HAI and WHO Medicine Prices- a new approach to measurement
Publication date: 2003
© World Health Organization and Health Action International 2003 All rights reserved. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization or Health Action International concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization or Health Action International in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. The World Health Organization and Health Action International do not warrant that the information contained in this publication is complete and correct and shall not be liable for any damages incurred as a result of its use. Contents Preface 1 Acknowledgements 3 Abbreviations and acronyms 5 1 WHY MEASURE THE PRICE OF MEDICINES? 7 Medicine prices and inequities in health 7 Why monitor the prices of medicines? 8 The need for a standard approach to measuring medicine prices 9 A new approach 10 Contents of the manual 11 2 OVERVIEW OF THE SURVEY 13 Steps in the survey 13 Survey planning and preparation 14 Collecting national pharmaceutical sector data 14 Identifying Sectors 14 Sampling 15 Selecting medicines 15 Training 16 Collecting data on the prices and availability of medicines 16 Identifying the components of medicine prices 17 Assessing affordability 17 Data entry 18 Data analysis and interpretation 18 Making international price comparisons 18 Identifying policy options 18 Reporting the survey findings 19 Repeating the survey 19 3 PLANNING 20 Personnel 20 Technical resources 22 Financial resources 22 Planning where to conduct the survey 23 Selecting a sample 24 Planning timeline 26 Seeking endorsements 26 4 DATA COLLECTION AT CENTRAL LEVEL 28 National Pharmaceutical Sector Form 28 Medicine Price Data Collection form 29 Components of medicine prices 38 Affordability 43 5 PREPARATION FOR DATA COLLECTION IN THE FIELD 45 Guidance for area supervisors 45 Sampling sites 45 Selecting data collectors 47 Training data collectors 47 Pilot testing 48 Medicine Price Data Collection forms 49 Planning the schedule of data collection visits 49 Letter of introduction 50 Checklist for area supervisors 50 Guidelines for data collectors 50 Coordinating meetings 50 6 DATA COLLECTION IN THE FIELD 52 Fieldwork: Area supervisors 52 Fieldwork: Data collectors 53 7 DATA ENTRY 58 Using the computerized Workbook 58 Overview of the Workbook and its operations 60 Home page 61 International Medicine Reference Price Data page 61 Field Data Consolidation pages 65 Standard Treatment Affordability page 70 Price Composition: Cumulative Mark-ups page 72 Price Composition: Components of Price page 73 8 DATA ANALYSIS AND INTERPRETATION 75 Overview of data analysis 76 Data on the national pharmaceutical sector 79 Within-sector price analyses 79 Cross-sector price and availability comparisons 89 Analysing treatment affordability 93 Analysing price composition 95 9 INTERNATIONAL PRICE COMPARISONS 98 Comparisons of the prices of individual medicines 99 Comparisons of the affordability of treatment 100 Comparisons of price composition 101 International comparisons of prices for a sample of medicines 102 10 EXPLORING POSSIBLE POLICY OPTIONS AND LINES OF ACTION 104 Data from the survey and its interpretation 105 11 REPORTING 109 Survey report 109 Presenting the findings 110 Disseminating the findings 111 12 DEVELOPMENT OF THE MANUAL AND BEYOND 113 Glossary 115 References 120 ANNEXES 123 1 Example of a letter of endorsement 125 2 National Pharmaceutical Sector form 126 3 Medicine Price Data Collection form 131 4 Example of a letter of introduction from the survey manager 135 5 Example of a survey report 136 CD-ROM 1 Full text of the manual in .pdf format 2 MS Excel computerized Workbook 3 Example of a letter of endorsement of the survey 4 National Pharmaceutical Sector form 5 Medicine Price Data Collection form 6 Example of a letter of introduction for data collectors 1 Preface In developing countries, most medicines are paid out-of-pocket by individual patients rather than being subsidized through social insurance. High prices are a major barrier to the use of medicines and better health, yet too little is known about the prices that people pay for medicines in low- and middle-income countries. This manual and the accompanying Workbook and database provide a new approach to measuring the prices of medicines. They result from the widely-felt need for greater transparency on prices in the global medicines marketplace. The work proposed can be carried out reliably and at low cost by consumer groups, academic centres concerned with public health, government departments or others. The survey is focused on thirty key medicines covering the spectrum of the global disease burden, particularly as it falls on low- and middle-income countries. The results should raise questions about the relative prices of innovator brand medicines and their generic equivalents, about prices in different parts of the same country, about the relationship between procurement prices and final prices to patients, about the affordability of treatment for ordinary people and about international differences in prices for the same medicines. The manual is the outcome of a technical project of the World Health Organization (WHO)/Public Interest Nongovernmental Organizations Roundtable on Pharmaceuticals, which was established in 1998 to strengthen collaboration between WHO and civil society. Public interest nongovernmental organization (NGO) participation is drawn from consumer, development, emergency relief, non- profit medicine supply and professional organizations. NGO coordination of the Roundtable and of this project is undertaken by Health Action International (HAI) Europe.* After reviewing experiences of monitoring the prices of medicines, Roundtable participants identified the need for the development of a standardized method for the collection and analysis of medicine prices and price composition within a country at a specific point in time and over time. During 2001 and 2002, project members field tested the manual in nine countries and four continents – in Armenia, Brazil, Cameroon, Ghana, Kenya, Peru, Philippines, South Africa and Sri Lanka. Progress in the work was assisted by a panel of highly experienced and widely recognized experts. The outcome is the new approach, described in this manual, to measuring the prices people have to pay for a selection of important medicines across local sectors (public, private retail pharmacies and other medicine outlets). The manual also outlines how to collect information on price composition, such as taxes, * Health Action International (HAI) is an independent, international network of groups and individuals who believe that policies and health care systems should meet people’s needs. HAI seeks to influence international and national policies and regulations to ensure that they protect and promote public health. HAI’s focus is on the promotion of the essential drugs concept, equitable access to quality medicines and the rational use of drugs. 2 mark-ups and fees, and assess the affordability and availability of medicines. To facilitate data analysis, a software application for Microsoft Excel has been designed to accompany this manual; this is provided on the CD-ROM in the inside front cover. The methodology has been designed primarily for use in low- and middle-income countries, but should be applicable to all countries. All users are encouraged to submit the results to the WHO Essential Drugs and Medicines Policy Department (WHO/EDM) and Health Action International Europe so that they can be lodged on the database that is specific to this initiative. This is accessible on HAI’s website (www.haiweb.org/medicineprices). The establishment of this database is an important step towards greater transparency and availability of reliable information on medicine prices in different settings. Despite the considerable expertise and field testing that went into developing this manual, WHO and Health Action International consider this first edition as a starting point. The methodology will be kept under review with accumulating experience and will be further developed as more surveys are undertaken. Please contact the WHO Essential Drugs and Medicines Policy Department or Health Action International Europe if you are contemplating undertaking a survey of medicine prices. Please also contact us if you have any queries or comments, particularly on aspects of the methodology that are unclear or prove to be difficult to implement. This is key to improving the methodology and, in turn, improving the transparency of information on medicine prices. Health Action International Europe Jacob van Lennepkade 334-T 1053 NJ Amsterdam The Netherlands E-mail: email@example.com World Health Organization Essential Drugs and Medicines Policy Department 1211 Geneva 27 Switzerland E-mail: firstname.lastname@example.org 3 Acknowledgements WHO and Health Action International wish to thank the Netherlands Ministry of Foreign Affairs and the Rockefeller Foundation for their generous support in funding this project. Special thanks are due to the following people who contributed much time and expertise in developing and testing the methodology, and managing the project. Project Management Margaret Ewen, Health Action International Europe; Andrew Creese, Essential Drugs and Medicines Policy Department, WHO. Consultants � Kirsten Myhr, Ullevål University Hospital, Norway: principal author � Dennis Ross-Degnan, Harvard University, USA: Workbook development � Richard Laing, Boston University, USA: data analysis � Jeanne Madden, Harvard University, USA: review of pilot field data � Sadara, Sadarainternetdiensten, Netherlands: database development � Jan Fordham, Open Learning Associates, UK: editing and production. Advisory Group K. Balasubramaniam, HAI Asia Pacific, Sri Lanka; Jorge Bermudez, National School of Public Health, Brazil; Jerôme Dumoulin, University of Grenoble, France; David Henry, University of Newcastle, Australia; Aarti Kishuna, Public Health Consultant, South Africa; Richard Laing, Boston University, USA; Barbara McPake, London School of Hygiene and Tropical Medicine, UK; Zafar Mirza, The Network for Consumer Protection, Pakistan; Elias Mossialos, London School of Economics, UK; Dennis Ross-Degnan, Harvard University, USA. Steering Group Harry van Schooten, Netherlands Ministry of Foreign Affairs; Anthony So, Rockefeller Foundation; Carmen Pérez-Casas, Médecins Sans Frontières; Mohga Kamal Smith, Oxfam UK; Daphne Fresle, WHO. Principal Investigators of Field Tests Movses Aristakesyan, Armenia; André Luis de Almeida dos Reis, Brazil; Meinolf Kuper, Cameroon; Charles Allotey, Ghana; Isaac Kibwage, Kenya; Javier Olivas Peru; Aldrin Santiago, Philippines; Aarti Kishuna, South Africa; Rajitha Wickremasinghe, Sri Lanka. Translators Simona Chorliet (French); José Antonio Valtueña (Spanish). Administrative Support Rose de Groot, Health Action International Europe. M E D I C I N E P R I C E S : A N E W A P P R O A C H T O M E A S U R E M E N T 4 The project managers would like to express their appreciation to the Rockefeller Foundation and the staff of the Bellagio Study and Conference Centre for the use of the Centre. Jonathan Soverow, in particular, provided valuable assistance for the project meeting in Bellagio. NGO participants in WHO/public interest NGO Roundtables on Pharmaceuticals (1998–2001) ECHO International Health Services, Ecumenical Pharmaceutical Network (EPN), Health Action Information Network (HAIN), Health Action International (HAI), Healthy Skepticism, International Network for Rational Use of Drugs (INRUD), International Society of Drug Bulletins (ISDB), Médecins Sans Frontières (MSF), Mission for Essential Drugs & Supplies (MEDS), Oxfam, Pharmaciens Sans Frontières (PSF), Save the Children Fund (SCF), Social Audit UK, The Network for Consumer Protection in Pakistan, World Council of Churches (WCC) and World Vision International. NGO members of the Roundtable are deeply indebted to Daphne Fresle, without whose support and encouragement this medicine pricing project, and indeed the Roundtable itself, may not have been realized. 5 Abbreviations and acronyms ARV Antiretroviral BNF British National Formulary CIF Cost, insurance and freight EML Essential medicines list FOB Free on board HAI Health Action International HAART Highly Active AntiRetroviral Therapy IRP International reference price LPG Lowest price generic equivalent MPR Median price ratio MSG Most sold generic equivalent MSH Management Sciences for Health MSP Manufacturer’s selling price MUP Manufacturer’s unit price NA Not available NGO Nongovernmental organization OECD Organization for Economic Co-operation and Development PBS Pharmaceuticals Benefit Scheme (Australia) SMUP Sector median unit price TRIPS Trade-Related Aspects of International Property Rights WHA World Health Assembly WHO World Health Organization WHOEML WHO Model List of Essential Medicines WTO World Trade Organization 7 1 Why measure the price of medicines? � One-third of the world’s population lacks reliable access to the medicines they need primarily because they cannot afford to purchase them � Little is known about the prices that people pay for medicines and how these prices are set � Reliable information on the prices of medicine is needed in order that more favourable purchasing agreements can be negotiated, domestic distribution better managed and pricing policies monitored � This manual offers a new approach to the measurement and monitoring of medicine prices � The methodology described in the manual is designed to assist governments, nongovernmental organizations, international agencies, health professionals and consumers in advocating for more equitable access to essential medicines. MEDICINE PRICES AND INEQUITIES IN HEALTH One-third of the global population lacks reliable access to needed medicines, according to estimates by the World Health Organization (WHO, 2000). The situation is worse in the poorest countries of Africa and Asia where up to 50% of the population are unable to obtain necessary medicines (WHO/WTO, 2001). Up to 90% of the population in developing countries have to buy medicines through out-of-pocket payments as opposed to around 20% in high income countries (WHO/WTO, 2001). Less than 10% of the population of Africa is protected by social insurance and publicly subsidized health services are both inadequate and located primarily in and around principal urban centres. Many direct and indirect pharmaceutical price regulations remain in effect in OECD countries (Jacobzone, 2000). In many developing countries, however, national medicine pricing policies are shifting from price controls to deregulation under the influence of structural adjustment and reform programmes. It is not yet clear how market forces affect medicine prices in this new environment. In the short term, at least, they may increase costs for which policy adjustments may be required. M E D I C I N E P R I C E S : A N E W A P P R O A C H T O M E A S U R E M E N T 8 Duties, taxes, mark-ups, distribution costs and dispensing fees are often high, regularly constituting between 30% and 45% of retail prices, but occasionally up to 80% or more of the total (Bale, 2001; European Commission, 2003; Levison, 2003). Prices are also influenced by whether the country observes patents, the level of domestic production of medicines, a lack of competition between pharmaceutical manufacturers and weak or non-existent price controls. Examples of inequalities in access to medicines � A full course of antibiotics to cure simple pneumonia in a low-income country can cost one month’s wages for the lowest paid unskilled government worker compared with two to three hours’ wages in a high- income country (WHO, 2000) � To pay for one course of tuberculosis treatment in the private sector, a Tanzanian would have to work for 500 hours in comparison with a Swiss who would have to work only 1.4 hours (WHO, 2001) � In 2000, lamivudine, used in the treatment of HIV/AIDS, was found on average to be 20% more expensive in real terms in Africa than in ten advanced industrialized countries (Pérez-Casas, 2000). WHY MONITOR THE PRICES OF MEDICINES? Medicines are not only unaffordable for large sectors of the global population, but are also a major burden on government budgets. In high-income countries, governments spend about 10% of their health budgets on medicines, while in low- income countries, medicines account for 25% of government health budgets. In most high-income countries, insurance covers the major part of medicine costs to the patient but, in Africa and South Asia, surveys show that medicine costs can dominate households’ health spending, at over 80% of the total. With shrinking incomes and increased inequity, national policies and medicine pricing and procurement strategies are required to ensure that medicines are affordable. Policies are also needed to improve health infrastructures, improve financing and ensure the rational use of medicines. But the price of medicines is one of the most important obstacles to access. Equitable pricing – selling the same medicines at different prices in different countries in accordance with people’s purchasing power – is infrequently implemented by pharmaceutical companies. Changes in trade regulations and particularly rules relating to intellectual property, such as patent rights, may also affect the international prices and availability of medicines (WHO, 1999). Prices thus need to be monitored. The approach outlined in this manual offers a basis for monitoring prices across medicines, sectors and countries as well as over time, and its future development is being closely coordinated with a WHO project concerned specifically with globalization, TRIPS and access to medicines (WHO, 2002). The difficulty in finding reliable information on medicine prices, and therefore in analysing their components, hinders governments from constructing sound medicine pricing policies or evaluating their impact. It also makes it difficult for governments to evaluate whether their expenditure on medicines is comparable to that of other countries at a similar stage of development and those responsible for purchasing medicines cannot negotiate cheaper deals because they have no sound basis from which to start their negotiation. Even in countries where W H Y M E A S U R E T H E P R I C E O F M E D I C I N E S ? 9 consumers and patients have greater purchasing power, governments, insurance funds and hospitals often find it difficult to make decisions on the selection of medicines because of a lack of information. It is, of course, the responsibility of governments to ensure that the health care needs of their populations are met through adequate funding of public sector health care delivery systems. In many cases, this would mean substantially enhancing the health budget. Steps can be taken to bring medicines within the financial reach of low-income populations and prevent unnecessary disease and death, but much more information is needed about medicine prices than is known at present. Some commonly used medicines have been found to be more expensive in developing countries than in industrialized countries. The ex-manufacturer price to countries may be confidential. Medicine price indicator guides (Management Sciences for Health; WHO-AFRO; UNICEF/UNAIDS/WHO-HTP/MSF) show the sales prices from large wholesalers of generically equivalent medicines, but do not give the price patients have to pay and often do not include new, essential but patented medicines. The monitoring of prices and cross-country comparisons are therefore important. THE NEED FOR A STANDARD APPROACH TO MEASURING MEDICINE PRICES If medicines are to be affordable, an appropriate and well-informed medicine pricing policy is required. This, in turn, requires a reliable analysis of medicine prices. The methodology to measure medicine prices in low- and middle-income countries, described in this manual, is a step in this direction. Since 1999 the World Health Assembly has made a number of resolutions that address medicine prices (WHO, 2000). Impetus to the discussion has also been provided by the potential impact of the World Trade Organization (WTO) agreement on Trade Related Aspects of International Property Rights (TRIPS) in 1998 which requires stronger and prolonged patent protection of pharmaceuticals, resulting in high prices for a longer period of time. While medicine prices have been monitored and reported in a number of countries, with varying objectives and success, the absence of a standard methodology has been a stumbling block in reliable monitoring and comparisons of prices within and between countries and over time. Without reliable data, advocacy to promote more equitable access to medicines will be ineffective. This manual and the accompanying software application aim to build on the strengths of earlier work by providing a methodology for measuring medicine prices that avoids the limitations of previous approaches. The methodology is intended to be a useful tool for: � Governments: – When monitoring the impact of policies relating to medicine pricing and medicine tariffs, the impact of generic competition, local production and the effects of patent protection – When purchasing medicines and negotiating for equitable medicine prices based on ability to pay (known as “differential” or “equity” pricing) M E D I C I N E P R I C E S : A N E W A P P R O A C H T O M E A S U R E M E N T 10 � NGOs, health professionals and consumers in identifying factors of inequity and unaffordability when advocating for equitable access to essential medicines � Governments and NGOs when measuring the affordability and availability of essential medicines globally, within countries, in different segments of the health care sector and over time � Development agencies and researchers when assessing the effects of policies on programmes. A NEW APPROACH The approach described in this manual has been designed for the collection and analysis of medicine prices in a standardized way. It has been developed for use by governments, nongovernmental organizations, international agencies, researchers, health professionals and consumer organizations. This new approach involves a systematic survey to collect accurate data and reliable information on a selected number of medicines; it is characterized as follows: � Standard list of medicines for comparison � Systematic sampling process � Use of international reference prices � Comparison of innovator brand and generically equivalent medicines � Sector comparisons: e.g. public, private for-profit, private not-for-profit � Affordability comparisons � Identification of the components making up the final price. A completed study using this approach enables the following questions to be answered: � What price do people pay for key medicines? � Do the prices and availability of the same medicines vary in different sectors: public health facilities, private retail pharmacies and other medicine outlets? � Do prices of the same medicines vary in different parts of a country? � What is the difference in prices of innovator brands and generically equivalent medicines? � How do procurement prices compare with international reference prices and with local retail prices? � What taxes and duties are levied on medicines and what is the level of various mark-ups, which contribute to their retail prices? � How affordable are medicines for ordinary people? A medicine price study using this methodology will enable the price of a medicine to be followed from the point at which it leaves the manufacturer to the time it reaches the consumer’s hands. It focuses on a limited number of medicines and enables their prices to be investigated across health care sectors within individual countries and also between countries. It is designed to measure medicine prices at a certain point in time, but can also be used to monitor them over a period of time. The methodology facilitates rapid and reliable data collection and should be easily replicable. W H Y M E A S U R E T H E P R I C E O F M E D I C I N E S ? 