The year in cardiology 2014: peripheral circulation.

In 2014, the debate on the indication of revascularization in case of asymptomatic carotid disease continued, while another one regarding the use of surgery vs. stenting addressed some new issues regarding the long-term cardiac risk of these patients. Renal arteries interventions trials were disappointing, as neither renal denervation nor renal artery stenting was found associated with better blood pressure management or outcome. In contrast, in lower-extremities artery disease, the endovascular techniques represent in 2014 major alternatives to surgery, even in distal arteries, with new insights regarding the interest of drug-eluting balloons. Regarding the aorta, the ESC published its first guidelines document on the entire vessel, emphasizing on the role of every cardiologist for screening abdominal aorta aneurysm during echocardiography. Among vascular wall biomarkers, the aorta stiffness is of increasing interest with new data and meta-analysis confirming its ability to stratify risk, whereas carotid intima-media thickness showed poor performances in terms of reclassifying patients into risk categories beyond risk scores. Regarding the veins, new data suggest the interest of D-dimers and residual venous thrombosis to help the decision of anti-coagulation prolongation or discontinuation after the initial period of treatment for deep vein thrombosis.

Odanacatib, a selective cathepsin K inhibitor to treat osteoporosis: safety, tolerability, pharmacokinetics and pharmacodynamics--results from single oral dose studies in healthy volunteers.

AIMS: To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of odanacatib (ODN), a cathepsin K inhibitor, in humans. METHODS: Two double-blind, randomized, placebo-controlled, single oral dose studies were performed with ODN (2-600 mg) in 44 healthy volunteers (36 men and eight postmenopausal women). RESULTS: Adverse experiences (AEs) with single doses of ODN were transient and mild to moderate, with the exception of one severe AE of gastroenteritis. Headache was the most frequent AE. After absorption of ODN (initial peak concentrations 4-6 h postdose), plasma concentrations exhibited a monophasic decline, with an apparent terminal half-life of ∼40-80 h. The area under the curve0-24 hours (AUC(0-24 h)), concentration at 24 hours (C(24 h)) and maximum concentration (C(max,overal)) increased in a less than dose-proportional manner from 2 to 600 mg. Administration of ODN with a high-fat meal led to ∼100% increases in AUC(0-24 h), C(max,day1), C(max,overall) and C(24 h) relative to the fasted state, while administration with a low-fat meal led to a ∼30% increase in those parameters. Reduction of biomarkers of bone resorption, the C- and N-telopeptides of cross-links of type I collagen, (CTx and NTx, respectively), was noted at 24 h for doses ≥5 mg and at 168 h postdose for ≥10 mg. In postmenopausal women administered 50 mg ODN, reductions in serum CTx of -66% and urine NTx/creatinine (uNTx/Cr) of -51% relative to placebo were observed at 24 h. At 168 h, reductions in serum CTx (-70%) and uNTx/Cr (-78%) were observed relative to baseline. Pharmacokinetic/pharmacodynamic modeling characterized the ODN concentration/uNTx/Cr relation, with a modeled EC50 value of 43.8 nM and ∼80% maximal reduction. CONCLUSIONS: Odanacatib was well tolerated and has a pharmacokinetic and pharmacodynamic profile suitable for once weekly dosing.

Barriers for nurses to safe medication management in nursing homes.

PURPOSE: This study aims to identify and compare the relevance of barriers that nurses in nursing homes experience in medication management in Belgium. DESIGN: The mixed-method study started with an expert meeting in November 2008 and was followed by a cross-sectional survey in February-March 2009, questioning 246 nurses and 270 nurse assistants in 20 nursing homes. METHODS: Twelve nurses represented nursing homes in an expert meeting and listed all barriers that might cause suboptimal medication management. Based on the results, a survey was developed in which respondents could indicate whether they were involved in a particular stage of the medication process and if yes, rate the relevance of the barriers in that stage on a continuous scale, varying from 1 =no barrier to 10 =strong barrier. Barriers scored 7 or more were defined as strong. FINDINGS: Nurses experienced a large number of barriers to safe medication management related to the nurse, organization, interdisciplinary cooperation, or to the patient and family. In preparing medication, medication administration and monitoring, being interrupted, not knowing enough on interactions, and barriers in interdisciplinary cooperation caused the most hindrance. In general, barriers in medication monitoring scored the strongest. CONCLUSIONS: In order to improve safe medication management by tailored interventions in nursing homes, through the use of a standard questionnaire, nurses and nurse assistants can give an overview of barriers they experience and rate their relevance. Nurses and nurse assistants had different opinions on the relevance of barriers, especially in the stage of medication monitoring. Job expectations in medication management were not always clear, creating additional barriers in medication safety. CLINICAL RELEVANCE: This study provides an overview of potential barriers to safe medication management in nursing homes, which can be addressed in practice. The relevance scoring of the barriers enables prioritization.

Nurses' practices in pharmacotherapy and their association with educational level.

