Search

Introduction Extravasation is a potentially severe complication of intravenous administration of antineoplastic drugs. The limited data makes it difficult to develop an optimal management scheme. The objective of this study is to describe the clinical practice in the extravasation management of antineoplastic agents in Spanish centers. Methods An online survey was distributed to oncology pharmacists using the email distribution list of the Spanish Society of Hospital Pharmacists. Respondents were surveyed on the standard operational protocol (SOP) of extravasation, tissue damage risk classification, and specific measures of extravasation management. Results A total of 68 surveys were completed. A specific extravasation SOP was available in 82.4% centers. The pharmacist participates in the authorship (100%) and actively collaborates in extravasation management (76.5%). A tissue damage risk classification based on the three categories was mostly adopted (48.2%) and 73.2% applied specific criteria based on concentration and/or extravasated volume. Extravasation management was mainly performed with the application of physical measures and/or antidotes (91.2%). High variability in the choices of pharmacological and/or physical measures recommended is outstanding. Conclusion The results of this study highlight the involvement of Spanish pharmacists in extravasation management, the application of physical measures and/or pharmacological measures as the method of choice in extravasation management, as well as the existing discrepancies in tissue damage risk classification and management recommendations

Our aim was to describe the incidence and characteristics of immune-related adverse events (irAEs) in patients with non-small-cell lung cancer (NSCLC) treated with immune checkpoint inhibitors (ICI) and to evaluate their impact on outcome. All cases of NSCLC patients treated with ICIs in the second-line setting between December 2015 and May 2018 were evaluated. Seventy patients were included. Mean age was 65.9 years, and the majority of male (n = 53, 75.7%), with PS of 0-1 (n = 62, 88.6%) treated with nivolumab (n = 51; 72.9%). Thirty-one patients (44.3%) experienced an AE, 5 (7.1%) were grades 3-4. Median OS in patients with AE was 30.1 months (95% CI, 16.7-43.5) compared with 5.1 months (95% CI, 1.2-9.0) in cases without AE (log-rank test: p = 0.010). The adjusted HR for OS was 0.46 (95% CI, 0.25-0.86) for the irAE occurrence and 3.60 (95% CI, 1.56-8.32) for PS 2-3 group. The development of irAEs was associated with improved patient outcome.

Data de publicació electrónica: 26-04-2022

Background Tigecycline is the first member of the glycylcyclines. Both the FDA (2010 and 2013) and the EMA (2011) issued safety warnings describing an increased mortality risk associated with tigecycline compared with other antibiotics treating severe infections. One of the best strategies to optimize antimicrobial therapies is through the establishment of antimicrobial stewardship programmes (ASPs) in hospitals. In June 2011, our ASP was implemented. Objectives To analyse trends in tigecycline prescription, after drug safety warning announcements by regulatory agencies and after an ASP implementation. Methods A 6 year prospective observational study of tigecycline use was performed, including all consecutive adult patients treated with at least one dose during the 6 years after approval of the drug for its use in the hospital. The primary outcome was tigecycline consumption assessed by DDD/100 bed-days. A segmented linear regression model for interrupted time series (ITS) was designed to detect any significant trend changes. Results A total of 524 patients were included. After the FDA warning alert, tigecycline consumption decreased by 35.9%. Moreover, following the ASP implementation, a dramatic reduction in tigecycline prescription by 67.3% was observed. Conclusions The role of the ASP was essential to establish adequate control of prescriptions, collaborating with the clinicians in a better adaptation of the tigecycline indication.

Introduction Aspergillus may cause different types of lung infections: invasive, chronic pulmonary or allergic bronchopulmonary aspergillosis. Pharmacological management with antifungals poses as a challenge. Patients diagnosed with pulmonary aspergillosis are complex, as well as the problems associated with antifungal agents. Areas covered This article reviews the pharmacology of antifungal agents in development and currently used to treat pulmonary aspergillosis, including the mechanisms of action, pharmacokinetics, pharmacodynamics, dosing, therapeutic drug monitoring and safety. Recommendations to manage situations that arise in daily clinical practice are provided. A literature search of PubMed was conducted on November 15th, 2020 and updated on March 30th, 2021. Expert opinion Recent and relevant developments in the treatment of pulmonary aspergillosis have taken place. Novel antifungals with new mechanisms of action that extend antifungal spectrum and improve pharmacokinetic-related aspects, drug-drug interactions and safety are under current study. For those antifungals already marketed, new data related to pharmacokinetics, pharmacodynamics, dose adjustments in special situations, therapeutic drug monitoring and safety are available. To maximize efficacy and reduce the risk of associated toxicities, it is essential to choose the most appropriate antifungal; optimize its dose, interval, route of administration and length of treatment; and prevent side effects.

