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

NCT ID: NCT05224804

Last Updated: 2022-02-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2021-09-10

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.

Conditions

Adverse Drug Reaction

Study Design

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

Interventions

knwoledge

Knowledge and Attitudes about ADRs Reporting

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Pharmacist graduates

Exclusion Criteria

undergrauate pharmacist

-

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fayoum University

OTHER

Sponsor Role: lead

Responsible Party

Marwa Kamal

lecturer of clinical pharmacy, phD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Marwa Kamal Ahmed Tolba

Al Fayyum, , Egypt

Countries

Egypt

References

Beninger P. Pharmacovigilance: An Overview. Clin Ther. 2018 Dec;40(12):1991-2004. doi: 10.1016/j.clinthera.2018.07.012. Epub 2018 Aug 17.

Reference Type: BACKGROUND

PMID: 30126707 (View on PubMed)

Other Identifiers

Pharmacovigilance

Identifier Type: -

Identifier Source: org_study_id