Sm. Sci. Med. Vol. 35, No. 11, pp. 132%1341, 1992 0277-9536192 $5.00 + 0.00 Printed in Great Britain. All rights reserved Copyright 0 1992 Pergamon Press Ltd A STRATEGY FOR PROMOTING IMPROVED PHARMACEUTICAL USE: THE INTERNATIONAL NETWORK FOR RATIONAL USE OF DRUGS DENNIS ROSS-DEGNAN,’ RICHARD LAING,2 * JONATHANQ UICK,~ HASSAN MOHAMEDA LI,’ DAVID OFORI-ADJEI, LATEEF SALAKO’ and BUDIONO SANTO& ‘Harvard Medical School, Boston, MA 02115, U.S.A., 2Management Sciences for Health, Boston, MA 02130, U.S.A., 3University of Khartoum, Khartoum, Sudan, 4Korle-Bu Medical School, Accra, Ghana, 5Federal Ministry of Health, Lagos, Nigeria and %adjah Mada University, Yogyakarta, Indonesia Abstract--Over the last decade, pharmaceutical selection, procurement, distribution, and financing have improved as a result of essential drugs programs. However, despite improved availability, pharmaceuticals are frequently used irrationally. The International Network for the Rational Use of Drugs (INRUD) has been established to help address this problem. The Network joins core groups of researchers from four African and three Asian countries with support groups in Boston, Sweden, WHO, and Australia. The activities of the Network are supported by multilateral, bilateral, foundation donors and by Management Sciences for Health. INRUD functions as a participatory organization in which members are involved in decision-making. The primary objective of the Network is to identify through a coordinated set of country-based research projects a set of effective interventions to recommend as policy options for the promotion of rational drug use. In developing these research projects, INRUD stresses the importance of a multi-disciplinary perspective for adequately understanding the reasons underlying inappropriate use of drugs. To better enable country groups to utilize strong research methodologies and to blend the strengths of multiple disciplines effectively, a major activity of the Network thus far has been the building of local research capacity. Key words-pharmaceutical use, developing countries, Africa, Asia, prescribing, behavior change, intervention studies INTRODUCTION Since 1981, the Action Programme on Essential Drugs (DAP) of the World Health Organization has Drugs have been used by healers in all societies been working to ensure the availability of essential throughout history, and the significance of prescrib- drugs in developing countries. An Expert Committee ing and dispensing of drugs as part of the healing has produced numerous revisions of a model list of process has been well-described [l, 41. Over the last essential drugs, including criteria for selection of 50 years, major advances in the formulation and drugs in a national program [8]; over 110 countries administration of pharmaceuticals have occurred have now established their own lists. Many countries such that drug therapy can now be very effective. have also taken action to better assure drug safety However, for a variety of reasons, appropriate and quality. Some have implemented regulations therapy is not always available to patients in develop- restricting drugs determined to be ineffective or ing countries [5,7], which use only about 15% of the dangerous. Quality control laboratories have been drugs available worldwide. established at national and regional levels and the Patients may lack geographical or financial access WHO has established a drug certification scheme to the modern health system. Within the health to monitor the quality of pharmaceutical products system, clinically and economically appropriate moving in international commerce [9-l 11. drugs are often not available because of problems in Because of improvements in procurement systems product selection, procurement, financing, or distri- and shifts to increasing use of generic as opposed to bution. Even if appropriate drugs are available, patented products, the price of pharmaceuticals in health workers may not have sufficient training in countries with efficient procurement systems has diagnosis or therapeutics to prescribe correctly, or declined during the last decade [5]. Efforts have been their prescribing may be inappropriate as a result made to improve the efficiency of drug distribution of social, cultural, or economic factors. and storage. Kit distribution systems have been established in some countries to ensure a regular supply of essential drugs to peripheral health units *Address correspondence to: Richard Laing, Network Co- ordinator, INRUD Support Group, Management [12-151. Considerable attention has been paid to the Sciences for Health, 165 Allandale Road, Boston, MA financing of drugs in developing countries [16-191, 01230, U.S.A. and a variety of programs have been established 1329 1330 DENNIS ROSS-DEGNAN ef al. which attempt to increase community potential dispensers, and how these differences influence drug to pay for drugs [20-231. The latest effort-“The use practices. Furthermore, drug use is affected by Bamako Initiative”-has sought to combine local many factors in addition to knowledge. The influence revolving drug funds with community controls and a of drug representatives and pharmaceutical company broadening of PHC efforts [24-261. marketing practices is anecdotally reported [34-371. During this rapid expansion of essential drugs The pressure from patients to prescribe certain medi- programs and related initiatives, primary emphasis cations such as injections or specific ‘strong or hot’ has been placed upon improving pharmaceutical medicines is recognized [38-411. Financial incentives supply, and upon ensuring that affordable drugs are for multiple prescribing also exist in many settings available in rough proportion to prevailing illness where personal or institutional revenues depend upon patterns. However, very little is known about whether the sale of drugs. However, little is known about the such activities have improved the subsequent appro- relative importance of these factors in determining priateness of medication use. Given the importance of prescribing. effective drug use for reducing unnecessary morbidity In light of the fact that many acknowledge the and mortality, and for maximizing the health impact existence of widespread problems in drug use, there of the scarce health resources applied to pharma- have been very few published reports from develop- ceuticals, questions about the appropriate utilization ing countries which critically evaluate interventions of drugs have begun to come to the fore. to improve these patterns of inappropriate care. One The WHO convened a conference of experts in study in Sri Lanka reported meaningful but not Nairobi in 1985 to discuss this issue. This conference statistically significant reductions in antibiotic use brought together academics, health planners, repre- following provider education and the dissemination sentatives of the pharmaceutical industry, and con- of printed materials [42]. In Yemen, a combination of sumer activists. With such varied participation, the training and the provision of a limited list of drugs report produced reflects a wide range of interests reduced the proportion of patients receiving anti- [27]. The importance of rational prescribing was biotics, the total number of