To reach at an expert consensus, using the Delphi method, for classifying the tissue-damaging potential of antineoplastic drugs, in order to facilitate the decision-making process in the event of extravasations.The panel of expert evaluators was made up of seven pharmacists belonging to the working group on extravasations. Other member served as coordinator. The likelihood of tissue damage was reviewed on the basis of eight reference documents. Four categories of drugs were established: vesicant (V); high risk irritant (HRI); low risk irritant (LRI) and non-irritant (NI). Two rounds of surveys were performed. The drugs with an agreement of less than 70% after the two rounds were discussed non-anonymously by the group. For each of the rounds the following was analysed: median of the degree of consensus and the interquartile range (IQR25-75), degree of agreement by tissue damage category, and percentage of antineoplastics reaching a degree of consensus of over 85% and of 100%. Drugs whose classification differed in the various reference documents were assessed separately. SPSS v23.0 statistical software was used.Seventy-one antineoplastics were evaluated. In the first round, the median for degree of consensus was 100.0% (IQR25-75: 71.4- 100.0%). In the second round, the median was 100.0% (IQR25-75: 85.7- 100.0%). The percentage of antineoplastics with a consensus of 85.7% or above increased from 66.7% to 85.9% in the second round. For the 30 antineoplastics whose values differed in the reference documents, the degree of agreement increased from 71.4% (IQR25-75: 57.1-87.7%) to 100.0% (IQR25-75: 85.7-100.0%) in the second round. The percentage of antineoplastics with a consensus of 85.7% or above increased from 40.0% to 76.7%. Four antineoplastics had a degree of agreement of less than 70.0%. The final classification of drugs per category, was: 17 vesicants; 15 HRI; 13 LRI; and 26 NI. The final degree of consensus was 85.7% or above for 90.1% of antineoplastics, and 100.0% for 74.6% of the same.In this area of scarce evidence and high variability, the Delphi method allows for consensus in classifying tissue damage risk, thus making it easier to reach clinical decisions. In approximately 90% of the antineoplastics, the degree of consensus reached by the expert panel was 85% or above. In 74% of the antineoplastics, it was 100%. This provides solid ground for management decisions.Objetivo: Realizar un consenso de expertos utilizando el método Delphi para la clasificación del potencial de daño tisular de los antineoplásicos que facilite la toma de decisiones ante una extravasación.Método: El panel de evaluadores estaba formado por siete farmacéuticos del grupo de trabajo de extravasaciones. Otro actuó como coordinador. Se revisó la probabilidad de daño tisular a partir de ocho documentos de referencia. Se clasificaron en cuatro categorías: vesicante, irritante de alto riesgo, irritante de bajo riesgo y no irritante. Se realizaron dos rondas; tras éstas los fármacos con consensolt; 70% se discutieron en grupo de forma no anónima. Se analizó para cada ronda: la mediana del grado de consenso y ámbito intercuartílico (AIQ25- 75), el grado de concordancia por categoría de daño tisular y el porcentaje de antineoplásicos con grado de consensogt; 85% y del 100%. Se analizaron de forma separada los fármacos con discordancias de clasificación entre los documentos consultados. Se utilizó el programa estadístico SPSS v23.0.Resultados: Se evaluaron 71 antineoplásicos. En la primera ronda la mediana del grado de consenso fue 100% (AIQ25-75: 71,4-100,0%) y en la segunda ronda 100% (AIQ25-75: 85,7-100,0%). El porcentaje de antineoplásicos con consenso ≥ 85,7% aumentó del 66,7% al 85,9% en la segunda ronda. Para los 30 antineoplásicos con discrepancias entre los documentos revisados, el grado de consenso aumentó del 71,4% (AIQ25- 75: 57,1-87,7%) al 100% (AIQ25-75: 85,7-100,0%) en la segunda ronda. El porcentaje de antineoplásicos con concordancia ≥ 85,7% pasó del 40,0% al 76,7%. Cuatro antineoplásicos presentaron consensolt; 70%. La clasificación final incluyó 17 fármacos como vesicantes, 15 como irritantes de alto riesgo, 13 como irritantes de bajo riesgo y 26 como no irritantes. El grado de acuerdo final fue ≥ 85,7% en el 90,1% de los antineoplásicos y del 100% en el 74,6%.Conclusiones: En este área de escasa evidencia y variabilidad la metodología Delphi permite alcanzar un consenso de clasificación del riesgo de daño tisular que facilita la toma de decisiones. Aproximadamente para el 90% de los antineoplásicos el grado de concordancia alcanzado por el panel de expertos fuegt; 85%, y para el 74% de los antineoplásicos la concordancia fue del 100%, aportando una base sólida para las decisiones de manejo.

