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OpenTrials
Completed

NCT Number: NCT04301219

Knowledge and Practices of ADR Reporting in LMICs

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.

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Key information

Conditions

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shaheed Zulfiqar Ali Bhutto Medical University

Karachi, Sindh, Pakistan

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Country-wise Analysis on knowledge of HCPs

    Time frame: 2 years

    Number of HCPs had knowledge about AR in their own country

  2. Country-wise Analysis on practices of HCPs

    Time frame: 2 years

    Number of HCPs practicing AR reporting in their own country

Sponsors and collaborators

Lead sponsor

Getz Pharma

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 10, 2020
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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