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Southern MedReview

Volume 4 Issue 1 April 2011

ISSN 1174-2704

An International Journal to Promote Pharmaceutical Policy Research

Social pharmacy: borrowing tools and theories the world over

Medicines use and access research: diverse methodologies show a complex picture requiring our attention

A history of medicines use in rural Nepal

Pharmaceutical situation in Afghanistan

A critical review of pharmacists’ impacts in primary health care

Medicines use in Cameroon

Selection of essential medicines in China


Southern MedReview

Editor-in-Chief

Z. Babar

Guest Editor

PJ Ballantyne

Associate Editors

S. Scahill

A. Tahira

Editorial SupportE.C.L. Cazedey

H. Håkonsen

S. Jamshed

A. Hussain

Graphic Designer

J. Allen

Technical Support

S. Chen

International advisory boardAgnes Vitry

Senior Research Fellow, School of Pharmacy, University of South Australia, Australia

Albert Wertheimer

Professor, School of Pharmacy, Temple University, Philadelphia, USA

Andy Gray

Senior Lecturer, Nelson R Mandela School of Medicine, University of KwaZulu-Natal,

South Africa

Anwar Gilani

Professor of Pharmacology, The Aga Khan University, Karachi, Pakistan

Bruce Scoggins

Former Chief Executive, Health Research Council (HRC), New Zealand

Dzulkifli Abdul Razak

Vice Chancellor, Universiti Sains Malaysia, Penang, Malaysia

Herida Regina Nunes Salgado

Universidade Estadual Paulista Rodovia Araraquara, Araraquara, Brazil

Janie Sheridan

Associate Professor, School of Pharmacy, The University of Auckland, Auckland,

New Zealand

K Balasubramaniam

Coordinator, Health Action International Asia Pacific (HAIAP),Colombo, Sri Lanka

Kirsten Myhr

Head, RELIS Drug Info and Pharmacovigilance Centre, Oslo, Norway

Margaret Ewen

Coordinator, Global Projects (Pricing) Health Action International Global, Amsterdam,

Netherlands

Mohamed Izham Mohamed Ibrahim

Professor, College of Pharmacy, Al Qassim University, Al Qassim, Saudi Arabia

Nadeem Irfan Bukhari

Assistant Professor, College of Pharmacy, University of the Punjab, Lahore, Pakistan

Peri Ballantyne

Professor of Sociology, Trent University, Ontario, Canada

Sanjay Garg

Associate Professor, School of Pharmacy, The University of Auckland, Auckland,

New Zealand


Southern MedReview

Context: In developing countries where health systems and health policy

are constantly evolving, there is a great need to publish informative research.

However, there are few avenues to do so. Also, some of the other challenges

are inexperienced or untrained researchers, topics out of the scope of current

mainstream journals and limited funding.

Aims and Objectives: Southern Med Review provides a platform for researchers

to disseminate commentary and empirical research findings, with a view to

improve the rational use of and access to essential medicines.

About the Journal: The Southern Med Review is an independent, open access,

not for profit, peer reviewed journal which is published 2 times a year from

Auckland, New Zealand. If you have interesting work to share, please contact the

editor: [email protected] or [email protected].

The Editor and Publisher of Southern Med Review is Zaheer Babar PhD, School of

Pharmacy, University of Auckland. Auckland, New Zealand. The journal’s financial

transactions are managed by Auckland UniServiced Ltd, Auckland, New Zealand.

The “Southern Med Review” can be distributed freely; however no part can be

copied without the permission of the Editor. The opinions and interpretations

expressed herein by the authors are their own and do not necessarily reflect those

of the publisher, editors, or organizations with which they are affiliated. Southern

Med Review (ISSN: 1174-2704) – All rights reserved, Copyright @2011.

Southern Med Review welcomes feature articles, research papers, learning in

practice, pharmacy in our part of the world, policy briefs, letters to the editor and

other forms of scholarship. All forms of articles should be within the range of

6000 words. Articles must be submitted in Vancouver Style, which is a numerical

style that follows the rules established by the International Committee of Medical

Journal Editors (http://www.icmje.org/).

Indexing and Abstracting: The journal is indexed in Scopus, CrossRef, EMBASE,

Directory of Open Access Journals (DOAJ), EBSCO Host, Open J Link, Gale, Global

Health, CAB Abstract Databases, Ulrich’s Periodical Directory and in New Zealand’s

National Library. Articles are also deposited in the WHO’s Essential Medicines

Documentation Database. The journal is also freely available from the Journal’s

website www.southernmedreview.org or from the University of Auckland’s

website www.fmhs.auckland.ac.nz/sop/smr


Southern MedReview

Contents

Social Pharmacy: borrowing tools and theories the world over 1Shane Lindsay Scahill, Zaheer-Ud-Din Babar

Medicines use and access research: diverse methodologies show a complex picture requiring our attention 2Peri Joanne Ballantyne

Mountains and medicines: history and medicines use in rural Nepal 4Susan Heydon

Sociocultural, economic and regulatory influences on medicine use by consumers in a rural township in Cameroon 9Robert Chapchet Chana, Hazel Bradley

Assessing pharmacists’ impacts in primary health care: are we asking the right questions? 17Peri Joanne Ballantyne

The selection of essential medicines in China: progress and the way forward 22Difei Wang, Xinping Zhang

Afghanistan pharmaceutical sector development: problems and prospects 29Jonathan Harper, Gunnar Strote

Performance based reward for immunization: experiences from GAVI 40Rete Trap, Birna Trap, Torsten Wind Hansen, Ebba Holme Hansen

1 Southern Med Review Vol 4 Issue 1 April 2011

Editorial

Social Pharmacy: borrowing tools and theories the world over Citation: Scahill SL, Babar ZU. Social Pharmacy: borrowing tools and theories the world over. Southern Med Review (2011) 4;1:1doi:10.5655/smr.v4i1.78

questions. Second, it provides an impetus for countries in the

Global South to view “medicines” in their totality, as part of

the wider health system, rather than just “isolated chemical

entities”. Increasingly pharmacy schools in low income countries

are teaching social pharmacy concepts7 and there is a greater

call for the strengthening of Social Pharmacy before establishing

clinical pharmacy practice8.

We are cognizant that there are three main mechanisms by

which the Social Pharmacy discipline can “spread the word”and

“show the value” in the broadest sense. Teaching, research

and partnering with or gaining support from significant non-

government organisations (NGO’s) such as the World Health

Organisation (WHO) are the main mechanisms cited in the

literature1. Apart from teaching and learning of Social Pharmacy,

more work needs to be undertaken to improve the other two

mechanisms of internationalization of our discipline; research

dissemination and development of partnerships.

Shane Lindsay Scahill, BPharm, MMgt

Zaheer-Ud-Din Babar, PhD

School of Pharmacy, University of Auckland, Auckland,

New Zealand

References1. Norris PT. Challenges facing social pharmacy. Research in Social

and Administrative Pharmacy. 2009;5(3):195-196.

2. Bissell P, Morgall Traulsen J. Sociology and Pharmacy Practice. 1st ed. London: Pharmaceutical Press; 2005.

3. About Social Pharmacy, Faculty of Pharmacy, Universitetet I Oslo, Norway. Available at, http://www.farmasi.uio.no/seksjoner/farmasoytisk/english.html. Accessed 23rd March 2011.

4. Department of Social Pharmacy, Faculty of Pharmacy, University of Kuopio, Finland. Available at, http://www.uku.fi/farmasia/sofa/english/. Accessed 23rd March 2011.

5. Section for Social Pharmacy, Faculty of Pharmaceutical Sciences, University of Copenhagen, Denmark. Available at, http://www.farma.ku.dk/index.php?id=181. Accessed 23 March 2011.

6. Babar Z, Beswick T. Southern Med Review: A New Forum to Publish “Local Pharmaceutical Policy in a Global Context”. Pharmacy World & Science. 2009;31(2):143.

7. Clinical and Social Pharmacy, Faculty of Pharmaceutical Sciences, Kwame Nkrumah University of Science and Technology, Ghana.Available at, http://www.knust.edu.gh/pages/sections.php?siteid=pharmacy&mid=607&sid=1827. Accessed 23rd March 2011.

8. Babar Z, Jamshed S. Social pharmacy strengthening clinical pharmacy: why pharmaceutical policy research is needed in Pakistan? Pharmacy World & Science. 2008;30(5):617.

There is no denying that challenges lay ahead for the discipline

of Social Pharmacy. These challenges are both considerable

and global; requiring the involvement of fraternities from both

academia and practice. To date, high income countries adopting

the western research paradigm have informed these challenges.

They centre on improving practice, teaching and research

through the application of knowledge and theories from other

disciplines1.

Beginning to think like those who trained outside of conventional

pharmacy, and applying accepted theoretical frameworks

requires a shift in thought, along with considerable time and

energy. Sustainable research streams within our emerging

discipline of Social Pharmacy need to be structured upon what

we need to know, but equally upon approaches that have gone

before us by other disciplines. Since the mid 1960’s the umbrella

of academic pharmacy has developed from a predominantly

science based paradigm to include a much broader view of the

world2. This has been achieved through the study of medicines

in society and the term “Social Pharmacy” was coined.

Social Pharmacy researchers based in the western world have

borrowed tools and theories from the social sciences including:

anthropology, sociology, history, economics and organizational

science in order to answer complex questions relating to society

and medicines2. Historically this occurred in the Nordic Countries

because Europe, in particular faced up to the challenges of their

ageing population3-5. Pharmacists were keen to study both

medicines seeking and medicines use behavior and it all began

from there. Elsewhere in high income countries, it has taken a

while however now it is happening and this demonstrates the

coming of maturity within the profession; at least in academic

terms.

In the same fashion we argue for the increased utility of Social

Pharmacy in the context of low and middle income nations. This

focus needs to be driven by academics resident in developing

countries, but also those academics within the high income

nations whom have a passion for, and are qualified to, explore

broader “medicines use issues” through a different lens. A

“North-South Collaboration” is increasingly happening, as

evidenced by the publications in this as well as previous issues

of this journal. The Southern Med Review provides a sound

platform for propagating this collaboration6.

We argue that the benefits of Social Pharmacy research in the

Global South are two-fold. First, techniques borrowed from

the social sciences could be applied to address fundamental


Guest Editorial

Medicines use and access research: diverse methodologies show a complex picture requiring our attentionCitation: Ballantyne PJ. Medicines use and access research: diverse methodologies show a complex picture requiring our attention. Southern Med Review (2011) 4;1:2-3 doi:10.5655/smr.v4i1.79

of access to and use of medicines by rural Nepalese. Heydon

describes how the unique historical context of (western) health

care development in the region - in particular, the introduction

of western medicine by the expedition culture from the 1960s,

and the ongoing influence of recreational visitors to the region

on medicines availability and use – has resulted in Sherpas’

familiarity with accessing and using ‘western’ medicines.

However, serious gaps in access to and the quality of western

health care (providers and medicines), has meant that a place

for traditional healers and medicines has never been usurped,

and a setting of medical pluralism prevails in the region.

Jonathan Harper and Gunnar Strote provide a broad, sweeping

look at the Afghanistan pharmaceutical sector, relying on a mix

of methods to examine current problems and prospects. They

report that despite assistance from the international donor

community in Afghanistan, its pharmaceutical sector “suffers

from major deficiencies in terms of policy implementation,

regulation, and management… with governance, structural

and capacity weaknesses at both the central and provincial

level”. They emphasize in particular the presence of a market

for counterfeit and substandard medicines as an urgent public

health problem.

My own article considers the pharmacist-professional role in

assuring the appropriate use of medicines by the public. The

article is intended to be a reminder that availability, access and

affordability aside, medicines-use outcomes may be harmful

if not carefully supervised. Demonstration of the positive and

negative impacts of medication supervision – or lack of it – from

pharmacists or other health care professionals (or from non-

professionals) on the public’s health is important, but must be

creatively planned and executed.

Robert Chapchet Chana and Hazel Bradley provide an interesting

view of medicine use by consumers in Tiko, Cameroon. Using

focus groups and key informant interviews, these authors

describe important social-cultural factors influencing medicine-

seeking and use – key among these is socio-economic status of

consumers, and the costs of medicines. Medicines-access and

use occur in a context of poor medicines regulation and control;

costs vary widely by provider (roadside kiosks, itinerant vendors,

In a guest editorial in the September 2009 special issue of SMR

(on access to medicines, pricing and generics), Professor Albert

Wertheimer describes the complex array of pre-conditions for

and consequences of an individual getting and using a medicine.

He states that “the patient gets the appropriate medication

only when there is a concordance of several endeavors. To

achieve success, we need to have availability, affordability and

access…”1.

Articles included in the current issue of SMR reinforce

Wertheimer’s assertion, as I describe here. However, I would

add that an additional endeavor ought to be added to his list.

Acknowledging the gap between expert/scientific knowledge

about medicines and lay perspectives and knowledge – I would

suggest that an additional factor influencing success in medicine

use outcomes is professional [pharmaceutical] care. Thus, in

reading the articles in the current issue, I would ask you to

consider [in addition to availability, affordability and access],

the importance of professional surveillance and supervision of

lay medicine use for optimal medicine use outcomes – and the

consequences of its absence. Additionally, the current issue

illustrates an impressive array of research approaches and

methodologies for assessing medicines availability, affordability,

access and care. We encourage readers to consider the utility of

these for their future research endeavors.

First, addressing access to essential medicines at a population

level, Trap Rete and colleagues describe the results of an

evaluation of the Global Alliance for Vaccine and Immunization

service support (GAVI-ISS) undertaken to assess the coverage

(as well as the quality, efficiency, security and usefulness of the

evaluation system) of childhood diphtheria-tetanus-pertussis

immunization (DTP3) in 9 developing nations. The GAVI-

ISS combines an evaluation of the quality of the country’s

immunization reporting system with performance based

financial rewards, country-specific recommendations and

implementation support. The authors detail the methods used,

and impressive outcomes – findings of improved reporting

quality for all nine countries included in the study.

Susan Heydon illustrates the use of historical case study

methodology to provide a perspective and understanding


Medicines use and access research

community medicines stores, private hospital pharmacy, public

hospital pharmacy and community pharmacies) in a setting

of “unbridled illicit trade in pharmaceuticals”. Medicines are

valued and sought after, funded out-of-pocket by people with

limited means, and commonly used without supervision.

Difei Wang’s article is focused on the important topic of the

evolving ‘essential medicine’ list that determines a population’s

access to medicines. Wang describes the history of World Health

Organization list of essential medicines (EM) and the Chinese

National Essential Medicines List (NEML), and compares their

convergences and differences over time. Wang reports significant

improvement in China’s NEML, but calls for improvements in the

transparency and accountability of medicines selected for the

list.

Peri Joanne Ballantyne, PhD

Department of Sociology

Trent University, Canada

References1. Wertheimer AI. Access to medicines: Complex entities and

behaviours seem unavoidable. Southern Med Review (2009)2; 2:1-1


Commentary

Mountains and medicines: history and medicines use in rural NepalSusan Heydon

School of Pharmacy, University of Otago, New Zealand

Address for Correspondence: Susan Heydon, School of Pharmacy, University of Otago, PO Box 56, Dunedin 9054, New Zealand. E-mail: [email protected]

Citation: Heydon S. Mountains and medicines: history and medicines use in rural Nepal. Southern Med Review (2011) 4;1:4-8doi:10.5655/smr.v4i1.77

AbstractThe aim of this article is to highlight the value of an historical approach for current health research into access and use of medicines. It

also suggests that historical research complements the perspectives of other social science disciplines. This study focuses on the rugged

Mt Everest region of Nepal and the mainly Sherpa inhabitants from the 1960s through to the present. It draws on an in-depth historical

case study of Khunde Hospital, which is the main provider of health services in the area, and an exploratory study of people’s use of

medicines over time. This historical perspective deepens our understanding of both the consumer and provider of medicines in the

Everest area. The research employs a variety of qualitative methods and uses a wide range of written and oral, primary and secondary,

published and unpublished sources as well as participant observation and further fieldwork. Multiple separate and interconnected

factors have influenced medicines use over time. The study identifies the importance of medicines in the introduction and spread of

‘modern’ medicine in the area, but like elsewhere in the Himalayan region modern health care and its medicines are used within a plural

medical environment. The Mt Everest region has become a major tourist destination which has led both to considerable economic

development in the area but has also influenced the supply and use of medicines. While medicines use unsurprisingly is different today,

this development overall has occurred within a framework of both continuity and change that underpins Sherpa life more broadly.

Keywords: medicines, mountains, Nepal, medicines use, medicines access, history

While there is a growing historical literature about the discovery

and role of medicines in tackling disease, there is little relating

to current medicines issues and pharmacy practice. The aim

of this paper is to bring an historical approach to considering

current access and use of medicines in rural Nepal. In particular

it will focus on the Mt Everest region. Although the number

of pharmacists and pharmacy assistants in Nepal has increased

considerably in recent years, in 2007 less than 8% of registered

pharmacists and 37% pharmacy assistants worked in hospital

and community pharmacies13. As is to be found elsewhere in

the wider region, most people in Nepal obtain their medicines

through various retail outlets where often the staff has little

training in medicines14. Also, as noted recently in Pakistan, most

pharmacies sell medicines without prescriptions15-16. In 2007

the Nepalese government declared that many basic medicines

could be obtained for free at government health institutions,

but in early 2010 local media, referring to a Ministry of Health

and Population source, claimed that 85% of government

health institutions in Nepal were without stocks of essential

medicines17. While a person was able to consult a health worker

for free, people had to go elsewhere and buy some or all of

the medicines they required from the private sector instead of

IntroductionIn the past ten years a number of articles have appeared in

a range of journals that discuss the value and ways of using

an historical approach in current health research, policy and

practice1-8. While an interest in history has long been present

in the study of health, these articles cumulatively suggest

that historians through their different interests, conceptual

approaches and particular methods can provide valuable insights

into today’s concerns9-10. These perspectives complement those

provided by researchers from other social science disciplines and,

in terms of the patient or consumer of services, further deepen

our understanding, whether at an individual or population

level. For the most part, this debate about history has been

conducted in and about developed countries and has focused

on public health. Nevertheless an increasing interest is being

shown in developing countries where these other social science

disciplines, and especially anthropology, already have a major

involvement in health research11. In late 2004 the World Health

Organization (WHO) established the Global Health Histories

(GHH) project which ‘promotes the concept that learning from

history is vital to help shape a healthier future for everyone,

especially those most in need’12.


Mountains and medicines: history and medicines use in rural Nepal

being supplied from the government clinic or hospital. Nepal

is one of the poorest countries in the world, but a 1998 study

showed that funds for almost three-quarters (74%) of the

country’s health care came from the out-of-pocket expenditures

of households18.

This paper draws on two historical studies undertaken in the

Mt Everest region: a case study of the area’s main provider of

health services and an exploratory study into changing patterns

of medicines use19-20. The research began as history of health,

but as its relevance to current practice became more striking its

focus shifted towards history in health1. Both studies draw on a

range of primary and secondary, written and oral sources, as well

as participant observation through being a volunteer at Khunde*

Hospital for over two years and subsequent visits. Documentary

sources include hospital records, reports, correspondence and

diaries, while oral history interviews were carried out with present

and former hospital staff and members of the local community.

The first part of the paper examines current access and use of

medicines in the Mt Everest area while the second section adopts

an historical approach to understanding these patterns.

Medicines in the Mt Everest area of Nepal The Mt Everest region is situated on Nepal’s northern border with

the Tibet Autonomous Region of China and is a spectacular and

challenging high-altitude mountain environment. There are no

roads. A national park, it is home to the Sherpas who during the

first half of the twentieth century became internationally famous

through their role as high-altitude support personnel on climbing

expeditions. In 1953 New Zealander Edmund Hillary and Tenzing

Norgay made the first successful ascent of Mt Everest. Today this

region, which has a population of approximately 3500, is one of

Nepal’s major tourist destinations19(p.321). The rise of tourism has

fuelled the area’s economic development and has encouraged

people from other ethnic groups to move into these high valleys

for employment.

Unlike most of rural Nepal the Everest region has had a permanent

and functioning health infrastructure since the 1960s. Currently,

while the main provider of services and medicines is Khunde

Hospital, which was built by Sir Edmund Hillary in 1966 as part

of his ongoing aid programme, people can also obtain medicines

from various other sources. These include the hospital’s village

clinics, government clinics, tourists (whether or not they are

health professionals), the dental clinic, various temporary or

permanent aid projects and non-government organisations

(NGOs), local initiatives, a licensed pharmacy and general

shops. Visitors to the area also donate medicines to local health

organisations. In general, people obtain most of their medicines

from facilities run by health personnel with varying levels of

training, but none have registered pharmacists or pharmacist

assistants on their staff.

Sherpas today are familiar with accessing and using medicines.

Despite the poverty of most Nepalese, many Sherpas are

affluent, travel and obtain medicines while away, whether

within Nepal, such as in the capital Kathmandu, or overseas on

a trip sponsored by a visitor. People are aware that medicines

exist for different health concerns, such as to relieve pain or

help one sleep, but mostly see them in terms of what they do

rather than by name21. For example, they know antibiotics can

be medicines that dry lesions. Communicable diseases remain

important health issues in Nepal, but chronic non-communicable

conditions are an increasing burden for health services. Among

Sherpas, a changing and often more sedentary lifestyle has led

to a growing number of people now needing to take medicines

on a long-term basis. Khunde Hospital’s annual report for

2008/09 notes that hypertension is common with more than

sixty people under regular medication22. The report also

mentions an increasing prevalence of type two diabetes mellitus

and gout. Currently, the hospital is able to obtain sufficient and

appropriate medicines for patients with chronic conditions, and

currently staff regard adherence as good21. Supplies are bought

in Kathmandu, but the hospital is also happy to accept medicines

donations from visitors. Internationally, the issue is of concern

regarding quality, appropriateness, expiry and proper disposal.

International guidelines exist, but mostly remain guidelines23.

Particularly useful donations for Khunde Hospital are analgesics

and antibiotics, but this is not the case with all medicines

received. Only some visitors ask the hospital what is needed.

Good relationships with organisations operational during the

trekking season may also see left over medicines coming to

Khunde. Currently this happens with the IPPG (International

Porter Protection Group)22.

In 2006/07 there were 8013 outpatient attendances at Khunde

Hospital(19p.320). Although many people now go to Khunde

Hospital as their first choice and use its medicines, especially

antibiotics and analgesics, modern medicine – as this type of

health care is often referred to in Nepal – also operates in a

fluid plural medical environment. Sherpas believe in a variety

of gods and supernatural spirits and these beliefs inform their

ideas about sickness, disease causation and the internal body.

