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Essential Drugs Monitor No. 028-029 (2000)
(2000; 36 pages) [French] [Spanish] View the PDF document
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View the documentEditorial - Antimicrobial resistance: A global threat
View the documentNewsdesk
View the documentAntimicrobial resistance
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View the documentNational drug policy
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Access

WHO and partners - taking the initiative to make a healthier world

There are several important and new international health initiatives involving WHO in global partnerships that are addressing some of the most pressing health problems of our time. Here we focus on some of them, beginning with WHO Director-General Gro Harlem Brundtland’s call for a concerted global effort to tackle diseases of poverty, made in October 2000.

Opening a meeting of 200 health and advocacy experts from 70 countries in Winterthur, Switzerland, Dr Brundtland said that although the world had long known that illness and poverty are closely linked, recent data show a much more devastating economic impact on developing country economies by a few infectious diseases, particularly malaria, HIV/AIDS and tuberculosis. But a number of effective health interventions exist that dramatically reduce mortality of these killers, she emphasised. “Quite simply, if we can take these interventions to scale - and by that I mean to a global scale - we have in our hands a concrete, result-oriented and measurable way of starting to reduce poverty.” Dr Brundtland said that a concerted global effort was needed that would involve a process, a road to follow, a framework for thinking and a set of values to underpin it all.

The forum followed recent announcements by the G8 leading industrial nations of targets to reduce the burden of malaria and tuberculosis by 50% within 10 years, and to reduce the spread of HIV/AIDS by 25% within the same time period. It also comes after the creation of a new policy framework by the European Commission intended to focus the European Union’s aid effort on reaching those targets.

ACCESSING VACCINES

Every year, nearly three million children die from diseases that could be prevented with currently available vaccines. The Global Alliance for Vaccines and Immunization (GAVI), formed in 1999, is a coalition of international organizations, with a mission to ensure that every child is protected against vaccine-preventable diseases. It wants to close the growing gap in the number of vaccines available to children in industrialised and developing countries. GAVI is working to:

• improve access to sustainable immunization services;

• expand the use of all existing cost-effective vaccines;

• accelerate the development and introduction of new vaccines;

• accelerate research and development efforts for vaccines and related products specifically needed by developing countries;

• make immunization coverage an integral part of the design and assessment of health systemsand international development efforts.

Since its inception the Alliance has received a great deal of interest from developing countries wanting to benefit from its work. On 20th September 2000 the Global Vaccine Fund, one of the financial tools used by the initiative, announced that it will be giving more than US$ 150 million worth of vaccines and funding over five years to improve immunization rates in Africa, Asia and Latin America. According to estimates more than 100,000 lives will be saved every year due to initial grants to 13 countries.

For further information check: www.who.int/vaccines/aboutus/gavi.htm

ROLLING BACK MALARIA

When she became WHO’s Director-General in 1998, Dr Gro Harlem Brundtland decided that malaria would be one of the Organization’s top priorities. She instigated Roll Back Malaria, a partnership involving a wide range of organizations at country, regional and global levels. The initiative’s goals include:

• support to endemic countries in developing their national health systems as a major strategy for controlling malaria;

• efforts to develop the broader health sector - all providers of health care to the community. This includes the public sector health system, civil society, NGOs and private health providers (including drug vendors and traditional healers) and others;

• encouragement to obtain the necessary human and financial investments for health system development.

In recent months Roll Back Malaria has received a major boost from the African summit meeting, which set the agenda for the continent’s efforts to beat the disease (see report on page 23).

Find out more at: www.rbm.who.int

ERADICATING POLIO

The Polio Eradication Initiative is on track to certify global eradication of the disease in 2005, with more than 190 countries and territories which will have interrupted poliovirus transmission by the end of the year 2000. This is an initiative that began in 1988, but it is entering an intensive final phase in order to mop up the final pockets of the virus.

In September 2000, a broad spectrum of leaders from business, governments, UN agencies and humanitarian groups, met at the United Nations in New York to galvanise the necessary financial resources and political will for the Initiative to ensure it meets the 2005 deadline. Over 250 participants pledged to help overcome the challenges: poliovirus was still circulating in up to 20 countries at the end of 2000, and US$ 450 million in new funding is needed to conquer the disease in those places. The 20 high-risk countries also present some of the most difficult logistical challenges to polio eradication, including populations that are geographically isolated and, in a handful of countries, living in the midst of severe civil conflict. Emphasising the urgency of the task, UN Secretary-General, Kofi Annan, said that “our race to reach the last child is a race against time. If we do not seize the chance now, the virus will regain its grip and the opportunity will elude us forever”.

A recent milestone

TheWHO Western Pacific Region was certified polio-free on 29 October 2000 by an independent panel of international public health experts. The Region includes 37 countries and areas ranging from tiny islands to China with a population of 1.2 billion people. The Regional Certification Commission on Poliomyelitis Eradication confirmed that no new cases of indigenous polio have been detected in the Western Pacific in the last three years, despite excellent surveillance for the virus - the major benchmark for certification.


