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Background In February 2017, a clinical pharmacy service (CPS) team based on the ward was implemented at the internal medicine service in a first-level Portuguese hospital with several objectives: to identify, solve and prevent the occurrence of therapeutic problems, to guarantee the rational use of medicines, to reduce hospital stay and improve treatment adherence to ensure medicines optimisation along with a multidisciplinary team. Purpose To identify the actions and results obtained after the implementation of a CPS at the internal medicine service in a first-level hospital in Portugal. Material and methods Retrospective and descriptive study carried out for 8 months (February to September 2017). Patients’ data were compiled and analysed in Microsoft Excel. Patients’ age, sex and provenance (home/hospice) were recorded. All the CPS interventions, the degree of acceptance by the medical team and main drugs involved were also recorded. Results CPS vetted remotely on the electronic prescription system 14 955 prescriptions with 902 alerts sent to the prescribers. One hundred and ninety-six active interventions (discussed on the ward) were performed in 163 patients, of whom 79 were males (48.47%). The mean age was 76.61 years. The majority of them (123) (75.46%) lived at home at the moment of hospital admission. A total of 121 interventions (61.73%) were accepted. The top drugs involved were paracetamol with 48 interventions (24.49%), enoxaparin with 29 (14.8%) and vancomycin with 20 (10.2%). The switch from endovenous to the oral route, inappropriate dose according to patient renal function and medicines’ reconciliation were the most frequent type with 61, 29 and 20 interventions (31.12%, 14.8% and 10.2%, respectively). Conclusion The CPS identified and intervened in a large number of inadequate/incomplete prescriptions in the internal medicine service. As a challenge it is expected that an extension to other clinical services will benefit from the activity of the clinical pharmacy team. References and/or Acknowledgements Thanks to all the great multidisciplinary internal medicine and pharmacy services teams No conflict of interest

Objective: To analyse the impact of a multidisciplinary and decentralised safety committee in the paediatric management unit, and the joint implementation of a computing network application for reporting medication errors, monitoring the follow-up of the errors, and an analysis of the improvements introduced. Materials and methods: An observational, descriptive, cross-sectional, pre-post intervention study was performed. An analysis was made of medication errors reported to the central safety committee in the twelve months prior to introduction, and those reported to the decentralised safety committee in the management unit in the nine months after implementation, using the computer application, and the strategies generated by the analysis of reported errors. Measured variables: Number of reported errors/10,000 days of stay, number of reported errors with harm per 10,000 days of stay, types of error, categories based on severity, stage of the process, and groups involved in the notification of medication errors. Results: Reported medication errors increased 4.6-fold, from 7.6 notifications of medication errors per 10,000 days of stay in the pre-intervention period to 36 in the post-intervention, rate ratio 0.21 (95% CI; 0.11–0.39) (P .05). The notification of potential errors or errors without harm per 10,000 days of stay increased 17.4-fold (rate ratio 0.005, 95% CI; 0.001–0.026, P 0,05. Se multiplica por 17,4 la notificación de errores sin daño o potenciales por 10.000 días de estancia, razón de tasas: 0,005 (IC 95%: 0,001–0,026) p

Resumen: Objetivo: Analizar el impacto en la notificación de errores de medicación de la puesta en marcha de un comité de seguridad multidisciplinar descentralizado en la unidad de gestión pediátrica, e implantación conjunta de una aplicación informática en red para la comunicación de errores de medicación, mediante seguimiento de los errores y análisis de las mejoras. Material y métodos: Estudio observacional, descriptivo, transversal pre-post intervención. Se analizan los errores de medicación notificados a la comisión central de seguridad, en los 12 meses previos a la implantación, y los notificados mediante la aplicación informática descentralizada a la comisión de seguridad de la unidad de gestión, en los 9 meses posteriores, y las estrategias generadas por el análisis. Variables medidas: Número de errores notificados por 10.000 días de estancia, número de errores con daño por 10.000 días de estancia, tipo, categoría en función de la gravedad, fase del proceso, colectivo que notifica y medicamentos implicados. Resultados: Se multiplican por 4,6 los errores de medicación notificados —7,6 notificaciones por 10.000 días de estancia en el periodo preintervención y 36 en el postintervención—, razón de tasas de 0,21 (IC 95%: 0,11-0,39) p 0,05. Se multiplica por 17,4 la notificación de errores sin daño o potenciales por 10.000 días de estancia, razón de tasas: 0,005 (IC 95%: 0,001-0,026) p .05). The notification of potential errors or errors without harm per 10,000 days of stay increased 17.4-fold (rate ratio 0.005., 95% CI; 0.001-0.026, P