For example, a pem (a type of ‘witch’ spirit) is usually held

responsible for prolonged diarrhoea and vomiting. People will

take medicines from the hospital to relieve the symptoms, but

the hospital is not the appropriate place for dealing with the pem

that has caused the illness. Sherpas, who originally came from

Tibet, are Buddhist and in the Everest area can obtain medicines

from some religious lama (a senior monk) and amchi (a Tibetan

medical practitioner). Recently an NGO project established

medical herb gardens and began to make medicines, but while a

Himalayan Trust nursery at Phurte grows some plants for Tibetan

medicines, a large tourist lodge now stands on what was the

Sacred Land project nursery site24. Nevertheless, the hospital and

community are used to each other in a relationship that is in

practice a coexistence of difference19. Each acknowledges and

incorporates aspects of the other’s beliefs and practices when

dealing with a person’s sickness, but remains separate. It is a

relationship that has built up over time.

* An alternative spelling is Kunde.



Historical perspectives on access and use of medicines in the Mt Everest regionA great strength of historical research is its interest in and ability

to investigate the wider context. While an examination of the

current situation identifies multiple aspects to medicines use in

the Everest area, historical perspectives explore these over time.

This research highlights the importance of medicines in the

introduction and spread of modern medicine in the area; that

multiple separate and interconnected factors have influenced

medicines use; and that while medicines use unsurprisingly

is different today from fifty years ago, this development has

occurred within a framework of both continuity as well as

change that underpins Sherpa life more broadly25.

Before the mid-1960s, people in the Everest region had very little

access to and so little use of modern medicines. Instead, Sherpas

used various rituals and a few herbal medicines. While Nepal had

few biomedical services, Sherpas employed on mountaineering

expeditions came into contact with their medical services. These

expeditions often carried extensive supplies of medicines26. A

few Sherpas were also trained to assist. New Zealand climber

Norman Hardie wrote about his five-month stay in 1954/55 in

the village of Khumjung and provides an explicit reference to

the important role of medicines in promoting the introduction

and spread of modern medicine: ‘This assistant could be taught

the uses of the appropriate pills for the treatment of the

major fevers, dysentery and high altitude headaches. Besides

assisting the party home, it would slowly diminish the deep-

rooted superstitions that exist in the home villages’27. Expedition

medical care, nevertheless, was a short-term option.

Although slowly expanding, government health services

throughout Nepal remained limited in the 1960s and especially

in rural areas where most of the population lived28. In the Everest

area the situation changed, particularly after the opening of the

small hospital at Khunde in 1966. The government also opened

a small clinic in the area’s administrative centre of Namche

Bazar. Khunde Hospital, run by Hillary’s aid organisation the

Himalayan Trust, soon became the main provider of both the

medical services and the medicines. Nevertheless people’s use

of the hospital was pragmatic and selective based on their

perceptions as to the hospital being the appropriate place

to go for their particular health concern19. Most people had

expectations that modern medicines should work in a very short

space of time29(p.268). If they did not, they tried other systems.

The overseas volunteer medical staff had to adapt their practice

to the conditions and to how people used the hospital and

its medicines – for example, how to devise a dosage regimen

when people did not have clocks30? Initially people thought

that the hospital’s medicines were no good because they were

free and it was only when people travelled to Kathmandu that

they found the same medicines could be expensive to buy31.

Then they began to increase their use of the hospital. Sherpas

considered that the new medicines could treat the symptoms

but were not the real cure32. In the 1950s and 1960s many

new medicines became available, especially antibiotics for the

treatment of infectious disease, impressing both local people

and the hospital staff. Overseas volunteer Lesley Evans wrote in

her diary in 1968 during the walk in to Khunde: ‘We saw awful

impetigo on two children in tonight’s surgery. … But gosh, how

speedily infections get better. They’re so sensitive to antibiotics

…’33.

At Khunde Hospital staff assumed they would have the necessary

medicines to treat a wide range of health problems presented by

the increasing number of patients. They thought of medicines

mainly in terms of supply issues. Between 1967 and 2006/07

patient numbers quadrupled, from 1924 to 801319(p.319-20).

Initially most medicines were brought in from New Zealand and

many of these were donated, but gradually as more medicines

became available in Nepal the hospital bought its supplies

internally. Contact with government health services was very

limited, except in the areas of medicines for government

preventive health programmes with which the hospital became

increasingly involved. These were vaccines, tuberculosis and

leprosy medicines, family planning supplies and iodised oil

injections. Most of these medicines came from international aid

sources, but while hospital staff initially obtained some directly

from the respective donor, increasingly staff found they were

instructed to obtain these through the particular government

programme as these developed34.

As with general use of the hospital’s services, therapeutic

success increased the hospital’s acceptance in the community,

although not everyone is happy with modern medicines. The

younger wife of an elderly man, who has forgotten the English

he learned while on expeditions in the 1960s, blames his loss of

‘memories’ on all the medicines he has taken during his life35.

While he still takes his medicines, treatment failure could have a

negative effect on people’s perceptions and use of the hospital.

Over time this has affected the hospital’s efforts to develop

services. In 1980 a one-year old child died in a village following

an injection of penicillin. Although unrelated, this hindered

uptake of the hospital’s vaccination programme in the villages

in the upper valley. Hospital staff made periodic attempts to

immunise, but not till 1997 was this successful36. While the issue

was more complex, the effect of the belief that ‘vaccinations kill

babies’ was powerful and long lasting37. Medicine and mode of

delivery were synonymous.

Like elsewhere in the Himalayan region, modern health services

functioned within a changing but plural medical environment,

with people deciding which system to use based on their

perceptions of the cause of their problem38. Religious and amchi

medicines also circulated in the community and ritual remained

important. Medicines were made by lamas from instructions in

the religious books, but some medicines were more preventive

and ‘not really medicine’21. Small red or brown/black pills,

which remain popular, were regarded as good for everything

and helped a person keep healthy. Their ingredients included

holy water and their preparation involved prayer. They were



also given for non-specific illness and people about to die. The

use of lhawa (a spirit medium/shaman) has decreased, but their

declining numbers were due more to the lure of employment in

the trekking industry than competition from modern medicine.

Amchi medicine had a more limited influence in the area29(p.261).

Sherpas used to supplement their subsistence lifestyle with trade

and while away bought medicines. Trade with Tibet declined

after the intensification of the Chinese presence in the 1950s,

but some amchi moved permanently into the Everest region.

The last aspect to be considered is the ongoing influence of

recreational visitors on medicines availability and use. When few

their impact was limited, but increasing numbers became integral

to the economic development of the area. Tourist numbers have

risen from 20 in 1964 to 28,999 in 2008/09, with totals peaking

in the spring and autumn trekking seasons19(p.322),22. Most visitors

experience some form of sickness, ranging from the relatively

minor inconvenience of the common cold to conditions resulting

in death. When sick, tourists self-treat, are treated by their group

or another visitor, or seek help from a health facility. At Khunde

Hospital, visitors consume medicines from the hospital’s supply

but pay for their cost.

Visitors have influenced medicines use in a number of ways that

may also conflict with one another. Individually and as groups,

they have provided much of the region’s health infrastructure

through a desire to help and have also been an important

source of medicines donations. These supplemented the

hospital’s supplies and therefore helped to contain costs and

to increase the quantity and variety of medicines available at

the hospital. On the other hand, despite the presence of health

facilities, climbing expeditions and trekkers have continued to

give out medicines and provide treatment to local people. In the

1970s and early 1980s Khunde Hospital staff were particularly

concerned about fragmentation of care for people with chronic

conditions such as tuberculosis which was common at the

time and had a longer treatment time than today19(p.209). Such

medical help was carried out in good faith on both sides, but

while a focus on the provision of basic health services may be

appropriate policy for the area, it is also not surprising that

local people wanted what they thought to be a better option.

They did not consider receiving treatment from various sources

to be a problem. They knew visitors carried medicines for

their own use and over the years this has created some issues

for staff at Khunde Hospital such as the use of antibiotics in

cases of diarrhoea, which is very common among both local

people and visitors. While the use of oral fluids for rehydration

is recommended in cases of uncomplicated diarrhoea, visitors

often have potent antibiotics, which can considerably speed up

recovery from an unpleasant condition. Not surprisingly local

people wanted similar treatment39.

ConclusionThis historical research has highlighted the central role that

medicines have had in the introduction and spread of modern

health care in the Mt Everest region of Nepal and has identified

the wide range of complex, separate and interconnected

issues and how these have changed over time. When Western

medicine encountered Sherpa beliefs and practices the response

was neither a one-way diffusion of Western medical practice,

nor a collision between the spirit-suffused system of the

Sherpas and scientific biomedicine. People used the hospital

and its medicines for some things but not others, based on their

perception as to whether the hospital was the effective and

appropriate option to take.

Nevertheless, as with the health services more broadly, multiple

factors have influenced access and use of medicines. Increasing

availability and use, together with changing patterns, has

occurred within a framework of both continuity and change

that underpinned Sherpa life more broadly and which we need

to better understand if we want to know more about what

people do when they incorporate dealing with sickness into

their and their family’s daily life. An understanding of these

complexities over time is important for developing strategies

to improve medicines policies and practices, whether, as in the

Everest area, other health professionals (such as a doctor, nurse

or medical assistant at Khunde Hospital) are involved rather

than pharmacists or pharmacy assistants. It is also important for

efforts to contain costs, an issue that is of concern not just to

Khunde Hospital or Nepalese government health services. The

increasing burden of chronic, non-communicable illness and the

need in many cases for long-term medication is an issue facing

all countries.

AcknowledgementI would like to thank the many people in Nepal and New Zealand

who have helped me with my research. I would also like to thank

the School of Pharmacy for a Start-up grant that enabled me to

return to Nepal in early 2010 to undertake fieldwork.

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Research Article

Sociocultural, economic and regulatory influences on medicine use by consumers in a rural township in CameroonRobert Chapchet Chana1, Hazel Bradley2

1Core Pharmacy, P.O.Box 332 Tiko, Cameroon 2School of Public Health, University of the Western Cape, South Africa

Address for Correspondence: Robert Chapchet Chana, Core Pharmacy Likomba, Tiko, South West Region, Cameroon. E-mail: [email protected]

Citation: Chana RC, Bradley H. Sociocultural, economic and regulatory influences on medicine use by consumers in a rural township in Cameroon. Southern Med Review (2011) 4;1:9-16 doi:10.5655/smr.v4i1.73

AbstractObjectives: The objective of the study was to analyze the sociocultural, economic and regulatory factors influencing access to and the

use of medicines by consumers in Tiko, Cameroon.

Method: Using focus group discussions information was obtained from members of Plantain Traders Association, Township Taxi

Drivers Association and Teachers of Government Bilingual High School (GBHS) Tiko. This information was triangulated with those

obtained from key informant interviews with sellers of medicines in community pharmacies.

Results: Key influences on medicines use were reported to have emanated from the sociocultural and economic background of the

people and also from inappropriate regulation on medicine distribution and sales and included the perceived need for medicines,

the cost of medicines, the purchasing habits, the medicine use culture, medicine supply channels and poor medicines regulation and

control.

Conclusion: Consumers’ perceived need for medicines generated a pattern of use that included medicines sharing attitudes and

polypharmacy. Their medicine purchasing attitudes were greatly influenced by their financial constraints. The lack of proper regulation

also contributed towards the irrational use of medicines.

Keywords: Medicines, medicines use, consumers, patients, community pharmacies, self medication, Cameroon.

The inappropriate use of medicines results in increased morbidity

and mortality, especially in disease conditions like hypertension,

diabetes and epilepsy where it is critical that medicines are taken

regularly and appropriately3. It also wastes resources and results

in poor patient outcomes and adverse drug reactions3. Antibiotic

resistance is on the increase due to overuse of antibiotics, and

inappropriate use of injections, especially non-sterile injections,

has resulted in increased transmission of HIV/AIDS and hepatitis4.

The rational use of medicines is one of the core components

of the pharmaceutical policy of Cameroon5. The strategic

document for the implementation of a National Pharmaceutical

Policy in Cameroon recognizes that, despite the creation of a

Central Pharmaceutical Store for the nation, health units still

IntroductionEssential medicines, or drugs, are those which satisfy the priority

health care needs of the population1. They should be of good

quality, available at all times and affordable. When used properly,

these medicines provide simple cost-effective solutions to our

health care needs1. “The rational use of medicines requires that

patients receive medications appropriate to their clinical needs,

in doses that meet their own individual requirements, for an

adequate period of time, and at the lowest cost to them and

their community.”2 Unfortunately, studies indicate that on a

global level, more than 50% of all medicines are prescribed,

dispensed, or sold inappropriately and 50% of patients fail to

take them correctly3.



run out of stock of essential medicines5. In addition, the illicit

trade in pharmaceuticals, most especially counterfeit medicines

is increasing and no public health programs exist to educate

actors involved in medicine use on the appropriate use of

pharmaceuticals, a problem which is further exacerbated by

the lack of sufficient number of health professionals. In 2000,

it was estimated that the pharmacist to population ratio was

1:26930 persons while for doctors (general practitioner) it

was 1:12,500 persons and for nurses 1:2083 persons5. This is

a particular cause for concern because modern medicines are

found everywhere and can be sold by anyone6. Previous studies

conducted in Cameroon to promote rational use of medicines

have focused on health worker prescribing and dispensing.

Enhancing optimal practices by heath care workers can only

partly improve the use of medicines, because Cameroonians,

instead of going to the formal health sector when sick regularly

self-medicate or visit a street vendor, traditional or faith healer7.

It was noted that when consumers self-medicate, they obtain

their medicines from informal drug distribution channels and

from pharmacies. It was estimated in 2006 that 44% of sick

patients in Cameroon relied on self treatment, 26% and 17%

respectively went to state-own health facilities and private health

facilities while 8% of patients went to an informal health facility,

mainly illicit drug retailers, traditional healers and religious

healers8. In addition, the use of medicines is not rationalized

and constitutes 81% of the total health expenditure8.

Frequently consumers request capsules or tablets of medications

ranging from anti-infectious agents such as antibiotics and

antimalarials to analgesics and, for various reasons, not all of

these patients buy the full course of therapy and even when

they do, they may not take all the medicines as prescribed.

In 2008 and 2009, it was estimated that households were

paying 77% to 90% of the annual total health expenditures

of Cameroon and that 94.8% of this contribution came

as out-of-pockets spending during illness episodes8 in the

formal and informal health sectors. Successful strategies to

improve the use of medicines by consumers must be based

on a clear understanding of consumers’ beliefs, expectations

and approaches to medicines, so that specific issues can be

targeted. This study therefore investigates the ways consumers’

in Tiko Sub division, Cameroon, use medicines and the factors

influencing them to do so.

The study took place in Tiko Sub-division, a rural sub-division in

the South-West Region, one of the two English speaking regions

of the Republic of Cameroon. Tiko Sub-division is a coastal plain

and has a hot climate. The population size is approximately

55,914 inhabitants9, made up of approximately 47.8 % males

and 52.2% females. The principal sources of income of the Tiko

population are trading, farming and plantation wage earnings.

Plantation wage earners and farmers make up 81% of the poor

population in Cameroon10. As in other parts of the country,

malaria, pneumonia and diarrheal diseases are the leading

causes of death especially of under-5 mortality11 while HIV/AIDS

and tuberculosis are also common. Tiko is an easy access point

to neighbouring countries like Nigeria and Equatorial Guinea.

English and French languages are the two official languages in

Cameroon. However, there are about 250 ethnic groups, each

with its own language. Pidgin is a frequently spoken language

and is used in various settings across Cameroon by all age

groups but more frequently nowadays, by the uneducated.

Pharmaceutical Situation in CameroonIn Cameroon, only pharmacists registered with the

Pharmaceutical Society of Cameroon are legally authorized to

import, stock, distribute and dispense medications. However,

in reality all doctors in private practice and some in the public

sector stock and dispense medicines to patients.

Cameroon runs a district health care system. Tiko health district

is governed by a district management committee and services

are provided in both the formal and informal sectors. The formal

sector consists of all accredited hospitals, health centers and

community pharmacies. The state owned health care services

in the formal sector consists of one district hospital, three

maternity units with facilities for out-patient consultations and

seven health centres. Private institutions in the formal sector

include two faith-based hospitals, two private surgeries and

five community pharmacies. There also exists a health service

complex owned by Cameroon Development Corporation (CDC)

which is intended to take care of employees of CDC. Apart

from CDC health staff, there are ten medical doctors working in

both the public and private sectors. The informal sector is made

up of medicine sellers in stalls, kiosks, hawkers and medicine

peddlers. Throughout Tiko Sub-division, it is estimated that

there are approximately 100 people involved in this informal

trade in medicines. Trading informally in medicines is against

the law; however, this practice thrives. Those involved in the

informal trade in medicine are not under the jurisdiction of any

professional body and do not need any formal qualification

to participate in the trade. The medicines they sell range from

simple over the counter medicines, like paracetamol, to the

most costly antibiotics like the third generation cephalosporins.

In this context, the present study was conducted. The objective

of the study was to analyze the sociocultural, economic and

regulatory factors influencing access to and the use of medicines

by consumers in Tiko, Cameroon.

MethodologyThis study was exploratory. The sample was selected from men

and women, aged 18 years and above, living in one of three

zones (Tiko town, Likomba and Mutengene) in Tiko Sub division.

The three zones of Tiko Sub-division were chosen because they

have more than 70% of the population, and about 80% of the

hospitals, community pharmacies and informal private medicine

stores and it was easy to commute within them.



Table 1. Process regarding focus group discussions

Focus Group 1: Researcher contacted and briefed head of plantain traders associa tion regarding the study

• T he researcher contacted plantain traders and sellers (inclusion criteria explained)

• The researcher met two focus groups (Dates and venues for focus groups agreed)

• Participant information sheet read out, informed consent obtained, focus groups discussions conducted

Focus Group 2: Researcher contacted and briefed taxi drivers association on the study

• The researcher contacted taxi drivers association (inclusion criteria explained)

• The researcher met two focus groups (Dates and venues for focus groups agreed)


Focus Group 3: Researcher contacted and briefed vice principal (VP) and a written request for the study was submitted to and approved by VP

• The researcher contacted teachers (inclusion criteria explained)

• Teachers met and two focus groups were formed (Dates and venues for focus groups agreed)


Table 2. Group numbers, names, dates and venues for focus group discussions

Serial no.

Group Name of groupNumber of members in

groupStudy period

1 Group 1 GBHS male teachers 10 March 2009

2 Group 2 Plantain sellers 1 8 March 2009

3 Group 3 Plantain sellers 2 7 March 2009

4 Group 4GBHS female teachers

9 April 2009

5 Group 5 Taxi drivers 1 7 April 2009

6 Group 6 Taxi drivers 2 7 April 2009

Sampling Procedures

Consumers of medicines, with whom focus interviews were

conducted, were purposively selected to represent the different

socioeconomic and educational levels of Tiko population. The

data collection process using focus groups has been shown in

Table 1.

Table 3. Process regarding key informant interviews

Informal sector

• Researcher and sellers in medicines stores

• Purpose of study and inclusion criteria explained (date and venue agreed)

• Participant information sheet was given and informed consent obtained

• Interviews conducted

Formal sector

• Researcher and pharmacists or pharmacy assistants

• Purpose of study and inclusion criteria explained (date and venue agreed)

• Participant information sheet and informed consent obtained

• Interviews conducted

Table 4. Name of community pharmacy, location and the month when the interview was conducted

Serial no.

Name of community pharmacy/Medicine

store*Location Month

1 Pharmacy A! Tiko Town May 2009

2 Pharmacy B Likomba May 2009

3 Pharmacy C Mutengene May 2009

4 X medicine store Long street Tiko May 2009

5 Y medicine store Likomba May 2009

6 Z medicine store Mutengene May 2009

*The names of the medicines stores were kept confidential

! The pharmacist assistant was contacted and interviewed

The consumers included two groups made up of eight and

seven members each of women selling plantain; two groups

each of seven members of taxi drivers; and two groups each

consisting of ten male and nine female teachers of a public

secondary school respectively. Table 2 shows the various focus

groups involved in the interviews.

The criteria for inclusion in discussions were that members must

be living in one of the three zones of Tiko Sub-division; they

must have lived in the area for the past five years; and they must

have purchased or used medicines at least once within 30 days

of the date of the focus group discussion. For the women selling

plantains and the taxi drivers, members for the interviews were

recruited with the assistance of the heads of both associations

after having been contacted and briefed on the study and

inclusion criteria. The vice principal of the government bilingual high school (GBHS) Tiko was contacted and briefed on the study and inclusion criteria. He assisted in recruiting teachers for the study.



Six key informant interviews were conducted, three each with

medicine sellers and pharmacy assistants. Table 3 shows the

sampling process for the key informant interviews.

The inclusion criteria for the key informants were that the

registered community pharmacy and the informal store must

have traded in that locality for at least three years and that

the person interviewed must have worked in that facility for

at least one year. Because pharmacy assistants often interact

with patients in this setting more than pharmacists, they were

interviewed. The interviewer personally contacted the key

informants. However, those in the informal sector preferred to

stay anonymous. Table 4 shows the community pharmacies and

the dates of interviews.

Data collectionThe focus group discussions were conducted in both English

and Pidgin. English language was used during the group

discussion with the male and female teachers while Pidgin was

used in the discussion with plantain sellers and taxi drivers. The

key informant interviews were conducted in English. Interviews

were conducted in the community pharmacies and in the

medicine stores.

For all the focus group discussions and key interviews, an

observer, a social science university student, took notes and

recorded non-verbal cues. The interviews were also audio-taped

and the recordings transcribed. The focus group discussions

and key informant interviews were conducted by the principal

researcher. The group discussions for taxi drivers and plantain

sellers were conducted in Pidgin and in English for the teachers.

The researcher and observer were Cameroonians fluent in both

English and Pidgin and they both translated the pidgin version

to English.

An interview guide was used for both interviews. The questions

focused on the effects of consumers’ health seeking behaviour,

access to medicines, the use of medicines and the type and

sources of information consumers have for the use of medicines.

Ethical approval for the study was accorded by the University

of the Western Cape Ethics Committee and supported by the

district medical officer of Tiko Health district.

Results

Sociocultural factors

Perceived need for medicines

Consumers’ reported their perceived need for medicines were

guided by feeling of ill-health, the feeling of wellness and the

desire to stay healthy.

