TY - JOUR
T1 - Impact of periodic safety update reporting system
T2 - A preliminary trial in a tertiary care teaching hospital of southern India
AU - Lokhande, Alkesh K.
AU - Prabhu, Mukhyaprana M.
AU - Mallayasamy, Surulivel Rajan
AU - Girish Thunga, P.
AU - Unnikrishnan, Mazhuvancherry K.
N1 - Publisher Copyright:
© 2018 Alkesh K. Lokhande et al.
PY - 2018/12/1
Y1 - 2018/12/1
N2 - The objective of this study was to assess the impact of implemented periodic safety update report (PSUR) system in our hospital via PSUR function assessment questionnaire (PFAQ) vetted by Delphi panel and by comparing frequency and rate of adverse drug reaction (ADR) reporting for three highly prescribed drugs. An PFAQ was validated by Delphi panel, in two successive rounds of revision and used to record the responses on Likert scale. Drugs with well-known ADR profiles in published literature were considered reliable markers of the impact of PSUR system implementation. Pre-PSUR retrospective data retrieved from medical records for 9 months and compared with the trend of frequency and rate of ADR reporting post-PSUR system implementation. Frequency and rate of ADR reporting for selected drugs rose by 68% post-PSUR system implementation. Participation of wards in ADR reporting and reporting of unexpected/unreported ADRs was also seen increased. Numbers of PFAQ responses for each performance indicator corresponding to the respective success factors were seen shifting favorably on the Likert scale in phase 2 study period. This study illustrates how drug safety reporting network can be established by reallocating existing resources, with minimal expenses on training/human resources and to improve poorly designed pharmacovigilance system in India that relies heavily on data from overseas.
AB - The objective of this study was to assess the impact of implemented periodic safety update report (PSUR) system in our hospital via PSUR function assessment questionnaire (PFAQ) vetted by Delphi panel and by comparing frequency and rate of adverse drug reaction (ADR) reporting for three highly prescribed drugs. An PFAQ was validated by Delphi panel, in two successive rounds of revision and used to record the responses on Likert scale. Drugs with well-known ADR profiles in published literature were considered reliable markers of the impact of PSUR system implementation. Pre-PSUR retrospective data retrieved from medical records for 9 months and compared with the trend of frequency and rate of ADR reporting post-PSUR system implementation. Frequency and rate of ADR reporting for selected drugs rose by 68% post-PSUR system implementation. Participation of wards in ADR reporting and reporting of unexpected/unreported ADRs was also seen increased. Numbers of PFAQ responses for each performance indicator corresponding to the respective success factors were seen shifting favorably on the Likert scale in phase 2 study period. This study illustrates how drug safety reporting network can be established by reallocating existing resources, with minimal expenses on training/human resources and to improve poorly designed pharmacovigilance system in India that relies heavily on data from overseas.
UR - http://www.scopus.com/inward/record.url?scp=85059531168&partnerID=8YFLogxK
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U2 - 10.7324/JAPS.2018.81213
DO - 10.7324/JAPS.2018.81213
M3 - Article
AN - SCOPUS:85059531168
SN - 2231-3354
VL - 8
SP - 112
EP - 123
JO - Journal of Applied Pharmaceutical Science
JF - Journal of Applied Pharmaceutical Science
IS - 12
ER -