WHO and HAI Measuring medicine prices, availability, affordability and price components

Publication date: 2008

Measuring medicine prices, availability, affordability and price components 2ND EDITION EDM_prices_couv_08.indd 1 14.5.2008 14:18:05 Measuring medicine prices, availability, affordability and price components 2ND EDITION WHO/PSM/PAR/2008.3 © World Health Organization and Health Action International 2008 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 and Health Action International concern- ing 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 specifi c companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization and 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. All reasonable precautions have been taken by the World Health Organization and Health Action International to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization and Health Action International be liable for damages arising from its use. Layout by mnimum graphics Printed in Switzerland iii Contents Abbreviations ix Foreword xi Acknowledgements xiii 1 INTRODUCTION 1 1.1 Why measure the price and availability of medicines? 1 1.2 The WHO/HAI Project on Medicine Prices and Availability 2 1.2.1 Background and project objectives 2 1.2.2 Development, testing and use of the manual 3 1.2.3 Survey results 4 1.2.4 Evidence for policy development and implementation 5 1.2.5 Related surveys and initiatives 6 1.3 The Medicine Prices and Availability survey manual – second edition 6 References 7 2 SURVEY OVERVIEW AND PRE-SURVEY PLANNING 9 2.1 Survey overview 9 2.1.1 Survey objectives 9 2.1.2 Key elements of the survey design 10 2.1.3 The standard approach to measuring medicine prices and availability 13 2.1.4 Steps in the survey 13 2.2 Pre-survey preparation 13 2.2.1 Establishing an advisory committee 15 2.2.2 Clarifying the specifi c survey objectives 16 2.2.3 Collecting information on the health system and pharmaceutical sector 16 2.2.4 Selecting survey personnel 18 2.2.5 Securing the technical and fi nancial resources required 20 2.2.6 Seeking endorsement for the survey 22 2.2.7 Preparing a survey schedule 22 3 PREPARATION 23 3.1 Determining the survey scope 23 3.1.1 Planning where to conduct the study – national or regional? 23 3.1.2 Identifying sectors to be surveyed 24 3.1.3 Identifying survey areas 27 3.2 Selecting the sample 28 3.3 Developing the list of medicines to be surveyed 34 3.3.1 Global and regional core lists of medicines to be surveyed 35 3.3.2 Supplementary list of medicines to be surveyed 37 iv MEASURING MEDICINE PRICES, AVAIL ABIL IT Y, AFFORDABIL IT Y AND PRICE COMPONENTS 3.4 Preparing the workbook and creating the Medicine Price Data Collection form 40 3.4.1 Elements of the Medicine Price Data Collection Form 48 4 TRAINING AREA SUPERVISORS, DATA COLLECTORS AND DATA ENTRY PERSONNEL 53 4.1 The importance of data quality and the consequences of poor-quality data 53 4.2 Overview of training 55 4.3 Preparing for the training workshop 57 4.4 Conducting the training workshop, including the data collection pilot test 60 4.5 Finalizing the Medicine Price Data Collection form 63 4.6 Training tools 63 5 PREPARING FOR DATA COLLECTION IN THE FIELD 65 5.1 Planning the data collection visits 65 5.1.1 Prepare a letter of introduction 65 5.1.2 Make initial contact with medicine outlets 66 5.1.3 Prepare a schedule of data collection visits 66 5.2 Preparing the Medicine Price Data Collection forms needed for fi eld visits 67 5.2.1 Generate the fi nal Medicine Price Data Collection form using the automated workbook 67 5.2.2 Make suffi cient copies of the Medicine Price Data Collection form for fi eld visits 67 5.2.3 Prepare a facility-specifi c Medicine Price Data Collection form for each medicine outlet to be visited 68 5.2.4 Arrange for storage of completed Medicine Price Data Collection forms 68 5.3 Preparing information materials and tools for data collectors 68 5.4 Arrange for regular communications 70 6 DATA COLLECTION IN THE FIELD 72 6.1 Fieldwork: area supervisors 72 6.1.1 Field supervision 73 6.1.2 Daily check of completed Medicine Price Data Collection forms 73 6.1.3 Validation of data collection 73 6.1.4 Calculating the unit prices of medicines 74 6.1.5 Storing completed Medicine Price Data Collection forms 74 6.2 Fieldwork: data collectors 74 6.2.1 Before going out into the fi eld each day 74 6.2.2 On arrival at the facility 75 6.2.3 Procedure for completing the Medicine Price Data Collection form 75 6.2.4 Before leaving the facility 78 6.3 Ensuring data quality 78 7 DATA ENTRY 80 7.1 Overview of the workbook and its operations 80 7.1.1 Moving between workbook pages 81 v 7.1.2 Protected and hidden cells 81 7.1.3 Ensuring accuracy 81 7.1.4 Saving and backing up your work 82 7.2 Home page 82 7.3 International Medicine Reference Price Data page 84 7.3.1 Entering the exchange rate 84 7.3.2 Medicine identifying information 84 7.4 Field Data Consolidation pages 86 7.4.1 Field Data Consolidation page sections 87 7.4.2 Action buttons 91 7.4.3 How to enter data 91 7.4.4 Double entry procedures 93 7.5 Standard Treatment Affordability page 95 7.6 Price Components: Data entry page 97 7.7 Data checker 97 7.8 Other pages 99 8 DATA ANALYSIS AND INTERPRETATION 100 8.1 Overview of data analysis 100 8.1.1 Within-sector analysis of medicine prices and availability 101 8.1.2 Cross-sector comparisons 102 8.1.3 Treatment affordability 102 8.1.4 Price components 102 8.2 Conducting data analysis 102 8.3 Within-sector analyses 106 8.3.1 Within-sector analyses: medicine procurement price data 106 8.3.2 Within-sector analyses: patient price and medicine availability data 111 8.4 Cross-sector analysis: price and availability comparisons 118 8.4.1 Cross-sector comparison of data for individual medicines 119 8.4.2 Comparison of summary data for each sector 120 8.5 Subgroup analysis 123 8.5.1 Selecting subgroups 124 8.5.2 Comparing subgroups 126 8.6 Analysis of treatment affordability 126 9 MEASURING PRICE COMPONENTS 129 9.1 Background 129 9.2 Overview of the price components survey methodology 130 9.3 Overview of price components 132 9.3.1 Stage 1: Manufacturer’s selling price + insurance and freight 133 9.3.2 Stage 2: Landed price 135 9.3.3 Stage 3: Wholesale selling price or central medical store price 138 9.3.4 Stage 4: Retail price (private sector) or dispensary price (public sector) 139 9.3.5 Stage 5: Dispensed price 140 9.4 Costs that are not included in price composition analysis 141 9.5 Planning the price components survey 142 CONTENTS vi MEASURING MEDICINE PRICES, AVAIL ABIL IT Y, AFFORDABIL IT Y AND PRICE COMPONENTS 9.5.1 Meeting with the advisory committee 142 9.5.2 Personnel 143 9.5.3 Seeking endorsements 143 9.5.4 Planning timeline 143 9.5.5 Planning where to conduct the study 144 9.6 Selecting the medicines to be surveyed 145 9.7 Selecting dispensing sites (medicine outlets) to survey 146 9.8 Selecting which price components to survey 147 9.9 Training 147 9.10 Planning data collection visits 149 9.11 Data collection 149 9.11.1 Central data collection on national pharmaceutical policies 150 9.11.2 Collecting data along the supply chain 151 9.12 The Price Components Data Collection form 152 9.12.1 Elements of the Price Components Data Collection form 153 9.12.2 Instructions for completing the Price Components Data Collection form 154 9.13 Data entry 159 9.13.1 Completing the data entry table 160 9.14 Data analysis 164 9.14.1 Analysing central data 164 9.14.2 Analysing data for individual medicines 164 9.14.3 Comparing central data with data from individual medicines 169 9.15 Reporting results 169 References 170 10 INTERNATIONAL COMPARISONS 171 10.1 Pitfalls in International comparisons 171 10.2 Where to obtain country data for comparison 172 10.3 Choosing what to compare 173 10.3.1 Choosing countries 173 10.3.2 Choosing medicines 173 10.4 Adjusting data in international comparisons 173 10.5 Comparisons of the prices of individual medicines 174 10.6 Comparisons of the availability of medicines 175 10.7 Comparisons of the affordability of treatment 176 10.8 International comparisons of price components 177 10.9 International comparisons by disease group 179 10.10 International comparisons of prices for a sample of medicines 180 10.11 International comparisons using other data sources 181 References 181 11 EXPLORING POSSIBLE POLICY OPTIONS AND LINES OF ACTION 183 11.1 Data from the survey and its interpretation 184 11.2 Policy options to address low availability 186 11.3 Policy options vary for originator brand and generic medicines 187 11.4 Policy options vary if medicines are purchased by the state or health insurance schemes compared with out-of-pocket purchases 188 vii 11.5 Controlling mark-ups is always diffi cult 188 11.6 Dealing with rebates and discounts is even more diffi cult 189 11.7 Monitoring and evaluation 190 11.8 Summary of policy options 190 11.9 Limitations of price controls 190 11.10 Conclusion 190 References 192 12 REPORTING 193 12.1 Survey report 193 12.1.1 Standard Report template 195 12.2 Disseminating the fi ndings 196 12.3 Reporting to HAI and WHO 197 13 USING THE EVIDENCE AND GETTING THE MESSAGES OUT 198 13.1 Advocacy and infl uencing processes 198 13.2 Developing an advocacy strategy 199 13.2.1 Analyse the problem and defi ne your objectives 201 13.2.2 Identify and understand those actors you want to infl uence 201 13.2.3 Build a strong case 204 13.2.4 Identify allies and experts who share your views 205 13.2.5 Identify and understand potential opponents 205 13.2.6 Develop a long-term plan 206 13.2.7 Take advantage of strategic opportunities 206 13.3 Communication 206 13.3.1 Media 207 13.3.2 Networking with civil society organizations 207 13.3.3 Communicating internationally 207 13.4 Materials – what needs to be produced 208 13.4.1 Survey report 208 13.4.2 Summary report 208 13.4.3 Policy briefi ng paper 208 13.4.4 Journal articles 209 13.5 Monitor and evaluate your activities 209 References 209 Background reading 210 14 MONITORING MEDICINE PRICES AND AVAILABILITY 211 14.1 Introduction 211 14.2 Background 212 14.2.1 Why monitor medicine prices? 212 14.2.2 Medicine-price reporting systems 212 14.2.3 Medicine price trend monitoring systems 213 14.3 How can medicine prices and availability be monitored in resource-poor countries? 214 14.3.1 What prices to monitor? 214 14.3.2 Ex-factory or ex-manufacturer price 214 14.3.3 Procurement price 215 CONTENTS viii MEASURING MEDICINE PRICES, AVAIL ABIL IT Y, AFFORDABIL IT Y AND PRICE COMPONENTS 14.3.4 Private sector patient price 215 14.3.5 Public sector patient price 215 14.3.6 Prices paid by patients at other access points 215 14.3.7 Important methodological considerations 216 14.3.8 Basic matters to consider 216 14.4 Overview of a methodology for routine monitoring of medicine prices and availability and pilot testing in three countries 220 14.4.1 Background 220 14.4.2 Overview of proposed methodology 220 14.4.3 Pilot testing 221 14.5 Medicine Price and Availability Monitoring Protocol – Kenya (Updated June 2007) 221 14.6 Medicine Price and Availability Monitoring Protocol – Malaysia 223 14.7 Medicine Price and Availability Monitoring Protocol – Pakistan 225 14.8 Results of pilot studies 227 15 NEXT STEPS IN THE WHO/HAI PROJECT ON MEDICINE PRICES AND AVAILABILITY 228 15.1 Undertaking research to inform policy interventions related to medicine pricing, availability and affordability 228 15.2 Evaluate policy interventions and expand the evidence base on effective policies for lowering medicine prices, increasing availability and improving affordability 229 15.3 To implement and evaluate advocacy strategies aimed at stimulating national, regional and global action to increase the availability of affordable medicines 229 GLOSSARY 231 ANNEXES 237 Annex 1 Abridged questionnaire on structures and processes of country pharmaceutical situations 239 Annex 2 Example of a letter of endorsement 254 Annex 3 Trainer’s Guide for training area supervisors, data collectors and data entry personnel 255 Annex 4 Example of a letter of introduction from the survey manager 275 Annex 5 Checklist for manual check of survey data 277 Annex 6 Price Components Interview Guide 280 Annex 7 Price Components Data Collection Form 286 Annex 8 International comparison of MPRs: adjustment for reference price year, infl ation/defl ation and purchasing power parity 289 CD-ROM Please refer to the accompanying CD-ROM for the full text of the manual in .pdf format, the automated data workbooks and other survey tools, resources and background materials. ix ATC Artemesinin-Based Combination Treatment AIDS Acquired Immunodefi ciency Syndrome ARVs Antiretrovirals CIF Cost, Insurance and Freight CMS Central Medical Stores CPI Consumer Price Index CSO Civil Society Organization DDU Delivered Duty Unpaid DFID Department for International Development (UK) EML Essential Medicines List EXW Ex-Works FOB Free on Board GDP Gross Domestic Product GST Goods and Services Tax HAI Health Action International HIV Human Immunodefi ciency Virus ID Identifi cation INF Insurance and Freight IUD Intrauterine Device INN International Nonproprietary Name IRP International Reference Price Km Kilometre LoC Letter of Credit LPG Lowest-Priced Generic MDGs Millenium Development Goals MPR Median Price Ratio MeTA Medicines Transparency Alliance (UK) MoH Ministry of Health MMV Medicines for Malaria Venture MRP Maximum Retail Price MSF Médecins Sans Frontières MSH Management Sciences for Health MSP Manufacturer’s Selling Price NA Not Available NEML National Essential Medicines List NGO Nongovernmental Organization NMP National Medicine Policy OB Originator Brand OCP Oral Contraceptive Pill PBS Pharmaceutical Benefi ts Scheme (Australia) PHARMAC Pharmaceutical Management Agency (New Zealand) Abbreviations x MEASURING MEDICINE PRICES, AVAIL ABIL IT Y, AFFORDABIL IT Y AND PRICE COMPONENTS PPP Purchasing Power Parity THE Total Health Expenditure USD U.S. Dollar VAT Value Added Tax Vs Versus WHO World Health Organization xi Foreword Access to essential medicines is part of the fulfi lment of the right to the highest attainable standard of health (in short: the right to health). So why do millions of people across the globe go without the treatments they need? The reasons are now becoming clearer – and the price and availability of medicines to those who need them are crucial factors. Prices for poor people are simply too high and products are often not available. This may not be news to the sick and poor, but it has been news for those whose responsibility it is to ensure the health of citizens. In 2001, the World Health Assembly passed resolution 54.11 which requested the Director-General “to explore the feasibility and effectiveness of implementing, in collaboration with nongovernmental organizations and other concerned partners, systems for voluntary monitoring drug prices and reporting global drug prices with a view to improving equity in access to essential drugs in health systems, and to provide support to Member States in that regard.” The fi rst edition of Medicine prices – a new approach to measurement was pub- lished in 2003 as a working draft for fi eld-testing and subsequent revision. Since then, more than 50 medicine price and availability surveys have been conducted in all regions of the world, using the recommended standard method. The results have exposed many problems of poor access to medicines, for example, people having to work 15 days or more to afford one month’s treatment for a chronic disease; important medicines simply not being available locally to patients; governments not passing on low procurement prices to their citizens; excessive mark-ups in the private sector, and taxes and duties being applied to essential medicines. From the evidence that has resulted from use of the WHO/HAI survey tool, medicine afford- ability and availability issues show no boundaries. Crucially, it is the poor who are really paying the price – both economically and with their health. The wealth of experience gained from four years of use of the WHO/HAI survey tool has led to a number of improvements in this second edition of the manual. We believe that the method is rigorous, facilitating reliable data collection and valid analysis. With the publication of the new edition, we encourage countries and or- ganizations to not only undertake surveys, but also to implement systems for the regular monitoring of medicine prices, availability and affordability. Gathering evidence is, of course, only the fi rst step – data alone cannot improve ac- cess to treatment. That takes commitment – from governments, civil society, inter- national organizations, health professionals, industry and many others, all working together to overcome the barriers. The work of the WHO/HAI Project on Medicine Prices and Availability and the survey teams across the globe has generated an extensive network of advocates, policy-makers, academics and others who are now focusing world attention on improving medicine affordability and availability. Producing this manual is the latest activity in the implementation of the 2001 World Health Assembly resolution. The work that has been done has resulted from the xii MEASURING MEDICINE PRICES, AVAIL ABIL IT Y, AFFORDABIL IT Y AND PRICE COMPONENTS joint efforts of the World Health Organization and Health Action International with their many partners. We hope the new edition of the manual will further encourage others to tackle this challenge of ensuring universal access to affordable medi- cines. Equitable access to essential medicines is the goal – it is the people’s right. Dr Hans Hogerzeil Dr Tim Reed Director Director Medicines Policy and Standards/ Health Action International Global Acting Director Technical Cooperation for Essential Amsterdam Drugs and Traditional Medicine World Health Organization Geneva xiii Acknowledgements Health Action International (HAI) and the World Health Organization (WHO) would like to thank all project members who over the years have so willingly given their time and expertise, and who continue to do so, thereby ensuring the success of the project. We are indebted to you all. We are also extremely grateful to the advice provided by WHO’s Regional Pharmaceutical Advisers. Your experience on pricing and related issues at the national and regional levels has been invaluable. We would also like to thank the project’s donors. Without your support this work would not have been possible. We especially want to thank all the survey teams, and in particular the survey man- agers, who undertook surveys using the 2003 methodology. Your advice on how to improve the manual and workbook has been very helpful. Most importantly, it is because of your efforts that we now know much more about the price, availability and affordability of medicines across the globe. WHO/HAI Project on Medicine Prices and Availability Project Management Group Margaret Ewen, HAI Global, the Netherlands; Richard Laing, Medicines Policy and Standards/Technical Cooperation for Essential Drugs and Traditional Medicine (PSM/TCM), WHO, Switzerland; Alexandra Cameron, PSM/TCM, WHO, Switzer- land. Advocacy: Akke-Jeanne Klerk, HAI Global, the Netherlands. Country support: Gilles Forte, PSM/TCM, WHO, Switzerland. Project Advisory Group Martin Auton, South Africa; Kumaraiah Balasubramaniam, HAI Asia Pacifi c, Sri Lanka; Douglas Ball, Philippines; Jorge Bermudez, UNITAID, Switzerland; Andrew Chetley, Healthlink Global, UK; Dennis Ross-Degnan, Harvard Medical School, USA; Jerôme Dumoulin, University of Grenoble, France; Yves-Antoine Flori (In Memoriam); Claudia Habl, ÖBIG, Austria; Lorraine Hawkins, London, UK; David Henry, University of Toronto, Canada; Panos Kavanos, London School of Economics, UK; Jeanne Madden, Harvard Medical School, USA; Barbara McPake, UK; Elias Mossialos, Lon- don School of Economics, UK; Kirsten Myhr, Ullevål University Hospital, Norway; Aarti Patel, University of Otago, New Zealand; Carmen Perez-Casas, Médecins Sans Frontières, Canary Islands; Anthony So, Duke University, USA; Klara Tisocki, Philip- pines; Brenda Waning, Boston University, USA. Project Steering Group Daphne Fresle, formerly with WHO; Ellen t’Hoen, Médecins Sans Frontières, France; Zafar Mirza, WHO Eastern Mediterranean Regional Offi ce, Egypt; Lander van Om- men, the Netherlands; Raffaella Ravinetto, Médecins Sans Frontières; Harry van Schooten, the Netherlands; Mohga Kamal-Yanni, Oxfam, UK. xiv MEASURING MEDICINE PRICES, AVA IL ABIL IT Y, AFFORDABIL IT Y AND PRICE COMPONENTS Consultants Rania Bader, Jordan; Simona Chorliet, Burkina Faso; Andrew Creese (also former project co-ordinator), France; Pierrick Gonnet, France; Anita Kotwani, India; Libby Levison, USA; Patrick Mubangizi, Kenya. Pricing Policy Group Dennis Ross-Degnan, USA; Jaime Espin, Spain; Claudia Habl, Austria; Lorraine Hawkins, UK; David Henry, Canada; Catherine Hodgkin, the Netherlands; Kees de Joncheere, Denmark; Panos Kavanos, UK; Zafar Mirza, Egypt; Andy Oxman, Nor- way; Anban Pillay, South Africa; Joan Rovira, Spain; Brenda Waning, USA; Krisantha Weerasuriya, India. Global Advocacy Group Andrew Chetley, UK; Ellen t’Hoen, France; Ravi Narayan, India. Administrative support Lisa Greenough, PSM/TCM, WHO, Switzerland; Rose de Groot, HAI Europe, the Netherlands; Patricia Stimpson, PSM/TCM, WHO, Switzerland. Project Sponsors Ministry of Foreign Affairs, the Netherlands; The Rockefeller Foundation, USA; Swedish International Development Cooperation Agency, Sweden; Department for International Development, UK; European Union DG Development; Open Society Institute, USA; WHO; and HAI’s Global Programme of Work (funded by the Nether- lands Ministry of Foreign Affairs, Swedish International Development Cooperation Agency and the Finnish International Development Agency). Revision of the manual HAI and WHO would like to thank Kirsten Myhr, Simona Chorliet, Libby Levison Douglas Ball, Andrew Chetley and Klara Tisocki who drafted specifi c chapters in the manual. Comments on chapters of the revised manual were sought from many experts. Responses were received from Martin Auton, Kirsten Myhr, Douglas Ball, Anita Kot- wani, Patrick Mubangizi, Klara Tisocki, Dennis Ross-Degnan, Andy Gray, Panos Ka- vanos, Dele Abegunde, Andrew Creese, Edson Meza, Kees de Joncheere, Abayneh Desta, Catherine Hodgkin, Anthony So, Carmen Perez-Casas, Daisy Carandang, Nathalie Van De Maele and Charu Garg. We are grateful for your advice. Thank you to Pierrick Gonnet who revised the workbook, and Martin Auton, Douglas Ball and Libby Levison who tested it. Editor Mary Falvey. 