Adverse drug reactions associated with the use of biological agents

Autor: Anyi Liliana Jiménez-Morales, Luis Fernando Valladales-Restrepo, Ilsa Yadira Parrado-Fajardo, Jorge Enrique Machado-Alba, Yulieth Carolina Moran-Yela
Rok vydání: 2020
Předmět:
Male
Epidemiology
Respiratory Tract Diseases
Psychological intervention
Etanercept
Pharmacovigilance
Medicine and Health Sciences
education.field_of_study
Multidisciplinary
Pharmaceutics
Incidence
Rheumatoid arthritis
Medicine
Female
Patient Safety
medicine.drug
Research Article
medicine.medical_specialty
Drug Research and Development
Drug Administration
Drug-Related Side Effects and Adverse Reactions
Science
Population
Immunology
Antineoplastic Agents
Rheumatoid Arthritis
Colombia
Skin Diseases
Autoimmune Diseases
Immunomodulation
Patient safety
Pharmacotherapy
Adverse Reactions
Drug Therapy
Drug Safety
Rheumatology
Internal medicine
Adalimumab
medicine
Adverse Drug Reaction Reporting Systems
Humans
Immunologic Factors
education
Retrospective Studies
Pharmacology
Biological Products
business.industry
Arthritis
Biology and Life Sciences
Retrospective cohort study
medicine.disease
Clinical Immunology
Clinical Medicine
business
Zdroj: PLoS ONE
PLoS ONE, Vol 15, Iss 12, p e0240276 (2020)
ISSN: 1932-6203
Popis: IntroductionBiotech drugs open new possibilities to treat diseases for which drug therapy is limited, but they may be associated with serious adverse drug reactions (ADRs).ObjectiveTo identify the ADRs associated with the use of biotech drugs in Colombia.MethodsThis was a retrospective study of ADR reports from 2014 to 2019, contained in the database of the pharmacovigilance program of Audifarma SA. The ADRs, groups of associated drugs, and affected organs were classified.ResultsA total of 5,415 reports of ADRs associated with biotech 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 commonly affected organ system (16.8%), followed by the skin and adnexa (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%).ConclusionsThere has been an incremental increase in the reporting of ADRs associated with the use of biotech drugs in the pharmacovigilance program, related to the strengthening and appropriation of the patient safety culture and improvement in the quality of the generated information. It is important to empower physicians and entire health teams to ensure the traceability of ADRs and to perform interdisciplinary interventions derived from pharmacovigilance at the individual and population levels.
Databáze: OpenAIRE
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