Do national medicinal drug policies and essential drug programs improve drug use?: a review of experiences in developing countries

Social Science & Medicine 53 (2001) 831–844 Do national medicinal drug policies and essential drug programs improve drug use?: a review of experiences in developing countries Sauwakon Ratanawijitrasina,*, Stephen B. Soumeraib, Krisantha Weerasuriyac a Faculty of Pharmaceutical Sciences, Chulalongkorn University, Phayathai Rd., Bangkok 10330, Thailand b Harvard Medical School, USA c Faculty of Medicine, University of Colombo, Sri Lanka Abstract Increasing concerns regarding access to and appropriateness of medicinal drug use have led many governments in developing countries to develop national policies and regulations intended to increase the affordability, supply, safety, and rational use of pharmaceuticals. However, little is known about the intended and unintended impacts of these social experiments on actual drug use. We conducted a critical review and synthesis of the international literature in an attempt to define the current state of knowledge regarding drug policy effects on drug use, and to extract from the evidence important lessons for future policy and research. Literature sources included the archives and computerized databases, articles published in medical and pharmacy journals, as well as published annotated bibliographies. The evaluated interventions included three broad categories: (1) multi-component national drug policies including essential drug programs; (2) drug supply and cost-sharing programs; and (3) regulatory measures. Most of these studies utilized weak research designs that evaluated programs solely on the basis of post-intervention measures. Only two studies measured pre-policy utilization, but did not include a control group. Thus, none of the results are conclusive, and the findings represent, at best, hypotheses for more rigorous studies of policy impacts. Some suggestive findings include an association between increases in the supply of essential drugs (combined with training) and more appropriate use of medications in primary care settings. In addition, preliminary data suggest some unintended effects of de-registration of drugs or upward reclassification of specific medicines. Similarly, loosening restrictions have sometimes been accompanied by increased dispensing of specific drugs by unqualified personnel. The available studies focused only on a few categories of national and regulatory policies. Because of poor study design, the results do not provide valid data to determine whether national drug policies improve drug use. Moreover, no studies have evaluated the effects of major and recent changes, such as increased use of product patents, national pharmaceutical insurance policies, and increased privatization of pharmaceutical products and services. Future studies need to explore the consequences of these emerging developments on drug access and use. Despite the difficulties inherent in evaluation of national policies, stronger research designs can and should be carried out. Interrupted time-series analysis and other more rigorous designs should become standard designs for policy evaluation in the same way that standard treatment guidelines are intended to guide medical practice. # 2001 Elsevier Science Ltd. All rights reserved. Keywords: Drug policy; Essential drug program; Drug regulation; Rational drug use; Access; Policy evaluation *Corresponding author. Fax: +662-2558227. E-mail address: rsauwako@chula.ac.th (S. Ratanawijitrasin). 0277-9536/01/$ - see front matter # 2001 Elsevier Science Ltd. All rights reserved. PII: S 0 2 7 7 - 9 5 3 6 ( 0 0 ) 0 0 3 9 0 - 7 832 S. Ratanawijitrasin et al. / Social Science & Medicine 53 (2001) 831–844 Background Public health and public safety are the realms in which many societies have demanded an active role of the State. Pharmaceuticals, as key health care technologies, involve both domains. Public concern regarding the effective and safe use of, as well as the access to, medicinal drugs has also led governments to target pharmaceutical supply and utilization for national policy and regulatory intervention (World Bank, 1993; Quirk, 1980). Traditionally, governments in many countries, particularly developed nations, have attempted to ensure the efficacy, safety, rational prescribing, and dispensing of drugs through pre-market registration, licensing, and other regulatory requirements. By contrast, many developing nations face a broader range of problems (World Health Organization (WHO), 1988a; Helling-Borda, 1995). At issue are not only efficacy, safety, and rational use, but also availability and affordability of drugs to the entire population. Within the context of insufficient supply of essential drugs, furnishing the right drugs in the right dosage to the right patient is hardly feasible. In such a context, making drugs available and affordable is, thus, a prerequisite to rational use. Therefore, many government policies in developing countries emphasize expanded access to essential drugs (Hogerzeil, Walker, Sallami, & Fernando, 1989). A vital role of government in drug systems has been recognized internationally. During the 1970 s, the World Health Organization (WHO) put forth an initiative calling for governments of its member countries to develop national drug policies to address the problems of availability, affordability, quality, and rational use of drugs. The report of the Nairobi Conference on Rational Use of Drugs in 1985 stated that there was a general agreement on the importance of governments in the formulation, implementation, and strengthening of national drug policies and regulatory mechanisms (WHO, 1987). Government interventions in drug systems take many forms. National policies, programs, and regulations are the basic devices employed by most governments. Except for a limited number of small-scale pilot projects and projects with selective targets, these interventions are normally applied on a broad scale and affect all members within a country. Hence, these are social experiments with far-reaching impacts on a large number of people. A thorough knowledge of whether these social experiments produce the intended effects, or whether they generate unexpected adverse consequences, is therefore critical. This is one of a series of papers to review existing literature on developing countries’ experience in improving use of medicines. It attempts to identify national policy and regulatory measures intended to promote rational use of drugs, and to extract from the empirical evidence important lessons (both from successes and failures) for future policy and research. Our principal conceptual models for organizing and interpreting existing research include: (1) the application of quasi-experimental designs to evaluate the impacts of these social experiments; and (2) the tendency for existing systems of health providers and patients to adapt creatively to externally imposed financial or regulatory policies, sometimes with unintended effects on unregulated care (Soumerai, McLaughlin, RossDegnan, Casteris, & Bollini, 1994). Randomized trials of national drug policies are rarely, if ever, feasible; therefore, use of the strongest quasi-experimental designs (e.g., pre–post with control group, time-series) are necessary to provide adequate evidence of policy impacts. A systems framework is necessary because regulations and cost-sharing rarely have isolated effects. Data from developed countries strongly suggest that providers often respond dynamically to policy changes. For