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Background Availability of clinically effective and cost-effective treatments for severe asthma would be beneficial to patients and national healthcare systems. The aim of this study was to evaluate clinical outcomes and healthcare expenditure after incorporating benralizumab into the standard treatment of refractory eosinophilic asthma. Methods This was a cross-sectional multicentre study of consecutive patients with refractory eosinophilic asthma who received treatment with benralizumab during at least 12 months. Patient follow-up was performed in specialised severe asthma units. The main effectiveness parameters measured were: the avoidance of one asthma exacerbation, a 3-point increase in the asthma control test (ACT) score, and the difference in utility scores (health-related quality of life) between a 1-year baseline treatment and 1-year benralizumab treatment. The health economic evaluation included direct costs and incremental cost-effectiveness ratios (ICERs). Results After 1 year of treatment with benralizumab, patients with refractory eosinophilic asthma showed an improvement in all the effectiveness parameters analysed: improvement of asthma control and lung function, and decrease in the number of exacerbations, oral corticosteroid (both as corticosteroid courses and maintenance therapy), and inhaled corticosteroid use. The total annual cost per patient for the baseline and benralizumab treatment periods were €11,544 and €14,043, respectively, reflecting an increase in costs due to the price of the biological agent but a decrease in costs for the remaining parameters. The ICER was €602 per avoided exacerbation and €983.86 for every 3-point increase in the ACT score. Conclusions All the pharmacoeconomic parameters analysed show that treatment with benralizumab is a cost-effective option as an add-on therapy in patients with refractory eosinophilic asthma.

Background and importance Tocilizumab is an anti-human IL-6 receptor monoclonal antibody used in the treatment of cytokine release syndrome in patients with pneumonia associated with coronavirus disease. Despite the data from the COVACTA study, tocilizumab continues to be the gold standard for patients in our centre. Aim and objectives To describe the use of tocilizumab in the first peak versus the second peak of the SARS-CoV-2 pandemic, and to describe the results of the use of tocilizumab in both situations. Material and methods All patients treated with tocilizumab were included in the study periods: first peak (March to June 2020) and second peak (August to the present 2020). Demographic and clinical variables were collected. Data were obtained from the electronic medical records and prescription applications. Results 65 patients were included, 36 patients (55.38%) in the first peak versus 29 patients (44.62%) in the second peak. Conclusion and relevance In the first peak, tocilizumab was prescribed to more serious patients: those admitted to the ICU, with a higher FINE score and needing aggressive support therapy. In addition, it was prescribed in patients with a higher D-dimer. Doses and number of administrations were higher in the first peak. New scientific evidence led to the use of different concomitant treatments in the second peak: corticosteroids (second peak dexamethasone versus first peak methylprednisolone) and antiviral therapy (only remdesivir in the second peak). In the second peak, hospital and ICU stays were shorter, probably because tocilizumab was used in less serious patients. Despite this, no differences in mortality were observed. A study limitation was sample size. References and/or acknowledgements Conflict of interest No conflict of interest

Background and importance Treatment goals for advanced or metastatic breast cancer include not only delaying progression of the disease and extending survival, but also maintaining or improving the quality of the patient’s life. New targeted therapies, such as cyclin dependent kinase (CDK) 4/6 inhibitors, have improved patient outcomes with hormonal receptor positive, HER negative, metastatic breast cancer compared with conventional single agent endocrine therapy. They contribute to clinical benefit but at the same time they are the cause of complex and potentially severe adverse events that require good clinical management of toxicities. Aim and objectives To assess the safety of CDK4/6 inhibitors, analysing the relevant adverse drug reactions (ADRs) and reviewing the clinical management of toxicities. Material and methods A retrospective observational study was conducted in a second level hospital. We assessed the safety of three CDK4/6 inhibitors (ribociclib, palbociclib and abemaciclib), reviewing the medical and pharmaceutical records of all patients that attended the pharmacy department from January to March 2020. Collected data were: age, ECOG, cancer stage, metastatic location, type of CDK4/6 inhibitor in combination with endocrine therapy, ADRs, grade and clinical management (dose reductions, temporary interruptions and permanent discontinuations). Results 58 patients were included, median age 55 years (75–39), and 67% (39) received ribociclib, 29% (17) received palbociclib and 4% (2) received abemaciclib. ECOG at the beginning was 0 in 55% (32) of patients, 1 in 28% (16) and 2 in 10% (6). 100% of patients had disease stage IV and the main metastatic location was bone (87%). Average number of cycles received was 15 (1–36). 38 (66%) patients had severe ADRs (grades 3–4), approximately 3 severe ADRs per patient. Neutropenia was the most common ADR grade 3/4 (85%) related to CDK4/6 inhibitors, and was highest with ribociclib compared with the other CDK4/6 inhibitors, followed by gastrointestinal disorders (5%). These severe ADRs required dose reductions in 15% (31), temporary interruptions in 37% (79) and permanent discontinuation of treatment in 4% (7). 19 patients also needed supportive treatments. Conclusion and relevance In spite of the manageable safety profile of CDK4/6 inhibitors in clinical practice, the frequency of severe ADRs associated with these treatments makes consistent close monitoring of side effects and toxicity necessary due to inter-patient variability, along with practical management strategies to find the optimal therapy for each patient. References and/or acknowledgements Conflict of interest No conflict of interest

Background and importance Immune checkpoint inhibitors (ICIs) represent a milestone therapy in many types of cancer, such as melanoma. Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody with antitumour activity in melanoma. Only a few studies have investigated the relationship between ICIs and disorders of the coagulation–fibrinolysis system. Aim and objectives To report a case of disseminated intravascular coagulation (DIC) in a metastatic melanoma patient treated with nivolumab. A 50-year-old woman was diagnosed with melanoma stage IB and resected in 2008. In December 2019, she relapsed (pulmonary and intracardiac metastasis). Then, she underwent treatment with nivolumab 240 mg/14 days, 14 cycles (last cycle 26 June 2020), with greater tumour partial response. During the last nivolumab cycles she had asthenia and thrombocytopenia and nivolumab was stopped. She was treated with methylprednisolone, but low platelet count persisted and she had extensive haematomas. She was admitted to hospital on 27 July due to probable DIC as an immune related adverse event (IrAE). Material and methods Laboratory tests on admission showed grade 3 thrombocytopenia (36×109L platelet count) and disordered coagulation (35 mg/dL fibrinogen, 75 468 ng/mL D-dimer). International normalised ratio for prothrombin time and activated partial thromboplastin time were in the normal range. PCR for SARS coronavirus screening and blood tests for mycobacteria were both negative. Results The patient was treated with fibrinogen. There was no evidence of tumoral progression or signs of infection. Furthermore, the patient had no history of other blood disorders, and there were no signs of trauma or sepsis. She was diagnosed with DIC related to nivolumab and she received gamma globulins, fresh frozen plasma and platelet transfusion with negative clinical evolution; so, she began treatment with infliximab and methylprednisolone pulse, without signs of bleeding, except for the persistence of haematomas and low levels of fibrinogen and platelets. The patient´s condition deteriorated, and platelet count decreased despite therapy with fibrinogen, anticoagulants, transfusions of blood and antibiotic–antifungal therapy. Finally, the patient showed neurological damage related to cerebral haemorrhage due to the low platelet count and she died in hospital. Conclusion and relevance Disseminated intravascular coagulation had the highest proportion of death outcomes among the top 10 most frequently reported ICI associated haematological IrAEs. For this reason, clinicians need to be careful, paying special attention during ICI treatment. This case report suggests a direct relationship between immunotherapy and disorder coagulation events; however, this cannot always be demonstrated but the diagnosis was made by exclusion. Therefore, extensive research in relation to haematological IrAEs and ICIs are necessary. References and/or acknowledgements Conflict of interest No conflict of interest

