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Southern MedReview
Volume 3 Issue 1 February 2010
ISSN 1174-2704
A bibliometric study of access to medicines research in developing countries
Community pharmacy based research activity in India
Medicines information in medical journal advertising in Australia, Malaysia and
the United States
Antimicrobial use in Ulaanbaatar, Mongolia
Value of pharmaceutical innovation
An International Journal to Promote Medicine Use and Access Research
An International Journal to Promote Medicine Use and Access Research
Southern MedReview
Editor
Z. Babar
Associate editors
S. Scahill
A. Tahira
Editorial supportQ. Rashid
H. Håkonsen
S. Jamshed
A. Hussain
Graphic designer
J. Allen
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
Dzulkifli Abdul Razak
Vice Chancellor, Universiti Sains Malaysia, Penang, Malaysia
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, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang,
Malaysia
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
An International Journal to Promote Medicine Use and Access Research
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 due to, also inexperienced or untrained
researchers, topics out of the scope of current mainstream journals and limited
funding are some of the other challenges.
Aims and Objectives: Southern Med Review provides a platform for researchers
to disseminate commentary and empirical research findings, with a view to
improving 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 2-3 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, of
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 @2010.
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. Full research papers should not exceed more than
4000 words. All other forms of articles should be within the range of 3000 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 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.
An International Journal to Promote Medicine Use and Access Research
Southern MedReview
Contents
Evidence based pharmaceutical policy research: Is it all talk or does it contribute to improving health in developing countries? 1Zaheer-Ud-Din Babar, Shane Lindsay Scahill
A bibliometric study of publication patterns in access to medicines research in developing countries 2Lindsay Sarah Ritz, Taghreed Adam, Richard Laing
Community pharmacy based research activity in India: A bibliometric study of the past ten years 7Subal Chandra Basak, Dondeti Sathyanarayana
Medicines information in medical journal advertising in Australia, Malaysia and the United States: A comparative cross-sectional study 11Noordin Othman, Agnes Isabelle Vitry, Elizabeth Ellen Roughead
Antimicrobial use in a country with insufficient enforcement of pharmaceutical regulations: a survey of consumption and retail sales in Ulaanbaatar, Mongolia 19Rie Nakajima, Takehito Takano, Vaanchig Urnaa, Nyambayar Khaliun, Keiko Nakamura
Assessing different perspectives on the value of a pharmaceutical innovation 24Albert Wertheimer, Larry Radican, Michael Robert Jacobs
Letter to Editor: A student reflects on the rest of the world through Southern Med Review 29Nicholas Budd
1Southern Med Review Vol 3 Issue 1 Feb 2010
Editorial
Evidence based pharmaceutical policy research: Is it all talk or does it contribute to improving health in developing countries?Citation: Babar ZU, Scahill SL. Evidence based pharmaceutical policy research: Is it all talk or does it contribute to improving health in developing
countries? Southern Med Review (2010) 3; 1:1-1
Nevertheless, the Southern Med Review is a journal with a
mission to support evidence based pharmaceutical policy
research and in the current issue two bibliometric reviews
focusing on “policy & practice” have been published. Ritz et
al provides us with a bibliometric study of publication patterns
in access to medicines research within the developing world.
The paper provides an understanding of the extent to which
medicines policy research is being undertaken and helps to set
a future research agenda. A letter to the Editor by a pharmacy
student published in the current issue also shows that our work
is stimulating comparative thought and making a difference
which is the primary objective of this journal.
With all of the above in mind, we welcome your contributions
and look forward to a challenging yet rewarding 2010.
Zaheer-Ud-Din Babar, PhD Shane Lindsay Scahill, BPharm, MMgt
School of Pharmacy, University of Auckland, New Zealand
References 1. Babar ZU, Ibrahim M Izham M, Singh H, Bukhari NI, Creese
A.(2007) Evaluating drug prices, availability, affordability, and price components: Implications for access to drugs in Malaysia. PLoS Med 4(3): 0466-0475
2. Prices, availability and affordability of medicines in Pakistan (2006). The Network for Consumer Protection, Islamabad, Pakistan. http://www.haiweb.org/medicineprices/surveys/200407PK/survey_report.pdf
3. Ministry mulls price control. The New Strait Times, 7th Jan 2007 Kuala Lumpur, Malaysia.
4. Access to medicines still good. The New Strait Times, 12th Feb 2007, Kuala Lumpur, Malaysia.
5. Cost of medicines: Study flawed because of assumptions. The New Strait Times, 3rd April 2007, Kuala Lumpur, Malaysia.
6. Drug price hike. Dawn 2nd Sep 2009, Karachi, Pakistan
7. Rationale behind drug prices. Dawn 26th Feb 2008, Karachi, Pakistan. http://www.dawn.com/2008/02/26/letted.htm#2
8. Drug price hike: industry’s version. Dawn 26 Sep 2009, Karachi, Pakistan. http://www.dawn.com/wps/wcm/connect/dawn-content-library/dawn/the-newspaper/letters-to-the-editor/drug-price-hike-industrys-version-699
9. Drug prices: pharma industry’s views. Dawn 7th Sep 2009, Karachi, Pakistan. http://www.dawn.com/wps/wcm/connect/dawn-content-library/dawn/the-newspaper/letters-to-the-editor/drug-prices-pharma-industrys-view-799
It is always said that the foundation to improving “medicines
use” and developing a “health system” is to create reliable data
- the hard core evidence to explore and solve problems. The
process of data gathering also has some other advantages; it
provides an accurate picture of a country’s pharmaceutical needs,
serves as a training tool for researchers, and it increases the
country’s scientific output. However, naturally the main question
we would be asking is, whether the data has managed to serve
its primary aim – to bring a positive change to people’s lives. The
answer to this question in many cases could be a ‘no’ as policy
implementation requires action, transparency and commitment.
The problem with data gained from pharmaceutical policy
research is, that if not properly used, its relevance diminishes
rapidly. Also, however credible the evidence is, implementing
policies requires political commitment. One such case study is
World Health Organization/Health Action International research
on medicine prices, availability and affordability. Examples from
many developing countries1,2 show that no matter how robust
the data is, stakeholders with vested interests are always willing
to lay counter arguments3-9. Most often, the aim is to question
the authencity of data. There is no problem in a scientific debate;
however very often during this disagreement process3-9, the truth
is lost and the public become confused with who is right and
who is wrong. As a result, the opportunity to inform and build
public opinion around a genuine public health issue vanishes.
The question then arises, what are developing countries gaining
from this hard core pharmaceutical evidence? In this scenario,
would it not be more logical for them to focus on “hands on
clinical pharmacy activities” or “individualized pharmaceutical
care” rather than investing on policy based work? These hands
on activities could be better inhaler techniques, improving
corticosteroid usage, monitoring adverse effects, medicines
interaction reporting and managing medicines compliance.
Would concentrating on these patient related activities
produce better “value for money” or even ”value for time”
in these countries? This is a rather provocative question, the
answer to which is not an easy one, however it certainly merits
investigation. Either way, as a journal we advocate that there is
a need to build a database which narrates the aims, objectives
and most importantly outcomes of pharmaceutical policy
based projects – what is achieved and what is lost, whether the
research has transformed into action or not.
2 Southern Med Review Vol 3 Issue 1 Feb 2010
Review Article
A bibliometric study of publication patterns in access to medicines research in developing countriesLindsay Sarah Ritz1,2, Taghreed Adam3, Richard Laing2 1 MPH Candidate, Dept. of International Health, Pharmaceutical Assessment, Management and Policy program, Boston University School of Public Health, USA.2 Dept. of Essential Medicines & Pharmaceutical Policies, World Health Organization, Geneva.3 Alliance for Health Policy and Systems Research, World Health Organization, Geneva.
Address for Correspondence: Lindsay Sarah Ritz, Dept. of International Health, Boston University School of Public Health, Boston, MA, USA. E-mail: [email protected]
Citation: Ritz LS, Adam T, Laing R. A bibliometric study of publication patterns in access to medicines research in developing countries. Southern Med Review (2010) 3; 1:2-6
Abstract Objectives: Developing countries face considerable problems in both accessing and properly utilizing essential medicines. One
challenge to achieving these goals in resource-poor settings is a limited knowledge base as to what works to improve the selection,
access and use of essential medicines including; ways to ensure affordable prices, increase sustainable financing, and strengthen
reliable supply systems that are relevant to these settings. The objective of this study was to search the existing evidence base on access
to medicine issues in developing countries and to assess publication patterns regarding the nature of topics studied, areas where gaps
of information exist and the general trends in publications in this area.
Methods: A PubMed search was conducted to retrieve publications on access to medicines in developing countries between 1999
-2008. Our search strategy builds and expands on a search strategy developed for a Cochrane review to include a wider range of topics
related to access to medicines and pharmaceutical policy. Retrieved articles were categorized by research topics, year of publication,
study area, and country of residence of corresponding author to establish patterns in publications with respect to these categories over
the past 10 years.
Results: Medicine selection, intellectual property rights, and monitoring and quality assurance were among the top topics studied
over the last 10 years. Corresponding authors residing in high-income countries represented around 50% of all publications relative
to low-income (18%) and middle-income countries (32%). Although an increasing trend in the number of publications per year was
found, the increase was relatively small and variable over a 10-year period.
Conclusions: There are few peer-reviewed publications on access to medicines in developing countries with an average of only 76
publications per year over the past 10 years. Increasing the local evidence base as to what works to improve access to medicines in
resource poor countries, particularly to the poor, is of the utmost priority to accelerating the achievement of global medicine goals.
Keywords: Bibliometrics, Access to Medicines, Essential Medicines, Drug Utilization
to 90% of people in developing countries have to pay for their
medicines out-of-pocket3. Individuals affected by these high
payments are disproportionately poor and medicines remain
unaffordable for many 2,3,4.
In 1978, the Declaration of Alma Ata identified the quality,
rational use and provision of essential medicines as one of
the eight key components of primary health care1. During
the 1985 Conference of Experts on Rational Use of Drugs in
Nairobi, the modern definition of rational use of medicines
was promulgated. This definition states, “rational use of
BackgroundThirty-two years have passed since the World Health Organization
(WHO) created the first Model Essential Medicines List (EML) in
1977 as a standard for countries to select medicines and to create
their own lists of essential medicines1. Increasing access to these
essential medicines is crucial to preventing millions of deaths
a year2. As of 2008, at least four out of every five countries in
the world had a national EML in place1. Medicines account for
20 – 60% of health spending in developing countries, and up
3Southern Med Review Vol 3 Issue 1 Feb 2010
A bibliometric study of publication patterns in access to medicines research
drugs 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 community5.” In both 1988 and 2003,
the WHO published Guidelines for Developing National Drug
Policies to help member countries create and improve their
own national policies and to increase access to medicines.
Despite all of these landmarks, the problems of limited access
to and the irrational use of medicines still persist, especially in
the developing world and for the world’s poorest citizens. One
factor could be the limited knowledge base in resource-poor
settings6. These countries are not well equipped to apply existing
knowledge to create effective mechanisms for improving the
selection and use of essential medicines, ensuring affordable
prices, increasing sustainable financing, and strengthening
reliable supply systems7. A solid and diverse evidence base is key
to informed policy making1,8.
Recently, four Cochrane reviews were published on
pharmaceutical policy, dealing primarily with pricing, financial
incentives for prescribers, rational use and the effects of caps and
co-payments on rational use9-12. However, very few of the papers
considered in these reviews were from developing countries.
In August 2008, the United Kingdom’s Department for
International Development (DfID) proposed the establishment
of a global Access to Medicines Research Network (ATM RN)
involving both high-income and developing country research
institutions13. The purpose of the ATM RN is to address the issue
of poor people’s access to essential medicines by producing
policy research on the topic, specifically focusing on medicine
availability, quality and utilization. One of the main priorities of this
network is to promote the generation and use of new research
on pharmaceutical policy relevant to developing countries and to
build capacity of developing country researchers to set priorities
for and undertake research relevant to their own settings13.
The objective of this study was to perform a bibliometric
analysis of publications related to access to medicines policies
in the published literature to assess the state of access to
medicines research in developing countries. Bibliometrics look at
publication patterns in research areas using quantitative analysis
and statistics to analyze citation data. An examination of the
nature of existing evidence through analysis of the data by topic
and study region occurred. Publication patterns were examined
to explore changes in the output of and capacity for research
in developing countries over the past 10 years. These findings
will serve as evidence based guide for the proposed ATM
Research Network and in setting priorities and building capacity
for research related to pharmaceutical policy in developing
countries in the future.
MethodologyA bibliometric search was performed in PubMed, building
on a search strategy developed in a Cochrane review on
pharmaceutical policy and expanded to include a wider range of
topics related to this area12. The targeted search included studies
published between 1999-2008. However in examining trends
we also explored any recent change in trends, i.e., between
2005 and 2008 that may be linked to the various initiatives to
improve research for health around this period, e.g., the Mexico
Summit for Health Research and efforts to accelerate progress
towards achieving the millennium development goals for health.
Articles were selected if they met the following criteria:
1. Focus on one or more of the following themes:
• Medicines regulation and classification (licensing) policies
• Drug monitoring
• Medicines selection
• Medicines pricing policies
• Medicines intellectual property/patent policies
• Medicines marketing policies
• Medicines information
• Prescribing policies
• Medicines utilization or medicines use
• Medicines insurance policy and medicines financing
• Medicine reform/policy
• Access to Medicines
• Medicines supply management
2. Publications concerning developing countries
3. Publication date: 1999 to 2008
4. Limited to human subjects
5. All languages were included
Studies on substance abuse or poisoning were excluded.