drugs prescribed, and use agreed upon by all; however, specific proposals of injectables, though the results were less than the for how more appropriate use of drugs should ideal according to standard treatment schedules [43]. be achieved were more elusive. Recommendations Other programs in Zimbabwe using education and were made for better drug information, proper train- in Ethiopia with the use of a limited list have been ing, and continuing education, but convincing evi- reported, although few results of proven impacts dence to demonstrate that these strategies would are presented [44,45]. In India, a community-based significantly and cost-effectively improve prescribing intervention that included mass education about is lacking. childhood pneumonia and training in simplified case management using cotrimoxazole for all levels of health worker resulted in reductions in pneumonia- DRUG UTILIZATION PROBLEMS IN DEVELOPING specific mortality compared to control areas [46]. COUNTRIES A study in Nepal based exclusively on case-finding and provision of drugs by community health workers Reports exist from many countries describing demonstrated similar reductions in mortality [47]. patterns of drug use in a range of health settings, One limitation of the handful of studies which have including hospitals, health centers, private prac- been published is that differences in methodology titioners, and pharmacies. These reports routinely and perspective make comparisons difficult. Very few highlight similar problems in drug utilization: reports provide results which can serve as the basis polypharmacy, due both to multiple prescriptions for generalizable policy initiatives for promoting the and the prescribing of fixed combination drugs; rational use of drugs. too frequent use of antibiotics, and injections, or Within developed countries, there have been an vitamins; use of incorrect medications to treat specific increasing number of research studies and review problems; and so forth. Examples of inappropriate articles published about different strategies for treatment abound: the use of tetracycline for changing prescriber behavior [48-511. In brief, these children, chloramphenicol for minor infections, studies show that face-to-face education, participa- dypyrone as an analgesic, antidiarrheal antibiotics tory prescriber reviews with feedback, structured for diarrhea where ORS will do [28-331. order forms, and the cooperative development Although many studies agree that inappropriate of formularies often have some effect [48, 50, 521. use of drugs is a common problem, few published The use of regulations unaccompanied by provider studies address the reasons for this irrational use, or consumer education, while sometimes effective or strategies for improving it, in more than a super- at promoting intended changes in drug use, can ficial way. Frequently, further education in ‘rational frequently have unexpected and often undesirable drug use’ is recommended, but little concrete infor- results [48, 53-551. For example, it has been shown mation is presented about the nature and extent that removing unsafe or ineffective drugs from the of deficiencies in knowledge among prescribers and market will not necessarily improve quality of care, International Network for Rational Use of Drugs 1331 due to increases in the use of equally irrational the optimal interventions to test would be those or unsafe substitutes [56]. Similarly an excessively designed to strengthen local institutional capability to low ‘cap’ or limit on the number of drugs patients implement similar programs on an ongoing basis can receive, intended to control costs and decrease within existing resources. excessive drug use, increased expenditures due to The specific research topics that need to be chronically-ill patients being admitted to nursing addressed will vary regionally and from country homes to receive needed therapies [57]. to country. However, certain important drug use In summary, effective essential drugs are now problems-such as the overuse of antibiotics and more widely available as a result of the growth of antidiarrheals in the treatment of diarrhea-are the essential drugs concept and the establishment common to many areas. In addition, particular strat- of national essential dugs programs. However, even egies for improving medication use may prove to essential drugs are frequently used in an irrational be effective in many environments. For example, in fashion, and it is not clear what methods might be developed countries the positive impact of face-to- effective in developing countries to promote more face educational programs for providers has been appropriate pharmaceutical use. There is also a more convincingly demonstrated in a variety of settings fundamental problem in defining ‘rationality’ in drug [59-631. Although most drug education programs for use in these environments when drugs play different the public have not been evaluated, consumers have culturally-determined roles [58]. been shown to change their drug use practices in response to warnings about drug safety, particularly when media reports have been involved, as with CRITICAL RESEARCH METHODOLOGIES AND TOPICS warnings about the role of aspirin in causing Reye’s The study of pharmaceutical utilization needs to syndrome [64]. There is a pressing need to test the move beyond the stage of identifying and describing efficacy of similar media-based public educational similar problems in different environments. In light strategies in developing countries where poster or of what is now unknown about the reasons for radio campaigns are widely used, as well as to observed patterns of inappropriate drug use and how evaluate the impact of individual drug education to modify them, two broad categories of research are for patients. indicated. Examples of some promising areas for research, Formative behavioral research is needed to discover and of the types of research questions that might and explore the motivations, expectations, and usefully be addressed, are presented in Table 1. This incentives which underlie the drug use behaviors of list of topics is by no means exhaustive, but rather providers and consumers. This research needs to indicates some of the more important questions that draw heavily on the broad array of methodologies have not been adequately addressed in previous that have been developed in the social sciences, which studies from developing countries. are only now beginning to be applied to the study of clinical problems in drug use. These formative studies ESTABLISHMENT OF INRUD must include application in different environments of some of the more promising qualitatively-oriented In this context, the International Network for the techniques, such as in-depth interviewing, focus Rational Use of Drugs was established in 1989 to groups, or case studies to examine the cross-cultural serve as a catalyst for the promotion of well-designed specificity or generalizability of their findings. research into drug utilization problems, and to Once the behavioral foundations of drug use identify interventions that are the most promising are better understood, applied intervention trials are for promoting rational drug use [65,66]. Initial dis- necessary to determine the relative impact of different cussions about the idea of a multi-country effort to strategies to improve drug use practices in a variety address the issue of inappropriate use of drugs were of high priority health problem areas. The behavior held in Germany in July, 1989, at a meeting of clinical change interventions to be investigated might be pharmacologists among individuals from Asian and regulatory, managerial, or educational in nature, or African countries and representatives of Manage- a mix of these strategies. ment Sciences for Health (MSH), a U.S.