Background and importance One of the main factors that increases antibiotic pressure and contributes to the development of bacterial resistance is an increase in duration of antibiotic treatment. Strategies to reduce the duration of antibiotic treatment should be implemented when it is not necessary to continue. Aim and objectives The aim of this study was to systematically review patients with antibiotic prescriptions with a duration of more than 10 days and to analyse the degree of acceptance of the interventions performed. Material and methods A prospective interventional study was conducted between February and April 2019. Twice a week, all patients receiving antibiotic treatment for >10 days were selected. These patients were analysed by two pharmacists. They checked if the patient needed to continue with antibiotic treatment. To assess the need for antibiotic treatment, they reviewed inflammatory markers (leucocytes and C reactive protein), microbiological cultures and clinical parameters, such as fever and blood pressure values. They also assessed if the patient‘s clinical situation had improved. The pharmacist intervention consisted of a message (with a recommendation to suspend treatment, through the electronic prescription programme) sent to the responsible physician, for those patients whose pharmacist considered that it was not necessary to continue antibiotic treatment. Results A total of 162 patients were selected (55.1% men, median age 66 years). The intervention with a proposal for suspension of treatment was performed in 63 patients. The medical staff accepted 73% (46) of the interventions and 37% (17) were denied. The most prescribed antibiotics were ceftriaxone (20.98%), piperacillin–tazobactam (14.19%), levofloxacin (7.40%) and metronidazole (7.40%). The number of interventions accepted by the services were: surgery 13 (28.2%), pneumology 12 (26.0%), internal medicine 11 (23.9%), digestive 7 (15.2%), oncology 3 (6.5%) and neurology 1 (6.5%). Conclusion and relevance The review by the pharmacy service of antibiotic treatments longer than 10 days avoided longer durations than necessary, in addition to reducing antibiotic pressure. This is important to decrease adverse effects and prevent the development of bacterial resistance. References and/or acknowledgements No conflict of interest.

Background and importance The integration of the pharmacist into the intensive care unit (ICU) is very useful to prevent malnutrition and to reduce mortality among these patients, as the pharmacist can advise the prescriber on how to choose the most appropriate parenteral nutrition (PN). Aim and objectives To describe and analyse pharmaceutical interventions (PIs) carried out for medical prescriptions of PN in patients admitted to the ICU. Material and methods A prospective study (June–September 2019) was carried out. Variables included demographics, duration of PN, indication for PN, type of PI and degree of acceptance. The data were obtained from medical and pharmaceutical nutrition records. Results Fifty-four patients were registered (71% men, average age 65 years (range 39–87)). The average duration of PN was 11 days (1–39). A total of 176 interventions were recorded (3.3 PIs/patient): 91.5% during follow-up and 8.5% after finishing PN. Distribution of PIs according to diagnosis were: polyvalent critical patients (48.1%); postoperative complications (29.6%); colorectal surgery (9.2%); upper gastrointestinal tract surgery (5.7%); pancreatitis (3.7%); and liver diseases (3.7%). According to the type of PI: 36.6% were related to a change in the composition of macronutrients, and 61% of these PIs were related to proteins (78%—increase in order to cover the nitrogen requirements), 23.7% were related to lipids (71%—restriction due to triglycerides >400) and 15.3% were related with carbohydrates (100%—decrease in the supply due to high levels of glycaemia); 31.7% were related to a change in the amount of electrolytes (53%—extra supply; 47%—restriction), with phosphorus being the electrolyte which generated the highest number of PIs (45%); 18.6% were related to addition of insulin in the PN; 10.6% were related to a request for a nutritional profile; and 2.5% were related to cycling of PN due to cholestasis. Most of the PIs (88.7%) were accepted by physicians. Conclusion and relevance The majority of interventions were due to changes in the composition of macronutrients and micronutrients of the PN, adjusting to the constant changes in the needs of critically ill patients. The high number of PIs per patient and the high degree of acceptance by physicians highlight the significant role of the hospital pharmacist in the nutritional control of critically ill patients. References and/or acknowledgements No conflict of interest.

