Knowledge and Practices of ADR Reporting in LMICs

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

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.

Study Overview

• Status: Completed
• Conditions: Adverse Reaction

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 Type: Observational
• Enrollment (Actual): 1500

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan
      • Shaheed Zulfiqar Ali Bhutto Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A self-administered questionnaire was distributed to 1500 HCPs in 11 countries (Afghanistan, Cambodia, Kazakhstan, Kenya, Laos, Myanmar, Nigeria, Pakistan, Philippines, Sri Lanka, and Sudan). The participants were approached at various scientific events and academic interactions during the period and were requested to participate in the survey on a voluntary basis.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Country-wise Analysis on knowledge of HCPs	Number of HCPs had knowledge about AR in their own country	2 years
Country-wise Analysis on practices of HCPs	Number of HCPs practicing AR reporting in their own country	2 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: November 26, 2019
• First Submitted That Met QC Criteria: March 5, 2020
• First Posted (Actual): March 10, 2020

Study Record Updates

• Last Update Posted (Actual): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 5, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: GTZ-PV-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No