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BackgroundIn the pivotal authorisation trial of carfilzomib, patients with severe cardiovascular abnormalities (NYHA III or IV), clinically significant and uncontrolled, were not included.PurposeThe aim of this study was to analyse the cardiovascular events (CVAE) associated with carfilzomib in patients in whom an electrocardiogram was performed prior to starting treatment and compare these data with those of the pivotal trial.Material and methodsRetrospective observational study in which all patients treated with carfilzomib were included. The data obtained from the electronic medical record were: age and comorbidities at diagnosis, schemes used prior to carfilzomib, dose of carfilzomib and development of CVAE after the use of carfilzomib.ResultsThirty-six patients (19 males) with a median age 59 years (RIQ 53–67) were included. Seventy-eight per cent had comorbidities at the time of diagnosis, the most frequent being arterial hypertension (HTA) (16), followed by diabetes mellitus and dyslipaemia (seven in both). The average of previous regimens was one (30), with VCD (bortezomib, cyclophosphamide and dexamethasone) in 28 patients. In 34 patients the scheme used was KRD (carfilzomib, lenalidomide and dexamethasone) at a dose of 27 mg/m2. In two patients the dose was reduced due to adverse effects (hepatotoxicity and nonspecific toxicity).The incidence of all grades CVAE was 19.4% (three congestive heart failure, two paroxysmal atrial fibrillation, and one transient ischaemia and new onset HTA). Of all of them, 71% presented as comorbidity to the diagnosis of hypertension. Median age of patients was 65 years (RIQ 65–76). Two patients discontinued the treatment, three patients required modification of the diuretic treatment and in one patient the infusion time of carfilzomib was modified.ConclusionAs in the ASPIRE study, patients are referred to the cardiology service prior to starting treatment and the expected results are similar (19.4% vs 22.3% in ASPIRE). The most vulnerable patients of developing CVE were those over 65 years of age, since they present more comorbidities pre-treatment. However, it should be mentioned that myeloma itself, or the corticosteroids, can also contribute to cardiovascular deterioration.References and/or acknowledgementsStewart AK, Rajkumar SV, Kimopoulos MA, et al; ASPIRE Investigators. Carfilzomib, lenalidomide, and dexamethasone for relapsed multiple myeloma. N Engl J Med 2015;372:142–52.No conflict of interest.

Background Malnutrition among hospital inpatients is very high (30-50%). It has important consequences in patients' clinical course and in hospitalisation costs so early detection and establishment of corrective action is crucial. Vitamin D deficiency is also common in the older, and leads to decreased bone mass and increased fractures and healthcare costs. Purpose Evaluate the nutritional status and vitamin D levels in an older medical unit. Evaluate whether corrective actions such as nutritional supplements or vitamin D prescription were established. Materials and methods Nutritional status was assessed in 50 randomly selected patients using CONUT (COntrol NUTritional) system, a validated tool that determines nutritional status according to serum albumin, cholesterol and lymphocytes. 25-OH vitamin D levels (deficiency <12 ng/mL; insufficiency 12-30 ng/mL; normal 30-80 ng/mL) were also measured. Prescription of nutritional or vitamin D supplements was registered. Results Medium age was 78.8 years. 22 were male and 28 female. Prevalence of malnutrition was very high (68%): It was mild in 19 patients (38%), moderate in 13 (26%) and serious in 2 (4%). Nutritional supplements were prescribed to just 6 patients (17,6%) with malnutrition. Forty-six patients (92%) had vitamin D levels below recommendations: 15 (30%) had vitamin D insufficiency (mean= 17.8; range 12.1-25.8 ng/mL) and 31 (62%) had deficiency (mean= 7.5; range 3-11.4 ng/mL). Calcium + vitamin D supplements were prescribed in eight (17.4%) patients with insufficiency or deficiency, three (7%) prescribed before admission and five (10.9%) during admission. Conclusions Due to the high prevalence of malnutrition and hypovitaminosis D in the older, it would be advisable to establish a nutritional screening system and to measure vitamin D levels at admission, so that corrective action such as prescription of vitamin D or nutritional supplements prescription can be established. In addition, general practitioners should continue monitoring malnutrition and vitamin D after patients are discharged.