When consumers felt sick “they rushed immediately to get some medicines”. Taxi drivers reported that when they “felt like having fever”, they visited road side kiosks and medicine stores

for a prescription and to purchase medicines. They called the

medicine they took “first aid” and said that if they did not get

better, they would then go to the hospital.

“Me a no di waste time. When ma skin wan just worry me I di

go find medicine. A di tell dat boy them wey them di sell say

make them mix me some merecin for fever. If a take am den

a well then fine. If no bi so then a go go hospital. Da merecin

them for corner road e just dey like na first aid”

The English version is:

“I do not delay. As soon as I feel sick, I look for some medicines. I

tell the sellers in the medicine store to mix for me some tablets. I

will go to the hospital only if the medicine I drank did not relieve

me of my sickness. Those medicines sold in medicine stores and

kiosks are for first aid purposes.”

Plantain sellers said that they often took pain killers when they

felt they were going to suffer from generalized body pains. They

said that they did so because they did not want to fall sick and

“lose market days”.

Pharmacy assistants and medicine sellers reported that

consumers often requested medicines because they felt sick or

were about to get sick and that they sometimes asked for “a

dose of red and yellow capsules to treat a running stomach” and

at other times the sellers prescribed and dispensed medicines to

consumers.

Taxi drivers and male and female teachers also reported that

they stopped taking medicines when they felt better while some

teachers deliberately did not use up all the medicines because

they thought that it was useful to have some medicines left over

to use if the sickness returned.

The desire to stay healthy was expressed by participants in

all the focus group discussions. They reported that they took

medicines “to stay healthy, for cleansing of the system and to

have energy”.

Medicine use culture

The consumers reported sharing medicines with one another,

taking various kinds of medicines mixed together, and taking

medicines kept from a previously uncompleted treatment.

Consumers reported various instances of sharing medicines with

their friends and neighbours.

A female teacher reported the way in which she participated in

medicine sharing.

“I used ranitidine for my gastric. I wanted to know if it was a

good medicine for gastric ulcer before I bought it. A friend of

mine gave me some tablets from her house. They were almost

expired but I drank some and they helped. However, kindly

let me know if it’s a good medicine before I buy because I do

not want to continue drinking the medicine which is about to

expire.”

Sellers in medicine stores and pharmacy assistants reported that

consumers requested for a mixture of various kinds of medicines

including, metronidazole for running stomach (diarrhea), or a



single or multiple dose of mix medication (chloramphenicol,

ibuprofen, iron tablet) for fever. They also reported that men

drank alcohol while taking their medications (some feeling that

there is a therapeutic benefit in doing so) and also that some

female students bought menstrogen during holiday periods

to terminate unwanted pregnancy. In addition, they reported

that females preferred doxycyline while men took tetracycline

capsules, which they referred to as “red and yellow capsule”

for cleansing of the system and against running stomach (for

this they take with a bottle of Guinness, an alcohol). These

medications are supposed to be dispensed strictly against a

prescription and some of the combinations requested contain

medicines belonging to the same therapeutic class. These

medicines were usually kept in their homes or purchased

regularly from the sellers. Pain medicines were used regularly

by all the groups. Male and female teachers and women selling

plantains kept medicines at home to treat fever, stomach

ache and worms. They reported that they kept paracetamol,

metronidazole, amodiaquine, quinine and mebendazole. They

did not know the strengths of the medicines. These medicines

were used to prevent malaria (reportedly administered every

six months) in their children, to treat “running stomach” in

addition to taking them as a “first aid measure” before a formal

consultation if necessary, with a health worker.

A male teacher said,

“I do keep medicines at home. I buy them from the pro pharmacy

in the hospital. I give malaria medicines to my children every six

months to prevent them from getting malaria fever. I also give

them worm medicines”.

Pharmacy assistants and medicine sellers reported that

consumers gave a variety of reasons when they came to

purchase medicines. Sellers in the medicine stores said that

some consumers bought medicines regularly because their

doctor told them to take the medicine for a long time while

others requested medicines for specific purposes. For instance:

antibiotics were reportedly requested because consumers are

using them to clean their system.

Pharmacy assistants also reported that consumers requested

refills of anti-diabetic and anti hypertensive without prescription

and that consumers requested multivitamin tablets for their

children for appetite. It was common for pharmacy assistants,

medicine sellers or consumers to make diagnoses and prescribe

to anyone in need of medication. A pharmacy assistant reported

as follows:

“…a pastor and another lady came here (pharmacy) to buy

medicine. After she (pastor) had narrated the problem of her

child, I concluded that the child had malaria and I told her.

When I was about to give her the anti-malarial medicine, the

woman who came with her said that it was “aspergic”( aspergic

is lysine acetylsalicylate) that was good for fever. I insisted and

told them that aspergic was only to bring down the body’s

temperature. She told me to give as her friend had suggested

saying that her friend has children at home so she knew it. I

gave as they requested. After about 24hours, the pastror came

back complaining that she wanted fever medicine and not

medicine to cool body temperature. Unfortunately for her, I was

the one on duty, and I told her it was her fault. Her friend looked

at the counter of medicines again and saw another medicine,

pregnatal (a ferrous product for pregnant women). She advised

the pastor to get it for the sick child because “pregnatal”it was

the best medicine to replenish iron during pregnancy but that

when her daughter went to the antenatal clinic they did not

prescribed it for her so she took her daughter to the pharmacy

and bought it for her”.

This narrative illustrates the complex interaction between

medicine sellers, consumers and the sick. Pharmacy assistants

and medicine sellers reported that consumers gave a variety of

reasons when they came to purchase medicines including advice

from their doctor to take the medicine “for a long time”.

Economic factors

Cost of medicines

All consumers said that medicines were expensive. The cost

of medicines influenced the way consumers’ access and used

medicines. Community pharmacies were reportedly the most

expensive source, followed by medicine stores and then the

public hospital pharmacies. Even though consumers believed

that community pharmacies had better quality medicines, they

still resorted to other medicine supply channels which had lower

cost medicines.

Because of cost, some male teachers said that when they went

for prescription from a doctor, they had to know why each

medicine was prescribed. While some male teachers reported

that they bought medicines from public hospital pharmacies

where some bought in bulk to “make sure” they had medicines

available when they needed them, others venture to avoid

paying high costs for medicines by purchasing them through

friends.

“My friend is a nurse in Yaounde. Whenever I need medicine as

I needed Oflocet recently I called my friend who gave whom I

sent 5000frs CFA to get me a packet. It is the same Oflocet that

is sold in the pharmacies for 11,000frs CFA. You know, in the

pharmacies they have various taxes they pay. They also have the

salaries of the workers to pay. These all put together make the

medicine expensive”.

Consumers said that community pharmacies did not split

packets of medicines. This made it difficult for them to buy from

there unlike medicine stores which retailed from packets and

offer a mixture of medicines. Plantain sellers said that before

they could go to the hospital they had to be sure that they

had sufficient money to buy the medicines to be prescribed.

When the prescribed medicines were not available at the public

hospital pharmacy, they bought the medicines from community

medicine stores except when the doctor insisted that they buy

them from the community pharmacies. However, even when the



doctor insisted, they did not at all times buy all the medicines

at once from the community pharmacies. They bought their

medicines one after the other as they had the money to pay

for it, a process that might undermine therapeutic efficacy of

prescribed medicines.

Consumers reported that because of cost of medicines, they

sought care where they could get services on credit and also

sought alternative sources of healing which some combined

with biomedicine. This was reported by female teachers and taxi

drivers. Taxi drivers further reported that they often contributed

money for a sick colleague who could not afford to go to the

hospital or buy his drugs. A female teacher said,

“I do not have sufficient money. I am a single mother and I have

to take care of the children. I have a friend who is a pharmacist.

She burrows me medicines when I do not have money. At times

I ask her to select those medicines which are very important so

I can buy them. I sometimes ask from her pharmacy that they

should give me the same medicine as that of the packet I have”.

Regulatory factors

All consumers interviewed reported that medicines were freely

available from a wide variety of sources and that there were no

restrictions to purchase. Medicine sellers said that they supplied

consumers with whatever medicines they requested, whereas

pharmacy assistants reported that they sold medicines according

to what they felt was professionally appropriate. All consumers

interviewed made out-of-pocket payments for their medicines.

Sellers in medicine stores and community pharmacies said that

they sold in cash based on the amount of money the patient

had.

The male teachers reported that the cost of medicines resulted

in everybody taking advantage of the high cost of medicines

in pharmacies by getting involved in selling medicines. In

the hospital pharmacies for instance, they reported that

the medicines which were not supposed to be sold without

prescription were sold even in bulk to those whom the sellers

knew and to some community medicine store owners. Even

nurses in the hospital sold medicines to patients.

DiscussionIt was found that the way members of the community obtained

and used their medicines appeared to be influenced by the way

they perceived their need for medicine. Also it was influenced by

their ideas about efficacy, costs and the availability of medicines.

The need for medicines was mentioned in a variety of contexts:

to treat illness, prevent an illness and to maintain wellness. It

was common for both male and female teachers, taxi drivers

and plantain sellers to obtain medicines to treat a variety of

symptoms, such as pains and fever. It was also common for them

to reserve their medicines without seeking medical advice, when

they felt well. Teachers, taxi drivers and plantain sellers also took

medicines because they wanted to stay strong and healthy.

This finding was similar on one hand to that of Rasmussen et

al., 12, who reported that consumers believed that “medicine

is needed for every illness. If medicine is not used, the illness

will become serious”. On the other hand, it could be said that

consumers’ perceived severity of disease seemed to influence

their continuation on therapy13.

Consumers’ perception of the ‘power’ of medicines seems to

influence their desire to acquire medicines. On the one hand,

consumers believed that medicines were powerful and could

“cure” certain conditions. For instance, medicine sellers from

both the formal and informal sectors reported that consumers

used antibiotics to “cleanse their systems”, especially after sexual

intercourse; and they also took multivitamin products to prevent

the skin of their palms from peeling off. Plantain sellers took

paracetamol to cure fever and body pains. Some of these uses

are inappropriate and it is uncertain how this misinformation

got into the community. It does however illustrate a lack of

reliable information about medicines which was found in similar

research in Ghana14 and in a Filipino village15,16.

Polypharmacy was also found to be rife with consumers

requesting mixtures of medication to treat their illnesses. This

seemed to indicate that they did not have sufficient trust in

one medicine to treat their illness and so they would “make

sure” by taking two or three medicines together - hoping that

at least one will work. For example, sellers of medicines from

the informal sector reported that a mixture of medicines that

included “buta” (an analgesic), indocid® (another analgesic and

anti-inflammatory), some quinine (for malaria), multivitamins

and chloramphenicol were put together in a medicine sachet

given for the treatment of typhoid and malaria. It was a common

practice for consumers to take antibiotics with Guinness when

they have “running stomach” (diarrhea). Guinness (an alcoholic

drink) was attributed by consumers in this community to “cause

a tight stomach” (constipation) -a counter to the running

stomach. In other settings polytherapy has been reported to be

the outcome of the uncertainty people have on the cause of

their illness and choice of therapy17. As has been observed in this

study and in addition to the above, it could be suggested that

polytherapy was practiced because people wanted to get well

fast in order to be relieved of the discomfort associated with

their illness and also, for economic reasons - so that they didn’t

have to be absent from their daily activities. This was particularly

true of the poorer groups - the plantain sellers and taxi drivers

who depended on their daily income. Some of the taxi drivers

reported using pain killers and traditional treatment when they

had sprains. Using such combination might lead to therapeutic

interaction or people may abandon one and move on to the

other. This may have an implication in chronic diseases condition

where the medicine has to be taken for a long time.

Sharing of medicines with neighbours and friends was a common

practice. Consumers did this by supplying medicines from those

stored at home from previous or current treatments. Whilst

sharing possessions and helping your neighbour was expected



by community members, it is not appropriate behaviour with

regard to medicines use. It may mean that individuals do not

get a full course of treatment, say for malaria or a sexually

transmitted infection, or they may receive below the therapeutic

dose for conditions like hypertension or epilepsy. This illustrates

lack of understanding of treatment regimens and may lead to

treatment failure and bacteria resistance in the case of the use

of antibacterials18; 4.

Consumers and sellers of medicines in the informal sector

believed that medicines have power to treat diseases and heal

the sick. However, because of the monetary value attached to

medicines, they treated medicines as objects of trade 19. Even

though medicines are treated in this manner all over the world,

it is not appropriate in the current setting because of poverty

and consumers make more than 80% out of pocket payment

for treatment. It was common in this study for consumers to

request for a “few tablets of….” and for sellers to offer a “few

tablets of antibiotics” for treatment of diseases. Trading in

medicines seemed to be seen as a means of making a living by

some medicine sellers. The study found that consumers wanted

to stay healthy - medicine was thought to be a tool to achieving

this and thus many people were trading in pharmaceuticals. 20; 19

In Tiko Sub-division, financial considerations seemed to have

played a key role in consumers’ access and use of medicines.

In Cameroon, consumers pay all costs including the costs

of medicines when they visit health facilities. The system of

user fees was introduced to decrease unnecessary demand

for health care services, raise additional funds for the health

system and improve efficiency, especially the availability of

essential medicines 21. Prior to the implementation of user fees

government pro-pharmacies always ran out of stock of essential

medicines22;23.

In public hospitals, essential medicines are sold in pro-

pharmacies and they are substantially cheaper when purchased

here than from other sources. However, consumers said that

they did not obtain medicines from the pro-pharmacies for

various reasons which included the fact that sometimes doctors

prescribed medicines that were not on the essential list and

therefore not stocked at the pro-pharmacy. So, this left them

with the option of having to obtain medicines either from a

range of informal traders or registered community pharmacies.

Both of these options posed problematic issues for the rational

use of medicines in this community.

Consumers reported that the medicines from the community

pharmacies were good quality but expensive. Van der Geest24

compared prices of medicines sold at the community pharmacies

with those sold at the government pro-pharmacies and found

that those sold through community pharmacies were about 400

times higher. This resulted in consumers asking pharmacists about

which medicines to buy from a list of prescribed medications. This

would result in patients not following the prescribed regimen.

This could have been different if pharmacists were stocking

generic medicines at affordable prices or consumers educated

to insist on generic medicines from community pharmacies. Pharmacies are challenged to provide cheaper generics where they can make generic substitution. Even though consumers should get quality medicines and advice from a community pharmacy this source is not accessible to many due to cost.

Many consumers said they visited medicine stores or hawkers as their first port of call because medicines from these places were cheaper than in community pharmacies. In addition they said medicine sellers were ‘more flexible’ and amenable to selling part of packets. The medicine store owners opened up packet of medicine and sold part of its content to the patient. Splitting a patient-ready pack of medicines is forbidden by law in Cameroon. The system is highly problematic, accounting for the problematic nature of medicine consumption by individual. More so, this practice of selling by the pill does not promote rational medicines use because most patients do not come back to complete their course of medicines. It was also reported that roadside sellers and kiosk owners put expired medicines into packets which had a valid date and sold them to unsuspecting consumers. Whilst selling of medicines by the pill could help alleviate immediate symptoms, it may not treat the underlying cause of the disease and in case of infectious disease; this might result in resistance to the microorganism 4.

Regulatory decisions about medicines are supposed to restrict the handling and use of medicines as a means of contributing to the safe and appropriate use of medicines but regulations are not enforced 25. More so, a comprehensive pharmaceutical policy for Cameroon detailing who does what and how is yet to be developed. This study found that consumers in Tiko Sub-division bought their medicines, in ascending order, from hawkers, street corners, medicine stores, pro-pharmacies and community pharmacies. Community pharmacies are the only officially licensed outlets to sell drugs to the public. Pro- pharmacies are to issue drugs to the sick who visit public hospitals. However, the illicit trade in pharmaceuticals is unbridled. The illicit trade in pharmaceuticals in the Cameroon and other African countries, Ghana and Nigeria, has been reported in other studies 20; 26; 14. The uncontrolled sale of medicines causes the circulation of poor quality medicines, compromising patient safety and rational use.

Consumers reported that medicines found in the various

medicine sales outlets were not of same quality. Poor quality

medicines were reported in the community medicine stores

and with hawkers. In community pharmacies, although the

medicines were of good quality, consumers reported, they were

expensive. In pro-pharmacies, the medicines were invariably out

of stock. It has been reported elsewhere that when medicines

were out of stock dispensers dispensed what they have in

stock 27. Sometimes they dispensed branded products when

international non-proprietary names (generic names) were

prescribed 28. Consequently, it is frequent in these settings that

dispensers and patients do not adhere to prescription regimens.

It was reported by male teachers that in Tiko Sub-division doctors

were few compared to population size and that some doctors

did not understand English or pidgin, which are the common



languages of community members. Holloway 25 suggested

that setting educational standards for health professionals and

developing and enforcing codes of conduct would improve

medicines use. Medicine use by community members is unlikely

to be appropriate if prescribers do not communicate adequately

with patients.

ConclusionSociocultural factors that affected consumers’ use of medicines

were found to relate to the perception that they needed

medicines to stay healthy and when they felt sick. The consumers

would also abandon their medicines when they felt they were

well again. As a result and because of their financial constraints

and the cost of medicines they adopted coping mechanisms

which included purchase of medicines in small quantities,

practiced polypharmacy/polytherapy, shared their medicines

with one another and also to self medicate with prescription

medicines. In conclusion consumers’ medicine purchasing were

greatly influenced by their financial constraints.

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11. World Health Organization (2010) Cameroon: Health profile. World Health Organisation, World Health Statistics. World Health Organisation. Last update 13 August 2010

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and Juroonisa (1996) Enhancing appropriate medicine use in the Karakoram Mountains. Community drug use studies. Amsterdam: Het Spinhuis; 1996

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14. Senah, K. A. (1994). ‘Blofa tshofa: Local perception of medicines in a Ghanaian coastal community.’ In: N. L Etkin and M. L Tan (eds), Medicines: Meanings and contexts. Quenzon City: HAIN: 83-101.

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16. Haafkens, J. (1997) Rituals of Silence: Long term tranquilizer use by women in The Netherlands. A social case study. Amsterdam: Het Spinhuis publishers 1997.

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18. Van der Geest, S., and Hardon, A. (1990) Self Medication in Developing Countries Journal of Social and Administrative Pharmacy. 7(4): 199-205

19. Van der Geest, S., and Whyte, S. R. (1991) ‘The charm of medicines: metaphors and metonyms.’ Medical Anthropology Quarterly 3(4): 345-367.

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Review Article

Assessing pharmacists’ impacts in primary health care: are we asking the right questions?Peri Joanne Ballantyne

Department of Sociology, Trent University, Peterborough, Ontario, Canada.

Address for Correspondence: Peri Joanne Ballantyne, Department of Sociology, Trent University, Peterborough, Ontario, Canada. E-mail: [email protected]

Citation: Ballantyne PJ. Assessing pharmacists’ impacts in primary health care: are we asking the right questions? Southern Med Review (2011) 4;1:17-21 doi:10.5655/smr.v4i1.76

AbstractIn some settings, steps are being taken to more fully integrate pharmacists in primary health care as a means of improving the public’s health and reducing drug-related iatrogenesis. Yet, evidence of improvement in health outcomes from pharmacists’ inputs is mixed; the diversity of research approaches and methodologies makes it difficult to reach an overall conclusion about it. A detailed review and analysis of two published articles using different methodological approaches to assess the role of community pharmacists in primary health care, but similarly reporting unfavourable findings regarding pharmacists’ impacts, is conducted. The Randomized Controlled Trials (RCT) design did not account for possible within-group differences in the delivery of the pharmacist intervention, and could not ascertain there were differences in pharmaceutical care received by intervention and control group heart failure patients. The RCT did not include an evaluation of pharmacists’ recommendations to physicians. The qualitative discourse analysis did not distinguish between patients’ response to pharmacists’ recommendations and the appropriateness of those recommendations. Researchers face two key challenges in demonstrating pharmacist impacts in primary care. The first is methodological – and relates to the need to identify, measure and evaluate the range and complexity of pharmacists’ work in conducting medication review and pharmaceutical care. The second relates to the differing levels of status and power of two key players in the field of medicines-related health care – the physician and pharmacist –a relationship whose contribution to ‘negative impact’ studies needs consideration. An appeal for ‘methodological creativity’ in pharmacist impact studies is made.

Keywords: pharmacist-impacts; pharmaceutical public health; methodology review; pharmacist-physician relationship

There are hundreds of individual pharmacist-impact studies

examining specific populations (i.e. elderly), specific disease

categories (i.e. asthma, hypertension) and various outcomes

(humanistic and quality of life, economic, clinical), and it is not

my intent to review these here. Published reviews of this literature

indicate that, given the variability in patient populations, disease

states, and pharmacists’ interventions included – and the varied

positive, neutral, and negative findings of individual studies, it

is difficult to reach an overall conclusion about the impact of

pharmacists’ health care provision on patient outcomes10-13.

Holland and colleagues11 provide a most strenuous argument for

the need to clarify what is known about pharmacists’ impacts

on the public’s health. In their review, Holland et al. examine

eight large studies of medication review in older populations.

They conclude that “the most successful interventions have

been delivered by small numbers of pharmacists working in

close liaison with primary care physicians, but that services…

set up at a distance from physicians, have either failed to

BackgroundGovernments in Canada, Britain and elsewhere are increasingly

recognizing the potential of a fuller integration of pharmacists

in primary health care as a means of improving the public’s

health and reducing drug-related iatrogenesis. For example,

the UK “Choosing Health through Pharmacy”1,2 initiative was

rolled out to enhance pharmaceutical-related public health

and the pharmacist’s role in it. In Ontario, Canada, in 2007

the Medscheck’3,4 program was piloted, initially providing cost-

free (government funded) pharmacist counselling to Ontarians

taking 3 or more medications for a chronic condition, and

expanded in 2010 to all residents of licensed long-term care

homes, all Ontarians living with diabetes, and to home-bound

persons not able to attend their community pharmacy for the

service. The growing recognition of pharmacy’s responsibility for

the publics’ uses of medicines is also reflected in pharmacists’

evolving role as prescribers – worldwide5; in Canada6,7 the UK8

and the US9.


