An Evaluation of Healthcare Providers' Adherence to Pharm... | NCT06428162

Studies
An Evaluation of Healthcare Providers' Adherence to Pharmacovigilance Practices in an African Community

NCT06428162

Sponsor

Deraya University

Status

Completed

Last Update Posted

Aug 7, 2024Actual

Enrollment

300Actual

Phase

Not provided

Conditions

Drug Reaction
Drug Hypersensitivity
Drug Abuse
Drug Interaction

Interventions

questionner

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 18, 2024Actual

Primary Completion Date

May 20, 2024Actual

Completion Date

Jun 20, 2024Actual

First Submitted Date

May 20, 2024

First Submission Date that Met QC Criteria

May 20, 2024

First Posted Date

May 24, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 6, 2024

Last Update Posted Date

Aug 7, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Soad Ali, associate professor of pharamcy practices, faculaty of pharmacy, Deraya University, Deraya UniversityPrincipal Investigator

Lead Sponsor

Deraya UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Egypt's several regions-rural, mixed, and urban-were given pre-designed surveys pertaining to drug adverse events and the role of pharmacovigilance in detection and reporting. The three sections of the survey were dedicated to studying health care professionals' knowledge concerning pharmacovigilance concepts and practices, as well as demographics and people reported or not reported. The survey also asked more questions regarding adverse occurrences that were reported.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
questionner	Other	three sections questioner including: demographics, reported cases, unreported cases

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
reported adverse drug reactions	collect recent adverse drug reaction reports	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all health care providers are invited to share in the study
minimum experience required is one year in health carrier.
accept sharing in the study

Exclusion Criteria:

health care providers who refuse to complete all data required in the survey.
fresh experience or participants who left health carrier

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

all health care providers that deals with drugs and medications as pharmacists, physicians, Dentists, nurses and medical reps are invited to share in this survey as a hard template. study included 300 subject in different disciplines at the period at 3 months. complete survey composed of 3 sections included previous reported ADVEs

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Deraya university		Minya		05673	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D064420	Drug-Related Side Effects and Adverse Reactions
D004342	Drug Hypersensitivity
D019966	Substance-Related Disorders

Ancestor Terms

ID	Term
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided