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(2004; 24 pages) [French] [Spanish]
Country-specific data boost monitoring impact
WHO is pioneering a "hierarchical" approach to monitoring medicines policy impacts at country level. Level I consists of a structured national pharmaceutical situation questionnaire and Level II consists of a systematic survey of health facilities and pharmacies. By moving from the general to the particular, the potential for making effective medicines policy decisions is increased.
In 2003, 145 countries completed the national pharmaceutical situation questionnaire. The questionnaire can be rapidly and easily completed with information collected mostly from health ministries and departments, and medicines regulatory authorities. Analysis of the 2003 questionnaire results has indicated which countries would benefit most from increased WHO support for medicines activities.
Are countries implementing and updating their national medicines policies?
Questionnaire results showed that countries that have updated their national medicines policy (NMP) within the previous 10 years increased from 49 in 1999 to 57 in 2003, and that 16 countries succeeded in moving from a draft NMP document in 1999, to an official NMP in 2003. But nine countries have still not managed to turn their draft NMP documents into official NMP documents. Implementation is progressing, though - whereas only 40% of countries had developed an NMP implementation plan in 1999, this figure had increased to 52% by 2003.
How do we know if NMP implementation is effective? By monitoring levels of access to medicines, and how rationally those medicines are being procured, paid for and used. Questionnaire results have given both cause for optimism, and a strong indication that greater efforts must be made by countries and their international partners to enhance medicines impact for public health.
Where are we in terms of access?
WHO is tracking the number of countries where more than 50% of the population has previously been reported as having no regular access to medicines. Questionnaire results showed that 11 of the countries surveyed (seven of which are in Africa) that reported less than 50% regular access in 1999, now report more than 50% access. However, five countries reported regular access as having declined from more than 50% in 1999 to less than 50% in 2003.
A valuable resource for health professionals, policy-makers and researchers, this publication guides readers through the process of developing, implementing and monitoring a national drug policy
Strategies to improve access to medicines include: public financing; generic procurement; health insurance; and appropriate procurement and medicines management schemes. Data collected showed that Eritrea, Mongolia and Sudan have all increased per capita public medicines expenditure to more than US$ 2.00, while in Bahamas and Belize, the increase was substantially higher. Fourteen countries that had not stipulated generic substitution in private pharmacies by 1999 had done so by 2003, while Benin, Guinea, Rwanda and Samoa have adopted public health insurance schemes that reimburse medicines expenditure. A further 11 countries now limit public procurement to medicines on their essential medicines lists. These include three countries in the Americas and three countries in Africa.
Rational to what extent?
Standard treatment guidelines, essential medicines lists (EMLs) and medicines information centres, each contribute significantly to ensuring that medicines are used to best effect, both therapeutically and financially. In 1999, only 23 countries reported having updated their standard treatment guidelines within the previous five years, but by 2003 this figure had risen to 31. And while in 1999 only 35 countries reported having medicines information centres that provided medicines information both to prescribers and dispensers, a further seven countries had established such an information centre by 2003. Still, the figures suggest that greater effort needs to be put into encouraging many other countries to make available the guidance and information needed to support rational medicines use.
The figures for EML updating are more impressive: before 1999, 68 countries had updated their national EML within the previous five years. By 2003, this figure had risen to 80 countries.
Monitoring at the next level
Dr Daisy Carandang, a medical officer in the Department of Essential Drugs and Medicines Policy at WHO Headquarters, has responsibility for monitoring the impact of medicines policy. She describes how Level II monitoring results, "enable a national pharmaceutical situation to be compared across different years, areas of concern to be pinpointed and progress to be monitored."
She notes that, "the culture of monitoring is quickly gaining ground. Before it was difficult to motivate countries to do assessments and monitoring to find out whether people are accessing medicines, where they are accessing them, and if they aren't able to do so, why not. But countries increasingly understand the benefits of collecting such data, and the impetus it gives to health policy-makers and managers to undertake further NMP development and implementation."
Results can be both encouraging and discouraging, pointing to the difficulties involved in tackling medicines issues. In the Philippines, the cost of treatment in many public health facilities (PHF) is lower than that available in private retail outlets. However, only one-third of essential medicines are available at all in PHFs, and are frequently out of stock. Moreover, only 20% of the PHFs use standard treatment guidelines and not one health facility had an EML. The negative results might be attributable to decentralization, which appears to have slowed NMP implementation.
