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PROMOTING RATIONAL USE OF DRUGS

AT THE COMMUNITY HEALTH CENTERS IN INDONESIA

 ARUSTIYONO

 DEPARTMENT OF INTERNATIONAL HEALTH

SCHOOL OF PUBLIC HEALTH

BOSTON UNIVERSITY

SEPTEMBER 1999


ABSTRACT

Rational use of drugs at health centers remains a problem in Indonesia. Polypharmacy (3.5 drugs per patient), overuse of antibiotic (43 %), misuse and overuse of injections (10–80 %), short consulting time (3 minutes) and poor patient compliance are common patterns of irrational use of drugs in Indonesia. These cause inefficiency and ineffective use of a limited drug budget.

Successful interventions have been made to improve drug use in Indonesia, for example self-monitoring followed by feedback, in-service training combined with monitoring and supervision, and small group discussion. However, the Ministry of Health has not yet adopted most of these proven interventions, since these studies did not involve decision-makers especially at the central level. The other reasons are the decision-makers may be unaware about the results of these studies, the interventions might be expensive and the interventions might not be able to be built into the current system.

Considering the results of the studies, available resources and technical feasibility, I would like to recommend that the Ministry of Health should strengthen the capacity of personnel at district health offices and pharmaceutical warehouses so that they can train personnel at health centers on rational drug use as well as monitor and supervise drug use at health centers. Self-monitoring method should be implemented in other places and prescribers should provide face-to-face education to patients based on printed education material at health centers.


ACKNOWLEDGMENTS

This paper describes the problems of drug use in Indonesia, the interventions which have been implemented, the sustainability of these interventions and also the possibility of replication of interventions in other places. This is as a requirement for the Master of Public Health degree with a concentration in International Health.

The author would like to acknowledge Professor Dr. Richard O Laing MBChB, MSc, MD as an advisor and main professor of Promoting Rational Drug Use (PRDU) course who has fully supported and provided inputs and guidance in writing this paper. The author also would like to acknowledge Professor Lucy Honig, a writing specialist, who has provided generous assistance in preparing this paper.

The author feels that knowledge, skill and experience that have been obtained from the PRDU class are tremendous and worthwhile for completion this paper. The contributions of Dr. Robert L. McCarthy, Brenda Waning MPH and Dr. Michael Montagne as assistant professors of PRDU course are also acknowledged.

The author’s gratitude also goes to WHO and World Bank supported Health Project IV that provided financial support as well as to the Director for Drug Control who nominated the author to study at Boston University School of Public Health.

Finally, the author thanks to all faculty members of International Health Department at Boston University School of Public Health, colleagues at Directorate General Drug and Food Control and friends who supported and gave suggestions in writing this paper. ii


CONTENTS

ABSTRACT i
ACKNOWLEDGEMENTS ii
I. INTRODUCTION 1
II. INDONESIA HEALTH SYSTEM 2
    A. General Information 2
    B. Policy and Objective 3
    C. Health Organization and infrastructure 3
III. NATIONAL DRUG POLICY 4
    A. Drug Regulatory Authority 4
    B. Selection 5
    C. Production and Quality Assurance 5
    D. Procurement and Distribution 6
    E. Use 6
IV. LITERATURE REVIEW ON MEASURING AND IMPROVING DRUG USE
A. Measuring Drug Use 7
    A.1 Quantitative method 8
    A.2 Qualitative method 9
    A.3 Drug use indicators 10
    B. Improving Use of Drugs 10
    B.1 Educational Approaches 10
    B.2 Managerial Approaches 13
    B.3 Regulatory Approaches 15
    B.4 Multiple Interventions 16
    B.5 Implementation issues 17
V. DISCUSSION 17
VI. RECOMMENDATIONS AND CONCLUSIONS 21
VII. REFERENCES 22
ANNEX 1 : WHO Drug Use Indicator 27
ANNEX 2 : The Organizational Structure of Health Care System in  Indonesia 28


PROMOTING RATIONAL USE OF DRUGS

AT THE COMMUNITY HEALTH CENTERS IN INDONESIA

I. INTRODUCTION

Many developing countries have a limited budget allocated to health care especially for drug procurement. Therefore it is imperative to optimize expenditures for drug purchases by selecting an essential drug list and promoting the rational use of drugs. Essential drugs are selected to fulfill the real needs of the majority of the population in diagnostic, prophylactic, therapeutic and rehabilitative services using criteria of risk-benefit ratio, cost-effectiveness, quality, practical administration as well as patient compliance and acceptance.1-4

Since WHO published the first report on the selection of essential drugs in 1977, the concept of essential drugs has been widely applied. It has provided a rational basis not only for drug procurement at national level but also for establishing drug requirements at various levels within the health care system. 3,4

The choice of drugs depends on many factors, such as the pattern of diseases, the treatment facilities, the training and experience of the available personnel, the financial resources available and demographic or environmental factors. The drugs selected should also have adequate data on efficacy and safety from clinical studies and have a variety of medical uses. The quality of selected drug must be assured and the drugs should be stable under anticipated conditions. 3,4