example, restrictions on access to individual drugs can lead to appropriate and inappropriate substitute prescribing (Soumerai, Ross-Degnan, Gortmaker, & Avorn, 1990). High drug cost-sharing can create economic barriers to patient drug regimen compliance and shift costs to institutional environments with full coverage for drug costs (Soumerai et al., 1994). Therefore, evaluations of drug policy changes must anticipate and measure effects on entire systems of care. Methods for review The scope The scope of this review covers national policies, including regulatory interventions, attempting to alter system behaviors with the ultimate aim of promoting rational drug use. We define ‘national policies’ as: * * Laws, rules, and administrative orders issued by governments. Policies and programs applied at national or regional levels, or applied to either the public or private sector. Studies of national programs with interventions solely targeting case management, for example education/ training (Ross-Degnan et al., 1997) and standard treatment guidelines, are not included in this paper. In addition to reviewing interventions which directly target drug use problems, this paper also covers National Drug Policies (NDPs) containing multiple objectives. Four main goals are usually embraced by a S. Ratanawijitrasin et al. / Social Science & Medicine 53 (2001) 831–844 national drug policy: availability, affordability, quality, and rational use (WHO, 1988b). Some countries with a domestic pharmaceutical industry usually add to their national drug policies a goal for national self-sufficiency. Because promotion of national self-sufficiency serves a non-health purpose, it is not covered by this review. Although availability and affordability of essential drugs (EDs) are insufficient factors for rational use of drugs (RUD), they are necessary conditions to the attainment of RUD. We, therefore, included in this review studies with an objective of assessing these intermediate goals } availability, affordability, and quality } as well as RUD. Literature search strategy To assess the experience from developing countries on the use of medicines, we undertook a systematic inventory of published and unpublished intervention trials and policy evaluations that met the following inclusion criteria: studies had to be from developing countries, broadly defined as countries in Asia, Africa, and Latin America not on the OECD list of industrialized countries; studies had to describe the results of a planned intervention or examine the impact of a clearly delineated government programs, policies, and mandates targeting patterns of drugs use and factors directly affecting use which are implemented on a national, regional, or sectoral scale. We first screened the archives and computerized databases of INRUD (Ross-Degnan et al., 1992) and WHO/DAP for relevant journal articles, research proposals, theses, reports, and newsletters describing interventions, completed or in progress. We next searched the Medline (1966–1999) and Healthline (1975–1999). We also hand searched articles published between 1990–1999 identified in the tables of contents of 27 medical and pharmacy journals that publish articles on drug utilization, as well as several published annotated bibliographies (Hardon, van der Geest et al., 1991; WHO, 1994). Finally, we solicited materials of interest via mailed letters and electronic correspondence on the E-Drug Internet mailing list from individuals and organizations known to be involved in improving the use of medicines. 833 of ED procurement program } were excluded from this review. Eighteen reports evaluating national policies were selected for analysis. The evaluated interventions fall into three broad categories: * * * Multi-Component National Drug Policies Drug Supply and Cost Sharing Programs Regulatory Measures The majority of these studies utilized weak research designs that evaluated programs solely on the basis of post-intervention measures. Thus, the reports of the effects of these policies must be interpreted with extreme caution because it is impossible to know whether any post-intervention observations were higher, lower, or the same as before the policy intervention. It has been established previously that such poorly controlled studies produce misleading and unreliable estimates of the effects of drug policies (Soumerai, Ross-Degnan, Fortess, & Abelson, 1993). Moreover, because most of these interventions were applied on a nation-wide basis, a control group is therefore not available for comparison. Fortunately, several evaluation designs were stronger (e.g., pre–post and post-only repeated measures). Because of the lack of sufficient objective, quantifiable data from these studies to determine how effective these interventions are, we decided not to estimate the effect size of the poorly evaluated interventions. The distribution of designs in the reviewed studies is presented in Fig. 1. The evaluation designs are sorted by types of intervention in Table 1. Table 2 summarizes types of intervention by country. These evaluations were conducted on national programs carried out in 14 Asian, 9 African, 1 Eastern European, and 2 Latin American countries. (Note that the WHO multi-country comparative analysis of national drug policies accounts for the Overview of the reviewed studies A total of 36 pieces of published and unpublished work } consisting of 18 journal articles, 13 reports, 1 book chapter, 1 booklet, 2 theses, and 1 conference presentation } were screened. Those reports that were not related to the issues addressed here } such as evaluations of NDP effects on local drug production capability, procurement price, and cost-benefit analysis Fig. 1. Distribution of research design in the reviewed studies. 834 S. Ratanawijitrasin et al. / Social Science & Medicine 53 (2001) 831–844 Table 1 Reviewed studies classified by type of intervention and study design Intervention Multi-component NDP Pre-post Post-only Repeated measures Post-only With Without control control With Without control control With control a Without control Dayrit (1999) Supply and cost sharing Regularoty De-registration Upward reclassification Regulate drug info Downward reclassification Total Total Chalker (1995) Hogerzeil (1989) Habiyambere (1992) Griffiths (1986) 8 Gaitonde (1986) Jallow (1991)a D Lee (1990) WHO (1990) WHO/DAP (1996) WHO/DAP (1991) Kafle (1992) 5 Mburu (1984) Bhutta (1996) 1 1 1 Ofori-Adjei (1996) 2 11 18 K Lee et al. (1995) Wibulpolprasert et al. (1996) Wright (1975) 2 2 3 Employed multiple designs. Relevant data came from post-only without control, 1-pt or 2-pt. measures. Table 2 Reviewed studies classified by type of intervention and country Intervention Asia Africa Europe Latin America Total NDP Iran Thailand (2) Bhutan Yemen (Arab) Phillippines (2) Sri Lanka Vietnam India Nepal (2) Yemen (Democratic) Pakistan Thailand Hong Kong Sri Lanka 14 Gambia Zambia Zimbabwe Chad Guinea Mail Bulgaria Guatemala Colombia 17 1 2 26 Supply and cost sharing Regulatory Total Uganda Rwanda Ghana 9 difference in the total number of the countries described in Table 2 and the number of studies in Table 1). Macro level interventions: existing evidence of policy performance (I) National drug policies We included in this category multi-component policies aimed at multiple aspects of a drug system (usually referred to as national drug policies or essential drug programs). An essential drug (ED) program that only addressed the problem of supplying drugs to health facilities is discussed in the section on drug supply and cost sharing