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Background In the pivotal authorisation trial of carfilzomib, patients with severe cardiovascular abnormalities (NYHA III or IV), clinically significant and uncontrolled, were not included. Purpose The 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 methods Retrospective 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. Results Thirty-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. Conclusion As 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 acknowledgements Stewart 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 Calcinosis 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. Purpose To 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 methods A systematic bibliographic search for available therapeutic options was made. An article by Perez-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. Results The 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. Conclusion Treatment 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 Acknowledgements Perez-Moreno MA, Alvarez del Vayo-Benito C, Flores-Moreno S, et al. Calcinosis cutanea grave tratada exitosamente con una formula magistral topica W/O de tiosulfato sodico al 10%. Acta Pediatr Esp 2014;72:e9-10 No conflict of interest.

Background New oral anticoagulants are an alternative to acenocoumarol in the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation. Purpose To 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 methods A 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. Results 64 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. Conclusion 94% 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. Reference Agencia Espanola de Medicamentos y Productos Sanitarios. Informe de posicionamiento Terapeutico UT/V4/23122013 No conflict of interest.

Background Oral chemotherapy against metastatic or advanced renal-cell carcinoma (mRCC) is currently benefiting from a wide range of possibilities. Purpose To analyse the effectiveness of the actual therapy for the treatment of the mRCC in real conditions based on survival at one and two years and modifications in dosage or drug. Materials and methods Retrospective evaluation of clinical history from November 2011 to September 2013. In our hospital tyrosine kinase inhibitors were the first line treatment and mTOR inhibitors were the second line. Results 68 patients were treated for mRCC. Male/Female: 73/27. Average age: 64.6 years. After 1 year of treatment 81.4% patients survived (22/27) and 42.8% after two years (3/7). 44/68 patients (65%), needed a drug change due to progression. Average time to change was 6.4 months (59% CL: 4.6–8.1) (median: 5.1). 8/68 (11.7%) required a treatment change towards a third line. Of these 8 patients; 3 restarted treatment with sunitinib as fourth line. Out of 41 patients who initiated therapy with sunitinib 50 mg once daily on schedule 4–2; 19 patients (46.3%) needed a descending adjustment of the dose. The average time to dose adjustment was 4.2 months (59% CL: 2.6–5.7) Conclusions Oral treatment of advanced renal cancer has several therapeutic possibilities; which must be treated with rigorous criterion in favour of the clinical benefit applying the maximum efficiency. Even limited by the small sample size, the results are similar to those previously reported in this setting. First year survival rate: 81.4% vs. 75% 1 Second year survival rate: 42.8% vs. 50% 1 Of the 68 patients studied, 65% required a drug change during their treatment mostly due to loss of efficacy. Sunitinib 50 mg 4–2 schedule dose adjustment: 46.3% vs. 46% 2 (33% + 13%) Time to dose adjustment: 4.2 months versus 7.5 months 2 References RJ Motzer, B Escudier, R Bukowski, et al . Prognostic factors for survival in 1059 patients treated with sunitinib for metastatic renal cell carcinoma. British Journal of Cancer 2013;108:2470-2477 Martin E Gore, Cezary Szczlik, Camillo Porta, et al . Safety and efficacy of sunitinib for metastatic renal-cell carcinoma: an expanded-access trial. Lancet Oncol 2009;10:757-63 No conflict of interest.

Background Systemic Autoimmune Rheumatic Diseases (SARDs) are a group of syndromes caused by antibodies inflammation related. Rituximab is a biological drug that targets antigen CD-20 present on the surface of B-Lymphocytes and thus potentially active against SARDs refractories to conventional treatment: steroids and immunosuppressants. Purpose To describe and evaluate safety parameters of the risk management protocol for adults SARDs patients treated with off-label Rituximab. Materials and Methods Descriptive-observational study from January 2011 to July 2012 realised by the Pharmacy and Rheumatology Service. Data were obtained from electronical medical records. Three types of risk management protocol data were evaluated. A) Clinical parameters: infection (including Tuberculosis), cardiovascular disease, severe cytopenia, neoplasia or new neurologic symptoms. B) Complementary tests: hemogram and general biochemistry while on Rituximab. C) Others: adverse events related with Rituximab infusion. Results 21 patients were included (mean age 52.71 ± 16.11 years). Diagnoses were Sjogren’s Syndrome (10), Systemic Lupus Erythematosus (4), Mixed Connective Tissue Disease (3), inflammatory myopathy (2), Systemic Sclerosis (1) and Wegener’s Granulomatosis (1). Clinical parameters: infection was detected on 5 patients (23%), severe cytopenia in 1 patient (4,7%) and peripheral neurological symptomatology in another one. Nor cardiovascular disease or neoplasia were detected. Complementary tests: patient presented severe thrombocytopenia (platelets Adverse events infusion related: detected on 19% of patients. Conclusions Rituximab off-label use for SARDs has increased over the last years and pharmacovigilance strategies as well as risk management protocols have proved useful identifying risks, controlling adverse events, improving quality of care and integrating Pharmacist into direct patient care. No conflict of interest.

