Evidence, cost and decision-making criteria used by provincial

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 (PTCs) 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 PTCs 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 participantswith
>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

Acknowledgements

Chemotherapy

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

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