Objectives: To analyze and report adverse drug reactions (ADRs) in a tertiary care teaching hospital. Methods: This was an observational study, conducted to analyze and communicate the ADRs reported from July 2016 to June 2017 in a south Indian tertiary care teaching hospital. On daily basis, ADRs reported by healthcare professionals (HCPs) were analyzed and the reports that meet pharmacovigilance programme of India (PvPI) reporting criteria were communicated to PvPI through a specified updated Indian Pharmacopoeia Commission (IPC) suspected ADR reporting form. In this study, ADRs were summarised based on demographics, drug, incidence, type of reaction and its outcome. Causality, severity, seriousness, and predictability were assessed through WHO causality assessment scale, Hartwig and Siegel Severity Assessment Scale and PvPI criteria. Results: A total of 254 ADRs communicated to PvPI through specified, updated IPC suspected ADR reporting form. The incidence of ADRs in both males and females was identical. The occurrence of ADRs in adult patients (71.26%) was significantly higher than other age groups. Of total ADRs, most of them were with Antibiotics (24.01%) followed by antipsychotics (11.42%). In causality assessment, a majority of ADRs (48.82%) were considered possibly related to the drug or treatment and 55.12% were mild in severity. Overall, 36.22% patients were recovered from ADRs. Most of the reported ADRs (54.33%) were probably preventable. Conclusions: The results provided an insight to the HCPs on the importance of monitoring and reporting of ADRs. High-quality data gathered through a reporting system, most of the reported ADRs were probably preventable; the proper review of patient history and monitoring by HCPs can reduce the incidence of ADR. Our study results emphasize a need for establishing a pharmacovigilance centre to ensure the safe use of drugs.

COVID-19 is primarily a respiratory disease caused by a newly discovered SARS-CoV-2 virus and identified in the city of Wuhan, China in December 2019. WHO has declared this disease as a pandemic, and warned other countries. Presently this has affected 216 countries, areas or territories worldwide, spreading of this disease is very fast in USA, Brazil, and Russia than in the country of its origin, China. Like other coronaviruses, this may develop respiratory tract infections in the patients range from mild to fatal illness like pneumonia and acute respiratory distress syndrome (ARDS). As of now, no effective drug, vaccine, or any procedure is available and experiments are underway. However, empirical therapy is being followed to manage and save the lives of the patients. There is a need for pharmacological alternatives to combat this deadly virus and its complications. Based on the previous experiences with similar coronavirus management and present preliminary data from uncontrolled studies, drugs like chloroquine, hydroxychloroquine, remdesivir, lopinavir/ritonavir, and favipiravir have been recommended by the researchers to manage COVID-19. This review had assessed the potential mechanisms, safety profile, availability and cost of these drugs. This review concludes that the drugs mentioned above are having different properties and act differently in combating the COVID-19 viruses. Instead of single drug, combination of antivirals with different mechanism of action may be more effective and at the same time their adverse events should not be underestimated.

Objectives: The present study was contemplated and done to assess the knowledge, attitude, and practices (KAP) toward adverse drug reactions (ADR) reporting and Pharmacovigilance (PV) of the Doctor of Pharmacy Pharm.D interns for the first time in South India, to get an insight into their awareness and reporting culture. Methods: A cross-sectional descriptive KAP questionnaire-based study was conducted for 6 months on Pharm.D interns. Results: A total of 603 Pharm.D interns were participated, among them 578 (95.85%) were considered for the analysis. On an average of 78.25% of the participants had a good knowledge, around 82% were aware that patients’ will be benefited from the ADR reporting. The majority of the participants had a positive attitude. Moreover, 59% had reported the ADRs through different ADR reporting procedures 52% were advised the awareness programs for improving the reporting culture, and 34% had the difficulty in deciding or diagnosing the ADR. Conclusion: The KAP of the Pharm.D interns toward the ADR reporting and PV is appreciable and may reduce the burden on the other healthcare workers and improve patient care.

Objectives: To analyse the adverse drug reactions (ADR) and related economic burden on the health care system and health seekers Methods: A prospective observational study was conducted in a South Indian tertiary care teaching hospital from July 2016 – December 2018.ADRs were analyzed for their causality, severity, predictability, and preventability through standard scales and were reported to the Pharmacovigilance Program of India (PvPI) through a specified updated Indian Pharmacopoeia Commission (IPC) suspected ADR reporting form. The total cost burden including both direct and indirect were calculated by assessing the ADR management including the clinical investigations done. The indirect cost was calculated based on the per capita analysis by using the Gross Domestic Product (GDP) of our study area. Results: Among 458 ADRs, 81.88% were reported in Adult population with an almost same incidence in both the genders, majority were probable (41.70%) and Antibiotics were most commonly involved (16.18%). Around 60% ADRs were treated with at least one drug, 27% ADRs required either hospitalization or increased length of Hospitalization. A total of 989164.5 Indian Rupee (INR) was spent by the hospital and the patients for the management of ADRs, of which 79% was direct cost and 21% was indirect cost. Conclusion: In this hospital, 26.88% of patients were identified with ADRs that were associated with high direct costs, due to hospitalization/extended hospitalizations, which resulted in an extra economic burden to the healthcare sector and seekers for the management of ADRs.

Introduction: Lack of awareness about pharmacovigilance (PV) is one of the most important causes of under-reporting, which is widespread and poses a daunting challenge in India. The aim of this study is to assess and to document the knowledge, attitude, and practices (KAP) of Doctor of Pharmacy (Pharm.D) interns who practicing in hospitals with regards to PV and adverse drug reaction (ADR) reporting and to identify the causes of under reporting. Methods: This cross-sectional descriptive study was conducted for a period of six months across ten hospitals in Andhra Pradesh, India. Results: Overall, 578 responses were analysed, 78% of the participants had good knowledge on reporting ADR, 82% were aware that patient will be benefited from the ADR reporting, and the majority of the participants had a positive attitude towards reporting ADR. Fifty-nine percentage of the participants had reported the ADRs through different ADR reporting procedures, 52% were advised the awareness programmes for improving the reporting culture, and 34% had the difficulty in deciding or diagnosing the ADR. Conclusion: The KAP of the Pharm.D interns is appreciable and may reduce the burden on the other healthcare providers and improve patient care.