Ghana: article on "topping up" drug management

Publication date: 1998

Managing Drug Supply 2–13 Benefits of Thailand’s collective bargaining system for drug procurement Drug supply choices: what works best? A primary distributor system for drugs in South Africa Guatemala’s strategies for improving drug supply and access And more. National Drug Policy 13–14 Meeting promotes African consumers’ involvement in drug policy Plus articles on Belarus and Zimbabwe Research 15–20 Reviving the popularity of commune health stations in a Vietnamese province Public education in rational drug use: research study shows the value and reveals the problems Training 20–21 Students taught how to develop a personal formulary Newsdesk 21–25 Change at WHO UK study shows patients don’t get the information they need And more. Drug Information 26–27 Communicating drug safety information effectively Meetings & Courses 27 Netscan 28 Letters to the Editor 28 Published Lately 29–30 Rational Use 31–36 How the Netherland’s pharmacotherapy discussion groups have evolved Essential drugs concept needs better implementation DOUBLE ISSUE – No 25 & 26 (1998) The Essential Drugs Monitor is produced and distributed by the WHO Action Pro- gramme on Essential Drugs. It is pub- lished in English, French, Spanish and Russian, and has a global readership of some 200,000 to whom it is free of charge. The Monitor carries news of develop- ments in national drug policies, therapeu- tic guidelines, current pharmaceutical issues, educational strategies and opera- tional research. WHO’s Action Programme on Essential Drugs was established in 1981 to provide operational support to countries in the de- velopment of national drug policies and to work towards the rational use of drugs. The Programme seeks to ensure that all people, wherever they may be, are able to obtain the drugs they need at the lowest possible price; that these drugs are safe and effective; and that they are prescribed and used rationally. All correspondence should be addressed to: The Editor Essential Drugs Monitor World Health Organization CH-1211 Geneva 27, Switzerland Fax: +41 22-791-4167 e-mail: DAPMAIL@WHO.CH Essential Drugs Monitor E S S E N T I A L D R U G S I N T H I S I S S U E : M O N I T O R E D I T O R I A L M Managing drug supply A ct io n P ro gr am me on E ssential Drugs and V accines A ct io n P ro gr am me on E ssential Drugs and V accines mid 1970s basic drug management concepts began to evolve in countries as diverse as Cuba, Norway, Papua New Guinea, Peru and Sri Lanka. Over the last 20 years countries have acquired considerable experience in managing drug supply. Broad lessons that have emerged from this experience include: that national drug policy pro- vides a sound foundation for managing drug supply; that wise drug selection underlies all other improvements; that effective management saves money and improves performance; that rational drug use requires more than drug information; and that systematic assessment and monitoring are essential. Over the years the Monitor has aimed to share both positive and negative expe- riences in this critical field. This issue reports on the strengths and constraints of some national, provincial and local initiatives to rationalise drug supply and use. It also draws on material published in the comprehensive second edition of Managing Drug Supply, issued in col- laboration with the Action Programme on Essential Drugs. This publication, which has long been a fundamental tool in many countries, now compiles state of the art knowledge, experience and guidance on every aspect of the drug management cycle. Watch out in future issues of the Monitor for a new “how to” section drawn from Managing Drug Supply and from accompanying training materials currently being developed. What works best in drug supply has no simple answer. As the article posing this ques- tion on p.7 concludes, it will never be possible to state that one particular system is “the best”. Each country brings unique political, economic and geographical factors to the equation. And to weigh the pros and cons of one drug sup- ply system against another cannot be properly done from a global perspective without detailed study. The Action Photo: WHO/E. Lauridsen OST leading causes of death and disability in developing countries can be prevented, treated or at least alleviated with cost-effective essential drugs. Despite this fact hundreds of millions of people do not have access to essential drugs. Although the relative frequencies of specific illnesses vary among countries, health services throughout the world are presented with a fairly common set of health problems for which essential drugs have an important role. Mortality figures across developing regions reflect a huge burden of illness that can be substantially reduced if carefully selected, low- cost pharmaceuticals are available and appropriately used. And even in indus- trialised countries escalating costs of health care have placed evidence-based and efficient drug supply management high on the agenda. Good drug supply management is an essential component of effective and affordable health care services globally. Within a decade after the first modern pharmaceuticals became available, efforts began to ensure their widespread availability. From the mid 1950s to the Programme is embarking on just such a multicountry study to examine in depth at the country level the outcomes of the drug supply systems in use. This study will look at the advantages and dis- advantages of the systems and the factors which influence the level of success or failure. However, what the experiences of countless countries and programmes do demonstrate is that substantive and sus- tainable improvements in the supply and use of drugs are possible. But an equal or greater number of negative experi- ences show that success is by no means assured. Clear goals, sound plans, effec- tive implementation and monitoring of performance are essential ingredients in pharmaceutical sector development. And we can be sure that if changes in a drug supply system are not based on a careful analysis of the underlying causes for the weaknesses of the existing system then they are unlikely to produce the desired outcome. Systems chosen, for example, because they function in a “successful” market economy may not prove the solution to the drug supply problems faced in the context of a developing country. o E S S E N T I A L D R U G S M O N I T O R2 Issue No. 25 & 26, 1998Act io n P ro gr am me on E ssential Drugs and V accines Health reform and drug financing a number of reasons, including limited formal employment and weak state mechanisms. There are benefits in providing phar- maceutical coverage together with health coverage although challenges, such as difficulties in tracking prescriptions, exist. Policy makers and managers need to be fully informed about the value of insurance coverage, alternative mecha- nisms for providing pharmaceutical benefits, and methods to ensure quality of care, while controlling costs. User charges User charges are increasingly being implemented by governments and local communities in countries at all levels of development, both to supplement general government revenues or insurance pre- miums, and to help control use (see Box 1). Often, however, such programmes have not learned from past experiences, are not well managed, and, as a result, access shows no improvement, revenue replaces rather than supplements government funding, and drugs are overprescribed. User fees can complement govern- ment allocations for pharmaceuticals, but should not replace them. Future efforts need to ensure that the lessons from existing research and actual ex- perience are applied to the design, implementation and monitoring of user fee programmes to ensure that access to drugs does improve, and that rational use does not suffer. When fee mechanisms are instituted at a national level, a top-down approach, starting with major national and local hospitals, may have advantages in terms of equity, reinforcement of the referral system, revenue potential, administrative capacity and impact evaluation. Donor financing and drug donations Donor financing includes bilateral and M A N A G I N G D R U G S U P P L Y H EALTH sector reform is a process aimed at improving equity, quality and efficiency in the health sector through changes in the organization and financing of health services. In this context, the role of WHO today is to explore and promote ways of organizing health services which respond better to the objectives of equity, quality and efficiency. Nearly every aspect of national drug policy and pharmaceutical sector devel- opment is directly or indirectly affected by health reform initiatives. An addition to DAP’s Health Economics and Drugs Series1, which is summarised here, focuses primarily on certain financial aspects of health reform. DRUG FINANCING REFORMS Governments have the responsibility to ensure that drug financing mechanisms are managed in such a way as to achieve equity of access to essential drugs. Fi- nancing mechanisms include public financing, health insurance, user fees, donor financing and development loans. Public financing Some public spending will always be needed to ensure access to drugs by the poorest in society; to ensure provision of drugs for tuberculosis, sexually transmit- ted diseases and other communicable diseases; and to ensure care for target groups, such as mothers and children. As a share of national economic output (GNP), public spending on health in developing countries is one-quarter to one-half that of industrialised countries. Health financing reform should improve the use of public resources, but it should not be aimed to further reduce public spending on health. The level of public commitment for financing health care and drugs should be a matter of explicit public policy, based on an analysis of health care needs and financing options. Policy makers, managers responsible for health care financing, and essential drugs managers should be familiar with the methods for analysing public financing for drugs and for planning public expenditures for drugs. Health insurance Formal health insurance and various informal community insurance pro- grammes represent a growing source of health and drug financing in transitional and developing countries. The experience of many countries has shown that com- pulsory social insurance can be the critical step to a more equitable health care sys- tem. It must be recognised, however, that some developing countries will have difficulties in implementing widespread insurance coverage in the short-term for multilateral grants. For some countries, internal financing mechanisms for drugs may prove insufficient, even after reforms, and therefore external funding can prove invaluable to relieving immediate human suffering and can allow countries to develop long-term solutions. The challenge with all external financing, but par- ticularly when it involves the financing of recurrent costs, is to not allow this to substitute for efforts by countries to develop sustainable financing mechanisms. Transitions from external mechanisms to internal mechanisms need to be incorporated in assistance plans from their concep- tion. But it should be recognised that sustainability may require relatively long-term commitments by donors. To promote beneficial drug donations and to minimise unintended problems with drug donations, interagency guide- lines2 have been published which set out core principles and 12 specific guidelines which should be followed in all drug donations. Development loans Development loans through the World Bank and regional development banks may contribute to long-term development of the human and physical infrastructure for the health sector. However, loans gen- erally should not be used for financing of the cost of drug supplies, as these re- present recurrent expenses. There can be certain exceptions to this which may jus- tify the use of loans for procurement (e.g. seeding of revolving drug funds). As with donor financing, conditions associated with development loans should not dis- tort national drug policies defined by governments. AFFORDABILITY AND EFFICIENCY The appropriate choice and use of drugs is the key to the achievement of pharmaceutical policy objectives and should lead to greater economic effi- ciency in the health sector. A variety of cost-control measures have been applied at different levels within public and private drug supply systems. The appropriateness of different measures varies with the particular health system. Affordability of drugs for consumers is a public health concern. Private expen- ditures for pharmaceuticals in developing countries typically account for 50 to 90% of all spending on drugs. Even for rural populations and the urban poor, the most common source of drugs is direct out-of- pocket purchase from the private market. Use of generic drugs and price con- trols are the two most commonly pursued mechanisms to promote affordability. Generic competition with price informa- tion is effective in this regard. But generic drug markets have grown very slowly in most countries. The strength of public policy commitment to generic drugs is a major determinant of the growth of ge- neric markets. Four essential factors for success appear to be supportive legisla- tion and regulation, reliable quality assurance, professional and public acceptance, and economic incentives (see Box 2). Various mechanisms exist to control producer prices and distribution margins. Wholesale and dispensing margins based on cost plus a fixed professional fee provide a better incentive for rational dispensing than margins based only on a percentage. The effects of pharmaceuti- cal price controls have been mixed. Paradoxically, a number of developing countries are relaxing price controls on drugs, while governments in indus- trialised countries are becoming increasingly concerned with pharma- ceutical prices. With or without price controls, price transparancy should be a central objective. ORGANIZATIONAL REFORMS Reforms to financing systems cannot be made without organizational reforms that should match the structure of the public and private sectors to their responsabilities in fulfilling policy objec- tives. Changes may include incorporation of competitive mechanisms within the public sector, decentralisation of health service provision, and a greater role for NGOs and other non commercial “third sector” entities. 3 Issue No. 25 & 26, 1998 E S S E N T I A L D R U G S M O N I T O R A ct io n P ro gr am me on E ssential Drugs and V accines Competitive mechanisms in public drug supply Alternative drug supply strategies for public drug supply include the traditional central medical stores system, autono- mous supply agencies, the direct delivery system, the prime vendor system and fully private supply. Several of these systems involve different public-private roles and rely on greater competition to improve efficiency. The practical results of different mechanisms for public drug supply have yet to be clearly documented. Govern- ments seeking to improve efficiency in public drug supply should do so with the knowledge that a number of options ex- ist and that success depends not only on choosing an appropriate option, but also on the way in which the option is implemented. Decentralisation and integration in drug supply systems Control and decision making in health systems is increasingly being decentral- ised. For drugs, decentralisation may improve quantification of drug require- ments, inventory control, prescribing and Recently some governments have ex- plored ways of carrying out “public” functions such as standard-setting or qual- ity control testing through innovative arrangements with third sector institu- tions. The various roles played by the third sector should be clearly acknow- ledged by policy makers, and ways to best support and involve the sector should be explored. o Health Reform and Drug Financing: Selected Topics is available, free of charge, from: dispensing. But some degree of centrali- sation may still be required for functions such as drug registration, development of essential drugs lists and standard treatments, quality assurance and bulk tendering. Efforts are also being made in some countries to integrate supply systems for family planning, tuberculosis control, and other “vertical” programmes into essential drugs programmes. Resource- intensive functions such as procurement, quality assurance, storage and physical distribution may be integrated under the essential drugs programme, while financing, quantification of needs and monitoring may remain under the management of the national control programme. Role of the “third sector” Discussions of public and private roles in the pharmaceutical sector should not ignore the vital role of the “third sector”. This includes NGOs’ health services, not-for-profit essential drugs supply agencies, professional associations, consumer groups, and spe- cialised NGOs such as some national pharmacopoeial organizations. Box 1 Observations from user fee experiences in Africa Revenue generation In 34 countries with user charges (out of 39 surveyed), the revenue generated by these fees was generally a very small share of public recurrent health expenditures (almost always less than 10%). However, for some of the systems which have remained in place over several years, modest improvements in this percentage have been observed. Recovery of funds Of the community drug funds operating in 17 Sub-Saharan African countries (Benin, Chad, Niger, Sierra Leone, and Zaire are some examples), the success rate for the recovery of funds was about 50% with positive margins ranging from 49–83% (depending on the margin type). Experiences of the Central African Republic indicate that public health centres which were self-managed, controlled their own drug sales, and had fees for all services, had higher cost-recovery rates than centres which did not exert as much control over drug sales and offered a range of free services. Utilisation of facilities and quality of care Demand for community health services which have user fees does seem to increase if quality, as measured by the availability of drugs, also increases. This is particularly true if accessing the next best care alternative involves significant time and travel costs. However, because user fees do not always succeed in making drugs more available, and other factors are also involved in utilisation, decreases in use of health facilities are also frequently observed. Utilisation of community health centres, after the adoption of revolving drug funds, was noted to have increased in seven countries, and to have decreased in four. Equity and affordability Studies of health care use following the charging of fees show that the poor are more likely than other segments of the population to treat price increases as deterrents to accessing services. Of 25 Sub-Saharan countries with cost recovery programmes, it appears that only one (Zimbabwe) had an official policy specifying national income ceiling criteria which would allow exemptions for the poor. Fourteen other countries indicated that exemptions for the indigent are permitted but did not provide criteria. The remaining 10 countries relied primarily on local and ad hoc measures for providing exemptions. Exemptions based on income are difficult to formulate and implement where formal employment is limited. In some countries, the fairness of certain exemption policies remains questionable. Therefore, equity remains a critical issue. Easy-to-use, reliable methods for determining exemptions in mechanisms charging user-fees are not readily available. Box 2 Mechanisms for promoting generic drug use Supportive legislation and regulation • abbreviated registration procedures (focus on drug quality) • product development and authorisation during patent process • provisions which permit, encourage, or require generic prescription and substitution • requirement that labels and drug information contain generic names Reliable quality assurance capacity • development of substitution, non substitution lists • procedures to demonstrate bioequivalence • national quality assurance capability • national drug manufacturer and drug outlet inspection capability Professional and public acceptance • involvement of professional associations in policy development • phased implementation, beginning with permission to substitute • required use of generic names in all education and training of health professionals • brand-generic and generic-brand name indexes available to health professionals • required use of generic names in clinical manuals, drug bulletins, and other publications • widespread promotional campaigns targeting consumers and professionals Economic incentives • public and professional price information • reference pricing for reimbursement programmes • retail price controls that favour generic dispensing • support by social and private health insurance organizations • incentives for generic drug industry • trade-offs with industry (reduced price regulation, increased patent protection) Action Programme on Essential Drugs, World Health Organization, 1211 Geneva 27, Switzerland. References 1. WHO/DAP. Health reform and drug financing: selected topics. Health Economics and Drugs Series No.6. Geneva: World Health Organization; 1998. WHO/DAP/ 98.3. 