Indonesia adopted the essential drug concept in 1980 and implemented this concept in the public health sector. At that time, the first National Essential Drug List (NEDL) was officially issued based on results of studies done in hospitals and health centers, the WHO list of essential drugs and other resources. This essential drug concept is used to promote the proper, rational and efficient use of drugs. 5-7

Inappropriate, ineffective and inefficient use of drugs commonly occurs at health facilities in developing and developed countries.8,9 Common types of irrational use of drugs include non-compliance with health worker prescription, self-medication with prescription drugs, overuse and misuse of antibiotics, overuse of injections and overuse of relatively safe drugs, use of unnecessary expensive drugs and poor patient compliance. 8-12

Many individuals or factors influence the irrational use of drugs such as patients, prescribers, the workplace environment, the supply system including industry influences, government regulation, drug information and misinformation.13-18

In addition to optimizing the use of limited budget, promoting the rational use of drugs aims to improve quality, increase accessibility and equity of health and medical care for the community. Successful interventions have been made to improve the drug use internationally and in Indonesia.2,8,9

This paper will examine the problems of drug use in Indonesia, the interventions which have been implemented, the sustainability of these interventions and also the possibility of replication of interventions in other places. This paper is written for the Director General of Drug and Food Control (DG DFC), the Director General of Community Health Services and Director General of Medical Care in Indonesia. It is also written for people who are interested in the drug use situation and possible interventions in Indonesia.


II. INDONESIA HEALTH SYSTEM

A. General Information

Indonesia has five main islands and 13,677 small islands, with an area of 5,193,250 sq. km, 39% of which is land and 61% sea territory. Indonesia is the fourth most populous country in the world; in 1997 the population was estimated to be 200 million. In 1993, mortality rates per 1000 live births were given as follows: 58 for infant mortality, 81 among the under five and 4.25 for maternal mortality.19

The current political system in Indonesia is based on representative democracy. People elect their representative for the parliament. The President and Vice President are elected by the parliament and President appoints Minister and Governors. The monetary crisis, which started in July 1997, and political crisis, which started in January 1998, caused disruptions in almost all provinces in Indonesia.

B. Policy and Objectives

Health is regarded as a human right in Indonesia. 21 The National Health System stipulates that the government’s health services are to be made available to all Indonesian citizens with special emphasis on serving low income groups. Indonesia subscribes to the concept of primary health care (PHC) and the achievement of the goal of Health for All by the Year 2000. Health services are also provided by the private sector. In the rural area, the public sector provides about 80 % health services and in the urban area private sector provides about 60 % health services.19

C. Organization and Infrastructure

The organization and infrastructure of health system in Indonesia is described in Annex 1. At the central level the Ministry of Health (MOH), the National Family Planning Board (BKKBN) and to a lesser extent the Ministry for Population and Environment have major roles in the formulation of policy, planning, coordination and supervision. At the peripheral levels, the Ministry of Home Affairs (MOHA) predominates through the provincial Governors, district Regents, sub-district officers and village chiefs. At the provincial level, the MOHA’s Provincial Health Office is operationally responsible for the delivery of all health services. The MOH’s Provincial Health Office supervises and coordinates activities, but has no routine operational authority or responsibility. There are 27 Provincial Health Offices in Indonesia. The referral system consists of 1026 hospital in districts and provinces. 21

At the district level, the organizational interrelationships of the health office are similar to those at the provincial level. In order to improve drug supply management for PHC in the public sector, a District Pharmaceutical Warehouse was established in every district by the MOH. The main suppliers of drugs for the public sector are Government-owned pharmaceutical companies. For self-medication people purchase drugs from drug stores and pharmacies. 21 At the sub-district level and village, public primary health care is provided through a network of 6,954 health centers, 19,977 sub-health centers, and 6,204 mobile health centers in 1993. Health services are provided by 14,072 physicians (1993), 4,635 dentists (1993), 114,712 nurse/midwives (1993), 6,245 pharmacists (1992) and 39,908 assistant pharmacists (1992). In 1994, the average number of outpatient visit to the health centers was 159,542 per 100,000 people per year, and the average number of outpatient visits to the hospital was 11,713 per 100,000 people per year. 19

The primary health care center or puskesmas provides the majority of health care services in Indonesia. These include health promotion, prevention, rehabilitation, and curative therapies. The staffing of each puskesmas consists of one or two physicians and a team of eight to ten paramedics/nurses as medical support staff.8 Due to administrative tasks and a heavy workload, it is not the physicians who see the majority of patients. The paramedics treat 70% of the patients visiting the center.22 Only 48 % of health centers have assistant pharmacists.23

The top three complaints afflicting the Indonesian population are respiratory disease (337 per 1000 diagnoses), skin diseases (168 per 1000 diagnoses), and musculoskeletal diagnoses (77 per 100 diagnoses). 22 Compared to the disease pattern in 1980, the current disease pattern has begun to shift from infectious disease to non-communicable diseases such as diabetes and heart disease.19


III. NATIONAL DRUG POLICY

The Indonesian National Drug Policy was established in 1983 with the objectives of ensuring availability of essential drugs through equitable distribution, ensuring drugs efficacy and safety, as well as promoting the rational use of drugs.5

