Indicators for Monitoring National Drug Policies
(1999; 250 pages) [French] View the PDF document
Table of Contents
View the documentACKNOWLEDGEMENTS
Open this folder and view contentsCHAPTER I: Introduction
Open this folder and view contentsCHAPTER II: Development of the manual
Open this folder and view contentsCHAPTER III: Model lists of indicators
Open this folder and view contentsCHAPTER IV: Methodology for indicator calculation
Close this folderCHAPTER V: Detailed presentation of indicators
View the documentStructural indicators
View the documentProcess indicators
View the documentOutcome Indicators
Open this folder and view contentsANNEX 1: Data collection forms
View the documentANNEX 2: Glossary
View the documentANNEX 3: Table of random numbers
View the documentBACK COVER
 

Structural indicators

These 50 indicators provide qualitative information on the basic structures (including mechanisms and systems) that are considered necessary for implementing a national drug policy. The indicators check whether the basic structures under each key component are present in the country. They do not evaluate the functioning of these structures. For example, these indicators check whether quality control facilities exist, but not whether they work efficiently. The performance of the structures is assessed with the process indicators. The structural indicators monitor the main aspects of the seven key components of drug policy:

• The establishment of appropriate legislation and regulation.

• The selection of essential drugs and the registration process.

• The importance of maintaining a significant drug allocation in the health budget and developing relevant financing policy in the public sector.

• The improvement of procurement procedures in the public sector.

• The strengthening of drug distribution and logistics in the public sector.

• The establishment of a drug pricing policy in both public and private sectors.

• The role of information and continuing education programmes to improve drug use.

The structural indicators are answered "Yes" or "No" on the basis of information usually available at the central level, with a "Yes" response intended to be positive. Many negative responses would suggest that improvements are required in institutional capacity if the drug sector is to make significant progress towards achieving the overall policy objectives. For certain indicators and according to specific country needs, the monitoring unit can decide to also collect some written statements to understand the situation better or to quantify some indicators. The results of the structural indicators should be analysed together with the results of the process indicators and this in the framework of each of the seven key strategies/components. For instance, to better understand the situation and the progress accomplished in the implementation of a selection of essential drugs and registration of all the drugs (component no. 2), it is necessary to analyse together structural indicators ST12 to ST18 and process indicators PR8 to PR13. For further explanation, see page 20.

The structural indicators can be used for assisting national and international decision-makers in formulating strategies and designing interventions to improve the pharmaceutical sector. They can be used in comparing the implementation of pharmaceutical policies in different countries. Structural indicators can also be used for advocacy purposes for increasing government and donors' support to the drug sector.

Based on field experience with this manual, structural indicators can be collected in a few days if adequate access exists to key personnel in the pharmaceutical sector (public and private). A model summary form is provided in Annex 1 (Summary Form 2). In this chapter, each indicator is described as follows:

Definition

What is the content of the indicator?

Use:

What will this indicator measure?

Why is this indicator important?

Description:

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 calculation:

What are the main sources and methods of data collection?

How should the indicator be calculated?

Limitations:

What are the main limitations of the indicator?

Legislation and regulation

Indicator ST1:

Is there an official national drug policy document updated in the past 10 years?

Use: To assess the political commitment and the capability of the government to define the objectives of its pharmaceutical policy and the activities to be undertaken for achieving these national objectives. A national drug policy, which covers both the public and the private sectors, is an expression of goals for improving the supply and use of drugs, the priorities among these goals and the main strategies for attaining them. It provides a framework for action. A written statement of the national drug policy is important, not only as it provides a comprehensive and detailed framework for all pharmaceutical development, but also because it explicitly demonstrates the full commitment of the government and the ministry of health.

Description: The national drug policy document is an officially approved document which should be widely available. It should contain not only the key objectives of the national policy but also the main strategies proposed by the government for achieving these objectives. Even if key objectives remain the same for long periods of time (e.g. to improve accessibility, affordability, quality and rational use of drugs), the national drug policy document should be updated at regular intervals to take into account changes in the national and international pharmaceutical markets and to adapt strategies accordingly. A national drug policy document is different from a Drug Act. The formulation of a drug policy should be followed by enactment of appropriate legislation to provide a legal basis and make the policy enforceable.

Sources and methods of data collection: The national drug policy document should be available from the ministry of health and/or from the national drug authority. In certain cases, the national drug policy is not a separate document but is part of the national health policy document.

Limitations: Some countries (especially developed countries) have no official national drug policy document, although the main components of a policy are in place. In this case, the indicator will not be meaningful if taken in isolation. On the contrary, countries can have an updated document and yet still have a pharmaceutical sector where no major strategies are implemented for improving the situation.

Legislation and regulation

Indicator ST2:

Is there drug legislation updated in the past 10 years?

Use: To assess the existence of a legal framework for the pharmaceutical sector. Because of the characteristics of drugs which make them different from other goods, government should enact legislation to ensure drug safety, efficacy and quality and to regulate production, marketing and dispensing.

Description: Drug legislation describes the legal conditions under which pharmaceutical activities should be organized in line with the national drug policy. It covers activities such as drug importation, distribution, production, registration and sales practices. It should clarify what is permissible and what is not in the field of pharmaceuticals as well as laying down who may manufacture or import drugs, and who may prescribe them. It concerns both public and private sectors. Drug legislation is normally voted in by Parliament. The continuing evolution of national and international pharmaceutical markets should lead government to adapt its national drug policy to those changes and therefore to update the law regularly.

Sources and methods of data collection: The national drug legislation documents are usually available from the ministry of health and/or from the national drug authority.

Limitations: The existence of drug legislation does not imply that the law is fully implemented. Other structural indicators will give more information on the presence at national level of basic structures for ensuring the application of the law (see particularly ST4, ST5, ST7, ST8 and ST9). Some process indicators will give additional information on how the various structures function (see particularly PR1 to PR7).

Legislation and regulation

Indicator ST3:

Have regulations based on the drug legislation been issued?

Use: To assess if there are regulations governing the standards and procedures for carrying out the provisions of the law.

Description: Regulations form the second stage of legislative procedures and are specifically designed to provide the legal machinery to achieve the administrative and technical goals. Most pharmaceutical activities have to be covered by regulations. These describe, for example, what the obligations of the professionals are, their responsibilities and the penal sanctions if they do not respect them. Drug regulation has to be published just after or at the same time as drug legislation. Drug regulation and legislation cannot exist separately. Regulations apply to the same fields as drug legislation; this indicator should therefore be analysed together with ST2. The answer to the indicator is "Yes" if the main aspects of the legislation are covered in the regulations.

Sources and methods of data collection: Drug regulatory documents are usually available from the ministry of health and/or from the national drug authority.

Limitations: The existence of a drug regulation does not necessarily mean the regulation is fully implemented. Other structural indicators will give more information on the presence at national level of basic structures for ensuring the application of the regulation (see particularly ST4, ST5, ST7, ST8, ST9 and ST11). Some process indicators will give additional information on how the various structures function (see particularly PR1 to PR7).

Legislation and regulation

Indicator ST4:

Is there a drug regulatory authority whose mandate includes registration and inspection?

Use: To assess the capability of the government to set up a regulatory body able to control the circulation of drugs in the market and to ensure that legislation and regulation are respected. Pharmaceutical products should be safe, effective and of acceptable quality, and should correspond to health needs. This calls for adequate systems for registration and inspection at national level.

