A Retrospective Analysis of Reporting of Adverse Drug Reactions in a Tertiary Care Teaching Hospital: One Year Survey

Pathak, Anuj Kumar; Kumar, Manish; Dokania, Shambhu; Mohan, Lalit; Dikshit, Harihar

doi:10.7860/jcdr/2016/18826.8284

Cited by 12 publications

(19 citation statements)

References 11 publications

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“…15 Study by Pathak et al intravenous route and per oral contributed 55.14% an 38.36% of reactions respectively, as compared to 80% and 20% by per oral and parenteral route respectively in our study. 16 More ADR were reported from males (57.6%, 56.5%, 56.8%, 61.7%) from the study by Jose, Pathak et al, Bhattacharjee et al and Gupta et al, respectively, which was similar to our study (60.6%). 14,16,18,19 Maximum number of ADRs were reported in the age group of 46-60 years (31.9%) and 16-30 years (33.9%) in the study by Jose, and Pathak et al respectively.…”

Section: Discussionsupporting

confidence: 91%

“…16 More ADR were reported from males (57.6%, 56.5%, 56.8%, 61.7%) from the study by Jose, Pathak et al, Bhattacharjee et al and Gupta et al, respectively, which was similar to our study (60.6%). 14,16,18,19 Maximum number of ADRs were reported in the age group of 46-60 years (31.9%) and 16-30 years (33.9%) in the study by Jose, and Pathak et al respectively. 14,16 In our study, the age group of 31-45 years reported the maximum number of adverse reactions (42.8%).…”

Section: Discussionsupporting

confidence: 91%

“…[15][16][17] Oncology (26.0%) and neurology (12.5%) by Jose, oncology (21.0%) and general medicine (15.0%) by Singh et al, oncology (18.84%), and general medicine (14.04%), by Pathak et al were the other major ADR reporting departments as compared to psychiatry (23.9%) and general medicine (18.3%) in our study. [14][15][16] There were no reported ADRs from oncology, neurology and gynaecology department in the study period.…”

Section: Discussionmentioning

confidence: 54%

“…A continuing adverse reaction preventive program in a hospital can guide us on the safety of drug therapies, measure the incidence rates, educate and increase awareness amongst healthcare professionals on detection and reporting of adverse reactions. 13 The overall incidence of ADRs reported in our study (both inpatient and outpatient) was 0.01%, as compared to 0.15% in the study by Jose, 0.044% in the study by Singh et al, 0.67% in the study by Pathak et al and 9.8% in the study by Arulmani et al [14][15][16][17] The low incidence of ADR reporting in our study could be due to many factors such as lack of awareness about reporting, lack of time, etc.…”

Section: Discussionmentioning

confidence: 63%

“…14,16,18,19 Maximum number of ADRs were reported in the age group of 46-60 years (31.9%) and 16-30 years (33.9%) in the study by Jose, and Pathak et al respectively. 14,16 In our study, the age group of 31-45 years reported the maximum number of adverse reactions (42.8%). In the ADR variations based on gender, it was observed that there is a significant difference between males and females for dermatological system.…”

Section: Discussionmentioning

confidence: 82%

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Adverse drug reaction reporting in a tertiary care teaching hospital in eastern India: a retrospective study

Misra

Bose

Parida

et al. 2019

Int J Basic Clin Pharmacol

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Background: Adverse drug reactions (ADRs) are one of the prime causes of morbidity and mortality, increase in hospital stay and socioeconomic burden on the patients. Periodic monitoring aids in formulating methods for safe usage of medicines in hospitals. This study was undertaken to study the patterns, assessment of causality, severity, preventability, body systems affected from ADRs received by the Pharmacovigilance cell, Department of Pharmacology between April 2018 to June 2019.Methods: The present study is an observational, retrospective, non-interventional analysis of voluntarily reported ADRs. Demography of patients, causative drugs, reactions, outcome, and severity are recorded. Data were analysed and expressed in numbers, percentages.Results: A total of 180 ADRs were spontaneously reported. Dermatology (42.8%), psychiatry (23.9%) and general medicine (18.3%) are the major departments reporting ADRs in our hospital. 60.6% reports were in males. The body system with maximum reactions is dermatological (51.1%). Drug class most commonly affected is anti-microbials (36.1%). Paracetamol (8.9%) is the most common drug with reactions. Causality assessment stated that 41.7% ADRs are probable and 58.3% were possible. Severity assessment showed 86.7% as mild and 13.3% as moderate. Preventability assessment stated that 93.3% ADRs not preventable, 5.6% probably preventable and 1.1% definitely preventable.Conclusions: The study provides a valuable insight with regards to the pattern of ADRs in our hospital. This will be useful in initiating a reporting culture, increase awareness, reducing under-reporting of ADR in our set up.

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Section: Discussionsupporting

confidence: 91%

Section: Discussionsupporting

confidence: 91%

Section: Discussionmentioning

confidence: 54%

Section: Discussionmentioning

confidence: 63%

Section: Discussionmentioning

confidence: 82%

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Adverse drug reaction reporting in a tertiary care teaching hospital in eastern India: a retrospective study

Misra

Bose

Parida

et al. 2019

Int J Basic Clin Pharmacol

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Development and Validation of a Deep Learning Model for Detection of Allergic Reactions Using Safety Event Reports Across Hospitals

et al. 2020

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Allergic Reactions Captured by Voluntary Reporting

Blumenthal¹,

Wolfson²,

Liu³

et al. 2019

J Patient Saf

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Background:The epidemiology of hospital adverse reactions (ARs), particularly allergic reactions, or hypersensitivity reactions (HSRs), is poorly defined. To determine priorities for allergy safety in healthcare, we identified and described safety reports of allergic reactions. Methods:We searched the safety report database of a large academic medical center from April 2006 to March 2016 using 101 complete, truncated, and/or misspelled key words related to allergic symptoms, treatments, and culprits (e.g., medications, foods). Patient and event data were summarized for ARs and two types of ARs, HSRs and side effects/toxicities.Results: Among 9111 key word search-identified events, 876 (10%) were ARs, of which 436 (5%) were HSRs and the remaining 440 (5%) were side effect reactions or toxicities. Whereas the most common HSRs were simple cutaneous reactions (83%), the following severe immediate HSRs were also identified: shortness of breath (16%), anaphylaxis (14%), and angioedema (12%). Most HSRs were caused by drugs (81%), with antibiotics (26%), particularly β-lactams (11%), and vancomycin (8%), commonly implicated. Other causes of drug HSRs included contrast agents (24%), chemotherapeutics (7%), and opioids (6%). Nondrug HSRs were from blood products (8%), latex (3%), and devices (3%). Food reactions were rarely identified (1%). Conclusions:We identified ARs, HSRs, and side effects/toxicities, contained in a decade of safety reports at an academic medical center. Allergy safety in the healthcare setting should target approaches to common and severe reactions, with a focus on the safe administration of β-lactams, vancomycin, contrast agents, chemotherapeutics, and opioids. Priority nondrug HSR culprits include blood products, latex, and devices.

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A Retrospective Analysis of Reporting of Adverse Drug Reactions in a Tertiary Care Teaching Hospital: One Year Survey

Cited by 12 publications

References 11 publications

Adverse drug reaction reporting in a tertiary care teaching hospital in eastern India: a retrospective study

Adverse drug reaction reporting in a tertiary care teaching hospital in eastern India: a retrospective study

Development and Validation of a Deep Learning Model for Detection of Allergic Reactions Using Safety Event Reports Across Hospitals

Allergic Reactions Captured by Voluntary Reporting

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