ABSTRACT
Background: Adverse drug reactions (ADRs) are one of the prime causes of morbidity and mortality, increase in hospital stay and socioeconomic burden on the patients. Periodic monitoring aids in formulating methods for safe usage of medicines in hospitals. This study was undertaken to study the patterns, assessment of causality, severity, preventability, body systems affected from ADRs received by the Pharmacovigilance cell, Department of Pharmacology between April 2018 to June 2019.Methods: The present study is an observational, retrospective, non-interventional analysis of voluntarily reported ADRs. Demography of patients, causative drugs, reactions, outcome, and severity are recorded. Data were analysed and expressed in numbers, percentages.Results: A total of 180 ADRs were spontaneously reported. Dermatology (42.8%), psychiatry (23.9%) and general medicine (18.3%) are the major departments reporting ADRs in our hospital. 60.6% reports were in males. The body system with maximum reactions is dermatological (51.1%). Drug class most commonly affected is anti-microbials (36.1%). Paracetamol (8.9%) is the most common drug with reactions. Causality assessment stated that 41.7% ADRs are probable and 58.3% were possible. Severity assessment showed 86.7% as mild and 13.3% as moderate. Preventability assessment stated that 93.3% ADRs not preventable, 5.6% probably preventable and 1.1% definitely preventable.Conclusions: The study provides a valuable insight with regards to the pattern of ADRs in our hospital. This will be useful in initiating a reporting culture, increase awareness, reducing under-reporting of ADR in our set up.
ABSTRACT
Background: Nursing staffs spend most time in patient care and are bedside caregivers. To expect voluntary reporting of adverse reactions, it is essential that they possess proper knowledge, right attitude and practice reporting. Therefore, the present study was aimed to assess the Knowledge, Attitude and Practice of Pharmacovigilance towards ADRs reporting.Methods: A prospective, cross sectional, observational, questionnaire-based survey was conducted among nurses in a tertiary care teaching hospital in Eastern India. Questionnaire containing 15 questions was used to assess knowledge, attitude and practice. The questionnaire was administered to 150 nurses. Analysis of data was done using statistical software..Results: The response rate in our study was 86.67%. Nurses have good knowledge of pharmacovigilance and adverse reaction. However, only 10% have reported an adverse reaction in our study. This shows that in spite of having a good knowledge of reporting, nurses have poor attitude, which is reflected by a low reporting rate. Nurses opined that taking patient care is of prime importance than report an adverse reaction. This corroborates the low reporting rate in our set up.Conclusions: Majority of nurses have good knowledge on pharmacovigilance and adverse drug reaction. The concern remains on the low reporting rate. Continuous training programmes, and reminders likely to enhance the voluntary reporting from the nursing staffs.