This is both good and bad . To the degree that FDA is working to improve its scientific capability , emulation is praiseworthy . Of serious concern, however, is the mandated move-laudable in its intentthat opens the decision-making process to public review . While agencies such as FDA should be accountable to the public and demonstrate the basis for their decisions, scientific controversies cannot be decided by popular ballot. The effect of too much visibility must be excessive caution , which is synonymous with stagnation. At the opposite extreme, in a nation such as France, the task of review is largely left to outside authorities and experts, mostly unknown to the manufacturers. While regulatory review is relatively new in Europe , its hallmark has usually been a high degree of professionalism within the agencies themselves. It is common knowledge that the agencies exchange information. As these agencies become more mature, the tendency exists for them to become more powerful and more bureaucratic . Germany, for example, is greatly enlarging its regulatory machinery, and it is greatly expanding its regulatory requirements. Since it has not been demonstrated that mass equals quality, this tendency can be expected to bring conflicting results. Even with a growing accountability to consumerism and with increasing public suspicion of multinational corporations the major regulatory agencies all over the world must strive to maintain a happy marriage of scientific professionalism and effective responsiveness . Certainly, the more flexible approach taken by a number of regulatory agencies abroad is salutory, even in its implications for medicine in the U.S. Most new prescription medicines developed in the U.S. are first introduced abroad, where regulatory wheels turn less ponderously. The

demonstrated su~cess of such products in the practice of medicine puts indirect pressure on FDA to make them available to physicians and patients in the U.S. Because of this, a fully justified concern with safety is kept somewhat in balance and cannot override indefinitely the patient benefits that new medicines offer. Even with the lag time of foreign (usually European) introduction over domestic release , now averaging four years, this has not, as some critics feared, jeopardized the public health in these countries. Indeed, it appears that the risks to public health may occur in the U.S. where effective new drug therapy is denied the general public for considerable periods .5 These examples show that drug regulatory mechanisms of different countries are varied and interacting in terms of the way products are introduced and controlled, as well as the way they are priced . Diversity, in this case, is both a stimulus and a safety valve. In the years ahead, there will certainly be a trend towards a more uniform approach and more uniform standards; these are promised by the EEC or the Andean Pact. As a convenience, and as a means of contributing towards improved world health, we should welcome greater t;niformity. But unless tomorrow's agencies can be free of the type of pressure that only punishes mistakes and often ignores progress , the price for conformity may be unconscionably high . •

Bush and Wertheimer (Continued from page 695)

tion phase, an experiment might be run in several areas. On-site health center pharmacy service could be instituted and those neighborhood pharmaCists who are economically threatened offered jobs in health centers with equivalent salaries and expanded roles . Such an experiment would require development of a stock absorption scheme and techniques to assess the monetary and social costs involved in alternative arrangements . For the government to undertake such experiments, however, there must be strong pressure from a con-

sumer or professional group. Such pressure is currently not in the offing. It cannot be expected that community pharmaCists, who represent the majority of pharmaCists on the register, will do anything to contribute to their own bankruptcies. For pharmacists to demand on-site health center pharmacy service , they will have to be convinced that such an arrangement is not only in their professional interest but in their financial interest as well. At present they are not so convinced.

a fully operational health center system could absorb 12,000 pharmacy equivalents of the 13,800 full-time equivalents now employed in the community.30 Considering that the new NHS career structure will absorb some pharmacists 31,32 and that the hospital pharmacy sector is expanding, the manpower excess could be reduced at the university intake level. As the NHS is in the current reorganiza-

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References 1. Helfand, W .H., " The United States and the Interna tional Pharmaceutical Market .. ' JAPhA (t2). NS10, 658 (Dec.

1970)

2. Pharmaceutical Manufacturers Association Newsletter, 2

(March 3. 1975)

3. Roemer, M.I., Henry E. Siger ist on the Sociology o f Medicine. New York . 131 (1960) 4. Na tional Hea lth Insurance Resource Book , U .S. House of Represe ntatives Com m ittee on Ways and Means ( 197 4) 5. Ro ll, G.F., " Dilemmas for the Pharmaceutica l Industry," Drug and Cosmetic Industry. 66 (Oct. 1974)

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Journal of the America n Pharmaceutical Association