Description: Experience shows that a regulatory body is necessary to control the activities of the pharmaceutical sector. This body can be an autonomous technical body outside the ministry of health but with a clear mandate from the government (see, for example, the Food and Drug Administration in the United States of America, the Medicines Control Agency in the United Kingdom and l'Agence nationale du Médicament in France) or it can be a division in the ministry of health. However, in many developing countries such regulatory bodies are very weak, or even non-existent. WHO has produced guidelines for establishing small national drug regulatory authorities which can be adapted to the local context. Among the essential functions of such an authority, registration of drugs and inspection are of the utmost importance. Registration of drugs, based on well-established criteria, is a tool to improve control of what is or should be available on the national market. The drug inspection body should support and, where necessary, enforce adherence to the minimum standards in public as well as private institutions. In certain countries, the inspection body is separate from the drug unit in charge of registration, laws, etc.

Sources and methods of data collection: Official documents describing the mandate of the various bodies in charge of registration and inspection are normally available from the ministry of health and/or from the national drug authority.

Limitations: The existence of a drug regulatory authority does not necessarily mean that it works properly. Other structural indicators will give more information on the presence at national level of basic structures for registration and inspection activities (see particularly ST5, ST7, ST8, ST9, ST11, ST16, ST17 and ST18). Some process indicators will give additional information on how registration and inspection are performing (see particularly PR1 to PR7, PR12 and PR13).

Legislation and regulation

Indicator ST5:

Is there a licensing system to regulate the sale of drugs (wholesalers, pharmacists, retailers)?

Use: To assess if a system has been set up to control who imports, distributes and sells drugs at country level. Drugs are not like other goods. For instance, if badly procured, stored or used, they can become dangerous. This is why their distribution and sale should be regulated. In most countries, drugs can only be imported, distributed or sold by a person who has a licence granted by the drug authority.

Description: Licences are usually granted for a limited period of time, which will vary according to the type of licence and the administrative and technical capacity of the drug authority. The licensing system sets out provisions on who should import drugs, what qualifications people in the importing agency should have and who should dispense and sell drugs. Although experience suggests that drugs should be dispensed by professionals with pharmaceutical knowledge and the ability to advise patients, the development of primary health care in many countries has resulted in a greater role for nurses and village health workers in dispensing drugs in the public sector or in community pharmacies or private drug outlets. The licensing system should incorporate all these practices, including what drugs may be dispensed at different levels of the health care system and minimum standards on storage, inventory control, premises, record-keeping procedures, etc. It should include both public and private sectors.

Sources and methods of data collection: Official documents (regulations) stipulating the conditions for licensing and application forms should be available from the ministry of health and/or from the national drug authority.

Limitations: The effectiveness of the licensing system is dependent on the functioning of the inspection system. Additional information on this aspect of the pharmaceutical sector will be provided by other structural indicators (see particularly ST7 and ST8) and by some process indicators (see particularly PR1, PR2 and PR3).

Legislation and regulation

Indicator ST6:

Are pharmacists legally entitled to substitute generic drugs for brand name products?

Use: To assess government commitment to promoting one of the major strategies for making drugs more affordable to the patient - generic substitution - by providing a legal framework. Drugs marketed under generic name are usually less expensive than drugs marketed under brand name.

Description: Generic substitution is defined as the practice of substituting a product, whether marketed under a trade name or generic name, by an equivalent product, usually a cheaper one, containing the same active ingredient(s). In a country, generic substitution by all pharmacists or only by some of them (the ones in the public sector, or the ones in the private sector, etc.), or by other paramedical personnel (e.g. nurses), can be allowed through laws or regulations. In certain cases pharmacists can only substitute if the prescriber has indicated this. This indicator belongs to the series of indicators which make it possible to assess the legal aspects of a national drug policy (component no. 1); therefore the answer to the indicator is "Yes" only when the substitution right is included in the legislation or the regulations.

Sources and methods of data collection: The legal right to substitute is described in the drug legislation and regulations. These documents are normally available from the ministry of health and/or at the national drug authority.

Limitations: This indicator does not measure whether generic substitution is actually practised. In fact, even when generic substitution is legally permitted, it is not always practised unless accompanied by a pricing policy which provides incentives to the pharmacists and also by a large promotion campaign among the general public.

Legislation and regulation

Indicator ST7:

Are there legal provisions for penal sanctions?

Use: To assess government's commitment to compelling the pharmaceutical sector to comply with legislation and regulation.

Description: Legislation and regulation should specify the sanctions that will apply in the event of failure to conform with any provision of the law. Sanctions can be administrative and/or penal according to the level of the offence. Information about these sanctions should be disseminated in the pharmaceutical sector. The national drug regulatory authority or the ministry of health should control compliance with the law through their inspection activities.

Sources and methods of data collection: The list of penal sanctions should be available from both the ministry of health and the ministry of justice. The national pharmaceutical association should also be able to provide such documents.

Limitations: The existence of a list of penal sanctions does not necessarily mean that in practice sanctions are implemented. Some process indicators will give more information on the level of implementation of sanctions (see particularly process indicators PR3 and PR7).

Legislation and regulation

Indicator ST8:

Is there a checklist for carrying out inspections in different types of pharmaceutical establishments?

Use: To assess the effectiveness of the inspection system. The existence of simple guidelines on how to inspect various types of pharmaceutical establishments shows the commitment of the drug inspection body to perform its tasks and to improve its effectiveness.

Description: Effectiveness of an inspection can be improved by standardizing the procedures. Simple checklists should be developed at national level taking into account international procedures (GMP, etc.). These lists assist the inspectors in controlling the different types of establishments (including producers, wholesalers and retailers in public and private sectors) and in ensuring that regulations are fully implemented and enforced.

Sources and methods of data collection: Checklists for carrying out inspection activities are normally available from the ministry of health and/or from the national drug authority and/or in the inspection unit.

Limitations: Even if standardization of the inspection procedures is important, the key factors for improving the quality of the inspection system remain the level of training and the commitment of the inspectors. These can partially be measured by some process indicators (see particularly PR1 to PR7).

Legislation and regulation

Indicator ST9:

Are there any institutions within or outside the country where quality control is carried out?

Use: To assess if there is a reliable mechanism for ensuring that drugs produced, entering or circulating in a country are of acceptable quality. This calls not only for adequate regulations, good manufacturing practices, an effective drug registration and inspection system but also for a quality control system capable of analysing and carrying out regular checks of all drugs used within the country.

Description: Quality control can be done both within and outside the country. Many developing countries have set up small national quality control laboratories which test locally produced drugs as well as imported drugs. If there is no reliable control laboratory, drugs can also be tested outside the country by an independent laboratory on a regular basis. The absence of any institution within or outside the country where quality control is carried out suggests that drugs are sold without any guarantee of quality and/or efficacy for the patients. However, quality control is not the only way to ensure the quality of drugs. For example, a well-organized registration system and the systematic use of international documents such as GMP certificates and certification schemes concerning the quality of drugs are also important ways of ensuring drug quality in a country.

Sources and methods of data collection: If a national quality control laboratory exists, it should be visited and information should be obtained on the type of quality control performed. If there is no national quality control laboratory, information on the types of controls carried out outside the country should be available from the ministry of health and/or the national drug authority.

Limitations: This indicator should be analysed with caution and will in some cases need to be accompanied by written statements on what kind of quality assurance system is in place. Indeed, in certain cases there is a quality control laboratory, but it does not function properly or only for certain drugs (e.g. drugs from the public sector). In other cases, there is no laboratory, but the other aspects of the quality assurance system are functioning very well.

Legislation and regulation

Indicator ST10:

Is the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce used systematically?

Use: To assess if the government uses all available tools to ensure drug quality. Government has the responsibility for monitoring and controlling the pharmaceutical substances it allows to be imported. The WHO certification scheme can play an important role in this endeavour.

