Knowledge, attitude and the practice (KAP) of Pharmacovigilance among health care professionals of a tertiary care teaching hospital of South India

Background: Skin is one of the most common targets of adverse drug reactions (ADRs) The practice of pharmacovigilance all over the world is 5% whereas in India, it is below 1%. Hence, the purpose of our study is to monitor and analyze the suspected cutaneous adverse drug reactions (ACDRs) reported at our tertiary care teaching hospital, to characterize the nature and predictability, severity and preventability of ACDRs and identify most common drugs causing cutaneous ACDRs so that they can be given cautiously and with keen surveillance.Methods: An observational study was conducted in patients attending outpatient and inpatient department for a period of 3 years. All ACDRs of patients were referred by health care professionals and the diagnosis were made by concern doctors. The recorded data was filled in the ADR form obtained from pharmacovigilance program of India (2011) and Central Drug Standard Control Organization (CDSCO) website.Results: Out of 1399 ADR reports analyzed, 564 reports (40.31%) were of ACDRs, female to male ratio was 0.85. Redness (44.32%) was most common symptom, followed by itching (44.14%) and rash (19.14%). Antimicrobials (43.97%), NSAIDS (21.63%), Anti-retroviral therapy drugs (13.65%) were common groups. As per WHO-UMC causality classification, modified Hartwig and Siegel severity scale, Thornton and Schumock preventability scale, ACDRs were probable, mild and possibly preventable respectively.Conclusions: Effective ADR monitoring plays a role in safety of medicines. So, awareness regarding early diagnosis and prompt treatment should be created among the health care professionals and reporting of ACDRs should be regularly practiced by all the departments.

Download Full-text

Health-care Professionals’ Knowledge and Perception of Adverse Drug Reaction Reporting and Pharmacovigilance in a Tertiary Care Teaching Hospital of Nepal

Hospital Pharmacy ◽

10.1177/0018578719883796 ◽

2019 ◽

pp. 001857871988379 ◽

Cited By ~ 2

Author(s):

Krisha Danekhu ◽

Sunil Shrestha ◽

Sushant Aryal ◽

P. Ravi Shankar

Keyword(s):

Health Care ◽

Teaching Hospital ◽

Health Care Professionals ◽

Tertiary Care ◽

Medical Doctors ◽

Tertiary Care Teaching Hospital ◽

Care Teaching ◽

Adr Reporting ◽

Adequate Knowledge ◽

Doctors And Nurses

Background: Underreporting of adverse drug reactions (ADRs) is common globally, and Nepal is not an exception to this. Health-care professionals (HCPs) play a vital role in reporting ADR during routine practice. Lack of knowledge and awareness about pharmacovigilance and reporting ADRs among HCPs may contribute to underreporting. Objective: The objective of this study was to evaluate the knowledge and perception of HCPs regarding ADR reporting and pharmacovigilance in a tertiary care teaching hospital in, Nepal. Methods: A descriptive cross-sectional study was conducted. A questionnaire was distributed to 215 HCPs (medical doctors, nurses, and pharmacists) between March and September 2018. Knowledge and perception regarding ADR reporting and pharmacovigilance were studied. Data were analyzed using IBM SPSS Statistics for Windows, Version 21.0 (IBM Corp, Armonk, New York). Results: The HCPs included 75 medical doctors, 126 nurses, and 14 pharmacists. Majority of the participants were female (67%), and the majority of participants were not aware of pharmacovigilance. Among the participants, pharmacists were found to have better knowledge regarding pharmacovigilance. However, other HCPs (doctors and nurses) strongly agreed about the necessity of having adequate knowledge about pharmacovigilance. Out of 215, 57.7% agreed that the important benefit of reporting ADR was to identify safe drugs and improve patient safety. The main reasons for not reporting were – ADR reporting was not widely promoted by relevant authorities (47%), followed by not knowing where and how to report ADR (34.9%). However, other HCPs (doctors and nurses) strongly agreed about the necessity of having adequate knowledge about pharmacovigilance. Conclusions: The knowledge of HCPs on ADR reporting and pharmacovigilance was poor. Despite a low knowledge of ADR reporting and pharmacovigilance among HCPs, there was a positive perception that ADR reporting is necessary and ADR monitoring system should be established in the hospital. This study also highlights a need for future intervention studies focusing on educating HCPs about ADR and pharmacovigilance.

Download Full-text