A sight that will soon disappear? A polio victim learns to walk with callipers

Photo: WHO/PAHO/C.Gaggero

For more news on the Polio Eradication Initiative check: www.who.int/vaccines-polio/

STOPPING TB

Tuberculosis (TB) remains the largest killer of young people and adults in the world, and the problem is growing with the spread of HIV/AIDS and drug resistant strains of the disease. Stop TB is a global movement to accelerate social and political action to stop the unnecessary spread of TB around the world. Its mission is to ensure that every person with TB has all the necessary information and access to treatment and cure. Stop TB is a partnership working with public and private organizations from the local to the global level. Donors, research institutions, industry, international agencies, governments and NGOs are all playing a role in:

• linking TB control to health sector development;
• linking TB control to poverty alleviation;
• linking TB control to relevant aspects of socioeconomic development;
• promoting a more client-centered approach for wider coverage and compliance by partnering with community-based groups and others.

For further information check: www.stoptb.org/stop.tb.initiative/index. html#StopTB

One of Stop TB’s partners is the Global Alliance for TB Drug Development, a not-for-profit venture that is accelerating the discovery and development of new drugs to fight the disease by drawing upon best practice and resources from the public and private sectors (see page 19). The Alliance aims to fill a gap in TB drug development by using a lean research and development operating model that outsources projects to public or private partners. It will survey all TB drug development and selectively intervene when its actions will help move a drug candidate towards registration and use in therapy. In this way the Global Alliance will build a portfolio of projects with varying levels of funding, management and ownership.

Further information is available at: www.tballiance.org/home.cfm

IMPROVING INJECTION PRACTICES

Injections are predominantly needed for the treatment of severe diseases, mostly in hospital settings. Nevertheless, they are overused to administer medications in many countries because of an ingrained preference for injections among health workers and patients. In developing countries up to 50% of injections are administered with re-used syringes and needles. Such unsafe practices have been linked to the transmission of many pathogens between patients, including the hepatitis, HIV, Ebola and dengue fever viruses, and the malaria parasite.

The Safe Injection Global Network (SIGN) is a coalition of several public and private partners, including WHO, UNICEF, UNAIDS, NGOs, governments, universities, health workers and industry. Formed in Geneva in October 1999, it aims to unite the partners’ strengths and skills to work together on injection safety. Because there have been few integrated programmes that link community and health systems to promote safe injection use, SIGN is coordinating the launch of pilot projects in five countries. Results of the pilot projects’ evaluation should be available by 2002, and will enable the Network to identify and adopt successful strategies to counter unsafe injections.

Positive developments

SIGN’s annual meeting, held in Cairo in October 2000, showed that there has already been progress. For example, Pakistan has set up a national “SIGN” group, Tanzania has launched an education campaign for the public and health workers, and Burkina Faso has made significant improvements in injection safety recently. Participants reviewed the previous year’s activities, exchanged information and coordinated their advocacy and public awareness activities.

New technical guidelines on preventing infection from injections are being prepared, and a provisional document open for comments from the public will be available on the SIGN Web site: www.injectionsafety.org

New drugs needed to fight TB

More than 120 tuberculosis (TB) and public health experts, government and industry representatives, researchers and donors discussed TB drug development at a two-day workshop in Cape Town, South Africa, in February 2000. They met because of the urgent need for new drugs to ensure shorter TB treatments and to fight the increasing resistance to existing drugs. Basic TB drugs are already 20 - 30 years old, and few new drugs have been marketed in recent years.

TB experts, including WHO representatives, described the need for new TB drugs, researchers presented promising state-of-the-art research methods and findings, and drug companies explained the difficulties of drug development.

Mixed panels discussed the pharmaco-economics of the TB drug market, which is predicted to be US$ 700 million for treating 10,000,000 TB patients worldwide by 2008. The general opinion was that the size of this market should enable the development of at least one or two new drugs.

But some participants argued that there was a reluctance to develop drugs for a market where most of the people are poor, and where developing countries, institutional buyers and agencies working on TB demand low prices. A guaranteed off-take or market would be a strong incentive for manufacturers. There was a view that “corporate awareness” of the problem is increasing. Some companies have specific TB projects, others are considering “donating” the licensing rights of economically less viable second-line TB drugs to public bodies.

Not only money...

Many participants warned that low cost drugs or even donations are no guarantee of solving the TB problem, as managerial problems in many countries with mid level economies have meant that they have only achieved 50 - 60% cure rates. Poor patient adherence after the first two months of a six-month treatment period increases the risk of drug resistance.

The meeting discussed accelerating the development of new TB drugs to improve prevention and treatment of the disease. It also decided to develop a dedicated Global Alliance for TB Drug Development, with partners from academia, industry, major agencies, NGOs and donors worldwide.

From vision to fruition...

By October 2000 the participants’ push for a Global Alliance for TB Drug Development became a reality with its launch by WHO’s Director-General, Dr Gro Harlem Brundtland, at a meeting in Bangkok. And in February 2001 the Alliance opened its head office in Cape Town, South Africa, to coordinate and fund research in tuberculosis in developing countries.

The main aim is to find a major new treatment for TB by 2010, specifically a drug that is more effective so that it needs to be used for a shorter time, reducing the treatment period by at least 50 per cent, and so increasing adherence.

The Alliance will not to set up its own research institutions but will support existing projects, particularly in developing countries, and coordinate their findings. The first funding allocations will be made in April 2001.

For further information on the Global Alliance for TB Drug Development see page 22.

Beating malaria: leaders pledge action at historic summit

Malaria, a disease that is preventable, treatable and curable, kills one million people a year in Africa, with nine out of 10 cases occurring in the sub-Saharan region. Now, the first summit of African heads of state to focus on the disease has committed to intensive efforts to halve malaria mortality by 2010. Held in Abuja, Nigeria, in May 2000, the summit was attended by representatives of forty-four of the fifty malaria-affected countries in Africa. Also present were officials from United Nations agencies and major international donors. The meeting culminated in the signing of the Abuja Declaration and the Plan of Action in which the leaders resolved to initiate sustainable actions to strengthen health systems, so that by 2005:

• at least 60% of those suffering from malaria have prompt access to, and are able to correctly use, affordable and appropriate treatment within 24 hours of the onset of symptoms;

• at least 60% of those at risk of malaria, particularly children under five years of age and pregnant women, benefit from the most suitable combination of personal and community protective measures. These include insecticide treated mosquito nets and other accessible and affordable interventions, to prevent infection and suffering;

• at least 60% of all pregnant women who are at risk of malaria, especially those in their first pregnancies, have access to chemoprophylaxis or presumptive intermittent treatment.

Commitment, targets and resources

The Heads of State called upon all countries to undertake and continue health systems reforms that will promote community participation in rolling back malaria, and so increase sustainability. Diagnosis and treatment of malaria should be available as peripherally as possible (including home treatment), and accessible to the poorest.

Amongst other things the signatories to the Declaration pledged to: prevent re-emergence of malaria; provide reliable information on the disease to decision-makers at all levels; and to reduce or waive taxes and tariffs for mosquito nets, insecticides, anti-malarial drugs, and other goods and services needed for malaria control strategies.

Hidden costs reinforce urgency

The summit’s importance was reinforced by simultaneous publication of a report showing that the cost of malaria is substantially greater than economists previously estimated. According to the report,1 the disease results in a loss of economic growth of more than one percentage point per year.

Previous estimates have looked only at immediate short-term financial implications, such as the loss of labour and the costs of treatment and prevention.

But the longer-term costs are even more devastating to the country, the report argues.


The world’s biggest bednet was erected at Abuja as a symbol of the 225 African children who die every two and a half hours from malaria

Photo: WHO/RBM

Reference

1. Gallup JL, Sachs JD. Economics of malaria. Centre for International Development, Harvard University and the London School of Hygiene and Tropical Medicine. (Forthcoming). Executive summary available on the Web at: http://www.malaria.org/jdsachseconomic.html

NGO meetings on drug access

Following their successful conference on compulsory licensing held in Geneva in March 1999 (see EDM-27), Médecins Sans Frontières, Health Action International and the Consumer Project on Technology have organized two more meetings on one of today’s most topical issues. A conference entitled Increasing Access to Essential Drugs in a Globalised Economy - Working Towards Solutions, brought together 350 people from 50 countries in Amsterdam in November 1999. Health advocates and public health professionals from developing countries, representatives from domestic and international NGOs, the pharmaceutical industry, international organizations, national governments and academics all contributed their ideas on how to achieve access to essential medicines. After two days intensive work, the Conference culminated in the drawing up of the Amsterdam Statement, which includes a recommendation for the World Trade Organization to create a Standing Working Group on Access to Medicines. The Group would work within the WTO to consider the impact of trade policies on people in developing and least developed countries. It would provide a public health framework for the interpretation of key features of WTO agreements, and WHO and other international organizations would support the activities of the Working Group.

Among the many thought-provoking speeches, Dr Gro Harlem Brundtland, WHO’s Director-General, told delegates that “Making a difference requires the often painful work to build consensus among stakeholders that can move things in the right direction. Health products and health services are tradable. Health products such as pharmaceuticals are produced, marketed and sold across the globe - benefiting some but failing to reach too many. So the rules that regulate this trade are key”, she told delegates.

The Director-General listed WHO’s five key public health messages on international trade agreements and pharmaceuticals (see box).


Intense concentration on the faces of delegates at the Nairobi meeting, which tackled complex and controversial issues

Photo: Médecins Sans Frontières

Moving on to Africa

The NGO campaign on access to essential drugs gathered further momentum in Nairobi in June 2000. The Kenyan capital was the venue for the East Africa Access to Drugs Conference, where representatives from 21 countries met to devise a regional strategy.

The presentation of a new study showing that East Africans pay more than Europeans for life-saving drugs1 was one of the conference highlights. Among the many examples cited in the study is that of the antibiotic, ciprofloxacin, which was found to be twice as expensive in Uganda as in Norway. Another example is fluconazole, a treatment for AIDS-related meningitis. In Thailand, where generic competition has lowered prices, fluconazole costs only US$ 0.30. However, the same drug costs US$ 18.00 in Kenya, where it is patent protected.

Participants argued that the reasons medicines are expensive in East Africa include high tariffs, taxes and lack of generic competition as well as strong patent protection. Discussion focused on strategies to enact legal safeguards to remedy the current situation. Delegates heard that, within existing international trade rules, such safeguards include parallel importing (the right to shop around for the best prices of branded products) and compulsory licensing (granting limited production rights to generic producers).