BackgroundA drug adjustment programme for patients with renal disease was started in 2013 in our hospital.In this system, information from the electronic prescription programme is linked (using an Access application) with information sent by the laboratory (creatinine) and with a list of drugs that may require renal adjustment. Afterwards, an adjustment warning for the physician is added to the electronic prescription programme.PurposeTo assess the acceptance by the physicians of pharmaceutical interventions in drug dosing in renal disease.Material and methodsThis prospective descriptive study was conducted in a tertiary university hospital with 1,200 beds. The study period was 39 days (from January 21st to March 20th, 2014).The pharmaceutical interventions were recorded during daily practice.The following data were collected: date of pharmaceutical intervention, clinical chart number, medical service, age, sex, creatinine, glomerular filtration rate, adjusted drug, adjustment warning.Finally, the degree of acceptance of these interventions by the physicians was reviewed.ResultsDuring the study period, 153 patients (mean age 75.3 years, 78 male and 75 female) were included and 271 renal adjustment interventions were performed (mean: 7 interventions per day).The degree of acceptance of the interventions was: accepted 84 (31.0%), partially accepted 25 (9.2%), not assessable 49 (18.1%), not accepted 112 (41.3%) and other (not an appropriate intervention) 1 (0.4%). Excluding not assessable and inappropriate interventions (finally 221 interventions), the result was: accepted 84 (38.0%), partially accepted 25 (11.3%) and not accepted 112 (50.7%).ConclusionThe acceptance of pharmaceutical interventions by the physicians is approximately 40%, which is relatively low. One of the reasons of this low acceptance could be the location of the adjustment warning.Finally, it is necessary to consider what could be done to improve the acceptance of this type of pharmaceutical interventions.References and/or AcknowledgementsNo conflict of interest.

Background It is necessary to monitor the effect of erythropoietin (EPO) on haemoglobin (Hb) levels to check the efficacy and safety of the medicine. The desirable therapeutic range of Hb according to the product information is from 10 to 12 g/dl and higher or lower levels can damage health. The tolerance, clinical need and urgency required in the resolution of the anaemia varies among patients, however, Hb ≥13 g/dl is associated with cardiovascular events such as thromboembolism, requiring urgent care. Purpose To determine the proportion of patients with anaemia linked to chronic renal failure in predialysis treated with EPO, with a value of Hb within or outside (lower or higher than) the therapeutic range. Materials and methods A retrospective study was performed of 155 nephrology patients who collect erythropoietin at the outpatient unit of the hospital pharmacy; duration 1 month. All of them had anaemia associated with chronic renal failure in predialysis and were treated with subcutaneous erythropoietin for at least 4 weeks. The outpatient dispensing program compiles items dispensed per patient, with dates, age, sex, medical record number, diagnosis, amount collected, dosage, department/ward and prescribing physician The last Hb value was obtained for the computerised medical history records and the proportion of patients below and above the therapeutic range was estimated. Results 139 patients, 61 women (43.9%) and 78 men (56.1%), between 21 and 101 years (mean 68.6). 48.9% (68) of the patients had an Hb within the therapeutic range (mean 11). 22.3% (31) had Hb less than 10 g/dl (mean 9.2 and minimum 6) while in 28.8% (40) it was greater than 12 (mean 13.2 and maximum 15.4). Conclusions 71 patients (51%) had Hb outside the therapeutic range. It is necessary to monitor the haemoglobin levels to check the safety and efficacy of erythropoietin. It is essential to include all episodes and data in the computerised medical history.