Retrieved articles and methods for analysis
A total of 761 publications were retrieved for the period
between 1999-2008; 350 were published between 2005-2008.
The retrieved citations were downloaded from the PubMed
database and analysed using Reference Manager and Excel
software. Extracted data included author names, publication
title and abstract, publication date, affiliation and country of
residence of corresponding author, study area, main theme with
respect to the categories listed above, and journal.
Three publications from 1999-2008 were eliminated because
they were published in 2009, this occurred because they were
published electronically in 2008. Only 535 publications had data
on country of residence of corresponding author.
The retrieved articles were further analyzed to categorize the
country of residence of corresponding author according to
World Bank country income classification and the World Bank
and the geographical regions14,15. A more detailed report
including the search strategy is available from the WHO16.
4 Southern Med Review Vol 3 Issue 1 Feb 2010
A bibliometric study of publication patterns in access to medicines research
We also analyzed the frequency of publications by topic for the
retrieved articles. This was done in two stages. The first following
the detailed topics listed above for the selection criteria and the
second using a more general categorization involving fewer
overarching content areas. The aggregated categories included
procurement, quality assurance and references to pharmacists.
It should be noted that the proportion of articles published by
theme does not add up to 100% as some articles are classified
under more than one theme.
ResultsTable 1 shows the distribution of articles per year. Although there
was a general increasing trend in the number of publications per
year, there was some fluctuation between years.
Table 1. Number of publications per year, 1999-2008
Year Number of Publications
1999 40
2000 48
2001 83
2002 75
2003 81
2004 84
2005 78
2006 59
2007 114
2008 96
The overall correlation reflecting the association between the
number of publications and year was 0.715 p< 0.05. The
R-squared value 0.51 suggests a steady and significant increase
over the 10 years.
Figure 1. Number of publications per year, 1999 – 2008
We cannot explain the increase in publications between 2006
and 2007. Further analysis revealed that authors residing in
Brazil tripled their previous contribution of four papers in 2002
to 12 in 2007, which may explain some of this difference.
However this was not sustained in 2008, when a total of 96
papers were published.
The top aggregated themes for both time periods were selection,
intellectual property, monitoring, regulation and quality
assurance, access, and insurance and financing. Monitoring
moved from fourth most common theme in 1999-2004 to the
most important theme from 2004-2008. Since several themes
might have been addressed in the same paper, this analysis only
gives a general description of the distribution and does not add
up to 100%, see Table 2.
Despite a limited increase in studies related to pharmaceutical
policy and reform, these papers ranked 7th for themes studied
in 2005-2008. The bottom four themes of pharmacists,
prescribing/utilization, information and marketing remained the
same for both time periods.
On average, 50% of corresponding authors resided in high-
income countries both during the whole 10-year period (1999-
2008) and the last four years (2005-2008). Corresponding
authors residing in low-income countries represented 18% and
19%, on average, of the total number of papers over the past
10 years and four years respectively, see Figure 2.
Table 2. Publication topics and numbers per year grouping
1999-2004 No. 2005-2008 No.
Selection 135 Monitoring 106
Intellectual Property 88 Selection 98
Regulation & Quality Assurance
84Regulation & Quality Assurance
62
Monitoring 70 Intellectual Property 46
Insurance and Financing
39 Access 35
Access 24Procurement & Distribution
25
Procurement & Distribution
21 Policy/Reform 17
Medicine Supply 13Insurance and Financing
16
Policy/Reform 9 Medicine Supply 12
Pharmacists 8 Pharmacists 11
Prescribing & Utilization
8Prescribing & Utilization
11
Information 4 Information 6
Marketing 3 Marketing 2
R2 = 0.5122
0
20
40
60
80
100
120
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008
5Southern Med Review Vol 3 Issue 1 Feb 2010
A bibliometric study of publication patterns in access to medicines research
Figure 2. Country of residence of corresponding authors by World Bank region
Figure 3 shows the contribution of the EURO and AMRO WHO
regions, who combined represent on average around 50% of
the total publications per year during the analysis period. The
next biggest contributors were authors residing in the Western
Pacific region with around 14% of publications per year on
average. EMRO country authors only contributed a total of 45
articles (8.5%) for the entire time period of 1999-2008, the
lowest of all WHO regions.
The top eight countries of residence of corresponding authors
in 2008 were the United States, the United Kingdom, Brazil,
China, India, the Republic of Korea, Nigeria and Japan, (Table
3). The following six countries all contributed two publications
in 2008 (Australia, Egypt, Malaysia, the Netherlands, Sweden
and Switzerland). Out of the 46 total publications representing
the top eight countries in 2008, 35% were from corresponding
authors residing in developing countries (China, India and
Nigeria). Korea went from 1to 2 articles a year for only four of
the previous nine years to six articles in 2008.
Figure 3. Country of residence of corresponding authors by World Health Organization region
Table 3. Top eight countries of residence of corresponding author, 2008
CountryNumber of Publications
United States of America 8
United Kingdom 7
Brazil 6
China 6
India 6
Republic of Korea 6
Nigeria 4
Japan 3
Discussion
Publications over time
While the number of publications has increased over the period
of review, there is considerable variation over the last decade.
These findings highlight the importance of examining the
content and geographical origin of publications over a series of
years rather than assuming that a cross-sectional examination at
a point in time is generalizable over a number of years.
Topics
Insurance and financing has dropped off in terms of relative
interest in recent years. This is concerning when one considers
that in developing countries, medicines account for 20-60%
of overall health care spending compared with less than
15% in most high-income countries2. The increased focus
on drug monitoring including adverse drug reaction and
pharmacovigilance in the developing world are heartening
since there seems to be a greater interest in whether or not
the medicines are working effectively.
Publications related to Intellectual property (IP) were high in
both time periods, since IP continues to create interest and
further policy debate. Publications on prescribing and utilization
remained low over the 10-year period. There is a need for
greater attention to the patterns of prescribing and utilization
of drugs to provide important data sources if policy planning is
to take place in the future. Such data will contribute to a better
understanding of how to best prioritize medications in low and
moderate-income countries.
Country of Origin of Corresponding Author
As predicted, high-income countries contributed most to
research on access to medicines relative to middle and low-
income countries. The EURO and AMRO regions were the
01999 2000 2001 2002 2003 2004 2005 2006 2007 2008
10
20
30
40
50
60
70
80
90
100 Low incomeLower middle incomeUpper middle incomeHigh income
01999 2000 2001 2002 2003 2004 2005 2006 2007 2008
10
20
30
40
50
60
70
80
90
100 AFRO (Africa)AMRO (the Americas)EMRO (Eastern Mediterranean)EURO (Europe)SEARO (South-East Asia)WPRO (Western Pacific)
6 Southern Med Review Vol 3 Issue 1 Feb 2010
A bibliometric study of publication patterns in access to medicines research
highest contributors to the literature on access to medicines.
Developing country authors have recently contributed to a
higher share of publications related to access to medicines in
their respective countries, which shows increased interest and
capacity to undertake this type of research from developing
country researchers.
Limitations
One of the main limitations of this study was limiting our search
to only the PubMed search engine and the journals covered by
this database. In addition this search does not include studies
published in the grey literature, sometimes the most common
form of publication in the developing world, but which is often
difficult to access. However, since the objective of this study
was to search for the nature of the evidence and its distribution
among topics and study areas, we believe that this analysis
provides a fair representation of the general trends regarding
the evidence. This study also provides a baseline with which to
compare future studies.
ConclusionAccess to essential affordable medicines is a Millennium
Development Goal. There is a need for increased capacity of
developing country researchers to perform research and take
the lead in choosing questions relevant to them, study the
issues and publish to share their knowledge. The evidence
base on medicines pricing, quality, affordability and the impact
of policies in developing countries should be strengthened to
better inform policy.
The recent initiative to create an ATM research network with
a particular focus on developing countries and other similar
initiatives will hopefully address some of these knowledge
gaps. The ATM Research Network could catalyse collaborative
opportunities for and investments in more relevant research
for the developing world, as well as increase the capacity to
undertake and use evidence from this research to improve
access to essential medicines in developing countries. Creating
and fostering cooperation and future integration between
developing and developed world institutions is an important
strategy to build this capacity and to achieve a sustainable
solution for improving access to medicines in developing
countries through informed policy-making.
This study provides the first bibliometric analysis of publications
in the access to medicines field. The findings presented in this
paper provide a solid basis for setting priorities for research on
access to medicines in developing countries and for monitoring
the progress in the knowledge base over time. In addition,
the search strategy developed for this analysis will assist policy
makers in identifying evaluations for different pharmaceutical
policy options and will inform future studies interested in both
the development of the field as well as in gathering the latest
evidence on available interventions.
AcknowledgmentsThis work was conducted in Geneva and Boston as an internship
activity through the Pharmaceutical Assessment, Management
and Policy program at Boston University School of Public Health
and the WHO Geneva.
References1. World Health Organization. Essential Medicines List (EML) 30
years of vital health care. Geneva: 2008. http://www.who.int/mediacentre/factsheets/fs325/en/index.html (Accessed 22 June 2009).
2. World Health Organization. WHO Medicines Strategy 2008-2013 [document on the Internet]. Geneva: 2008. http://www.who.int/medicines/areas/policy/medstrategy_consultation/en/index.html (Accessed 22 June 2009).
3. Cameron A, et al. Medicine prices, availability, and affordability in 36 developing and middle-income countries: a secondary analysis. Lancet 2009. 373: 240–249.
4. MDG Gap Task Force. Millennium development goal 8. Delivering on the global partnership for achieving millennium development goals. Geneva: 2008. http://www.who.int/medicines/mdg/MDG8EnglishWeb.pdf (Accessed 12 Aug. 2009).
5. World Health Organization. The rational use of drugs: report of the Conference of Experts, Nairobi. Geneva: 1987.
6. Harris E. Building scientific capacity in developing countries. EMBO Report 2004; 5(1): 7-11.
7. UN Millennium Project. Prescription for Healthy Development: Increasing Access to Medicines. Report of the Task Force on HIV/AIDS, Malaria, TB, and Access to Essential Medicines, Work ing Group on Access to Essential Medicines. 2005. Sterling, VA: Earthscan.
8. Bennett S, et al. From Mexico to Mali: progress in health policy and systems research. Lancet 2008; 372(9649): 1571-1578.
9. Aaserud M, et al. Pharmaceutical policies: effects of reference pricing, other pricing, and purchasing policies. Cochrane Database Syst Rev 2006, Issue 2. Art. No.: CD005979.
10. Austvoll-Dahlgren A, et al. Pharmaceutical policies: effects of cap and co-payment on rational drug use. Cochrane Database Syst Rev 2008, Issue 1. Art. No.: CD007017.
11. Sturm H, et al. Pharmaceutical policies: effects of financial incentives for prescribers. Cochrane Database Syst Rev 2007, Issue 3. Art. No.: CD006731.
12. Aaserud M, et al. Pharmaceutical policies: effects on rational drug use, an overview of 13 reviews (Protocol). Cochrane Database Syst Rev 2006, Issue 2. Art. No.: CD006731.
13. DfID, Access to Medicines Research Network On-line Consultation: Summary of Responses. London: 2008. http://www.dfid.gov.uk/Documents/consultations/ATMRN-consult-summary.pdf (Accessed 23 June 2009).
14. World Bank. Country Groups. 2009. http://go.worldbank.org/D7SN0B8YU0 (Accessed 22 June 2009).
15. WHO. WHO – its people and offices. 2009. http://www.who.int/about/structure/en/index.html (Accessed 22 June 2009).
16. Ritz L, et al. Access to medicines Publications in Developing Countries: A Bibliometric Study and its Implications for the Access to Medicines Research Network. [document forthcoming]
7Southern Med Review Vol 3 Issue 1 Feb 2010
Review Article
Community pharmacy based research activity in India: A bibliometric study of the past ten yearsSubal Chandra Basak, Dondeti Sathyanarayana
Department of Pharmacy, Annamalai University, Annamalainagar 608002, Tamilnadu, India
Address for Correspondence: Subal Chandra Basak, Department of Pharmacy, Annamalai University, Annamalainagar 608002, Tamilnadu, India. E-mail: [email protected]
Citation: Basak SC, Sathyanarayana D. Community pharmacy based research activity in India: A bibliometric study of the past ten years. Southern Med Review (2010) 3; 1:7-10
AbstractObjectives: The objective of this study was to analyze and record the published evidence regarding community pharmacy practice in
India during the past decade (1998-2008).
Methods: A bibliometric review analysis of the original papers was undertaken to assess the different aspects of community pharmacy
practice in India. The MEDLINE, Index Copernicus, IndMed, DOAJ databases and the journals such as Indian Journal of Pharmaceutical
Sciences and Indian Journal of Hospital Pharmacy were used as data sources. Type of papers, type of journals, category of papers,
production indicators and impact factor of the journals were analyzed.
Results: Thirty papers were included in the study. The papers were published in 13 different journals, 33.3% of them being in the
Indian Journal of Hospital Pharmacy. The average number of authors per paper was 2.73 (SD=1.41). Impact factor was available for
only three journals.
Conclusions: There are limited studies being published in India which cover the community pharmacy related activities in India. The
key indicators which emerge from the literature review present some fundamental challenges to the development of the role of the
community pharmacist in India.
Keywords: Community pharmacy, India, Community pharmacy practice, Bibliometric review
community based pharmacy activities. Also, in the recent decade
or so, there has been a noteworthy increase in the number of
presentations at national conferences focusing activities in
community pharmacies necessitating the need to record the full
extent of community pharmacy based publication.