1 Introduction 1 1.1 WHY MEASURE THE PRICE AND AVAILABILITY OF MEDICINES? One third of the global population lacks reliable access to needed medicines (1). The situation is even worse in the poorest countries of Africa and Asia, where as much as 50% of the population lacks such access. While some 10 million lives a year could be saved by improving access to essential medicines and vaccines – 4 million in Africa and South-East Asia alone (2) – a major obstacle to achieving this has been price. Average per capita spending on pharmaceuticals in high-income countries is 100 times higher than in low-income countries – about US$ 400 compared with US$ 4. The World Health Organization (WHO) estimates that 15% of the world’s population consumes over 90% of the global production of pharmaceuticals (by value) (3). Access to health care is a fundamental human right, enshrined in international treaties and recognized by governments throughout the world. However, without eq- uitable access to essential medicines for priority diseases the fundamental right to health cannot be fulfi lled. Access to essential medicines is also one of the United Nations’ Millennium Development Goals (MDGs) (1). In developing countries today medicines account for 25–70% of overall health- care expenditure, compared to less than 10% in most high-income countries (1,3). The cost of newer products with proven advantage over older medicines, such as antiretrovirals, medicines for tuberculosis and new antimalarials, limits access to medicines in resource-poor settings. Moreover, up to 90% of the population in low- and middle-income countries must pay for medicines out of pocket due to lack of social insurance and inadequate publicly subsidized services (1,4). Not only are medicines unaffordable for large sectors of the global population, they are a major burden on government budgets. In Member Countries of the Organization for Economic Co-operation and Develop- ment (OECD), many direct and indirect pharmaceutical price regulations remain in effect (5,6). However, in many low- and middle-income countries, national medicine pricing policies have been shifting from price controls to deregulation under the infl uence of structural adjustment and reform programmes. Duties, taxes, mark-ups, distribution costs and dispensing fees are often high, regularly constituting between 30 to 45% of retail prices, but occasionally up to 80% or more of the total (7–9). The higher the manufacturer’s selling price, the more these elements increase the fi nal price. Prices are also infl uenced by factors EDM_prices.indd 1EDM_prices.indd 1 30.4.2008 12:57:3930.4.2008 12:57:39 2 MEASURING MEDICINE PRICES, AVAIL ABIL IT Y, AFFORDABIL IT Y AND PRICE COMPONENTS such as whether the country observes patents and the level of fl exibility allowed under international treaties – which is eventually incorporated into national patent law; the level of domestic medicine production; national policies on protecting local industries; the level of competition between pharmaceutical manufacturers; and price regulation policies. National policies, medicine pricing and procurement strategies are required to ensure that medicines are affordable (1). While policies are also greatly needed to improve health infrastructure and fi nancing as well as to ensure the rational use of medicines, high medicine prices are one of the biggest obstacles to access. Never- theless, even in the face of a weak infrastructure and poverty, improvements in access can be achieved (10). The diffi culty in fi nding reliable information on medicine prices and availability – and therefore in analysing their components – hinders governments in constructing sound medicine pricing policies or evaluating their impact. It also makes it diffi cult for them to evaluate whether their expenditure on medicines is comparable to that of other countries at a similar stage of development. Moreover, 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 consum- ers and patients have greater purchasing power, governments, insurance funds and hospitals often fi nd it diffi cult to decide on the selection of medicines because they lack information. Prices of the same medicines frequently vary between countries (11); some com- monly used medicines have been found to be more expensive in developing countries than in industrialized ones (12–14); and many studies have shown that affordabil- ity is unrelated to purchasing power. The ex-manufacturer prices to countries – in particular for the private sector – are often confi dential. Medicine price indicator guides1 provide the sales prices from large wholesalers of generically equivalent medicines to governments. However, they do not give the price patients must pay in either the public or private sectors and often do not include new, essential but patented medicines. A few countries have publicly available prices, but the informa- tion’s use is obstructed by the country-specifi cs that apply and language barriers. The monitoring of prices and cross-country comparisons are therefore important. 1.2 THE WHO/HAI PROJECT ON MEDICINE PRICES AND AVAILABILITY 1.2.1 Background and project objectives In the mid-1990s, civil society organizations in developed and developing countries – including Health Action International (HAI), Médecins Sans Frontières (MSF), the Consumer Project on Technology and Oxfam – started drawing attention to the need for increased access to medicines as part of the fi ght against poverty. Unafford- able medicine prices were considered a barrier to accessing treatment, but at this time only a few small-scale studies in developing countries had been carried out to measure medicine prices and make international comparisons. Methodological diffi culties left many of these studies’ results open to criticism. Study results by HAI Asia Pacifi c (13,14) and others were discussed with WHO at the WHO/Public Interest NGO Roundtables held in the late 1990s. While it ap- peared that prices were higher in low-income countries compared to some more 1 Management Sciences for Health (MSH); the WHO Regional Offi ce for Africa; UNICEF/UNAIDS/WHO-HTP/MSF. EDM_prices.indd 2EDM_prices.indd 2 30.4.2008 12:57:4030.4.2008 12:57:40 3 1. INTRODUCTION wealthy nations, relatively little was known about prices in different settings in low- and middle-income countries, and about the factors that make up the fi nal patient price. The absence of a standard methodology was seen as a stumbling block in reliable price measurement and international comparison. Both WHO and the nongovernmental organizations (NGOs) recognized that the avail- ability and affordability of essential medicines had to be improved through develop- ing evidence-based national policies and programmes. To this end, the WHO/HAI Project on Medicine Prices and Availability was established in 2001 to: � develop a reliable methodology for collecting and analysing medicine price, availability, affordability and medicine price component data across health-care sectors and regions in a country; � publish survey data on a publicly accessible web site to improve price transpar- ency; and � advocate for appropriate national policies and monitor their impact. In May 2001, delegates to the World Health Assembly endorsed and gave further support to the project. They requested WHO “to explore the feasibility and effective- ness of implementing, in collaboration with NGOs and other concerned partners, systems for voluntary monitoring [of] drug prices and reporting global drug prices with a view to improving equity in access to essential drugs” (15). A year later, the World Health Assembly called on WHO to “provide technical support, especially to developing countries, to establish drug-pricing policies” (16). 1.2.2 Development, testing and use of the manual In Phase I of the project, WHO, HAI and a group of international experts drafted a methodology to measure medicine prices, availability, affordability and price com- ponents. Following pilot testing in Armenia, Brazil, Cameroon, Ghana, Kenya, Peru, the Philippines, South Africa and Sri Lanka, the methodology was launched at the 2003 World Health Assembly as a draft manual and Excel workbook for fi eld testing (17). Despite considerable pilot testing, HAI and WHO viewed the fi rst edition of the manual and workbook merely as a starting point. As more surveys were undertak- en, the methodology was kept under review and further developed in collaboration with survey managers in the light of accumulating experience. To improve price transparency, a database of survey results was established on HAI’s web site.1 This enables international comparisons to be made, since all sur- veys have used the WHO/HAI standardized approach. In addition to the database, the web site also provides all survey documents, any updates to the methodology, survey reports, advocacy material as well as project and related publications. In Phase II of the project (which began mid-2003), HAI, WHO and project members provided technical assistance to ministries of health, NGOs, university researchers and others who undertook national or provincial/state surveys using the WHO/HAI methodology. This assistance was provided through regional pre- and post-survey workshops (in anglophone and francophone Africa, Asia/Pacifi c, Central Asia, the Eastern Mediterranean and India), various national workshops and through online advice. During Phase II, studies were undertaken to validate the sampling methodology, the volatility of the reference prices and to compare actual prices paid with those 1 www.haiweb.org/medicineprices EDM_prices.indd 3EDM_prices.indd 3 30.4.2008 12:57:4030.4.2008 12:57:40 4 MEASURING MEDICINE PRICES, AVAIL ABIL IT Y, AFFORDABIL IT Y AND PRICE COMPONENTS collected by data collectors. The results confi rmed the strength and appropriate- ness of the WHO/HAI approach. At the request of survey managers, a system to regularly monitor medicine prices, availability and affordability was developed and piloted in various countries in Africa and Asia in Phase II of the project (see Chapter 14). 1.2.3 Survey results By the end of 2007, over 50 surveys had been undertaken across the globe, from Cameroon and the Cook Islands to El Salvador, South Africa and the Syrian Arab Republic. They have generated reliable evidence showing, for the fi rst time, some startling facts about the affordability and availability of medicines. The results of these surveys1 revealed that in many low- and middle-income countries: � medicine prices are high, especially in the private sector (e.g. over 80 times an international reference price); � availability can be low, particularly in the public sector (including no stocks of essential medicines); � treatments are often unaffordable (e.g. requiring over 15 days’ wages to pur- chase 30 days’ treatment); � government procurement can be ineffi cient (e.g. buying expensive originator brands as well as cheaper generics); � mark-ups in the distribution chain can be excessive; and � numerous taxes and duties are being applied to medicines. The results confi rm that in many countries access to essential medicines is hin- dered by low availability and unaffordable prices. For example, salbutamol inhaler – an important medicine used to treat asthma – is virtually unavailable in the public sector of many countries (where medicines are generally cheaper or even free) and when purchased from the private sector, can cost the lowest-paid, unskilled gov- ernment worker several days’ wages (Table 1.1). As Fig. 1.1 illustrates, people are paying high prices for many medicines. The price of originator brand atenolol 50 mg tablets is over 20 times the international reference price in all the countries except India (where it is still high at 5 times the reference price) and Kazakhstan. Even the lowest-priced generic is very expensive in all countries, and there are some huge brand premiums, e.g. in Uganda the originator brand is about 13 times the price of the generic. Table 1.1 Availability and affordability of 1 salbutamol inhaler 0.1mg/dose in selected countriesa Availability – public sector facilities Affordability – private sector facilities Originator Lowest-priced generic Originator Lowest-priced generic Uganda, April 2004 0% 0% 5.6 days 2.0 days Ghana, October 2004 4% 11% 8.0 days 4.6 days Mali, March 2004 0% 0% 4.2 days 2.7 days Pakistan, July 2004 0% 3% 1.4 days 1.4 days Indonesia, August 2004 13% 0% 4.1 days – a Results of national medicine price and availability surveys conducted using WHO/HAI standard methodology. Data are available from http://www.haiweb.org/medicineprices/. 1 http://www.haiweb.org/medicineprices EDM_prices.indd 4EDM_prices.indd 4 30.4.2008 12:57:4030.4.2008 12:57:40 5 Regional analyses of data have been undertaken or are currently being drafted for surveys conducted in India (18), the WHO Eastern Mediterranean Region (19) and the WHO African Region (20), respectively, as well as Central Asia. An international comparison of prices, availability and affordability of medicines to treat chronic diseases has also been done (21), and analyses of price and availability of medi- cines in various therapeutic groups are underway. Reports of these analyses can be found on the HAI web site. 1.2.4 Evidence for policy development and implementation The project’s objective is to improve the availability and affordability of essential medicines through the development of evidence-based national policies and pro- grammes. It has been encouraging, therefore, to see survey reports being dissemi- nated and findings discussed in different national, regional and global forums. Following the 2006 World Health Assembly, the British Medical Journal published an editorial drawing attention to the WHO/HAI report on prices, availability and affordability of chronic disease medicines that stated “the report’s findings make explicit what has long been recognized: that the cost of medical care impoverishes or is simply beyond the reach of many people in developing countries. Amid the gloom, however, there is some light. Simply collecting data and presenting it to governments can stimulate action” (22). Indeed, some countries have acted on the evidence, among them the Government of Indonesia, which reduced the price of 458 generic medicine formulations from 5%–70% and implemented regulations to standardize prices for all public purchasing; the Government of Lebanon, which re- duced the prices of a quarter of medicines on the market and introduced regressive 1. InTROduCTIOn Fig. 1.1 Median price ratios, atenolol 50 mg tablets, purchased from private retail pharmacies Source: Gelders S et al. Price, availability and affordability: an international comparison of chronic disease medicines. Cairo, World Health Organization, 2006. 0 20 40 60 80 Max: 78.82 Median for originator: 33.98 Min: 2.45 Median for generic: 5.28 Originator Generic Cameroon (2002) Ghana (2002) uganda (2004) peru (2002) Jordan (2004) Kuwait (2004) Lebanon (2004) Armenia (2001) Kazakhstan (2004) Tajikistan (2005) India/Chennai (2004) India/Haryana (2004) India/Karnataka (2204) India/Maharashtra (4 regions) (2004) India/Maharashtra (12 districts) (2004) India/Rajasthan (2003) India/West bengal (2004) Indonesia (2004) Fiji (2004) Malaysia (2004) Mongolia (2004) philippines (2002) EDM_prices.indd 5 13.5.2008 15:47:58 6 MEASURING MEDICINE PRICES, AVAIL ABIL IT Y, AFFORDABIL IT Y AND PRICE COMPONENTS mark-ups; the Government of Nigeria, which is drafting a medicines policy, based on its survey fi ndings; and the Government of Tajikistan, which abolished 20% VAT on medicines. In Phase III, the project will support countries to develop and implement policies and programmes that result in improved availability of medicines and more affordable treatments. Additionally, the project will support establishing national monitoring systems to evaluate the impact of policy changes (see Chapter 14). Changes in national policies feature in the project’s bulletin Medicine Pricing Matters along with publications and other interesting outcomes of pricing work being carried out worldwide. This quarterly bulletin was fi rst published in December 2007.1 1.2.5 Related surveys and initiatives It has been encouraging to see other price studies utilizing the WHO/HAI survey methodology. In Nepal and Nicaragua, John Snow International and PATH conducted a survey of commodities for reproductive health (OCP, IUD, condoms, vaccines and other medicines) using an adaptation of the WHO/HAI methodology (23, 24). In 2005, WHO’s Noncommunicable Diseases and Mental Health Cluster used the WHO/HAI methodology to survey the price, availability and affordability of 35 medi- cines used to treat chronic conditions (25). The surveys were done in Bangladesh, Brazil, Malawi, Nepal, Pakistan and Sri Lanka. More recently, the Medicines for Malaria Venture (MMV) has conducted a survey in Uganda looking at the price, availability, affordability and quality of all antimalarials on the market, using and adaptation of the WHO/HAI methodology.2 MMV is planning to conduct a number of surveys in other countries. The Medicines Transparency Alliance (MeTA) is a new initiative of the United King- dom Department for International Development (DFID). MeTA will work with national and international partners, including WHO and the World Bank, to support national efforts to enhance transparency and build capacity in medicines policy, procure- ment and supply chain management. DFID envisages international actors supporting national efforts, coupled with focused technical and fi nancial support to strength- en transparency and accountability. Such national efforts would seek to improve access to information about medicine quality, availability and pricing, with strong civil society and consumer involvement in scrutiny and debate. MeTA has identifi ed the WHO/HAI price measurement methodology as the key tool for measuring medi- cine prices, availability, affordability and component costs. MeTA will be launched in May 2008, with pilots in several countries in Africa, Asia, Central Asia, the Eastern Mediterranean and Latin America.3 1.3 THE MEDICINE PRICES AND AVAILABILITY SURVEY MANUAL – SECOND EDITION Published in 2003, the fi rst WHO/HAI medicine prices manual Medicine Prices – A New Approach to Measurement. Draft for fi eld-testing provides a draft methodology and tools to conduct national medicine prices and availability surveys. This second 1 Contact HAI if you wish to be placed on the mailing list. WHO’s Essential Drugs Monitor (http://www.who.int/ medicines/publications/monitor/en/index.html) regularly features articles on medicine pricing work and the 33rd issue (http://mednet2.who.int/edmonitor/33/mon33.html) carried a 16-page supplement on survey fi ndings and analyses, policy changes and advocacy. Contact edmdoccentre@who.int to receive a copy of this edition or to be placed on the mailing list. 2 http://www.mmv.org/IMG/pdf/Prices_of_Antimalarials_MMV_survey_July_07_website_19_Sept.pdf 3 Additional information on MeTA can be found at http://www.dfi dhealthrc.org/MeTA/index.html EDM_prices.indd 6EDM_prices.indd 6 30.4.2008 12:57:4130.4.2008 12:57:41 7 edition of the survey manual has been updated to refl ect the wealth of practical experience in conducting medicine prices and availability surveys garnered in the project’s fi rst two phases. The new manual and accompanying tools have been developed through a con- sultative process with project participants, national collaborators and the WHO/ HAI Project on Medicine Prices Steering and Advisory Groups. A technical meeting was held in Cairo from 27 November to 3 December 2006 with the medicine prices project management team, advisory and steering groups, selected survey manag- ers and consultants to recommend changes to the methodology and revisions to the survey manual. This group has also been consulted throughout the manual revision process, and has contributed to sections of the manual related to their respective areas of expertise. In the manual’s second edition, the survey methodology has been refi ned, based on the lessons learnt in the more than 50 surveys conducted to date. New methodolo- gies and tools have also been developed in the areas of price component surveys (Chapter 9) and routine monitoring of medicine prices and availability (Chapter 14). The revised manual also provides signifi cantly more guidance in the areas of policy options and lines of action (Chapter 11) as well as advocacy strategies aimed at stimulating reform of medicine price policies (Chapter 13). The second edition includes the revised survey manual along with updated ver- sions of the automated data workbooks and survey instruments: it also includes a CD-ROM of survey tools, resources and background materials. The CD-ROM and the HAI web site1 will be updated periodically with new materials as these become available. Feedback on the second edition of the medicine prices and availability survey man- ual is welcome and encouraged.2 REFERENCES WHO medicines strategy 2004–20071. . Geneva, World Health Organization, 2004 (WHO/EDM/2004.5) (http://whqlibdoc.who.int/hq/2004/WHO_EDM_2004.5.pdf, accessed 2 December 2007). Increasing access to essential medicines in the developing world: UK Government policy and plans2. . London, Department for International Development, 2004 (http://www.dfi d.gov.uk/Pubs/fi les/ accessmedicines.pdf, accessed 2 December 2007). The world medicines situation3. . Geneva, World Health Organization, 2004 (WHO/EDM/PAR/2004.5) (http://www.cdf.sld.cu/World_Medicines_Situation.pdf, accessed 2 December 2007). McIntyre D et al. What are the economic consequences for households of illness and of paying 4. for health care in low- and middle-income country contexts? Social Science and Medicine, 2006, 62:858–65. Jacobzone S. 5. Pharmaceutical policies in OECD countries: reconciling social and industrial goals. (Labour market and social policy – occasional papers No. 40). OECD, 2000 (DEELSA/ELSA/ WD (2000)1) (http://www.olis.oecd.org/OLIS/2000DOC.NSF/c5ce8ffa41835d64c125685d 005300b0/c125685b0057c558c12568c400331a1e/$FILE/00075948.pdf, accessed 2 De- cember 2007). Dukes MNG et al., eds. 6. Drugs and money. Prices, affordability and cost containment. Copenha- gen, World Health Organization Regional Offi ce for Europe, 2003. Bale H. 7. Consumption and trade in off-patented medicines. Commission on Macro economics and Health, Working Paper Series, Paper No. WG4:3, 2001 (http://www.icrier.org/pdf/bale65.PDF, accessed 2 December 2007). 1. INTRODUCTION 1 http://www.haiweb.org/medicineprices/ 2 Please contact HAI (info@haiweb.org) or WHO (medicineprices@who.int). EDM_prices.indd 7EDM_prices.indd 7 30.4.2008 12:57:4130.4.2008 12:57:41 8 MEASURING MEDICINE PRICES, AVAIL ABIL IT Y, AFFORDABIL IT Y AND PRICE COMPONENTS Working document on developing countries’ duties and taxes on essential medicines used in the 8. treatment of the major communicable diseases. European Commission, Directorate-General for Trade, 2003 (http://trade.ec.europa.eu/doclib/docs/2003/june/tradoc_113184.pdf). Levison L, Laing R. The hidden costs of essential medicines. 9. Essential Drugs Monitor, 2003, 33:20–21 (http://mednet2.who.int/edmonitor/33/EDM33_20-21_Hidden_e.pdf, accessed 3 December 2007). Public health, innovation and intellectual property rights. Report of the Commission on Intellectual 10. Property Rights, Innovation, and Public Health. Geneva, World Health Organization, April 2006, p. 125. Wagner JL, McCarthy E. International differences in drug prices. 11. Annual Review of Public Health, 2004, 25:475–95. Myhr K. 12. Comparing prices of essential drugs between four East African countries and with in- ternational prices. Nairobi, Médecins Sans Frontières, 2000 (http://www.accessmed-msf.org/ prod/publications.asp?scntid=3920012349208&contenttype=PARA&, accessed 3 December 2007). Bala K, Lanza O, Kaur SL. Retail drug prices: the law of the jungle. 13. Health Action International News, 1998, 100:2–4:13–16. Bala K, Sagoo K. Patents and prices. 14. Health Action International News, 2000, 111 (April/May) (http://haiweb.org/pubs/hainews/April2000.html, accessed 3 December 2007). Resolution WHA 54.11. WHO Medicines Strategy. In: 15. Fifty-fourth World Health Assembly, Geneva, 14–22 May 2001. Volume 1. Resolutions and decisions, and list of participants. Geneva, World Health Organization, 2001. Resolution WHA 55.14. Ensuring accessibility of essential medicines. In: 16. Fifty-fi fth World Health Assembly, Geneva, 13–18 May 2002. Volume 1. Resolutions and decisions, and list of partici- pants. Geneva, World Health Organization, 2002. Medicine prices: a new approach to measurement17. . Working draft for fi eld-testing and revision. Geneva, World Health Organization and Health Action International, 2003 (http://www.haiweb. org/medicineprices/manual/manuals/MedicinePrices.pdf, accessed 5 December 2007). Kotwani A et al. Prices & availability of common medicines at six sites in India using a standard 18. methodology. Indian Journal of Medical Research, 2007, 125:645–54. Ball D, Mirza Z, Ewen M. 19. Prices, availability and affordability of medicines in the World Health Or- ganization Eastern Mediterranean Region: a synthesis report of medicine price surveys undertaken in selected World Health Organization Eastern Mediterranean Region countries (in press). Auton M, Guimier J-M, Sturm T. 20. Medicine prices in Africa. Analysis of fi ndings from 11 countries in the WHO African Region (in press). Gelders S et al. 21. Price, availability and affordability. An international comparison of chronic disease medicines. Cairo, World Health Organization and Health Action International, 2006 (WHO-EM/ EDB/068E), (http://mednet3.who.int/medprices/CHRONIC.pdf, accessed 2 December 2007). Richards T. The great medicines scandal. 