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Adverse Drug Reactions in Bangladeshi Health

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Article in Research Journal of Pharmacy and Technology November 2015
DOI: 10.5958/0974-360X.2015.00287.5

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Research J. Pharm. and Tech. 8(11): November 2015

ISSN

0974-3618 (Print)
0974-360X (Online)

www.rjptonline.org

REVIEW ARTICLE

Adverse Drug Reactions in Bangladeshi Health Care Setup: An Update

Badar Uddin Umar1, Mainul Haque2*
Faculty of Medicine, AIMST University, Semeling, 08100 Bedong, Kedah, Malaysia
2
Faculty of Medicine, Universiti Sultan Zainal Abidin, Medical Campus, Jalan Sultan Mahmud, 20400 Kuala
Terengganu, Terengganu, Malaysia
*Corresponding Author E-mail: runurono@gmail.com
1

ABSTRACT:
The safety of medicines has been a major issue involving health care delivery systems worldwide. Adverse drug
reactions (ADRs) cause a huge burden accounting for considerable morbidity, mortality, andextra costs both
developed and developing nations. Monitoring ADRs and pharmacovigilance (PV) is not adequate in many
developing countries like Bangladesh. A literature search revealed only a few publications on ADRs in
Bangladesh. These scientific reports revealed that the rate of ADRs are comparable with many countries, but the
alarming issue is regulatory agencies are not much concern about the atrocities of ADRs. Despite the existing
functional government organizations for monitoring ADRs which reports ADR cases to the WHO, it fails to keep
pace with the current global situation. The Government of Bangladesh and other stakeholders should take up
immediate initiatives in boosting up monitoring, and enhance awareness to report ADRs by the doctors, nurses,
pharmacist and patients. PV studies and research on ADRs in Bangladesh should be encouraged.

KEYWORDS: Adverse drug reactions, pharmacovigilance, Steven Johnsons Syndrome, antibiotics,

Fluoroquinolones.

INTRODUCTION:
There have been major concerns over the safety of
medicines and healthcare delivery system globally,
including Bangladesh. [1-5] Injury caused by medicine
can reach up to an extent that is comparable to four
jumbo jet crashes every alternate day only in the United
States. [6-8] Occurrence of adverse drug reactions (ADRs)
remain between 4th and 6th leading cause of death in the
US with an overall incidence rate of 6.7% of which
0.32% were fatal (hospitalized cases). [9-10]
Hospitalization due to ADR and ADR- following
hospitalization remain major issues in UK and USA. [1113]
Similar or even higher ADR rates have also been
reported from India, Bangladesh, and other developing
countries. [14-17] Definition of ADR was much debated
and as such various definitions were adopted by some
experts and the World Health Organization (WHO).
Some reports emphasized on the noxious and unintended
serious outcomes of the drug used while others reported
on the harm caused by medications and leading to a
subsequent negative effect on patient safety. [18]
Received on 29.06.2015
Accepted on 23.07.2015

Modified on 20.07.2015
RJPT All right reserved

Research J. Pharm. and Tech. 8(11): Nov., 2015; Page 1598-1602

DOI: 10.5958/0974-360X.2015.00287.5

PV the pharmacological science related to detection,

assessment, understanding and prevention of ADRs,
remains very significant in ensuring drug safety. [19-22]
Effective post-marketing surveillance systems for ADR
have been developed in UK and US since long. [23-24]
Yellow Card reporting system exists for reporting
ADR in The UK, used by the doctors in The UK for
reporting ADRs though it is not mandatory. [25-26]A
number of the developed and developing countries have
their own reporting system and PV center too. [21,27]
Bangladesh being developing nation but has very rapidly
growing pharmaceutical sector over the past few
decades. Bangladesh currently exports drugs to 55
countries since the 80's. But PV system has not been
developed here still and lack many essential components,
especially on the awareness ADR reporting. [1,20-21,28-29]
Bangladesh like other developing countries underreporting of adverse drug reactions remains one of the
major factors that contribute to PV program
letdown.[29-32] Therefore it is imperative, that the PV
system and the ADR monitoring system be strengthened
more in Bangladesh since major electronic databases that
we searched failed to produce such evidence. No