-based non- Because of the many different environments in profit health consulting company, the Drug Policy which pharmaceuticals are recommended and used, Group of Harvard Medical School, and the Depart- experimental intervention programs could take a ment of International Health Care Research of variety of forms. Candidate settings would include Karolinska Institute. hospitals, health centers, private practices, pharma- It was agreed that rational use of drugs was a cies, and the community at large. To adequately high priority health research issue, and that establish- address questions about the relative cost-effectiveness ing multi-disciplinary groups in a limited number of different interventions, it is important to measure of developing countries working together was a the magnitude and duration of changes in pharma- promising strategy for organizing research efforts. ceutical and other service use in key populations. A decision was made not to organize these groups In addition, to achieve maximum long-term impact, around a single set of institutional relations within a 1332 DENNISR OSS-DEGNAeNt al. Table I. Imoortant unanswered auestions for drop use research preparation of country experience papers, and devel- Regulafory and Managerial Interventions opment of a country action plan. Nine countries with . What are the expected and unanticipated impacts on service use and outcomes of public sector policies like: limited lists, user fees, identified individuals active in drug use research or co-payment for drugs, caps on the number of drugs allowed per essential drugs programs were selected for visits: visit, banning of unsafe or overly expensive drugs, or limitations Nigeria, Ghana, Sudan, Kenya, $hd Tanzania in on the use of particular classes of drugs to providers with specific levels of training? Africa; Bangladesh, Nepal, Pakistan, and Indonesia Drug Kif Distribution in Asia. The visits, which occurred in late 1989, were . Has the drug kit distribution system adopted by some countries, undertaken by two-person teams, typically by one in which a standard mix of essential drugs based on observed developing country and one developed country repre- health problem patterns is supplied to peripheral facilities, been effective in improving the clinical appropriateness of treatments sentative of the group who attended the Germany for these problems? meeting. From these 9 countries, 6 were to be selected Standard Treatment Protocols by a vote of the planning committee as initial mem- l How useful has the development of standard treatment protocols been in promoting the use of specific drugs and dosages for specific bers. A firm decision was made that following the problems? selection of country members, all significant decisions l What factors determine whether treatment protocols are followed would be made on a collective basis with each especially over time? country group of the Network contributing to the Moniforing Prescribing Practices . What is the best way to monitor the prescribing practices of process, but no organizational form was applied to providers in the public sector? this principle at the time. The administrative support l Is it feasible to collect similar data on the prescribing practices of for the Network was provided by the Network Co- private sector providers or drug retailers? ordinator employed by Management Sciences for Impact of Education . Can face-to-face models of prescribing education, using specially Health. trained health educators (physicians, clinical pharmacists, or other The country visits served to introduce the concept personnel) b-e conducted cost-effectively in developing countries? l Are well-designed small-group or seminar-style educational pro- and plans for the INRUD Network, and to invite grams effective in changing prescribing practices? country core groups to prepare two papers, one Retailers and Drug Sellers describing relevant experience with key policies or . What factors underlie the recommendations of drug sellers? programs designed to promote rational drug use, and l Is it possible to design educational programs to improve drug use by these important providers which acknowledge economic incen- the other an action plan outlining a program of tives but nevertheless promote therapeutically effective products? research on drug use which members of the core Traditional Healers group would propose to undertake. Because of the l Is it possible to improve drug use by traditional healers, who in emphasis on individuals rather than institutions, each many countries have begun to rely on Western medicines for certain types of health problems? [SO] country visit was different in terms of who was seen Markefing of Pharmaceuticals and where the visits occurred. Local support for the l What is the impact ofmarketing activities aimed at prescribers and goals of INRUD was considerable, particularly in the of consumer advertising on the use of drugs? l Is it possible in countries where advertising is allowed to socially academic community, but the involvement of govern- market products with particular public health value? ment officials varied from country to country. Microbial Resistance Following each visit, a report was written by the l How are long-term increases in the prevalence of microbial visiting team outlining the experiences, perceived resistance to antibiotics, antimalarials, or other essential drugs affected by programs which improve their use? strengths, and weaknesses of the country groups, and this report was used in the selection process. Planning Committee members were asked to country, such as through the WHO country office or rank the country groups, and to suggest which six government to government bilateral organizations, countries should be included in the Network. This but rather to link interested individuals wherever they participatory process of selection was important in were placed in a network arrangement. This ensured determining the future development of the Network. that individuals in universities, government dzpart- Different individuals used different criteria for assess- ments, NGOs, and the private sector could be in- ing the country papers and reports, and variation volved. It was acknowledged as a key principle of this in rankings occurred, but the final decision was a initiative that the irrational use of drugs is a complex collective one. When the results were received there problem of behavioral dynamics and not caused was strong support for seven countries (Nigeria, simply by a lack of knowledge, and the importance Ghana, Sudan, Tanzania, Nepal, Bangladesh, and of involving behavioral scientists in each country Indonesia), and