Study of publication patterns, known as bibliometric study is
a useful tool for obtaining information and trends in a certain
subject area. There are reviews of the scientific literature
concerning community pharmacies in various countries3-4, but
there is no bibliometric analysis focusing on Indian community
pharmacy publications. The aim of this study was to undertake
a bibliometric analysis of the published literature regarding
community pharmacy practice in India.
MethodsA bibliometric review of articles or papers that described the
community, retail or private pharmacy practice in India was
undertaken. The search covered the period 1998 to December
IntroductionThe expansion of the role of community pharmacists was given
an important boost in 1990, when Hepler and Strand1 coined
the term ‘pharmaceutical care’. However, community pharmacy
is not considered a well established healthcare profession in
India. Community pharmacies are managed by less qualified
(as compared to many countries) diploma trained pharmacists.
Recently many pharmacists, institutions and professional
organizations have indicated a clear strategy for pharmacist’s
involvement in management of modern medicines including
their selection, optimization, safe and cost effective therapy.
Though for sometime the World Health Organization has had
a vision for the pharmacists’ role in health promotion2 and in
safe and effective use of medicines. To date the involvement of
Indian community pharmacists in such activities are not known.
Recently revised and new journals such as Indian Journal of
Hospital Pharmacy, Indian Journal of Pharmacy Practice and
International Journal of Community Pharmacy are focusing on
8 Southern Med Review Vol 3 Issue 1 Feb 2010
Community pharmacy based activity in India
2008 using Medline/Pubmed, Index Copernicus, IndMed and
DOAJ databases. A direct search was made in primary sources,
specifically in the journals Indian Journal of Pharmaceutical
Sciences (online) and Indian Journal of Hospital Pharmacy
(offline). Google, Google Scholar and Scirus search engines
were also used.
Search strategies included the terms: community (or retail,
private) pharmacy in India, community pharmacy practice in
India and community (or retail) pharmacist in India. For the
PubMed/Medline search, the term community pharmacy and
India was used. The search strategy for the review included
all the permutations of each term, including plurals as well
as associated words: pharmacy, pharmacies, pharmacist,
pharmacists, pharmacists’, drug retailer(s) among others.
Reference lists of retrieved papers were also scanned for other
relevant papers.
Papers or articles were included in the review if they met the
following criteria: English language, publication dates between
1998 to December 2008, relevant to community pharmacy,
and research (or review) based on Indian scenario. The study
restricted to English language as the language for pharmacy
teaching, administration, management and practice is English
in India. Papers were excluded if they were hospital and clinical
studies. Editorials, letters, and articles available in pharmacy
news weeks or periodicals were also excluded.
The search strategies were refined after conducting pilot
searches. All terms were searched for in title, abstract and
main body text. We reviewed the outcome of each search. The
title and the abstract of the articles retrieved were analyzed
to identify original papers. Identification of relevant papers
was based on strict predetermined criteria. All original papers
(research and review) which provided an aspect of community
pharmacy based activity were included in our study. The articles
restricted to opinions and studies that did not involve community
pharmacists/ pharmacies were excluded. Also excluded were
papers relying on anecdotal evidence to provide a general
overview or statement.
The variables recorded for each paper were: main author,
number of authors, year of publication, journal type, area of
study, origin of bibliographic references. The change in the
number of publications in the period studied, the number of
authors per publication, authors’ affiliation, the citation index,
the impact factor of the journals in which the articles were
published, were all recorded and analyzed.
Results One hundred fifty four papers were identified, of which 109
were journal based, and 45 non journal articles. After excluding
non journal articles and duplicated papers, only 24 complied
with the inclusion criteria. A further 6 relevant papers were
identified from cross reference lists, a total of 30 papers were
therefore included in the review and analysis5-34.
The papers included for consideration were published in 13
journals (Table 1), and 33.33% of the papers were published in
Indian Journal of Hospital Pharmacy. A total of 22 papers were
published in Indian journals, whereas the remaining 8 papers
were published in the Pharmaceutical Historian, Social Science
and Medicine, The Pharmaceutical Journal, Research in Social,
Administrative Pharmacy, American Journal of Health-System
Pharmacist, International Pharmacy Journal and in International
Journal of Tuberculosis and Lung Diseases.
Of all the papers, 36.66% were surveillance studies, 26.6%
case (or research) studies, and remaining reviews, reports or
commentaries. Figure 1 shows number of papers published
during 1998-2008. Four papers published in impact factor
(IF) or indexed journals were contributed by non-pharmacy
researchers.
The total number of authors was 82, which corresponded to
68 different individuals. Seven papers were written by a single
author and the average number of authors per paper was 2.73
(SD=1.41). Sixty three authors from a total of 68 published
one paper (92.6%). The number of authors listed according
to number of paper published is shown in Table 2. The Impact
factors (IF) of the journals in which the papers were published
are depicted in Table1.
Discussion A total of 30 papers on Indian community pharmacy aspects (3
papers per annum) represent a very low rate of publication in
this area of study. There could be many reasons for this including
the non availability of appropriate pharmacy practice journals in
India and also may be long time required for publication in the
leading Indian journals such as Indian Journal of Pharmaceutical
Sciences. More than 50% of the papers are published in 3 Indian
journals; Indian Journal of Hospital Pharmacy, Indian Journal of
Pharmaceutical Education and Research, and Indian Journal of
Pharmaceutical Sciences. None of these journals are included
in the Science Citation Index (SCI) of the Journal Citation
Reports (JCR) database managed by the Institute for Scientific
Information (ISI) and therefore is not considered for the impact
0
8
98 99 00 01 02 03 04 05 06 07 08
No.
of
pape
rs p
ublis
hed
2
1
6
3
2
1
3
4
3
4
1
Figure 1. Distribution of papers by year of publication
9Southern Med Review Vol 3 Issue 1 Feb 2010
Community pharmacy based activity in India
Table 1. Distribution of papers and journals impact factor (IF)
Journal ISSNArticles published
IF (year)
Indian Journal of Hospital Pharmacy
0019-526X 10 No
Indian Journal of Pharmaceutical Education and Research*
0019-5464 4 No
Indian Journal of Pharmaceutical Sciences
0250-474X 3 No
Eastern Pharmacist 0012-8872 3 No
International Journal of Tuberculosis and Lung Diseases
1027-3719 22.24 (2007)
Research in Social and Administrative Pharmacy
1551-7411 1 NA
Pharma Review 0973-399X 1 No
American Journal of Health-System Pharmacist
1079-2082 11.71 (2007)
International Pharmacy Journal
1010-0423 1 No
Pharmaceutical Historian (London)
0079-1393 1 No
Social Science and Medicine
0277-9536 12.45 (2007)
The Pharmaceutical Journal
0031-6873 1 No
International Journal of Community Pharmacy
NA 1 No
NA- Not available; *-Previous name- Indian Journal of Pharmaceutical Education
factor (IF) calculation. The absence of IF and non-indexation in
those databases prevents wide publicity or further citation of
the work. However, recently the latter two journals are included
in Science Citation Index Expanded database, which will boost
citation index of the papers published in these journals. Many
of the studies carried out are descriptive studies of community
pharmacy practice primarily concerned with a limited number of
specific issues and a few are speculative opinion. Also, there is
no study involving controlled randomized experimental designs.
The results may, however, serve as an indictment of pharmacy
policy and decision makers for failing to encourage researchers
about the discipline.
To our knowledge this is the first bibliometric study of the
literature in the community pharmacy based research in India.
The community pharmacy practice aspects in India are neglected
field in terms of scientific publication output as compared with
the publication of papers in other fields of pharmaceutical
sciences. There is a need to undertake research into community
pharmacists’ activities and to systematically assess their
education and training needs.
Table 2. Number of authors according to the number of papers published
No. of papers 1 2 3 5 8
Authors 63 02 01 01 01
Percent 92.6 1.47 1.47 1.47 1.47
ConclusionWe conclude that only a small number of research or review
articles on community pharmacy activity were available. This is
perhaps indicative that less emphasis has been placed on the
community pharmacy research necessitating the need to focus
on the areas such as medicine utilization and appropriate use
of medicines.
Acknowledgements The authors thank Prof V. Srinath of Department of
Pharmacy, Annamalai University for his invaluable advice and
encouragement.
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pharmaceutical care. Am J Hosp Pharm1990;47:533-543.
2. The role of the pharmacist in the health care system. Report of a WHO Consultative Group, New Delhi, India, 13-16 December 1988. WHO/PHARM/94.569.
3. Sokar-Todd HB, Einarson TR. Community pharmacy practice research: a systematic review of the past 32 years. Can Pharm J 2003;136(8):26-38.
4. Andres Iglesias JC, Andres Rodriguez NF, Fornos Perez JA. Community pharmacy-based research in Spain (1995-2005): a bibliometric study. Pharm Pract 2007;5(1): 21-30.
5. Patil S, Kadam S, Jadav N. Assessment of retail pharmacists for professional approach in western maharastra. Int J Community Pharm 2008;1(3):28-33.
6. Gharat MS, Bell CA, Ambe GT, Bell JS. Engaging community pharmacists as partners in tuberculosis control: a case study from Mumbai, India. Res Social Adm Pharm 2007;3(4):464-70.
7. Carvalho S, Nagavi BG. Impact of Community Pharmacy based patient education on the Quality of Life of Hypertensive Patients. Indian J Pharm Educ Res 2007;41(2):164-169.
8. Adepu R, Rasheed A, Nagavi BG. Effect of patient counseling on quality of life in type-2 diabetes mellitus patients in two selected south India community pharmacies: A study. Indian J Pharm Sci 2007;69(4):519-524.
9. Chhatwani K, Mahtani A, Jangir A, Bhambhani G, Lala RR. Status of pharmacists in modern Indian society. Indian J Hosp Pharm 2007;44:174-177.
10. Kumar BJM, Ramesh A, Nagavi BG. Impact of patient education in a South Indian community pharmacy on health related quality of life in patients with diabetes mellitus. Indian J Pharm Educ Res 2006;40(1):34-39.
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33. Jani TR, Shah D. Community pharmacy. Indian J Hosp Pharm1998;35: 217-227.
34. Kamat VR, Nichter M. Pharmacies, self-medication and pharmaceutical marketing in Bombay, India. Soc Sci Med 1998;47(6):779-94.
11. Adepu R, Nagavi BG. General practitioners’ perceptions about the extended roles of the community pharmacists in the state of Karnataka. Indian J Pharm Sci 2006;68 (1):36-40.
12. Van Sickle D. Management of asthma at private pharmacies in India. Int J Tuberc Lung Dis 2006;10(12):1386-1392.
13. Sawant KK, Yedurkar PD, Ahire VJ, Shah PJ, Sheth NY. Are we ready for community pharmacy in India?-a case study. Indian J Hosp Pharm 2005;42:66-69.
14. Talegaonkar S, Iqbal Z, Jalees FA, Gaud RS. Creating future pharmacists: introducing community service in the pharmacy curriculum Indian J Pharm Educ 2005;39(1): 47-50.
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16. Dandiya PC. The community pharmacy of my country. Pharma Review 2005; 4(19): 61-62.
17. FIP Meetings Report. How pharmaceutical services are provided to patients around the world. The Pharmaceutical Journal 2004;273:359.
18. Sogali SR, Nagavi BG. Perceptions of community pharmacist on misbranding of drugs: A study. Indian J Hosp Pharm 2004;41:49-53.
19. Chowdary KPR, Ramaprasad LA, Swarnalatha P, Srinivasa Rao K, Haritha VL. A critical study of competency of community pharmacists in new standard of practice. Indian J Hosp Pharm 2004;41:105-106.
20. Adepu R, Nagavi BG. Community Pharmacy Practice: A Review. Indian J Pharm Educ 2003;37:14-27.
21. Rajeswari R, Balasubramanian R, Bose MS, Sekar L, Rahman F. Private pharmacies in tuberculosis control--a neglected link. Int J Tuberc Lung Dis 2002;6(2):171-173.
22. Basak SC, Arunkumar A, Masilamani K. Community pharmacists’ attitudes towards use of medicine in rural India – An analysis of the current situation. Int Pharm J 2002;16 (2): 32-35.
23. Mohanta GP, Manna PK, Valliappan K, Manavalan R. Achieving good pharmacy practice in community pharmacies in India. Am J Health Syst Pharm 2001;58(9):809-10.
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25. Singh H. European pharmacies in Colonial India. Pharm Hist (Lond) 2001;31(4):58-67.
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27. Rajendran SD, Satish T, Ulaganathan K. Impact of improved pharmacy services in community pharmacies on patient perception. Indian J Hosp Pharm 2000;37:11-13.
28. Basak SC. Community Pharmacist’s involvement in maximizing use of medicines in rural areas, Eastern Pharmacist 2000;43(Dec):39-42.
29. Ramesh A, Nagavi BG, Ramanath KV. A critical review of community pharmacies (drug stores) in Mysore city. Indian J Hosp Pharm 2000;37:91-93.
30. Miglani BD. Pharmaceutical care vis-à-vis hospital and community pharmacy. Indian J Hosp Pharm 2000;37:129-138.
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11Southern Med Review Vol 3 Issue 1 Feb 2010
Research Article
Medicines information in medical journal advertising in Australia, Malaysia and the United States: A comparative cross-sectional studyNoordin Othman1, 2, Agnes Isabelle Vitry1, Elizabeth Ellen Roughead1
1Quality Use of Medicines and Pharmacy Research Centre, School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, Australia. 2Kulliyyah of Pharmacy, International Islamic University Malaysia, Kuantan, Pahang, Malaysia.