Background and importance The most frequent adverse effect of palbociclib is neutropenia, resulting in dose reductions and treatment interruptions. Recently, it has been reported that early palbociclib related neutropenia was associated with a prolonged progression free survival (PFS)1. However, there are no analysis data based on the real world setting, outside of clinical trials. Aim and objectives To determine whether early neutropenia in our cohort of patients was associated with disease response to palbociclib combined with fulvestrant or an aromatase inhibitor. Material and methods This was a retrospective study including all patients who started treatment with palbociclib between December 2016 and January 2020. Demographic and clinical data were obtained from the electronic clinical records. Primary endpoints included both PFS and overall survival (OS). Early neutropenia was defined as the nadir absolute neutrophil count (ANC) during the first two cycles of treatment. PFS and OS were analysed with Kaplan–Meier survival curves comparing neutropenia grades using the log rank test to check differences between survival curves. Multivariate Cox proportional hazard regression model was also used to predict OS. Results A total of 61 patients were included. Demographic and clinical characteristics are shown in table 1. 28 patients (45.9%) stopped treatment and 24 (85.7%) discontinued due to progression. 25 patients (41.0%) required ≥1 dose reduction. In the first two cycles, 54 patients (88.5%) experienced grade 1–4 neutropenia. Patients who experienced grade 2–4 neutropenia in the first two cycles were associated with significantly prolonged median OS (log rank p=0.019). However, there was no significant association with prolonged median PFS (log rank p=0.572). After adjusting for potential cofounders (baseline ACN, age and weight), grade 2–4 neutropenia remained significantly and independently associated with prolonged OS (HR 0.26, 95% CI 0.09 to 0.77, p=0.015). Conclusion and relevance Early neutropenia was significantly associated with a prolonged OS, supporting the suggestion that neutropenia could be a pharmacodynamic marker for palbociclib dosing. References and/or acknowledgements McAndrew NP, et al. Br J Cancer 2020;123:912–18. Conflict of interest No conflict of interest

Breast cancer is the most prevalent and lethal cancer among women. Forty-one percent of cases occur in people ≥ 70 years, hindering their treatment given its comorbidities and polypharmacy (PP). Potential drug–drug interactions (PDDI) were analyzed in elderly breast cancer patients between daily and oncospecific treatments and their associations with Age, BMI, Mini Nutritional Assessment (MNA), Frailty categorization, PP, and adverse effects. A cohort of 77 patients ≥ 70 years with breast cancer who underwent a Comprehensive Geriatric Assessment (CGA) were included. Clinical characteristics were collected using medical records. PDDI between treatments were analyzed using two databases. Data were assessed using linear regression, Chi-square, Mann–Whitney U, and Kruskal–Wallis tests. Finally, a multivariate logistic regression model was built and tested to predict adverse effects. From 719 PDDI, 530 (74%) were moderate (r2 = 0.72) and the median number of drugs during oncospecific treatment (r2 = 0.73) was 9 (range 3–26). Overall, 59 patients (77%) had adverse effects associated with Frailty categorization and MNA (p

Our objective was to evaluate the prevalence of discrepancies between primary care electronic medication records (EMR) and patient reported medication (PRM) in ambulatory patients starting a hospital dispensing treatment (HDT) at a hospital-based ambulatory care pharmacy (HACPh). Our secondary aims were to analyse factors associated with the presence of discrepancies and their impact on the prevalence of potential drug-drug interactions (DDIs) with the HDT.Retrospective study including 230 patients starting a HDT at the HACPh. Pharmacists interviewed patients and PRM was compared with EMR. Discrepancies were classified as omissions (medication in the PRM not present in the EMR) and commissions (medication active in the EMR that the patients were not taking). Potential DDIs with the HDT were screened, and univariate and multivariate analyses were performed to detect factors associated with the presence of discrepancies.We identified 221 discrepancies in 116 (50.4%) patients. Being visited by three or more medical specialties (OR 1.93, 95% CI 1.11 to 3.37) and attending private healthcare (OR 4.36, 95% CI 1.14 to 16.72) in the 12 months before the study inclusion were the factors independently associated with the presence of discrepancies. Among patients with commissions (n=91), 15.4% had a potential DDI between the HDT and one medication from the EMR that they were not taking at that moment. Among patients with omissions (n=45), 11.1% had a potential DDI between the HDT and a medication in the PRM not present in the EMR.About 40% of patients had one or more medications in the EMR which they were not taking and one fifth used medications that were not listed in the EMR. EMR should not be used as the only source of information when screening for DDIs, especially in patients followed by different medical specialties or combining private and public healthcare.

5-Fluorouracil (5-FU) is combined with folinic acid (FA) for enhancing its cytotoxic effects in the colon cancer chemotherapy treatment. Folinic acid has rarely been involved in hypersensitivity reactions. Here, we report a case of FA hypersensitivity in an adult patient initially attributed to oxaliplatin administered concurrently. A 56-year-old male patient diagnosed with colon cancer received twelve cycles of FOLFOX4, one cycle of FOLFIRI plus cetuximab and nine cycles of FOLFOX6 uneventful. At the tenth cycle of FOLFOX6 chemotherapy, after 15 minutes of starting the infusion of oxaliplatin and FA, the patient reported flushing, pruritus and abdominal pain and erythema and oedema developed over the face and thorax. After progression, FOLFIRI plus aflibercept was scheduled and another reaction occurred. At this time, FA was discontinued and the patient received another cycle consisted on irinotecan plus 5-FU without incidences. This episode of hypersensitivity reaction following FA infusion with no oxaliplatin empirically confirmed that the hypersensitivity reaction was secondary to FA. Clinicians should be aware of hypersensitivity reaction with FA, especially when FA is administered concomitantly with oxaliplatin, despite its lower risk to cause hypersensitivity reactions. Furthermore, the similar signs and symptoms associated to the hypersensitivity reactions of each agent, highlight the importance of having a specialised allergist team for to make a prompt diagnose of the causative agent in order to prevent patient harm and proceed properly without unnecessary delays in the scheduled chemotherapy treatments.

