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Evidence, cost and decision-making criteria used by provincial pharmacy and therapeutics committees in South Africa Pillay T, Hill SR, Walkom E. School of Medical Practice and Population Health, Newcastle University, Australia. (1) Rating the importance of 25 drug selection criteria on a five point Likert scale. The criteria were classified in 5 groups: WHO recommendations (burden of disease, efficacy, safety, quality), patient factors (compliance, QOL, age of patient, severity of disease), cost factors (number of patients, impact on budget, costeffectiveness), procurement factors (supply capability, generic vs patented drug) and other factors (political pressure, drug listed on another provincial list, clinician involved in clinical trial, availability of other drugs). (2) Selection of 10 drugs from a list of 20 essential and non-essential drugs, assuming a capped budget. The 20 drugs represented 6 categories: chronic therapies, preventive therapies, infectious diseases, lifestyle therapies, potentially life saving therapies, and widely prescribed drugs such as multivitamins, cough mixtures. (3) Knowledge of terminology used in clinical trials and economic analyses, assessed in 2 parts: PART 1: Participants were required to rate their own understanding of terms used in clinical trials and economic analyses. PART 2: Participants were given a list of statements relating to the terms listed below and were required to answer “true” or “false”. The South African National Drug Policy (NDP) emphasises the importance of establishing Pharmacy and Therapeutics Committees (PTC’s) in each of the provinces. Provincial PTCs were appointed with the responsibility of reviewing and adapting standard treatment guidelines, undertaking drug utilisation review and drug selection using evidence of efficacy, safety and cost-effectiveness from clinical trials. Most PTC’s required additional training and resources to carry out their new role in considering these issues. At least one PTC member from each province had attended international courses that were potentially relevant to develop the necessary skills for their new responsibilities. This study attempts to identify the criteria that provincial PTCs apply in drug selection and whether committees possess the necessary skills to assess applications for listing that make claims of greater efficacy, safety or cost effectiveness. Study Aims • • To identify criteria that drug selection committees in South Africa consider important in decision making. To examine the influence of a limited budget on drug selection. To assess drug selection committees’ knowledge of terminology used in clinical studies and economic analyses. Methods All PTCS in South Africa were asked to participate. Those who agreed were asked to complete a question during a PTC meeting. Data were coded and analysed. Six committees agreed to participate, a total of 72 committee members. Respondents that reported understanding the clinical trial terms and scored >50% in the knowledge assessment 90 80 70 60 50 40 30 20 10 0 Levels of Evidence Least important criteria (<3) The cost-effectiveness of the treatment Efficacy of the drug Severity of the clinical indication The side effects of the drug Whether the drug improves QOL The total annual cost to the budget Availability of other treatment alternatives The drug cures the underlying disease or only provides symptomatic relief The cost of treatment for one patient Likelihood the patient will comply with the treatment The reputation/credibility of the manufacturer The doctors experiences with the new drug External pressure to make the drug available The drug is likely to be stolen from the public sector. Whether the drug is the original or the generic B C D E F Antiasthmatics drugs √ √ √ √ √ √ Antidiabetic √ √ √ √ √ √ Contraceptives √ √ √ √ √ √ Antibiotics √ √ √ √ √ √ Anti-tuberculosis √ √ √ √ √ √ Antihypertensives √ √ √ √ √ √ Vaccines √ √ √ √ √ √ Antiepileptics √ √ √ √ √ √ Drugs for sexually transmitted diseases √ √ √ √ √ √ √ Antimalarials Analgesics Number Odds Ratio Confidence Needed to Interval Treat 80 70 60 50 40 30 20 10 0 Respondents that reported understanding the economic terms and scored >50% in the knowledge assessment CostCost Cost-benefit Incremental Cost-utility effectiveness minimisation analysis costAnalysis ratio analysis effectiveness ratio Sensitivity Analysis Economic terms This is the first attempt at assessing decision making by pharmacy and therapeutics committees in South Africa. The findings of this study could form the basis of a more in-depth assessment of pharmacy and therapeutics committee decision making. A √ Absolute Risk Reduction Conclusion Drug selection within a capped budget Oral Rehydration Solution Relative Risk Reduction Self reported understanding vs actual knowledge of terms used in economic analyses Results : criteria used in decisionmaking Most important criteria (>4) Relative Risk Clinical trial terms % of participants with >50% correct Background and Setting % of participants >50% correct Problem Statement: The WHO recommends that drug selection should be based on an assessment of the comparable quality, efficacy, safety and cost-effectiveness. Drug selection committees are often required to consider other factors such as compliance or external pressure from the public to make the drug available. It is unclear particularly in developing countries, which of these factors committees consider important in their selection process or how technical assessments of comparative effectiveness or cost effectiveness are made. Objectives: To identify criteria used for drug selection, priority setting with limited budgets, understanding of terms used in clinical trials and cost-effectiveness studies. Design: Cross-sectional survey questionnaire of all South African (SA) provincial pharmacy and therapeutics committees (PTC) were invited to participate were invited to participate. Methods: Participants had to complete the questionnaire during a PTC meeting. The questionnaire was made up of following sections. (1) ratings of the importance of 25 criteria on drug selection. (2) selection of 10 drugs from a list of 20 essential and non-essential drugs, given a limited budget (3) knowledge and understanding of terminology used in clinical trials and economic analyses Results: Seventy-two provincial committee members (from 6 provinces) completed the questionnaire. Participants rated the following criteria as always important: quality of life, potential for the drug to be abused, patient compliance, severity of the clinical indication, burden of disease and whether the drug provided symptomatic relief or cured the condition. When asked to choose 10 drugs given a limited budget there was a trend towards choosing drugs to treat chronic conditions (hypertension, diabetes, etc.) and infectious diseases (antibiotics and anti-TB drugs). Participants rated their understanding of clinical and economic terms as high. However, less than 30% answered the knowledge questions correctly. Conclusions: Drug selection committees consider a range of other factors in addition to WHO criteria. These criteria are not applied equally in every decision e.g. burden of disease was rated highly however antiretroviral therapy for HIV/AIDS (highest contributor to mortality in SA) was not selected by any of the committees. Committees consider cost-effectiveness and efficacy as priority issues in drug selection. However, results of the knowledge assessment suggest that committee members are not familiar with terminology used in clinical trials and economic analyses. • Self reported understanding vs actual knowledge of clinical trial terms Summary of questionnaire Abstract The study findings suggest that provincial pharmacy and therapeutics committees consider drug efficacy, safety and cost-effectiveness as important issues in drug selection. However there is some concern that committees do not have sufficient expertise in epidemiology, biostatistics and pharmacoeconomics to support their decision making. Further intensive training in the areas of epidemiology, biostatistics and pharmacoeconomics appear to be necessary however this should be conducted after a more detail assessment of committees knowledge of epidemiology, biostatistics and pharmacoeconomics. √ √ √ Thrombolytics √ Chemotherapy √ Acknowledgements T Pillay was supported by an Aus AID fellowship. Cholesterol lowering drugs Anti-Retrovirals Impotence therapy Multivitamins Cough mixtures Anti-ulcerants WHO Collaborating Centre for Training in Pharmacoeconomics and Rational Pharmacotherapy