programs. Countries use somewhat different mechanisms to attain different goals. However, the main features of most NDPs and ED programs are an essential drugs list (or national formulary), supply system, quality control laboratory, and training. As mentioned earlier, the majority of the countries set availability, affordability, quality, and rational use as the goals of their drug policies. Some countries } for example, Bangladesh, S. Ratanawijitrasin et al. / Social Science & Medicine 53 (2001) 831–844 Iran, Thailand } also include self-sufficiency as one of the policy goals. Of the 8 studies included in this category, one is a journal article, another one is a Ph.D. dissertation, and the rest are unpublished reports. Seven out of the eight evaluations reported on NDP are post-only evaluation designs without control groups. The main components of the NDP packages in these evaluation studies and their outcome measures relevant to this review are summarized in Table 3. Five of these evaluations } the reports on the Iranian (Griffiths, 1986), Thai (Gaitonde, 1986), Bhutan (WHO, 1990), Yemen Arab Republic (WHO/DAP, 1991), and Guatemalan national drug policies (Lee, 1990) } were made by missions sponsored by WHO. In these cases, evaluations were carried out using unstructured methods such as review of official statistics and records, interviews of staff and consultants, and observation during site visits. An assessment of the post-revolution Iranian drug supply system was undertaken in 1986, six years after the policy initiation. The Iranian policy consisted of a combination of interventions such as a national formulary, standards for good manufacturing practice, a national distribution system, quantification of drug demands, drug quality control and pricing mechanisms. The study team based their evaluation of the system effectiveness on recorded statistics and judgments of the mission’s experts. Overall, the team found the increase in drug prices to be much less than general inflation over the years. While several policy devices were designed to improve the drug supply system, the team was unable to judge its achievements other than stating that the general impression was good. On drug prescribing practice, poly-pharmacy still existed with an average of 3 to 6 drugs per prescription (Griffiths, 1986). Review of the Thai NDP was conducted in 1986. The NDP, implemented since 1981, included a broad range of measures such as drug selection, procurement, distribution, and use. The interventions reviewed by the mission included the national essential drug list, procurement mandates for public sector health facilities, establishment of village drug cooperatives, and development of training programs for primary health care personnel. The report described the NDP-related activities the country had taken, and concluded that many achievements had been reached. However, no evidence of policy impacts were provided (Gaitonde, 1986). Bhutan’s essential drug program began in 1986. The program elements consisted of a regulatory system, essential drug list, standard treatment guidelines, new procurement procedures and information system to allow for quantification of drug requirements, and training on drug use and supply management. Certain pre-program data or data from the first or the second 835 year of program existed. Availability of allocated drugs at health facilities was found to be improved. Procurement prices increased seven percent between the year immediately before the program and the fifth year after the program. The team judged the goal of affordability to be achieved. Quality control, which did not exist before the program, was operational in the post-policy period. However, no baseline data were available to assess RUD. Using the WHO-INRUD drug use indicators, the study was able to establish some quantitative data on drug use patterns. The indicators showed a ‘reasonable’ drug prescribing behavior. Training appeared to be effective in bringing down the number of drugs per prescription and improving diagnostic ability of paramedics, but without a comparison group, it is difficult to know whether this was a result of the policy, normal maturation, or other factors (WHO, 1990). A less impressive performance was described in the post-implementation evaluation of the Yemen Arab Republic’s national policy by WHO experts. Yemen Arab Republic’s essential drug program was quite similar to those of Bhutan’s (WHO/DAP, 1991). The expert team found the policy was not being fully implemented as planned. Overall, drug supply was inadequate, procurement prices were high, distribution was not in control, a training manual was not developed and organization of training received little attention by the implementers. The only policy achievement at the time of evaluation was the building of a quality control laboratory (Lee, 1990). An evaluation of the Guatemalan essential drug project on primary health care was conducted in the Solola Health Area which was considered representative of the country’s health situation (Lee, 1990). The essential drug project included a national essential drug list, extra funding for drug supply, quality assurance system, therapeutic audit and drug use seminars. Since quantitative baseline data were lacking, information provided by project staff through interview was used. The general conclusion was that there had been improvement in ED availability, removal of expired and ‘deficient’ drugs, and drug quality. The five-year-old Gambian NDP was evaluated in a study conducted by Jallow. The policy package consisted of a new drug law and registration requirements, public sector essential drug list, treatment manual, and training. Multiple methods of data collection and analysis, and multiple data sources were employed in this study. The designs include post-intervention repeated measures for unit costs of basic drugs, pre- and post-implementation comparison of certain types of registered drugs, and a post-intervention study of prescriber knowledge and behavior. Findings on drug supply show fluctuations in procurement prices, a decrease in drug availability due to lack of foreign 836 Table 3 Main Components in the NDP Packages and Relevant Outcome Measures Study Main components Availability Affordability Use Prescribing (Griffiths, 1986) IRAN * * * * * * * National formulary Supply: GMP standard, distribution system, demand quantification, QC Pricing: fixed Knowledge Polypharmacy * * * Village drug Coops EDL PTC Treatment guidelines Regional QC Lab * Registration EDL Treatment manual Training * * % village drug cooperatives * * * Post-only without control Judgement+records WHO mission Post-only without control Judgement+records WHO mission Mainly described activities (Jallow, 1991) GAMBIA * * * * * * * #drug outlets % brand drugs % combined drugs Harmful drugs * * * * * * * (Lee, 1990) GAUTEMALA * * * * * (WHO, 1990) BHUTAN * * * * * Registration Supply QC Lab Treatment guidelines Training * Regulation EDL Treatment guideline Supply Training * * Various WHOINRUD DUIs #drug per patient % patient given drugs % ED prescribed % Generic prescribed % injection prescribed % antibacterials prescribed * Mainly post-only without control * Post-only without control, qualitative * Post-only without control Quantitative+qualitative WHO Mission ED availability Removal of expired and ‘‘deficient’’ drugs * Health post personnel’s compliance with protocol % allocated drugs variable * Various WHOINRUD DUIs * Paramed ability to diagnose * * S. Ratanawijitrasin et al. / Social Science & Medicine 53 (2001) 831–844 * (Gaitonade, 1986) THAILAND Drug price index Design/Method Pre-post without control * % facilities with 1stline antibiotics Use of equipment supplied * * * Training Supply Mass media campaign Immunization * Note: QC=quality control, EDL=essential drug list, PTC=pharmacy and therapeutic committee, DUI=drug use indicator. * % patients adequately treated * * Post-only without control NDP indicators * * (Dayrit, 1999) PHILIPPINES * * * * (WHO/DAP, 1996) Multicountries (WHO/DAP, 1991) YEMEN ARAB Table 3 (continued) * EDL Supply QC Lab Computerized registration Training Vary Outcome Indicators Outcome Indicators Outcome Indicators * * * Post-only without control Judgement+records WHO mission S. Ratanawijitrasin et al. / Social Science & Medicine 53 (2001) 831–844 837 exchange and a jump in demand. The drug registration and control system resulted in the elimination of ‘drug peddlers’, and certain ‘obsolete and harmful’ drugs, as well as a large decrease in the percentage of brand and combination drugs. Drug use indicators were employed to examine prescribing patterns of physicians and nurses. However, no pre-policy information on these indicators existed to allow comparison. Interviews indicated that although most of the prescribers were aware of the essential drug program, more than half of respondents could not identify the policy’s contents. The author concluded that the program was functioning to a certain extent, but that greater attention should be paid on training and provision of drug information (Jallow, 1991). Twelve countries } Bulgaria, Chad, Colombia, Guinea, India (Andra Pradesh only), Mali, Philippines, Sri Lanka, Thailand, Vietnam, Zambia, and Zimbabwe } participated in a comparative analysis of NDPs project coordinated by WHO, Karolinska Institute, and the Harvard School of Public Health, undertaken between 1994 and 1996 (WHO/DAP, 1996). The study was a cross-sectional assessment of drug systems existing in these countries. Drug policies in these countries varied greatly. Some countries had a wellestablished pharmaceutical legal system, while others did not have any drug legislation. Some adopted a national essential drugs list, others had no EDL – i.e. Bulgaria and Vietnam. All the participating countries had a drug regulatory authority. Ten policy indicators on outcome were used to assess availability, affordability, quality, and rational use of drugs. Study results also varied greatly. The percentage of certain essential drugs available in a sample of remote health facilities ranged from a low of 54 in the Philippines and 54.8 in Zambia to 100 in Sri Lanka. The average retail price of a standard treatment for pneumonia (standardized to the average retail price of a basket of food for a family) varied from 9 in the Philippines’ public health facilities to as high as 280 in Bulgaria. A measure of drug quality, the percentage of drugs that failed quality control testing, was found to be 0 in Colombia, but 92 in the private sector of Chad. The average number of drugs per prescription was 1.93 in the private sector in Andra Pradesh in India, and 3.8 in the Vietnamese public facilities. The percent of prescriptions with at least one injection was about 3% in the private facilities in Zimbabwe and public hospitals in Thailand, but 66% in the public facilities in Andra Pradesh. The percentage of children under five with diarrhea receiving inappropriate antidiarrhoeal drugs varied from 9 in Colombia, to 78 in Andra Pradesh, to 95 in the private drugstores in Thailand. While this study presents a very interesting set of cross-sectional data which indicate comparative performance for selected indicators across countries, it is not possible to trace the specific policies 838 S. Ratanawijitrasin et al. / Social Science & Medicine 53 (2001) 831–844 or other factors leading to such outcomes (WHO/DAP, 1996). The Philippine Control of Acute Respiratory Infections Program is a nation-wide program implemented as part of the rational drug use component under the NDP. It employed several methods of intervention and spanned over 9 years. The program started in 1989 with two core components } training plus supply. Drugs for treating ARI (co-trimoxazole, penicillin, chloramphenicol) and equipment (1-min timers, oxygen tanks, pediatric otoscopes) were supplied to hospitals. Training was provided for midwives, nurses and doctors in small health stations. In 1992, although training target was exceeded, it was found that only 69% of patients with pneumonia were adequately treated. Furthermore, only 52% of the facilities had first-line antibiotics available, thus reducing their capability to treat ARIs adequately. From 1993 to 1995, refresher courses were provided for midwives and a mass media campaign was carried out to educate caregivers on identification and referral of cases with rapid breathing. A later review of the program found that the training and media campaign were implemented haphazardly, while some equipment distributed to remote district hospitals was hardly used because of lack of knowledge of how to utilize the equipment. A large-scale immunization campaign was organized in 1997–1998 in response to large numbers of measles cases. It was concluded that after almost 9 years, the program did not demonstrate beneficial impacts on the incidence of pneumonia or associated mortality among children in the target group (Dayrit, 1999). Results from the evaluations of the various NDPs appear to be mixed. Some programs were judged to be working while others were not. Policies with similar contents may produce greatly different outcomes. The study on Bhutan and Yemen Arab Republic provide an example of this observation. In the only evaluation employing before-and-after data, the Philippines’ ARI control program failed to reduce the incidence of pneumonia and mortality. This study, nevertheless, offers important lessons on how poor program implementation can undermine program success. The majority of these studies suffer from three methodological limitations: (1) the use of post-intervention designs, either with or without comparison groups, in almost all the studies reviewed, (2) the inability to isolate a specific policy measure for investigation of specific effects, and (3) the heavy reliance on qualitative, descriptive, and sometimes subjective, assessments. Findings from most of these studies lack comparable quantitative information that would allow for objectively judging whether and by how much progress on the various outcomes have been made by implementation of the programs. Consequently, we could not draw any concrete conclusions about the impacts of any of these national drug policies on the rationality of drug use. (II) Drug supply and cost sharing programs Some ED programs only seek to increase availability by using supply mechanisms. A variety of supply mechanisms exist. In some arrangements, EDs are supplied directly to health service facilities in the form of ration kits on a regular basis. In other settings cost recovery is allowed to make the programs self-sustaining. In some cases, the ED program is the only source of drug supply. In others, the ED program may only supplement regular distribution channels by sending extra supplies of drugs to a health facility. Five reviewed studies evaluated supply programs. Again, all of these studies used weak post-only designs, and only three utilized comparison groups. In a study of Democratic Yemen’s national essential drug policy, drug availability and utilization patterns from randomly selected health units participating in the ED program were