Assessment of Knowledge, Attitude and Practice of Pharmacovigilance and Adverse Drug Reaction Reporting among Nursing Staff

INTRODUCTION: WHO characterizes adverse drug reaction (ADR) as any reaction to a medication which is harmful and unintended, and which happens at measurements typically utilized as a part of man for prophylaxis, analysis or treatment of illness or for the alteration of physiological capacity. Antagonistic medication responses are negative outcomes of medication treatment. They are one of the main sources of grimness and mortality. It has been assessed that around 2.9-5.6% of all clinic affirmations are because of ADRs and upwards of 35% of hospitalized patients encounter an ADR amid their hospitalization. An unconstrained revealing of ADRs has remained the foundation of pharmacovigilance and is imperative in keeping up tolerant wellbeing. In India, all social insurance experts including specialists, medical caretakers, and drug specialists can report an ADR by filling an ADR type of the Central Drugs Standard Control Organization. The dynamic interest of social insurance experts in the pharmacovigilance program can enhance the ADR revealing. AIM OF THE STUDY: To assess the knowledge, attitude and practice of pharmacovigilance and adverse drug reaction reporting among nursing staffs. OBJECTIVES: 1. To assess the knowledge of pharmacovigilance towards adverse drug reaction reporting. 2. To assess the attitude and practice towards adverse drug reaction reporting. 3. To determine the factors that encourages the study subjects to report adverse drug reaction. 4. To evaluate the factors that discourages the study subjects not to report adverse drug reaction. NEED OF THE STUDY: The most serious ADRs lead to hospitalization, and hospital stays can lead to further ADRs. Hence, HCPs and hospitals can play a significant role in minimizing ADR-related morbidity and mortality. HCPs can play multiple roles by carefully reviewing the full patient history, particularly the drug allergy and drug-drug interaction history, to avoid any unwanted ADRs. In addition, reporting ADRs to the responsible office at their hospital or the regulatory authority is a pharmacovigilance approach that can be used to minimize ADRs because reporting ADRs can increase HCPs’ awareness of reactions, which could result in the avoidance of particular drugs, thus reducing the harm associated with reactions to particular drugs. Several drugs have been withdrawn from the market as a result of HCPs reporting ADRs. However, understanding the knowledge and practice of health care professionals regarding ADR reporting is very important for enhancing the reporting of ADRs. Therefore, the present study is undertaken to determine the current status of ADR reporting and also to investigate knowledge and attitude of particularly nursing staffs towards pharmacovigilance and ADR reporting. METHODOLOGY: The study was conducted in 3 different multi-speciality hospitals, at Chennai. Study design: Cross sectional, questionnaire based study Study setting: This study was conducted from December 2017 to August 2018 for a period of 10 months. Study sample: The study sample size was 300. Inclusion criteria: Nurses, Any age group. Exclusion criteria: Other health care professionals, Study participants with unwillingness are excluded. CONCLUSION: The study discloses that nursing staffs have poor knowledge and poor practice but good in attitude towards ADR reporting. Even though they have reported more number of severe ADRs, they didn’t perform any further interventions to prevent it. The major factor which discourages them from reporting ADR is a patient confidentiality issue and managing patient was more important. Seriousness of reaction, unusualness of reaction, involvement of new drug, confidence in diagnosis of ADR was the factors that encourage nursing staffs to report ADR. Based on the outcomes of the present study following recommendations are concluded. ADR reporting forms should be freely available in all hospitals as it can improve the reporting rates of ADR in the country. ADR reporting should be mandatory for all healthcare professionals. Each hospital should have a database on ADR which should be considered by healthcare professionals. The nursing syllabus curriculum needs to be revised to include ADR and pharmacovigilance. Continuous education programme and workshop want to be conducted regularly relate to how and where to report ADR