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
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.
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
To assess drug selection committees knowledge of
terminology used in clinical studies and economic
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
Respondents that reported understanding the clinical trial terms and scored >50% in the
Least important criteria (<3)
The cost-effectiveness of the
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
Availability of other treatment
The drug cures the underlying
disease or only provides
The cost of treatment for one
Likelihood the patient will comply
with the treatment
The reputation/credibility of
The doctors experiences with
the new drug
External pressure to make the
The drug is likely to be stolen
from the public sector.
Whether the drug is the
original or the generic
Drugs for sexually transmitted diseases
Number Odds Ratio Confidence
Respondents that reported understanding the economic terms and scored
>50% in the knowledge assessment
Cost-benefit Incremental Cost-utility
effectiveness minimisation analysis
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
Drug selection within a capped budget
Oral Rehydration Solution
Self reported understanding vs
actual knowledge of terms used in
Results : criteria used in decisionmaking
Most important criteria (>4)
Clinical trial terms
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
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
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
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
Summary of questionnaire
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.
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