A retrospective analysis of adverse drug reaction reported in a tertiary care hospital

Saxena, Kirti N; Tailor, Chaitali; Mehta, Chaitali; Gajera, Paresh; Srivastava, Saumya

doi:10.18203/2319-2003.ijbcp20171667

Cited by 2 publications

(1 citation statement)

References 5 publications

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“…These results were similar to some studies but different from the results observed in them. 19,31,32 According to modified Hartwig and Siegel severity scale 33 major part of the ADRs belonged to moderate category, followed by mild and severe category. These patterns of ADRs were consistent with other studies.…”

Section: Discussionmentioning

confidence: 99%

Analysis of reporting of adverse drug reactions in a tertiary care hospital: One year survey

Likhitkar¹,

Shakur²,

Roy³

et al. 2020

IJCAAP

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Introduction: Adverse drug reactions (ADRs) are inevitable component of drug therapy which negatively affects quality of life, increases physician visits, hospitalizations and even death. It also poses economic burden on health care system. Aim: To ascertain various ADRs occurring in our hospital; this can generate a notion to inculcate the culture of ADR reporting in view of improving the health safety of patients. Materials and Methods: A retrospective, record based study, conducted by analyzing ADR forms, reported over a period of 12 months and were further analyzed for demographic details, organ system involved, types of ADRs, suspected drugs, causality, severity, outcome and reporters qualification. Results: A total of 532 ADR reporting forms were studied in which 563 types of ADRs were seen. Male preponderance (57.1%) was seen with majority of ADRs between 40-59 yrs. of age (33.2%). Gastrointestinal tract (47.24%) was most commonly affected with abdominal pain, diarrhea and nausea. Antibiotics were the most common suspected group of drugs. Majority of ADRs were probable/likely (46.35%) and were of moderate category (56.12%). Most of the patients recovered/resolved (91.35%) from the reaction and majority of reports was from non-health professionals/consumers (53.19%). Conclusions: Results drawn from this study suggests reinforcing Pharmacovigilance Programme of India as it can help in minimization/prevention of ADRs through early detection. Also, it would be helpful if the system of ADR monitoring is designed in such a way that it encourages health care professionals to report ADRs spontaneously and intensively through a proper communication channel for ensuring patient safety.

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Section: Discussionmentioning

confidence: 99%

Analysis of reporting of adverse drug reactions in a tertiary care hospital: One year survey

Likhitkar¹,

Shakur²,

Roy³

et al. 2020

IJCAAP

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Patterns of adverse drug reaction reporting in Ethiopia

Gebretsadik

Abacioglu

2022

Asian Pacific Journal of Tropical Medicine

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Objective: To examine the frequency and profile of spontaneous reports of adverse drug reactions (ADRs) sent to Ethiopia’s pharmacovigilance (PV) database system. Methods: The descriptive and retrospective study analysed spontaneous ADR complaints reported to the PV database by healthcare professionals between 2013 and 2018. Spontaneous ADR reports that reached the PV center and met the minimum reporting criteria were identified and assessed in terms of reporting rate, patient characteristics, type of ADRs, suspected drugs, report sources, and reporters’ profession. Results: A total of 657 spontaneous ADR reports were filed to the PV center between 2013 and 2018. During the study period, the reporting pattern of ADRs changed dramatically. The number of reports increased from 2013 (n=12) and peaked in 2015 (n=205), and then declined from 2016 to 2018 (n=144, 142 and 65 in 2016, 2017 and 2018, respectively). Females had a higher percentage of reported cases (56.3%) than males (43.7%). The highest number of ADRs was reported in the age categories of 15-64 years (475, 72.3%), followed by 0-14 years (154, 23.4%), and 65 years and above (21, 3.2%). Pharmacists reported the majority of ADRs (81.7%), followed by health officers (7.2%), nurses (5.8%), and physicians (5.2%). Skin and subcutaneous tissue abnormalities were the most commonly reported ADRs. The anatomical therapeutic chemicals code class “anti-infective for systemic use” was the most usually suspected medication. Trimethoprim with sulfamethoxazole as a combination ADRs was the most commonly reported drug that cause ADRs (14.2%). Conclusions: The number of ADRs reported in Ethiopia was small and unpredictable compared to developed countries, indicating the performance of PV system and level of awareness of health care professionals towards ADR reporting was not satisfactory. In order to increase the frequency of spontaneous reports, more efficient PV methods and public policies must be implemented.

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A retrospective analysis of adverse drug reaction reported in a tertiary care hospital

Cited by 2 publications

References 5 publications

Analysis of reporting of adverse drug reactions in a tertiary care hospital: One year survey

Analysis of reporting of adverse drug reactions in a tertiary care hospital: One year survey

Patterns of adverse drug reaction reporting in Ethiopia

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