C Romero Delgado

1ISG-003 Cost saving in antiretroviral therapy through breaking fixed-dose combination and switch to generic formulations

Background The commercialisation of fixed-dose combination meant an improvement in antiretroviral therapy (ART). With generics we have the opportunity to maintain the therapy at a lower cost, but we complicate the dosage regimen again. Purpose To assess the effect in costs of a two-pill, generic-based regimen compared with a branded coformulated regimen, and to project the potential annual savings in the first year of a switch to generic-based ART. We replaced Triumeq® (ABC/3TC/DTG) by a combination of Tivicay® (DTG) +generic ABC/3TC, and Atripla® (TDF/FTC/EFV) by Truvada® (TDF/FTC)+generic EFV. Material and methods We selected and analysed all patients who received Atripla® (TDF/FTC/EFV) and Triumeq® (ABC/3TC/DTG) from June 2016 to September 2017. Data were collected from the medication consumption files of the institution. We analysed the records related to the treatment. The economic savings associated with the change of treatment were quantified. Results 313 patients were analysed, 108 (34.5%) initially treated with Atripla® and 205 (65%) initially treated with Triumeq®. A total of 252 (80.5%) patients were switched to a new treatment (162 patients with Triumeq® and 90 patients whith Atripla®), four (1,27%) of whom returned to initial treatment for adverse effects. A total of 61 patients were not changed. The main reason for opposing the change was the difficulty in adherence 17 (27.8%), followed by patient refusal four (6.5%) The change to Triumeq® meant a saving of €22.380/month and the change to Atripla® a saving of €10.100/month. This represents a total saving of €389.772/year. Conclusion Generics formulations in ART is an opportunity to contain pharmaceutical costs in hospitals. Changes in therapy produced a low rate of adverse reactions (1.27%) and a cost saving of €389.772/year. It requires adherence data to be able to affirm that this strategy decreases costs without prejudice to the patient. References and/or Acknowledgements All staff of our pharmacy service No conflict of interest

CP-018 Effectiveness of omalizumab in asthmatic patients

Background Omalizumab is a humanised monoclonal antibody manufactured by recombinant DNA technology. It is indicated as an add-on therapy to improve asthma control in patients with severe persistent allergic asthma with forced expiratory volume in 1 s(FEV1) <80%. Purpose To evaluate the effectiveness of omalizumab (Xolair) in asthmatic patients treated with this drug in a tertiary hospital during 2015. Material and methods This was an observational retrospective study of patients treated for asthma with omalizumab during 2015 in a tertiary hospital. Data were obtained by Farmatools and Drago AE programmes. All patients treated with omalizumab for at less 1 year were included. Clinical variables collected were: FEV1(RD >80%), serum total level of IgE (RD <100 UI/mL) and omalizumab dose. Effectiveness was evaluated by number of emergency department visits for asthma. Results 66 patients were included in the study with a mean age of 37 years (40 women, 26 men). 94% of patients did not require emergency visits for asthma. At the start of the study, they presented mean serum levels of IgE of 1702 UI/mL; during this period, a mean decreased of 47% was observed. However, at the end of the study period, we observed increased serum levels of IgE in all patients. For FEV1, at the end of study, we found that: 17% of patients had FEV1 <60%, 57% had FEV1 60–80% and FEV1 was >80% for the rest of the patients. As omalizumab is indicated in patients diagnosed with persistent allergic asthma, we should consider discontinuing treatment in patients with FEV1 <80% . Conclusion Omalizumab was highly effective in this study, similar or even better than the effectiveness showed in clinical trials. We observed that lower baseline total IgE was associated with less effective treatment. References and/or acknowledgements Technical data for omalizumab. No conflict of interest

PKP-002 Continuous infusion vancomycin, a case report

Background Administration of continuous infusion of vancomycin is an alternative to administration of this drug. Purpose To evaluate the clinical efficacy and incidence of adverse effects with a regimen of vancomycin as a continuous infusion. Material and methods This was an observational retrospective study of the use of vancomycin in a child diagnosed with ganglioneuroblastoma L2. The information was obtained from the electronic clinical history (SELENE) and the pharmacy service managing software (FARMATOOLS). The programme used for monitoring the pharmacokinetics of drugs is PKS. Results The patient was a 4-year-old admitted to the paediatric ward of a hospital with febrile neutropenia after receiving the second cycle of chemotherapy (cyclophosphamide+vincristine+adriamycin). Empirical antibiotic therapy was started: vancomycin (15 mg/kg/6 hours) and amikacin (15 mg/kg/24 hours). Vancomycin trough levels obtained during the first 3 days of treatment were very low (2 µg/mL) so a continuous infusion of vancomycin was started. With 60 mg/kg/24 hours of vancomycin, steady state plasma concentration (Css) of 12.1 µg/mL were obtained. Optimal Css levels for vancomycin for prophylaxis treatment are 15–20 µg/mL. Because of persistent fever and worsening of clinical status, the dose was increased to vancomycin 70 mg/kg/day and optimal plasma levels were obtained (17.5 µg/mL). The dose of amikacin was maintained at 15 mg/kg/24 hours, obtaining optimal plasma levels (trough level <1 µg/mL and peak level 30–40 µg/mL). Antibiotic treatment was continued for 7 days and the child had a good response. Conclusion Administration of continuous infusion vancomycin reached therapeutic levels with good clinical efficacy and no evidence of renal injury, so it is a therapeutic strategy for patients with low levels of drugs in plasma. Moreover, it is a more comfortable administration, with decreased nursing workloads and less manipulation of intravascular catheters. We need more paediatric studies to evaluate the efficacy and safety of these patients using this type of administration. References and/or acknowledgements Pharmacokinetics manual pharmacy service. Data sheet of vancomycin and amikacin. Clinical Report. Evaluation of a paediatric continuous-infusion vancomycin therapy guideline (Susan McKamy, Tempe Chen, Michelle Lee, Peter J Ambrose). No conflict of interest

