Patient risk factors for developing a drug-related problem in a cardiology ward.

BACKGROUND: Because of the high incidence of drug-related problems (DRPs) among hospitalized patients with cardiovascular diseases and their potential impact on morbidity and mortality, it is important to identify the most susceptible patients, who therefore require closer monitoring of drug therapy. PURPOSE: To identify the profile of patients at higher risk of developing at least one DRP during hospitalization in a cardiology ward. METHOD: We consecutively included all patients hospitalized in the cardiology ward of a teaching hospital in 2009. DRPs were identified through a computerized warning system designed by the pharmacy department and integrated into the electronic medical record. RESULTS: A total of 964 admissions were included, and at least one DRP was detected in 29.8%. The variables associated with a higher risk of these events were polypharmacy (odds ratio [OR]=1.228; 95% confidence interval [CI]=1.153-1.308), female sex (OR=1.496; 95% CI=1.026-2.180), and first admission (OR=1.494; 95% CI=1.005-2.221). CONCLUSION: Monitoring patients through a computerized warning system allowed the detection of at least one DRP in one-third of the patients. Knowledge of the risk factors for developing these problems in patients admitted to hospital for cardiovascular problems helps in identifying the most susceptible patients.

An overview of randomized clinical trials in metastatic breast cancer: variables affecting regulatory drug approval.

The aim of this study was to analyse trial variables affecting drug approval in metastatic breast cancer (MBC). A literature search from 2000 to 2012 retrieved 66 phase III randomized controlled trials with reported primary endpoints in MBC and known outcomes in terms of approval. The influence of the primary endpoint, the line of therapy, crossover and the sample size was analysed. The primary endpoints used most frequently were progression-free survival (PFS) and time to progression or time to treatment failure (N=47; 71%). Overall survival (OS) was a primary endpoint in nine trials (14%). In 26 trials (39%), statistically significant results were found with respect to the primary endpoint, and in 13 trials (20%), this was found with respect to the secondary endpoint. Gains in OS were found in 12 trials (18%), whereas a benefit to PFS was found in 30 trials (46%). The average median OS was 23.1 months. Postprogression survival accounted for 64% of OS. Trials with crossover did not have OS as the primary endpoint. Trials that resulted in drug approval had a more pronounced gain in OS or PFS and had more patients than those without regulatory consequences. PFS was the main primary endpoint in randomized clinical trials in MBC and was significantly associated with drug approval. OS benefit was rarely achieved in trials where this was not the primary endpoint. The number of randomized patients, the primary endpoint and crossover are factors linked to regulatory requirements for approval, which should be considered in future trial designs.

Survey of oral chemotherapy safety and adherence practices of hospitals in Spain.

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.

A multidisciplinary support programme increases the efficiency of pegylated interferon alfa-2a and ribavirin in hepatitis C.

BACKGROUND & AIMS: Adherence to antiviral treatment is important to achieve sustained virological response (SVR) in chronic hepatitis C (CHC). We evaluated the efficiency of a multidisciplinary support programme (MSP), based on published HIV treatment experience, to increase patient adherence and the efficacy of pegylated interferon alfa-2a and ribavirin in CHC. METHODS: 447 patients receiving antiviral treatment were distributed into 3 groups: control group (2003-2004, n=147), MSP group (2005-2006, n=131), and MSP-validation group (2007-2009, n=169). The MSP group included two hepatologists, two nurses, one pharmacist, one psychologist, one administrative assistant, and one psychiatrist. Cost-effectiveness analysis was performed using a Markov model. RESULTS: Adherence and SVR rates were higher in the MSP (94.6% and 77.1%) and MSP-validation (91.7% and 74.6%) groups compared to controls (78.9% and 61.9%) (p<0.05 in all cases). SVR was higher in genotypes 1 or 4 followed by the MSP group vs. controls (67.7% vs. 48.9%, p=0.02) compared with genotypes 2 or 3 (87.7% vs. 81.4%, p=n.s.). The MSP was the main predictive factor of SVR in patients with genotype 1. The rate of adherence in patients with psychiatric disorders was higher in the MSP groups (n=95, 90.5%) compared to controls (n=28, 75.7%) (p=0.02). The cost per patient was € 13,319 in the MSP group and € 16,184 in the control group. The MSP group achieved more quality-adjusted life years (QALYs) (16.317 QALYs) than controls (15.814 QALYs) and was dominant in all genotypes. CONCLUSIONS: MSP improves patient compliance and increases the efficiency of antiviral treatment in CHC, being cost-effective.