Description: The WHO certification scheme can be used for imported drugs to ensure that they are of good quality. Under the certification scheme, the exporting country must certify that the drug is registered and authorized for sale in that country. The competent authority of the exporting country must also certify that the manufacturer's facilities are inspected regularly. The scheme also provides the product information which is issued in the exporting countries. It does not provide assurance on the quality of each batch. The scheme can be used for all imported products, both for the public and the private sectors.

Sources and methods of data collection: Information on the use of the WHO scheme can be obtained from interviews with the main importers, including the central procurement unit. In certain cases, the scheme will not be used by all the importers and this can be noted in the final report.

Limitations: The validity of the WHO certification scheme depends on the quality of the inspection system of the exporting country, as the inspectors are the ones assessing if GMP are followed by the producers. It depends also on the seriousness of the national drug authority in completing the certificate.

Legislation and regulation

Indicator ST11:

Are there controls on drug promotion based on regulations and consistent with the WHO Ethical Criteria for Medicinal Drug Promotion?

Use: To assess if the tools for better control of drug promotion are in place. Controlling the marketing, presentations and types of medicines can play an important role in preventing irrational use of drugs. It is the specific responsibility of government to develop measures to ensure that promotional practices involving drugs are in keeping with acceptable ethical standards.

Description: The controls on drug promotion and advertising can be of various types: drug promotion can be controlled before the advertisement or the promotion is launched or it can be done retrospectively on the basis of a set of rules and regulations. If drug registration is functioning properly, the guiding principle is that information and promotional activities should be consistent with the terms and conditions of product approval. To enforce adherence to ethical criteria requires their inclusion in legislation and provisions for sanctions. To assess rules and regulations drawn up at national level, the ethical criteria for medicinal drug promotion, developed by WHO with an international group of experts, can be used. These criteria constitute general principles for ethical standards which could be adapted by governments. They apply to prescription and non-prescription drugs ("over the counter drugs") and to all informational and persuasive activities by manufacturers and distributors, the effect of which is to induce the prescription, supply, purchase and/or use of drugs (promotion, advertisements, medical representatives, etc.). Among other criteria, promotion should be reliable, accurate, truthful, informative, balanced, up to date and in good taste.

Sources and methods of data collection: Information for the indicator will be available through review of documents (laws, regulations, etc.) to assess if regulations exist and through interviews with officials from the ministry of health and/or national drug authority to assess if controls are implemented.

Essential drug selection and drug registration

Indicator ST12:

Is there a national essential drugs list (EDL)/formulary using INN officially adopted and distributed countrywide?

Use: To assess the existence of a key element of an efficient pharmaceutical supply system: the selection of drugs to meet the health needs of the population. Evidence suggests that drug selection and prioritization bring more advantages than disadvantages to public health. By focusing on fewer drugs, the efficiency of the procurement process can be improved, distribution is simplified, and provision of objective information is facilitated.

Description: A national essential drugs list is defined as a booklet containing all the drugs approved for use in the public sector. In certain cases, there is one booklet which contains all the drugs agreed for all health care levels. In others, there are lists/booklets by level of use (tertiary, secondary, primary care). The booklet may contain additional information on each of the drugs. In certain countries the essential drugs lists may also apply to the private sector. For the indicator to be positive, the list should be officially approved by the ministry of health, should be written using INN and distributed widely in the public sector. The international nonproprietary name (INN) is the shortened scientific name based on the active ingredient; WHO is responsible for assigning INN to pharmaceutical substances.

Sources and methods of data collection: The national essential drugs list/formulary is usually available from the ministry of health. Information on the use of INN and on the distribution of the list can be obtained from interviews with health personnel.

Essential drug selection and drug registration

Indicator ST13:

Is there an official drug committee whose duties include updating the national essential drugs list (EDL)?

Use: To assess if there is a formal mechanism in place to develop, adapt and update the national essential drugs list. To be well accepted by prescribers and the public the list should be revised regularly. A committee which will systematically collect information on new drugs, real health needs and demands from consumers will be an important tool in securing adherence to the list.

Description: The committee for updating the national list of essential drugs can be a specific committee set up for this purpose or it can be a committee with other functions, such as development of standard treatment guidelines, quantification of drug needs, etc. The members of the committee should be officially appointed and include experts in clinical medicine, pharmacology, pharmacy and, where appropriate, nursing.

Sources and methods of data collection: The official documents setting up the functions of the committee and its composition are usually available from the ministry of health and/or from the national drug authority. These functions are often included in the drug regulations.

Limitations: The indicator does not measure the functioning of the committee. To provide useful information, it should be used in conjunction with structural indicators ST12 and ST14.

Essential drug selection and drug registration

Indicator ST14:

Has the national essential drugs list (EDL)/formulary been updated and distributed countrywide in the past five years?

Use: To assess the continuous adaptation of the national essential drugs list to pharmacological, therapeutic and other changes. The list, which is often the heart of national drug policy and strategies for rational drug use, should be revised regularly in order to respond to evolving needs and pharmaceutical advances and to be well accepted by prescribers.

Description: This indicator should be read in conjunction with structural indicators ST12 and ST13. If the answer to ST12 is "No", the response to this indicator will also be "No". If the answer to ST12 is "Yes", the additional information given by this indicator relates to the date of the last revision of the list. It is suggested, in WHO documents, that the list be revised every two years; however, in a number of countries this will be difficult to achieve. Five years seems a more realistic target, particularly in the least developed countries.

Sources and methods of data collection: Information on the date of the last revision is usually available from the ministry of health and is normally given on the document containing the national essential drugs list.

Essential drug selection and drug registration

Indicator ST15:

Do drug donations comply with the national essential drugs list (EDL)?

Use: To assess the capacity of the government to ensure that organizations which donate drugs comply with the national drug policy. Drug donations often constitute a problem as they do not always match needs and in certain cases may even conflict with overall government drug policies. In many situations, donations containing only the most essential drugs included in national drugs lists would be the most appropriate.

Description: The indicator should: (1) assess the existence of guidelines/regulations produced by the government which require that drug donations should consist of drugs included in the national essential drugs list; (2) check if the guidelines are respected for the main drug donations.

Sources and methods of data collection: The information can be obtained through review of legal or administrative documents available from the ministry of health and through interviewing key staff at the ministry, in the central procurement unit and in the main NGOs and international organizations receiving or sending drug donations. If guidelines do not exist, it will still be feasible, through interviews, to assess if major drug donations comply with the national essential drugs list.

Essential drug selection and drug registration

Indicator ST16:

Are there formal procedures for registering drugs?

Use: To assess if a proper registration procedure exists for drugs on the market. Drug registration is mandatory to ensure that drugs available on the market are of acceptable quality, safety and efficacy. To be effective this registration should follow a set of procedures.

Description: The formal procedures for registering drugs can differ from one country to another but would most likely include the following elements: (i) well-established criteria (clauses on INN, cost, need, etc.) reflected in the regulations; (ii) provision in the legislation for temporary registration of drugs obtained by tender; (iii) availability of an application form for registration which should be completed by the manufacturer/importer and signed by the national drug regulatory authority; (iv) a list of the required documentation which should be submitted with each application; (v) a mechanism to assess the application form and a formal notice of approval or rejection.

Sources and methods of data collection: The information will be available from the national drug authority and can be obtained through interviews and reviewing various drug registration documents.

Essential drug selection and drug registration

Indicator ST17:

Is there a drug registration committee?

Use: To assess if one of the mechanisms for proper drug registration is in place. In most well-organized registration systems, a committee is used to assist the national drug authority to assess the documentation accompanying each application for registration and prepare a brief appraisal for the ministry of health.