DI-067 Analysis of the use of teriflunomide in a tertiary hospital

Background Teriflunomide is an immunomodulatory agent with anti-inflammatory properties that inhibits the mitochondrial enzyme dehidroorotato-dehydrogenase (DHO-DH), which is required for the synthesis of pyrimidine, blocking the proliferation of activated B and T lymphocytes. It is believed that the therapeutic effect is related to the reduction in the number of lymphocytes. It is indicated for the treatment of adult patients with relapsing-remitting multiple sclerosis with the advantage of oral administration. Purpose To analyse the use of teriflunomide in patients diagnosed with multiple sclerosis. Material and methods A retrospective observational study from January 2013 to May 2015. We used the SAP program to evaluate the clinical history and dispensations of patients treated with teriflunomide. The following data were recorded: sex, age, EDSS, previous treatments, control of liver enzymes, kidney function, blood pressure and pregnancy test. Results 18 patients, 17 women and 1 man, were evaluated, with an average age of 41.11 years (range 23–79). Mean EDSS was 1.85 (1–5). All patients had recorded blood pressure, blood count, and kidney and liver function approximately every 2 weeks. Teriflunomide was prescribed as the firstline treatment in 5 patients (27.77%), as secondline in 3 patients (16.66%), as the third treatment in 8 patients (44.44%), and as the fourth and fifth treatments, respectively, in 1 patient (5.55%). Two patients began it before marketing. The immediately preceding treatment was glatiramer acetate in 5 patients, dimethyl fumarate in 1, interferon beta 1a 44 µg in 5 and interferon beta-1a 30 µg in 2 patients. The reasons for the change were cutaneous adverse effects on local reaction at the injection site in all cases except for dimethyl fumarate (digestive intolerance). The average duration of treatment with teriflunomide was 3.77 months (1–20), without any abandonment of treatment by that time. Conclusion While reports of teriflunomide therapeutic positioning is indicated at the forefront of relapsing-remitting multiple sclerosis, only 29.41% of our patients were prescribed this as the first choice. In the future, more patients may start teriflunomide as the firstline treatment given the comfort of the route of administration and good tolerance. Due to the short time to market, a longer term review is needed to verify the response to the drug. References and/or Acknowledgements http://www.aemps.gob.es/medicamentosUsoHumano/informesPublicos/docs/IPT-teriflunomida-aubagio.pdf No conflict of interest.

DI-018 Eculizumab in the atypical haemolytic uraemic syndrome: A case report

Background Atypical haemolytic uraemic syndrome (aHUS) is a severe life threatening disease with progression to end stage renal disease. Eculizumab, a humanised anti-C5 monoclonal antibody targeting the activated complement pathway, has been introduced as a therapy against aHUS. Purpose To demonstrate the efficacy and safety of eculizumab in brief and sustained interruption of the thrombotic microangiopathy process, increase in the number of platelets and significant improvement in renal function in the long term with important reductions in the need for dialysis and plasmapheresis. Material and methods Observational, retrospective and descriptive study of a patient with aHUS. The information was obtained from the electronic clinical history (SELENE) and the pharmacy service managing software (Farmatools). Results The patient was a 60-year-old woman who was hospitalised with renal failure symptoms (Cr 16.6 mg/dL) associated with severe anaemia (Hb 4.5 g/dL) and thrombopenia (platelets 111 000 U/µL) without previous infection. She was started on alternative renal therapy and red blood cell transfusion. Autoimmune studies were requested detecting ANCA+ antibodies and so steroid treatment was started, associated with cyclophosphamide with no response. Due to thrombopenia persistence, we decided to start plasmapheresis with good response, stabilising haemoglobin and increasing the platelet count; however, renal failure function and MAT parameters persisted. From the time of admission (7 January 2015 to 22 February 2015), she needed 14 plasmapheresis sessions and 2 cyclophosphamide boluses with active haemolysis pattern and so was dependent on substitutive renal therapy. The patient started this therapy on 22 February 2015 with 4 doses, 900 mg/week, with good response. No further transfusions or plasmapheresis were needed, with an increase in platelet count (50 000 to 135 000 U/µL) and creatinine (7 to 5.42 mg/dL). After a week without this drug, analytical values got worse (platelets 111 000 U/µL and creatinine 11.71 mg/dL), and so eculizumad was authorised as maintenance therapy, 1200 mg/15 days. After a month with this maintenance therapy, the result was an increase in platelet count up to 182 000 mg/dL, haemoglobin increase to 9.1 g/dL and creatinine increase to 7.33 mg/dL. Conclusion FDA, EMA and AEMPS have approved the use of eculizumab for treating aHUA. With this good response in this clinical case, eculizumab was effective in aHUS. However, the treatment’s high cost requires correct pathological identification in patients, so each case should be studied by a multidisciplinary team (haematology, nephrology and pharmacy). References and/or Acknowledgements Eculizumab summary of product characteristics. No conflict of interest.