Summary Background To develop a prediction rule to describe the risk of death as a result of enterococcal bloodstream infection. Methods A prediction rule was developed by analysing data collected from 122 patients diagnosed with enterococcal BSI admitted to the Clinica Universidad de Navarra (Pamplona, Spain); and validated by confirming its accuracy with the data of an external population (Hospital del Mar, Barcelona). Results According to this model, independent significant predictors for the risk of death were being diabetic, have received appropriate treatment, severe prognosis of the underlying diseases, have renal failure, received solid organ transplant, malignancy, source of the bloodstream infection and be immunosuppressed. The prediction rule showed a very good calibration (Hosmer–Lemeshow statistic, P = 0.93) and discrimination for both training and testing sets (area under ROC curve = 0.84 and 0.83 respectively). Conclusions The predictive rule was able to predict risk of death as a result of enterococcal bloodstream infection as well as to identify patients, who being below the threshold value, will have a low risk of death with a negative predictive value of 96%.

Background The incidence of ampicillin-resistant Enterococcus faecium bacteraemia is increasing. Vancomycin remains the first-line treatment in areas with a high prevalence of glycopeptide-susceptible isolates, but data comparing its clinical outcomes with other treatments are lacking. The objective of this study was to compare the effectiveness and safety of linezolid and glycopeptides for the treatment of glycopeptide-susceptible E. faecium bloodstream infection (GSEF-BSI). Methods This retrospective observational cohort study was conducted from January 2006 to May 2018 at the Hospital del Mar, Barcelona, Spain, and compared the clinical outcomes and safety of linezolid and glycopeptides in adult patients with GSEF-BSI. The main outcomes included clinical cure at the end of therapy, 30-day mortality, microbiological eradication and attributable length of stay (LOS). Propensity score matching was performed to reduce potential confounders among groups. Results In total, 105 patients with GSEF-BSI were included (linezolid, n=38; glycopeptides, n=67). After propensity score matched analysis, 56 (53.3%) patients, 28 in each cohort, entered the final analysis. No differences were observed in any of the main clinical outcomes among patients treated with linezolid or glycopeptides: clinical cure [16/28 (57.1%) vs 13/28 (46.4%), P=0.593], 30-day mortality [8/28 (28.6%) vs 12/28 (42.9%), P=0.403], microbiological eradication [22/28 (78.6%) vs 20/28 (71.4%), P=0.758] and median attributable LOS (18.0 vs 17.0 days, P=0.924). Adverse events were similar in both groups. Conclusions Linezolid and glycopeptides showed similar clinical effectiveness and safety in the treatment of GSEF-BSI. Linezolid could be an alternative to glycopeptides in the treatment of GSEF-BSI.

Purpose The potential impact of drug-related problems (DRP) on morbidity and mortality is a serious concern in hospitalized patients. This study aimed to design a risk score to identify patients most at risk of a DRP. Methods Data from patients admitted to a tertiary university hospital between January and August 2009 were used to design the risk score (training set). DRP were detected through a pharmacy warning system integrated in the computerized medical history. The variables associated with developing a DRP were identified through a binary multivariate logistic regression analysis and were used to compute the DRP risk score, which was subsequently validated in patients admitted between September and December 2009 (validation set). Results Of the 8713 patients included in the training set, at least one DRP was detected in 2425 (27.8%). Prescription of a higher number of drugs, higher comorbidity, advanced age, certain groups of the Anatomical Therapeutic Chemical classification system, and some major diagnostic categories were associated with risk of DRP. These variables were used to compute the DRP risk score. The area under the receiver operator characteristic curve was 0.778 (95%CI [0.768, 0.789]). Of the 4058 admissions included in the validation set, at least one DRP was detected in 876 (21.6%). The area under the receiver operator characteristic curve was 0.776 (95%CI [0.759, 0.792]). Conclusions Knowledge of the variables associated with DRP could aid their early detection in at-risk patients. The use of an application that can be continually updated in daily clinical practice helps to optimize resources. Copyright © 2014 John Wiley & Sons, Ltd.