Assessing pharmacists’ impacts in primary health care: are we asking the right questions?

deliver clear positive outcomes, or have potentially worsened

health outcomes” (p. 92). These authors question the logic of

the UK government investment of £40 million for community

pharmacist led services1, asserting:

…medication review, like drugs themselves, has the potential to

yield benefits, but may also cause harm. The [medication review]

intervention delivered by professionals not primarily responsible

for prescribing decisions should be considered in the same way

as other health technologies and be expected to adequately

demonstrate not just effectiveness, but also cost effectiveness

before being introduced more widely. At the moment, the jury is

still out on this newly promoted form of public health pharmacy

(pp. 92-93)11”.

I argue here that two key challenges confront researchers

seeking to clarify the impacts of pharmacist efforts in primary

care. The first is methodological – and relates to the requirement

that research studies identify, measure and evaluate the range

and complexity of pharmacists’ work in conducting medication

review and pharmaceutical care. The second relates to the

differing levels of status and power of the two key players in

the field of medicines-related health care – the physician and

pharmacist – a relationship whose contribution to ‘negative’ or

‘positive impact’ studies needs to be carefully examined.

In this article, I conduct a detailed critical analysis of two empirical

studies taking different methodological approaches to assessing

the role of community pharmacists in primary health care, but

similarly reporting ‘unfavourable findings’ regarding the role

of pharmacists in improving patient outcomes. I summarize

how pharmacists’ impacts were evaluated in each study; and

re-direct attention to the array of pharmacist activities – and

to pharmacist-physician relations that – had they been more

closely scrutinized in each study - might have led the authors to

different, potentially more positive, conclusionsi.

Reviewing how we analyze pharmacist-impacts: two illustrative casesThe two studies examined here include a randomized controlled

trial of the effectiveness of visits from community pharmacists

for patients with heart failure15; and a qualitative discourse

analysis of the advice giving role of the pharmacist during

consultations for medication review with patients aged 80 or

more16. In the following paragraphs, the key design features and

results of each study are examination and discussed in detail.

The Holland et al. randomized controlled trial (RCT)15, included

149 heart failure patients in a pharmacist-intervention group,

and 144 heart failure patient-controls who received ‘usual care’.

The authors’ recognition of the need for specialist personnel to

deliver education and self-management intervention to heart

failure patients; a shortage of specialist staff, and an abundance

and wide availability of community pharmacists motivated the

study.

The intervention involved two home visits by one of 17

community pharmacists within 2 and 8 weeks of patients’

discharge from hospital, and included numerous inputs:

intervention pharmacists educated patients about heart failure

and their medications; they gave basic exercise, dietary and

smoking cessation advice; they encouraged completion of

simple sign and symptom monitoring diary cards; they removed

discontinued medication. Intervention pharmacists were also

required to provide recommendations to the general practitioner

and the local pharmacist – regarding the need for medication

adherence aids15.

Intervention pharmacists had post-graduate qualifications

in pharmacy practice or recent professional development in

therapeutics. All intervention pharmacists had 7 contact training

hours including a lecture on heart failure, heart failure drugs,

exercise, diet and smoking cessation; more than half attended

two evening training events on communication skills (4 contact

hours); 14/17 intervention pharmacists received training in

medication review as part of previous trial (14 contact hours),

the other 3 received additional medication review training (1

day)15.

The primary outcome was total emergency admissions to hospital

at 6 months. The secondary outcomes included mortality;

quality of life, medication adherence; a heart failure self care

behaviour scale; and primary care activity. The authors reported

finding no significant differences in hospital admissions at six

months, quality of life, or mortality between the intervention-

group patients and heart failure patients who received ‘usual

care’15.

In this study, the authors’ aims to understand the impact

of pharmacists’ care on an extremely vulnerable patient

population is laudable. However, a vision of pharmacists’ care as

‘standardized’ and thus as suitable for a RCT is concerning, and

leads to a number of questions pertaining to the design of the

study and its findings. Here, I consider the following: a) was the

intervention different from ‘usual care’ provided to heart failure

patients?; b) in what ways are the study outcomes problematic?;

and c) what might an analysis of intervention pharmacists’

recommendations to patients and physicians have taught us

about the appropriateness of (requirement for) pharmacists care

of heart failure patients?

Question a) suggests a need to examine the standards of

practice in pharmacy, specifically, professional autonomy around

the delivery of ‘pharmaceutical care’. As with other professional

occupations, pharmacy practice involves the provision of

standardized and non-standardized services to members of

the public17. In this study, patients in the control-group may

have encountered pharmacists with similar qualifications to

the intervention group pharmacists; and ‘usual care’ for the

control group heart failure patients may have been very similar

to the care provided to intervention group patients. That is,

if good pharmacists deliver pharmaceutical care – a hallmark

of the claim to professional status, involving the pharmacist’s

i This analysis is an elaboration of an editorial addressing the same issue, published in the British Medical Journal in 200714



cooperation with the patient and other professionals in

implementing a therapeutic plan that addresses the individual

needs of the (heart failure) patient18 – then the ‘intervention’ in

the study may have been redundant.

Further, like other health professionals, pharmacists

have tremendous autonomy in their everyday delivery of

pharmaceutical care. This means that of the 17 pharmacists

who participated in the ‘intervention’, the quality and nature

of pharmaceutical care delivered to heart failure patients was

likely quite variableii. In this study, the impact of variation in the

‘intervention’ was not examined in a systematic way (it is not

a feature of the RCT), but it might have been. For example, it

was reported that 91% of patients received one or two visits

from [intervention] pharmacists15, but differences in outcomes

for intervention-group patients who received 1 rather than 2

visits were not assessed.

Thus, the potential lack of differentiation in pharmacy-related

services received by intervention- and control-group patients,

within-group variation [among intervention– but also among

control-group pharmacists], as well as the range and complexity

of intervention-pharmacists’ activities suggest the RCT may not

be the best methodology to assess the impacts of pharmacist-

delivered primary health care.

Question b) is related to the outcomes of the RCT which included

no statistically significant differences in hospital readmissions at

six months, quality of life, or mortality between intervention-

group patients and heart failure patients who received ‘usual

care’; and a 17% overall increase in primary care activity in the

intervention- as compared to the control-group15.

The reporting of global outcomes in this way (i.e. reporting

of differences between intervention and control groups, as is

standard in RCT studies) obscures an analysis of the processes

that led to the particular outcomes assessed. For example, it

could be interpreted that intervention pharmacists’ activities led

to necessary primary care – visits to doctors, medication reviews

– and sometimes to hospital admissions – and that these actions

may have reduced illness and possibly saved lives. Instead, the

global outcomes were interpreted as negative, based on an

assumption that a successful intervention would reduce heart

failure patients’ use of any health care resources.

An additional outcome measured in the study was medication

adherence, which was reported to be unusually high in both

intervention and control groupsiii. This finding, too, makes

plausible an interpretation that all heart failure patients received

similar pharmaceutical care from all pharmacists (intervention,

community or hospital pharmacists), or from other health care

professionals (physicians, nurses) encountered since their first

heart failure incident.

Question c) pertains to the limitation of the RCT methodology

to capture and evaluate details such as whether pharmacists’

recommendations to physicians were relevant, whether/to

what extent physicians responded to them; and the effects

of action/non-action on individual patient outcomes. In this

study, it is reported that pharmacists’ home visits to patients

with heart failure resulted in 384 recommendations to general

practitioners15. These recommendations were made despite the

very high levels of adherence mentioned previously - in other

words, the recommendations to doctors appear not to have

been motivated by patient medication non-adherence. Further,

the authors reported that only 51% of recommendations

were fully or partly enacted by general practitioners after the

pharmacists’ first patient home-visits, while no data were

provided as to whether second home-visit recommendations

were enacted by GPs15.

This aspect of the study highlights the differing levels of status

and power of the two key players in the field of medicines-

related health care – the physician and pharmacist – and the

uneven playing field in which pharmacists interact with patients.

The failure of physicians to follow up on a large proportion of

(potentially life saving) recommendations made by pharmacists

regarding seriously ill heart failure patients highlights both

the discretionary power of the physician as well as the lack

of respect shown to pharmacists by physicians (at least in this

particular study). Without a clear analysis of the consequences

of pharmacists’ recommendations – whether they were

appropriate, whether the physician heeded them, and what

particular effect was produced as a result of the pharmacist’s

recommendation - it seems premature to judge the impact of a

pharmacist-led intervention with heart failure patients.

In the second study, Salter et al., examined elderly patients’

responses to advice given by a pharmacist during medication

reviews. This is an important study that highlights the value of

using qualitative methods to examine the practice of medication

review, and to understand it from a patient-perspective. In

the article, the authors report that despite finding many

opportunities to offer advice, information and instruction,

the didactic, pharmacist-initiated and controlled encounter

was frequently resisted or rejected by elderly patients and

‘interactional difficulties’ with the pharmacist ensued16. Through

analysis of the discourse between pharmacist and patient, the

authors rightfully problematize the practice of medication

review, and raise questions related to the potential negative

impact of certain forms of interaction.

Salter et al. are emphatic about the negative impact of

pharmacists’ advice-giving – the major finding and the emphasis

of discussion in this article. The authors emphasize the potential

harm of (unsolicited) advice-giving on patients’ sense of

competence and self-governance, observing that pharmacists

ii The study authors also were interested in the delivery of the intervention by pharmacists. They recorded a selection of pharmacists’ visits to investigate the intervention’s delivery and the pharmacists’ communication skills (p. 2 of 7), reporting that each component of the intervention was delivered, and that pharmacists used good consultation styles (p. 6 of 7)15.iii In a recent review, it is estimated that general non-adherence is about 20-50%19; whereas Holland et al. report adherence levels at ~ 95% for both groups (using mean adherence scores), at baseline, at 3 months and 6 months15.



“provided advice, information or instruction on a constant

basis” (p.3 0f 6); and that almost no patient-initiated requests

for advice or information were observed16. They reported that

in resisting or rejecting pharmacists’ advice, “patients adopted

a variety of conversational strategies, including direct or indirect

challenges to the pharmacists’ authority and knowledge

boundaries” (p. 3 of 6)16. The authors reported that “one of

the strongest rebuttals to the pharmacists’ attempts to counsel

and give advice was patients’ use of the higher authority of the

doctor” (p. 4 of 6)16.

However, in this study there was a failure to recognize the

important distinction between patients’ unwillingness to

accept pharmacists’ advice from the appropriateness of that

advice itself. Its design did not include the identification and

classification of the specific drug-related problems identified

which would have enabled an assessment of the potential harm-

averted by the pharmacist’s advice. Further, the pharmacist’s

drug review and advice may have led patients to seek necessary

care that resulted in necessary attention …even if, in interaction

with the pharmacist, the advice remained unacknowledged or

was resisted or rejected.

At the least, the findings from this study, as with the previous

one, indicate that pharmacists uncovered numerous problems

regarding patients’ medicine regimes. That the patients were

uncomfortable with the (unsolicited) input from the pharmacist

doesn’t detract from that important conclusion.

ConclusionI have argued that two key challenges need to be addressed in

research designed to assess the effectiveness of the pharmacists’

provision of primary care. First is the limitations imposed

by a standardization method like the RCT used in a context

where professional services are not readily standardized. The

assessment of the ‘pharmacist-consultation-as-intervention’

does not provide any means of discerning the diverse ‘inputs’

of an individual pharmacist in consultation with an individual

patient. Hence, study findings of differences between patients

assigned to intervention and control groups in the trial run

the risk of internal invalidity…a failure to discern that within

an ‘intervention’, specific aspects of pharmacists’ work may

improve patient outcomes, while other aspects may alienate the

patient, or otherwise fail to impact his or her outcomes.

A second key challenge relates to the differing levels of status

and power of two key players in field of medicines-related health

care – the physician and the pharmacist – whose contribution

to outcome studies needs consideration. The importance

of this relationship was alluded to by Holland et al. in their

review of pharmacist-impact research, where it was observed

that successful interventions involved pharmacists working

closely with primary care physicians11. In my review here, I

have suggested how in future research, if study designs are

to distinguish the relevance of pharmacists’ recommendations

from patients’ and physicians’ responses to them, very different

conclusions about the impact of pharmacists’ involvement in

primary health care may be reached.

AcknowledgementsThis paper elaborates on an editorial by the author published in

the BMJ in 200714, and a presentation at the 15th International

Social Pharmacy Workshop, Queenstown, New Zealand, July,

2008.

References1. Reports. Choosing health through pharmacy implementation.

The Pharmacueutical Journal 278(7442). March 10 2007. p. 285.

2. Choosing health through pharmacy – a programme for pharmaceutical public health 2005 – 2015. UK Department of Health, 2005. www.dh.gov.uk/publications.

3. About MedsCheck, Ministry of Health and Long Term Care, Government of Ontario, Canada, Queen’s Printer for Ontario. http://www.health.gov.on.ca/en/public/programs/drugs/medscheck/medscheck_original.aspx; Accessed February 24, 2011.

4. Ministry of Health and Long Term Care, Government of Ontario, Canada. (2007). McGuinty Government Unveils New Health Care Service for Ontarians. Medscheck Offers Free, One-on-One Pharmacist Review of Clients’ Medication. http://www.hlth.gov.on.ca/medscheck_nr_05_20070416.pdf Accessed February 24, 2011.

5. Emmerton L, Marriott J, Bessell T, Nissen L, Dean L. Pharmacists and prescribing rights: review of international developments. J Pharm Pharmaceut Sci 2005; 8(2): 217-225.

6. Puxley C. (2008). Ontario Pharmacists Could Become the Latest in Canada to Prescribe Drugs. Canadian Press. http://redorbit.com/modules/news/tools.php?tool=print&id=1411450

7. Pearson GJ. (2007). Evolution in the practice of pharmacy – not a revolution! CMAJ 176(9): 1295-96. April 24, 2007.

8. Weiss MC & Sutton J. The changing nature of prescribing: pharmacists as prescribers and challenges to medical dominance. Soc Hlth Illness 2009, 31(3): 406-421.

9. Status of collaborative drug therapy management in the United States, March 2004. Am J Health Syst Pharm 2004;61:1609-10.

10. Pickard AS, Hung S-Y. An update on evidence of clinical pharmacy services’ impact on health-related quality of life. Ann Pharmacother 2006;40:1623-34.

11. Holland R, Smith R, Harvey I. Where now for pharmacist led medication review? J Epidemiol Community Health 2006; 60:92-93.

12. Van Wijk BLG. Effectiveness of interventions by community pharmacists to improve patient adherence to chronic medication: a systematic review. Ann Pharmacother 2005;39(2): 319-28.

13. Anderson C, Blenkinsopp A, Armstrong M. Feedback from community pharmacy users on the contribution of community pharmacy to improving the public’s health: a systematic review of the peer reviewed and non-peer reviewed literature 1990 – 2002. Health Expectations 2004; 7: 191-202.

14. Ballantyne P. (2007). The role of pharmacists in primary care. British Medical Journal (May 26) 334: 1066-1067. (Editorial).

15. Holland R, Brooksby I, Lenaghan E, Ashton K, Hay L, Smith R, et al. Effectiveness of visits from community pharmacists for



patients with heart failure: HeartMed randomised controlled trial. BMJ 2007; 334/ BMJ, doi:10.1136/bmj.39164.568183.AE (published 23 April 2007).

16. Salter C, Holland R, Harvey I, Henwood K. “I haven’t even phoned my doctor yet.” The advice giving role of the pharmacist during consultations for medication review with patients aged 80 or more: qualitative discourse analysis. BMJ 2007;334; 1098; BMJ, doi:10.1136/bmj.39164.568183.AE (published 23 April 2007).

17. Buerki RA and LD Vottero. The purposes of professions in society. In Pharmaceutical Care, CH Knowlton and RP Penna (eds). Pp. 3-17. Chapman and Hall, 1996.

18. Hepler, D.D., Strand, L.M. Opportunities and responsibilities in pharmaceutical care, Am J Pharm Ed, 1989, 53, 7S – 15S.

19. Kripalani, S., Yao, X., & Haynes, B. Interventions to enhance medication adherence in chronic medical conditions. Archives of Internal Medicine, 2007,167, 540-550.


Analysis

The selection of essential medicines in China: progress and the way forwardDifei Wang, Xinping Zhang

School of Health and Medical Management, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.

Address for Correspondence: Xinping Zhang. School of Medical and Health Management, Tongji Medical College of Huazhong University of Science and Technology, Wuhan City, Hubei Province. Peoples Republic of China. E-mail: [email protected]

Citation: Wang Wang D, Zhang X. The selection of essential medicines in China: progress and the way forward. Southern Med Review (2011) 4;1:22-28 doi:10.5655/smr.v4i1.71

AbstractObjective: The objective of this paper is to analyze the development of China’s national essential medicines list (NEML) from 1979 to 2010. These findings were then used as a basis to provide suggestions on how to improve essential medicines selection in China.

Methods: The literature search was conducted on the issues related to “essential medicines”, “China” and “national essential medicines lists”. The information on essential medicines principles, criteria and procedures was also reviewed. Literature review and key informants interview were also conducted. Key informants were interviewed mainly on how medicines are selected at central and provincial level and how medicine selection could be improved in China.

Results: In the past, China’s national essential medicines list has not been successful in promoting access to essential medicines. Reasons for this failure included biased selection and non evidence-based selection. Analysis of China’s essential medicines list and WHO’s generic essential medicines show that two lists varied substantially in disease coverage. The NEML failed to cover some diseases of public health significance in China such as cancers. The way medicines are classified and defined is also different between the two lists, e.g., medicines in the NEML are listed without defining the dose. There are differing levels in transparency, involvement, collaboration and accountability in the way the medicines are selected. Lastly, most of the provinces selected additional medicines to complement NEML. However, in 2009 version of Chinese essential medicines list, some improvements have been noted.

Conclusions: There has been significant improvement in China’s NEML. The latest NEML made progress by setting achievable targets, adopting balanced guidelines and updating principles and criteria. However, there is still need to increase evidence-based selection, reassess which diseases are in need to be covered and define medicines with dosage forms and doses. In selecting medicines, efforts should be made towards higher transparency, involvement, collaboration and accountability. Provincial selection should be improved by establishing relevant measures and receiving technical support from the national government.

Keywords: essential medicines, medicines list, selection, China

total income in public health facilities in 2009 was generated

by using and selling medicines5. The high medicine expenditure

was indeed attributable to irrational use of medicines and

prescriber’s preference of high price medicines over low price

genenics6. The use and access of medicines could be improved

by proper selection and implementation of a national essential

medicines list (NEML). In the latest health reform initiated in

2008, the government made a commitment to provide basic

health care, including essential medicines, to all by 20207.

This paper describes and identifies the progress and challenges

in the essential medicines selection from 1979 to 2010. We

compare the latest NEML to the WHO model list in terms of

IntroductionEssential medicines (EMs) are medicines that address the

priority health care needs of the population. They are selected

with regards to public health relevance, evidence on efficacy

and safety and comparative cost-effectiveness1. Establishing

a national essential medicines list (NEML) is a core element to

national pharmaceutical policy2,3.

As the largest developing country with the population of more

than 1.34 billion and medicines accounting for over 40% of

total health expenditure, promoting essential medicines use

in China is extremely important. China’s public health facilities

sell medicines for profit with a mark up of 15%4. Over 45% of


The selection of essential medicines in China

medicine inclusion criteria and selection procedures. We use

these as a basis to provide suggestions on how to improve

essential medicines selection in China.

MethodologyThe literature review was performed on published peer-

reviewed papers on essential medicines in China. The search was

performed in English and Chinese. We indentify publications

through PubMed for English written papers and the China

National Knowledge Infrastructure (CNKI) for Chinese written

papers. Our search terms includes: essential medicines, essential

drugs, medicine selection, essential medicines list and essential

drug list. One hundred and seventeen (117) English language

scientific articles and 771 Chinese articles were retrieved from

PubMed and CNKI respectively. We included research papers

which are relevant to essential medicines selection. Duplicated

Chinese papers, research within one area and information papers

were excluded. We performed Google online search for technical

documents published by international organizations such as

World Health Organization (WHO), World Bank, and Health

Action International (HAI). Key informants were interviewed on

how national and provincial essential medicines are selected and

how to improve the selection. We interviewed 17 informants

in both China and at WHO. These include 4 technical officers

in WHO (Essential Medicines and Policy Department in Geneva,

WHO Headquarters, Essential Medicines Unit in WHO/WPRO

and in WHO China country office).

We also interviewed 7 government officers in China whose work

was related to essential medicines selection. Out of 7, 3 worked

at Ministry of Health in Department of Essential Medicines

System, while 4 were from Unit of Pharmaceutical Policy in each

province. Six physicians and pharmacists were also interviewed

who have participated in the selection of national essential

medicines selection. The key questions asked from them were

(1) how essential medicines at national and provincial level are

selected and (2) how essential medicines selection in China

could be improved.

ResultsThe history of essential medicines in China

Following the resolution of World Health Assembly in 1978

which urged WHO member states to establish their own list of

EMs, the Chinese government introduced the concept in 19798.

An expert group to select medicines for the National Essential

Medicines List (NEML) was established by Chinese Ministry of

Health (MOH) and former State Food and Drug Administration

(SFDA). The first edition of NEML was produced in 1982 with

278 western medicines9. A committee which acted as overall

managing authority for the selection of NEML was assembled

in 1992. It included representative from the Ministry of Health

and three other government departments. In 1996, it issued

the first revised list which increased the number of medicines in

Table 1. Changes in NEML from 1982-2004

YearModern

medicinesTCMs Total medicines

1982 278 0 278

1996 699 1699 2398

1998 740 1333 2073

2000 770 1249 2019

2002 759 1242 2001

2004 773 1260 2033

the essential medicine list to 2398 medicines. The list contained

699 modern medicines and 1699 Traditional Chinese Medicines

(TCMs). From 1998 to 2004i, the NEML was revised every

two years. During this time the NEML served as a base for

the selection of social health insurance medicines lists9. From

2004 the NEML ceased updating until the latest NEML was

released in 2009ii. The changes of NEML from 1982 to 2004 are

summarized in Table 1.

A number of studies quoted that the NEML was not successful

in promoting the use of EMs and the accessibility of the

medicines10-12. The principle which stated that NEML should

include 40%-50% registered medicines was accountable for

the sharp expansion of the list13.

During this period, health providers’ preference of non EMs

and fierce competition in generics also pushed down the

volume and prices of EMs14. Manufactures and distributors were

therefore reluctant to produce medicines that were neither

preferred nor profitable15. Availability of EMs in China remained

low in both public and private sector. Many essential medicines

could not been found in many health facilities or drug stores

in both rural and urban areas16-18. Data from the WHO suggest

that the availability of EMs was below 20% in China which

is significantly lower than neighboring countries with similar

economic development level19.