2. WHO/DAP. Guidelines for drug donations. Geneva: World Health Organization; 1996. WHO/DAP/96.2. Table 1 Public health and drug expenditures for selected countries Total public health Total public drug expenditures expenditures as % GNP per capita as % health per capita (US$) budget (US$) Bulgaria 3.8% 44.76 18.4% 8.24 Chad 0.6% 1.06 4.5% 0.05 Colombia 1.6% 20.03 18.0% 3.61 Guinea 0.4% 1.73 15.8% 0.27 India (Andhra Pradesh) 3.2% 1.93 6.8% 0.13 Mali 0.4% 0.74 18.8% 0.14 Philippines 0.5% 4.53 13.3% 0.60 Sri Lanka 1.5% 8.58 15.6% 1.34 Thailand 2.0% 33.65 5.6% 1.89 Viet Nam 1.1% 2.32 20.0% 0.46 Zimbabwe 2.8% 12.43 36.1% 4.49 Sources: Shaw PR, Ainsworth M. Financing health services through user fees and insurance. World Bank discussion paper No. 294, 1996. WHO/SHS. Experience with organizational and financing reform in the health sector. Geneva: World Health Organization; 1995. WHO/SHS/CC/94.3. Source: WHO/DAP. Public–private roles in the pharmaceutical sector. Geneva: World Health Organization; 1997. Data are from the most recent year available, generally in the early 1990s. Figures from Chad, Colombia, Sri Lanka and Viet Nam are still considered preliminary. u u u Source: WHO/DAP. Public-private roles in the pharmaceutical sector. Geneva: World Health Organiza- tion; 1997. WHO/DAP97.12. E S S E N T I A L D R U G S M O N I T O R4 Issue No. 25 & 26, 1998Act io n P ro gr am me on E ssential Drugs and V accines M A N A G I N G D R U G S U P P L Y The top-up system With the top-up system total responsibility for supply is given to the supplier. It is a kind of imprest system that has proved effective for drug distribution within hospitals. As with other imprest systems, the maximum (imprest) level of stocks is agreed with the ward/department in charge. The content of the list of stocks to be held is based on the regularly used drugs, and the final list is an agreement between the “user” and the pharmacy (store). The stock level of each drug is based on the known average use of the drug and the interval between stock replacements. In the top-up system it is the pharmacy staff who visit the ward/department on agreed days and note how much of each drug is needed to make the stock up to the imprest level. The pharmacy staff then deliver the noted items to the ward/department. In this system there is no need for ward or department staff to order, the stock is auto- matically renewed by the pharmacy. The system depends on good communication and trust between user and supplier. Pharmacy technician, Margaret Fianko-Sakyi (right), discussing a point with Nurse Stella Opoku during one of the weekly meetings at the Bank of Ghana Clinic. These meetings are vital to the success of the Clinic’s drug management system Sample weekly replenishment form Item Maximum Stock Top-up Expiry description allowed level quantity date quantity as at: Sign 1 Date Sign 2 Remarks: Ph ot o: D . S ek ye re M ar fo T How “topping-up” improved drug management at a small clinic in Ghana DANIEL SEKYERE MARFO* HE adoption of the top-up system of drug supply has led to an improvement in drug supply management at the Bank of Ghana Clinic in Accra. As a result a small project that started with injectables has now been extended to other items with equal success. The Bank of Ghana Clinic is a fairly small quasi-Government outpatient health facility. It was established in June 1988, mainly to provide quality health care (in terms of economy, efficiency, effective- ness and equity) for the Bank’s staff and their dependants. It is also open to a small group of non entitled but authorised paying patients – mostly expatriates and tourists. The clinic’s professional staff is made up of two doctors, one pharmacist, three pharmacy technicians, 10 nurses, one medical laboratory technologist, three medical laboratory technicians and a part-time physiotherapist. The clinic is organized on a “func- tional unit” basis with medical consulting, nursing, pharmacy, medical laboratory and support units. It is funded entirely by annual budgetary allocations from the Bank of Ghana. Treatment, including drugs, is free for all members of staff and their dependants. Patients receive drugs of proven efficacy, purchased from reli- able sources. They are counselled against abuse and misuse, and possible or ex- pected adverse effects of drug therapy. They are also encouraged to complete the full course of treatment, to follow instruc- tions correctly and to refrain from sharing drugs with colleagues, relations or friends. Additional written instructions and labels are provided to ensure adher- ence to treatment, successful outcome and patient safety. The pharmacy unit, which dispenses about 17,000 prescriptions per annum, is also responsible for managing medical stocks at the health facility, in- cluding selection, sourcing, procurement, storage and distribution through the system. With the exception of injectables, all other dosage forms are supplied to patients directly on prescription from the pharmacy, as described earlier. Injectables are first supplied to the injection room, where they are managed by the nursing staff. PROBLEMS OF RATIONAL SUPPLY AND USE The rational use of drugs is a pre- requisite for good health delivery. The impact of drug use on the health of a population does not only depend on avail- ability, affordability or accessibility, but even more importantly on the rational use of drugs at clinic level. This is particularly true in situations of relative plenty, in other words where pharmaceu- ticals are generally available, affordable (at no cost at all to users) and accessible. Sometimes health workers in such situa- tions are overwhelmed by the variety and quantity of drugs available, and the result is excessive and unnecessary expenditure on drug supply. IMPLEMENTING A TOP-UP SYSTEM OF INJECTABLES Essentially a top-up system is based on real need and involves the replenish- ment of running stock with quantities equal to those used (see Box). Meetings are held between the pharmacy unit and the nursing unit to discuss the issues involved in the supply of injectables. ä Initially a survey was carried out to determine the actual weekly consump- tion pattern of all injectable items supplied to the nursing unit. Record- ings in the nursing books were extracted and analysed, with a safety margin of 10%. ä This information was used to agree on maximum weekly stockholdings. Review meetings were also planned. ä New weekly injection supply forms were designed to provide data on quantity used, top-up quantity and expiry dates. ä Since September 1996, at the begin- ning of each working week, the difference between the current stock and the maximum agreed stocks has been provided as replenishment. The nursing staff fill in the current stock levels and send the forms to the phar- macy. A pharmacy technician sends the week’s supply to the injection room where he or she assists in up- dating records of stock levels and expiry dates. MEASURING SUCCESS A comparative study of the value of stock requests before and after the insti- tution of the top-up system (changed in September 1996) was carried out. The 13 most commonly used drugs were selected for study. Stock requests for the 13 drugs over a period of four months before and after September 1996 were recorded and analysed. The results indicated a general trend of over-stocking before the top-up system was introduced illustrated by an average 46.8% reduction in nursing re- quests after it began. The other obvious advantage is a notable reduction in inven- tory value. The success of the initial trial led to the extension of the new system to the supply of dressings and other sundries, followed by drug procurement. Currently procurement is largely on a replenishment basis. Over-stocking is pre- valent in most government funded medical stores. It is our belief that a main cause lies in structures and procedures; the suc- cess achieved with the top-up system has sub- stantiated our conviction. However, the outcome of the trial could have been different if the pharmacy unit had decided to “go it alone” in the effort to change the old style of supplying injections to the nursing unit. The in- volvement of the nursing unit, as the major in-house customers of pharmacy services, was crucial. The top- up system of drug supply has proved to be very useful if well managed. The phar- macy can have better control over running stock. Drug needs’ estimation can be more accurate and thus funds and needs can be better matched for greater efficiency. Drug budgets and therefore real expendi- ture can be reduced by the adoption of the top-up system of drug supply on an even wider scale. o * Daniel Sekyere Marfo is Chief Pharma- cist, Bank of Ghana Clinic, Accra, Ghana. 5 Issue No. 25 & 26, 1998 E S S E N T I A L D R U G S M O N I T O R A ct io n P ro gr am me on E ssential Drugs and V accines Good drugs at low cost: Thailand’s provincial collective bargaining system for drug procurement MONGKOL NA SONGKHLA, SUWIT WIBULPOLPRASERT, PHUSIT PRAKONGSAI* RUG expenditure constitutes approximately 35% of total health expenses in Thailand. Attempts to procure good quality drugs at a lower price are therefore important to improve health service efficiency, particularly in the current economic crisis. This article describes one such attempt at increasing bargaining power through collective provincial bargaining by all district hospitals in one province. The system not only brings down drug prices but also improves the quality of drugs, the efficiency of the drug management system and the strength of the referral system. In 1994 the Ministry of Public Health finally took up the model, and applied it to all 75 provinces. Success was limited to only three provinces during the first three years (1995– 1997). However, after the economic crisis, with the reduced drug budget and increase in drug prices, the mechanism was implemented more vigorously and successfully on a wider scale. Currently 67 (out of 75) provinces implement the system and they have achieved a 25% reduction in drug expenditure. hospitals and health centres, under the Public Health Ministry in each province, report to the Provincial Chief Medical Officer. Drug expenditure in 1993 was US$34 per capita (retail value) and constituted roughly 35% of total health expenditure2. Drugs are distributed through all public and private facilities, including more than 10,000 private pharmacies. Services in public facilities are not free of charge. Unless patients are covered by some kind of insurance, they have to pay a subsidised level of user fees. The pub- lic hospitals thus receive financial support through government budget (tax rev- enues), insurance premiums and user fees. Each hospital is authorised to use these funds to purchase drugs. According to government regulations, public hospitals have to purchase 60%–80% of their drug budget based on items in the essential drugs list. Drugs are produced locally by 176 private factories and a few public enterprises, the biggest one being the Government Pharmaceutical Organi- zation. Locally produced drugs have a 50%–60% market share. There are also 460 drug importers. Most public hospitals purchase drugs from both the Government Pharmaceutical Organiza- tion and private companies. Only those private drug factories with Good Manufacturing Practice (GMP) Certifi- cates from the Thai Food and Drug Administration are allowed to sell drugs to public hospitals. The prices of drugs from the Govern- ment Pharmaceutical Organization are fixed, and quality control is carried out Thailand is a lower middle income country in South-East Asia with a popu- lation of 60 million in 1997. It consists of 75 provinces, 774 districts, 81 sub- districts, 7,255 Tambons (communes) and 66,974 villages. The health care delivery system is composed of both public and private facilities. The public facilities have a 75% share of resources while pri- vate facilities have 25%. Approximately 80% of all public health resources are located within the Ministry of Public Health, with its extensive network of pro- vincial general hospitals, district hospitals and commune health centres. In 1997 there were 89 general hospitals, 703 dis- trict hospitals and 9,132 commune health centres1. Administratively all public by the Organization itself. On the other hand, prices of drugs from private com- panies depend on direct bargaining without a good quality control system on the buyer’s side. Thus drugs are purchased, based on different hospital drug lists, at varying prices and quality levels in different hos- pitals. Bigger provincial hospitals usually have more bargaining power and more access to better quality drugs. Under this system, different drugs are used by dif- ferent health facilities in the same provinces. THE PROVINCIAL BARGAINING SYSTEM In 1990, in order to solve the problems of inefficient drug procurement – high prices and questionable quality– a collective provincial bargaining system was developed in one of the biggest prov- inces in Thailand, Nakorn Ratchasima. The system aims at procuring good qual- ity drugs at lower prices, and ensuring an adequate supply of the same essential drugs to all district hospitals and health centres. The rationale of the system is summarised in Figure 1. This system consists of six sub-systems3: 1. Establishment of a common hospital drug list Representatives of doctors and pharmacists in all 23 district hospitals collectively developed the common drug list of Nakorn Ratchasima district hospitals, under the Provincial Pharmaceutical and Therapeutic Com- mittee. Since the first list was drawn up in 1990 it has been reviewed annually, and in 1997 contained 356 drugs. This is the essential initial step to reduce unneces- sary drug items and establish a common list for collective bargaining. This common drug list is also used in the procurement of drugs for the commune health centres. 2. Drug procurement system A drug procurement committee, comprising pharmacists from all district hospitals, invited private drug companies to join the provincial bargaining system. A short-list of companies was prepared through an extensive survey of drug fac- tories by the committee members, relying on their previous experiences as a further determinant. In 1994, 78 companies (45 local, 27 imported) declared their inten- tion to join the system. However, only 39 (50% – 25 local, 14 imported) of these were short-listed. Each hospital prepares an annual drug requirement plan according to its past utilisation experience. The plans are aggregated into the provincial plan, and the short-listed companies are requested to submit offers. The companies with the lowest price for each item are selected to provide drugs to the system. The prices offered stand for a year. Each hospital then places orders dur- ing the year, according to need, directly with the winning drug companies. After receiving the orders, the companies send their drugs and the bills directly to the hospitals. There is no central provincial stock, no need for provincial financial Figure 1 Rationale of the provincial bargaining system M A N A G I N G D R U G S U P P L Y Common drug list with purchasing plan Collective bargaining Centralised cold chain GMP factories Factory visits Post delivery Q.C. District drug management system Different drugs in different hospitals and health centres Inefficient, costly, and maybe harmful district health services Inefficient referral system and no continuity of care Different hospital drug list No district drug management Individual bargaining Many inessential drugs Continuity of supply Dead stock/ overstock Drug expenditure No purchasing Q.C. Ineffective cold chain Supply problems High commission Low bargaining power Quality Price New collective bargaining Previous system of individual purchasing A young Thai woman being examined at a primary health care centre Ph ot o: W H O /A .S . K oc ha r D .cont’d on pg. 6 à E S S E N T I A L D R U G S M O N I T O R6 Issue No. 25 & 26, 1998Act io n P ro gr am me on E ssential Drugs and V accines management and no provincial bureaucratic steps to follow. Through increasing bargaining power, this collective bargaining system has resulted in 12%–20% reduction in drug prices. For example, in 1989, before the system was implemented, ampicillin injection (1 gm.) was purchased at a price of between 13–26 Baht/vial. In 1994, af- ter establishing the new system, the price was 11.75 Baht/vial (less expensive even after five years of inflation), due to the power of collective bargaining. In 1991, 19.5 million Baht of drugs were pur- chased, saving 5.3 million Baht. In 1993, 20.4 million Baht of drugs were pur- chased, with a saving of 2.8 million Baht. 3. Drug quality control system The quality of drugs purchased was controlled through the process of short-listing the companies and post procurement sampling for quality testing. Only drug factories with GMP Certificates from the Food and Drug Administration were short-listed. Drugs from factories with GMP Certificates are three times less substandard than those from factories without GMP (8% as com- pared to 25%)2. In 1998, 127 of the 175 private drug factories (72.1%) received GMP Certificates. Short-listed factories were then visited by representatives of pharmacists from the district hospitals. During visits to the factories the quality of raw materials, the manufacturing proc- esses, the drug quality control processes, and the external quality control system were thoroughly checked. Only approved factories were allowed to join the collective bargaining system. After the drugs were received at the district hospitals, samples were system- atically collected according to the sampling plans, and sent to the Regional Medical Science Centre for analysis. The sampling plans usually focus on anti- biotics, commonly used drugs, drugs for specific diseases and life saving drugs. With this system, the proportion of substandard drugs was reduced from 30% before, to under 15% after imple- mentation of the system (see Table 1). 4. Low temperature drug management system Supplying low temperature drugs to rural health facilities requires a good cold chain system. Private drug companies usually hesitate to send low temperature drugs to individual district hospitals be- cause of the difficulty with the cold chain system. Thus the provincial health office Table 1 Quality of drugs before and after implementation of the system in 1990. Year Samples Number of Percent analysed substandard drugs substandard 1988 207 62 29.95 1990 32 4 12.50 1991 65 2 3.08 1992 66 2 3.03 1993 46 2 4.34 1994 70 5 7.14 1995 143 17 11.88 1996 31 3 9.68 1997 57 8 14.04 Source: Provincial Health Office, Nakorn Ratchasima Province. was designated by the committee to procure and stock these drugs to supply to all district hospitals. This sub-system not only reduces the drug price and im- proves quality, but also guarantees the availability of good quality low tempera- ture drugs. In 1991, 22 such drugs were included in the sub-system. 5. Drug supply system to commune health centres There are 287 commune health cen- tres in the Province. Previously their drugs were supplied through the Provin- cial Health Office. There were problems of expired stock, overstock and shortages of some drugs due to unresponsiveness of the Provincial Health Office to meet the demand of various health centres. Under this new system, the district hospitals maintain the district stock of drugs to be supplied to the lower level commune health centres according to their demand and allocated budget. This system gives more flexibility and reduces unnecessary expired stock. Most impor- tant of all it allows the same type of drugs to be used in the district health systems, which strengthens the referral system in the districts. 6. Monitoring the districts’ drug management system The ordering and sampling of drugs by district hospitals is monitored closely by the Provincial Health Office’s pharmacists. The district level drug management system is monitored through indicators covering the development and implemen- tation of the drug management plan, continuous supply of drugs, drug utilisa- tion, overstock and the expired stock. Forty-one specific indicators in 10 sub- groups under three main groups were developed. The scores of all 41 indica- tors amounted to 200. The districts were classified by grades A to F according to their level of management achievement. There was much improvement after the implementation of the system (see Table 2). Satisfaction levels of the district hos- pitals and commune health centres were also surveyed and it was found that the system was highly accepted. FACTORS BEHIND THE SUCCESS Several factors contributed to the success of this system: Strong leadership Drug procurement often involves many vested interests and much Table 2 Improvement in the district drug management system % of the districts in each level of drug management * Year A B C D F 1992 28.29 27.51 27.90 12.40 3.87 1993 59.77 23.31 11.28 3.01 2.63 1994 58.33 24.24 12.88 3.03 1.52 1995 86.06 9.84 3.28 0.00 0.82 1996 85.14 9.90 2.97 1.48 0.50 1997 80.79 15.25 2.26 1.12 0.56 * Scoring for each level of drug management: A = 181–200 B = 161–180 C = 141–160 D = 121–140 F = < 120 Source: Provincial Health Office, Nakorn Ratchasima Province. inefficiency. In many cases 20%–30% commission is requested or paid to the hospital authority. Thus some hospitals did not want to participate in the system, and some were hesitant. Strong leader- ship both from the Provincial Chief Medical Officer and peer influence among district hospital directors was es- sential to the initiation and the success of the preliminary phase of development. In the case of Nakorn Ratchasima, the Provincial Chief Medical Officer, who initiated this system in 1990, used his strong leadership and perseverance to overcome the vested interests. He was strongly supported by a few leading dis- trict hospital directors and pharmacists who dedicated their time and wisdom to together with information on corruption in drug procurement, also prompted the Anticorruption Committee of the Prime Minister’s Office to demand the Minis- try of Public Health to implement the system on a nationwide basis. THE WAY FORWARD: OPPORTUNITIES FOR CHANGE The success in Nakorn Ratchasima Province prompted others to follow. In 1992 Ayuthaya Province started the sys- tem, to cover not only the district hospitals and health centres but also the main pro- vincial hospital. The number of drugs for common bargaining increased from five design, develop and manage this system. Sound justification The system was able to show the expected outcomes – better quality drugs at lower prices, a better drug management system, and better support to the district referral systems. Only such evidence can satisfy all partners and guarantee continuity of the system. Partnership Active involvement of all district hospitals created an environment to support ac- countability, transparency and acceptance of the system, without increasing any bureaucratic steps or any vested interests, at the provincial level. This, backed by strong leadership and sound justification, was essential to the sustainability of the system. The system in Nakorn Ratchasima Province has been on-going up to present (eight years) despite the change of four Provincial Chief Medical Officers. Publicity and strong civil society Publicising the results created public awareness, strengthened civic movements and supported the sustainability of the system. It was also a strong advocacy tool to get policy support for wider implemen- tation. The Thailand Health Research Institute evaluated the system in 19934. Its report was widely publicised and fi- nally, in 1994, discussed in the National Drug Committee chaired by the Minister of Public Health. The Minister then brought the issue into further discussion in the ministerial committee, and a Min- istry policy was developed. The report, in 1992 to 23 in 1995. They were able to save from 0.33 million Baht in 1992 to 4.7 million Baht in 1995. Other provinces, such as Burirum, Surin and Lumpoon, started to follow. In November 1994, three years after the system was launched and the success story was publicised, the Ministry of Pub- lic Health put forward a policy to establish such a system in all provinces. However, during an era of high economic growth with a high drug budget (1995–1997), the response was rather weak. Evaluation of the implementation in 1996, by the Na- tional Health Foundation, found that only three provinces implemented the system as intensively as Nakorn Ratchasima. Another 30 provinces did it weakly to moderately and the rest did not implement it at all5. The current severe economic crisis, which began in July 1997, is a good op- portunity for further development. The system was promptly included in a com- prehensive “Good Health at Low Cost” policy package. Inspector Generals of the A pharmacy in Thailand, where collective bargaining is helping to keep Government drug expenditure down .cont’d on pg. 7 à Ph ot o: W H O /W . L in de r Thailand. cont’d from pg. 5 7 Issue No. 25 & 26, 1998 E S S E N T I A L D R U G S M O N I T O R A ct io n P ro gr am me on E ssential Drugs and V accines Drug supply choices: what works best? mechanisms be used to improve public sector efficiency and, thereby, improve access to essential drugs through govern- ment health services? It is important to remember that one element which stimu- lates efficiency in the private sector is the existence of competition. Various strategies have been tried in order to provide access to pharma- ceuticals and, in particular, to essential ised, non CMS approach in which drugs are delivered directly by suppliers to districts and major facilities. The government drug pro- curement office tenders to establish the supplier and price for each item, but the government does not store and distribute drugs from a central location; ä Primary distributor system: another Stores (CMS) approach, in which drugs are financed, procured and distributed by the government, which is the owner, funder and manager of the entire supply system. Selection, procurement and distribution are all handled by the central government, often by a unit within the ministry of health. Financing is usually from central treasury allocations and/or donors, though a CMS can function as a revolving drug fund. This is a demanding approach in terms of human resources, physical infra- structure, management systems and communication systems, requiring the state to manage and fund every aspect of the system. It has been a logical approach in situations where the vast majority of items were imported through one channel; the demand was predictable; finance and administration were highly centralised; and a developed and profes- sional private sector did not exist. Traditional CMS structures continue to be used in a number of countries includ- ing Ghana, Oman and Zimbabwe. However the distribution and financing mechanisms in use vary. Using the traditional CMS system the availability of drugs in the public sector has deteriorated in many (but not all) countries as the nature of medical practice has changed and real financial resources have diminished. At the same time the demand for, and cost of, health service provision has increased. The causes are many. The drug sup- ply environment has changed drastically from a range of chemicals and galenicals to a multiplicity of manufactured finished products. CMSs have experienced problems with financial management, quantification of requirements, manage- ment of tenders, warehouse management, transport and security of drugs. These problems have also been exacerbated by political or administrative influences and M A N A G I N G D R U G S U P P L Y Effective supply of essential drugs includes rational selection, quality assurance, good procurement and storage practices, and timely distribution Ph ot o: S ist er P at ric ia M cC us ke r Ministry of Public Health have been sent into each province to ensure its intensive implementation. Nine months later, the situation has improved with 67 provinces now actively implementing the system, although in other provinces the old sys- tem of individual purchasing prevails or implementation of the new system is still weak. The impact has been clear in the 67 provinces where collective bargaining is used: drug costs were lowered by 24.7%, from 622.05 million Baht (if purchased under the regular individual purchasing system) to 468.03 million Baht, a very significant saving6. Never- theless, this 622.05 million Baht accounts for only about 10% of the Ministry of Public Health’s drug budget. Most of the drug budget is still spent on individual purchasing and procurement through GPO. With the economic crisis, political reform, public sector reform, stronger civil society and decentralisation, a transparent and efficient public manage- ment system is essential. This will enable the provincial bargaining system to dig deeper roots and gain wider implementation in the near future. o * Dr Mongkol Na Songkhla is Secretary General, Food and Drug Administration, Thailand, Dr Suwit Wibulpolprasert is Assist- ant Permanent Secretary, Ministry of Public Health, Thailand and Dr Phusit Prakongsai is Director, Kao Sukim Hospital, Chuntaburi, Thailand. Update: In December 1998 the Ministry of Public Health announced a policy aiming to use the collective bargaining system for 50% of its hospital drug expenses. This would mean that at least 5,000 million Baht worth of drugs would be purchased under the sys- tem, a possible saving of 1,250 million Baht. Improved drug quality would also be en- sured, thus achieving greater efficiency and quality in the midst of economic crisis. References 1. Bureau of Health Policy and Planning, MoPH. Health in Thailand 1995–1996. Bangkok: The Veteran Press; 1997; p 110, 124. 