Background Inhaled antibiotics are increasingly used in patients with non-cystic fibrosis bronchiectasis as off-label treatment, without quantifiable effectiveness. Patients’perspective is an important part of healthcare quality. Due to internal procedures the pharmacy service supervises off-label treatments. Purpose To explore in a group of patients suffering from bronchiectasis, their perception of their last year and their current health status. Materials and methods Prospective study based on a survey given to patients treated with inhaled colistimethate for last year at least. Surveys were delivered between October 2012 and June 2013 containing 10 items about their current health status and the perceived changes in their physical and mental health during last year. A four-point scale was used for all questions (1 = never/poor health; 2 = sometimes/regular health; 3 = usually/good health; 4 = always/very good health). Colistimethate was dispensed once a month at the pharmacy service and the procedure for completing the survey was explained by a clinical pharmacist. The questionnaire could be completed by the patient himself or by a caregiver. Results 97 questionnaires were delivered, 67 (69%) were returned: 40 (41%) were useful and 27 weren’t completely filled in. Mean age was 72 years (32–93). 82.5% of patients referred to having bad or moderate health, however 52% believed their health was better than the previous year. During the last year 48% of patients had to reduce the working time (always) and 78% had less activity than desired (always) while 43% never or sometimes had difficulty performing certain activities. 72% had a perception of bad or very bad health, and almost all (95%) believed that their health was going to get worse. Relating to mental health 93% felt calm and quiet and only 40% never had moments of discouragement or depression. Conclusions It’s difficult to measure health benefits in chronic degenerative diseases. Despite their situation half of our patients believed their health had improved during last year. No conflict of interest.

BackgroundPercutaneous radiologic gastrostomy (PRG) consists of inserting a long-term catheter in the gastric cavity through the anterior abdominal wall. The catheter is replaced every 6 months (180 days). However, it can often require a replacement in advance due to obstruction or bad management of the catheter.PurposeTo analyse the most common causes of PRG replacement and its frequency.Material and methodsAn observational retrospective study was conducted. All patients with PRG were included. Also analysed was PRG indication, number of replacements and its causes, the average duration of catheter placement and the reason of removing it. All the data havw been collected from electronic medical records and have been processed through the Stata statistics program.ResultsA total number of 63 patients that had a 16 Fr catheter in place were included; 42 were males and 21 females with a mean age of 65.5±11.8. The median follow-up was 113 days. PRG indications were: 46% (29) head and neck tumour, 17.5% (11) amyotrophic lateral sclerosis (ALS), 16% (10) cerebrovascular accident, 1.5% (one) dementia and 19% (12) others.Ninety-four catheters were replaced, from which 79% (74) were not programmed due to: 34% (32) catheter came out, 17% (16) broken catheter, 9.5% (nine) medicines obstruction, 5.5% (five) obstruction due to liquid diet, 3.5% (three) leak, 1% (one) infected stoma and 8.5% (eight) others. The average duration of PRG before being replaced was 205±190 days in those patients that were programmed, whereas 78±66 days in those non-programmed.The average duration for a gastrostomy was 170 days. Results vary depending on the pathology: 263±164 days for ALS, 173±179 days for head and neck tumour and 134±123 days for cerebrovascular accidents.In 52 patients the catheter was removed, due to recovery (32%) or death (68%).ConclusionOnly one-fifth of the catheter replacements were programmed. The most common causes were because they came out or they were broken. In order to prevent these complications it is necessary to develop standard operational procedures and patient information leaflets on catheter management by a multidisciplinary team including nursing, medical and pharmacy staff.