Extravasation of cytotoxic agents is a true medical emergency. Dexrazoxane is the only licensed drug for the treatment of anthracycline extravasations. Dexrazoxane proved to be effective and moderately well tolerated. However, alternative approaches for the management of anthracycline extravasations are available such as topical DMSO and cooling. There appears to be general agreement about dexrazoxane usefulness when extravasations involve large volumes of anthracycline and/or central venous access device. Nevertheless, the non-invasive combination of DMSO and cooling is the most commonly described therapy, particularly in small anthracycline extravasations. Further research is still needed to establish unequivocal situations where dexrazoxane must be initiated.

Objective: To present current developments in the specific management of extravasations of antineoplastic agents after the extravasation. Method: We conducted a search in PubMed, Medline and IDIS-Iowa to identify papers written in English or Spanish that described new specific measures for the management of extravasations. We also reviewed the references given in these papers and recent tertiary sources related to oncology or cytostatic agents. The search covered the period between 1997 and 2010. Results: There are only specific measures for the treatment of extravasations of 22 cytostatic agents. These measures are presented for each cytostatic agent, according their drug group.

Dexrazoxane is now authorized for the treatment of anthracycline extravasations. Several clinical cases of doxorubicin extravasation treated with dexrazoxane have been reported to date, but detailed cases have not been published. We report a case of a successful dexrazoxane treatment for a potentially severe extravasation of concentrated doxorubicin. We also describe objective outcome of this treatment, drug tolerance to dexrazoxane and long follow-up. A 29-year-old man diagnosed with Hodgkin's lymphoma was prescribed a regimen including 90 mg of doxorubicin in a 50 ml infusion using a reduced occlusion infusion pump. After this infusion, the patient complained of pain around the site of injection and presented a 10x6-cm swollen area with erythema and inflammation. A significant portion of doxorubicin was extravasated. Dexrazoxane was prescribed as an antidote. Side effects of dexrazoxane were restricted to reversible hematological toxicity, nausea, and vomiting. The next day, the inflammation of the extravasation area was reduced. On day 7, a painless mild induration in the extravasated area was the only remaining sign of the extravasation. On day 40, an arm nuclear magnetic resonance image showed no focal injuries. At 6-month follow-up, the patient has no sequelae. The two risk factors that could have increased the severity of the extravasation are the use of an infusion pump and the high drug concentration. Dexrazoxane proved to be effective and moderately well tolerated. A dexrazoxane stock in oncological facilities could help to promptly handle emergencies like this. Anthracyclines can be administered using reduced occlusion infusion pumps, but it seems preferable to always administer a free-running infusion to minimize accidents like this one.

Resumen Introduccion Los enterococos son causantes de infecciones graves, como endocarditis y bacteriemias. Durante las ultimas decadas, las infecciones enterococicas han ganado importancia debido al aumento del numero de casos. El conocimiento de los factores predisponentes al aislamiento de Enterococcus faecalis o Enterococcus faecium puede ser util para mejorar el tratamiento empirico de las bacteriemias. Metodos Estudio retrospectivo de los pacientes hospitalizados diagnosticados de bacteriemia enterococica (enero 2000–diciembre 2006). Se analizaron datos demograficos, clinicos, microbiologicos, exposicion antibiotica, tratamientos y pronostico. Para identificar los factores predisponentes al aislamiento de E. faecalis o E. faecium se llevo a cabo un analisis comparativo univariado y despues un analisis multivariado. Resultados Se estudiaron 228 episodios de bacteriemia: 168 de E. faecalis y 60 de E. faecium . Todos los aislamientos de E. faecalis fueron sensibles a ampicilina, aunque solo el 25% lo fue en el grupo de E. faecium . Hubo un caso de resistencia a vancomicina. Las variables que se asociaron independientemente a la adquisicion de bacteriemia por E. faecium cuando se compararon con las bacteriemias producidas por E. faecalis fueron el ingreso en una unidad quirurgica (OR: 4,223; p=0,001), mas de 5 dias de tratamiento previo con cefalosporinas o carbapenemicos (OR: 2,564; p=0,013 y OR: 2,652; p=0,027, respectivamente), la administracion previa de penicilinas (OR: 2,008; p=0,044), Simplified Acute Physiology Score superior a 30 al ingreso (OR: 3,530; p=0,001) y enfermedad hepatica de base (OR: 3,754; p Conclusiones Debido al diferente patron de resistencia de ambas especies enterococicas, es esencial el conocimiento de los factores predisponentes a la adquisicion de bacteriemia por una u otra especie a fin de establecer un tratamiento empirico antibiotico adecuado.

Despite the increasing ethnic diversity, there are few studies of its influence on the pharmacokinetics of amikacin. The objective of this study was to compare the pharmacokinetics of amikacin in different populations: Asian, Hispanic, North Africans and Caucasian.A retrospective observational study was performed in a tertiary teaching hospital during eight years. It was included all patients with intravenous amikacin treatment in extended interval dosing regimen with therapeutic drug monitoring of amikacin. Pharmacokinetic parameters were analysed. A bivariate and multiple linear regression statistical analysis were carried out.164 patients were included: 7 asians, 135 Caucasians, 11 Hispanics and 11 from North Africa. It was shown a lower plasma concentrations of amikacin in North Africa population due to its greater clearance.Amikacin plasma concentrations monitoring is advisable in patients from North Africa in order to avoid subtherapeutic concentrations.

