Background Omalizumab is indicated as add-on treatment to improve asthma control in patients with severe persistent allergic asthma who have reduced lung function as well as frequent symptoms. Purpose To assess the use and efficacy of omalizumab in a regional hospital. Materials and methods We conducted a retrospective study from April 2007 to August 2013. We included all patients who were treated for at least 16 weeks with omalizumab. To evaluate use and efficacy we reviewed: baseline IgE levels, volume exhaled during the first second of a forced expiration (FEV1), use of inhaled and/or oral corticosteroids before and after treatment and disease evaluation after 16 weeks. It was considered that patients with baseline IgE lower than 76 IU/ml were less likely to experience benefit as stated in the omalizumab SPC. We defined reduced lung function as FEV1 lower than 80%. Results Total patients: 10 (9 females); mean age 52 (39–77); 9 patients with allergic asthma and 1 with chronic urticaria. There were 4 patients with moderate persistent allergic asthma and the remainder with severe asthma. Mean basal IgE 177.2 IU/mL (47–431.6). 4 patients were prescribed omalizumab with IgE lower than 76 IU/mL. The FEV1 value was only determined in 5 patients before starting treatment with omalizumab: 3 patients had FEV1 lower than 80% (49, 69 and 59), and it increased in all cases after omalizumab initiation (75, 72 and 71). 2 patients had FEV1 higher than 80% (104 and 96), which increased in the first case and decreased in the other after commencing omalizumab (117 and 78). Both had baseline IgE levels less than 76 IU/mL. After starting omalizumab all patients continued treatment with inhaled corticosteroids and 3 also with oral corticosteroids. 1 patient was completely asymptomatic, 2 had improved respiratory status, 5 were stable from a respiratory standpoint and 1 experienced non-respiratory changes with the introduction of omalizumab. Of the patients who started omalizumab with IgE levels higher than 76 IU/mL, 4 were stable from a respiratory standpoint and 1 had an improved respiratory status. We had 1 patient diagnosed with chronic urticaria with IgE 518.4 IU/mL on treatment with omalizumab 300 mg every 6 weeks (off label). The patient is currently without skin rash or need to take antihistamines. Conclusions Only 33% (3/9) patients experienced an improvement in respiratory status and 55% (5/9) were stable from a respiratory standpoint. These data are lower compared with other studies (1) reporting up to 55% effectiveness. No patients discontinued treatment with corticosteroids. Is necessary to develop a protocol to ensure that omalizumab is used in the most suitable patients and review effectiveness after starting treatment to avoid unnecessary exposure to the drug in non-responders. Omalizumab treatment for chronic urticaria has been effective. Reference Padeulles Zamora N, et al. Estudio observacional retrospectivo de la utilización de Omalizumab en el tratamiento del asma grave persistente. Farm Hosp. 2013;37(...

BackgroundBotulinum toxin (BT) is a neurotoxin produced by C. botulinum that blocks the release of acetylcholine at peripheral cholinergic nerve endings.PurposeTo evaluate the profile of BT use in our hospital, as well as the savings due to the manufacture of pre-filled syringes in the Pharmacy Department.Material and methodsRetrospective study (Jan–Dec 2013). Data collected: IU consumed of BT, doses, Medical Department, number of patients, indication and cost. Vials of BT (100 IU) were reconstituted with sterile saline 0.9% (in a Horizontal Laminar Flow cabinet). The reconstituted solution was stable for 4–24 h at 2–8°C.1,2 After reconstitution pre-filled syringes were prepared and conditioned with the exact doses requested. After processing, the remaining material was discarded in an appropriate container.ResultsBT manufactured (IU): 11,615, 259 patients (682 doses). Consumption/ Medical Department, Pain Unit: 4,208 IU, General Surgery: 3,074 IU, Rehabilitation: 1,900 IU, others: 2,433 IU. Doses more frequently used were 7 IU/0.21 mL by General Surgery (392), 75 IU/2 mL and 100 IU/2 mL by Pain Unit (31 units and 19 units, respectively) and 5 IU/0.15 mL by Ophthalmology (48). The main ward using pre-filled syringes was General Surgery (400), followed by Ophthalmology (135), Pain Unit (75), others (72). The cost of BT was €28,482.5. 80% of BT was used in blepharospasm and focal spasticity. The manufacture of pre-filled syringes in the Pharmacy Department represented a saving of 81 vials. We estimate a potential saving/year (direct cost) of €12,729.6 (-45%).ConclusionThe Pain Unit and Surgery General presented the higher consumption of BT. The manufacture of pre-filled syringes by the Pharmacy Department allowed us to optimise the consumption of this drug, achieve considerable cost savings as well as ensure the sterility of the process.ReferencesXeomin®. Botox®. No conflict of interest.

