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Background and objective The main objective was to evaluate the impact of Hepatitis C Virus treatment with direct-acting antiviral agents on tacrolimus blood levels in recipients of kidney and heart allografts. Method We analysed Hepatitis C Virus infected adult patients who received tacrolimus as immunosuppressive maintenance therapy and received direct-acting antiviral agents treatment in a tertiary hospital with solid transplant multidisciplinary program in Madrid, Spain. Liver and renal function, tacrolimus dose and blood levels were analysed before and 12 weeks after the end of treatment. Results We identified 7 kidney and 2 heart transplant recipients. All patients achieved sustained virologic response at 24 weeks. At week 12 after treatment, all liver functionality tests improved significantly with no significant changes in renal function. A decrease in the tacrolimus blood level/dose ratio for every patient was observed (370.04 ± 253.93 vs. 186.44 ± 123.74 ng/mL per mg/kg; p < 0.05). The requirements of tacrolimus dose increased after Hepatitis C Virus treatment (0.03 ± 0.04 vs. 0.04 ± 0.03 mg/kg/day, p < 0.05) to reach lower blood levels than before treatment (6 ± 2.25 vs. 4.67 ± 1.51 ng/mL, p < 0.05). Conclusion Caution is advised to clinicians; close monitoring of tacrolimus levels after direct-acting antiviral agents is recommended in order to avoid infradosification that could pose a risk of graft rejection.

Background Severe non-chemotherapy drug-induced neutropenia is a rare idiosyncratic drug reaction that is considered potentially fatal. Objective To report, in terms of drug safety surveillance, the results of an institutional strategy for NCDIN. Method An observational and prospective study including all adult patients who received filgrastim for the treatment of NCDIN from June 2015 to December 2017 was carried out by hematologists and clinical pharmacists. Results 13 patients with severe NCDIN were included in the study. The median age was 51 (range 24-80) years old and 46.2% were male. Seven patients had one or more negative prognostic factors (age > 65 years, renal impairment, autoimmune diseases and/or a neutrophil count at diagnosis < 0.1 × 109 cells/L). A single drug was identified as causative in 3 patients, while in 10 cases, 2-3 drugs were considered as potentially causative. The most frequent drugs were metamizole, piperacillin/tazobactam, dexketoprofen and linezolid, among others. Seven patients developed NCDIN during their hospital stay while 6 were admitted to the emergency department. Patients were using a median of 11 drugs (IQR 8-15) at the time of diagnosis. No deaths were recorded. Conclusion Metamizole and piperacillin/tazobactam are the most common drugs linked to non-chemotherapy drug-induced neutropenia in our cohort.

Background: Self-administration of oral chemotherapy regimens in the home setting leading to new challenges in the health system., Objective: To develop and evaluate a comprehensive pharmaceutical care program for cancer outpatients treated with oral antineoplastic agents., Setting: A Spanish tertiary hospital., Methods: During 2012, a comprehensive pharmaceutical care program was elaborated following the standards recommended by ASCO. It comprised a standard procedure focusing on: drug indication, dosing regimen, required laboratory tests, route of administration, interactions with other current medications and adverse events; a checklist and informational brochures. A pharmaceutical follow up was defined and structured into three clinical interviews over 6 months which focused on safety and efficiency outcomes. Patients starting treatment with oral antineoplastic agents during 2011 (control group) without pharmacist monitoring were compared to patients beginning treatment at some point in 2013 who were prospectively monitored by a pharmacist (intervention group). Statistical analysis was performed by the statistical program SPSS, 21.0 and p < 0.05 was considered significant., Main Outcome Measures: Patient demographics and clinical data were recorded. The primary endpoint was safety outcomes: detection of drug related problems, drug interactions, and adverse events. Adherence, permanence and patient satisfaction were also collected., Results: A total of 249 patients were enrolled in the study. Two hundred and seventy-five medication errors were recorded [106 in the control group and 169 in the intervention group (p = 0.008)]. The pharmacist intervened in 362 occasions being accepted 88.8 % of the time, mainly to reinforce patient education and literacy and giving information on co-administration with other drugs and herbal medicines. Adherent patients increased at the 6th month of treatment in the intervention group by 20 % (p < 0.001). High satisfaction was reported., Conclusion: The program has been implemented and evaluated successfully. It ensures a high quality and standard of pharmaceutical care with high patient satisfaction rate and the key points to prioritize for improvement in terms of safety (interactions and administration errors) and efficiency (adherence and permanence) of oral antineoplastic agents.