A. Drug Regulatory Authority

At the central level, the regulatory authority for pharmaceuticals is the Directorate General of Drug and Food Control (DG DFC). Its main functions are to formulate policies and programs on drugs; to control production, distribution and utilization of drugs; and to supervise and control the supply of drugs for the public sector. In the private sector, DG DFC performs drugs registration, provides licenses for drugs imports and exports, controls drug promotion, monitors and supervises for implementation of Good Manufacturing Practices (GMP), assures the quality of drugs before and after in the market and monitors distribution of drugs. The Directorate General of Community Health Services coordinates with DG DFC to develop Standard Treatment Guidelines for primary health care. 21

B. Selection

The Indonesia Essential Drug List (EDL) is revised every three years. The revisions are a result of meetings and consultations organized by the Committee for Essential Drugs List Formulation and Revision appointed by the Minister of Health. 5 The Indonesia EDL is stratified to reflect requirements at different levels such as hospital, primary health center and village drug depots, while the WHO EDL is not stratified into different levels of health care. Compared to WHO EDL, the Indonesia EDL has fewer items.6

Public hospitals and community health centers are obliged to use drugs on National Essential Drug List (NEDL). Use of drugs outside of the NEDL is not allowed in community health centers but is allowed in hospitals. This deviation must be approved by the hospital director and reported to the National Committee on the NEDL. Due to budget limitation the total value of these deviations should not be more than 25% by value. The private sector is not obliged to follow the NEDL. However, some private hospitals have started using the NEDL as a reference for developing their own hospital formulary. 6,7

C. Production and Quality Assurance

There are 287 registered pharmaceutical companies consisting of 40 multinational, 243 national and four government companies. In terms of value, 95% of all drugs for public and private sectors are produced locally. The national private pharmaceutical companies produce almost all drugs including vaccines on the NEDL. Drugs for the public sector and generic drugs are mainly produced by government-owned pharmaceutical companies. 6,7

The National Quality Control Laboratory (QC Lab) and the 27 provincial QC Lab were developed with the assistance of WHO. The government controls for quality by taking samples from the field to be analyzed in the quality control laboratory. Implementation of Good Manufacturing Practices (GMP) in pharmaceutical factories was started in 1971. 6,7

D. Procurement and Distribution

At the health center level, quantification of drug need is mainly done at the district level, while procurement occurs at several different levels. There are multiple budget sources with different disbursement schedules and different procurement committees. Most of the drug budget come from central government routine budget (70%). These drugs are procured at the central level. Each hospital has a drug procurement committee and the composition of that committee is decided by the hospital. The hospitals have authority to procure and dispense drugs outside the NEDL up to the 25% limit mentioned earlier. 6,7

The distribution network is made up of public sector units as well as private sector outlets. Drugs are distributed by suppliers directly to district pharmaceutical warehouses. Staffs from primary health care level facilities come to the district pharmaceutical warehouse on a monthly basis to collect their drugs.

As the results of the monetary crisis, the Indonesia currency (rupiah) fell to 15,000 per dollar in late December and early January 1998 from 2,800 per dollar. At this exchange rate, the price of imported drugs raw material increased five times in term of the rupiah. Most of the national pharmaceutical companies could not produce drugs because of raw materials shortage. This caused the price of drugs to increase by five times especially for brand name drugs both for the public and private sector.

E. Drug Use

Despite improvements through essential drugs programs in pharmaceutical selection, procurement, distribution, and financing, problems remain in the rational use of drugs. Multiple drugs on a prescription (polypharmacy), the over prescribing of antibiotics, the misuse of injections and poor patient compliance are common patterns of irrational drug use in Indonesia.6,7

Study reported that on average patients received 3.5 drugs and more than 50% of patients receive 4 or more drugs per prescription.23 In addition the average number of drugs per case for all diagnoses was 3.68 for all children under of five years and 3.58 for those aged five and over.23 One out of four drugs prescribed was an injection. Generally drugs were given for 3 days including antibiotics. This leads to sub-therapeutic dose of antibiotics being administered.22,23

In terms of mild URI (Upper Respiratory Infection) treatment, 75-86% of patients received antibiotics, 68-70% of patients received analgesics, and 36-41% of patients received cough and cold medicines. For treatment of diarrhea, 46% of patients aged under five received ORS (Oral Rehydration Salt), and 73% of those patients received oral antibiotics. Thirty six percent of patients age 5 and over received ORS, 91% received oral antibiotics. Twenty five percent of patients received an antibiotic injection. Frequent use of antidiarrheal combinations and vitamins also occurred.23

Injection use was widespread ranging from 10% to 80% of patients. For diarrhea, 33% of patients aged under five and 50% of patients aged five and more received at least one injection. For mild URI, 53% of patients aged under five and 20% of patients aged five and over received at least one injection.23 Injections and multiple drugs are frequently used to treat myalgia in five and over age groups. Non-physicians used 40% more injections for patient aged five and over and used twice as many injections for under fives as doctors used.22

In terms of cost, antibiotics ranked highest, followed by cough and cold medicines, and analgesics. Observed treatment cost was Rp. 512 per case while standard treatment cost would have been Rp. 153,- per case. Antibiotics accounted for 60-63% of URI (Upper Respiratory Infection) costs.24 Drugs for the treatment of diarrheal diseases and respiratory conditions accounted for 68% of all under five health center drug costs and 38% of all over-five drug costs.24


