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

2019 ◽  
pp. 001857871988379 ◽  
Author(s):  
Krisha Danekhu ◽  
Sunil Shrestha ◽  
Sushant Aryal ◽  
P. Ravi Shankar

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.

2019 ◽  
Vol 9 (6-s) ◽  
pp. 44-52
Author(s):  
A. V. Kishore Babu ◽  
A. Srinivasa Rao

Objectives: The main purpose of the study is to assess the causality, severity, preventability of ADRs and factors associated with ADRs in chronic disease patients of tertiary care teaching hospital. Study setting and Design: A Prospective observational longitudinal study was conducted in a tertiary care teaching hospital at Hyderabad, India, for 3 years. Materials and Methods: Patients of age group > 18 years were included in the study. All the patients were distributed according to their gender, age, number medications used, disease condition, and socioeconomic state. The reported ADRs were analyzed by WHO-UMC causality, Hartwig’s Siegel’s scale and modified Shumock and Thornton criteria respectively. Statistical analysis used: Descriptive statistical analysis was used. Results: A total of 691 patients enrolled in the study, in that 391 patients reported with 510 ADRs. Of these 37.0% are in-patients and 62.9% are out-patients. Majority of the patients are female category (58.0%) and 45.8% of ADRs reported from adults (41-60 years). 65.8% patients are non-adherent to medication. Life style habits, economic status and education are found to be predictors for ADRs. WHO-UMC scale showed 42.9% of ADRs probable. Hartwig’s and Siegel’s severity scales shown 13.1 % ADRs are severe followed by 33.7% moderate ADRs and 40% of ADRs were preventable. Conclusion: Hence our study advises that there is a need of improvement in ADR reporting from health care professionals. This study also suggests further research in India for the improvement of possible intervention strategies to reduce burden and cost of ADR. Keywords: Prospective, ADR reporting, WHO-UMC, Hartwig’s Siegel’s scale, Shumock and Thornton.


Author(s):  
Vandana Badar ◽  
Vidisha Vivek Parulekar ◽  
Priti Garate

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.


2020 ◽  
Vol 14 (2) ◽  
pp. 1527-1536
Author(s):  
Vasantha Priya Jeyasheelan ◽  
Sumetha Suga Deiva Suga ◽  
Sindhura Myneni ◽  
Divya Ravikumar ◽  
Manuel Raj Kumar ◽  
...  

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