Background and importance The antimicrobial stewardship programmes are essential to achieve proper use of antibiotics, especially in units of special complexity, such as the intensive care unit (ICU). Aim and objectives To show the antibiotic pressure in the ICU and the groups of antibiotics with greatest deviation in their consumption (2017); to describe the activities carried out by the ICU antimicrobial stewardship team (ICU-AST) from 2018 to June 2019; and to show the results obtained in 2018 and in the first and second quarters of 2019. Material and methods • This was a prospective intervention study from January 2018 (when 2017 ICU antibiotic pressure data were obtained) to June 2019. • The ICU-AST comprised an intensive care doctor, microbiologist and hospital pharmacist, all with experience in AST. • The activities and interventions of the ICU-AST were agreed in the commission of infections after analysis of the data obtained. To measure antibiotic pressure, the rate DDD/1000 bed days was used. All antibiotic pressure data were obtained by the hospital pharmacist who analysed consumption in the ICU from electronic prescriptions data. • All actions carried out by the group were recorded in a database (Excel) where all variables were coded (date, training activity, information feedback and modification in prescriptions). Results Data were adjusted so that changes in DDD (2019) did not generate interference. Antibiotic pressure in the ICU (2017): 2295.85 DDD/1000 bed days. Groups of antibiotics with greatest deviation: carbapenems 333.03 DDD/1000 bed days and antifungals 210.95 DDD/1000 bed days. Activities carried out by ICU-AST: in 2018, the interventions (n=943) performed to reduce antibiotic pressure and carbapenem and antifungal consumption were adequacy of prescriptions to the internal guidelines (33.54%), de-escalation of treatments (27.32%), proposition of short course treatments (19.36%), broad spectrum restriction (10.57%) and other (9.21%). Four training sessions on antibiotic prescriptions were conducted (2018) and antibiotic pressure data were shown quarterly (2018–June 2019). All antibiotic treatments were reviewed 48–72 hours after initial administration by the ICU-AST. No additional economic resources were needed as the ICU-AST was formed by professionals who already worked in the centre. The results obtained were Antibiotic pressure: 2018: 2078.88 DDD/1000 bed days 1st quarter 2019: 1760.55 DDD/1000 bed days 2nd quarter 2019: 1830.95 DDD/1000 bed days Carbapenems: 2018: 329.43 DDD/1000 bed days 1st quarter 2019: 211.34 DDD/1000 bed days 2nd quarter 2019: 232.29 DDD/1000 bed days Antifungals: 2018: 132.26 DDD/1000 bed days 1st quarter 2019: 120.22 DDD/1000 bed days 2nd quarter 2019: 108.67 DDD/1000 bed days Conclusion and relevance In 2017, antibiotic pressure in the ICU was high. Two groups of antibiotics had excessive consumption: carbapenems and antifungals. The ICU-AST carried out training sessions, feedback of antibiotic pressure data and intervened directly, modifying the antibiotics treatment. This intervention achieved a decrease in global antibiotic pressure in the ICU. In addition, the ICU-AST achieved a reduction in antibiotic pressure in the groups with greater deviation: carbapenems and antifungals. A limitation of the study was that mortality was not measured, although no significant change is expected as the mortality commission did not report any significant change during the study period. References and/or acknowledgements No conflict of interest.

Background and importance The prescriptions of new antibiotics should be done with caution as improper use can lead to the emergence of new antimicrobial resistance. The antimicrobial stewardship team (AST) and the commission of infections (CI) have a fundamental task of achieving adequate use of these drugs. It is important to establish a suitable circuit for the control of their prescriptions. Knowing how this circuit operates is essential to establish if it is necessary to make any modifications. Aim and objectives To analyse the operation of the prescription/revision circuit for new antibiotics included in the pharmacotherapeutic guide, and to show the adequacy of the prescriptions of antibiotics recently included in the hospital’s pharmacotherapeutic guide. Material and methods Inclusion criteria: prescriptions (January 2018 to September 2019) of ceftaroline, dalbavancin, ceftolozano/tazobactam, ceftazidime/avibactam, tedizolid and isavuconazole. Exclusion criteria: prescriptions in the intensive care unit (which has a different prescription circuit). The CI and AST decided the indications for the new antibiotics and their prescription circuit. A non-restrictive attitude was decided. Prescription of these antibiotics could be carried out by any specialist, with or without prior advice from the AST. Prescriptions made without AST supervision were reviewed by the AST in 24–48 hours. The information for review was obtained from medical and electronic prescription records. Results A total of 28 prescriptions were reviewed: 39.3% (n=11) ceftazidime/avibactam, 28.6% (n=8) dalbavancin, 14.3% (n=4) ceftaroline, 7.2% (n=2) ceftolozano/tazobactam, 7.2% (n=2) isavuconazole and 3.4% (n=1) tedizolid. A total of 50% (n=14) of prescriptions were made by the AST and 50% (n=14) were performed by doctors who did not belong to the AST, of which 36% (n=5) had prior consultation with the AST and 64% (n=9) did not consult the AST. Of the prescriptions that did not receive prior advice from the AST, 55.55% (n=5) were reviewed by the AST. All of the prescriptions (100%, n=14) made by the AST or under their supervision were within the indications established by the CI. Five of 28 prescriptions were not adequate (2 isavuconazol, 2 ceftaroline, 1 tedizolid). These were prescriptions made without the advice or revision of the AST. Three of the incorrect prescriptions were in August 2018 and one in August 2019. Conclusion and relevance In general, our circuit worked correctly. Some of the prescriptions out of indication were during the holiday period and not all AST members were working. Therefore, this team should operate at full capacity all year round. The adequacy of antibiotics is greater when there is AST prescription or intervention. References and/or acknowledgements No conflict of interest.

Background Tolvaptan and, recently, urea were both indicated for the treatment of hyponatraemia secondary to the Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) in our country. The FDA also contemplated its use in patients with heart failure (HF). Regarding safety of these drugs, patients with very low baseline natraemia may be at risk for too-rapid correction of serum sodium (>12 mEq/L/24 hours). Purpose To analyse the effectiveness and safety of tolvaptan and urea, and its use in relation to the diagnosis of hyponatraemia. Material and methods Retrospective observational study of all cases of severe symptomatic hyponatraemia diagnosed during 2016 in a tertiary care hospital and patients who started treatment with oral urea or tolvaptan during hospitalisation. Variables collected: etiology of hyponatraemia, analytical parameters, dose and duration of treatment. Results Seven patients treated with tolvaptan: four diagnosed with HF and three with SIADH. Dose ranged from 15 mg/day to 30 mg/day. Median duration: 7 days (2–28). Baseline and final mean natraemia: 119.8 mEq/L and 133 mEq/L respectively. Two patients with SIADH and one with HF had eunatraemia. Three patients were exitus. Six patients were treated with urea, five diagnosed with SIADH and one with adrenal insufficiency. Urea dose ranged from 15 g/day to 30 g/day. Median duration of treatment: 15 days (7–147), three patients continued at home. Baseline and final mean natraemia were 123.4 mEq/L and 133 mEq/L respectively. Three patients with SIADH achieved eunatraemia, two patients were exitus. Only three urea patients had all necessary data for a diagnosis of SIADH. The mean increase in natraemia at 24 hour was 4.57 mEq/L (0–8) in the urea group; 9.9 mEq/L (−3 to 21) in the tolvaptan group (>12 mEq/L in the three cases of SIADH and one case of HF). Deaths were due to complications related to their advanced disease. Conclusion Off-label use of tolvaptan in HF has not been shown to be effective. Regarding hyponatraemia in SIADH, tolvaptan has shown to be moderately effective, but the correction was too rapid. This result can be related to an incorrect diagnosis of SIADH and/or a too low baseline natraemia. Urea proved to be an alternative of moderate efficacy but safer, allowing its ambulatory use. Therefore, the pharmacy service proposed to establish in our hospital a protocol for the management of severe hyponatraemia to improve the efficacy and safety of tolvaptan and urea. References and/or acknowledgements No conflict of interest.

