ABSTRACT
INCLUSION CRITERIA
BACKGROUND
BIBLIOGRAPHY
RESULTS
RECOMMENDATIONS
Overview of Systematic Reviews on Pharmaceutical Policy, and their relevance to Low- and Middle-Income Countries Andy Gray1 and Fatima Suleman2
1Department of Therapeutics and Medicine Management and 2School of Pharmacy & Pharmacology
University of KwaZulu-Natal, Durban, South Africa
Problem Statement: The evidence base for large-scale
pharmaceutical policy interventions has not been systematically
summarised or assessed for relevance in low- and middle-income
countries (LMIC).
Objectives: To determine the impact of pharmaceutical policies
by means of an overview of systematic reviews (SRs) on
pharmaceutical policy; to assess the relevance of such evidence in
LMICs.
Design: Relevant databases (MEDLINE, EconLit, CINAHL, Cochrane,
ProQuest, EMBASE, JOLIS, ISI Web of Science, IPA, INRUD, NTIS, PAIS,
SourceOECD and WHOLIS) were searched, from inception to May
2009, to identify SRs on
13 pre-determined policy categories.
Pharmaceutical policies were defined as laws, rules, financial and
administrative orders made by governments, non-government
organisations or private health insurers that are intended to directly
affect the use or cost of medicines.
Results: Searches yielded a total of 7129 citations; 55 were
identified for full text retrieval but 38 were considered relevant only
as background material or as policy options that have not yet been
applied at scale and17 were considered for inclusion into the review.
Three were subsequently rejected and the findings of 14 SRs were
extracted and their applicability in LMICs considered. No SRs
assessed patent and profit policies, sales and dispensing policies,
policies that regulate the provision of health insurance including
medicines coverage, or policies that deal with the provision of
patient information. One SR dealt with registration and classification
policies (the scientific basis for generic medicine registration,
applicable to all countries); 1 with marketing policies (the effects of
direct-to-consumer advertising; though not explicitly allowed in any
LMIC, still of relevance); 1 with policies on price and purchasing
(reference pricing; of limited applicability in LMICs not using
insurance financing); and 2 with prescribing policies that rely on
financial incentives (replacing fee-for-service remuneration with
alternatives, such as capitation; neither easily applicable in LMICs
where there is no separation of healthcare financing from provision
of services). Nine SRs dealt with one or more of the following:
prescribing policies that rely on educational or regulatory policies
targeting prescribers, policies that determine which medicines are
reimbursed, restrictions on reimbursed medicines (such as prior
authorization), co-payments and caps. The dissemination of
educational materials alone had little effect. Group education might
have some effect, and one-on-one academic detailing, computerised
alerts and reminders, and pharmacists’ interventions (such as
pharmacist-led collaborative care) were effective in changing
prescribing behaviour. Application at scale is limited in LMICs by the
shortage of trained health professionals and computerization.
Managed care formulary management tools have little direct
applicability in LMICs outside of private insurance schemes, and the
effects of cost shifting from third-party payers to poor and
vulnerable patients need attention. Such tools will be of greater
relevance as more middle income countries introduce national health
insurance schemes.
Conclusions: More primary evidence of the application of
pharmaceutical policies at scale in LMIC settings needs to be
published. LMICs should be encouraged to fund monitoring and
evaluation units within their national structures to
generate and assess such evidence.
Funding Source: Alliance for Health Policy and System Research
WHO has published a systematic,
quantitative review of studies about
medicines use in developing and
transitional countries conducted
between 1990 and 2007, and
attempted to assess the impact of
these interventions (World Health
Organisation 2009). However, the
interventions described were not “at
scale” nor could they be described as
constituting “pharmaceutical
policies”. Aaserud et al. (2006) have
described thirteen pragmatic
pharmaceutical policy categories.
OBJECTIVE
The objective was to determine the
effects of pharmaceutical policies on
rational drug use by means of an
overview of systematic reviews on
pharmaceutical policy, with particular
focus on the relevance of such reviews
to low- and middle-income countries
(LMICs).
The objective of this paper is thus to determine the effects of pharmaceutical policies on rational drug use by means of an overview of systematic reviews[1] on pharmaceutical policy, with particular focus on the relevance of such reviews to low- and middle-income countries (LMIC).
[1] For the purposes of this overview, all systematic reviews with a clearly formulated question that used systematic and explicit methods to identify, select and critically appraise relevant research, and to collect and analyse data from the included studies were retrieved.
All systematic reviews with a clearly
formulated question that used
systematic and explicit methods to
identify, select and critically appraise
relevant research, and to collect and
analyse data from the included studies
were retrieved.