compared with those without the program. The program was introduced to improve drug supply by providing monthly ration kits to health units. In addition, health units’ personnel were trained to use treatment guideline on RUD. The findings showed a significantly greater availability, higher level of knowledge on rational use, lower use of antibiotics and injections, and fewer drugs per prescription. However, while the findings are suggestive of some success, the failure to ascertain what existed before the policies makes it difficult to rule out the alternative explanation that the participating facilities were already superior to the comparison facilities even before the policy was put into effect (Hogerzeil et al., 1989; Walker et al. 1990). Another post-only comparison group strategy was used to assess the effect of a drug supply and cost sharing system on prescribing and utilization in Nepal. A drug scheme was established to deal with inadequate drug supply at peripheral health facilities. The normal government annual drug supply system was supplemented by an extra supply from the scheme, and a fixed per prescription price (copayment) was charged to the users. Chalker (1995) used a non-random comparison method to assess drug utilization between the drug scheme district (DSD) which received the supplemented supply and a non-scheme district which received the regular supply from the government. The DSD patients received more items per prescription, and more antibiotic prescription than those in the control group. Average per prescription cost was higher in the DSD. Both districts had high levels of inadequate dosing. But the impact of the DSD scheme on these patterns of prescribing is unknown because of the lack of data on pre-intervention drug utilization. The essential drug program in Rwanda is similar to the program in Nepal with respect to the use of cost recovery mechanisms. The program was a Bamako Initiative aiming to improve drug availability while S. Ratanawijitrasin et al. / Social Science & Medicine 53 (2001) 831–844 ensuring program financial sustainability. Main components of the program were a national list of essential drugs, a system of user charges on drugs, and provider autonomy over drug revenues. At the time the evaluation was undertaken, the program covered about onethird of the health centers in that country. The assessment was a post-intervention study to compare performance of 3 groups of health centers: government health centers participating in the program (57 centers), government health centers not participating in the program (52 centers), and health centers under nongovernmental organizations (73 centers). An equal number of randomly selected samples of health centers from each group was used to examine the availability, affordability, prescribing behavior and knowledge of providers. The results indicated that essential drugs availability was greater in the NGO’s health centers than those in the program, while the non-program governmental health centers had the lowest number of EDs. The NGO’s centers also had the largest number of expired drugs, however. Average treatment costs were lowest in the health centers participating in the program. Percentages of prescriptions in accordance to standard treatment protocols were low in all three groups, 32%, 28%, and 32% for program, non-program, and NGO’s health facilities, respectively. Prescribers’ drug knowledge was around 2.5 on a 4-point scale, with no significant difference among the groups. Prescribers’ knowledge of essential drug concept was even lower } 1.6 –1.7 on a 4-point scale } again with no difference among the groups (Habiyambere, 1992). Another study on Nepal drug supply programs compared availability, affordability, and patient care performance between health posts using the same type of intervention but under two different organizations } one group financed by WHO and the other by Health Development Project. The results showed only slight differences between the two groups (Kafle & Shrestan, 1992). The fifth study examined drug availability of rural health facilities under the UNICEF drug kits program in Uganda. EDs were found to be inadequate to cover patient loads and did not last more than 6 weeks. In addition, over and under prescribing in the health centers under the program were common (Mburu, 1984). Both studies used post-only designs without control groups, so the policy impacts are uninterpretable. Among the above three studies employing comparison groups, the supply programs seemed to produce quite different results. Drug availability, use, and prescribers’ knowledge were better in program’s health units than the control group in Democratic Yemen, while those from Rwanda and Nepal did not demonstrate improved performance. The essential drugs program in Democratic Yemen differed from those of the other two countries in that there was a training element. 839 Acknowledging the inadequate number of studies under review and the limitation of the designs, these findings suggest a potential advantage of combined interventions. In other words, without any emphasis on educating prescribers, simply supplying essential drugs to health facilities may not improve drug use. (III) Regulatory measures Regulation is a key instrument employed by many governments to modify the behavior of drug systems. In most countries, registration is required prior to the introduction of a drug preparation into the market. Registered drug products are often further classified into schedules differing in degree of control. Moreover, not only drug products are regulated; often drug information is also subjected to regulatory mandates. Some regulations impose more restrictive requirements on the sale and use of drugs. Most regulatory measures are intended to ensure drug efficacy and safety (e.g. through registration), to improve affordability or to enhance sustainability of health programs, such as in price control or reimbursement schemes. Alternatively, such interventions can also be employed to loosen controls, usually in order to achieve greater access to drugs. This category includes a wide range of interventions with different goals and target groups. Regulatory measures addressed in the reviewed studies included: de-registration of existing products; regulation of drug labels and advertisements; and upward or downward reclassification of products in drug control schedules. De-registration De-registration involves removing existing products from the market (and banning similar drugs from entering the market). In 1990, the Pakistan authority withdrew paediatric anti-motility formulations from the market. A survey conducted by Bhutta & Balchin (1996) assessed the effectiveness of the withdrawal and examined possible unintended substitution effects. The study, which used a post-only design, used both overt (questionnaire) and covert (simulated client) surveys to collect data on availability of the de-registered preparations in retail drug outlets and substitutes suggested for the deregistered formulations. It was found that the products were withdrawn from the majority of the retail outlets, although they were still available in the black market in one city. The substitution practices posed a more serious problem. The de-registered formulations were being accompanied by misuse of adult formulations. Unfortunately, without any data on pre-intervention drug use, we have no idea whether the inappropriate drug use represents an increase from pre-intervention levels of use (possible substitution effect) or whether they are simply a continuation of historical trends. 