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Research J. Pharm. and Tech. 8(11): November 2015

ongoing researches were found on ADR or PV systems drugs. [36-37] It was reported that 24% SJS cases due to
in Bangladesh.
use of some offending drugs: sulphonamides (42%),
indigenous drugs (25%), anticonvulsants (25%) and
quinolones (8%). [36] More recently, another study
MATRIALS AND METHODS:
This updated review was designed based on synthesis of described 45% cutaneous ADRs were the fixed drug
[37]
Highest
published materials extract relevant information and eruptions type, 20% urticarial and 15% SJS.
analyze related data) on ADR and PV in Bangladesh. number of cases was due to sulfur-containing drugs
Topic/ subject searches: definition of ADR and PV, (40%) followed by NSAIDs (30%), quinolones (30%)
[37]
incidences and factors involving ADRs globally and in and Metronidazole (15%).
Bangladesh, ADR monitoring and PV systems in
Bangladesh and other countries. A computerized Males were found to be affected more often than females
[35, 37]
But another study reported [38]
literature search was performed utilizing major search in two of the studies.
engines like: Google, Google Scholar, PubMed and females to be more affected by ADRs due to antiResearch Gate using 4 keywords: adverse drug reactions, tubercular therapy (DOTS). Considering the review
side effects, drug reactions and pharmacovigilance in articles, it clearly demonstrates a marked deficiency in
Bangladesh. The search was carried out for the period of ADR monitoring systems in Bangladesh including a
[20-21, 39]
1971 through 2014 (since inception of Bangladesh). All gross lack of the awareness in reporting ADRs.
published relevant original papers or review articles, However most authors describe the current situation of
case reports, letter to the editor and reports on ADR and PV in Bangladesh agreeing to accept the inadequacy of
PV in any journals and newspaper were included in the scientific and administrative initiatives both by
Government and non-government organizations towards
search.
bringing a positive change in PV situation in the
[20-21]
In a newspaper report mentioned [29] that
RESULTS,
DISCUSSION
AND country.
only 50 ADRs reported in 20 years (1994-2013) as
CONCLUSION:
Google, Google Scholar, and Pub Med were used to reported to the Directorate General of Drug
search the relevant documents and revealed only 19 Administration, Government of Bangladesh and among
publications relating ADRs and PV in Bangladesh (from those reports only 20% of those were complete. The
1971 through 2014) in various sources and journals. Same article concluded that despite having quality
Among these 19, one was reported in the daily pharmaceutical industries in Bangladesh, but the country
newspaper and other two reports one from (USAID) and is still facing barriers in drug export to developed
only because not attaching the proper ADR/PV
Systems for Improvised Access to Pharmaceuticals and countries[29]
Services Program (SIAPS) project and the other on reports. [22] Another study report also mentioned similar
This study also revealed many gaps in PV
Uppsala Monitoring Centre update report, of the issues.
system
and
ADR monitoring in Bangladesh. [21] Despite
remaining, 7 were original research papers (37%), 6
were review articles (32%), and the rest (31%) having Government agencies and other stakeholders
[40]
comprised case reports, letter to the editor and others. working on PV very little development was noted.
Methodologically 5 were prospectively designed cross- The good news was found in UPPSALA monitoring
sectional studies, 4 were descriptive and 1was center (The WHO) website where they declared the
observational study and remaining were of other joining of Bangladesh in the WHO program by
categories. Most of the papers/reports that were submitting first reports of ADRs to VigiBase through
2014. Bangladesh applied for
published was after 2010, showed due concerns about VigiFlow in December [41]
this
membership
in
2013.
ADR and PV in Bangladesh.
Of the total 19 publications only 2 were case reports on
SJS, first one in 2005 following Levofloxacin intake by a
15-year-old male with a fatal outcome, and the other
fatal case in 2008 was a 40 years old female taking
azithromycin.[33-34] Of 7 original studies conducted over
the period of 2004-2014, revealed skin was the most
affected system with ADR.[16-17, 35] Highest number
ADRs were reported due to antibiotics (AB) intake
(43%-53%) followed by NSAIDs (27%-33%). [16-17]
Though fatality rate was quite low as most of the studies
reported except one having very high fatality rates (25%)
most of which were SJS and TEN, SJS being in 55%
alone. [35] Two studies were only had cutaneous
manifestations of ADRs pertaining to use of different

Though we have employed a literature review search to

yield all relevant data on ADRs in Bangladesh, however,
some of the ADRs cases might be dropped out due to i)
some cross references reporting only descriptive findings
rather than numbers of ADRs, ii) our search might have
certain limitations of not being able to find out every
related article as usually done by a systematic review,
and, iii) some of the ADRs which might have really
occurred in the country but not reported anywhere or not
been data based/incorporated in the web, as of today.
However, it is noteworthy that not a single case of ADRs
was found to be recorded in the website of DGDA,
Bangladesh though a literature review in Bangladesh
revealed 19 publications with varying numbers of ADR

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Research J. Pharm. and Tech. 8(11): November 2015

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