all were included in the initial group. group was stressed. This was a major development, The two country groups excluded at this stage were as prior to the initiative one common response to assured that at a future date they would be eligible for the problem of irrational drug use was to propose inclusion. improved scientifically-based education of prescribers From the outset, one goal of INRUD has been to WI. build a consensus among donors that funding activi- A Planning Committee was established of those ties to promote rational use of drugs is an important who attended the initial meeting. The Planning investment in health system development. Initial Committee agreed that initial member countries funding for the establishment of the Network was should be selected on the basis of country visits, provided by WHO/DAP, Geneva. Core funding for International Network for Rational Use of Drugs 1333 the first 2 years of Network activities was provided INRUD countries on how to undertake studies of by Pew Charitable Trusts, with subsequent partial this sort. The inventory of the available drugs was funding for core activities from the Danish Inter- carried out at both public and private drug outlets. national Development Agency (DANIDA). Support In addition, providers and clients were interviewed for the first Network meeting was provided by at each drug outlet, and a household survey was the Dutch Ministry of Foreign Affairs (NGO Aid undertaken. The combination of research techniques Section), AIDAB (Australian International Develop- can serve as a model fdr other INRUD members ment Assistance Bureau), and SIDA (Swedish Inter- on how to undertake studies of this sort. The study national Development Authority). Support for produced interesting results related to access, choice country visits has come from UNICEF. Applications of facility, utilization patterns, affordability and continue to be made to multilateral and bilateral ability to pay for drugs, and information about agencies and to foundations for future core and drugs. project-specific funding, and to ensure communi- The Sudan country paper described how the cation between various funding groups. national drug policy, and particularly limitations on The current level of funding does not allow for the drug market, had been implemented [69]. Prior the full-time funding of Network coordination or to 1983, there were 17,000 pharmaceutical products administration. This leads to activities occurring in available in the country; this number has now been bursts, with gaps when the part-time Coordinator is reduced to 4000. Low cost People’s Pharmacies have undertaking other activities. Over time, other support been established to make drugs available at a sub- group and country members are becoming more stantially reduced cost compared to the private retail active in linking to individual country groups. As pharmacies. Despite these gains, a problem which effective interventions are identified, there may be Sudan continues to face is drug ‘dumping’ through a desire to expand the Network beyond the initial donations of expired and inappropriate drugs by member countries. Alternatively, agencies such as international assistance organizations. WHO and the World Bank may absorb the ideas and The Tanzanian paper also described the develop- implement them on a large scale in many countries. ment and formulation of the national drug policy This would change the need for a separate organiz- [70]. The policy document specifically identifies ation like INRUD and perhaps require a different rational drug use as an important policy area, out- focus. lining specific objectives concerning education and training, drug information, hospital pharmaceuticals DEVELOPMENT OF COUNTRY PAPERS and supplies committees, and advertising and pro- motion. A detailed time plan for the implementation The country groups were asked to complete their of the various components of the policy is also country experience papers, expanding on specific described. In its organization and completeness, the areas of previous work within their countries that Tanzania drug policy can serve as a resource for might be of most interest to other INRUD countries. countries planning to revise their national policies. Each paper was reviewed in detail, and revised to be The Nepal core group described the difficult presented at the first INRUD meeting. These papers logistics related to the organization of drug supplies describe experiences in improving drug utilization in the country, and an innovative drug retailers undertaken within member countries prior to the training course [71]. This training program has, since development of INRUD, and they encompass a 1983, provided a mechanism for drug sellers to range of relevant topics. undertake a 40-45 hr orientation course to improve The Nigerian paper described the development of their service to the public. Over 5000 participants the modified curriculum in medicine, dentistry, and have been trained, with 4046 successfully passing the pharmacy, which incorporated the essential drugs post-training examination. The Nepalese approach of concept [67]. The curriculum included sections on the upgrading drug sellers’ skills may have relevance for essential drugs concept, the national drug policy, other countries where drug sellers are a major source rational prescribing, pharmacokinetics, patient edu- of pharmaceuticals. cation and counselling, and financial management. The Indonesian paper described a series of drug Similar curricula have been developed for nurses and utilization studies which examined patterns of drug midwives. consumption and prescribing in the public sector [72]. The Ghana group described a baseline survey of A multi-institutional working group, representing the five districts in four vegetational zones carried out Ministry of Health, the private sector, and donor as a baseline for implementation of the Bamako groups, looked in one study at drug expenditures Initiative in Ghana [68]. The survey used both quan- and consumption in seven provinces, followed by titative and qualitative methods to review health a detailed health center prescription analysis in management practices in the public sector, and two provinces. The major problems identified were to inventory community resources and activities multiple drug prescriptions, the frequent use of injec- related to PHC. The combination of research tech- tions and antibiotics, and the lack of variation in niques employed can serve as a model for other treatment across diagnoses. The paper summarized SSM35 1I-1- B 1334 DENNIS ROSS-DEGNAN et al. the macro and micro approach to organizing a materials included training materials, questionnaires, program of drug use research. regulations, curricula, and newsletters. The Bangladesh group reported on how the Formal training sessions were held to bring partici- well-known Bangladesh drug policy had been im- pants to a similar level of knowledge. These sessions plemented, and some of its macroeconomic impacts covered topics such as qualitative and quantitative [73]. Of interest, however, was a small study at local research methods, educational interventions, man- level which showed that serious problems in terms agerial and