Background The recent approval of the new direct acting antivirals (DAAs) has extended treatment options in hepatitis C virus (HCV) genotype 1 infected patients with compensated liver disease. Purpose To evaluate which factors can influence the selection of DAAs in genotype 1 HCV patients in our setting. Material and methods Retrospective study including genotype 1 HCV patients treated with interferon free DAAs from December 2014 to September 2015. Data collected: demographics, genotype 1 subtype, HIV infection, presence of liver cirrhosis (LC), prior treatment status (naive or pretreated) and other concomitant drugs. DAAs were classified­ as follows: sofosbuvir+simeprevir±ribavirin (SOF/SMV); sofosbuvir+daclatasvir±ribavirin (SOF/DCV); sofosbuvir/ledipasvir±ribavirin (SOF/LDV); ombitasvir/paritaprevir/ritonavir+dasabuvir±RBV (OBV/PTV/r/DSV). The χ 2 test and the Mann-Whitney U test were used for categorical and quantitative variables, respectively. Results We included 124 patients: 79 (63.7%) male; mean age 60.8 (±SD 11.5) years; 35 (28.2%) genotype 1a; 26 (21%) HIV/HCV coinfected; 79 (63.7%) LC; 65 (52.4%) naive; and 56 (45.2%) with polypharmacy (>3 drugs, median value). DAA regimen selected: 34 (27.4%) SOF/SMV; 14 (11.3%) SOF/DCV; 34 (27.4%) SOF/LDV and 42 (33.9%) OBV/PTV/r/DSV. There were statistically significant differences in the frequency distribution of the different selected DAAs (table 1) A tendency was observed when comparing different genotype subtypes (p = 0.094) or presence of polypharmacy (p = 0.088). Conclusion HIV/HCV coinfected and cirrhotic patients were more likely to be treated with SOF/LDV while HCV monoinfected and non-cirrhotic patients with likely to receive OBV/PTV/r/DSV. Pretreated patients were more likely to be treated with SOF/SMV while those naive with more likely to receive OBV/PTV/r/DSV. The major potential for drug-drug interactions of OBV/PTV/r/DSV and its lower experience in advanced liver disease and previous triple therapy failure could have influenced these findings. References and/or Acknowledgements Pawlotsky JM. EASL Recommendations on Treatment of Hepatitis C 2015. J Hepatol 2015 No conflict of interest.

Background Despite current highly active antiretroviral therapy (HAART), some patients still do not achieve an undetectable viral load, and it is important to identify treatment failure (TF) associated factors. Purpose To determine the incidence and risk factors for TF in a cohort of HIV infected patients. Material and methods Cross sectional study in an initial cohort of 1562 HIV infected patients from June 2014 to July 2015. 1259 were finally included and interviewed, to collect the following data: demographics, current ART and adherence, concomitant medications and drug interactions (DI) (according to the University of Liverpool database). TF was defined as confirmed HIV RNA >50 copies/mL. A logistic regression analysis was used to identify variables independently related to TF. Results Patients included: 1259 (80.6%); patients excluded: 303 (19.4%) due to lack of data or lost to follow-up. Univariate analysis Patients with and without TF: 151 (12.0%) versus 1108 (88.0%), male (82.1% vs 80.1%, p = 0.587), age (42.9 vs 48.0 years, p + T cell count (526.0 vs 716.3 cells/µL, p HAART: non-nucleoside/nucleotide reverse transcriptase inhibitors (NNRTI) (35.8% vs 55.0%, p Adherence 90 (8.1%), p Goodness-of-fit: Hosmer and Lemershow test (p = 0.889). Discriminative ability: AUC 0.744 (95% 0.702 to 0.787), p Conclusion Risk factors related to treatment failure were younger age, alcohol or drug use, poor adherence and use of HAART not including an NNRTI. Despite advances in HIV treatment, poor adherence is still the most important factor for treatment failure and justifies the need for multidisciplinary management of these high risk patients. No conflict of interest.