Description: The drug registration committee is, in general, an advisory committee to the national drug regulatory agency on matters relating to registration of drugs and cancellation or suspension of such registration, based on evaluation of the quality, safety, efficacy and usefulness of the products. It should consist of people with the widest possible education, knowledge and experience in the field of pharmacy, medicine and pharmacology, such as pharmaceutical chemistry, pharmaceutical formulation, internal medicine, toxicology and clinical pharmacology. It should be granted the authority to request more information or documentation if necessary, to ensure the quality, efficacy and safety of the product and to seek the assistance of specialists in the various medical or pharmaceutical disciplines if needed.

Sources and methods of data collection: Information on the drug registration committee is available from the ministry of health and/or from the national drug authority.

Essential drug selection and drug registration

Indicator ST18:

Is drug registration renewal required at least every five years?

Use: To assess if there is a mechanism to regularly review the drugs which are allowed on the market. In most countries, manufacturers are requested to renew the registration of their drugs at regular intervals to ensure that the national drug authority is aware of the drugs available on the market (some may not be marketed any more). In the case of application for renewal of registration of a drug, the manufacturer/importer should be allowed to refer to previously submitted documentation and information on the product.

Description: The provision about the period of time for which a drug is registered should be explicitly stipulated in the law/regulations.

Sources and methods of data collection: The information will be available from the national drug authority and can be obtained through interviews and reviews of various legal and administrative documents (regulations, registration procedures, etc.).

Limitations: In certain cases, the provision exists in the law/regulations but is not applied.

Drug allocation in the health budget/public sector financing policy

Indicator ST19:

Is the public drug budget spent per year more than 20% of the ministry of health operating budget spent per year for the last three years?

Use: To assess the commitment of the government to support the financing of drugs, with the ultimate objective of greater accessibility and equitable supply. For many years, the drug budget represented an important share of the ministry of health budget; however, many countries faced with the economic crisis had to reduce the share of the drug budget. It is still considered important to secure a contribution from the government (for instance through a percentage of the ministry of health budget) in order to ensure that the poorest are not deprived of drug treatments. The figure of 20% is based on review of country experiences; this figure can be adapted at national level according to the policy and targets of the country.

Description: Public drug budget is defined as the total amount of money spent on pharmaceutical products by the government through the ministry of health, other ministries and hospitals. Public finance is understood as general government revenues and compulsory health insurance (sometimes known as social insurance) that is either publicly managed or heavily regulated by governments (see footnote 7, page 18). The operating budget of the ministry of health includes all expenditures which are not investments (i.e. salaries, drugs, national programmes, etc.). For this indicator, only the drug budget and the operating budget really spent should be taken into account.

Sources and methods of data collection: The information is available, in most countries, in documents published by the ministry of finance and through interviews with government officials, including the procurement unit staff. The estimate must include drug budgets from all ministries. The indicator is obtained by dividing the sum of the drug expenditure for the last three years by the sum of the ministry of health operating budget spent for the same years, as below:

The answer to the indicator is "Yes" if the figure obtained is above 20%.

Drug allocation in the health budget/public sector financing policy

Indicator ST20:

Is the public drug budget spent per capita per year more than US$ 1.00 per year for the last three years?

Use: To assess the commitment of the government to support the financing of drugs, with the ultimate objective of greater accessibility and equitable supply. One US dollar per year has frequently been given as the lowest possible amount for minimum coverage of the population with essential drugs. It is still considered important to secure a contribution from the government in order to ensure that the poorest are not deprived of drug treatments.

Description: Public drug budget is the same figure as in the previous indicator and is defined as the total amount of money spent on pharmaceutical products by the government through the ministry of health, other ministries and hospitals. Public finance is understood as general government revenues and compulsory health insurance (sometimes known as social insurance) that is either publicly managed or heavily regulated by governments (see footnote 7, page 18). In countries where the annual increase in population is high, it is important to get accurate annual estimates of this population.

Sources and methods of data collection: The information is available, in most countries, in documents published by the ministry of finance and through interviews with government officials, including the procurement unit. The estimate must include budgets from all ministries. An estimate of the population for each year can be obtained from the planning office. The indicator is obtained by dividing the sum of the drug expenditure for the last three years by the sum of the population for the same years.

Drug allocation in the health budget/public sector financing policy

Indicator ST21:

Is the public drug budget spent for national hospitals less than 40% of the total public drug budget spent for the last three years?

Use: To assess the commitment of the government to a primary health care policy. Since the beginning of the 1980s, most countries have adopted a primary health care policy, which entails a reallocation of resources towards primary and secondary levels. For drugs, this means that the main part of the budget should go to primary health care institutions, rather than to national hospitals. In most countries it has been shown that it is common for 40% of the total drug budget to be directed to national hospitals - a proportion which is too high.

Description: Public drug budget is defined as the total amount of money spent on pharmaceutical products by the government through the ministry of health, other ministries and hospitals. Public finance is understood as general government revenues and compulsory health insurance (sometimes known as social insurance) that is either publicly managed or heavily regulated by governments (see footnote 7, page 18). The operating budget of the ministry of health includes all expenditures which are not investments (i.e. salaries, drugs, national programmes, etc.). National hospitals are the main referral hospitals, normally situated in the capital city and in the main towns. In certain cases, the national hospitals have a separate budget. This separate budget should be added to the public drug budget as long as it is also funded from government revenues.

Sources and methods of data collection: The information is available, in most countries, in documents published by the ministry of finance and through interviews with government officials. The estimates for public drug expenditure and for the national hospitals' drug expenditure must include expenditures from all ministries. The indicator is then obtained by dividing the sum of public drug expenditure for the national hospitals by the total public drug expenditure, and multiplying the result by 100.

Drug allocation in the health budget/public sector financing policy

Indicator ST22:

Has the public drug budget spent per capita increased in the last three years?

Use: To assess the commitment of the government to support the financing of drugs with the ultimate objective of greater accessibility and equitable supply. The government drug budget, which is often very limited, should not decrease in real terms. With a growing population it should, on the contrary, increase over the years in order to cover at least the most vulnerable groups.

Description: Public drug budget is defined as the total amount of money spent on pharmaceutical products by the government through the ministry of health, other ministries and hospitals. Public finance is understood as general government revenues and compulsory health insurance (sometimes known as social insurance) that is either publicly managed or heavily regulated by governments (see footnote 7, page 18). It should take into account the inflation rate (real terms) in order to obtain comparable figures for the last three years.

Sources and methods of data collection: The information is available in most countries in documents published by the ministry of finance and through interviews with government officials, including the procurement unit. Data on population can be obtained from the planning office. The following data are needed: public drug expenditures for the current year and the previous three years (the estimate must include expenditure from all public sources at central and local levels); population for the current year and the previous three years; and the inflation rate for the current year and the previous three years. Donations should be included if they have been accounted for in the budget. It happens that drug donations are valued at a very high price (for instance, pharmaceutical companies often give drugs under brand name, and the price of these drugs may be much higher than existing alternatives on the market). In this case, it is desirable to calculate the value of the donation at the average price of the same product on the international market.

Drug allocation in the health budget/public sector financing policy

Indicator ST23:

Are there any financing systems in addition to the public drug budget that contribute to the provision of drugs in the public sector?

Use: To assess if there are other mechanisms to increase the provision of drugs in the public sector and therefore to increase coverage. Many countries have developed financing systems aimed at collecting additional revenues at the health facility level in order to buy drugs and cover a limited number of expenditures (cf. Bamako Initiative). In general, these systems allow patients to have access to essential drugs at a lower price than in the private sector. However, these schemes should not be the only source of finance for health care.