840 S. Ratanawijitrasin et al. / Social Science & Medicine 53 (2001) 831–844 Regulation of drug information Availability, accuracy, and clarity of drug information can affect drug use decisions. As a consequence, drug information usually becomes a target of regulation. Many countries require pre-approval of drug labels and promotional and advertising materials. Attempting to reduce simultaneous use of the same drugs under different brand names, the Thai FDA imposed a generic regulation on OTC drug labels and advertisements in 1995. A study, carried out by Wibulpolprasert et al. (1996) examined the effects of this legal requirement. The study employed a post-only repeated-measures-without-control design. The results showed that the percentage of labels and advertisements with generic names in the market gradually increased, even when the regulation was later withdrawn. However, percentage of drugstore clients with knowledge of generic names was only 17, 28 and 27 for the three rounds of data collection } during the first, sixth, and twelfth month after the initial implementation date. The percentage of the same clients with knowledge of the drug’s active ingredients remained about the same, indicating that those who knew what a generic name meant also knew the names of active ingredients in a drug product. The low percentage of consumers who understood the information provided may have represented an impediment to the use of information mechanisms for promoting rational drug use. Upward-reclassification An upward reclassification changes the legal status of a drug product by moving it into a drug control schedule with tighter requirements. This mechanism is often stipulated in response to drug abuse or unexpected harm caused by a drug after being released on to the market. Such a case occurred in Hong Kong when the Government’s Pharmacy and Poisons Board reclassified 3 benzodiazepines } brotizolam, flunitrazepam, and triazolam } as dangerous drugs in 1990, and later extended the same measure to all benzodiazepines in 1992. The new schedule required a prescription and detailed records for all supply and dispensing of the drugs. Lee et al. (1995) analyzed the effects of this intervention using the 1990–1993 sale statistics of these drugs. Figures in 1991 showed a decrease in sale of the three reclassified drugs with an increase for some other benzodiazepines } such as diazepam, lorazepam, and temazepam } which remained unrestricted. After all drugs in the group were reclassified, sales of all except midazolam fell substantially. The researchers reasoned that the increase in midazolam use may have been due to increased clinical use. In addition, the proportion of newly reported drug abusers of the first three reclassified drugs fell between 1990 and 1992. However, no information was given on substitution of other psychoactive drugs, many of which are much more toxic or addictive (e.g., barbiturates and meprobamate) than benzodiazepines. Downward-reclassification In some circumstances when greater access and wider distribution of a drug is a priority, regulators may reclassify a product or a group of products down the drug control scheme in order to loosen the requirements on prescribing, dispensing, and/or use. Oral contraceptives have been a frequent target for such reclassification. In 1993 the government of Ghana reclassified low dose oral contraceptives (OCs) to allow for dispensing without prescription by licensed pharmacists and chemical sellers, as well as prescribing by trained staff of family planning programs. Using a post-only without comparison group design, Ofori-Adjei, Arhinful, and Quarshie (1996) examined the availability of and accessibility to OC, as well as provider knowledge and practice of OC dispensing and prescribing. The survey found that OCs were readily available, and most clients found it easy to get to their supplier. Even though the law intended that OC be distributed by pharmacists and chemical sellers through retail outlets, only 34.8% of the pharmacists and 58% of chemical sellers were present at the outlets. Thus, most of the services were provided by untrained staff. Provider knowledge was limited. More than 50% of providers could not identity any side-effects of OC pills. Over 60% of trained providers recommended the wrong type of pills. 46.7% of attendants at pharmacy shops and 34.5% at chemical seller shops did not ask their clients for complaints when re-supplying OCs. Another study of downward reclassification was conducted by Wright (1975) who evaluated the effects of a combined measure of drastic price reduction and loosening of controls on OC. In 1968, Sri Lanka’s Ministry of Health cut OC price by half and authorized trained midwives to prescribe and supply pills outside the clinic. Wright used statistics from family planning clinics between 1967 and 1969 to analyze the changes. OC use increased as a percentage of distribution among four categories of contraception methods: oral contraceptives, IUD, sterilization, and others. In 1969 OCs were chosen by 45% of new acceptors of family planning, compared to 24% in 1967 and 33% in 1968. It is unknown, however, how many women continued to use OC once they left the clinics. Nevertheless, by including more than one or two observations, this study was better able than most reviewed evaluations to measure a change in practice following a change in policy. Summary of studies of regulatory measures Several legal mechanisms are used to modify the degree of access to a drug. Registration and de- S. Ratanawijitrasin et al. / Social Science & Medicine 53 (2001) 831–844 registration simply determine whether a drug should be present within a national boundary; upward and downward reclassifications set requirements on qualification of personnel allowed to prescribe and dispense a drug. Results of all the studies on legal measures generally indicate mixed results. The ban on paediatric antimotility preparations in Pakistan was able to eliminate the products from most retail outlets but may have resulted in unintended substitutions of more inappropriate agents (but the design was too weak to detect this). The Hong Kong’s reclassification of benzodiazepines led to reduction in sales and use, but the study did not assess likely inappropriate substitutions to more toxic alternative drugs; such outcomes have been observed following benzodiazepine regulations in the US (Weintraub, Singh, Byrne, Maharaj, & Guttmacter, 1991). The reclassification of OC may have made the products more readily available and used in Ghana and Sri Lanka. However, in the Ghanan case, the research design does not allow one to rule out possibility that access was already high before the reclassification, and that the step taken was to legalize the existing practice. Did these achievements help to make drug use more appropriate? Several better-controlled studies in the US indicate that the simple regulatory policies (e.g., withdrawing reimbursement for specific drugs) can have complex (both intended and unintended) effects (e.g., substitution of more effective or more inappropriate/ toxic drugs (Soumerai et al., 1993). The success of such a policy then lies in its ability to address possible sideeffects that may follow. Although downward reclassification creates greater access to OCs, easier access does not necessarily lead to more appropriate use. Impacts of this type of policy often rely on other factors, such as provider knowledge, which may hinder the success of policies. Discussion Evaluating the evaluation methods