11 The methodology requires a systematic survey of the prices of a core list of medicines and allows for a supplementary list of medicines that are selected by each country on the basis of their importance in treating major national health problems. Data analysis, using the software application on the CD-ROM accompanying this manual, will generate the following information: � The prices of selected medicines in different sectors, geographical areas, health facilities and pharmacies � The components of medicine prices � The affordability of the medicines � The availability of the medicines. A database of results has been created by HAI. Each country undertaking a survey using this methodology is encouraged to send the results to HAI Europe and WHO/EDM so they can be shared with other countries; this will enable international price comparisons to be made and increase transparency in medicine pricing. These tools alone will not, of course, solve the problem of high medicine prices. The studies proposed are small in scale and cover only a handful of medicines. The findings of these surveys will, in most cases, serve to define the price problem rather than to solve the challenge of making medicines affordable. That task demands the engagement of many actors and resources beyond these small-scale explorations. But work based on these tools should provide a systematic and reliable set of basic data which will become increasingly widespread. Such data provide reliable evidence for advocacy. Defining the problem is the first step on the road to tackling high medicine prices. CONTENTS OF THE MANUAL The remainder of the manual contains the following chapters. Chapter 2: Overview of the survey introduces the survey methodology and the data that will be collected. Chapter 3: Planning outlines the steps involved in conducting a medicine price survey, considers the human, technical and financial resources that will be required and explains the sampling process. Chapter 4: Data collection at central level provides guidance on adapting and completing the forms used for data collection at central level (the National Pharmaceutical Sector form and the Medicine Price Data Collection form) and collecting data on price components. Chapter 5: Preparation for data collection in the field focuses on planning and preparation for field work, including sampling sites, the selection and training of data collectors, pilot testing and the finalization of the Medicine Price Data Collection form used to collect price data from health facilities and pharmacies. Chapter 6: Data collection in the field provides guidance for area supervisors and data collectors on the data collection process and completing the Medicine Price Data Collection form. Chapter 7: Data entry describes how to enter data from the field into the computerized Workbook accompanying this manual. M E D I C I N E P R I C E S : A N E W A P P R O A C H T O M E A S U R E M E N T 12 Chapter 8: Data analysis and interpretation explains how to generate and present summary results for each medicine in each sector included in the survey and to analyse treatment affordability, availability and price composition. Chapter 9 : International price comparisons describes how survey data from individual countries can be used to make cross-country comparisons of the prices and affordability of medicines. Chapter 10 : Exploring possible policy options and lines of action discusses how data collected in the survey can be used to develop appropriate strategies to influence the price and availability of medicines. Chapter 11: Reporting provides guidance on reporting the findings of the survey and suggests different forms in which the results can be presented in order to achieve the most effective dissemination to different target audiences. An example of a report is included in Annex 5. Chapter 12: Development of the manual and beyond outlines how the manual will be developed following the completion and evaluation of further surveys. The next phase of the project is also outlined. The manual also contains: � Glossary of terms � References. 13 2 Overview of the survey � This survey has been designed to provide a comprehensive picture of the prices of selected medicines in your country � You should follow the methodology in order to ensure that your data are reliable and that international comparisons are possible � This chapter outlines the key steps in the process which are discussed in detail in subsequent chapters � A computerized Workbook is provided for data processing � The survey should be repeated periodically in order to assess the impact of policy changes on the prices of medicines. If you, the commissioning organization (NGO, government, public health researcher, etc.), are considering a medicine price survey, spend some time clarifying and drafting the objectives. Be very clear about who you will direct the results and recommended actions to and who else could work with you to achieve the objectives. You will need to designate a survey manager. Most of this manual is addressed to the survey manager. However, we recommend that the commissioning organization should be thoroughly familiar with the survey procedures. STEPS IN THE SURVEY The survey of medicine prices involves the following steps. 1 Survey planning and preparation. 2 Gathering baseline information on the national pharmaceutical sector. 3 Identifying sectors for price comparisons. 4 Selecting geographical areas, health facilities, pharmacies and other medicine outlets in the chosen sectors for sampling. 5 Finalizing the selection of medicines for inclusion in the survey. 6 Training of data collectors and data entry personnel. 7 Collecting data on the prices and availability of medicines in the chosen health facilities and pharmacies. 8 Identifying the components of medicine prices. 9 Assessing affordability. M E D I C I N E P R I C E S : A N E W A P P R O A C H T O M E A S U R E M E N T 14 10 Data entry and processing. 11 Data analysis and interpretation. 12 Making international price comparisons. 13 Identifying policy options. 14 Reporting the survey findings and advocacy. 15 Repeating the survey. All of these are discussed in detail in the following chapters. SURVEY PLANNING AND PREPARATION Careful planning and preparation are essential before data collection commences, including: � Selecting survey personnel: the survey manager, area supervisors, data collectors, data entry personnel and data analyst and the appointment of an Advisory Group � Securing the technical and financial resources required � Selecting sectors and geographical areas for inclusion in the survey � Sampling health facilities, retail pharmacies and other medicine outlets � Preparing a survey schedule � Seeking endorsement for the survey. Note: those undertaking a survey should periodically check the HAI website. Updates, clarifications, tips from survey managers, examples of advocacy documents, etc. will be added to the site as surveys and advocacy are undertaken. COLLECTING NATIONAL PHARMACEUTICAL SECTOR DATA The health care system and the organization of the pharmaceutical sector vary widely between countries. Before beginning the survey, it is important to have a clear understanding of how pharmaceutical services are organized and to determine the relative contribution of various sectors to the procurement and distribution of medicines. Additionally, the main distribution channels for pharmaceuticals should be clearly identified. This will enable you to put medicine prices in a country-wide context and will permit the identification of countries with similar pharmaceutical characteristics, enabling a useful comparison to be made. These data will enable you to take into account the relative importance of different market segments and different financing arrangements, such as social insurance, in making internal and international price comparisons. Check with the Ministry of Health, National Statistical Office or WHO office whether a recent survey has been undertaken for a national medicines policy review. IDENTIFYING SECTORS The survey measures medicine prices at procurement and in three sectors, as follows: � Public sector: government, municipality or other local authority health facilities, including: O V E R V I E W O F T H E S U R V E Y 15 – Clinics and hospitals – Health centres – Pharmacies – Central and/or regional medical stores � Private sector, including retail pharmacies and pharmacies in private clinics and hospitals; note that health facilities operated by private companies, such as mining companies, are excluded � “Other” sector, which you may define according to local circumstances, such as: – Health facilities run by nongovernmental organizations (NGOs) including religious organizations, such as church missions, charitable organizations and relief and development agencies – Dispensing doctors – Other non-pharmacy private medicine outlets. Some of these facilities and sectors may not exist in your country. SAMPLING Data need to be collected in a systematic way in order to ensure that the findings are representative of the country or region in which the survey is being conducted. It is usually not feasible to collect data from a large number of health facilities, pharmacies and other medicine outlets, so a small sample of facilities should be selected in at least four geographical areas: the main urban centre and three other administrative areas. Once these areas have been selected, a sample of facilities and medicine outlets should be chosen for data collection. The sample usually includes facilities in the public, private and “other” sectors. SELECTING MEDICINES Many different medicines are registered and available. A national essential medicines list, which is often only applied in the public sector, normally contains between 250 and 500 substances. In the private sector, however, several thousand medicines may be available. In order to make the survey manageable and to enable comparability, a short “core” list of 30 medicines has been selected as the basis for data collection and analysis. For each medicine, the core list contains one dosage form, one strength, one recommended pack size and up to three products to measure: the innovator brand, the most sold generic equivalent and the lowest price generic equivalent. Core list of medicines It is important to use the core list of medicines as the basis for the survey as this will enable you to compare your prices with those in other countries, where they are available. The 30 medicines contained in the core list have been selected because they meet the following criteria: � Global burden of disease: they are all used to treat common conditions, acute and chronic, that cause significant morbidity and mortality, including M E D I C I N E P R I C E S : A N E W A P P R O A C H T O M E A S U R E M E N T 16 cardiovascular diseases, diabetes, asthma, respiratory tract infections and mental health � Availability: they are available in standard formulations and are widely used in many countries � Importance: the majority are included in the WHO Model List of Essential Medicines (WHOEML) � Patent status: they represent medicines that are both new and on patent, and older medicines that are off patent. In some instances, both new and older products for the treatment of the same condition have been included. Supplementary list of medicines In addition to surveying the prices of medicines included on the core list, you may wish to select up to twenty additional medicines that are commonly used in the treatment of important national health problems, particularly if some medicines on the core list are not available in your country. The supplementary list could also include medicines that are pharmaceutically equivalent to ones on the core list but that are more frequently used in your country, such as another ACE- inhibitor, antidiabetic or antacid medicine. International reference prices Reference prices are used to facilitate national and international comparisons. Summary measures of the medicine prices found during the survey will be expressed as ratios relative to a standard set of reference prices. The Management Sciences for Health (MSH) reference prices have been selected as the most useful standard. The MSH reference prices are the medians of recent procurement or tender prices offered by not-for-profit suppliers to developing countries for multi-source products. TRAINING All personnel involved in data collection and data entry require training to ensure the reliable and accurate completion of the data collection forms and their transfer to the Workbook. It is recommended that a pilot test should be conducted during the training of data collectors. COLLECTING DATA ON THE PRICES AND AVAILABILITY OF MEDICINES The prices of medicines vary according to a number of factors, including: � The sector in which they are purchased: the price is often higher in the private for-profit sector � The type of procurement agent: for example, different prices may be paid for the same product by a public sector purchaser, such as the Ministry of Health, the health facility that supplies the medicine to the patient, and the individual who purchases the medicine � The distribution route: a patient who purchases a medicine at a public hospital pharmacy, for instance, may have to pay more if the hospital O V E R V I E W O F T H E S U R V E Y 17 pharmacy purchased the product from a local wholesaler than if it has been purchased by tender and supplied through the public health sector distribution system � The patent status: the price of patented medicines is often higher than that of their generic equivalent, at least while the patent is in force. If a medicine is under patent in a given country, only the innovator brand or a licensed product will be on the market, unless measures are taken to allow the penetration of generically equivalent products. If it is off patent, a number of generically equivalent products are likely to be available. For each medicine, data collectors are asked to record three prices on the Medicine Price Data Collection form in each health facility and pharmacy included in the sample: � The innovator brand � The most sold generic equivalent in your country � The lowest price generic equivalent in the medicine outlets surveyed. The methodology also measures the availability of the selected medicines. The medicines included in the core list may not be the most frequently used in your country and may not even be on your essential medicines list. In most cases, there are pharmaceutically equivalent medicines that you may have chosen to include on your supplementary list. The estimate of availability may therefore be more accurate for the supplementary list. For both lists, however, it does provide an indication of where action may be required. IDENTIFYING THE COMPONENTS OF MEDICINE PRICES The final price of a medicine paid by a government facility, a health insurer or the patient reflects the manufacturer’s selling price (MSP), plus all intervening price additions. These add-ons to the producer’s price are known as “price components” and represent the cost of importation, distribution and dispensing. They consist of local costs that may differ substantially from one country to another, within a sector and even between medicines. They typically include: � Pharmaceutical import duties � Taxes � Mark-ups by importers, wholesalers and retail distributors � Distribution costs � Dispensing fees. ASSESSING AFFORDABILITY One of the best ways of illustrating the impact of medicine prices on the cost of health care for individual patients and society is to compare the cost of treatment with peoples’ income. For this survey, the daily wage of an unskilled government worker is used for comparison. When price data are entered in the computerized Workbook, the affordability of treatment for a selection of conditions will be calculated automatically. This will enable you to identify the number of days an unskilled government worker would have to work in order to afford the cost of a defined course of treatment for these conditions. M E D I C I N E P R I C E S : A N E W A P P R O A C H T O M E A S U R E M E N T 18 DATA ENTRY Data entry and analysis generally take place at central level. A computerized WHO/HAI International Medicine Price Workbook, which is a special application for Microsoft Excel, is used to enter the data collected in the field, consolidate and summarize results and print tables that serve as the basis for reports. The Workbook, which is provided on the CD-ROM accompanying this manual, allows rapid entry and analysis of data on the price and availability of medicines and facilitates international price comparisons. DATA ANALYSIS AND INTERPRETATION The Workbook also provides automatic summaries of data to permit four types of data analysis: � Price and availability comparisons within any one sector � Price and availability comparisons between different sectors � Treatment affordability � Price composition. The Workbook automatically generates summary tables which compare the median prices from your survey with international reference prices and which provide the evidence base for your report. MAKING INTERNATIONAL PRICE COMPARISONS Comparisons of medicine prices with those in other countries can provide powerful tools for advocacy and help to identify policy changes and possible lines of action to reduce high prices. HAI has established a database on its website so that price data collected using this methodology are accessible to all. All countries undertaking a survey of medicine prices are encouraged to send the completed Workbook and survey report for inclusion on this database to enable international comparisons to be made of: � The prices of individual innovator brand or generically equivalent medicines, from each defined sector, on the core list � The affordability of selected courses of treatment, measured against the minimum wage for a government worker � The price composition of a medicine. IDENTIFYING POLICY OPTIONS The ultimate objective of the price survey is to bring about changes in national medicines policies which will result in making medicines affordable for all people. High medicine prices may be attributable to a number of factors; accordingly, an understanding of the most important contributing causes is needed in order to advocate for the most appropriate policy options and lines of action. O V E R V I E W O F T H E S U R V E Y 19 REPORTING THE SURVEY FINDINGS Reliable data and the accurate analysis and interpretation of data form the foundation of the survey, but its effectiveness in stimulating policy changes to reduce the price of medicines will, in part, be determined by the way in which the findings are presented and the advocacy that follows. The findings of the survey can be presented in a number of formats. To achieve the maximum coverage and impact, they should be reported in the most appropriate form for the various target audiences. An example of a survey report is included as Annex 5. The survey report should be prepared and disseminated as quickly as possible to avoid the findings becoming outdated. REPEATING THE SURVEY The prices of medicines do not remain static and need to be monitored at regular intervals. In addition, the findings from one survey could lead to changes in policy that should be monitored. The survey should, therefore, be repeated regularly, preferably every one or two years. It is important to survey the same medicines at the same sites as in the original survey in order to measure any changes in prices as accurately as possible. You should also identify the price components that have changed and determine further action that might be taken to reduce the prices paid. You may also want to include new products in a repeat survey. These should be added to your supplementary list of medicines. Alternatively you may wish to delete others if they are no longer widely available or commonly prescribed. When surveys are repeated, external conditions such as inflation may influence price stability and make comparison difficult. You may have to discuss their impact with economists and get advice on how to adjust for these conditions. 20 3 Planning � Identify the personnel, technical and financial resources required to conduct the survey before starting data collection and data processing � It is essential to follow the survey design and process, particularly in relation to the sampling technique � The survey should take between six and eight weeks to complete, including data collection, data entry, data analysis and report writing � An official letter of endorsement from the Ministry of Health and/or the Pharmacy Association will facilitate data collection. PERSONNEL The survey will require the involvement of the following personnel: � Survey manager, supported by an Advisory Group � Area supervisors � Data collectors � Data entry personnel � Data analyst. Survey manager A survey manager should be designated to plan and coordinate the survey at national level. For NGOs, this role will usually also include fundraising and advocacy. Wherever possible, the survey manager should be a pharmacist with some experience in conducting surveys. A familiarity with Microsoft Excel spreadsheets, basic statistics (such as ratios, medians and percentiles) and interpreting data is highly desirable. Successful communication of the survey results also requires an understanding of the policy-making process and advocacy strategies. Where the survey manager does not possess all these qualities, he or she should select the Advisory Group members to ensure that the survey management team includes pharmacy, survey, statistics, policy and advocacy skills. Advisory Group A group of carefully selected advisers should be useful in helping to plan and support the survey and promote its findings. The membership should complement P L A N N I N G 21 the survey manager's skills in the areas above and include at least one medical doctor as well as stakeholders, such as policy makers, health care providers, relevant professional associations, public health institutions, academic institutions and consumer organizations. It may be wise to include the data analyst and an area supervisor to ensure that the Advisory Group understands local realities. The role of the Advisory Group will include: � Determining the specific focus of the survey: i.e. national or regional � Identifying the sectors to be surveyed � Supporting the survey manager in setting up and conducting the study � Advising on any matters that arise during survey preparation, data collection and data analysis, including how to solve any problems that may be encountered � Assisting in preparing the survey report and making recommendations on policy options and possible lines of action � Promoting the findings of the survey and advocating appropriate changes in policy. Area supervisors In a small country or in a survey that is conducted in a single region of the country, it may be possible for all field work to be undertaken by a central team. Experience from conducting pilot studies has shown that in larger-scale studies, however, it is advisable to designate a supervisor, preferably a pharmacist, in each of the geographical areas that will be surveyed. Area supervisors should be experienced in data collection and be familiar with pharmaceutical terminology. They will be instrumental in gaining access to facilities and in choosing local data collectors, if they are not sent from central level. If any area supervisor is unfamiliar with their designated area, a local contact may be needed to assist in identifying facilities and pharmacies. Data collectors Wherever possible, data collectors should: � Have previous experience of conducting surveys � Have some pharmaceutical training � Be familiar with the locality. Ideally, data collectors should work in pairs so that they can make systematic checks of entries in the Medicine Price Data Collection form. Each visit to a health facility or pharmacy is likely to require about 1-2 hours plus transport time. In practice, this means that a team of two data collectors can probably survey two to four facilities per day. Data entry personnel Accurate data entry is vital to ensure the reliability of the results. Two data processing personnel with experience in using Microsoft Excel are required: one to enter the data and the other to re-enter the same data to check that the entries are correct. The computerized Workbook has been designed to identify any discrepancies in data entry using this “double-entry” process. M E D I C I N E P R I C E S : A N E W A P P R O A C H T O M E A S U R E M E N T 22 Data analyst Data analysis requires an understanding of the pharmaceutical sector and experience in computer use and the interpretation of statistics. Where possible, data analysis should be undertaken by the survey manager. TECHNICAL RESOURCES The computerized Workbook is a specially designed software application for Microsoft Excel. In order to use it, a computer that meets the following minimum requirements will be needed: � An IBM-compatible PC with a Pentium 3 or higher processor � Windows operating environment � 48 megabytes of system memory � Microsoft Excel Office 97 or later version � A CD drive or internet access, so that the Workbook can be loaded from the CD-ROM supplied with the manual or downloaded from the HAI website. Very few other resources are needed to conduct the survey. Each area supervisor should be supplied with a simple calculator to calculate unit prices. Transport will be needed to take the data collection teams to health facilities and pharmacies, and to the geographical sites selected, if the teams are not from the local area. FINANCIAL RESOURCES When planning the survey, reporting and advocacy, it is essential to ensure that there is an adequate budget for the following items: � Personnel: – Survey manager – Area supervisors – Data collectors – Data processing personnel – Data analyst � Training: – Training venue – Daily allowance and accommodation – Transport – Materials � Data collection: – Daily field allowance and accommodation for data collectors – Transport – Materials: pens, calculators – Photocopying � Advocacy: for example, meetings, seminars, briefing materials � Communications � Overhead � Contingency. P L A N N I N G 23 PLANNING WHERE TO CONDUCT THE SURVEY Defining the type of survey Most medicine price surveys will involve examining prices and price variations in an entire country or in a large region of a country. However, the methodology can be adapted for different purposes such as to contrast prices in two geographic areas or to monitor changes in prices in a sample of medicine outlets over time. The ideal national survey would collect data from a large number of health facilities and other medicine outlets scattered around the country. However this would require a great deal of time and resources. To make the survey feasible, therefore, it is based on small samples of geographic areas and medicine outlets. Through careful selection, these study sites can adequately represent the situation in the country as a whole. If resources allow, increasing the numbers of geographic areas and medicine outlets above the minimum numbers recommended below will increase the accuracy of the survey. If you plan to increase the number of facilities surveyed, increasing the number of geographic areas will provide a more representative sample than simply increasing the number of medicine outlets surveyed in the same geographic areas. Selecting sectors One key issue for the study planning team to decide is how many sectors to include in the survey. Each sector represents a conceptually different source of medicines or prices to be assessed and compared. Most national surveys will examine at least three of the following four sectors. 