Potential role of tedizolid phosphate in the treatment of acute bacterial skin infections.

Tedizolid phosphate (TR-701), a prodrug of tedizolid (TR-700), is a next-generation oxazolidinone that has shown favorable results in the treatment of acute bacterial skin and skin-structure infections in its first Phase III clinical trial. Tedizolid has high bioavailability, penetration, and tissue distribution when administered orally or intravenously. The activity of tedizolid was greater than linezolid against strains of Staphylococcus spp., Streptococcus spp., and Enterococcus spp. in vitro studies, including strains resistant to linezolid and those not susceptible to vancomycin or daptomycin. Its pharmacokinetic characteristics allow for a once-daily administration that leads to a more predictable efficacy and safety profile than those of linezolid. No hematological adverse effects have been reported associated with tedizolid when used at the therapeutic dose of 200 mg in Phase I, II, or III clinical trials of up to 3 weeks of tedizolid administration. Given that the clinical and microbiological efficacy are similar for the 200, 300, and 400 mg doses, the lowest effective dose of 200 mg once daily for 6 days was selected for Phase III studies in acute bacterial skin and skin-structure infections, providing a safe dosing regimen with low potential for development of myelosuppression. Unlike linezolid, tedizolid does not inhibit monoamine oxidase in vivo, therefore interactions with adrenergic, dopaminergic, and serotonergic drugs are not to be expected. In conclusion, tedizolid is a novel antibiotic with potent activity against Gram-positive microorganisms responsible for skin and soft tissue infections, including strains resistant to vancomycin, linezolid, and daptomycin, thus answers a growing therapeutic need.

Tumores malignos de células germinales: estudio clínico patológico de cinco casos / Malignant germ cell tumors: clinical and pathological study of 5 cases

Se presenta una serie de cinco casos de tumores malignos de células germinales diagnosticados en el Servicio de Anatomía Patológica del Hospital "Miguel Pérez Carreño", IVSS, Caracas, Venezuela, entre enero de 1992 y junio de 1993, con los principales hallazgos clínicos-patológicos. Tres de estos casos fueron tumores mixtos: dos con predominio de saco vitelino, uno de ellos asociado a un carcinoma embrionaro del testiculo y el segundo a un teratoma ovarico; el tercer caso constituido por un disgerminoma mas un teratoma. Se presentan además un caso de disgerminoma puro y un teratoma quistico benigno de ovario con transformación maligna. Se revisa la literatura al respecto

Aneurisma disecante de la aorta: estudio anatomopatologico de treinta casos / Dissecting aneurysm of the aorta: an anatomopathological study of 36 cases

Se efectuó el estudio Anatomo-Patológico de una serie de 30 casos de aneurisma disecante de la aorta, autopsiados en el Instituto de Anatomía Patológica, provenientes del Hospital Universitario de Caracas. Se establecieron algunas comparaciones con otras casuísticas respecto a la frecuencia, edad, sexo, antecedentes, asociaciones patológicas y complicaciones. Se revisó la literatura sobre el tema y terminología actual, clasificación y etiopatogenia

Cáncer del colon en la infancia: presentación de dos casos / Cancer of the colon in childhood: report of 2 cases

Se presentan los hallazgos clínico-patológicos de dos casos de adenocarcinoma de tipo mucinoso, en dos niños. En uno de los casos la evolución ha sido satisfactoria, encontrándose aparentemente libre de la enfermedad, luego de 18 meses de haber sido intervenido. En el otro caso no se tienen datos de su evolución actual. Se revisa la literatura tomando en cuenta las diferentes series de casos registrados en las tres primeras décadas de la vida y se coincide en la baja incidencia de esta neoplasia en niños y adolescentes. Se hacen algunas consideraciones respecto a la clínica, factores epidemiológicos, anatomía-patológica, pronóstico y tratamiento