Address for Correspondence: Noordin Othman, Quality Use of Medicines and Pharmacy Research Centre, School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, Australia. Email: [email protected]
Citation: Othman N, Vitry AI, Roughead EE. Medicines information in medical journal advertising in Australia, Malaysia and the United States: A comparative cross-sectional study. Southern Med Review (2010) 3; 1:11-18
AbstractObjective: The aim of this study was to compare the provision of medicines information in medical journal advertising in Australia,
Malaysia and the United States.
Methods: A consecutive sample of 85 unique advertisements from each country was selected from the advertisements published
between January 2004 to December 2006 in three widely circulated medical journals and one prescribing reference manual. The
availability of brand name and generic name, indication, contraindications, dosage, side-effects, warnings, interactions and precautions
was compared between the three countries.
Results: We examined 255 distinct advertisements for 136 pharmaceutical products. Journal advertising in Australia, Malaysia and
the US usually provided brand names and generic names (range 96 -100%). Information on dosage was significantly less likely to be
mentioned (32%) in the US than in Australia (92%) and Malaysia (48%) (P < 0.001). Warning information was significantly less likely
to be provided in Australia (5%) than in the US (81%) and Malaysia (9%) (P < 0.001). Apart from information on brand name, generic
name, warnings and dosage, other product information significantly less likely to be provided in journal advertising in Malaysia than
in Australia and the US (P < 0.001). Similar trends in the provision of product information for the same medicines published in these
countries were noted. Brand name and generic name were always provided in the three countries (100%). However, information on
the negative effects of medicines was less frequently provided in Malaysia than in Australia and the US.
Conclusions: Journal advertising in Australia, Malaysia and the US failed to provide complete product information. Low quality of
information provided in Malaysia indicates the need for effective regulation of provision of medicines information in journal advertising.
Different standards of medicines information provided in these three countries suggest that pharmaceutical promotion needs to be
better controlled at the international level.
Keywords: Pharmaceutical advertisements, promotion, regulation, Malaysia, Australia.
Following the World Health Organization (WHO) Conference
of Experts on the Rational Use of Drugs in1985, the WHO
has introduced a set of Ethical Criteria for Medicinal Drug
Promotion7. The Ethical Criteria for Medicinal Drug Promotion
was established to support and encourage the improvement
of health care through the rational use of medicinal drugs7.
It sets out the general standards for ethical promotion of
pharmaceutical products that can be used as a model by
governments7.
Introduction
Journal advertising is used by pharmaceutical companies as a
marketing strategy to promote pharmaceutical products to
health professionals. In 2004, pharmaceutical companies in the
United States (US) spent $0.5 billion on journal advertising 1.
The companies have been criticised for providing poor quality
information2-4 that may negatively influence doctors’ prescribing
behaviour5, 6.
12 Southern Med Review Vol 3 Issue 1 Feb 2010
Medicines information in journal advertising in Australia, Malaysia and the United States
The International Federation of Pharmaceutical Manufacturers
Association (IFPMA) code of conduct sets standards for the
ethical promotion of medicines by pharmaceutical companies8.
The IFPMA code generally is based on the WHO Ethical Criteria
for Medicinal Drug Promotion7. However, the IFPMA code allows
less medicines information to be presented in advertisements
than the WHO Ethical criteria7, 8. Contrary to the WHO Ethical
Criteria, the IFPMA code does not require information on
warnings, major interactions, and content of active ingredient
per dosage form or regimen and name of other ingredients
known to cause problems to be provided in advertisements. The
IFPMA code requires that all promotional material should be
consistent with locally approved product information8.
In addition to the IFPMA, in most countries pharmaceutical
promotion is controlled by governmental agencies9 and/or by
the pharmaceutical companies through voluntary codes of
conduct, most often underpinned by legislation10.The US is a
country with a long-established control system by governmental
agencies9. Australia11 and Malaysia12 are examples of developed
and emerging countries, respectively, where pharmaceutical
companies self-regulate their promotional activities by
implementing voluntary codes of conduct which complement
the requirements set by government legislation. The codes,
regulations and legislation provide standards for all types of
promotional materials for prescription medicines including all
printed and audiovisual promotional materials.
In Australia, pharmaceutical advertising is regulated by
government legislation through the Therapeutic Goods Act
198913. Medicines Australia, which represents research-based
pharmaceutical companies, administers a code of conduct for
promotional practice11. Similarly, in Malaysia pharmaceutical
advertising for prescription medicines is regulated by government
legislation through the Medicine (Advertisement and Sale) Act
195614. The Pharmaceutical Association of Malaysia (PhAMA),
which represents pharmaceutical companies, administers a
code of conduct as a guide for the advertising of prescription
medicines12. Adherence to the codes is a condition of Medicines
Australia and PhAMA membership. Failure to comply with
the codes will result in sanctions including discontinuation or
modification of any practice that is determined to breach the
code, the issuance of retraction statements, fines, suspension or
expulsion from Medicines Australia or the PhAMA11, 12.
In the US, pharmaceutical promotion is regulated by the
Food and Drug Administration (FDA)15. The FDA’s Division of
Drug Marketing and Communication (DDMAC) is responsible
for ensuring that promotion of medicines is in compliance
with the FDA’s rules and regulations15. The laws require that
pharmaceutical advertising provide accurate and balanced
information relating to the medicine’s risks and benefits16. FDA
may issue regulatory letters to any pharmaceutical company
that is found to be in breach of the laws. The letters may serve
as a basis for additional regulatory action including recalls or
seizures of promotional materials or activities, and criminal
prosecution16.
Most pharmaceutical companies are international companies.
Generally, every pharmaceutical company has their own
set of ethical standards based on the standards set forth in
the IFPMA code of conduct. According to the codes that are
publicly available17-19, promotional materials should support
the appropriate use of medicines by presenting information
accurately, without exaggeration and must follow all relevant
local laws and company policies and procedures.
Despite the existence of regulations and control of medicine
promotion, the quality of medicines information in journal
advertising has been questioned. A systematic review20
identified nine studies that evaluated provision of medicines
information. Three were multinational comparative studies and
seven studies were single country studies. The multinational
comparative studies revealed that the provision of balanced
medicines information in journal advertising was a problem
both in developed and developing countries. The negative
effects of a medicine, which may discourage use of that
medicine, less commonly appeared in advertisements. All of
the multinational comparative studies were published before
1998. Similar to multinational studies, single country studies
suggested that medicines information was poorly presented
in journal advertising. In 1992, a content analysis of 109
pharmaceutical advertisements in ten leading American medical
journals found that in 40% of the cases, information on efficacy
was not balanced with that on contraindications and side
effects 21. In Australia, only one study22 examined the availability
of medicines information in journal advertising. In 1994, in a
review of 12 advertisements in four medical journals, 9% failed
to mention approved names of the medicines22.The provision
of information on the negative aspects of medicines, which
is essential for appropriate use of medicines, was not further
explored in this study.
To our knowledge, no study has assessed the quality of medicines
information in journal advertising in Malaysia and the most
recent studies in Australia and the US were published in 1994
and 1992 respectively. No comparative study has been conducted
on the quality of medicines information in journal advertising
among these three countries. Moreover, no comparative data is
available on the presentation of medicines information for the
same products in different countries. This study provides the first
data on the standards of journal advertising in Malaysia, recent
data on the quality of information in journal advertising in
Australia and the US, and also comparative data on the quality
of information in journal advertising in Australia, Malaysia and
the US.
We aimed to compare the provision of medicines information in
medical journal advertising in Australia, Malaysia and the United
States. The specific objectives were:
– to compare the availability of medicine information (brand
name, generic name, indications, contraindications, dosages,
side-effects, warnings, interactions and precautions) in
pharmaceutical advertisements.
13Southern Med Review Vol 3 Issue 1 Feb 2010
Medicines information in journal advertising in Australia, Malaysia and the United States
– to assess whether specific aspects of Medicines Australia’s
and Pharmaceutical Association of Malaysia’s (PhAMA) codes of
conduct were implemented in practice.
– to compare the availability of medicines information in
pharmaceutical advertisements for the same medicines
promoted in Australia, Malaysia and the US.
MethodsThis research was specifically designed as an exploratory and
descriptive analysis of the availability of medicines information
in medical journal advertising in Australia, Malaysia and the
United States.
Selection of advertisements
We used a convenience sample of one major national family
practice journal in Australia and the US. As there was no such
journal in Malaysia, we chose the Medical Journal of Malaysia
and the Monthly Index of Medical Specialities (MIMS), the latter
because it is widely used by general practitioners as a reference.
The journals selected to cover primary care practitioners’
publications were:
– Australian Family Physician, which is the official journal of the
Royal Australian College of General Practitioners (readership =
38,608 with about 28,000 of these being general practitioners)
(Jonathon Tremain, personal communication 2009 Feb 02).
– American Family Physician, which is the official clinical journal
of the American Academy of Family Physicians (readership =
over 188,200, no data are available on the general practitioners’
readership)23. MIMS, which is regarded as an official drug reference
of the Malaysian Medical Association (MMA) (readership = 7000,
with about 4200 of these being general practitioners) (Eileen
Khoo, personal communication 2009 Feb 03),
– Medical Journal of Malaysia (MJM), which is the only
Malaysian medical journal that is subscribed by the three
established medical schools in Malaysia, University of Science
Malaysia, National University of Malaysia and University
Malaya (readership = over 3500, no data are available on the
general practitioners’ readership) (Matilda Cruz, personal
communication 2009 Feb 03).
We estimated that the majority of general practitioners in
Australia subscribed to the Australian Family Physician. However,
we were unable to accurately estimate the percentages of
general practitioners subscribed to the journals and prescribing
index in Malaysia and the US because the information on the
total number of general practitioners for each country was not
available in the public domain.
A consecutive sample of 85 unique advertisements from
each country was chosen from the selected publications.
The publications were published between January 2004 to
December 2006. An abstraction form was developed to record
the availability of product information.
All prescription medicine advertisements were extracted. A
product advertisement different from other advertisements for
the same product in terms of graphic presentation or written
content was considered to be one unique advertisement. All
unique advertisements of the same product that appeared
in separate issues of a publication were counted as one
advertisement.
The availability of brand name and generic name, indication,
contraindications, dosage, side-effects, warnings, interactions
and precautions in the main body of advertisements and separate
fine print product information was recorded. The separate fine
print product information that appeared on different page of
advertisement but in the in the same publication was considered
as part of the advertisement if there was a statement provided
to readers to refer to it.
The presence or absence of information on Pharmaceutical
Benefit Scheme (PBS) listings and restrictions (a requirement
of Medicine Australia’s code of conduct) and the provision of
minimum abbreviated product information which must include
approved indication, dosage, contraindications, precautions and
side effects (a requirement of the Pharmaceutical Association of
Malaysia’s (PhAMA) code of conduct) was also recorded.
Data analysisData entry was undertaken using SPSS database version 14.0.
Chi-square analysis was used to assess differences between
countries. The Bonferroni correction for multiple comparisons
was applied in dividing our significance level (0.05) by the
number of tests that were conducted, and applied the value as
our new cut off level for statistical significance.
ResultsInter-rater reliability
All data were extracted by one researcher. Three other
researchers, a researcher from Australia, a pharmacist and
a family medicine specialist from Malaysia, independently
determined the availability of product information in a randomly
selected sample of 30 advertisements from each country. The
availability of product information was defined as the presence
or absence of any information on brand name, generic
name, indications, contraindications, dosages, side-effects,
warnings, interactions and precautions. We did not assess the
completeness or accuracy of product information. Kappa tests
were conducted with STATA version 10 to assess the consistency
between observers. Kappa (κ) for inter-rater reliability for the
presence or absence of product information between the
researchers was 0.91 (almost perfect agreement) (z = 63.3, p
< 0.001)24.
A total of 255 distinct advertisements for 136 pharmaceutical
products were included in the analysis. All advertisements in the
US (n=85) and none in Australia and Malaysia referred readers
to separate fine print product information. All advertisements
were published over a two-year period (Table 1).
14 Southern Med Review Vol 3 Issue 1 Feb 2010
Medicines information in journal advertising in Australia, Malaysia and the United States
Table 1. Circulation list of advertisements
Country 2004 2005 2006 Total
Australia 15 32 38 85
Malaysia 33 31 21 85
US 24 25 36 85
Availability of product information
The availability of product information varied between countries
(Figure 1 and 2). In the US, most information was frequently
found in advertisements (range 81-100%). However, information
on dosage was significantly less likely to be mentioned (32%)
than in Australia (92%) and Malaysia (48%) (χ2 = 66.8; df=2,
P < 0.001). Similar to the US, in Australia, most information
was always provided (92-100%) but warning information was
significantly less likely to be provided (5%) than in the US (81%)
and Malaysia (9%) (χ2 = 144.1; df=2, P < 0.001).
In Malaysia, information on side effects, contraindications,
warnings, interactions and precautions appeared in less than
half of advertisements (range 9-41%). Apart from information
on brand name and generic name, warnings and dosage, other
product information was significantly less likely to be provided
in advertisements published in Malaysian journals than in
Australian and US journals (P < 0.001).
Nearly all advertisements (98%) appearing in the Australian
medical journals provided information on Pharmaceutical
Benefit Scheme (PBS) listings and restrictions. In Malaysia,
31% of advertisements provided the minimum abbreviated
product information including approved indication, dosage,
contraindications, precautions and side effects as required by
the Pharmaceutical Association of Malaysia (PhAMA) code of
conduct.