Description: Financing systems are defined as any systems which, in the public sector, contribute to the provision of drugs by charging patients or the community. These systems can include out-of-pocket payments (e.g. user charges) or voluntary health insurance (see footnote 7, page 18). They can cover all or part of the costs of the drugs. The indicator should be analysed in conjunction with indicators ST19 and ST20.

Sources and methods of data collection: The information can be easily obtained through interviews at the ministry of health.

Public sector procurement procedures

Indicator ST24:

Are drugs usually procured in the public sector through competitive tender?

Use: To assess the capacity of the public sector to procure essential drugs at low cost. Many countries pay prices for drugs that are far above those on the international market because of the absence of a centralized purchasing system and procedures for tendering. By using such a tender system, the cost of drugs can be considerably reduced.

Description: Competitive tender is defined as a procedure for procuring drugs which puts a number of suppliers into competition. Purchasing is done on the basis of quotations submitted by the suppliers in response to a public notice. Depending on the country situation, tenders can be open or restricted to a more limited list of already known suppliers, including local producers. Restricted tender is preferred by many countries as it is easier to manage, and evidence shows that it provides drugs of quality at low cost. The term "usually" quoted in the definition of the indicator means that most of the drug procurement (in value and in volume) is done by tender.

Sources and methods of data collection: Information is available from the ministry of health or from the central procurement unit (CMS, etc.).

Public sector procurement procedures

Indicator ST25:

Is there a system for monitoring supplier performance?

Use: To assess the capacity of the procurement unit to effectively manage the procurement procedures. In order to obtain drugs of good quality and to be sure they will arrive in time, it is important to select suppliers carefully. A system which monitors the performance of suppliers over a number of years allows the identification of the best suppliers and assists in guaranteeing the smooth supply of drugs of acceptable quality.

Description: A system for monitoring supplier performance is defined as a system which provides information on the past performances of each supplier. It should include information on delivery time, adherence to delivery instructions, packaging and labelling, expiring products policy, quality of the pharmaceutical products supplied, etc.

Sources and methods of data collection: The information is available from the procurement unit and can be obtained through interviews and review of the system, in order to check if most of the necessary data are included.

Public sector procurement procedures

Indicator ST26:

Is most of the tendering done under international nonproprietary name (INN)?

Use: To assess the commitment and the capacity of the public sector to procure drugs at low cost. The use of the international nonproprietary name is essential in drug procurement as it allows all the suppliers which manufacture a given substance to participate in the tender, and therefore reduces prices through increased competition.

Description: Tender is defined as a procedure for procuring drugs which puts a number of suppliers into competition. Purchasing is done on the basis of quotations by the suppliers submitted in response to a public notice. INN is the shortened scientific name based on the active ingredient. WHO is responsible for assigning INN to pharmaceutical substances. The answer to the indicator is considered to be "Yes" if the vast majority of tendering measured in value (80% and above) is done under INN.

Sources and methods of data collection: The information is available from the procurement unit and can be obtained through interviews and review of the most recent major tenders.

Public sector procurement procedures

Indicator ST27:

Does the procurement unit receive foreign currency in less than 60 days (from request to release)?

Use: To assess if the government is committed to efficient and relatively fast procurement of drugs. In a well-functioning procurement system, drugs should be bought from reliable suppliers by tender (see indicators ST24, ST25 and ST26). In addition, the foreign exchange needed should be made available in good time to the procuring unit. Otherwise, suppliers will not trust the procurement unit, supply will take a long time and shortages may occur.

Description: In most countries, the procurement unit needs to request foreign currency from the government to pay for drugs. This indicator looks at the interval of time between the moment the request is made and the moment the foreign exchange is allocated.

Sources and methods of data collection: The information is available from the procurement unit and from the ministry of finance, and can be obtained through interviews with the procurement staff and review of relevant documents.

Limitations: In countries where the central procurement unit operates a revolving fund and can obtain foreign currency on the financial market and in countries where all drugs are procured locally, the indicator is not valid.

Public sector procurement procedures

Indicator ST28:

Is procurement in the public sector limited to drugs on the national essential drugs list (EDL)?

Use: To assess the willingness of the government to implement good drug procurement practices and to rationalize the public sector drug supply system. A national list of essential drugs includes all the drugs needed in a given country to cover most therapeutic needs. Therefore procurement in the public sector should be limited to the list. In addition, by focusing on a reduced number of drugs, the efficiency of the procurement process can be significantly improved, discounts for bulk purchase obtained and quality control analysis undertaken more easily.

Description: Drugs procured for the public sector include drugs for all health care levels. This means that procurement done directly by hospitals, by projects supported by bilateral or multilateral organizations or by vertical programmes (e.g. TB) should be reviewed and should, for the indicator to be positive, be in line with the national essential drugs list.

Sources and methods of data collection: Information is normally available from the procurement unit and from the main procuring bodies (hospitals), and can be obtained through interviews and review of orders.

Limitations: If the national essential drugs list has not been revised for a long time, it may be that some new drugs are procured which are necessary although not on the list. Rather than looking at the details, this indicator should look at the general policy in terms of procurement. If there is not a national list of essential drugs but only lists for certain levels of the health care system, the indicator will not be valid (see particularly ST12 to ST15).

Public sector procurement procedures

Indicator ST29:

Is the average lead time (from order to receipt at central level) less than eight months?

Use: To assess the efficiency of the procurement procedures. This indicator provides additional information on the procurement procedures. The procurement agency, if it performs well, should obtain drugs procured by international tender in a reasonable period of time. Experience shows that a period of longer than eight months between the time drugs have been ordered and delivery is indicative of poor performance by the procurement unit, as it increases the pressure on major stock items and the risk of shortages.

Description: The lead time is defined as the number of months between the moment tenders have been issued and the moment drugs arrived in the country. It includes the bidding process, the selection of suppliers, etc. This average lead time should be calculated on the basis of main orders during the last three years.

Sources and methods of data collection: Information is available from the procurement unit and can be obtained through interviews and review of the main orders during the last three years.

Limitations: This indicator is not valid if, for a given reason, a lead time exceeding eight months has been formally agreed between the supplier and the procurement unit. In addition, delays can be due to the slow release of foreign currency and therefore are not the responsibility of the procurement unit (see indicator ST27).

Public sector procurement procedures

Indicator ST30:

Is procurement based on a reliable quantification of drug needs?

Use: To assess the efficiency of procurement procedures. A far more complex task than selecting the drugs is deciding on the quantities needed. The procurement unit should be able to supply the correct quantities of drugs in order to prevent surplus and shortages at health facility level. In many countries, this quantification is not always easy because of poor recording systems, limited budget, irrational drug use, etc.

Description: Reliable quantification of drug needs is defined as a careful evaluation of the quantities needed of each drug, based on either adjusted past consumption or anticipated pattern of diseases and standard treatment. In order to get a more precise answer, one can look at performances in previous years and see if shortages were common. If this is the case, one should try to identify the reasons for shortages, and one of them can be unreliable drug quantification.

In countries where there is no central procurement unit but regional units, the indicator can be slightly modified and become "Is procurement based on a reliable quantification of drug needs in the majority of these units?". In the results, the indicator can be presented with detailed information on the number of units where procurement is based on a reliable quantification of drug needs.

In countries where drugs are bought directly by the health facilities, the indicator can be obtained from a sample of health facilities, for instance when conducting surveys for process or outcome indicators. Data Collection Form 2 (Annex 1) can be adapted and the result will be presented as a percentage: percentage of health facilities surveyed where procurement was based on a reliable quantification of drug needs.