Monitoring progress in the Americas
In 2003, the WHO Regional Office for the Americas/Pan American Health Organization (AMRO/PAHO) organized a regional Level II/systematic survey training workshop in the Dominican Republic. Participant countries - Bolivia, Brazil, the Dominican Republic, El Salvador, Honduras, Nicaragua and Venezuela, and a representative of the Caribbean - developed an implementation plan for country pharmaceutical assessment and monitoring using Level II indicators.
Level I monitoring had already produced some interesting results. Analysis of the responses indicated areas in which WHO and countries need to focus greater effort. For example, only 11 of the 24 countries that responded indicated that they have a national strategy to combat antimicrobial resistance. And despite increasing use of medicinal plants, most of the countries do not yet include medicinal plants in their national medicines lists.
But questionnaire responses revealed some encouraging signs of progress too. Procurement of essential medicines only by the public sector had increased from 33% in 1999 to 50% in 2003. Several countries have increased their capacity to test the quality of medicines available on their markets. In 1999, only 54% of official laboratories were involved in testing quality control, but by 2003, this figure had risen to 70%.
However, the number of samples tested varies widely from country to country, demonstrating that there is still a need to build national capacity to run a systematic and self-financed programme of quality control testing as a key element of national medicines quality assurance.
Medical schools increasingly include essential medicines in their curricula. In 1999, only 25% of medical schools did so. But by 2003, the figure had grown to 41%. Drug information centres are more widely appreciated, and both generic prescription and generic substitution have increased since 1999.
Commented Dr Rosario d'Alessio, AMRO/PAHO's regional adviser for pharmaceuticals, "The assessments are vital not only for WHO identification of priorities for technical assistance, but also to enable systematic documentation of country-level progress and shifts in pharmaceutical sector priorities."
In the Islamic Republic of Iran, survey data revealed that prescribing of medicines is excessive and that the average number of medicines per prescription is high. The Ministry of Health has responded by establishing a rational use centre to promote and monitor rational use of medicines.
Monitoring has highlighted many other areas requiring improvement at national level. In Nigeria, assessment of facilities showed inadequate record-keeping, especially at primary health care level. Thus although 46% of key medicines were available at public health facilities, 7% of them had expired. By comparison, no expired medicines were found on the shelves in private drug outlets.
Results also sometimes indicate when national medicines targets are not being met. In Ethiopia, the national average for availability of key essential medicines in health facilities was 70%, 85% and 91% for public health facilities, regional medicines stores and private medicines retail outlets respectively. The figures are lower than the 100% target set out in the Health System Development Plan.
Priorities for 2004
WHO aims to further institutionalize medicines policy monitoring. It will also encourage use of monitoring results in the planning and implementation of national programmes, and of WHO medicines activities at country and regional levels.
Daisy Carandang - firstname.lastname@example.org;
WHO pharmaceutical situation data can be accessed at: http://mednet.who.int
A vision for essential medicines: WHO Medicines Strategy 2004-2007
"In many ways the challenges remain the same. But the knowledge about how to tackle them is improving. If this knowledge was to be combined with political will and enough resources to put policy into practice, WHO could without doubt achieve its medicines objectives," comments Dr Guitelle Baghdadi. As programme officer in essential drugs and medicines policy at WHO Headquarters, she coordinated a global process leading to the WHO Medicines Strategy 2004-2007.
Five key working groups composed of WHO staff in Headquarters, WHO regions and countries together reviewed medicines challenges and planned WHO responses for addressing them during 2004-2007. Dr Baghdadi continues, "The new strategy is coherent and easy to follow. We have also included some new areas that were not included in the previous strategy (WHO Medicines Strategy 2000-2003), reflecting the evolution of the environment in which we work. So access to essential medicines as a human right, the promotion of ethical practices in the pharmaceutical sector, the UN prequalification project, our work with the Global Fund, and the promotion of innovation based on public health needs, but especially for neglected diseases, are all now covered."