AIM: This paper is a report of a study of the association between educational level and nurses' practices in pharmacotherapeutic activities in three clinical settings. BACKGROUND: The preparation and administration of medication are at the core of nursing practice, and nurses' involvement in pharmacotherapy is essential to medication safety. Nursing strategies to improve patient adherence to treatment and to identify adverse drug reactions have been described, but nurses' practice patterns in monitoring adherence and adverse drug reactions remain undocumented. METHODS: A cross-sectional correlational survey design was used. Data were collected between 2005 and 2007. Each year, the focus was on a different setting. Nurses were selected by convenience sampling: 260 worked in nursing homes, 82 in community care services and 1070 in hospitals. Questions focused on the provision of medication information, observation of patient medication adherence and identification of adverse drug reactions during the preceding month. RESULTS: Involvement in providing drug information varied considerably, from 50% among hospital nurses to 82% among nurses in community care services. Statistically significantly fewer nurses observed non-adherence in hospitals (50%) than in the other settings (about 80%). Between 40% and 49% of the nurses had observed an adverse drug reaction. Nurses' information-seeking behaviour and problem responses also varied according to setting. Bachelor's degree holders were 35% more likely than diploma holders to have observed an adverse drug reaction. CONCLUSION: Nurses assume considerable pharmacotherapeutic responsibilities. Practice patterns are codetermined by the healthcare setting and nurses' educational level.

The development and test of an intervention to improve ADR screening in nursing homes.

OBJECTIVES: The aim of this study was to develop and test the effect of an instrument, Pharmanurse, to facilitate nurse-driven adverse drug reaction (ADR) screening as an input for interdisciplinary medication review in nursing homes. DESIGN: Intervention study with a pre-posttest design PARTICIPANTS: All residents of a convenience sample of 8 nursing homes of more than 80 beds were eligible if they resided at least 1 month in the nursing home and took 4 or more different medications. Residents receiving palliative care were excluded. INTERVENTION: The intervention consisted of interdisciplinary medication review, prepared by nurse observations of potential ADRs using personalized screening lists generated by the Pharmanurse software. Pharmanurse is specifically adapted to use by nurses and to use in nursing homes. MEASUREMENTS: Outcome parameters were the number of ADRs detected by nurses, ADRs confirmed by general practitioners, and medication changes. After the intervention, health care professionals involved completed a questionnaire to evaluate the value and the feasibility of the intervention. RESULTS: Nurses observed 1527 potential ADRs in 81% of the 418 residents (mean per resident 3.7). Physicians confirmed 821 ADRs in 60% of the residents (mean per resident 2.0). As a result, 214 medication changes were planned in 21% of the residents (mean per resident 0.5) because of ADRs. Health care professionals gave the Pharmanurse intervention a score of 7 of 10 for the potential to improve pharmacotherapy and 83% of the physicians were satisfied about nurses' screening for ADRs. CONCLUSIONS: The Pharmanurse intervention supports nurses in ADR screening and may have the potential to improve pharmacotherapy.

Nursing students' pharmacological knowledge and calculation skills: ready for practice?

OBJECTIVES: To evaluate graduating students' pharmacological knowledge and calculation skills and describe their self-rated readiness to safe medication care in practice on two nurse educational levels. Additionally, the study describes some characteristics of pharmacology in nurse education in Flanders, Belgium. METHODS: Thirty-eight nursing schools (bachelor's degree in nursing [N=18] and diploma in nursing [N=20]) were asked to provide details on their pharmacology curriculum and to let their graduating students participate in a cross-sectional survey using the Medication Knowledge and Calculation test in February/March 2009. RESULTS: The 29 participating schools showed a large diversity in pharmacology curricula. Mean scores on the pharmacology section and calculation section were 55% and 66%, respectively, for bachelor's degree and 52% and 53% for diploma students. On a scale of 1-10, 27% had a self-rated readiness perception≤5. Results differed significantly between schools. CONCLUSIONS: Just before graduation, nursing students' pharmacological knowledge and calculation skills are limited. Apart from the test results, students did not perceive themselves able to deliver safe medication care in practice. Schools need to address the shortcomings. In practice, awareness is needed regarding possible limitations of the newly graduated.

A pilot study evaluating the safety of vaginal administration of a multi-particulate pellet formulation.

AIM: Quantitative evaluation of the effect caused by vaginal administration of gelatin capsules loaded with starch pellets and lyophilized powder, respectively, on vaginal pH and microflora. METHOD: Administration of gelatin capsules loaded with fast-disintegrating starch pellets (group P) or lyophilized lactose/skimmed milk (group L) was compared to no intervention (group C) in a 3-way randomized, double-blinded, parallel study with 18 volunteers. Follow-up visits were at day 6 (immediately after administration), day 14 (pill stop), day 22 (after withdrawal bleeding) and day 35 (midcycle). Vaginal pH was measured and swabs were taken for Gram staining and culture to assess the presence of hydrogen peroxide-producing lactobacilli. Colposcopy was performed to assess the occurrence of adverse effects on the vaginal and ectocervical mucosa. RESULTS: No severe adverse events occurred. For all women, vaginal pH and Gram stain were normal from screening until pill stop. Although immediately after withdrawal bleeding, 8 out of 18 women had an elevated pH, a disturbed microflora or lacked hydrogen peroxide-producing lactobacilli, all women had hydrogen peroxide-producing lactobacilli and a normal vaginal pH at midcycle, and all but two had a normal Gram stain. CONCLUSION: No major differences could be observed between the groups, whereby all changes in pH and microflora could be ascribed to withdrawal bleeding, indicating that gelatin capsules, starch pellets and lyophilized powder are acceptable carrier materials for the vaginal delivery of probiotic strains.