Background Traditionally, the functions of the clinical pharmacist in the intensive care unit (ICU) of our hospital were based on pharmaceutical interventions (PIs) concerning parenteral nutrition (PN), the preparation of these formulas and checking that the composition was adapted to the nutritional requirements and the clinical situation of the patient. Nevertheless, the same pharmacist can also collaborate with the ICU staff (physicians or nurses) in the optimisation of the pharmacological treatment of critically ill patients. Purpose To describe the number and type of PIs upon medical prescriptions of critical care patients and to assess the impact of these PIs according to the degree of acceptance by the ICU staff. Material and methods We carried out a prospective study between 1 April and 31 May 2018 in an ICU of 18 beds of a tertiary teaching hospital. Inclusion criteria: ICU patients who received PN during the stay. Variables included: type of PI (made after daily review of the nutrition and drugs prescriptions that were communicated verbally to the ICU staff), demographics and acceptance by the ICU staff. Results During the study period, 232 patients were admitted to the ICU, 30 (12.9%) of whom received PN (mean age 62, range 13–93; 32% females; mean length of stay 3 days: range 1–36). A total of 134 PIs were recorded: 56.7% were related to PN prescriptions (27.6% of this kind of PI were modifications of insulin, 14.5% were modifications of electrolytes); 16.4% enteral nutrition PIs; 7.5% administration of drugs via the nasogastric tube; 7.5% giving information about drugs administration; 4.5% stability of intravenous mixtures; 3% conciliation of medication; 3% suggestions for changing one drug for another (due to inefficiency); and 1.5% concerning maximum dose alerts. Eighty-three per cent of PIs were accepted by the ICU staff. Conclusion More than four PIs were performed per patient and the percentage of rejected PIs was very low. Although the main task of our clinical pharmacist was focused on clinical nutrition, this study demonstrates the role and importance of this professional incorporated into the ICU multidisciplinary team, since PIs contribute to prevent medication errors and to improve the effectiveness and safety of the total pharmacological treatment in critically ill patients. References and/or acknowledgements No conflict of interest.

Background The World Health Organisation recognises the need to improve uptake and completion rates for postexposure prophylaxis (PEP). Purpose To analyse PEP dispensed by the pharmacy service to patients after an occupational (OE) or nonoccupational (NOE) exposure to the human immunodeficiency virus (HIV). To compare usual clinical practice in our centre for PEP to European acquired immune deficiency syndrome (AIDS) Clinical Society guidelines.1 Material and methods A descriptive, observational and retrospective study performed in a third-level hospital regarding PEP dispensed from January 2015 to March 2018. The following data were retrieved from an electronic prescription program management tool (outpatients’ clinical module) and electronic clinical records: sex, age, year, time from exposure, nature of exposure (sexual contact (SC) vs blood contact (BC)), OE vs NOE, service of the prescribing doctor, antiretroviral drugs (AD) prescribed, following monitoring in outpatient visit, positive infection detected after PEP, further episodes of PEP and positive infection nowadays. We reviewed the current version of the European AIDS Clinical Society guidelines.1 Results Current guidelines recommend 4 week treatment with AD after OE or NOE as early as possible (no later than 48/72 hours). PEP regimen: emtricitabine/tenofovir disoproxilfumarato (FTC/TDF)+raltegravir (RAL) or darunavir/ritonavir (DRV/r) or lopinavir/ritonavir (LPV/r). Re-evaluation of PEP indication by HIV experts is recommended within 48–72 hours. Clinical records of 57 patients were analysed: distribution per year 2015 24.5% (n=14), 2016 33.3% (n=19), 2017 33.3% (n=19), 2018 8.7% (n=5). Median age 29.9 years, 77.2% (n=44) males. Time from exposure Conclusion PEP is more frequently prescribed in young males after NOE by SC, and in our centre is not uniform regarding prescribing doctor, AD used or subsequent monitoring of patients. Our clinical practice differs from European guidelines in AD use and patient monitoring. In order to comply with those guidelines, we will implement a protocol to optimise PEP prescription and patient follow-up. References and/or acknowledgements 1. European AIDS Clinical Society (2017). EACS guidelines version 9.0, October 2017. No conflict of interest.

Background Medicines shortages (MS) have become a complex global issue, forcing changes in the hospital formulary and increasing the risk of medication errors. Additionally, problems related to these MS create difficulties for healthcare professionals and require urgent pharmacist-led action. Purpose To analyse the impact of MS in our centre and to describe the different actions performed by the Pharmacy Service (PS) to minimise risks regarding medication errors. Material and methods Descriptive, observational and retrospective study performed in a third-level hospital regarding MS registered in our centre from January 2017 to September 2018. The following data were retrieved from the MS listed in the Spanish Agency for Medicines and Health Products (AEMPS) online platform and Farmatools management tool: affected medicine (active substances and pharmaceutical forms); inclusion in the hospital formulary; and measures implemented to solve the MS (only when included in the hospital formulary). Results During the study period, there were 476 medicines affected by shortage problems in our country. Three-hundred and twenty-three (67.8%) active substances were included in our hospital formulary, but only 138 (29.9%) had the same dosage and pharmaceutical form, and consequently, needed to be managed by the pharmacist. The strategies for the management of MS were: Changing the provider or buying a different packaging in 55 cases (39.9%). Using a therapeutic alternative in 13 cases (9.4%). Medicine imported from other countries through AEMPS authorisation was available in 26 cases (18.9%) but we only used it in 11 cases (8%) because of the need to repack each unit with a translated label and product data sheet before its distribution in the hospital. Restricted use of available pharmacy stock in 14 cases (10.1%), according to clinical criteria agreed with medical staff. No action was needed in 45 cases (30.6%) due to infrequent use of the medicine affected and/or enough pharmacy stock available until resupply. Conclusion A large number of medicines were affected by shortages in our centre. These MS have shown an important degree of compromise in patient care and treatment safety. Pharmacists are required to take urgent action to manage problems caused by MS, which implies greater workload due to administrative procedures, determination of therapeutic alternatives and communication with health professionals involved, so as not to compromise the continuity of treatments. References and/or acknowledgements No conflict of interest.

