Dataset Information

Adverse drug reactions associated with the use of biological agents.

ABSTRACT:

Introduction

Biological drugs open new possibilities to treat diseases for which drug therapy is limited, but they may be associated with adverse drug reactions (ADRs).

Objective

To identify the ADRs associated with the use of biological drugs in Colombia.

Methods

This was a retrospective study of ADR reports from 2014 to 2019, contained in the database of Audifarma SA pharmacovigilance program. The ADRs, groups of associated drugs, and affected organs were classified.

Results

In total, 5,415 reports of ADRs associated with biological drugs were identified in 78 Colombian cities. A total of 76.1% of the cases corresponded to women. The majority were classified as type A (55.0%) and B (28.9%), and 16.7% were serious cases. The respiratory tract was the most affected organ system (16.8%), followed by the skin and appendages (15.6%). Antineoplastic and immunomodulatory drugs accounted for 70.6% of the reports, and the drugs related to the greatest number of ADRs were adalimumab (12.2%) and etanercept (11.6%).

Conclusions

The reporting of ADRs has increased in recent years and these reactions are mostly classified as tyoe A or B, categorized as serious in almost one-fifth of the reported cases and associated mainly with immunomodulators and antineoplastic agents. This type of study can support decision makers in ways that benefit patient safety and interaction with health systems.

SUBMITTER: Machado-Alba JE

PROVIDER: S-EPMC7748267 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Adverse drug reactions associated with the use of biological agents.

Machado-Alba Jorge Enrique JE Jiménez-Morales Anyi Liliana AL Moran-Yela Yulieth Carolina YC Parrado-Fajardo Ilsa Yadira IY Valladales-Restrepo Luis Fernando LF

PloS one 20201218 12

<h4>Introduction</h4>Biological drugs open new possibilities to treat diseases for which drug therapy is limited, but they may be associated with adverse drug reactions (ADRs).<h4>Objective</h4>To identify the ADRs associated with the use of biological drugs in Colombia.<h4>Methods</h4>This was a retrospective study of ADR reports from 2014 to 2019, contained in the database of Audifarma SA pharmacovigilance program. The ADRs, groups of associated drugs, and affected organs were classified.<h4>R ...[more]

PMID: 33338057

Similar Datasets

Project description:BackgroundNumerous observational studies suggest that preventable adverse drug reactions are a significant burden in healthcare, but no meta-analysis using a standardised definition for adverse drug reactions exists. The aim of the study was to estimate the percentage of patients with preventable adverse drug reactions and the preventability of adverse drug reactions in adult outpatients and inpatients.MethodsStudies were identified through searching Cochrane, CINAHL, EMBASE, IPA, Medline, PsycINFO and Web of Science in September 2010, and by hand searching the reference lists of identified papers. Original peer-reviewed research articles in English that defined adverse drug reactions according to WHO's or similar definition and assessed preventability were included. Disease or treatment specific studies were excluded. Meta-analysis on the percentage of patients with preventable adverse drug reactions and the preventability of adverse drug reactions was conducted.ResultsData were analysed from 16 original studies on outpatients with 48797 emergency visits or hospital admissions and from 8 studies involving 24128 inpatients. No studies in primary care were identified. Among adult outpatients, 2.0% (95% confidence interval (CI): 1.2-3.2%) had preventable adverse drug reactions and 52% (95% CI: 42-62%) of adverse drug reactions were preventable. Among inpatients, 1.6% (95% CI: 0.1-51%) had preventable adverse drug reactions and 45% (95% CI: 33-58%) of adverse drug reactions were preventable.ConclusionsThis meta-analysis corroborates that preventable adverse drug reactions are a significant burden to healthcare among adult outpatients. Among both outpatients and inpatients, approximately half of adverse drug reactions are preventable, demonstrating that further evidence on prevention strategies is required. The percentage of patients with preventable adverse drug reactions among inpatients and in primary care is largely unknown and should be investigated in future research.

Dataset Information

Adverse drug reactions associated with the use of biological agents.

Introduction

Objective

Methods

Results

Conclusions

Publications

Adverse drug reactions associated with the use of biological agents.

Similar Datasets

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