IV. LITERATURE REVIEW ON MEASURING AND IMPROVING DRUG USE

A. Measuring Drug Use

The first stage of understanding a drug use problem is measuring existing drug use practices. The purpose of this data collection is to learn about the exact nature of the problem, and to clarify the underlying causes. This requires the use of quantitative and qualitative methods.2 The method to be used in a particular situation depends on the nature of the problem, the objectives of collecting data, the availability of resources and the time available.2

Quantitative methods describe drug use patterns, or pinpoint specific problems that need attention. However, quantitative methods are limited in understanding why these patterns or problems exist. Qualitative techniques are better suited to examine underlying feelings, beliefs, attitudes, and motivations. 2,25,26

The approach used is affected by the costs of different method. One approach may be cheaper or more feasible than another. Using routine reports is usually cheaper, but the qualities of those reports are often poor. Undertaking a survey would result in complete and accurate data but this method is expensive compared to other methods of assessment.

A.1 Quantitative method

Quantitative methods are used to collect quantitative data such as number of drugs prescribed and number of patients who received antibiotic or injection. These data are used to create rates, averages and other summary measures to describe the nature and extent of drug use practices. Quantitative data can be collected by many different methods such as consumption data, record review, small scale surveys and from household data.2,25,26

In the consumption data method, data sources come from drug supply orders, stock cards, shipping and delivery receipts. This method is useful for studying aggregate patterns of drug use and expenditure, comparative use of drugs within therapeutic classes and comparative use by different facilities or areas. The required data are usually in district health offices and Pharmaceutical Warehouses. 2,22,25

Data sources for record review come from patient registers, health worker logs, medical records and pharmacy receipts. This method is useful for studying drug use per case, overall and by group (age, sex and health problem), provider-specific prescribing patterns and features of patient-prescriber interaction. 2,25,26

WHO has published a small scale health facility survey manual which is the most widely used method for collecting drug use data.2,25 These surveys gather information, once or at multiple points in time, about a sample of patients, health facilities, or events (e.g., prescribing encounters). This method can be conducted retrospectively or prospectively. Retrospective data can be obtained from patient registers, health workers logs, pharmacy receipts and medical records. Prospective data can be obtained from patient observations, and patient exit surveys.2,22,25,26

The household data collection method is useful for studying total community drug use, care-seeking behavior, self-medication practices, family drug use and patient compliance. The sources of data are family medical records and household surveys. 2,25,26

A.2 Qualitative methods

Qualitative methods are based on talking to or observing people to explore the cause of the problem, constraints to changes in behavior and opportunities for correcting the problem. These methods often involve trained interviewers or observers and are directed by an experienced social science researcher. However, managers and policy makers can use qualitative methods to assess the underlying factors that influence drug use, so that they can decide how to design and implement appropriate intervention. Managers themselves do not need to know how to conduct qualitative techniques, but only what these techniques are and how they may be useful. 2,25,26

Some common methods to collect qualitative data on drug use include in-depth interviews, focus groups, structured observations, structured questionnaires, and simulated patient visits. These methods have different strengths and weaknesses. The appropriate method depends on the nature of the problem, what the objectives of collecting the data are, what resources and time are available and the local capacity and experience of studying drug use.2,25,26

However, in order to address drug use problems effectively, we often need to find out more information on why they are happening. For this purpose, it is helpful to collect qualitative data about the problem in the form of descriptions, ratings, observations, or some other less easily quantifiable form. These qualitative data allow us to look in more depth at a problem in order to understand its causes and possible strategies for changing it. Although qualitative data are not collected as numbers, the content of the data may be organized and analyzed later according to a structured coding system. 2,25,26

In general, it is desirable to combine quantitative and qualitative methods. Each method used can look at different aspects of a problem. One strategy to integrate data efficiently is to conduct a synthesis meeting of everyone involved in the investigation process. This meeting should then direct its attention to designing the intervention.2

A.3 Drug use Indicators

WHO has developed a standard set of indicators which can be used to assess drug use.2,25 These indicators have been selected through a process of discussion, field testing, and revision, involving a wide range of people coordinated by INRUD (International Network on Rational Use of Drugs), with support from WHO/DAP (Drug Action Program). Other indicators may be used when different needs arise. 2,8,25

The WHO indicators are divided into three groups: Prescribing Indicators; Patient Care Indicators; and Facility Indicators (Annex 2).