1 Medicine Procurement Prices: prices that the government and other purchasers pay to procure medicines. 2 Public Sector Patient Prices: if patients in public health facilities are charged for medicines, these prices may be considered a second sector, which can be compared to procurement prices. Even if medicines are free in public facilities, most surveys will want to examine the availability of the target medicines in the public sector. 3 Private Sector Retail Prices: prices that patients pay in private pharmacies. 4 Other Sector Patient Prices: depending on the nature of the pharmaceutical sector, there may be a fourth, “other” sector you may wish to include in the survey. Examples include: � Health facilities run by church missions or other nongovernmental organizations, such as charitable organizations or relief and development agencies � Dispensing doctors � Other non-pharmacy private retail outlets that stock a reasonable range of products. The computerized Workbook is designed to measure prices in up to four sectors. M E D I C I N E P R I C E S : A N E W A P P R O A C H T O M E A S U R E M E N T 24 Choosing study areas Once a decision has been made on the number of sectors to be included, you will need to determine where to collect data. Procurement data can usually be collected centrally from the office of the procurement officer or central medical stores. Data on prices and availability in the public, private and “other” sectors are obtained by data collectors in the field. Collecting data in many areas increases the cost and complexity of a survey but, if prices vary widely by area, sampling too few will bias results. Include at least four geographic areas in a national or regional survey, as follows: � Select the major urban centre (usually the capital) � Select three other administrative areas (e.g. districts, municipalities, counties) chosen randomly from a list of areas that can be reached in one day from the urban centre. In a large country, distant or remote areas will be under-represented in a sample of this size. If you want to examine prices in a large country, it is preferable to conduct multiple surveys in different regions, with each survey collecting data in four geographic areas as above. SELECTING A SAMPLE Once geographic areas have been chosen, you will need to choose a sample of medicine outlets in which to gather data. A typical survey includes public health facilities, private pharmacies and one other type of medicine outlet. Generally, lists of public health facilities are available at central level, so these facilities can be selected centrally. However, accurate lists of private pharmacies, dispensing doctors or other private medicine outlets may need to be compiled in the field. The overall sampling approach is shown in Figure 3.1. Retail pharmacies/medicine outlets in other sectors are selected according to their proximity to the public health facilities Central data collection Figure 3.1 Sampling approach Local data collection: other administrative area 3 Main public hospital Other public health facility Other public health facility Other public health facility Other public health facility Local data collection: other administrative area 2 Main public hospital Other public health facility Other public health facility Other public health facility Other public health facility Local data collection: other administrative area 1 Main public hospital Other public health facility Other public health facility Other public health facility Other public health facility Local data collection: major urban centre Main public hospital Other public health facility Other public health facility Other public health facility Other public health facility P L A N N I N G 25 Selecting public sector facilities For convenience, public health facilities are used to anchor the sample, with other types of medicine outlet chosen by their proximity to these facilities. You will need to obtain lists of all public health facilities that have pharmacies or dispensaries in each survey area that are within a three hour drive of the main government hospital. Most countries have several levels of facilities, from hospitals down to health centres or dispensaries. Lower level facilities are often more widely dispersed than upper level ones. Generally, both upper and lower level facilities should be included if they are expected to stock most of the medicines included in the study. Choose at least five public health facilities in each survey area, as follows. 1 Select the main public hospital in the area (district or regional hospital). 2 Select four facilities from the ones remaining on your list: � If there is only one level of facilities on the list, choose four at random � If there are two or more levels on the list: – Divide the list by level (hospitals versus all other facilities) – Select two facilities randomly from each level � If there are fewer than two facilities on any list, increase the number selected from the other lists accordingly � If there are fewer than five public health facilities in any of the administrative areas chosen for the survey, extend the lists to include the closest facilities in a neighbouring area. Selecting private pharmacies Private pharmacies will be sampled by their proximity to the public health facilities selected. 1 Obtain lists of pharmacies registered in each study area centrally if they are available (e.g. from the Ministry of Health, Pharmacy Association or business registry). The lists may be incomplete so they should be checked and updated by the area supervisor in the study area by consulting with local officials. These lists can help to guide the pharmacy selection process. 2 Once the public health facilities have been selected, the pharmacy that is closest to each facility should be selected by the area supervisor. 3 If there is no pharmacy within 5 km of a remote facility, another pharmacy in the urban centre should be selected. This process will result in a sample of at least five pharmacies in each survey area. The process of selecting private pharmacies in the field is described further in Chapter 5. Selecting other types of medicine outlet Up to five outlets in each sample area will also need to be selected for the “other” sector in your survey. The selection procedure will depend on the nature of the sector. In your country, you may not have such sectors. M E D I C I N E P R I C E S : A N E W A P P R O A C H T O M E A S U R E M E N T 26 NGO health facilities For a sector that includes NGO health facilities, the selection procedure is as follows. 1 Create centrally a list of all facilities in each survey area by consulting the proper administrative authorities. 2 From each list, choose the facility that is closest to each public health facility in the sample. 3 If there is no facility on the list within 10 km of a given public health facility, substitute another NGO health facility from the urban area. 4 If there are fewer than five facilities on the list, select all the facilities. This process will result in a sample of up to five NGO health facilities in each survey area. Other medicine outlets For other types of medicine outlet (e.g. dispensing doctors, non-pharmacy medicine stores), the sample will usually have to be selected locally, as with pharmacies. The process of selection is described in Chapter 5. This process will result in a sample of up to five other medicine outlets in each survey area. Experience from pilot studies confirms the importance of following the survey design and process described above and paying particular attention to the sampling technique. Selecting a smaller sample size, for instance, weakens the validity of the data. PLANNING TIMELINE Once the sample has been selected, you will need to prepare a timetable of activities. Experience from pilot field studies indicates that a survey should take between six and eight weeks to complete, including data analysis and report writing. Further time should be included for advocacy. Figure 3.2 shows the main steps in the survey and indicates activities that need to be undertaken at: � Central level � Field level. Figure 3.2 also indicates the section of the manual in which each activity is described in detail. SEEKING ENDORSEMENTS A signed, official letter endorsing the price survey can be of great help to all involved in carrying out the survey. If the survey manager can approach the relevant bodies with an example of the kind of letter that is sought, it may be ! P L A N N I N G 27 Figure 3.2 Steps in conducting the survey Activity Central/field level Reference Identify Advisory Group Central pp. 20–21 Fill in National Pharmaceutical Sector form Central pp. 28–29 Determine scope of survey (national/regional) Central p. 23 and identify sectors Select geographic study areas Central p. 24 Prepare budget and secure funds Central p. 22 Seek endorsements Central pp. 26–27 Finalize list of medicines to be surveyed Central pp. 29–38 Identify health facilities Central pp. 24–26 Select and train area supervisors Central p. 45 Identify pharmacies and medicine outlets Field pp. 45–46 Select and train data collectors Field pp. 47–48 Prepare data collection forms Field p. 49 Prepare letter of introduction Field p. 50 Schedule survey visits Field pp. 49–50 Conduct survey Field pp. 52–57 Identify components of medicine prices Central pp. 38–43 Data entry Central pp. 58–74 Data analysis and interpretation Central pp. 75–97 Compare with survey data from other countries Central pp. 98–103 Identify policy options Central pp. 104–108 Write report Central pp. 109–110 Present findings and advocate for change Central pp. 110–112 Note: as an alternative, data collectors can be selected centrally and survey all geographic areas easier for the Ministry of Health or the Pharmacy Association to provide such an endorsement for the survey. An example of a letter of endorsement, shown in Annex 1, is included as a Word file on the CD-ROM which you can modify locally, as appropriate. WHO will also provide a letter of endorsement on request. Contact the Essential Drugs and Medicines Policy Department by e-mail at email@example.com. 28 4 Data collection at central level � Standard survey forms are provided on the CD-ROM � The National Pharmaceutical Sector form should be completed before data collection begins in the field � The Medicine Price Data Collection form should be reviewed, the core list of medicines checked and the supplementary list added � For price comparisons between countries and for repeated surveys it is of utmost importance not to divert from the selected medicines, their strengths and dosage forms and to use the pack size recommended, wherever possible. Before data collection commences in the field, some data need to be collected at central level. NATIONAL PHARMACEUTICAL SECTOR FORM The National Pharmaceutical Sector form is used to collect baseline information on national medicines policy, procurement and distribution, government and private sector price policy and financing of medicines. This will provide a good overview of the pharmaceutical sector in your country which will help you in interpreting the survey findings and identifying policy options. This form should be completed by the survey manager at central level. Completing the National Pharmaceutical Sector form The National Pharmaceutical Sector form is shown in Annex 2. 1 Transfer the National Pharmaceutical Sector form to your computer. You can do this by: � Copying the file from the CD-ROM that accompanies this manual � Downloading the latest file from the HAI website: (http://www.haiweb.org/medicineprices). 29 D A T A C O L L E C T I O N A T C E N T R A L L E V E L 2 As soon as you open the file, save it with a filename that indicates the year of your survey so that you retain a clean form to use for future surveys. For example, you might choose a filename such as NPS.03.xls. 3 Complete the whole form, ensuring that you record the following information on the first page: � Daily wage of the lowest paid unskilled national government worker � Exchange rate. This information will later need to be entered into the computerized Workbook (see Chapter 7). Information should be available from the Ministry of Health or the local WHO office. In addition, the following sources may be useful: � WHO Medicines Database: http://www.who.mednet.int (online registration required) � WHO/Euro country profiles: http://www.euro.who.int/InformationSources/Evidence/20010828_1 � PAHO/AMRO country profiles: http://www.paho.org/english/sha/profiles.htm Wage level The daily wage of the lowest paid unskilled national government worker will be used to measure the affordability of medicines. You may be able to obtain this information from the personnel office in the Ministry of Health. If it is not available, contact a recently employed low-level worker to find out the net salary: � After all compulsory deductions of charges and taxes � Excluding allowances: e.g. housing, travel, hardship, leave allowance. Reduce the salary to a daily wage by dividing by 365, 30, 14 or 7, depending on the pay period. Exchange rate Enter the rate of exchange to US dollars. The exchange rate is the commercial “buy” rate on the first day of data collection. MEDICINE PRICE DATA COLLECTION FORM The model Medicine Price Data Collection form should be used as the basis for the Medicine Price Data Collection form used in the field to collect data on the retail prices and availability of medicines. You will need to download this form onto your computer and amend it so that it contains the medicines on the core list and the supplementary list in your country. As with the National Pharmaceutical Sector form, you can do this by: � Copying the file from the CD-ROM that accompanies this manual � Downloading the latest file from the HAI website: http://www.haiweb.org/medicineprices. As soon as you open the file, save it with a filename that indicates the year of your survey, such as MPDC.03.xls. M E D I C I N E P R I C E S : A N E W A P P R O A C H T O M E A S U R E M E N T 30 Core list of medicines Figure 4.1 shows the core list of 30 medicines that should be included in the survey if they are available in your country. This list appears in Column A of the Medicine Price Data Collection form. Figure 4.1 Core list of medicines to be surveyed Generic name Dose Dosage form Medicine category Aciclovir 200 mg tablet Antiviral Amitriptyline 25 mg tablet Antidepressant Amoxicillin 250 mg capsule/tablet Antibacterial Artesunate 100 mg tablet Antimalarial Atenolol 50 mg tablet Antihypertensive Beclometasone 50 mcg per dose inhaler Antiasthmatic Captopril 25 mg tablet Antihypertensive Carbamazepine 200 mg tablet Antiepileptic Ceftriaxone 1 g powder for injection Antibacterial Ciprofloxacin 500 mg tablet Antibacterial Co-trimoxazole (8 + 40) mg/mL paediatric suspension Antibacterial Diazepam 5 mg tablet Anxiolytic Diclofenac 25 mg tablet Antiinflammatory Fluconazole 200 mg tablet/capsule Antifungal Fluoxetine 20 mg tablet/capsule Antidepressant Fluphenazine decanoate 25 mg/ml injection Antipsychotic Glibenclamide 5 mg tablet Antidiabetic Hydrochlorothiazide 25 mg tablet Antihypertensive Indinavir 400 mg capsule Antiviral Losartan 50 mg tablet Antihypertensive Lovastatin 20 mg tablet Serum lipid reducing Metformin 500 mg tablet Antidiabetic Nevirapine 200 mg tablet Antiviral Nifedipine retard 20 mg retard tablet Antihypertensive Omeprazole 20 mg capsule Antacid Phenytoin 100 mg tablet Antiepileptic Pyrimethamine with (500+25) mg tablet Antimalarial sulfadoxine Ranitidine 150 mg tablet Antacid Salbutamol 0.1 mg per dose inhaler Antiasthmatic Zidovudine 100 mg capsule Antiviral Modified release formulations Most tablets and capsules are designed so that the active ingredient(s) is released immediately the medicine is taken. Others have modified release characteristics. These are referred to using a number of terms including sustained release (SR), slow release (SR), controlled release (CR), retard, modified release (MR) or long acting (LA) tablets or capsules. These work by gradually releasing D A T A C O L L E C T I O N A T C E N T R A L L E V E L 31 the active ingredient as the capsule or tablet moves down the gastrointestinal tract. Some medicines are marketed in both immediate release and modified release formulations. In Kenya, for example, nifedipine is available as 10 mg, 20 mg and 30 mg capsules, 10 mg and 20 mg tablets, 10 mg and 20 mg retard tablets, 10 mg and 20 mg SR tablets, and 30 mg LA tablets. It is vital that you collect the price of the medicine, dosage form and strength as stated on the form. The only modified release preparation on the core list of medicines is nifedipine retard 20 mg tablets. Collect data only on the 20 mg retard formulation, in tablet form. Be aware that nifedipine is available in various forms and strengths. Core list of medicines The first step in preparing the Medicine Price Data Collection form is to prepare the core list of medicines for your country and to amend the form, if necessary. 1 Review the list of 30 core medicines in Column A of the form. 2 If any medicines on the core list are unavailable in your country, delete them from the core list on the form in the Word file. When data processing begins, they will also need to be deleted from the core list in the Workbook (see Chapter 7). 3 If a medicine is available in your country, but the stated dosage form or strength differs from that on the core list, delete it from the core list and include it in the supplementary list of medicines. 4 If a pharmaceutically equivalent medicine is widely used instead of a medicine on the core list, you may wish to add it to your supplementary list of medicines. Some substances remain under patent in countries that observe medicine patents; others are off patent or have never been patented. As patent status varies by country and over time, this manual cannot identify the patent status of the core medicines, but some new medicines are included that are still under patent in the USA and/or Europe. The core list should not be considered as a recommendation for inclusion in national treatment guidelines. Medicine quality The availability and use of substandard and counterfeit medicines are serious problems in some countries, particularly in those where there is a poor regulatory framework or inadequate enforcement of relevant laws and regulations. In order to ensure that information is not collected on substandard or counterfeit medicines, all products included in the survey must be registered or have market authorization in your country. Supplementary list of medicines The next step is to prepare the supplementary list of medicines for your country. Up to 20 medicines supplementary to the core list may be selected for domestic comparison and for monitoring trends over time. The supplementary list of medicines should reflect national or local disease and treatment priorities, based on criteria such as: � Burden of disease � Local production M E D I C I N E P R I C E S : A N E W A P P R O A C H T O M E A S U R E M E N T 32 � Availability of fixed dose combination products � Availability of an international reference price (MSH or other). Examples of diseases with high prevalence in certain regions are tuberculosis, malaria, sleeping sickness, trachoma, anaemia and parasitic diseases. If your country has a high prevalence of HIV/AIDS and antiretroviral triple therapy is available, you should include one of the fixed dosage combinations or the single medicines constituting first line Highly Active AntiRetroviral Therapy (HAART), if this is in use and if the medicines in the national guidelines differ from the ones included in the core list. In many countries, combination products are more common than products with single agents. The WHO Essential Medicines List prefers to use products with one single ingredient which allows more flexibility in prescribing and dosing, although there is now an increasing move towards fixed dose combinations for malaria, tuberculosis and HIV. This is also the policy of many regulatory authorities and agencies that develop therapeutic guidelines. This may be one reason why you may find few of the products on the core list of medicines. If so, you may wish to include some combination products on your supplementary list of medicines to better reflect the national situation. Be aware, though, that this may limit the number of generically equivalent alternatives because different manufacturers may use different combinations. International reference prices The medicine, dosage form and strength should have an international reference price (see Chapter 7). Wherever possible, only prescription medicines should be included on the supplementary list of medicines. Components of the Medicine Price Data Collection form For each medicine, there are three rows and nine columns. Rows 1 and 2 of the form should be completed at central level before the survey starts. Row 1: The first row is for recording information on the innovator brand. It may be changed to the brand name for the same product used by the manufacturer in your country (see p. 34 and Chapter 6). Row 2: The second row is for recording information on the most sold generic product equivalent to the innovator brand (see p. 34 and Chapter 6). Row 3: The third row is for recording information on the lowest price generic product equivalent to the innovator brand. The data collectors will identify this product in each medicine outlet surveyed and enter the information onto the form (see p. 35 and Chapter 6). For the purpose of this study, the following definitions are used: � Innovator brand: the originator pharmaceutical product � Generic equivalent: all products other than the innovator