22. British Medical Journal, 2006, 332:1345–6 (10 June) (http://www.bmj.com/cgi/reprint/332/7554/1345, accessed 13 December 2007). Prices of reproductive health medicines in Nicaragua23. . Seattle, PATH, March 2006 (http://www. haiweb.org/medicineprices/related/09062006/NicaraguaPricingStudy_Final.pdf, accessed 13 December 2007). Rao R, Thapa D. 24. Nepal: reproductive health commodity pricing survey: understanding equity, ac- cess, and affordability of essential reproductive health commodities. Arlington, John Snow, Inc./ DELIVER, for the United States Agency for International Development, 2005 (http://www.hai- web.org/medicineprices/related/12012006/NepalRHPricing_fi nal%20rpt.pdf, accessed 13 De- cember 2007). Mendis S et al. The availability and affordability of selected essential medicines for chronic 25. diseases in six low- and middle-income countries. Bulletin of the World Health Organization, 2007, 85(4):279–87 (http://www.who.int/bulletin/volumes/85/4/06-033647.pdf, accessed 2 December 2007). 9 2 Survey overview and pre-survey planning 2.1 SURVEY OVERVIEW 2.1.1 Survey objectives The survey’s objective is to generate reliable information on the price, availability and affordability of selected important medicines and price components in the sup- ply chain, with the ultimate goal of improving access to affordable medicines for all. The survey 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 sector, private sector and other medicine outlets)? � Do prices and availability vary in different parts of a country? � What is the difference in prices and availability of originator brands and generi- cally equivalent medicines? � Do prices vary between product types (e.g. originator brands and generics) within the same sector? � How do government procurement prices compare with patient prices in the public sector? � How do national prices compare with international reference prices? � What taxes and duties are levied on medicines and what is the level of various mark-ups that contribute to their retail and public sector prices? � How affordable are medicines for ordinary people? The medicine price and availability study focuses on a limited number of medi- cines and enables their prices and availability to be investigated across health-care sectors within individual countries and also between countries. It is designed to measure medicine prices and availability 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 is easily replicable. The survey measures real paid prices, i.e. what patients pay in retail medicine outlets, and the price the govern- ment procurement agency paid; it does not rely on list prices produced by wholesal- ers, manufacturers and insurers, etc. A medicine price and availability study using this methodology also enables the price of selected medicines to be followed from EDM_prices.indd 9EDM_prices.indd 9 30.4.2008 12:57:4130.4.2008 12:57:41 10 MEASURING MEDICINE PRICES, AVAIL ABIL IT Y, AFFORDABIL IT Y AND PRICE COMPONENTS the point at which it leaves the manufacturer to the time it reaches the consumer’s hands. The survey identifi es issues related to procurement price effi ciency, public and private sector availability and prices, price structure and mark-ups, and crucially, the affordability of treatments for people with lower incomes. It is a useful tool for policy-makers and others concerned about access to medicines, and serves as an important basis for more in-depth analysis of various issues that might be identi- fi ed, policy considerations and interventions. If you are considering a medicine price and availability survey, spend some time clarifying and drafting your specifi c objectives. Consider the expected results and how you will use them to achieve the objectives identifi ed, including any advocacy strategies that may be needed. Be very clear about to whom you will direct the results and recommended actions, and who else could work with you as a team to achieve the survey objectives. This survey has been designed to provide a comprehensive picture of the prices and availability of selected medicines in a country. It should be repeated periodically to assess the impact of policy and programmatic changes on the prices of medicines. The survey has been developed for use by governments, civil society groups, in- ternational agencies, researchers and health professional organizations. A survey manager coordinates the survey management. The survey manager is the prima- ry audience for this manual, though the commissioning organization should also be thoroughly familiar with the survey procedures. An advisory committee should always be established to provide support and expertise throughout the survey and to initiate policy discussions based on the fi ndings. The inclusion of prominent and respected stakeholders will enhance the credibility of the study, report and recommendations. LESSONS FROM THE FIELD “Undertaking such a survey is beyond the scope of an individual, and requires the commitment of a group of people. We contacted people – consumer associations, academics, pharmacists, pharmacy and medical associations and NGOs to contribute in one way or another.” Baber Z, Ibrahim M. Conducting a medicine pricing survey: experiences and challenges. Essential Drugs Monitor, 2005, Issue No. 34. 2.1.2 Key elements of the survey design In the survey, data are collected on the availability and price of a selection of impor- tant medicines from a sample of medicine outlets in the public, private and other sectors (e.g. NGOs) in six regions of a country or – in the case of large countries – of a state or province. Data on medicine prices, but not availability, are also collected for government procurement; these data are usually collected at the central level (e.g. government procurement offi ce). Most surveys are national, however in large countries it is recommended that the methodology be applied at the state or pro- vincial level or that the number of regions surveyed be increased. Sampling is done in a systematic way to ensure that the fi ndings are representative of the country or state/province in which the survey is being conducted. EDM_prices.indd 10EDM_prices.indd 10 30.4.2008 12:57:4130.4.2008 12:57:41 11 2. SURVEY OVERVIEW AND PRE-SURVEY PL ANNING The survey methodology also includes a process for collecting information on the add-on costs that contribute to the fi nal price of medicines. This involves beginning with the fi nal (patient) price of selected medicines and tracking these prices back through the distribution chain. Identifying price components is an essential part of the survey, both for understanding price results and for determining their policy implications. 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 is selected in at least six geographical areas: a country’s main urban centre and fi ve other administrative areas (survey areas). In each survey area, a sample of medicine out- lets are examined from each of the public sector, e.g. primary health-care centres and government hospitals, and the private sector, e.g. licensed pharmacies and licensed drug stores. Up to two ‘other’ sectors where medicines are commonly sold can also be surveyed, such as the mission sector and dispensing doctors. In each survey area, data are collected in at least fi ve medicine outlets per sector, for a total of fi ve outlets x six survey areas = 30 outlets per sector. Up to 50 medicines are included in the survey. The list of survey medicines is gener- ally composed of: � 14 global core medicines; � 16 regional core medicines; and � 20 supplementary medicines. The global and regional core medicine lists are part of the WHO/HAI standard methodology. By standardizing the medicines surveyed at the global and regional levels across surveys, countries can compare their fi ndings with other countries and other international comparisons can be conducted. Supplementary medicines are selected at the country level for their national importance, or to collect data on a particular therapeutic class. For each medicine in the survey, data are collected for two products: the originator brand (previously called innovator brand), and the lowest-priced generic equivalent found at each medicine outlet. In each survey area, data collection is managed by an area supervisor. Data col- lectors, who have received standardized training, including a data collection pilot � Data collection takes place in six areas of the country (survey areas) � Medicine outlets from the public, private and up to two other sectors are surveyed. Prices are also collected for government procurement. � Up to 50 medicines are surveyed, including core medicines that allow for global and regional comparisons, and supplementary medicines of local importance. � Data on the price and availability of medicines in the public, private and other sectors are obtained by data collectors during visits to medicine outlets. Public procurement data are usually obtained centrally, e.g. from the offi ce of the procurement offi cer or central medical stores. � For each medicine, data are collected on the originator brand and the lowest-priced generic equivalent found at each medicine outlet. � A second, important part of the methodology is the price components survey, where information is collected on the various charges applied to medicines as they proceed through the distribution chain. 12 MEASURING MEDICINE PRICES, AVAIL ABIL IT Y, AFFORDABIL IT Y AND PRICE COMPONENTS test, visit medicine outlets in pairs and record whether medicines are found, and if so, their price. When less than 50% of expected medicines are available at a given outlet, data collectors visit a back-up facility and repeat the data collection. This ensures that a suffi cient number of medicine prices are collected to allow for robust analyses. However, the data from the original facility are also kept and used in the analysis to provide an accurate representation of medicine availability. To ensure data quality, area supervisors check data collection forms at the end of each day of fi eldwork and follow up on any incomplete, erroneous or illegible data. They also validate data collection by re-conducting the survey at 20% of the sam- ple medicine outlets and comparing their results to those of data collectors. Once data collection is completed, verifi ed data collection forms are sent to the survey manager at the central level. Data entry personnel enter the data into the compu- terized WHO/HAI Medicine Price and Availability Workbook – Part I and Part II, which is a customized application for Microsoft Excel®. To guard against errors, data are entered twice by separate personnel and cross-checked (double entry). The work- book’s data-checker function is then used to highlight suspicious data that require verifi cation. Ensuring the quality of the data entered into the workbook is critical to the accuracy of the survey results. Data analysis is conducted using the electronic workbooks, which is pre-pro- grammed to consolidate and summarize results. The availability of individual medi- cines is reported as the percentage (%) of medicine outlets in which the medicine was found on the day of data collection. To facilitate international comparisons, medicine prices found during the survey are expressed as ratios relative to a stand- ard set of international reference prices, known as the median price ratio or MPR. The ratio is an expression of how much greater or less the median local medicine price is than the international reference price, e.g. an MPR of 2 would mean that the local medicine price is twice the international reference price. Management Sciences for Health (MSH) reference prices1 are recommended as the most useful standard. These are prices offered by mostly not-for-profi t suppliers to developing countries for multi-source products, and generally do not include insurance or trans- portation charges. Affordability is estimated using the daily wage of the lowest-paid unskilled gov- ernment worker by determining the number of days’ wages required to purchase selected courses of treatment for common acute and chronic conditions. Data collected on the components of medicine prices are analysed according to fi ve common stages in the supply chain that all medicines go through as they move from manufacturer to patient: Stage 1: manufacturer’s selling price + insurance and freight Stage 2: landed price Stage 3: wholesale selling price (private sector) or Central Medical Stores price (public sector) Stage 4: retail price (private sector) or dispensary price (public sector) Stage 5: dispensed price This categorization allows comparisons both between health systems and between countries. Data on price components are also entered into the workbook, which automatically calculates the contribution of each stage of the supply chain to the 1 http://erc.msh.org/ EDM_prices.indd 12EDM_prices.indd 12 30.4.2008 12:57:4230.4.2008 12:57:42 13 fi nal price as well as the total contribution of price components to the fi nal price of medicines. 2.1.3 The standard approach to measuring medicine prices and availability The standard approach described in this manual involves a systematic survey to collect accurate data and reliable information on medicine prices and availability. It is characterized as follows: � standard global and regional lists of medicines for international comparisons � systematic sampling process � use of international reference prices � comparison of originator brand and generically equivalent medicines � sector comparisons: public (patient and procurement prices), private and other sectors � treatment affordability comparisons � identifi cation of price components, e.g. taxes and mark-ups, which contribute to the fi nal patient price of medicines � standard data entry and analysis methods using computerized workbooks � standard report format The standard methodology must be followed to ensure that the data are reliable and that international comparisons are possible. 2.1.4 Steps in the survey Table 2.1 provides an overview of the survey’s steps, the activities to be under- taken at each step and the chapter in the manual where detailed instructions are provided. 2.2 PRE-SURVEY PREPARATION The following resources are provided to assist you in conducting the survey: � Survey manual � Survey templates, tools and supporting materials (on CD-ROM) � Computerized workbooks for generation of survey instrument (data collection form), data entry and processing 2. SURVEY OVERVIEW AND PRE-SURVEY PL ANNING Note that the workbook is in two parts: Part I is used to enter the study medicines and international reference prices, generate the data collection form for the price and availability survey, enter unit prices collected in the public sector (procurement and patient prices), private sector and other sectors, analyse prices and availability, and assess affordability Part II is for entering and analysing price component data EDM_prices.indd 13EDM_prices.indd 13 30.4.2008 12:57:4230.4.2008 12:57:42 14 MEASURING MEDICINE PRICES, AVAIL ABIL IT Y, AFFORDABIL IT Y AND PRICE COMPONENTS Table 2.1 Steps in the survey Step Survey activity Chapter Pre-survey preparation 1. Establish an advisory committee and meet to clarify survey objectives, scope 2 Estimated duration: (national vs provincial survey, survey areas, sectors), medicines to be surveyed, two to three weeks source of procurement data, personnel and other resource needs, timelines, budget, potential donors (if needed). 2. Collect background information on the pharmaceutical sector. 3. Recruit survey personnel. 4. Secure technical and fi nancial resources. 5. Seek endorsement for the survey. 6. Prepare a survey schedule. Planning the survey 1. Select the sample of medicine outlets. 3 & 4 Estimated duration: 2. Finalize list of medicines to be surveyed. two to three weeks 3. Develop draft survey protocol, submit to HAI or WHO for review. 4. Develop Medicine Price Data Collection form. 5. Plan and conduct training course, including data collection pilot test. Preparation for data 1. Prepare Letter of Introduction. 5 collection in the fi eld 2. Plan schedule of data collection visits and transport/accommodation in the fi eld. Estimated duration: one week 3. Prepare Medicine Price Data Collection forms for fi eld visits. 4. Prepare information materials and tools for data collectors. 5. Arrange for regular communications during fi eldwork. Data collection in the fi eld 1. Collect central government procurement data. 6 Estimated duration: 2. Assemble materials necessary for local data collection. two weeks (if three data 3. Confi rm appointments with medicine outlets. collection teams, each 4. Visit medicine outlets and any regional government procurement units, collect data surveying two areas, are used on medicine availability and price, and complete Medicine Price Data Collection form. and sampling distances are 5. At the end of each day, check data collection forms and resolve missing/unreliable adhered to) information. 6. Validate data collection by re-conducting survey at 20% of medicine outlets. 7. Copy and store data collection forms and, upon completion of data collection, transfer originals to survey manager for initial visual inspection. Data entry, analysis and 1. Enter data twice, using double-entry function and verify/correct any inconsistencies. 7, 8 & 10 interpretation 2. Run “data checker” and verify/correct any suspicious data. Estimated duration: 3. Send data to HAI or WHO for a data quality review. three weeks 4. Conduct analyses of medicine availability, price and affordability, including international comparisons as appropriate. 5. Meet with advisory committee to analyse and interpret results, explore possible policy options and lines of action, and plan price components survey. The latter includes identifying key sources of information; determining priority price components to be surveyed; and selecting regions, medicine outlets and medicines for tracking medicines through the supply chain. Price components survey 1. Recruit survey personnel as needed and conduct training. 9 Estimated duration: 2. Plan schedule of data collection visits and any transport/accommodation in the fi eld. three weeks 3. Visit key informants and collect central level data on national policies related to price components. 4. Collect data on the actual charges applied to selected target medicines. Visit the dispensing point for each sector and track target medicines backwards along the supply chain to their point of origin, recording the charges incurred. 5. Enter data on the charges applied to target medicines in the workbook. 6. Conduct analysis of the contribution of price components to the fi nal price of each target medicine, by stage and overall. 7. Prepare report on price components. 15 Before starting to plan the survey, read the manual in full and familiarize yourself with the resources included on the accompanying CD-ROM. Some survey managers have said the manual needs to be read two or three times for a thorough under- standing of the methodology! Careful planning and preparation are essential before data collection begins. Experience in the surveys conducted to date shows that most errors and missed opportunities could have been avoided by better pre-survey planning. 2.2.1 Establishing an advisory committee An advisory committee should be assembled to help plan and support the survey and promote its fi ndings. Advisers should be involved from an early stage to ensure their support of the validity of the survey results and their assistance in promot- ing pricing policy changes. Involving key stakeholders and opinion leaders will also strengthen the credibility of the survey fi ndings. The role of the advisory committee should include: � clarifying the survey’s objectives; � assisting in obtaining endorsement for the survey; � identifying possible sponsors (if needed); � supporting the survey manager in planning, preparing and conducting the study, and identifying important policy issues that should inform the survey protocol (e.g. medicine selection); � advising on any matters that arise during survey preparation, fi eldwork and data analysis; � assisting in planning and conducting the price components survey, including identifying and contacting key informants; � assisting in interpreting data and developing policy recommendations; � promoting the survey’s fi ndings and advocating for appropriate policy changes; and � assisting in carrying out a follow-on, in-depth study or intervention study. Holding regular meetings with the advisory committee, throughout the survey proc- ess, is important. You should hold at least one meeting to support the planning and preparation of the medicine prices and availability survey and one post-survey meeting for interpreting survey results and developing recommendations. The lat- ter meeting should also be used to plan the price components survey if it is being conducted after the general pricing survey. You should hold a second post-survey meeting following the price components survey to discuss the results and their policy implications, consolidate all survey results and fi nalize recommendations. Table 2.1 Continued Step Survey activity Chapter Using the information 1. Meet with advisory committee to analyse and interpret price components results; 11, 12 & 13 collected consolidate all survey results; and fi nalize recommendations. Estimated duration: one to two 2. Draft survey report. weeks for survey report, with 3. Share preliminary fi ndings with key stakeholders and consult on next steps. advocacy and communications 4. Plan and implement advocacy and communications activities. ongoing 2. SURVEY OVERVIEW AND PRE-SURVEY PL ANNING EDM_prices.indd 15EDM_prices.indd 15 30.4.2008 12:57:4230.4.2008 12:57:42 16 MEASURING MEDICINE PRICES, AVAIL ABIL IT Y, AFFORDABIL IT Y AND PRICE COMPONENTS You should select the advisory committee membership carefully. It should comple- ment the survey manager’s skills and include at least one medical doctor and pharma- cist, a health economist (where possible) and stakeholders such as policy-makers, relevant professional associations, public-health institutions, academic institutions and civil society groups working on health issues (preferably access to medicine issues). At least one member should be knowledgeable about the medicines sup- ply chain in various sectors to provide support to the price components survey. If there is a market survey company active in your community, such as Intercontinental Medical Statistics (IMS) Health, you may wish to involve them in the committee. It may also be wise to include an area supervisor with an understanding of local reali- ties. The size of the advisory committee should be kept suffi ciently small to enable regular meetings, however if this is not possible, working groups can be formed to address specifi c topics (e.g. methodology, price components, advocacy). 2.2.2 Clarifying the specifi c survey objectives The broad objective of any medicines price and availability survey is to generate reliable information on the price, availability and affordability of selected important medicines with a view to ensuring access to affordable medicines for all. However, the specifi c research and policy objectives of each individual survey will vary. For ex- ample, a country may wish to investigate the impact of originator brand product use on medicine affordability as a means to support introducing a generic substitution policy. Another country might want to survey prices and availability of all medicines in a particular therapeutic group (e.g. antimalarials or palliative care medicines). The commissioning organization, advisory committee and survey manager should work together to clarify the survey’s research and policy objectives so that a survey design is developed according to these objectives. They should also consider whether any other research is needed to provide a broader perspective (e.g. assessing sales volume). Well-defi ned survey objectives will also help to guide data analysis and interpretation, as well as follow-on communication and advocacy activities. 