Which macro policy interventions are effective in making drug use more rational? Unfortunately, evidence from the existing literature does not seem to provide any solid data on this important question. The use of weak research designs produced results that are ambiguous or inconclusive. Post-only designs cannot provide valid, reliable or actionable data on impacts of policy changes. Even pre–post designs without comparison series can result in misleading conclusions. For example, one study of one-year trends in use of 23 drug categories among 390,000 patients } at a time with no changes in drug policies } found that 25% of drugs exhibited an 11–83% reduction in use: utilization of another 25% of these therapies increased by 20–68% } indicating 841 that utilization of many medications changed substantially over time for a variety of reasons (Soumerai et al., 1993). Failure to control for these pre-existing trends risks inappropriate attribution of naturally-occurring changes to the effects of drug policies. Policy evaluation studies often seem to suffer from weak research designs. Similar problems of lack of rigorous evaluation were also found in other reviews of policy studies as well. For example, in a review of the effects of regulatory drug price controls in developed countries, Bloor, Maynard, & Freemantle (1996) had to conclude, ‘‘[we] did not identify any rigorous evaluations of the impact of different policies to control drug prices, although they are practically possible’’. However, the fact that there are few rigorous studies of the impacts of macro policies on drug use may stem, in part, from the complexities of the policies themselves. Four characteristics of national drug policies which may be sources of difficulty in policy evaluation are identified below. Multi-stage causal relationship Underlying every policy is a set of assumptions that the policy intervention causes the intended policy effects. These causal relationships may be direct or indirect. Most national policies addressing problems of drug use have an indirect multi-step causal relationship with the ultimate goal of rational drug use. Fig. 2 depicts key assumptions of such policies. The main assumption of a generic labeling policy, for example, is that information requirements for labeling increases consumer access to drug information, which will then lead to rational use. However, several questions arise from this assumption, for instance: What kind of information? How is it displayed? Do consumers pay attention to this information? Do consumers understand the messages? Do consumers change their behavior because of the information? Availability of drug information is a necessary but insufficient condition for rational drug use. Likewise, supply, pricing, and regulatory policies all rest upon such multi-stage relationships to alter drug use behavior. For these policies to be effective in promoting rational drug use behavior, it requires that the two sequential causal relationships are valid. Evaluation of these policies is usually based on their intermediate goals rather than on drug use behavior. Multi-component policy package Most national drug policies consist of multiple measures aimed at addressing several related problems at the same time. The frequent joint implementation of multiple interventions poses great challenge to understanding of the effect of national policies. Results of each element in a policy package may be intertwined with those from another element. Some elements affect drug use problems significantly; others may be dormant. 842 S. Ratanawijitrasin et al. / Social Science & Medicine 53 (2001) 831–844 Failure to disentangle the independent effects of all the policy components makes it difficult for policy makers to identify successes or failures of each of the policy components and modify the policies accordingly. Here lies the dilemma in policy design and policy evaluation. While the need to assess effects of each policy measure requires that policies be implemented one at a time, so that its effects can be evaluated sequentially to allow learning about the effectiveness of each innovation, the complex nature of policy problems may demand that multiple measures be implemented simultaneously in order to bring about the intended effects or to prevent unintended effects. For example, previous evidence has shown that combining supply mechanisms with case management guideline and education was successful in controlling infant and childhood diarrhea (El Rafie et al., 1990), and in improving prescribing behavior (Kafuko, Zirabamuzaale, & Bagend, 1994). In other examples, implementation of guidelines and education programs to encourage use of appropriate replacement therapy following drug removal helped prevent substitution of more harmful products (Soumerai et al., 1993). Theoretical failure versus implementation failure For a policy to be effective, two conditions must be met: (1) that particular intervention is able to ‘cause’ the particular effect, and (2) the policy is carried out as intended. The former has to do with policy design; the latter is concerned with policy implementation. National. policies often include a range of policy interventions that require concerted actions in their implementation. How a policy is implemented in each of the organizations involved is crucial to the overall attainment of the policy goals. Since national policies are usually carried out through a hierarchy of bureaucratic agencies and coordination points, they are prone to implementation failure. The policy literature is full of examples that illustrate how poor implementation led to poor policy outcomes (Pressman & Wildavsky,1973; Williams & Elmore, 1976; Grindle,1980; Mazmanian & Sabatier,1983; Edwards, 1984). A study of final policy performance evaluates the results of both policy content and policy implementa- Fig. 2. Multi-stage relationships of major drug policies. tion. When it is found that a policy intervention fails, the failure may either lie with the design of the policy or the way it is implemented. The inability to pinpoint which of these two factors lead to policy performance } particularly a failure } makes it difficult to judge if that particular policy is ineffective. Hence, looking into the process of how a policy is carried out may generate lessons on policy experience as important as those to be learned from looking at policy outcomes. National scale National policies are large social experiments that often applied to entire populations. The lack of any nonexposed comparison groups is a major challenge for evaluators of such country-wide drug policies. In such situations, the only feasible and rigorous design is the interrupted time-series design, which can estimate prepolicy trends in important outcome measures (e.g., utilization of specific drugs), and determine if there is an immediate change in trends after initiation of the new policy. Drug policy evaluation: what exists and what is expected in an evolving policy environment Existing empirical studies of national policies on drug use have been limited in both focus and method. In terms of focus, the available evaluation studies have concentrated only on a few categories of typical national policies } National Drug Policy packages, supply programs, and several regulatory interventions, including de-registration, reclassification, and regulation of drug information. As a result, existing evaluations fail to keep pace with emerging developments in the drug system, both within and beyond national boundaries. These recent developments } from