brand that contain the same active ingredient (substance), whether marketed under another brand name or the generic name. See the Glossary for fuller definitions of innovator brand and generic equivalent. D A T A C O L L E C T I O N A T C E N T R A L L E V E L 33 Rows 2 and 3 for each medicine can be identical if the most sold generic equivalent is also the lowest priced. However, the product in Row 1 can appear only in that row. Figure 4.2 shows an extract from the Medicine Price Data Collection form. Note that some cells are shaded grey. These cells should not be amended. Figure 4.2 Extract from the Medicine Price Data Collection form: core list of medicines In public, private and “other” health facilities, there will generally be only one product and hence only one price per medicine to collect. In private pharmacies, a wider range of innovator brands and generic medicines is usually available so the prices of all three (innovator brand, most sold generic equivalent and lowest price generic equivalent) are likely to be collectable. Supplementary list of medicines Once the core list of medicines has been reviewed and, where necessary revised, add your supplementary list of medicines to the Medicine Price Data Collection form in the Word file. They should appear in the same form as on the core list, and should state the dosage form and strength. Figure 4.3 shows an example of a supplementary list of medicines in which the brand name and manufacturer of the innovator brand have been added. Note that Figure 4.3 Example of Medicine Price Data Collection form: supplementary list of medicines A B C D E F G H I Generic name, dosage form, strength Brand name(s) Manufacturer Available tick ✓ for yes Pack size recommended Pack size found Price of pack found Unit price (4 digits) Comments Aciclovir tab 200 mg Zovirax GSK 25 /tab Most sold generic equivalent 25 /tab Lowest price generic equivalent 25 /tab Amitriptyline tab 25 mg Tryptizol MSD 100 /tab Most sold generic equivalent 100 /tab Lowest price generic equivalent 100 /tab Amoxicillin caps/tab 250 mg Amoxil SKB (GSK) 21 /tab Most sold generic equivalent 21 /tab Lowest price generic equivalent 21 /tab A B C D E F G H I Generic name, dosage form, strength Brand name(s) Manufacturer Available tick ✓ for yes Pack size recommended Pack size found Price of pack found Unit price (4 digits) Comments Albendazole tab 200 mg Zental GSK 2 /tab Most sold generic equivalent 2 /tab Lowest price generic equivalent 2 /tab Lamivudine+zidovudine tab 150+300 mg Combivir GSK 60 /tab Most sold generic equivalent 60 /tab Lowest price generic equivalent 60 /tab Metronidazole tab 200 mg Flagyl Aventis 200 /tab Most sold generic equivalent 200 /tab Lowest price generic equivalent 200 /tab Amoxicillin+clavulanic acid tab 250+125 mg Augmentin GSK 21 /tab Most sold generic equivalent 21 /tab Lowest price generic equivalent 21 /tab M E D I C I N E P R I C E S : A N E W A P P R O A C H T O M E A S U R E M E N T 34 for each medicine, the innovator brand, most sold generic equivalent and lowest price generic equivalent have the same recommended pack size. To facilitate data collection, the core medicines and supplementary medicines can be combined into one list in alphabetical order by generic name on the Medicine Price Data Collection form. When medicine names are entered into the computerized Workbook, the core medicines and supplementary medicines will be combined automatically into one list. Row 1: Identifying the innovator brand product For each medicine, the form lists the innovator brand name that is most commonly used by the manufacturer in English-speaking countries. If the manufacturer uses another brand name in your country, change the innovator brand name on the form. Row 2: Identifying the most sold generic equivalent Row 2 for each medicine is used for measuring the price of the most sold generic equivalent to the innovator brand that is listed in Row 1. Official figures may be publicly available in your country on the most sold products in sales volume in the private sector. Other sources include IMS Health, insurance companies, customs and the government body responsible for the pharmaceutical sector. Where such data are not available, it is recommended to undertake an initial survey of large geographically dispersed pharmacies or wholesalers, perhaps by telephone. Enter the name of the product and the manufacturer on the form. Note that the product may not be the most sold generic equivalent in all individual pharmacies. The Medicine Price Data Collection form is modelled on the private sector which will have the widest range of medicines and in which it will normally be possible to find the innovator, most sold generic equivalent and lowest price generic equivalent for each medicine. In all sectors, there may be only one or two products for each medicine; if this is the case, enter information as follows: � If there is no innovator brand, leave Row 1 blank � If there is only one generically equivalent product available, it will be both the most sold and the lowest price generic equivalent: enter the same information in Row 2 and Row 3 and note this in the ‘Comments’ column (Column I) � If more than one generically equivalent product is available and the most sold generic equivalent also has the lowest price, enter the information for the most sold generic equivalent in both Row 2 and Row 3 and note this in the ‘Comments’ column (Column I). The name of each most sold generic equivalent surveyed will be the same for all pharmacies and other medicine outlets and should be entered at central level. The price of the product may differ, however, and will be collected in each facility. D A T A C O L L E C T I O N A T C E N T R A L L E V E L 35 Row 3: Identifying the lowest price generic equivalent Row 3 is for collecting information on the lowest price generic product equivalent to the innovator brand (Row 1) found in a pharmacy or other medicine outlet. The product’s name and manufacturer is identified in each pharmacy and medicine outlet surveyed. The data collectors will need to enter the following information for each medicine listed on the form (see Chapter 6): � Column B: the name of the lowest price generic equivalent � Column C: the manufacturer of the lowest price generic equivalent. The lowest price generic equivalent identified in each pharmacy may vary. The name may also vary between pharmacies and other medicine outlets. Column A: Name of medicine, dosage form and strength Column A lists: � International Non-proprietary Name (INN) of the medicine � The dosage form of the medicine � The strength of the medicine. Do not change Column A of the core list in the Medicine Price Data Collection form. A medicine may be available in different dosage forms: tablet/capsule, mixture/ syrup, suspension, injection, cream/ointment and so on. Tablets and capsules are normally considered equivalent, unless they are retard, SR, etc. (see p. 30). Information should be collected only for the dosage form listed in Column A. The oral form is used for most substances. Plain tablets or capsules should be used for all oral dosage forms, with the exception of nifedipine. Some medicines will be marketed in more than one strength: for example, fluconazole may be marketed as 50 mg, 150 mg and 200 mg tablets/capsules. The Medicine Price Data Collection form lists the strength selected for inclusion in the survey; this is the only strength on which information should be collected. If this strength is not marketed in your country, delete the medicine from the core list on the form. If only other dosage forms or strengths are used, you may choose to add the medicine to your supplementary list with the dosage form and strength used in your country. Column B: Brand name The form lists the most common innovator brand name used in Anglophone countries for each medicine. However, the manufacturer may not use the same name worldwide; for example, omeprazole is called both Prilosec and Losec, and fluoxetine is called both Prozac and Fontex. Other names may also be used. If the innovator brand name used in your country differs from the one on the form, you can change the name of the medicine on the core list, as long as the medicine, the dosage form and strength are the same. An innovator brand has been identified for all 30 substances on the core list of medicines. If your supplementary list includes old medicines that were probably never patented, choose the most expensive brand name product in the market and enter the name in Column B and the manufacturer in Column C of the form. M E D I C I N E P R I C E S : A N E W A P P R O A C H T O M E A S U R E M E N T 36 Column C: Manufacturer In Row 1, this column contains the name of the innovator (patent holder). In Row 2, the manufacturer’s name for the generically equivalent product to be monitored should be entered. The data collectors will complete Row 3 in each individual pharmacy with the name of the manufacturer of the cheapest generic equivalent found there (see Chapter 6). Column D: Available Medicine Procurement Prices Column D should be completed at central level in the office of the procurement officer or central medical stores to indicate all medicines on the list that are available. Public Sector Patient Prices, Private Sector Retail Prices and Other Sector Patient Prices This column will be completed by the data collectors in the field. They should record that the innovator brand, most sold generic equivalent and lowest price generic equivalent are available only if they actually see a pack of the medicine. Column E: Pack size recommended All the medicines on the core list are in oral solid form (tablet or capsule), with the exception of: � Ceftriaxone injection � Co-trimoxazole paediatric suspension � Fluphenazine decanoate injection � Beclometasone and salbutamol inhalers. There may be several pack sizes available, such as a box or pack of 30, 100, 250 or 1000 tablets or capsules, and single vials, 10 vials or 100 vials for injection. Mixtures may be available in different volumes: e.g. 50 ml, 70 ml, 100 ml. The price per unit may vary between pack sizes. One pack size for each medicine has been selected in order to facilitate comparisons between products, sectors and countries. Column E lists the recommended pack size to monitor; this is as close to recommended treatment lengths as possible. Chapter 6 gives guidance on what data collectors should do if that pack size is not available. The public sector and “other” sector are likely to have less variety of products and larger pack sizes. If the pack size of a medicine is standard and is known centrally, amend the form before data collection begins. Column F: Pack size found This column should be completed by the data collectors in the field. Column G: Price of pack found This column should be completed by the data collectors in the field. Column H: Unit price This column should be completed by area supervisors after the data collectors have returned their completed forms and these have been checked at the end of the day in the field. D A T A C O L L E C T I O N A T C E N T R A L L E V E L 37 Column I: Comments Column I is used for recording any comments on the medicines included in the core or supplementary lists, such as their unavailability in the country or their temporary unavailability in a specific pharmacy. Comments may be added by the survey manager, area supervisors or data collectors. The core and supplementary lists of medicines should be reviewed following the pilot test and, where necessary, revised before the survey begins. Chapter 7 gives instructions on amending the core list of medicines, adding the supplementary list in the Workbook and entering price and availability data. Figure 4.4 shows an extract from a completed Medicine Price Data Collection form: Medicine Procurement Prices in which the tender prices have been entered at central level. In some countries, central and regional tender prices may vary. For national surveys, use the central tender price. For regional surveys, use the regional tender price. Aciclovir is not on the Essential Medicines List in this example and price information is therefore not recorded for this medicine. Figure 4.5 shows an extract from a Medicine Price Data Collection form: Private Sector Retail Prices in which the brand name and manufacturer of the most sold Figure 4.4 Extract from a Medicine Price Data Collection form: Medicine Procurement Prices, with information entered at central level Figure 4.5 Extract from a Medicine Price Data Collection form: Private Sector Retail Prices, with information entered at central level A B C D E F G H I Generic name, dosage form, strength Brand name(s) Manufacturer Available tick ✓ for yes Pack size recommended Pack size found Price of pack found Unit price (4 digits) Comments Aciclovir tab 200 mg Zovirax GSK 25 /tab Not on EML Most sold generic equivalent 25 /tab Lowest price generic equivalent 25 /tab Amitriptyline tab 25 mg Tryptizol MSD 100 /tab Most sold generic equivalent Amitriptyline Pharma ✓ 100 1000 970.00 0.9700/tab Only 1 generic found Lowest price generic equivalent Amitriptyline Pharma ✓ 100 1000 970.00 0.9700/tab Amoxicillin caps/tab 250 mg Amoxil SKB (GSK) 21 /tab Most sold generic equivalent Amoxicillin Ratiopharm ✓ 21 500 2407.00 4.8140/tab Only 1 generic found Lowest price generic equivalent Amoxicillin Ratiopharm ✓ 21 500 2407.00 4.8140/tab A B C D E F G H I Generic name, dosage form, strength Brand name(s) Manufacturer Available tick ✓ for yes Pack size recommended Pack size found Price of pack found Unit price (4 digits) Comments Aciclovir tab 200 mg Zovirax GSK 25 /tab Most sold generic equivalent Acivir Cipla 25 /tab Lowest price generic equivalent 25 /tab Amitriptyline tab 25 mg Tryptizol MSD 100 /tab Not available in country Most sold generic equivalent Amitriptyline Cosmos 100 /tab Lowest price generic equivalent 100 /tab Amoxicillin caps/tab 250 mg Amoxil SKB (GSK) 21 /tab Most sold generic equivalent Moxacid Dawa 21 /tab Lowest price generic equivalent 21 /tab M E D I C I N E P R I C E S : A N E W A P P R O A C H T O M E A S U R E M E N T 38 generic equivalent have been entered at central level. These cells are shaded grey because they should not be amended by data collectors in the field. COMPONENTS OF MEDICINE PRICES Prices can be seen as links in a chain, stretching from the manufacturer to the consumer. The computerized Workbook enables you to see how much is added to manufacturers’ prices in the distribution process by comparing the median final price for each medicine with the manufacturer’s unit price. This is known as the cumulative mark-up. The study will also help you to identify each individual link in the price chain to give a full picture of the composition of the prices of one or two medicines. The following components are commonly found in the medicines price chain: � Manufacturer’s import (selling) price (MSP) or procurement price � Cost, insurance and freight (CIF) � Import tax or duty � Port and inspection charges � Distribution margin/wholesale mark-up � Retail mark-up � Value Added Tax (VAT)/Goods and Services Tax (GST) � Dispensing fees. Governments may not always have a complete picture of the price components of medicines as different Ministries may be involved in their purchase and distribution. However, accurate information on the various price components, including the manufacturer’s selling price, is required for reliable international price comparisons as well as to identify measures that can be taken to reduce the prices paid for medicines. Information on some price components, such as procurement prices, can be obtained from official documents issued by the Ministry of Health, Finance, Industry or Trade and should be known to the Chief Pharmacist; see the column entitled “Possible sources of information” in Figure 4.6. For the private or “other” sector, however, it may be advisable also to check prices with a wholesaler or other sources to find out what they actually pay. There may be special arrangements or exemptions from certain tariffs for some medicines, particularly in the public sector. This is the reason why price components should be identified in all sectors. Procurement price or manufacturer’s selling price (MSP) Information on the procurement price or manufacturer’s selling price (MSP) is sometimes not available in the private sector, but the aim of this survey is to identify it as accurately as possible. In the public and “other” sectors, it might appear as one of the following: � The awarded tender price (if import, including CIF) � The import price, if freight charges are included (CIF) � The export price in the country the medicine is shipped from, if freight charges are not included: i.e. free on board (FOB) � The price that the wholesaler or the public or private procurement agency pays a local manufacturer. D A T A C O L L E C T I O N A T C E N T R A L L E V E L 39 For the private sector, the wholesaler(s), customs or the Ministry of Health will often be able to provide information on the import price and/or its buying price (import price + port charges). Cost, insurance and freight (CIF) For imported products, cost, insurance and freight is the price paid to the manufacturer or wholesaler from whom the product is imported. This means that the landing cost includes insurance and freight. If insurance and freight are not included, the landing cost is FOB (free on board) and the recipient will pay insurance and freight. If these charges appear separately, they should be recorded and added to the manufacturer’s selling price. Import tax or duty Import tax or duty can be quite substantial. If there is an import tax, it may apply to some or all imported medicines. Possible exemptions include: � Some or all of the medicines on the essential medicines list � Medicines for public health programmes � Some or all of the medicines on the public tender � Medicines imported by NGOs � Donations. Check whether the same level of tax or duty applies to all products. Exemptions and deviations should be recorded: for example, if some of the medicines monitored are exempt, others may be taxed. Note that import tax or duty may also apply to imports of raw material for local production, but this should not be recorded here. Figure 4.6 Possible medicine price components and sources of information Tariff/tax Possible sources of information Manufacturer’s selling price (MSP) Manufacturer’s list prices (from wholesalers), public sector tenders, customs declaration forms CIF charge Make a rough estimate: may vary or may not be included in tender price Tenders, customs declaration forms Port charges, clearance Customs, medical stores, importers Import duty May vary by product and/or sector Customs, Ministries of Health, Trade, Finance, medical stores, importers Inspection Medicines regulatory body Fee to Pharmacy Council/Board Ministries of Health, Trade, Finance, medical stores and/or statistics Distribution margin/wholesale mark-up Vary by sector. Margins charged by medical stores should be recorded here Wholesaler, medicines regulatory authority/Ministry of Health/Pharmacy Association/retailers Retail mark-up Applies to private sector Retailers, medicines regulatory authority/Ministry of Health/Pharmacy Association Value Added Tax/Goods and Retailers Services Tax Dispensing fees Pharmacies, Ministries of Health or Trade M E D I C I N E P R I C E S : A N E W A P P R O A C H T O M E A S U R E M E N T 40 Port and inspection charges Other charges may apply to cover such costs as clearance, storage in port and inspection. Governments may charge for documentation, such as data collection for statistical purposes. Distribution margin/wholesale mark-up A mark-up is a certain percentage added to the purchasing price to cover the costs and profit of the wholesaler or retailer. It is common to find that a ceiling applies and the government allows a maximum percentage to the wholesale mark-up. However, you may also find that pricing is free: that is, the government does not restrict the margins and manufacturers, wholesalers and pharmacies may charge what they wish. The wholesale mark-up can also be recorded as the difference between: � The wholesaler’s buying price: the price paid to the manufacturer/ importer � The pharmacy’s buying price: the price paid to the wholesaler. Retail mark-up The retail mark-up is the percentage that retailers (pharmacies) add to cover their costs, including profit. It is common to find that a ceiling applies and the government sets a maximum percentage mark-up. The government may also set a maximum sales price and leave it to the wholesaler and retailer to agree on their respective mark-ups (see Glossary: Rebate). Pharmacies may charge different mark-ups on innovator brands and generically equivalent products. In some countries, for example, the mark-ups are higher on generic equivalents because they are considered to be very cheap. If this applies, it should be recorded on the form even if the precise figures are unknown. In some countries, there may be different maximum mark-ups for different price bands: this is called “degressive mark-up” and means that a more expensive medicine will have a lower mark-up. If this is the case, record both the lowest and the highest mark-ups (e.g. 11% and 25%). To ensure reliability, information on retail mark-ups should be collected on a number of different medicines (three are recommended). This is particularly important in countries where prices are not regulated or where regulations are not enforced. If medicines are sold in the informal sector (medicine outlets), it is recommended that information is collected from these facilities as well. Value Added Tax (VAT)/Goods and Services Tax The size of a Value Added Tax on goods varies considerably from country to country, ranging from 2% up to 25% in some European countries, for instance. VAT may also vary from state to state within a country, as in Brazil and the USA. In many countries, however, medicines are exempted from VAT. VAT is normally charged at all levels. Retailers pay cost plus VAT and add VAT to their selling price. The VAT is then refunded to them so that each link pays VAT only once. Only the VAT added to the final price (which is paid by the patient) should be recorded. In some countries, a Goods and Services Tax (GST) or other sales tax is charged on medicines. As with VAT, only the tax added to the final price should be recorded. D A T A C O L L E C T I O N A T C E N T R A L L E V E L 41 Distribution charges In the public sector and in parts of the “other” sector, such as the church mission sector, medicines are distributed from a central warehouse directly to health facilities or via regional and/or district depots. Depending on the financing arrangements, a margin or fee may be charged per level to cover handling and transport between the different levels of depot and lastly to the health facility. All margins of this kind are components of the final price and should be recorded for these sectors in the Price Composition: Components page in the Workbook. Dispensing fees Pharmacies may be allowed to charge a dispensing fee; this is normally a fixed fee per prescribed item instead of, or in addition to, a percentage mark-up. The fee more accurately reflects the work involved in handling a prescription; a percentage mark-up makes profit dependent on the sale of expensive medicines. Price components that should not be entered in the Price Composition: Components page in the Workbook The following components of the medicine price should not be entered in the Price Composition: Components page in the Workbook. Registration fees The National Medicines Regulatory Authority or Medicines Control Agency may charge a fee when a product is registered in the country plus an annual fee for as long as the product is on the market. As these fees are charged only when a market authorization is issued or as an annual fee per product, irrespective of sales volume, they should not be included here as a price component, but should be recorded on the National Pharmaceutical Sector form (Annex 2). Patient co-payments and fees for service Information on the following charges should be recorded on the National Pharmaceutical Sector form (Annex 2): � Patient co-payments: payments by patients of a fixed amount per prescribed medicine, even if reimbursement applies � Fees for services in addition to the cost of the medicine, such as the doctor’s consultation. Where a standard charge (e.g. fee for the consultation/fee for service, including medicines) is