2. Wibulpolprasert S. (ed.). Thai drug system: a situation analysis for further development. Bangkok: Desire Co. Ltd., 1995; p 21, 29. 3. Prakongsai P. Summary of provincial bargaining system for drug procurement in Nakorn Ratchasima Province 1990–1994; 1996 (mimeograph in Thai). 4. Tangcharernsathien V. Evaluation of the provincial bargaining system for drug procurement in Nakorn Ratchasima Province. Bangkok: Thailand Health Research Institute; 1994 (mimeograph in Thai). 5. Thailand Health Research Institute. Evaluation of the policy for provincial bargaining drug procurement sys- tem of the MoPH, 1995–1996. Bangkok: Thailand Health Research Institute; 1998 (mimeograph in Thai). 6. Rural Hospital Division, MoPH. Progress report on the drug management under the Good Health at Low Cost Policy Package. Report to the Permanent Secretary. .cont’d on pg. 8 à drugs. At least five alternatives exist for supplying drugs to governmental and nongovernmental health services. ALTERNATIVE SYSTEMS OF DRUG SUPPLY ä Central medical stores (CMS): conventional drug supply system, in which drugs are procured and distrib- uted by a centralised government unit; ä Autonomous supply agency: a centralised supply system in which the management responsibility is devolved to an autonomous or semi-autonomous Board; ä Direct delivery system: a decentral- non CMS system, in which the government drug procurement office establishes a contract with a single primary distributor, as well as separate contracts with drug suppliers. The primary distributor is contracted to manage drug distribution by receiving from the suppliers, storing, and distributing all drugs to districts and major facilities; ä Fully private supply: in some countries, drugs are provided by private pharmacies in or near government health facilities. It is possible to identify some advan- tages and disadvantages for each of the above systems and to make some theo- retical comparisons, but true comparisons of cost-effectiveness have not been made. In part this is because other issues have made such comparisons very complex. The introduction of policies on user charges, decentralisation, contracting-out and privatisation all have an impact on the drug supply system. The Central Medical Stores system The historical approach to public sector drug supply is the Central Medical Thailand. cont’d from pg. 6 P ERSPECTIVES on the role of government in health vary from a social welfare approach (the state should provide all health and other social services except where it is unable to do so) to a self-help or market economy approach (the private market should provide most health services). In the past many governments (in both de- veloping and developed countries) have subscribed to the social welfare approach, particularly when health technology was limited in scope and cost and was there- fore affordable. Increasing complexity and technology has taken the cost of health care provision beyond the reach of most developing country governments, and there is a growing emphasis on the responsibility of the individual to provide for their own health care. In fulfilling the goals of a national drug policy government has a central role in ensuring that drugs distributed through the public and private sectors are of ac- ceptable quality, safe and effective. Also government has a responsibility to pro- mote the rational use of drugs. In addition, it is necessary to actively promote drug availability (geographic access) and affordability (economic access) if a large share of low income and remote populations depend on private sector drug supply. Among the decisions which govern- ments have to face in the pharmaceutical sector the most complex and the most costly often concern the financing and supply of drugs for government health services. In some countries public sector drug supply is well financed and admin- istratively efficient. In other countries the drug supply system is unreliable and shortages are common. Such systems suffer from inadequate funding, outdated procedures, inefficiency or a mixture of these and other problems. In a situation of diminishing resources one response is to maximise them by increasing efficiency. Can private sector E S S E N T I A L D R U G S M O N I T O R8 Issue No. 25 & 26, 1998Act io n P ro gr am me on E ssential Drugs and V accines weak staff discipline proce- dures in an atmosphere of diminishing incentives. Where public financing is adequate then the public sector CMS system can be effective in pro- viding a supply of drugs as has been demonstrated in the past in many countries and is still seen in some. The inability of the CMS system to achieve its purposes in the current economic and commercial climate in many countries indicates a need to consider alternative mecha- nisms for the procurement and distribution of drugs. Autonomous supply agency system The problems which have been experienced with CMS systems have led some govern- in the context of a public sector revolv- ing drug fund, where fees are used to purchase drugs on a cash-and-carry basis as in Benin, or in a system where government institutions purchase drugs with centrally allocated treasury funds as in Uganda, or where budgets are still centrally controlled as in Tanzania. Whatever the financing mechanism, au- tonomous agencies can only function if there is a market for their products and if the client(s) has funds to purchase the products. Autonomous agencies are likely to improve drug supply only if structured to overcome the constraints of the CMS approach. Experience to date, though limited, suggests that features which should be sought in establishing autonomous supply agencies, include: u supervision by an independent are political appointees rather than professional managers appointed by an independent management board. Similarly if the government retains the authority to require distribution of drugs without charge or on a credit basis (with- out ensuring payment). Again, if special interests outside the agency influence drug procurement, or if the agency is required to retain staff members regard- less of their ability or performance, these factors will be counter-productive. Countries considering an autonomous supply agency should recognise that this approach will not solve problems related to lack of funding for drugs. Direct delivery system In general, CMS and autonomous sup- ply services involve bulk procurement into, and distribution from, a central ware- house. The costs and logistical problems associated with central storage and dis- tribution are substantial. An alternative is the direct delivery system. In this non CMS model, a government procurement office tenders to establish prices and suppliers for each essential drug, but drugs are then delivered directly by the suppliers to individual regional stores, district stores or major health facilities. Variations of direct delivery contracts have been implemented in many countries, including Chile, Colombia, the Eastern Caribbean, Indonesia, Mexico, South Africa, Thailand, UK and Peru. In Indonesia annual allocations for drugs are made on a per capita basis to each district. Using their budget and the Ministry’s current price list for essential drugs, each district determines its own drug order. Contracts for direct delivery may specify fixed quantities with scheduled deliveries (generally the approach in In- donesia) or estimated quantity tenders with orders placed by the local store or health facilities as needed. Financing ar- rangements can be a sensitive issue. Debts can quickly accumulate if drug supplies are not balanced against available funds. This means maintaining separate ac- counts for each supply point (if funding is from central allocations) or ensuring that all supplies are paid for at the time of delivery. Like most procurement systems, direct delivery con- tracts require a sole-source commitment, that is, for the tender drugs the local ware- houses and facilities will order from the supplier who holds the tender contract. The local purchasers are free to order drugs that were not on the tender from any supplier. Direct delivery supply agreements depend on and en- courage further development of an effective private sector distribution system. In princi- ple, they reduce storage and transport requirements and risks for the government by specifying in the procurement contracts that drugs are to be delivered directly to district stores and major health facili- ties. The government then has ments to establish systems which place the responsibility for bulk procurement, quality assurance, storage, distribution and financial management in the hands of an autonomous or semi-autonomous supply agency. This model has been tried in several countries, particularly in Africa and Latin America. Autonomous supply agencies are of- ten constituted as parastatals, either under the ministry of health or as independent organizations, with a board of directors including representation from other (than health) government ministries. Their pri- mary and priority client is government health services and they may or may not operate on a non profit basis. Examples of such supply agencies have been func- tioning in Benin, Haiti, Sudan, Tanzania, Uganda and Zambia. A commonly seen Ministry of Health organigram is as follows: only to store drugs at the regional or dis- trict level and deliver them to health centres and peripheral health units. Direct delivery contracts preserve the benefits of centralised selection (the essential drugs list), bulk procurement (suppliers offer favourable prices to get all the business for the products they are awarded), and centralised quality control (only reputable suppliers are invited to tender). Hospitals and/or districts benefit from being able to manage their own funds and determine the exact quantities needed. Also, the problems of security, central storage and transport are shifted from the ministry to the private suppliers. With a direct delivery system, however, district level and facility level drug management responsibilities are much greater, since the quantities and quality of drug deliveries must be con- firmed. Success will depend on the ability and willingness of staff to manage the increased responsibilities. Finally, direct delivery in itself cannot solve problems of inadequate financing. Primary distributor system The primary distributor system is a variation of direct delivery in which the public procurement agency tenders and establishes two types of contracts. The public procurement agency contracts with any number of suppliers to establish the source and price for each drug. But the drugs are not delivered by the suppliers directly to health facilities; instead, a separate contract is negotiated (through tender if feasible) with a single private sector distributor, the primary distributor. Two provinces in South Africa use the primary distributor system for delivery of drugs and medical supplies to hospitals (see p.10). Contracts for the procurement of drugs are negotiated nationally using competitive tenders. The suppliers deliver tender drugs to the primary distributor, who is responsi- ble for maintaining sufficient stocks to fill orders from regional warehouses, district stores and/or health facilities. Primary dis- tributors may maintain their own vehicle management board; u professional pharmaceutical supply managers; u good personnel manage- ment; u adequate financing; u public accountability and sound financial management; u focus on essential drugs (rather than “profitable” alternatives); u focus on quality assurance, both in terms of products and of services provided. The intention is that an autonomous supply agency will achieve greater value for money and improved drug availabil- ity through more efficient management. Three important characteristics that are needed to promote efficiency are flexibil- ity, incentive and competition. The existence of competition will encourage efficiency, but in the majority of situa- tions the monopoly of the CMS continues to apply to the autonomous agency, with no pressure to improve the quality of services and products or aim for the lowest prices. A whole series of difficulties may occur, for example, if senior managers where the board is autonomous in running the agency but reports to the min- ister of health, who may be involved in the appointment of the chairman of the board and/or the executive officer. The goals of establishing an auto- nomous supply agency are to achieve the efficiency and flexibility associated with private management and private sector employment conditions. At the same time sufficient public sector supervision is maintained to ensure that the services provide a range of essential drugs, at reasonable prices, with adequate control of quality. The basic concept is that, under the right conditions, a well-constituted management board or board of directors will have the freedom to appoint quali- fied senior managers, who will in turn ensure an efficient, accountable supply agency. Supply agencies may be established Drug supply choices. cont’d from pg. 7 Graphic: Zimbabwe Essential Drugs Action Programme Director of Medical Services “Medical Stores” Board of Directors Ministry of Health 9 Issue No. 25 & 26, 1998 E S S E N T I A L D R U G S M O N I T O R A ct io n P ro gr am me on E ssential Drugs and V accines fleet or subcontract transportation. Like other direct delivery contracts, this system depends on sole-source commitment for the essential drugs list, though districts and health facilities may be allowed to purchase non-tender drugs from any source. The system also requires the same level of good information and monitoring. The primary distributor is paid a fee or commission for storage and delivery services. The primary distributor may appear to add an extra middleman and extra costs, but the expectation is that the cost of the primary distributor will be less than the cost to the government of run- ning the warehouse and distribution system itself. Competitive bidding for the primary distributor contract is important to achieve this efficiency. Fully private supply system Finally, national policy, insufficient financing or management problems have led some countries to avoid responsibil- ity for providing hospitals and health equipment maintenance, laundry and food services. Contracting out services is com- mon within the private sector. Often companies find that outside contractors who specialise in specific services such as managing staff cafeterias or repairing computers can provide those services at lower cost and higher quality than providing the service in house. The philosophy prevails in industrialised economies that if you can find someone else to do a specific task then pay them to do it rather than committing the capital resources to do it yourself; for example, distribution is usually contracted out by large supermarket firms. Primary distributor systems, transport contracts, port-clearing services and related approaches to private sector involvement require contracting for services in contrast to contracting for products (drugs, for example). However to contract out activities requires the skills of writing, negotiating and monitoring contracts. Contracting functions most effectively where there is competition as with any tendering process. Contracting- out also demands a commitment to pay the contractors according to the terms of the contract. Privatisation in health is properly de- fined as transfer of ownership from the public to the private sector. But the term is also applied, less precisely, to contract- ing government services to the private sector (as with direct delivery contracts) or introducing private sector features into the public sector (as with government owned but semi autonomous supply agencies). The full privatisation of drug supply would have implications for equitable access to drugs in an access for the poor, children, patients with communicable diseases and other vulnerable groups. IMPLICATIONS OF DECEN- TRALIZATION, CONTRACTING OUT AND PRIVATISATION These health reform strategies are among many being tried in developed and developing countries to improve the efficiency and outcomes of health care delivery. They have often been initiated in response to the situation in developed countries and are being proposed as po- tential answers to the problems faced in the delivery of health care in developing countries. These strategies have signifi- cant implications for drug supply systems in developing countries which may not have been factors in their implementation in developed countries. Decentralisation either as delegation or devolution is intended to improve the responsiveness, quality and efficiency of health services. Decentralisation Some experiences with competitive mechanisms for public drug supply Autonomous supply agency in Tamil Nadu, India The Tamil Nadu Medical Services Corporation (TNMSC) was created in 1995 to contain drug costs and reduce shortages by purchasing and supplying drugs to government health care facilities. TNMSC is set up as a government company, with a Board chaired by the Secretary of Health, which is accountable to the Minister of Health. The TNMSC created a list of 267 essential drugs from the previous state drug list of 900 items. Drugs are procured through tender and delivered directly to district level stores. Quality assurance procedures are in place, including sampling of products from manufacturers and district stores. Testing is contracted to reputable private laborato- ries through tenders. TNMSC adds a 5% charge to fund its own operations. Each facility is given a budget target and issued a “pass book” in which to record the value of drugs it has received. Through prompt payment and other administrative efficiencies, TNMSC has considerably reduced drug costs, while maintaining reliable supply. Combined supply strategies in Zimbabwe The Zimbabwe Essential Drugs Action Programme (ZEDAP) uses different systems for different categories of drugs. High-usage drugs on the essential drugs list are pro- cured, stocked and distributed in bulk through the central medical stores. For high-cost, slow-moving specialist items, direct delivery contracts are used. For most specialist items an annual tender is conducted to fix the price for the year. Drugs are then ordered as needed by the roughly two dozen national hospitals and NGO hospitals which require them. Orders are delivered directly to the hospitals. Finally, for cancer agents and some other highly specialised drugs, no contract exists. Instead, drugs are purchased by the Ministry’s pharmaceutical division by individual order, with permission from the Secretary of Health. Sometimes Central Medical Stores leave a lot to be desired, as can be seen here in a country in Sub-Saharan Africa aims to achieve these benefits through greater local involvement, more direct public accountabil- ity, increased flexibility to adjust to local circum- stances, more rapid and more accurate commu- nication, and quicker adaptation to changing conditions. Problems that have occurred when attempts have been made to decen- tralise drug management functions include the following: u Lack of capacity: drug management re- sponsibility may be decentralised without ensuring there are sufficient local staff and management ca- pacity to sustain such services. u Lack of financial re- sources: responsibility is sometimes decen- tralised for all drug supply without pro- viding an adequate budget. In this case Ph ot o: W H O /O . B ra ss eu r centres with even essential drugs. Where this is the case, retail pharmacies become the source of supply, especially in urban environments. Often the pharmacies are located very close to the hospital, and may be located inside the hospital. Such pharmacies may be part of a parastatal pharmaceutical enterprise (Sudan), or they might be an institutional enterprise (Ghana), or they may be independent enterprises. In some countries, patients receiving health care through the public sector are left to buy virtually all drugs on their own from the private sector. This situation usually results from complete lack of government funds, rather than as part of an official drug management plan. As with revolving drug funds operated by the government, the greatest concern with fully private supply is equity of decentralisation simply becomes abandonment of responsibility. u Increased corruption: because of the money involved, interference for per- sonal gain is common in drug supply systems. While decentralisation is meant to improve accountability, it makes it easier for local officials or other special interests to profit fraudulently. u Increased cost: decentralisation of procurement usually means smaller order quantities. It can result in higher prices for essential drugs, although this problem can be overcome with central contracts coupled with decentralised ordering. Contracting-out or resourcing in health care has most commonly been tried for non clinical services such as environment where profit will become the motive for supply. CONCLUSIONS If a different drug supply system is not chosen as a result of a careful analysis of the underlying causes for the weaknesses of the existing system in a particular coun- try, the change may not produce the desired outcome. Systems chosen because they function in the climate of a “success- ful” market economy may not prove to be the solution to the problems faced in the supply of drugs in the context of a developing country. To weigh the pros and cons of one drug supply system against another can- not properly be done from a global perspective without detailed study. Each country brings unique political, economic and geographical factors to the equation. It will never be possible to state that one particular system is “the best”. However some basic factors will point in the di- rection of certain systems, for example, the existence of an effective private sector is necessary for either direct delivery or prime distributor systems to function. The Action Programme on Essential Drugs has initiated a multicountry study to examine in depth at country level the outcomes of the drug supply systems in use. This study will look at the advan- tages and disadvantages of the systems, and the factors which influence the level of success in correcting problems and meeting needs. o This article has been adapted from Drug Supply Strategies, Chapter 6 of Managing Drug Supply (see reference below). Source: Bennett S, Muraleedharan VR. Personal communication on Tamil Nadu Medical Services Corporation. 