30 março 2014

1ª Ed. 2014 Editora Medfarma
ISBN 9788589248136
Nº de págs.: 962
Capa flexível
Formato: 16 x 23 cm

    Manual de Medicamentos Citostáticos é um livro com todos os fundamentos necessários para uso pela Equipe Multiprofissional que atuam em Unidades ou Centros de Assistência de Alta Complexidade em Oncologia (CACON), que apresenta informações sobre medicamentos citostáticos para todos os estudantes e profissionais da área de saúde, com o objetivo de complementar uma abordagem multiprofissional ao paciente oncológico. Livro contendo 184 medicamentos e com os seguintes capítulos: glossário farmacêutico, glossário de oncologia, lista de abreviaturas e siglas, tabela geral de diluição, manipulação de drogas citostáticas, PGRSS com pictogramas e símbolos de identificação de grupos de resíduos, medicamentos com resumo das toxicidades e as monografias dos medicamentos. Neste sentido, o livro aborda as seguintes informações:  nome genérico do produto,  nomes comerciais, sinonímia e outras denominações, forma farmacêutica, categoria terapêutica, farmacocinética, posologia, reações adversas, regimes especiais de posologia, alertas de administração, precauções, interações medicamentosas, condutas na superdose, medidas após a contaminação acidental, protocolo para extravasamento, biossegurança ocupacional, normas internacionais de transporte do produto, PGRSS, estabilidade da solução reconstituída no frasco de vidro, concentração após reconstituição no frasco de vidro,  vias e formas de administração, diluentes, volume final e tempo de infusão, compatibilidade com as soluções e com os equipamentos,  incompatibilidade com as soluções e com os equipamentos, estabilidade em seringa plástica, estabilidade em bolsa plástica de PVC, poliolefina, PEBD e de EVA. Considero este livro uma futura publicação multiprofissional indispensável para todos os profissionais da área de saúde, que necessitam de informações atualizadas e precisas, abordando de maneira clara, simples e objetiva os estudos, principalmente, sobre protocolos para extravasamento, em condutas na superdose e na contaminação acidental, normas do PGRSS, assim como a diluição, compatibilidade e estabilidade de medicamentos citostáticos.

05 março 2014


N Stoner, B Vadher, J Floyd, E Sparkes, C Henriquez.

Oxford University Hospitals NHS Trust, Pharmacy, Oxford, UK

Background Cancer patients at the Oxford University Hospitals NHS Trust receive the majority of their chemotherapy treatments as daycase patients. The clinical pharmacy service provision to patients receiving chemotherapy did not move with the patients from the inpatient to the daycase setting. The lack of clinical pharmacy provision to the day treatment unit (DTU) resulted in medicines wastage and an increase in nursing time to educate patients on their medication.

Purpose The pharmacy service to the DTU was reconfi gured to provide a clinical pharmacy and medicines management service, and to dispense medicines as pre-packs at the patients’ bedside.

Materials and Methods One pharmacist and half of a technician were funded from cost savings to implement the new service. Medication record cards were developed for each supportive regimen as a counselling aid to patients. A patient satisfaction survey was undertaken prior to initiating the new service, and two months after initiation. Drug expenditure and medicine wastage savings were recorded prior to and two months after implementation of the service. A satellite pharmacy was set up to dispense medicines next to the DTU. A trolley was used to dispense pre-packs at the bedside. Data was collected prior to and two months after initiation of the new service to assess patient satisfaction, impact on nursing time, medicines wastage and savings.

Results It was anticipated that approximately £25,000 [€31,000] per month would be saved on medicines wastage. Patients were very satisfi ed with the new service. The service resulted in a reduction in nursing time of 37.5 hours/week. The results of the service impact after two months will be presented.

Conclusions The DTU pharmacy service ensures medicines optimisation, reduces medicines expenditure, and improves the quality of patient care. Patients receiving chemotherapy as inpatients always benefited from a clinical pharmacy service, so it is appropriate to provide this service in the day case setting.

Reference Eur J Hosp Pharm 2013;20(Suppl 1):A1–238


M Scaldaferri, E Sciorsci, F Re, C Calvo, M Chiumente, D Barilà, A Chiesa, M Ferroni, S Stecca, F Cattel.

A.O.U. San Giovanni Battista, Pharmacy, Turin, Italy; University of Turin, Faculty of Pharmacy, Turin, Italy; 3University of Turin, School of Hospital Pharmacy, Turin, Italy

Background At our centre, haematologists and department pharmacists constantly monitor outcomes and safety of treatment with lenalidomide.

Purpose To describe clinical outcomes and safety of lenalidomide in our lymphoma and myelodysplastic syndrome patients.