set for all patients in public health facilities, data collection on pricing at each individual facility is not necessary. The information should be recorded on the National Pharmaceutical Sector form (Annex 2). However, data on availability should still be collected in individual facilities. Note on prices in the public and “other” sectors One or both of these sectors may provide medicines free to patients or for a fixed fee (see below). If patients do not pay the full price of the medicines, the procurement prices (e.g. from a tender, if available) should be entered on the form at central level. The data collectors should then simply record whether the medicine is available or not in each facility they visit. M E D I C I N E P R I C E S : A N E W A P P R O A C H T O M E A S U R E M E N T 42 Informal charges There may also be informal charges about which no information is publicly available. The only way of measuring these charges is by household surveys (interviewing patients at home) or exit interviews (interviewing patients when they leave the pharmacy or doctor). Surveys of this kind are not covered here, but can be developed as separate projects. Collecting data on the components of medicine prices Data on the components of medicine prices should be collected at central level and entered directly into the Workbook. It is recommended that you select three tracer medicines (i.e. three medicines on the core list of medicines) that are widely used in all sectors in your country. You will need to add the price components that apply in your country. Collect data on each product for each sector (i.e. a total of up to 12 sets of data). Chapter 7 describes how to enter data on price components in the Workbook. Print this page from the Workbook and fill in the price components. The worksheet contains eleven columns, as shown in Figure 4.7. Columns B–F identify the medicine and the dispensed quantity and Columns G–K itemize the price components and mark-ups, as follows. B Name of the medicine. C Medicine strength: this is entered automatically when the name of the medicine is entered into the Workbook. D Dosage form: this is entered automatically when the name of the medicine is entered into the Workbook. E Target pack size: this is entered automatically when the name of the medicine is entered into the Workbook. F Dispensed quantity. G Type of charge: identifies the type of charge added to the CIF price of the medicine. You should complete this according to your country’s charging structure. Figure 4.7 Extract from a Price Composition: Components page of the Workbook Describe sector and type of medicine A B C D E F G H I J K Example 1: Medicine name Medicine Strength Dosage Form Target Pack Size Dispensed Quantity Type of Charge Charge Basis Amount of Charge Price of Dispensed Quantity Cumulative % Mark-up Cost, insurance, freight (CIF) price NA NA 0.00% D A T A C O L L E C T I O N A T C E N T R A L L E V E L 43 H Charge basis: each individual type of charge will be either a percentage addition or a flat rate fee. Identify the category that applies to each charge. I Amount of charge: enter either the percentage add-on or the flat rate amount. J Price of dispensed quantity: the Workbook automatically calculates the price of the dispensed quantity at each point in the price chain. K Cumulative % mark-up: this is calculated automatically by the Workbook, based on all the preceding components. The last figure in this column indicates the total value of local add-ons to the CIF price of the medicine. AFFORDABILITY Treatment course Figure 4.8 lists nine preselected clinical conditions (ten medicines) for which the cost of treatment, and hence its affordability, will be calculated by sector. These conditions have been selected to facilitate international comparisons. However, you may wish to include additional conditions and treatments in the Workbook – or alternatives if some of the medicines are not included in your survey. Figure 4.8 List of pre-selected conditions and medicines to determine affordability Condition Medicine, Daily dose Treatment Total no. References strength, duration units per dosage form (days) course of treatment Diabetes Glibenclamide 2 tablets 30 60 WHO Model Formulary 2002; 5 mg tablets BNF 43 (Mar 2002) Section 126.96.36.199 Hypertension Hydrochlorothiazide 1 tablet 30 30 WHO Model Formulary 2002; 25 mg tablets BNF 42 (Sept 2001) Section 2.2.1 Atenolol 1 tablet 30 30 WHO Model Formulary 2002; 50 mg tablets BNF 43 (Mar 2002) Section 2.4 Respiratory tract Amoxicillin 3 capsules/ 7 21 WHO Model Formulary 2002; infections: adults 250 mg capsules/tablets tablets BNF 43 (Mar 2002) Section 188.8.131.52 Respiratory tract Co-trimoxazole paediatric 10 ml 7 70 WHO Model Formulary 2002; infections: children suspension 40+200 mg/ BNF 43 (Mar 2002) Section 5.1.8 6 months–5 years 5 ml Gonorrhoea Ciprofloxacin 1 tablet 1 1 WHO Model Formulary 2002; 500 mg tablets BNF 43 (Mar 2002); Section 5.1.12 Arthritis Diclofenac 2 tablets 30 60 BNF 43 (Mar 2002); Section 10.1.1 50 mg tablets Depression Amitriptyline 3 tablets 30 90 WHO Model Formulary 2002; 25mg tablets BNF 43 (Mar 2002) Section 4.3.1 Asthma Salbutamol inhaler As needed 200 doses WHO Model Formulary 2002; 0.1 mg/dose (1 inhaler) BNF 43 (Mar 2002) Section 184.108.40.206 Peptic ulcer Ranitidine 2 tablets 30 60 BNF 43 (Mar 2002); Section 1.3.1 150 mg tablets WHO Model Formulary 2002 is available electronically at http://www.who.int/medicines/organization/par/formulary.shtml The British National Formulary is available electronically at http://bnf.vhn.net/home/ M E D I C I N E P R I C E S : A N E W A P P R O A C H T O M E A S U R E M E N T 44 The treatment courses for the medicines included in the core list are based on guidelines in the WHO Model Formulary and the British National Formulary (BNF), as in the following examples: � One dose for gonorrhoea � Seven days for an acute infection � 30 days for a chronic treatment in adults. The WHO Model Formulary and the BNF have been selected because the recommendations on dosages are well-known and accepted and because they can both be accessed electronically. It is important to note that the courses of treatment used in this manual are statistical or average measures that are used to standardize the methodology and facilitate international comparisons. They should not be regarded as recommendations on treatment courses; although they are based on internationally accepted clinical guidelines, other guidelines for treatment may be in use locally or nationally. You are requested to use the treatment courses given in Figure 4.8 to enable international comparisons to be made. However, if your country uses other dosage schedules, these may be used for the national report. For your national survey, you may also wish to make comparisons, such as between the affordability of old and new medicines. Chapter 7 explains how to use the computerized Workbook to enter data on medicine prices. The treatment cost and affordability are calculated automatically by the Workbook. Benchmark The benchmark of the daily wage of the lowest paid, unskilled national government worker is regarded as the most reliable and accessible measure for judging affordability. The information is also easily available and locally understandable. A large proportion of the population will, of course, earn less than an unskilled government worker, but a treatment that is not affordable to the lowest paid government worker is definitely not affordable to those on incomes below that level. 45 5 Preparation for data collection in the field � The sampling and selection of public sector health facilities should be completed before preparation for fieldwork begins � Careful selection and training of data collectors is required � A pilot test should be conducted during the training of data collectors to give data collectors practice in collecting data and to identify any amendments needed to the Medicine Price Data Collection form � A letter of introduction should be prepared for data collectors. The success of the medicine pricing survey is dependent on the collection and recording of accurate, reliable data by the data collectors in the field. This requires careful planning and preparation for fieldwork. This chapter deals with the issues that need to be addressed when preparing for the field survey. It builds on information already discussed in the previous chapters. GUIDANCE FOR AREA SUPERVISORS Area supervisors should be thoroughly familiar with the contents of this manual in order to ensure a consistent approach to the organization of data collection in the field. In particular, the survey manager should highlight the following issues during training: � Sampling private sector retail pharmacies and other medicine outlets � Gaining access to health facilities, pharmacies and other medicine outlets � Preparing the Medicine Price Data Collection forms � Daily check of completed forms � Field supervision � Calculating the unit prices of medicines. SAMPLING SITES The selection of public health facilities for data collection should be made by the survey manager at central level (see Chapter 3). However, most or all of the private sector retail outlets will have to be identified locally by the area supervisors. M E D I C I N E P R I C E S : A N E W A P P R O A C H T O M E A S U R E M E N T 46 ! Private sector retail pharmacies The private pharmacies will be sampled by their proximity to the public health facilities selected, so sampling will usually have to be done locally in the field by the area supervisor. The sampling process will be easier if a list of pharmacies registered in each study area is provided by the survey manager. Once the public health facilities have been selected, the pharmacy that is closest to each facility should be selected. If there are a number of pharmacies close to each facility, one should be selected at random, using the list of registered pharmacies obtained at central level. If there is no pharmacy within 5 km of a facility, no pharmacy should be chosen for that facility, but another pharmacy in the urban centre should be substituted. This process will result in the selection of at least five pharmacies in each survey area. “Other” sector medicine outlets The selection of medicine outlets in the “Other” sector will depend on the nature of the sector chosen. If the sector includes NGO health facilities, the sampling should have been completed at central level (see p. 26). This will result in a sample of up to five NGO health facilities in each survey area. For other types of medicine outlet (e.g. dispensing doctors, non-pharmacy drug stores), the sample will usually have to be selected locally, as with pharmacies. Once the public health facilities have been selected, the medicine outlet that is closest to each facility should be selected. If there are a number of medicine outlets close to each facility, one should be selected at random. If there is no medicine outlet within 5 km of a facility, no outlet should be chosen for that facility, but another outlet in the urban centre should be substituted. This process will result in a sample of up to five other medicine outlets in each survey area. Back-up facilities In addition to the pharmacies and other medicine outlets selected for inclusion in the survey, two back-up facilities should be identified in advance for each team of data collectors each day. Data collectors should visit a pre-selected back-up facility if: � Less than 50% of the medicines on the Medicine Price Data Collection form are available � Health facility, pharmacy or medicine outlet managers will not give permission for data collection, even after being shown the letter of introduction and being assured of anonymity. Where possible, two back-up facilities should be identified in advance for each team of data collectors each day. P R E P A R A T I O N F O R D A T A C O L L E C T I O N I N T H E F I E L D 47 SELECTING DATA COLLECTORS Data collectors will need a basic knowledge of pharmaceuticals, some understanding of the principles of sample surveys and an appreciation of the logistical requirements for carrying out field studies. The survey methodology has been designed to minimize as far as possible the need for a high level of sophistication in these areas although in-depth follow-up activities will in many cases require a higher level of technical expertise. Criteria for selecting data collectors Data collection can be tedious work and requires an aptitude for concentration and attention to detail. The best data collectors combine the discipline of collecting data in a standardized way with the flexibility to adapt procedures to the requirements of unusual situations. Data collectors should be familiar with pharmaceuticals and the different dosage forms and pack sizes in order to be able to extract the required information, both from health professionals and from written material such as packs and order lists, and to record it accurately during observations. The most effective data collectors are likely to be people with relevant experience such as pharmacists, pharmacy technicians and nurses. However, other Ministry of Health staff and temporary employees with some health-related experience can be hired specifically to collect and record data. At a minimum, post secondary school education is required. Familiarity with the local dialect will be advantageous. The process of data collection is separate from data entry and processing which will be undertaken at a later stage. Data collectors should be trained to record only the information required. Lessons from the field In the field study in South Africa, regional pharmacists were recruited as data collectors because they are known to the pharmacists and doctors in the area and also know the facilities in the area. TRAINING DATA COLLECTORS Data collectors should be well trained to ensure the accuracy and reliability of the data gathering procedure. Training should focus on teaching the participants: � The overall purpose of the survey � How to collect data � How to complete the Medicine Price Data Collection form. Figure 5.1 on p. 48 shows an example of a training plan for data collectors. The Medicine Price Data Collection form must be available during training sessions so that the data collectors are made aware of the data to be collected and how to complete the form. Wherever possible, data collectors should work in teams of two. To ensure consistency in results, it is preferable to train all data collectors together and then allow them to practise together at the pilot sites. This is an important step that will provide an opportunity to identify and solve unforeseen problems and help M E D I C I N E P R I C E S : A N E W A P P R O A C H T O M E A S U R E M E N T 48 to identify “natural leaders” who can assist other data collectors in case of difficulty. It will also enable realistic estimates to be made of the time required for collecting data at each study site. Duration of training As shown in Figure 5.1, at least two days will be required for training, including: � Initial training: half day � Pilot test: each survey pair should survey at least 10 medicines in both a public and private facility � Debriefing on practical details of the survey: half day � Allocation of data collectors into teams. In addition, adequate time should be allocated for issues such as transport planning, paying travel advances and providing the Medicine Price Data Collection forms. When the survey is being undertaken for the first time, three days may be required for training to ensure that the data collectors are adequately prepared. It is generally safest to train a few more data collectors than are needed in case any have to drop out of the survey. PILOT TESTING It is recommended that a pilot test should be conducted during the training of the data collectors. All aspects of the survey should be pilot tested, including the data collection process and the completion of the Medicine Price Data Collection forms. Figure 5.1 Example of a training plan Training activity Time Day 1 General introduction 1 hour Introduction of data collectors General presentation: � Purpose of the survey � Training objectives � Location of survey sites � Discussion on data collectors’ expectations and/or concerns � Work schedule and compensation Review of Medicine Price Data Collection form 2–3 hours Role play in small groups to check reliability of data collection skills 1 hour Pilot test: visits to facilities to practise completing the Medicine Price 2–3 hours Data Collection form Day 2 Debriefing on pilot testing and discussion on any revisions required 2–3 hours to the Medicine Price Data Collection form Allocation of data collectors to teams 3 hours Planning of regular team meetings General review and questions Review of supervisory role with all area supervisors (if appointed) 1 hour P R E P A R A T I O N F O R D A T A C O L L E C T I O N I N T H E F I E L D 49 The area supervisors should check the completed Medicine Price Data Collection forms to identify any inaccuracies or other problems that indicate the need for further action. They should then report their findings and recommendations to the survey manager to identify whether: � Area supervisors or data collectors need further training to ensure the accurate collection of reliable information � Revisions are needed to the core and supplementary lists of medicines on the Medicine Price Data Collection form � Area supervisors or data collectors faced any constraints in sampling or in collecting data. Any issues that may affect the quality of data collection must be addressed by the survey manager before the survey begins. MEDICINE PRICE DATA COLLECTION FORMS After the pilot test, the Medicine Price Data Collection forms should be reviewed and revised, if necessary: for example, the core and supplementary lists of medicines may need to be amended if a medicine is rarely available or is found only in a different dosage form and strength. Each data collection team should be given a set of the revised Medicine Price Data Collection forms, preferably colour-coded for each sector. Details of the facility should be added to the first page of each form by the area supervisor before the visit. Arrangements should be made for the safe storage of completed forms from each sample site in secure conditions for an indefinite period in case any data need to be checked at a later date. PLANNING THE SCHEDULE OF DATA COLLECTION VISITS Before data collection starts, a schedule of visits should be prepared with the proposed dates for visits to each site. A written schedule should be provided for each data collection team. The number of days required to collect the data can be estimated on the basis of the number of facilities to be visited in each geographical area, the distance between them and the mode of transport available. In general, 1–2 hours plus travelling time will be required for data collection in each facility. Making initial contact with health facilities It is essential that good relations are established with the pharmacist/dispenser in each facility to be surveyed since they will have to set aside considerable time to provide information on the prices and availability of medicines. Area supervisors should visit them personally in advance to seek their permission for data collection in their facility or medicine outlet, avoiding peak periods when they may be busy M E D I C I N E P R I C E S : A N E W A P P R O A C H T O M E A S U R E M E N T 50 ! with patients. They should show them the letter of endorsement, but should not inform them about the specific medicines included in the survey. An appointment should be made for data collection to take place on a date and at a time that is convenient for the manager of each facility and medicine outlet. This process may be time consuming, but it is important to invest in it since it will facilitate data collection. LETTER OF INTRODUCTION A letter of introduction from the survey manager will be invaluable in introducing area supervisors and data collectors to staff in the health facilities and pharmacies being surveyed. The letter of introduction should include the following information: � The name of the organization conducting the survey and the contact details of the survey manager � The purpose of the study � The names of the data collectors who will visit the facility � The time required for data collection in each facility. The letter should also provide reassurance that the anonymity of the facility or pharmacy will be maintained. An example of a letter of introduction is included as Annex 4 and is provided as a Word file on the CD-ROM for local adaptation, as appropriate. It is advisable that data collectors should carry an identity document with a photograph, wherever possible. CHECKLIST FOR AREA SUPERVISORS Prior to going out into the field, the area supervisor must ensure that data collectors have the necessary tools and information with them. An example of a checklist for area supervisors is provided in Figure 5.2. GUIDELINES FOR DATA COLLECTORS Written guidelines should be provided for data collectors on the procedure to be followed during visits to health facilities and pharmacies. These should be developed by the survey manager and distributed to the data collectors by the area supervisors. COORDINATING MEETINGS As you plan, prepare, undertake the survey, enter the data, analyse and produce the survey report, you will need to meet regularly with your key team members. Schedule these meetings in advance. Remember, the more you prepare, the smoother the survey will go. , P R E P A R A T I O N F O R D A T A C O L L E C T I O N I N T H E F I E L D 51 Figure 5.2 Example of checklist for area supervisors Item 1 List of data collection teams 2 Contact details of the area supervisor and data collectors 3 Schedule of visits to survey sites 4 Contact details of the sites to be visited 5 Details of back-up facilities to be visited if scheduled visits are not possible or less than 50% of the medicines are available 6 Copies of letter of endorsement and letter of introduction for data collection team 7 Guidelines for data collectors 8 Examples of completed set of Medicine Price Data Collection form 9 Medicine Price Data Collection forms for each team of data collectors 10 Medicine Price Data Collection forms for each back-up site 11 Pens and other supplies 12 Field allowance for local expenses 52 6 Data collection in the field � Data collection must be accurate and reliable since it forms the basis for the remainder of the survey � Data collectors will record data on the prices and availability of medicines � Area supervisors should supervise data collectors and check completed Medicine Price Data Collection forms at the end of each day � Area supervisors should calculate the unit prices of all available medicines. FIELDWORK: AREA SUPERVISORS Area supervisors are responsible for ensuring the accuracy and reliability of data collection. This involves the following activities. Field supervision Area supervisors should meet with the data collectors at the end of each day to get feedback on the data collection process and identify any problems. They should go out into the field regularly with the data collection teams to ensure that the agreed procedures are being followed. They should also return to randomly selected facilities or pharmacies to collect the same data and check the accuracy of the data collected earlier. Ideally, this validation should be performed for 10% of the facilities. Any problems that cannot be resolved in the field should be discussed with the survey manager. Daily check of completed Medicine Price Data Collection forms It is essential that area supervisors review completed Medicine Price Data Collection forms at the end of each day to check that the data are complete, consistent, and legible. Once the team has left the field, it becomes difficult to verify information that may be missing or incomplete. The supervisors should highlight any missing or unreliable information on the form and identify the source of the problem. If necessary, data collectors should return to the facility to collect any further data required. The area supervisors should sign the first page of each form to record that it has been checked. 53 D A T A C O L L E C T I O N I N T H E F I E L D Calculating the unit prices of medicines After checking the completed Medicine Price Data Collection forms, the area supervisors should calculate the unit prices of the medicines that have been found, using the following procedure. 