Latest NEML and its selection

A new general idea for essential medicines was established in

2009. It reiterated that the national essential medicines system,

the overall supporting policy system for the promoting access

to EMs, should focus on “providing basic medicines to meet

people’s basic need”20. Under this, the latest NEML for grass

root health facilities was established in August 2009. National

formulary and clinical guidelines for EMs were established and

disseminated in Dec 2009 in order to guide use of EMs at grass

root level21. This edition of NEML contains 307 items, including

255 western medicines and 102 Traditional Chinese Medicines

(TCMs) as one item in NEML may include a series of medicines or

variation of one medicine. Western medicines are listed by their

generic names (or part of international non proprietary names

which indicate its main active chemical ingredients) and forms.

i China’s National Essential Medicines List 2004, http://archives.who.int/tbs/ChinesePharmaceuticalPolicy/BackgroundENGdefault.htmii China’s National Essential Medicines List 2009, http://www.moh.gov.cn/publicfiles/business/htmlfiles/mohywzc/s3580/200908/42506.htm



Table 2. Discrepancies between the WHO list and the NEML

ItemsThe WHO model list

16th editionNEML for grass root

level

Medicines 358 357

Western medicines 358 255

TCMs 0 102

Complementary medicines

Complementary list Provincial selection

Revising interval 2 years 3 years

Classification methodology

Anatomical Therapeutic Chemical Classification

Clinical Pharmacology Classification

Defined forms for western medicines

Yes Yes

Supporting documentsSTGs, formulary for essential medicines

National formulary and guidelines for EMs

Essential medicine list for children

Yes No

The overall managing authority called National Essential

Medicines Working Group decides the new principles and

criteria22. Medicines are listed on the basis that they should be

necessary for clinical use and disease prevention and should

be of high efficacy, safety and assured quality. They should be

convenient to use and rationally priced. The managing authority

reiterates that TCMs should be considered with same importance

as western medicines. Selecting principles and criteria apply

to both western medicines and TCMs. It also states that the

selection should “learn from international experience”22.

The Ministry of Health (MOH) is responsible for selection of

EMs for the latest NEML. The MOH has formed a committee

which consists of a pool of experts in the field of medicine,

pharmaceutical economics, pharmacy, health insurance, health

management and pricing. Experts are divided into a review group

and a consult group whose members are mutually exclusive. The

consult group evaluates medicines and proposes their opinions

on the medicines before forming candidate lists. The reviewing

group votes for the candidate lists and determines the draft list.

The draft list receives comments from government departments

before handing to managing authority for final approval23.

The WHO model list and the NEML

By comparing the WHO EM list and the NEML of China, we can

see some important differences. First, the quantity of included

western medicines varied substantially. As a result, the diseases

covered by the two lists are different. The WHO list has 358

western medicines which is 103 more than NEML. The WHO

list covers some important diseases such as cancers that the

NEML does not cover. The WHO list also covers more medicines

within some disease, e.g. there are more medicines for diabetes

in the WHO list than the NEML24. In the WHO list, medicines

are defined using doses and dosage forms. In the NEML

list medicines are only defined using dosage forms for both

western and TCMs. This influences the EMs manufacturing,

procurement and use. Second, medicine classification and

the definition of medicines varies between the two lists. The

Anatomical Therapeutic Chemical Classification (ATC-C) is used

in the WHO list to classify medicines while Clinical Pharmacology

Classification is used for western medicines in the NEML. This is

because the NEML may need to conform to other medicines

lists for social health insurance schemes. Third the WHO has

selected a complementary list which presents EMs for priority

diseases that need specialized diagnostic or monitoring facilities

and may have lower cost-effectiveness in some circumstances25.

The WHO has also selected two editions of essential medicines

for children. Even though a group of national representatives in

China urged the government to select essential medicines for

children26, no official response has been found for this appeal.

The NEML does not have complementary medicines; however,

provincial selection is allowed to add medicines to complement

NEML but must include every medicine in the NEML27. We

summarize discrepancies between the two lists in Table 2.

Discrepancies in selection

The different selection procedures of the WHO list and the

NEML could have an effect on end users. The WHO’s selection

criteria, used as a model for countries, emphasizes evidence

of medicines’ safety and efficacy, cost-effectiveness and total

cost of treatment, availability and stability of medicines and

high priority of single-compound medicines1. The NEML,

which is aimed at the needs of China, emphasizes similar

criteria of WHO’s selection with additional consideration given

to the medicines needed in grass root level, local availability,

affordability, priority diseases22.

Although it is important that China establishes its own list, the

list should be made in a way that is transparent, involves all

stakeholders and accountable to the population. The WHO

makes its list using a presenter from the expert committee who

is appointed to summarize data on comparative efficacy, safety

and cost-effectiveness. The recommendation is written by the

presenter and is sent to experts inside the WHO for review

and is posted on the WHO website for public comments. The

expert committee reviews all the information and makes final

selection recommendations28. In China, medicines are chosen

and the candidate list is made by a group of consultants. The

candidate list is sent to a review group whose members vote

for medicines in the candidate list. The draft list is built on the

result of voting29. Detailed information of selection procedures

is not revealed and information on the methods of selection is

not disclosed.

There are also differences in the number of experts and the

size of the selection committee. The expert advisory panels

and committees contain 781 experts of various areas (January

2006)30. When selecting the WHO list, 8-12 members are

chosen from expert committees for the selection of EMs, who

then make the selection decision for the WHO list28. The expert

pool for the NEML is substantially larger, containing over 3000



Table 3. Discrepancies in selection between the WHO list and the NEML.

Items WHO selection NEML selection

Unit for selection decision

WHO expert committee for EMs selection

Core members in selection pool

Number of expert committee for selection

8 to 12 Unknown

Number of expert pool 781 Over 3000

Involved technical organization

Cochrane, MSH, UNICEF, MSF, WCCs

Unknown

ProceduresDetailed procedures for processing applications and systematic review

General steps for selecting medicines and establishing the

professionals from various fields related to the selection within

China. The organization structures of two selections also have

substantial difference. The selection of the WHO list is an open

system, in which the work is performed by technical clusters

inside the WHO, WHO Cooperating Centers and external

organizations. The selection system also accepts suggestions

from the public and stakeholders for changes to the list31.

The NEML selection is completed by experts chosen from the

expert pool. Table 3 outlines discrepancies found in selection

procedures, arrangements and structures between the WHO list

and the NEML.

Provincial selection

The central government gave authority to provincial

governments to select additional medicines to complement the

NEML. These complementary medicines are from the national

basic health insurance and working injury medicines list, which

is the medicine reimbursement list for social health insurance

scheme. The reason the authority was given to the provinces is

to address local need. Provincial governments cannot remove

medicines already in the NEML. Provincial government can add

more medicines at provincial level and publish provincial list,

transfer the power of selection to municipal governments while

setting upper limit or range, or the provinces may opt not to

conduct provincial selection27. Up to the end of 2010, out of

31, 22 provinces had published their own lists, and of those,

17 provinces published provincial lists with additional western

medicines and TCMs. Shandong province and Anhui province

have published separate lists for urban and rural areas. In terms

of numbers of medicines selected, the provincial selection of the

17 provinces ranged between 76 and 381 medicines with an

average of 179.9. We summarize the provincial lists in Table 4.

Three of the provinces have set an upper limit or range of

additional medicines at provincial level and gave the authority of

selection to cities. In Guangxi, the provincial government allows

municipal governments to select 30% more medicines than the

NEML. In Hunan province, the provincial government authorizes

the municipal government to select 70-90 additional medicines.

Table 4. Quantity of additional medicines in provincial

lists

ProvincesNumber of selected

medicines

Selected Western

medicines

Selected TCMs

Hubei 118 113 5

Shandong* (rural areas) 210 142 68

Shandong* (urban areas) 206 143 63

Anhui* (rural areas) 172 120 52

Anhui* (urban areas) 114 77 37

Guangdong 244 120 124

Jiangsu 292 179 113

Jiangxi 76 75 1

Zhejiang 150 97 53

Yunnan 96 62 34

Sichuan 143 87 56

Chongqing*** 200 N.A N.A

Hebei 193 99 94

Fujian 148 99 49

Shanxi** 209 132 77

Tianjin 230 120 110

Shanghai 381 236 145

Qinghai 100 30 70**

Shanxi** 191 112 79

Average 179.9 112.6 70.0

* Shandong and Anhui publish separate lists for rural and areas. We calculate them by adding them and divide them by 2

**Two independent provinces with similar pronunciation ***Of the 70 medicines 40 are ethnic medicines

Most of the cities have selected 90 additional medicines.

Henan province authorizes the municipal government to select

200 additional medicines. Two provinces, both of which are

autonomous regions, have selected a considerable number

of ethnic medicines to complement the NEML. Tibet selected

340 Tibetan medicines while Inner Mongolia selected 122

Mongolian medicines.

Economic and technical influence on provincial selection

We allocated provinces to one of three categories according to

their level of Gross Domestic Product per capita. More developed

provinces included more medicines than less developed

provinces. The eight provinces that do not have complementary



Table 6. Difference in transparency and accountability in the selection of the WHO list and NEML

ItemsPublic accessibility to information

WHO selection NEML selection

Information on experts in expert pool Yes Yes but limited

Signed conflicts of interest by experts Yes No

Result of medicines review Yes No

Proper involvement of stake holders Yes Yes but limited

Accept public application to add or delete medicines

Yes No

Standard operating procedures for decision making

Yes Yes but limited

provincial selection fall in the medium developed area or least

developed area with the exception of Beijing. This may reflect

financial barriers. Table 5 illustrates economic influence on

provincial selection. Due to insufficient human resources, poor

and remote provinces may have difficulty in conducting the

evidence based selection process.

Discussion

Improving selection by comparing the model list and NEML

The WHO list is meant to be a model for countries to follow

but must be adapted in country to fit the needs of the

population32. However, many national lists tend to include

medicines that are not in the WHO list33. The nationally and

locally selected medicines which do not appear in WHO list

should be systematically evaluated to justify their inclusion in

the NEML. Special attention should be paid to those medicines

that were deleted from WHO list. Health policy makers must

analyze the disease burden and medicine expenditure before

deciding on medicines for the NEML. Another important step

to improve the list would be to include forms and dosage of

medicines. Defining the form(s) and dosage(s) has three obvious

advantages: 1) it is helpful on comparison among candidate

medicines; 2) it allows prescribers to prescribe accurately; and

3) it makes procurement and logistics more efficient. Because of

these reasons, in most national EM lists, medicines are defined

by both form and dosage. In the WHO list, the ratio of number

of dosage forms plus dose (F+D) divided by medicines number

is around 1.8. The ratio varies greatly in national lists; some

countries have a higher ratio while the other has a lower ratio34.

When updating the NEML, the F+D of medicines should be

defined. When defining forms and dose for medicines, attention

should be paid to medicines available on the market as EMs in

China tend to have much different medicines doses and forms

than other countries17-18.

Increasing transparency, involvement and accountability in selection

The selection in general should be transparent, involve

stakeholders and should be accountable to the population.

Transparency will help ensure that the selection is unbiased and

that the medicines included meet the needs of the population.

The selection process has improved, but there is still a need to

improve it further. The government should be more open about

how the evidence-based selection is conducted. Criteria for

selecting committee members, conflict of interests and standard

operating procedures should also be provided to make the board

more accountable. Opinion from the public, especially from

patients should be asked for and considered during the drafting of

the NEML list. Table 6 summarizes the difference in transparency

and accountability in the selection of the WHO list and the NEML.

Table 5. Quantity of additional medicines at provincial level

Most developed areas Medium developed areas Least developed areas

NameNumber of medicines



Shanghai 381 Shanxi* 191 Guangxi 93

Shandong 208* Hubei 118 Anhui 134*

Guangdong 244 Hunan 90 Jiangxi 76

Jiangsu 292 Henan 200 Yunnan 96

Zhejiang 150 Chongqing 200 Sichuan 143

Fujian 148 Hebei 193 Qinghai 100

Tianjin 230 Shanxi* 209

Average 236.1 Average 171.6 Average 107.0

*Shandong and Anhui publish separate lists for rural and urban areas. We calculate them by adding them and then dividing them by 2



Graph 1. Correlation of GDP per capita and number of additional medicines

the basic needs of medicines in China. To build a better selection

system, it is necessary to increase transparency, participation and

accountability in the selection process to ensure the selection

process is unbiased. The national government should assist and

cooperate with the provinces to make sure that they have the

financial resources and expertise to establish a list that meets

the needs of the people.

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12. Gu X. Governace reform in China’s essential medicines sysetm. Chinese Jounrnal of public administration. 2009(11). Available at: http://www.chinareform.org.cn/society/medical/Forward/201007/t20100709_33568.htm

13. Jiaqi X. To Meet the Basic Medicine Needs: From Perspective of the Changing Essential Medicines list. Beijing 2009 [cited 2010 12/11]; Available from: http://www.chinanews.com/jk/ylgg/news/2009/04-17/1651110.shtml.

14. Tang SL, Jing Sun, Gang Qu, Wen Chen. Pharmaceutical Policy in China: Issues and Problems. Available at http://archives.who.int/tbs/ChinesePharmaceuticalPolicy/English_Background_Documents/summarypapers/PPChinaIssuesProblemsShenglan.doc

15. Chen W, Tang S, Sun J, Ross-Degnan D, Wagner AK. Availability and Use of Essential Medicines in China: Manufacturing, Supply, and Prescribing in Shandong and Gansu provinces. BMC Health Serv Res. 2010;10:211.

16. Yang H, Dib HH, Zhu M, Qi G, Zhang X. Prices, Availability and Affordability of Essential Medicines in Rural Areas of Hubei Province, China. Health Policy Plan. 2010 May;25(3):219-29.

1500

13500

11500

9500

7500

5500

3500

GD

P pe

r ca

pita

(US$

)

Additional medcines selected at provincal level

50 100 150 200 250 300 350 400

Enhancing collaboration to maximize efficiency

The selection of NEML should fully utilize the results of evidence-

based selection completed by the WHO and its partners. Using

the evidence-based selection already completed by the WHO

would decrease the costs of making the NEML because it would

not have to do its own evidence evaluation. Within China, a

cooperative network could be assembled to fully utilize existing

resources and established facilities. Instead of the national and

provincial governments drawing up their lists independently,

they can do so cooperatively and merge some procedures which

could reduce costs of making the lists for both parties. The

MOH should provide technical support to provinces, especially

to undeveloped provinces which might not be able to carry out

evidence-based selection. Information on medicines selection

should be shared among the NEML selection and provincial

selection.

China covers a vast and diverse territory. Within the country,

different provinces have different disease profiles and social

development levels which lead to difference in selecting

provincial medicines lists. We summarize this in Graph 1. It is

also important to make sure that appropriate local medicines are

included because the provincial lists are used in health facilities.

Although the provinces can make their own lists, it is important

to examine why the number of medicines on the provincial list

varies. One consideration that needs to be made is that less

developed provinces may have higher need for EMs.

ConclusionThe latest NEML for health facilities in grass root level is

significantly improved over the past lists. The establishment

of China’s latest NEML has made great progress in setting

appropriate targets, selection principles and criteria. The

selection is more transparent and evidence-based than in the

previous years. With the updated selection process, promoting

NEML should be within national capacity and relevant to meet



17. Lu Y. A Survey of Medicine Prices, Availability and Affordability in Shanghai, China using the WHO/HAI Methodology: WHO/HAI2006. Available at: http://www.haiweb.org/medicineprices/surveys/200609CNS/survey_report.pdf

18. Qiang S. A Survey of Medicine Prices, Availability, Affordability and Price Components in Shandong Province, China: HAI2005. Available at http://www.haiweb.org/medicineprices/surveys/200411CN/survey_report.pdf

19. WHO. MDG Target 8.E: In Cooperation with Pharmaceutical Companies, Provide Access to Affordable Essential Drugs in Developing Countries. 2010 [cited 2010 11/10]; Available from: http://www.who.int/gho/mdg/medicines/situation_trends_availability/en/index.html.

20. China’s State’s council. CPC and state’s council’s opinions on health sector reform. Beijing;2009.

21. Ministy of Health, et al. National clinical guidelines and formulary for essential medicines list. Beijing: 2009.

22. Minstry of Health, et al. Notice on publishing managing measures(temporary) for national essential medicines list. Beijing: 2009.

23 Zheng H. Press conference of Ministry of Health on establishing nationl essential medicines system: how national essential medicines list is selected. Beijing: 2009. Available at: http://www.china.com.cn/zhibo/2009-08/20/content_18365751.htm

24. Wang L, Zhang C, Yuan Q, Zhang LL, Li YP. A comparsion between WHO essential medicines list and China’s national essential medicines list. China’s Journal of evidence-based medicine. 2009, 9(11): 1173 1184. Available at: http://www.healthpolicy.cn/rdfx/jbywzd/gjjy2/who/yjwx/201002/P020100311037204598531.pdf

25. World Health Organization. The selection and use of essential medicines : report of the WHO Expert Committee, 2003 (including the 13th Model list of essential medicines. Geneva: World Health Organization; 2004.

26. Li Z. Experts urge to add essential medicines for children. Nanfang Daily. Guagnzhou; 7/15/2010.

27. Minstry of Health, et al. Opinions on establishing essential medicines system. Beijing: 2009. Available at: http://www.moh.gov.cn/publicfiles/business/htmlfiles/mohywzc/s3581/200908/42498.htm

28. World Health Orgnization. Revised procedure for updating WHO’s Model List of Essential Drugs. EB109/8;2001.

29. Zheng H. The participation of thousands experts ensure appropriate selection for essential medicines. Interview on director of national pharamceutical policy and essential medicines, Ministry of Health. Beijing: 2009. Available at: http://news.xinhuanet.com/video/2009-08/21/content_11923014.htm

30. WHO. The expert advisory panel and committees. Geneva: World Health orgnization, 2006.

31. Kishore SP, Herbstman, BJ. Adding a medicine to the WHO model list of essential medicines. Clin Pharmacol Ther. 2009 Feb85(23):237-9.

32. Azizkhon Jafarov. Selection of Essential Medicines in Central Asian Republics. Comparsion and discrepancies. 2002 May. Available at http://dcc2.bumc.bu.edu/richard l/RPM+_project/aziz.htm

33. Jean Claude Mugiraneza. Is the World Health Organization Model List of Essential Drugs Relevant to Member States? National Essential Drugs Lists of Selected African Countries in Comparative Perspective. Buffalo, NY: 2009. Available at: http://apps.who.int/medicinedocs/en/m/abstract/Js16786e/

34. Laing R, Waning B, Gray A, Ford N, t Hoen E. 25 years of the WHO essential medicines lists: progress and challenges. Lancet. 2003 May 17;361(9370):1723-9.


Research Article

Afghanistan pharmaceutical sector development: problems and prospectsJonathan Harper1, Gunnar Strote2

1 Independent International Pharmaceutical Policy & Regulation Consultant, Budapest Hungary2 GFA Consulting Group, Hamburg Germany

Address for Correspondence: Jonathan Harper, Dunasétány 7, Budakalász 2011 Hungary. E-mail: [email protected]

Citation: Harper J, Strote J. Afghanistan pharmaceutical sector development: problems and prospects. Southern Med Review (2011) 4;1:29-39doi:10.5655/smr.v4i1.75

AbstractObjective: To provide an up to date comprehensive overview of the Afghanistan pharmaceutical sector situation and its future

development needs and priorities.

Methods: The methods employed for researching and writing this paper were based on (i) structured interviews and workshop with

Afghanistan pharmaceutical sector stakeholders, (ii) site visits, (iii) sector data review of relevant reports and documents, and (iv) use of

sector assessment tool methodology. A full review of sector policy, regulation and management was conducted covering the complete

pharmaceutical supply chain.

Results: The International Donor Community (IDC) in recent years has provided major assistance for the development of the

Afghanistan health sector with some tangible successes. However, for several reasons the Afghanistan pharmaceutical sub sector

suffers from major deficiencies in terms of implementation of policy, regulation and management. There are significant governance,

structural and capacity weaknesses at both the central and provincial level. The consequence of this has been a pharmaceutical market

and supply system contaminated with substandard, falsified, counterfeit and diverted medicines. The accessibility, affordability and

availability of medicines are highly variable across the country.

Conclusions: Reports on the Afghanistan pharmaceutical sector have hitherto been scarce in the international literature and the

quality and availability of sector data is generally low. The sector for several reasons is one of the least developed in the world, operates

in a chaotic faction and suffers from many weaknesses that cover the entire spectrum of sector activities. The market presence of

substandard and counterfeit medicines is likely to be significant and should be considered a public health menace demanding urgent

attention. A number of sector development interventions are required to address both institutional and market weaknesses.

Keywords: Medicines policy, medicines regulation, medicines pricing, counterfeit medicines, pharmaceutical situation; Afghanistan.

Health Organization (WHO) in 2002, and highlighted severe

infrastructural damage, lack and low quality of essential

medicines, widespread irrational medicines usage and reliance

on medicines donations by the international community9.

The WHO classifies Afghanistan as belonging to a group of

countries (including Iraq, Palestine, Sudan, and Somalia) that

have ongoing emergency situations and that require emergency

supply of medicines with as much quality control as possible.

These countries require major assistance for pharmaceutical

sector strengthening and provision of adequate pharmaceutical

public health.

The Afghanistan pharmaceutical sector is currently, and for

the foreseeable future, managed and publicly financed via

a dual administrative system: (i) the General Directorate for

IntroductionGeneral background

The Islamic Republic of Afghanistan is a landlocked central

Asian country consisting of 34 provinces and with a population

of approximately 28 million. It is classified by the UN as a Least

Developed Country (LDC), is in a state of ongoing conflict and

can be described as both a fragile1 and failed state2. The poor

health, socioeconomic and governance status of Afghanistan

is summarised by a number of indicators presented in Table 1.

