The copyright of this thesis vests in the author. No quotation from it or information derived from it is to be published without full acknowledgementTown of the source. The thesis is to be used for private study or non- commercial research purposes only. Cape Published by the University ofof Cape Town (UCT) in terms of the non-exclusive license granted to UCT by the author. University An economic evaluation of task-shifting approaches to the dispensing of anti-retroviral treatment in the Western Cape, South Africa Thesis presented in partial fulfilment of the requirements for the degree of MASTERS IN PUBLIC HEALTH (Health Economics) In the Health Economics Unit School of Public Health and Family Medicine Faculty of Health Sciences University of Cape Town yJuly of 2011 Cape Town Candidate UniversitNicola Foster Supervised by Prof Di McIntyre (Health Economics Unit, University of Cape Town, South Africa) This dissertation is dedicated to My son, Michael Louis Foster because you inspire me to make the world a better place and to My husband, Clint Foster for being so supportive and for complementing my English language skills y of Cape Town Universit Contents Abstract i Acknowledgements ii Abbreviations iii Index of key terms iv PART A: RESEARCH PROTOCOL 1. INTRODUCTION 1 1.1. PROBLEM STATEMENT 2 1.2. JUSTIFICATION OF THE STUDY 2 1.3. AIMS AND OBJECTIVES 3 2. LITERATURE SUMMARY 3 3. METHODS 8 3.1. LITERATURE REVIEW 8 3.2. STUDY DESIGN 8 3.3. STUDY POPULATION AND SAMPLING 8 3.4. SAMPLE SIZE CALCULATION 10 3.5. MEASUREMENT TOOLS y of Cape Town 11 3.5.1. Facility observation 12 3.5.2. Patient exit interviews 13 3.6. PILOT STUDY 13 3.7. FIELD MANAGEMENT 13 3.8. QUALITYUniversit CONTROL 14 4. LOGISTICS AND TIME SCHEDULE 16 5. DATA MANAGEMENT AND ANALYSIS 16 5.1. ACCESS EVALUATION FRAMEWORK 16 5.2. ANALYSIS OF PRIMARY DATA 17 5.2.1. Univariate distributions 18 5.3. COST ANALYSIS 18 5.3.1. Costing conceptual framework 18 5.3.2. Provider costs 19 5.3.3. Patient costs 21 5.3.4. Start-up costs 21 5.3.5. Costing assumptions 22 5.4. UNCERTAINTY 22 6. BUDGET 23 7. ETHICS 24 8. DISSEMINATION OF FINDINGS 25 REFERENCES 26 PART B: LITERATURE REVIEW 9. INTRODUCTION AND METHODOLOGY 29 10. DRUG SUPPLY MANAGEMENT 29 11. HUMAN RESOURCES FOR HEALTH 31 11.1. INTRODUCTION TO THE HRH PRODUCTION FUNCTION 32 11.1.1. Skills mix 34 11.2. SCARCITY OF HUMAN RESOURCES FOR HEALTH 35 11.3. TASK-SHIFTING 39 12. PHARMACEUTICAL CARE: THE ROLE OF THE PHARMACIST 41 12.1. PHARMACISTS IN PRIMARY HEALTH CARE 42 12.2. TASK-SHIFTING: THE PHARMACISTS ASSISTANT DEBATE 43 12.3. METHODOLOGICALy CONSIDERATIONS of Cape Town 45 13. CONCEPTUAL FRAMEWORK 49 14. ACCESS TO ART SERVICES 50 14.1. AVAILABILITY 52 14.1.1. TransportUniversit as a barrier to access 52 14.1.2. Drug “stock-outs” as a potential barrier to access 53 14.2. AFFORDABILITY 54 14.3. ACCEPTABILITY 55 14.3.1. Stigma 56 15. SUMMARY 58 REFERENCES 60 PART C: JOURNAL ARTICLE MANUSCRIPT 69 PART D: POLICY BRIEF MANUSCRIPT 95 PART E: APPENDICES 102 APPENDIX 1: RESEARCH INFORMATION SHEET 103 APPENDIX 2: PATIENT EXIT INTERVIEW CONSENT FORM 108 APPENDIX 3: PATIENT EXIT INTERVIEW QUESTIONNAIRE 106 APPENDIX 4: OBSERVATION TOOL 110 APPENDIX 5: UCT RESEARCH ETHICS COMMITTEE APPROVAL 111 APPENDIX 6: DOH RESEARCH APPROVAL LETTER 112 APPENDIX 7: INSTRUCTIONS FOR AUTHORS 114 y of Cape Town Universit Index of tables PART A: RESEARCH PROTOCOL Table 1 Participant inclusion and exclusion criteria 9 Table 2 Summary of sampling strategy 11 Table 3 Data collection tools and sources 12 Table 4 Costs and sources of cost data 20 Table 5 Outline of budget 23 PART B: LITERATURE REVIEW Table 1 Pharmacy health human resources 43 Table 2 Pharmaceutical care services delivery models 48 PART C: JOURNAL ARTICLE MANUSCRIPT Table 1 Profile of respondents 76 Table 2 Summary characteristics of ART service by facility 77 Table 3 Average cost per patient visit 80 Table 4 Cost of ART service use, compared between different levels of 82 service y of Cape Town Table 5 The cost of upgrading a medicine room to a dispensary 83 Table 6 Sensitivity analyses 84 Table 7 Comparison of pharmaceutical care models 87 PART D: POLICYUniversit BRIEF MANUSCRIPT Table 1 Staff cost of ART service use, compared between different 97 levels of service Table 2 The estimated cost of upgrading a medicine room to a 100 dispensary Index of figures PART A: RESEARCH PROTOCOL Figure 1 Proposed time schedule 16 Figure 2 Access evaluation framework 17 PART B: LITERATURE REVIEW Figure 1 Human resources for health production function 32 Figure 2 Graphical presentation of the human resources for health 34 production function PART C: JOURNAL ARTICLE MANUSCRIPT Figure 1 Respondent travel- and waiting time 81 y of Cape Town Universit Abstract Human Resources for Health (HRH) have been identified as one of the primary constraints to achieving universal Anti-retroviral Treatment (ART) coverage in South Africa. This scarcity is exacerbated by the focus on decentralised, primary health care