Another report presented at the meeting on patent protection and medicines in Kenya and Uganda2, calls on governments to ensure these safeguards, and to include Ministry of Health representatives and health professionals when negotiating and adopting trade agreements.

References

1. Myhr K. Pharmaceutical pricing: law of the jungle. Amsterdam: Health Action International; 2000.

2. Boulet P. Patent protection of medicines in Kenya and Uganda. Geneva: Médecins Sans Frontières; 2000.

Further information on this series of meetings on access to essential drugs can be found at: www.haiweb.org

Five key messages from WHO on trade agreements and pharmaceuticals

First, patent protection is a necessary and effective incentive for research and development for needed new drugs. Essential drugs are a public good and not simply just another commodity. Patents must therefore be managed in an impartial way to benefit both the patent holders and the public.

Protectionism has never benefited public health. WHO supports governments to enact national legislation which can draw advantage from more open trade and a better regulated international system. And we support governments in incorporating the safeguards that have been built into the WTO TRIPS Agreement to protect the rights of the public.

Second, priority-setting for research and development in the pharmaceutical market is imperfect. There are also striking market failures when there is such desperate demand for products that are available - but not within reach of those in need. WHO has initiated, with other partners, innovative mechanisms to stimulate research and development in areas of high public health need, such as malaria and tuberculosis. Through its Medicines for Malaria Venture (MMV), the Global Alliance for Vaccines and Immunization (GAVI) and other initiatives, WHO is actively encouraging public sector financing for critical public health problems and neglected tropical diseases.

Third, WHO strongly supports development of mechanisms for preferential low prices for essential drugs in lower-income countries. Lower-income countries simply cannot be expected to pay the same price for essential drugs as the wealthier countries.

For governments, industry, and other stakeholders, there is a range of measures which might be used to achieve preferential pricing. But where there is an abuse of patent rights, where patented essential drugs are unavailable or where a national emergency exists, recourse to compulsory licensing is a legitimate measure consistent with the TRIPS Agreement.

Fourth, WHO supports implementation of the TRIPS Agreement to ensure prompt availability of generic drugs upon patent expiration. WHO has long promoted use of generic drugs of assured quality. Experience from countries with “generic-friendly” policies clearly demonstrates that the market competition created by these policies increases affordability of medicines, stimulates true innovation within the research-based industry, and encourages increased production efficiency by the generic industry.

Finally, trade agreements should not create barriers to trade. An important WTO principle is that technical regulations, standards and assessment procedures should be based on international standards, guides and recommendations. In the area of pharmaceuticals, WHO norms, standards and guidelines represent such international consensus. So we will actively promote these guidelines”.

Trade and access: Ugandan groups push for progress

The title of a workshop held in Kampala, Uganda, in February 2000, certainly conveyed the spirit of the event and the breadth of subjects addressed. “Advocacy and Campaign for Better Trade, Access to Essential Medicine and Promoting Rational Drug Use in Uganda “ was the result of collaboration between Uganda’s Consumers Protection Association, Action Aid Uganda, Health Action International and Médecins Sans Frontières.

Participants left this lively meeting in February 2000 determined to push for better trade policy, improved health services and increased consumer awareness of pharmaceutical issues. They agreed that access to drugs is a crosscutting issue, and that to be more effective they need to network and to create awareness of key issues using various media. Discussions also highlighted the importance of involvement in legislation review and formulation (particularly the draft bill on intellectual property rights), and participation in Uganda’s National Drug Policy review. Delegates were urged to campaign for improved infrastructure. Only when this is in place can important developments get underway, such as offering incentives to open drug outlets in poor rural areas.

For further information contact: R. Mutambi, Health and Gender Officer, Uganda Consumers Protection Association, Desai House, Plot 4, Parliament Avenue, PO Box 23783, Kampala, Uganda. Tel: + 256 41 234 002, Fax: + 234003, e-mail: ucpa@imul.com


This ambulance may be stuck in the mud in Uganda, but the description could not apply to campaigners pushing for improvements in the pharmaceutical sector

Photo: E.Paterson

Transforming drug supply in Dar es Salaam

KARIN WIEDENMAYER, DEO MTASIWA*

* Dr Karin Wiedenmayer is a pharmacist at the Swiss Tropical Institute, Socinstrasse 57, CH-4002, Basle, Switzerland, and Dr Deo Mtasiwa is the City Medical Officer of Health, Dar es Salaam, United Republic of Tanzania.

In 1990 the inadequacy of the pharmaceutical supply system in Dar es Salaam, commercial capital of the United Republic of Tanzania, was evident. There was chronic shortage of drugs at health facilities, supply was erratic as was Government funding, drug supply management was poor and use of drugs irrational. Despite a national policy to provide drugs free of charge, unofficially patients often had to pay for them. Drugs were purchased from the national Central Medical Stores, which was seen as inefficient, unreliable and poorly stocked. Drug quality was questionable and pharmacy premises were often unsuitable - hot, humid and cluttered with piles of drugs, some of them expired. Pharmacists tended to have low professional visibility and not to be involved in hospital committees. At a time when studies showed that patients equated availability of drugs with good quality of care1, a survey of user patterns in Dar es Salaam in 1990 reported that “the majority of patients complained that usually health facilities do not have drugs at all”.