Availability of product information for the same medicines by country
Four medicines were advertised in all the three countries in
32 unique advertisements (Table 2). One company promoted
two medicines and three companies promoted one medicine
respectively. Product information for all categories except
for brand name, generic name, dosage and warnings was
significantly less likely to be provided in advertisements published
in Malaysia compared with Australia and the US (Figure 3 and
4). Our analysis of availability of product information for the
same medicines found that brand name and generic name were
always provided by all the pharmaceutical companies in the
three countries. However, information on the negative effects
of medicines was less frequently provided in Malaysia than in
Australia and the US (Table 3).
DiscussionPharmaceutical advertisements in medical journals in
Australia, Malaysia and the US usually provided brand names
and generic names. Information on indications, side effects,
contraindications and precautions was more commonly provided
in Australia and the US than in Malaysia. Information on dosage
was less commonly mentioned in the US and information on
0
10
20
30
40
50
60
70
80
90
100
Brand name Generic name Indication*# Dosage*+
Product information* for p < 0.001 for comparison Australia/Malaysia,# for p < 0.001 for comparison Malaysia/US,+ for p < 0.001 for comparison Australia/US,Non significant if no symbol
AustraliaMalaysiaUS
Perc
enta
ge
0
10
20
30
40
50
60
70
80
90
100
Product information* for p < 0.001 for comparison Australia/Malaysia,# for p < 0.001 for comparison Malaysia/US,+ for p < 0.001 for comparison Australia/US,Non significant if no symbol
Perc
enta
ge
Side e
ffects
*#
Contra
indica
tions
*#
War
nings
*#+
Inter
actio
ns*#+
Preca
ution
s*#
AustraliaMalaysiaUS
Figure 1. Comparative availability of information on benefits of medicines in advertisements (n/85 x 100%)
Figure 2. Comparative availability of information on harmful effects of medicines in advertisements (n/85 x 100%)
15Southern Med Review Vol 3 Issue 1 Feb 2010
Medicines information in journal advertising in Australia, Malaysia and the United States
Table 2. Number of the same products advertised in Australia, Malaysia and in the United States
Generic name Brand name Company Australia
nMalaysia
nUS n
Total n
Candesartan Atacand® AstraZeneca 3 1 1 5
Ezetimibe/simvastatin Vytorin®MSD and Schering-Plough
2 1 1 4
Esomeprazole Nexium® AstraZeneca 4 2 1 7
Atorvastatin Lipitor® Pfizer 4 8 4 16
Total 13 12 7 32
warnings less likely to be provided in Australia. Similar trends
in the provision of product information were noted for the four
products advertised in these three countries. Pharmaceutical
companies in Australia nearly always provide information on the
Pharmaceutical Benefit Scheme (PBS) listings and restrictions.
Two-thirds of advertisements in Malaysia failed to provide
the minimum abbreviated product information as required
by Pharmaceutical Association of Malaysia (PhAMA) code of
conduct12.
Complete information on benefits and risks of medicines
provided in pharmaceutical promotion is crucial to doctors
in order to determine the most appropriate treatment
for patients. However, we found that essential information
on negative effects of medicines was frequently missing in
Malaysia compared with Australia and the US. Similar findings
have been observed in two comparative multi-country studies,
where more balanced information was provided in developed
countries than in an emerging country25, 26. Even the minimum
abbreviated prescribing information required by the Malaysian
PhAMA code of conduct12 was not commonly provided in our
study. The failure of pharmaceutical companies in Malaysia to
provide balanced and complete information as required by their
marketing code is even more a concern as Malaysia has no
comprehensive independent source of prescribing information
unlike Australia and the US. Malaysian doctors may be more
likely to rely on commercial sources of information27.
The quality of medicines information in journal advertising is
lower in Malaysia than in Australia despite apparent similarities
in the type of advertising control via the industry code of
conducts. There may be several reasons which could explain
the differences observed. Firstly, the administration of the code
0
10
20
30
40
50
60
70
80
90
100
Brand name Generic name Indication*# Dosage*+
Product information* for p < 0.05 after adjustment for multiple comparisons for Australia/ Malaysia,+ for p< 0.001 for comparison Australia/US,other results assumed to be non significant if no symbol
Perc
enta
ge
AustraliaMalaysiaUS
0
10
20
30
40
50
60
70
80
90
100
Product information* for p < 0.05 after adjustment for multiple comparisons for Aus/Mal,^ for p< 0.001 for comparison Aus/Mal,+ for p< 0.001 for comparison Aus/US,& for p< 0.001 for comparison Mal/US,Non significant if no symbol
Perc
enta
ge
Side e
ffects
Contra
indica
tions
*
War
nings
+
Inter
actio
ns*&
Preca
ution
s
AustraliaMalaysiaUSFigure 3. Comparative availability of information on
benefits for the same medicines advertised in the three countries (n/85 x 100%)
Figure 4. Comparative availability of information on harmful effects for the same medicines advertised in the three countries (n/85 x 100%)
16 Southern Med Review Vol 3 Issue 1 Feb 2010
Medicines information in journal advertising in Australia, Malaysia and the United States
Table 3. Availability of product information for the same medicines by each company
CompanyAustralia n=7
Malaysia n=3
US n=2
AstraZeneca Brand name, generic name, indications, dosage, side effects, contraindications and interactions were provided in all advertisements. Precautions were missing in two advertisements and warnings were missing in all advertisements.
Brand name, generic name, indications, dosage, side effects, contraindications, interactions and precautions were provided in all advertisements. Warnings and precautions were missing in one advertisement.
Brand name, generic name, indications, dosage, side effects, contraindications, interactions and precaution were provided in all advertisements. Warnings were missing in one advertisement.
CompanyAustralia n=4
Malaysia n=8
US n=4
Pfizer Only information on warnings was not provided in all advertisements.
Only brand name and generic name were provided in all advertisements
Only information on dosage was not provided in all advertisements.
CompanyAustralia n=2
Malaysia n=1
US n=1
Schering -Plough and Merck Sharp and Dohme
Brand name, generic name, indications, dosage, side effects, contraindications and interactions were provided in all advertisements. Warnings and interactions were missing in all advertisements.
Only brand name and generic name were provided in the advertisement.
Only information on dosage was not provided in the advertisement.
of conduct in Australia is a transparent process. Medicines
Australia publishes on its website comprehensive reports on all
code breaches and sanctions imposed28. In Malaysia, no similar
information is available in the public domain. The PhAMA ethics
committee discloses information about its rulings and the names
of companies involved in complaints only to its members12.
Public reporting of violations of the code is a strong incentive
for pharmaceutical companies to comply with the code in order
to avoid negative publicity and deterioration of their public
image29. The availability of information on complaints, code
breaches and sanctions may discourage repeated breaches
and support a more careful approach to future promotional
activities29.
Secondly, the range of financial sanction imposed is lower in
Malaysia than in Australia. PhAMA code of conduct states
that a company that is found to be in breach could be fined
up to US $ 13,917.00, much less than in Australia (up to US
$ 135,280.00)12. This level of financial sanction is still small
compared to the amount of money invested by pharmaceutical
companies on promotion30. Increasing the amount of fines may
deter pharmaceutical companies from breaching the code29.
Efforts to improve the quality of medicines information provided
in advertisements published in Malaysian medical journals
are needed. A range of policy options need to be considered
including the improvement of the PhAMA code of conduct by
requiring public reporting of all code violations and increasing
the financial sanctions when advertisements are found in
breach of the code. Other policy options include proactive
screening of all advertisements by an independent body before
they are published in medical journals. This may prevent the
dissemination of incomplete information to doctors which may
lead to irrational prescribing. The Malaysian Advertisements
Board (MAB) 14 is a unit of Ministry of Health Malaysia which
oversees medicines advertisements in Malaysia. To date,
the MAB has only provided a guideline on the promotion of
non-prescription medicines to the public 14. It scrutinises all
publications from the print and electronic media concerning
the use of medicines by the public. Although the MAB is
empowered by law to set policies, directives and guidelines for
all advertisements related to medicines that have medical and/
or health claims, its activities do not focus on direct-to-doctors
advertising 14. The role of the MAB needs to be expanded to
oversee direct-to-doctors advertising.
Most advertisements (95%) published in Australia failed to
provide information on warnings. In contrast with Malaysia and
the US, the Australian minimum product information 11 only
requires provision of information on boxed warnings and not
on all warnings included in the product information. Further
analysis of the Australian advertisements found that only one
advertisement did not provide the required box warning as
included in the product information. Our results suggest that
there is a need for Medicines Australia to strengthen its code of
17Southern Med Review Vol 3 Issue 1 Feb 2010
Medicines information in journal advertising in Australia, Malaysia and the United States
conduct to include the requirement for warnings in the minimum
product information. Australian health professionals may be
missing important safety information in journal advertising.
Unlike in Australia and Malaysia, information on dosages is not
required in the American advertisements 15. Only a minority
of pharmaceutical companies in the US voluntarily provided
information on dosages in advertisements (32%). These findings
suggest that most pharmaceutical companies will only provide
the medicines information when they are required to do so.
The FDA should be proactive in updating the requirements for
the provision of medicine information in advertisements; given
dosage information is essential for correct prescribing as well as
for the appropriate use of medicines.
Our analysis on the provision of product information for the
same medicines marketed in the three countries is limited by the
small sample size ( 32 advertisements for four products). The
medicines were promoted for cardiovascular and gastrointestinal
diseases. At the time the advertisements appeared in journal
advertising, the medicines were new and no generic options
were available. The medicines provided no incremental benefit
and in some countries they were more expensive than existing
treatments. Moreover, the market for these medications was
huge with global sales estimated at US$ 59 billion in 200631.
However, essential information required for appropriate
prescribing was often missing in advertisements of the same
medicines published in Malaysia compared with Australia and
the US. All companies that had a product included in our analysis
have their own guideline or code of conduct on pharmaceutical
promotion32-35. All guidelines and codes of conduct state that
companies have to comply with relevant international and local
regulations. However, the different standard of information
provided in these three countries suggests that the companies
apply their marketing standards differently in different
countries. Our findings lend support to earlier observations that
some pharmaceutical companies employ different standards
in their promotional activities in countries with different types
of controls and resources to control promotional activities36.
Collaboration between regulating bodies in different countries
would be beneficial in controlling multi-country pharmaceutical
promotion activities.
Our study showed that medicines information in journal
advertising across these three countries was often incomplete
and the problem was not limited to a developing country. These
results are consistent with the findings of a recent systematic
review that showed that the low quality of information in
journal advertising was a global issue20. Effective control over
incomplete medicines information in journal advertising would
appear necessary not only in developing countries where
regulation of pharmaceutical promotion might be weak but also
in developed countries which have stricter regulations10.
Our study was limited by the sample size. The results may not be
generalisable to other countries and other medicines. Our study
was designed to assess the presence or absence of product
information. We did not attempt to examine the accuracy or
completeness of information.
ConclusionPharmaceutical companies provide different standards of
medicines information in Australia, Malaysia and the US. Less
medicine information was provided in journal advertising in
Malaysia than in Australia and the US. Warnings and dosage
information was less likely to be presented in advertisements in
Australia and the US respectively. As information on medicines
in pharmaceutical promotion may influence doctors’ prescribing
practices, regulation of promotional practices in Australia,
Malaysia and the US need to be strengthened, both by the
government and pharmaceutical companies. Effective regulatory
systems to control pharmaceutical promotional activities in
countries with different local standards is crucial.
Competing Interests: Two of the authors Noordin Othman
and Agnes Vitry and one of the reviewers Robyn Clothier are
members of Healthy Skepticism, an international non-profit
organisation aiming to improve health by reducing harm from
misleading drug promotion. Azidah Abdul Kadir has been funded
by several pharmaceutical companies to perform research,
attend conferences and has received speaking honorariums.
Acknowledgements: We thank Robyn Clothier (Healthy
Skepticism, Adelaide, Australia), Dr Azidah Abdul Kadir
(Department of Family Medicine, School of Medical Sciences,
Universiti Sains Malaysia, Health Campus, Kelantan, Malaysia)
and Rohana Hassan (Department of Pharmacy, Seberang
Jaya Hospital, Penang, Malaysia) for their help in reviewing
advertisements for the inter-rater reliability test.
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19Southern Med Review Vol 3 Issue 1 Feb 2010
Research Article
Antimicrobial use in a country with insufficient enforcement of pharmaceutical regulations: A survey of consumption and retail sales in Ulaanbaatar, Mongolia Rie Nakajima1, Takehito Takano2, Vaanchig Urnaa2, Nyambayar Khaliun1
, Keiko Nakamura1
1International Health and Medicine, Graduate School of Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku Tokyo, Japan2Health Promotion, Graduate School of Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku Tokyo, Japan
Address for Correspondence: Takehito Takano, Department of Health Promotion, Tokyo Medical and Dental University, 1-5-45 Yushima,
Bunkyo-ku Tokyo, Japan. E-mail: [email protected]
Citation: Nakajima R, Takano T, Urnaa V, Khaliun N, Nakamura K. Antimicrobial use in a country with insufficient enforcement of pharmaceutical regulations: a survey of consumption and retail sales in Ulaanbaatar, Mongolia. Southern Med Review (2010) 3; 1:19-23
AbstractObjective: To examine the inappropriate use of antimicrobials by investigating (1) actual utilization pattern and retail sales and (2)
antimicrobial resistant information provided by health professionals in Ulaanbaatar, Mongolia.
Methods: We investigated antimicrobial use in Ulaanbaatar, Mongolia by surveying 619 consenting customers who attended 250
randomly chosen pharmacies in December 2006. Pharmacy staff were also interviewed about antimicrobials purchased. In January
2007, we surveyed 117 consenting Ulaanbaatar medical doctors from seven local hospitals about their perceptions of treatment failure
due to antimicrobial resistance.