ART delivery that necessitates a rapid scale up and strengthening of pharmacy services in terms of supply, infrastructure requirements and HRH to ensure a safe and efficient pharmaceutical service. The shortage of pharmacists has led to the use of alternative pharmaceutical care models including indirectly supervised pharmacists assistants (ISPA) and nurses; however evidence on the costs, benefits and challenges faced in the implementation of these models are lacking. This study therefore aims to critically evaluate the ISPA and nurse-based pharmaceutical care models against the standard of care that involves a pharmacist dispensing ART, on the basis of cost, and patient preference. A cost analysis was conducted from the societal perspective and informed by patient exit interviews (240 respondents), expert interviews, and time and motion studies to calculate waiting time. The study was set in a peri-urban district of the Western Cape of South Africa. y of Cape Town While both of the decentralised pharmaceutical care models (ISPA and nurse-driven) were found to minimise the costs incurred by patients, in travel costs and time, the nurse-driven pharmaceutical care model was found to be significantly more costly (per patient visit)Universit from the provider’s perspective than the ISPA model. However, many patients had a preference for nurse dispensing, generally linked to stigma concerns when collecting medicines in the pharmacy. The study highlights the importance of considering the cost of task-shifting on nurses and the inherent value of their time. Patient preferences and challenges in the implementation of the pharmaceutical care models are also explored. i Acknowledgements The original idea and inspiration for the study came from the Indirectly Supervised Pharmacist Assistant (ISPA) model developed and supported by Ms Lindsay Wilson. I further acknowledge the assistance of the facility staff and management of the Infectious Diseases Unit in the Cape Winelands, under the leadership of Dr Dirk Hagemeister. I am indebted to the ANOVA staff, Dr Nelis Grobelaar, Dr Mea van Huyssteen and Mr Theunis Hurter for their assistance, comments and suggestions on earlier drafts and providing me with the platform to present the study to clinical staff and receive feedback. Ms Vanessa Daries, from the Health Economics Unit was an invaluable source of information and wisdom on the mechanics of conducting and managing field research and I owe her a great deal of thanks. In addition, I could not have interviewed and conducted the fieldwork without the assistance of Ms Sibongile Bovana. I would also like to thank A/Prof Susan Cleary for helpful comments on earlier drafts, and Ms Sheetal Silal for advice on the statistical aspects of the study. y of Cape Town Finally, I would like to thank my excellent supervisor Prof Di McIntyre who contributed to the initial conceptualisation of the study, supervised the analysis and provided many helpful suggestions, while trying to keep me focused on the issue at hand. The study was made possible by the support of the National Research Fund (NRF): Health andUniversit Wealth chair. ii Abbreviations AIDS Acquired Immunodeficiency Syndrome ART Antiretroviral Therapy DOH Department Of Health FTE Full-Time Equivalent HIV Human Immunodeficiency Virus HRH Human Resources for Health IMCI Integrated Management of Childhood Illness ISPA Indirectly Supervised Pharmacists Assistant LMIC Low- and Middle Income Countries NGO Non-Governmental Organisation OSD Occupation Specific Dispensation PA Pharmacists Assistant PHC Primary Health Care SAPC South African Pharmacy Council WHO World Health Organisation y of Cape Town Universit iii Index of key terms Dispensing related activities is defined, for the purposes of this analysis, as activities relating to stock control, administrative tasks (incl. collecting medication from a central dispensing unit where applicable), the interpretation and evaluation of the prescription, the preparation and labelling of the prescribed medicine as well as counselling of the patient on the safe and effective use of the medication (adapted from the Pharmacy Act). Pharmacists Assistant (PA): While there are different levels of PAs employed by the Department of Health, dependent on their level of completed in-service training, where the term is used in this dissertation we are referring to PAs who are fully qualified as Post-basic PAs and are therefore under the Pharmacy Act, able to work under indirect supervision. The training of a PA from Learner Basic PA to Post-basic PA takes a minimum of two-years of in-service training under the guidance of a pharmacist. y of Cape Town Universit iv Part A: Research protocol 1. INTRODUCTION Due to the worsening scarcity of health care workers in Sub-Saharan Africa there has been an increased focus on task-shifting of the duties of doctors and nurses, but there is a lack of research on similar strategies to address the shortage of pharmacists.