Background: Information on the use of ankylosing spondylitis (AS) therapies in clinical practice is a key factor in decision making, as more efficient treatments may involve substantial savings while maintaining the clinical benefits for the patient., Objective: To assess the mean annual doses and associated costs of the three main anti-tumour necrosis factor agents used in Spanish daily clinical practice in ankylosing spondylitis patients and to correlate these costs with disease activity., Setting: This retrospective, observational study included adult ankylosing spondylitis patients over a 4-year period that had been treated for at least 6 months with adalimumab, etanercept or infliximab at two University Hospitals in Spain., Methods: Disease activity was estimated with Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores at the start of anti-tumour necrosis factor (anti-TNF) therapy and in the last visit or whenever the drug was switched. Mean costs were estimated for a 52-week horizon from the delivered doses registered by pharmacy records. Outcomes were the doses and costs of anti TNFs administered to each patient, and the BASDAI score., Results: A total of 119 patients (137 cases) were included (28 cases treated with adalimumab, 48 cases with etanercept and 61 with infliximab). Mean doses of adalimumab and etanercept were 92.8 and 88.8% of the initially prescribed doses, respectively, while the mean dose of infliximab administered was 102%. There were no statistical differences among treatments in terms of clinical effectiveness. Associated mean patient-year costs were significantly higher in the infliximab group (€14,235), compared to the other treatments [adalimumab €11,934; etanercept €10,516; (P < 0.05)]., Conclusion: In certain ankylosing spondylitis patients, doses and associated costs of biological therapies can be reduced while controlling disease activity. Mean doses used in our clinical practice vary from the recommended doses and are significantly lower for adalimumab and etanercept than for infliximab. These differences impact directly on associated patient-year costs, and, thus, on treatment efficiency.

Background: Medication reconciliation is a key tool in the prevention of adverse drug events., Objective: To assess the impact of an electronic reconciliation tool in decreasing unintended discrepancies between medications prescribed after surgery and the patient's usual treatment., Setting: General Surgery Department of Gregorio Marañón's University General Hospital, Madrid., Method: A pre-post intervention study with no equivalent control group was carried out between June 2009 and December 2010. Patients hospitalized in the General Surgery Department for 24 h or more, and whose prescriptions prior to admission included three or more drugs were included in the study. Patients were interviewed to gather information about their usual treatment drugs. Discrepancies between the latter and the drugs prescribed after surgery were assessed before and after the medication reconciliation electronic tool was implemented., Main Outcome Measure: Proportion of patients with at least one unintended discrepancy., Results: A total of 107 patients in the pre-intervention phase and 84 patients in the post-intervention phase were included. We detected 1,678 discrepancies, 167 were found to be unintended. The number of patients with at least one unintended discrepancy was 43 (40.2 %) in the pre-intervention phase, and 38 (38.1 %) in the post-intervention phase, p = 0.885. The percentage of unintended discrepancies over the total amount of drugs reconciled was lower in the post-intervention phase than in the pre-intervention phase (6.6 vs. 10.6 %), p = 0.002. Regarding unintended discrepancies 79.2 % were grade C severity (the error reached the patient but caused no harm), 13.6 % grade D (the error reached the patient and required monitoring or intervention to preclude harm) and 7.1 % grade E (the error may have contributed to or resulted in temporary harm to the patient and required intervention)., Conclusion: Implementation of an electronic tool facilitated the process of medication reconciliation in a general surgery unit. The proportion of unintended discrepancies over the total amount of drugs reconciled was reduced after the implementation of the reconciliation programme. However, we could not demonstrate a more significant impact due to some methodological limitations.