PS-086 Essential thrombocythaemia in pregnancy

Background Essential thrombocythaemia (ET) is an uncommon myeloproliferative disorder with an elevated platelet count. ET occurring in pregnancy has been reported to be mainly associated with first trimester abortion, preterm delivery, intrauterine growth retardation, placental abruption and preeclampsia. Purpose To describe the case of a pregnant patient diagnosed with essential thrombocythaemia who could not remain untreated due to complications of the disease. Materials and methods 35-year-old female patient diagnosed with essential thrombocythaemia untreated for months so she could try for a baby reached platelet counts of 1,118,000/mL. In the first month of pregnancy this could not be left untreated because complications can arise as such microthrombosis in blood vessels, leading to a high incidence of abortions in these patients. The treatment requested from pharmacy services for this case was interferon alpha-2 beta (IFN α-2b) which has shown no teratogenicity compared to other alternatives such as hydroxyurea or anagrelide. Low-dose acetylsalicylic acid is contraindicated in patients with platelet counts of more than a million/mL, due to the possibility of acquired Von Willebrand syndrome. Interferon alfa has not been approved for the indication of essential thrombocythaemia so its off-label use required approval by the hospital management. 3 MUI of IFN α-2b were administered twice weekly IV during gestation. Results Platelet counts decreased gradually from the beginning of treatment passing from 1,118,000/mL to 680,000/mL in two weeks, then 602,000/mL in the third month, in the fourth month 530,000/mL, 487,000/mL in the fifth month, in the sixth month 462,000/mL and in the seventh month 328,000/mL. During week 29 + 2 gave birth by emergency Caesarean section because of severe preeclampsia. Despite the complications, mother and child progressed favourably. Conclusions Essential thrombocythaemia is a difficult to treat disease in pregnancy. Sometimes you have to use drugs off-label. In this case, the IFN α-2b successfully reduced the platelet count during pregnancy. No conflict of interest.Background Essential thrombocythaemia (ET) is an uncommon myeloproliferative disorder with an elevated platelet count. ET occurring in pregnancy has been reported to be mainly associated with first trimester abortion, preterm delivery, intrauterine growth retardation, placental abruption and preeclampsia. Purpose To describe the case of a pregnant patient diagnosed with essential thrombocythaemia who could not remain untreated due to complications of the disease. Materials and methods 35-year-old female patient diagnosed with essential thrombocythaemia untreated for months so she could try for a baby reached platelet counts of 1,118,000/mL. In the first month of pregnancy this could not be left untreated because complications can arise as such microthrombosis in blood vessels, leading to a high incidence of abortions in these patients. The treatment requested from pharmacy services for this case was interferon alpha-2 beta (IFN α-2b) which has shown no teratogenicity compared to other alternatives such as hydroxyurea or anagrelide. Low-dose acetylsalicylic acid is contraindicated in patients with platelet counts of more than a million/mL, due to the possibility of acquired Von Willebrand syndrome. Interferon alfa has not been approved for the indication of essential thrombocythaemia so its off-label use required approval by the hospital management. 3 MUI of IFN α-2b were administered twice weekly IV during gestation. Results Platelet counts decreased gradually from the beginning of treatment passing from 1,118,000/mL to 680,000/mL in two weeks, then 602,000/mL in the third month, in the fourth month 530,000/mL, 487,000/mL in the fifth month, in the sixth month 462,000/mL and in the seventh month 328,000/mL. During week 29 + 2 gave birth by emergency Caesarean section because of severe preeclampsia. Despite the complications, mother and child progressed favourably. Conclusions Essential thrombocythaemia is a difficult to treat disease in pregnancy. Sometimes you have to use drugs off-label. In this case, the IFN α-2b successfully reduced the platelet count during pregnancy. No conflict of interest.