Abstract
Background: Adverse drug events (ADEs) comprise the largest category of adverse events in hospitalized patients. ADEs encompasses adverse drug reaction (ADR) and medication error (ME).Objective: To determine prevalence and risk factors of ADEs in patients hospitalized in a General Hospital.
Methods: Case-control, observational, retrospective study of patients with ADEs. Statistical analysis: percentages, frequencies, averages. Odds ratio, Chi square. Multiple binary logistic regression. Statistical Package, for the Social Sciences 23.
Results: ADEs prevalence 3.6%. 132 patients, 66 cases (26 ME and 40 ADR), 66 controls, reported medications: antibiotics, anti-inflammatories, mean age 35 years (ES17.4), ADEs, sex: 39.3% men, 60.7% women, reported services; emergencies, surgery, frequent route of administration: intravenous (32.3%) frequent symptoms: cutaneous. ADR associated symptoms: TypeA pruritus OR 8.5 p=0.001(95%CI 0.035-0.393), TypeB pruritus OR 11 p=0.001(95%CI 0.021-0.368) urticaria OR19 p=0.005(95%CI 0.007-0.412). Associated risk factors ADEs : woman OR2.6p=0.05(CI95%1.33-5.43), history of allergy OR 3.4p=0.033(CI95%1.04-8.40), prolonged hospital stay OR5.4p=0.023 (CI95%3.82-6.74). Conclusions: The largest Part of the ADEs were ME or type A ADR, both of which are preventable reactions, so patient safety must be a priority when prescribing.
References
-Leape L, Brennan T, Laird N. The Nature of adverse events in hospitalized patients. Results of the Harvard Medical Practice Study II. N Engl J Med 1991; 324:377-384. doi: 10.1056/NEJM199102073240605.
-Wittich C, Burkle C, Lanier W. Medication errors: an overview for clinicians. Mayo Clin Proc 2014; 89:1116. DOI:https://doi.org/10.1016/j.mayocp.2014.05.007.
-Wilmer A, Louie K, Dodek P, et al. Incidence of medication errors and adverse drug events in the ICU: a systematic review. Qual Saf Health Care 2010; 19 (5):e7. doi:10.1136/qshc.2008.030783.
-Evans R, Lloyd J, Stoddard G, et al. Risk factors for adverse drug events: a 10 -year analysis. Ann Pharmacother 2005; 39:1161-8. doi: 10.1345/aph.1E642.
-Alomar MJ. Factors affecting the development of adverse drug reactions (review article). Saudi Pharm J 2014; 22(2):83-94. doi: 10.1016/j.jsps.2013.02.003.
-Al Hamid A , Ghaleb M , Aljadhey H , et al. Systematic review of hospitalization resulting from medicine-related problems in adult patients. Br J Clin Pharmacol 2014; 78(2): 202-217. doi: 10.1111/bcp.12293.
-Resende LSO , Santos-Neto ET. Risk factors associated with adverse reactions to antituberculosis drugs. J Bras Pneumol 2015; 41(1): 77-89. doi: 10.1590/S1806-37132015000100010.
- Milhajlovic S, Gauthier J, MacDonald E. Patient Characteristics Associated with Adverse Drug Events in Hospital: An Overview of Reviews. Can J Hosp Pharm 2016; 69(4): 294-300. doi:10.4212/cjhp.v69i4.1583.
- WM A. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. JAMA 2013; 310 (20) :2191-2194. doi:10.1001/jama.2013.281053.
- Montserrat-Capella D, Suárez M, Ortiz L, et al. AMBEAS Group Frequency of ambulatory care adverse events in Latin American countries: the AMBEAS/PAHO cohort study. Int J Qual Health Care 2015; 27(1): 52-9. doi: 10.1093/intqhc/mzu100.
-European Medicines Agency.Good practice guide on risk minimisation and prevention of medication errors [Online].; 2015. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2015/11/WC500196981.pdf.
- Mollar J, Aranaz J, Martin J, et al. Eventos adversos relacionados con la medicación en los hospitales de la comunidad Valenciana. Estudio EPIDEA 2005-2013. Rev Esp Quimioter 2017; 30(5): 319-326.
- Benkirane R, R-Abouqal R, Haimeur C, et al. Incidence of Adverse Drug Events and Medication Errors in Intensive Care Units: A prospective multicenter study. J Patient Saf 2009; 5:16-22. doi: 10.1097/PTS.0b013e3181990d51.
- Kunac D, Tatley M. Detecting Medication Errors in the New Zealand pharmacovigilance Database A retrospective Analysis. Drug Saf 2011; 34(1): 59-71. doi: 10.2165/11539290-000000000-00000.
- Haile D, Ayen W, Tiwari P. Prevalence and Assessment of factors contributing to adverse drug reactions in wards of a tertiary care hospital, India. Ethiop J Health Sci 2013; 23(1): 39-48.
- de Vries E, Ramrattan M, Smorenburg S, et al. The incidence y nature of in-hospital adverse events: a systematic review. Qual Saf Health Care 2008; 17(3): 216-23. doi: 10.1136/qshc.2007.023622.
- Giordani F, Rozenfeld S, Martins M. Adverse drugs events identified by triggers at a teaching hospital in Brazil. BMC Pharmacology and Toxicology 2014; 15 (1): 71. doi:10.1186/2050-6511-15-71.
- Vitorino M, Aguiar P, Sousa P, et al. In-hospital adverse drug events: analysis of trend in Portuguese public hospitals. Cad Saúde Pública 2020; 36(3): e00056519. doi: 10.1590/0102-311x00056519.
- Demoly PBJ. Epidemiology of drug allergy. Curr Opin Allergy Clin Inmmunol 2001; 1(4):305-10. doi: 10.1097/01.all.0000011031.16814.e0.

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Copyright (c) 2023 Revista Alergia México