Many developing nations have developed national drug policies, a concept that has been actively promoted by the WHO. For example, the national drug policy for IndonesiaWorld Health Organization (1990) Review of the drug program in Indonesia. Report of a WHO mission 16 October-3 November 1989. DAP. 90(11): 1-36. drawn up in 1983 had the following objectives: To ensure the availability of drugs according to the needs of the population. To improve the distribution of drugs in order to make them accessible to the whole population. To ensure efficacy, safety quality and validity of marketed drugs and to promote proper, rational and efficient use. To protect the public from misuse and abuse. To develop the national pharmaceutical potential towards the achievements of self-reliance in drugs and in support of national economic growth.
To achieve these objectives in Indonesia, the following changes were implemented: A national list of essential drugs was established and implemented in all public sector institutions. The list is revised periodically. A ministerial decree in 1989 required that drugs in public sector institutions be prescribed generically and that Pharmacy and Therapeutics committees be established in all hospitals. District hospitals and health centers have to procure their drugs based on the essential drugs list. Most drugs are supplied by three government-owned companies. Training modules have been developed for drug management and rational drug use and these have been rolled out to relevant personnel. The central drug laboratory and provincial quality control laboratories have been strengthened. A major teaching hospital has developed a program on rational drug use, developing a hospital formulary, guidelines for rational diagnosis and treatment guidelines for the rational use of antibiotics. Generic drugs have been available at affordable costs to low-income groups.
Encouraging rational prescribing
One of the first challenges is to promote and develop rational prescribing, and a number of international initiatives exist in this area. WHO has actively promoted rational drug use as one of the major elements in its Drug Action Programme. In its publication A Guide to Good Prescribingde Vries TPG, Henning RH, Hogerzeil HV, Fresle DA (1994) Guide to Good Prescribing. WHO/DAP. 11: 1-108 the process is outlined as: define the patient's problem specify the therapeutic objectives verify whether your personal treatment choice is suitable for this patient start the treatment give information, instructions and warnings monitor (stop) the treatment.
The emphasis is on developing a logical approach, and it allows for clinicians to develop personal choices in medicines (a personal formulary) which they may use regularly. The program seeks to promote appraisal of evidence in terms of proven efficacy and safety from controlled clinical trial data, and adequate consideration of quality, cost and choice of competitor drugs by choosing the item that has been most thoroughly investigated, has favorable pharmacokinetic properties and is reliably produced locally. The avoidance of combination drugs is also encouraged.
The routine and irrational use of injections should also be challenged. One study undertaken in Indonesia found that nearly 50% of infants and children and 75% of the patients aged five years or over visiting government health centers received one or more injections.Management Sciences for Health (1998) Health Center Prescribing and Child Survival in East Java and West Kalimantan, Indonesia. Child survival pharmaceuticals in Indonesia. Part II. Report of the Ministry of Health and Management Sciences for Health. The highest use of injections was for skin disorders, musculoskeletal problems and nutritional deficiencies. Injections, as well as being used inappropriately, are often administered by untrained personnel; these include drug sellers who have no understanding of clean or aseptic techniques.
Another group active in this area is the International Network for the Rational Use of Drugs (INRUD). This organization, established in 1989, exists to promote rational drug use in developing countries. As well as producing training programs and publications, the group is undertaking research in a number of member countries, focused primarily on changing behavior to improve drug use. One of the most useful publications from this group is entitled Managing Drug Supply.Management Sciences in Health (1997) Managing Drug Supply: the selection, procurement, distribution, and use of pharmaceuticals. Kumarian Press. Connecticut. It covers most of the drug supply processes and is built up from research and experience in many developing countries. There a number of case studies described, many of which have general application for pharmacists working in developing countries.
In all the talk of rational drug use, the impact of the pharmaceutical industry cannot be ignored, with its many incentive schemes for doctors and pharmacy staff who dispense, advise or encourage use of particular products. These issues have been highlighted in a study of pharmaceutical sales representative (medreps) in Mumbai.Kamat VR, Nichter M (1997) Monitoring product movement: an ethnographic study of the pharmaceutical sales representatives in Bombay, India. In: Bennett S, McPake B, Mills A (eds) Private Health Providers in Developing Countries: serving the public interest? Zed Books, London & New Jersey. This was an observational study of medreps' interactions with pharmacies, covering a range of neighborhoods containing a wide mix of social classes. It is estimated that there are approximately 5000 medreps in Mumbai, roughly one for every four doctors in the city. Their salaries vary according to the employing organization, with the multinationals paying the highest salaries. The majority work to performance-related incentives. One medrep stated "There are a lot of companies, a lot of competition, a lot of pressure to sell, sell! Medicine in India is all about incentives to doctors to buy your medicines, incentives for us to sell more medicines. Even the patient wants an incentive to buy from this shop or that shop. Everywhere there is a scheme, that's business, that's medicine in India.'