Sources and methods of data collection: Information is available from the procurement unit and/or the ministry of health. It can be obtained through interviews and review of procedures used to calculate drug needs.

Public sector procurement procedures

Indicator ST31:

Are good storage practices observed in the central procurement/distribution unit and/or major regional warehouses?

Use: To assess the capacity of the central procurement unit or of the agency in charge of storage and distribution of drugs in the public sector to store drugs properly. No drug policy can be considered complete unless it pays proper attention to modern drug storage management methods. Bad storage practices, including cumbersome procedures, can lead to shortages, expired drugs and inefficient use of resources.

Description: Good storage practices include elements such as: cleanliness of stores, aeration, FIFO (first in, first out) procedures, arrangement of products, stock control forms, etc. The indicator can be measured for the central level or for both the central and regional levels. In this case the results can be presented for the two or separately. If there are major discrepancies in the results between central and regional levels, the results should be given separately in order to facilitate future action. In countries where drugs are bought directly by the health facilities, the indicator can be obtained from a sample of health facilities, for instance when conducting surveys for process or outcome indicators. Data Collection Form 2 (Annex 1) can be adapted and the result will be presented as a percentage: the percentage of health facilities surveyed where good storage practices are observed.

Sources and methods of data collection: The information can be obtained by a visit to the procurement unit at central and/or regional levels. The monitoring unit should prepare a checklist of good storage practices. The information can also be quantified. In Zimbabwe, a list of good storage practices was developed and the percentage of practices in the warehouses in accordance with the list was calculated. Fifty-nine per cent of the practices which should have been carried out in the warehouse were observed.

Public sector procurement procedures

Indicator ST32:

Is the information recorded on the stockcards for a basket of drugs the same as the quantity of stock in store?

Use: To assess if the storage procedures are properly managed and if storekeepers are performing well. Storage problems may be of different types, but discrepancies between what is recorded and what is in stock are a good indicator of problems such as a bad recording system and diversion. In an efficient supply organization, the management information system should be accurate and up to date, otherwise it will create problems in the supply cycle.

Description: A basket of drugs is provided as an example in Chapter IV (see page 59). It can be adapted to the country context. The stock record cards and the bin cards should provide a continuous record of the amount of each drug in stock. The quantity recorded should be the same as the number on the shelves. In certain cases, all the recording is done by computer and the data collector will need to retrieve the information from the computer. The indicator can be calculated only for the central level or for the central and the regional levels. Results should be presented separately. The indicator will be considered positive if, for more than 90% of the drugs included in the basket, the quantity recorded on the stockcards is the same as the quantity in store. As with indicators ST30 and ST31, this indicator can be easily adapted to take into account the national context.

Sources and methods of data collection: The information can be obtained during a visit to the central and/or regional stores. The monitoring unit should prepare a form listing the drugs from the basket and the data collector should carry out a physical count of the stock and tick the "Yes" or "No" columns for each drug, depending on whether the quantity in stock tallies with the quantity recorded on the stockcard. The indicator will then be obtained by dividing the number of drugs with a "Yes" answer by the number of drugs in the basket and multiplying the result by 100. If for more than 90% of the drugs the answer is "Yes", the indicator will then be "Yes". The answer can be given as a percentage: in Zimbabwe, for 88% of the drugs checked, the quantity recorded on the stockcards was the same as the quantity of stock in store.

Public sector procurement procedures

Indicator ST33:

Are the stocks for a basket of drugs within their expiry dates in the central procurement/distribution unit and/or major regional warehouses?

Use: To assess the effectiveness of the management of drug storage at different levels. If drugs are not properly stored and recorded and if the FIFO (first in, first out) procedures are not respected, the number of expired drugs can be significant. The presence of expired drugs is a good indicator of some deficiencies in management.

Description: A basket of drugs is provided as an example in Chapter IV (see page 59). It can be adapted to the country context. Expiry dates are usually written clearly on the boxes. In certain cases, codes are used and data collectors will need to know these codes; storekeepers can provide this information. The indicator can be obtained only for the central level or for the two levels. Results should be presented separately. In countries where drugs are bought directly by the health facilities, the outcome indicator OT6 can be used instead of this one.

Sources and methods of data collection: The information can be obtained during a visit to the central stores and/or the regional stores, at the same time as for indicator ST32. The monitoring unit should prepare a form listing the drugs from the basket and the data collector should carry out a physical examination of the stock and tick the "Yes" or "No" columns for each drug, depending on whether they are within expiry date or not. The indicator will then be obtained by dividing the number of drugs with a "Yes" answer by the number of drugs in the basket and multiplying the result by 100. If the answer is "Yes" for more than 90% of the drugs, the indicator will then be "Yes".

Limitations: As the basket of drugs contains drugs which are very common and in general have a high turnover, this indicator will not be very sensitive. For more accuracy, some important essential drugs with a lower turnover may be included in the basket.

Public sector procurement procedures

Indicator ST34:

Have all incoming products been physically inspected for the last three deliveries in the central procurement/distribution unit and/or in major regional warehouses?

Use: To assess if one of the elements of a quality assurance system exists. Ensuring that drugs procured are of acceptable quality is a responsibility which is shared by many actors and which encompasses good manufacturing practices, proper selection of suppliers and quality control testing. At the level of the procurement unit it is important to set up a system which will ensure at each step of the supply cycle minimum standards of quality. Inspection of the products when they arrive is one way to ensure that the specifications laid down in the tender have been respected by the supplier.

Description: Physical inspection is defined as an established procedure where each shipment is inspected in its entirety by staff trained in judging the physical appearance of products. All deliveries are compared with the purchase order and invoice. The indicator can be obtained only for the central level if all drugs procured arrive at this level. If some drugs are procured directly by the regional stores or are delivered directly to these stores from abroad or from local suppliers, the indicator should be obtained for the two levels and results should be presented separately. As for indicators ST30, ST31 and ST32, this indicator can be easily adapted to take into account the national context.

Sources and methods of data collection and measurement: The information can be obtained from central and/or regional stores through interviews with the staff in charge of receiving drugs and through review of documents related to the last three main deliveries (checklists, etc.).

Public sector procurement procedures

Indicator ST35:

Are only drugs which are on the national essential drugs list (EDL) in stock in the central procurement/distribution unit and/or in major regional warehouses?

Use: To assess if the procurement unit follows the national drug policy. The national list of essential drugs is usually a tool to rationalize procurement, storage and distribution and to save limited resources. The presence of drugs which are not on the list is a good indicator of some problems with drug supply.

Description: In certain cases a few items which are not on the national essential drugs list will be in stock. The reasons for this should be analysed. It can, for example, be donated drugs, with no possibility of the procurement unit imposing its policy. Only when it is clear that the reason for the presence of non-EDL drugs is independent of the procurement unit will the indicator be rated positive. This indicator can be analysed in conjunction with indicator ST28. The indicator can be obtained only from the central level or from the two levels (mainly when drugs are procured directly by the two levels). Results should be presented separately. As with indicators ST30, ST31, ST32 and ST34, this indicator can be easily adapted to take into account the national context.

Sources and methods of data collection: The information can be obtained during a visit to the central and/or regional stores through interviews and physical inspection of the stocks.

Limitations: If the national essential drugs list has not been revised for a long time, it may be that some drugs are procured which are necessary although not on the list. This indicator is not intended to be very precise quantitatively but to give an indication of the supply agency's practices.

Public sector procurement procedures

Indicator ST36:

Are 80% or more of the vehicles of the central procurement/distribution unit and/or major regional warehouses in working condition?

