PHARMACOVIGILANCE STUDIES INVOLVING HEALTHCARE PROFESSIONALS AND STUDENTS IN NEPAL: IMPACT ASSESSMENT ON KNOWLEDGE, AWARENESS, ADVERSE DRUG REACTIONS REPORTING AND DRUG SAFETY COMMUNICATIONS
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Date
2010-05
Authors
PALAIAN, SUBISH
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Abstract
The concept of phannacovigilance is new in Nepal. The present study analyzed the
pattern and cost of pharmacotherapy of Adverse Drug Reactions (ADRs) reported to the
western regional pharmacovigilance center at Nepal, and evaluated the Knowledge,
Attitude and Practices (KAPs) of healthcare professionals in Manipal Teaching Hospital
(MTH) towards drug safety. It also aimed at evaluating pharmacovigilance education
modules for community pharmacy practitioners, medical, pharmacy and nursing students
and analyzed the drug safety communications produced by the western regional
phannacovigilance center. ADR reports received and the drug safety communications
produced by the center from 14th September 2004 till 13th September 2008 were
analyzed. KAP of the healthcare professionals from MTH and community pharmacy
practitioners from Pokhara valley, western Nepal were evaluated using two different
pretested questionnaires with Cronbach alpha of 0.72 and 0.61, respectively. Thirty
community pharmacy practitioners with high KAP scores were trained III
pharmacovigilance and the KAP improvements were noted. Their feedback on the
training was obtained using a Likert-type scale quest~onnaire. Educational modules were
developed for pharmacy, medical and nursing students and evaluated by comparing the
students' knowledge and perception scores prior and following interventions and their
feedback on the sessions. Of the total 266 ADRs received, 153 (57.7%) were reported
from females. Antibiotics caused the highest percentage (22.2%) of ADRs. The baseline
KAP scores were 35.8±3.7 for nurses (n=46), 40.0±3.5 for doctors (n=29) and 38.9±4.8
for pharmacists (n=14); the maximum possible score was 50. Among the 108 community
pharmacy practitioners enrolled, 78.7% (n=85) were males. The mean±sd baseline KAP
scores was 31.4±2.2 (maximum possible score was 40). Of the 71 ADRs reported by
them, antibiotics/antibacterials accounted for 42.0% (n=37) of the ADRs. The median
(interquartile range) feedback score was 79.0 (73.5-81.0); maximum possible score was
100. Altogether, 124 pharmacy, 116 nursing and 229 medical students were enrolled.
The baseline median (interquartile range) of the total score was 39.0 (37.0-41.0) for
pharmacy (maximum possible score was 50); 32.5 (31.0-34.0) for nursing (maximum
possible score was 40) and 31.0 (29.0-33.0) for medical students (maximum possible
score was 38). Upon educational intervention, their scores improved. The median
(interquartile range) feedback scores were 86 (81.5-90.0), 85.0 (80.7-88.2) and 83 (78.0-
87.0) for pharmacy, nursing and medical students, respectively; the minimum possible
score was 50 and the maximum possible score was 100. Among the 18 case reports
published by the pharmacovigilance center, a majority followed the International Society
of PharmacovigilancelInternational Society of Pharmaepidemiology guidelines. In
conclusion, the pharmacovigilance activity in western Nepal is successful and needs to be
strengthened and sustained.
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Keywords
PHARMACOVIGILANCE , DRUG SAFETY