BackgroundCalcinosis cutis is caused by accumulation of calcium salts in the tissues, with subcutaneous nodules, atrophy and ulceration over the affected area. The therapeutic approach is not clearly established, particularly in neonates.PurposeTo treat calcinosis cutis in a topical non-invasive way in two premature neonates and to describe their clinical evolution.Developing a standard operating procedure (SOP) for compounding a 10% sodium thiosulfate W/O topical cream.Material and methodsA systematic bibliographic search for available therapeutic options was made. An article by Pérez-Moreno et al.1 was found, describing the elaboration procedure of a 10% sodium thiosulfate W/O cream and its use in a 6-year-old child with calcinosis cutis. However, no evidence was found regarding topical treatment of calcinosis cutis in neonates.Risks and benefits of using the topical formula in premature neonates were assessed: excipients were found to be suitable and the risk of incremented absorption was considered acceptable.It was decided to reproduce the formula for its use in two cases of IV calcium extravasation (confirmed by echography and clinical signs) in two premature neonates (born at 31 and 34 weeks).Modus operandi consisted of:Dissolving 10 g of pentahydrated sodium thiosulfate in 10 mL of distilled water.Adding it to the external oil phase (a commercial cold cream (COLDBASE) was used qs 100 g).Mixing it until an homogeneous W/O emulsion was obtained.ResultsThe elaboration process was simple, and the resultant cream homogeneous and with suitable organoleptic characteristics.Clinical evolution was satisfactory in both patients, gradually reducing visible injuries, subcutaneous calcifications, induration and swelling. Both patients regained arm mobility completely.ConclusionTreatment of calcinosis cutis with topical sodium thiosulfate was safe and effective in both patients. The clinical benefit in premature patients was thereby confirmed in these cases.References and/or AcknowledgementsPérez-Moreno MA, Álvarez del Vayo-Benito C, Flores-Moreno S, et al. Calcinosis cutánea grave tratada exitosamente con una fórmula magistral tópica W/O de tiosulfato sódico al 10%. Acta Pediatr Esp 2014;72:e9-10No conflict of interest.

BackgroundIn our hospital, prescription, assessment and complication management of patients with tube feeding by enteral nutrition (EN) is made by a hospital pharmacist, who systematically monitors patients with EN.PurposeTo describe the role of a hospital pharmacist monitoring patients with EN via different types of enteral tubes and to analyse the interventions made.Material and methodsAll patients (except those from the intensive care unit) were evaluated from 1 January to 31 July 2015. Data were obtained from the pharmacist´s nutritional records.Results49 patients, 65% men, median age 66 years (45–84), were evaluated.Diagnoses were: 11 laryngeal (22%), 7 oesophageal (14%), 7 oral (14%), 3 pharynx (6%), 2 jaw (4%) and 1 mediastinal cancer (2%), 4 swallowing disorders (8%), 3 amyotrophic lateral sclerosis (6%), 3 chylothorax (6%), 3 stroke (6%), 1 acute pancreatitis (2%), 1 pharyngocutaneous fistula (2%), 1 parapharyngeal abscess (2%), 1 intestinal (2%) and 1 oesophageal perforation (2%).Enteral access were: 20 gastrostomy (41%), 19 nasogastric tube (NGT) (39%), 3 nasojejunal tube (NYT) (6%), 3 oral (6%), 1 gastrojejunostomy (2%), 2 NGT followed by gastrostomy (4%) and 1 NGT followed by NYT (2%).The administration method used was: intermittent administration exclusively in 28 (57%); continuous tube feeding infusion exclusively in 8 (16%); in 9 (18%) intermittent was changed to continuous because of diarrhoea. 4 (8%) started continuous infusion because of tolerance problems and changed to intermittent after achieving good tolerance. Among patients with continuous infusion, EN was cyclically administered in 62%.Mean duration, volume and energy intake per day were: gastrostomy (10 days, 1462 mL, 1729 kcal); NGT (15, 1539, 1804); NYT (19, 2150, 2163); oral (7, 1583, 1583); and gastrojejunostomy (39, 750, 750).3 (6%) required oligopeptidic EN because of diarrhoea.25 (51%) had complications: diarrhoea 14 (29%), fullness 3 (6%), nausea 2 (4%), hyperglycaemia 2 (4%), tube output 2 (4%), aspiration 1 (2%) and obstruction 1 (2%).ConclusionMost patients were oncologic with gastrostomy. Diarrhoea was the most common complication. It was managed by changing the administration method and EN type. Knowledge of the pharmacist about nutrition, industry prepared EN composition and management of complications improved, especially for oncologic patients with gastrostomy.No conflict of interest.