1 For each product, divide the Price of Pack Found (Column G) by the Pack Size Found (Column F). 2 Retain at least four digits after the decimal point when calculating the unit price. 3 Enter the calculated unit prices in Column H of the form and double- check the calculations. Storing completed Medicine Price Data Collection forms Completed forms should be stored in waterproof plastic bags in the field. FIELDWORK: DATA COLLECTORS Preparation for fieldwork Before going out into the field each day, data collectors should check that they have: � Contact details of the area supervisor � Schedule of visits to survey sites and contact details � A copy of the letter of endorsement and letter of introduction � Guidelines for data collectors � A Medicine Price Data Collection form for each site to be visited and for each back-up site � Pens: pencils should not be used to record data. Data collectors should avoid visiting the facility in peak hours and should telephone before the visit, if possible, to confirm that the appointment is still convenient. On arrival at the facility On arrival at the health facility, pharmacy or other medicine outlet, data collectors should: � Check that the information on the facility on the first page of the Medicine Price Data Collection form is complete and correct and inform the area supervisor if there are any inaccuracies � Enter the following information on the first page of the Medicine Price Data Collection form: – Name(s) or codes of the data collector(s) – Name of the person in charge at the facility: e.g. the head of the hospital pharmacy, pharmacist, pharmacy owner or medicine outlet licence holder – Name of the person(s) who provided information on medicine prices and availability (if different from the person in charge). M E D I C I N E P R I C E S : A N E W A P P R O A C H T O M E A S U R E M E N T 54 Data collection Information on prices and availability should be entered with the aid of the person in charge of the facility. The Medicine Price Data Collection form should not be left at a facility or pharmacy to be collected later with the promise that it will be filled in. Completing the Medicine Price Data Collection form Data collectors should complete a separate Medicine Price Data Collection form for each health facility, pharmacy and other medicine outlet. They should follow the procedure below. Entering data � Complete Row 3 for each medicine: – Enter the name of lowest price generic equivalent – Enter the manufacturer of lowest price generic equivalent Rows 2 and 3 for each substance can be identical, but the product in Row 1 can appear only in that row (see p. 55) � Complete Columns D, E, F and, where appropriate, Column I � Do not complete Column H; unit prices will be calculated by the area supervisor � Do not enter data in any other rows or columns. Dosage form A medicine may be available in different dosage forms, including tablets/capsules, mixture/suspension, injection, cream/ointment and so on. Tablets and capsules are considered equivalent (except for nifedipine retard tablets). Column A lists the only dosage form on which information should be collected for a medicine. If the dosage form listed in Column A is not found, do not complete the row. Strength Column A lists the only strength on which information should be collected for a medicine. If the strength listed in Column A is not found, do not complete the row Collect data only for the dosage form and strength listed in Column A. Note: for nifedipine, collect data only on the 20 mg retard formulation, in tablet form (see p. 31). Column D: Available Complete Column D for each medicine by ticking whether each of the following are available: � Row 1: Innovator brand � Row 2: Most sold generic equivalent � Row 3: Lowest price generic equivalent. Ask to see a pack of the product before recording that it is available. D A T A C O L L E C T I O N I N T H E F I E L D 55 In all sectors, there may be only one or two products for each medicine; if this is the case, enter information as follows: � If there is no innovator brand, leave Row 1 blank � If you find only one generically equivalent product, it will be both the most sold and the lowest price generic equivalent: enter the same information in Row 2 and Row 3 and note this in the ‘Comments’ column (Column I) � If you find more than one generically equivalent product and the most sold generic equivalent also has the lowest price, enter the information for the most sold generic equivalent in both Row 2 and Row 3 and note this in the ‘Comments’ column (Column I). If a product is temporarily out of stock: � If price data are available, record the price and state that the product was out of stock in Column I: Comments � If no price data are available, do not enter any data in the relevant row � Do not substitute an alternative product. If several medicines listed on the form are unavailable: � Collect data for as many medicines as possible � If less than 50% of the medicines on the form are available: – Visit an additional facility, identified in advance as a back-up, and conduct the survey again – Report the problem to the area supervisor. Column F: Pack size found In Column F for each medicine, enter the pack size actually found in the facility for: � Row 1: Innovator brand � Row 2: Most sold generic equivalent � Row 3: Lowest price generic equivalent. The pack size should be identical to the recommended size (Column E). If this is not available, select the closest, larger pack size found. Select the same pack size for innovator brand and generically equivalent products, whenever possible. Collect the price for one pack size only for each medicine. Column G: Price of pack found In Column G, enter the price of the pack actually found, in the national currency for: � Row 1: Innovator brand � Row 2: Most sold generic equivalent � Row 3: Lowest price generic equivalent. Ask to see either the price list or price label on the product before entering the price on the form. M E D I C I N E P R I C E S : A N E W A P P R O A C H T O M E A S U R E M E N T 56 Record the price the patient pays. If part of the price is paid by insurance or other means, record the full price the pharmacist charges the patient. For instance, if the pharmacy is reimbursed 80% and the patient pays 20%, you should record the full price (100%). Do not record “special discounts” (discounts available only to certain group of patients). However, you should record discounted prices if they apply to all patients. Add a note in the comments column. In the public sector, medicines are often distributed free of charge or for a fixed fee for either the medicine or the visit: � If medicines are distributed free or for a fixed fee, record the price the pharmacy/dispensary pays to its supplier � If the patient pays a different price, record this price. Column I: Comments Column I can be used for explanatory comments or any additional information, such as: � Product temporarily out of stock � Percentage discounts offered. Figure 6.1 shows an extract from a completed Medicine Price Data Collection form: Public Sector Patient Prices which has been completed by data collectors in the field. The unit prices have been entered by the area supervisor. Figure 6.2 shows an extract from a Medicine Price Data Collection form: Private Sector Retail Prices which has been completed by data collectors in the field. The unit prices have been completed by the area supervisor. Checking the Medicine Price Data Collection form Data collectors should check that the form is accurate and complete before leaving the facility and return completed forms to the area supervisor. They should report any problems as soon as possible. Figure 6.1 Extract from a Medicine Price Data Collection form: Public Sector Patient Prices, with data entered in the field A B C D E F G H I Generic name, dosage form, strength Brand name(s) Manufacturer Available tick ✓ for yes Pack size recommended Pack size found Price of pack found Unit price (4 digits) Comments Aciclovir tab 200 mg Zovirax GSK 25 /tab Not available Most sold generic equivalent 25 /tab Lowest price generic equivalent 25 /tab Amitriptyline tab 25 mg Tryptizol MSD 100 /tab Most sold generic equivalent Amitriptyline Pharma ✓ 100 1000 1261.00 1.2610/tab Only 1 generic found Lowest price generic equivalent Amitriptyline Pharma ✓ 100 1000 1261.00 1.2610/tab Amoxicillin caps/tab 250 mg Amoxil SKB (GSK) 21 /tab Most sold generic equivalent Amoxicillin Ratiopharm ✓ 21 500 3129.00 6.2658/tab Only 1 generic found Lowest price generic equivalent Amoxicillin Ratiopharm ✓ 21 500 3129.00 6.2658/tab D A T A C O L L E C T I O N I N T H E F I E L D 57 Figure 6.2 Example of Medicine Price Data Collection form: Private Sector Patient Prices, with data entered in the field A B C D E F G H I Generic name, dosage form, strength Brand name(s) Manufacturer Available tick ✓ for yes Pack size recommended Pack size found Price of pack found Unit price (4 digits) Comments Aciclovir tab 200 mg Zovirax GSK ✓ 25 25 5392.70 215.7080/tab Most sold generic equivalent Acivir Cipla ✓ 25 100 12396.90 123.9690/tab Lowest price generic equivalent Virucid-200 Aegis ✓ 25 25 1600.00 64.0000/tab Amitriptyline tab 25 mg Tryptizol MSD 100 /tab Not available in country Most sold generic equivalent Amitriptyline Cosmos ✓ 100 100 80.00 0.8000/tab Lowest price generic equivalent Amitriptyline Cosmos ✓ 100 100 80.00 0.8000/tab Same as most sold Amoxicillin caps/tab 250 mg Amoxil SKB (GSK) ✓ 21 100 776.00 7.7600/tab Most sold generic equivalent Moxacid Dawa ✓ 21 100 413.00 4.1300/tab Lowest price generic equivalent Moximed Medivet ✓ 21 1000 3334.00 3.3400/tab 58 7 Data entry � Data entry and analysis will generally take place at central level � The computerized Excel WHO/HAI Medicine Pricing Workbook that accompanies this manual is used to enter the data collected in the field, consolidate and summarize results, and print tables that will serve as the basis for reports � The exchange rate must be entered in the International Medicine Reference Price Data page � Medicine identification and medicine unit price data must be entered in the Field Data Consolidation Pages for Procurement, Public Sector, Private Sector or Other Sector Price Information � The Workbook will automatically summarize and compare the data by sector and by medicine in the following pages: – Sector Availability and Price Summary – Medicine Availability and Price Summary � The daily wage of the lowest paid unskilled government worker must be entered in local currency in the Standard Treatment Affordability page � Additional data can be entered to complete supplementary analyses in the following pages: – Treatment Affordability by Sector – Price Composition: Cumulative Mark-ups – Price Composition: Components of Price � You should have the Workbook open as you read this chapter. USING THE COMPUTERIZED WORKBOOK The specially-designed computerized WHO/HAI Medicine Pricing Workbook that accompanies this manual allows rapid entry and analysis of medicine price data. After data have been entered, the Workbook automatically generates summary tables that form the basis of data analysis. You will find it helpful to run the Workbook for the first time while reading this chapter. If you have problems with the Workbook or discover any bugs, please send an e-mail message describing the problem with the problem file attached to Health Action International Europe (firstname.lastname@example.org), which will try to respond promptly. 59 D A T A P R O C E S S I N G Getting started 1 Transfer the Workbook to your computer. You can do this by: � Copying the file from the CD-ROM that accompanies this manual � Downloading the latest file from the HAI website: (http://www.haiweb.org/medicineprices). 2 Start Excel and open the file WHO-HAI Medicine Pricing Workbook.xls that you copied onto your hard disk. Choose the option to “Enable Macros” as the file is opening. 3 Do not save data in the original Workbook. As soon as you open the file, save it with a filename that indicates the country and date of your survey. For example, you might choose a filename such as SouthAfrica.May2003.xls. In this way you retain a clean Workbook to use for future surveys. Moving between Workbook pages You can use either of two methods to move between pages. 1 Use the movement buttons. From the Home Page, click a button with the name of the desired page to go to that page. From any other Workbook page, click the Go To Home Page button to return to the Home Page. 2 Click on the tabs at the bottom of each page to move between pages of the Workbook. Entering data You can enter or edit data in any unshaded cell in a data entry form. Within the Workbook, all shaded areas are “protected” from entering data and other areas are “hidden” from view. These areas contain formulas or data that allow the Workbook to carry out its calculations automatically. Errors in the Workbook’s operation may result if you unprotect or reveal these areas. In order to guarantee the integrity of the calculations, these cells should not be modified. Within each Field Data Consolidation page, a double-entry function is provided. While you do not have to use this feature, you are strongly advised to do so since this procedure will improve the accuracy of data entry. More details about double entry are given on pp. 69–70. Ensuring accuracy The quality of the information generated by the medicine price survey depends on the accuracy of data collection and data entry. The survey manager has overall responsibility for the quality of the data. The area supervisors and data entry staff should receive regular supervision. Attention to the details of supervision will pay off in the ease with which data entry and analysis occur. The following steps will also help to ensure greater accuracy. 1 Establish procedures to check for data completeness, consistency, plausibility and legibility in the field when it is still possible to correct errors or to fill in missing information. The area supervisors should M E D I C I N E P R I C E S : A N E W A P P R O A C H T O M E A S U R E M E N T 60 review data collection forms every day after completion of the field work and resolve any problems before the next day of data collection. 2 Plan random checks to ensure the quality of data collection. The area supervisor should return to randomly selected facilities or pharmacies to collect the same data in order to check the accuracy of the data collected earlier. Ideally, this validation should be undertaken for 10% of the facilities. 3 Develop procedures for storing paper data collection forms safely and securely. Forms should be stored in waterproof plastic bags in the field and in secure filing cabinets or store rooms at the study office. 4 Identify the resources needed for data entry and checking before data collection begins and plan data processing carefully. Ideally data entry should take place at one site where the survey manager can supervise the process. Information on the Medicine Price Data Collection forms should be checked again for legibility and consistency during data entry. Saving and backing up your work Save the Workbook periodically as you work to prevent data loss in the event of power failure. Always make a back-up copy of the file on your hard drive or a CD-ROM after adding a substantial amount of data. Since Excel files write over the previous versions as they save, it is safest to retain intermediate versions under different file names. OVERVIEW OF THE Workbook AND ITS OPERATIONS The computerized Workbook consists of the following pages: 1 Home Page 2 International Medicine Reference Price Data 3 Field Data Consolidation: Medicine Procurement Prices 4 Field Data Consolidation: Public Sector Patient Prices 5 Field Data Consolidation: Private Sector Retail Prices 6 Field Data Consolidation: Other Sector Patient Prices 7 Sector Availability and Price Summary 8 Medicine Availability and Price Summary 9 Standard Treatment Affordability 10 Price Composition: Cumulative Mark-up 11 Price Composition: Components of Price D A T A E N T R Y 61 HOME PAGE The top section of the Home Page contains a box with action buttons that are used to move to different parts of the Workbook. Click a button to jump to the page indicated. The lower section of the Home Page contains a box with action buttons that allow you to erase previously entered data from the Workbook. It is generally easier to start a new survey by opening and renaming the original master Workbook. In some circumstances, however, it may be more efficient to erase parts of an existing Workbook to start a new survey: for example, if you have collected data on the same list of medicines from several provinces and use the same medicine lists, defined treatments and so on for each province. Click on a button to erase data on a specific page or on the Erase & Reset All Data button to erase all data in the Workbook. After clicking the button, you will be prompted to confirm that you want to erase the data indicated. Once you confirm, all data you have entered on a page will be erased, so take care using this function. Before erasing anything, you may want to save the entire Workbook under a separate file name as a back-up in case you need to return to it later. INTERNATIONAL MEDICINE REFERENCE PRICE DATA PAGE The International Medicine Reference Price Data page contains important information on the medicines in the survey that is used in subsequent pages. This page must be completed first, preferably during survey preparation. Figure 7.1 contains a picture of the page as it appears in the Workbook. ! Figure 7.1 International Medicine Reference Price Data page M E D I C I N E P R I C E S : A N E W A P P R O A C H T O M E A S U R E M E N T 62 1 At the top of the page (cell J3), you must enter the current Exchange Rate of your local currency in US dollars, which are the standardizing currency for these surveys. Once you have entered the exchange rate, you should not change it. Note that there may be a buying rate and a selling rate. In some countries, multiple rates may co-exist. For example, there may be an official rate, a commercial rate, and a parallel or “black market” rate. Use the commercial “buy” rate on the first day of the survey. 2 To document your decision, enter: � The name of your local currency (cell H4) � The date for which the exchange rate is valid (cell H5) � The source of the exchange rate you used (cell H6). Medicine identifying information The Workbook is supplied with a list of core medicines that should be monitored in all studies in order to facilitate international comparisons. The following data elements are already included in the Workbook for each medicine in the core list. 1 Medicine Name: Name (typically the INN or other generic name) of the target product. These names must be unique for the Workbook to function properly. If an additional product with the same generic name is to be included as a locally-selected supplementary medicine (see below), different names must be used. For example, if amoxicillin suspension is to be added as a supplementary medicine, it should be called “amoxicillin suspension” and the name of the core medicine should be changed to “amoxicillin capsule/tablet” to prevent confusion. 2 Medicine Strength: The strength of the target product, expressed as the number of milligrams or grams of active ingredient per dosage form (see item 3 below). Take special care in expressing the strength and dosage form of inhalers, injections and suspensions to prevent confusion in determining the unit price. 3 Dosage Form: The dosage form of the medicine for which the unit price is to be determined. The dosage form will most commonly be “cap” or “tab” for products administered as capsules or tablets. However, the dosage form may be: � Millilitre (“ml”) for orally administered liquids and some injections � Gram (“g”) or International Unit (“IU”) for other injections � “Dose” for medicines administered through inhalers or nebulizers. 4 Target Pack Size: Different pack sizes are used in many countries and unit prices vary by pack size. Field data collectors should try to find a pack size identical to or larger than the target pack size. The Target Pack Size is not used in Workbook calculations and is included for reference purposes only. 5 Core List (Yes/No): Selected from a drop-down list that identifies whether or not the medicine is on the core list. Core list medicines are marked “Yes”. If you decide not to include one of the core list medicines in your survey (for example, because it is not available in your country), you can delete it from the list by deleting its name. D A T A E N T R Y 63 International reference prices Reference prices are used to facilitate national and international comparisons. Summary measures of the medicine prices found during the survey will be expressed as ratios relative to a standard set of reference prices. The Management Sciences for Health (MSH) reference prices have been selected as the most useful standard. The MSH reference prices are the medians of recent procurement prices offered by not-for-profit suppliers to developing countries for multi-source generically equivalent products. These prices are available on the Web at http:/ /erc.msh.org. The 2002 MSH reference prices, which were current when this manual was produced, are already entered in the Workbook. Before entering any price data, find out if they are still current by checking the HAI website. If there is an updated version of the Workbook with more recent MSH reference prices, download it and use it for entering your survey data. Note that these prices reflect the global wholesale prices of medicines from not- for-profit suppliers. The reliability of these reference prices generally depends on the number of suppliers quoting for each product. If you have medicines on your supplementary list for which there are no MSH reference prices, you must use a different set of reference prices for all medicines on the core list and supplementary list. As an alternative, you might consider using the Australian Pharmaceutical Benefits Scheme (PBS) prices. These are the reimbursement prices that the Government of Australia has agreed to pay for the medicines it makes available in government-supported insurance programmes. These are generally among the lowest reimbursement prices paid in developed countries. The full list of PBS prices can be found on the Web at: http://www1.health.gov.au/pbs/index.htm. The MSH and PBS reference prices were chosen as the recommended standards because they are updated frequently, are always available and are relatively stable. However, note that the two sources are quite different: � MSH prices are wholesale not-for-profit procurement prices � PBS prices are reimbursement (similar to retail) prices, including dispensing fee. Many other reference price lists are now available and you may choose to use an alternative set of reference prices for your own purposes (see WHO Medicine Prices website at http://www.who.int/medicines). However, you should always add the name of the reference price in the Workbook and include the following information in the final report: � The name of the reference price list you chose � Your reasons for choosing it � The date on which you obtained the price data from the list � The dates for which the price list was reported to be valid. Whatever reference price list is chosen, it is important to use the same reference price list for the entire list of medicines in your survey. Before beginning data entry for your survey, you should enter or check the following reference price information for each of the core medicines. ! M E D I C I N E P R I C E S : A N E W A P P R O A C H T O M E A S U R E M E N T 64 6 MSH Unit Price: The median price of the target core medicine in the most recent MSH Medicine Price Indicator Guide. Even if another set of prices is being used for your national analyses, entering the most recent MSH prices will allow other countries to compare their data to yours. 