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Background Respiratory syncytial virus (RSV) infections can be prevented by good hygiene and prophylactic palivizumab, a monoclonal antibody against the fusion protein of VRS. The criteria for selecting patients for palivizumab prescription in our hospital are: Purpose To describe the use of palivizumab in the vaccination campaign in our hospital, evaluating the appropriateness of its use by the established criteria and its effectiveness. Material and methods We performed a retrospective observational study. All patients who received palivizumab between 01/10/2013 and 31/03/2014 were included. The data collected using the clinical records were: sex, gestational age, selection criteria, and number of hospitalizations due to acute bronchiolitis between 01/10/2013 and 30/09/2014. RSV was analysed in these patients by Polymerase Chain Reaction (PCR). Results Palivizumab was administered to 68 patients (48.5% female) with a median gestational age of 209 days (176–287). 24 patients (35.3%) fulfilled criterion 2, 14 (20.6%) criterion 1, 10 (14.7%) criterion 4, 5 (7.3%) criteria 1 and 3, 4 (5.9%) criteria 2 and 4, 3 (4.4%) criterion 3, 2 (2.9%) criteria 3 and 4. 4 patients did not meet any criteria and 2 had no data. Only 6 patients who received palivizumab were hospitalised with a diagnosis of acute bronchiolitis and their RSV PCRs were negative. Conclusion Palivizumab is used under the established criteria in our hospital. The study data show that immunising these at-risk patients with the palivizumab vaccine was an effective strategy for at least one year. Although the study period was 1 year, it would be desirable to measure effectiveness over a longer period. References and/or Acknowledgements No conflict of interest.

Background Triple therapy-based treatment with protease inhibitors in infected genotype 1 hepatitis C (HCV) patients improves efficacy measured as sustained virological response (SVR). Purpose To compare the effectiveness and safety of triple therapy-based treatment in mono-infected and co-infected HCV-HIV patients. Material and methods All treatments started between 2012/07/01 and 2013/12/31 were analysed. A retrospective evaluation was made of electronic medical records and outpatient pharmacy records. SVR was defined as undetectable viral load at week 60. Results 83 patients were included, 80 treated with telaprevir and 3 with boceprevir, 58 mono-infected and 25 co-infected patients. Baseline characteristics in mono-infected patients were: 83% male, mean age 54 years; 26 genotype 1a, 30 1b, 2 untypable; 64% F4; 40% were treatment-naive, 14% relapsers, 12% partial responders, 31% null responders and 3% no data. In co-infected patients: 84% male, mean age 50 years; 17 genotype 1a, 71b, 1 untypable; 92% F4; 40% were treatment-naive, 28% relapsers, 12% partial responders, 12% null responders and 8% no data. We were able to assess the effectiveness of treatment in 71 patients, who achieved 60 weeks of treatment: 51 mono-infected and 20 co-infected. In the mono-infected group: 21 (41%) achieved SVR (86% treatment-naive or relapsers), 20 (39%) had a detectable viral load (50% null responders) (3 boceprevir-treated) and 10 (20%) discontinued treatment due to toxicity or disease progression. This compared with 11 (55%) (73% treatment-naive or relapsers), 8 (40%) (38% null responders) and 1 (5%) in the co-infected group. Adverse events were: anaemia 58%, neutropenia 81% and thrombocytopenia 36% in mono-infected vs. 44%, 80% and 52% in co-infected patients. Conclusion The rate of SVR was about 50%, higher in co-infected than in mono-infected HCV patients. However, it may have been affected by a greater proportion of null responders in the mono-infected group (p > 0.05), because as in published trials, the rates of SVR differed among patients with different responses to previous treatments. References and/or Acknowledgements Zeuzem S, Andreone P, Pol S, et al . Telaprevir for retreatment of HCV infection. N Engl J Med 2011;364:2417–28 Jacobson IM, McHutchison JG, Dusheiko G, et al . Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med 2011;364:2405–16 No conflict of interest.