Resumen: Introducción: Los «medicamentos de alto riesgo» son aquellos con un «riesgo» muy elevado de causar daños graves o incluso mortales cuando se produce un error en el curso de su utilización. El Institute for Safe Medication Practices (ISMP) elaboró una relación aplicable a la población general, sin diferenciar población pediátrica y adulta, por lo que existe carencia de información para la población pediátrica. El objetivo de este trabajo es elaborar una lista de medicamentos de alto riesgo adaptada a la población pediátrica y neonatal que sirva de referencia para el personal sanitario de un hospital pediátrico. Material y métodos: Se realizó una búsqueda bibliográfica en mayo del 2012 en las principales bases de datos biomédicas, para identificar posibles listas o referencias publicadas en relación con medicamentos de alto riesgo en población pediátrica y neonatal. Resultados: Se encontraron 15 trabajos, seleccionándose 9 para el objetivo principal del estudio. Se elaboró una lista guía tomando como base la del ISMP, añadiendo fármacos con alta percepción de riesgo para la población pediátrica y eliminando aquellos cuyo uso en pediatría era anecdótico. Conclusiones: No se encontró una lista publicada que se adaptase totalmente a nuestro objetivo. La lista de medicamentos de alto riesgo en población pediátrica y neonatal elaborada puede ser modelo de referencia para hospitales pediátricos. Su conocimiento y utilización, así como actividades derivadas de la misma enmarcadas dentro de la política de seguridad, ayudará a evitar errores de medicación en cada proceso de la cadena terapéutica (prescripción, transcripción, dispensación y administración). Abstract: Introduction: «High-risk drugs» are those that have a very high «risk» of causing death or serious injury if an error occurs during its use. The Institute for Safe Medication Practices (ISMP) has prepared a high-risk drugs list applicable to the general population (with no differences between the pediatric and adult population). Thus, there is a lack of information for the pediatric population. The main objective of this work is to develop a high-risk drug list adapted to the neonatal or pediatric population as a reference model for the pediatric hospital health workforce. Material and methods: We made a literature search in May 2012 to identify any published lists or references in relation to pediatric and/or neonatal high-risk drugs. Results: A total of 15 studies were found, from which 9 were selected. A model list was developed mainly based on the ISMP one, adding strongly perceived pediatric risk drugs and removing those where the pediatric use was anecdotal. Conclusions: There is no published list that suits pediatric risk management. The list of pediatric and neonatal high-risk drugs presented here could be a «reference list of high-risk drugs » for pediatric hospitals. Using this list and training will help to prevent medication errors in each drug supply chain (prescribing, transcribing, dispensing and administration).

Objective: The primary objective of this review was to analyse the differences in efficacy between the administration of intermittent and continuous/expanded perfusion of piperacillin-tazobactam. Secondary objectives were to analyse the differences in safety, pharmacokinetic/ pharmacodynamic parameters, and cost-effectiveness between the two forms of administration. Method: We performed two different independent bibliographic searches. We encountered a total of 38 articles, and the final number included in the study was 6. We analysed the articles and collected the following variables: design, treatment administered to each group, total number of patients and number of patients in each study, variables collected in each study, and results. Results: We encountered significant differences in the primary variable in two of the six studies favouring continuous/expanded perfusion. The study by Lodise et al found differences (P=.04) in mortality (31.6% for intermittent perfusion vs 12.2% for continuous/expanded perfusion). The study by Lorente et al found differences (P=.001) in terms of clinical recovery (56.5% for intermittent perfusion vs 89.2% for continuous/expanded perfusion). As for secondary variables, we only found differences in one of the studies in relation to cost-effectiveness, in favour of the group who underwent continuous/expanded perfusion method. Conclusion: The analysed data suggest that continuous/expanded perfusion would be at least as effective as intermittent perfusion, and that it could be more effective in severe patients with infections from more resistant micro-organisms such as Pseudomonas aeruginosa. Additionally, this form of administration is more cost-effective, at least in theory.

