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.