A Systematic Approach to Improve Rational Medicine Use in Eswatini

A systematic approach to improve rational medicine use in Eswatini Nondumiso Beauty Queeneth Ncube Student number: 3616957 Submitted in fulfilment of the requirements for the degree PhD in the School of Public Health, Community and Health Sciences Faculty, University of the Western Cape Supervisor: Dr. Hazel Anne Bradley Co-Supervisors: Prof Helen Schneider and Prof Richard Laing i http://etd.uwc.ac.za/ Abstract Studies on rational medicine use (RMU) have mainly focused on identifying, quantifying, and addressing irrational use without exploring reasons behind this irrational use. In addition, minimal work has been conducted on irrational use of medicines in the context of the growing burden of non-communicable diseases (NCDs). This PhD research examined medicine use in Eswatini, (previously Swaziland) between April 2017 and March 2019, with a focus on prescribing practices linked to specific diagnoses. It further explored factors influencing RMU, which included testing the effects of a short intervention - prescription audit and feedback coupled with small group education - on prescribing practices in health facilities. This intervention study employed a mixed methods approach with both quantitative and qualitative components. RMU was assessed based on the World Health Organization/ International Network for the Rational Use of Drugs (WHO/INRUD) prescribing indicators at three time points: baseline, post intervention and post follow-up. Baseline results were used to design an unblinded intervention in 32 health facilities, randomly allocated to intervention (16) and control (16) arms. The intervention, prescription audit coupled with small group education, was designed based on baseline findings. Percentage of prescriptions with at least one antibiotic was used to allocate facilities to intervention and control arms. The intervention was rolled out in two visits, two months apart to intervention facilities. Descriptive statistics, mean difference-of-differences (MD), and multilevel mixed logistics models were performed to analyse data, comparing intervention and control facilities. Analyses of RMU are provided nationally and disaggregated to regional levels, as well as by diagnoses and level of care. In the qualitative component, semi-structured interviews were conducted to ascertain perspectives of policy makers, supervisors, and frontline managers across the four regions of the country at baseline (39 participants) and at the end of the study (28 participants). Drawing on Social Practice Theory, these interviews explored the material (health system context), competence (provider) and cultural (patient and provider) factors influencing prescribing practices. The research documented widespread irrational use of medicines in Eswatini. Most WHO/INRUD prescribing indicators, except prescribing of injections, were outside the WHO recommended standards. Although not reaching statistical significance, small changes were documented ii http://etd.uwc.ac.za/ immediately post intervention: the average number of medicines per prescriptions increased more in control than intervention facilities (mean difference of differences (MD) = -0.23; p = 0.48); generic prescribing increased in both groups, more in control facilities (MD = -4.38; p = 0.35); antibiotics prescribing decreased slightly in both intervention and control facilities, with a higher decrease in control facilities (MD = 7.06; p = 0.26). A statistically significant increase in the use of antibiotics in control facilities was observed at the end of the follow-up period (MD = -8.31, p = 0.03, 95% CI = -15.74 - -0.89). Improvement in prescribing indicators was observed more in secondary than primary level facilities. Most of these changes, however, were not sustained at the end of the follow-up period. Polypharmacy and high levels of antibiotic prescribing persisted in all regions, with some regional variations (notably in the Shiselweni and Lubombo regions). Importantly, our study found a previously unreported finding that antibiotics were frequently prescribed for chronic non-communicable conditions (26% at baseline, 23% post intervention, and 24% post follow up period). A variety of factors contributing to irrational use of medicines were reported by participants. Material factors included: poor use of standard treatment guidelines, lack of RMU policies, poorly functioning pharmaceutical and therapeutics committees, stock-outs of medicines, lack of pharmacy personnel in primary healthcare facilities, and restrictions of medicines by level of care (secondary vs primary healthcare). Provider-related factors included: inadequate knowledge, experience and practice ethic, symptomatic prescribing and high patient numbers. Patient-related factors included late