Indian Journal of Pharmacy and Pharmacology

145-149

Authors: Manjunath S M, Nagesh Raju G, Someswara GM

Background: Adverse effects due to medicines are common cause of morbidity and mortality. ADRs have a major impact on public health by imposing a considerable economic burden on the society. Objectives: To assess the awareness of pharmacovigilance among fifth term medical students. Methods: This was an observational, cross-sectional study based on the questionnaire. The study was conducted on IInd year (fifth term) medical students in the Department of Pharmacology of BMCH, Chitradurga. A questionnaire containing 15 questions with 2-5 options were given to each student and they were asked to mark one best suitable option. Totally 70 students participated in the study, out of which 4 questionnaires were incomplete and eliminated while evaluating results. So, we analysed data of 66 participants. The results were evaluated graphically using Microsoft excel sheet. Results: Majority of the students had correct understanding regarding Pharmacovigilance and its role in identifying the safety of drugs. 89.93% of students were aware of all the activities involved in Pharmacovigilance. 48.48% of the students had an idea that all the health care professionals (i.e. doctors, pharmacists, nurses) are responsible for reporting ADR. 34.84% of students had wrong perception that WHO online database for reporting ADRs was Medsafe and 31.81% thought Vigibase as the WHO online database. 48.48% had the correct understanding that CDSCO is the regulatory body for monitoring ADRs in India. 66.66% students thought that, all the types of ADRs (mild, moderate & severe) irrespective of their severity have to be reported. 61% of students thought that ADR reporting is a Professional obligation. 91% of the students were aware that all the measures (stop the drug, report ADR & treat the condition) have to be taken when an ADR is suspected. Other findings included like, 68% students knew drugs banned because of ADR. Majority of students wrote Thalidomide & Nimesulide as an example for a drug banned because of ADR. Conclusion: The current study revealed that medical students had good awareness about Pharmacovigilance and ADR reporting. Better understanding of the subject on Pharmacovigilance in these undergraduates would help them as future doctors in improving the quality of health care, as well as safety of the patients.

155-159

Authors: Ajay Kumar Halwai, Rajesh Hishikar, Manju Agrawal, Usha Joshi, Suraj Agrawal, Basant Maheshwari,

Epilepsy is a prevalent chronic neurological disorder in peadiatric population and Anti-epileptic Drugs (AEDs) have a narrow margin of safety. The aim of this study was to analyse use of various AEDs and type of epilepsy prevalent in our population. In this study prescriptions for epilepsy from paediatric outpatient department, over five month period (from January 2015 to May 2015) were retrospectively analysed. Total of 160 prescreptions were analysed. 95 (59.3%) were female and 65 (40.7%) were males. 70 (43.8%) patient belonged to 11-15 years of age group, 49 (30.6%) patient belonged to 6-10 years age group, 41 (25.6%)patient belonged to 0-5 years age group. Generalised Tonic Clonic Seizure (GTCS) was the most common diagnosed epilepsy (61.5%), followed by Partial seizure (30.6%) and Absence seizure (8.5%). 117 (73.1%) patient were prescribed monotherapy whereas polytherapy were given to 4 (2.5%) patient. 39 (25%) patient were given two drug combination. Sodium valproate was commonest monotherapy (53%) followed by Carbamzepine (29.9%), Phenytoin (8.5%) and Phenobarbitone (8.5%). Sod. Valproate with Phenytoin was commonest prescribed two drug combination (48.7%) followed by Sodium valproate with Phenobarbitone (28.2%). Among polytherapy Sodium valproate with Phenytoin and Levetiracetam were given to 3 patient. In this study GTCS was most common diagnosis and conventional AED were commonly used. Sod. valproate was commonest prescribed AED as monotherapy and in combination therapy .

169-175

Authors: Agrawal M, Hishikar R, Joshi U, Halwai A, Toddar TL, Khubchandani V, Jaiswal S, Agrawal AC

Drugs are approved for clinical use after passing stringent protocol of preclinical and clinical trials so that they are safe for human consumption. But they provide limited information as they are conducted under strictly controlled conditions and largely focus on efficacy evaluation and adverse drug reactions being secondary parameters assessed. Some ADR can be detected only after Long term use in a large population and in specific patient groups due to genetic variability or difference in life style and food habits, concomitant disease prevalence and medication use . We are reporting the scenario of spontaneous suspected ADRs reported at ADR Monitoring Center (AMC) of Pt JNM medical college Raipur, Chhattisgarh, India. A retrospective, cross sectional observational study of ADRs reported spontaneously between June 2014 and May 2015 done at our AMC. The study protocol was approved from Institutional ethical committee. Odds ratio and Percentages were calculated. Of the total of 26 suspected ADRs received, 61.5% (n=16) were females. Only 11.53% (n=3) were serious. The most common ADR presented were with dermatological symptoms 65.38% (n=17) and the most common offending class of drug was of musculoskeletal class -NSAIDs -38.46% (10). 53.84 % (n=14) ADRs were possible, 26.92% (n=7) were probable, 15.38% (n=4) were certain and 3.84% (n=1) was unclassified. 57.69% (15) patients had received generic formulation and 73.07 % (n=19) ADRs were due to single drug formulation. Measures to improve adverse drug reaction detection and reporting by all healthcare professionals should be undertaken, to ensure patient's safety.