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Background: Drugs are double edged weapons, they are used in treatment of the patients but in return can harm as well. The safety of drug prescribing has become a need of the hour topic in medicine. Safety monitoring of patients via Pharmacovigilance tool has become an integral part of pharmacotherapy. This study has been undertaken to analyze the various individual case safety reports including the Special situation cases of medicational error and over dose and to promote the reporting of adverse drug reactions (ADRs) among the healthcare professionals (HCPs).Methods: A retrospective non-interventional observational study was done for indexed period of six months at AMC-PvPI under Osmania Medical College and General Hospital. The reported individual case safety reports (ICSRs) are evaluated on basis of demographics of age and gender, seriousness criteria, outcome parameters and causality assessment of suspected drug (s) and suspected ADR/AE (s) as per the ICH guidelines and WHO causality assessment scale.Results: A total of 177 ICSRs are reported out of that 137 were ADRs, 36-medication error cases and 4-cases of over dose. The incidence of ADRs in females are high compared with males was identical. The occurrence of ADRs in adult patients (61%) was significantly higher than other age groups. Of total ADRs, most of them were with analgesics (26%) and highly reported system organ classification was CNS. Overall, 79% patients were recovered from ADRs.Conclusions: The results depicted an insight to the HCPs on the importance of monitoring and reporting of ICSRs. Our study results emphasized need to roll out a pharmacovigilance practice tool to ensure the safe use of drugs for better Pharmacotherapy and development of pharmacogenomic studies.
RESUMO
Objective ： Infliximab is a chimeric monoclonal antibody against tumor necrosis factor (TNF) -α that is indicated in the treatment of chronic inflammatory diseases. Infliximab is administered by intravenous infusion and may be associated with infusion related reactions (IRRs). Recent study showed that the use of concomitant antihistamines associated with an increased incidence IRR, using an observational registry database in Canada. The aim of this study was to determine whether the use of concomitant antihistamines associated with an increase in the proportional reporting ratio (PRR) of IRR, using individual case safety reports (ICSRs) with infliximab as one of the suspected drugs, not only from Canada, but also from the United States of America (US), the United Kingdom (UK), and Japan.Design ： Case-control studyMethods ： We used VigiBase, the WHO's global safety report database, in this study. One-to-one propensity-matching analysis was performed in each country using IBM SPSS version 24 to evaluate outcomes. The primary endpoint was the assessment of concomitant medications associated with IRR in the cases treated with infliximab.Results ： There were 35,729, 19,095, 4,618, and 1,565 ICSRs in which some adverse events were reported with infliximab as one of the suspected drugs in Canada, the US, the UK, and Japan, respectively, after the exclusion of ICSRs with unknown patient age or unknown patient sex. IRRs were reported in 2,293, 1,427, 303, and 69 ICSRs, respectively. The use of concomitant antihistamines was significantly associated with an increased PRR of IRR in Canada (p<0.001). The uses of concomitant antihistamines were also significantly associated with an increased PRR of IRR in the US (p<0.001), the UK (p<0.001), and Japan (p＝0.007).Conclusion ： The uses of concomitant antihistamines were associated with an increased PRR of IRR with infliximab in the case-control study using ICSRs from Canada, the US, the UK, and Japan.
RESUMO
Objective：Infliximab is a chimeric monoclonal antibody against tumor necrosis factor (TNF) -α that is indicated in the treatment of chronic inflammatory diseases. Infliximab is administered by intravenous infusion and may be associated with infusion related reactions (IRRs). Recent study showed that the use of concomitant antihistamines associated with an increased incidence IRR, using an observational registry database in Canada. The aim of this study was to determine whether the use of concomitant antihistamines associated with an increase in the proportional reporting ratio (PRR) of IRR, using individual case safety reports (ICSRs) with infliximab as one of the suspected drugs, not only from Canada, but also from the United States of America (US), the United Kingdom (UK), and Japan.Design：Case-control studyMethods：We used VigiBase, the WHO's global safety report database, in this study. One-to-one propensity-matching analysis was performed in each country using IBM SPSS version 24 to evaluate outcomes. The primary endpoint was the assessment of concomitant medications associated with IRR in the cases treated with infliximab.Results：There were 35,729, 19,095, 4,618, and 1,565 ICSRs in which some adverse events were reported with infliximab as one of the suspected drugs in Canada, the US, the UK, and Japan, respectively, after the exclusion of ICSRs with unknown patient age or unknown patient sex. IRRs were reported in 2,293, 1,427, 303, and 69 ICSRs, respectively. The use of concomitant antihistamines was significantly associated with an increased PRR of IRR in Canada (p<0.001). The uses of concomitant antihistamines were also significantly associated with an increased PRR of IRR in the US (p<0.001), the UK (p<0.001), and Japan (p＝0.007).Conclusion：The uses of concomitant antihistamines were associated with an increased PRR of IRR with infliximab in the case-control study using ICSRs from Canada, the US, the UK, and Japan.