To analyze the impact of a multidisciplinary and decentralized safety committee in the pediatric management unit, and the joint implementation of a computing network application for reporting medication errors, monitoring the follow-up of the errors, and an analysis of the improvements introduced.An observational, descriptive, cross-sectional, pre-post intervention study was performed. An analysis was made of medication errors reported to the central safety committee in the twelve months prior to introduction, and those reported to the decentralized safety committee in the management unit in the nine months after implementation, using the computer application, and the strategies generated by the analysis of reported errors.Number of reported errors/10,000 days of stay, number of reported errors with harm per 10,000 days of stay, types of error, categories based on severity, stage of the process, and groups involved in the notification of medication errors.Reported medication errors increased 4.6 -fold, from 7.6 notifications of medication errors per 10,000 days of stay in the pre-intervention period to 36 in the post-intervention, rate ratio 0.21 (95% CI; 0.11-0.39) (P.001). The medication errors with harm or requiring monitoring reported per 10,000 days of stay, was virtually unchanged from one period to the other ratio rate 0,77 (95% IC; 0,31-1,91) (P.05). The notification of potential errors or errors without harm per 10,000 days of stay increased 17.4-fold (rate ratio 0.005., 95% CI; 0.001-0.026, P.001).The increase in medication errors notified in the post-intervention period is a reflection of an increase in the motivation of health professionals to report errors through this new method.

Background Congenital hyperinsulinism (HIC) constitutes the more frequent cause of recidivate hypoglycaemia in neonates and lactates. Dose administration of 15 mg/kg/day is the cornerstone of HIC medical treatment. Purpose To evaluate tolerance, effectiveness and security in a masterly formula of diazoxide 5 mg/mL with sorbitol in a patient with suspicion of congenital HIC. Material and methods Diazoxide is an active principle with very poor water solubility, which must be mixed with ethanol and glycerol in order that it can be administered as a masterly formula. There are various formulations for the neonatal patient with congenital HIC of diazoxide suspension 5 mg/mL with sorbitol in different concentrations. Because a limit on the concentration for sorbitol does not exist, a bibliographic search on Medline was performed, combining the terms ‘excipients’ and ‘infants’. It was found that the level of sorbitol concentration to which neonates were exposed fluctuated between 0.1 and 2 g/kg/week; the upper limit is where the appearance of gastrointestinal disorders begins. 4 weekly solutions were produced with 0.5, 1, 1.5 and 2 g/kg of sorbitol. Prospective monitoring of the patient was carred out for 9 months to evaluate tolerance and effectiveness of the formula using glycaemia analytics. Results The newborn presents with hypoglycaemia, the patient begins vomiting and has glucoscaemia of 56 mg/dL. Metabolic study shows a high glucose/insulin ratio. With a concentration of 0.5 g/kg of sorbitol the patient presented nausea and controlled glycaemia (85.105). Weight 3.6 kg. With a solution of 1 g/kg of sorbitol the patient did not present any nausea, with some glycaemia controls >90 mg/dL. Weight 3.6 kg. With a solution of 1.5 g/kg of sorbitol, the patient did not present any nausea. Glycaemia controls was >90 mg/dl. Weight 4.4 kg. With a solution of 2 g/kg of sorbitol, the patient did not present any nausea. Glycaemia was maintained controlled, in every situation, >90 mg/dl. Weight 5.2 kg. Conclusion Thanks to sorbitol, tolerance was improved without any episodes of nausea and vomiting. Masterly formula of diazoxide in oral suspension helped to resolve HIC in the neonate in a safe and effective way. References and/or Acknowledgements We thank Torrecardenas Hospital No conflict of interest.

The primary objective of this review was to analyse the differences in efficacy between the administration of intermittent and continuous/expanded perfusion of piperacillin-tazobactam. Secondary objectives were to analyse the differences in safety, pharmacokinetic/pharmacodynamic parameters, and cost-effectiveness between the two forms of administration.We performed two different independent bibliographic searches. We encountered a total of 38 articles, and the final number included in the study was 6. We analysed the articles and collected the following variables: design, treatment administered to each group, total number of patients and number of patients in each study, variables collected in each study, and results.We encountered significant differences in the primary variable in two of the six studies favouring continuous/expanded perfusion. The study by Lodise et al found differences (P=.04) in mortality (31.6% for intermittent perfusion vs 12.2% for continuous/expanded perfusion). The study by Lorente et al found differences (P=.001) in terms of clinical recovery (56.5% for intermittent perfusion vs 89.2% for continuous/expanded perfusion). As for secondary variables, we only found differences in one of the studies in relation to cost-effectiveness, in favour of the group who underwent continuous/expanded perfusion method.The analysed data suggest that continuous/expanded perfusion would be at least as effective as intermittent perfusion, and that it could be more effective in severe patients with infections from more resistant micro-organisms such as Pseudomonas aeruginosa. Additionally, this form of administration is more cost-effective, at least in theory.

