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WHAT IS KNOWN AND OBJECTIVE: Limited data are available on co-administration of acenocoumarol with direct-acting antiviral agents for chronic hepatitis C virus infection. CASE SUMMARY: We report a case of a patient who required a significant increase in acenocoumarol weekly dose probably due to an interaction with ombitasvir/paritaprevir/ritonavir and/or dasabuvir. A causality assessment of the drug-drug interaction leading to a reduced INR was conducted according to the Naranjo algorithm. A score of 6 suggested that the adverse drug reaction was probable. WHAT IS NEW AND CONCLUSION: Because of possible INR abnormalities during the concomitant use of acenocoumarol, ombitasvir/paritaprevir/ritonavir and dasabuvir, clinicians should closely monitor INR values.

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AIM: The aim of the study was to evaluate the effectiveness of a multidisciplinary intervention to reduce the risk of bleeding associated with antithrombotic drugs in patients with acute coronary syndrome (ACS). METHODS: We designed a pre-post quasi-experimental intervention study using retrospective cohorts. The first cohort was analysed to detect correctable measures contributing to bleeding (PRE: January-July 2010). Second, a bundle of interventions was implemented and third, a second cohort of patients was evaluated to investigate the impact of our measures in bleeding reduction (POST: September 2011-February 2012). RESULTS: A total of 677 patients were included (377 in PRE and 300 in POST). The bundle of interventions was: Overdose avoidance measures: the percentage of patients overdosed was reduced by 66.3% (p < 0.001). Institutional protocol update to include the latest recommendations regarding bleeding prevention: In POST, the percentage of patients treated with fondaparinux increased (2.4% vs. 50.7%; p < 0.001). In PRE, 11 patients were treated with the combination of abciximab and bivalirudin; whereas in POST, only one patient received the combination (p = 0.016). Mandatory measurement of body weight: the percentage of patients with unknown body weight was reduced by 35% (p = 0.0001). In POST, the total bleeding rate was reduced by 29.2% (31.6% in PRE vs. 22.4%, p < 0.05, OR: 0.62; 95% CI: 0.44-0.88). It was necessary to implement the interventions in 11 patients to prevent one bleeding episode (95% CI: 7-39). CONCLUSION: The multidisciplinary programme has been effective in reducing bleeding episodes. The interventions were effective in reducing antithrombotic drugs overdosage, incorporating the use of fondaparinux to the NSTE-ACS therapeutic arsenal, limiting the use of bivalirudin with abciximab and obtaining body weight for most patients.

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AIMS: The aim of the study was to evaluate the impact of the ENDORSE study results on thromboprophylaxis prescribing patterns in medical patients attending the Emergency Department (ED) by assessing prescribing appropriateness at admission. METHODS: A cross-sectional, observational, descriptive study was designed and included all adult medical patients admitted from an ED between 20 November 2012 and 26 November 2012 at a large tertiary hospital. Patients to whom anticoagulants were prescribed for therapeutic purposes, patients admitted to Intensive Care Unit or maternity wards were excluded. Prescribing appropriateness was assessed using the Padua Prediction Score (ACCP 2012 guideline) for thromboembolic risk assessment and the NICE model to determine risk of bleeding. The primary end-point was the adequacy of thromboprophylaxis prescribed at the ED according to the ACCP 2012 guideline. RESULTS: A total of 393 patients were examined and 207 patients were included in the study (53.1% were male) with a median age of 75.3 years. The most common diagnosis at admission was related to a respiratory disease (41.1%). In 34.8% of the patients (72 patients), the recommendation of prophylaxis according to ACCP 2012 guideline did not match with the prophylaxis prescribed at admission. Reasons for non-concordance were undertreatment (14.5%) and overtreatment (20.3%). CONCLUSIONS: The adequacy of thromboprophylaxis in high risk patients for VTE has improved compared with the ENDORSE study. However, the percentage of patients with discordant prescriptions remains high. Despite the existence of treatment omissions, this percentage has been overcome by patients overtreated.

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OBJECTIVE: To review medicines pregnancy category and establish the degree of conformity between the two systems more used: FDA (Food and Drug Administration) and ACPM (advisory Committee on Prescription Medicines). METHODS: drugs used in most frequent pathologies during pregnancy have been selected and found its pregnancy category according to FDA and ACPM. The degree of conformity has been established between both categorisation systems. RESULTS: a total of 270 medicines were reviewed. 260 drugs had pregnancy category by FDA and 245 by ACPM system. 232 drugs had pregnancy category defined by both classifications (FDA and ACPM). We found 70,2% of them in the same pregnancy category. CONCLUSIONS: The discrepancies found in both pregnancy categorisation systems can be confused in order to prescribe and know its safety statement of medicines during pregnancy which can limits its utility. It would be desirable more studies after medicines registered to get more information which could help to use safety drugs during pregnancy and minimize discrepancies between both pregnancy categorisation systems.

OBJETIVO: Revisar la categoría de riesgo de los medicamentos durante el embarazo y establecer el grado de concordancia entre los dos sistemas de clasificación más empleados: FDA (Food and Drug Administration) y ACPM (advisory Committee on Prescription Medicines). MÉTODOS: Se seleccionaron los fármacos de prescripción más frecuente durante el embarazo y se buscó su categoría de riesgo en el embarazo de acuerdo con la FDA y el ACPM. Se estableció el grado de concordancia para ambos sistemas de clasificación. RESULTADOS: se revisó un total de 270 medicamentos. 260 fármacos tenían una categoría para el embarazo según la FDA y 245 en el sistema ACPM. 232 fármacos tenían una categoría para el embarazo definida por ambas clasificaciones (FDA y ACPM). Encontramos que el 70,2% de ellos estaban en la misma categoría. CONCLUSIONES: Las discrepancias encontradas entre ambos sistemas de categorización pueden generar confusión a la hora de la prescripción y conocer las advertencias de seguridad de los medicamentos durante el embarazo, lo cual puede limitar su utilidad. Sería deseable que se hiciesen más estudios tras el registro de los fármacos para obtener más información que podría ayudar al empleo de fármacos seguros durante el embarazo y minimizar las discrepancias entre ambos sistemas de categorización.

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