Evaluation of adverse drug reactions in a pharmacy department: four years of experience of a pharmacovigilance program

Authors

  • Tania González Furelos Servicio de Farmacia, Complexo Hospitalario Universitario de Ferrol, Ferrol https://orcid.org/0000-0002-0190-2802
  • Iria Rodríguez Legazpi Servicio de Farmacia, Complexo Hospitalario Universitario de Ferrol, Ferrol https://orcid.org/0000-0001-8582-4444
  • Eva Fraga Bueno Servicio de Farmacia, Complexo Hospitalario Universitario de Ferrol, Ferrol https://orcid.org/0000-0002-2799-0994
  • Monica Granero López Servicio de Farmacia, Complexo Hospitalario Universitario de Ferrol, Ferrol
  • Isaura Rodríguez Penín Servicio de Farmacia, Complexo Hospitalario Universitario de Ferrol, Ferrol

DOI:

https://doi.org/10.60103/phc.v27.e866

Keywords:

Adverse Drug Events; Pharmacovigilance; Drug safety; Pharmacist

Abstract

Introduction: Adverse drug reactions are one of the main adverse events that can lead to hospital admissions. The aim of this study was to analyze the main drugs causing adverse reactions, their severity and the degree of reporting.

Material and methods: observational, retrospective and single-center study, carried out in the pharmacy service of Ferrol hospital from 2019 to 2022. All patients registered in a healthcare database were included. Related variables: adverse reaction, severity, drug, mode of detection and notification were recorded. 

Results: A total of 2,237 adverse reactions were detected (934 severe, 692 moderate and 611 mild). The main pharmacological groups were: antineoplastics (38.94%), corticosteroids (14.71%), diuretics (14.04%) and antibacterials (10.05%). Most of the severe adverse reactions were caused by antineoplastics (37.94%), antithrombotics (7.07%) and beta-blockers (5.03%). 

Conclusions: Antineoplastic drugs and blood disorders were the most frequently detected drugs and adverse reactions, respectively. The active participation of the pharmacist and the integration of pharmacovigilance in daily healthcare practice contribute to the identification and reporting of a large number of adverse reactions.

Downloads

Download data is not yet available.

References

Esteban Jiménez O, Navarro Pemán C, González Rubio F, Lanuza Giménez FJ, Montesa Lou C. Análisis de la incidencia y de las características clínicas de las reacciones adversas a medicamentos de uso humano en el medio hospitalario. Rev Esp Salud Publica [Internet]. 2017 [citado 6 septiembre 2023] ; 91: e201712050. Disponible en: https://scielo.isciii.es/scielo.php?script=sci_abstract&pid=S1135-57272017000100424.

European Commission. Memo/08/782, Brussels, 10 December 2008. Strengthening pharmacovigilance to reduce adverse effects of medicines. [citado 12 diciembre 2023]. Disponible en: http://europa.eu/rapid/press-release_MEMO-08-782_en.htm?locale=en .

Aranaz JM, Aibar C, Vitaller J, Ruiz P. Estudio Nacional sobre los Efectos Adversos ligados a la Hospitalización. ENEAS 2005. Disponible en: https://seguridaddelpaciente.sanidad.gob.es/proyectos/financiacionEstudios/estudiosEpidemiologicos/eneas.htm

Oscanoa TJ, Lizaraso F, Carvajal A. Hospital admissions due to adverse drug reactions in the elderly. A meta-analysis. Eur. J. Clin. Pharmacol. 2017;73(6):759-70. doi: 10.1007/s00228-017-2225-3

Pirmohamed M, James S, Meakin S, Green C, Scott AK, Walley TJ, et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ. 2004 Jul 3;329(7456):15-9. doi: 10.1136/bmj.329.7456.15.

Osanlou R, Walker L, Hughes DA, Burnside G, Pirmohamed M. Adverse drug reactions, multimorbidity and polypharmacy: a prospective analysis of 1 month of medical admissions. BMJ Open. 2022;12(7):e055551. doi: 10.1136/bmjopen-2021-055551.

Pharmacovigilance [Internet]. [citado 6 septiembre 2023]. Disponible en: https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance

Montpart Costa E. El Sistema Español de Farmacovigilancia. Offarm. 2003;22(2):120-8.

BOE-A-2013-8191 Real Decreto 577/2013, de 26 de julio, por el que se regula la farmacovigilancia de medicamentos de uso humano. [Internet]. www.boe.es. [citado 6 septiembre 2023]. Disponible en: https://www.boe.es/buscar/act.php?id=BOE-A-2013-8191

Schnipper JL, Kirwin JL, Cotugno MC, Wahlstrom SA, Brown BA, Tarvin E, et al. Role of pharmacist counseling in preventing adverse drug events after hospitalization. Arch Intern Med. 2006;166(5):565-71. doi: 10.1001/archinte.166.5.565.

Leape LL, Cullen DJ, Clapp MD, Burdick E, Demonaco HJ, Erickson JI, Bates DW. Pharmacist participation on physician rounds and adverse drug events in the intensive care unit. JAMA. 1999;282(3):267-70. doi: 10.1001/jama.282.3.267.

