Journal of Pharmacovigilance

Practicality of direct reporting of ADRs to ADR monitoring centers by patients - Based on survey of knowledge, attitude and perceptions/practices of patients in India towards Adverse Drug Reaction (ADR) reporting

3^rd International Conference and Exhibition on Pharmacovigilance & Clinical Trials

October 27-29, 2014 Hyderabad International Convention Centre, India

Mala Kharkar and Suresh Bowalekar

Scientific Tracks Abstracts: J Pharmacovigilance

Abstract:

Objective: To find out practicality of direct reporting of ADRs to ADR monitoring centers by patients - Based on survey of knowledge, attitude and perceptions/practices of patients in India towards Adverse Drug Reaction (ADR) reporting Methods: A questionnaire was designed to assess knowledge, attitude, perceptions/practice of patients towards Adverse Drug Reactions and its reporting. The questionnaire was tested by 10 patients attending clinics of randomly selected Medical Practitioners. Based on their suggestions the questionnaire was finalized and used in the survey. We approached 6000 patients randomly from the clinics of medical practitioners in our earlier study. Results: Only 5735 (95.6%) patients out of 6000 could be contacted. 5040 out of 5735 has provided response to the questionnaire. Thus overall response rate was around 84% if we consider 6000 as the base and was about of 87.9% with 5735 as the base. Conclusion: Enhancing awareness among common people is expected to increase direct ADR reporting by patients to ADR monitoring centres managed by government authorities. This will increase ADR reporting rate and thus contribute effectively to get rid of currently observed under reporting issue in India in particular and in the world in general.

Biography :

Mala Kharkar is a Vice Principal of Patkar College which is a 50 year old renowned college in Mumbai, India. She has completed her Post graduation in Statistics and Information Technology from Mumbai University in India. Prior to her appointment as Vice Principal she has worked in Hewlett Packard, CA, USA for 9 Years. She is involved in statistical analysis of clinical trial projects. She has a special interest in the field of Adverse Drug Reactions and pharmacovigilance because of which she has registered herself for PhD in applied statistics to Adverse Drug Reaction related topic under the guidance of Suresh Bowalekar from Yashwantrao Chavan University, India. She has completed her work related to PhD and submitted the thesis to the university. She has about 6 published papers and also invited as a guest speaker to university and its affiliated colleges to address professors.