Knowledge and Practices of ADR Reporting in LMICs

NCT ID: NCT04301219

Last Updated: 2020-03-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2018-12-01

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)

Conditions

Adverse Reaction

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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)

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Getz Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mahwish Raza, Pharm-D

Role: PRINCIPAL_INVESTIGATOR

Shaheed Zulfiqar Ali Bhutto Medical University

Locations

Shaheed Zulfiqar Ali Bhutto Medical University

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

GTZ-PV-001

Identifier Type: -

Identifier Source: org_study_id