Background Dronedarone is a drug related to amiodarone, marketed in 2010. Soon after, there were several safety alerts that forced Health Authorities to reduce their use, and require hepatic and renal function cheques. The alert (reference SGMUH (FV), 16/2011) requires initial and then at least 6-monthly hepatic and renal function tests.
Purpose To assess the degree of compliance with the analytical tests required by the Competent Authority in patients taking dronedarone (creatinine and liver enzymes) in a health area of 200,000 inhabitants.
Materials and Methods We selected patients who were prescribed dronedarone during the last half of 2011. These patients were identified by querying the electronic prescription billing system. The prescriptions were analysed in three groups of patients: those who started treatment after publication of the alert so cheques 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). Serum creatinine concentration was considered valid as a cheque of renal function; transaminase levels were suitable for the liver function test. Selene (clinical history management software) and Agora Plus (primary integrated medical record-hospitalisation management software) were used to retrieve the serum concentrations.
Results We examined 72 clinical histories. Group A contained 17 patients. Only 5% had liver and kidney function tests as required by the Competent Authority. In group B (48 patients), 31.2% had none of the controls required. Only 6.2% of patients had a creatinine cheque. Only 4.1% of patients had a liver function cheque. In Group C with 7 patients (two deaths), 71.4% had no analytical controls of any kind, and in only 14.2% were renal function tests performed.
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. Computer systems such as the Agora Plus that integrate primary and hospitalisation data are critical for this type of monitoring.
No conflict of interest.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.