Pharmaceutical sector background

The first Afghanistan pharmaceutical sector assessment after

the fall of the Taliban regime was conducted by the World


Afghanistan pharmaceutical sector development: problems and prospects

Table 1. Afghanistan Governance, Socioeconomic and Health Indicators

Indicator Value Year

Failed State Index (rank out of 177)2 6 2010

Corruption perceptions index (rank out of 178)3 176 = 2010

Human Development Index rank4 (rank out of 169) 155 2010

Gross national income (PPP $US per capita)5 1,100 2008

% population living on < 1 $US / day (national poverty line)6 42 2009

Crude birth rate (per 1,000)5 47 2008

Crude death rate (per 1,000)5 20 2008

Life expectancy at birth (total years)7 42 2008

Under-5 mortality rate (per 1,000 live births)7 257 2008

Maternal mortality rate (per 1,000 live births) 7 14 2008

Adult mortality rate (per 1,000)7 479 2008

Health system performance rank8 168 2004

Total health expenditure (as % of GDP)7 7.3 2008

Public health expenditure per capita ($US)7 10 2008

Total health expenditure per capita ($US) 7 48 2008

Health expenditure, public (% of total public expenditure)5 3.7 2008

Health expenditure, public (% of total health expenditure)7 21.2 2008

Total pharmaceutical expenditure (as % of total health expenditure)8 15 2004

Note: PPP = Purchasing Power Parity

Pharmaceutical Affairs (GDPA), a directorate of the Ministry

of Public Health (MoPH), which also oversees sector provincial

management via a system of Provincial Pharmacy Officers (PPOs)

located in Provincial Public Health Departments (PPHDs); and

(ii) the International Donor Community (IDC), principally the

World Bank, US Agency for International Development (USAID)

and European Commission (EC), which finances and oversees

the provision of medicines supplied via the Basic Package of

Health Services (BPHS) by International Donor Community (IDC)

contracted Non-Governmental Organisations (NGOs).

The corner stone of Afghanistan health and pharmaceutical

sector development since 2003 has been the implementation

of a BPHS10 which includes a defined set of cost-effective

interventions aimed at addressing the principal health problems

of the population, with an emphasis on the most vulnerable

groups, women and children, but with provisions made for

the eventual incorporation of interventions targeting other

vulnerable groups. More recently in 2005, the Essential Package

of Hospital Services (EPHS) has been created in an attempt to

develop a functional referral system for more severe cases of

disease11.

Since 2002 there has been a significant increase in the quantity

of both donated and privately imported medicines entering

Afghanistan following the involvement of the international

community in this country’s health sector. The profile of the

Afghanistan pharmaceutical market can only be described in

general terms as there is a lack of accurate collected data12;

and where such data has been collected it is largely done on

an ad hoc and non-repeated basis. For example, only one

comprehensive baseline pharmaceutical sector indicator

study, designed in accordance with WHO recommended

Afghanistan Stakeholders International Donor Community (IDC) Stakeholders

1 Deputy Minister, Ministry of Public Health (MoPH) 1 Task Manager Health and Disability Sector, Delegation of the European Commission (EC)

2 Director, General Directorate for Pharmaceutical Affairs (GDPA) 2 Project Manager, EC Afghanistan Provincial Public Health Project

3 Senior Officer, Essential Drug Department GDPA 3 Team Leader, EC Support for Institutional Development of the Afghanistan MoPH Project

4 Director, National Medicines Quality Control Laboratory Kabul 4 Health, Population and Nutrition Officer, US Agency for International Development (USAID)

5 Director, MoPH Central Medical Stores Kabul 5Project Manager, USAID Techserve / Strengthening Pharmaceutical Systems Afghanistan program

6 Dean, Kabul University Pharmacy Faculty 6 Afghanistan Public Health Specialist, World Bank

7 MoPH Technical Advisory Board for Pharmaceutical Affairs (TAB) 7 HIV/AIDS Adviser, World Bank Afghanistan HIV/AIDS Control Program

8 General Director, Avicenna Pharmaceutical Industry Kabul 8 Project Manager, Johns Hopkins University Afghanistan MoPH Support Project

9 Local Pharmacies (N = 10) 9 Health Cooperation Planning Officer, Japan International Cooperation Agency (JICA)

10 Local Health Facilities (N = 3) 10 Medical Officer, WHO Representative Office Kabul

11 Afghan BPHS NGOs (N = 3) 11Team Leader, Afghanistan Blood Transfusion and Diagnostic Facility Project, French Development Agency

12 International BPHS NGOs (N = 2)

Table 2. Afghanistan Pharmaceutical Sector Key Stakeholders Interviewed



Title Theme

1 Baghdadi G, Chomilier C, Graaff P. Pharmaceutical Situation in Afghanistan. WHO Preliminary Assessment (14-23 January 2002) Sector Assessment

2Mansoor, B, Najib, Mohd. Baseline Drug Indicator Study, A comparative Cross-Sectional Study in SCA Health Facilities in Afghanistan, Part II Results and Next Steps. Swedish Committee for Afghanistan (2003)

Sector Assessment

3 Afghanistan Private Pharmacies Survey. Management Sciences for Health (August 2004) Sector Assessment

4 Understanding markets in Afghanistan: A study of the market for pharmaceuticals. Afghanistan Research and Evaluation Unit (December 2005) Sector Assessment

5 2006 Afghanistan Health Survey. Ministry of Public Health, Islamic Republic of Afghanistan (2006) Sector Assessment

6 2007 Afghanistan National Health Services Performance Assessment. Johns Hopkins University (2007) Sector Assessment

7 Afghanistan National Medicines Policy (2003) Policy

8 Drug donation guidelines. HealthCare and Promotion Department, Ministry of Public Health, Islamic Republic of Afghanistan (2003) Policy

9 International Donor Community Afghanistan Health Sector Strategic Planning Retreat Report (October 2007) Policy

10Afghanistan Donor health sector review: ‘Building on early gains: the role and structure of government in further strengthening Afghanistan’s health sector’ (October 2007)

Policy

11 Draft Terms of Reference for General Directorate of Pharmaceutical Affairs (2007) Policy

12 Afghanistan National Essential Drug List (December 2007) Policy

13Provincial Pharmacy Officer Job Description. General Directorate for Pharmaceutical Affairs Ministry of Public Health, Islamic Republic of Afghanistan (2007)

Policy

14Afghanistan Health and Nutrition Sector Strategy (HNSS) 2008-2013. Ministry of Public Health; Ministry of Agriculture, Irrigation & Livestock Ministry of Public Health, Islamic Republic of Afghanistan (2008)

Policy

15 Workshop Report for Pooled Procurement of Essential Drugs. Management Sciences for Health (July 2003) Medicines Supply

16 Inventory of drugs available in Kabul. Ministry of Public Health, Islamic Republic of Afghanistan (2004) Medicines Supply

17Procurement Procedure of Goods, Services, Medicine-Medical Items for the Procurement Department of Ministry of Public Health. Oxford Policy Management (February 2005)

Medicines Supply

18Concept Paper for the General Directorate of Planning & Procurement, Ministry of Public Health; Procurement Reform in the Ministry of Public Health, Afghanistan, JICA (February 2006)

Medicines Supply

19Assessment of the Pharmaceutical Logistics Management Capacity of REACH Grantee NGOs - Rural Expansion of Afghanistan’s Community-based Healthcare Program (MSH / REACH, USAID), (July 2006)

Medicines Supply

20MIAR (Monthly Integrated Activity Report) – Facilities with at least 1 stock out by province. Ministry of Public Health, Islamic Republic of Afghanistan (March 2006-March 2007)

Medicines Supply

21 Strengthening Logistics System in Urban Kabul Project. JICA (August 2007) Medicines Supply

22 Terms of Reference for EC NGO BPHS Contractors concerning drug provision (2007) Medicines Supply

23Coordinated Procurement and Distribution System (CPDS) Governance Framework. General Directorate of Pharmaceutical Affairs Ministry of Public Health, Islamic Republic of Afghanistan (March 2010)

Medicines Supply

24 Drug Quality Assessment Study Afghanistan 2007. Ministry of Public Health Islamic Republic of Afghanistan (2007) Regulation

25National Licensed Drugs List. General Directorate of Pharmaceutical Affairs, Ministry of Public Health, Islamic Republic of Afghanistan; Essential Drug Department, Avicenna Pharmaceutical Institute (December 2007)

Regulation

26Procedure for application for inclusion of medicines on the essential drugs list of the Ministry of Public Health of Afghanistan. General Directorate of Pharmaceutical Affairs, Ministry of Public Health, Islamic Republic of Afghanistan; Essential Drug Department, Avicenna Pharmaceutical Institute (2007)

Regulation

27Procedure for application for inclusion of medicines on the essential drugs list of the Ministry of Public Health of Afghanistan. . General Directorate of Pharmaceutical Affairs, Ministry of Public Health, Islamic Republic of Afghanistan; Essential Drug Department, Avicenna Pharmaceutical Institute (2007)

Regulation

28Procedure for application for inclusion of medicines on the licensed drugs list of the Ministry of Public Health of Afghanistan. . General Directorate of Pharmaceutical Affairs, Ministry of Public Health, Islamic Republic of Afghanistan; Essential Drug Department, Avicenna Pharmaceutical Institute (2007)

Regulation

29 Afghanistan National Medicines Law (2006) Legislation

30 Regulation on ‘import and production of medicines and medical devices’ (2005) Legislation

31 Regulation on ‘pharmacies’ (2006) Legislation

Table 3. Principal Documents and Reports Reviewed



Table 4. Afghanistan Pharmaceutical Sector Functional Analysis Scheme (adapted from WHO National Medicines Policy scheme)14

Policy Objectives Responsible Organisation

Access QualityRational

Use

Policy Components:

Selection of essential medicines

X (X) X 1

Affordability X (X) 1

Financing X 1

Supply systems X X (X) 1,2,3

Regulation and quality assurance

X X 2,3

Rational use X 1,3

Research X X X 1

Human resources X X X 1

Monitoring and evaluation X X X 1,2,3

Stakeholder coordination X X X 1,2

Policy Output Indicators:

Public health medicines needs met

Pharmaceutical market efficiency & effectiveness

Notes X = direct link and (X) = indirect link between policy components and policy objectivesResponsible organisation (in a model country): 1 = Ministry of Public Health (MoPH) Pharmaceutical Policy Department, 2 = National Medicines Regulatory Authority (NMRA), 3 = Provincial pharmaceutical management system

methodology13, has been conducted in recent years; in 2003

by the Swedish Committee for Afghanistan14. Other sector data

and reports, where they exist, tend to be focused on specific

sub sectors (particularly medicines procurement and distribution

which is perhaps justifiable given the health sector priority of

BPHS implementation) thus several sector knowledge gaps exist.

In this context, the objectives of this paper are to provide (i)

a descriptive comprehensive overview of the pharmaceutical

sector situation in Afghanistan, and identify (ii) future sector

development needs and intervention priorities.

MethodologyThe following methods were used to collect the data for this

project. These methods are also discussed in a 2007-08 report

by the author (JH) to the European Commission12.

Structured interviews and workshop with Afghanistan

pharmaceutical sector stakeholders

Table 2 lists the various stakeholders interviewed. Following

interviews, a workshop was conducted with all stakeholders to

present the initial review findings and to obtain feedback and

further clarifying information so as to assist completion of the

review.

Sector data review

A thorough review, listed in Table 3, of (a) all local available

relevant health and pharmaceutical sector documents

and reports (particularly from the MoPH and IDC), and (b)

regional and international pharmaceutical sector reports and

publications was conducted so as to inform the analysis and

recommendations made by the EC Identification Mission.

Use of sector assessment tool methodology

Assessment was carried out based on available WHO sector

assessment tools13, 15 according to the scheme illustrated in

Table 4, and which is adapted by the authors from the WHO

National Medicines Policy (NMP) scheme16 which matches NMP

components against the NMP objectives of medicines access,

quality and rational use.

Apart from the above, in order to obtain a ‘grass roots’

feeling of the Afghanistan pharmaceutical sector situation, a

number of facility visits were conducted to public and private

health facilities, pharmacies, distributors, local pharmaceutical

manufacturers, medical stores and medicines quality control

facilities. Following the above steps, a full review and analysis of

Afghanistan pharmaceutical sector policy and its implementation

was conducted, covering sector administration, management,

regulation, financing and pricing, supply system and market

characteristics.

Results and discussionA summary of key findings is presented in Table 5 in accordance

with the sector overview scheme presented in the results and

discussion section. Results are discussed under each sector area

heading.

Medicines Supply and Market Profile

Afghanistan has a dual public and private sector medicines supply

system. The public system concerns the provision (procurement,

import, storage, distribution and dispensing) of the Basic and

Essential Packages of Health Services by the Ministry of Public

Health and the International Donor Community, principally

the World Bank, USAID and EC who have divided geographic

management responsibility of the 34 Afghan provinces

between them and contracted national and international Non

Governmental Organisations to implement medicines supply.

The number of participants in the private supply system is

larger at every point in the supply chain compared to other

economic sectors in Afghanistan. There is an oversupply of

importers (~200 licensed), distributors (~ 200 known licensed

and unlicensed) and pharmacies (~13,000 known licensed and

unlicensed), as well as many grocery stores and street vendors



Table 5. Summary of Sector Key Findings

1. Medicines Supply and Market Profile

• Dual public and private sector medicines supply system

• Public sector BPHS/EPHS scheme jointly operated by Afghan MoPH and IDC and implemented by NGOs

• Private supply system extremely complex, chaotic, inflated and under regulated

• Weak availability of market data

• Illegal imports likely to account for >50% of the total pharmaceutical market

2. Medicines Policy and Legislation

• International standard NMP in place since 2003 but relatively few of its provisions implemented

• Legislative gaps and inconsistencies exist in comparison to model national medicines legislation

• Provisions for inspection, enforcement and sanctions are weak

3. Sector Administration and Management

• Sector command versus market economy management conflict

• MoPH GDPA undergoing continuous restructuring

• Weak decentralised sector management

• Sector professional human resource shortfall

• Weak sector stakeholder national and international coordination

4. Informing Policy – Sector Monitoring and Evaluation (M&E)

• Pharmaceutical sector M&E system is very limited

• Existing M&E system oriented toward medicines inventory management

5. Medicines Regulation

• Prescriptive and rigid medicines registration system

• All batch imports are required to be tested

• National MQCL is dilapidated, not internationally accredited and suffers from serious resource and operational deficiencies

• Rigid batch import control system leads to supply delay, diversion and wastage

• No pharmacovigilance system in place

6. Medicines Financing, Reimbursement and Pricing

• Weak central medicines accounting and budgeting system

• 70% of medicines needs are provided via the private sector with the balance by the BPHS/EPHS scheme (although the latter provides a greater proportion of essential medicines compared to the private sector)

• Large provincial variations in medicines availability and per capita BPHS medicines expenditure

• No health insurance or patient co-payment system is planned

• Lack of enforcement of medicines price margins and an unofficial retail external reference price system exists with medicines from Pakistan and Iran

7. Rational Medicines Usage

• Irrational medicines usage widespread

• Weak availability of objective medicines information and implementation of NMP RMU provisions

8. Local Pharmaceutical Industry Development and Trade Policy

• Pre-existing local production based severely damaged but beginning to re emerge

• Basis exists for production and export of herbal ingredients

Table 6. Observed Deficiencies in the Afghanistan Pharmacy Sector

• Many pharmacies are unlicensed;

• Many pharmacies operate without a qualified pharmacist or even a pharmacy technician on site (one study showed that only 14% of dispensers are qualified pharmacists18);

• Drugs are often sold as unpacked blisters (with no patient information leaflet), often they are expired;

• Prescription only medicines are sold without prescription and often directly to children;

• Rules on pharmacy physical conditions and coverage are frequently not observed (e.g. very often pharmacies are clustered together in central urban locations and there is a limited number of pharmacies in rural districts);

• Pharmacies frequently do not stock the full range of essential drugs;

• Pharmacy inspection is uncommon and haphazard and where it occurs it is conducted by a variety of inspectors from different authorities and not according to any particular inspection protocol);

• There is no evidence of any enforcement (no reported cases exist of pharmacies being closed for infringement of regulatory requirements).

that retail medicines. Many of these enterprises are unlicensed

and thus are a major component of the large illegitimate supply

chain.

The Ministry of Public Health (MoPH ) is responsible for assuring

good medicines warehousing and storage for both the public

and private sector. However, except in the case of a few

international donors, existing medicines storage conditions do

not meet international standards. Distributors are licensed by

the MoPH and a qualified person is a licensing requirement, but

the extent to which this enforced is not clear. Good Distribution

Practice Guidelines (GDP) 17 do not exist and thus are not applied

in country. The MoPH has a regulation on pharmacy supervision,

but despite adequate legal provisions many deficiencies exist

with respect to the operation of pharmacies and these are

summarised in Table 6.

The Afghanistan medicines supply system is seriously under-

regulated with weak provincial management leading to a

chaotic supply situation. Afghanistan is not alone in having a

lack of medicines supply chain oversight as in many countries

Good Manufacturing Practices (GMP) inspection receives

more attention and resources than inspection of distribution

channels19. Medicines importation control is a difficult business

in view of the extensive porous borders Afghanistan has with

neighbouring countries. Ensuring the quality and provenance of

medicines, in accordance with standards established by WHO/

GDP17, is also problematic but a task that should be considered

to be a regulatory priority. Thus there is a need to strengthen

supply chain oversight through providing appropriate legal

provisions, inspection, enforcement and sanctions and adoption

of Good Governance for Medicines (GGM) practices20. Despite

supply chain chaos, complexity and oversight weaknesses,

there has been some success with the IDC-supported BPHS/

EPHS programme for essential medicines provision since its

implementation in 2003, and recent efforts have been made



to establish a BPHS/EPHS coordination mechanism via the

Governance Framework on Coordinated Procurement and

Distribution System (CPDS)21.

In the absence of accurate data, it estimated that (i) the private

sector accounts for 70% of the total pharmaceutical market (of

which 95% consists of imported medicines from many sources in

the region), and (ii) 30% of the market consists of international

drug donations which are provided largely through the BPHS/

EPHS essential medicines scheme, the balance provided through

international humanitarian pharmaceutical assistance12, 22. Illegal

imports, which can also contaminate the legitimate supply

chain, probably account for greater than 50% of the total

pharmaceutical market12, 22; a major contributory factor that

Afghanistan has lengthy porous borders, particularly the borders

with Pakistan and Iran. The MoPH estimates that the number of

unregistered far exceeds registered medicines on the market12.

Although identification of substandard and counterfeit

medicines in the Afghanistan market is a straight forward task

and cases can readily be identified12, for a number of reasons

the estimation of the prevalence of substandard, counterfeit

(falsified), adulterated and diverted medicines in Afghanistan is

extremely difficult. Difficulties in estimating prevalence are due

to weak Post Market Surveillance (PMS), a chaotic and complex

supply chain and an absence of clear and internationally

harmonised definitions of counterfeit and substandard

medicines.

One recent study23 was conducted in Afghanistan to examine

medicines quality and which concluded that medicines provided

publicly by the IDC through the BPHS were generally of an

acceptable standard; however the sample size from the private

sector was too small to draw any conclusions concerning

private sector substandard medicine prevalence. Given the

estimated high proportion of illegal imports a high prevalence

of substandard (and counterfeit) medicines cannot be ruled

out and PMS efforts need to be enhanced. The Afghan conflict

situation is likely to provide fertile ground for pharmaceutical

crime activity, particularly given the close association between

organised crime and medicines counterfeiting24. Counterfeiting

is also perhaps a disincentive for research-based and branded

medicines manufacturers to register their products in

Afghanistan.

In 2010, the WHO conducted a questionnaire-based survey of

several EMROi and SADCii countries25, including Afghanistan,

with the objective of reviewing the counterfeit medicine

situation so as to provide a more informed basis for developing

and implementing counterfeit medicine policy and action.

Conclusions applicable to most countries surveyed, including

Afghanistan, were a need for (i) specific legislation that

empowers National Medicines Regulatory Authorities (NMRAs)

and criminalises medicines counterfeiting, (ii) strengthened

cooperation and information-sharing among the various

key players at national, regional and global levels, and (iii)

strengthened weak market control systems. Thus, in order

to tackle the problem in Afghanistan a number of actions

are required, several of which will require IDC assistance for

implementation.

Medicines Policy and Legislation

Afghanistan is in possession of a National Medicines Policy (NMP) dating from 2003 and which has been designed in accordance with the WHO national medicines policy model scheme and guidelines16. Aside from the creation of an Essential Medicines List (EML), last updated in 2007, and the supply of essential medicines via the BPHS/EPHS, other NMP provisions (e.g. rational medicines usage policies) are underrepresented in the MoPH pharmaceutical sector management programme, the latter effectively being the NMP implementation plan26. While medicines supply management is an important policy area and which hitherto has been seen as a priority area in view of the emphasis on BPHS implementation, other areas of NMP equally deserve and require attention for implementation.

The sector legislative and regulatory framework is provided by a framework Medicines Law (2006) and Regulations covering local manufacturing, import, procurement, distribution and retail. The Afghanistan Medicines Law omits several regulatory areas that would normally be included in a model national medicines law and includes a number of areas that normally would not be included12. For example, the law makes no provision for medicines intellectual property issues (IPR) issues, i.e. patent and brand name protection, data exclusivity and issues relating to Trade Related Intellectual Property Rights (TRIPS) flexibilities. Provisions for implementation and enforcement of the law and sanctions for violations are weak. There is scope to align the existing medicines legislation in accordance with regional and international standards and practices and to introduce stronger provisions concerning implementation, enforcement and sanctions.

Sector Administration and Management

Health sector stewardship is defined by the WHO as being one

of the four essential functions of the health system in addition

to service provision, resource generation and financing27, 28. The

Ministry of Public Health General Directorate for Pharmaceutical

Affairs is responsible for pharmaceutical sector stewardship

(sector policy and regulation) but also, as a legacy of the

Soviet occupation period, continues to perform a command

style of sector management and consequently conducts a

range of commercial activities outside of its stewardship role

and not related to medicines policy and regulation such as

manufacturing, operating a pharmacy retail chain, wholesaling,

warehousing and importing. This situation is in conflict with

market economy based systems being introduced by the IDC

and has a detrimental impact on activities that are within its

terms of reference.

The MoPH, and particularly its GDPA, is continuing to undergo

a long period of restructuring with regular organisational

changes often driven by political reasons and consequently

remains unsettled and not modelled in conformance with the

i East Mediterranean Regional Office of the WHOii SADC – Southern African Development Community. Inter-governmental organisation of 15 southern African states



Table 7. Afghanistan Pharmaceutical Sector Performance Indicators

a. MoPH HMIS (Health Management Information System) - MIAR (Monthly Integrated Activity Report) – healthcare facilities with at least 1 drug stock out (assessed by province);

b. Balanced Score Card (BSC) performance assessment of BPHS delivery (indicator relevant to the pharmaceutical sector is ‘Indicator 7: Drug availability index’*;

c. USAID assessment of the pharmaceutical logistics management capacity of NGO grantees (utilising an Inventory Management Assessment Tool).

