RESUMO
Background: Adverse drug reactions (ADRs) is one of the important factors contributing to morbidity and mortality among patients and is a major public health burden. Spontaneous ADR reporting plays an important role in detection of ADRs, reducing their incidence and improving patient safety. India has one of the lowest ADR reporting rates in the world. Aim and Objective: The aim of the study was to assess the knowledge, attitude and practice (KAP) of doctors towards pharmacovigilance. Materials and Methods: A KAP questionnaire validated by subject experts was given to the doctors outside the teaching profession within 50 km of Government TD Medical College, Alappuzha, who consented to be a part of the study. The questions were structured to obtain the demographic details of the doctors, their KAP toward pharmacovigilance. No identifiable information regarding the participants was collected and the participants were assured of their confidentiality. A week’s time was given to the participants to answer the questions. Results: During the period of 1 year from June 2019 to May 2020, a total of 121 doctors responded to the questionnaire. The respondents aged from 26 to 67 years with the mean age being 37.31 ± 14.15 years. 94 (77.7%) thought that anyone could report an ADR while 16 (13.2%) thought that only doctors could report ADRs. Only 76 (62.8%) were aware of the existence of National Pharmacovigilance Centre in India. Ninety-eight (81%) did not know how to submit the ADR form to the nearest pharmacovigilance center. A vast majority 99 (81.8%) thought that ADRs to drugs of any system of medicine could be reported, while 20(16.5%) felt that only ADRs to modern medicines need to be reported. Among the factors discouraging doctors from reporting ADRs, lack of training to report an ADR 99 (81.8%) and lack of time during practice 83 (68.5%) were cited as the common reasons. A vast majority 116 (95.9%) had not received any formal training on ADR reporting and 114 (94.2%) opined that they would like to receive a formal training on the same. Conclusion: Doctors were largely aware of pharmacovigilance but had lack of KAP of reporting ADRs and filling up an ADR form. It emphasizes the need for regular mandatory education and training on ADR reporting among healthcare workers, and also the need to run continuous awareness campaigns on spontaneous reporting of ADRs to enhance reporting rate.
RESUMO
Background: Coronavirus 2019 was declared as a pandemic by the World Health Organization in March 2020. Bereft of specific treatment for the disease, vaccinations and COVID appropriate behavior have come to be the main approaches to combat the pandemic. A number of vaccines have been approved after clearing clinical trials. Hence, it is essential to evaluate the safety profile of each vaccine for ensuring optimum health of the general population. This study was conducted to evaluate the adverse events following CoviShield vaccination in a tertiary care center. Aims and Objectives: The aim of the study was to describe the pattern of adverse effects, treatment given, and comorbidities seen in healthcare workers (HCW) who reported to the adverse drug reaction (ADR) monitoring center in the department of pharmacology Government T.D. Medical College, Alappuzha, following CoviShield vaccination from January 2021 to October 2021. Materials and Methods: A retrospective and descriptive study was carried out at Department of Pharmacology, GTDMCA involving all HCW who reported side effects following CoviShield vaccination in the ADR monitoring centre (AMC) in the Department of Pharmacology, GTDMCA from January 2021 to Oct 2021. Results: Out of 620 HCWs who reported adverse event following vaccination, majority (45%) were from the age group 21–30 years. About 83% of HCWs who reported adverse effect were women. Majority of the respondents (96%) experienced the adverse effects within 24 h. About 88% of respondents experienced these adverse effects after the initial dose alone. Commonly encountered adverse effects were fever (57%), headache (43%), myalgia (38%) etc. Hypertension (7%) was the most common comorbidity seen. Majority of the beneficiaries (70%) took paracetamol for the treatment of the adverse effect. Conclusion: Majority of the vaccinated HCWs experienced minor and self-limiting adverse event following immunization (AEFI) with Chimpanzee Adenovirus Oxford novel CoronaVirus-19. No serious AEFI were reported to the AMC. Despite the record speed at which the vaccine has been developed, it has shown to have a good safety profile considering the millions of doses that have been administered.