Notificación de reacción adversa grave a propofol. Liderazgo enfermero en farmacovigilanciainiciativa de transformación asistencial

  1. Natalia Rodríguez Galán 1
  2. Emilio Vargas Castrillón 2
  3. Daniel Muñoz Jiménez 3
  4. Carla Pérez Ingidua 2
  1. 1 Servicio de Farmacología Clínica. Hospital Clínico San Carlos.
  2. 2 Instituto de Investigación Sanitaria Hospital Clínico San Carlos (IdISSC), Madrid.
  3. 3 Área Funcional de Procesos, Investigación, Innovación y Sistemas de Información. Hospital Clínico San Carlos, Madrid
Journal:
Revista ROL de enfermería

ISSN: 0210-5020

Year of publication: 2021

Volume: 44

Issue: 7-8

Pages: 33-38

Type: Article

More publications in: Revista ROL de enfermería

Abstract

The incorporation of the nurse in the clinical pharmacovigilance teams gives us a privileged position for the detection and prevention of risks in the use of medicines. The identification and notification of suspected adverse drug reactions (ADR) is one of the most efficient and simple methods to promote safe care processes within our reach. Objective: To promote spontaneous reporting of suspected adverse drug reactions (ADR) among healthcare professionals. Method: A case of severe and unexpected adverse reaction to propofol is present. Young adult suffers cardiorespiratory arrest during the performance of an endoscopic technique, it is identify by nursing as suspected ADR to propofol and she contacts to pharmacovigilance’s nurse. The methodology used for the evaluation of the case of suspected ADR by the pharmacovigilance nursing team, the process of searching the literature of similar cases and review of the sources of information on drugs to determine the frequency of adverse reactions detected like similar situations. Results: A suspected of serious ADR is identify because the patient’s life is at risk, the notification process to the Spanish Pharmacovigilance System is describe, the electronic form www.notificaRAM.es is explain and the pharmacovigilance nursing recommendations of Clinical Pharmacology Department are listed. Conclusion: The identification of suspected serious, unexpected or unknown ADR and the notification or publication of those cases are especially relevant for the knowledge of the scientific society and the general population. Nursing professionals could consider it as complementary activity to their common practice. What is known? The relevant role of nursing in the detection and notification of ADR, being the healthcare professional closest to the patient and the problem of under notification by nursing. What this study adds? Promote the culture of notification by all nursing professionals, either spontaneously or collaboratively, through knowledge of the methodology and tools used by the nurses of a pharmacovigilance team of the Clinical Pharmacology Service of the Hospital Clínico San Carlos.

Bibliographic References

  • Morrison-Griffiths S et al. Reporting of adverse drug reactions by nurses. The Lancet. 2003; 361:1347–8.Jun; 63(6):613–8.
  • Bäckström, M., Aman, E. y Mjörndal, T. Informe de reacciones adversas a medicamentos por enfermeras en Suecia. Eur J Clin Pharmacol 63, 613–618 (2007). https://doi.org/10.1007/s00228-007-0274-8
  • Rex DK, Deenadayalu VP, Eid E, Imperiale TF, Walker JA, Anadu K, et al. Endoscopist-directed administration of pro-pofol: A worldwide safety experience. Gastroenterology .2009; 137: 1229—37.
  • Espinoza-Ríos J, Chirinos JA, Tagle Arróspide M. Seguridad en la administración de propofol dirigido por gastroenterólogo entrenado en procedimientos endocópicos: experiencia de 10 años en clínica privada en Lima, Perú [Safety of gastroenterologist-directed propofol administration for endoscopic procedures: 10-year experience in a private clinic in Lima, Peru]. Rev Gastroenterol Peru.2018; 3 8(2):157–163.
  • Hallas J, Harvald B, Gram LF, et al. Drug related hospital admissions: the role of definitions and intensity of data collection, and the possibility of prevention. J Intern Med. 1990; 228(2):83‐90. doi:10.1111/j.1365-2796.1990.tb00199.x
  • Venulet J. Methods of monitoring adverse reactions to drugs. En: Progres in Drug Research; Juseken E (editor). Berghausen Verlag. Basilea 1977:277-4.
  • Aguirre C, García M. Evaluación de la causalidad en las comunicaciones de reacciones adversas a medicamentos. Algoritmo del Sistema Español de Farmacovigilancia [Causality assessment in reports on adverse drug reactions. Algorithm of Spanish pharmacovigilance system]. Med Clin (Barc). 2016; 147 (10):461–464. doi:10.1016/j.medcli.2016.06.012
  • Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther.1981; 30:239–45.3.