patent to privatization } will eventually impact upon drug use. These recent developments also raise a new set of policy research questions. For example, as more and more developing countries have adopted pharmaceutical product patent legislation, price increases are expected to follow. What are the impacts of monopolistic practices in the supply of pharmaceuticals on affordability of drugs and, ultimately, on drug use? Will current supply programs and policies on drug procurement be valid under the new policy environment with increasing number of patented drugs? Many developing countries are shifting from public financing systems and public delivery of health services to insurance-based health systems. What are the effects of different insurance policies on drug use behavior of health care providers and patients? Finally, many of the former socialist countries are transforming their drug systems by liberalizing drug control and public procurement, and privatizing drug distribution. What will be the policy consequences on drug availability, affordability, S. Ratanawijitrasin et al. / Social Science & Medicine 53 (2001) 831–844 and use? To be relevant in answering important policy questions, evaluation of drug policies must effectively address both existing and emerging issues. In terms of methodologies, the majority of the existing studies employed inadequate research designs which severely weaken the validity and usefulness of the findings. Despite the difficulties inherent in evaluation of national policies, stronger research designs can be and should be carried out. Interrupted time-series analysis and other more rigorous designs should be made standard designs for policy research in the same way that standard treatment guidelines are intended to guide medical practice. To conclude, the question posed in the title } Do national drug policies and essential drug programs improve drug use? } is not answerable at present, due to lack of reliable data. But the challenge is to refine as well as develop methods to identify policy interventions that will and will not encourage rational drug use and to persuade countries to embark on such studies. To ignore evaluation and to implement national policy interventions based on logic and theory, is to expose society to untried and untested measures in the same way that patients were exposed to untested medicines. Acknowledgements The authors wish to thank the Action Programme on Essential Drugs (DAP) of the World Health Organization for its financial contribution to the preparation of this paper. References Bhutta, T. I., & Balchin, C. (1996). Assessing the impact of a regulatory intervention in Pakistan. Social Science & Medicine, 42(8), 1195–1202. Bloor, K., Maynard, A., & Freemantle, N. (1996). 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Studies in Family Planning, 6(4), 102–105. [...]... in Nepal Health Development Project Kafuko, J., Zirabamuzaale, C., & Bagend, D (1994) Rational drug use in the rural health units of Uganda: Effect of national standard treatment guideline on rational drug use DANIDA/ Uganda Essential Drugs Management Program Lee, D (1990) Primary Health Care and Essential Drugs Project, Solola: an evaluation report DAP, TDR #7 Lee, K., Chan, T., Chan, A. , Lau, G., &... H., Walker, G., Sallami, A. , & Fernando, G (1989) Impact of an essential drugs programme on availability and rational use of drugs Lancet, 21, 141–142 Jallow, M (1991) Evaluation of the national drug policy in The Gambia, with special emphasis on the essential drugs Programme Norway: University of Oslo Kafle, K K., & Shrestan, N (1992) Performance assessment of drug schemes in Surkhet district in Nepal... essential drugs program on governmental health centers in Rwanda Ph.D thesis University of Philadelphia Hardon, A. , van der Geest, S (1991) Annotated bibliography of studies of the social and cultural aspects of pharmaceuticals, unpublished Helling-Borda, M (1995) The role and experience of the World Health Organization in assisting countries to develop and implement national drug policies Australian Prescriber,... and what is expected in an evolving policy environment Existing empirical studies of national policies on drug use have been limited in both focus and method In terms of focus, the available evaluation studies have concentrated only on a few categories of typical national policies } National Drug Policy packages, supply programs, and several regulatory interventions, including de-registration, reclassification,... outcomes have been observed following benzodiazepine regulations in the US (Weintraub, Singh, Byrne, Maharaj, & Guttmacter, 1991) The reclassification of OC may have made the products more readily available and used in Ghana and Sri Lanka However, in the Ghanan case, the research design does not allow one to rule out possibility that access was already high before the reclassification, and that the step taken... Geneva: World Health Organization World Health Organization (WHO) (1990) Bhutan’s essential drugs programme Evaluation report by a joint WHO and DANIDA mission, Geneva: World Health Organization World Health Organization (1994) Annotated bibliography of drug use studies Report World Health Organization /Drug Action Programme (WHO/ DAP) (1996) Comparative analysis of national drug policies Report of the second... countries are shifting from public financing systems and public delivery of health services to insurance-based health systems What are the effects of different insurance policies on drug use behavior of health care providers and patients? Finally, many of the former socialist countries are transforming their drug systems by liberalizing drug control and public procurement, and privatizing drug distribution What... national drug policies and essential drug programs improve drug use? } is not answerable at present, due to lack of reliable data But the challenge is to refine as well as develop methods to identify policy interventions that will and will not encourage rational drug use and to persuade countries to embark on such studies To ignore evaluation and to implement national policy interventions based on logic and. .. effective in promoting rational drug use behavior, it requires that the two sequential causal relationships are valid Evaluation of these policies is usually based on their intermediate goals rather than on drug use behavior Multi-component policy package Most national drug policies consist of multiple measures aimed at addressing several related problems at the same time The frequent joint implementation of. .. Use and abuse of benzodiazepines in Hong Kong 1990–1993 } The impact of regulatory changes Clinical Toxicology, 33(6), 597–602 Mazmanian, D A. , & Sabatier, P A (1983) Implementation and public policy IL: Scott, Foresman Mburu, F (1984) Managing essential drug supplies to rural health by UNICEF Uganda DAP Technical Report Ofori-Adjei, D., Arhinful, D., & Quarshie, N (1996) Reclassification of the regulatory ... health units of Uganda: Effect of national standard treatment guideline on rational drug use DANIDA/ Uganda Essential Drugs Management Program Lee, D (1990) Primary Health Care and Essential Drugs... Bulgaria, Chad, Colombia, Guinea, India (Andra Pradesh only), Mali, Philippines, Sri Lanka, Thailand, Vietnam, Zambia, and Zimbabwe } participated in a comparative analysis of NDPs project coordinated... Sri Lanka Vietnam India Nepal (2) Yemen (Democratic) Pakistan Thailand Hong Kong Sri Lanka 14 Gambia Zambia Zimbabwe Chad Guinea Mail Bulgaria Guatemala Colombia 17 26 Supply and cost sharing