The whole system is geared to winning over confidence and getting results in terms of sales; this is often achieved by means of gifts or invitations to symposia to persuade doctors to prescribe. With the launch of new and expensive antibiotics worldwide, the pressure to sell with little regard to the national essential drug lists or rational prescribing. One medrep noted that this was not a business for those overly concerned with morality. Such a statement is a sad reflection on parts of the pharmaceutical industry, which has an important role to play in the development of the health of a nation. It seems likely that short-term gains are made at the expense of increasing problems such as antibiotic resistance. The only alternatives are to ensure practitioners have the skills to appraise medicine promotion activities or to more stringently control pharmaceutical promotional activities.
Rational dispensing In situations where medicines are dispensed in small, twisted-up pieces of brown paper, the need for patient instruction takes on a whole new dimension. Medicines should be issued in appropriate containers and labelled. While the patient may be unable to read, the healthcare worker is probably literate. There are many tried-and-tested methods in the literature for using pictures and diagrams to aid patient compliance. Symbols such as a rising or setting sun to depict time of day have been used, particularly for treatments where regular medication is important, such as cases of tuberculosis or leprosy.Georgiev GD, McDougall C (1998) Blister calendar packs - potential for improvement in the supply and utilization of multiple drug therapy in leprosy control programs. International Journal of Leprosy and Other Mycobacterial Diseases. 56(4): 603-10.
Poverty may force patients to purchase one day's supply of medicines at a time, so it is important to ensure that antibiotics are used rationally and not just for one or two days' treatment. Often, poor patients need help from pharmacists to understand which are the most important medicines and to identify the items, typically vitamins, that can be missed to reduce the cost of the prescription to a more manageable level.
The essential drugs concept
The essential drugs list concept was developed from a report to the 28th World Health Assembly in 1975 as a scheme to extend the range of necessary drugs to populations who had poor access because of the existing supply structure. The plan was to develop essential drugs lists based on the local health needs of each country and to periodically update these with the advice of experts in public health, medicine, pharmacology, pharmacy and drug management. Resolution number 28.66 at the AssemblyWorld Health Organization (1985) Handbook of Resolutions and Decisions of the World Health Assembly and Executive Board, vol II 1973-1984. World Health Organization. Geneva. requested the WHO Director-General to implement the proposal, which led subsequently to an initial model list of essential drugs (WHO Technical Series no 615, 1977). This model list has undergone regular review at approximately two-yearly intervals and the current 14th list was published in March 2005.World Health Organization (2005) Essential Drugs WHO Model List (revised March 2005). The model list is perceived by the WHO to be an indication of a common core of medicines to cover most common needs. There is a strong emphasis on the need for national policy decisions and local ownership and implementation. In addition, a number of guiding principles for essential drug programs have emerged. The initial essential drugs list should be seen as a starting point. Generic names should be used where possible, with a cross-index to proprietary names. Concise and accurate drug information should accompany the list. Quality, including drug content stability and bioavailability, should be regularly assessed for essential drug supplies. Decisions should be made about the level of expertise required for drugs. Some countries make all the drugs on the list available to teaching hospitals and have smaller lists for district hospitals and a very short list for health centers. Success depends on the efficient supply, storage and distribution at every point. Research is sometimes required to settle the choice of a particular product in the local situation.
The model list of essential drugs
The model list of essential drugs is divided into 27 main sections, which are listed in English in alphabetical order. Recommendations are for drugs and presentations. For example, paracetamol appears as tablets in strengths of 100 mg to 500 mg, suppositories 100 mg and syrup 125 mg/5ml. Certain drugs are marked with an asterisk (previously a ៛), which denotes an example of a therapeutic group, and other drugs in the same group could serve as alternatives.
The lists are drawn up by consensus and generally are sensible choices. There are ongoing initiatives to define the evidence that supports the list. This demonstrates the areas where RCTs (randomized controlled trials) or systematic reviews exist and serves to highlight areas either where further research is needed or where similar drugs may exist which have better supporting evidence.
In addition to work to strengthen the evidence base, there is a proposal to encourage the development of Cochrane reviews for drugs that do not have systematic review evidence.