7 Other Unit Price: If another set of reference prices is being used for the analysis, enter the appropriate unit price for each of the core medicines. Take special care to use the correct dosage form price for injections, inhalers and liquids. Note that these prices need to be entered in US$ equivalents. For example, if you use the PBS prices, you should convert them to $US equivalents or the comparisons in the Workbook that use these prices will not be correct. Enter the source of the unit prices you used in cell H7. Once you have entered an exchange rate, unit prices and target pack sizes, the Workbook automatically calculates: � Price of Target Pack (US$) � Price of Target Pack (local currency) � Reference Unit Price (local currency). The values in the Reference Unit Price (local currency) column are used in calculating the price ratios. You can switch between the two different sets of reference medicine prices by clicking the MSH/Other Prices button at the top of the page. Many Workbook calculations depend on the set of reference prices chosen. Switching reference prices will change the calculations. If you wish to obtain reports using both sets of prices: 1 Select the MSH prices. 2 Print all reports. 3 Switch sets of reference prices. 4 Print all reports a second time. All pages that depend on reference price indicate the source used. Adding supplementary medicines Up to 20 locally-defined supplementary medicines can be added to the pricing survey. If you wish to add supplementary medicines, you will need to enter the same identifying information as for those on the core list. 1 Enter the Medicine Name to be added in the next available empty row. Remember that each medicine name must be unique. After you press “Enter” or move away from the cell, the Workbook will automatically sort the medicine name you entered into alphabetical order. 2 Enter the Medicine Strength, Dosage Form and Target Pack Size as described on p. 62 for the core medicines. 3 In the Core List column, select “No” from the drop-down list to indicate that this is a supplementary medicine. D A T A E N T R Y 65 4 Enter the median MSH Unit Price for the medicine. Be sure to obtain the median supplier price per unit (e.g. per tablet or per millilitre) from the MSH price list. 5 If you plan to use a different set of reference prices for your national report, enter the Other Unit Price for the medicine. Save the Workbook frequently as you work. Click on the Go To Home Page button when you have finished work on this page. Removing medicines from the medicine list To delete a medicine from either the core list or supplementary list in the Workbook, simply delete the medicine name. You will be prompted to confirm deletion of the medicine. If you confirm the deletion, all information about the medicine contained in the row will be deleted, and the empty row will be removed. FIELD DATA CONSOLIDATION PAGES There are four Field Data Consolidation pages in the Workbook, allowing price information from up to four sectors to be entered. 1 Medicine Procurement Prices 2 Public Sector Patient Prices 3 Private Sector Retail Prices 4 Other Sector Patient Prices: for example, prices from facilities in the NGO sector, the church mission sector or the defence sector. These pages are used to enter unit price data collected in the field using the Medicine Price Data Collection forms. The sectors to be included in the survey should have been selected before data collection started in the field (see Chapter 3). The lists of medicines on the Field Data Consolidation pages are derived directly from the International Medicine Price Reference Data page, which must be completed before data entry begins. The unit prices entered on the Medicine Procurement Prices page should be prices from recent medicine orders, usually from public sector centralized medicine procurements. For the Field Data Consolidation pages for the other three sectors, the prices entered will be the medicine-specific patient or customer charges that were collected at different facilities and medicine outlets in the survey. Field Data Consolidation page sections The Field Data Consolidation pages contain four sections. These sections can be displayed in different ways by use of the action buttons in the upper left corner of the page (described below). The sections of the page are: ! M E D I C I N E P R I C E S : A N E W A P P R O A C H T O M E A S U R E M E N T 66 1 Medicine list: This list (columns A–C) is generated automatically from the medicines listed on the International Medicine Price Reference List page. The list contains three rows for the three different types of prices obtained in the field for each medicine: � Row 1: Innovator brand � Row 2: Most sold generic equivalent � Row 3: Lowest price generic equivalent. 2 Summary ratios by medicine: This section has five columns (columns D–H). These compare different summary measures that describe the distribution of unit prices entered for each medicine with the medicine’s reference unit price. The five summary ratios that describe the distribution of unit prices are: � Median: i.e. the median of the unit prices entered divided by the reference unit price � 25th percentile � 75th percentile � Minimum � Maximum. The Medicine Procurement Prices page also computes (in column I) the total number of procurement prices (orders) entered for each medicine. The other three Field Data Consolidation pages compute the percentage availability of each medicine, based on the number of unit prices entered divided by the total number of outlets or facilities in the survey. At the top of the summary ratio section is a blue area in which you enter (cell G10) the minimum number of unit prices required for each medicine in order for summary measures to be computed: � A single procurement price may be sufficient � A minimum of four unit prices should be obtained from different public health facilities or medicine outlets for the other three sectors. 3 Data entry grid: An empty data grid in which you enter information about: � The source of each column of unit price data (Rows 7–9) � The unit prices found for each medicine (Rows 12–161). The Medicine Procurement Prices page allows you to enter up to 10 sets of procurement prices for each medicine. To identify each set, you specify: � An arbitrary Procurement ID (Row 7) � The Procurement Agency (Row 8) � The Procurement Date (Row 9). The other three Field Data Consolidation pages allow you to enter data from up to 60 public health facilities, private pharmacies and other medicine outlets. For each set of prices, you specify: � An arbitrary Medicine Outlet Study ID (Row 7) � A code for the Region where the outlet was located (Row 8) D A T A E N T R Y 67 � A measure of Distance From Population Centre (Row 9), which allows you to classify facilities as urban or rural. 4 Summary table: A table that summarizes the results in each sector across all medicines in the survey for all the summary measures. The measures in the summary tables are explained in detail in Chapter 8. Figure 7.2 on p. 68 shows part of the empty data entry section for the Field Data Consolidation: Private Sector Retail Prices page with the summary ratios section displayed, while Figure 7.3 shows the empty summary table for that page. Action buttons Each Field Data Consolidation page has a set of action buttons at the top that control the way the page is displayed. There are four buttons in the upper left corner (see Figure 7.2): � Go To Home Page button. � Data/Summary This button causes the page to display either the data grid or the summary table. When the summary table is displayed, all the action buttons in Row 5 are hidden. � Ratios On/Off This button reveals or hides the columns that contain the summary ratios (Columns D–I). Turning off the summary ratios simplifies the process of data entry by displaying a greater number of data columns. � Double Entry Once data from the field have been entered the first time, clicking this button displays a menu that allows you to carry out the three steps required for double data entry. These steps are described on pp. 69–70. In addition to the page display buttons, there are four action buttons at the top of the data entry grid (Columns K–O) that allow you to sort the columns in the grid from left to right according to the identifying information entered in Rows 7–10. Sorting will allow you to select certain subsets of the data for analysis (see Chapter 8). You can sort the columns on the Medicine Procurement Prices page by: ����� ID (Row 7) ����� Agency (Row 8) ����� Date (Row 9) ����� Number (Row 11, the default sort order). You can sort the columns on the other three Field Data Consolidation pages by: ����� ID (Row 7) ����� Region (Row 8) ����� Distance (Row 9) ����� Number (Row 11, the default sort order). To the right of the data sorting buttons (at the top of Column Q–S), there is one additional action button. During data analysis (described in Chapter 8), you can choose to limit analysis to selected medicine orders (on the Medicine Procurement Prices page) or selected outlets (on the other Field Data Consolidation pages) by changing the “1”s in Row 10 to “0”s for all outlets to be excluded from analysis. The Include All button restores all the orders or outlets to the analysis by replacing all “0”s with “1”s. M E D I C I N E P R I C E S : A N E W A P P R O A C H T O M E A S U R E M E N T 68 Figure 7.2 Part of the data grid from the Field Data Consolidation: Private Sector Retail Prices page Figure 7.3 Summary table from the Field Data Consolidation: Private Sector Retail Prices page No. of meds. included D A T A E N T R Y 69 How to enter data All the Field Data Consolidation pages use the same procedures for entering data. The following steps describe how to enter data on the Private Sector Retail Prices page. 1 Use the action buttons on the Home Page to switch to the Private Sector Retail Prices page. 2 If the summary table is displayed, click on the Data/Summary button to switch to the data entry grid. 3 If Columns D–I are visible, click on the Ratios On/Off button to hide them. 4 Enter the identifying information for the first medicine outlet: � Enter the Medicine Outlet Study ID in Cell J7 � Enter the Region code in Cell J8 � Enter the Distance from Population Centre in Cell J9. Distance should be entered as the approximate number of kilometres from the medicine outlet to the largest population centre in the region. 5 Starting at Cell J12 and proceeding down the column, enter the unit prices for each of the medicines in the list. You have calculated unit medicine prices in Column H of the Medicine Price Data Collection form. The unit medicine prices should always be entered in local currency. 6 Repeat steps 4–5 for each private sector retail outlet included in the survey, using Columns K–BQ. You can enter data for up to 60 outlets. To protect against data loss, save the Workbook periodically throughout the data entry process and again when data from all medicine outlets have been entered. After medicine unit prices from at least four medicine outlets have been entered for a given medicine, summary statistics for the medicine will be calculated in Columns D–I. You can view these summary statistics at any time by pressing the Ratios On/Off button. Double entry procedures Entering detailed data such as long columns of the unit prices of medicines can lead to substantial numbers of errors. The quickest and most efficient way to find these data entry errors is to have a second person enter all data a second time and then identify where the numbers entered disagree. The Workbook contains a set of procedures to lead you through this process. Pressing the Double Entry button will display the menu of double entry procedures, as shown in Figure 7.4. The functions of the four action buttons on the menu are described below. � Step 1: Hide Current Data Pressing this button will copy all the data in the data entry grid to a hidden part of the Workbook; the data in the data grid will then be erased. The identifying information for the facilities or outlets will remain in Rows 7–9 to ensure that the same columns are used for the second round of data entry. ! M E D I C I N E P R I C E S : A N E W A P P R O A C H T O M E A S U R E M E N T 70 Figure 7.4 Menu of double entry procedures � Step 2: Compare current and hidden data After you complete the second round of data entry, pressing this button will generate an automatic comparison of the data entered in the second round with the data entered in the first (hidden) round. Any cells that do not agree will be highlighted in red. If there are no errors, all the cells in the data entry grid will remain clear with no red cells. � Step 3: Correct errors Once any errors have been identified and highlighted in red, you can return to the original data collection forms to determine the correct values. Pressing this button will make the Workbook: – Proceed one by one through the highlighted errors – Display a window that shows both the first and second values entered – Allow you to enter and save the final value to be used. Ideally the survey manager should make all final determinations about ambiguous data values. � Cancel Pressing this button will exit the double entry menu without making any changes. STANDARD TREATMENT AFFORDABILITY PAGE The Standard Treatment Affordability page defines standard treatments and expresses the costs of the treatments in terms of: � Median treatment prices (using the median unit prices of the brand, most sold generic or lowest price generic equivalent products from each sector) � The number of days’ wages of the lowest paid government worker (useful for inter-country comparisons). Ten standard treatments, for nine conditions, have been entered on this page (see Figure 4.8, p. 43 for the list of medicines and conditions). If your survey did not include one of these medicines, Columns H to O will be blank. You can replace it with another medicine from the core or supplementary D A T A E N T R Y 71 list (see below). In addition to the ten standard treatments, space is provided to enter two further standard treatments using survey medicines. The standard treatment chosen would usually be one locally defined for a target condition by the Ministry of Health, a professional association or an expert panel. If there are no locally-defined standard treatments for a condition you wish to include in the affordability analyses, you can use a standard treatment defined by an international organization such as WHO or BNF. Standard treatments would be entered as follows: � Acute conditions: full courses of therapy � Chronic conditions, where therapy continues indefinitely: monthly courses of therapy. Click on the Treatment Affordability button on the Home Page to move to the Standard Treatment Affordability page. There is space to analyse the affordability of up to 12 standard medicine treatments. To define standard treatments: 1 First, in Cell J6 enter the daily wage of the lowest paid government worker in local currency. (See p. 29 for a description of how to obtain this figure.) To define new standard treatments: 2 Enter the name of the standard treatment to be defined in Cell B68 (overwriting the default text “Enter Condition”). Type the name of a selected condition and press “Enter”. 3 Enter in Cell B70 the Medicine Name of the medicine used in the standard treatment. The medicine must be one included in the survey. The easiest way to enter the medicine name is to move the cursor into the cell and click on the selection arrow that appears to the right of the cell. You will then see an alphabetical list of all medicine names in the survey. Use your mouse or the arrow keys to select the medicine that you want on the list, and click on it. Alternatively you can type in the medicine name, but the spelling must be exactly the same as the name of a medicine on the medicine list. After a medicine name is entered, the Medicine Strength and Dosage Form will appear automatically in Columns C–D. 4 In Column E, enter the Treatment Duration, which is number of days for a typical course of therapy. For a chronic disease for which a medication is taken daily, this would be 30 (to define a monthly treatment), while for acute illnesses it would be the total duration of therapy. 5 In Column F, enter the Total # of Units per Treatment, which is the number of units of the medicine that would be given for the treatment duration that you specified. For example, for omeprazole 20 mg, the treatment duration might be 30 days and the number of units per treatment might be 30 (capsules). 6 After the Medicine Name and the Total # of Units per Treatment have been entered, the Workbook automatically calculates the Median Treatment Price in local currency for each sector for all three medicine types based upon the median unit prices of the data that you collected. M E D I C I N E P R I C E S : A N E W A P P R O A C H T O M E A S U R E M E N T 72 It also expresses the treatment price in terms of Days’ Wages for the wage rate specified in step 1. 7 Repeat steps 2–5 for additional treatments you wish to define. Further space is provided, starting in Cell B74. Alternatively, you can replace one (or more) of the preselected treatments that were not surveyed (Columns H–O will be blank). In this case, you will be overwriting the name of the condition, Medicine Name, Treatment Duration and Total # of Units per Treatment. If a particular treatment requires more than one medicine, you can enter the same treatment name in more than one block of data and enter the information in separate blocks for the different medicines required. In reporting the Median Treatment Price and Days’ Wages for this condition, you would need to add together the information from all medicines to get totals for the treatment. Be careful when entering the units required for liquids, injections, or inhalers. Note that for inhalers the unit is a single dose of inhalant, not the number of inhalers. This would mean that you need to calculate and enter the total number of doses required in a month in the Total # of Units per Treatment. Expressing the dose of combination products can also be confusing. For co-trimoxazole, the medicine unit is written as 8+40 mg/ml. The treatment regimen might be 2 doses of 5 ml per day for 7 days, which would amount to 70 ml (2 doses x 5 ml x 7 days) for the total treatment course. PRICE COMPOSITION: CUMULATIVE MARK-UPS PAGE The Price Composition: Cumulative Mark-ups page allows you to enter manufacturers’ ex-factory package prices for packs of a given size. It then generates information about how that price compares to an international reference price as well as the overall mark-up over the manufacturer price in different sectors. Click on the Price Composition: Mark-ups button on the Home Page to move to the Price Composition: Cumulative Mark-ups page. 1 In Cell B7, enter the Medicine Name of the target medicine from the survey. As on the Standard Treatment Affordability page, the easiest way to enter the medicine name is to move the cursor into the cell, click on the selection arrow to the right and select the medicine that you want from the list displayed. The medicine name can also be typed in, but the spelling must be exactly the same as the name on the medicine list. After a medicine name is entered, the Medicine Strength and Dosage Form will appear automatically in Columns C–D. 2 For each sector included in the survey, enter in Columns G, H and I the Manufacturer Pack Price and the Manufacturer Pack Size (expressed as the number of dosage forms) found in that sector for the brand, most sold and lowest price items. The Workbook then calculates the Manufacturer Unit Price (MUP) and the Ratio of Manufacturer Unit Price to reference unit price. In addition, the Sector Median Unit Price (SMUP) found for the sector is inserted from the Field Data Consolidation pages and % Mark-up of Sector Median Unit Price over Manufacturer Unit Price is calculated. Note that this mark-up figure may include many components such as D A T A E N T R Y 73 taxes, duties and fees, as well as wholesale and retail mark-ups. These different components are dealt with in the following Price Composition: Components of Price page. The sector-specific mark-ups can be calculated for up to ten different medicines from the survey by repeating steps 1–2 for each medicine. PRICE COMPOSITION: COMPONENTS OF PRICE PAGE On the Price Composition: Components of Price page, the final page in the Workbook, you can enter information about the different types of duties, charges, or mark-ups that are applied to up to twelve medicines as they proceed from the manufacturer to patient purchase in different sectors. If all medicines face the same structure of duties, charges and mark-ups, you would need to enter only one medicine. However, if different types of medicines face different duties (e.g. originator medicines versus generic medicines, or imported medicines versus locally manufactured medicines) in different sectors, you may wish to enter several examples. To get to the page, click on the Price Composition: Components button on the Home Page. 1 In Cell D6, enter a description of the type of medicine whose components of price you will detail, and the sector (or sectors) to which these components of price apply. 2 In Cell B9, enter the first Medicine Name using the drop-down list or typing in an exactly spelled name as you have done for the two previous sheets. The Workbook automatically inserts the Medicine Strength, Dosage Form and Target Pack Size in the next three columns. 3 For charges and mark-ups that are percentages, any quantity can be used as the base for calculations. However, some charges, such as dispensing fees, may be charged as fixed fees when a medicine is dispensed. For this reason, the components of price will be entered and calculated in relation to a dispensed quantity of medicines rather than a target pack size, which may contain more than the dispensed amount. � In Column F, enter the typical Dispensed Quantity of the target medicine to be used as the base for calculations. � In Column J, enter the CIF (ex-factory) Price of Dispensed Quantity of this medicine when it is sold in the target pack size. This price can be calculated as the dispensed quantity divided by the size of the target pack times the price of the target pack. 4 In Column G, enter descriptions of all the different Types of Charge that are added to the CIF price of the medicine as it moves through the delivery system. These charges might include: � Port clearance charges � Stamp duties or other duties � Wholesale and/or retail mark-ups (as allowable or actual percentages) � Packing fees M E D I C I N E P R I C E S : A N E W A P P R O A C H T O M E A S U R E M E N T 74 � Various other levies: for example in Sri Lanka, a defence levy was charged on all items at the time of the study � Taxes (sales or VAT) � Dispensing fees. There may be different charges for the public or private sectors, so you would use a second example to enter them. Be sure to enter the types of charge in the order in which they are levied, since percentage charges will be compounded on totals from previous charges 5 For each of the types of charge entered in Column G, indicate in Column H the Charge Basis: either percent or fixed fee. Use the drop-down function to enter the type of charge that applies. 