regulatory interventions, and intervention of polypharmacy and irrational drug use continue to selection. These sessions gave participants the oppor- exist. While significant policy changes can make a tunity to relate personal experiences and to discuss difference in terms of drug supply, these changes may alternative approaches to research. have very little impact on drug use patterns at the At the beginning of the second week, individuals village level. were asked to analyze the first week’s discussions in In summary, the experience papers developed by terms of cross-cutting themes. The themes reviewed the country core groups as their initial contribution were: impacts of national drug policy on rational use; to INRUD documented the unique experiences of strategies for limiting availability of drugs on the member countries in a way that Network members market; implementation of standard treatment guide- and others could share and benefit from each group’s lines; curricula on essential drugs and rational use; experiences. The papers served as one central focus patient and consumer education; provider in-service for discussion at the first INRUD workshop. In light education; and the relation of drug financing to of the overall goals of INRUD to promote multi- rational use. This encouraged participants to think disciplinary research, what is notable about these about and discuss these issues in a broad fashion, papers is that most tended to emphasize discussion of attempting to identify how different issues crossed national policies or were descriptive studies. None national boundaries and continents, and how poss- related directly to learning about behavioral factors ible solutions could be adapted from other country which influence drug use, or to the testing of interven- experiences. tions. The mix of study methodologies in the Bamako A major activity of the workshop was a field baseline study in Ghana, and the multiple sequential assessment of patterns of drug use and reasons drug use studies with related objectives in Indonesia underlying them in the area where the conference represent two examples of strong foundations for was held. This activity, described below, was very future intervention research. important in welding the disparate members into an INRUD collective group. By working together, THE INRUD WORKSHOP defining research issues, developing data collection instruments, collecting, analyzing, and presenting The first INRUD workshop was held in data, the INRUD members gained respect for the Yogyakarta, Indonesia in July 1990, for two weeks. variety of skills and experiences present in the group. Three people from each of the Network countries Each country group met together and with support were invited, and each country was encouraged to group members to further develop and refine short- select at least one social/behavioral scientist to par- and long-term country research plans. These plans ticipate. Attenders included clinical pharmacologists, were presented and discussed with constructive com- physicians, Ministry of Health officials, pharmacists, ments being offered by other Network members, and social scientists trained in geography, sociology, based on their own experiences. A cooperative re- anthropology, and statistics. Support group members search project, where a similar intervention protocol attending the meeting included physicians, medical would be used in a number of INRUD countries, was anthropologists, health education specialists, and developed at the meeting. Network plans were made health policy researchers. In addition, representatives for a series of inter-country visits to observe ongoing of multilateral (WHO and UNICEF) and bilateral programs, or share technical expertise. (USAID, Danida and SIDA) agencies attended. Considerable discussion occurred at the meeting on Experience sharing was achieved by both formal the best way the Network could be coordinated. The and informal interactions. Participants presented final decision was that a Network Committee would their country experience papers in formal sessions. be elected, to be comprised of one person from each The social scientists led a panel where they presented country and an additional social scientist from the individual perspectives on their professional role in Asian region and the African region (see Appendix). relation to drug use. Thus, a medical geographer, a This Committee would replace the functions of the psychologist, an anthropologist, and a medical soci- Planning Committee which had guided the develop- ologist all had the opportunity to suggest how their ment of the Network to this point. The role of the skills were relevant, which was particularly useful to Network Committee will be to decide by consensus, clinicians whose experience in this area was limited. at an annual meeting or by ad hoc polling, on Participants also brought examples of descriptive and all important policies related to the governing on educational materials from their countries, and these INRUD, including which activities are to receive were copied for use in other countries. Such greater priority and how the overall growth of the International Network for Rational Use of Drugs 1335 Network will proceed. All research proposals are to problem by having a multi-disciplinary group of be reviewed and approved by at least two members observers carry out a number of linked qualitative of the Committee. Because of contractual needs and quantitative research activities. A second objec- of donors and in light of the inevitable delays in tive at the meeting was to familiarize INRUD mem- international communication, the responsibility for bers with features of specific methodologies, in order day-to-day decisions about communication, logistics, to highlight and contrast the potential contributions and expenditures is left in the hands of the Network of these techniques. The sequence of activities that Coordinator and the staff at the Support Office based comprised the problem assessment methodology, at MSH. as they were applied at the INRUD workshop, is described in Table 2. Individual activities were led by country or support FIELD METHODOLOGY FOR ASSESSING PROBLEMS IN DRUG UTILIZATION group members familiar with a particular method- ology, and with how this method can be applied The decisions and behaviors that determine quickly and simply in the field. If this assessment drug use encompass a variety of actors and settings, exercise were carried out within the context of on- and often a wide geographical area. Pharmaceutical going health services or a university research pro- supply managers, manufacturers’ representatives, gram, many of the component activities would be health providers, drug sellers, patients and their carried out more systematically. However, it is often families all play a role in determining how drugs are true that health managers have few resources and used. In assessing problems of choice on the part of limited time to apply to this sort of activity. One specific providers and consumers of drugs, it is both of the major lessons of the assessment exercise at revealing and necessary to examine their behaviors in the INRUD meeting was that useful and often un- the context of these