1997. MSH/WHO/DAP. Managing Drug Supply, 2nd ed. Hartford, CT: Kumarian Press; 1997. E S S E N T I A L D R U G S M O N I T O R10 Issue No. 25 & 26, 1998Act io n P ro gr am me on E ssential Drugs and V accines specifications are essential elements for success. Tender specifications may need to vary according to the needs of different provinces. In Province A, seven years’ experience – one of the former homelands had already used contracting out services prior to 1995 – have shown the following requirements to be necessary for a successful system: u Procurement: The province must manage the procurement database and have the final say on orders, including prices. u Warehousing and inventory manage- ment: At least one senior pharmacy manager should be on the provincial payroll for this task. The public sec- tor should own the warehouse and equipment. This ensures independ- ence so that if the contractor does not perform to specifications, the province has the facilities to continue opera- tions. However, the contractor is responsible for the maintenance and insurance of the facilities and stocks. The Department, in negotiation with the contractor, determines stock levels. This precaution ensures that adequate levels of stocks are kept in a situation where the contractor pays insurance coverage. The contract should include the installation of adequate computer hardware and software for inventory management at hospital pharmacies, and for on-going staff training. u Distribution: The contractor’s own transport is to be used; courier and similar services are not acceptable. When other transport is used, medi- cines are not always regarded as priority by the transport contractor and deliveries may not be according to a schedule. u Management information: The contractor is required to supply com- prehensive management information reports at agreed intervals. u Billing: As the contractor is paid a commission on items delivered to hospitals the billing structure must separate these costs from the cost of purchasing stocks into the warehouse. In an earlier South African experience with limited contracting out the com- pany received a commission on stock purchased into the warehouse and not on stock delivered to clients. This ar- rangement left many opportunities to purchase inappropriate medicines and quantities. u Human resource development: The entire contract must be seen as a part- nership between the Department and “Contracting-out” drug procurement and distribution: experience with a primary distributor system in South Africa rational, with around 2600 items on the national pharmaceuticals tender list. (This situation is currently being changed: the National Essential Drug List Committee, as part of the process of drafting stand- ard treatment guidelines, has established a database of conditions and related medicines, which will lead to drug ration- alisation in the public sector. The EDL currently comprises just over 900 items, and is being further streamlined.) After the 1994 elections, the newly consolidated provinces had to integrate the various pharmaceutical services, in common with health and other services. Provinces generally had their own ware- houses and sent estimates of their requirements to the Coordinating Com- mittee for Medical Supplies (COMED), which coordinates the national tender. Payment is made by the provinces directly to the suppliers. The government of the newly consti- tuted Province A sought to integrate the drug supply systems of four authorities as part of its efforts to establish a single health authority. Following recommen- dations of a 1994 evaluation, Province A, (which has high unemployment, low average individual income and a pre- dominantly rural population), decided in 1995 to contract out the procurement, warehousing and distribution of pharma- ceutical supplies. These functions were contracted out to a private company at a commission of 8.05% of the value of the products. The contract also included a 2.2% commission for computerisation of hospital pharmacies and computer train- ing of provincial pharmaceutical staff. From January 1996, medicinal supplies have been distributed from a single de- pot in the centrally situated provincial capital. In Province B, an essentially rural area with less infrastructure than Province A, a similar contract was awarded early in 1997. A provincial warehouse was built on the western border of the province, in March 1997. A more central site would have facilitated distribution. Contracting-out is one of the options described for public sector/private sector cooperation in drug supply1. In South Africa all of these factors needed to be tackled: ä The public sector does not insure stock against theft, fire or natural disasters, so all losses occur at government ex- pense, if services are not contracted out. Theft is a major problem in pharmaceutical warehouses in South Africa. ä Strikes have become increasingly common since the 1994 elections as trade unions are trying to negotiate new equitable rules and remuneration in the labour sector. ä Vehicle maintenance, cost-effective staffing and management information are areas where the public sector has not always been efficient in the past. Government departments have been notoriously overstaffed, but employ- ees were poorly paid and often underqualified. Many motivated workers found work more rewarding in the private sector. With limited fi- nancial and logistic resources, services in remote areas were not easy to manage. The decision of two provinces to “con- tract-out” procurement and distribution to hospital level provided experience from which important lessons can be drawn. TENDER SPECIFICATIONS Against this background, clear structure, process and performance Some advantages of “Contracting-Out” 1. All losses by fire, theft or natural disasters are the responsibility of the contractor. 2. The staff required to run a warehouse efficiently and effectively is expensive. Cost- effectiveness of this component will be monitored closely by the contractor, because of the effect of poor performance on profitability. 3. Strikes and industrial disputes can be a major threat to the health services in a situation where all medicines are distributed from one depot. The service provider will be responsible for ensuring continuity of services. 4. Transport is a major cost component in the distribution cycle. Adequate vehicle maintenance and efficient scheduling of deliveries become the responsibility of the contractor. 5. Management information on drug availability and use can be improved without major investment by the public sector. See Chapter l7 of Managing Drug Supply6 for a more detailed description of issues involved in contracting out pharmaceutical services. M A N A G I N G D R U G S U P P L Y P R.S. SUMMERS1, H. MÖLLER2, D. MEYER3, R. BOTHA4 UBLIC/private sector relationships have been suggested as a means of achieving some of the goals of national drug policies and essen- tial drugs programmes1. Because of work which showed that “contracting-out” the procurement and distribution of drugs can offer advantages and improve perform- ance, two of the country’s nine provinces have opted for this approach. South African provinces have a considerable degree of autonomy. In this method, structure, process and outcome specifications are established by a public sector authority and offered to prospective providers on “tender”. The authority, usually through a bidding proc- ess administered by a tender board, will then select and establish a formal contract with a provider. Experience and some critical lessons learned in using this approach in South Africa are described here, providing valuable insight into one of the few docu- mented primary distributor systems outside the USA. BACKGROUND South Africa, with a total population of just over 40 million2, had a pharma- ceuticals’ expenditure of some 4.8 billion Rand in the private sector and 1.8 billion Rand in the public sector in 1996 (when R1 was approximately US$0.22)3. Annual per capita expenditure on drugs for the 85% of the population who rely on public sector health services was approximately R52 (US$11). For the remaining 15% served by the private sector the equiva- lent figure was around R792 (US$174). To place this figure in context, the World Bank quotes an average drug expenditure of US$2.1 for nine African Countries in the mid-1980s4. While in 23 Sub-Saharan African countries drug consumption was valued at less than US$5 per capita in 19905. The procurement and distribution of pharmaceuticals in the public sector is centrally coordinated; the provinces pro- vide estimated quantities to the National Tender Board, which then calls for and awards supply tenders. The provinces purchase their requirements from the suc- cessful tenderer through a provincial depot. This system has encountered some major difficulties over the years. These mainly revolved around stock losses and inexplicable variations between recorded purchases and actual stock-on-hand. There was also a general lack of infor- mation, and the selection process was not 11 Issue No. 25 & 26, 1998 E S S E N T I A L D R U G S M O N I T O R A ct io n P ro gr am me on E ssential Drugs and V accines the contractor. The Department must also ensure that the contract is carried out according to the specifications. This necessitates the active involve- ment of provincial staff members in the entire process from database man- agement, and procurement to receipt and distribution. CURRENT CHALLENGES Sufficient data are available to enable an evaluation of how the first two ele- ments listed above have contributed to goal of improved drug supply 6. Procurement and financial control Procurement was initially effective in Province A. Towards the end of 1997, however, and for approximately the first quarter of 1998, the situation deteriorated. This situation arose because of financial difficulties within the Province which led to the transfer of funds from Health to Education to offset overexpenditure on the Education budget. In Province B, the situation mani- fested major difficulties from the start. Initially, accurate demand data had not been given to the contractor. Hence, or- der quantities did not match requirements. Cash flow problems surfaced as a result of a backlog in payments during 1997/ 1998. More recently, the health budget was decentralised to district management, which caused major difficulties with cash flow at the depot. Suppliers who had not been paid suspended deliveries. Warehousing and inventory management As described earlier there were significant differences in the location and available space of the two depots. In addition to the poor siting and in- adequate space at the depot of Province B, attracting (and retaining) professional staff to the area has been a major problem. These factors significantly influenced the performance of the depot which was, reflected in a relatively high number of out-of-stock items. Between March and June 1998, the percentage of 132 essential items listed as out of stock by Province B increased from 23% to 35%. Twelve critically important drugs were listed for virtually the entire period. We have rated procurement and stock control systems as ineffective when more than 15% of items are always out of stock. (Contractor)(Province/ contractor) (Contractor) (Contractor) (Contractor) (Province/ contractor) (Facility) (Province)(Province) Procurement Consumption reports Collect consumption information Delivery and payment Ordering/ requisitioning by facility Storage (at depot) Receipt and inspection (Contractor) (Province monitor contractor) (Contractor) (Contractor) (Contractor) (Contractor/ province) (Province pays contractor – Contractor pays suppliers) (Province) (Province) Set order parameters (e.g. stock level of 6 weeks) Determine quantities needed Reconcileneeds and funds Choose procurement method Select supplies Specify contract terms Monitor order status Receive and check Pay suppliers Distribute Set format of reported information Collect consumption information Review process (Province) (Province) (Province) (Province) distribution from the depot to facilities. It meets this responsibility by checking the performance of the contractor through the data in the management information system, without being involved in day-to-day procedures. Here the contractor plays the main role but is supported by important inputs from the province. In both provinces, the con- tractor’s responsibility extends only to the hospital level. Thereafter, to the clinics, the responsibility for effective delivery and inventory control becomes that of the province. Transport and management A health centre in a rural area of South Africa Ph ot o: W H O /H .V . H og er ze il Figure 1 Procurement cycle The situation at the depot of Province B is therefore very poor. Over the first six months of 1998, Province A, which operates a simi- lar system but has a provincial chief pharmacist at its depot at all times, had a stock-out rate between 7% and 22%. This perform- ance was also far from ideal but better than Province B. The reasons for the stockouts included poor selection of supplier, who may have overtendered and therefore could not deliver; ably, in some cases the contrac- tor paid suppliers of critical stock out of its own funds in order to maintain services to patients. For a project like this to suc- ceed both parties need to have insight into, and understanding of, the functioning of a depart- ment of health. This will then be manifested in the acceptance and support of the service by its users. Here too there was a sig- nificant difference between the two provinces. In conclusion we have at- tempted to identify critical issues, lessons and key success factors from these two cases, which had payment difficulties (see above) and poor depot management. Prov- ince A faced mainly the first two problems, whereas all three applied to Province B from time to time. RELATIONSHIPS BETWEEN THE PLAYERS To obtain a perspective of the actual difficulties involved we ex- amined the components of the procurement and distribution cy- cles in terms of the relationships between, and responsibilities of, the two role players (see Figures 1 and 2). The provincial authority is involved in every element except receipt and checking of goods at the depot and information at this level have often been problematic. LESSONS LEARNED Perhaps the core lesson learned is that what occurs in contracting-out is a part- nership. If either partner does not deliver, and there are weak links in the chain, the process will fail! There were differences in perform- ance between the two provinces. These lay in the partnerships and inputs in each case. In the early stages of the process in Province A, there was extensive prepara- tion by both parties. Facilities had adequate stock in place. Stock at differ- ent depots was checked and consolidated. This was not the case in Province B. The depot there had been newly set up and had encountered difficulties in establish- ing its own management information system. In addition the depot was too small for the Province B’s needs. It lacked adequate senior provincial supervision, which is essential for proper control of public sector resources and funds. Too many items were listed at the various levels of pharmaceuticals distribution in this province. Towards the end of the financial year, both provinces faced payment difficulties which inhibited procurement. In Province A, where the budget was centralised, budget over-runs in departments other than Health and Welfare led to the with- drawal of funds from Health. In Province B, decentralisation of budgets and res- ponsibility for payment to district level management, continued to cause major cash flow difficulties with consequent difficulty in paying suppliers. These dif- ficulties were the main reason for the high number of out-of-stock items. Commend- the common factor of the same supplier, but which differed markedly in performance. ä An integrated approach and planning by the public sector provider and the contractor is essential. ä The provincial drug list, which must have the sup- port of its users, should be strictly applied and there should be a provincial veto on non list items. ä The storage depot needs to be carefully sized and cen- trally located. ä Appropriate facilities and systems need to be established for current and future requirements. ä A management information system is needed to monitor order and delivery status. ä Contractor selection should be based on previous performance and capac- ity to undertake the work, and include quality assurance for service delivery. ä Contractual terms and specifications must be fully detailed. ä Purchasing and payment methods need to be spelt out. ä Finally, and perhaps most critically, there has to be a sustained cash flow from recipient to contractor to supplier. o * Professor Rob Summers, School of Phar- macy, MEDUNSA, Helene Möller, South African Drug Action Programme, Department of Health, Pretoria, Danie Meyer, Pharma- ceutical Services, Northern Province, Pietersburg, Rainier Botha, Vuna Health Care Logistics, Johannesburg. For further information contact: Professor Summers, Head, School of Pharmacy, PO Box 218, Medunsa 0204, South Africa. n n n References 1. Bennett S, Quick JD, Velasquez G. Public-private roles in the pharmaceutical sector. Geneva: World Health Organization; 1997. WHO/DAP97.12 2. Central Statistical Services. Census ’96: Preliminary estimates of the size of the population of South Africa. Central Statistics, Pretoria, 1997. 3. Summers RS, Suleman F. Chapter 8: Drug policy and pharmaceuticals. Chapter 8. In: South African Health Review 1996. Durban: Health Systems Trusts and Cali- fornia: Henry J Kaiser Family Foundation; 1996. 4. World Bank. Better Health in Africa. Washington: World Bank; 1994 5. Balance R, Pogany J, Forstner H. The world’s pharma- ceutical industry. Aldershot, UK: Edward Elgar; 1992. 6. Contracting for drugs and services. In: Quick JD, Rankin JR, Laing RO, O’Connor RW, Hogerzeil HV, Dukes MNG, Garnett A, editors. Managing drug supply, 2nd ed. West Hartford, CT: Kumarian Press; 1997. p. 256– 269. Figure 2 Distribution cycle E S S E N T I A L D R U G S M O N I T O R12 Issue No. 25 & 26, 1998Act io n P ro gr am me on E ssential Drugs and V accines Improving the supply, quality control and access to essential drugs in Guatemala ä revision of the legal framework; ä new guidelines for the purchase of drugs; ä an improved system of logistics for the provision of supplies; ä establishment of a drug vigilance programme. Reform of the drug regulatory authorities and the official quality con- trol laboratory was achieved through strengthening the management structure, decentralisation of finance, staff training programmes and a review of salaries. Other measures included: the establish- ment of new administrative procedures for the register of authorised drug sales; better quality control of medicines; the creation of a standardised system for drug registration; better inspection of Good Manufacturing Practices; the purchase of laboratory equipment; and the develop- ment of a computerized data system for drugs. Elsewhere, the Quality Standards Working Group studied the list of 1,400 drugs purchased by the Government – which contained many duplicate products – and recommended the use of the 13th edition of the US Pharmacopeia and the US Pharmacopiea Dispensing Infor- mation, to define the specifications of products purchased by the Government. Other products on the list had to be ratified from alternative sources, such as the British, French and Japanese Pharmacopoeias. The Working Group also estimated supply needs on the basis of figures pro- vided by different health units. The aim was to establish quantities that would be attractive to suppliers and ensure savings through bulk purchase orders. Medical surgical materials and medical equipment were handled in a similar way, using international standards such as those of the US Food and Drug Administration, as well as alternative standards. At every stage, both consumers and suppliers were involved in defining the quality of the product. A second working group was established to review the legal aspects of Government purchases of medicines and medical surgical materials2. As part of the modernisation process, the law was updated and a new Health Code issued3. The regulation4 that this law implements facilitates Guatemala’s par- ticipation in the globalisation process, and establishes responsibilities for all person- nel involved in the supply of medicines. A computerized system has been developed for this. Resources must be used rationally to allow for extended coverage. Meanwhile, quality must be in conformity with the US Pharmacopeia, and all medicines referred to by their International Non- proprietary Name. Norms have been established for the qualification and awarding of suppliers and products, together with a procedure and payment guarantee to ensure successful relation- ships. This agreement provides for M A N A G I N G D R U G S U P P L Y Meanwhile, overall control remains within the Ministry of Health. The legal framework pro- vides for the development of a Programme of Ease of Ac- cess to Medicines5 through already established state and municipal pharmacies6, and the establishment of a Sales of Medicines for Community Benefit scheme7 run by civil- ian groups to ensure they are self-financing and sus- tainable. The proposal for the Purchase of Medicine system, which came into operation in early 1997, adopted the open contract system already in force for Government purchases. This is an administrative tool with centralised negotiation and decen- tralised execution – designed to guarantee the quality of the product, purchased at prices previously determined at central level. ENSURING TRANSPARENCY IN SUPPLY The new drug purchasing system was modified to include an open tendering system, with control over those who make the offers, and clear rules to ensure trans- parency and bring an end to corruption. payment within a maximum of 30 days after receiving the product, compensation in the event of fluctuations in the ex- change rate and payment of interest on delayed invoices. Sanctions can now be imposed for the supply of poor quality products and for failure to deliver within the agreed timeframe (with a maximum penalty of five years’ suspension as a Government supplier). The new system allows for a maxi- mum of 3% deviation in the minimum price offered by a maximum of eight sup- pliers. Meanwhile, an inter-institutional commission has been established to over- see the operation of the open contract system and apply sanctions for non- fulfilment. The private sector participates as an observer in this commission. The Process of Public Awarding provides for the participation of personnel from the ad- ministrative units and executing officers from the public health sector as well as observers from private sector organiza- tions and professional colleagues (doctors and pharmacists). FOCUS ON QUALITY The establishment of administrative and technical norms was also necessary to guarantee that the item gets to the user in perfect condition, in the correct quan- tity and on time. These included a definition of the role of the professional pharmacist to ensure that drugs are used and administered correctly. Norms wereDispensing drugs to a patient at Panajachel Health Centre, Guatemala The central drug warehouse in Solola District. The Guatema- lan Government is implementing measures to improve drug supply Ph ot o: A . R ut ge rs Ph ot o: A . R ut ge rs O MANUEL ENRIQUE LEZANA* VER the past 15 years, Guatemala has followed through its commit- ment to the concept of essential drugs by developing a range of strategies and actions designed to improve the supply of drugs and ensure wider access to them1. More recently, the Guatemalan Ministry of Health has drawn up a blueprint for overall health policies to the year 2000. The proposals include: the modernisation of state health services through decentralisation of finance and administration; strengthening the capac- ity of governing bodies; improving sectorial and intersectorial coordination; and making better use of existing re- sources for health. The Ministry of Health is also committed to improving the quality of health services and ensuring wider access as well as improving the management of health services. Within the Health Ministry’s budget, the largest items of expenditure are medi- cines (10%), surgical materials (5%) and medical equipment, including mainte- nance and replacement equipment purchases (6%–7%). However, over time, the administration of this budget has lacked transparency in the selection, pur- chase and distribution of these products. The quality of the product purchased was neither defined in advance nor checked on receipt. Meanwhile, suppliers had no guarantee of