Comparison of methods of submission of suspected adverse drug reactions to the ADR monitoring centers in India

Kuchya, Sachin; Shrivastav, Sarita

doi:10.18203/2319-2003.ijbcp20173292

Cited by 3 publications

(1 citation statement)

References 8 publications

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“…Each of these large sections were given 10 points. [ 12 13 ] Total score out of 40 was calculated by adding available information from the four mandatory sections [ Table 1 ]. The total completeness score was calculated as average out of ten.…”

Section: Methodsmentioning

confidence: 99%

Adverse drug reactions reporting: Five years analysis from a teaching hospital

Thakare

Patil

Jain

et al. 2022

Journal of Family Medicine and Primary Care

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A BSTRACT Background: Adverse drug reactions (ADRs) are important cause of morbidity and mortality. Despite its known importance, rate and quality (completeness score) of ADR reporting is not satisfactory. The objective of this study was to analyze pattern and completeness score of ADRs during past five-years. Material and Methods: In this retrospective study, ADRs reported between 2017 to 2021 were analyzed according to year, gender, age-group, pharmacological class and department. The completeness score of ADRs was calculated. The number of sensitization programs conducted over 5 years and its impact on the completeness score was also evaluated. Results: A total of 104 ADRs were reported among 61 (58.6%) female and 43 (41.4%) male patients. Adults (18-65 years) comprised the most affected age group, accounting for 82 (79%) patients. Out of all, 35.5% ADRs were reported in 2018, whereas 27% were reported during 2021. Except during 2017, percentage of females with ADRs was more. Department of pulmonary medicine and dermatology contributed to maximum extent in ADR reporting. Antibiotics [23 (22.11%)], antitubercular drugs (AKT) [21 (20.19%)], and vaccines [13 (12.4%)] represented the most common agents with which ADRs were reported. ADR reporting was very low in 2017 (4/104). Percentage improvement in completeness score in 2021 vs. 2018 was 11.95% ( P < 0.05). Positive trend in the improvement of average completeness score with number of sensitization programs was observed. Conclusion: Incidence of ADRs was more common in females. AKT and antimicrobials are commonly implicated in ADRs. Increase in awareness of ADR reporting through sensitization programs can help to improve rate and quality of reporting.

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Section: Methodsmentioning

confidence: 99%

Adverse drug reactions reporting: Five years analysis from a teaching hospital

Thakare

Patil

Jain

et al. 2022

Journal of Family Medicine and Primary Care

View full text Add to dashboard Cite

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Adverse Medication Response Recorded in a Referral Health Facility: An Observational Study

G. Vekhande,

Sawant,

Dass

et al. 2024

International Journal of Innovative Science and Research Techno

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Introduction: The incidence of adverse drug reactions (ADRs) has significant implications for patient safety and public health. In 1937, the introduction of sulphanilamide for streptococcal infections marked a pivotal moment in drug safety. Present study assessed the pattern, causality and severity of the ADRs reported from a tertiary referral centre.  Materials and Methods: Study conducted at the Mahatma Gandhi Mission Medical College and Hospital Kamothe Navi Mumbai recorded the pattern of ADRs between January 2021 and December 2022. The data was collected from the ADR Monitoring Center using the suspected ADR reporting form, version 1.4 of IPC, Ghaziabad, India. The suspected ADR forms were assessed to understand the pattern of ADRs regarding the completeness score of the ADR form.  Findings and Discussion: A total of 111 ADRs were recorded, with 43.24% of cases falling within the age range of 21 to 40. Antimicrobial medications were the main culprits behind the majority of ADRs reported by the departments of dermatology and general medicine. Rashes, edema, and urticaria are among the skin-related symptoms among the most frequently reported adverse drug reactions (ADRs). 72.9% of instances were classified as mild, according to severity assessment, whereas 57.65% of ADRs were found to be likely.  Conclusions: Because ADRs represent a serious threat to public health, our study highlights the significance of pharmacovigilance in tracking and preventing them. Databases on a national and international level are enhanced by systematic, regular reporting and monitoring of ADRs. In order to raise awareness of ADRs among patients and healthcare professionals, spontaneous reporting is still essential.

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Evaluation of Elective Posting on Adverse Drug Reaction and Pharmacovigilance under Competency-based Medical Education Curriculum among Undergraduates: A New Step in Medical Education

Narwane,

Agrawal,

Mahavarakar

2024

Journal of Datta Meghe Institute of Medical Sciences University

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Context: The revised competency-based medical education, the students of 3rd-year part I MBBS are required to undergo elective postings of 1 month based on the student’s needs and choice. Aims: This study was undertaken to evaluate the outcome of elective posting of pharmacovigilance and adverse drug reaction (ADR) reporting as a new teaching tool in pharmacology among 3rd-year part I MBBS students. Settings and Design: The students undergoing the elective posting of pharmacovigilance and ADR reporting were evaluated for their knowledge, completeness score (out of 10) of ADRs reported, and their feedback with respect to the posting, in a pretested questionnaire. Subjects and Methods: It was a descriptive cross-sectional type conducted in the Pharmacology Department of Dr. Balasaheb Vikhe Patil Rural Medical College and Dr. Vitthalrao Vikhe Patil Pravara Rural Hospital, Loni. Results: Six students participated in the study, who reported 96 ADRs. Most of the ADRs (39, 40.6%) were reported immediately after their appearance. The average completeness score of the ADRs reported was 9.44 ± 0.41. The students gave an average score of 1.2 for overall experience of the posting (1 – best and 5 – worst). Conclusions: The elective posting with pharmacovigilance and ADR reporting module had a positive impact on the quality of ADR reporting in terms of completeness, causality assessment as well as time of reporting. The students felt confident in reporting ADRs and reflected positively toward the training module.

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Comparison of methods of submission of suspected adverse drug reactions to the ADR monitoring centers in India

Cited by 3 publications

References 8 publications

Adverse drug reactions reporting: Five years analysis from a teaching hospital

Adverse drug reactions reporting: Five years analysis from a teaching hospital

Adverse Medication Response Recorded in a Referral Health Facility: An Observational Study

Evaluation of Elective Posting on Adverse Drug Reaction and Pharmacovigilance under Competency-based Medical Education Curriculum among Undergraduates: A New Step in Medical Education

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