Background Interferon free treatments (IFT) for chronic hepatitis C (CHC) consist of more feasible and better tolerated regimens that could help to improve adherence. Nevertheless, little is known about adherence to these treatments in clinical practice. Purpose To evaluate adherence to IFT in clinical practice and non-adherence risk factors. Material and methods Patients completing IFT for CHC in a tertiary hospital were included (December 2014 to September 2015). Baseline characteristics including concomitant medications were recorded. Adherence was calculated as a percentage from pill count records performed in each drug dispensing visit (every 4 weeks) and at the end of treatment. Ribavirin dose reductions were not considered as lack of adherence. Bivariate analysis of baseline characteristics in patients with and without 100% adherence was performed. Fisher’s test and the Mann-Whitney U test were used for categorical and continuous variables, respectively. Results 78 patients were included: median age was 59 years, 55 (70.5%) were male, 48 (61.5%) with genotype 1b, 15 (19.2%) with HIV coinfection, 53 (67.9%) with cirrhosis and 36 (46.2%) were naive. Mean number of concomitant drugs was 3.31 (SD 2.7). 69 (88.5%) patients received 12 weeks of treatment. No differences were found in demographics, genotype, HIV coinfection, previous antiviral treatment or number of concomitant medications between patients with and without 100% adherence. Conclusion Observed adherence rates to all IFT in clinical practice were superior to 90%. None of the analysed factors seemed to influence patient adherence, probably due to the low number of patients and the excellent rates of adherence observed. References and/or Acknowledgements Pawlotsky JM. EASL Recommendations on Treatment of Hepatitis C 2015. J Hepatol 2015 No conflict of interest.

Background Oral chemotherapy is increasingly used for cancer therapy but, without proper practices, creates safety and adherence issues. However, little is known on safety and adherence practices in wide clinical settings. Objective To assess the implementation level of safety and adherence practices in oral chemotherapy in Spanish hospitals. Setting All Pharmacy services from prescription, dispensation, patient education and monitoring hospitals that prescribe oral chemotherapy of Spain. Main outcome measure Level of safety practices regarding oral chemotherapy prescription, dispensation, patient education and adherence. Method An 11 multiple-choice-item questionnaire made in consensus with GEDEFO (Spanish Group of Oncology Pharmacists) was sent to all pharmacy services from hospitals that prescribe oral chemotherapy. This questionnaire comprised prescription, dispensation, education and monitoring. We arbitrarily defined three levels of practices: no sufficient specific practices were reported (we termed this as ‘level I’); performance of an initial visit with a pharmacist providing written patient educational materials and monitoring adherence (termed as ‘level II’); and level II requirements plus electronic chemotherapy ordering system and extra safety practices (termed as ‘level III’). Results Of the 169 targeted health-care settings, 86 (50.9 %) responded to the survey. The majority of responding hospitals were public, general, and teaching hospitals with more than 200 beds. Main discrepancies were in electronic prescription of oral chemotherapy and monitoring adherence. There were 32 hospitals (37.2 %) with level I of safety and adherence practices, 38 hospitals (44.2 %) accomplished level II, 16 (18.6 %) hospitals reached level III. No hospital variables were found to be correlated with each level of safety. Conclusions The majority of responding hospitals have safety and adherences practices for oral chemotherapy. However, the level of these practices varies. There are significant opportunities for improvement, particularly with regard to electronic prescription of oral chemotherapy and monitoring adherence.

• Two recent surveys on oral chemotherapy from Spain and France provide novel data in a European setting on this field. • Depending on the country, oral chemotherapy can be dispensed by community pharmacists or by hospital pharmacists, with notable differences in their involvement in the safety practices. • It is valuable to have a hospital pharmacist with experienced in oncology to be directly involved in the education also when an oral antineoplastic agent is dispensed to minimize potential errors, improve patient outcomes and compliance.

The purpose of this investigation was to compare the risk factors, clinical features and outcomes in cancer patients with bacteraemia caused by vancomycin-susceptible Enterococcus faecalis and E. faecium. A retrospective, observational 7-year study was carried out in a 450-bed, acute-care university-affiliated hospital. We performed univariate comparisons between the two groups and then multivariate analysis to identify patient risk factors for E. faecium isolation. Seventy-three patients were included in the analysis: 54 (74.0%) with bacteraemia caused by E. faecalis and 19 (26.0%) by E. faecium. The Simplified Acute Physiological Score (SAPS) value was significantly greater in E. faecium isolates (40.7 vs. 35.2; p = 0.009). Diabetes mellitus was more frequently diagnosed in patients with E. faecium bacteraemia (52.6% vs. 24.1%; p = 0.021). Prior penicillin exposure was more frequent in patients with E. faecium bacteraemia (68.4% vs. 29.6%; p = 0.003). There was a trend toward higher mortality in E. faecium bacteraemia patients (47.4% vs. 25.9%; p = 0.084). Independent patient risk factors for E. faecium isolation were prior penicillin exposure (odds ratio [OR], 6.479; p = 0.003) and SAPS > 34 (OR, 6.896; p = 0.009). When compared to E. faecalis bacteraemia, E. faecium bacteraemia in cancer patients is independently associated with more severe illness and prior use of penicillins; therefore, empiric treatment which would cover E. faecium should be considered in cancer patients suspected of having bacteraemia.