payment – resulting in price speculation of up to 400% of the original price. One of the first steps taken was to form a group of national consultants to work with the WHO Regional Office for the Americas and the Pan American Health Organization. The group was to draw up a strategy to resolve existing problems and capitalise on the then current employ- ment of an international company with expertise in drug purchasing systems. SWEEPING POLICY CHANGES A Multisectorial Commission for Policies on Medicines was formed within the Public Health Ministry with represen- tation from both the private and public sector as well as international health or- ganizations. The Commission’s remit was to advise the Ministry on new policies for the quality control and supply of drugs. Because of the seriousness of the problems encountered, it was decided to implement new policies across the board. These included: ä strengthening the drug regulatory authorities and the official quality control laboratory; ä setting up working groups to develop quality standards and new procedures for administration, purchasing and distribution; 13 Issue No. 25 & 26, 1998 E S S E N T I A L D R U G S M O N I T O R A ct io n P ro gr am me on E ssential Drugs and V accines Belarus: progress in the pharmaceutical sector Important steps on the road to pharmaceutical sector reform in Belarus u u u In April 1991 the first version of the essential drugs list was adopted. It has been reviewed annually since then and is widely used. The list is the basis for procurement at all levels of the health care system and ensures guaranteed coverage of the popula- tion’s pharmaceutical requirements. In September 1992 the Principal Department of Pharmacy, Medical Equipment and Regulation was established. Within this framework the process of developing a national drug policy started. In December 1992 licensing of the pharmaceutical market was initiated. This allowed the Govern- ment to preserve its control of the pharmaceutical sector and to regu- late newly established pharmacies, regardless of their ownership. In November 1993 the Pharmaco- logical Commission was reorganized into the Pharmacological and Pharmacopoeia Committees. Require- ments for drug registration in Belarus were defined and legally approved. ln November 1993 the national programme for pharmaceutical industry development was adopted. The list of drugs produced in Belarus increased from 150 to 300 items. In October 1997 the Republican Centre of Expertise and Trials in Health Care was established. This facilitated reorganization of drug registration and pharmaceutical licensing procedures to meet international standards. MAJOR CHANGES AHEAD Step by step over the next five years, Belarus will introduce international stand- ards for good manufacturing practice. It will modernise and increase the capacity of existing production plants, build new plants, widen the list of drugs produced, and strengthen the State’s role in drug production to better satisfy national drug requirements. The Ministry foresees the further de- velopment of the network of newly established private pharmacies and im- proved regulations that will ensure increased access to drugs for the rural population. There are plans to review ex- isting pharmacy regulations and to introduce a list of compulsory medicines that should be available in every phar- macy at all times. Plans are also underway to: encour- age the more rational use of drugs, especially within the drug reimburse- ment scheme; increase the role of the essential drugs list; introduce drug treatment guidelines; improve doctors’ access to drug information; encourage the procurement of drugs in the hospital package; and review the price regulation system. FRUITS OF COLLABORATION International contacts, especially those established during 1993/1994, have played a significant role in allowing Belarus to make more rational decisions on how to organize its drug regulation and supply systems. Agreements on collaboration in the pharmaceutical sector have been signed with the Health Ministries of Latvia and Ukraine, as well as with the French Medi- cines Agency, and the US Food and Drug Administration. This allows Belarus to receive much needed drug information more efficiently, and to organize training for its experts at these institutions. Contacts and cooperation with the Pharmaceuticals Programme at WHO’s Regional Office for Europe has also broadened knowledge on all aspects of the pharmaceutical sector. Belarus has also benefitted from an Interstate Commission for standardisation and quality control of pharmaceuticals and medical equipment established under the Commonwealth of Independent States Council for Cooperation in Health. It has allowed better harmonisation of pharma- ceutical standards and requirements for products manufactured in these countries, and the simplification of their circula- tion within the Commonwealth’s internal markets. o This article is based on an interview with Gennady Godovalnikov, Head, Pharma- ceutical Department of the Ministry of Health of Belarus, which first appeared in: Pharmacuetical Reforms, WHO News for Newly Independent States, No.3, June 1998. N A T I O N A L D R U G P O L I C Y also established for selection, purchase, reception, storage and distribution in or- der to ensure the punctual delivery of the correct medicines. A system was put into place to deal with complaints about the efficacy or safety of products, and take appropriate action wherever needed. In late 1997 doubts about the quality of medicines purchased through prescrip- tion prompted the launch of clinical studies of some products. The finding that some products were lacking in efficacy led to the establishment of the Drug Vigilance Programme – designed to assess complaints about therapeutic failure and/or adverse reactions to medi- cines purchased through the open contract system. The new policies have met with op- position from some groups – including prescribers and suppliers who failed to win contracts – each preferring to main- tain the status quo on drug supplies. Other problems have included inadequate supply forecasting – leading to drug shortages – and budgetary restrictions on efforts to ensure vigilance and control. However, failure by some suppliers to provide the correct amount and quality of drugs has led to the imposition of sanc- tions, including five-year exclusion from the Government supply system. Among the major achievements of the new system are the savings on drug budg- ets and the extended coverage with low cost, high quality medicines. The Minis- try of Health has saved 65% of its budget and the Guatemalan Institute of Social Security – the country’s other public health service provider – saved 23% of its drugs budget. Meanwhile, through the Access to Medicine Programme – which benefits from decentralised price negotiations – medicines are now being made available to underserved communities. Elsewhere, quality standards have been established for the purchase of medi- cines and sanctions put in place to deter the supply of poor quality medicines or late deliveries. Multidisciplinary teams now partici- pate in negotiations for the purchase of drugs and other medical items, and the decentralisation of health budgets facilitates the prompt payment of suppliers. o * Ing. Manuel Enrique Lezana is Chief of the Drug Coordination Office, Ministry of Health, Guatemala. References 1. Working together, learning together. Essential Drugs Monitor [editorial] 1992; 13. 2. Governmental Agreement 472–96, dated 4 November 1996, related to the quality of medicines and medical surgical materials in which the purchasing standards are established. 3. Legislative Agreement 90–97 in force from February 1998. 4. This regulation is awaiting final Presidential approval. 5. Governmental Agreement 714–97 dated 8 July 1997. 6. Ministerial Agreement 161–98 dated 26 May 1998. 7. Ministerial Agreement 162–98 dated 26 May 1998. T HE Ministry of Health in Belarus has set out its plans for health sector development, which in- clude changes in the pharmaceu- tical sector. Among proposals are that a network of state and private pharmacies will develop in parallel, with their activi- ties strictly regulated. At the same time, state control of drug pricing will continue. Drugs will be supplied to the population through both centralised and decentral- ised procurement, using the country’s list of essential drugs. Other important initiatives include a campaign to pro- mote the rational use of drugs, and plans to hold a national conference to adopt a new approach for developing the pharmaceutical education system. It is hoped the Government will adopt the public health development package by the end of 1998. The country plans two main ap- proaches for the pharmaceutical industry: the production of generics included in the essential drugs list for centralised drug supply, in accordance with state directives; and the modernisation and upgrading of existing pharmaceu- tical manufacturing enterprises. Three new factories have already begun pharmaceutical production. Over the next five years it is planned to develop and introduce up-to-date requirements for clinical trials and standards for drug quality and production, and to review other regulations covering pharmaceutical issues. INCREASED ROLE FOR REGULATORS The drug regulatory authority is expected to have a stronger role and independent status. Recently, the Minis- try of Health established the Republican Centre of Expertise and Trials in Health Care. The aim is to help solve current problems in the drug supply system, and to improve the drug registration process, authorisation of products for medical use and industrial production, licensing of pharmaceutical activities, and control over drug imports to Belarus. The Minis- try intends to implement national drug policy through the Centre, and through all these measures to exercise effective control over the pharmaceutical sector. ENSURING ACCESS Centralised procurement of certain important medicines will continue, among them those for treating diabetes, cancer and tuberculosis. Such procure- ment is done on a large scale, in bulk and exclusively on a tender basis. This sys- tem allows the purchase of needed drugs to be more cost-effective, and ensures access to these vital drugs for the popu- lation. All pharmaceuticals supplied in this way are free of charge to patients. E S S E N T I A L D R U G S M O N I T O R14 Issue No. 25 & 26, 1998Act io n P ro gr am me on E ssential Drugs and V accines Zimbabwe launches National Drug Policy Drug Policy was not new to Zimbabwe and that work on it started soon after the country gained its independence in 1980. At the same time promotion of the rational use of drugs and production of standard treatment guidelines and essential drugs lists had also begun. The launch of the policy is “the Government’s commitment to the goals described” said Minister Stamps, whilst urging everyone to familiarise themselves with its contents and to identify their individual roles in its implementation. Also speaking at the launch was the Consumer Council of Zimbabwe’s representative, Mrs Keretia Chikowe. She explained that access to correct drug Involving African consumers in drug policy the people at an affordable price, ensur- ing safety, efficacy, good dispensing practices and patient education. Obstacles to overcome However, discussions revealed that the national drug policies adopted by other countries in the region are less clear. Other problems also emerged. In many Southern African countries there is an acute shortage of public sector health care providers, especially pharmacists. This has a serious impact on the success of national drug policies. Key positions remain vacant and trained workers often leave for better-paid jobs in the private sector. Inadequate budgets, major local currency devaluations, drug shortages and emergency procurement damage the N A T I O N A L D R U G P O L I C Y national drug policy’s possible impact. Rising drug prices make drugs inaccessi- ble to many consumers in the region. Due to economic liberalisation, drug pricing is not effectively controlled by legislation and instead relies on market forces. Prices for the same drugs vary widely depend- ing on where they are bought. Rational drug use goals are further upset by many countries’ dependence on donations – which are often sent in an uncoordinated way. Yet there have been encouraging de- velopments which will help to solve these problems. In Malawi and Lesotho, for example, donors have begun to contact church groups to ask if certain drugs are needed and they then send them in usable quantities. In Zimbabwe the Con- sumer Council is lobbying for legislation to control drug prices, and a number of groups attending the workshop have initiated a regional drug pricing survey to address unacceptable price variations. Spreading the word Despite so many constraints groups in the region are active in making consum- ers more aware of the issues involved in national drug policies. For example, the meeting heard that in Mozambique a new consumers’ organization has campaigned for rational use of drugs. The group, ProConsumers, has publicised the dan- gers of using expired drugs and broadcast radio programmes informing people about the dangers of buying drugs from the informal sector. Health Action Cen- tre in Nigeria has relied on creative means to educate consumers, including traditional storytelling and drama presen- tations to point out drug hawkers’ tricks, such as changing expiry dates, copying labels and substituting ingredients. The Group makes any location a potential learning place, by meeting with consum- ers in their homes, at schools, in churches and market places, during women’s organizations’ meetings or on buses. Before the meeting closed, partici- pants discussed the next phase in HAI’s three-year project, Networking for Rational Drug Use in Africa. Plans are already well advanced for a third regional workshop, this time in francophone Africa. o A report of the workshop is available from: HAI-Europe, Jacob van Lennepkade 334T, 1053 NJ Amsterdam, the Netherlands. Source: HAI News, August 1998. information was a funda- mental consumer right, and that increased literacy levels in Zimbabwe had increased consumer’s critical aware- ness. Presenting a copy of the Patients Charter to the Min- ister, she impressed on him the need for Parliamentarians to have a clear understand- ing of the National Drug Policy, so that legislation to support the Policy would be put in place. WHO Representative, Dr Levon Arevshatian, stressed the importance that WHO attaches to the development and imple- mentation of national drug Consumer groups in many African countries are realising the value of health education. Here in The Gambia women gather to listen to health messages on the radio Aidan Chadirikere (right), Director of Pharmacy Services and Norman Nyazema (left), Professor of Pharmacology at the University of Zimbabwe celebrate the launch of Zimbabwe’s new national drug policy document choir from the Harare Central Hospital School of Nursing was on hand to sing the Zimbabwe National Drug Policy into life. o Ph ot o: W H O Ph ot o: Z ED AP W HILE many countries in Africa have adopted national drug policies these policies do nothing for the public they are meant to serve if they remain only written plans. Consumer involvement in implementing such policies is crucial in order to address the public’s real needs regarding health and medicines. In many cases countries have done little to make sure national policies address consumer’s health needs in a participatory and attainable way. The reasons behind these successes and fail- ures, and strategies for ensuring consumer involvement in various aspects of these policies were the focus of HAI’s second regional workshop for Africa. Entitled Networking for Rational Drug Use in Southern Africa: Consumer Involvement in National Drug Policies, the meeting was held from 30 May to 5 June 1998. It brought 34 participants – including consumer activists, NGO representatives, drug information experts, journalists, pharmacists and clinical pharma- cologists from 11 African countries – to Johannesburg, South Africa. In his introductory remarks to the workshop, Dr Harm Pretorious, Deputy Director-General of South Africa’s Department of Health, spoke about this critical period for his country’s drug policy. After South Africa’s first demo- cratic elections in 1994, the Department of Health had revised its policy in order to remove all of the health sector’s past inequalities. The new policy was devel- oped through broad consultation and included many stakeholders because of its far-reaching impact on all groups in society. The policy’s main objective is to supply essential drugs to the majority of Z IMBABWE’S National Drug Policy was formally launched in March 1998 by the Minister of Health, Dr Timothy Stamps, at a colour- ful ceremony at the Harare Central Hospital. Simultaneously the Policy was launched in four other centres throughout the country. The launch is a culmination of the efforts of all sectors of the health system – including health service providers, the pharmaceutical industry, various ministries and other stakeholders. A five-year work plan underlies the Policy, and has been in operation even before the formal launch. Dr Stamps stressed that the concept of a National policies. Other speakers underscored the need for a concerted multidis- ciplinary approach for successful policy implementation. Finally, the 15 Issue No. 25 & 26, 1998 E S S E N T I A L D R U G S M O N I T O R A ct io n P ro gr am me on E ssential Drugs and V accines I Improving quality of care in Hai Phong Province at the CHSs and altering the public’s awareness of issues surrounding the ra- tional use of drugs. It was assumed that this would increase the standing of the CHSs and therefore improve the chance of the commune investing in them, considerable period. We hypothesised that if good prescribing habits could be estab- lished for more than half a year then there was every hope that they would continue. We therefore used other aspects of im- proving quality of care as both carrots and R E S E A R C H .cont’d on pg. 16 à stick towards changing prescribing habits. We reasoned as follows: 1. Carrot Research: if all work was based on locally found research results, the “top down” image would be broken and we would be seen to be basing our work on the real situation. Treatment guidelines: if simple guidelines were developed, then it would be easy to judge the quality of treatment. If these guidelines concentrated on the most frequently seen conditions in all dis- tricts covering more than 80% of patients, then only some 10 conditions would need to be covered. Limited drug list: by looking at the guidelines and adding a few more for emergency situations, an agreed list of drugs could be determined. Participation: if the health workers participated in forming these treatment guidelines and drug list, they would be more likely to have a sense of ownership of the results. Retraining: by concentrating on the management of these 10 basic conditions and the limited list of drugs, retraining could be feasible and effective. Supervision: regular supervision of quality of prescribing from the district health centre would be a vital aspect of in-service training, morale building and developing a unified system. Drug fund: if the CHS had a suffi- cient drug fund to stock the needed drugs from the limited list, it could purchase these drugs locally and sell them at a com- petitive price to the private market. This preserving the preventive care that they offered. We hypothesised that if the commune health stations offered a good service, where common diseases were well managed; where necessary drugs at affordable prices were supplied in the right doses at the right times; where people with more se- rious problems were referred in a timely way to hospitals; where they had the basic drugs as a well managed re- volving fund; and where the necessary basic equipment was present, then several Participants at one of the district workshops which drew up standard treatment guidelines Ph ot o: S av e th e C hi ld re n Fu nd JOHN CHALKER* BACKGROUND N 1993/94 the system of commune health stations (CHSs) in Hai Phong Province, Viet Nam, was in danger of collapse. This was a system that had provided a health station in every commune in Hai Phong with a staff of four to six para-medics, trained for three to four years at the secondary medical school (these schools exist in most provinces to train nurses, midwives and medical, pharmacy and laboratory as- sistants). The health stations were a focus for all preventive and curative activity. They were mainly financed by the com- mune, but carried out Health Ministry vertical control programmes as well as providing obstetric and curative care. Each commune has an average popula- tion of around 6,000 people, and few people are more than 10 or 15 minutes from their nearest station. It was this extensive infrastructure that was a large contributory factor to Viet Nam’s excellent health statistics on infant mortality and life expectancy, which are comparable to countries with a much higher gross national product. Since 1989, under the Government’s policy of “Doi Moi” or renewal, private practice in the health sector was legitimised. This new ap- proach, coupled with inflation, meant that in practice invest- ment in the stations virtually ceased. At the same time many private drug sellers (both licensed and unlicensed) appeared. Salaries for health workers reduced to non living wages in real terms (about US$6 a month). The stations fell into poor states of disrepair and equipment was not replaced. In pre project research in early 1995, we found that the average value of drug stocks in a selection of Hai Phong CHSs was about US$20 per station. Drugs were bought locally by the health staff, and were sold and replaced frequently via user fees. The staff had very little retraining. District supervision of quality of treatment did not exist, and treatment standards were deteriorating. At the same time attendance fell by more than half from 1989 to 1993. People had access to drugs from the proliferating number of drug sellers. In fact more than 70% went to these drug sellers as a first recourse when sick. At the drug sellers they would very often receive the wrong, frequently poor qual- ity drug, in the wrong dose for the wrong length of time. Important and dangerous This poste r, used in the proje ct, gives t wo piece s of advic e on antibio tic use: if you think you need antibiotic s go to yo ur doctor; a nd if you need anti biotics tak e the full course of treatment otherwise they will not be as effective next time symptoms would be missed so that timely referral to hospital would be delayed. The spiral of decline in the commune health workers’ morale: the decreasing respect of the public; the reduction of dis- trict supervision; and the lack of a living wage which led to increasing numbers of health workers starting a private practice or taking up other income generating activities; all illustrated a breakdown of the health services. The consequence had serious implications for preventive care. With the reduced esteem of the CHSs due to declining curative activity, there was a concomitant reduction in motivation to finance the CHS by the communes. This threatened the very existence of the institutions that delivered the preventive care. It was the project’s goal to break this cycle of decline. THE PROJECT The project was a co-operation between Save the Children Fund UK, and the Hai Phong Provincial Health Bureau, supported by the Ministry of Health and partly financed by the European Union. Its objectives grew directly out of the previous analysis. They were all aimed at improving the quality of curative care consequences would follow. The first would be that more people would use the CHS. If this were the case, then the small profit made on drug sales would increase. These together would improve the health workers’ morale and financial situation. The second con- sequence would be that the commune, district and provincial people’s commit- tees would realise what an excellent resource they had in the CHSs and would mobilise more funds to main- tain them. In this way the institutions of preventive care would be preserved and the spiral of decline would be broken. Strategy We aimed to affect several as- pects of quality of care. We would improve the basic medical equip- ment, drug availability and the level of staff training. In addition we would help them construct a sustainable accounting system for ongoing drug supply, de- velop standard treatment guidelines, create district su- pervision of the quality of prescribing and accounting, and improve the rational use of drugs. Changing people’s prescribing habits has been shown worldwide to be extraordinarily difficult. These habits are not just formed from a rational knowledge base, but are affected by many financial, social and cultural factors. Pre- scribing (both bad and good) is a habit. To break the bad habits and establish good habits a combination of “carrot” and “stick” need to be employed over a E S S E N T I A L D R U G S M O N I T O R16 Issue No. 25 & 26, 1998Act io n P ro gr am me on E ssential Drugs and V accines would please health worker and public alike. Accounting system: developing an accessible, transparent book keeping sys- tem kept by the CHS would help to ensure the existence of an ongoing revolving fund. Equipment: the possibility for the CHS to choose basic equipment from an agreed list every three months for nine months would act as a real incentive to change prescribing habits. Patient load: with an increasing pa- tient load, income would increase. 