Results: Among 619 pharmacy customers, 48% of them had bought at least one type of antimicrobial medicine and, of these,
42% had a prescription to purchase antimicrobials. On average, 67% of the customers reported that a pharmacy worker had given
them information regarding the dose and timing at which the medicine should be used but only 9% reported that they had been
given information regarding possible adverse effects. The survey of medical doctors suggested that some antibiotics had become less
effective clinically between 2001 and 2006.
Conclusion: The study shows that less than half of all customers who purchased an antibiotic at a pharmacy had a prescription. This
shows that antimicrobials can be readily purchased without a prescription despite the existence of laws making such practices illegal.
There is a need to establish a vigilant drug regulatory authority to promote enforcement and regulation of medicines in Mongolia. To
create awareness regarding the dangers of antimicrobial resistance, educational campaigns for consumers are also necessary.
Keywords: antimicrobial utilization, antimicrobial resistance, developing country, Mongolia.
Organization (WHO) warns that the purchase of antimicrobials
without a prescription leads to the misuse and overuse of
antimicrobials, resulting in the emergence of antimicrobial-
resistant pathogens1.
Many developing countries have a limited ability to
manufacture antimicrobial medicines; therefore, they must
obtain antimicrobial medicines from other countries. Numerous
commercial dealers of pharmaceutical products compete with
IntroductionDuring the past few decades, the number of antimicrobial-
resistant pathogens has increased rapidly in many parts of
the world1. Of note, the rate of increase of antimicrobial-
resistant pathogens in Asia is the highest in the world2-4. One
of the major reasons for the increase in antimicrobial-resistant
pathogens in many developing countries is that antimicrobials
can be purchased without a prescription5. The World Health
20 Southern Med Review Vol 3 Issue 1 Feb 2010
Antimicrobial use in Ulaanbaatar
one another to extend sales in developing countries, providing
imported medicines to meet the demand for antimicrobials in
these countries6. However, the control and regulation measures
for the sale of pharmaceuticals in developing countries are often
insufficient. Mongolia is one such country where antimicrobials
can be widely purchased without a prescription, despite the
existence of laws prohibiting this act. Penalties imposed on
offenders guilty of such acts include closure of a store where
such a trade has been conducted7. Despite this, the measures
to control and regulate the sale and purchase of antimicrobials
in Mongolia are insufficient8, 9. This is a problem that not only
affects Mongolia, but also impacts many developing countries
throughout the world10-12. In this context, the objectives of
the present study were to explore the antimicrobial utilization
pattern and retail sales; another objective was to explore the
perceptions of clinicians regarding antimicorbial resistance.
MethodsWe conducted three surveys using structured questionnaires:
one for pharmacy workers, one for pharmacy customers, and
one for practicing medical doctors. The study protocol was
approved by the ethical review boards of the Tokyo Medical and
Dental University and the Ministry of Health, Mongolia.
Study area
The study was carried out in Ulaanbaatar, the capital city
of Mongolia, where the general public’s accessibility to
antimicrobials has been rapidly increasing in recent years as a
result of the rapid economic development.
Mongolia is a landlocked central Asian country, with a total area
of 1.6 million square kilometers. Among the total 2.7 million
populations, 32% are living in Ulaanbaatar, the capital of
Mongolia8. On the financial side, the Mongolian economy has
experienced positive GDP growth averaging 8.7 percent from
2004 to 200613.
Mongolia’s current health system has been evolving for more
than 70 years and is characterized by three levels of care: primary,
secondary and tertiary care14. Although these health facilities still
do not meet the current needs of the country, 8 it is reported that
for every 1000 Mongolians 2.7 physicians are available14. Health
insurance was introduced in 1994 and it is estimated that about
78% of the population is covered. However, it is still common
that patients have to pay out of pocket in private pharmacies to
obtain the necessary medications8.
Subjects, sampling and questionnaire procedures
The pharmacies surveyed in the present study (both pharmacy
workers and customers) were selected from a list provided by
the Mongolian Ministry of Health. A total of two hundred and
fifty pharmacies were randomly selected from amongst the five
hundred pharmacies registered in Ulaanbaatar. Interviewers of
the pharmacy and customer survey were clinical pharmacology
professionals with sufficient knowledge of antimicrobials and
pharmaceutical practice. A three day training workshop was
conducted to train the interviewers, providing them with
knowledge and interviewing skills. Two interviewers visited
each of the pharmacies and interviewed the pharmacy staff.
Following individual interviews with the pharmacy workers,
the study team spent one hour outside of the pharmacy and
approached customers who had just left the pharmacy and
asked for their cooperation in completing a short interview. A
total of 619 pharmacy customers agreed to participate in the
study.
The survey for practicing medical doctors was a self-administered
report based on a structured questionnaire form: the reports
were collected after a complete explanation of the purpose
of the survey and a step-by-step explanation of the questions
had been made by specially trained doctors. All queries were
collected and answers and clarifications were given to the
participating medical doctors before they submitted their
completed questionnaire forms. The self-administered survey of
the medical doctors was completed by 117 medical doctors who
agreed to participate in the study. These doctors were selected
from amongst 7 leading hospitals in Ulaanbaatar .
Face to face in depth interview of ten medical doctors were
conducted. These doctors were randomly selected from
participants of the medical doctor’s survey. These doctors
answered questions regarding antimicrobial therapy. The
questions were also asked regarding doctors’ knowledge on
Centre for Disease Control guidelines15.
Questionnaire items
The interview questionnaire for the pharmacy workers included
the following items: the names of all the antimicrobial medicines
sold at the pharmacy (regardless of strength), the average
number of customers who bought medicine per day, and
the average number of customers who bought antimicrobial
medicine per day during the two week period prior to the study.
The interview questionnaire for the pharmacy customers
included the following items: customer’s age, sex, educational
background, purchase of antimicrobial and non antimicrobial
medicines, types and whether it was the oral or injectable form.
The other questions were age, symptoms of the expected user
of the medicine, presentation of the prescription (to purchase
antimicrobial medicines), and instructions given by the pharmacy
staff regarding the use of the medicines.
The self-administered questionnaire for the medical doctors
asked for their professional estimates as to the current
prevalence of antimicrobial resistance, their clinical experiences
with antibiotics and the expected number of ineffective
treatments encountered during the application of each of the
antimicrobial agents.
Period of the survey
The pharmacy staff and customer interviews were conducted
in December 2006, while the survey of medical doctors was
performed in January 2007. The study was performed during
21Southern Med Review Vol 3 Issue 1 Feb 2010
Antimicrobial use in Ulaanbaatar
the winter season because the prevalence of acute respiratory
infection is typically high during this time and thus a large
number of antimicrobials are prescribed.
Analysis
All data were entered and analyzed using SPSS software (version
14.0). The average numbers of pharmacy customers who bought
specific antimicrobial medicines per fifty customers (who bought
both antimicrobial and non-antimicrobial medicines) from that
pharmacy were calculated for each type of antimicrobial. This
indicator was used to represent the retail sales of antimicrobials.
ResultsResults and knowledge from pharmacy workers reveal the
types of antimicrobials which has been sold to customers at
pharmacies during the two weeks prior to the study (Table 1).
Table 1. Types of antimicrobials sold to customers at community pharmacies in Ulaanbaatar, Mongolia
Group Name
Penicillins Benzylpenicillin
Phenoxymetylpenicillin
Oxacillin
Ampicillin
Amoxicillin
Cephalosporins Cefazolin
Cefrtiaxone
Cephalexin
Aminoglycosides Gentamycin
Tetracyclines Tetracycline
Doxycycline
Macrolides Erythromycin
Clarithromycin
Azithromycin
Others Chloramphenicole
Vancomycin
Synthetic antibacterial medicines
Sulfonamide Sulfamethoxazole-trimethoprim
Quinolones Ofloxacin
Ciprofloxacin
Others Metronidazole
Antimicrobials reported to have been sold during the 2 weeks
prior to the interview day at community pharmacies.
Table 2. Number of customers who bought antimicrobials per 50 customers who visited pharmacies to buy medicine.
Antimicrobials Number of customers who bought antimicrobials per 50 customers who visited pharmacies to buy medicine*
Mean ± SD
Amoxicillin 6.2 ± 5.5
Ampicillin 5.9 ± 5.3
Benzylpenicillin 1.3 ± 2.1
Phenoxymethylpenicillin 1.3 ± 2.3
Cefazolin 1.5 ± 2.2
Chloramphenicol 2.9 ± 3.7
Ciprofloxacin 2.3 ± 3.5
Doxycycline 1.7 ± 2.6
Erythromycin 2.8 ± 2.9
Gentamycin 1.0 ± 1.8
Metronidazole 5.8 ± 4.9
Sulfamethoxazole-
trimethoprim
5.4 ± 4.8
* Average for 250 pharmacies located in Ulaanbaatar, Mongolia.
Table 2 shows the number of customers who bought each
type of antimicrobial medicine per 50 customers who visited
pharmacies to buy medicine.
Among the 619 pharmacy customers who agreed to participate
in this study, 48.0% of them (297 customers) had bought at
least one type of antimicrobial medicine. Among those who
bought antimicrobials, 42.1% of them (125 customers) had a
prescription for the antimicrobial medicine that was purchased.
Antimicrobials commonly used by injection were benzylpenicillin
(used by 90% of customers who bought antimicrobials),
cefazolin (80%) and gentamicin (90%).
The most common reasons for purchasing antimicrobials
were acute respiratory disease (54.8%), genitourinary disease
(15.5%), and gastrointestinal disease (10.7%). Among the
pharmacy customers who suffered from acute respiratory
disease, 45.1% of them bought oral penicillin, either amoxicillin
(24.6%) or ampicillin (20.5%). The most common strength
of these two antimicrobials was 500 mg (selected by 70% of
customers who bought amoxicillin or ampicillin), and rest of
them (30%) bought 250 mg which mainly used for children.
22 Southern Med Review Vol 3 Issue 1 Feb 2010
Antimicrobial use in Ulaanbaatar
Table 3. Instructions given by pharmacy staff to customers regarding various parameters
Antimicrobials
n
Dose & timing
Side effect
Allergies
% % %
Amoxicillin 91 65.9 3.3 6.6
Ampicillin 76 63.2 11.8 9.2
Benzylpenicillin 9 66.7 11.1 11.1
Phenoxymethyl-
penicillin
4 50.0 0.0 25.0
Cefazolin 12 66.7 25.0 8.3
Chloramphenicol 23 43.5 4.3 0.0
Ciprofloxacin 11 90.9 9.1 9.1
Doxycycline 9 100.0 11.1 0.0
Erythromycin 10 60.0 10.0 0.0
Gentamycin 11 45.5 0.0 0.0
Metronidazole 26 69.2 7.7 11.5
Sulfamethoxazole-
trimethoprim
22 72.7 13.6 13.6
Table 3 shows the summary of instructions given by pharmacy
workers to pharmacy customers. On average, 67.3% of the
customers reported that a pharmacy worker had given them
information regarding the dose and timing at which the
medicine should be used; 8.9% of them reported that they had
also been given information regarding adverse effects.
The study reveals that the doctors feel that the medicines such
as benzyl penicillin, gentamicin, metronidazole, ampicillin,
phenoxymethyl penicillin, and ciprofloxacin are no longer very
effective in treatment as they may have a problem of antibiotic
resistance.
Discussion
The results of the pharmacy worker and pharmacy customer
surveys were consistent, with about half of the pharmacy
customers purchasing antimicrobial medicines: the pharmacy
worker survey indicated that an average of 4.6 (SD = 1.8) out
of 10 customers purchased antimicrobial medicines, while the
pharmacy customer survey showed that 48.0% of the pharmacy
customers purchased antimicrobial medicines. The results of
the pharmacy worker and pharmacy customer surveys also
consistently showed that 40% of the customers who purchased
antimicrobials had a prescription: the pharmacy worker survey
reported that 4.0 (SD = 2.3) out of 10 customers who purchased
antimicrobials had a prescription, while the pharmacy customer
survey showed that 42.1% of the customers who purchased
antimicrobials had a prescription. These results are based on
customers who visited community pharmacies in Ulaanbaatar.
The pharmacy worker survey indicated that, amoxicillin and
ampicillin, sulfamethoxazole-trimethoprim, and metronidazole
were the most frequently sold antimicrobials in Ulaanbaatar
pharmacies. The frequent sale of amoxicillin and ampicillin, both
of which are oral penicillins, as over-the-counter drugs has also
been reported in Vietnam and Mexico16, 17. The frequent use
of these medications is most likely explained by their cost and
availability: amoxicillin and ampicillin are generally less expensive
than other antimicrobials, and over 70% of all pharmacies
throughout the world sell amoxicillin18. All pharmacies in the
present study sold both amoxicillin and ampicillin. Generally,
variations in the types, frequency, and methods in which
antimicrobials are used by the general public vary in countries
according to disease patterns, patient characteristics, and
the quantity and quality of care services at health facilities19.
Variations in the general characteristics of antimicrobial use
in developing counties also arise from the ability to purchase
antimicrobials inexpensively and without a prescription.
Among the pharmacy customers who bought over-the-
counter medicines, more than half of the customers were
seeking treatment for acute respiratory diseases; amoxicillin
and ampicillin were sold to more than half of these customers.
Antimicrobials were also frequently sold to patients suffering
from genitourinary or gastrointestinal diseases.