Use: To assess the capacity of the central procurement/distribution unit to distribute drugs to the regional stores and/or to the health facilities on a regular basis. Logistical problems often hinder the delivery of safe and effective drugs to people. Vehicles are only one of the elements of a well-managed distribution system, but without them the whole distribution system collapses.

Description: In most countries, the central procurement/distribution unit and the regional stores distribute drugs to the health facilities with their own fleet of vehicles. The vehicles which should be counted for this indicator are only the vehicles which are used for the transport of drugs. Vehicles for supervision or other purposes should not be counted. The indicator can be calculated only for the central level or for the two levels. In this case, the result can be presented as an average of the two, or separately. If there are major discrepancies in the results between central and regional levels, the results should be given separately to facilitate future action.

Sources and methods of data collection: The information can be obtained by a visit to the procurement unit at central and/or regional level and interviews with the people in charge of logistics. The indicator is obtained by dividing the number of vehicles used for the distribution of drugs which are in working condition by the total number of vehicles which should be used for the distribution of drugs, and multiplying by 100.

Limitations: In certain countries, the distribution of drugs is not done by the central unit but by private companies, or health facilities can collect the drugs they have ordered themselves. In this case, the indicator cannot be measured, but an indication of the effectiveness of the distribution system will be provided through some process indicators (PR27, PR28 and PR29) and one outcome indicator (see OT1).

Pricing policy

Indicator ST37:

Are drug prices regulated in the private sector?

Use: To assess the role of the government in regulating the pharmaceutical sector. Essential drugs should be affordable for the whole population through the public and the private sectors. The government can influence the price of drugs for the consumer and increase their affordability through regulation/control of drug prices.

Description: Price regulations include any regulation established by government to control drug prices. This control can be direct or indirect and includes: setting of fixed margins at various levels (wholesalers, retailers), reimbursement control (positive lists, reference prices, percentage of co-payment), ceiling price, etc. The private sector includes all private wholesalers and retailers (pharmacies as well as other drug outlets) which are licensed for selling drugs (see indicator ST5).

Sources and methods of data collection: The information can be obtained from the ministry of health, ministry of finance, importers, wholesalers, pharmacists, etc. through interviews and document review (price lists, regulations, etc.).

Limitations: This indicator will in some cases need to be accompanied by written statements on what kind of price regulations are used, since they have different policy implications. The indicator does not provide information on the enforcement of these various regulations. This can be described separately.

Pricing policy

Indicator ST38:

Is there at least one major incentive for the private sector to sell essential drugs at low cost?

Use: To assess if the government is committed to a drug policy based on essential drugs at low cost. By introducing incentives to sell essential drugs at low cost, the government will foster the availability and affordability of much-needed drugs.

Description: Essential drugs are the ones which are on the national list of essential drugs. These drugs can be sold under INN, generic name or brand name. The INN is the international nonproprietary name. In some cases the drugs are known under a generic name (common name) which can be different from the INN. Incentives can include lower taxes for essential drugs under INN, pricing policy in favour of generic products (e.g. higher margins for these products), right to generic substitution, etc. A major incentive would be one that directly benefits drug sellers. Merely promoting essential drugs is insufficient to change prescribers', pharmacists' and users' behaviours and therefore cannot be counted as a major incentive.

Sources and methods of data collection: The information can be obtained from the ministry of health, ministry of finance and the customs unit through interviews and review of documents (regulations, price structure, etc.).

Limitations: This indicator will in some cases need to be accompanied by written statements on what kind of incentives are used, since they have different policy implications. The indicator does not provide information on the enforcement of these various regulations. This can be described separately.

Pricing policy

Indicator ST39:

Is the total margin used by wholesalers and retailers less than 35% of the CIF price?

Use: To assess if the difference between the CIF price and the retail price is in an acceptable range. In many countries, fixed margins are added to the CIF/ex-factory price, plus taxes and duties. Although the system does not prevent high CIF/ex-factory prices, the regulation of the margins can lead to a slight decrease in the price of the drugs to the consumer.

Description: The total margin should be understood as the margin of the wholesaler added to the margin of the pharmacist. These margins are normally given as a percentage of the CIF price, plus taxes. If, for example, the margin for the wholesaler is 10% for a drug with a CIF price plus taxes and duties of 100, the price for the retailer will be 100 x 1.10 = 110. If, for example, the margin for retailers is 20% for a drug with a price of 110, the selling price to the consumer will be 110 x 1.2 = 132. The total margin will be 32%. Thirty-five per cent is an acceptable margin in many countries; however, a national standard should be established. The CIF price is the price of the drug at the port of entry. Taxes and duties are the national ones applied to drugs imported or produced locally.

Sources and methods of data collection: The information can be obtained from the ministry of health, the national drug authority, the wholesalers/importers, the pharmacists through interviews and review of documents (regulations, price lists, etc.).

Limitations: In certain countries, prices are totally uncontrolled; wholesalers and pharmacies can decide the price they want for pharmaceutical products. In this case, the indicator can be adapted and calculated for a basket of drugs in conjunction with process indicator PR21.

Pricing policy

Indicator ST40:

Is there a system for monitoring drug prices?

Use: To assess the capacity of the government to keep informed of drug prices in order to develop policies and adjust strategies aimed at increased affordability of drugs in the public and the private sectors. In order to increase drugs affordability, a government has many options, e.g. to control prices or to allow competition with limited control. In all cases, it will need to know how prices fluctuate and to adjust its policies if necessary.

Description: The system for monitoring drug prices is defined as any system which provides information on retail prices of all the drugs or of certain drugs on a regular basis. This system can be based on surveys, questionnaires, etc; it can be managed by the public or the private sectors within or outside the health sector. The answer should be "Yes" only if the monitoring is done regularly and provides information on price trends.

Sources and methods of data collection: Information on the existence of the system can be obtained from the ministry of health or the national drug authority. Additional information can be obtained from the people in charge of the system: ministry of health, ministry of planning, pharmaceutical association, private companies, NGOs, etc.

Pricing policy

Indicator ST41:

Are essential drugs under INN or generic name sold in private drug outlets?

Use: To assess if there is a policy to sell essential drugs under INN or generic name in the private sector. This indicator shows the commitment of the government and of the private sector to increase the availability of the most-needed drugs at low cost, as drugs marketed under generic name are in general less expensive than drugs marketed under brand names.

Description: Essential drugs are the drugs included in the national list of essential drugs. The INN is the international nonproprietary name. In some cases the drugs are known under a generic name (common name) which can be different from the INN.

Sources and methods of data collection: The information can be obtained from the ministry of health and/or the national drug authority through interviews and review of documents (regulations) and can be supplemented by a visit to a limited number of private drug outlets.

Limitations: The indicator does not provide information on the extent of the sales of essential drugs under INN in the private sector; this is provided by background information indicator BG22.

Information and continuing education on drug use

Indicator ST42:

Is there a national publication (formulary/bulletin/manual, etc.) revised within the past five years, providing objective information on drug use?

Use: To assess if there is a source of objective information on drugs available to health personnel, especially prescribers. Inappropriate drug prescribing and use are growing problems in both the public and the private sectors. Contributing factors to this irrational use include the lack of up-to-date information. Although the presence of such information is not sufficient, it is a good indication of the willingness of the ministry of health and/or other partners to improve the situation.

Description: Such a national publication is defined as any manual which for each drug contains at least the following impartial information: active ingredient, dosage, indications, contraindications, side-effects and precautions. This information should have been revised and updated within the past five years. This publication is normally a national drug formulary.