Background Drug dispensing errors are a common reason for medicines errors in hospitals, although they don’t usually reach the patient. Different situations contribute to their appearance, such as the availability of drugs from the same supplier, similarity in names, physical closeness, etc. Purpose To analyse the drugs most commonly involved in medicines errors during the dispensing process in a tertiary hospital. To study the possible causes thereof. Materials and methods Since 2011, medicines errors detected during the drug dispensing process after prescription-transcription in hospitalised patients have been recorded using an internal pharmacy database. Data collected: drug involved, pharmaceutical form, prescription frequency, person notifying, whether the report was correct and possible reason. We extracted errors reported from 571 hospital beds over 2 years (July/2011–June/2013) from the database and analysed each one. Results 1049 dispensing errors were detected and included in the database, all notified by staff nurses. 81.7% were confirmed to be errors. In 14 cases, the medicines box was empty (because of movements in patient census). In 4 cases, different drugs were involved. Pharmaceutical forms detected were oral (79.24%), injectable (14.71%), inhalational (4.3%) and topical (1.66%). 11.86% of the reported errors corresponded to High-Alert Medicines from the ISMP (Institute For Safe Medication Practices) list. The most frequent were heparins (7.11%), which accounted for 4.12% of the total of prescriptions. Insulin and anticoagulant drugs only had 4 and 6 errors, respectively. Other common drugs involved and the frequency of their prescription compared to the total of prescriptions were: furosemide (5.93%-3.14%), omeprazole (4.86%-4.65%), amoxicillin/clavulanic acid (2.97%-2%), ipratropium (2.25%-0.82%), piperacillin/tazobactam (1.78%-1.76%), methylprednisolone (1.78%-1.11%), carvedilol (1.66%-1.01), amlodipine (1.42%-0.76%), atorvastatin (1.42%-0.53%) and levothyroxine (1.42%-0.33%). For 9 of these drugs, there were similar presentations with different doses and/or physical proximity. Conclusion The main drugs involved in dispensing errors are drugs for which there are various doses and frequent prescriptions (such as heparins) or those most frequently prescribed (such as omeprazole and furosemide), specially oral drugs. The number of errors with High-Alert Medicines was low. It’s important to know the distribution/availability of similar drugs to establish corrective measures for procurement and distribution and to minimise errors. No conflict of interest.

Background Some autoimmune diseases can develop renal manifestations that are refractory to conventional drug treatment, making haemodialysis the only therapeutic alternative. Purpose To analyse the response rate to rituximab as third-line treatment in patients with renal manifestations secondary to autoimmune diseases. Materials and methods Retrospective, observational study. Inclusion criteria: all patients with renal manifestations secondary to autoimmune disease treated with rituximab. Exclusion criteria: those treated with rituximab in acute or chronic renal transplant rejection. Data collected: patient age, gender, diagnosis, rituximab regimen and response (complete remission, partial or no response). The response was measured up to about 3 months of treatment. Results 27 patients were included: 18 women and 9 men. Mean age was 36 ± 14 and 34 ± 13 years old, respectively. Diagnoses were with lupus nephritis in 11 (41%), membranous nephropathy in 7 (26%), ANCA-positive vasculitis in 3 (11%), mesangiocapillary glomerulonephritis in 2 (7%), minimal change disease in 2 (7%), Wegener’s granulomatosis in 1 (4%) and focal segmental glomerulosclerosis in 1(4%). 16 patients received the standard cycle of rituximab (375 mg/m 2 weekly for 4 doses), 2 patients received 2 cycles, 1 received 4 cycles, 1 received 6 cycles and 1 patient received only 2 weekly doses. Response was complete in 11 (41%) patients (7/11 in lupus nephritis, 2/7 in membranous nephropathy, 1/1 in Wegener’s granulomatosis and 1/1 in mesangiocapillary glomerulonephritis), partial response in 11 (41%) and no response in 5 (24%) (2/3 ANCA-positive vasculitis). Conclusions Patients with renal manifestations secondary to autoimmune disease treated with rituximab may get a complete or partial response. This has some advantages in the therapeutic approach, allowing doses of other immunosuppressive agents (steroids, tacrolimus, etc.) to be reduced or the relapse of nephrotic syndrome to be delayed. The autoimmune disease that responded least well to rituximab was ANCA-positive vasculitis. No conflict of interest.