Background Etanercept is a biological drug that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF) with a considerable economic impact on the hospital’s annual budget. Biosimilar therapies are expected to be less costly for healthcare systems. Purpose The primary endpoint was to analyse treatment costs with etanercept biosimilar (EB) vs etanercept reference product (ERP) as initial treatment and the potential economic impact of switching to EB for maintenance therapy. Material and methods Retrospective observacional study including all patients treated with etanercept from March to September 2017. Data on prescription details, number of prescriptions and costs, were retrieved from the Farmatools ® management tool (outpatients clinical module). The Pharmacy and Therapeutics Committee included EB as a cost-effective alternative and in the light of available scientific data, prescribers agreed with the pharmacy staff to use it as initial therapy. Regarding switching maintenance therapy from ERP to EB, prescribers were responsible for individualising the decision according to patients’ medical records. Results During the study period 190 patients were treated with etanercept. Seventy-eight per cent were rheumatology patients and 22% were dermatology patients. EB was prescribed as initial treatment in 100% of cases (25 new treatments in rheumatology, nine in dermatology). No switching to EB was prescribed in maintenance therapy. A total of 256 doses of EB 50 mg were dispensed, which generated savings of €43.491, when compared to ERP’s best offer. Regarding the potential economic impact of switching maintenance therapy, we estimated that this strategy would mean savings of €339.012 to our centre. No adverse effects or low efficacy data were reported with EB treatments. Conclusion Introducing EB as initial therapy for rheumatology and dermatology patients has resulted in a modest reduction in drug spending in our centre. Potential savings justify the urgent need to implement agreed protocols for switching to EB in maintenance therapy as well. This would mean significant cost savings and improved access for patients to these highly effective therapies. A cross-sectoral collaboration among prescribers, pharmacists and nurses facilitate pharmacovigilance activities, in order to assure the quality, safety and efficacy of EB. No conflict of interest

Background Secukinumab has demonstrated efficacy in moderate to severe plaque psoriasis (PP) by improving the Psoriasis Area and Severity Index (PASI), but patients’ quality of life is not always quantified in clinical trials. Purpose To evaluate the efficacy of secukinumab in PP treatment and how it affects patients’ quality of life. Material and methods An observational and prospective study was conducted. Patients diagnosed with moderate to severe PP who began treatment with secukinumab in the period between January 2016 and June 2017 were included. Patients that did not complete at least 16 weeks with the treatment and those who did not sign the written informed consent form were excluded. To evaluate the response to secukinumab, PASI score was measured before and after 16 weeks of treatment: data obtained from the hospital database. The results on PASI were presented as a percentage response rate: PASI 75, PASI 90 and PASI 100. The participants filled out the Dermatology Quality of Life Index (DLQI) questionnaire: DLQI A (before secukinumab) and DLQI B (week 16) in our hospital Pharmacy Department. Results The study was carried out in 36 patients. Average age was 48.8 years (34–67). Median time since diagnosis of PP was 17.6 years (6–32). All patients had been treated with metotrexate before starting biologic therapy. 86.1% of patients were previously exposed to biologics, 25 had been treated with anti-TNF agents (etanercept, infliximab and/or adalimumab), six had been treated with anti- IL12/IL13 (ustekinumab) and 5 were naive. Medium PASI score before and after 16 weeks of treatment was 21.5 (9–35) and 1.7 (0–10) respectively. Average score of DLQI A was 20.1 (6–28) and 1.3 (0–11) for DLQI B. PASI 100 was achieved in 58.3% of patients (21), PASI 75 responders were 22.2% and 19.4% did not reach PASI 75. Patients who reached the best DLQI variation were those who achieved PASI 100. Conclusion Secukinumab is a good alternative to naive patients and those who have not had a good response to other biologics. According to the correlation between PASI and DLQI scores, the more efficacy in treatment, the better improvement in quality of life. No conflict of interest

Background Drug therapy represents a major portion of healthcare spending. Drug utilisation research contributes to optimise drug policies in a rational drug use context. Purpose To analyse PQI results in our centre and to identify new strategies in order to reinforce its compliance. Material and methods Descriptive study based on the information arising from the PQI results from November 2015 to October 2016 compared to the previous two years. PQI is a tool proposed by our healthcare service (HCS) in order to establish a qualitative and quantitative assessment of drug prescribing. The index includes 14 items for specific improvement objectives for different therapeutic areas, and they are weighted according to their importance in global pharmaceutical spending (optimal 10 points, minimum 5). Data on defined daily dose (DDD) and prescriptions (number, cost, medical department) were retrieved from the Microstretegy® assistance application. Results From November 2013 to October 2014, our centre scored 6.71 (HCS average 4.83), from November 2014 to October 2015, 4.72 (4.83) and from November 2015 to October 2016 2.54 (2.37). Due to the evident decline,an in-depth analysis it was imperative to reverse this trend. Analysis showed an imbalance when data were broken down by medical department. Most of the medical departments achieved a minimum score of 5 points at PQI, but they did not reach minimum score for those items with higher impact in their pharmaceutical consumption. Comparing the data between November 2014 to October 2015 and November 2015 to October 2016, we observed poorer results for the following items (therapeutic group (treatment of choice)): second-line antihyperglycaemic therapies (glicazide,glipizide,glimepiride); insulin treatment (intermediate and biphasic); lipid lowering medication (simvastatin); high-blood pressure medication (angiotensin-converting-enzyme inhibitor ±tiazides and angiotensin-II-receptor-antagonists losartan ±tiazides); and antidepressants (selective serotonin reuptake inhibitors). Endocrinology, cardiology and mental health medical departments were responsible for the low scores in those items. Consequently, a programme was designed and implemented to ensure the achievement of the PQI objectives: medical departments will have to comply with only 3/14 items from the PQI, and those who represent ≥80% overall DDD consumption in their department. Scores are now regularly reviewed in order to identify possible deviations and take the actions necessary to correct them. First results are reported as positive (August 2017, 2.88), particularly in the cardiology department. Conclusion Analysis of PQI results is essential to adapt the specific improvement objectives to the medical units, in order to grant a sustainable high-quality public health system. No conflict of interest

Background Drug shortages are becoming more common and may involve a reduction in pharmacotherapeutic efficacy and increased medication errors. Problems caused by medicines’ shortages are serious, threaten patient care in hospitals and require urgent action. Purpose To analyse the impact of shortages and to describe the different actions carried out by the Pharmacy Department. Material and methods A retrospective descriptive study was carried out from January 2017 to October 2017. The data collected were: affected drug, duration of the shortage and measures implemented. The data were obtained from the drug shortages’ list of the Spanish Agency for Medicines and Health Products (AEMPS). We analysed every drug included in the hospital pharmacotherapy guide. Results During the study period, there were 226 drugs affected by supply problems, 172 of them active principles included in our pharmacotherapy guide, specifically 98 pharmaceutical specialties. The strategies for the management were: To change the provider or the form of presentation (packaging) in 38 cases (38.77%). To use a therapeutic alternative in 13 cases (13.26%). The AEMPS authorised temporarily the importation of six medicines with the outer packaging and package leaflet in a language other than Spanish, but this option was not used. In eight cases (8.16%) there was controlled distribution of certain drugs just in case of clinical need. Despite the AEMPS offer to import 17 foreign medicinal products, only nine applications (9.18%) were processed. The foreign medicinal products were relabelled in Spanish before being dispensed in the hospital. No action was taken in 30 cases due to the low prescription rate in our centre or the availability of sufficient stock. Conclusion The unpredictability of shortages and lack of information provided to healthcare professionals make it increasingly difficult to plan effective coping strategies to provide medication to patients. In fact, it implies a greater workload for hospital pharmacists due to administrative procedures, the determination of therapeutic alternatives and the need to inform all health professionals so as not to compromise the continuity of treatment, increased stress and confusion within safety-critical working environments, the frequent high costs of procuring alternative medicines and the cancellation of service improvements due to resources needing to be reallocated to deal with medicines’ shortages. No conflict of interest