B. Improving Use of Drugs

There are three broad categories of interventions to improve drug use. These have been classified as educational approaches, managerial approaches and regulatory approaches. 2,9,28-30

B.1 Educational Approaches

Educational approaches attempt to inform or persuade prescribers, dispensers, or patients to use drugs in the proper, rational and efficient way. There are many types of this approach such as in-service training, face-to-face education, small group discussions, seminars, workshops and printed education materials. 28-31,41

The purpose of training prescribers and dispensers is to improve knowledge and change habits. Lack of knowledge and poor habits are often underlying factors for irrational drug use. One important foundation for long-term improvement in drug use is improving the quality of pre-service training about therapeutics.39-40 Some studies have shown that a short, interactive, problem-oriented training course using appropriate training materials significantly improved drug prescribing practices. 36,42 For example one study on the impact of short course in pharmacotheraphy for undergraduate medical students was conducted. That study was carried out in 7 universities in Groningen (Netherlands), Katmandu (Nepal), Lagos (Nigeria), New Castle (Australia), New Delhi (India) and Yogyakarta (Indonesia). Result showed that the students from the intervention group prescribed significantly better than controls in all patient problems presented.43

Face to face education or persuasion is a common intervention strategy. It consists of interactive group discussions for prescribers and / or and patients. The principle of this method is to talk directly to practicing prescribers and patients about appropriate drug use. Approaches based on face-to-face contact are educational outreach, patient education and influencing opinion leaders. 2,11,28,29,32 In educational outreach which is usually used to improve prescribing practices after completion of training, principles of communications theory and behavioral science are combined with conventional education technique.32 This method provides information to physicians about drugs that are often used inappropriately and to promote their replacement with more therapeutic alternatives. 2,32 A study in the USA described an intervention that targeted authoritative senior department members on the issue of antibiotic prophylaxis of caesarian sections. The intervention involved developing guidelines, which were presented to leaders in the department of obstetrics and gynecology in a hospital. These department leaders ensured through various means that the desired antibiotic cefazolin was used rather than cefoxitin. A dramatic change in usage patterns occurred and was sustained. 38

Another educational approach, small group discussion, attempts to explore the underlying causes of irrational use of drugs. Results are then used to develop specific interventions. 9,28,34 A study done in Indonesia showed that a small group discussion was effective in improving irrational use of drugs in acute diarrhea. Also on site a small-group face-to-face educational intervention had greater A study done in in reducing the inappropriate use of drugs than a large-group formal seminar away from the work-site. 35

Interactive group discussion is a form of behavioral intervention. A variety of persons with different motives interact in a discussion led by an expert facilitator. This method is a modification of a standard group psychotherapeutic technique, but it has not previously been used to alter prescribing behavior.44 A study from Indonesia about the efficacy of the interactive group discussion demonstrated a significant decrease in injection use from 69.5% to 42.3 % in the intervention group compared to decrease from 75.6% to 67.1% among controls. The conclusions of the study were that Interactive Group Discussion significantly reduces the overuse of injections and had long term impact as well as injections were not substituted for other drugs. 44

A study from Kenya and Indonesia reported in 1996 showed that small-group training of counter attendants and one-on-one interactions with pharmacists could also improve diarrhea treatment in private pharmacies, significantly increasing sales of ORS and reducing sales of antidiarrheals. After training, there was a significant increase in knowledge about diarrhoea. ORS sales in intervention pharmacies increased by 30% in Kenya and 21 % in Indonesia compared to control groups. Antidiarrhoeal sales declined by an average of 15 % in Kenya and 20 % in Indonesia compared to controls. There was a trend toward improved communication in both countries. 45

Patient or consumer education also has an important role in improving irrational use of drugs since inappropriate prescribing patterns may derive from the demands of patients. These demands are often exaggerated by prescribers to justify their prescribing habits. 2,37 At health facilities in developing countries, the average patient contact time is often only one to three minutes.27 This is too short for effective communication.

Printed materials including posters are the most common and least expensive type of educational interventions. Printed material can be mailed to prescribers and dispensers, posted on health centers and hospital walls, and personally handed to prescribers and patients. Scientific literature, pharmacy and therapeutics newsletters, and printed guidelines are examples of printed materials used as interventions. In general, using printed materials alone as the way to improve prescribing is based on two assumptions. The first is that the main reason for incorrect prescribing is a lack of information. The second is that if prescribers had the correct information, their prescribing would automatically improve.2,33 However this is not always the case. Studies in Western countries have shown that distributing printed education materials alone resulted in brief, very small or non-existent improvements in prescribing. Many times these material are not even read by prescribers.33

B.2 Managerial Approaches

Managerial strategies attempt to improve drug decision-making by a variety of techniques including use of specific processes, forms, packages and monetary incentives. The interventions using this approach include developing and implementing Essential Drug Lists or Drug Formularies, Standard Treatment Guidelines, implementing drug supply kit system, monitoring and feedback, establishing representative Pharmacy and Therapeutics Committees, establishing structured drug prescribing form, providing cost information, and set-up financing. 2,9,28-30

Essential Drug Lists or Drug Formularies provide prescribers with a list of the drugs felt to be most effective and economic in treating important health problems. In general, larger drug lists are considered appropriate in settings with better-trained health workers, for example physicians, while community health workers may only be able to prescribe 20 drugs effectively.2,28,29

Standardized diagnostic and treatment protocols are decision rules, which lead health workers to the most appropriate actions based on patient symptoms and clinical signs. Certain factors are important in determining how effective such guidelines will be in changing behavior in different settings, for example, how the guidelines are produced, how the guidelines are disseminated and whether the guidelines are "user-friendly". 2,9,28 A study from Uganda showed that implementing Standard Treatment Guidelines followed by training and supervision was more effective in reducing the average number of drug prescribed and percentage of cases given antibiotics compared to distributing STG alone.46 Another study from Tanzania showed that developing and implementing STGs followed by monitoring reduced incorrect treatment. 47