2.2.3 Collecting information on the health system and pharmaceutical sector A critical step in preparing for the medicines price survey is to collect background information on the pharmaceutical sector. This information is indispensable for survey planning, e.g. selection of sectors to study and medicines to survey. It will also be of critical importance in analysing the data and formulating policy recommendations. The structure of the health-care system and the organization of the pharmaceuti- cal sector vary widely between, and sometimes within, countries. Before beginning Medicine price monitoring: lessons from the fi eld “In Kenya, the collaboration between the Ministry of Health (MoH) pharmacy division and the WHO National Professional Offi cer has been instrumental in facilitating the survey. The advisory group, composed of individuals from relevant Ministry departments and NGOs, has also been extremely important. The MoH is considering institutionalizing this work as part of monitoring and evaluation and the chief pharmacist uses the reports frequently. We now have a strong team of data collectors whose capacity has been built and who are undertaking other monitoring and evaluation activities in the area of medicines.” Patrick Mubangizi, Survey Manager, Medicine Price Monitoring, Kenya EDM_prices.indd 16EDM_prices.indd 16 30.4.2008 12:57:4230.4.2008 12:57:42 17 the survey, it is important to have a clear understanding of how pharmaceutical services are organized, including the relative contribution of various sectors to the supply of medicines. Additionally, the main procurement and distribution channels for pharmaceuticals should be clearly identifi ed. This will allow you to put medicine prices in a countrywide context and identify countries with similar pharmaceutical characteristics, thus enabling you to make useful comparisons. Specifi cally, these data will allow you to consider the relative importance of different market segments and different fi nancing arrangements, such as social insurance, in making national and international price comparisons. Data on the national pharmaceutical sector are collected using an abridged version of the WHO Questionnaire on structures and processes of country pharmaceutical situations.1 This questionnaire measures structures and processes at the level of national governments, including policies, regulations, quality control measures, es- sential medicines list, supply system, fi nancing, access, production, rational use and intellectual property rights legislation. It is a basic assessment tool that pro- vides a rapid means of obtaining information on the existing infrastructure and key processes of each component of the pharmaceutical sector. Administered through the WHO Medicines Policy and Standards/Technical Cooperation for Essential Drugs and Traditional Medicine department, the questionnaire is distributed every four years to all Member States, most recently in 2007. WHO uses the results to assess the global pharmaceutical situation, evaluate progress achieved towards goals set in the WHO Medicines Strategy, make plans and set targets for WHO work for the next four years. An abridged version of the questionnaire that includes only those questions relevant to medicine pricing, availability and affordability has been developed for use as part of the survey. A set of supplementary questions important to the medi- cine prices and availability survey has also been included. The abridged version of WHO’s Questionnaire on structures and processes of country pharmaceutical situations, available in Annex 1 and on the CD-ROM that accompa- nies this manual, should be completed before beginning to plan the survey. Survey managers should check with the WHO Department of Medicines Policy and Stand- ards/Technical Coooperation for Essential Drugs and Traditional Medicine2 to see if the full questionnaire has been administered recently. In addition to completing the abridged questionnaire, survey managers should also collect as many other relevant materials as possible, such as the national medi- cines policy or other related policies; the essential medicines list; and the reports of medicine use studies where these have been conducted. It is useful to check with the MoH, national statistical offi ce or WHO offi ce to see whether any recent surveys have been undertaken as part of a national medicines or health-system policy review. Collecting baseline information on the organization of the pharmaceutical sector is essential for appropriate survey planning and later for interpreting the survey fi ndings and identifying policy options. Allocate suffi cient time for collecting information and do not begin planning the survey until the abridged WHO Questionnaire on structures and processes of country pharmaceutical situations is completed. 1 This questionnaire replaces the National Pharmaceutical Sector form used in the fi rst edition of the survey methodology. 2 Contact Dr Daisy Carandang at carandange@who.int 2. SURVEY OVERVIEW AND PRE-SURVEY PL ANNING EDM_prices.indd 17EDM_prices.indd 17 30.4.2008 12:57:4230.4.2008 12:57:42 18 MEASURING MEDICINE PRICES, AVAIL ABIL IT Y, AFFORDABIL IT Y AND PRICE COMPONENTS Descriptive information on your country’s health-care system and pharmaceutical sector can be very valuable in explaining or interpreting the survey fi ndings. Data on the national pharmaceutical sector should therefore be summarized in the back- ground section of your survey report (see Chapter 12). Depending on the country situation and the survey results obtained, some aspects of WHO’s Questionnaire on structures and processes of country pharmaceutical situations may benefi t from further elaboration in the survey report, particularly where they are likely to have a substantial impact on medicine prices or availability. You may also want to add additional information to your summary on topics not included in the questionnaire to help readers understand the survey setting and results. 2.2.4 Selecting survey personnel The survey will require the involvement of the following personnel: � the survey manager, supported by an advisory committee; � area supervisors; � data collectors; and � data entry personnel. Survey manager The survey manager plans and coordinates the survey at the central (national) level. This includes planning the survey’s technical and logistical aspects, recruiting and training survey personnel, supervising data collection and data entry, conducting data quality assurance and data analysis, interpreting results and preparing a sur- vey report. For NGOs, this role may also include fundraising to support the survey and related follow-up activities. Wherever possible, the survey manager should be a pharmacist with experience in conducting surveys and familiarity with the health-care system. The survey manager should be familiar with Microsoft Excel spreadsheets, basic statistics (such as ra- tios, medians and percentiles) and interpreting data. Successful communication of the survey results also requires an understanding of the policy-making process and different advocacy strategies. Where the survey manager does not possess all of these qualities, he or she should select the advisory committee members to ensure that the survey management team includes the necessary pharmacy, surveying, statistics, policy and advocacy skills. Area supervisors Area supervisors are responsible for overseeing all aspects of data collection in the survey area(s) for which they are responsible. In a small country or in a survey that is conducted in a single region of a country, it may be possible for all fi eld work to be undertaken by a single team. Experience 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 have a crucial role to play in ensuring data quality and consistency. They should be experienced in data collection and be familiar with pharmaceutical terminology. They will also be instrumental in gaining access to facilities; if any area supervisor is unfamiliar with their designated area, a local contact may be needed to assist in identifying medicine outlets. Area supervisors may also be responsible for choosing local data collectors when they are not sent from the central level. EDM_prices.indd 18EDM_prices.indd 18 30.4.2008 12:57:4330.4.2008 12:57:43 19 Data collectors Data collectors are responsible for visiting medicine outlets and recording informa- tion on medicine prices and availability with a high degree of accuracy. The survey methodology has been designed to minimize as far as possible the need for a high level of technical expertise. However, data collectors should, wherever possible, have the following skills and capabilities: � a basic understanding of pharmaceuticals, including different formulations (strengths, dose forms, etc.) and pack sizes, in order to be able to extract the re- quired information from both health professionals and from written material such as packs and order lists. (Ideally, data collectors should have some pharmaceuti- cal training and/or experience since previous survey experience shows that the most effective data collectors are those with relevant knowledge and experience, e.g. pharmacists, pharmacy technicians, pharmacy students and nurses.) � some understanding of the principles of sample surveys, ideally with some previ- ous experience in conducting surveys; � an appreciation of the logistical requirements for carrying out fi eld studies; � a minimum of post-secondary school education; and � familiarity with the locality and local language/dialect. 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 ability to identify unusual situations that require advice from the area supervisor or survey manager. The number of data collectors required depends on the sample size of the survey. Data collectors should work in pairs so that they can make systematic checks of entries into the Medicine Price Data Collection form. Each visit to a health facil- ity or pharmacy is likely to require about one to two hours plus transport time. In practice, this means that a team of two data collectors can probably survey two to four facilities per day. Depending on the locations of the survey areas, travel condi- tions and number of medicine outlets to be surveyed, you will probably need 6–12 data collectors (1 pair per survey area or per 2 survey areas). It is better to have a smaller number of better qualifi ed data collectors than to have a large team where some data collectors lack the necessary skills. Area supervisors have a crucial role to play in ensuring data quality in the fi eld. Data entry personnel Accurate data entry is vital to ensure the reliability of the results. Two data process- ing 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 LESSONS FROM THE FIELD In the 2002 survey in South Africa, regional pharmacists were recruited as data collectors because they were known to the pharmacists and doctors in the area and also knew the facilities in the area. Kishuna A. Drug Pricing Survey in KwaZulu-Natal. Essential Drugs Monitor, No.32, 2003. (http://mednet2.who.int/edmonitor/32/32_2. pdf, accessed 13 December 2007) 2. SURVEY OVERVIEW AND PRE-SURVEY PL ANNING EDM_prices.indd 19EDM_prices.indd 19 30.4.2008 12:57:4330.4.2008 12:57:43 20 MEASuRInG MEdICInE pRICES, AvA IL AbIL IT y, AFFORdAbIL IT y And pRICE COMpOnEnTS correct. The computerized workbook has been designed to identify any discrepan- cies in data entry using this “double-entry” process. double entry is essential to ensuring the accuracy of the data entry process. In some cases, it may be possible to use the same personnel for both data collection and data entry, provided they have the necessary expertise to undertake both functions. Fig. 2.1 illustrates the survey’s organizational structure. 2.2.5 Securing the technical and financial resources required Technical resources The computerized workbook used for data entry and analysis is a specially de- signed software application for Microsoft Excel. To use it, a computer that meets the following minimum requirements will be needed:  a personal computer (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 web site. very few other resources are needed to conduct the survey. Area supervisors and data collectors should be supplied with a simple calculator to determine unit prices. paper will be needed for data collection forms. Transport will also be needed to take the data collection teams to the medicine outlet visits. If the teams are not from the local survey area, transport to and from the survey area, as well as accommoda- tion, will also be required. Fig 2.1 Organizational structure of the survey Advisory Committee Guidance on survey methodology and related policy and advocacy Survey Manager Overall management and coordination of survey Data entry personnel Area 1 Supervisor Supervises survey at local level Data Collectors Area 2 Supervisor Supervises survey at local level Data Collectors Area 3 Supervisor Supervises survey at local level Data Collectors Area 4 Supervisor Supervises survey at local level Data Collectors Area 5 Supervisor Supervises survey at local level Data Collectors Area 6 Supervisor Supervises survey at local level Data Collectors Note: Some area supervisors and data collectors may survey more than one survey area; six separate teams are not always required. EDM_prices.indd 20 13.5.2008 15:47:59 21 Financial resources The survey methodology has been designed to be feasible and carried out easily with minimal technical and fi nancial resources. However, when planning the survey, it is essential to ensure that there is an adequate budget for the following items: � personnel: — survey manager — area supervisors — data collectors — data entry personnel � training: — training venue — daily allowance and accommodation — transport — materials — expenses related to pilot test � data collection and validation, including price components: — daily fi eld allowance and accommodation for data collectors — transport — materials: paper, pens, calculators — photocopying — communication (e.g. telephone charges) � meetings of the advisory committee � report production and dissemination – layout, printing, postage � advocacy and communications � overhead � contingency, including data collection at back-up facilities A budget template is provided as part of the Survey Protocol template that should be completed and sent to HAI1 or WHO2 for review prior to the initiation of data col- lection. The Survey Protocol template is available on the CD-ROM that accompanies this manual. Data collection includes validation at 20% of medicine outlets, as well as potential visits to back-up facilities. These activities are integral parts of the survey methodology that should be built into the survey budget and timeline. 1 Contact info@haiweb.org 2 Contact medicineprices@who.int 2. SURVEY OVERVIEW AND PRE-SURVEY PL ANNING EDM_prices.indd 21EDM_prices.indd 21 30.4.2008 12:57:4330.4.2008 12:57:43 22 MEASURING MEDICINE PRICES, AVAIL ABIL IT Y, AFFORDABIL IT Y AND PRICE COMPONENTS 2.2.6 Seeking endorsement for the survey A signed, offi cial letter from the MoH or national pharmacy association endors- ing the survey can be of great help when seeking funding and when collecting data in the fi eld. If the survey manager approaches the relevant bodies with an example of the kind of letter that is sought, it may be easier for them to pro- vide such an endorsement. A sample letter of endorsement, shown in Annex 2, is included as a Word fi le on the CD-ROM for modifi cation as appropriate. WHO will also provide a letter of endorsement on request.1 2.2.7 Preparing a survey schedule The complete survey should generally take about 14 weeks to complete, including preparation, data collection, data entry and analysis and report writing. Further time should be allotted for advocacy and follow-on activities. Given that medicine prices are subject to change based on exchange rates, mar- ket infl uences and other factors, it is important that data collection be conducted rapidly and the report generated within one month of completing the survey. In countries with fl uctuating infl ation rates, it is particularly important that the survey be completed in as short a time frame as possible. A survey schedule should be developed and consulted regularly to ensure that activities are proceeding according to plan. A sample survey schedule is provided as part of the Survey Protocol template that should be completed and sent to HAI2 or WHO3 for review before initiating data collection. The complete survey should take about 14 weeks to complete, including data collection, data entry, data analysis and report writing. Given that price data can quickly become out-of-date, it is important that the survey report be generated within one month of completing data collection. An offi cial letter of endorsement from the ministry of health and/or the national pharmacy association will facilitate data collection. 1 Contact you local WHO country offi ce or WHO headquarters at medicineprices@who.int. 2 Contact info@haiweb.org 3 Contact medicineprices@who.int EDM_prices.indd 22EDM_prices.indd 22 30.4.2008 12:57:4330.4.2008 12:57:43 23 3 Preparation You may begin detailed planning of the survey after attaining a thorough under- standing of the national pharmaceutical sector and obtaining the necessary human, technical and fi nancial resources required to carry it out. Chapter 3 describes the various activities required to create a country-specifi c survey design based on the standard methodology. This effort involves: � identifying the regions in which to conduct the survey (‘survey areas’); � identifying the sectors to include in the survey (‘sectors’); � developing the sample of medicine dispensing points to survey for each sector (‘medicine outlets’); � fi nalizing the list of medicines to be surveyed; and � for each medicine to be surveyed, identifying the originator brand product and manufacturer (lowest-priced generic products will be identifi ed at individual medi- cine outlets). Once the various elements of the survey design have been developed, a survey protocol should be prepared and sent to HAI1 or WHO2 for review prior to starting the survey. The Survey Protocol template is provided on the accompanying CD- ROM. Meaningful survey results depend on an appropriate survey design. This requires strict adherence to the medicine price survey standard methodology and process, as well as careful consideration of the national pharmaceutical situation. It is essential to follow the survey methodology, particularly the sampling methods. 3.1 DETERMINING THE SURVEY SCOPE 3.1.1 Planning where to conduct the study – national or regional? Most medicine price surveys will involve examining prices and price variations in an entire country. The ideal national survey would collect data from a large number of health facilities and other medicine outlets situated throughout the country. 1 Contact info@haiweb.org 2 Contact medicineprices@who.int EDM_prices.indd 23EDM_prices.indd 23 30.4.2008 12:57:4430.4.2008 12:57:44 24 MEASURING MEDICINE PRICES, AVAIL ABIL IT Y, AFFORDABIL IT Y AND PRICE COMPONENTS However, this would require a great deal of time and resources. To make the survey feasible, therefore, it is based on small representative samples of geographical areas and medicine outlets. Validation studies have shown that through careful selection, these study sites can represent the situation in the country as a whole adequately. However, in large countries (e.g. large in geographical size or popu- lation or number of medicine outlets), the sample size may not be nationally representative. In these cases, it is recommended that the methodology be ap- plied as a state or provincial survey or that the total number of survey areas be increased. If resources allow, a series of state- or provincial-based surveys should be conducted. For simplicity, this manual describes a national medicine prices survey. However, it can easily be applied to a state- or provincial-based survey, like those that have been conducted in Brazil, People’s Republic of China, India and Sudan.1 If you are in any doubt about the design of your survey, contact HAI2 or WHO3 for advice. 3.1.2 Identifying sectors to be surveyed The next step in developing the survey design is to decide which sectors to sur- vey. Each sector represents a different source of medicine prices and availability to be assessed and compared. In identifying sectors, consider both the structure of the health system and the relative importance of various sectors in supplying medicines. Most surveys will examine at least three of the following sectors. 1. Public sector procurement prices. These are prices that the government pays to procure medicines. Unlike other sectors where data are always collected at a sample of medicine outlets, procurement data are usually collected centrally from the ministry of health (from tender or other documents) or at central or re- gional medical stores. However, where there is decentralized procurement or a mix of centralized and decentralized procurement, data are collected from public health facilities (see page 52). For this sector, data are only collected on medi- cine prices and not availability. Some countries have both a central store and regional medical stores. Both cen- tral and regional procurement data can be entered on the Field Data Consolidation: Public Sector Procurement Prices page of the workbook, but each should be clearly labelled so that separate analyses are possible (see Chapter 8, page 106). Medicine procurement prices from other sectors, such as the private sector, the NGO sector or mission sector, can also be collected. Procurement prices from different sectors must always be analysed separately and should never be combined into one set of procurement results. It is therefore very important to clearly label each set of procurement data according to sector. More information on entering and analysing procurement data from different sectors is provided in Chapters 7 and 8. 2. Public sector patient prices. Public sector patient prices can include govern- ment, municipality or other local authority health facilities, where patients re- ceive medicines, such as hospitals, clinics and health centres. Note that for the hospitals included in the public sector sample, medicine price/availability data 1 http://www.haiweb.org/medicineprices/surveys.php. 2 info@haiweb.org 3 medicineprices@who.int EDM_prices.indd 24EDM_prices.indd 24 30.4.2008 12:57:4430.4.2008 12:57:44 25 are collected for the outpatient/primary health care service. The structure of the health system, including the expected availability of medicines at each level of care, should be considered when developing the public sector sample. In most countries, governments supply medicines through the public sector. In some countries, medicines in the public sector are free to all, or to certain cat- egories of people (e.g. the elderly). In other countries, patients have to pay either the full cost of the medicine or a standard (fi xed) fee that may or may not include consultation costs. Where medicines are available for free or for a fi xed fee, this should be described in the survey report. Where medicines are provided free to all patients, or are always available at a standard fee irrespective of the medicine dispensed, the cost of medicines is covered by another means (e.g. social health insurance). There are therefore no patient medicine prices to measure in the public sector. In such cases, collect data on medicine availability but not price. There could also be instances in which some, but not all, medicines are provided free of charge in the public sector (e.g. certain medicines are provided free through donation programmes). In such cases only availability data are collected for the free medicines, and both price and availability are collected for other medicines. 