* measures the continuous availability of a set of essential drugs in health facilities. This indicator is included in the BSC system adopted by the Afghanistan MoPH as a tool to measure and manage BPHS performance delivery30. The median score for this indicator in 2004 was 69% and which had risen to 85% by 2006, thus indicating an increase in public sector essential drug availability.

tasks necessary to conduct its sector stewardship function. In

comparison to other MoPH directorates, the GDPA has lacked

IDC support which has contributed to both its unsettled

organisational situation and lack of development. Afghanistan

is a highly decentralised country and effective management of

its pharmaceutical sector is reliant on the Provincial Pharmacy

Officer system which is principally tasked with ensuring public

sector medicines supply via the BPHS/EPHS programme in the

provinces. An examination of the PPO task description and

PPO-GDPA reporting system was conducted and revealed

several inadequacies, particularly an absence of any provincial

regulatory function as well as coordination activity with the IDC

system that provides the BPHS/EPHS.

In 2004, the WHO estimated that a third of countries have

no medicines regulation or a regulatory capacity that hardly

functions8; it is certain that Afghanistan belongs in this category,

particularly given the findings from the EC sector survey12 which

highlight major regulatory gaps and weaknesses as evidenced

by the chaotic nature of its pharmaceutical market. Concerning

sector human resources, Afghanistan has one pharmacy faculty

training 120 pharmacists annually and which recommenced

operations in 2001 following a long hiatus due to many years of

conflict. Afghanistan health sector human resource development

strategy is skewed towards recruitment of doctors and thus

there is a major shortfall in qualified pharmacists and pharmacy

technicians against the background of a rapidly expanding

private pharmaceutical sector12 which hinders effective sector

functioning.

A necessary measure for effective and efficient sector

management is sufficient coordination with sector stakeholders

at both the national and international (particularly the Asia

region) levels. An examination of national sector coordination

between the various stakeholders revealed that this was very

weak (even between the different IDC parties), and also at the

international level, although Afghanistan is a member of the

regional Economic Cooperation Organisation (ECO)iii (which

offers a framework for pharmaceutical regulatory cooperation)

and the South Asian Association for Regional Cooperation

(SAARC)iv. The Afghanistan pharmaceutical sector largely

operates in an international void against the background of a

global pharmaceutical market, a situation which is not conducive

for its development.

Afghanistan is judged to be the second most corrupt country in

the world3 and evidence suggests that the Afghanistan health

and pharmaceutical sector is particularly adversely affected by

corruption12, 22, 29. Transparency International claims that in some

countries up to two thirds of hospital medicines supplies are

lost to corruption and fraud and it is estimated that 10–25%

of global spending on public medicines procurement is lost to

corruption3. This leads one to conclude that there is a pressing

need to introduce medicines good governance measures in

Afghanistan which can potentially be achieved via adopting the

WHO Good Governance for Medicines (GGM) programme20 in

this country.

The Afghanistan pharmaceutical sector possesses a satisfactory

enabling policy (and to a lesser extent legislative) framework

and thus sector development now needs to focus on a number

of areas which all require long term IDC support:

(i).capacity building (e.g. human resource development);

(ii). institution building. It is necessary to build an international

standard medicines regulatory structure and function as a

priority and which operates in accordance with the principles

of good regulatory practices. Medicines policy and regulation

functions require significant rationalisation and development to

meet international norms and standards. This can be facilitated

by benchmarking pharmaceutical regulatory structure and

activities against those of other countries in the region and

elsewhere. Further GDPA institution building efforts will require

a functional separation of sector administration from service

delivery;

(iii). sector coordination (with corresponding authorities)

strengthening at both the national and international levels; and

(iv). introduction of medicines good governance.

Informing Policy – Sector Monitoring and Evaluation (M&E)

Sector Monitoring and Evaluation (M&E) is a vital stewardship

function (i.e. generation of intelligence) which permits

evidence-based policy making. However, pharmaceutical Sector

M&E (and supporting sector management information systems),

within the framework of overall health sector M&E and national

health accounts is extremely limited in Afghanistan. Existing

sector performance indicators tend to be directed towards

medicines inventory management and are summarised in Table

7. In addition to the national level drug inventory Monitoring &

Evaluation system, one international donor (USAID) employs a

detailed Basic Package of Health Services inventory management

assessment tool, while other donors employ no assessment tool

at all.

iii Afghanistan, Azerbaijan, Iran , Kazakhstan, Kyrgyzstan , Pakistan, Turkey, Turkmenistan, Tajikistan and Uzbekistaniv Afghanistan, Bangladesh, Bhutan, India, the Maldives, Nepal, Pakistan and Sri Lanka



Other sector data, where it is available, tends to be collected

on an ad hoc basis by the IDC and contracted NGOs, however

many sector areas outside of medicines inventory management

are not monitored or evaluated (e.g. medicines quality, safety,

usage and pricing). The failure of sector data coordination occurs

due to the fact that the sector is currently managed jointly by

the Afghan authorities and several international donors. The

actual assimilation and utilisation of available sector data by the

MoPH GDPA is hard to determine. Thus, as is often the case in

developing countries, local data is sparse and the majority of

policy decisions tend to be based on data which is gathered,

modelled and published by international agencies31.

There is much scope to adopt a unified, standardised and

comprehensive pharmaceutical sector M&E system (which

should be incorporated into the overall health sector M&E

system) to serve the purposes of both the MoPH and the IDC.

The introduction of regular pharmaceutical sector baseline

studies can complement and feed into this system.

Medicines Regulation, Registration and Quality Control

The Afghanistan Licensed Drug List (LDL)32 is determined jointly

by the MoPH and IDC, is based on the WHO Model List of

Essential Medicines (MLEM) and prescribes which medicines

can be registered in Afghanistan as well as included in the

Afghanistan Essential Medicines List (EML). A full medicines

registration dossier, that should include both clinical efficacy and

safety evidence and pharmacoeconomic data33, is required to be

submitted for all LDL applications. Thus there are no provisions

for abbreviated medicines registration in the case of an existing

reference product on the Afghanistan market. Limited provisions

exist concerning intellectual property issues (i.e. data exclusivity,

patent protection, registration of brand and trademark names).

The Ministry of Public Health Medicines Quality Control

Laboratory (MQCL) is responsible for medicines Quality Control

(QC) and carries out testing for registration, batch import QC,

and ostensibly for Post Market Surveillance (PMS) purposes. As

there is no capacity to conduct Good Manufacturing Practice

(GMP) inspections and a lack of recognition of international

manufacturing authorisations and GMP certificates, the MoPH

relies on a system of testing every imported batch (except for

batches imported by some international donors who have

obtained a MoPH testing waiver), although the capacity and

capability of the national Medicines QC laboratory to do such is

far from adequate. The MQCL is not internationally accredited,

is operating in a dilapidated condition, suffers from serious

resource (staff and equipment) and operational deficiencies,

and is inadequate in all respects to be able conduct medicines

testing according to international standards12. The ultimate

organisational position of the MQCL is yet to be determined.

Medicines import and export is regulated according to a batch

import licensing system; however customs control procedures

are reported by several stakeholders as being detrimental,

inefficient and non transparent12. The rigid import license

process and requirement for all batches to be QC tested by

the central MQCL often results in delays of approximately

three months for medicines to be imported into Afghanistan;

often large amounts of import batch stock are damaged or

misappropriated (diversion, ‘system leakage’) while in customs

clearance; no customs risk analysis procedure is applied to

imported medicines and there is no central customs bonded

warehouse22. There is no system of medicines export and transit

licensing. Importers are licensed by the MoPH and licenses can

be obtained by general traders (i.e. not just specialist medicine

distribution companies that employ a qualified person).

The Afghanistan medicines regulation system is underdeveloped,

weakly implemented and not internationally harmonised. There

are a number of weaknesses and gaps and principally there is a

need to harmonise the medicines law and its regulations with

existing international models, adopt internationally harmonised

medicines registration procedures, invest in an adequate

medicines QC infrastructure and implement a pharmacovigilance

system.

Medicines Financing, Reimbursement and Pricing

It is difficult to make an accurate assessment of the public

medicines financing situation in Afghanistan for a number of

reasons: (i) no national health account system exists, (ii) there

is no central compilation of medicines financing statistics or

national medicines budget formula in operation, (iii) public

health financing is derived and applied by a number of

funders, i.e. Ministry of Public Health and International Donor

Community, and (iv) medicines financing data is not routinely

collected and where it exists it is of a limited nature. Thus there

is a need for the IDC to assist and involve the MoPH in assessing

medicines needs and monitoring sector financial flows.

The public Basic and Essential Packages of Health Services

medicines budget is ~ 4 USD per capita per year12. The best

available statistics suggest that 70% of the country’s medicines

needs are provided via the private sector with the remainder

being supplied by the 100% publicly funded essential

medicine BPHS/EPHS scheme (90% funded by IDC with the

Afghanistan Ministry of Finance contributing the balance);

however the proportion of essential medicines provided by

the public BPHS/EPHS scheme which is estimated to have 80%

population coverage (as a % of total essential drugs supplied) is

proportionately higher. It is estimated that an average of 20% of

the BPHS/EPHS budget across all donors is spent on medicines12,

although there is a wide variation in per capita medicines

expenditure between provinces and between donors (as a result

of variations in medicines financing policies between the donors

and which are not centrally coordinated).

Large variations occur in medicines availability and per capita

BPHS medicines expenditure between the provinces for reasons

that are not entirely clear and may be partly related to donor and

MoPH incoordination in terms of estimating medicines needs. In

spite of the public BPHS/EPHS system ‘out of pocket’ payments



for medicines constitute a significant part of private household

expenditure34. Anecdotal evidence suggests that patients meet

a substantial part of their medicines needs from the private

sector for a number of reasons; e.g. perception of product

quality source, lack of availability in public health facilities, long

waiting times, ability to obtain medicines without the need for

a prescription. Thus fundamental medicines availability issues in

Afghanistan require major attention.

Afghanistan Medicines legislation makes provision for

controlling medicines prices via defining import, wholesale and

retail margins, for both publicly and privately supplied medicines.

Despite the existence of legislation governing medicines price

margins, observance of regulated margins is not followed

in practice and are hardly inspected or enforced. Very often

pharmacies set retail prices by referring to the retail price of

medicines in either Pakistan or Iran. The BPHS/EPHS medicines list

is based on the MoPH EDL and inclusion of a medicine on the list

requires the submission of pharmacoeconomic data35, however

the appropriateness and capacity of the Afghanistan authorities

to employ pharmacoeconomic analysis in medicines assessment

has to be seriously questioned. Strong arguments exist against

blindly applying developed country pharmacoeconomic

models and techniques in LDCs as they can in the first instance

effectively manage scarce resources by applying effective pricing

policies, differential pricing and by improving transparency and

accountability within the medicines system36.

It is unrealistic in the long term to expect the IDC to continue to

fund Afghanistan’s essential medicines needs so a system needs

to be put in place whereby all regulatory-approved essential

medicines, irrespective of source, come under the provisions of

a national medicines financing and reimbursement system and

with the introduction of international reference prices.

Rational Medicines Usage (RMU)

Irrational medicines prescribing, dispensing and consumption

have been reported as being widespread in Afghanistan and

include overuse of antimicrobials and injections and the

dispensation of half treatment courses9, 14. Medicines are widely

available without prescription and a serious problem exists with

diagnosis and prescription by unqualified persons posing as

doctors in private clinics and working in private pharmacies as

well as by street vendors22. It has been noted that consumers

cannot always afford complete courses of therapy and that

generic medicines are perceived to be of low quality leading

to the prescription of high doses and multiple products in the

same therapeutic category9. The usage of traditional and herbal

medicines in Afghanistan medical practice continues to be a

major part of health care delivery although utilised traditional

remedies may or may not be clinically appropriate22.

The availability of objective medicines information is particularly

weak although a few public education campaigns on medicines

usage are in existence22. The Afghanistan National Medicines

Policy makes provision for implementing several RMU policy

measures, e.g. creation of impartial medicines information

resources (such as a national medicines information centre and

a national medicines formulary) and national clinical protocols,

but aside from the creation of the EML so far none have been

implemented due to capacity and resource constraints.There

is a real need for the implementation of a range of RMU

policy measures including professional curricula development,

medicines utilisation review and household consumption studies,

health facility Drugs and Therapeutics Committees (DTCs),

objective medicines information (for prescribers, dispensers and

consumers), clinical protocols, and Good Pharmacy Practice

guidelines.

Local Pharmaceutical Industry Development and Trade Policy

Only a decade ago Afghanistan was producing the majority of

its medicine needs inside the country and was even developing

an export market. As a result of the many recent conflicts in is

history, Afghanistan’s pharmaceutical industry, which was strong

in the period between the 1970s to the early 1990s, has been

severely damaged. There are currently two credible foreign-

owned manufacturers and a pre-existing major state-owned

manufacturer (the latter existing in a dilapidated condition

but attempting to revitalise its production base in accordance

with international manufacturing standards). In addition there

are a large number of small scale 100 percent Afghan-owned

pharmaceutical manufacturers, the number of which is growing.

Afghanistan also produces many herbal ingredients that are

exported for use in herbal medicines; 28.6 million US$ of

‘medical plants’ were exported in 2010 accounting for 7%

of total exports37. Thus the development of herbal medicine

local production appears rational as the country is a reservoir

of potentially valuable herbal active substances with cultivation

experience.

The MoPH considers the development of local production

and import substitution to be a major pharmaceutical sector

strategic objective, but no state incentive schemes exist for

supporting local essential medicines production. Due to its land-

locked location the costs of importing bulky essential drugs

can be prohibitive and above international reference prices and

its porous borders make it difficult to control imports. Thus

there is real justification for developing a local pharmaceutical

industry that can contribute to supplying the country’s essential

medicines needs and which will require introducing effective

import substitution policy measures.

Conclusions The Afghanistan pharmaceutical sector for several reasons is

one of the least developed in the world, operates in a chaotic

faction and suffers from many weaknesses that cover the

entire spectrum of sector activities. The market presence of

substandard and counterfeit medicines is likely to be significant

and should be considered a public health menace demanding



urgent attention. As a result of International Donor Community

assistance, there are signs of improvement in Afghanistan

healthcare delivery (particularly the contribution of the Basic

Package of Health Services / Essential Package of Hospital

Services programme), although the country still remains at the

bottom of the world health league. However, the IDC focus

on providing its health sector development support to the

BPHS/EPHS programme has meant that pharmaceutical sector

development has been relatively neglected.

Afghanistan pharmaceutical sector development needs and

intervention priorities can be described under the separate

headings of institutional and market. Institutional needs and

priorities cover strengthening (i) sector stewardship, good

governance and full National Medicines Policy implementation,

(ii) organisational capacity and resources, (iii) sector Monitoring

& Evaluation, and (iv) national and international sector

coordination. Market needs and priorities cover strengthening

(i) medicines regulation - ensuring medicines quality, safety and

efficacy, (ii) supply chain regulation, (iii) the drug financing,

reimbursement and pricing system, (iv) rational medicines

usage, and (v) local pharmaceutical industry.

The sector is currently being financed and managed jointly by

the Afghanistan government and the IDC; a situation that is

likely to continue for the foreseeable future and which should

coexist with an ongoing IDC-supported Afghan MoPH and

GDPA capacity building programme and sector infrastructural

investment that will address the numerous challenges that the

sector faces.

Acknowledgements and fundingThis work was supported by a GFA Consulting Group Hamburg

research grant. The authors would like to acknowledge the

funding provided by the European Commission (and the mission

support provided by AEDES Brussels) for the Afghanistan

Pharmaceutical Sector Identification Mission carried out in

2007-8 that greatly informed the writing of this paper.

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Research Article

Performance based reward for immunization: experiences from GAVIRete Trap1,2, Birna Trap2,3, Torsten Wind Hansen2, Ebba Holme Hansen4

1Department of Surgery, Aabenraa, University Hospital, Denmark2Euro Health Group, Denmark3Management Sciences for Health, SURE Program, Kampala, Uganda4Faculty of Pharmaceutical Sciences, Department of Pharmacology and Pharmacotherapy, University of Copenhagen

Address for Correspondence: Rete Trap, Aabenraa University Hospital, Egelund 10, 6200 Aabenraa, Denmark. E-mail: [email protected]

Citation: Trap R, Trap B, Hansen TW, Hansen EH. Performance based reward for immunization: experiences from GAVI. Southern Med Review (2011) 4;1:40-47 doi:10.5655/smr.v4i1.69

Abstract Objective: To assess whether linking the Global Alliance for Vaccine and Immunization (GAVI) service support with performance-based interventions has influenced the quality of reporting and of immunization systems. GAVI Service Support (ISS) combines performance assessment, recommendations and implementation support with financial reward.

Methods: A retrospective study based on data from Data Quality Audit (DQA), a validated standardized indicator-based performance assessment tool which evaluates reporting consistency, accuracy and the quality of the immunization system. Participants are nine developing countries, sampling 421 health units, 72 districts, which have had two consecutive DQAs in the period 2002 to 2005.

Results: Both the quality of reporting and the immunization system improved following GAVI ISS intervention. Reporting quality was associated with the enhanced overall quality of the immunization system and with immunization coverage. Immunisation coverage improved in eight of the nine countries.

Conclusions: The study indicates that the combined GAVI ISS intervention strategy is effective, resulting in increased immunization coverage, enhanced reporting quality and improved quality of the immunization system set-up at all levels of healthcare. High quality reporting is instrumental in focusing immunization management on setting targets for increased coverage, demonstrated by the correlation between increased reporting quality and immunization coverage. Repeated assessments are recommended to ensure sustainable immunization system improvements.

Keywords: Immunization system; immunization reporting; quality improvements; performance-based financial reward strategy; Global Alliance for Vaccines and Immunization

Based Financial Rewarding (PBFR), a scheme that pays a fixed

fee for children immunised with DTP3 as reported by the

country1,6-7. Immunization service support funding is calculated

based on the prospective performance indicator multiplied

by US$20 in the first investment phase and by US$20 in the

reward phase. Reliable and accurate reporting of the number

of children immunised is a prerequisite for being allowed to

participate in the reward scheme. The Global Alliance for

Vaccines and Immunization uses a data quality audit (DQA) with

a pass and fail limit to verify the consistency and accuracy of

the EPI (expanded programme on immunization) administrative

reporting system6,8.

An independent DQA is conducted at national (Nat), district (Dis)

and health unit (HU) levels. After a DQA has been completed,

IntroductionGlobal coverage of childhood Diptheria-Tetanus-Pertussis

(DTP3) immunization increased to 80% in 1990, after

which immunization rates declined considerably in many

countries1,2. Several initiatives have been introduced to

strengthen immunization3-5. The Global Alliance for Vaccines

and Immunization (GAVI) initiative, the most costly, has been

introduced in over 75 countries. However, the effectiveness of

this initiative needs to be further investigated.

The Global Alliance for Vaccines and Immunization (GAVI), a

public-private global health partnership, was established in

1999 for strengthening immunization service support (ISS).

Immunization service support (ISS) is linked to Performance-


Performance based reward for immunization: experiences from GAVI

immunization system quality findings and recommendations are shared with national authorities. A country that fails the DQA is given a second chance two to three years later2,6,9.

Ronveaux et al. conducted a validation of the DQA by reviewing the results from 27 DQAs undertaken8. The DQA was found to be a tool that provides a sound basis for assessing the quality of the national immunization system: a) the consistency and accuracy of the EPI administrative reporting system, and b) the overall quality of the national immunization set-up8. Accurate immunization reports are essential for depicting the actual situation, for decision making and achieving increased immunization coverage10. Much effort has been put into strengthening reporting and data quality and management, e.g. by developing guidelines, training initiatives and standard practices8-10. However, as demonstrated by the findings from GAVI, these initiatives have not led to the desired reporting quality as almost half of the 41 assessed countries did not pass DQA due to poor reporting quality11.

The new GAVI initiative links the reporting quality assessed by DQA with performance-based financial rewarding, providing country-specific recommendations and implementation-support in order to improve reporting quality and thus immunization.

The objective of this study is to assess the effectiveness of the

combined GAVI immunization service support strategy, utilizing

countries that have had two consecutive DQAs in a pre-DQA

and post-DQA study design. This study assesses whether

the GAVI ISS strategy linking reward-based interventions to

immunization system assessment (DQA) and recommendations

for improvements and implementation support have improved

the quality of the national immunization systems in terms of:

a. the consistency and accuracy of the expanded programme on

immunization administrative reporting system and

b. the overall quality of the national immunization set-up.

MethodologyData Quality Audit

Data quality audit, a WHO validated and standardised survey

method based on sentinel indicators measuring consistency of

national reports and quality, efficiency, security and usefulness

of the immunization set-up at each reporting level (national,

district and health unit), was conducted pre and post in all nine

countries8.

Box 1

Verification factor (VF), a key performance measure at national (Nat), district (Dis) and health unit (HU) levels, measuring reporting consistency.

VF (HU): Calculated in each districti (based on the previous year’s reported activity) as the sum from all 6 selected HUs(j=1-6) of the quotient: the numbers of DTP3 vaccinations that are recounted from records in the selected health units, divided by the number of DTP3 vaccinations entered in the district files as reported from the very same health units.

(Xij = the number of recounted DTP3 vaccinations found in the records of the HUj in the Disj;

Yij = the number of reported DTP3 vaccinations found in district file records as reported by the HUj in the Disi)

VF (Dis): Calculated as VF (HU) Disi multiplied by the ratio of all DTP3 vaccinations reported to national level from all HUs in the districti found at district level, divided by number of all reported DTP3 vaccinations found at national level from districti.

(Rdi = At district level, the number of all DTP3 vaccinations reported from all HUs from the district to the national level; Rni = At national level, the number of DTP3 vaccinations reported by the district)

VF (Nat): Calculated as the weighted average of the VF (Dis), from all four selected districts.

A score of 1 is a complete match between recounted/reported. No more then 20 % deviation is accepted for a passing DQA score, so scores between 0.8 and 1.2 in the VF (Nat) are the threshold for release of funds8.

VF (HU) Disi =

=

=

6

1

6

1

jij

jij

y

x

VF (Dis)i =i

i

jij

jij

RnRd

i

i

RnRd

y

x

=

=

6

1

6

1 [ ]iDisHUVF )(=



Box 2

Quality scores (QS), a performance measure at national (Nat), district (Dis) and Health Unit (HU) levels, measuring quality of the system.

