International Seminar on Access to Treatment for HIV in Developing Countries  5-6 June 1998 London, UK

Essential Drugs and the impact of choice
 
Dr. Richard Laing
Department of International Health
Boston University School of Public Health, USA

This paper aims to describe what are essential drugs and the programs designed to make them available. It will also address the issue of choice and essential drugs. The essence of making a choice is that one option is preferred over another. In every choice there are "winners" and "losers". Within poor countries the major challenge is to make the "least bad" choice because we are frequently faced with choosing between good choices. Within a poor country many different groups exist and choices may affect them in different ways.

There are likely to be multiple different health providers ranging from traditional, to public and private providers. When discussing choice there may be a public health perspective and a private perspective. For example, in some malarious countries chloroquin is available in both the public and private sectors while halofantrine, an expensive and marginally effective anti-malarial is available in the private though not public sector facilities. The public health authorities have chosen to register the drug on the basis of safety and efficacy to be available in the country but have also chosen not to provide the drug through public sector facilities.

The essential drug concept has existed for over 20 years (Quick et al 1997). At the 1978 Alma Ata meeting, essential drug provision was recognised as one of the eight key components of Primary Health Care. Essential drugs have been defined as those drugs which satisfy the health care needs of the majority of the population; they should therefore be available at all times in adequate amounts and in the appropriate dosage forms (WHO 1995).  This definition implies that drugs are chosen on the basis of safety, stability, efficacy in the particular environment and when these criteria are met, cost would be considered. Essential Drug Lists are lists of drugs which have been chosen by authorities to be those drugs which are considered so important that special efforts will be made to ensure that they are available and are used correctly. Many hospitals and health organisations in developed countries use such drug lists or formularies. They generally do not exclude the use of other safe and efficacious drugs but there are usually other procedures which must be followed before those drugs can be used.

Most developing countries have essential drug lists and these are used primarily in public sector programs though in some cases the lists are used to set tariff rates, import duties, manufacturing subsidies or markups for the private sector. Essential drug lists are used as the basis for procurement, distribution, training and quality assurance activities. In some countries the lists have been further refined by having drugs designated on the list for the different levels of health care system. This can assist in streamlining the storage and distribution of drugs.

The methods by which these lists are developed varies. In many cases, the starting point is the WHO Model Drug list which is then reviewed by an expert committee and a local adaptation is made. A more rational approach is to determine the epidemiological pattern of illness in the country, agree on standard treatment guidelines for those conditions and based on these two pieces of data generate an essential drug list. By using this approach it is easy to define the levels of the drug list as this would be determined by the quality of care available at different levels of the health system. The vast majority of drugs on essential drug lists are off patent and are thus available as generic drugs.

Drug procurement occurs in different ways; open tender, restricted tender, negotiated procurement and direct purchase. Open international tenders, in which a list of drug requirement is advertised and bids are solicited from all comers, have been found to be very inefficient taking more than a year usually. While the World Bank usually favours this approach their own analysis of purchases which they have funded has shown how inefficient and time consuming the method is. There are also grave risks related to the quality of the supplied drugs and the need and cost of an intensive quality assurance program. Restricted tenders, in which a list of pre-qualified suppliers are asked to bid, tend to provide the best balance of price and efficiency. A number of small (Eastern Caribbean States) and large (Indonesia) countries and large organisations (UNICEF, CIDA) use this method of procurement.

Negotiated procurement may appear an attractive option but the opportunities for corruption or the appearance of corruption make this a highly problematic approach. When drugs need to be procured rapidly purchasing through non profit suppliers frequently offers the best option for cost efficient procurement.

Organisations such as UNICEF, ECHO and IDA publish price lists regularly and these can be used to determine what the international prices of generic drugs are.  Very considerable variation exists in drug prices between brand and generic drugs and even within these categories for the same drugs.