Background Amiodarone and dronedarone decrease the risk of recurrences in patients with paroxysmal or persistent atrial fibrillation or atrial flutter. Both drugs are P-glycoprotein inhibitors and they are substrate/inhibitor of CYP3A4. Purpose To assess the safety profile of amiodarone and dronedarone in patients treated with oral vitamin K antagonists. Materials and methods Prospective study in a hospital for 12 months. Data collected: demographics and INR levels. Patients included: age >18 treated with acenocoumarol who were started on dronedarone or amiodarone. In patients with AF an INR of 2.0–3.0 was considered as therapeutic. We included patients who had an INR stable for at least 3 months prior to starting treatment with either drug. We monitored the INR for a month after initiation of antiarrhythmic treatment. We considered the effect of other factors in altering the INR. Safety profile of the drugs: class A-mild (INR: 3–4), class B-moderate (INR: 4–5), class C-severe (INR: >5). We considered an INR <3 a lack of interaction. Results Patients included: 30. Patients treated with amiodarone: 18, 61.1% (11/18) females, mean age (years): 72 (range: 59–89). Patients treated with dronedarone: 12, 33.3% (4/12) females, mean age (years): 69 (range: 37–80). Patients treated with amiodarone, class A: 5 (27.8%), class B: 6 (33.3%), class C: 7 (38.9%). Patients treated with dronedarone, class A: 8 (66.7%), class B: 3 (25%), class C: 0, absence of interaction: 1 (8.3%). INR remained stable for at least 3 months in all cases after an alteration of INR had been detected and the pattern of acenocoumarol had been changed. No effects were observed due to other drugs, food or lifestyle changes in these patients. INR was altered only with the use of dronedarone or amiodarone. Conclusions Dronedarone had a better safety profile than amiodarone in elderly patients treated with acenocoumarol. However, further studies should provide a greater degree of evidence in this regard and clarify the mechanisms of action involved in this interaction. No conflict of interest.

Background Short Bowel Syndrome (SBS) requires comprehensive nutritional control. Today’s personal media available to healthcare systems do not allow daily monitoring of SBS patients. New technologies should be incorporated into Pharmaceutical Care and specifically in nutritional support. Purpose To monitor SBS outpatients daily using new technologies. To check the health impact and directly assess the professional care obtained by the patient. Materials and methods Prospective study in a tertiary hospital during the period January to May 2013. Patients with SBS were selected who had got support from the Pharmacy Department at admission. Of the patients who received nutritional support two agreed to continue receiving support using new technologies. They were seen in consultation at hospital discharge and after 1, 3, 6 and 12 months. Blood tests were performed on each one, reviewing them with the patient by phone or email if any treatment was necessary and by Whatsapp if the blood tests were completely normal. Results During this period, nutritional and metabolic parameters (albumin, pre-albumin, GOP, GPT, etc.) tended to normalise. No readmissions during the study. No alterations in nutritional stress during the study. Throughout the process with regard to nutritional and pharmacological recommendations, the two patients received nutritional supplements with vitamin B12, folic acid, iron, calcium, vitamin D, potassium and magnesium. Rating of service by patients: excellent and necessary. Recommendation by the patients: 100% Yes. Conclusions Hospital Pharmacy in a highly specialised profession. Likewise nutritional support is an area where hospital pharmacists necessarily complement the clinical team. The union of Hospital Pharmacy and Nutritional Support as reported benefits patients. No conflict of interest.

Objectives To analyze the main epidemiological and clinical characteristics of patients with neurological involvement related to sarcoidosis. Methods In May 2013, the Study Group on Autoimmune Diseases (GEAS-SEMI) created the national registry of patients with sarcoidosis (SARCOGEAS-SEMI Registry). Patients presenting with neurological features were specifically evaluated. Results In December 2013, a total of 719 patients with sarcoidosis were included in the SARCOGEAS-SEMI Registry; 52 (7.2%) had neurosarcoidosis, 22 men and 30 women, with a mean age at diagnosis of neurosarcoidosis of 50.1 years (range 23-84 years). The main neurological involvement consisted of cranial neuropathies in 27 (52%) patients, followed by CNS involvement in 23 (44%), peripheral neuropathies in 6 (10%) and muscular involvement in 4 (8%). The most frequent cranial neuropathies included involvement of VII pair (17 cases) followed by VIII pair (5 cases) and V and VI pairs (4 cases each); other cranial nerves affected included IX (n=3), III (n=3), XI (n=2), I (n=1), II (n=1) and XII (n=1); 12/27 (44%) patients showed multiple cranial neuropathies. With respect to CNS involvement, meningeal involvement (15%) and vascular/demyelinating lesions (10%) were the most frequent involvements; other features consisted of parenchymatous cerebral lesions (n=4), encephalopathy (n=4), hypothalamic involvement (n=3), seizures (n=2) and hydrocephalia (n=1). All patients received corticosteroids (10 received methylprednisolone pulses) and 9 immunosuppressants (methotrexate in 5, azathioprine in 4, cyclophosphamide in 2). One patient refractory to standard therapy was treated with infliximab. Nearly half the cases showed improvement or stabilization (46%), 34% showed complete resolution, 16% worsened and 4% died. Conclusions Nearly 10% of patients with sarcoidosis present with neurological involvement. The main involvement of neurosarcoidosis consisted of cranial neuropathies in half the cases. Twenty percent of patients showed a worse outcome, with a mortality rate of 4%. Neurological involvement is a significant cause of morbidity and mortality in patients with sarcoidosis. Disclosure of Interest : None declared DOI 10.1136/annrheumdis-2014-eular.5374