6 In Column I, enter the Amount of Charge. If the charge is a percentage, enter the amount as a percentage (e.g. “2.5%” or “0.5%”), not a decimal. Be sure to include the percent sign. If the charge is a fixed amount, enter this in local currency using numbers and decimals. Using the charge data entered, the Workbook then calculates the Price of Dispensed Quantity and the Cumulative % Mark-up. A hypothetical example illustrating the entry of data for the components of price analysis for a medicine is shown in Figure 7.5. Note that if you have entered reasonable amounts for the various charges and mark-ups, the final unit price of the dispensed quantity of the example medicine should be approximately equal to the median unit price you observed for this medicine in this sector when collecting data in the field. Figure 7.5 Hypothetical example of price components analysis 75 8 Data analysis and interpretation � Four main types of data analysis are possible: – Price and availability comparisons within any one sector – Price and availability comparisons between different sectors – Treatment affordability – Price composition � The Workbook automatically generates summary tables which compare the median prices from your survey with international reference prices � The summary tables provide the evidence base for your report � This chapter shows how to examine, summarize and print your survey data � It also makes suggestions on how to interpret and report your findings � You should have the Workbook open as you read this chapter. Once the price data collected during the survey have been entered into the Workbook, they can be used for different types of analyses. You can use the summaries calculated automatically by the Workbook to analyse: � Medicine price levels and variations in different sectors, geographical areas, medicine types and individual medicines � Treatment affordability in relation to the daily wage of the lowest paid government worker � Components of the prices of medicines paid by purchasers and consumers. To carry out these analyses you will need to: � Examine and compare summary results on medicine availability, median price and price variation: – By sector – Across sectors – For different medicines � Examine overall treatment cost and affordability of standard treatments for important clinical conditions in the sectors for which price data were collected M E D I C I N E P R I C E S : A N E W A P P R O A C H T O M E A S U R E M E N T 76 � Compare the final purchase prices for example medicines in different sectors with import or manufacturers’ prices when these medicines entered the market, and detail subsequent charges and mark-ups that contribute to the final price in different sectors. OVERVIEW OF DATA ANALYSIS The Workbook simplifies the process of analysing data from the medicine pricing survey. Once price data have been entered, automated summary tables compare median prices: � With standard reference prices across different product types: innovator brand, most sold generic and lowest price generic equivalents � In different sectors (procurement prices, public sector patient charges, private retail prices, and patient charges in NGO/other facilities). The median prices are also used to examine key aspects of treatment affordability and medicine price composition. Types of data analysis The data in the pricing survey can be used for many different types of analyses at both the national and international levels. This chapter focuses on national- level analysis. There are four basic types of analyses at the national level: 1 Within-sector analyses: Analyses of data from a single sector include examining: � Median medicine price levels in relation to international standard prices � Variations in price across medicine procurements or medicine outlets � Comparisons between innovator brand and generically equivalent products � Product availability in medicine outlets. 2 Cross-sector comparisons: Overall medicine availability and prices can be compared between the different sectors for which price data were collected in the survey, both for individual medicines and median price ratios across medicines. 3 Treatment affordability: Using standardized treatment regimens for key health problems, affordability can be expressed in terms of treatment cost for an episode of illness, as well as the number of days’ wages of the lowest paid government worker required to pay for the cost of treatment. 4 Price composition: Price composition analyses include: � Comparing final patient prices to ex-factory prices for a set of medicines in different sectors � Examining the different charges and mark-ups that contribute to final price. Other types of analysis, such as comparisons by region or distance, are possible from the data in your Workbook. D A T A A N A L Y S I S A N D I N T E R P R E T A T I O N 77 Before starting analysis, you should define the analyses and summary tables that you will include in the survey report, assign appropriate personnel to each task and prepare a time schedule for outputs. This will help to prevent delays in writing up and releasing results. In countries with inflation, fluctuating currency exchange rates or unstable prices, data need to be analysed and presented quickly to ensure their relevance. Understanding reference prices The use of standard international reference prices facilitates comparisons of price levels between sectors and across countries by providing a measurement against which prices can be compared. By default, the reference prices used in the Workbook are international not-for-profit supplier/tender prices listed in the International Medicine Price Indicator Guide published by Management Sciences for Health (MSH). However, you can choose to use another set of reference prices for your analyses or switch between the two sets. It is important to emphasize that MSH reference prices are international not-for-profit supplier/tender prices, not retail prices. While centralized procurement prices or patient charges in public sector facilities may be fairly close to the MSH prices, private retail prices and patient charges in other sectors (e.g. NGO or private hospitals) are likely to be considerably higher. This is due to the charges and profits added on to the procurement price of a medicine as it proceeds through the distribution system. The extent to which these retail prices are higher depends on the country and situation. If a medicine is rarely used, the price differential is likely to be greater. Under some circumstances, medicines sold in private sector outlets may cost as much as 100 times the MSH price or more. For medicines with very large price differentials, your price component analyses may reveal why the prices are so high. Printing Summary Tables Before starting analysis, you should print out the raw data you have entered for each sector (medicine unit prices in local currency) in the Field Data Consolidation pages. This will allow you to make a visual check that your data are broadly correct and contain no obvious mistakes. All pages in the Workbook are set up so that the relevant sections will print in a convenient format when you use the Excel print functions. To see how a printed page will appear, first go to the page using the buttons on the Home Page. For a Field Data Consolidation page, be sure that the summary table and not the data grid is displayed. To preview how the page will look, you can: � Press the Print Preview icon ( ) if it appears in the tool bar on the top of your Excel screen or � Select File-Print from the Excel main menu, and press the Preview button when the print pop-up window appears. Depending on your paper size and printer setup, you may need to adjust page margins so that all columns in a summary table appear together on the same page. Once you are satisfied with the layout, you can print the table by: � Using the Excel print icon ( ) or � Pressing OK from the Print pop-up window. M E D I C I N E P R I C E S : A N E W A P P R O A C H T O M E A S U R E M E N T 78 Selecting subgroups for analysis National analyses using the complete sample of field data are the primary focus of the pricing survey. However, you may also wish to assess or compare prices in different subgroups within a sector. For example, you may wish to compare prices in outlets from different regions, or outlets in urban versus rural areas, or procurements by the central Ministry of Health versus regional procurement agencies. To allow subgroup analyses, the Field Data Consolidation pages permit you to exclude selected columns of data from analyses. By default, analyses in the Workbook include all the columns of data you enter. To make it easier to exclude certain columns, the Field Data Consolidation pages allow you to sort procurements or outlets (left to right) by variables you entered as identifying information (see Chapter 7). For the Medicine Procurement Prices page, these identifying variables are: � ID number � Procurement agency � Procurement date. For the other Field Data Consolidation pages, the variables are: � ID number � Region � Distance from the nearest population centre. Pressing the Number button returns to the original sort order. Selecting subgroups To select subgroups, first sort the data (left to right) by any identifying variable to make it easier to find the columns to exclude. Changing the “1”s in Row 10 to “0”s will exclude the columns from calculations. For example, Figure 8.1 shows prices from public sector outlets that have been sorted by region; in this example, all outlets except those in the North region have been excluded. If you were interested in the effect of distance, you could sort by distance and exclude all columns above or below a target distance. To include columns again, either change the “0”s back to “1”s, or press the Include All button. Figure 8.1 Selecting subgroups of outlets for analysis D A T A A N A L Y S I S A N D I N T E R P R E T A T I O N 79 Comparing subgroups To compare subgroups, first select the columns corresponding to one subgroup and print out the summary table. Then change the selection and print out the summary table for a different subgroup. On all summary tables, you are provided with a space to describe the sample of data included in the analysis. Be sure to complete this description before printing. You can then compare different subgroups as you write your report. Final word on data quality The rest of this chapter explains how to use the Workbook to perform several different analyses of medicine prices and how to interpret and report the results. Errors in data collection, processing or entry may cause substantial errors in summary results. If the prices for one or several medicines appear to be quite different, you should first check to be sure that the difference is not due to error. One common error is incorrect calculation of the unit price. For example, the price of an entire 200 dose inhaler may have been entered in some data collection forms instead of the unit price of a dose of inhalant. Ideally, most errors will be caught during data processing, but surprising findings should be checked once again for errors during data analysis and reporting. DATA ON THE NATIONAL PHARMACEUTICAL SECTOR In order to present some of the context within which your survey was conducted, the survey includes the National Pharmaceutical Sector form (Annex 2 and on the CD-ROM) to record basic descriptive information on your country’s health care system and pharmaceutical sector. These data are not used in any of the actual price analyses, but they can be helpful for explaining or interpreting findings. The completed electronic form should be included as an annex to your report. There are no specific procedures for analysing the data on the health care system and the pharmaceutical sector. In an introductory section, it may be useful to provide a brief overview of these data organized according to the different sections on the data collection form. You may want to add additional information to your summary on topics not included on the form to help readers understand the survey setting and results. WITHIN-SECTOR PRICE ANALYSES Each survey can accommodate price data from up to four sectors, although not all sectors need to be defined for a given survey. The Workbook automatically produces analyses both within and between whichever sectors have been defined. The possible sectors include: 1 Medicine Procurement Prices: Procurements would usually be conducted by centralized public sector agencies, but data can also be included from other public and private procurement systems. ! M E D I C I N E P R I C E S : A N E W A P P R O A C H T O M E A S U R E M E N T 80 2 Public Sector Patient Prices: In some countries, patients pay for medicines in public sector health facilities, often at subsidized prices, and these charges can be examined in this sector. Even if patients do not pay for medicines, this sector can also be used to examine medicine availability at public facilities. 3 Private Sector Retail Prices: These prices usually come from a sample of private retail pharmacies and other types of medicine outlet, although private retail pharmacies at health facilities might also be included in some settings. 4 Other Sector Patient Prices: This sector can be defined in various ways to examine patient charge data from different care systems, including mission or NGO hospitals, military hospitals and community revolving medicine funds. Although entry of the medicine price data from all four sectors is quite similar (see Chapter 7), the analysis of medicine procurement price data differs somewhat between the analysis of patient charge data and the other three sectors. The following sections describe both types of analysis. Analysing medicine procurement price data The Field Data Consolidation: Medicine Procurement Prices page is used to enter medicine procurement price data: i.e. the amounts paid by large purchasing agencies to obtain medicines from suppliers. Usually the purchasing agency will be the central Ministry of Health purchasing unit although, in some countries, there are regional public purchasing units or pooled purchasing systems that supply medicines to NGO hospitals. You may choose to enter and summarize prices from a single medicine order only. However, the Workbook allows entry of up to ten different sets of procurement data from different points in time or from different purchasing agencies. In your report, remember to identify clearly the purchasing agency or agencies and the period of time over which the procurements took place. These procurement data may be the only public sector price data available in systems where medicines in the public sector are distributed to patients at no charge or for a fixed fee per medicine or per visit. If the fee that patients pay varies by medicine or type of medicine, those variable fees should be entered in the Field Data Consolidation: Public Sector Patient Prices page and analysed separately. Examining summary statistics on procurement prices for individual medicines After all the procurement prices collected during the survey have been entered into the Workbook, you can begin analysis by examining the summary ratios for individual medicines. These summary ratios appear on the Field Data Consolidation pages in Columns D–I. If they are not visible, press Ratios On/Off to reveal them. Figure 8.2 shows an example of the summary ratios for a few medicines after all procurement data have been entered. Column D contains the median price ratio (MPR) for individual products, which is the median procurement price observed for each medicine divided by its international reference price (IRP). The median price ratio for procurement data is a measure of purchasing efficiency. D A T A A N A L Y S I S A N D I N T E R P R E T A T I O N 81 In general, procurement prices for the most sold and lowest price generically equivalent products should be fairly close to the MSH international supplier/ tender prices (that is, ratios up to 1.00). If the medians of the median price ratios (median MPRs) are 20% above or below the MSH prices (i.e. ratios up to 1.20), the procurement system is working very efficiently. The median price ratios for innovator brand products may be much higher, since the MSH international reference prices are prices for products procured in generically equivalent form. The difference between the median price ratio for an innovator brand product and the median price ratio for its lowest price generic equivalent is a measure of the “brand premium” paid for purchasing innovator brand products. Begin analysis by examining the median price ratios: � Across medicines � Across products within a medicine. In the example table in Figure 8.2, the median price ratios (MPR) for ciprofloxacin are between 26.20 and 39.29, which is a sign that this procurement system is not obtaining very competitive prices. For co-trimoxazole suspension, the median price ratio for the innovator brand version is many times higher than the most sold or lowest price generically equivalent versions (that is, there is a very high brand premium); for the other medicines, the innovator brand prices are somewhat closer. When there are multiple procurement prices for each medicine (the number of orders for each medicine is shown in Column I), you should also examine the range between the 25th and 75th percentiles and between the Minimum and Maximum to see if there are wide variations in procurement prices across orders. In the example, the ratios across orders are reasonably stable. However, for some products (e.g. innovator brand ciprofloxacin or generic co-trimoxazole suspension), the price on at least one order was very much lower than the typical price. You should examine such outliers carefully to see if they are errors. If not, finding out how a low price was obtained in one order may point to ways to make the procurement process more efficient. Figure 8.2 Example of medicine-specific summary procurement statistics M E D I C I N E P R I C E S : A N E W A P P R O A C H T O M E A S U R E M E N T 82 In your report, you may want to highlight examples where there are large differences observed between the median price ratios for different types of products or where the range of procurement prices varies widely across orders. Producing a summary table of procurement price data While data on the prices of individual medicines can be revealing, the main purpose of the survey is to analyse the “typical” prices paid for an entire set of medicines, both within and across sectors. Each Field Data Consolidation page in the Workbook automatically creates a summary table that contains statistics calculated across medicines from the median price ratios in Column D. The five summary measures calculated are: � Median (mid-point) median price ratio of the medicines on the list � 25th percentile median price ratio � 75th percentile median price ratio � Minimum median price ratio � Maximum median price ratio. To produce and print the summary table on the Medicine Procurement Prices page, carry out the following steps. 1 If the data entry grid is displayed on the page, click on the Data/Summary button to make the summary table visible (as shown in Figure 8.3). 2 In Cell F166, enter a description of the procurements that are included in this analysis, including the procurement agency and range of dates. 3 Decide whether you would like to display summaries only for the core survey medicines (i.e. the set of 30 medicines recommended for Figure 8.3 Example of summary table containing procurement price data D A T A A N A L Y S I S A N D I N T E R P R E T A T I O N 83 international comparisons) or for all the medicines that you have studied in the survey, both core and supplementary. Click Core Meds./All Meds. to shift between the two sets of medicines. 4 Examine the summary table to be sure the data look sensible. Investigate any values that look unusual to check they are not based on errors. After previewing the printed version of the summary table (as described above), print the table and use it as the basis for your report. Interpreting the procurement price data summary table First, note the table headings. The first heading contains data on the number of different sets of procurement prices included in the survey. If only one set of procurement prices has been entered, this heading would read “Medicine Procurements (n=1 in survey)”. The next heading describes the medicines that are included in the table, either core medicines only or all medicines (both core and supplementary). The heading calculates the number of medicines listed on the International Medicine Reference Price page that fall in whichever of these two categories has been selected. Note that the set of reference prices used for comparisons (MSH or an alternative set of prices) is indicated at the bottom of the table. The third row of headings describes the two different types of summary data contained in the table. On the left of the table are three columns of data summarizing the median price ratios for medicines which had the minimum number of procurement prices (usually 1). These three columns are for the three product types (innovator brand, most sold and lowest price generic equivalents). The first row of data in this section shows how many medicines of each product type had the minimum number of procurement prices reported. In the example table, for the 30 medicines in the survey, 23 innovator brand products had at least 1 procurement price, while only 21 most sold and 19 lowest price generic equivalents had at least one price. The bottom section on the left calculates the five different summary measures from the median price ratios for included medicines. In the example table, the median of the median price ratio across the 23 innovator brand products for which prices were found was 8.96, while the 25th and 75th percentiles of the median price ratios for these medicines were 3.69 and 25.48 respectively. Obviously, if prices were found for nearly all of the medicines within each product type, the summary statistics on the left side of the table will be fairly representative and comparisons across the three product types will be valid. However, if prices for all medicines were not found, and especially if different medicines were found for each product type, it is more valid to use the data in the six columns on the right side of the table. On the right side, only medicines that “match” are included; that is, each pair of columns limits analysis to medicines with prices for both of the product types in the pair. In the sample table, 17 matching medicines were found for the comparison between innovator brand and most sold generic medicines, while 18 pairs were found for each of the other two comparisons: innovator brand versus lowest price generic equivalent and most sold versus lowest price generic equivalent. Unfortunately, if few pairs of prices are found in a particular survey, the comparisons are less likely to be representative of the broader medicine pricing situation in this sector. For government procurement data, you may well find that a high percentage of prices are found only for lowest price generically equivalent products, since the government may not purchase innovator brands. M E D I C I N E P R I C E S : A N E W A P P R O A C H T O M E A S U R E M E N T 84 Reporting summary results on procurement prices The data in this table can be used to explore how efficiently the procurement system is working. If the median of the median price ratio is much lower than 0.80, then (after checking your data for errors) congratulate your procurement officer. If the median of the median price ratio for generic products is very high, you should investigate the reasons. Reasons for high price ratios in comparison to international reference prices may include: � Patent protection on innovator brand items � Lack of generic competition � Generic medicines priced by suppliers only slightly below the innovator brand � Small quantities being procured � Lack of transparency in procurement � Inefficiency in procurement � Lack of price regulation. Your survey will give you data to start such an assessment. In your report, you should try to describe the overall situation regarding the number of medicines procured and the levels and variability of the median price ratios that you found for each product type. To the extent that product types have enough common medicines to be compared, you should also compare median price ratios across product types. If a reasonably high percentage of products “matched” across sectors, then you should base analyses on the right “paired” side of the table since these provide fairer comparisons. You interpret these paired summaries in a similar way as the unpaired ones on the left side, but you should explain that the statistics are for matched pairs. Analysing patient price and medicine availability data Three Field Data Consolidation pages are used to summarize price data gathered from the different types of facilities or medicine outlets that you included in your survey. You can use the same approaches to summarize and analyse data from each of these pages. The analysis process will be described in detail below using example data from a set of 20 private sector retail pharmacies. Simply adapt and repeat this approach to analyse data from the Public Sector Patient Prices or the Other Sector Patient Prices pages. Examining summary statistics on patient prices for individual medicines As with the procurement price data, you should begin analysis of patient price data by examining the summary statistics that appear in Columns D–I for individual medicines. Figure 8.4 shows an example of these summary statistics after all price data for a sample of 20 private sector pharmacies and medicine outlets have been entered. The median price ratio in Column D is equal to the median medicine price to patients across the included outlets divided by the medicine’s international reference price. For patient price data, the median price ratio measures the magnitude of price mark-up to end-users. Begin analysis by examining the median price ratios: � Across medicines � Across pro
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