The new strategy retains the same four core objectives as the previous strategy (policy; access; quality and safety; and rational use), which are divided into components and expected outcomes, with a clear indication of what is needed in countries to turn WHO's vision for medicines into reality.
Progress in medicines work will continue to be tracked via a set of country progress indicators. The strategy can be accessed at: http://www.who.int/medicines/strategy/stmission.html.
The WHO Medicines Strategy 2004-2007 provides guiding principles for medicines activities at country, regional and global levels
Guitelle Baghdadi - email@example.com
Highlights of WHO work in traditional medicine in 2003
• A global survey of national policy on traditional medicine and regulation of herbal medicines was carried out to: obtain baseline information; assess the impact of the WHO Traditional Medicine Strategy to date; and identify the technical support needs of Member States. Analyses of the survey results and summaries have been prepared for easy consultation. This activity was supported by Japan's Nippon Foundation. Many other new partners are working with WHO to implement the strategy. In 2003, they included the Regional Government of Lombardy, Italy and the Prince of Wales's Foundation for Integrated Health.
• A series of regional workshops - supported by the Luxembourg Government - was held to familiarize national regulatory authorities with herbal medicine quality and safety issues, and requirements for registration. More than 60 countries from all six WHO regions participated in the workshops.
• WHO Guidelines on Good Agricultural and Collection Practices for Medicinal Plants were published to promote herbal medicine quality control through good agricultural practices and sustainable collection of medicinal plants.
• A WHO Consultation was held in Milan, Italy in December, to finalize the WHO Guidelines Medicine, with support from the Regional Government of Lombardy, Italy.
• Organized largely by the WHO African Regional Office, the first African Traditional Medicine Day was held in August, highlighting the role and value of traditional medicine in African culture.
• The third meeting of the WHO African Regional Expert Committee on Traditional Medicine was held in South Africa to: share country experience regarding traditional medicine R&D for treatment of HIV/AIDS, malaria, sickle cell anaemia, diabetes and hypertension; review draft guidelines for conducting clinical observation studies of use of traditional medicine; review draft guidelines on research methodology for evaluating the quality, safety and efficacy of traditional medicine in Africa; and review a regional framework on intellectual property rights for the protection and benefit-sharing of traditional medicine knowledge and the use of Africa's biodiversity.
His Royal Highness the Prince of Wales, President of the Prince of Wales's Foundation for Integrated Health meets Dr Xiaorui Zhang, team coordinator of the traditional medicine team at WHO Headquarters
PHOTO: George Bodmar
Xiaorui Zhang - firstname.lastname@example.org; email email@example.com for copies of the guideline documents mentioned.
Medicines advisers: maximizing medicines impact at country level
WHO medicines advisers are now working in 11 WHO country offices in Africa. Their task is to work with ministries of health and other stakeholders to plan, implement and monitor national medicines policies. Their ultimate goal is to improve access to and rational use of good-quality essential medicines, especially those for treating HIV/AIDS, tuberculosis and malaria.
During 2003, the medicines advisers supported their respective ministries of health in conducting baseline surveys of the pharmaceutical sector. Through these surveys, national capacity in monitoring and evaluation was greatly strengthened. Ogori Taylor, medicines adviser for Nigeria (see box), comments that, in the case of Nigeria, the pharmaceutical sector review was extensively referred to during revision of the national medicines policy.
In Ghana, Kenya and Uganda the baseline surveys were implemented with the support of the Regional Collaboration for Action on Essential Medicines in Africa. This is a programme that is jointly implemented by WHO and Health Action International Africa (a network of civil society organizations). The Collaboration provides intensified support to increase the coordination and participation of ministries of health, civil society and WHO in planning, implementing, and monitoring medicines policies and programmes.
As well as the baseline surveys, the Collaboration has supported a number of activities related to pricing and intellectual property issues. In 2003, the Collaboration and WHO medicines adviser for Uganda, Joseph Serutoke (see box), provided technical and financial support to the Uganda Coalition for Access to Essential Medicines, to host a national stakeholder workshop on "promoting public health through patent legislation".
