Adverse Drug Events Presented in Health Institutions in Monteria, Colombia, 2018–2021

Abstract

Purpose

To analyze the adverse events reported in the pharmacovigilance of the health service provider institutions of the municipality of Monteria in the period 2018–2021.

Patients and Methods

Descriptive, cross-sectional, retrospective, and quantitative approach study, the information was analyzed by statistical analysis by multiple correspondence using Orange Data Mining software; the analysis consisted of visual programming to perform interactive data exploration, to identify and differentiate associations or oppositions between different categories in space.

Results

The most frequently reported adverse events were allergic reactions, with 28.5%. Female sex and adult age are the groups most prone to present these events; antibiotics were the pharmacological group that produced the most adverse events with 18.3%; the main errors that produce these events are related to prescription.

Conclusion

Age and sex increase the risk of adverse drug events; most of these events are the product of erroneous prescriptions. The findings presented in this article are useful for pharmacovigilance programs in health institutions.

Keywords:

• adverse event
• patient safety
• drug
• pharmacovigilance
• public health

Ethics Statement

Ethical approval was not required. The open database of the INS consulted, the only data that were provided about the patients were age and sex, personal data that violated their rights and self-determination of the participants were kept under protection and anonymity, only information of interest to them was obtained. To analyze adverse drug events, this research was carried out considering the current ethical regulations: Declaration of Helsinki. For the execution and management of the information in this research, the provisions of Resolution 8430 of 1993, issued by the Ministry of Health of the Republic of Colombia, which establishes scientific, technical, and administrative standards in order to establish requirements for the development of research activity in health, were considered; in this study, retrospective, non-experimental documentary research techniques and methods were used. No intervention or intentional modification of the biological, physiological, psychological, or social variables of the individuals who participated in the study was carried out; only access to databases was provided for the purpose of analyzing the information and characterizing adverse events related to medicines; for this reason, this exploration can be classified as a risk-free research study.²¹ The data obtained remain anonymous. The collection of research data complies with national laws, regulations, and social ethics.

Acknowledgments

The authors would like to extend their sincere appreciation to the University of Córdoba - Colombia (Grant No. FCS 01-22) for the financial support of this research. The authors also express their deepest gratitude to all participants for their contribution to the study.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

The authors report no conflicts of interest in this work.