3. Private sector patient prices. The private sector includes licensed retail pharma- cies and licensed drug stores only. Note that in some countries, drug stores may be far more prevalent than pharmacies and should not be overlooked in develop- ing the private sector sample. The private sector does not include unlicensed drug stores, drug sellers in the informal sector, pharmacies in private clinics and hospitals or health facilities operated by private companies, such as mining companies. If these medicine sources are of interest, they can be considered as ‘other’ sectors (see below). Licensed drug stores could also be considered as an ‘other’ sector separate from licensed pharmacies, if regulations and/or prices are expected to vary sig- nifi cantly between the two. 4. ‘Other’ sector patient prices. Depending on the nature of the pharmaceutical sector and the survey’s policy objectives, there may be ‘other’ sectors you may wish to include in the survey. In general, if a sector other than the public and private sectors supplies medicines to a substantial number of patients, it should be included as an ‘other’ sector. The computerized workbook can accommodate up to two other sectors. Examples of other sectors include: — health facilities run by NGOs, such as charitable organizations; — health facilities run by religious organizations, such as church missions; — private hospitals; and — dispensing doctors. Some of these facilities and sectors may not exist in your country. In some coun- tries, there may be no ‘other’ sectors that supply medicines; in such cases the survey is limited to the public and private sectors. 3. PREPARATION Whereas in other sectors both the price and availability of medicines are measured, only medicine prices are collected for procurement. EDM_prices.indd 25EDM_prices.indd 25 30.4.2008 12:57:4430.4.2008 12:57:44 26 MEASURING MEDICINE PRICES, AVAIL ABIL IT Y, AFFORDABIL IT Y AND PRICE COMPONENTS If specialized or hospital-only medicines are of particular interest, for example in surveying a particular therapeutic group, public hospitals can also be included as an ‘other’ sector. Although hospitals are included as part of the public sector sam- ple, this sector is focused on medicines available through the outpatient/primary health-care services of district or regional hospitals. You may wish to survey basic inpatient care or tertiary care services as an ‘other’ sector to capture data on the medicines available through these services. Different sources of medicines (e.g. mission hospitals, dispensing doctors) should always be considered separately and never be combined into one ‘other’ sector. BOX 3.1 Selecting sectors – special cases Private pharmacies in public hospitals Private pharmacies operating in public hospitals may have different medicine availability and prices than both public pharmacies in public hospitals and private retailers in the community. They should not be included in either the public or private sector samples, but rather should be surveyed as an ‘other’ sector. Pharmacies with both public and private counters or mixed public/private counters In pharmacies where both public and private services co-exist, these should be treated as two separate sectors. In cases where public and private counters co-exist, these should also be surveyed separately, i.e. as two different sectors. Vertical health programmes as an ‘other’ sector A vertical health programme is a package of activities designed to deal with a single health problem (e.g. tuberculosis, HIV/AIDS) or a group of linked health problems (e.g. reproductive health). The programme may be located in hospitals – sometimes with independent staffi ng, infrastructure and logistic systems – or in the community. In vertical programmes, any core or supplementary medicines that are not relevant to the target health problem will usually not be available; similarly, medicines available through the vertical programme may not be available in any other sectors. This reduces the number of medicines upon which price analyses are based, thereby weakening summary data. As a result, if a vertical health programme is selected as an ‘other’ sector, it is recommended that a set of medicines specifi c to the target programme be surveyed in addition to the 20 supplementary medicines. Note that to obtain an accurate estimate of availability, medicines only available through vertical programmes will need to be excluded from the availability analysis in other sectors. Similarly, core or supplementary medicines that are not available through vertical programmes will need to be excluded from the availability analysis in this sector. Chapter 8 (page 123) provides further information on excluding individual medicines from summary results. The computerized workbook is designed to measure prices, availability and afford- ability in up to fi ve sectors: public sector procurement prices, public sector patient prices, private retail patient prices and two ‘other’ sectors. In a survey that includes more than fi ve sectors, data for the additional sectors can be entered into a sec- ond workbook. However, this will limit the ability to conduct comparative analyses between sectors in different workbooks. Consideration should also be given to the additional time and resources required to survey multiple other sectors. In general, it is recommended that the survey be limited to a maximum of fi ve sectors. EDM_prices.indd 26EDM_prices.indd 26 30.4.2008 12:57:4430.4.2008 12:57:44 27 3.1.3 Identifying survey areas Survey areas are administrative areas (e.g. districts, municipalities, counties) in your country, where data will be collected from medicine outlets. Most countries will have multiple administrative divisions that could be used as survey areas. When deciding which administrative division to use, the following criteria should serve as a guide: � Each survey area should cover a population of about 100 000 to 250 000 (in small countries a lower population coverage may be appropriate). � All survey areas should be reachable within one day’s travel from the country’s main urban centre. � The six survey areas in the sample should be large enough to represent the coun- try (for a national survey) and contain the requisite number of health facilities (see below). Six survey areas should be selected for data collection: Choose the country’s major urban centre (usually the capital city) as one area. Choose an additional fi ve survey areas randomly from all the administrative areas that can be reached within one day from the major urban centre using the most appropriate means of transportation, usually car, bus or train (see Fig. 3.1). � If your country has another important major urban centre (e.g. provincial or business capital), choose this as a survey area. Then choose four more areas randomly from all the administrative areas that can be reached within one day from the major urban centre. � If your country does not have another important major urban centre, choose fi ve more areas randomly from all the administrative areas that can be reached within one day from the major urban centre. In some cases, there may be a valid reason for excluding an area from the random sample, e.g. political instability or risk of cross-border trade/smuggling. Decisions to exclude certain areas from the survey should be made prior to sampling and should be justifi ed in the survey report. The geographical distribution of population should be considered in selecting sur- vey areas to ensure that both urban and rural areas are surveyed. If there are large differences in the population densities of administrative areas: � Divide the administrative areas that can be reached within one day from the major urban centre into groups according to population density (e.g. urban, rural, periurban). � Randomly select survey areas from each group, allocating the number of survey areas to each group roughly according to the proportion of population it repre- sents. Alternatively, it would also be possible to stratify the selection of survey areas by socioeconomic status: � Divide the administrative areas that can be reached within one day from the major urban centre into groups according to their socioeconomic status (e.g. low-, medium- or high-income). � Randomly select survey areas from each group, allocating the number of sur- vey areas to each group roughly according to the proportion of population it represents. 3. PREPARATION EDM_prices.indd 27EDM_prices.indd 27 30.4.2008 12:57:4430.4.2008 12:57:44 28 MEASURING MEDICINE PRICES, AVAIL ABIL IT Y, AFFORDABIL IT Y AND PRICE COMPONENTS 3.2 SELECTING THE SAMPLE Once the geographical survey areas have been chosen, the sample of medicine outlets in which to gather data will need to be identifi ed in each of the public, pri- vate and ‘other’ sectors (note that public procurement data are usually collected centrally). For convenience, public medicine outlets are used to anchor the sample, with other types of medicine outlets chosen by their proximity to these facilities. Experience from over 50 studies confi rms the importance of following the recommendations on survey design and sampling carefully. Selecting a smaller sample size severely weakens the data’s reliability. Increasing the numbers of medicine outlets above the minimum numbers recommended below will increase the survey’s accuracy. In increasing the sample size, it is recommended that the number of survey areas be increased to provide a more representative sample, rather than increasing the number of medicine outlets surveyed in each survey area. To facilitate data collection, all survey areas should be reachable within one day’s travel from the urban centre using the most appropriate means of transportation, usually car, bus or train. Fig. 3.1 Six survey areas: the capital city plus fi ve areas reachable within one day’s travel 1 day’s travel SA 2 SA 3 Survey area 1: Capital city SA 5 SA 6 SA 4 EDM_prices.indd 28EDM_prices.indd 28 30.4.2008 12:57:4430.4.2008 12:57:44 29 STEP 1: In each survey area, choose the main public hospital (generally district or regional hospital, though it could be a tertiary hospital). These hospitals will be part of the sample of medicine outlets that you will survey. Data are collected for each hospital’s outpatient/primary health-care services. 3. PREPARATION STEP 2: Create a list of public sector medicine outlets in each survey area. For each survey area, create a complete list of all public health facilities that have pharmacies or dispensaries that are within three hours’ travel from the main hospi- tal selected in Step 1. Note that for hospitals, only those with outpatient/primary health-care services should be included. Lists of public health facilities are gener- ally available at the ministry of health. Some survey managers have found central lists to be somewhat out-of-date, with the regional ministry offi ces able to provide more up-to-date lists. Most countries have several levels of facilities, from hospitals down to health cen- tres or dispensaries. Include all types of facilities that are expected to stock most of the medicines included in the study. Rural health posts or village health workers may only stock a small number of emergency medicines, in which case these facili- ties should be excluded from the sample. If certain levels of health facilities are excluded from the sample frame, it should be noted in the survey report. � If there are fewer than fi ve medicine outlets within three hours’ travel distance from the main hospital, extend the perimeter until you have at least fi ve medicine outlets on your list. � If there are fewer than fi ve medicine outlets in the whole survey area, include the closest medicine outlets from a neighbouring area. To facilitate data collection visits, all medicine outlets should be within three hours’ travel of the main public hospital in each survey area. However, if travel conditions signifi cantly limit the distance that can be covered in that time, the limitations on maximum travel time can be relaxed, resources and time allowing, to increase the level of representation. SURVEY AREA Main public hospital EDM_prices.indd 29EDM_prices.indd 29 30.4.2008 12:57:4530.4.2008 12:57:45 30 MEASuRInG MEdICInE pRICES, AvA IL AbIL IT y, AFFORdAbIL IT y And pRICE COMpOnEnTS StEp 3: Select four public sector outlets in each survey area. For each survey area, randomly select four public sector medicine outlets from the lists you created in Step 2.  If there is only one level of health facility on the list (e.g. only primary health-care centres), choose four at random.  If there are two or more levels on the list (e.g. primary health-care centres and district hospitals): — divide the list by level. — Randomly select an equal number of medicine outlets for each level (e.g. two district hospitals plus two health centres). — If there are fewer than two medicine outlets in any level, increase the number selected from the other level accordingly (e.g. one district hospital plus three health centres). You should now have five public medicine outlets (main public hospital plus four public medicine outlets) selected for each survey area. If a survey area includes a mix of urban, peri-urban and/or rural areas, the sample can reflect this distribution by dividing the list of public medicine outlets by rural/urban/peri-urban breakdown, and then randomly selecting outlets from each list according to the proportion of the population it represents. SURVEY AREA 3-HOUR DRIVE public medicine outlet public medicine outlet public medicine outlet public medicine outlet EDM_prices.indd 30 13.5.2008 15:48:00 31 STEP 4: Select an additional four public medicine outlets in each survey area, as back-up outlets. In addition to the public sector outlets selected for the survey, a set of back-up medicine outlets should be identifi ed. Data collectors will survey a pre-selected, back-up outlet if less than 50% of the medicines on the Medicine Price Data Collec- tion form are available at a medicine outlet in the primary sample. Surveying back- up outlets will ensure that a suffi cient quantity of price data is collected to allow for robust analyses. However, the data from the original outlet are still entered in the workbook to provide an accurate representation of availability. For each public medicine outlet in the sample (i.e. selected in Steps 1 and 3 above), select the nearest public medicine outlet for use as a back-up outlet. To the ex- tent possible, back-up outlets should represent the same level of care as sample outlets. Back-up outlets can also be visited if managers from medicine outlets in the pri- mary sample will not give permission for data collection, even after being shown the letter of introduction and being assured of anonymity. However, experience from previous surveys has shown this to be uncommon. For each medicine outlet in the sample, only one back-up should be identifi ed. If less than 50% of the medicines on the Medicine Price Data Collection form are available at the back-up outlet, then these data would be entered and analysed, but no additional back-up outlets would be visited. STEP 5: Select fi ve private sector medicine outlets in each survey area. While the survey manager should select public health facilities at central or regional level, area supervisors may have to identify private retail medicine outlets. � Obtain lists of licensed pharmacies/drug stores registered in each study area, centrally if they are available (e.g. from the ministry of health, drug controller’s offi ce, pharmacy association or business registry). The lists may be incomplete so the area supervisor in the study area should check and update them by con- sulting with local offi cials. These lists can help to guide the selection process. If it is not possible to obtain a list of licensed pharmacies/drug stores from a central source, the area supervisors will need to develop it for their region(s). � Choose the private medicine outlet that is closest to each public medicine outlet selected (including the main public hospital). If there are a number of private outlets close to each public facility, one should be selected at random, using the list of facilities obtained at central or regional level. � If there is no private outlet within 10 km of a remote public facility, another private outlet in the urban centre should be selected. 3. PREPARATION You should now have fi ve private medicine outlets selected for each survey area. Only licensed pharmacies and licensed drug stores should be included in the private sector sample. Unlicensed drug stores and drug-sellers in markets or elsewhere should not be included. EDM_prices.indd 31EDM_prices.indd 31 30.4.2008 12:57:4530.4.2008 12:57:45 32 MEASuRInG MEdICInE pRICES, AvA IL AbIL IT y, AFFORdAbIL IT y And pRICE COMpOnEnTS StEp 6: Select an additional five private sector medicine outlets in each survey area, as back-up facilities. From the lists of pharmacies/drug stores registered in each survey area, select the next closest private medicine outlet to each public medicine outlet selected (includ- ing the main public hospital), to serve as back-ups should they be needed. StEp 7: Select five medicine outlets for each ‘other’ sector in each survey area. For each ‘other’ sector in your survey, five outlets in each survey area will also need to be selected. For each ‘other’ sector:  Create a list of all the medicine outlets in this sector in each survey area. In many cases this list can be obtained centrally by consulting the appropriate administra- tive authority (e.g. a list of nGO outlets). In other cases, the list will have to be developed by area supervisors in the field.  In each survey area, select the ‘other’ sector medicine outlet that is closest to each public medicine outlet selected. If there are a number of medicine outlets close to the public sector outlet, one should be selected at random. — If there are fewer than five ‘other’ sector medicine outlets in the survey area, select all of them. — If there is no ‘other’ sector medicine outlet on the list within 10 km of a given public sector outlet, substitute with an additional outlet in the main urban centre. For each ‘other’ sector, you should now have up to five medicine outlets selected for each survey area. = private sector outlet Rx Rx Rx SURVEY AREA 3-HOUR DRIVE public medicine outlet public medicine outlet public medicine outlet public medicine outlet Rx Rx Rx EDM_prices.indd 32 13.5.2008 15:48:00 33 StEp 8: In each survey area, select an additional five medicine outlets for each ‘other’ sector in your survey, as back-up facilities. From the list(s) of other sector medicine outlets in each survey area, select the next closest outlet to each public sector outlet selected (including the main public hospi- tal), to serve as a back-up facility. Repeat this process for each ‘other’ sector in the survey. note that in some cases, there may not be a sufficient number of outlets in other sectors to identify back-up facilities. Where limited data are available for other sectors, it may be preferable to present results as a case study rather than a quantitative analysis. StEp 9: Create a contact list of medicine outlets for each survey area. For each survey area, create a contact list of the medicine outlets that will be sur- veyed (as identified above), including their up-to-date contact information, if avail- able. Group outlets by sectors (public, private, etc.) and number them (e.g. 1 to 20) for easy identification. For each outlet, indicate the back-up outlet that should be visited if fewer than 50% of medicines are found. 3. pREpARATIOn Rx Rx Rx SURVEY AREA 3-HOUR DRIVE public medicine outlet public medicine outlet public medicine outlet public medicine outlet other 1 other 2 other 1 other 1 other 1 other 1 other 2 other 2 other 2 other 2 Rx Rx Example: Survey area: Eastern Region Name of medicine outlet Contact details Sector Number Back-up outlet name and contact details ABC Pharmacy 45 Main Street Private 01 Main Street Chemist Eastern City 59 Main Street +22 414 000 Eastern City EDM_prices.indd 33 13.5.2008 15:48:01 34 MEASURING MEDICINE PRICES, AVAIL ABIL IT Y, AFFORDABIL IT Y AND PRICE COMPONENTS 3.3 DEVELOPING THE LIST OF MEDICINES TO BE SURVEYED In every country, many different medicines are registered and sold on the market, and therefore could be included in the survey. A national essential medicines list, which is frequently only applied in the public sector, generally contains between 200 and 400 medicines. In the private sector, however, several thousand medi- cines may be available. To make the survey manageable, up to 50 medicines will be surveyed. These medi- cines come from three different sources: 1. A global core list of 14 medicines that are included in all medicine price surveys to enable international comparisons; 2. A regional core list of 16 medicines that accounts for regional differences in medicine usage but still allows for comparisons across countries within the same region; 3. A supplementary list of at least 20 medicines, selected at the country level for their local importance. Each survey medicine has a specifi c dosage form and strength; this is the only dosage form and strength for which data are collected. Different dosages forms and/or strengths of the same medicine may have different prices. Data must be collected on the same dosage form and strength in all medicine outlets so that results are comparable. Medicines on the global and regional core lists have pre-determined dosage forms and strengths for which data are collected. If it is of interest to collect data on a different dosage form and/or strength (e.g. amoxicillin 250 mg cap/tab in addition to amoxicillin 500 mg cap/tab), this medicine can be added to the supplementary list of medicines and considered as a separate survey medicine with a distinct set of availability/price data. Data collectors must be very careful to avoid errors when collecting data on alternate dosage forms and/or strengths of the same medicine. In addition, each medicine has a recommended pack size, which generally corre- sponds to a standard course of treatment. When a medicine is available in multi- ple pack sizes, data are collected on the recommended pack size or – if this is not available – on the next largest pack size. This standardizes results as much as possible, and counteracts price differences arising from economies of scale (i.e. lower unit price offered for larger pack sizes). For each medicine, prices and availability are collected for two products: the origi- nator brand and the lowest-priced generic equivalent. Originator brand products are standard for the country and do not vary from outlet to outlet. They are identi- fi ed centrally before data collection. Lowest-priced generic equivalents are defi ned as the generically equivalent products with the lowest unit price available at each medicine outlet (e.g. health centre, private pharmacy) on the day of the survey. The actual product can therefore vary from outlet to outlet according to which generic products are available. To enable price comparisons between countries and for repeated surveys, it is important to comply with the recommended lists of global and regional medicines, in their specifi ed strengths, dosage forms and pack sizes. In conducting repeat surveys, if a medicine is no longer generally available, it can be removed from the list of survey medicines. EDM_prices.indd 34EDM_prices.indd 34 30.4.2008 12:57:4630.4.2008 12:57:46 35 While it is important to survey all global and regional core medicines that are registered in the country so that international comparisons can be made, it is equally important from the national perspective that 20 supplementary medicines be surveyed. 