broader influences. expected information can be discovered in a short Although a large part of the INRUD meeting was period by allowing people with different disciplinary devoted to conceptual or administrative activities, perspectives to observe behaviors and environments these served as a counterpoint to the field activities, simultaneously using multiple methodologies. which were the most important part of the meeting. The assessment team in this case consisted of the This field work demonstrated and tested a method- 30 individuals who attended the INRUD meeting. ology for rapidly examining the dynamics of drug Most of the time, this large team was broken use problems. The principal objective of this assess- into smaller groups of 4-6 individuals representing ment methodology is to better understand a drug use different disciplines; each small group worked inde- Table 2. Sequence of activities in the problem assessment process Activitv Description Time Frame Observe Drug Use . Conduct informal observations of activities related One full day Environment to drug use in a number of environments, including: l District health administration . District drug warehouse . District hospital inpatient, outpatient, pharmacy . Health center services, community health programs l Private polyclinic, private practitioner l Licensed pharmacy, drug retail store, marketplace Identify Problem . Describe behaviors and perceived problems in each If-2 hr Practices location . Highlight differences in perceptions between separate teams of observers, between disciplines l Identify similarities and differences among environments that are part of the drug use system Select a Problem . List identified cross-cutting problems in drug use 2 hr for Study worthy of further study . Establish priorities to select the focus of further study . Identify single problem to examine with multiple methods Develop Protocols . Identify study methods and particular locations to 2-g hr and Methods be studied depending on . Develop necessary data collection instruments method . Design protocols and sampling methods Collect Data . Implement individual research methods as planned 36 hr in . Describe successes and unanticipated problems in field, plus 1-2 hr implementing the research method synthesis Analyze and . Process data and prepare data displays Cl0 hr analysis, Synthesize . Present findings of individual studies plus 4 hr reporting . Describe recommended changes in study methodology . Synthesize information on the problem studied . Synthesize lessons from study process 1336 DENNIS ROSS-DEGNAN et al. pendently of the other small groups. This style of of the process and the valuable input of behavioral multi-disciplinary rapid assessment could be under- scientists helped to make these investigations accept- taken with a smaller assessment team, but for the able to those observed. INRUD meeting, having a number of small groups At an initial planning session, the large study team allowed the different components of the exercise to be met to define the goals of the assessment process. This carried out in a relatively brief time span. One reason was followed by a day-long field visit, during which for organizing the assessment process around small each small group observed three locations involved in working groups was to avoid overwhelming the the supply or use of drugs (listed in Table 2). Follow- individuals from or about whom data were being ing these observations, the large group reconvened to collected any more than necessary. The exception was describe what they had seen, and to give an opportu- a short, formal presentation by the district medical nity for each small group to present their perspectives officer to all the assembled study groups to orient on factors encouraging and discouraging rational use them to the demography, health problems, and health of drugs in these environments. The study team then services of the district studied. selected a common drug use issue to be addressed by The support of district administration and of indi- the smaller working groups. Because of its import- viduals at each of the locations studied is essential if ante as the major source of visits to the health system the rapid assessment process is to be both practical in Indonesia, acute respiratory infection was selected and informative. Because the process is intended to as the topic for study. be brief and focused, an effort is made to minimize Each small group was responsible for applying a the administrative burden to these individuals. single methodology to the study of problems of drug use Although studies of work behavior are often threat- in ARI; for example, one group designed and carried ening, especially ones sanctioned by higher levels of out a focus group for mothers on this topic. The the political or medical administration, the breadth variety of techniques used in the assessment process Table 3. Research methods used for drug use problem assessment Characteristics Method Study units Description measured Review data on l Records at district office . Compilation and review of . Reported morbidity profile drug consumption data on morbidity patterns and drugs consumed and morbidity and drug consumption for l Problem patterns for target health problem(s) particular health facilities, health problems, or drugs Audit of . Hospital outpatient clinic . Retrospective review of . Usual treatment practices prescriptions records records in one or more for target conditions . Health center registers or health facilities . Key features of prescription records . Data elements: age, inappropriate drug use for diagnosis, drug and quantity target conditions prescribed, type of . Particular health facilities or prescriber, quantity types of prescribers with dispensed problem practices Patient interviews . Patients attending health . Short structured . Health complaints of facilities questionnaire interviews patients with patients arriving at or . Number and types of drugs exiting health facilities prescribed and dispensed . Exit interviews can be . Patient understanding about restricted to patients with a health problem or drugs particular complaint . Reported satisfaction with services provided Observation of . Patients presenting for care . Observation of the process . Quality of care from the health care process at health centre with target of care for a small sample patient perspective conditions of patients from an . Adequacy of examination, anthropological or clinical diagnosis, drug dispensing perspective . Constraints on performance . Venues include patient by prescribers or dispensers waiting area, clinical . Quality of communication examination room, drug between patients and dispensary care-givers Focus groups . Physicians or other l Group discussions guided by . Beliefs motivations, imagery, providers a trained moderator on a incentives related to topics l Patients or mothers of defined set of topics among discussed children with target a small, homogeneous group . Contrast of the perspectives condition of participants of prescribers and consumers of drugs In-depth interviews . Physicians or other l Extended open-ended l Beliefs, motivations, prescribers interview on a defined set of imagery, incentives related l Patients