Enterococci are responsible for severe infections, such as endocarditis and bacteremia. During recent decades, enterococcal infections have grown in importance because of the increasing number of cases. Knowledge of the factors predisposing to acquisition of infection by E. faecalis or E. faecium may be useful to improve the empirical treatment.Retrospective study of patients diagnosed with enterococcal bacteremia and hospitalized over a 7-year period (January 2000-December 2006), analyzing demographic data, clinical and microbiological characteristics, antibiotic exposure, treatment, and outcome. To identify the predisposing factors for isolation of E. faecalis or E. faecium in a clinical specimen, we performed univariate comparisons between the 2 groups, and subsequently, multivariate logistic regression analysis.A total of 228 episodes of bacteremia were recorded, 168 caused by E. faecalis and 60 by E. faecium. All E. faecalis isolates were susceptible to ampicillin, but only 25% of E. faecium were ampicillin-susceptible. There was only 1 vancomycin-resistant isolate. The variables independently associated with acquisition of E. faecium bacteriemia were surgical ward admission (odds ratio [OR], 4.223; P=.001),5 days of previous treatment with cephalosporins (OR, 2.564; P=.013),5 days of carbapenems (OR, 2.652; P=.027), previous administration of penicillins (OR, 2.008; P=0.044), SAPS score30 at admission (OR, 3.530; P=0.001), and hepatobiliary disease as a comorbid condition (OR, 3.754; P0.001),Because of the differing susceptibility patterns of the enterococcal species studied, it is essential to know the factors predisposing to acquisition of infection by one or the other species to initiate adequate empirical treatment.

Background There has been a remarkable growth in approved oral anticancer agents (OAA) in recent years. This situation involves the pharmacist as a key part of the interdisciplinary team ensuring the safety and an adequate knowledge of the treatment with OAA. This may enhance compliance and reduce adverse events. A patient educational surgery was established by a team of a pharmacist and a nurse (PESPN). Purpose To describe the first PESPN patients. To compare the number of calls received by the continuing oncology care unit (COCU) before and after the establishment of PESPN. Materials and methods Prospective observational study from 2010 to present in a tertiary hospital. The authors included all patients initiating OAA. The information tools employed were validated leaflets about each drug, others leaflets related to symptoms management and personalised treatment calendars. Furthermore, The authors checked potential interactions between OAA and other concomitant treatment. Data collected: demographics, family support, KI (Karnofsky index), comorbidities, disease, staging, treatment type, information support, concomitant medicines, interactions prevented, number of phone calls received by the COCU. Results 34 patients. No. (%): women: 20 (60.6%); age (mean 66.5+/-15.2); family support 28 (84.8%); KI 90-100%: 28 (84.8%); comorbidities: 20 (60.6%); disease: breast 14 (42.4%), lung 9 (27.2%), CNS: 8 (24.2%), colon: 2 (6.1%); stageIV: 32(97.0%); metastatic: 23(69.7%), adjuvant: 10 (30.3%); indication for OAA: progression by imaging: 15 (45.5%), first-line treatment: 13 (39.4%), biochemical progression: 3 (9.1%), patient preference: 2 (6.1%), pathological progression: 1(3.0%); OAA: vinorelbine: 11(33.3%), capecitabine: 8 (24.2%), temozolomide: 8 (24.2%), topotecan: 3 (9.1%), erlotinib: 2(6.1%), gefitinib 1(3.0%); information tools: OAA leaflets: 31(93.9%), personalised calendar: 4(12.1%), others 3(9.1%); concomitant medicines: 32 (97.0%)(mean 3.8+/-2.2); complementary medicine: 2 (6.1%); total interactions: 6(18.2%); erlotinib-omeprazole:3(9.1%), erlotinib-acenocoumarol: 1(3.0%), capecitabine- acenocoumarol (3.0%), valproic-temozolomide: 1(3.0%). Phone-calls received by COCU: year 2009:1320 versus year 2010:1087 (17.7% reduction). Conclusions The typical patient profile was a woman with metastatic breast cancer initiating OAA after imaging progression. The treatment most dispensed was vinorelbine and the patients were given information leaflets specifically about the OAA. Almost all patients were on concomitant medicines and potential interactions were prevented. There was a significant reduction in the number of telephone inquiries received by COCU.

We assessed the adherence to the prescribing hospital protocol for tigecycline and factors associated with noncompliance. A total of 103 patients were included in the study. In 23 (22.3%) patients, tigecycline was not administered according to the protocol, mostly because of the availability of other therapeutic alternatives and prescription for indications that were not included in the guidelines. factors independently associated with nonadherence to the protocol were community-acquired infection (OR, 14.01; 95% CI, 1.54-127.12; P=0.019), and empirical tigecycline treatment (OR, 6.97; 95% CI, 0.88-55.40; P=0.066). penicillin allergy (OR, 0.004; 95% CI, 0.000-0.071; P=0.001) and previous antibiotic treatment (OR, 0.025; 95% CI, 0.003-0.233; P=0.001) were factors associated with adherence to the hospital protocol. A positive time trend between total number of prescriptions and non-compliant prescriptions with the protocol was observed (Spearman's rho coefficient 0.971; P=0.001). Adherence to tigecycline protocol could be improved by focusing on protocols for community-acquired infections, mainly skin and soft tissue infections.