Background Our Hospital Pharmacy Service (HPS) participates in the process of authorising off-label indications (OLIs) of drugs. Immunosuppressants are often used in OLIs. Purpose To analyse prescriptions for oral immunosuppressants dispensed as OLI in our HPS Outpatient Unit (HPSOU) to identify points in the system that could be improved. Material and methods Retrospective study of oral immunosuppressants dispensed at our centre between March 2012 and March 2014. Variables collected were age, sex, drug, prescribing service and indication; obtained from the HPSOU database and the electronic medical history. Results 269 patients (median age 52 years (5–92), 135 women (50%) and 134 men (50%)) were evaluated. 6 drugs were dispensed in 8 different medicinal products: tacrolimus 94 patients (35%), mycophenolate mofetil 78 (29%), mycophenolic acid 56 (21%), ciclosporin 34 (17%), everolimus 6 (2%) and sirolimus 1 (0.3%). 11 services were involved: Haematology (89 patients: 33%), Rheumatology (61: 23%), Nephrology (56: 21%), Ophthalmology (15: 6%), Digestive (14: 5%), Pneumology (10: 4%), Paediatrics (9: 3%), Neurology (8: 3%), Internal Medicine (4: 1%), Dermatology (2: 0.7%) and Oncology (1: 0.3%). Immunosuppressants were dispensed for 35 different indications. Main indications and their treatments were: Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) for 75 patients (28%), with tacrolimus (71%), mycophenolate mofetil (17%) and ciclosporin (12%); Systemic Lupus Erythematosus (SLE) for 46 (17%), with mycophenolate mofetil (62%), mycophenolic acid (30%) and tacrolimus (8%) and Membranous Glomerulonephritis (MGN) for 20 (7%), with mycophenolic acid (50%) and tacrolimus. Conclusion The use of oral immunosuppressants as OLI is an established treatment for various indications, specially, allo-HSCT, SLE and GMN. The creation of multidisciplinary groups to develop protocols for the management of these drugs is required. References and/or Acknowledgements Summaries of product characteristics of the evaluated medicinal products. 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 Inhaled colistimethate is a drug dispensed in hospital pharmacy services, commonly used in obstructive lung diseases. Purpose To describe and evaluate the causality of a case of thrombocytopenia after initiating inhaled colistimethate treatment. Materials and methods Thrombocytopenia was reported by a patient in our outpatient hospital pharmacy service when he came to return Promixin (sodium colistimethate) 1 MIU. The clinical record was retrospectively reviewed to evaluate the possible causality by the Karch-Lasagna algorithm. The adverse event (AE) was notified to the regional pharmacovigilance centre, which consulted national and European agencies about more notifications. Results A 79 year-old man with diffuse interstitial lung disease (DILD) began inhaled treatment with sodium colistimethate 0.5 MIU/12 h to prevent Pseudomonas sp colonisation. Initial platelet level was normal (130,000 cell /mcL), but after six months’ treatment, he presented haematomas in mouth, eye, back and leg with a platelet count of 6, 000 cell/mcL, so colistimethate was discontinued. A week later, after receiving immunoglobulins and corticoids, his platelet level recovered (98,000 cell/mcL). After six weeks, the platelet level had normalised (205,000 cell /mcL) and treatment was restarted at the same dose. Thrombocytopenia reappeared (58,000 cell/mcL) after 15 days of treatment, therefore the drug was definitely stopped. The AE was classified as probable, as it appeared with treatment initiation, disappeared when drug was withdrawn and reappeared after readministration without any alternative explanation. There were no notifications of this AE in the Spanish Pharmacovigilance System and four had been described in the European Medicines Agency database. Conclusions Inhaled colistimethate-induced thrombocytopenia is a serious, rare AE we need to look out for as part of the pharmaceutical care in lung disease patients. 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 The Spanish Nephrology Society and the Spanish Enteral and Parenteral Nutrition Society issued a consensus statement about indications, contraindications and the composition of intradialyticparenteral nutrition (IDPN) in 2010. Purpose To find out whether these guidelines are being followed. Materials and methods Patients who started IDPN during 2010 were included. Medical histories were revised retrospectively. The start and end date, subjective global assessment (SGA), intake of food, body mass index (BMI), age, creatinine, albumin and prealbumin were recorded. Results 21 patients were included. Median age was 63. Start criteria: all had found supplementary oral intake impossible and had rejected a nasogastric tube according to the consensus. In addition, 3 criteria referred to in the table had to be present. Composition criteria: All patients had Oliclinomel N7-1000 ml (Baxter). It complied with the recommendations except that: ▶It had 40 grams of protein, which corresponded to 0.5-0.8 g/kg/day (consensus 0.8-1.2/kg/day) ▶It had no vitamins, no added insulin and no phosphorus ▶Carnitine was not added in dyslipidaemic patients Discontinuation criteria: Only albumin was assayed. No patients were discontinued because of complications or intolerance. Four patients complied with the discontinuation criteria (albumin >3.8 g/dl). Conclusions 19% of patients fulfilled the start criteria, 43% the discontinuation criteria and the composition did not fully fit the consensus. Initial screening should be improved by recording caloric and protein intake and SGA. It would be desirable to choose an IDPN better adapted to protein needs, and consider the addition of vitamins and carnitine in dyslipidaemic patients, as well as individualising phosphorus and insulin requirements.

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.