Background Computerized physician order entry (CPOE) implementation in hospitals has become an important tool for interactive validation of medical orders as well as a facilitator for pharmacist interventions. However several studies have investigated the ‘alert fatigue’ phenomenon caused by an elevated number or recommendations which can lead to relevant clinical interventions being bypassed. Purpose To compare the degree of acceptance of pharmacist’s interventions after medical order validation using CPOE versus direct phone conversation with the physician. Materials and Methods Observational, descriptive and prospective study from May to August 2012. The intervention chosen for comparing the systems was FDA recommendation for simvastatin use regarding contraindications and maximum recommended doses. Interventions were generated using a quasi-random allocation method and physicians could refuse recommendations. When an intervention assigned to the telephone call group was not possible, CPOE was used as a second option. Acceptance of recommendations and time to modifications of the prescriptions were recorded. Results Phone call: only 34 of 42 attempted interventions were possible due to the prescriber’s unavailability. CPOE: 46 interventions and 54 interventions in total after the first attempt by phone call. Rate of recommendations accepted was 82% for phone calls while only 52% of CPOE interventions. Time to medical order modification since intervention was 0.26 days for the phone call group versus 2.18 days for CPOE group. Conclusions CPOE is a useful tool for pharmacists to communicate with the multidisciplinary patient care team but when a relevant clinical intervention is necessary direct phone calls to prescribers are more effective and quicker. No conflict of interest.

Background Multiple myeloma (MM) is a malignant monoclonal gammapathy that occurs mainly in patients over 65 years. Lenalidomide is indicated in combination with dexamethasone for the treatment of MM in patients who have received at least one prior treatment regimen. All this makes it likely the patient will require Pharmaceutical Care (PC). PC consists of collaboration with other health professionals and with the patient to design a safe and effective treatment plan, as well as to identify Drug Related Problems (DRPs) and to resolve and prevent negative outcomes associated with medication (RNMs). Purpose To evaluate the impact of pharmaceutical intervention in patients diagnosed with MM treated with lenalidomide in a pharmacists-led haematological consultation within the Pharmacy Service. Materials and Methods Quasi-experimental study of 4 months duration on patients diagnosed with MM treated with lenalidomide. Clinical practise follow-up procedures used the Dader method adapted to the study situation. Data were obtained from interviews with patients, electronic medical records and Outpatient Service Pharmacy records. Results During this period, 29 patients were diagnosed with MM and treated with lenalidomide, 21 joined the study (4 didn’t gave consent and 2 weren’t able to visit the pharmacy), 11 women and 10 men. Average age: 70.3 years (52–89). During study a total of 17 DRPs were detected: 4 related to the indication, 1 to the effectiveness and 8 to the safety, and a total of 35 RNMs: 4 related to the need, 5 to the effectiveness and 26 to the safety. Of these 35, 45.7% could have been avoided. A total of 25 pharmaceutical interventions were made: 10 related to the amount of drug, 9 to the pharmacological strategy and 6 to patient education. Conclusions A variety of goals were achieved through pharmaceutical interventions: medicines reconciliation, resolution of health problems by detecting RNMs and avoidance of RNMs by detecting DRPs. No conflict of interest.

Background Vitamin D is essential for strong bones because it helps the body use calcium from the diet. Because most people have low levels of vitamin D, correcting to the recommended ranges will bring added value to patient healthcare in hospital. Purpose To detect patients with low vitamin D levels in an Orthopedic ward. To evaluate the degree of acceptance of the pharmacist9s recommendations to correct vitamin D levels by the physicians. To devise an educational session for patients and evaluate the efficacy of the intervention. Materials and methods From 7/03/2011 to 9/03/2011, total serum 25-hydroxycholecalciferol ((25OH)D 3 ) was measured in patients on the Orthopedic ward. A lack of vitamin D was defined as ((25OH)D 3 ) ≤30 ng/mL. The individual recommendation for vitamin D supplementation was written in each patient9s medical record by the pharmacist. Patients presenting low vitamin D levels were randomised to enrol in the educational programme, consisting of a 15-min session about vitamin D, nutritional habits, and supplementation with vitamin D. All patients were given an appointment 2 months later for a vitamin D test to evaluate the efficacy of the intervention. Conclusions There was a significant vitamin D deficiency in the population studied. Pharmaceutical intervention has been proved useful when adjusting vitamin D levels.