The manual is divided into five chapters, which are designed to be used in different ways. Chapter II provides an explanation of the procedures used to develop the indicators. The core method for indicator development was a Delphi survey among a panel of 54 international experts, which obtained consensus on seven priorities for improving the pharmaceutical situation in the public and the private sectors in developing countries2. These were:
1. The establishment of appropriate legislation and regulation.
2. The selection of essential drugs and the registration process.
3. The importance of maintaining a significant drug allocation in the health budget and developing relevant financing policy in the public sector.
4. The improvement of procurement procedures in the public sector.
5. The strengthening of drug distribution and logistics in the public sector.
6. The establishment of a drug pricing policy in both public and private sectors.
7. The role of information and continuing education programmes to improve drug use.
2 Rainhorn JD, Brudon-Jakobowicz P, Reich MR. Priorities for pharmaceutical policies in developing countries: results of a Delphi survey. Bulletin of the World Health Organization, 1994, 72(2):257-264.
The indicators described in the manual have therefore been selected to evaluate the pharmaceutical situation in countries and to measure progress in the seven priority areas outlined above and in the four overall objectives of any national drug policy.
Chapter III presents the model lists of the indicators, with a brief description of the use of each list. The indicators are divided into four categories:
This first set of indicators is intended to provide data on the demographic, economic, health and pharmaceutical contexts in which drug policy is being implemented in a given country. The information is quantitative data, at a single point in time, which in most countries are readily available at the central level. The manual provides 31 background information indicators.
These indicators provide qualitative information to assess the pharmaceutical system's capacity to achieve its policy objectives. They are intended to check whether the key structures/systems/mechanisms necessary to implement a pharmaceutical policy exist in the country, for each of the seven key strategies noted above. These structural indicators are answered "yes" or "no" on the basis of information usually available at the central level. The manual provides 50 structural indicators.
These indicators provide quantitative information on the processes by which a national drug policy is implemented. They assess the degree to which activities necessary to attain the objectives are carried out and their progress over time. As with the structural indicators, the process indicators monitor the main activities under the same seven key strategies of drug policy. These process indicators are based on information available at the central level and/or obtained through surveys. The manual provides 38 process indicators.
These indicators measure the results achieved and the changes that can be attributed to the implementation of the national drug policy. They have been selected to assess the effects of implementing the policy on the overall NDP objectives: availability and affordability of essential drugs, drug quality and the rational use of drugs. These outcome indicators are based on information available at the central level and/or obtained through surveys. The manual provides 10 outcome indicators.
Although a national drug policy is ultimately intended to improve the overall health of a population, health impact indicators are not included in this manual for three main reasons: the multifactorial nature of health status, the consequent complex issues of causality associated with drug policy and health status, and the unresolved methodological difficulties of selecting reliable health indicators directly related to the use of drugs. The manual therefore recommends the use of indicators that measure the effectiveness and efficiency of key components of a national drug policy. It is assumed that these will have an impact on the availability and accessibility of essential drugs and on the quality and use of drugs - to the ultimate benefit of the health status of the population. In some circumstances, however, a manager may decide to use a few health status indicators if the data are relatively simple to collect and can be reliably related to drugs. However, such data should be interpreted with great care.
Chapter IV describes the various steps to be followed when applying indicators - from the selection of appropriate indicators, the collection of data, the training of staff and the calculation of the indicators, to the presentation of results. It includes a detailed discussion of the procedures for conducting surveys and for calculating the value of a basket of drugs. It also provides a number of suggestions on how to establish a monitoring system.
Chapter V presents each indicator on a single page; this chapter is intended to serve as the core reference section of the manual. Each indicator (except for the background indicators) is described with a brief statement that includes:
What is the content of the indicator?
What will this indicator measure?
Why is this indicator important?
What are the definitions of key terms?
What is the scope of the indicator?
How can the results be interpreted?
Sources and methods of data collection and indicator calculation3:
What are the main sources and methods of data collection?
How should the indicator be calculated?
3 The method of calculating the indicator is provided only for process and outcome indicators as structural indicators require a Yes/No response.
What are the main limitations of the indicator?
These detailed guidelines should be read carefully before applying the indicators. The information they contain can be adapted at country level, according to national targets and priorities. They can also be used for training data collectors. When new indicators are developed, similar pages should be prepared.
Annex 1 provides model data collection forms to be used for entering the information gathered either at central level or during the surveys. These forms can be directly copied or modified according to the country-specific context.
Annexes 2 and 3 of the manual provide respectively a glossary and a table of random numbers.