2. Stick Withholding of equipment: if the agreed treatment guidelines and book keeping system were not followed, then the equipment would not be forthcoming. Peer pressure: the withholding of equipment would be public knowledge. Supervision: the regular supervision would also be a form of inspection. Public expectation: if, through a se- ries of television and radio programmes, leaflets and posters, the public were informed about key aspects of drug use and CHS service, then their demand for irrational treatment would decrease. PHASED IMPLEMENTATION The project was implemented, district by district, in all 12 districts in 217 com- munes in Hai Phong covering a population of 1.6 million people. In each district the whole process took up to one year. We started with the rural areas and ended with the urban and island districts. Work started in the first district in June 1994 and the last in January 1996. It covered a series of activities aimed at improving aspects of quality of care. Pre implementation in each district Baseline research on key drug use indicators and which diagnoses were being made at CHSs was carried out in all CHSs of the district. This was either done by retrospective examination of out patient books or if these were absent, by prospectively giving prescription pads and examining them after one month. As a pre-condition for joining the project, each district health office had to agree to set up and run a team of supervi- sors to monitor the quality of treatment and of book keeping in each commune each month. This information was to be fed back to the provincial health office and project office every month, establish- ing a record of key indicators for each CHS and aggregated for each district. It was mainly on the basis of these records that the decision was made whether to donate or not, money for equipment to each CHS each three months. The key indicators used were those that had been shown to be most problematical during baseline research (see Table1). Preparation In each of the 12 districts, a series of workshops was carried out – normally two in each district but this varied with the number of staff needing to attend. The workshops were with: ä Key commune and CHS leaders, to agree the plan of activity of the project. This was basically to enlist their support and explain the ap- proach. It included them approving regular supervision by district staff, the formalising of the selling of drugs, instigating an accounting system and agreeing that the CHS drug seller could purchase drugs from the agreed list from any registered drug seller. They would also understand that equipment donation was dependent on good prescribing. ä CHS curative staff, to create a stand- ard treatment guideline based on the most frequent diagnoses and to agree a drug list. A senior staff member from the Ministry of Health’s Education and Science Department facilitated these workshops. The standard treat- ment guidelines were based on commune prescribing patterns over previous months and on the diagnoses made. This information was found either by looking at records or if these did not exist, by supplying duplicate prescription pads to all staff, collecting them after one month and analysing the data. Treatment guidelines were made for the 10 most common conditions that covered more than 80% of patients seen in each particular district. While the process was participatory, the final say rested with the facilitator, who was familiar with national and WHO policies for treating the most prevalent diseases. Compilation of the drug list was then relatively easy, as usually eight or nine drugs had been used in the treatment guidelines and then, extra drugs were discussed and agreed, us- ing the same facilitator. Each district’s drugs list was slightly different, containing between 29 and 31 drugs. When the programme ended they were combined into one list of some 32 drugs. ä CHS book keepers, to develop an appropriate book keeping system. Box 1 The Information, Education and Communication (IEC) campaign in Hai Phong to promote the rational use of drugs IEC campaign principles Messages were agreed and prioritised on the basis of research. These messages addressed the same problems found with CHS prescribing. They were repeated as often as possible, using a variety of media channels. Main problems identified • Antibiotics are used too often. • When antibiotics are used they are used in too small a dose. • Injections are often preferred to tablets. • The majority of sick people are not using CHSs. Agreed messages • Never use injections if tablets will do. Injections can be dangerous and are usually not necessary. • If you need antibiotics, you must use a full dose. Not finishing the dose means that next time you need them they may be less effective. • When you are ill do not self prescribe, ask your local expert. Use your Commune Health Station. • Save the Children Fund from the UK is here to help upgrade your local Commune Health Stations. Using your local CHS when you are ill is beneficial for your health and the station. Media used These were variously applied from June 1994 to November 1995. Two posters were designed in Hai Phong for the first two messages and every CHS was given four or five of each. Four radio programmes (short plays of five minutes starting and finishing with the message) were written and recorded first by a district radio and secondly by provin- cial radio. They were transcribed onto cassette and distributed to every CHS to broadcast on the commune public address system. Four radio spots each 30 seconds long were treated the same way. TV programmes. Provincial TV recorded four programmes, each approximately five minutes long, with a respected person talking about one of the messages. These were shown several times over several months. TV spots of one minute were treated in the same way. Newspaper advertisements were taken out for each of the messages on the provincial newspaper’s back page. Leaflets. A simple leaflet was designed and given to each houshold in five communes. Meetings. A key physician from each district was trained on the messages, but this has not yet been taken any further. Cost. All these inputs came to a total of US$2,200. ä District supervisors, to develop and learn methods to monitor the agreed key drug use indicators that were seen to be a problem on the basis of the research findings. At the conclusion of the workshops a ceremony was held, where each actor (from the Provincial Health Bureau, Dis- trict Health Office, Commune Peoples Committee and CHS) signed a contract to agree their role in the plan of activi- ties. A week of retraining for all curative staff was organized through the second- ary medical school, to reinforce basic diagnosis and treatment for common conditions. With this done, Save the Children Fund UK transferred an average of US$300 to each CHS for them to set up a revolving drug fund. It also supplied books and calculators for book keeping. This took around two months in each district. In addition an information campaign on key drug use issues was launched using television, radio, newspapers, posters and leaflets. The messages were based on survey results (see Boxes 1 and 2). Ongoing work With satisfactory results from the regular supervision of the district teams, at three monthly intervals, each CHS was allowed to choose around US$250 worth of basic medical equipment from an agreed list. This equipment was condi- tional on following the treatment guidelines and book keeping system. Initially some CHS staff found it difficult to understand and adhere to the new accounting and prescribing proce- dures. However, the district health team’s supervisory visits and at least one early visit from a Save the Children team mem- ber helped to resolve problems. After this visit, when processing the monthly infor- mation for the district, the project wrote to the district health officer highlighting any unsatisfactory practices within particular CHSs, (such as overuse of antibiotics or injections). If, after warn- ings, bad practices went unchanged, the requested equipment was refused until improvements had been made. The supervisors’ motivation and abilities were another concern. If highly qualified the supervisors were reluctant to travel around to the CHSs. If they were less highly qualified they were more willing to travel but did not have the authority to advise the medical assistants on their practice. This problem was tackled differently in each dis- trict, but on the whole the supervisors managed to collect the necessary information. The head of the district health office reviewed the supervisors’ progress each month when they came in to collect their salaries. The review was based on the information that had been collected. When information had not been collected for the month because the supervisors had not done their work, equipment distribution was stopped in the whole district. We also stopped delivery if the information seemed unre- liable, for example if everything was scored at 100%. The reliability of the HAI Phong. cont’d from pg. 15 17 Issue No. 25 & 26, 1998 E S S E N T I A L D R U G S M O N I T O R A ct io n P ro gr am me on E ssential Drugs and V accines Box 2 The Information Education and Communication campaign evaluation u u u Evaluation Two hundred households from five communes were randomly selected and interviewed. The results showed that the IEC campaign had been memorable: • 89% of households could report some IEC messages. • Only 25% claimed no change in knowledge. The other 75% claimed a change in knowledge, practice or both. The most effective means of commu- nication was the commune public address system. 67% of respondents remembered at least one message from these. 52% of all households remembered something from TV (51% of the households owned a TV). 53% remembered something that their CHS staff had told them. Newspapers and posters were less effective with only 7.5% and 15% remembering something from these. The leaflet was not remembered very often (37%), but in the communes where the leaflet was not distributed to each house, respondents were twice as likely not to remember any message. Conclusions IEC campaigns based on locally made programmes and research- based messages can be very effective and inexpensive in Viet Nam. Commune public address systems are still effective in rural areas. This is based on the decentral- ised media system of province, district and commune. This has profound implications for future campaigns on, for example, nutrition, weaning practices or HIV. (A full report of the IEC evaluation is available from the address at the end of the article). baseline research was carried out. The studies involved randomly choosing 40 CHSs and looking at the out patient book, the accounting books, the drug cabinet and performing some interviews. From the out patient book, the last 30 treatments were looked at in each CHS for the pre- scribing indicators. A major impact As the project was started district by district over an 18-month period, the base- line research in new districts acted as a rolling control to the results shown. Each new district showed broadly the same pattern of results as the original baseline, thus showing that most of the impact could be attributed to the project activi- ties. The most significant finding was the large improvement in the prescribing pa- rameters as can be seen in Table 1. In each district these improvements took place in the first month after the workshops, and then went on improving over the next few months to reach a plateau which was maintained to six months beyond the end of the project (see Table 1). This shows that good prescribing becomes a habit when maintained due to incentives over a considerable period. The treatment guidelines and agreed limited list of drugs were successfully developed in each district. The week of retraining concentrated on these. Each district guidelines covered around 10 con- ditions that covered more than 80% of patients. The 12 district guidelines were eventually combined into one book for the Province. As shown in Table 1, the guidelines were followed in a large per- centage of cases. The CHSs stocked an average of 27 of the 29 or 30 recom- mended drugs, but continued to stock an average of 23 other drugs, and 55% of CHSs stocked specifically non regulation drugs such as steroids, gentamycin and lincomycin. When asked they said that they sold these profitably over the coun- ter, from their drug store, and therefore liked to stock them. Anecdotally this is an improvement on the pre-existing situ- Table 1 Hai Phong baseline, Hai Phong research and Hai Phong latest supervisors’ reports Hai Research Latest Research Latest Phong RESULTS Super- RESULTS Super- Baseline vision vision Reports Reports n = 690 n = 1,200 n = 4,050 n = 1,200 n = 6,510 MONTH August December 1995 September 1996 1994 Patient numbers per CHS per month 76 115 120 114 137 ITEM/PT 2.3 1.4 1.5 1.5 1.4 % patients given VITAMINS 75% 8% 8% 6% 6% % patients given INJECTIONS 33% 7% 7% 6% 6% % patients given ANTIBIOTICS 69% 46% 45% 48% 43% % antibiotic DOSES OK 29% 91% 98% 93% 98% % treatments following the STG 92% 93% 86% 95% to buy drugs, presumably because there was a consensus that this purchased enough of the products on the drug list to have a sufficient store. This has impor- tant implications for funding of projects in the future. The excess money was kept safely in reserve, and may help the drug fund’s sustainability. The accounting sys- tem was only fully operated in around 65% of the CHSs. Profit was not one of the things we asked to be recorded, as this is a sensitive issue with potential tax con- sequences. However the average monthly purchasing of drugs was around US$150, so assuming a 10% mark up, an extra US$15 a month served to supplement salaries which were only $6 a month. This was not a fortune, but was a significant addition. All 217 CHSs eventually received the equipment they requested, although some was delayed because the station did not fulfil the criteria of good prescribing. Using the equipment donation in this way provided a much-needed leverage to give overall profit from selling drugs should have increased due to the number of patients being seen. The quality of care given to patients improved in the form of better drug and equipment supplies, better staff know- ledge in diagnosis and treatment, and above all better prescribing. It should be emphasised that this was first and foremost a practical project to improve the deteriorating health care situation, and only secondly a research project. The Hai Phong authorities had no interest in research as such, but wanted benefit for their people as soon as possi- ble. The whole project was run on operational research lines. The justifica- tion was that all information used should be locally derived to increase the relevance, and that supervision data were a useful management tool and a necessary way of assessing whether equipment should be donated or not. The project itself was multi-faceted, using innovative together with well-tried techniques that had been shown to work in other situations. This means that we cannot say which part of the project was responsible for its success. However this was never the intention. It is the very multiplicity of approaches that has now been shown to be effective. The innova- tion is the combination of the factors involved, with particular focus on the con- ditional donation of chosen equipment depending on good prescribing and the effective setting up of district wide supervision. o * Dr John Chalker was Project Manager for the Hai Phong Project, from December 1993 to March 1996, for Save the Children Fund UK. n n n For further information on the Programme contact: The Field Director, Save the Children Fund UK, 218 Doi Can Street, Ba Dinh District, Hanoi, Viet Nam. Reports on the Programme evaluations, including the public information campaign, are available from this address. Other publications are pending. supervisors’ information was checked through evaluation exercises and was found to be very good. Supervision results showed a large improvement in prescribing habits and book keeping over the first five months of activity for each district (see Table 1). Evaluation Supervisors’data were checked by quantitative evaluations in December 1995, before the project had finished and then again in September 1996, six months after the end of the external inputs. These were retrospective studies, in the eight rural districts which the origi- nal project covered, and where the ation when all CHSs stocked such drugs. The supervision system eventually functioned well in all districts. The information produced in this way was shown as reliable when compared to the evaluation research (see Table 1). In two districts, after three months, when the equipment was due, we refused to release the equipment to any of the CHSs, as we felt the super- vision results were unreliable or they had not been pro- duced. After this things improved. The conditionality of equipment donation on At the end of a series of training workshops John Chalker presents a participant with a set of posters, a cash box plus padlock and a calculator. Inside the box are all the accounts and record keeping books necessary for one year. All commune health stations received these reliable and regular supervision proved an effective incentive. CONCLUSIONS A drug fund was supplied to each CHS, tracked by an accounting system. Interestingly only an average of US$150 (out of the US$300 supplied) was used an incentive towards rational drug use. Patient attendance increased during the project and maintained that level for six months after the project’s end (see Table 1). This may have been in part due to the IEC campaign (see Boxes 1 and 2). This means that although each patient may be treated more rationally, and therefore be given fewer drugs, the Ph ot o: S av e th e C hi ld re n Fu nd E S S E N T I A L D R U G S M O N I T O R18 Issue No. 25 & 26, 1998Act io n P ro gr am me on E ssential Drugs and V accines Survey highlights failings in public education in rational drug use A surprise finding was that there were fewer differences than expected between the types of programmes in developing and developed countries. The most significant was the different media used. While education programmes in devel- oped countries relied more on the printed word to get their message across, programmes in developing countries re- ported more frequent use of the mass media, especially radio. In developing countries, the most popular channel of communication was the mass media (76% of projects) followed by workshops (70%) and the distribution or display of printed materials (26%). Developed coun- tries focused mainly on printed materials (61% of projects) and the mass media (56%). Reaching out to schoolchildren and the elderly School projects accounted for a large number of education programmes, espe- cially in developed countries, but only Sweden had launched a nationwide programme targeting all schools. Projects ranged from a novel “pill-box” informa- tion campaign in secondary schools in Belgium (see Box 1), to projects for younger children in the United States, involving the use of pharmacy students to teach drug safety and compliance, and encourage children to take responsibility for their own health. Many of the sample school kits submitted had been developed in collaboration with the pharmaceutical industry or pharmacy organizations. Most failed to highlight the risk/benefit equa- tion of drug use, or even that the same active substance may be marketed under different brand names and at different prices. In addition, little effort was made to encourage children to develop a more objective view of the commercial promotion of drugs. A variety of innovative approaches are being used by groups in both developed and developing countries to get the message across. In Germany, the BUKO Pharma-Kampagne uses street theatre presentations to raise public awareness about rational drug use, while in Australia, the Medicine Information Project makes use of trained elderly volunteers as peer educators to promote rational drug use among the elderly population. Volunteers receive an initial five days’ training, updated four times a year. The topics R E S E A R C H The report by the Action Programme on Essential Drugs is based on the first ever global survey of public education in rational drug use. The study set out to establish who and what is being targeted by rational use programmes; who is doing the work, how and why; what are the needs and lessons learned; and what future action needs to be taken. The sur- vey included data from about 100 questionnaires and educational mate- rial gathered from 38 countries (25 developing and 13 developed countries). Critical need for public education The report points out that in many parts of the world up to 80% of illness episodes are self-treated with modern pharmaceuticals. And even where formal health care channels are used, it is the consumer – not the prescriber – who de- termines whether and how the drugs are used. These decisions are based on the shared beliefs of family, friends or the wider community; information from pre- scribers and dispensers; and promotional material. As a result, consumers need ac- cess to accurate and understandable information about the potential benefits and risks of medicines in general, includ- ing possible side effects; how they act within the body; and the limitations of pharmacotherapy and other treatment options. “With the exception of Australia, no country – developed or developing – has undertaken a structured public educational programme, targeting all members of the community and devel- oped by a coalition of stakeholders,” says the report. The authors point out that in developing countries it is not surprising that, in view of the wide range of other competing areas of drug policy, public education in rational drug use is often given low priority. But its neglect by developed countries is more difficult to understand. “It is more difficult to explain the lack of commitment by developed countries to systematic and structured public edu- cation in rational drug use, given the potential economic and public health benefits,” the report states. Until now few public education in rational drug use interventions have been documented or evaluated. As a result, experience cannot be shared or built on. The DAP survey was intended to help close this gap. Box 1 “Far-Well” and “Medi-Studt”. The best medicine for students – Belgium Students are “open” to new information; learning is their job. Students are also prone to using medications, especially in order to study well during examination time. Knowing this, the higher-educational institutions (non university) in Belgium requested Projekt Farmaka, a non profit independent organization, to assist. The result, de- signed and developed by a planning group consisting of a pharmacist, prescribers and students, was an innovative “pill-box” of information destined for distribution in schools and student clubs. The choice of subject matter in these “pill-boxes” was based on the most common illnesses and complaints, and on the most commonly used medicines by students. The main message? “Use a medicine ONLY WHEN IT IS NEEDED.” But activities went far beyond the simple distribution of the “pill-boxes”. Information stands were set up during school breaks and at lunchtime, with displays and posters. In order to get a “pill-box”, a student had to complete a quiz form with five pertinent questions. Workshops were held with the students to discuss the information. Mass media also participated, with radio interviews and television announcements. The campaign was well-timed. It was held during the examination period, when students are prone to taking vitamins and “pep pills”, and to having sleep-related problems. The students were particularly open to discussions about medications, and wanted to learn more. Some schools have established a “medicines panel” to disseminate additional information about problem drugs, and to discuss issues like sports and diet. Other schools are organizing question-answer sessions focusing on medications. The “pill-box” concept was innovative and sparked people’s curiosity. The materials could be improved, to be sure, and future campaigns will take into consideration more of the students’ views on content, in addition to design. Box 2 Michoacan, Mexico holds a campaign: Towards the Rational Use of Drugs Given evidence of an overabundant use of medications by the general population, of an over-prescription of medications by medical doctors, and of unethical drug promotion, a nongovernmental organization in one state of Mexico embarked on a short but intense educational campaign. Participants in the planning were prescribers, government officials, community members, students, the media, and communication experts. The campaign targeted the general public, but also prescribers and medical students. Materials devel- oped included posters, leaflets, press articles, slides, radio and television programmes, and posters for doctors. Many of the printed materials were displayed at points of prescription; others were used during 3-day seminars held at the local medical school. The mass-media broadcasts lasted for three months, with increas- ing intensity just prior to the medical school conferences. Feedback after the campaign was very positive. Medical professionals and students expressed increased awareness of the problems. The pharmacology curriculum of the local university was revised. Articles published in the local and national press suggested a significant change in general knowledge about rational drug use. No words are necessary to convey this message on the dangers of becoming dependent on tranquilisers AI S Pe ru A global survey of public education in rational drug use1 has revealed that efforts in both developing and developed countries are being severely hampered by under-funding, lack of support and a shortage of expertise. The outcome, says the report, is a vicious circle in which projects are poorly planned, weakly implemented, and not evaluated rigorously enough. 