3.3.1 Global and regional core lists of medicines to be surveyed Global and regional core medicines are standardized across WHO/HAI surveys to enable international comparisons of medicine prices, availability and affordability. Core survey medicines are divided into a global list and region-specifi c lists to account for the wide variations in the general usage of individual medicines across regions. The medicines on the global and regional core lists have been selected based on the following criteria: � Global/regional burden of disease/prevalence patterns: used to treat common acute and chronic conditions that cause signifi cant morbidity and mortality, in- cluding cardiovascular diseases, diabetes, asthma, respiratory tract infections and mental illness. � Evidence-based: recommended, usually as fi rst-line courses of treatment, in global, regional and national treatment guidelines. However, medicines on core lists should not be considered as a recommendation for inclusion in national treatment guidelines. � Availability: available in standard formulations and widely used in many coun- tries/regions, as demonstrated by the medicine prices surveys conducted to date and by IMS Health national databases. � Importance: the majority are included in the WHO Model List of Essential Medi- cines (WHO EML).1 Medicine price surveys have shown the global core medicines (Table 3.1) to be widely available in all regions, thereby allowing international comparisons to be made. All the medicines on the global core list are in oral solid form (tablet or capsule), with the exception of: � Ceftriaxone injection; � Co-trimoxazole paediatric suspension; � Salbutamol inhaler; and � Paracetamol suspension. Regional core medicine lists (available in the workbook Part I, on the CD-ROM and on the HAI web site) have been developed as a complement to the global core list to address regional differences in the usage of medicines. Although medicine us- age also varies across countries in a region, standardizing the medicines surveyed within a region will facilitate regional comparisons. Regional core medicine lists have been developed based on burden of disease, availability data derived from medicine pricing surveys and other sources (e.g. IMS Health sales volume data), and in consultation with WHO regional pharmaceutical advisers, various pharma- ceutical experts and the members of the WHO/HAI Project on Medicine Prices and 3. PREPARATION 1 http://www.who.int/medicines/publications/essentialmedicines/en/ EDM_prices.indd 35EDM_prices.indd 35 30.4.2008 12:57:4630.4.2008 12:57:46 36 MEASURING MEDICINE PRICES, AVAIL ABIL IT Y, AFFORDABIL IT Y AND PRICE COMPONENTS Availability. The regional lists will be updated periodically to refl ect new data on medicine availability. When planning a survey, survey managers should check the HAI web site2 to be sure that they have the most recent list for their region. Regions have been selected based on the WHO classifi cation of countries into six administrative regions.3 In some cases, WHO regions have been further divided into groups of countries with similar socioeconomic and epidemiologic profi les. Such sub-divisions are largely dependent on the availability of IMS Health medicine sales data upon which to base the development of medicine lists; additional lists will be created for other regions as more data become available. Regional core medicine lists are currently available for: � Central Asia � Eastern Mediterranean � Sub-Saharan Africa � Central and South America � South East Asia � Western Pacifi c Medicines on both the global core list and the applicable regional core list should always be included in the survey if they are registered in your country. This will enable you to compare your prices with those in other countries. In the surveys conducted to date, perceived non-availability of certain medicines has often proved to be wrong. Before removing a medicine from the global or regional list, verify its availability and, when in doubt, include it in the survey to avoid a missed opportunity. The following are instructions for fi nalizing the global and regional core lists of medi- cines to be surveyed: Table 3.1 Global core list of medicines to be surveyed Disease Namea Strength Dosage form 1 Asthma Salbutamolb 0.1 mg/dose inhaler 2 Diabetes Glibenclamide 5 mg cap/tab 3 Cardiovascular disease Atenolol 50 mg cap/tab 4 Cardiovascular disease Captopril 25 mg cap/tab 5 Cardiovascular disease Simvastatin 20 mg cap/tab 6 Depression Amitriptyline 25 mg cap/tab 7 Infectious disease Ciprofl oxacin 500 mg cap/tab 8 Infectious disease Co-trimoxazole 8+40 mg/ml suspension 9 Infectious disease Amoxicillin 500 mg cap/tab 10 Infectious disease Ceftriaxone 1 g/vial injection 11 CNS Diazepam 5 mg cap/tab 12 Pain/infl ammation Diclofenac 50 mg cap/tab 13 Pain/infl ammation Paracetamolc 24 mg/ml suspension 14 Ulcer Omeprazole 20 mg cap/tab a Medicine names may be spelt differently in different countries. Consult the HAI web site1 for alternative spellings of global and regional core medicines. b Also called albuterol. c Called acetaminophen in some countries. 1 http://www.haiweb.org/medicineprices/ 2 http://www.haiweb.org/medicineprices/ 3 WHO African Region (AFR), WHO Region of the Americas (AMR), WHO Eastern Mediterranean Region (EMR), WHO European Region (EUR), WHO South-East Asia Region (SEAR), WHO Western Pacifi c Region (WPR). EDM_prices.indd 36EDM_prices.indd 36 30.4.2008 12:57:4630.4.2008 12:57:46 37 1. Review the lists of global and regional core medicines. 2. If any global or regional core medicine is not registered in your country, remove it from the list. 3. If a medicine is registered in your country, but the stated dosage form or strength differs from that on the global/regional core list, remove the core medicine from the list and add the alternate form and/or strength to the supplementary list of medicines. For example, while atenolol 50 mg is a global core medicine, in Country X atenolol 100 mg is the only strength available. In this case, atenolol 50 mg should be removed from the global core list, and atenolol 100 mg should be added as a supplementary medicine. 4. If a therapeutically equivalent medicine is widely used in addition to or instead of a medicine on the global or regional core list, add it to your supplementary list of medicines. For example, simvastatin 20 mg is a global core medicine, how- ever in Country X lovastatin 20 mg is also widely used. In this case, simvastatin should be kept on the global core list, with lovastatin added as a supplementary medicine. Instructions are provided in Section 3.4 for generating the Medicine Price Data Collection form from the workbook according to the global core, regional core and supplementary medicines to be surveyed in your country. If any medicine from either the global or regional core list is excluded from the survey, this should be reported and justifi ed in the survey report. 3. PREPARATION BOX 3.2 Patent status Some substances remain under patent in countries that observe medicine patents; others are off patent or have never been patented. Since patent status varies by country and over time, this manual cannot identify the patent status of medicines. Once the national list of medicines to be surveyed has been fi nalized, the patent status of each medicine should be checked with the local patent offi ce. Generic equivalent products might not be available for medicines that are still on patent; this should be considered in the analysis of availability (See Chapter 8, page 125). 3.3.2 Supplementary list of medicines to be surveyed The survey methodology allows for the addition of supplementary medicines selected at the national level. Where all 30 global or regional core medicines are in- cluded in the survey, 20 supplementary medicines should be selected. If some core medicines have been removed due to lack of registration in the country, additional supplementary medicines can be selected to obtain a total list of 50 medicines. As stated above, the supplementary list of medicines should include: � different strengths and/or dosage forms of medicines on the global and regional lists (where commonly used); and � commonly used therapeutic alternatives to those on the global or regional core lists, such as another ACE-inhibitor or antidiabetic medicine. EDM_prices.indd 37EDM_prices.indd 37 30.4.2008 12:57:4730.4.2008 12:57:47 38 MEASURING MEDICINE PRICES, AVAIL ABIL IT Y, AFFORDABIL IT Y AND PRICE COMPONENTS The following selection criteria should also be considered when developing the sup- plementary list of medicines to be surveyed: � International reference price Medicine price data obtained in the survey are analysed in relation to an inter- national reference price (Box 3.5). Supplementary medicines, in their specifi ed dosage form and strength, must have an international reference price from the same set of prices used for global and regional core medicines (usually MSH).1 In previous surveys, countries have identifi ed medicines for inclusion in their survey that did not have international reference prices. Prices were collected for these medicines, only to fi nd that they could not be analysed. This meant that there was unnecessary time and effort spent on data collection and that a smaller group of medicines was available from which to analyse results and draw conclusions. All supplementary medicines, in their specifi ed dosage form and strength, must have an international reference price. The same set of reference prices (usually MSH) must be used for all medicines surveyed – global, regional and supplementary. � Burden of disease and national or local disease and treatment priorities The supplementary list can be used to study medicines that are commonly used in the treatment of important national health problems. Drug utilization studies, where available, can assist in identifying common treatments. � Global and national treatment guidelines Medicines should be in line with current treatment recommendations as indi- cated in global and/or national treatment guidelines. BOX 3.3 Modifi ed release formulations Most tablets and capsules are designed so that the active ingredient(s) is released immediately after the medicine is taken. Others have modifi ed release characteristics. These are referred to using a number of terms, including: � sustained release (SR) � slow release (SR) � controlled release (CR) � retard (R) � modifi ed release (MR) � long acting (LA) These work by gradually releasing the active ingredient as the capsule or tablet moves down the gastrointestinal tract. Some medicines are marketed in both immediate release and modifi ed 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. While plain, fi lm-coated tablets and plain capsules are equivalent, modifi ed release formulations must be considered separately. 1 http://erc.msh.org/ EDM_prices.indd 38EDM_prices.indd 38 30.4.2008 12:57:4730.4.2008 12:57:47 39 � Expected availability in primary health-care outlets Since primary health-care facilities form most of the public sector sample, the medicines selected for the supplementary list should be available at this level of care. However, a small number of medicines that are only available at hospi- tals can be included on the supplementary list if they are of special interest. To ensure that suffi cient price data are collected to allow for robust analysis, it is recommended that no more than four ‘hospital-only’ medicines be included on the supplementary list. Note that the supplementary medicine list can include medicines on the national essential medicines list as well as those that are not, and should include both if price differences are suspected between the two categories. � Registration or market authorization The availability and use of medicines not approved by the relevant authorities can be a serious problem in some countries, particularly in those where there is a poor regulatory framework or inadequate enforcement of relevant laws and regulations. To ensure that information is only collected on approved medicines, all products included in the survey must be registered or have market authori- zation in your country, and only licensed premises should be included in the survey. � Local production In some countries, it may be of interest to study the availability and price of medi- cines that refl ect local production capacity. � ‘Problem medicines’ It may be of interest to investigate medicines that represent or are suspected to represent a high fi nancial burden to patients or governments or those thought to be irrationally used. Such ‘problem medicines’ can be included as supplementary medicines provided they have an international reference price (see above). � Availability of fi xed-dose combination products In many countries, combination products exist together with products containing single agents. The WHO Model List of Essential Medicines prefers to use prod- ucts with one single ingredient (co-trimoxazole being one of the few exceptions), which allows more fl exibility in prescribing and dosing, although there is now an increasing move towards fi xed-dose combinations for malaria, tuberculosis and HIV. Many regulatory authorities and agencies that develop therapeutic guidelines also have this policy. This is one reason why there are few combination products on the core lists of medicines. You may wish to include some combination prod- ucts on your supplementary list to better refl ect the national situation. Be aware, however, that this may limit the number of generically equivalent alternatives because different manufacturers may use different combinations. It will also limit the selection of reference price sources. � Prescription status In most countries, only prescription medicines should be included on the sup- plementary list of medicines. However, in countries where prescription control is limited to a small number of medicines (e.g. analgesics, narcotics, psychotrop- ics) prescription status may not be an appropriate selection criteria. 3. PREPARATION EDM_prices.indd 39EDM_prices.indd 39 30.4.2008 12:57:4730.4.2008 12:57:47 40 MEASURING MEDICINE PRICES, AVAIL ABIL IT Y, AFFORDABIL IT Y AND PRICE COMPONENTS In most countries, a total of 50 medicines should be surveyed. In surveys studying a particular therapeutic group, the list of medicines to be surveyed may be considerably longer. To ensure that the selection of supplementary medicines refl ects availability and usage patterns, it is useful to check with large public and private wholesalers from various regions when developing the supplementary medicine list. The core and supplementary lists of medicines should be reviewed following the pilot test conducted as part of the training workshop and, where necessary, revised before the survey begins. 3.4 PREPARING THE WORKBOOK AND CREATING THE MEDICINE PRICE DATA COLLECTION FORM The Medicine Price Data Collection form is the survey tool used in the fi eld to col- lect data on medicine prices and availability. The form is automatically generated from the survey workbook Part I, where all relevant information on the survey medi- cines is stored. Chapter 7 contains detailed instructions on using the computerized workbook. Before beginning your survey, check the HAI web site2 to make sure that you have the most recent version of the workbook. You will need to generate the data collection form for use in the pilot test conducted as part of the survey training workshop (see Chapter 4). However, before you do this, you need to do the following in the workbook: BOX 3.4 Surveying therapeutic groups The supplementary list of medicines can be used for studying medicines from a particular therapeutic category or group of conditions, such as paediatrics, reproductive health or chronic diseases. For example, surveys of chronic disease medicines have been carried out in six countries using the WHO/ HAI standard methodology (1). Surveying all therapeutic alternatives for a particular condition provides a more accurate representation of availability and price than if one or two medicines are surveyed when alternative products exist. However, the global and regional core medicines should still be surveyed to enable comparisons with other countries. For conditions with a large number of treatment alternatives, the supplementary list of medicines can become quite long. The time and resources required to conduct a survey with an extensive medicine list should be considered carefully. Guidance on conducting therapeutic group surveys is provided on the CD-ROM that accompanies this manual. Supplementary medicine lists that have been used to study selected therapeutic categories will be included on the CD-ROM and on the HAI web site.1 When surveying a particular therapeutic class of medicines, care should be taken to ensure that the common routes of distribution are covered in the survey sample. For example, the centralized nature of HIV/AIDS treatment has thus far limited the ability to include antiretrovirals (ARVs) in the survey. In future, as treatment becomes more decentralized, the inclusion of ARVs in the survey may become more feasible. 1 http://www.haiweb.org/medicineprices 2 http://www.haiweb.org/medicineprices EDM_prices.indd 40EDM_prices.indd 40 30.4.2008 12:57:4730.4.2008 12:57:47 41 3. PREPARATION BOX 3.5 International reference prices In this survey, medicine prices are expressed as ratios relative to a standard set of reference prices to facilitate national and international comparisons. Median prices listed in MSH’s International Drug Price Indicator Guide have been selected as the most useful standard since they are updated frequently, are always available and are relatively stable.1 These prices are recent procurement prices offered by both not-for-profi t and for-profi t suppliers to developing countries for multi-source products. When no supplier prices are available, buyer prices are used, but a single supplier price is still preferable to multiple buyer prices. The 2007 MSH reference prices, which were current when this manual was produced, are already entered in the workbook. When planning your survey, check the HAI web site to make sure you have the current set of reference prices. 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. How representative reference prices are generally depends on the number of suppliers quoting for each product. For example, if a medicine has a single, high supplier price, a low median price ratio (MPR) will be obtained, which can be misinterpreted as low national prices. This has been observed in previous surveys with losartan 50 mg; in this case, a high 2005 MSH buyer price (no supplier prices available) resulted in very low MPRs. When very high or low MPRs are observed, it is useful to check the international reference price to see if this is the reason. If the international price is indeed found to skew the MPR of a medicine, affordability results will provide a better refl ection of national price since these are based on medicines prices measured in local currency. All survey medicines must have an international reference price, and the same set of reference prices must be used for all survey medicines (global core, regional core and supplementary). If you have a medicine on your supplementary list for which there is no MSH reference price, you should consider replacing it with another medicine for which there is an MSH reference price. Otherwise, you will need to use a different set of reference prices for all medicines. Since the vast majority of surveys conducted thus far have employed MSH reference prices, using a different set of prices will limit your ability to conduct international comparisons and is therefore discouraged. Should you choose to use an alternative set of reference prices, you might consider using the New Zealand Pharmaceutical Management Agency (PHARMAC) prices2 or the Australian Pharmaceutical Benefi ts Scheme (PBS) prices.3 PHARMAC prices are reimbursement prices paid by the Government of New Zealand; since some products are not fully subsidized, median supplier prices should be used. PBS prices are reimbursement prices that the Government of Australia has agreed to pay for the medicines it makes available in government-supported insurance programmes. Careful interpretation is required when using an alternative set of reference prices. For example, while MSH prices are procurement prices (mainly not-for-profi t and not including insurance and freight charges), PHARMAC and PBS prices are reimbursement (similar to retail) prices. Furthermore, PHARMAC and PBS prices differ in that PBS prices include a dispensing fee while PHARMAC prices do not. If an alternative set of reference prices is used, you should always add the name of the reference price in the workbook and include the following information in the fi nal 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. 1 MSH prices are available at http://erc.msh.org. 2 http://www.pharmac.govt.nz/ 3 http://www.pbs.gov.au/html/healthpro/home EDM_prices.indd 41EDM_prices.indd 41 30.4.2008 12:57:4830.4.2008 12:57:48 42 MEASURING MEDICINE PRICES, AVAIL ABIL IT Y, AFFORDABIL IT Y AND PRICE COMPONENTS � upload the relevant regional core list of medicines for your survey; � delete any medicines from the global and regional core lists which are not regis- tered in your country; � add the supplementary medicines, including strengths and dosage forms, that you are surveying; � check that the MSH prices already entered in the workbook are current, and enter the reference price for each supplementary medicine; � identify which medicines are on the national essential medicines list, where one exists; � for the public sector, identify the level(s) of care where each medicine is expected to be available; and � identify and enter the name of the originator brand product and its manufacturer for each supplementary medicine to be surveyed, and check the name of each originator brand on the global and regional core list (the identifi cation of the lowest-priced generic product is done at each individual medicine outlet). STEP 1: Transfer the workbook to your computer You can do this by: � copying the fi le from the CD-ROM that accompanies this manual � downloading the latest fi le from the HAI web site:1 Start Microsoft Excel® and open the fi le WHO/HAI Medicine Price WorkbookI.xls that you copied onto your hard disk. Note: Macros will need to be enabled in order for the workbook to function correctly (see below). Macros A macro is a series of commands and functions that enable tasks to be performed automatically. The survey workbook contains macros that must be enabled for it to function correctly. Microsoft Excel provides safeguards that help protect against viruses, which can be transmitted by macros. Depending on the security settings of your computer, macros may always be enabled when you open fi les (low security), or you may receive a warning when a macro is encountered (medium security), or macros may be automatically disabled without any warning (high or very high security). To be sure that the workbook is run with the necessary macros, open Excel and in the Toolbar, click on Tools → Macros → Security, and set the Security Level to “Low” or “Medium”. You should now receive a security warning when you open the workbook; select “Enable Macros” to open the workbook with the necessary macros. 1 http://www.haiweb.org/medicineprices EDM_prices.indd 42EDM_prices.indd 42 30.4.2008 12:57:4830.4.2008 12:57:48 43 Do not save data in the original workbook since it is useful to retain a clean version. As soon as you open the fi le, save it with a fi lename that indicates the country and date of your survey. For example, you might choose a fi lename such as SouthAfricaVersion1.May2006.xls. STEP 2: Enter general survey information and upload the relevant regional core list of medicines The Home page of the workbook is used for recording important general information about your survey. At the top of the page you are asked to enter your country name. By right-clicking on the empty box (Cells C/D5) you will access a drop-down list of countries. Once you have selected your country, the WHO region corresponding to your country will be automatically uploaded into Cells C6/D6. You should also enter: � if a state or provincial survey is being conducted, the name of the state or prov- ince in Cells C/D7 � the name of the fi rst ‘other’ sector surveyed, if applicable, in Cells C/D8 � the name of the second ‘other’ sector surveyed, if applicable, in Cells C/D9 � the names of the six survey areas in Cells C/D12 The date of the fi rst day of data collection (Cells C/D10) should only be entered once data collection has been initiated. Next, go to the International Medicine Reference Price Data page where information on the medicines in the survey is entered and stored. Note that the 14 global core medicines are already listed in Rows 11–24. Click on the “Add regional medicines” button in Cell C9; a pop-up box containing the regional core medicines for your WHO region will appear. You can add one regional medicine at a time by selecting the medicine name and clicking on the “Add medicine” button, or you can add all regional medicines at once by clicking on the “Add all medicines button” (adding all medicines may take several seconds). STEP 3: Delete any medicines on the global or regional core list that are not reg- istered in your country The International Medicine Reference Price Data page should now contain the global and regional core medicines in the survey. This page is described in more detail in Chapter 7, page 84. Click on the cell containing the medicine you wish to delete and hit <Backspace> or <Delete>. A pop-up box will appear asking “Do you want to delete this medicine?”