Sources and methods of data collection: The information can be obtained from the ministry of health and/or universities through interviews and a review of the publication to check if it contains objective information.

Information and continuing education on drug use

Indicator ST43:

Is there a national therapeutic guide with standardized treatments?

Use: To assess if one of the many tools which contribute to more rational drug use is in place. Inappropriate drug prescription is a growing problem in both the public and the private sectors. Contributing factors include the lack of diagnostic skills and pharmacological knowledge. A guide which provides information on the main diseases and a standardized approach to their treatment will contribute to a more rational use of drugs. In addition, it will facilitate quantification of drug needs and procurement.

Description: A national therapeutic guide is defined as a manual which for each disease contains the main diagnostic steps and reference treatments. Such national therapeutic guides should clearly define for each disease the specific drugs to be given and the quantities. This information should have been revised and updated within the past five years and should be objective. Objective information should be understood as information produced by independent scientific sources without any support from the pharmaceutical industry or private firms involved in the drug sector.

Sources and methods of data collection: The information can be obtained from the ministry of health and/or universities through interviews and a review of the publication to check if it contains objective information.

Information and continuing education on drug use

Indicator ST44:

Is the concept of essential drugs part of the curricula in the basic training of health personnel?

Use: To assess the importance given to the essential drugs concept at university level. In order to improve drug use and to achieve the objectives of the national drug policy, health personnel should be taught to choose and prescribe essential drugs rationally.

Description: Basic training in schools of medicine, pharmacy and public health, and in paramedical training institutions, should cover issues such as selection and use of essential drugs, rational prescribing and dispensing. To answer "Yes", at least 10 hours should be devoted to essential drugs in the official curricula of basic training of health personnel.

Sources and methods of data collection: The information can be obtained from the ministry of health and from the various schools and universities through interviews and review of existing curricula. The information, if different for the different schools, should be presented separately.

Information and continuing education on drug use

Indicator ST45:

Is there an official continuing education system on rational use of drugs for prescribers and dispensers?

Use: To assess if one of the main tools to improve drug prescribing and use is in place. Country experiences suggest that a good system of continuing education on the rational use of drugs and practical therapeutics is one of the most cost-efficient ways to improve drug use.

Description: A continuing education system is defined as a system based on regular workshops, seminars and/or in-service training which provides all prescribers and dispensers with refresher courses on drug issues. The system can deal with issues other than drugs but to qualify for the indicator, drug issues should figure prominently on the programme. Meetings organized with the support of the pharmaceutical industry or private firms involved in the pharmaceutical sector should be excluded. If the system is only for the public sector or only for the private sector, this should be indicated. If the answer is different for the prescribers and the dispensers, the results should be given separately.

Sources and methods of data collection: Information can be obtained from the ministry of health and/or universities and medical/pharmaceutical associations through interviews and review of documents such as course programmes.

Information and continuing education on drug use

Indicator ST46:

Is there a drug information unit/centre?

Use: To assess the existence of a key tool which contributes to a better knowledge of drugs and therefore to rational drug use. In many developing countries the absence of objective information is one of the main reasons for irrational use of drugs. Some country experiences show that such drug information units/centres can play a major role in providing the health community with objective information on various aspects of drug consumption.

Description: A drug information unit or centre is defined as an organization within or outside the ministry of health which collects and provides objective information on drugs to health personnel and the public. These organizations can have additional tasks (adverse drug reactions, analysis of drug statistics, etc.). Objective information should be understood as information produced by independent scientific sources without any support from the pharmaceutical industry or private firms involved in the drug sector.

Sources and methods of data collection: Information on the existence of a drug information unit/centre can be obtained from the ministry of health and/or the national drug authority. Additional information can be obtained from the unit/centre itself whether within or outside the ministry of health.

Information and continuing education on drug use

Indicator ST47:

Does the drug information unit/centre (or another independent body) provide regular information on drugs to prescribers and dispensers?

Use: To assess the availability of regular and updated information on drugs to prescribers and dispensers. This indicator is linked with indicator ST46 as it assesses the functioning of the drug information unit/centre. In many developing countries the absence of objective information is one of the main reasons for irrational use of drugs. Some country experiences show that such drug information units/centres can play a major role in providing the health community with objective information on various aspects of drug consumption.

Description: A drug information unit or centre is defined as an organization within or outside the ministry of health which collects and provides objective information on drugs to health personnel and the public. These organizations can perform additional tasks (adverse drug reactions, analysis of drug statistics, etc.). Regular information should be understood as information provided on a regular basis such as monthly or quarterly. However, the indicator can be measured in the absence of a drug information unit/centre if there is another body which is independent and which provides regular unbiased information on drugs to prescribers and dispensers (e.g. university, NGO). If the information is only provided to the public sector or only to the private sector, this should be indicated. If the answer is different for the prescribers and the dispensers, the results should be given separately.

Sources and methods of data collection: Information can be obtained from the drug information unit/centre through interviews and review of bulletins and journals. It can also be obtained through interviews with a limited number of prescribers and dispensers in both public and private sectors.

Information and continuing education on drug use

Indicator ST48:

Are there therapeutic committees in the major hospitals?

Use: To assess if a system is in place at hospital level which contributes to the rational selection, procurement and use of drugs. Therapeutic committees, which exist in most developed countries and in many developing countries, provide a forum for discussion on drug issues within hospitals and are useful in making prescribers more aware of the importance of these issues. They should ideally exist in all major hospitals.

Description: A therapeutic committee is defined as a group of scientists and members of the hospital community such as pharmacologists, clinicians, pharmacists, etc. Doctors practising outside the hospitals are often members of such therapeutic committees as they bring another perspective on the use of drugs. Major hospitals are defined as national and/or teaching hospitals and the main regional hospitals.

Sources and methods of data collection: Information can be obtained from the ministry of health and the major hospitals through interviews with the members of such committees.

Information and continuing education on drug use

Indicator ST49:

Are there public education campaigns on drug use?

Use: To assess if an important strategy to promote rational drug use is in place. Although effective public education is not easy to implement, it is a vital component of any rational drug use policy and should be included in the health policy of every country. Patient expectations can and do influence prescribing patterns. In addition, self-medication is widely practised. Therefore, public education is essential if the role of medicines and how they should be taken are to be properly understood.

Description: A public education campaign on drugs is defined as any programme or campaign conducted at local or national level by the ministry of health, by other ministries or by other bodies, aimed at increased awareness of drug issues and improvements in the use of drugs by the public, as long as the information provided is unbiased. The frequency of such campaigns will depend on the country's context.

Sources and methods of data collection: The information can be obtained from the ministry of health or other bodies responsible for public education through interviews and review of reports on previous campaigns.

Information and continuing education on drug use

Indicator ST50:

Is drug education included in the primary/secondary school curricula?

Use: To assess if an important strategy to promote rational drug use is in place. The education of school children in appropriate drug use is an efficient strategy to improve the quality of medicine use throughout a community and for future generations. Without a formal education in drug use, children are learning how to use medicines by observation; however, this way of learning is not going to teach children how to use medicines wisely. Thus, the rational use of drugs should be included in comprehensive school health promotion curricula. Currently, this is still rare. This indicator will therefore provide useful information on the level of a country's commitment to improving drug use in the long term.

Description: Drug education should cover issues such as the appropriate treatment of common diseases and injuries, provision of essential drugs, proper drug storage and use, side-effects, and advice on self-care and self-medication. Such curricula can be more complex as children get older. To answer "Yes" at least 10 hours should be devoted to drug education in the official curricula of primary/secondary schools.

Sources and methods of data collection: The information can be obtained from the ministries of education or health and other bodies responsible for school education and through review of curricula.

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