Drug supply kits are an extreme example of the essential drug list concept where a limited number of drugs are supplied in fixed quantities at a regular interval to health facilities. Drug kits are usually used in peripheral areas, which are difficult to supply effectively. 2,10,29 One study of an essential drugs kit program in Yemen showed that the number of drugs prescribed in the intervention district was 1.5 per patient compared to 2.4 in the comparison area, and that both antibiotic use (44% vs. 66%) and injection use (24% vs. 58%) were lower. However, kit systems are more suitable for emergency than regular supply situations. 48

In hospitals, it may be possible to create simple drug prescribing forms to correct common prescribing errors. For example, a study evaluated an i.v. antibiotic order form developed at a Boston teaching hospital. This simple intervention, which combined both managerial and educational elements to improve prescribing, results in savings by reducing unnecessary drug expenditures. 53

Implementing self-monitoring prescribing practices in health facilities is another type of managerial intervention. In general, there are three steps for implementing self-monitoring. The first is identifying suspected problems in drug use. The second is developing self-monitoring tools and the third is implementing self-monitoring method. A key aspect of the self-monitoring intervention includes the active involvement of the local staff at all stages of the study and use of locally meaningful indicator.2,28,29,30 A study of self monitoring of drug use indicators at health facilities in Indonesia showed that the self-monitoring was effective in reducing injection use, antibiotic use and average number of drugs. Compared to the baseline study, polypharmacy had been reduced by 26 % (from 4.2 to 3.1), antibiotic use had been reduced by 51% (from 63% of patients to 31%) and injection use had been reduced by 74% (from 76% to 20%). 49

Another managerial approach, the utilization audit, involves collecting and analyzing data on past or current prescribing by health facilities, clinical departments, or individual prescribers. Data on performance are usually fed back to prescribers. 2,28,29

Hospital Pharmacy and Therapeutics Committees are designed to ensure the safe and effective use of medications in hospitals. This committee promotes the rational use of drugs through the development of relevant policies and procedures for drugs selection, procurement and use as well as through the education of patients and staff. However, there has been little critical evaluation of the clinical or economic impacts of this approach in developing countries. 2

Finally, fiscal management strategies may also improve prescribing practices. Providing cost information can encourage physicians and paramedical staff to consider cost in their selections. This includes using cost bar graphs, drawing up facility drug budgets, and printing prices in drug manuals and on requisition forms. Setting prices and changing the way fees are collected can affect the way drugs are used. This includes using price setting, capitation-based reimbursement and drug sales by prescriber. 2

B.3 Regulatory Approaches

Regulatory approaches attempt to restrict allowable decisions by placing absolute limits on availability of drugs. These strategies rely on rules or regulations to change behavior. Interventions using this approach are limiting or banning registration, changing product registration status as well as prescribing and dispensing controls. 2,28,29

Limiting registration or banning is a common strategy for limiting the use of specific undesirable products. Usually these regulatory controls are applied to drugs for which there are concerns about safety, doubts about efficacy, or which are felt to be too expensive to justify their clinical value. As long as there is enforcement of registration decisions, not allowing a drug to be registered is an effective strategy to control use. However, banning a product which is already in use carries the risk of encouraging unintended substitutions of drugs which are equally unsafe or ineffective.2,10,29,30 For example, there is some evidence from Bangladesh that the banning of all antidiarrheals resulted in increased use of metronidazole and mebendazole as "antidiarrheal" substitutes. 51

Changing the prescription-only status of drugs is one way to encourage or discourage their use. Making a product over-the-counter (e.g., specific non-steroidal anti-inflamma-tories) would encourage its use in relation to competitors, while making a drug prescription-only (e.g., antibiotics or antidiarrheal previously available as OTCs) would tend to reduce use. There is a recent tendency in many countries to increase the number of products available over-the-counter in order to reduce cost and increase access.2,28,29

A number of countries have adopted regulations to encourage the use of generic, non-branded drugs. Generic products offer therapeutic efficacy equal to their branded equivalents at much lower cost. As with other types of regulation that limits the availability of certain drugs, generic policies can cause shifts in utilization to the private sector. In addition, since prescribers and dispensers are often unaware of the exact ingredients of a drug, regulations requiring generic prescribing or allowing generic substitution can cause unintended errors in therapy. 2,9,28,29 A study from the Philippines showed that the implementation of a drug generic law without education had a lower impact on prescribing practice than regulation paired with education and sanctions. 52

Limits on the number or quantity of drugs dispensed are another type of regulatory intervention. In settings where over-prescribing is common and pharmaceutical resources are scarce, this method attempts to limit the number of drugs that can be prescribed to a single patient, for example 2-3 drugs. In other settings, limits are placed on the number of days of drugs supply that can be dispensed to a patient at one time. To receive the rest of a course therapy, patients are expected to return for another clinic visit.2 There is a risk with this type of arbitrary limits that patients will not receive essential drugs that they need. Previous study in developed country showed that prescription limits can results in increased use of other, more expensive types of health care. 53

Regulatory interventions may have unintended impacts that could adversely affect the program. Great care should be taken in planning, implementing and monitoring the intended impacts of any regulatory action.2