Background Apremilast is a phosphodiesterase4 inhibitor. Two pivotal trials were carried out comparing apremilast to placebo in plaque psoriasis (PP). At week 16, significantly more patients taking apremilast achieved PASI75 (28.8%–33.1%) in both trials, versus placebo (5.3%–5.8%). Purpose To assess the adaptation of the PP treatment prescriptions of apremilast under the Hospital Protocol and its economic impact, and to assess the percentage of patients who reached PASI75 at week 16. Material and methods A descriptive, retrospective study was conducted between March 2016 and October 2017 on apremilast prescriptions. Patients with PP treated with apremilast were included and data were available from medical histories. According to the use protocol (UP) of apremilast, it should be used in patients with PP who have any contraindication to biologic therapies (BT) such as immunosuppression, due to the fact that indirect comparisons suggested that it is less efficient than BT. Results After designing the UP of apremilast, 32 prescriptions from the Dermatology Department were registered. 34.37% of patients (11/32) met the requirements of use (contraindication of BT). If the compliance of the UP had been 100%, 21 patients would have been treated with etanercept (the first-line BT chosen in our centre). Thus, it would have lead to a cost saving of 19.85% of the cost per patient/year in PP treatment since a year of treatment with etanercept costs €6245.52, whereas with apremilast it is €7794.2. Data concerning initial PASI and PASI at week 16 were available in 56.25% (18/32), in which 27.77% reached PASI75 (5/18). Among 43.75% (14/32) of patients without PASI75 results, 42.85% (6/14) had no data about PASI, 42.85% (6/14) had not already reached week 16 and in 14.28% (2/14) the treatment had been withdrawn because of adverse events (AE). Twenty-five per cent (8/32) of patients did not currently continue with the treatment, 25% (2/8) of them because of AE and 75% (6/8) because of lack of efficacy. Conclusion The implementation of a consensual UP for new treatments such as apremilast could enhance the rational use of this drug, but further collaboration with the physicians is needed to achieve a better optimisation of the available resources. No conflict of interest

Background Disease modifying therapies (DMT) for multiple sclerosis (MS) have a considerable economic impact on hospitals’ annual budgets. Since February 2017, there has been a shift of power from our Health Service Area to local MS committees to evaluate the appropriateness of DMT prescriptions. Purpose To evaluate the benefits of including a pharmacist in the MS Committee in a third-level hospital. Material and methods Descriptive, observational and retrospective study based on the information arising from the prescription of DMT for MS from February to August2016 vs February to August 2017. Patient and treatment data (prescriptions, previous DMT, costs) were retrieved from the Farmatools® management tool (outpatients clinical module). The MS Committee organised weekly meetings with the neurologists in charge of monographic consultations for MS in our centre. The objective was to choose the most cost-effective alternative for those patients who were candidates to initiate or change their DMT. An evidence-based algorithm was designed to assist the Committee in decision-making. Results Patients were classified regarding if they used home treatment: oral (dimethyl fumarate, teriflunomide, fingolimod) or injectable (interferon s1A and 1B, glatiramer acetate), or infusion therapies (natalizumab and alemtuzumab). In 2016 215 patients received home treatment vs 243 in 2017, and the estimated annual cost per patient decreased by 10.5% (€10.428 vs €9.326). Despite the increase in patients being treated, the positive economic results were possible due to the prescription of more cost-effective alternatives for initial treatments such as interferon s1B (2016, 0% vs 2017, 23%) and glatiramer (2016, 0% vs 2017, 13%) both considered as safe first-line treatments in MS. The same trends were observed in infusion therapies: 2016, 59 patients vs 2017, 61 patients, decrease of 12.5% in estimated annual cost per patient (€17.106 vs €14.962). In this case, this was explained by the administration of natalizumab using extended interval dosing (every 5 weeks). Conclusion Including a pharmacist on the MS Committee has permitted the optimisation of the management of DMT in a Rational Use of Medicines context. Evidence-based clinical protocols are essential in order to contribute to the financial sustainability of public healthcare and to improve patient access to existing medicines. No conflict of interest

Background Proprotein inhibitors convertase subtilisin/kexin9 (i-PCSK9) are new drugs for hypercholesterolaemia used in monotherapy or in combination with statins, which have numerous interactions. It may be useful to study the efficacy of I-PCSK9 as a single therapy. Purpose To compare the efficacy of i-PCSK9 alirocumab and evolocumab in monotherapy versus bitherapy with statins, in order to define the clinical benefit of deprescribing statins in these patients. Material and methods A retrospective observational study was conducted in our centre from March 2016 to March 2017. Patients treated with I-PCSK9 with/without combining it with statins were included. Low-density lipoprotein cholesterol (LDL-C) levels were measured before starting the treatment and at weeks 8 and 24. Data were available from medical histories. Adherence was calculated indirectly by consulting the dispensing of statins at the pharmacy office in the application for external prescription of our Autonomous Community. Results During the study period, 42 patients, 25 males and 17 females, were treated with i-PCSK9 in our centre. Sixteen started i-PCSK9 as a single treatment because of their intolerance to statins. Among the 26 patients who continued their treatment with statins, 58% (15/26) had a treatment adherence of 90%. Forty-two per cent (11/26) of these patients dropped out from treatment with statins before week 8. In the subgroup of patients in treatment with i-PCSK9 in monotherapy (because of lack of adherence or intolerance to statins) the lowering of LDL-C at week 8 (n=10) was compared to patients treated with bitherapy (n=9) (all other patients were excluded because they had not completed 8 weeks of treatment or because of lack of data). An average reduction in LDL-C from a baseline of 57% (95% CI: 40 to 74) and 80% (95% CI: 40 to 74) was obtained respectively. Conclusion A high rate of patients who start i–PCSK9 therapy do not continue statin treatment. In our study, the reduction in LDL–C with i–PCSK9 as a single agent is similar to the results of the LONG TERM trial (60%) in which only patients with biotherapy were included. Regarding the results obtained and the added complexity of using statins, it seems reasonable to research the efficacy of i–PCSK9 in monotherapy. No conflict of interest