Background Clofarabine is a recently marketed drug used in paediatric patients with refractory acute lymphoblastic leukaemia (ALL) after at least two prior chemotherapy regimens. Its safety and effectiveness have not been evaluated in adults. Purpose To evaluate the effectiveness and safety of clofarabine in adult and paediatric patients in a tertiary hospital and compare the results between the two populations. Materials and methods Retrospective and descriptive study. Inclusion criteria: all patients treated with clofarabine in the hospital. Data collected from clinical history and pharmacy database: patient age, diagnosis, prior relapses and number of cycles of clofarabine received. Efficacy variables: disease remission (complete/partial) and the need for transplantation. Safety variables: all serious adverse reactions observed. Results 16 patients were included: 10 adults and 6 children. Mean age was 33.4 (18–63) and 8 (3.7–13.5) years old, respectively. Diagnoses were ALL (10 patients), acute myelogenous leukaemia (5) and lymphoblastic lymphoma (1). 2 (12.5%) patients received 2 cycles and the rest (87.5%) 1 cycle, all after the second relapse. A complete response was attained in 33.3% of adults and 50% of children. 10% of adults had a partial response and 40% of adults and 33.3% children didn’t respond. 56.25% of patients needed subsequent transplantation. The most significant adverse reactions in children were post-chemotherapy pancytopenia with infections (66.67%) and fulminant hepatic failure (16.67%). In adults pancytopenia (100%), bacteraemia, sepsis and severe infections (70%), hepatotoxicity (40%), central venous thrombosis (20%), severe gastrointestinal toxicity (20%), grade 4 mucositis (10%) and tumour lysis syndrome (10%) were observed. 13 patients died at the end point. 2 adults and 1 child died immediately after clofarabine treatment (due to post-chemotherapy hypovolaemic shock, tumour lysis syndrome and fulminant hepatic failure, respectively). Conclusions Clofarabine effectiveness is low and bears a high risk of severe adverse effects in adults (especially infectious diseases or liver toxicity). In paediatric patients, clofarabine is more effective and better tolerated. No conflict of interest.

Background Crizotinib is a cytostatic oral ALK inhibitor, a newly-introduced oral cytostatic to treat non-small cell lung cancer (NSCLC) that has been accessible through an expanded use programme prior to marketing authorization. Purpose To analyse the effectiveness and safety of crizotinib treatment in patients with NSCLC in a tertiary hospital. Materials and Methods A retrospective descriptive study of patients taking crizotinib from August 2011 to July 2012. The following information was collected: demographic (gender and age), background (smoker/non-smoker), basal situation (Performance Status (PS), ALK-positive or negative), diagnosis and staging, dose of crizotinib, results (progress and current status) and adverse reactions. The average length of survival was determined using SPSS 20. The information sources were the electronic health records. Results 4 patients were recruited. 3 (75%) were women. The mean age was 47. All the patients were non-smokers. Initial situation: 3 patients had a PS of 1 and the other one had 2. All of them were ALK-positive and were diagnosed with stage IV NSCLC. 2 patients received crizotinib 250 mg/12 h and the other 2 200 mg/12 h. Evolution: in 2 (50%) patients the tumour mass in the lungs did not change. In 1 (25%) the lung tumour shrank slightly. To sum up: 3 (75%) patients presented stable disease and 1 died. Adverse reactions: 3 (75%) patients had gastrointestinal reactions (diarrhoea and mucositis), 2 (50%) patients presented asthenia and 1 (25%) visual disturbances. Lastly, the average length of survival was 6 months (IC95%, 2.33–9.66). Conclusions Due to the low number of patients recruited the effectiveness of the treatment cannot be demonstrated. Nevertheless, it is important to highlight that the disease stabilised in 3 out of 4 patients. Gastrointestinal problems were the most frequent adverse reactions. It is important to detect ophthalmological adverse reactions in time to begin patient tracking. This treatment is well tolerated in patients with a bad prognosis and few treatment options. No conflict of interest.