A cross-sectional, questionnaire-based study on knowledge, attitude, and practice of pharmacovigilance among post-graduates at a tertiary care teaching hospital, Telangana

Background: Pharmacovigilance is the process of drug safety monitoring that improves patients' quality of life through the collection and analysis of Adverse Drug Reactions (ADRs). In our state, most of the ADRs are reported by a spontaneous reporting system of individual cases from health care professionals to Adverse Drug Reaction Monitoring Centre (AMC) under the Pharmacovigilance Programme of India (PvPI). Post-graduates (PGs) play a vital role in reporting ADRs as they are in personal evidence with all events after drug administration. The main objective of our study is to evaluate the Knowledge, Attitude, and Practice of Pharmacovigilance among post-graduates.Methods: The present study was a cross-sectional questionnaire-based study on knowledge, attitude, and practice (KAP) of Pharmacovigilance among 150 post-graduates at a tertiary care teaching hospital, Telangana. The statistical analysis was done using Statistical Package for Social Sciences (SPSS) version 25 software.Results: The results showed that there is relatively less knowledge among postgraduates. Attitude and practice-based questions evidenced a paradigm shift towards the construction of an organized Pharmacovigilance system. This study also highlights the under-reporting and the interventions needed to improve spontaneous reporting of ADRs.Conclusions: The knowledge of Pharmacovigilance with a positive attitude and practice among post-graduates is essential for reporting ADRs and reducing under-reporting.ng

BIG DATA ANALYTICS IN PHARMACOVIGILANCE - A GLOBAL TREND

Big data analysis has enhanced its demand nowadays in various sectors of health-care including pharmacovigilance. The exact definition of big data is not known to many people though it is routinely used by them. Big data refer to immense and voluminous computerized medical information which are obtained from electronic health records, administrative data, registries related to disease, drug monitoring, etc. This data are usually collected from doctors and pharmacists in a health-care facility. Analysis of big data in pharmacovigilance is useful for early raising of safety alerts, line listing them for signal detection of drugs and vaccines, and also for their validation. The present paper is intended to discuss big data analytics in pharmacovigilance focusing on global prospect and domestic country-India

ASSESSMENT AND ANALYSIS OF ADVERSE EVENTS FOLLOWING COVID-19 VACCINATION AMONG CHILDREN AGED 15-18 YEARS AT TERTIARY CARE TEACHING HOSPITAL, TELANGANA: A PROSPECTIVE OBSERVATIONAL STUDY

Objective: Government of India (GOI) has allowed vaccination for age group of 15-18 years. It is a positive step toward boosting immunization rates across the nation. As per guidelines, BBV152 vaccine, Bharat Biotech's “Covaxin” is approved for adolescents. The study was designed to evaluate adverse events following immunization (AEFI) among adolescents.  Methods: A prospective, observational survey was carried out among the first 315 beneficiaries (adolescents of age 15-18 years) for a period of 5 months at Osmania medical college and hospitals. Within 24 hours, 48-72 hours, and two weeks following first and second doses of Covaxin, active and passive surveillance using telephonic inquiry and documentation relating to adverse events was conducted. The prevalence of AEFI and its association with demographic factors have been identified. Collected data were analyzed using SPSS 25.  Results: The first 315 beneficiaries (Adolescents between the ages of 15 and 18) who received Covaxin were identified. All AEFIs reported were within the first 24-72 hours of vaccination. AEFI incidence was higher in 1st dose (16.6%) when compared to 2nd dose (3.5%). No AEFIs were noted after 2 weeks. We found no association of AEFI with sex, age group, and past history of Covid as this finding is not significant (p>0.05). Conclusion: Overall, Covaxin has good safety profile in adolescents. Symptoms were transient and of low intensity. There were no documented severe and serious AEFI. It is obligatory for documentation as the AEFI profile will encourage vaccine adoption and lessen reluctance

ASSESSMENT OF KNOWLEDGE, ATTITUDE, AND PRACTICE OF HAEMOVIGILANCE AMONG POST-GRADUATES AT A TERTIARY CARE TEACHING HOSPITAL IN HYDERABAD–A CROSS-SECTIONAL STUDY

Objective: Transfusion of blood and blood products is a life-saving intervention but has the potential to cause adverse events. Haemovigilance is an organized system that includes monitoring, identification, reporting, investigating, and analyzing adverse events related to transfusion and the manufacture of blood products. However, reporting of adverse reactions is markedly less in our country. This study is intended to assess knowledge, attitude, and practice of Haemovigilance among post-graduates (PGs) and to scrutinize various causes of Underreporting. Methods: A cross-sectional pre-validated questionnaire-based study was carried out in Osmania medical college and hospital, Hyderabad over 4 months among 150 PGs. Results: Only120 PGs out of 150, provided their responses. Only 20% of the PGs knew about the Haemovigilance program. 41.6% knew how to report and who can report. 2% knew about Hemo-vigil and Donor vigil software. 100% of PGs show a positive attitude towards transfusion reaction reporting and agreed that Haemovigilance activities should include in the undergraduate curriculum. Medicolegal liability issues, lack of knowledge, and lack of time were the main factors that forbade them from reporting. Conclusion: A positive attitude towards Haemovigilance exists among PGs but knowledge regarding the Haemovigilance program was poor and the practice of transfusion reactions reporting was significantly reduced. Hence, our study suggests the inclusion of the procedure of transfusion reactions reporting in the Undergraduate curriculum and augmentation of CMEs/workshops/seminars to PGs