Knowledge and Practices of ADR Reporting in LMICs

Completed

• Conditions: Adverse Reaction

• Registration Number: NCT04301219
• Lead Sponsor: Getz Pharma

Brief Summary

The reported literature suggests that knowledge about pharmacovigilance is on a lower side and ADR reporting is not common in developing countries. This survey may help us to identify the common gaps in knowledge and practices about pharmacovigilance so that we can devise the strategy on the basis of outcome.

Detailed Description

Safety evaluation of a product in a market is like a moving ball which need re-evaluation as the data gather in its life cycle.(1) As per the definition of International society of harmonization and World Health Organization, adverse reaction is Adverse drug reaction (ADR) is defined as "A response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for modification of physiological function." (2) Adverse reaction and adverse event are interchangeable use in pharmacovigilance sector by knowing the difference is that ADR term used when drug is causing the effect (1). The frequency of ADR is getting higher due to the increasing prevalence of chronic disease with the growing trend of combination drugs (3). The non-profitable organization of pharmacovigilance is playing tremendous role in disseminating the awareness of proper usage of drug globally.(3) According to Uppsala database statistics, approximately 3 million reports were listed as suspected ADRs. (4) Nearly 6.7% of hospitalizations were due to serious ADRs (5)

Study Timeline

• Study Start: 2017-04-01
• Primary Completion: 2018-03-01
• Study Completion: 2018-12-01
• Study First Submitted: 2019-11-26
• Status Verified: 2020-03
• Study First Submitted QC: 2020-03-05
• Last Update Submitted: 2020-03-05
• Study First Posted: 2020-03-10
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• Participants who would like to voluntarily fill the survey form

Exclusion Criteria

• Students
• Other than Health care professionals (including but not limited to Physicians, Doctors, Nurses and/or pharmacist)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Country-wise Analysis on knowledge of HCPs	2 years	Number of HCPs had knowledge about AR in their own country
Country-wise Analysis on practices of HCPs	2 years	Number of HCPs practicing AR reporting in their own country

Trial Locations

Locations (1)

Shaheed Zulfiqar Ali Bhutto Medical University; 🇵🇰 Karachi, Sindh, Pakistan