Background The National Institute for Occupational Safety and Health USA (INSHT) in collaboration with the Spanish Society of Hospital Pharmacy (SEFH) has conducted a compilation of all drugs used in hospitals considered dangerous, with recommendations for proper preparation and administration, considered of great interest for all workers and patients. Purpose To optimise pharmaceutical care in outpatient consultation by including INSHT recommendations into the pharmacotherapeutic interview, and by updating the written information received by patients. Material and methods In September 2016, the INSHT’s list of hazardous medications was published in collaboration with SEFH. Medications included in our pharmacotherapeutic guide that were administered to outpatients were revised. Pharmaceutical care protocols including the aforementioned medications were revised and modified. Also, necessary modifications to the information sheets were made. The following items were included in the information sheets for patients: preparation recommendations, administration recommendations and causes of hazard. Results Of the 319 pharmaceuticals labelled hazardous by INSHT, 24 hazardous pharmaceuticals were detected, which were being administered in the outpatient care area. The majority of those phamaceuticals were antivirals against HIV and chronic hepatitis virus (33.33%), immunosuppressants (25%) and medication for pulmonary hypertension (16.66%). Pharmaceutical care protocols and information sheets for patients were modified in 100% of all medications involved, which included a section with specific recommendations. Conclusion Patients and healthcare workers are exposed to a series of chemical hazards due to preparation and administration of drugs. They must take preventive measures in order to avoid exposure, as its effects can be dangerous for the workers. Periodic review and update of pharmaceutical care protocols, and of all materials employed, improves both the quality of outpatient healthcare services and patient safety. No conflict of interest

Background The introduction of PCSK9 inhibitors in the treatment of hypercholesterolaemia marks a breakthrough for patients unresponsive to traditional treatment. However, in our country, 44.9% of adults have high LDL-C levels (≥ 130 mg/dL or under treatment), so inadequate use of these innovative drugs might have a strong impact on efficiency and safety. The national atherosclerosis association published a document regarding the restricted indications for use of the PCSK9 inhibitors, and we adapted it to our centre. Purpose We evaluated compliance with the protocol for prescription of PCSK9 inhibitors in our centre. Material and methods In March 2016, the pharmacy and therapeutics committee created their own protocol together with internal medicine, cardiology and endocrinology services. It turned out to be more restrictive than the national guidelines, with higher LDL-C levels required. Based on the available evidence and taking into account criteria of efficacy and safety, four indications were included: (1) HoFH: homozygous familial hypercholesterolaemia with LDL-C >120 mg/dL with the maximum tolerated dose of statin and ezetimibe; (2) HeFH: heterozygous familial hypercholesterolaemia with LDL-C >120 mg/dL with the maximum tolerated dose of statin and ezetimibe; (3) previous cardiovascular event (pCVE) with LDL-C >100 mg/dL with the maximum tolerated dose of statin and ezetimibe; and (4) any of the above with LDL-C >120 mg/dL in patients who are statin intolerant, or for whom a statin is contraindicated. We evaluated the compliance with our protocol for prescribing PCSK9 inhibitors from March to September 2016, based on computerised medical records. Results We received 26 prescriptions, 20 from the internal medicine service, 3 from the endocrinology service and 3 from the cardiology service. All complied with the protocol, except for 1 that was approved by the committee for the treatment of hyperlipoproteinaemia. The following patients were treated: 18 HeFH, 6 pCVE and 1 pCVE who was statin intolerant. Conclusion In our centre, there was high compliance with the protocol for the prescription of PCSK9 inhibitors. Due to the major economic impact of these new drugs, continuous follow-up would be required to ensure that every prescription meets the requirements of the protocol in the treatment of hypercholesterolaemia with PCSK9 inhibitors. No conflict of interest

Background Electronic prescription was traditionally used in our country by primary health centres but it has also been progressively introduced into hospitals. This has had an economic impact on some products, such as those used in artificial home nutrition. Purpose To assess the economic impact arising from electronic prescription of diet products at a specialty hospital. To establish effective measures to compensate for the economic impact resulting from the transfer of responsibilities from primary health care to hospital care. Material and methods Retrospective observational study of the increase in spending and number of prescriptions for diet products in outpatient clinics and on hospital discharge. The period from November 2014 to October 2015 was compared with an equivalent period from the previous year. These data were then correlated with percentage of implementations of the electronic prescription module. Prescription details, number of prescriptions and costs were retrieved from the Microstrategy assistance application. The data were broken down by medical service, prescriber and product. Results After analysing the data, an increase in home prescriptions for diet products was found: the number of prescriptions rose by 45.24%, which caused a total increase in costs of 55.14%. These data are explained by a higher degree of implementation of the electronic prescription module (88% in 2014 vs 98.28% in 2015), as well as greater flexibility in computer based procedures for visa issuance. The endocrinology department was responsible for 66.9% of diet product spending. We observed a greater increase in prescription of complete formulae for diabetics (99.08%); polymeric, normoproteic, normocaloric, fibre-free formulae (538.46%), and hypercaloric, fibre-rich formulae (149.36%). A project was developed to incorporate the pharmacist into the visa circuit, in order to ensure efficient management of diet products in compliance with national legislation. To accomplish this goal, the unit of clinical management of pharmacy undertakes the management of visa approval for diet products. Conclusion Prescribing via electronic prescription has involved an increase in spending on artificial home diet at our centre. Incorporating a hospital pharmacist into the visa circuit might optimise usage of dietary therapeutic products, thereby ensuring compliance with safety and efficacy criteria, as well as appropriateness of treatment and patient follow-up. No conflict of interest

Background Macitentan is a new endothelin receptor antagonist (ERA) which was compared with placebo in the SERAPHIN trial. The results showed no superior efficacy or safety compared (indirectly) with other ERAs but better hepatic tolerance. Purpose To assess adaptation of pulmonary arterial hypertension (PAH) treatment prescriptions under our hospital protocol and its economic impact, and to describe the clinical results of using a new ERA, macitentan. Material and methods A use protocol for ERAs was established in September 2016 in our hospital, evaluating cost effectiveness as the main criterion for prescription. Thus bosentan was chosen as the first option for treatment as macitentan had not shown superiority with regard to either efficacy or safety. According to the use protocol, macitentan should be used in naive patients with liver dysfunction or in those patients treated with bosentan who have developed treatment related hepatic toxicity. Several clinical parameters assessed PAH disease before and after treatment: functional class, baseline oxygen saturation (%SpO 2 ) and NT-proBNP levels. Results After designing the use protocol for ERAs, 9 prescriptions for macitentan from the respiratory department were registered. 44% of patients (4/9) met the requirements of use of macitentan (increased transaminases before using bosentan). The treatment cost per month with a standard maintenance dose of bosentan 125 mg/12 hours was €414, while the treatment cost per month with a standard dose of macitentan 10 mg/24 hours was €2063. After 4 months of treatment with macitentan, patients with elevated transaminases had returned to normal levels but all patients maintained the same functional class and there were no clinically significant differences in%SpO 2 or NT-proBNP (p>0.05). Conclusion If compliance with the use protocol for ERAs had been 100%, 5 of the patients would have been treated with bosentan, leading to a cost saving of about €1649 for patient per month, a total amount of €74205 so far this year. Implementation of a consensual use protocol for ERAs could enhance the rational use of this drug, but further collaboration with physicians is needed to achieve better optimisation of available resources. No conflict of interest