Ten years on and the picture is very different. Dar es Salaam has a decentralized supply system with drug requisition at district level and local procurement from a newly restructured Medical Stores Department, financed by cost-sharing schemes and Government contributions, and based on the National Drug Policy. How was this achieved?

The structural and functional rehabilitation of Dar es Salaam’s Government health facilities, based on primary health care principles, started in 1990 with an intergovernmental agreement between Switzerland and Tanzania, with the Swiss Tropical Institute as the executing agency. The overall goal of the Dar es Salaam Urban Health Project, created at this time, was, and remains, to improve the health status of people in the Dar es Salaam region. As regards drug supply, the main aim was to improve resource administration at all levels of care, to create a reliable, efficient and sustainable drug management system, addressing both effective supply and rational use of essential drugs.

The Project serves three districts each with one district hospital, one or two health centres and a total of about 60 dispensaries in urban and semi-rural areas. In 1990 the population of Dar es Salaam was estimated at 1.5 million and the current population is approximately 2.5 million.

THE BACKGROUND: DRUG SUPPLY HISTORY IN DAR ES SALAAM

During the late 1960’s the number of health units in Tanzania increased considerably. This increase and the economic crisis of the late 1970’s led to a drug crisis in the public health sector. The lack of drugs was caused by: the acute shortage of foreign currency; an increase in access to health units; people’s greater awareness of modern medicines; and wastage of drugs due to poor planning, procurement, storage, distribution and transport, as well as irrational use.

In 1984, the Government created the Essential Drugs Programme to provide essential drugs to health facilities. The Programme introduced a prepacked drug kit system, which partially improved the situation for health centres and dispensaries, but not for the hospital sector. And the foreign financed and operated (by WHO, the Danish International Development Agency and the United Nations Children’s Fund) drug kit system did not help to improve management of the drug sector’s infrastructure.

In the early 1990s, when the Dar es Salaam Urban Health Project began, Tanzania started to restructure the economy towards a market-oriented environment. In the health sector this translated into the appearance of the private profit oriented sector and the introduction of user fees. In 1991, Tanzania formulated the National Drug Policy, which aimed to improve the whole pharmaceutical sector, and ensure a regular supply and rational use of essential drugs throughout the country. Later, the Health Sector Reform Action Plan 1996 - 1999 covered decentralised district-based drug supply and management, liberalised drug procurement, quality assurance, and equitable access and affordability of drugs. Here we highlight the main elements of the Health Project’s work and how against this background, it has transformed drug supply in the region.

BUYING DRUGS: WHICH, HOW MUCH AND WHERE?

Drug need quantification was initially done by morbidity and later by the consumption method. Drug selection was based on the National Essential Drug List. Drug kits for the Dar es Salaam Health Project were procured through restricted international tender. The kit system was centrally and externally organized, donor funded, supplied and imported from overseas, with little or no involvement or commitment from the recipient side. The project bypassed the national procurement system, the former Central Medical Stores being unreliable and inefficient. Later the organization was restructured and became an autonomous department within the Ministry of Health, under the responsibility of an external management team. In 1996, the new Medical Stores Department was operating efficiently, and it was considered appropriate to start using the existing local drug procurement infrastructure. The Department’s performance has been good overall, with an adequate product range, appropriate pricing, good quality and service, and sufficient provision for emergency situations. The Medical Stores Department has become the backbone of the Project’s supply system.

Drug kits are a good but not optimal solution. Because of their predetermined contents (selection and quantity) certain items were regularly out of stock, others were piling up and some even expired before redistribution. Quantification was therefore introduced at the health facilities and ordering is now done by decentralised requisition, i.e. the indent system has gradually replaced the push system with prepacked kits. A recent study on quality of care showed a significant improvement in drug availability. For example, the level of availability of four key drugs rose to 95% in 1998 compared with 64% in 1992.

DISTRIBUTION AND STORAGE

Initially drug kits were delivered monthly to the three district hospital pharmacies. From there, subsequent distribution to the hospitals, health centres and dispensaries was the responsibility of the district pharmacist, who supervised all peripheral distribution and monitoring. Delivery of drugs from the district stores to the hospital posed no problems as they were on the same premises. From the district hospitals the kits were distributed by vehicle to health centres and dispensaries on a monthly basis. Logistics were more problematic and deliveries were often delayed due to lack of transport, distance and road conditions. Health workers inspected the kits on arrival and documented receipt. All reorganized facilities had adequate and secure drug storage areas. Functioning cold chain equipment was also available, however, storage conditions in district stores were inadequate, with high temperatures and humidity affecting drug quality. Pileups and expired drugs that were not disposed of took up valuable space. Storage and inventory management was done haphazardly and did not follow good practice. Bin cards were unavailable, drug flow monitoring was difficult and documentation was poor.

By 2000, full decentralisation to the districts was complete, on structural, administrative and operational levels. Pharmacy premises have been reorganized, and hospital and district pharmacies have been physically separated. The separation of these premises considerably facilitates storage and inventory practice, as well as drug flow monitoring, which have consequently improved. District pharmacies are located within the newly constructed district medical offices, at a distance from the district hospitals.