Ogori Taylor is national programme officer/medicines adviser for Nigeria. In describing her role as medicines adviser, she comments, "The challenges for Nigeria's pharmaceutical sector are enormous, but I've been able to provide insight into medicines management and rational use problems, especially in terms of how they impact on patient care." She is heavily involved in access, quality and rational use issues, especially in relation to antimalarials and antiretrovirals.
Joseph Serutoke is WHO medicines adviser for Uganda. He is a registered pharmacist, qualified from Uganda's Makerere University Medical School and with postgraduate training in Health Systems Management and Development from Galilee College, Israel and Karolinska Institute, Sweden. Having worked in public health services, academia and the private sector on national medicines procurement and supply, regulation of the pharmacy profession, and health sector reform, he has accumulated a wealth of experience. Mr Serutoke comments that WHO medicines advisers are "involved on a daily basis in exciting and challenging work, seeking and implementing innovative approaches and strategies, with many others, to improve access, quality and rational use of medicines in our communities."
At WHO Headquarters, Gilles Forte - firstname.lastname@example.org;
Joseph Serutoke - email@example.com;
Ogori Taylor - firstname.lastname@example.org
Medicine prices - measuring the difference
"If you have a peptic ulcer and require a month's treatment, the originator brand version of ranitidine will cost you the equivalent of 50 days wages in Cameroon, almost 19 days of pay in Armenia and 13 days in the Philippines…If a partner and children get sick, then the medicines bill will rapidly devastate a household income."
With this truth, the new joint WHO-Health Action International (HAI) project manual Medicine Prices - a New Approach to Measurement was launched in 2003. The manual and accompanying workbook, which are available in Arabic, English, French and Spanish present a rigorous method for data collection and analysis, for use by governments, nongovernmental organizations and others interested in price information.
Applying the methodology at country level
In addition, a series of regional workshops on medicine prices is being organized. The first of these was held in October 2003 in Cairo. Those taking part were split into working groups focusing on data collection (via local pharmacies) and workbook data-entry exercises. The workshop was also a forum to share country-specific price issues.
The Medicine Prices manual, an essential tool for collecting medicine prices information.
Two members of the University of Kuwait's Faculty of Pharmacy attended the Cairo workshop, as preparation for a medicine pricing survey in Kuwait. Dr Douglas Ball, Associate Professor of Pharmacy Practice, commented, "Apart from making contact with other interested groups in the Arabic-speaking countries and learning about their particular concerns and situations, more specific benefits were realized. Hearing Dr Anita Kotwani's experience in Rajasthan, India, clarified the planning and administration necessary for successfully completing a pricing survey. This was complemented with the mock data collection and entry exercise, which provided insight into the practical difficulties that can be encountered. Overall, the Cairo workshop was a rewarding experience that helped to prepare us for conducting a medicine survey in Kuwait."
Participants generally conduct country medicine price surveys after attending an initial workshop and then attend a second workshop, to consider data analysis and interpretation issues. Lebanon has already initiated a price survey and other countries are set to follow suit in 2004.
Higher prices in poor countries
Andrew Creese, a health economist working on medicine pricing at WHO Headquarters comments, "What is clear is that manufacturers' pricing policies and government pricing policies often result in much higher prices in poor countries for the same drug, and the problem is made worse by poor people having to buy their own medicines. This mechanism doesn't apportion blame. But it does give a good methodology for comparing prices. It also reveals huge differences in the price break you can get with generics. It's an evidence-based means of empowering policy-makers."
Margaret Ewen, Director of Health Action International Europe and project coordinator, is categorical about the need for governments to act regarding medicine prices, "No longer can governments stand idle while the poor die because they cannot afford medicines. They must implement sound pricing policies. But to do this, careful diagnosis of prices is needed - that's where the WHO-HAI methodology is so useful. It can point the way to bringing medicine prices down."
The project is having other benefits. Ms Ewen continues, "The WHO-HAI project has not only produced a much-needed survey tool. It's also shown the synergistic value of WHO and civil society working together. We saw this during the development of the methodology and, importantly, when the surveys were undertaken. Most surveys are now undertaken as collaborations between civil society, government, WHO and academia."
Andrew Creese - email@example.com; Marg Ewen - firstname.lastname@example.org; email email@example.com - for a copy of the Medicine Prices manual.