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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


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


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.


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


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.



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



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)



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]


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


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



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.



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.

15. Basak SC, Prasad GS, Arunkumar A, Senthilkumar S. An attempt to develop community pharmacy practice: results of two surveys and two workshops conducted in Tamilnadu. Indian J Pharm Sci 2005;67 (3): 362-367.

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.

24. Basak SC, Raja R, Ramesh S, Senthil Kumar S. From policy to practice of community pharmacy in India: A growing need. Indian J Hosp Pharm 2001;38:169-172.

25. Singh H. European pharmacies in Colonial India. Pharm Hist (Lond) 2001;31(4):58-67.

26. Varma D, Girish M, Shafanas KK, Renjit PB. A study on community pharmacy in Kerala. Indian J Hosp Pharm 2000;37:49-52.

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.

31. Sharma SN. Community pharmacy: education and training. Eastern Pharmacist 2000;43(June):21-26.

32. Basak SC. Community pharmacy-past, present and future. Eastern Pharmacist 1999;42 (Oct):31-34.


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.


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.



– 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).



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%)



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%)



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.


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.


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



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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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


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



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.



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



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.


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


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



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.



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.



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.


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]