KEEPING TRACK OF DRUGS: MONITORING AND DOCUMENTATION SYSTEM

The Project implemented a disease and drug monitoring system. Forms were developed for data collection on morbidity, drug consumption and kit distribution. However these were not used routinely, little evaluation was done, and little attempt made to give health facilities feedback on the data. Follow-up of drug consumption, distribution and performance monitoring was almost impossible. Drug flow could not be traced and accountability was difficult to enforce.

To improve this situation, a Pharmacy Plan of Operations and a Monitoring/Supervision Form were drawn up with all pharmacists. Operational objectives/activities, implementors, a timeframe, reporting channels and evaluation outputs were defined. Several documents and forms have been standardised, incorporated in the documentation system and used in all health facilities. Today, pharmacy management tools are available and are to varying degrees integrated into district and hospital operational plans. Documentation and monitoring of drug flow have improved.


Delivering drug kits to a dispensary in Dar es Salaam

Photo: K.Wiedenmayer

Security of drugs has always been a major concern. Not all drugs used to reach the intended patient. Pilferage and misappropriation was a significant problem that is hard to quantify. Despite there being sufficient drugs, some patients still complained about not receiving drugs or of occasionally being forced to pay. Internal monitoring also indicated that drugs, particularly antibiotics, were used by health staff for their own and their families’ treatment. However, increased supervision, professional ownership and accountability are improving the situation. Good inventory practice and drug monitoring have helped reduce pilferage. Each health facility has a Health Board, so involving the concerned community, which has also helped to reduce the problem.

QUALITY OF DRUGS

The main mechanism used for quality assurance of drugs is supplier selection and contract conditions with the Medical Stores Department. However, there is no formal reporting system for drug quality problems. Pharmacists and patients have to learn that they have a right and a duty to complain and follow-up on substandard drugs. Since 1997, operations and management at the National Pharmacy Board have been restructured in order to enforce drug regulation and quality assurance. More recently a new quality control laboratory has begun operating.

BEING IN CHARGE OF DRUGS: HUMAN RESOURCES AND TRAINING

At the beginning, the Project’s pharmacists generally had limited management skills - a major reason why the drug supply system functioned poorly. Today, each district has a district pharmacist operationally responsible for supervision of district health facilities, including district hospitals. Hospital pharmacists are more involved in the usual drug supply management activities, such as quantification, procurement, storage and distribution of drugs, as well as in some clinical activities within hospital committees and in drug information. However, pharmaceutical management capacity, particularly at district level, remains weak and should be strengthened. Decentralisation needs to be founded on capacity-building at local level.

With the focus on general district management in the Project’s early years, training for pharmacists did not receive the necessary attention. Human resources were neglected. Only much later were the district pharmacists and pharmacy technicians consulted, and invited to discussions and activities aimed to improve the drug supply system. Pharmacists have therefore mainly been responders to change rather than reformers themselves, even though policy implementation and operational planning in part depend on them.

Ten years later pharmacists are more involved, visible and in control. They have gained some self-confidence and a voice. Pharmacists are part of the hospital and district health management team. One pharmacist received training in the UK and all pharmacy staff participated in the training programme on rational prescribing (see below).

PROMOTING RATIONAL USE

All efforts put into a well functioning drug supply system can be futile if not followed by rational use of drugs by prescribers, dispensers and patients. From its inception, the Project has emphasised the importance of promoting rational drug use. In 1994, a programme was started to improve prescribing. A general quantitative drug use indicator study clarified the drug use situation. A concurrent qualitative study investigated motivations and underlying causes of prescribing habits and constraints within the system. Problems identified were overprescribing of antibiotics and injections, low availability of the national Standard Treatment Guidelines and incorrect prescribing according to norms. Based on these findings, interventions were selected and implemented to improve prescribing and quality of care. They include new Standard Treatment Guidelines, a Drug Information Manual, concurrent training, continuing education and supervision.

Since printed material alone has shown very little effect on prescribing practices, continuing education and supervision are necessary tools to assure sustained impact. Training sessions were conducted in all districts. Within five months a total of 328 Project prescribers (80%) in the three districts’ health facilities were trained. Unfortunately, despite the existence of approved tools and an agreed schedule, planned activities for continuing education and supervision are not yet conducted in a systematic way.

PAYING FOR DRUGS

After liberalisation of the health sector, a 1995 study identified that about 35% of the population used public health facilities as first contact. It was estimated that drug expenditure for essential drugs to all public health facilities of the City Council amounted to between US$ 0.7 million and US$ 1.1 million a year. This represents a yearly per capita drug expenditure of about US$ 1 to 1.5, which is in line with the generally accepted figure for essential drugs coverage in Africa3. A recent study concluded that drugs account for 40% of the total governmental and external health expenditures at Dar es Salaam level.

From 1992 until 1996, the City Council health facilities were supplied with essential drugs financed by an untied non-reimbursable allocation from the Swiss Government. In 1993, the Tanzanian Parliament allowed health services to be charged for. Cost sharing was introduced in Dar es Salaam public hospitals as in the rest of the country. A pilot Bamako-type project successfully implemented full cost-recovery of drugs in a few Dar es Salaam public dispensaries. The donor contribution gradually decreased and ended in 2000 with that phase of the Project. The budget gap has been filled by Tanzanian Government contributions and cost-sharing schemes.