19 Issue No. 25 & 26, 1998 E S S E N T I A L D R U G S M O N I T O R A ct io n P ro gr am me on E ssential Drugs and V accines covered include consumer rights and responsibilities, use of specific medica- tions, assertiveness, problem-solving, as well as presentational and listening skills. developed countries. The report highlights the failure of most projects to evaluate the impact of their activities. As a result, cost/benefit to have been a failure. The main problems faced by projects included: ä shortage of funds; ä inadequate external col- laboration and support; ä poor coordination; ä shortage of time and personnel; ä opposition from vested interests (both commer- cial and professional); ä unsupportive legislation. Of these, the lack of funds was the major problem for developing countries, while for developed coun- tries, the principal constraint was a shortage of time and personnel. On sources of funding, the survey found that developing country projects were most likely to be funded by international organizations or inter- national NGOs, while ministries of health and professional associations were the major source for developed countries. Tackling the problems The report notes that if public educa- tion is to be properly researched, backed by the necessary tools and knowledge, and be effective and sustainable, it must be adequately resourced – ideally from a variety of funding sources. It says new, more creative and sustainable sources of funding are needed, possibly including: ä a tax on commercial drug information budgets to provide independent infor- mation to consumers and to support community projects; ä incentives to dispensers to develop community education projects or extend individual counselling – particularly in countries where dispensing is covered by social insurance schemes; ä independent consumer information for sale at a price that covers recurrent costs. The report also highlights the need for greater advocacy at international, national and regional levels to promote the impor- tance and rationale of public education in rational drug use. It says there is a need for greater understanding of its potential contribution to public health and savings in health expenditure. Better advocacy, say the authors, would help “avoid sim- plistic, unsustainable, and token approaches that contribute little to real community empowerment and under- standing, but simply pay lip service to the very real information and educational needs of the community in this important area.” Also needed are opportunities for short-term training and access to simple, practical tools essential for research and development activities, especially for small-scale community-based pro- grammes. The authors point out that no courses exist in the area of public educa- tion in rational drug use, and call for the This Kenyan health education poster warns against one of the most common dangers in many developing countries – untrained drug vendors whose products are often substandard or counterfeit development of an international training course through which educators could strengthen their communication skills and, in turn, train national colleagues through in-country training programmes. “Organizations or people who intend to carry out public education projects need clear, usable guidelines to help them better plan and structure their activities, including better definitions of the theme(s), the desired outcomes of the project, and the target audience.” The report also calls for the develop- ment of supportive coalitions and partnerships which could help strengthen the work and long-term sustainability of many organizations, especially those working in relative isolation. But it also warns that organizations need to ensure they are not hijacked by powerful inter- ests “less interested in the community’s own perception of needs and empower- ment, and more concerned with ‘marketing’ behaviour considered desirable by the dominant group.” The most encouraging finding of the survey was, despite its current failings, at its best, public education on rational drug use can and does work. Among de- veloping countries this was the second most important lesson learned and for developed countries the third most impor- tant. In Bolivia, a primary health care project declared that it was possible to get the community to take responsibility for their health, while rational use of drugs campaigners in Bangladesh reported that effective lobbying had shown that “con- tinuous, logical insistence to producers on rational/ethical production works.” Elsewhere, in Australia, the Medicine Information Project noted that, “empow- ering consumers can drive change at all levels of the health system.” o Reference 1. WHO/DAP. Public education in rational drug use: a global survey. DAP Research Series No.24. Geneva: World Health Organization; 1997. WHO/DAP/97.5. Both health professionals and the general public need better information and education about when and how to use drugs Elsewhere, telephone services in Peru and the Netherlands have been forced to expand the service after being swamped with calls on medicine-related health issues. Weaknesses identified The authors warn that the use of a wide range of different materials in some developing country projects – inadvertently promoted by funding and supporting agencies – may lower their effectiveness by diluting the message. The report highlights the difficult balance needed between having a few, well- developed and well-used complementary materials and a large number of relatively unconnected ones. The report reveals that almost half the projects used educational material that had never been pre-tested. Of those that did pre-test materials, most reported that the materials needed subsequent revision. Although the survey did not extend to the quality of pre-testing, the authors warn that the methodology for this is often lax. Common weaknesses in the material submitted included a proliferation of messages and the over- use of scare tactics, while some required considerable training before they could be used effectively. The report recom- mends the development of relatively simple methodologies to ensure that all materials can be thoroughly pre-tested and, where necessary, revised before use. Another weak spot identified in the report is the lack of structured planning. Most projects selected fairly general themes on the basis of “perceived need” and their target groups and expected out- comes were also very broad. However, significantly more developing countries (43%) than developed countries (27%) had based their projects on research find- ings (including consumer and practitioner surveys, focus-group discussions, and patterns of drug sales). Of the specific drug problems targeted, developing countries most frequently cited antidiarrhoeals and antibiotics, while developed countries focused more often on benzodiazepines and other sedatives. The illnesses most often targeted were diarrhoea and malaria in developing countries and asthma in the analysis is impossible – deterring many potential donors. Very few projects were able to provide evalua- tion reports. And, with the exception of rational use of drugs projects in Australia and Viet Nam, most focused on activity monitoring rather than impact assessment. “This is unfortunate,” the authors point out, “for pub- lic education programmes are often accused of a lack of rigour in their work, lead- ing to a questioning of their value and consequent diffi- culties in obtaining support for such programmes.” However, the report also warns that the impact of public education strategies is often incremental – moving gradually from initial awareness raising, to knowl- edge creation, community empowerment and behavioural change. “This may be difficult to evaluate in the short-term – particularly using classical methodolo- gies,” say the authors,” and care is needed that we do not ‘throw out the baby with the bath water’ in an attempt to evaluate impact with scientific rigour.” In the absence of systematic evalua- tion studies, many projects gave estimates of the impact of their activities. In devel- oping countries, 40% of projects judged that their project had met its objectives, compared to 66% in developed countries. Meanwhile, 60% of developing countries and 30% of developed countries said the project objectives had been partially met. No developing country and only 4% of developed countries deemed their project Disseminating the survey results is essential to promote effective public education. Here the global survey is publicised at a pharmacists’ association meeting in the Netherlands Ph ot o: W H O /D .A . F re sle N at io na l C ou nc il on P at ie nt In fo rm at io n an d Ed uc at io n, U SA M in ist ry o f H ea lth , K en ya E S S E N T I A L D R U G S M O N I T O R20 Issue No. 25 & 26, 1998Act io n P ro gr am me on E ssential Drugs and V accines Advantages of pre-packaged antimalarials Sustainability – cheap, readily available materials. Acceptability – to both staff and pa- tients. Because of the clear advantages of pre-packaged antimalarials, Ghana’s district medical officers are eager to extend the practice to other commonly used drugs. The Ghanaian study adds to the evidence from similar research on pre packaging in South-East Asia. For example, in China, blister packaging of antimalarials produced 97% adherence to treatment compared to 83% in the con- trol group, whose drugs were handed out in envelopes (which are often lost or dis- integrate in the rainy season associated with malaria). Why patients need information Other Ghanaian studies have shown how much greater the effect of pre- packaging antimalarials is when better information is provided to patients by pre- scribers and dispensers. These studies were part of the series being carried out by district medical teams in collaboration with the Health Ministry’s Health Research Unit, in the context of Ghana’s health sector reforms. A Phase 1 study had indicated that many patients who receive chloroquine are not given any informa- tion about how many tablets to take or how often to take them. They may also be given either more or less chloroquine than they need. This is important because failure to comply with the full course of treatment affects both the patient’s cure and the drug resistance of parasites. number of patients strictly complying with these instructions. The proportion of people obtaining at least enough chloro- quine on each of the three days of treatment increased from 29% to 54%. The proportion of children who obtained R E S E A R C H T R A I N I N G Course offers flexible approach to community-based health education workplace for a diploma, based on implementation of a project that they designed at Leeds. The aims of the course are to provide skills in research, planning, management and evaluation of health education, and provide opportunities to apply these skills to a problem from the participant’s own work setting. Applicants should be expe- rienced managers and staff within field projects who require a short course to improve their capacity to plan, implement and manage the health promotion com- ponents of projects. Module on medicines and essential drugs… Among topics covered in this module will be: ä Appropriate use of medicines, includ- ing an introduction to: the essential drugs concept and appropriate use of medicines; the work of WHO’s Ac- tion Programme on Essential Drugs, international pressure groups and con- sumer movements; and problems arising from inappropriate use of medicines. ä Health seeeking behaviours: self- medication, informal market sectors for medicines and problems of implementing essential/rational drug policies. ä Assessment of needs for health education/health promotion support for appropriate use of medicines. ä Community, social and economic influences on use of medicines and the role of multinational companies. ä Health education and health promo- tion methods in various settings: national campaigns, mass media, patient education, community self help groups, community pressure groups, training of pharmacists, and training in the informal sector. ä Planning for programmes to promote appropriate use of medicines: selec- tion of indicators for monitoring and evaluation. The course is expected to cost £3,000 for academic tuition and field visits, with subsistence/accomodation expenses of approximately £2,500. o For further details contact: Overseas Admis- sions Tutor, Health Education, Room F505, Leeds Metropolitan University, Calverley Street, Leeds LS1 3HE, UK. Tel: + 44 113 28322600, fax: + 44 113 2835921, e-mail: health-promotion@lmu.ac.uk Diseases, 1211 Geneva 27, Switzerland. Source: TDR Newsletter No. 54, October 1997. Reference 1. The study was part of a project to improve malaria control in Ghana, co-sponsored by the UK’s Department for International Health, Liverpool School of Tropical Medicine (UK), the Ministry of Health in Ghana and WHO’s Special Programme for Research and Training in Tropical Diseases (TDR). The follow-up intervention ensured that prescribers and dispensers provided full information to patients about the duration of therapy and the quantity of chloroquine to take each day. As well as verbal instructions patients were given a diagrammatic explanation to take home. Following the intervention there was a significant increase in adherence to treatment – from 25% to 50% – in the The packaging process for antimalarials, seen here at the National Institute of Medical Research, Lagos, Nigeria. Pills are bagged, heat sealed and labelled with dosage instructions Ph ot o: W H O /T DR /A . C ru m p at least the recommended minimum dose of chloro- quine syrup on each of the three days increased from 59% to 85%. Sample sizes used in the study were between 55 and 75 patients. This work shows that a little time invested in provid- ing appropriate information to the user at primary health care facilities will, in the long run, pay dividends in terms of increased patient adherence to treatment. o For further information contact: World Health Organization, Special Programme for Re- search and Training in Tropical A Ghanaian study1 has shown that treatment of malaria is more cost- effective, in terms of both time and money when antimalarials are pre-packed in daily doses. Preliminary observations in six districts indicated that some of the major problems in malaria control programmes are: high cost of treatment; high chloroquine consumption (in syrup form); long waiting times at dispensaries; and a large number of untrained/unqualified dispensers who are unable to give advice. Two types of pre-packaging were used in the study – plastic bottles for chloro- quine syrup and sealed plastic bags for chloroquine tablets. The advantages of pre-packaged antimalarials were found to include: Reduced cost because of: reduction in the number of drugs prescribed; smaller volumes of syrup consumed; reduction in the number of injections given; reduction in excess chloroquine consumption. Improved drug management – easier to balance books; easier to monitor drugs issued; reduced contamination; less wastage. Improved case management – doses given according to weight. Improved compliance – easy to understand and easy to remember instructions; more effective counselling. Reduced waiting times in dis- pensaries. I N publicising one of its newest courses, Leeds Metropolitan University in the UK sets out clearly the benefits of health edu- cation: the awareness it creates among the community, policy makers and health care providers of the advantages of a rational drugs programme and the proper use of medicines; the increase in the skills of health care providers in the delivery of sensitive, appropriate and effective pa- tient education; and the encouragement it gives for community and political action to prevent the misuse of drugs and medicines. The University is offering a 10-week course in community-based health education and health promotion with specialist options, including one on medi- cines and essential drugs. Participants either finish after 10 weeks and receive a certificate of attendance or study further by distance learning within their own 21 Issue No. 25 & 26, 1998 E S S E N T I A L D R U G S M O N I T O R A ct io n P ro gr am me on E ssential Drugs and V accines T R A I N I N G N E W S D E S K Personal formulary system helps university students Guide to Good Prescribing). One side of the page contains the information needed to check not only whether a specific drug is indicated for the disease but also whether the drug is suitable for the individual patient (see Figure). If the doctor or student has de- cided that the drug can be prescribed, they then turn to the other side of the page. Here a prescription can be made out together with the necessary information and instructions for the patient, as well the date of the next appointment, where appropriate (see Figure). Information about monitoring the drug treatment can also be inserted here. With the loose-leaf system, the content of the personal formulary can be easily changed. The simplest way is to write or type the information about each P-drug. A computer programme has been developed for this with technical support from the WHO Collaborating Centre for Pharma- cotherapy Teaching and Training at Groningen University. Using this programme, the data can be typed, and printed in a standard format as shown in the Figure. Students can also add and remove drugs, and revise any of the in- formation about an individual drug. In this way students build up their own personal formulary. To help make it more personalised, each printout includes the name of the student. The programme can be installed on a computer network – a university network, for example – or on a personal computer. In the computer network of the Free University of Amsterdam, information on over 90 drugs has been included in the reference database. Clinical experts within the university consider these drugs appropriate for the treatment of 129 dis- eases and symptoms. At the end of the six-year undergraduate course medical students must be able to treat correctly, within 10 minutes, a real patient suffer- ing from any one of these diseases. At the start of the second year, students receive a personal formulary with a printed ver- sion of the basic information on the full range of over 90 drugs and can copy this information to their personal database. Next they are trained in developing and using their personal formulary. Up to the fourth year they practice in small groups by treating both textbook and simulated patients. A syllabus has been developed for this which includes about 200 text- book cases together with treatment plan forms (following the sequential approach of the Guide to Good Prescribing) and suggestions for patient role-playing ex- ercises. During the internships in the fifth and sixth year, the students practice with real patients. Students can buy a personal formulary and the syllabus for US$20. They also receive the Dutch Drug Com- pendium free of charge from the National Sick Fund. Initial results so far from the personal formulary system have been promising. During a realistic training session, involv- ing three simulated patients, the second year students taught in this way pre- scribed drugs more rationally and correctly than graduates who had fol- lowed the traditional curriculum. o * Theo P.G.M. de Vries is Professor of Pharmacotherapy at the Free University of Amsterdam, Van der Boechorststraat 7, 1081 BT Amsterdam, the Netherlands. Fax: + 31 20 444 8100. Guide to Good Prescribing available in more languages To add to the list of locally produced versions of Guide to Good Prescrib- ing, editions have now been published in Brazil (Portuguese), in India (in Bengali), Iraq, Italy, Japan and Pakistan. A Spanish edition will follow by the end of 1998. The personal formulary is a practical elaboration of the P(ersonal)-drug concept, which is outlined in Part 2 of the WHO Guide to Good Prescribing. It con- sists of a sequential approach for selecting a personal set of drugs for the treatment of specific diseases. By using a loose-leaf notebook and a small manual, practical information about the selected diseases and P-drugs can be inserted, changed or deleted. In this way a personal formulary can be developed. The personal formulary is divided into sections. The first section is used to list selected diseases. For each disease, a chosen standard drug and non-drug treatment can be described extensively or merely summarised. For example, (Dutch Standard Guidelines): Essential hypertension: start with weight, salt, and stress reduction. If no result: 1. atenolol or hydrochlorothiazide; if no result: 2. atenolol + hydrochlorothiazide; if no result: 3. captopril; if no result: 4. consider calcium antagonist, alpha 1-blocker, or referral. The second section contains practical information for prescribing the drugs listed in the previous section. Each page has information on a single drug, and the information is organized along the lines of the sequential approach to treating patients (outlined in Part 3 of the Addressing supply issues in the Eastern Caribbean quantification of needs, drug donations, medical store management and inventory control and drug utilisation reviews. Par- ticipants discussed their own experiences and worked hard to complete realistic work plans and timelines for improve- ment projects to be implemented upon their return to work. These plans were shared with the Ministries of Health and will receive support and follow up from the Eastern Caribbean Drug Service. o Source: INRUD News, February 1998. ANAGEMENT Sciences for Health and the Eastern Caribbean Drug Service offered a special eight- day course on managing drug supply, held in Dominica from 19–28 January 1998. The 18 participants in- cluded central medical stores’ managers and hospital drug supply managers from all nine countries in the Organization of Eastern Caribbean States. The course was specially designed to address