Table 1: Comparative Drug Prices
 

Drug	Generic Price per 100	Brand Price per 100
Amoxycillin	$10 (Indonesia)  $22 (Philippines)	$40 (Indonesia)  $29 (Philippines)
Cotrimoxazole	$6 (Zimbabwe)  $3 (Pakistan)	$ 19 (Zimbabwe)  $5 (Pakistan)
Propranalol	$4 (Indonesia)  $7 (Australia)	$74 (Indonesia)  $7 (Australia)
Frusemide	$6 (Malaysia)  $9 (US)	$22 (Malaysia)  $24 (US)
Erythromycin	$5 (Sri Lanka)  $6 (UK)	$9 (Sri Lanka)  $21 (UK)

Source Balasubramaniam 1995

Expertise in procurement is frequently lacking in government systems and this often complicates drug procurement. In addition the process of analysing bids is complicated and frequently requires the use of computers which may not be available. However when efficient and transparent systems are in place drugs can be procured at prices which enable reasonable access to primary health care drug. If a country could afford to spend $2-3 per capita per year they could meet their basic drug supply needs!

Distribution of drugs remains a problem in many countries. Inherent problems exist where centralised government medical stores staff often earn government salaries of $25 to $50 per month and are expected to deal with drug orders worth millions of dollars. Also due to delays that exist due to transport and other problems large stocks tend to be held to prevent stock outs. This frequently leads to expiry of drugs. Central stores have worked in some countries where adequate expertise exists but in many cases a strong case can be made for privatising or closing these stores and having a central procurement purchasing unit which negotiates prices. Then individual facilities or district stores procure directly from the suppliers winning the tender awards. This is the system in use in the Eastern Caribbean and in Indonesia.

In emergencies and in some countries a pre-packed "kit" of 15-35 drugs and selected supplies are sent regularly to a facility. The kit content is uniform and is calculated based on the "average" utilisation of the facility, the "average" morbidity pattern and the "average" treatment practices. If such a prepacked "kit" system is used shortages and excesses inevitably occur. If an indent system is used in which orders for drugs are placed based on consumption, considerable management skills are needed at both the supplier and recipient ends of the supply system. Some NGO systems e.g. MEDS in Kenya, use such a system efficiently but in other situations problems occur. Private sector distributors may offer an efficient alternative to public sector distribution systems.

Rational use occurs if staff are able to diagnose, prescribe and dispense drugs which are always available and the patient understands how to take the medicines correctly. This implies that there are facilities available to take a history and examine patients in privacy with the required instruments. In addition the health provider needs to know how to take a history, examine, diagnose and prescribe correctly and have the time to perform these functions. When the correct drug is prescribed, it must be available and dispensed in such a way that the patient knows how to take the drug and is motivated to do so. It is a challenge to achieve this situation! There is considerable variation between and within countries as to how drugs are used. Considerable progress has occurred over the past decade in measuring and improving drug use. In 1997 a major conference was held in Chiang Mai Thailand at which this progress was reported. http://www.who.ch/dap-icium/index.html

The quality of drugs available in public systems depends more on procurement practices, storage and distribution than on laboratory testing. If drugs are procured on a regular basis from a reliable supplier, stored in well ventilated stores and distributed promptly using First In, First Out practices good quality drugs are likely to be available. Depending on a laboratory to assure quality is likely to be expensive and ineffectual. While counterfeit drugs are of concern particularly for brand name drugs, sub standard drugs due to a lack of manufacturing quality assurance are more common.

Financing of essential drugs has changed over the past decade with greater emphasis on cost recovery and the introduction of fee systems. This has occurred in different ways through the Bamako Initiative, cost sharing, cost recovery or revolving drug funds. The net effect has generally been to increase health costs to those least able to pay but in some cases improving drug availability. In general when fees are introduced there is a drop in utilisation unless there is an improvement in quality of services which often translates into improved drug availability. At present health services which promote the public good (e.g. immunisation or TB treatment) are usually free but this practice is being challenged.