Pharmaceutical policies were defined
as laws, rules, financial and
administrative orders made by
governments, non-government
organisations (NGOs) or private health
insurers that were intended to directly
affect the use or cost of medicines.
7388 citations retrieved
from databases
searched
7038 citations
350 duplicates
6983 rejected
55 citations retrieved in
full text version
38 citations included as
background material
17 reviews analysed
3 rejected (added to
background material)
14 reviews included in
overview
Policy Type No
SRs
Applicability
Registration and
classification policies
1 The general principles are applicable in all
settings. The challenge for LMICs is the provision
of detailed data in a transparent fashion, through
well developed information systems.
Patent and profit
policies
0 No SRs were retrieved which assessed patent
and profit policies, sales and dispensing policies,
policies that regulate the provision of health
insurance including medicines coverage, or
policies that deal with the provision of patient
information.
Marketing policies 1 The single SR included focused on the effects of
direct-to-consumer advertising of prescription
medicines. Although this form of advertising is
not explicitly allowed in any LMIC, the potentially
negative effects of such a policy need attention.
Sales and Dispensing
policies
0 No SRs were retrieved for this policy area.
Prescribing Policies –
Financial incentives
2 Both SRs included covered the issue of replacing
fee-for-service remuneration with alternative
methods (such as capitation). One SR provided
very limited evidence related to prescribing
practices, but neither provided evidence that is
easily applicable in LMICs, except where there is
separation of healthcare financing from provision
of services. As in many areas, the applicability of
such policies is hampered by the absence of
strong health information systems in many
LMICs.
Prescribing Policies –
educational or
regulatory policies
targeting prescribers
2 The available evidence confirmed that the
dissemination of educational materials alone had
little effect. While group education might have
some effect, one-on-one academic detailing,
computerised alerts and reminders, and
pharmacists’ interventions (such as pharmacist-
led collaborative care) were effective in changing
prescribing behaviour. This evidence would seem
to match that long advocated for developing
countries, but its application at scale is limited in
LMICs by the shortage of trained health
professionals and also of computerised
prescribing and dispensing systems.
Provision of health
insurance including
medicines coverage
0 No SRs were retrieved for this policy area..
Reimbursement of
medicines
6 Dealt with under Multicomponent policies.
Restriction on
reimbursed drugs
7 Dealt with under Multicomponent policies.
Price and Purchasing 1 This SR covered the issue of reference pricing,
which is of limited applicability in many LMICs,
but can be applied in those countries that use
insurance as a financing model.
Co-payment and caps 6 Dealt with under Multicomponent policies.
Patient Information 0 No SRs were retrieved for this policy area..
Multicomponent
policies
9 These interventions (reimbursement, co
payments, caps) were assessed in developed
countries that effectively separate the financing
from the provision of health care, and also tend
to have more robust health information systems.
Policies that rely on classical formulary
management tools, as applied in developed
country managed care organizations (MCOs)
have little direct applicability outside of private
insurance schemes in LMICs, but the available
evidence does reinforce concerns about the
effects of cost shifting from third-party payers to
patients, particularly among the poor and
vulnerable.
Summary of conclusions per pharmaceutical policy type
More sound primary evidence of the application of
pharmaceutical policies at scale in LMIC settings needs
to be published. This requires close attention not only
to issues of methodological rigour, but also to research
capacity in such countries.
A careful balance needs to be struck between
extreme methodological rigour and the need to produce
and use evidence for policy. Where high quality
evidence is lacking, policymakers can still have recourse
to rapid assessments and outlines of experiences with
the application of pharmaceutical policy interventions.
LMICs should be encouraged to fund monitoring and
evaluation units within their national structures, to
gather evidence and to commission and co-ordinate
studies of adequate rigour to inform policy
development.
Consideration needs to be given to the development
of suitable methods to assess and collate evidence from
studies other than randomized controlled studies, as
systematic reviews seeking such studies may not be the
most appropriate way in which to gather such evidence
in ways that are relevant to policymakers, particularly
in LMICs. This is particularly true of regulatory
interventions that do not lend themselves to assessment
by controlled trials.
Where SRs of pharmaceutical policy interventions are
performed, authors should be persuaded to explicitly
reflect on the applicability of the evidence gathered to
LMICs, and to make recommendations for additional
research in this regard.
Aaserud M, Dahlgren AT, et al. (2006). Pharmaceutical policies: effects of reference pricing,
other pricing, and purchasing policies. Cochrane Database of Systematic Reviews (2).
World Health Organisation (2009). Medicines use in primary care in developing and
transitional countries: Fact book summarising results from studies reported between 1990
and 2006. Geneva, World Health Organisation.