Alonso Herreros JM1, Escudero Galindo DM2, Bernal Montañes JM3
1 Especialista en Farmacia Hospitalaria. Especialista en Farmacia Industrial y Galénica.
Hospital General Universitario Los Arcos. Mar Menor. Murcia (España)
2 Licenciada en Farmacia. Universidad Miguel Hernández. Elche. Alicante (España)
3 Especialista en Farmacia Hospitalaria. Hospital Reina Sofía de Murcia (España)
Este trabajo ha sido presentado parcialmente en el 18th Congreso of European Association of Hospital Pharmacy. March 2013, París
Rev. OFIL 2016, 26;2:123-126
Fecha de recepción: 01/06/2015 – Fecha de aceptación: 14/03/2016
Introduction: Dronedarone was marketed in 2010. There were several safety alerts that forced Health Authorities to reduce their use, (Alert-SGMUH (FV)16/2011).
Objetive: To assess the degree of compliance with the analytical tests required by the Competent Authority in patients taking dronedarone (hepatic and renal function tests) in a health area of 210,000 inhabitants.
Materials and methods: We selected patients who were prescribed dronedarone during the last half of 2011. The prescriptions were analysed in three groups of patients: those who started treatment after publication of the alert so checks should have been performed in patients prior to dronedarone treatment (GROUP-A), those who started the treatment before the alert (GROUP-B), and finally patients who discontinued this semester (GROUP-C). In group-B patients we checked whether the ongoing controls specified in the alert had been done. Similarly, in Group-A patients we checked whether the start of treatment controls had been done (renal and hepatic function before and the week of the start of treatment).
Results: We examined 72 clinical histories. Group-A contained 17. Only 1 had liver and kidney function tests as required by the Competent Authority. In group-B (48), 15 had none of the controls required. In Group-C with 5 (two deaths), 3 had no controls.
Conclusions: The degree of compliance with tests required by the Health Authority in patients taking dronedarone is very low. It seems necessary to review and improve the system of drug alerts to physicians, and the pharmaceutical-care of patients seen in primary healthcare.
Key Words: Dronedarone, drug safety, pharmaceutical care.
José Mª Alonso Herreros
Hospital General Universitario Los Arcos – Mar Menor
Paraje Torre Octavio, 54
30739 San Javier (Murcia)
Correo electrónico: firstname.lastname@example.org