B.4 Multiple Interventions

In general combining interventions is likely to have a synergistic effect. A study from Indonesia showed that disseminating leaflets combined with face-to-face education reduced antibiotic use and increase ORS use in diarrhea at health centers.55

A recent series of interventions by a group in Mexico City aimed at improving the treatment of diarrhea offer a good example of how interventions can combine different approaches.49 In the initial intervention, a prescribing survey for diarrhea was carried out and then was followed for the next six months by a peer review committee activity. In the second phase, the training workshops to review the normative treatment algorithms were conducted by "opinion leaders" in 18 Mexico City clinics. In the final phase of work, the algorithm was simply taught to health staff in 124 clinics. The use of the algorithm improved by 6.5%.49

This sequence of studies illustrates the magnitude of additional impacts that are possible by combining intervention strategies. The most effective interventions often combine different aspects of educational, managerial and regulatory strategies to achieve maximum impact.

B.5 Implementation Issues

The practical problems of improving the drug use should not be underestimated since the potential impacts on health care can be formidable. Collaborative efforts involving health researchers, health care professionals, health managers, health policy decision-makers and consumers / patients are of utmost important in developing interventions.2

Intervention studies should be carefully examined for effectiveness in improving drug use, before they are implemented in all health facilities. Interventions should focus on the major underlying causes of the irrational use of drugs.2,9,28-30

In order to be effective, intervention needs to be focused to achieve a specific goal or address specific disease and targeted at those prescribers who have a particular prescribing problem. For example, an intervention focused on the correct treatment of diarrhea through promoting the use of ORS and reducing the use of antidiarrheal, antibiotics and injections, should be targeted at paramedics who prescribe poorly and particular health centers that have problems in diarrhea treatment.2


V. DISCUSSION

Rational use of drugs in health centers is still a problem in Indonesia. Polypharmacy (3.5 drugs per patient), overuse of antibiotic (43 %), misuse and overuse injections (10–80 %), short consulting time (3 minutes) and poor patient compliance are common patterns of irrational use of drugs in Indonesia. 27 Data from other countries show that polypharmacy is 1.4 drugs per patient in Bangladesh and 3.8 drugs per patient in Nigeria. The antibiotic use is 25 % in Bangladesh and 63 % in Sudan. The injection use is 11 % in Zimbabwe and 36 % in Sudan.27

Reducing irrational use of drugs at health centers in Indonesia is not easy since there are constraints, such as lack of resources, lack of knowledge of paramedics, low levels of patient’s knowledge and habits as well as demographic constraints. Basically there are two types of experiences of improvement of drug use in Indonesia. The first is efforts which were conducted by the Ministry of Health and the second is intervention studies which were conducted by the other organizations, for example universities.

The MOH has undertaken some activities that attempted to improve use of drugs. A standard treatment guideline for health centers and a National Drug Formulary for over-the-counter (OTC) drugs have been developed. Also a National Drug Formulary for health professional and materials for improving drug counseling are being developed.

In Indonesia, regulation requires that drug information on labels or promotional materials for drug advertising must conform to criteria of objectivity and completeness and should be unbiased. Drugs products to be promoted must be registered and approved for marketing by the MOH. A guideline on drug advertising was established in 1994, based on the WHO Ethical Criteria for Medicinal Drug Promotion and adopted to meet Indonesian needs. Advertisement on OTC drugs can only be made after obtaining approval from MOH.

To improve drug accessibility, the MOH promotes the use of generics. The generic drug program was launched in 1991. The quality and price of generic drugs are controlled by the MOH and public health facilities are obliged to use them. There are public campaign to promote use of generic drug through television and posters.

Training in the rational use of drugs including the use of standard treatment is not a regular feature in health services in Indonesia but it is done in limited areas. Generally implementation of STG is combined with training but is not followed up by continuous monitoring and supervision to reinforce their use. Training prescribers usually is more expensive compared to other interventions. The effectiveness of the training physicians is often low since the turnover of physicians in primary health facilities is high and most patients are treated by paramedics.

The Ministry of Health disseminated drug use information to prescribers in the health centers but usually there is no follow-up. The effectiveness of this activity was therefore low. As an isolated activity, this approach has failed universally. As part of face-to-face education these printed materials may play a role but in isolation they are not recommended.

Some of the guidelines and manuals available in Indonesia are considered by the field staff to be either "too complicated", "too lengthy", or "contain too many messages". Others said that they had never read them. Paramedical staff, who in fact do most of prescribing in health centers, receive very little training in rational use of drug during their education or later after some years of service.

However, the impacts of those activities on rational use of drugs are not known yet since there was limited evaluation of these efforts. Evaluation of all activities should be conducted since the results of evaluation can be used to improve the program.

There have been some successful rational drug use studies conducted in Indonesia. One study looked at training activities combined with improved supervision or monitoring. 42 This study showed that the most effective in-service education is likely to be problem-oriented, repeated on multiple occasions, focused on practical skill, and linked to the use of STGs. Adult education techniques using interactive methods, such as discussion and feedback, are more effective than traditional training methods such as lecturing. When the roles of supervisors and trainers are combined, the impact of in-service training on prescribing practice is further enhanced. These approaches may require the training of trainers and supervisors to use these adult education techniques.

