Background: The burden of dermatological Adverse Drug Reactions (ADRs) is resulting into switching or discontinuation of drug as well as medication non-adherence. Active search is essential for evaluating, managing, reporting ADRs and strengthening the activity of pharmacovigilance of the country. The purpose of the study was to evaluate causality, severity and preventability of Dermatological ADRs. Method: A prospective, observational study was carriedout over a period of six months at Out Patient Department of Dermatology, Sheth V.S. hospital, Ahmedabad with diagnosed dermatological ADRs. The suspected ADRs were evaluated for causality by WHO-UMC causality and Naranjo's scale, severity by Hartwig and Siegel scale, and preventability by Schumock and Thornton criteria. The agreement between causality scales was obtained by Cohen's Kappa test. Result: Total of 51 patients were enrolled with 74 suspected ADRs. The incidence of dermatological ADR was 3.78%. Most commonly manifested ADR was rash (26.67%). Total 97 drugs were suspected. Maximum incidence of dermatological ADRs were observed with antimicrobial agents (43.30%) followed by non-steroidal antiinflammatory drugs (26.80%), possible (54.64%) and 35 (36.08%) probable ADRs by WHO-UMC scale. Naranjo's scale showed most cases of probable (74.23%). ADRs were of moderate severity (98.97%) and definitely preventable (72.16%). The causality scales showed 'slight agreement' with kappa value 0.012. Conclusion: Dermatological adverse drug reactions were a common occurrence and awareness about them was found to be essential for early detection and prevention. The healthcare system can promote the spontaneous reporting of dermatological ADR top Pharmacovigilance centre's for ensuring safe drug use and patient care.

Inappropriate use of antimicrobials is highly prevalent in surgical chemoprophylaxis leading to higher surgical site infection rate. Adoption of international standard and formulation of locally feasible guidelines can help overcome this situation.

Objective: To assess prevalence and pattern of off-label and unlicensed use of drugs in paediatric outpatient department. Methods: In this prospective study, children attending paediatric outpatient department of a tertiary care teaching hospital were enrolled. Demographic data, clinical history and completeprescription given to the patient were noted. Prescriptions were analysed for off-label and unlicensed drug use with the help ofrecent British National Formulary for Children (BNFC) and National Formulary of India (NFI). Results: Total of 170 patient's data was collected over 2 months with mean age 4.19 ± 3.66 years. Out of total of 405 drugs prescribed, 41 (10.1%)-BNFC and 32 (7.9%)-NFI were used in off-label manner. Number of children who received at least one off-label drug as per BNFC and NFI was 22.4% and 17.1%, respectively. Most common off-label drug was amoxicillin being 48.8%-BNFC and 34.4%-NFI of all drugs prescribed in this manner. Most common category for off-label prescription was inappropriate dose. Only one case was noted for unlicensed drug use. Offlabel drug prescribing significantly correlated with age of the patient and number of drugs per prescription. Conclusion: Off-label drug use is prevalent in paediatric outpatient department, amoxicillin being the commonest drug.

Objective: The goal of this study was to examine correlation between various causality assessments scales and their agreement in reporting ADRs in children. Methods: All hospitalized pediatric patients were followed up for adverse drug reaction in a single pediatric unit for one year. We compared the WHO, Naranjo, CIOMS/RUCAM and French causality assessment scales in 36 identified ADRs in pediatric ward during 2012. The agreement between obtained causality assessments were analyzed by Cohen's Kappa (K) statistical test. Results: In the 290 pediatric patients, 36 adverse drug reactions were noted. Prevalence of ADR was 10.3%. Maculopapular rash was most frequently observed ADR. Antimicrobials (56%) were the most commonly involved drug group in ADR and cephalosporin's being the most frequent cause for ADR. RUCAM and French scale showed better agreement (K:0.067) with each other as compared to other scales. WHO and French scale showed least agreement (K:-0.026) with each other as compared to other scales. Naranjo's scale showed poor agreement (K:0.014) with WHO scale and worse agreement (K:-0.016) with French scale. There was no correlation between RUCAM and Naranjo's scale. Conclusion: Full agreement was not found between any of two scales of causality assessment. There was discrepancy seen between scalesdue to different definitions of causality criterias for assessing adverse drug reactions.This can influence the outcome of causality assessment significantly.

Introduction: Drug-induced seizures are a growing problem due to their relatively high prevalence; poor prognosis and a large number of different drugs being associated with the etiology. Although rare, seizures reported with sertraline include myoclonic seizures, partial seizures, and generalized seizures. We report the case of a young female with no prior history of seizures who developed an episode of seizures with possible use of sertraline. Case Report: A 40-year-old female presented with the episode of seizures. On examination, Glassgow Coma Scale score was E1V1M4. Three months earlier, she was diagnosed with intraparenchymal hemorrhage (IPH) with neurological deficits. Levetiracetam was started as prophylactic for seizures. Sertraline was added for concomitant depression. Dose increase of sertraline was done by the psychiatrist due to inadequate response for depression. About 1½ months after the dose increase, she presented with seizures. Conclusion: IPH and neurological deficits could be causative for seizures. However, seizures as an adverse drug reaction of sertraline cannot be ruled out as they occurred after the dose increase of Sertraline. Although rare, one should be watchful for this adverse effect of sertraline.