The QS is based on defined sets of questions and observations, 53 at national level, 38 at district level and 31 at HU level. The questions and observations are scored 1 if acceptable, 0 if the event was done incorrectly or not performed/observed and ‘na’ if not applicable. The quality of the immunisation set-up is measured in up to five components: recording (1), storing / reporting (2), monitoring / evaluation (3), denominator (4), system design (5). Combined QS is also calculated.

The QS for each component (1-5) is obtained by adding the scores of the component-related questions and observations and dividing them by ‘valid’ answers (excluding ‘na’), and then multiplying by 5. Thus all component scores are in the range of 0 to 55-6.

The district QS and HU QS for individual components are calculated as the average of the four districts, 24 health units, respectively:

The combined QS expresses the quality of the set-up at each level in one figure by combining the QS for all components relevant to the specific level:

QS (Nat) 1-5 = QS component 1-5

QS (Dis) 1-4 =4

4

141

=j

tQScomponen; j being Dis 1-4

QS (HU) 1-3 =24

24

131

=i

tQScomponen; i being HU 1-24

Combined QS (Nat) = 5

)( 51componentNatQS

Combined QS (Dis) = 4

)( 41componentDisQS

Combined QS (HU) = 3

)( 31componentHUQS

The reporting quality (accuracy and consistency) is measured by

the verification factor (VF), which is the proportion of children

<12 months vaccinated with all three doses of diphtheria-

tetanus-pertussis vaccine (DTP-3) that can be traced through the

reporting system from the vaccine delivery points to the national

coverage estimates (See Box 1).

To measure system set-up quality, efficiency, security and

usefulness, DQA measures a quality score (QS) based on 53 to

31 indicators (questions and observations), with most indicators

at national level and fewest at HU level. The indicators are

grouped into five components. At national level the components

are: 1) recording; 2) storing/reporting; 3) monitoring/evaluation;

4) denominator and 5) system design. At district level the QS

is based on components 1-4 and at HU level components 1-3

(See Box 2)8.

The DQA process

DQA teams were composed of trained external independent

DQA auditors and internal auditors from the respective

Ministries of Health, who undertook the DQAs using the GAVI

indicator-based data collection tools and guidelines9. Different

DQA teams carried out the pre- and post- DQA. Each DQA was

conducted as on-site evaluation on three levels of care: national,

district and HU. A multi-stage sampling procedure was used in

which four districts were selected by probability proportional

to the reported immunization measured by reported doses of

DTP-3 administered in the previous year, followed by random

sampling of six HUs in each of the four districts, a total of 24

HUs per country.

The DQA sample size was determined with regard to precision

of the results, logistics and finance, to allow maximum data

collection within a two-week assessment period.



Districts and HUs were excluded if they had serious access and

security problems, or if a district had less than six HU’s9.

Collected data were entered into an Excel workbook, which

automatically generated scores for the performance measures.

The DQA findings were summarised in country reports available

on the GAVI web page12. Practical management and system

recommendations derived from the DQA were provided covering

all components at all three levels, related to achieving a reliable

and accurate reporting system measured by the Verification

Factor (VF), and a good quality immunization set-up measured

by the Quality Score (QS) indicators. In 2005 a data quality

self-assessment tool was developed, modelled on the DQA

methodology, to help countries diagnose and solve problems in

their healthcare system5. In addition GAVI provided support for

implementing the recommendations and monitoring progress in

annual progress reports.

The DQA measures

The DQA key indicators are the verification factor (VF), which

assesses reporting quality, and quality score (QS), which assesses

the quality of the immunization system set-up.

The VF reports the difference between recounted and reported

DTP3 vaccinations for an audit year that could be verified by

written documentation (See Box 1)8. A VF >1 indicates that

some of the doses recounted at HU level were not reported to

the levels above (‘under-reporting’), while a VF <1 indicates that

not all doses appearing in the reports could be recounted and

verified at HU level (‘over-reporting’).

In addition to the QS measured for up to five components,

the combined QS expresses in one figure, the quality of the

immunization set-up at each level. Combined QS is calculated

by combining the QS for all components relevant to the level.

(See Box 2)

Data Collection

By the end of year 2007, more than 75 countries had undertaken

a DQA. Of these, nine countries (Burkina Faso, Cameroon,

Guinea, Kenya, Madagascar, Sudan, Burundi, Nigeria and

Zimbabwe) that failed their pre-DQA have had a post-DQA

after a time span of two to three years. Data from the DQA

Excel workbooks were extracted retrospectively: year of DQA;

immunization coverage; number of eligible and non-eligible

HUs and districts; reporting quality at national level (VF Nat); VF

at district level (VF Dis); data to calculate VF at HU level (VF HU)

(Box 1); and QS for all components at national, district and HU

level and a combined QS (Box 2)12.

The number of eligible HUs was 667 in the pre-DQA,

corresponding to 94% of the total HUs and 645 (85%) in

the post-DQA. At the point of data collection, 11 HUs were

excluded due to unforeseen factors such as the fact that the

HUs no longer existed and insufficient time to carry out the

survey. The number of eligible districts was 617 in the pre-DQA,

corresponding to 97% of the total districts, and 556 (89%) in

the post-DQA. There was no significant difference in the number

of non-eligible HUs and districts in the pre- and post-DQAs.

Data Analysis

Tests for differences were calculated between the VF (Nat) for

the pre-DQA and the post-DQA and between the combined

QS in pre-DQA and post-DQA (paired test at Nat level and

unpaired test at District and HU level). Linear regression

analysis was undertaken to assess the correlation between VF

and combined QS at all three levels. Tests for difference were

calculated between the immunization coverage for the year of

pre-DQA and post-DQA (paired test). The correlation between

VF and immunization coverage was calculated (paired test). To

account for the fact that VF is not a linear concept, VFs > 1

were transformed by subtracting the verification excess (above

1) from 1, a method applied earlier8. We tested for differences

in numbers of eligible HUs and districts between the two DQAs.

Analyses were conducted using the statistical program® SPSS

version 15.0 with the level of significance 0.05 (CI 95%).

ResultsDQA data showed that all nine countries improved their

reporting quality measured by the VF to passing level in the

span of 2-3 years (average 2.3 years) from pre-DQA to post-

DQA (Table 1). The VF (Nat) increased from an average of 0.59

(Standard Deviation (SD): 0.082) in pre-DQAs to 0.93 (SD:

0.047) in post-DQAs; p<0.009. Further, in eight countries the

combined QS increased at all three levels from pre-DQA to post-

DQA. Moreover, the mean of the combined QS at national level

for all nine countries changed from 2.944 (SD: 0.643) in pre-

DQAs to 3.900 (SD: 0.456) in post-DQAs; p<0.008, at district

Figure 1. Changes in Combined Quality Score between pre and post data quality audits by country at National, District and Health Unit levels.

0

.5

-0.5

-1.0

1.0

1.5

2.0

2.5

3.0

National levelDistrict LevelHealth Unit level

Com

bine

d Q

ualit

y Sc

ore

Cha

nges

Burki

na

Faso

Buru

ndi

Camero

on

Guinea

Kenya

Mad

agas

car

Nigeria

Suda

n

Zimba

bwe



level from 3.069 (SD: 0.4391) to 4.005 (SD: 0.384); p<0.002

and at HU level from 2.747 (SD: 0.736) to 4.223 (SD: 0.259);

p<0.002. The changes in the combined QS were highest at HU

level and lowest at national level (Figure 1).

The one country with a decrease in the combined QS was

Zimbabwe. However, the score remained at a high level and

decreased by only 0.1. In addition, reporting consistency in

Zimbabwe improved at district level with the range of the VF

(Dis) narrowing from pre-DQA to post-DQA by 0.46 - 1.11 and

0.90 - 1.12 respectively.

Figure 2* displays the combined QS found in the two

consecutive DQAs for all nine countries at the three levels. The

figure shows that there was a general increase at all three levels

and a reduction in the SD.

Table 1 shows that there was no unified direction for the

changes in the five QS components at the various levels in the

nine countries. Immunization coverage was seen to increase

significantly in all but one country, from an average of 59.9%

(SD: 21.2) in pre-DQAs to 66.4% (SD: 19.6) in post-DQAs;

p<0.02.

Table 2 shows the correlation between the VF and the combined

QS and the components QS. A correlation was found between

the VF (Nat) and the combined QS (Nat), the VF (Dis) and

the combined QS (Dis), and between the VF (HU) and the

combined QS (HU), showing that an improvement in the quality

of the overall immunization set-up was associated with an

improvement in the quality of reporting.

A correlation was found between reporting quality (VF) and all

five QS components except the denominator component, but

not at all levels. At national level we found a correlation between

the VF (Nat) and the QS component, system design (Table 2). At

district level a correlation was found between the VF (Dis) and

the QS components, recording and monitoring/evaluation. At HU

level, a correlation was found between the VF (HU) and the three

QS components, recording, storing/reporting and monitoring/

evaluation (Table 2). Hence, all QS components with the exception

of the denominator were related to reporting quality.

We found a significant correlation between the VF (Nat)

and immunization coverage, with a positive and moderate

correlation of 0.43; p<0.009 (Figure 3).

DiscussionFinding improved reporting quality from pre-DQA to post-DQA

in all nine countries is really quite astounding, especially when

taking into consideration the short average time span of 2.3

years that it took to implement the changes and make the

improvements even down at rural health facility level. National

interventions such as the revision or introduction of standardised

operational procedures, report formats and use of carbon

paper reports as recommended following the DQA are believed

to have led to the improved reporting quality. Moreover, the

recommendations provided in the pre-DQAs regarding system

quality have led to documented improvements at all levels in the

quality of the immunization set-up. In spite of the acknowledged

difficulties in ensuring appropriate reporting management,

this study suggests the effectiveness of the GAVI ISS strategy,

a strategy which combines auditing, recommendations and

reward, in identifying and improving reporting quality as well as

in strengthening the quality, efficiency, security and usefulness

of the system at all levels.

In Zimbabwe, only the verification factor improved. It is likely

that the minimal decrease in the quality of the set-up observed

Figure 3. Verification Factor and Immunization Coverage (DTP3) in the nine countries with pre and post data quality audits.

0 0

20

40

60

80

100

0.2

0.4

0.6

0.8

1

VFImm Cov

Verif

catio

n Fa

ctor

– V

F

Imm

unis

atio

n C

over

age

(%) –

Imm

Cov

1 3 5 7 9 11Pre- and Post-Date Quality Audit date of the nine countries

13 15 17

* DQA1 Nat CQS (0.56; 2.5) Nigeria and DQA2 Nat CQS (0.95; 3.9) Burundi are not depicted in the figure, as they are “behind” identical figures for DQA1 District CQS and respective DQA2 Health Unit CQS.

Figure 2. National Verification Factor versus the Combined Quality Score at National, District and Health Unit levels in nine countries with pre and post data quality audits.

1.5

2.5

2.0

3.0

3.5

4.0

4.5

5.0

0.4 0.5 0.6 0.7 0.8 0.9 1.0

Com

bine

d Q

ualit

y Sc

ores

National Verification Factor

DQA1 National CQSDQA1 District CQSDQA1 Health Unit CQSDQA2 National CQSDQA2 District CQSDQA2 Health Unit CQS

Pre data quality audit (DQA1): symbolised byPost data quality audit (DQA2): symbolised by



Tab

le 1

. Nat

ion

al v

erifi

cati

on

fac

tor

(VF)

, im

mu

niz

atio

n c

ove

rag

e, c

om

bin

ed a

nd

co

mp

on

ent

qu

alit

y sc

ore

(Q

S) a

t n

atio

nal

, dis

tric

t an

d

hea

lth

un

it le

vel f

rom

nin

e co

un

trie

s th

at h

ad p

re a

nd

po

st d

ata

qu

alit

y au

dit

s (D

QA

) 20

01-2

005.

Coun

tryBu

rkin

a Fa

soBu

rund

iCa

mer

oon

Gui

nea

Keny

aM

adag

asca

rN

iger

iaSu

dan

Zim

babw

e

DQA

year

2001

2004

2002

2005

2001

2003

2001

2003

2001

2003

2002

2004

2002

2005

2001

2003

2003

2005

VF(N

at)

0.58

0.96

0.72

0.95

0.48

0.89

0.57

0.95

0.50

0.85

0.58

1.02

1.44

0.89

0.69

0.96

0.67

0.93

Imm

un. C

over

age

(%)

64.3

87.9

94.5

82.9

43.1

72.7

62.6

62.7

66.4

73.2

58.4

79.0

16.0

34.3

70.9

73.9

63.2

89.3

Com

bine

d an

d Co

mpo

nent

QS

(Nat

)N

atio

nal

Nat

iona

lN

atio

nal

Nat

iona

lN

atio

nal

Nat

iona

lN

atio

nal

Nat

iona

lN

atio

nal

Com

bine

d Q

S (N

at)

3.3

3.8

2.8

3.9

3.4

4.3

2.9

3.1

3.3

4.0

1.8

3.3

2.5

3.9

2.5

4.6

4.0

3.9

Reco

rdin

g pr

actic

es

3.3

5.0

2.1

5.0

3.3

4.3

0.8

4.3

4.2

5.0

4.2

1.4

3.6

5.0

1.7

5.0

5.0

5.0

Stor

ing

/ Rep

ortin

g 3.

83.

02.

04.

02.

55.

03.

00.

02.

04.

02.

04.

01.

05.

02.

05.

03.

04.

0

Mon

itorin

g / E

val.

3.2

4.4

4.4

3.6

4.3

4.7

2.5

2.8

3.8

4.4

1.6

4.4

2.5

3.9

2.1

4.7

3.6

3.1

Deno

min

ator

4.5

3.5

2.5

3.5

3.3

3.0

5.0

4.0

4.0

3.3

2.2

2.5

3.3

2.0

4.0

4.0

3.5

2.8

Syst

em D

esig

n1.

53.

12.

73.

53.

54.

63.

04.

62.

53.

53.

14.

22.

33.

82.

54.

25.

04.

6

Com

bine

d an

d Co

mpo

nent

QS

(Dis)

Dist

rict

Dist

rict

Dist

rict

Dist

rict

Dist

rict

Dist

rict

Dist

rict

Dist

rict

Dist

rict

Com

bine

d Q

S (D

is)3.

44.

23.

03.

72.

94.

43.

54.

33.

24.

12.

64.

42.

53.

32.

73.

93.

83.

7

Reco

rdin

g pr

actic

es2.

95.

03.

44.

32.

64.

73.

34.

41.

94.

92.

94.

72.

43.

22.

33.

93.

84.

6

Stor

ing

/ Rep

ortin

g 3.

13.

43.

02.

63.

84.

03.

95.

04.

43.

62.

14.

14.

23.

83.

23.

83.

12.

2

Mon

itorin

g / E

val.

2.9

4.4

2.1

3.6

2.5

4.5

2.4

4.2

2.4

3.9

2.0

4.3

1.8

3.1

2.3

3.8

3.9

3.8

Deno

min

ator

4.5

4.1

3.5

4.3

2.9

4.3

4.2

3.7

4.2

4.0

3.5

4.5

1.8

3.1

3.0

4.3

4.5

4.4

Com

bine

d an

d Co

mpo

nent

QS

(HU)

Heal

th U

nit

Heal

th U

nit

Heal

th U

nit

Heal

th U

nit

Heal

th U

nit

Heal

th U

nit

Heal

th U

nit

Heal

th U

nit

Heal

th U

nit

Com

bine

d Q

S (H

U)2.

54.

42.

63.

92.

54.

23.

54.

52.

14.

42.

84.

32.

53.

71.

94.

34.

34.

3

Reco

rdin

g pr

actic

es2.

74.

32.

53.

82.

53.

93.

94.

51.

84.

12.

13.

82.

43.

62.

53.

73.

84.

0

Stor

ing

/ Rep

ortin

g2.

34.

63.

14.

03.

04.

53.

34.

93.

04.

74.

44.

82.

74.

52.

14.

95.

04.

6

Mon

itorin

g / E

val.

2.4

4.4

3.0

4.1

2.1

4.2

3.4

4.0

0.7

4.3

1.8

4.3

0.9

2.9

1.2

4.4

4.2

4.4



is related to the initially high and above-average level of quality

coupled with the limited availability of resources as a result of

the prevailing political and socio-economic situation.

The GAVI ISS strategy provides an assessment of the

national immunization system (DQA) recommendations for

improvements and reward funding. Many factors influence

the impact of an intervention. To adequately assess the impact

of the GAVI intervention it ought to be controlled for existing

trends or other influencing factors. A rigorous controlled trial

study design would therefore have been preferable rather

than this pre-post study. In studies related to rational drug use,

combining managerial and financial strategies has proven to be

the most effective and sustainable strategy13-14. Moreover, there

are longstanding concerns that performance-oriented initiatives

such as GAVI ISS might encourage over-reporting2,15. However,

this study documents that combining financial, managerial

and educational strategies not only increased reporting quality

(VF>80%), but decreased over-reporting from 40% to 7%,

and improved overall system quality. An earlier study found

that over-reporting tended to increase with time and was most

pronounced after three years15. Although the present study

indicates that the GAVI ISS strategy ensures high reporting

quality, the sustainability is not known. Therefore repeated

follow-up DQA is recommended.

Our findings showing improvements at all levels indicate that corrective measures, as outlined in the DQA recommendations, have been implemented at all levels within a very short span of time, less than three years. As the reward system is directly linked to a passing verification factor score, improvements in the VF alone would have been sufficient. However, the documented improvement in set-up quality indicates that the nationally applied strategies focused not only on increasing the VF but on the overall immunization system as well. The correlation between the VF at the three levels and all the QS components apart from the denominator indicates that an immunization system providing a reliable and accurate reporting system is associated with high quality immunization procedures and managerial set-ups at all levels. In line with our findings, a previous GAVI study found that there was a correlation between the QSs at the various levels (Nat, Dis and HU)11.

The explanation of non-significance with the denominator component might be the low sample number (nine), as the denominator is only measured at national level. The importance of the comprehensive ISS strategy, e.g. country-specific recommendations and implementation support in achieving such nationwide improvements, is not clear. However, there is good reason to believe that such specific and practical recommendations combined with implementation support and progress reporting have been crucial to the demonstrated improved overall quality of the national immunization system.

We found a positive correlation at all three levels between VF and combined QS, while earlier studies only found a correlation between VF and combined QS at district and HU level8,11. Our findings indicate that a well functioning, high quality immunization set-up, including all the QS components and at all levels, with correctly implemented operational procedures, leads to accurate and reliable reporting.

A correlation was only found between the VF and system design at national level, whereas more components were correlated to the VF at lower levels, i.e. recording and monitoring / evaluation at district level and all three (recording, monitoring / evaluation and storing / reporting) at HU level indicating that the QS at district and HU levels have the highest impact on the VF. Therefore interventions to support a country in passing the DQA must ensure system improvements at all levels, particularly at HU and district levels. An analysis of the correlation between the QS components and the VF has not been included in the prior analysis8,11. Based on the significant correlation between QS and VF shown in this study it is justified and rational to introduce and implement interventions to strengthen the system and thereby improving the VF.

Despite the fact that passing the DQA is only linked to the VF score, the fact that improvements were found in all the QS components except the denominator QS component indicates that there is no need to establish minimum or ‘pass’ scores for

the QS as the QS is indirectly linked to passing.

Moreover, the finding of a significant increase in immunization

coverage in eight of the nine countries points to the

Table 2. Correlation between the combined and component quality scores (QS) and the verification factor (VF) at national, district and health unit levels.

VF Level Quality Score (QS) p- values ß-values

VF(National)

VF(District)

VF(Health Unit)

Combined QS (National)

Combined QS (District)

Combined QS (Health Unit)

* 0.01

* 0.00

* 0.00

0.608

0.431

0.592

VF(National) QS (National), Recording

QS (National), Storing / Reporting

QS (National), Monitoring / Evaluation

QS (National), Denominator

QS (National), System Design

0.37

0.06

0.08

0.26

* 0.01

1.430

1.300

0.883

0.789

0.790

VF(District) QS(District), Recording

QS(District), Storing /Reporting

QS(District), Monitoring / Evaluation

QS(District), Denominator

* 0.00

0.97

* 0.00

0.06

0.585

0.780

0.567

0.677

VF(Health Unit) QS(Health Unit), Recording

QS(Health Unit), Storing /Reporting

QS(Health Unit), Monitoring / Evaluation

* 0.00

* 0.00

* 0.00

0.518

0.770

0.952

Test method: Linear regression analysis, ß = mean change in VF per unit in QS * indicates significant correlation (p<0.05)



appropriateness of the combined GAVI ISS strategy. Based

on the improved reporting quality and the decrease in over-

reporting between the pre- and post- DQAs, which provided

more reliable data, it is reasonable to assume that the measured

increase in DPT3 is a real increase. This assumption is further

substantiated by the fact that even with constant coverage the

decrease in over-reported vaccinations would have resulted in a

decrease in coverage.

The finding of a positive and moderate correlation between

reporting quality and immunization coverage indicates that

improved reporting quality enables better target setting,

which leads to strengthened immunization management and

thereby improved coverage. However, in line with our findings,

earlier studies indicate that having a system with a high

quality of reporting ensures evidence-based decision making

and management which aims at increasing immunization

coverage7,10,16.

ConclusionAs demonstrated by the fact that all the countries in the study

passed their second assessment, there is good reason to believe

that the combined GAVI ISS strategy linking reward-based

interventions to immunization system assessment (DQA) and

recommendations for improvements and implementation

support have been instrumental in improving the quality of

reporting. Moreover, quality reporting which provides accurate

and consistent data is instrumental in focusing immunization

management on setting targets for increased coverage,

demonstrated by the correlation between increased reporting

quality (VF) and increased immunization coverage. Finally, the

study showed that improvements in the immunization set-up

at all levels were fundamental to improving reporting quality

as demonstrated by the correlation between VF and combined

QS. However, it is not clear if the achieved improvements in

the national immunization system (VF, QS) are sustainable.

Therefore, we recommend that system assessment be repeated

regularly, either by self-assessment or DQA.

AcknowledgmentWe would like to thank Bjørn Melgaard (Euro Health Group),

Olivier Ronveaux and Abdallah Bchir (GAVI Alliance, Geneva,

Switzerland) for their suggestions on the manuscript at several

stages. We also thank the staff in all the countries concerned

with GAVI and DQA for their support and collaboration.

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