presenting at health topics between key to topics discussed facility for target conditions informant(s) and trained . Contrast the perspectives of observer prescribers and consumers of drugs International Network for Rational Use of Drugs 1337 are listed in Table 3. In each small working group, In order to ensure the comparability of meaning disciplines and professional backgrounds were mixed of these indicators across countries and over time, in order to encourage contrasting perspectives. The a standardized methodology is being developed to small groups independently identified their own collect the data necessary to measure them in either specific study questions, planned the field methods a retrospective or prospective manner. A number of for each research technique, and collected, processed the member countries will test this methodology as and analyzed their own data. Following these inde- part of their country action plan. Field tests have pendent analyses of field data, the large group met a already been undertaken in Indonesia, Bangladesh, last time to hear a description and critique of the Nepal, Nigeria and Tanzania with the support of methods and findings of the individual studies, to WHO. To standardize the data collection method- discuss general conclusions relevant to the under- ologies, and as another vehicle for building local standing and treatment of ARI, and to integrate their research capacity in member countries, the field tests separate experiences and findings. have been led by INRUD members with specific experience in this type of data collection travelling between the different participating countries. DEVELOPMENT OF DRUG USE INDICATORS In order to promote more general&able and reliable drug use research, participants at the first IMPACT OF THE FIRST INRUD MEETING INRUD workshop took the first steps towards the development of a draft set of indicators related to The INRUD workshop had three major effects: appropriate drug use. The intention is that these country research teams and proposed plans were indicators be used as consistent measures of import- strengthened; multi-disciplinary research was encour- ant aspects of drug use when surveys or studies are aged through both technical presentations and field undertaken. An effort was made to select indicators experiences; an organizational structure for the Net- which would mean the same in different countries, yet work and a framework for cross-country collabor- which might also be expected to be able to change ation was developed. Following the meeting, a range over time as a result of interventions designed to of activities were undertaken. These included visits to improve drug use policies and practices. The indi- member countries by other members to share techni- cators covered five areas: prescribing, patient care, cal experiences and skills, development of research drug supply, marketing, and policy. Brief descrip- proposals, undertaking multi-disciplinary field re- tions of these draft indicators, as they were proposed search, and the field testing of drug use indicators at the meeting, are given in Table 4. described below. Table 4. Draft drug use indicators proposed at INRUD meeting Prescribing Indicators l Average number of drugs prescribed at primary care level at each visit. l Proportion of primary care outpatient cases receiving antibiotics. . Proportion of primary care outpatient cases receiving an injection. . Percentage of children under 5 with diarrhea receiving ORS. . Percentage of children under 5 with diarrhea receiving antidiarrheal drugs. . Percentage of cases who receive treatment according to the national or institutional standard treatment schedules. . Percentage of patients leaving a primary care unit without a drug being prescribed. . Percentage of drugs prescribed in generic form. l Percentage of drugs prescribed in a fixed dose combination form. Patient Care Indicators l Percentage of patients leaving a unit at defined level able to report the correct dosing schedule. l Percentage of patients attending a primary care unit who receive a minimal basic examination, e.g. temperature, pulse. . Average consultaton time period with a prescriber. l Percentage of penicillin resistant infections at primary level. Drug Supply System Indicators l Per capita consumption of specific indicator drugs (g. per capita). . Per capita expenditure on drugs. . Percentage of total expenditure on antibiotics. . Percentage of total expenditure on injectables. l Percentage of drugs in a facility not on the essential drug list or formulary. . Availability of drugs for treating the 5 most common conditions. Marketing Indicators l Number of drug representatives employed compared to number of physicians registered. l Number of breaches of IFPMA marketing code. Policy -related Indicators . Presence of a national essential drug list. . Percentage of prescribers with access to impartial pharmaceutical information. . Are antibiotics, steroids, or psychotropic drugs available without a prescription? 1338 DENNIS ROSS-DEGNAN et al. Many of the first round of studies undertaken approach was that substantial time during the by the core groups were reported at the Inter- meeting was spent on introductory methodological national Conference on Social and Cultural Aspects presentations and on later field work and data of Pharmaceuticals in Developing Countries, held in analysis, and inadequate time was left for intensive the Netherlands in October 1991. At this meeting, development of future proposals. This has meant that attended by twelve INRUD members, six papers were significant delays occurred after the meeting in final- presented by INRUD country members based on izing and obtaining funds for later research activities. research sponsored by INRUD. These included an INRUD has funded a number of small research assessment, using retrospective analysis of prescrib- projects, including some of those presented in the ing and focus groups, of the impact of in-service Netherlands, while WHO and the USAID Applied training for medical assistants on the clinical manage- Diarrhea1 Disease Research Project have agreed to ment of malaria in Ghana [74]; an observational and fund larger projects in Nepal and Indonesia. interview study of drugs as an element of the inter- action between patients and physicians in both public and private practice in Bangladesh [75]; a report on THE ROLE OF ONGOING INRUD ACTIVITIES two community studies of ethno-medicine in Nepal [76]; a focus group study of mothers examining Country and support group members contribute the socio-cultural aspects of the use of drugs in the to a number of ongoing activities in order to treatment of childhood diarrhea in Nigeria [77]; and a advance INRUD’s primary objective of promoting study in Indonesia, also using focus groups, investi- applied intervention research. These activities are gating indigenous beliefs about drug use in Indonesia, intended to promote effective communication among which is part of the formative phase of a controlled members and with other interested individuals; to intervention comparing the efficacy of different types increase support for related activities among donors of provider education in changing diarrhea treatment and