Sánchez I, Amador C, Plaza JC, Correa G, Amador R. Impacto clínico de un sistema de farmacovigilancia activa realizado por un farmacéutico en el reporte y subnotificación de reacciones adversas a medicamentos. Rev Med Chil. 2014;142(8):998-1005. doi: 10.4067/S0034-98872014000800007.

van Grootheest AC, van Puijenbroek EP, de Jong-van den Berg LTW. Contribution of pharmacists to the reporting of adverse drug reactions. Pharmacoepidemiol Drug Saf. 2002;11(3):205-10. doi: 10.1002/pds.702. PMID: 12051119.

Pérez-Ricart A, Gea-Rodríguez E, Roca-Montañana A, Gil-Máñez E, Pérez-Feliu A. Integración de la farmacovigilancia en la rutina del servicio de farmacia: nueve años de experiencia. Farm Hosp. 2019;43(4):128-33. doi: 10.7399/fh.11169.

Phansalkar S, Hoffman JM, Nebeker JR, Hurdle JF. Pharmacists versus nonpharmacists in adverse drug event detection: a meta-analysis and systematic review. Am J Health Syst Pharm. 2007;64(8):842-9. doi: 10.2146/ajhp060335.

Pérez-Ricart A, Gea Rodríguez E, Gil Máñez E, Pérez-Feliu A, Roca Montaña A, Pacual MArtínez O. Implicación del farmacéutico de hospital en la farmacovigilancia. El Farmacéutico Hospitales. 2017;211:10-14.

Hazell L, Shakir SAW. Under-reporting of adverse drug reactions : a systematic review. Drug Saf. 2006;29(5):385-96. doi: 10.2165/00002018-200629050-00003.

Jeetu G, Anusha G. Pharmacovigilance: a worldwide master key for drug safety monitoring. J Young Pharm. 2010;2(3):315-20. doi: 10.4103/0975-1483.66802.

Yun IS, Koo MJ, Park EH, Kim SE, Lee JH, Park JW, et al. A comparison of active surveillance programs including a spontaneous reporting model for phamacovigilance of adverse drug events in a hospital. Korean J Intern Med. 2012;27(4):443-50. doi: 10.3904/kjim.2012.27.4.443.

Bénard-Laribière A, Miremont-Salamé G, Pérault-Pochat MC, Noize P, Haramburu F, EMIR Study Group on behalf of the French network of pharmacovigilance centres. Incidence of hospital admissions due to adverse drug reactions in France: the EMIR study. Fundam Clin Pharmacol. 2015;29(1):106-11. doi: 10.1111/fcp.12088.

Cano FG, Rozenfeld S. Adverse drug events in hospitals: a systematic review. Cad Saude Publica. 2009;25 Suppl 3:S360-372. doi: 10.1590/s0102-311x2009001500003.

Walsh D, Lavan A, Cushen AM, Williams D. Adverse drug reactions as a cause of admission to a Dublin-based university teaching hospital. Ir J Med Sci. 2015;184(2):441-7. doi: 10.1007/s11845-014-1140-1.

Doshi MS, Patel PP, Shah SP, Dikshit RK. Intensive monitoring of adverse drug reactions in hospitalized patients of two medical units at a tertiary care teaching hospital. J Pharmacol Pharmacother. 2012;3(4):308-13.

Moore N, Berdaï D, Blin P, Droz C. Pharmacovigilance - The next chapter. Therapie. 2019;74(6):557-67. doi: 10.1016/j.therap.2019.09.004.

Bihan K, Lebrun-Vignes B, Funck-Brentano C, Salem JE. Uses of pharmacovigilance databases: An overview. Therapie. 2020;75(6):591-8. doi: 10.1016/j.therap.2020.02.022.

Liu F, Jagannatha A, Yu H. Towards Drug Safety Surveillance and Pharmacovigilance: Current Progress in Detecting Medication and Adverse Drug Events from Electronic Health Records. Drug safety. 2019;42(1):95. doi: 10.1007/s40264-018-0766-8.

Chapman AB, Peterson KS, Alba PR, DuVall SL, Patterson OV. Detecting Adverse Drug Events with Rapidly Trained Classification Models. Drug Saf. 2019;42(1):147-56. doi: 10.1007/s40264-018-0763-y.

Información para las notificaciones de sospechas de reacciones adversas a medicamentos por parte de profesionales sanitarios [Internet]. Agencia Española de Medicamentos y Productos Sanitarios. 2019 [citado 19 noviembre 2023]. Disponible en: https://www.aemps.gob.es/medicamentos-de-uso-humano/farmacovigilancia-de-medicamentos-de-uso-humano/notificacion-de-sospechas-de-reacciones-adversas-a-medicamentos-ram-de-uso-humano/notificasospechas-ram-profsanitarios/

Published

2025-02-03

How to Cite

González Furelos, T., Rodríguez Legazpi, I., Fraga Bueno, E., Granero López, M., & Rodríguez Penín, I. (2025). Evaluation of adverse drug reactions in a pharmacy department: four years of experience of a pharmacovigilance program. Pharmaceutical Care España, 27. https://doi.org/10.60103/phc.v27.e866

Issue

Section

Originales