Currently, all dispensaries and health centres operate a Bamako-type model of a drug revolving fund. Hospitals have introduced 50% to 80% cost-sharing and are supported with donor and, unfortunately irregular, Government contributions. User fees allowed donor contributions to gradually decrease. Government funding is still essential for hospitals, cost-sharing exemptions, staff costs etc., and needs to continue to complement user fees or future insurance schemes. The system is no longer dependent on donor funds. Long-term sustainability will require continued political will and Government funding, together with further improvements in drug supply management and accounting.

REVIEW OF EXPERIENCE

The objective of drug availability has been achieved with large investments and is one of the Project’s recognised accomplishments: visible, appreciated by patients and health workers, and valuable for the health care system. This has contributed greatly to the credibility of Dar es Salaam’s health care delivery system and the willingness of patients to share the cost of services.

Professionally defined quality of care relating to drugs (availability, prescribing practice, drug quality) has improved, whereas community perceived quality of services (dispensing practice, patient care, affordability) is less enthusiastic.

Achievements

• The Project has a functional drug supply system in place that assures continued availability of essential drugs at Dar es Salaam public health facilities. The drug supply system is decentralised and integrated as part of the general district management structure within a reformed health organization in the framework of health sector reform. Pharmacists have gained a voice, are more involved, better informed, more interested in their work and more present in the system.

• A purchase agreement with the Medical Stores Department constitutes the basis for local procurement of drugs. Drugs are of good quality since most are bought from a reputable non profit international procurement agency. Storage and inventory practice has improved. Monitoring and documentation tools are available and partially used. The indent system (drug requisition) has been introduced and kits are gradually being phased out.

• Drugs are financed by full drug cost-recovery at dispensaries and health centres, and by cost sharing at hospitals. Attendance rates have changed little, and exemption policies are in place. The budget gap is filled with Government and donor contributions. Financial sustainability seems possible provided there is continued political support, and improvements in management and accounting.

• A programme to promote rational drug use has been implemented, with Standard Treatment Guidelines and training of all prescribers in the districts.

Shortcomings

• Management capacity is still insufficient (storage, inventory management, documentation, monitoring of drug flow) particularly at district hospital level. Supervision needs to be strengthened and accountability reinforced.

• The human resource potential of pharmacy staff should be strengthened further (knowledge, skills, motivation and involvement). Quality of care in terms of attitude and patient care needs improvement.

• Rational drug use needs further promotion to improve prescribing behaviour (continuing training and supervision). Dispensing of drugs needs attention (training of drug dispensers). There is a great need to educate patients about drug use.

• Dialogue with the private sector is minimal.

Summary of development and achievements of Dar es Salaam Urban Health Project drug supply

Drug related activities

1990

2000

Selection

Appropriate

­

Procurement

Foreign kit import
(kits being phased out)

­ ­

Distribution

Deficient

­ ­

Storage

Poor

­ ­

Monitoring and documentation

Poor

­

Quality assurance& security

Poor

­

Promotion of rational drug use

Irrational use

­

Management

Poor

­

Training

None

­

Financing

Donor dependent
(reduction in dependence)

­ ­

Indicators

1990

2000

     

Availability

Poor

­ ­

Affordability

Free

*

Quality

Poor

­ ­

Rational use

Poor

­

Sustainability

No

­ ­

Quality of care

Poor

­

­­significant improvement
­ some improvement
* Cost-sharing/full cost recovery with little change in attendance rates, exemption policy

LESSONS LEARNT

The Dar es Salaam Urban Health Project’s drug supply experience was and is a learning process. An efficient, reliable and sustainable drug supply system depends on a variety of internal and external factors, and many components and actors determine its success. In retrospect we learnt the following lessons:

• Initially there was mainly an external materials injection, i.e. provision of drugs, which increased their short-term availability. Human resources, infrastructure such as pharmacy premises, and drug supply management skills were neglected. The provision of drugs was important, as a visible symbol of development, to gain people’s confidence and satisfy politicians, but it was not sustainable by itself.

• There was insufficient effort to involve, train, empower and motivate pharmacy staff. To have had pharmacy staffproficient in drug supply management from the beginning would have been extremely important for improving allegiance and cooperation, including early capacity-building and training. Emphasis needed to be placed on improving skills, increasing motivation and changing attitudes. Supportive supervision and monitoring as well as continued education are important tools.

• In order to follow-up, monitor and evaluate the quantitative and qualitative outcome of a high investment drug supply system over 10 years, a detailed baseline assessment with structure, process and outcome indicators should have been conducted at the beginning of the project. However only some rather randomly and informally collected information was available, which makes evidence-derived outcome measurement difficult.

• An efficient national Medical Stores Department has proven to be one of the main pillars for the drug supply system, providing drugs of good quality at affordable prices. Thus externally organized tendering and import from overseas could be replaced by local and professional bulk purchasing, clearing, distribution and storage of essential drugs.

• The Tanzanian National Drug Policy has been an important tool and framework for the development of a more efficient, equitable and sustainable drug supply system for the Dar es Salaam Project.