. Click <Yes> to delete. If you confi rm the deletion, all in- formation about the medicine contained in the row will be deleted, and the empty row will be removed. STEP 4: Add your supplementary medicines to the Reference Price page For each supplementary medicine, enter the following information: 1. Medicine Name (Column C): The name is usually the International Nonproprie- tary Name (INN). The workbook requires that each medicine have a unique name to avoid confusion during data entry and analysis. If the survey includes two 3. PREPARATION EDM_prices.indd 43EDM_prices.indd 43 30.4.2008 12:57:4830.4.2008 12:57:48 44 MEASURING MEDICINE PRICES, AVAIL ABIL IT Y, AFFORDABIL IT Y AND PRICE COMPONENTS different strengths or dosage forms of the same medicine, then each must be given a unique name. 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 changed to “amoxicillin capsules” to prevent confu- sion. As well as the name, it is also recommended that you include the dosage form in the name for all cases other than immediate release tablets and capsules e.g. co-trimoxazole suspension, salbutamol inhaler, benzylpenicillin injection. 2. Medicine Strength (Column D): The strength of the medicine, usually 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 of inhalers, injections and liquids (suspensions, syrups) to prevent confusion in determining the unit price. 3. Dosage Form (Column E): The dosage form of the medicine for which the unit price is to be determined. The dosage form will most commonly be “cap/tab” for medicines administered as normal release capsules or tablets. Note that dis- persible tablets should be considered separately from non-dispersible tablets. Other dosage forms include: — “millilitre” for orally administered liquids, suspensions, topical solutions, eye drops, and injections in liquid form — “gram” for powder for injection, eye ointments, topical creams and ointments. — “dose” for medicines administered through inhalers or nebulizers. — “MR tab” for modifi ed release tablets, “MR cap” for modifi ed release capsules — “pessary” or “suppository” Be very careful in expressing the strength and dose form of injections. For example, if gentamicin injection is available as 80 mg/2 ml in your country, you should enter this strength in the workbook so that it is printed on the data collection form. However, you need to enter ‘millilitre’ as the dosage form since that is the unit (not one ampoule, which is 2 ml). For an injection such as benzathine penicillin 2.4 MIU/ml injection, the unit will also be millilitre. These units should be the same as those used in the MSH reference price list. 4. Target Pack Size (Column F): Different pack sizes are used in many countries, and unit prices often vary by pack size. Field data collectors should try to fi nd 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. Medicine List: This identifi es whether the medicine is on the global, regional or supplementary list. Select “Supplementary” from the drop-down list by clicking on the arrow next to the empty cell. To facilitate data collection, the workbook will automatically combine core medicines and supplementary medicines into one list in alphabetical order by medicine name (this may take several seconds). Medicines will therefore appear in alphabetical order on the Medicine Price Data Collection form, and not according to global/regional/supplementary list. EDM_prices.indd 44EDM_prices.indd 44 30.4.2008 12:57:4830.4.2008 12:57:48 45 STEP 5: Identify medicines on the national Essential Medicines List (EML) (Column H) Previous surveys have shown that it is often useful to disaggregate medicine price and availability results by EML and non-EML medicines, particularly in the public sector. Column H: National Essential Medicine List allows you to identify those sur- vey medicines that are contained in the national Essential Medicines List. Select “Yes”, “No”, “Don’t Know” or “No List” (if your country does not have a national EML) from the drop-down list by clicking on the arrow next to the empty cell. STEP 6: Check/enter the reference price information for each medicine As described in Box 3.5, there are several sources of international reference prices that can be used in the survey. Whatever source is chosen, it must be used for the entire list of medicines in your survey (global core list, regional core list and supplementary list). MSH reference prices, which are recommended as the most useful standard, have been provided for the global and regional core medicines in Column I of the Refer- ence Prices page. Even if you choose to use another reference price list for national analysis, it is a good idea to include the most up-to-date MSH reference prices in the workbook. This will allow for comparisons of prices for individual medicines with other countries, most of which have used MSH reference prices in their surveys. � For the global and regional core medicines, check that Column I of the Reference Prices page contains the most up-to-date MSH international reference prices.1 � For each supplementary medicine, enter the most recent MSH international refer- ence price (median supplier price, or median buyer price if there is no supplier price) into Column I of the Reference Prices Page. � If another set of reference prices is being used for the analysis, enter the ap- propriate unit price for each medicine into the “Other Unit Price” column (Column J). Take special care to use the correct dosage form for injections, inhalers and liquids. Note that these prices need to be entered in US$ equivalents, otherwise the conversion to local currency will be incorrect. For example, if you use the PBS prices, you should fi rst convert them from Australian dollars to US dollar equiva- lents, then enter that price. Enter the source of the unit prices you used in cell I7. STEP 7: Identify which levels of public health facilities are expected to stock each survey medicine (Column O) As mentioned in Section 3.3.2, the supplementary list of medicines can include a small number of medicines that are only available at specialized hospitals (if this is of special interest). Further, some global or regional core medicines may also only be available at more specialized centres. To prevent under-reporting of the availabil- ity of these medicines, the availability analysis must be restricted to those public sector health facilities where the medicine is expected to be available. For example, primary health care centres should not be included in the availability analysis of a specialized medicine that is only provided at secondary or tertiary hospitals. The workbook is therefore programmed to calculate the availability of individual medi- cines based on the level of care where they are expected to be available. 3. PREPARATION 1 MSH prices can be found in the MSH International Drug Price Indicator Guide at http://erc.msh.org EDM_prices.indd 45EDM_prices.indd 45 30.4.2008 12:57:4930.4.2008 12:57:49 46 MEASURING MEDICINE PRICES, AVAIL ABIL IT Y, AFFORDABIL IT Y AND PRICE COMPONENTS � For each medicine, indicate the level of care where the medicine is expected to be available in Column O on the Reference Prices page. Enter “1” for primary, “2” for secondary and “3” for tertiary. For the purposes of the survey, primary care refers to the fi rst point of contact with the health system for access to essen- tial health care (e.g. rural health posts, community health centres); secondary care refers to specialized ambulatory medical services and fi rst line referral to outpatient and inpatient hospital care (e.g. district hospitals); and tertiary care refers to medical and related services of high complexity (e.g. regional or central hospitals). Your national EML may be broken down by level of care; if not, consult treatment guidelines for common conditions or check with your survey advisory committee. � If levels of care are not relevant to your survey, enter “1” for all medicines so that the availability analysis includes all health facilities in the public sector sample. If a medicine is selected as “level 1”, i.e. available at primary care level, this medicine should also be available at secondary and tertiary levels of care. The availability analysis will therefore include all health facilities in the public sector sample. If a medicine is selected as “level 2”, i.e. available at secondary care level, this medicine should also be available at the tertiary level. The availability analysis will include all secondary and tertiary health facilities in the public sector sample, but will not include level 1 facilities. If a medicine is selected as “level 3”, i.e. available at tertiary care level, this medicine should only be available at tertiary level facilities. The availability analysis will be restricted to tertiary health facilities. STEP 8: Identify the originator brand product for each medicine to be surveyed The originator pharmaceutical product or originator brand is generally the product that was fi rst authorized worldwide (not nationally) for marketing (normally as a pat- ented product) on the basis of the documentation of its effi cacy, safety and qual- ity, according to requirements at the time of authorization. The originator product always has a brand name (e.g. Valium®), however this may vary between countries. That is, the manufacturer may not use the same name worldwide; for example fl uox- etine is called both Prozac® and Fontex® in different countries. While lowest-priced generically equivalent products are identifi ed at individual facili- ties during data collection, originator brand products are identifi ed centrally before fi eldwork begins. � Go to the Study Medicines: Originator Brand Products Surveyed page of the work- book. � For each global and regional core medicine, the originator brand name that is most commonly used by the manufacturer in English-speaking countries, is listed in Column H. Check that the name in this column is the name used in your coun- try. A list of originator brand names for commonly surveyed medicines, as well as medicines for which there is no originator brand name, is available on the HAI web site.1 Occasionally the manufacturer listed in Column I may license produc- tion to another manufacturer. Where this happens, change the name but make it clear it is a licensing arrangement. 1 http://www.haiweb.org/medicineprices/ EDM_prices.indd 46EDM_prices.indd 46 30.4.2008 12:57:4930.4.2008 12:57:49 47 � If the originator brand name used in your country differs from the one in the work- book, change the name of the medicine in Column H, as long as the medicine, dosage form and strength are the same. This change should be noted in your survey report. � For each supplementary medicine, enter the originator brand name used in your country in Column H. Enter the name of the manufacturer in Column I. If the man- ufacturing entity is complex, or if there are multiple sources for a single originator brand, enter all the relevant information, e.g. “Wockhardt Ltd. under licence from Merck”. The originator brand products and manufacturers identifi ed on the Study Medicines: Brand Products Surveyed page of the workbook are automatically entered into the Medicine Prices Data Collection form. Some substances are so old that no originator brand can be identifi ed and patent was probably never claimed. This is the case with such substances as penicillin V, prednisolone and isoniazid. If your supplementary list includes old medicines that were probably never patented, leave Columns H and I blank for these medicines. Multinational manufacturers may have a licensing agreement with a local manufac- turer for the in-country production of an originator brand product. In such cases, identify both the multinational and the local subsidiary to ensure that data collec- tors do not overlook any products. 3. PREPARATION STEP 9: Generate the Medicine Price Data Collection Form To access the Medicine Price Data Collection form, press on the Data Collection tab at the bottom of the workbook. From the Medicine Price Data Collection Form page you will be able to view and print the form (Select File → Print from the Excel toolbar). Note that the form is not complete until it contains the complete list of survey medicines, including the originator brand names used in your country. A draft form should be generated for use in the training workshop, following which changes may need to be made to the list of survey medicines based on the results of the data collection pilot test (see Chapter 4, Page 63). Once the list of medi- cines has been fi nalized, the Medicine Price Data Collection form should be used to record data in all sectors, including public sector procurement prices. Fig. 3.2 shows an extract from the Medicine Price Data Collection form, generated using the computerized workbook. Note that some cells are shaded grey; these cells should not be amended or altered during data collection. It is important to identify the originator brand name used in your country correctly for each of the survey medicines. If the wrong name is used the product will not be found, which will bias the availability results and reduce the number of medicines included in the price analysis. If in doubt contact HAI1 or WHO2 for advice. 1 info@haiweb.org 2 medicineprices@who.int EDM_prices.indd 47EDM_prices.indd 47 30.4.2008 12:57:4930.4.2008 12:57:49 48 MEASURING MEDICINE PRICES, AVAIL ABIL IT Y, AFFORDABIL IT Y AND PRICE COMPONENTS 3.4.1 Elements of he Medicine Price Data Collection form For each medicine, the Medicine Price Data Collection form contains two rows (originator brand and lowest-priced generic equivalent) and ten columns (A to J). Row 1: The fi rst row is for recording information on the originator brand. Since origi- nator brands are identifi ed centrally prior to data collection, the Medicine Price Data Collection form already contains the originator brand name for each of the survey medicines. Row 2: The second row is for collecting information on the lowest-priced generic equivalent product to the originator brand in Row 1. The data collectors will identify this product in each medicine outlet surveyed and will enter the following informa- tion onto the form (see Chapter 6): BOX 3.6 Customizing the Medicine Price Data Collection form You may wish to further customize the Medicine Price Data Collection form that is generated by the survey workbook. For example: � You may wish to highlight the dosage forms or strengths of certain medicines that may lead to error (e.g. “Nifedipine retard 20 mg tab”) � For those medicines that are not tablets or capsules, a common mistake is to record the pack size as “1 inhaler” instead of “200 doses”, or “1 bottle” instead of “100 ml”. This makes calculation of the unit price impossible. To guard against this error, you can indicate the unit (e.g. “ /ml”) in the Pack size found column (Column G). � If a medicine is under patent, there could be no generics available for which to collect data. Contact the regulatory authority to verify whether there are generics registered for the medicine despite a patent being in force. Similarly, if a medicine is so old that the originator brand cannot be identifi ed, there will be no originator brand for which to collect data. In such cases it may be useful to black out these rows of the data collection form so that it is clear that data is not being collected on these products. To customize the Medicine Price Data Collection form, go to the Medicine Price Data Collection form page and select the cells that correspond to the full form. Copy and paste the selection into a Microsoft Word® document. Once in Word format, you will be able to modify, save and print the form. Figure 3.2 Extract from the Medicine Price Data Collection form A B C D E F G H I J Generic name, Medicine Brand or Manufacturer Available: Pack size Pack Price Unit price Comments dosage form, type product “yes” or recom- size of pack (4 digits) strength name(s) “no” mended found found Amitriptyline Originator brand Tryptizol MSD 100 /tab cap/tab 25 mg Lowest-priced 100 /tab generic Amoxicillin Originator brand Amoxil GSK 21 /tab cap/tab 500 mg Lowest-priced 21 /tab generic Atenolol Originator brand Tenormin Astra Zeneca 60 /tab cap/tab 50mg Lowest-priced 60 /tab generic EDM_prices.indd 48EDM_prices.indd 48 30.4.2008 12:57:4930.4.2008 12:57:49 49 3. PREPARATION � Column C: the name of the lowest-priced generic equivalent product � Column D: the manufacturer of the lowest-priced generic equivalent product. Defi nitions For the purpose of this study, the following defi nitions are used: � Originator brand: the international originator brand product for the medicine. � Generic equivalent: all products other than the originator brand that contain the same active ingredient (substance), whether marketed under a brand name (“branded generic”) or the generic name. Refer to the Glossary for expanded defi nitions of originator brand and generic equivalent. Column A: Name of medicine, dosage form and strength Column A lists: � the medicine’s International Nonproprietary Name (INN) � the medicine’s dosage form � the medicine’s strength 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, sustained release, etc. (see page 76). Information should only be collected for the dosage form listed in Column A. The solid oral form is used for most medicines. Many medicines will be marketed in more than one strength. For example, amoxicil- lin may be marketed as 250 mg and 500 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. Column B: Medicine type This column is used to distinguish between the two product types collected in the survey: the originator brand product and the lowest-priced generic equivalent. Column C: Brand or product name(s) While Column A contains the medicine’s INN, Column C contains the names of in- dividual products. For generically equivalent medicines, the product name may be the same as the INN and will be entered in Row 2 by the data collectors at each medicine outlet. Column D: Manufacturer In Row 1, this column contains the name of the originator (patent holder). The data collectors will complete Row 2 in each individual outlet with the name of the manu- facturer of the lowest-priced generic equivalent found (see Chapter 6). The generic equivalent product with the lowest unit price may vary from one medicine outlet to another. EDM_prices.indd 49EDM_prices.indd 49 30.4.2008 12:57:5030.4.2008 12:57:50 50 MEASURING MEDICINE PRICES, AVAIL ABIL IT Y, AFFORDABIL IT Y AND PRICE COMPONENTS Column E: Available: “yes” or “no” � Public Procurement Prices: Column E will usually be completed at central level in the offi ce of the procurement offi cer or central medical stores. � Public Sector Patient Prices, Private Sector Patient Prices and Other Sector Patient Prices: the data collectors in the fi eld will complete this column. For each medicine, they should record that the originator brand and lowest-priced generic equivalent are available only if they actually see a pack of the medicine. Column F: Pack size recommended For each medicine several pack sizes may be available, such as a pack of 30, 100, 250 or even 1000 tablets or capsules, and single vials or 10 vials for an injection. Mixtures may also be available in different volumes: e.g. 70 ml or 100 ml. The price per unit may vary between pack sizes, generally with larger pack sizes sold at a lower unit price. In order to facilitate comparisons between products, sectors and countries, a “rec- ommended pack size” has been selected for each medicine (See Chapter 6, page 77). These are as close to recommended treatment lengths as possible. If the pack size of a medicine is standard and is known centrally, the data collection form should be amended before data collection begins. Column G: Pack size found The data collectors in the fi eld should complete this column. If several pack sizes are available for the same product, data collectors should select the recommended pack size or the next larger pack size. Note that the public sector and ‘other’ sec- tors are likely to have less variety of products and larger pack sizes. In some cases medicines may not be sold as a full pack but rather by individual strip (e.g. a pack of 60 tablets may be composed of 6 strips of 10 tablets each). If certain medicines are only sold by the strip, record the number of tablets/capsules in the strip as the pack size found (Column G), record the price of the strip as the price of pack found (Column H), and note this in the Comments column (Column J). If medicines are sold both as a complete pack and as individual strips, record the pack size and price of the full pack. In some cases pharmacies or health centres may only stock a bulk pack of a medicine, from which smaller quantities are dispensed to patients. In such cases data collectors should use the recommended pack size listed in Column F as the pack size found (Column G), and should record the price of purchasing this pack size (Column H). The pack size and price of that pack is only entered on the form if it is physically in stock (the data collector must actually ask for and see it). If the outlet is temporarily out of stock of the product, then it is recorded as not available and no price and pack size is entered on the data collection form. EDM_prices.indd 50EDM_prices.indd 50 30.4.2008 12:57:5030.4.2008 12:57:50 51 Column H: Price of pack found The data collectors in the fi eld should complete this column. If patients receive the medicine free of charge or pay a fi xed fee, the price of pack found should be left blank. Column I: Unit price Unit price refers to the price per individual tablet, capsule, millilitre (for injections, liquids, etc.), gram (for creams, etc) or dose (for inhalers). This column is complet- ed by dividing the price of the pack found by the pack size. For example, if a pack of 60 atenolol 50 mg tablets costs 80.00 in local currency, the unit price is 80.00/60 or 1.4167 per tablet. Unit prices are generally calculated by area supervisors follow- ing data collection, except in cases where data collectors need to calculate the unit prices of several generic equivalent products to determine the lowest-priced generic (See Chapter 6, pages 75–76). Column J: Comments Column J is used for recording any comments on the medicines included in the core or supplementary lists, such as their temporary unavailability in a specifi c pharma- cy. The survey manager, area supervisors or data collectors may add comments. Fig. 3.3 shows an extract from a completed Medicine Price Data Collection form: Public Sector Procurement Prices in which the tender prices have been entered at central level. In the example below, public sector procurement is limited to generic versions of medicines listed on the national essential medicines list (NEML). As such, procurement data was not found for originator brand products or for non- NEML medicines such as atenolol, as indicated in the Comments column. 3. PREPARATION Fig. 3.3 Extract from a Medicine Price Data Collection form: Medicine Procurement Prices, with information entered at central level A B C D E F G H I J Generic name, Medicine Brand or Manufacturer Available: Pack size Pack Price Unit price Comments dosage form, type product “yes” or recom- size of pack (4 digits) strength name(s) “no” mended found found Amitriptyline Originator brand Tryptizol MSD No 100 /tab generics only cap/tab 25 mg Lowest-priced Amitriptyline Pharma Yes 100 1000 970.00 0.9700/tab generic Amoxicillin Originator brand Amoxil GSK No 21 /tab generics only cap/tab 500 mg Lowest-priced Amoxicillin Ratio- Yes 21 500 2407.00 4.8140/tab generic pharma Atenolol Originator brand Tenormin Astra Zeneca No 60 /tab Not on EML cap/tab 50mg Lowest-priced No 60 /tab Not on EML generic EDM_prices.indd 51EDM_prices.indd 51 30.4.2008 12:57:5030.4.2008 12:57:50 52 MEASURING MEDICINE PRICES, AVAIL ABIL IT Y, AFFORDABIL IT Y AND PRICE COMPONENTS REFERENCES Mendis S et al. The availability and affordability of selected essential medicines for chronic dis-1. eases in six low- and middle-income countries. Bulletin of the World Health Organization, 2007, 85(4):279–288. 