Even before the HIV/AIDS epidemic countries were facing difficulties in maintaining or expanding essential drugs access due to structural adjustment programs, rapid urbanisation, emergence of resistant diseases, and the movement to downsize government. These factors have been complicated by the rising cost of medical technology, the increase in chronic diseases and particularly in Asia and Latin America the lengthening of life expectancy. Recent moves for health sector reform and decentralisation have aggravated these pressures.

The HIV/AIDS epidemic has dramatically increased demand for the treatment of common infections such as pneumonia, thrush, tuberculosis and septicaemia. In most developing countries the majority of HIV positive patients will present at health facilities for treatment of common conditions without being diagnosed as being HIV positive. Health workers would treat them ass any other patients. But the HIV status of the individual is likely to increase the frequency of infections and attendance at health facilities. In addition, rare conditions such as fungal meningitis, Kaposi sarcoma and pneumocystis pneumonia have increased demands for pharmaceuticals. This has occurred at a time when governments and people have been less able to meet these demands due to the broader impact of the AIDS epidemic on families, communities and countries.

It should be remembered that most HIV patients presenting at a health facility are not diagnosed as being HIV positive but are treated for their infection to which they frequently respond. However in many countries very treatable conditions such as TB, STDs, and fungal infections are not treated adequately because the needed drugs are not available. The treatment of STD's has been shown to be a cost effective means of reducing HIV transmission. Tuberculosis affects all members of the community and would have probably increased even without HIV due to poverty, overcrowding due to urbanisation and the emergence of resistant organisms. Effective means exist to treat tuberculosis but in many circumstances due to drug shortages or the absence of adequate supervision cure rates of less that 50% are common. Any choice which is made which reduces the availability of effective STD or TB drugs or common antibiotics or antifungals could have very serious effects on mortality and morbidity patterns in a country.

In December 1997 the WHO Expert committee approved zidovudine (AZT) to be on the latest model essential drug list for treating mothers to prevent perinatal transmission. I believe that this was a mistake as this drug is not cost effective when compared to STD treatment in preventing HIV transmission. The provision of this drug could lead to widespread misuse and the allocation of resources to buying this drug rather than the purchase of more cost effective essential drugs. For the individual woman who knows that she is HIV positive, is willing to forgo breast feeding and who can afford to buy the drug this treatment may be an option. But as a public health measure to reduce the incidence of HIV infections, this is not an option for a country which is not able to treat every STD or TB case fully!

Discussion:
Margaret Duckett,  12th World AIDS Conference Community Forum, mentioned that the lesson to be learned from TB and essential drugs is that political commitment is crucial. NGOs have an important role in finding political commitment for health issues from governments and multilateral organisations. For example, at the Pacific NGO Conference on AIDS in Fiji last year attended by NGOs from 23 Pacific countries, Ms. Duckett spoke on early intervention with therapies. The islanders had not previously seen treatment as an option because of cost limitations. But they began to consider HIV/AIDS as not necessarily a death sentence. They went on to discuss nutrition interventions which were well within the cost structure of the islands, and deal with co-infection with TB etc. Following that meeting, NGOs returned to their countries and put pressure on their governments to look at therapy options. As a result there is now a regional capacity-building programme for the Pacific looking at basic health infrastructural issues within existing budgets.

ARVs could be used as a push to get TB, essential drugs and other issues addressed. Because AIDS is seen as a priority concern and if there is a political push for action, this could strengthen other areas too.

WHO, The Use of Essential Drugs WHO Technical Report Series 850 World Health Organization Geneva 1995.

MSH, International Drug Price Indicator Guide 1996. Management Sciences for Health 1515 Wilson Boulevard, Suite 710,  Arlington VA 22209-2402 USA.

Balasubramaniam, K. Background Document Paper for the Asia Pacific Seminar on Implementing National Drug Policies. Sydney 1995.