government agencies; and to increase local practice [78]. capacity for designing, conducting, analyzing, and In comparison to the work reported at the first disseminating the results of drug use research. INRUD meeting one year previously, what was The Network Coordinator, based at MSH, pro- noticeable about these papers was the use of a duces a semiannual newsletter as a primary mechan- variety of different methodologies, particularly more ism for communication, and also as a tool for qualitative ones emphasized during the field assess- promoting ideas about how drug use could be im- ment of drug utilization in Yogyakarta. Also notable proved in developing countries. This publication, is a stronger emphasis on action-oriented research with a current circulation of 2000, includes news as the countries build toward the testing of interven- about member countries and their ongoing activities, tions. reviews of relevant recent articles, material on im- The Amsterdam Conference on Social and portant topics in drug use, commentary contributed Cultural Aspects of Pharmaceuticals was immedi- by interested readers, and notices about future activi- ately preceded by a smaller meeting of members of ties. As an indication of its success in stimulating the INRUD committee, support groups, and country interest, there have been over 800 responses, from 69 social scientists. In contrast to earlier meetings the countries, to the first three issues of the newsletter. Network members were able to participate confi- Frequently, researchers and government officials in dently in discussions and argue a shared perspective developing countries do not have access to modern due in part to their joint field experience in Indonesia, journals or even abstract services. Without such and to the development of a common understanding access, it is difficult to avoid situations where useful about key issues and approaches that has occurred methodologies are not standardized, and where with the visits and research undertaken thus far. interventions which already have been proven ineffec- In evaluating an experience such as the first tive are repeated. To partially address this need, a INRUD workshop, outcome criteria are difficult to bibliography of over 1450 references on drug use define. If one criterion is, “Has the work undertaken in developing countries has been created, combining since the workshop been significantly better?“, the material from bibliographies produced by WHO/ country experience papers can be compared with the DAP, University of Amsterdam, and Harvard papers presented in the Netherlands. Clearly there is Medical School. A regular MEDLINE search on a consistent improvement in terms of the range of key topics in drug use is carried out to update the techniques used, the orientation to action, and the database. Bibliographic software has been supplied emphasis on behavioral aspects of drug use. to Network members and the support groups One element which contributed to the relative (Reference Manager 5.0 [79]), to enable them to have success of the meeting was the process by which access to relevant information quickly and efficiently, participants worked together to learn common les- and complete copies of referenced articles are pro- sons. This process of data collection, analysis, and vided to members on request. A text copy of the reporting was more significant in many ways than current bibliography is supplied to anyone requesting the actual results. However, one weakness of this it for the cost of copying (about $10.00). International Network for Rational Use of Drugs 1339 The research proposal development and review be whether the local capacity in member countries process is an area where developing country pro- to design and conduct relevant, methodologically- fessionals are often at a competitive disadvantage as sound research increases consistently over time, and compared to developed country researchers. Com- most importantly, whether effective interventions munication with donors about funding possibilities to improve drug use can be identified and widely and with colleagues about potential research topics disseminated. is more difficult, and opportunities for training in proposal development skills are limited. Once an initial research proposal has been developed by a REFERENCES country group, it is reviewed by two Network mem- 1. Mitchell M. F. Popular medical concepts in Jamaica bers, one from a country group and one from a and their impact on drug use. West. J. Med. 139. support group, with an eye toward strengthening its 841-847, 1983. focus and methods. Whenever possible, country 2. Kleinman A. Patients and Healers in the Context of Culture. University of California Press, California, group members with similar interests are requested to 1980. comment. This facilitates constructive input, informs 3. van der Geest S. 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Version 5/01 service training on the clinical management of malaria was released in November, 1990. by assistants in Ghana. Presented at the International 80. Foster G. M. Anthropological research perspectives Conference on Social and Cultural Aspects of Pharma- on health problems in developing countries. Sot. Sci. ceuticals, The Netherlands, 17-21 October 1991. Med. 18, 847-854, 1984. APPENDIX INRUD Commitee and Support Group Members INRUD committee Professor Budiono Santoso Professor Hassan Mohamed Ali Department of Clinical Pharmacology Department of Pharmacology Faculty of Medicine Faculty of Pharmacy Gadjah Mada University University of Khartoum Sekip Utara, Yogyakarta 55281, Khartoum, Sudan Indonesia Professor A. K. Azad Chowdhury INRUD support group Department of Pharmacy Department of International Health Care University of Dhaka Research (IHCAR) Dhaka 1000, Bangladesh (Dr G&an Tomson) Karolinska Institutet Dr Ananda Mohan Das 10401 Stockholm, Sweden National Institute of Preventive and Social Medicine Drug Policy Group Mohakhali Department of Social Medicine Dhaka 12 12, Bangladesh Harvard Medical School (Dr Dennis Ross-Degnan) Dr Bosede Folasade Iyun 643 Huntington Avenue Department of Geography Boston, MA 02115, U.S.A. University of Ihadan Ibadan, Nigeria Drug Management Program Management Sciences for Health Professor Kumud K. Kafle (Dr Richard Laing) Head of Clinical Pharmacology 165 Allandale Road Institute of Medicine Boston, MA 02130, U.S.A. Tribhuvan University Teaching Hospital Maharajganj, Kathmandu, Nepal World Health Organization Action Programme on Essential Drugs Professor A. F. B. Mabadeje 1211 Geneva 27, Switzerland Department of Pharmacology and Therapeutics World Health Organization University of Lagos, College of Medicine Control of Diarrhoeal Diseases Programme P.M.B. 12003, Idi-Araba 1211 Geneva 27, Switzerland Lagos, Nigeria University of Newcastle Medical School Professor Gabriel Mwaluko Department of Clinical Pharmacology Dean, Faculty of Medicine (Dr Anthony Smith, Dr David Henry) Muhimbili Medical Centre Newcastle, Australia Dar es Salaam, Tanzania DANIDA Professor David Ofori-Adjei (Dr Rene Christensen) Centre for Tropical Clinical Pharmacology Ministry of Foreign Affairs University of Ghana Medical School Asiatisk Plads, 2 Korlebu, Accra, Ghana DK-1448 Copenhagen K, Denmark