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Knowledge and Practices of ADR Reporting in LMICs

Sponsor
Getz Pharma (Industry)
Overall Status
Completed
CT.gov ID
NCT04301219
Collaborator
(none)
1,500
Enrollment
1
Location
20
Actual Duration (Months)
75
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    1500 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Knowledge and Practices of Adverse Drug Reaction Reporting Among Healthcare Professionals in Low and Middle-income Countries: a Cross-sectional Survey.
    Actual Study Start Date :
    Apr 1, 2017
    Actual Primary Completion Date :
    Mar 1, 2018
    Actual Study Completion Date :
    Dec 1, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Country-wise Analysis on knowledge of HCPs [2 years]

      Number of HCPs had knowledge about AR in their own country

    2. Country-wise Analysis on practices of HCPs [2 years]

      Number of HCPs practicing AR reporting in their own country

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shaheed Zulfiqar Ali Bhutto Medical University Karachi Sindh Pakistan

    Sponsors and Collaborators

    • Getz Pharma

    Investigators

    • Principal Investigator: Mahwish Raza, Pharm-D, Shaheed Zulfiqar Ali Bhutto Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Getz Pharma
    ClinicalTrials.gov Identifier:
    NCT04301219
    Other Study ID Numbers:
    • GTZ-PV-001
    First Posted:
    Mar 10, 2020
    Last Update Posted:
    Mar 10, 2020
    Last Verified:
    Mar 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Mar 10, 2020