the specific drug supply issues of the island countries, including: lack of national drug policies; lack of current M T THEO P.G.M. DE VRIES* HE development of a personal formulary system by university teachers in the Netherlands is proving to be a valuable tool for students in learning how to prescribe drugs rationally. The personalised compendium of drugs not only helps students learn about the drugs they prescribe, it also helps them choose alternatives in case one drug is unsuitable for a particular patient. Betty H. O. Student 12-06-98 Pharmac 95 Page 1 tablet 25,50,100 mg Beta blocker atenolol Atenolol is a selective beta blocker without intrinsic sympathicomimetic activity. It depresses myocardial contractility and reduces the heart rate. This initially causes a fall in blood pressure. With continued treatment the cardiac output returns to normal but blood pressure remains low because the peripheral vascular resistance is ‘reset’ at a lower level. In addition it may also increase the perfusion of the ischaemic area. It has very limited solubility in lipids (limited capacity to pass Blood Brain Barrier). Check indication Indication Angina pectoris, Hypertension Alternatives Hydrochlorothiazide, Captopril Check suitability of the patient Side effects Hardly any in normal dosages. Sometimes slight sedation, reduced exercise tolerance, or bronchospasm. Contra-indic. Sinusbradycardia, AV block, hypotension, cardiogenic shock, heartfailure, asthma. Interactions Some calcium antagonists, some anaesthetics. Betty H. O. Student 12-06-98 Pharmac 95 Page 2 tablet 25,50,100 mg Beta blocker atenolol Dosage Adjust to each patient individually, start as low as possible. Raise the dose after 2 weeks if needed. Higher dosages do not increase therapeutic effect, but may increase side effects. Hypertension Start with 50 mg in the morning; average 50–100 mg per day Angina pectoris 100 mg per day in 1–2 doses Give patient information Information Hypertension: drug decreases blood pressure. You will usually not notice any effect but the drug is needed: it will prevent complications of high blood pressure (angina, heart attack, stroke). Angina pectoris: decreases blood pressure, prevents heart from working too hard, preventing chest pain. Hardly any side effects; sometimes slight sedation. In some cases shortness of breath; in that case phone me. Instructions Take the drug … times per day, for … days; Warnings Angina pectoris: do not suddenly stop taking the drug Appointment Hypertension: one week Angina pectoris: within one month, earlier if attacks occur more frequently, or become more severe. Follow-up Hypertension: first few months check BP and pulse weekly; try to decrease dosage after three months, and to stop after one year. Angina pectoris: in case frequency or severity of the attacks increase, more diagnos- tic tests or other treatment are needed. Try to stop drug treatment from time to time. E S S E N T I A L D R U G S M O N I T O R22 Issue No. 25 & 26, 1998Act io n P ro gr am me on E ssential Drugs and V accines T N E W S D E S K Change at WHO HE Fifty-first session of the World Health Assembly, meeting in Geneva in May 1998, elected Dr Gro Harlem Brundtland of Norway to be Director-General of WHO for a five-year term which started on 21 July 1998. Dr Brundtland had been nomi- nated to the position by the 101st Session of the WHO Executive Board in January 1998. Former Prime Minister of Norway, Dr Gro Harlem Brundtland, Director-General of WHO the world one step closer to that goal is our call for action”. On her first day in office Dr Brundtland announced her new management team. Of the 10 cabinet members, eight come from outside WHO, and six are women. Mem- bers are evenly split between the North and the South, and all WHO regions are represented. Governments pledge support for WHO campaign The week that Dr Brundtland was elected Director-General and announced that one of her goals was to “Roll back malaria”, good news came from the G8 summit meeting of the world’s foremost industrialised nations. Leaders attending the UK summit in May 1998 agreed to support WHO’s campaign against infec- tious and parasitic diseases, particularly malaria. o Rational use conference in Palestine health policy that meets the needs of all Palestinians. Held at Beir Zeit University in Octo- ber 1998, the conference was organized by the Union of Palestinian Medical Relief Committees with the support of the French Government and the United Nations Development Programme. o For further information, contact: Nadine Kamal, Head Pharmacist, Union of Palestin- ian Medical Relief Committees, P.O.Box 51483, Jerusalem. Tel: + 972 2 5834 021, fax: + 972 2 5830 679, e-mail: NadineKamal@hotmail.com Executive Board acts on Revised Drug Strategy each region (of which at least one would be currently entitled to designate a person to serve on the Executive Board). As directed by the Board, WHO’s Regional Committees discussed the Revised Drug Strategy at their autumn meetings, and nominated their representa- tives for the sub-group. The group met for the first time in Geneva in October 1998, and fulfilled its main objective of drafting a new resolution on drug strategy. A total of 59 Member States participated in the meeting. As part of the sub-group’s deliberations a one-day panel discussion was held, which included pres- entations from interested international and nongovernmental organizations. The Executive Board will discuss the draft resolution at its 103rd session in January 1999. o African countries share information on drug prices regular tender information received from public drug procurement agencies, such as central medical stores, in 16 African countries. The information covers drug designation, package size, unit, price, supplier, currency used and exchange rate in US$. A comparison of prices from international suppliers, compiled by Management Sciences for Health, is also included to provide a global perspective. o Copies of the AFRO Essential Drugs Price Indicator are available, free of charge, from: Essential Drugs Programme, WHO Regional Office for Africa, P.O. Box BE 773, Belvedere, Harare, Zimbabwe, or from Action Programme on Essential Drugs, World Health Organization, 1211 Geneva 27, Switzerland. The Essential Drugs Monitor encourages the reproduction of articles for non profit uses. Please clearly credit WHO’s Essential Drugs Monitor as the source, and send us a copy of the reprinted article to the ad- dress given on page 1. M A LTHOUGH the availability of essential drugs in Africa has im- proved during the last decade, it is estimated that one-third to a half of the 700 million people in the re- gion still do not have regular access to the drugs they need. Over 40% of deaths in Africa are due to infectious diseases for which effective medicines exist, but which are not available to those who are ill. Drug shortages remain chronic in most African countries due to such fac- tors as inadequate national supply systems and weak implementation of national drug policies. Poor knowledge of the in- ternational drug market and the lack of effective national quality assurance sys- tems can lead to excessive prices and low quality products. Appropriate and objec- tive information on drug prices and quality standards is therefore essential for drug procurement agencies. In order to help countries in the region to address these issues, WHO’s Re- gional Office for Africa, in collaboration with the Action Programme on Essential Drugs, has developed the AFRO Intensi- fied Essential Drugs Programme. The new programme will focus on capacity building, strengthened drug supply systems, including quality assurance, and the rational use of drugs. One priority activity is the AFRO Essential Drugs Price Indicator. This new publication shares information on current drug procurement prices in Africa with the aim of providing purchasing bodies with a better negotiating position. Data in the first edition are based on the latest T EETING on 19 May 1998, WHO’s Executive Board decided to establish a two-tier method of working to explore the complex issues, (including those related to globalisation and trade), raised by Reslolution 24 on the Revised Drug Strat- egy, passed by the Board in 1997. An ad hoc working group would be open to all Member States wishing to participate; and a sub-group would be created to assist WHO in its contacts with relevant part- ners. These include the World Trade Organization, the World Intellectual Prop- erty Organization, the pharmaceutical industry and NGOs. The Board decided that the sub-group would comprise the Chair of the drafting group on the Revised Drug Strategy, established during the 51st World Health Assembly in 1998, and two Member States from HE first Palestinian conference on rational use of drugs brought together an enthusiastic group of health workers, nurses, pharma- cists and doctors from throughout the health sector. Speakers from international and local NGOs, Palestinian universities, and physicians’ and pharmacists’ associa- tions helped to raise awareness of rational use issues. Discussions ranged from the impact of inappropriate drug use to stand- ard treatment guidelines, essential drugs policy, drug information, continuing edu- cation for pharmacists, quality assurance and drug donations. The event is seen as an important step in moves to design a and the first woman to become Director- General of WHO, Dr Brundtland studied medicine at the University of Oslo and has a Masters degree in Public Health from Harvard University, USA. After taking the oath of office, Dr Brundtland addressed the World Health Assembly. She immediately affirmed her conviction that societies can be changed and that poverty can be fought. “The chal- lenge goes to all of us. WHO can and must change. It must become more effective, more accountable, more transparent and more receptive to a changing world”. Referring to the complex processes of transition that WHO must cope with, the new Director-General said: “The transi- tion from one century to another sees changes which will be faster and more dramatic from an economic, social and health perspective…Still we are faced with daunting challenges. Above all they Ph ot o: W H O are linked to the persistence of poverty. The imbalances are striking. People in developing countries carry over 90% of the disease burden, yet have access to only10% of the resources used for health. As regards the transition from the com- municable to the noncommunicable diseases, Dr Brundtland noted: “We need to fight both. The burden of disease is the burden of unful- filled human development”. Dr Brundtland concluded her speech saying: “My mo- tivation will be this: making a difference – being able to make an effort – being one of many dedicated people working together for what we believe in. I envisage a world where solidarity binds the fortunate with those less favoured. Where our collec- tive efforts will help roll back all the diseases of the poor. Where our collective efforts will assure universal access to compassionate and com- petent health care. Bringing E S S E N T I A L D R U G S M O N I T O R 23 Issue No. 25 & 26, 1998 E S S E N T I A L D R U G S M O N I T O R A ct io n P ro gr am me on E ssential Drugs and V accines N E W S D E S K First national formulary for Australia HE first edition of the Australian Medicines Handbook is the cul- mination of seven years’ planning and hard work. The need for an independent and up-to-date source of drug information to foster rational prescribing in Australia has long been dis- cussed. In February 1991, the Consumer Health Forum and the Australasian So- ciety of Clinical and Experimental Pharmacologists and Toxicologists con- vened a meeting to discuss how drug prescribing in Australia might be im- proved. Representatives of prescribers and pharmacists, teachers of pharmacol- ogy and therapeutics, government and consumer groups attended the meeting. There was unanimous agreement that Australia should develop a national formulary, like the British National Formulary, which since 1981 has achieved a reputation as an indis- pensable and widely used source of independent drug information. The task of developing a national formulary, to be called the Australian Medicines Handbook, was ultimately taken by three organizations: the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists, the Pharmaceutical Soci- ety of Australia and the Royal Australian College of General Practitioners. These organizations obtained a grant from the Commonwealth Department of Health and Human Services in 1995 to produce a hard copy of the first edition of the Handbook. Work began on the content in 1996. Whilst modelled on the concept of the British National Formulary, the Handbook was to be totally Australian and its contents were to reflect contem- porary Australian clinical practice. To this end, the editors recruited a large number of expert reviewers from all disciplines and all parts of the country. SERVING READERS’ NEEDS The philosophy of the Australian Medicines Handbook is to use the best available evidence to support prescribing and dispensing recommendations, and thus the publication actively discourages the use of drugs where the evidence for their efficacy is lacking or poor. The pur- pose of the Handbook is two-fold: firstly, to provide a readily accessible, concise, up-to-date source of independent drug information to facilitate effective, ra- tional, safe and economical prescribing and dispensing; secondly, to provide an educational tool for practitioners and students. Readers are likely to use the formulary in different ways. Students might want to read a whole chapter to learn about a drug class, whilst prescrib- ers might want to focus only on specific information, such as the dosage or the common adverse effects of a drug. The first 20 chapters contain in- formation which provides, in part, a theoretical framework for the reader to use the individual drug monographs. These monographs are organized within chapters, each of which represents an organ system, and the major therapeutic drug classes within the system. Compara- tive information about different drugs within the same class, or for other drugs for the same indication, is highlighted so that the reader can make an informed choice about the most appropriate drug to use. Since a book of this size cannot be exhaustive, the writers and members of the editorial advisory panels have in- cluded only that material which they consider to be the most relevant and useful for rapid reference by the busy health professional. The Handbook should be supplemented, where necessary, by more comprehensive texts and by the manufacturer’s product information. It will complement existing publications, such as the journal, Australian Prescriber, and the Therapeutic Guidelines series (see EDM-24 Published Lately). Future editions of the Australian Medicines Handbook will be published annually and all relevant material up- dated. The next edition will be expanded to contain information on fluids, electro- lytes and nutritional agents; anti cancer drugs; and emergency drugs; and will provide more expansive information on anaesthetics and psychiatric drugs. An electronic version will be available later in 1998. The three organizations participating in this project have high expectations of the Handbook. Firstly, the independent evidence-based material it contains should enable practitioners to make in- formed choices for their patients, which will improve outcomes, reduce unwanted drug effects and provide value for money. Secondly, students should be able to use the formulary to acquire a strong ground- ing in therapeutics as undergraduates and to continue to use it when they become practitioners. Finally, the Handbook can become an important vehicle for enhanc- ing the quality use of medicines in Australia to the benefit of all. o Australian Medicines Handbook Pty Ltd, PO Box 240, Rundle Mall, Adelaide SA 5000 Australia. Tel: + 61 8 82225861, fax + 61 8 82225863, e-mail: gmisan@ amh.adelaide.edu.au and homepage: http:// www.amh.net.au Price: AUS$125 and AUS$85 for students. UK study says patients not receiving information they need choices about treatments and are in effect excluded from the decision making process. The report details a study in which 62 patients and 28 clinical experts reviewed a wide range of leaflets, videos and audiotapes in current use. It concludes that the information they contained was often out-of-date and inaccurate, and sometimes seriously misleading. It did not include full details of treatment options, information about outcomes and treat- ment effectiveness was often omitted or was unreliable, and patients’ questions were left unanswered. Change necessary The patients involved in the study felt that many of the leaflets were patronis- ing and failed to recognise their right to be actively involved in decisions about their care. The report recommends that above all, information should start by answering the questions and concerns raised by patients. The language used should be simple without being patronis- ing. It should be honest about benefits and risks of treatment. So far, the National Health Service Executive has failed to take the initiative on patient information, the report states. Informing Patients recommends that they should fund development and evaluation of materials about common clinical conditions. These could be used alongside the clinical guide- lines to be commissioned by the National Institute for Clinical Excellence. There should also be a system for accrediting written and computerized materials, the Fund believes. A patient participating in one of the focus groups for the research, said: “When they measured my cholesterol lev- els, I tried to find out what the numbers meant, what the safe levels were and the role of triglycerides. I also asked whether the tamoxifen I am taking for breast cancer would have an effect on my cholesterol and on my heart. “I was com- pletely brushed aside; they ignored the knowledge I had acquired from my own research and I was told not to read too much! They also said no one else had complained about lack of information. I’m still none the wiser about the facts and my own condition.” The King’s Fund is urging the Government, the National Health Service Executive and health authorities to support good quality information, to enable patients to participate in decisions about their treatment and to improve the effectiveness of clinical care. o Informing Patients: An Assessment of the Qual- ity of Patient Information Materials is available from the King’s Fund Bookshop, 11–13 Cavendish Square, London, W1M OAN, UK. Tel: + 171 307 2591. Price: £16.95. Reference 1. Materials were studied about the following conditions: back pain, cataract, depression, glue ear, high choles- terol, hip replacement, infertility, menorrhagia, prostate and stroke. P ATIENTS in the UK are being denied access to reliable informa- tion about treatment options, according to a new study1 from the King’s Fund, an independent British health charity. Health professionals either do not know the answers to questions, withhold the information or simply fail to present the whole picture about ben- efits and risks. Despite endless surveys demonstrating that patients want good, clear information, the study concludes that it is not forthcoming. Yet it is highly likely that good information would save the health service money in the long run, the Fund believes, since it would help patients to look after themselves in terms of prevention and self-treatment. The study report, Informing Patients: An Assessment of the Quality of Patient Information Materials1, demonstrates that good quality information can improve the effectiveness of patient care. Without it, patients are unable to make informed T E S S E N T I A L D R U G S M O N I T O R24 Issue No. 25 & 26, 1998Act io n P ro gr am me on E ssential Drugs and V accines N E W S D E S K IDA celebrates and looks to the future Availability of Essential Drugs”. They stressed the need to ensure that generic drugs of assured quality were trusted and accepted both by prescribers and patients. They argued that all countries need to develop and maintain a national drug policy to ensure continuing progress in the pharmaceutical sector. A representative from DAP discussed WHO’s role, stressing that it would con- tinue to be complementary to that of bilateral organizations, industry and non profit suppliers in moving from assistance in acute relief situations to the stage of progressive development. The time reserved for discussions and questions saw a lively interaction between the audience and speakers. Debate ranged over many topics, including the impor- tance of national drug policies and rational drug use; the need to control drug donations; the harmonisation of registra- tion rules; the role of national quality control laboratories; and the need to fur- ther develop the WHO Certification Scheme on the Quality of Pharmaceuti- cal Products moving in International Commerce. On this memorable occasion IDA had sought to provide a forum for the ex- change of facts and ideas – to look at what has been achieved in the area of essential drugs and what remains to be done. Guests left the symposium with a much better understanding of the problems and the opportunities in this critical area. o Controlling research data and updating for the Internet: journal editors revise guidelines Opinions differ on how editors of medical journals should handle the ques- tion of commercial influences on research that they report. After reflecting at length on this complex issue, the International Committee of Medical Journal Editors (still commonly known as the Vancouver Group) altered its guidelines when it met in Boston, USA, in May 1997. On the issue of controlling research data, the Vancouver Group agreed that: “Scientists have an ethical obligation to submit creditable research results for pub- lication, and should expect to do so. As the persons directly responsible for their work, the authors as individuals should not enter into agreements that interfere with their control over the decision to publish.” On the precise influences that a spon- sor might have in a research setting, the Group wrote that: “Editors should require authors to describe the role of these sources, if any, in study design, collec- tion, analysis and interpretation of data, and writing of the report. If the support- ing source had no such involvement, the authors should so state. Because the bi- ases potentially introduced by the direct involvement of supporting agencies in research are analogous to methodolo- gical biases of other types (e.g. study design, statistical and psychological factors etc.), the type and degree of in- volvement of the supporting agency should be described in the methods section. Editors should also require disclosure of whether or not the support- ing agency controlled or influenced the decision to submit the final manuscript for publication.” The second issue that the Group tackled was the standards for posting medical and health information on the Internet. The principles that apply to ad- vertising in journals must now be adapted for the Internet. The Vancouver Group tackled this rapidly changing area with the expectation that their statement will need to be revised as web technology develops. The Group agreed that: “Elec- tronic publishing (which includes the Internet) is publishing. Authors, editors and publishers of biomedical journals who post medical and health information on the Internet connected to these publi- cations should follow the policies established by the International Commit- tee of Medical Journal Editors as the Uniform Requirements for Authors Sub- mitting Articles to Biomedical Journals and related statements. The nature of the Internet requires some special considerations within these well established and accepted policies. As a minimum, sites should indicate the names of editors, authors, and contribu- tors and their affiliations, relevant credentials, and relevant conflicts of in- terest; documentation and attribution of references and sources of all contents; information about copyright; disclosure of site ownership; and disclosure of sponsorship and commercial funding. Linking from one health or medical Internet site to another may be perceived as recommendation of the quality of the second site. Journals thus should exercise caution in linking to other sites. If links to other sites are posted as a result of fi- nancial considerations, such should be clearly indicated. All dates of content posting and updating should b

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