Antimicrobials sold to these patients included not only
penicillins, but also a wide range of other antimicrobials
including chloramphenicol and gentamicin. There is a concern
that the amount of antimicrobial use is related to the increase
in drug-resistant pathogens20. In fact, our survey of perception
of medical doctors showed that the antimicrobials which were
frequently sold in community pharmacies were losing their
effectiveness for the treatment of patients.
High consumption of antimicrobials among patients with
common diseases such as acute respiratory disease and
gastrointestinal disease were frequently reported in several
countries16, 17 and the same has been observed in Mongolia.
Especially the patients who are suffering from genitourinary
disease are on rise in Mongolia and these patients frequently
visit community pharmacies.
There is a tendency in developing countries to take antimicrobials
even when their symptoms are not serious or even when
there are no signs of infection21. One such medicine is
chloramphenicol, which is widely used in developing countries,
primarily because it is cheap and broad spectrum. However, this
medicine is now rarely used in developed countries because of
its serious adverse effects, such as the development of aplastic
anemia22. The present survey shows that chloramphenicol is
commonly used in Mongolia, especially for the treatment of
gastrointestinal disease. However, the present study shows that
23Southern Med Review Vol 3 Issue 1 Feb 2010
Antimicrobial use in Ulaanbaatar
only 4% of the customers, who purchased chloramphenicol,
received information regarding side effects.
To date, there have been limited laboratory studies conducted
on antimicrobial sensitivity in Mongolia and it is difficult to
establish whether antimicrobial resistance has increased or not.
Hence, promoting the use of an antimicrobial sensitivity test
before prescribing antimicrobials is an important approach to
monitor and to control the further emergence of antimicrobial
resistance.
Although it is a crude measure of changes in resistance,
this survey of experienced medical doctors in Ulaanbaatar
also suggested that based on their clinical experience some
antimicrobials are losing their effectiveness for the treatment of
patients with infectious disease.
There are no specific antibiotic guidelines in Mongolia and it
is necessary to promote and establish best practice clinical
guidelines. These guidelines should not be limited to medical
doctors, but should also target and include pharmacists and
pharmacy workers. The knowledge of pharmacy workers about
antimicrobials play a key role in promoting the rational use
of antimicrobials, considering the fact that many consumers
purchase directly in Ulaanbaatar. Hence, the education of
prescribers and dispensers (including drug sellers) is important
for appropriate antimicrobial use and for the containment of
antimicrobial resistance.
This study provides an understanding of the sale and use of
antimicrobials by a sample of the general public in Ulaanbaatar,
Mongolia. At present, the public can purchase antimicrobials for
the treatment of common diseases, such as acute respiratory
infection, without requiring a prescription and without receiving
proper instructions regarding the use of such medicines. The
development of comprehensive and consistent control measures
at national level to regulate the medicine quality and distribution
is urgently needed in Mongolia. Also, antimicrobials should not
be available as over-the-counter drugs.
ConclusionThe present study is first of its kind and it explores the use of
antimicorbials in Mongolia. The study reveals that antibiotics
are commonly available in Mongolia and the consumers have
easy access to these medicines. Establishing a drug regulatory
authority could improve the enforcement and also can aid to
improve the quality use of antimicrobials. Mass educational
campaigns could also create awareness regarding the use of
antimicrobial in Mongolia.
Conflict of interestsThe authors report no conflicts of interest.
FundingThis study was supported by Grants-in-Aid of Scientific Studies
of the Japan Society for the Promotion of Science.
References1. World Health Organization Global Strategy for Containment of
Antimicrobial Resistance. World Health Organization, 2001. WHO/CDS/DRS/2001.2 http://www.who.int/csr/resources/publications/drugresist/en/EGlobal_Strat.pdf (Accssed 17/11/ 2009)
2. Lee NY et al. Carriage of antibiotic-resistant Pneumococci among Asian children: A multinational surveillance by the Asian Network for Surveillance of Resistant Pathogens. (ANSORP). Clin Infect Dis 2001;32:1463-1469.
3. Song JH et al. High prevalence of antimicrobial resistance among clinical Streptococcus pneumoniae isolates in Asia (an ANSORP study). Antimicrob Agents Chemother 2004; 48:2101-2107.
4. Akita H. Penicillin resistant Streptococcus pneumoniae: Actual condition of overseas. Shonika Rinsho 2002; 55:2291-2296. [in Japanese]
5. Hoban D et al. Demographic analysis of antimicrobial resistance among Streptococcus pneumoniae: worldwide results from PROTEKT 1999-2000. Int J Infect Dis 2005:9; 262-273.
6. WHO. Priority medicines for Europe and the world. In: World Health Organization. 2001. http://archives.who.int/prioritymeds/report/index.htm ( Accssed 17/11/2009)
7 Ministry of health Mongolia. Drugs act of 1998. Ulaanbaatar, Mongolia, 1998. http://moh.mn/moh%20db/Healthreports.nsf/ (Accessed 12 Aug 2009).
8. Bolormaa T et al. Mongolia: Health system review. Health Systems in Transition. 2007; 9: 1-151.
9. Ministry of health Mongolia. Mongolia Pharmaceutical sector assessment report. Ulaanbaatar, Mongolia, 2004.
10. Borg MA, Scicluna EA. Over-the-counter acquisition of antibiotics in the Maltese general population. Int J Antimicrob Agents 2002; 20:253-257.
11. Al Bakri AG et al. Community consumption of antibacterial drugs within the Jordanian population : sources, pattrns and appropriateness. Int J Antimicrob Agents 2005; 26: 389-395.
12. Mitsi G et al. Patterns of antibiotic use among adults and parents in the community: A questionnaire-based survey in a Greek urban population. Int J Antimicrob Agents 2005; 25: 439-443.
13. UNDP. Employment and poverty in Mongolia. In: United Nations Development Programme.2007.http://hdr.undp.org/en/reports/nationalreports/asiathepacific/mongolia/name,3392,en.html (Accessed 20 Nov 2009).
14. WHO Regional Office for the Western Pacific. Country health information profiles. In: World Health Organization Regional Office for the Western Pacific. 2007. http ://www.wpro.who.int/countries/2007/mog/ (Accessed 17 Nov 2009).
15. CDC. Infectious Disease guidelines. In: Centers for Disease Control and Prevention. http://www.cdc.gov/ncidod/guidelines/guidelines_topic.htm (Accessed 10 Aug 2009).
16. Duong DV et al. Availability of antibiotics as over-the-counter drugs in pharmacies: a threat to public health in Vietnam. Trop Med Int Health 1997; 2: 1133-1139.
17. Calva J. Antibiotic use in periurban community in Mexico: a household and drug store survey. Soc Sci Med 1996; 8: 1121-1128.
18. Cameron A et al. Medicines prices, availability, and affordability in 36 developing and middle-income countries: a secondary analysis. Lancet 2008; 373:240-249.
19. Dong H et al. Association between health insurance and antibiotics prescribing in four counties in rural China. Health Policy 1999; 48:29-45.
20. Albrich WC et al. Antibiotic selection pressure and resistance in Streptococcus pneumoniae and Streptococcus pyogenes. Emerg Infect Dis 2004; 10:514-517.
21. Okumura J et al. Drug utilization and self-medication in rural communities in Vetnam. Soc Sci Med 2002; 54:1875-1886.
22. Duke T, et al. Chloramphenicol versus benzylpenicillin and gentamicin for the treatment of severe pneumonia in children in Papua New Guinea: a randomized trial. Lancet 2002; 359:474-480.
24 Southern Med Review Vol 3 Issue 1 Feb 2010
Research Briefs
Assessing different perspectives on the value of a pharmaceutical innovationAlbert Wertheimer1, Larry Radican2, Michael Robert Jacobs1
1School of Pharmacy, Temple University, 3307 North Broad Street, Philadelphia PA 19140, USA.2Global Outcomes Research Department, Merck and Co., Inc., Whitehouse Station, NJ 08889, USA.
Address for Correspondence: Albert I Wertheimer,School of Pharmacy, Temple University, 3307 North Broad Street, Philadelphia PA 19140. Email: [email protected]
Citation: Wertheimer A, Radican L, Jacobs MR. Assessing different perspectives on the value of a pharmaceutical innovation. Southern Med Review (2010) 3; 1:24-28
AbstractNumerous pharmaceutical products are launched each year for the treatment of various medical conditions. The prescriber is in a
difficult position to determine which the optimal product is for a specific patient, when he has available immediate release as well as
sustained action capsules and tablets, chewable tablets and liquid dosage forms. Some have activity within 15 minutes while others
take longer. Some are more costly but have never been implicated with gastric distress; some are very widely prescribed and others are
not well known. Some are promoted as enhancing compliance and others for schedule simplicity.
In order to make sense of the array of diverse product attributes and to determine the value associated with different dosage form
features, separate panels of practicing physicians, practicing pharmacists and patients were asked to ascribe value to a list of 10
drug product features that were mentioned in drug product advertisements in medical journals, by indicating what percentage price
increase that feature might merit over a basic product without that feature. In addition, the respondents were asked to rank order the
mentioned product features.
In all three panels, efficacy and safety were accorded the highest status. Pharmacists and patients appeared to be most welcoming
of some of the listed features. This pilot study demonstrates that there appears to be a recognized value assigned to some product
features and it may differ by audience.
drugs but the prospective prescriber will have to study multiple
monographs, if they even exist, since they are paid for by their
manufacturers and not all drugs are included. No one has the
time to undertake that effort.
Services such as the Medical Letter makes comparisons of
therapeutic areas from time to time, but often these are not
frequent enough to be definitive and they are rather brief. Other
reference works, such as Facts and Comparisons list the most
significant features of the drugs comprising a category but do
not offer recommendations.
And on top of this uncertainty, one can never tell what features
or characteristics are important to an individual prescriber.
The determination of value has been little studied in the
serious professional and scientific literature. In 1993, Coyle
and Drummond published a paper: “Does Expenditure on
Pharmaceuticals Give Good Value for Money: Current Evidence
and Policy Implications,” in Health Policy1 that asked some of
these questions. A few years later in 1996, Grund published
Introduction Pharmaceutical products can often ameliorate disease symptoms,
control and stabilize chronic conditions, reduce risk factors and
even cure some conditions. Some new drugs frequently reach
a market where existing drugs treat the same conditions, often
providing some improvement over the older therapy – e.g.,
perhaps doing so more rapidly, or more safely or with fewer
adverse events or treatment failures. Since new drugs reaching
the market are often not tested “head-to-head”, against current
therapies, but rather are evaluated against placebos in Phase III
registration trials, it is difficult for a pharmacist or prescriber to
assess the relative value of two therapeutic options for the same
condition.
Today, if a physician wants to know which the best product in a
category is, or which drug demonstrates the greatest efficiency,
there are only a limited number of resources to turn to. The
Physician’s Desk Reference (PDR) or MIMS describe individual
25Southern Med Review Vol 3 Issue 1 Feb 2010
Assessing different perspectives on the value of a pharmaceutical innovation
an article, “The Societal Value of Pharmaceuticals: Balancing
Industrial and Healthcare Policy,” in PharmacoEconomics,
but the focus was societal2. More recently, there have been
further efforts to discern value, such as the article by Berndt,
“Pharmaceuticals in U.S. HealthCare: Determinants of Quantity
and Price,” in the Journal of Economic Perspectives3.
Moreover, the pharmacist or physician faces a second hurdle in
that the newer, sometimes improved product may often have a
higher price than the older product. In essence, the prescriber
is caught in the dilemma of having to determine the new
drug’s value. Value can be difficult to define, and is often quite
subjective. This question is faced by consumers of all manner
of goods and services on an everyday basis. Is the self cleaning
oven worth the $100 greater price versus a manually cleaned
oven? Is the video camera with six hours capacity worth the
higher price, compared with a four hour capacity camera?
The assessment of value sometimes becomes so complex
that consumers and potential buyers give up the quest of
independently determining value and turn to professional
resources. In consumer goods, that might be a report in
“Consumer Reports” or in another journal for lay persons. In
health care, for example, a prescriber can review journal reports
about new health technologies, or wait for assessments from
organizations such as the Emergency Care Research Institute
(ECRI), the National Institute for Health and Clinical Excellence
(NICE) or other health technology assessment organizations,
or from respected neutral publications such as “The Medical
Letter” or “Facts and Comparisons”.
Unfortunately though, such product evaluation bodies rarely
conduct or have head-to-head comparisons. They often must
resort to comparing results from different placebo controlled
trials. In addition, the goal of selecting the product(s) of greatest
value is made quite difficult by the wide array of diverse product
features such as differing efficacy claims, tolerability profiles,
formulations, dosage forms and indications.
There are continuing calls for a more efficient and improved,
and less costly health care system in the United States and in
most countries around the globe. Pharmaceuticals account
for more than 10 percent of total healthcare expenditures in
many developed countries, and a higher percentage in lesser
developed countries. Pharmaceuticals are only evaluated
for safety and efficacy in clinical trials, but increasingly they
must demonstrate economic value when compared to other
treatments or no treatment at all. Data on costs and treatment
outcomes (e.g., morbidity, mortality, quality of life) are collected
either prospectively or retrospectively, and economic analysis
such as cost-effectiveness or cost-benefit can be conducted to
ascertain relative value. Pharmacoeconomic studies along with
clinical trial data can often provide a better measurement of
treatment value than clinical trials alone, but unfortunately,
the outcomes data used in pharmaco-economic analysis is not
available until after a product has been on the market for an
extended period of time, such as a year or longer, when there
are a sufficient number of users.
