www.ijbcp.com International Journal of Basic & Clinical Pharmacology | July-August 2016 | Vol 5 | Issue 4 Page 1448
IJBCP International Journal of Basic & Clinical Pharmacology
Print ISSN: 2319-2003 | Online ISSN: 2279-0780
Research Article
Pharmacovigilance programme of India from the perspective
of nursing students
Karunasree Nagarur
1
*, Karunasree Podila
2
INTRODUCTION
Pharmacovigilance is the branch of science and activities
relating to the detection, assessment, understanding and
prevention of adverse effects or any other drug-related
problem. Good Pharmacovigilance programs help in
identifying the risks and risk factors associated with
drugs in the shortest possible time so that harm can be
avoided or minimized. Without the Pharmacovigilance
programme, many adverse effects of the drugs have not
been known and the banned drugs would be still in the
market causing potential harm.
1
When communicated effectively, this informationallows
for the intelligent, evidence-based use ofmedicines and
has the potential for preventing manyadverse reactions.
Physicians, pharmacists, nurses and the consumers play a
key role in Pharmacovigilance programs, but in many
studies underreporting was observed. An estimated
median underreporting rate (defined as percentage of
ADRs detected from intensive data collection that were
not reported to relevant spontaneous reporting systems)
of 94% and occurs frequently for serious and unlabelled
reactions.
2,3
This can delay detection of important ADRs.
Studies from different settings indicate inadequate
knowledge about pharmacovigilance among healthcare
professionals as well as attitudes that are associated with
ABSTRACT
Background: Lack of knowledge and awareness of reporting adverse drug
reactions is common among the nursing staff. As the nursing staffs are more
close to the patients, this study was undertaken to evaluate their knowledge,
attitude and perception about pharmacovigilance and ADR reporting. The
objective of this study was to assess the knowledge, attitude and perception of
nursing staff about pharmacovigilance programme and finding out the ways of
improving the ADR reporting rate.
Methods: Across-sectional, anonymous, questionnaire based study was
conducted at the Government hospital, Nizamabad among the nursing staff. A
predesigned, pretested and validated questionnaire consisting of 15 questions
and 8 statements on knowledge, attitude and practice aspects of
Pharmacovigilance programme in India. All the nursing staffs were explained
about the purpose of the study and the questionnaire was distributed. Adequate
time was given to fill them. Data spread on the excel sheet and the results were
analysed using Microsoft office 2007 version.
Results: Out of 65 students, 74.1% were aware of the term pharmacovigilance,
44.4% of the pharmacovigilance programme in India and 70.4% of the
pharmacovigilance cell in their institute. 22.2%stated that known reactions,
14.8% unknown and 63% that all ADRs are to be reported.63% stated herbal
drugs are safe, 44.4% that over the counter drugs are safe. Reporting system
stated was by making call/by e-mail (25.9), written form (29.6%).
Underreporting was due to lack of awareness (51.9%), lack of time (22.2%),
feeling of creating negative impression on heath personnel (11.1%), or due to
the feeling of waste of time (14.8%).
Conclusions: Lack of facilities and clinical knowledge about ADR discourages
them from reporting. Educational interventions and improvement of facilities
were also suggested to enhance reporting rate in the hospital.
Keywords: Pharmacovigilance, ADR reporting, Nursing staff, Knowledge,
Attitude and practice
DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20162451
1
Department of Pharmacology,
Government Medical College,
Nizamabad, Telangana, India
2
Department of Pharmacology,
ESIC Medical College,
Sanathnagar, Hyderabad, India
Received: 14 May 2016
Accepted: 09 June 2016
*Correspondence to:
Dr. Karunasree Nagarur,
Email: raja_narasimharao@
yahoo.com
Copyright: © the author(s),
publisher and licensee Medip
Academy. This is an open-
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