Pharmacists' Knowledge and Attitudes About ADRs Reporting and Pharmacovigilance Practice in Egyptian Hospitals

Completed

• Conditions: Adverse Drug Reaction

• Registration Number: NCT05224804
• Lead Sponsor: Fayoum University

Brief Summary

The present study has assessed the knowledge, attitude and practice of ADRs reporting among pharmacists, and the perceived factors that may influence reporting.

Detailed Description

The practice and science of pharmacovigilance is described as the gathering, identification, monitoring, assessment, and prevention of adverse medication effects using pharmaceutical products. The term "pharmacovigilance" comes from the Greek words pharmakon (drug) and vigilare (vigilance) (monitor or keep an eye on). Pharmacovigilance (PV) is defined by the World Health Organization (WHO) as "the science and practices relating to the detection, assessment, understanding, and prevention of adverse effects or other drug-related problems". PV assesses the risk-benefit profile of medicines in order to improve patient safety. As a result, adverse drug reaction (ADR) reporting is the bedrock of any PV system, and early detection and reporting of ADRs to regional or national drug-regulatory bodies is important.

ADRs are defined by the World Health Organization as an unpleasant and unexpected response to a medicine that occurs at levels usually employed in man for the prevention, diagnosis, or therapy of disease, or for the alteration of physiological function". Adverse drug reactions (ADRs) are major public health issues that have been linked to longer hospital stays and higher therapeutic costs. According to recent systematic reviews and meta-analyses of observational research, the rate of hospital admissions linked to ADRs is between 3-5 percent.

A number of factors have been linked to HCPs, particularly pharmacists, reporting ADRs. Several studies have indicated reasons for not reporting observed ADRs, and pharmacists have been polled to determine the most important facilitators and barriers to spontaneous reporting. The seven deadly sins were coined by Inman and later defined by Lopez-Gonzalez et al., into professional and personal traits, as well as knowledge and attitudes toward reporting. Pharmacists from throughout the world have highlighted a number of barriers to reporting ADRs, including a lack of time, the inability to correlate an adverse event (AE) to a specific medicine, and the absence of readily available reporting forms . It has also emphasized the necessity of educational measures to encourage ADR reporting, such as awareness lectures and workshops.

Egypt joined the WHO International Program for Drug Monitoring in 2001, but no concrete actions were done until 2009, when the Egyptian Pharmacovigilance Center was established (EPVC). Receiving ADR reports, detecting safety signals, sending frequent newsletters with pharmacovigilance (PV)-related updates, and conducting awareness training are only a few of EPVC's responsibilities.

Study Timeline

• Study Start: 2020-05-01
• Primary Completion: 2021-09-10
• Study Completion: 2021-09-10
• Status Verified: 2022-01
• Study First Submitted: 2022-01-29
• Study First Submitted QC: 2022-02-03
• Last Update Submitted: 2022-02-03
• Study First Posted: 2022-02-04
• Last Update Posted: 2022-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Pharmacist graduates

Exclusion Criteria

undergrauate pharmacist

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacists' Knowledge and Attitudes about ADRs Reporting and Pharmacovigilance Practice in Egyptian Hospitals	1 year and 4 month to collect data.	The majority of pharmacists was knowledgeable about pharmacovigilance and had a favourable attitude toward ADR reporting. There are several variables that discourage pharmacists from reporting suspected ADRs, including the belief that there is no advantage to reporting, the presence of administrative barriers, the lack of availability of the ADR reporting form, and the lack of encouragement from hospital administration.

Trial Locations

Locations (1)

Marwa Kamal Ahmed Tolba; 🇪🇬 Fayoum, Egypt