While these interventions were effective enough in improving use of drugs, they may not be sustainable since generally these interventions need follow-up and cost more money. Without financial allowances and political-will from decision-makers, these interventions are unlikely to be implemented on a countrywide basis.

Staff at district health offices and pharmaceutical warehouses are meant to supervise drug use at health centers but this is often irregular and usually there is no follow-up. Often supervisors do not have sufficient knowledge and skill to supervise drug use effectively at health centers.

Other studies showed that group process among health workers or among health workers and patients have been successful. 44,45 These are potentially powerful approaches to improve the use of drugs. This can occur because group commitment to standard treatment guidelines by staff at health facilities or continuing involvement in peer monitoring may motivate change.

Group discussion has proven to be effective in improvement of drug use in Indonesia.34 Group development of treatment norms has also shown improvement in several settings. The impact of these interventions stems from the powerful forces generated during group discussions. Members of the group absorb the group norms and are motivated to change their practices more profoundly than in a passive learning environment.

Self-monitoring and supervision was another successful Indonesian study.50 This method uses monthly audit and feedback of performance indicators. This self-monitoring method has demonstrated consistently positive impact on prescribing practice. This approach should be tested more widely, and if successful, it can be implemented for all health facilities. This method is likely to be implemented in other places because this can be built into the system.

Managerial strategies may take a major effort but are likely to be most successful and sustainable. Improving irrational use of drugs through implementation of STGs is one example of a managerial strategy. This requires initial work and continuous effort. The STGs should be introduced through an official launch combine with intensive training program and supervision and further training should reinforce their use. STGs will gain greater acceptance if the focus is put on improving the quality of care rather than simply reducing cost. In a number of settings where STGs have been developed by an expert committee and simply sent out to health workers, no impact has occurred.

Generally the Ministry of Health has not yet adopted most of these proven interventions, since these studies did not involve decision-makers, especially those at the central level. The other reasons are that the decision-makers may be unaware of the results of the studies, or the interventions might be expensive. Therefore the replication of these interventions depends on the political-will of the decision-makers. This fact means that decision makers need to be informed about the results of successful intervention and involved from the outset in future interventions.

The improvement of drug use becomes more important since Indonesia has had its recent economic crisis. In the current situation, the drug budget decreases while the drug prices increase. Therefore, the drug budget should be optimized through rationalization of drug use. This can be achieved through conducting interventions that have the greatest impact, are economically feasible and can be built into the current system.


VI. CONCLUSIONS AND RECOMMENDATIONS

Considering the results of the studies described, available resources and technical feasibility, I would like to make the following recommendations to promote rational use of drugs in community health centers.

- Each district health office with assistance of the Ministry of Health should develop simplified standard diagnostic and treatment guidelines that are adapted to local specificity.

- The Ministry of Health should strengthen the capability of district health office staff in order to conduct paramedics training, monitor and supervise drugs use at health centers.

- The district health offices should provide pre-service and in-service training on standard treatment protocols to paramedics working in health services on a regular basis. This activity should be followed by monitoring and supervision in order to give feedback on patterns of drugs use to health centers routinely.

- The district health offices should provide training on implementing self-monitoring of drug use to health center staff and audit prescriptions as well as give feedback to the health centers on a regular basis. The audit should be focused on leading causes of disease.

- The Ministry of Health should assure the availability and the quality of essential drugs in the health centers and should train district pharmaceutical warehouse on drug supply management.

- To increase patient’s knowledge and to change the patient’s behavior, the Ministry of Health should routinely conduct public campaigns on rational drug use and prescribers should provide face-to-face education to patients at health centers based on printed education material.

These recommendations attempt to strengthen the capacity of the district level, so they can improve drug use at the health centers by themselves, using effective and efficient methods.

Indonesia has done well in drug selection, drug production and quality assurance as well as drug procurement and distribution but the final step of assuring correct use of medicines in all health facilities remains a challenge. By implementing the recommendations given, the final component could be achieved.


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Annex 1 : WHO Drug Use Indicator

Core Drug Use Indicators

Prescribing Indicators

1. Average number of drugs per encounter

2. Percentage of drugs prescribed by generic name

3. Percentage of encounters with an antibiotic prescribed

4. Percentage of encounters with an injection prescribed

5. Percentage of drugs prescribed from essential drug list or formulary

Patient Care Indicators

6. Average consultation time

7. Average dispensing time

8. Percentage of drugs actually dispensed

9. Percentage of drugs adequately labeled

10. Patient’s knowledge of correct dosage

Health Facility Indicators

11. Availability of a copy of essential drugs list or formulary

12. Availability of key drugs

Complementary Drug Use Indicators

13. Percentage of patients treated without drugs

14. Average drug cost per encounter

15. Percentage of drug costs spent on antibiotics

16. Percentage of drug costs spent on injections

17. Prescription in accordance with treatment guidelines

18. Percentage of patients satisfied with care they received

19. Percentage of health facilities with access to impartial drug information

Reference : 2, 25


Annex 2 : The Organizational Structure of Health Care System in Indonesia.

MOH has 4 Directorate General :

- Community Health Services

- Drug and Food Control

- Medical Services

- Communicable Disease Control andEnvironment of Health

Reference : 19, 21