Materials and Methods Onco-AIFA Registry and medical records were checked as of 30/06/2012 for diagnosis, duration of treatment, incidence of adverse drug events (ADRs).

Results Data of 34 patients were reviewed, with the following diagnoses: Diffuse large B-cell lymphoma (DLBCL), 24 patients; 5q-myelodysplastic syndrome (MDS5q-), 11 patients and mantle cell lymphoma (MCL), one patient. Of patients with DLBCL, one discontinued treatment because of serious ADRs, two because of death and 4 for disease progression after an average of 4.4 treatment cycles, corresponding to 7 months (range: 2–18). Of patients with MDS5q-, 8 stopped treatment, two of whom because of disease progression or death and two for toxicity. The median duration of treatment was 11.8 cycles (range 1–29). Seventeen DLBCL patients and 3 MDS5q- patients are still on therapy. 34 non-serious ADRs relating to 14 patients and 5 serious ADRs relating to 4 patients were reported, two of which were cases of development of solid neoplasia. Non-serious ADRs were mostly cases of haematological toxicity, alterations of the skin and of nervous system and infections.

Conclusions Lenalidomide seems to control the disease in patients with MDS5q- for long periods, while the Time to Progression in patients with DLBCL appears shorter. The treatment-related toxicity appears in most cases acceptable. Despite the limited number of data, our analysis highlights the need for close monitoring of the patients both during treatment and on follow-up, as evidenced by the two cases of onset of neoplasia. The progressive collection of data is providing the haematologists and pharmacists the information to design a model for optimised appropriate treatment with lenalidomide.

Reference Eur J Hosp Pharm 2013;20(Suppl 1):A1–238

01 fevereiro 2014


AE Fagour, M Desbourdes, N Colombini, R Vialet, M Buès-Charbit.
Hôpital Nord, Pharmacy, Marseilles, France; Hôpital Nord, Pediatric ICU, Marseilles, France

Background: the availability of drugs specifi cally assessed for use in neonates is limited as evaluation is more diffi cult in neonates than in adults. The result is a widespread off-label use of drugs, especially in neonatal intensive care units. Such practise is an essential part of their care and should be based on the best available evidence.

Purpose: to describe and analyse the off-label use of medicines in a neonatal intensive care unit.

Materials and methods: prospective observational study conducted over three months, from 27 February 2012 to 27 May 2012. All the drugs prescribed were analysed with regard to their licence status for the: indication, dose, route of administration, mode of administration, age category, formulation (compounding of capsules, oral suspensions, eye drops), contraindications and warnings specified in the summary of product characteristics of the marketing authorization.

Results: in total, 638 prescriptions, comprising 59 different medicines were written, 107 newborn babies were admitted (60 male, 47 female). Their age varied from 0 to 27 days (average: 2 days), their mean gestational age was of 34 weeks of amenorrhea (65% premature), their weight ranged from 630 g to 4700 g (average: 2230 g). A total of 487 prescriptions were written offlabel (76%), with 101 patients (94%) receiving at least one drug used off-label. Drugs were prescribed off-label mostly concerning the indication (48%), then came off-label use for the dose and the age category. The medicine most often prescribed off-label was caffeine citrate.

Conclusions: critically ill neonates are exposed to numerous medicines, a signifi cant proportion of which are not yet approved for use in this vulnerable group of patients. Despite European initiatives aiming to promote greater awareness and research in the paediatric population, there is still a high percentage of unlicensed or off-label drug use in neonatal intensive care. This study underlines the need for clinical research and approval of the clinical data acquired within the neonatal population.

No confl ict of interest.

Eur J Hosp Pharm 2013;20(Suppl 1):A1–238


C Zaugg, J Behringer, M Walther, M Köhler.
Spitalapotheke, Kantonsspital Aarau; Klinik für Kinder und Jugendliche, Kantonsspital Aarau

Introduction: for children, many drugs are used without marketing authorization (“unlicensed”, e.g. imported drugs, drugs prepared by a pharmacy) or outside the terms of marketing authorization (“off-label”). In Switzerland, around half of all prescriptions for paediatric inpatients were either off-label or unlicensed [1].

Purpose: to determine the proportion of unlicensed and off-label prescriptions at discharge, which has not been investigated previously, and the proportion of parents informed about such a prescription.

Materials and methods: prospective study including all discharge prescriptions of inpatients over a two-month period at the Children’s Hospital of Aarau. Exclusion criteria: hospitalisation for chemotherapy only, age over 18, re-entry during study period, no informed consent of parents. At discharge parents were asked to fill in a questionnaire about the information they got on discharge medicines as well as about their satisfaction with this information. This questionnaire was available in German, French, Croatian, Turkish, Albanian, Spanish and English.