presentation, language and the perceived patient pressure on providers to prescribe many medicines. This research concludes that there is irrational use of medicines in Eswatini, when assessed against WHO recommended standards. The lack of impact of this intervention, when combined with the qualitative findings, indicates that irrational use of medicine is a complex problem that is beyond prescribers and supervisors in facilities alone to resolve. Improving rational medicines use in Eswatini requires mixed interventions and concerted effort from a range of stakeholders and policy makers in both the ministries of health and finance. iii http://etd.uwc.ac.za/ The thesis offers a number of recommendations for strengthening policy and practice to promote RMU in Eswatini. These include drawing on the tools used in this research to develop an ongoing system using data from the client management information system (CMIS) of monitoring and evaluation (M&E) of medicine use at facility, regional and national levels; and linking M&E to the strengthening of facility Pharmaceutics and Therapeutics Committees (PTC) as well as to national planning for the country. In this regard, the research provides a baseline against which to evaluate future strategies. Recommendations are also made on RMU training of frontline managers, supervisors, and policy makers, and on the role and availability of pharmacy personnel in support of RMU at all levels of care. Findings of this research and the recommended strategies are likely to have relevance for other similar, low-middle-income settings. The research fills a number of gaps in the literature on RMU in Eswatini, namely, prescribing and use of medicines in health facilities, regions and levels of care, including reasons behind certain prescribing practices. It further provides information on use of medicines in the management of chronic non-communicable disease. Finally, it is recommended that future studies focus on system-level factors, in particular, the effect of availability of pharmacy personnel, availability of stock and stock management practices on rational use of medicines. iv http://etd.uwc.ac.za/ Keywords Appropriate medicines use Medicines use WHO prescribing indicators Rational medicine use Prescribing practices Prescriber attitudes Swaziland Eswatini Social practice theory Theoretical domains framework v http://etd.uwc.ac.za/ Abbreviations ACE Angiotensin Converting Enzyme ADR Adverse Drug Reaction AIDS Acquired Immune Deficiency Syndrome AMR Antimicrobial Resistance ARB Angiotensin Receptor Blocker ART Antiretroviral Therapy ARV Antiretroviral CCB Calcium Channel Blocker CI Confidence Interval CKD Chronic Kidney Disease CMIS Client Management Information System CMS Central Medical Stores CVD Cardiovascular Disease DDPS Deputy Director Pharmaceutical Services DM Diabetes mellitus EML Essential Medicines List FIP International Pharmaceutical Federation GINA Global Initiative for Asthma HCW Healthcare Worker HIV Human Immunodeficiency Virus HTN Hypertension IDF International Diabetes Federation INRUD The International Network for the Rational Use of Drugs JNC Joint National Committee KI Key Informant LMIC Low- and middle-income Country MoH Ministry of Health MSH/SIAPS Management Sciences for Health/Systems for Improved Access to Pharmaceuticals and Services NCD Non-communicable Diseases NDoH National Department of Health NEMLC National Essential Medicines List Committee NEMP National Essential Medicines Policy NHP National Health Policy NPP National Pharmaceutical Policy PI Principal Investigator PTC Pharmaceutics and Therapeutics Committee RCT Randomised Controlled Trial RHMT Regional Health Management Team RHO Regional Health Office RMU Rational Medicine Use SPT Social Practice Theory STG Standard Treatment Guidelines TB Tuberculosis TDF Theoretical Domains Framework vi http://etd.uwc.ac.za/ TTM Trans Theoretical Model URTI Upper Respiratory Tract Infection WHO World Health Organization vii http://etd.uwc.ac.za/ Preface I declare that “A systematic approach to improve rational medicine use in Eswatini” is my own work. It is being submitted to the University of the Western Cape for the first time and has not been submitted for any examination or qualification in any other University. I also declare that I have acknowledged all sources used in this work. Name: Nondumiso Beauty Queeneth Ncube Signature: Date: 27 July 2020 viii http://etd.uwc.ac.za/ Dedication I dedicate this work to my two girls - Imanathi and Yenzokuhle Ncube, to encourage you to be hard-working girls that break every societal barrier to reach your potential! I also dedicate it to my late parents: Mr Meshack Jabulani and Mary Ginindza for sacrificing all they had for me to get an education. Though you physically are

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