Background and Objective: Reducing bleeding events is a priority in patients diagnosed with acute coronary syndromes (ACS). The effectiveness of optimization measures for reducing abciximab-related bleeding was evaluated through the implementation of a pilot program developed by the Pharmacy and the Cardiology Departments at a tertiary-care hospital., Main Outcome Measure: Percentage of bleeding events., Results: Intervention was effective in reducing the incidence of the three factors associated with an increased risk of bleeding between the pre-intervention phase (n = 86) and the post-intervention phase (n = 73): unknown body weight (24.4 vs. 1.4 %, p = 0.0001), overdosing (31.4 vs. 0 %, p < 0.0001) and combination with bivalirudin (12.8 vs. 1.4 %, p = 0.016). Bleeding events associated with these factors were numerically reduced in all three cases but these differences were not statistically significant between both periods., Conclusion: The implementation of a multidisciplinary prevention program can reduce situations associated with an increased risk of bleeding in patients treated with abciximab. Larger scale trials are needed to confirm whether such programs can also reduce the incidence of bleeding at a statistically significant level.

Background: Some publications have shown that equivalent doses of erythropoiesis-stimulating agents (ESA) defined on label differ from those effective in clinical practice. Therefore, real costs could vary from theoretical costs in the treatment of anaemia in chronic kidney disease (CKD)., Objectives: To perform a cost-minimization analysis to establish the economic impact of the principal ESAs used in treating anaemia secondary to CKD in daily practice., Secondary Objectives: to determine patient-month cost based on the erythropoietin resistance index (ERI); to analyze the difference in cost between pre-dialysis and peritoneal dialysis (PD) patients; and to analyze the association between iron deposits and ESA cost., Setting: This study was carried out at 2 tertiary hospitals in Spain., Method: A multicentre cost-minimization analysis was performed in adult outpatients treated with ESAs for anaemia due to CKD., Main Outcome Measure: The primary outcome was the patient-month cost for each ESA., Results: 409 patients were included. Median patient-month cost was: epoetin (103.2 [63.7, 187.8] euros), darbepoetin α (134.4 [67.2, 216.0] euros) and CERA (147.5 [98.3, 196.7] euros). Median patient-month cost according to ERI was: epoetin (1.60 [0.90, 2.60] euros/kg), darbepoetin α (2.01 [0.95, 3.48] euros/kg) and CERA (1.87 [1.33, 3.00] euros/kg). Median patient-month cost in pre-dialysis was 126.0 (73.7, 201.6) euros and in PD 153.0 (100.2, 275.4) euros. Median patient-month cost for patients with TSI < 20% was 147.5 (98.3, 224.9) euros compared to 100.9 (67.2, 196.7) euros which was the cost for patients with IST ≥ 20%. The median patient-month cost for patients with ferritin < 100 mcg/l was 134.4 (85.0, 201.6) euros compared to 100.8 (68.8, 196.7) euros, which was the cost for patients with ferritin ≥ 100 mcg/l (p = 0.242)., Conclusion: Doses of CERA used in clinical practice are lower than those recommended on label, which directly influences cost and treatment efficiency. Cost stratification based on iron deposits has shown that patients with low TSI or ferritin require higher doses and consequently an associated higher cost. Thus, to guarantee adequate iron levels is essential in the rational use of ESAs.

Purpose: To assess the main differences in clinical significance of the prescribing errors intercepted by clinical pharmacists in paediatrics and obstetrics and the reasons for these prescribing errors, as well as the differences in pharmacists' activity indicators., Methods: The was a cross-sectional epidemiological study analysing the activities of paediatric pharmacists in a maternity and children's hospital with 180 paediatric beds and 138 obstetrics and gynaecology beds between January 2007 and December 2009. The following variables were analysed: clinical significance of prescribing errors intercepted, reason for the error, impact of the intervention by pharmacist, acceptance rate of the recommendation made, medication involved, intervention detection date and observations., Results: A total of 2,449 interventions in medical orders were recorded. Interventions that were not accepted by doctors were excluded, leaving 43 cases (2.1%) of extremely significant interventions and 170 (8.4%) very significant interventions. Interventions in what were deemed to be error-free situations were excluded. Significance testing (based on 2,035 errors detected) showed that 1.7% of the detected errors were potentially lethal (35 cases), while 10.2% (210 cases) were clinically serious. The main reason for the interventions was the detection of a dosage between 1.5- and tenfold higher than the recommended dosage. The overall rate of acceptance of the pharmacist's suggestions was 92.2%. Pharmacists carried out an average of 0.016 interventions/patient-day throughout the study period., Conclusions: Paediatric patients had a fourfold higher risk of serious errors than the maternity population. Pharmacist intervention had a major impact on reducing prescribing errors in the study period, thus improving the quality and efficiency of care provided.