Knowledge and Practices of ADR Reporting in LMICs

Adverse Reaction Clinical Trial

Official title:

Knowledge and Practices of Adverse Drug Reaction Reporting Among Healthcare Professionals in Low and Middle-income Countries: a Cross-sectional Survey.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04301219
• Other study ID #: GTZ-PV-001
• Status: Completed
• Start date: April 1, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: March 2020
• Source: Getz Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: December 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Adverse Reaction

Locations

Country	Name	City	State
Pakistan	Shaheed Zulfiqar Ali Bhutto Medical University	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Getz Pharma

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Country-wise Analysis on knowledge of HCPs	Number of HCPs had knowledge about AR in their own country	2 years
Primary	Country-wise Analysis on practices of HCPs	Number of HCPs practicing AR reporting in their own country	2 years