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THE PHARMA REVIEW
(NOVEMBER - DECEMBER 2011) |
Knowledge, Attitude and
Perception of Pharmacy Professionals Towards ADR
Reporting - A Pharmacoepidemiological Study
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1Rakesh Kumar
Rishi, 2Rakesh K. Patel & 3Anil Bhandari
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Abstract: Knowledge, attitude and perception
of pharmacy professionals towards ADR reporting was
assessed by self administered, anonymous questionnaire
containing closed ended questions. A total of 249
pharmacy professionals (mainly students) responded to
the questionnaire. Majority of the respondents (81.52%)
disagree that drugs available in the market are safe and
85.94% said that pharmacists should report ADRs. When
asked whether training for ADR reporting to the
pharmacists is needed, 90.36% agreed to that. The
opinion regarding legal liability was divided among the
respondents. A total of 69.07% said that ADR reporting
is a time consuming activity with no outcome. Majority
of the respondents (87.55%) said that ADR reporting by
pharmacist would be useful in providing better patient
care. Half of the study population was aware of the
pharmacovigilance programme in India. A total of 16.8%,
14%, and 4.8% respondents said that ADR reporting should
be done to doctor/hospital, to drug manufacturers, and
to the Government authorities respectively. Only 2.8%
said that reporting should be done to the head of the
institution. Majority of the respondents (48.19%) said
that ADRs should be reported to all of the above
authorities. When asked in the questionnaire about what
to report, 11.24% of the respondents said that only mild
ADRs which cause less inconvenience should be reported.
A total of 12.45% said that serious and life threatening
ADRs should be reported. While 6.24% of the study
population said that severe ADRs that cause disability
should be reported, majority of the respondents (63.45%)
were in the favour of reporting ADRs in all of the above
cases. Present study concludes that pharmacy profession
in India is supportive to ADR reporting and if given the
opportunity, seeks its active role in pharmacovigilance.
Introduction: Adverse drug reactions are known to
be a major cause of morbidity and mortality all over the
world. However, only a small proportion of ADRs are
reported which does not give a clear picture of the
overall safety of the medicinal product. It is a well
known fact that ADR reporting is fundamental to the
safety surveillance of the marketed medicinal products.
The spontaneous reporting of adverse drug reactions (ADRs)
is an important method for detecting new safety issues
related to drugs. Pharmacovigilance is defined by the
World Health Organization (WHO) as "the science and
activities relating to the detection, assessment,
understanding and prevention of adverse effects or any
other drug related problem". An adverse drug reaction (ADR)
has been defined as any noxious, unintended and
undesired effect of a drug which occurs at a dose used
in humans for prophylaxis, diagnosis, therapy or
modification of physiological functions (WHO).
Pharmacovigilance not only help early detection of ADRs,
but also facilitate in identifying both risk factors and
the mechanism underlying the ADR. The pharmacovigilance
also benefit the drug regulatory agencies as they take
precautions against future risks of medicinal products
that can potentially lead to large costs to the society
1,2.
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