Training prescribers in rational use of drugs

Photo: K.Wiedenmayer

A TENTATIVE OUTLOOK

A drug supply system cannot be managed in an isolated way but needs to be considered as part of a larger socio-cultural, political and economic context and environment. It is also part of an organization, the supporting health system, from which it cannot be isolated. Each sub-system, such as drug supply, is a resource for and in interrelation with other sub-systems that have to be coordinated. For the new drug supply system, which developed over nearly 10 years, to be sustainable active consolidation is necessary. New structures and processes need to be kept alive, to be to implemented and to become established, to avoid falling back into old patterns. Active consolidation involves strengthening as well as internal and external support. This translates into careful monitoring, supportive supervision and continuing education. A key assumption is a stable and supportive political environment.

References

1. Kanji N, Kilima PM, Munishi GM. Quality of primary curative care in Dar es Salaam. Dar es Salaam: Dar es Salaam Urban Health Project; 1992.

2. Wyss K, Whiting D, Kilima P, Mc Larty DG, Mtasiwa D, Tanner M, Lorenz N. Utilisation of Government and private health services in Dar es Salaam. East African Medical Journal 1996; 73:357.

3. World Bank. Better health in Africa. Experiences and lessons learnt. Washington D.C.: World Bank; 1994.

Why do the poor pay more? Survey reveals disparity in drug prices

What effect is an increasingly globalised economy with tighter intellectual property systems having on developing countries’ efforts to make essential drugs available and affordable? A Consumers International and HAI survey in 1999 addressed this crucial question. The survey examined retail prices of 16 drugs in 36 countries - 10 advanced economies and 25 developing ones in Africa, Asia and Latin America, plus one from the Commonwealth of Independent States.

For the study the drugs were grouped into three categories according to their patent status: those still under patent in some countries; drugs whose patents will expire soon or have recently expired; and multisource drugs with several companies’ products available in all the countries. The drugs are all widely prescribed.

HAI partners and Consumers International members visited leading retail pharmacies in the 36 capital cities seeking information on the:

• availability and retail prices of the proprietary or brand name product of the 16 drugs;

• total number of products which include the originator’s brand, branded generics and generics of each of the 16 drugs available in the pharmacy;

• retail prices of the originator’s brand and the package size. Where several products of the drug were available, the prices of the next two best-selling products in addition to the proprietary brand or top-selling brand.

• prices of each package size in the national currency and then converted to US dollars.

In line with the results of other studies reported at the Nairobi Conference (see page 20), the survey found a very wide variation in retail prices in the countries surveyed. Among its most striking findings were that:

• in some developing countries retail prices were higher than in developed countries. This was the case for 15 out of 18 dosage forms of 11 drugs (those for which comparable data exist);

• proprietary brand forms of several of the multisource drugs surveyed are the only products available in many of the African countries. This is even though low priced generic equivalents are available in the world market, in countries not offering patent protection to pharmaceuticals;

• survey differences in the retail prices of proprietary drugs are much wider (range 1:16 - 1:59), than those for prices of generic equivalents (range 1:7 - 1:18);

• variations in the retail prices of multisource drugs in developing countries are much wider than the variations in the developed countries.

While the study did not analyse the sources of price variations, researchers suggest that the small difference in prices in the industrialised countries may in part be due to co-marketing arrangements by manufacturers, parallel importing, reference pricing and drug pricing policies. Other studies have shown that producer/importer prices vary between countries. And that import duties and distribution costs, pharmacy margins and local taxes also vary greatly between countries, but particularly from one developing country to another, so contributing to price differentials.

This wide range in proprietary drug prices in developing countries (1:4 - 1:59) is shown in the Table, with India having the lowest prices for six out of nine dosage forms. Consumers International and HAI argue that the Indian situation proves that competition is possible in the pharmaceuticals market and that it brings prices down. They say that India underscores the need for national policies on intellectual property systems with provisions to enable national firms to begin production of new drugs as quickly as possible. Indian firms could do this by reverse engineering (a practice for discovering the manufacturing process of a product starting from the finished product), as the country’s legislation did not provide patent protection for products, the authors state.

The report advocates that provisions for compulsory licensing and parallel imports should be in all national legislation on intellectual property rights as permitted by TRIPS. It states that this will help developing countries ensure regular access to good quality essential drugs at affordable prices.

For further information contact: Consumers International, 5th Floor Wisma WIM, 7 Jalan Abang Haji Openg, Taman Tun Dr. Ismail, 60000 Kuala Lumpur, Malaysia. Fax: + 60 3 772 61599, e-mail: consint@ciroap.org

Price comparison of 8 proprietary brand drugs in developing countries in the study

Generic name

Retail price of 100 units in US$

Ratio of lowest to highest price

 

Country

Price

Country

Price

 
 

Lowest

Highest

 

Acyclovir 200 mg

Togo

50

Indonesia

371

1:7

Acyclovir 800 mg1

India

94

South Africa

790

1:8

Atenolol 25 mg

India

03

Cameroon

53

1:18

Ciprofloxacin 500 mg

India

15

Mozambique

740

1:49

Diclofenac 50 mg

India

02

Argentina

118

1:59

Nifedipine 20 mg

India

03

Peru

96

1:32

Omeprazole 20 mg

Zambia

30

Brazil

477

1:11

Ranitidine 150 mg

India

02

South Africa

116

1:58

Zidovudine 100 mg

Pakistan

81

Argentina

316

1:4

 

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The WHO Essential Medicines and Health Products Information Portal was designed and is maintained by Human Info NGO. Last updated: June 25, 2014