1 If local purchasing of medicines is known to occur, this should be described in the survey report. BOX 3.7 Collecting public sector procurement prices Procurement price data can be gathered at a government central medical store from a series of procurement orders during the past year. Alternatively, they can be obtained from tender documents held by the ministry of health. These tender prices generally result from negotiations between manufacturers or importers and a government procurement agency, and the prices usually remain valid for an entire year. In some countries, central and regional tender prices may vary. For national surveys, use the central tender price except where decentralized procurement predominates for the medicines being studied, in which case use collect regional tender prices. For regional surveys, use the regional tender price. Where individual public health facilities purchase directly from distributors and/or wholesalers, procurement prices should be collected at all medicine outlets in the public sector sample where such purchasing is known to occur. If multiple procurement systems are operating at the central, regional and local level, procurement prices should again be collected at individual medicine outlets. One advantage of this method is that facility prices will include any local ad hoc purchases,1 which would not be refl ected in central/regional procurement data. The same procedures should be followed for completing the Medicine Price Data Collection form for patient price data. These procedures are described in Chapter 6. EDM_prices.indd 52EDM_prices.indd 52 30.4.2008 12:57:5030.4.2008 12:57:50 53 4 Training area supervisors, data collectors and data entry personnel This chapter provides practical guidance on conducting a training workshop for area supervisors, data collectors and data entry personnel. It does not cover training on price components, since this is generally a separate activity with different per- sonnel. Chapter 9 provides guidance on training for the price components survey. Training is an important element of survey preparation because it helps ensure the accuracy and reliability of the data-gathering and data entry procedures. Conse- quently, this chapter also covers the issue of ensuring data quality. When multiple surveys are being carried out in the same region, WHO and HAI sometimes hold regional training sessions for survey managers who, in turn, train their survey personnel during a national workshop. It is useful to check with WHO and HAI to see if any such regional training workshops are being planned or could be organized. This chapter has been developed to assist survey managers in con- ducting training workshops for their survey personnel, regardless of whether they have attended any previous training. � Training of survey personnel is an essential part of survey planning � Comprehensive training is required to ensure data quality � Area supervisors and data collectors must be trained prior to initiating fi eldwork � Generally, training on price components is conducted as a separate activity from the broader training workshop (see Chapter 9) � A trainer’s guide (Annex 3) and sample training materials are provided on the CD-ROM that accompanies this manual 4.1 THE IMPORTANCE OF DATA QUALITY AND THE CONSEQUENCES OF POOR-QUALITY DATA Why is data quality important? � Solid data supports conclusions and recommendations � Future policy decisions may rely on the evidence generated in the survey � Critics and opponents will look for weaknesses in the survey methods and results EDM_prices.indd 53EDM_prices.indd 53 30.4.2008 12:57:5030.4.2008 12:57:50 54 MEASURING MEDICINE PRICES, AVAIL ABIL IT Y, AFFORDABIL IT Y AND PRICE COMPONENTS � Results will be publicly accessible and may be used by others, e.g. in conducting international comparisons � To respect the values of integrity and transparency in the WHO/HAI Medicine Prices and Availability project In previously conducted surveys a number of common data problems have been identifi ed: � Wrong prices collected in the fi eld – wrong medicine, wrong strength (the most common mistake), or wrong dosage form � Illegible or incomplete data collection forms or both � Mistakes in entering the price (e.g. decimal in the wrong place, extra or missing zeroes) � Medicine price entered without indication of whether medicine was available � Originator brand prices collected and/or entered as lowest-priced generic prices or vice versa � Ambiguous data, e.g. unclear pack size (e.g. ‘one bottle’ rather than the number of millilitres, leading to incorrect calculation of unit price); absent/unclear com- ments (e.g. medicine is available but no price data are recorded, with no com- ment to confi rm medicine is provided for free) � Prices noted on paper forms and entered in the workbook when medicine is out of stock � A discount was applied to the recorded price, but was not applicable to all patients � Recorded price was actually a fl at dispensing fee rather than the true price � Recorded price included additional fees, such as injection fees � Errors in the calculation of unit prices � Data entry errors Data collection errors need to be verifi ed and corrected or deleted from the results. In some surveys, large segments of incorrect or unreliable data have had to be excluded from the analysis or re-collected. This weakens the overall survey results and wastes resources, since time and effort have been spent on collecting data that cannot be used. There are several reasons for the data problems commonly encountered as part of the survey: � The survey manager did not read the manual thoroughly or misunderstood it � Area supervisors, data collectors and data entry personnel received insuffi cient or poor-quality training � The pilot survey was not conducted properly � There was inappropriate selection of supplementary medicines � Work in the fi eld was of poor quality (insuffi cient supervision, no quality control for submission of completed forms, misunderstanding of instructions, etc.) � Data were not checked at every stage of the survey process EDM_prices.indd 54EDM_prices.indd 54 30.4.2008 12:57:5130.4.2008 12:57:51 55 � Data were entered only once (double entry not used) � Data-checking function of workbook was not used or questionable values were not verifi ed � Human error Data problems can therefore be avoided by: � Studying the survey manual and accompanying materials carefully at every step and following instructions � Selecting capable and reliable personnel and ensuring they are well trained in the survey methodology � Encouraging personnel to communicate openly about uncertainties in survey pro- cedures and questionable data � Double-checking data collection forms for accuracy and completeness after each data collection visit, at the end of each day of fi eldwork and prior to data entry � Conducting double entry of the survey data into the workbook – data are entered twice by different people and then cross-checked � Conducting a manual check of data entered into the workbook and running the automated data-checker programme (identifi es unusual or outlying results that require verifi cation) 4. TRAINING AREA SUPERVISORS, DATA COLLECTORS AND DATA ENTRY PERSONNEL Thorough training of survey personnel is one of the most important ways of en- suring accurate data collection and good-quality data. Experience from previous surveys has shown that poor survey preparation, including inadequate training of survey personnel, results in onerous and time-consuming data checking that can signifi cantly delay the survey’s completion. It is therefore more effective and effi - cient to apply rigorous data collection methods than to try to clean or correct data once they are already collected. Experience from previous surveys shows that data problems are a normal and expected part of data collection and data entry. Data checking and cleaning can be a time-consuming process, but it is critical to ensuring reliable results. Do not move on to analysis and report writing until you are sure that data are accurate. 4.2 OVERVIEW OF TRAINING All personnel involved in data collection, supervision and data entry require training to ensure reliable and accurate data collection, completion of the data collection form and transfer of data to the workbook. Training should also foster an apprecia- tion among survey personnel of the importance of generating high-quality data. The training ensures a common understanding of the terms and defi nitions used in the survey manual. Thorough training of survey personnel and consequent rigorous application of the survey methodology will save much time and effort during the data checking and data entry stages. EDM_prices.indd 55EDM_prices.indd 55 30.4.2008 12:57:5130.4.2008 12:57:51 56 MEASURING MEDICINE PRICES, AVAIL ABIL IT Y, AFFORDABIL IT Y AND PRICE COMPONENTS A training workshop for survey personnel should be held as part of survey prepara- tion. The training workshop’s overall objective is to provide area supervisors, data collectors and data entry personnel with the knowledge and skills required to carry out the medicine prices and availability survey in an accurate and reliable manner. Upon completion of the training, participants should: � be familiar with the key aspects of the survey and how it is conducted; � understand their roles and responsibilities in the survey, including specifi c tasks, timelines and reporting requirements; � understand the critical content required to do their job effectively and possess the skills required to undertake each of their activities; � be aware of common issues that may arise during survey activities, and trouble- shooting/problem-solving strategies to address these issues; and � recognize the intrinsic value of good-quality data and be motivated to ensure data quality as part of their activities. Training should therefore focus on teaching the participants: � the survey’s overall purpose; � the consequences of poor-quality data; � how to conduct medicine outlet visits and collect price and availability data; � how to complete the Medicine Price Data Collection form; � problem-solving in the fi eld; � how to enter data into the electronic workbook and use the double-entry feature; and � common data collection and data entry mistakes. It is recommended that a training workshop that covers both data collection and data entry last at least three days (a two-day workshop may be suffi cient for data collection only). It should include a data collection pilot test in which survey person- nel visit public and private sector medicine outlets and collect data in the same way they would during actual fi eldwork. This will not only provide survey personnel with practical experience in collecting data, but will also serve as a check of the appropriateness of the draft list of survey medicines. The trainer is usually the survey manager or could be a resource person from the WHO/HAI project. The participants should include all area supervisors, data col- lectors and data entry personnel. Training on data entry can be held as a separate workshop/session for data entry personnel, if this is more convenient (e.g. if the survey is being conducted in a region or state but data entry will be undertaken at the central level). However, there may be some advantage in holding a combined training session on data collection and data entry, since it will sensitize area super- visors and data collectors to the diffi culties in entering poor-quality data. Note that a basic understanding of Microsoft Excel is required for data entry using the electronic workbook; if data collectors lack such technical knowledge then data collection and data entry should be conducted as two separate training sessions. It is also recommended that the members of the Advisory Group be invited to the introductory session of the training workshop to meet survey personnel and discuss the survey methodology. The training workshop should be held as close as possible to the initiation of data collection – immediate departure for data collection can be scheduled if the EDM_prices.indd 56EDM_prices.indd 56 30.4.2008 12:57:5130.4.2008 12:57:51 57 survey manager has prepared well. Time lags between training and data collection should be avoided so that survey personnel have better recall of the data collection protocol. 4.3 PREPARING FOR THE TRAINING WORKSHOP Planning the training workshop can require substantial time and preparation. Work- shop preparations should begin early in the survey development process and should run in parallel to other survey planning and preparation activities. In preparing the training, it is essential to ensure that there is an adequate budget for the training ven- ue, daily allowance and accommodation for participants, transport and materials. 4. TRAINING AREA SUPERVISORS, DATA COLLECTORS AND DATA ENTRY PERSONNEL BOX 4.1 Training recommendations from previous surveys � A training workshop is crucial for ensuring successful data collection. All survey personnel must be trained. � Ideally all area supervisors and data collectors should be trained together at the same workshop to ensure consistency in the instructions received. Data entry personnel can be trained together with other personnel or separately. � Only survey managers should be required to read the entire manual; simplifi ed handouts and instructions should be available for other personnel (examples are available on the CD-ROM). � The data collection pilot test is the most important part of training; suffi cient time should be allocated to ensure that the test is conducted thoroughly, with adequate time for debriefi ng. � A variety of training formats and tools (e.g. presentations and exercises) should be used to keep the training interesting and promote recall of training material. BOX 4.2 What the trainer should do before the workshop � Above all, become thoroughly familiar with all aspects of the survey methodology. This requires careful study of the survey manual and tools on the accompanying CD-ROM. Contact HAI1 or WHO2 to clarify any uncertainties. � Organize the training workshop’s logistics, including the data collection pilot test. � Follow the guidance on training given in the Trainer’s Guide and plan how to conduct each session. Select a training venue Select a training venue based on the following criteria: � availability of a room of appropriate size to hold the workshop; � availability of essential technical resources, namely an accessible printer and photocopier; � proximity to medicine outlets that can be surveyed during the data collection pilot test; 1 info@haiweb.org 2 medicineprices@who.int EDM_prices.indd 57EDM_prices.indd 57 30.4.2008 12:57:5130.4.2008 12:57:51 58 MEASURING MEDICINE PRICES, AVAIL ABIL IT Y, AFFORDABIL IT Y AND PRICE COMPONENTS � accessibility by routine modes of transport; � on-site or nearby refreshments and accommodation for out-of-town participants; and � reasonable cost. It is useful to check with Advisory Committee members to see if a meeting room can be made available for the training workshop at low or no cost. Schedule dates of the training workshop The training workshop should be scheduled close to the anticipated start of data collection. Do not plan the workshop during a time when weather or other condi- tions may delay the initiation of data collection. All survey personnel must attend the workshop and should be advised of the dates as early as possible. Invitations to attend the introductory session of the workshop should also be sent to Advisory Committee members. Training should be held close to the initiation of data collection. Time lapses between training and data collection increase the chances that important details about the survey protocol will be forgotten. Plan data collection pilot test During the data collection pilot test, each data collection team (area supervisor and his or her data collectors) will visit one public medicine outlet and one private medicine outlet and collect data by following the survey procedures. Thus, one pub- lic medicine outlet and one private medicine outlet is required for each data collec- tion team to serve as pilot sites. The participation of pilot sites should be secured well in advance of the training workshops. The appointments should be made in advance and reconfi rmed before the training session, avoiding peak periods when outlets may be busy with patients. Do not send more than fi ve survey personnel (e.g. one area supervisor and four data collectors) to a pilot site. In small retail drug stores, it may only be possible to send three people. If survey teams consist of larger numbers of personnel, they will need to be split into smaller groups for the pilot test. Prior to the training workshop a written schedule should be prepared for each data collection team, indicating the time and location of each medicine outlet visit, in- cluding the name and contact details of the person in charge at the facility. The schedule should also contain the survey manager’s telephone number so that survey personnel can call if there is a query/problem. Secure equipment needed � Ideally, one computer per data collection team, plus one for data entry person- nel, with Microsoft Excel installed. If training on data entry is being conducted separately, two computers (one per data entry personnel) are required; � Access to printer and photocopier for reproducing Medicine Price Data Collection forms; EDM_prices.indd 58EDM_prices.indd 58 30.4.2008 12:57:5130.4.2008 12:57:51 59 � Calculators for participants to determine the unit prices of medicines; � Pens, notepad, clipboards; � Mobile phones for data collection teams to carry during the pilot test. Prepare documentation materials � One copy of handouts, exercises and tests for each participant (samples are provided on the CD-ROM); � Two copies of the Medicine Price Data Collection form for each participant for use during the pilot test (see below). Prepare suffi cient copies of the Medicine Price Data Collection form for use in pilot test You should generate a draft Medicine Price Data Collection form from the work- book,1 where all relevant information on the survey medicines is stored, and photo- copy it for use during the data collection pilot test. However, before generating the data collection form for use in the pilot test, in the workbook you need to: � delete any medicines from the global and regional core lists that are not regis- tered in your country; � add the supplementary medicines that you are surveying; � check whether the MSH prices already entered in the workbook are current, and enter the reference price for each supplementary medicine; � identify which medicines are on the national essential medicines list, where one exists; � for the public sector, identify the level(s) of care where each medicine is expected to be available; and � identify and enter the name of the originator brand product for each supplemen- tary medicine to be surveyed, and check the name of each originator brand on the global and regional core list (the identifi cation of the lowest-priced generic product is done at each individual medicine outlet). Chapter 3 provides detailed instructions on preparing the workbook for your specifi c survey. To access and print the Medicine Price Data Collection form, press on the Data Col- lection tab at the bottom of the workbook. From the Data Collection page you will be able to view and print the form. Note that the form is not complete until it contains the complete list of survey medicines, with the corresponding international refer- ence prices and the originator brand names used in your country. Each workshop participant will need two copies of the Medicine Price Data Collection form – one for each medicine outlet to be visited as part of the data collection pilot test. 4. TRAINING AREA SUPERVISORS, DATA COLLECTORS AND DATA ENTRY PERSONNEL 1 See Chapter 3, page 47. EDM_prices.indd 59EDM_prices.indd 59 30.4.2008 12:57:5230.4.2008 12:57:52 60 MEASURING MEDICINE PRICES, AVAIL ABIL IT Y, AFFORDABIL IT Y AND PRICE COMPONENTS Load Excel workbook onto each computer A copy of the survey workbook Part I, prepared for your specifi c survey (e.g. survey medicines entered and sectors identifi ed), should be loaded onto each computer for use during the training workshop. During the workshop participants will enter the data they collected during the pilot test into the workbooks. Important: To allow participants to view summary results of data generated from the pilot test, you will need to make the following adjustments before loading the workbook onto the computers: 1. Enter an exchange rate in cell J3 of the Reference Prices page. Enter a sample/ average exchange rate of your local currency to US$. 2. Set the minimum number of unit prices required for median price ratios to be computed to ‘1’. During the survey a minimum of 4 unit prices is needed for the median price ratio to be calculated, however since only one set of data per sec- tor is being collected during the pilot test, setting this parameter to 1 will allow participants to view summary results. On the Field Data Consolidation pages for both the public and private sectors, select ‘Ratios On’ to display columns of summary data, and set cell H10 to ‘1’. 3. Enter the daily wage of the lowest-paid government worker in Cell J6 of the Standard Treatment Affordability page, if you want to show participants sample affordability results. In addition, the workbook relies on a series of automated commands (called macros) to function. You will need to ensure that macros are enabled on each of the computers to be used. In the Excel toolbar, click on Tools → Macros → Security, and set the Security Level to ‘Low’ or ‘Medium’. If ‘Medium’ is chosen, then the participants will have to be instructed to choose ‘Yes’ when asked whether they should allow macros to run upon opening the workbook.1 As part of the training tools provided on the CD-ROM, a data-checking exercise us- ing a workbook containing fi ctitious data has been developed to assist personnel in identifying common data errors (‘Data Checker exercise.xls’). If you choose to use this exercise as part of the training workshop you will also need to load the Data Checker workbook onto each computer. 4.4 CONDUCTING THE TRAINING WORKSHOP, INCLUDING THE DATA COLLECTION PILOT TEST A trainer’s guide is provided in Annex 3 and on the CD-ROM that accompanies this manual. Survey managers are strongly encouraged to use this guide as a starting point for planning their training workshop. The guide provides guidance to survey managers in conducting a training workshop for their survey personnel, including: � how a training programme can be conducted; � what basic steps should be followed; � what material should be covered; and � training activities and aids that can be used. Sample presentations, handouts and exercises are also available to accompany the guide. The Trainer’s Guide and materials have been developed based on previ- 1 See Chapter 3, page X EDM_prices.indd 60EDM_prices.indd 60 30.4.2008 12:57:5230.4.2008 12:57:52 61 ous experience in conducting training workshops for the medicine prices and avail- ability survey. The Trainer’s Guide is divided into modules according to the sample training agenda. Each module outlines the objectives of the training session, instructions for training activities to be conducted, materials required and the key messages that should be emphasized. Refer to the sample presentations for a more detailed outline of the content to be covered in each of the modules. The Trainer’s Guide should serve as an example only; the training plan and mate- rials will need to be adapted to fi t the specifi cities of each survey. For example, if medicines are provided for free in the public sector of a country, all training activi- ties and materials will need to refl ect this. Similarly, the specifi c ‘other’ sectors that will be included in the survey will need to be incorporated into the training materials. Considerations in developing country-specifi c survey materials should include sur- vey personnel’s level of experience, the survey’s specifi c objectives; any deviations from the standard me

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