Background The addition of telaprevir to peg-interferon and ribavirin represents a new treatment for hepatitis C (HCV) associated with an improvement in treatment response rates but an impairment of the safety profile. Purpose To evaluate the safety of telaprevir-based treatment in patients with HCV infection in real clinical practise in a specialty hospital. Materials and Methods Prospective and observational study of patients who started telaprevir between April and September 2012. Data were collected at each treatment visit at the hospital pharmacy through clinical interview and revision of analytical parameters. Results We enrolled 14 patients treated with telaprevir, 9 mono-infected and 5 co-infected. All patients were between 18 and 70 years old, had HCV genotype-1 infection and had at least stage 3 liver fibrosis (Metavir score).Only two patients had received no previous treatment. In the pre-treated group, 42% of the patients had a previous relapse, 33% had a partial response, and 25% had no response. 43% of patients required ribavirin dose reduction due to anaemia (haemoglobin 23% of patients needed erythropoietin-stimulating agents due to anaemia (haemoglobin 8% of patients required a blood transfusion Telaprevir was stopped in one patient because of rash. No patients discontinued treatment because of anaemia. Conclusions The safety profile of telaprevir was consistent with the findings in clinical trials. However, most of the adverse events were reported more frequently in patients in real clinical practise compared with previous results in clinical trials. These serious and frequent adverse events may be an opportunity for pharmacists to get involved to improve the safety of this treatment. No conflict of interest.

Background In the pharmacy there is a unit where certain drugs are dispensed to outpatients. Pharmacists provide pharmaceutical care to all patients starting new treatment. Purpose 1) To identify and classify drug interactions (DIs) in all patients starting any treatment in the outpatient unit of our hospital pharmacy. 2) To carry out pharmaceutical interventions. 3) To identify patients who suffer more frequently from DIs. Materials and methods Prospective intervention study (January–May 2011) that included patients who started treatment at the outpatient unit of the hospital pharmacy. Data were obtained from the medical prescription and an interview with the patient. To detect and classify DIs the authors used the software ‘Lexi-Interact-Online’ and the book ‘Stockley, Drug Interactions. Third Edition (2009). Data were analysed with SPSS-15.0. Results Data collection comprised results from 104 patients (39 women, 65 men). Median age 53. SD 20 years (18–92). 187 DIs were detected (incidence 50.96%). 10.16% of the interactions occurred between drugs dispensed in hospital and concomitant home medicines (CHMs). 89.83% of the interactions detected were CHM-CHM. The risk of DI was rated as ‘major’ (14.43%), ‘moderate’ (79.14%) and ‘minor’ (6.43%). The reliability of the DI was ‘excellent’ (6.95%), ‘good’ (32.08%), ‘reasonable’ (57.75%) and ‘poor’ (3.22%). The mechanisms by which the DI developed were ‘pharmacokinetic’ (50.26%), ‘pharmacodynamic’ (35.82%), ‘unknown’ (12.3%), ‘other’ (1.09%) and ‘mixed pharmacokinetic/pharmacodynamic’ (0.53%). 38.46% of patients were polymedicated (≥6 drug). In these patients DI incidence was 87.70% versus a single drug in which DI was 12.3%. Pharmaceutical interventions were: monitoring DI from the outpatient unit in the pharmacy (10.6%), informing doctors (45.45%), advising on administration (31.81%), informing/educating patients (11.36%). Causes of non-intervention: habitual association/DI clinically irrelevant (51.93%), DI beneficial (25.12%), literature reports that there is no action required (12.59%), others (10.38%). Conclusions 1) The appearance of DIs in patients starting treatment in the outpatient units is common. CHMs should also be reviewed to detect DIs. 2) Every DI must be assessed individually and appropriate pharmaceutical interventions made. Not all DIs are harmful or clinically relevant. 3) Polymedicated patients are a group of special interest because most of the interactions occur in them.

Background Myelodysplastic syndromes (MDS) are a heterogeneous group of clonal haematopoietic neoplasms, characterised by the presence of morphological and functional alterations in different haematopoietic cell lines and anaemia, leucopenia and thrombocytopenia. 5-Azacitidine (AZA) is a hipomethylating agent indicated for the treatment of adult patients, who are not eligible for haematopoietic stem cell transplantation with intermediate-2 and high-risk MDS, according to the International Prognostic Scoring System (IPSS).Its effectiveness was evaluated in 3 studies conducted by the Cancer and Leukaemia Group B. Purpose This study aims to evaluate the effectiveness of AZA in patients diagnosed with MDS, outside the scope of CT. Materials and methods Results are taken from a retrospective observational study, including all patients with MDS treated with AZA 75 mg/m2 subcutaneously in our Hospital, during the period November 2007-April 2011. The World Health Organisation (WHO) criteria for diagnosis (bone marrow examination and cytogenetics studies) and classification of MDS were used. Response to treatment was assessed using the International Working Group (IWG 2006) criteria: overall response (complete and partial remission), stable disease, time of transformation to acute myeloid leukaemia (AML), overall survival, cytogenetic response and hematologic improvement. Results Data collection comprised results from 16 male and 9 female with a median age of 68,72 (±12,52) years. The average time to diagnosis of MDS was 22.56 (± 22.11) days. The number of blasts in bone marrow of patients at the time of diagnosis was on average 11%. An intermediate-2/high IPSS risk was documented in 76% of the patients, an intermediate-1 IPSS risk in 24%. The most frequently used dose was 75 mg/m2 subcutaneously, 12% of the patients required dose adjustment. The mean number of administered cycles was 9 (±6,08). 68% of patients had high transfusion requirement. Overall response was achieved in 29,16% of patients, stable disease in 33,34%, cytogenetic response in 48% and transfusion independence in 25%. The rate and the time of transformation to Acute myeloid leukaemia (AML) was 20,83%. The median overall survival was 32 months (95% CI 10.72-53.29) and the median time to AML transformation in 23 months (95% CI 21.54-24.4). Conclusions Results demonstrate that 5-azacitidine is an effective drug in the treatment of MDS, outside the scope of CT, which improves overall survival, quality of life and delays AML transformation.