To understand the true value of pharmaceuticals it may be
prudent to go beyond the commonly used outcomes of
morbidity, mortality and quality of life. Indeed other attributes
such as ease of compliance, fewer side effects, doctor familiarity
with the product, patient understanding of the disease
treatment, can also influence how a drug is perceived, valued,
used by patients and ultimately even the outcomes. For the last
twenty years, pharmacoeconomic studies have demonstrated
that certain medications can reduce emergency room visits
and hospital admissions even though they may be expensive
on a first look1; the use of statin therapy to treat people with
high cholesterol, for example, reduces hospital admissions and
cardiac surgeries2; also the use of anti-retroviral drugs reduces
mortality and morbidity for HIV/AIDS patients3,4. In summary,
drugs can be a viable economic alternative to patients being
hospitalized with catastrophic illnesses3.
Some medicines, when taken as prescribed, can reduce costs
in health care and increase productivity. People with depression
often report related ailments such as back pain, headaches, lack
of focus, and even heart disease. While depression treatment
may not directly act upon these other disorders, often it is
associated with more successful treatment, improved worker
productivity and decreased hospitalizations3.
New drugs in a therapeutic class may have fewer side effects,
and improved safety records and effectiveness which encourage
compliance with the prescribed regimens5. Improved compliance
can ultimately lead to better patient outcomes6. So, we are left
with a quandary for health care professionals in their evaluation
of competing drug products.
ObjectiveThe objective of this study was to more fully characterize the
determinants of pharmaceutical product value and to develop
a simplified value assessment methodology to aid in formulary
decision making.
Since today, even without comparative risk/benefit and other
quantitative data, some products within a therapeutic category
become very popular with healthcare providers and others
languish on pharmacy shelves and in warehouses with minimal
sales activity. There must be some features or variables about
these drug products that drive this differentiation.
This study was conducted in an effort to ascertain the perceived
value of selected drug product features.
MethodsSeveral pharmacy students were recruited in 2007 to review
pharmaceutical product advertisements in twelve leading
American medical journals from issues published in 2005 and
2006. From these twelve journals, which comprised general
medical and several medical specialties, drug advertisements
were individually analyzed and the principal message determined
26 Southern Med Review Vol 3 Issue 1 Feb 2010
Assessing different perspectives on the value of a pharmaceutical innovation
and recorded. Messages included claims such as, for example,
“more potent than existing products”, or “new levels of safety”.
The messages from those advertisements (N=200) were
condensed into 10 categories, by the investigators, which are
shown in Table 1. There were, of course, many more messages
in the 200 advertisements that were reviewed, but duplicates
were eliminated as were messages that appeared as only to
inform readers of the availability of a product, without featuring
any advantages or reasons why that specific product should be
prescribed. The investigators reduced the number of message
categories by a continuous chain of refinement to eliminate
duplicate categories by referring, where necessary to the original
advertisement to gauge the thematic and athematic message
components.
Table 1. Key product features from medical journal drug advertisements*
Combination Product; Relieving Pill Burden
Ease of Use
Facilitates Compliance
Full Range of Strengths Available
Highly Effective/Superior
No Addiction Risk
Once daily Dosing
Rapid Relief/Effect
Safety
Schedule Simplicity
*listed alphabetically
The list of product features seen in Table 1 was shown to three
groups of respondents who were asked to rank them from one
to ten according to importance and to provide an estimate of
what they would consider a reasonable and fair percentage
price increase over a basic product lacking that specific feature.
Each of the ten characteristics was considered independently.
This pilot study was administered to a convenience sample of
practicing pharmacists (n=12), practicing physicians (n=12) and
patients (n=12) at a large medical center in a major urban area
in the Northeast USA. Each respondent was asked to provide
their personal opinion, and not as a representative of any group
or organization.
One final word about the methodology is probably in order. In
the United States, pharmaceutical product advertisements are
not pre-screened or approved by the F.D.A. or any governmental
agency, as is the case in numerous countries. Manufacturers
push as for as they believe they can go without subsequent FDA
rebuke and in some cases, advertisements do not provide a fair
balance of risks and benefits, and benefits may be exaggerated
or bloated a little, but not enough to warrant governmental
intervention.
For example a firm could promote its antacid as “the woman’s
antacid” even if clinical results do not demonstrate any special
advantage for women using that product versus any other
antacid on the market.
ResultsThe findings differed as evaluated by the three cohorts. In
terms of willingness to pay an increased price for innovative
features, patients and pharmacists were the most welcoming of
improved features (price increase ranged from 5-30% and 10-
50%, respectively, and for all product features), and physicians
the least (price increase ranged from 0-10%, and only for two
product features). Across all three study groups the greatest
price increases were consistently for efficacy and safety.
Table 2. Evaluation of higher price worthiness for additional feature by Physicians (M.D.s), Pharmacists, and Patients. (Mean scores)
Feature M.D.s (%)Pharmacists (%)
Patients (%)
Rapid Relief 0 10 20
Ease of Use 0 15 5
Facilitate
Compliance0 10 10
Schedule Simplicity 0 15 10
Highly Effective/
Superior10 15 20
Once Daily dosing 0 15 10
Safety 10 50 30
Combination
Product0 15 20
No Addiction Risk 0 20 30
Full Range of
Strengths0 10 10
When asked specifically to rank order the ten product features
(Table 3), improved efficacy or safety were the number one
choice for all three study groups. However, after efficacy and
safety, there were subtle yet noteworthy differences in ranking
for other product features. For example, where compliance was
noted as relatively unimportant to patients and pharmacists,
it was considered much more important by physicians. And,
where rapid symptom relief was less important to physicians, it
was clearly more meaningful to pharmacists and patients.
27Southern Med Review Vol 3 Issue 1 Feb 2010
Assessing different perspectives on the value of a pharmaceutical innovation
Table 3. Ranking of importance of drug product features by Physicians, Pharmacists, and Patients (1=highest, 10=lowest)
Feature M.D.s Pharmacists Patients
Rapid Relief 7 2 4
Ease of Use 6 3 3
Facilitates
Compliance2 10 8
Schedule Simplicity 5 5 7
High Effective/
Superior3 4 1
Once Daily Dosing 4 6 2
Safety 1 1 6
Combination 8 7 5
No addiction 10 9 9
Full Range of
Strengths9 8 10
Discussion & ConclusionThe results obtained from this pilot study cannot be generalized
because of a very small sample size, as well as the use of a
convenience sample of respondents. Nevertheless, our study
provides proof of concept that there are measurable differences
in perceived value of pharmaceuticals based on product
characteristics and upon whom one asks, and that in order to
fully assess value it is necessary to include a broad perspective
comprising providers and patients. Although we did not include
payers or payer advisors in our study, clearly this group should
be included as well in future research.
In addition, our method and findings can be useful in
drug development decision making, where pharmaceutical
manufacturers can perhaps guide research and development
efforts along the lines of characteristics most highly valued by
patients, providers and payers. This preliminary study suggests
that a more robust follow-up investigation using an increased
sampling frame with greater geographic dispersion, along with
randomization of respondents, could be highly informative.
A more complete treatment of this subject would include the
assessments of feature value by consumers/patients, the very
persons who must endure the effects of these medications.
In addition, it could be useful to add a willingness to pay
evaluation in an effort to appreciate real monetary numbers
instead of theoretical percentage increases supplied by the
respondents to this study. Also, more detail could be provided
on the product features – especially regarding relative efficacy,
safety and tolerability. Perhaps greater price increases would
be acceptable with greater improvements in efficacy and/or
lower risks of side-effects. One commonly heard dilemma from
personnel at health authorities and managed care organizations
is: How does one differentiate products where there may be
very little difference among products in a class and between the
original molecules? Here, we might find that while the clinical
effectiveness is quite similar, that different metabolic pathway
may lead to fewer interactions, or one may cause less gastritis,
or be more greatly tolerated and therefore be taken close to the
prescribed regimen, and may lead to superior outcomes. And
this may be expected to influence patient preference for certain
products because of their unique features.
Traditionally, product pricing decisions by pharmaceutical
companies consider the avoided cost of care without drug
treatment such as surgery or hospitalization, and a further
consideration of other therapies; competing drugs or medical
procedures, but they normally do not consider patient opinion.
Yet, if patients report to their physician that one drug was
responsible for unpleasant diarrhea, that physician will most
likely veer toward the use of a different product in the future.
Finally, studies like this hold the possibility of demonstrating
to health plans, Ministry of Health or Social Security personnel
that while they might not place a high value on certain product
characteristics or features, that the persons who must endure
the disease and the use of the product – the patient, may feel
differently about the importance or worth of some aspects of
the product. As members of, and contributors to, health plans
and/or national heath care systems, patient perspectives and
preferences are critical to consider.
The authors urge investigators to explore this area further
using randomly selected and larger sample sizes (to allow for
statistical tests and modeling), diverse populations of patients,
providers and payers, and more comprehensive and detailed
value assessment techniques.
AcknowledgementMerck and Company Inc. provided an unrestricted grant to assist
in this work.
References:1. Coyle D. Drummond M. Does expenditure on pharmaceuticals
give good value for money?: current evidence and policy implications, Health Policy, 26, 1, 55-75, November 1993.
2. Grund J. The Societal Value of Pharmaceuticals: Balancing Industrial and Healthcare Policy, PharmacoEconomics, vol 10, Nr. 1, Pages 14-22, July 1996.
3. Berndt ER. Pharmaceuticals in U.S. Health Care: Determinants of Quantity and Price, Journal of Economic Perspectives, vol 16, Nr. 4, Fall 2002, pages 45-66.
4. Brophy JM, Joseph L, Rooleau JL. Beta Blockers Improve Survival and Decrease Hospitalization in Patients with Heart Failure, Annals of Internal Medicine, 134, Nr. 7, 594, 3 April 2001.
28 Southern Med Review Vol 3 Issue 1 Feb 2010
Assessing different perspectives on the value of a pharmaceutical innovation
5. John IP, Kantipudi S, Khasnis, A, Cholia, A, Dickinson M. Statin Therapy Is Associated with Improved Survival in Ischemic and Non-Ischemic Heart Failure, Congestive Heart Failure, Vol 10, Nr. 6, Pages 313-315, November/December 2004.
6. PhRMA, Value of Medicines: Facts and Figures 2006 http://www.phrma.org/files/attachments/Value%20of%20Medicine%202006.pdf (Accessed 13/2/2010)
7. Gadelha AJ, Accacio N, Costa RLB, Galhardo MC et al. Morbidity and Survival in Advanced AIDS in Rio de Janeiro, Brazil, Revista do Instituto de Medicina Tropical e Sao Paulo, Jul/Aug, 2002.
8. Wertheimer AI, O’Brien T, Levy R. The Value of Incremental Pharmaceutical Innovation for Older Americans, National Pharmaceutical Council, Reston, VA, 2001.
9. Fincham JE. Patient Compliance with Medication: Issues and Opportunities, Haworth, Binghamton, NY, 88, 2007.
10. Lichtenberg FR. Are the Benefits of Newer Drugs Worth Their Cost? Evidence From the 1996 MEPS, Health Affairs, Vol 20, nr. 5, pages 241-251, Sept/October 2001.
29Southern Med Review Vol 3 Issue 1 Feb 2010
Letter to the Editor
A student reflects on the rest of the world through Southern Med Review
Citation: Budd N. A student reflects on the rest of the world through Southern Med Review. Southern Med Review (2010) 3; 1:29
Nearing completion of my four year Pharmacy degree in New Zealand I recall learning plenty about Pharmaceutical Management
Agency Ltd (PHARMAC), the government-operated agency responsible for purchasing all of the medicines used by New Zealanders.
I learned that the PHARMAC system has advantages and disadvantages and is unique to New Zealand. No other place in the world
has a system like this, i.e. the ‘New Zealand system’ is unique, and different to ‘Everywhere Else’.
Reading the Southern Med Review teaches me something about ‘Everywhere Else’ and in the bigger picture of the world-wide
pharmaceutical market it seems that the situation in every other country is just as unique and different as in my own country.
It is interesting to learn how differently the rest of the world approaches the medications side of healthcare. That, in countries such
as Veitnam, price and even the availibility of medicines varies from city to city. Drug companies are free to distribute any informative
material they wish in Nepal without interference from the government. Issues over things like counterfeit medicines never arise in
New Zealand but seem to be a problem in countries like Thailand. The role of community pharmacists in India is very different to the
way pharmacy is practiced in New Zealand. I also find it interesting to compare the affordability of drug therapies between other
countries and my own.
As a full time student I earn an income working during the weekends, and when making purchases I compare the prices of goods
relative to the time I spent working to pay for them. A full tank of petrol costs me six hours of my time at work, and lunch costs me
what I earn in thirty minutes. A similar technique was applied in the article titled ‘Medicine prices, availability, and affordability in
Vietnam’ (Vol 2 Issue 2 Sep 2009) where it was reported that an average, unskilled government worker in Veitnam would have to
commit twenty one days worth of his wages to cover the cost of one course of innovator brand ranitidine. The lowest price generic
brand only costs 1.3 days worth of wages when treatment is sought from the private sector.
Amount of time spent working to pay for medical treatment is an easily understandable unit of measure, far more relevant than the
usual method of comparing $ with $, which is usually only reported in US$ and does not take into account affordability, the cost
relative to the average wage.
Each article I have read outlines important and challenging issues faced by countries, which are interesting to me because each
situation is very different to New Zealand. There are lessons to be learned from the unique solutions which follow, and I look forward
to reading future issues while practicing as a pharmacist.
Nicholas Budd
Auckland, New Zealand
*Nicholas Budd was a 4th year pharmacy student at School of Pharmacy, University of Auckland when this letter to editor was submitted. Now Nicholas is an intern pharmacist at Middlemore hospital, Auckland, New Zealand. He can be contacted via email: [email protected]