Results: during the study period 503 children were discharged, 231 children could be included. Discharge prescriptions were written for 140 children (61%). A total of 227 drugs were prescribed, especially anti-infl ammatory/analgesic, anti-asthmatic and anti-infective drugs. 38.5% of all prescriptions were off-label, regarding dosage in 51%, age in 40% and indication in 9% of all cases. Only 0.5% of drugs were unlicensed. Discharge questionnaires were returned by 103 of 140 children. Most parents (>80%) were informed about purpose, dosage and use of the drugs for their child, and satisfi ed with obtained information, but only 9% of parents getting an off-label/unlicensed prescription for their child were informed about the off-label/unlicensed use.

Conclusions: there is a high percentage of drugs prescribed offlabel at hospital discharge. Most drugs are well known substances and regularly prescribed for children. This emphasises the need toupdate marketing information for older substances, or the need for a national database for drug use and dosage in children.

Reference: 1. Paolo, E et al, 2006. Swiss. Med. WKLY. 136, 218–222.

No conflict of interest.

Eur J Hosp Pharm 2013;20(Suppl 1):A1–238

15 janeiro 2014


Márquez Saavedra E, Viguera Guerra I, Franco García F, Valverde Toresano L, García Martínez L, Berenguer García MJ.
Hospital Universitario Reina Sofía. Córdoba. España.

OBJETIVOS: Identificar y analizar los riesgos para la seguridad del paciente utilizando la metodología AMFE (Análisis Modal de Fallos y Efectos) en el proceso asistencial de Dispensación de medicamentos en dosis unitaria (Unidosis) y desarrollar un plan de acciones preventivas para evitar estos riesgos.

MATERIAL Y MÉTODOS: Un equipo multidisciplinar formado por profesionales de todos los estamentos que participan en el proceso de Unidosis (dos farmacéuticos, dos enfermeros de planta, un médico, una auxiliar de farmacia y un miembro del personal distribuidor de medicamentos), coordinado por el Servicio de Calidad y Documentación Clínica, identificó y analizó los riesgos relacionados con los fallos reales o potenciales del proceso de la Unidosis. Para cada fase del proceso de la Unidosis se detectaron los fallos, las causas que los originaban, el evento adverso al que podrían dar lugar y se propusieron las posibles acciones preventivas para cada uno de los fallos. La aplicación de la metodología AMFE nos permitió ponderar cada fallo en razón del Índice de Prioridad de Riesgo (IPR), que es un código numérico adimensional que se calcula teniendo en cuenta la gravedad, frecuencia y detectabilidad que cada miembro del equipo da a cada uno de ellos. Esta ponderación, una vez finalizado el análisis, permite priorizar la urgencia de la intervención, así como el orden de las acciones correctoras a implementar para la mejora del proceso. Así, se consideró que los fallos con IPR inferior a 100 no requerirían intervención a corto plazo, salvo que la mejora fuera fácil de introducir y contribuyera a mejorar aspectos de calidad del proceso.

RESULTADOS: Se identificaron 31 fallos o riesgos para la seguridad del paciente, encontrando para cada uno de ellos múltiples causas, que sumaron un total de 154. La fase del proceso de Unidosis en la que se detectaron mayor número de riesgos fue la de transcripción y validación farmacéutica (6 fallos). Dieciséis de los 31 (52%) riesgos encontrados, presentaron un IPR mayor de 100 y, por tanto, requerirían intervención a corto plazo para evitarlos. Se propusieron 64 acciones preventivas, de las que se desestimaron cuatro por la dificultad para su desarrollo. Para la elaboración del Plan de acciones de mejora se priorizaron 37 de las 60 acciones propuestas (62%), que eran todas las que podrían evitar los riesgos con IPR > 100. Por último, cada acción se asignó a una persona del servicio de Farmacia como responsable de su desarrollo, implantación y seguimiento y se fijó un cronograma de trabajo.

CONCLUSIONES: Gracias a la aplicación de la metodología AMFE se lograron identificar los puntos críticos del proceso de Unidosis y ponderar su riesgo. Sobre esto se ha desarrollado un Plan de acciones de mejora en el cual, cada acción se le asigna a una persona responsable. Estas acciones están organizadas en un cronograma de trabajo que comenzó en diciembre de 2012. Las tareas por las que se comenzó a trabajar fueron aquellas de más fácil aplicación y las que evitaban los fallos con un IPR más alto.

Farm Hosp. 2013;Supl. 1:65-499 - 499

18 novembro 2013

07 outubro 2013