BackgroundNew oral anticoagulants are an alternative to acenocoumarol in the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation.PurposeTo assess the suitability of prescriptions for new oral anticoagulants for those diagnoses, in accordance with criteria established by the health organisation and to analyse pharmaceutical interventions.Material and methodsA prospective, observational and cross-sectional study of all patients admitted to our hospital who were prescribed dabigatran, rivaroxaban or apixaban from 01/02/2014 to 31/08/2014. Electronic medical records and electronic medical prescriptions were used as data sources. Demographics (age, gender), reason for admission, indication for anticoagulation, risk factors for complications such as renal and hepatic failure, concomitant drugs that increase the risk of bleeding (NSAIDs, platelet inhibitors, low molecular weight heparins) and adverse events were collected. In addition, adverse drug-related events avoided were also recorded.Results64 patients (36 men) with mean age of 76 years (range 35–95) were included. 24 patients were treated with dabigatran, 38 with rivaroxaban and 2 with apixaban. 4 of these treatments were used as off-label treatments.8 patients had renal failure and 23 had a risk of major bleeding due to concomitant treatments, mainly NSAIDs. Pharmaceutical interventions were performed in the 8 cases of renal failure because the doses needed adjustment. 14 patients with concomitant drugs that could increase the risk of bleeding were also monitored. 100% of recommendations were accepted by physicians.2 severe adverse events were recorded: 2 bleeding episodes.Conclusion94% of new oral anticoagulant prescriptions met the criteria established by the healthcare organisation. Pharmacists were involved in the optimisation of a third of the treatments, with total acceptance. It would be desirable to extend this activity, individualization of anticoagulant treatment, into primary medical care.ReferenceAgencia Española de Medicamentos y Productos Sanitarios. Informe de posicionamiento Terapéutico UT/V4/23122013No conflict of interest.

Bovine herpesvirus 4 (BoHV-4) is increasingly considered as responsible for various problems of the reproductive tract. The virus infects mainly blood mononuclear cells and displays specific tropism for vascular endothelia, reproductive and fetal tissues. Epidemiological studies suggest its impact on reproductive performance, and its presence in various sites in the reproductive tract highlights its potential transmission in transfer-stage embryos. This work describes the biological and genetic characterization of BoHV-4 strains isolated from an in vitro bovine embryo production system. BoHV-4 strains were isolated in 2011 and 2013 from granulosa cells and bovine oocytes from ovary batches collected at a local abattoir, used as \"starting material\" for in vitro production of bovine embryos. Compatible BoHV-4-CPE was observed in the co-culture of granulosa cells and oocytes with MDBK cells. The identity of the isolates was confirmed by PCR assays targeting three ORFs of the viral genome. The phylogenetic analyses of the strains suggest that they were evolutionary unlinked. Therefore it is possible that BoHV-4 ovary infections occurred regularly along the evolution of the virus, at least in Argentina, which can have implications in the systems of in vitro embryo production. Thus, although BoHV-4 does not appear to be a frequent risk factor for in vitro embryo production, data are still limited. This study reveals the potential of BoHV-4 transmission via embryo transfer. Moreover, the high variability among the BoHV-4 strains isolated from aborted cows in Argentina highlights the importance of further research on the role of this virus as an agent with the potential to cause reproductive disease in cattle. The genetic characterization of the isolated strains provides data to better understand the pathogenesis of BoHV-4 infections. Furthermore, it will lead to fundamental insights into the molecular aspects of the virus and the means by which these strains circulate in the herds.