Knowledge, Attitude and the Practice of Pharmacovigilance among the healthcare professionals

Not yet recruiting

• Conditions: Healthy Human Volunteers

• Registration Number: CTRI/2018/02/012106
• Lead Sponsor: All India Institute of Medical Sciences Jodhpur

Brief Summary

**Methodology**

A cross-sectional study will be carried out using a pretested questionnaire. The questionnaire will be designed to assess the KAP regarding pharmacovigilance. The healthcare professionals (doctors, nurses, and pharmacists) working in the AIIMS, Jodhpur (Rajasthan) during the study period will be included. Only those who gave their consent to participate were included in the study. Face Validity of the questionnaire has been confirmed by sending it to 10 experts in the field of medicine and modifying the questionnaire as per their suggestions and comments. Care will be taken to protect the confidentiality and anonymity of participants. Data analysis was done using Statistical Package for Social Sciences (SPSS) version 21.

Inclusion Criteria:

1.      Doctors working in Clinical and Nonclinical departments of AIIMS, Jodhpur

2.      Doctors willing to give written informed consent.

Exclusion Criteria: None

Design: Cross sectional study and survey.

Study group: Clinical, Non Clinical and Para Clinical Doctors in Tertiary care hospital.

Evaluation: Responses of the doctors will be recorded and analysed. Confidentiality and anonymity of the participants will be maintained as no personal information will be recorded on the questionnaire. After the responses are recoded, comparison will be done with regard to knowledge, attitude and practice of pharmacovigilance among consultant and residents and also among doctors of clinical and non-clinical doctors.

**Statistical Analysis**

Information from the returned pretested questionnaire will be coded and entered into Statistical Package for Social Sciences (SPSS) software version 21. Spearman’s correlation will be used to determine any relationship between training of pharmacovigilance and reporting ADR.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-15
• Last Update Posted: 2018-12-02

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1.Doctors working in Clinical and Nonclinical departments of AIIMS, Jodhpur 2.Doctors willing to give written informed consent.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the knowledge, attitude, and practices (KAP) of the healthcare professionals about pharmacovigilance in All India institute of medical Sciences, Jodhpur (Rajasthan), a tertiary care teaching hospital.	Single point recording at the time of enrolment

Secondary Outcome Measures

Name	Time	Method
To assess the causation of underreporting of adverse drug reactions (ADRs) as it needs to be well-assessed in India.	Single time point recording at the time of enrolment

Trial Locations

Locations (1)

All India Institute of Medical Sciences Jodhpur; 🇮🇳 Jodhpur, RAJASTHAN, India

All India Institute of Medical Sciences Jodhpur

🇮🇳Jodhpur, RAJASTHAN, India

Dr Surjit Singh

Principal investigator

8003996895

sehmby_ss@yahoo.com