Alcohol-free Benzydamine mouth gel

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Alcohol-free Benzydamine mouth gel recommendations and experiences in oral mucositis

D. Keiner, D. Stephan, L. Krüger
SRH Zentralklinikum Suhl, Zentralapotheke, Suhl, Germany

Background: Chemotherapy- and radiotherapy-induced oral mucositis (OM)represents a therapeutic challenge frequently encountered in cancer patients. More than 40 different substances were evaluated in terms of prevention and treatment of mucositis. The implementation of an alcohol-free benzydamine mouth wash in pharmaceutical care is discussed. Benzydamine is one option supported by an evidence base.

Material and Methods: A mouth gel with 0.15% benzydamine hydrochloride has been developed, which is in line with recommended requirements alcohol-free preparation, no growth factor, easy to use oral, pleasant taste and consistency, moderate price) and has been analyzed concerning its safety and effectiveness, using both subjective and objective measures.

Results: Its lead compound alcohol mouth gel contains benzydamine HCl, sodium hydrogen carbonate, saccharine sodium, polysorbate, polyvidone, glycerol and hydroxyethyl cellulose. The evaluation of OM by longitudinal survey in the Head and Neck Clinic (n=10;20 % female, 48-65 y) was recorded before cytotoxic therapy (T0) and at day 7 (T1). The Brief Pain Inventory pain intensity score decreased(T0:12.6 + 4.1; T1: 9.4 + 3.0). The pain during a 24-hour recall period was reduced by 36.5 + 9.4 %. Patients reported less use of analgesic medications (non-opioid medications). The mouth gel was applied undiluted on average 4 times per day (Min: 3, Max: 5). Patients developed mostly OM-degree 1 (WHO, 80%).

Conclusion: Health-related quality of life is improved by reducing pain. This new
intervention for the prevention and treatment of OM could ultimately lead to reduced patient suffering and improve cancer treatment outcome. The 0.15% alcohol-free benzydamine mouth wash can beproduced easily from any pharmacy.

References: 16th Congress of EAHP. 30 March - 01 April 2011. Viena. Austria

PLAYING FOR CHANGE CHANDA MAMA

FELIZ NATAL...............

Farmácia HC-UFPR

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Esta é uma homenagem do blog para o Serviço de Farmácia do HC-UFPR.

Vídeo elaborado para apresentação em confraternização natalina, homenageando a equipe de servidores/funcionários da farmácia hospitalar do HC-UFPR. Natal 2009.

Implementation of a protocol for pharmacokinetic monitoring of high-dose methotrexate

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Implementation of a protocol for pharmacokinetic monitoring of high-dose methotrexate

Beatriz Garcia Robredo, Maria Amalia Fernandez Feijoo, Miguel Angel Calleja Hernandez

Hospital Pharmacy Department, Virgen de las Nieves University Hospital, Granada, Spain

Background and Objective: To quantify the impact of the implementation of a protocol for the pharmacokinetic monitoring of patients receiving high-dose methotrexate.

Design: Prospective experimental study, in which the Hospital Pharmacy Department designed a specific protocol for the pharmacokinetics follow-up of these patients and for gathering the data required for a correct rescue. Results were compared between three months before and three months after implementation of this new protocol.

Setting: 24-hr infusions of methotrexate at a dose of C1 g/m2 were evaluated in adult patients admitted to the Oncohaematological Area of a tertiary level hospital.
Main Outcome Measures: Number of infusions started at the correct time, number of missed blood extractions, number of missed leucovorin doses, calculation of the elimination half-life, and measurement of the urinary pH (dichotomous variables). Degree of compliance with the leucovorin rescue dosage protocol was measured on a scale of 0–3 points, with all items carrying the same score (correct loading dose, dosage as function of body surface area, and dosage as function of the concentrations of methotrexate obtained).

Results: The number of infusions started at the correct time increased from 50% to 60%. The number of missed blood extractions fell from 1.6 to 0.4 extractions per course; and missed leucovorin doses dropped from 0.25 to 0 per course. The elimination half-life could be calculated in only 25% of courses in the first study period versus 100% of courses after protocol implementation. Urinary pH changed
from not being measured in any cycle to being measured in 100% of cycles. Compliance with rescue dosage protocol was scored with 1.9 points before versus 2.8 points after implementation.

References: Poster in: ESCP 36th European Symposium on Clinical Pharmacy ‘Implementing Clinical Pharmacy in Community and Hospital Settings: Sharing the Experience’, Istanbul, Turkey 25–27 October 2007

Stability of 25 mg/mL azacitidine suspensions stored in polypropylene syringes at -20*C

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Stability of 25 mg/mL azacitidine suspensions stored in polypropylene syringes at -20ºC

J. Vigneron, A. Duriez, H. Zenier, I. May, B. Demoré
University Hospital Brabois, Pharmacy, Vandoeuvre, France

Background: The manufacturer of azacitidine (Vidaza®) indicates a stability of 45
minutes at room temperature and 8 hours at 2-8°C.The aim of this study was to look for a longer period of stability.

Purpose: We investigated how freezing at -20°C affects the stability of azacitidine suspension 25 mg/mL in polypropylene syringes. This could allow to prepare suspensions in advance.

Material and methods: Azacitidine was manipulated under aseptic conditions:
reconstitution with sterile water for injection and preparation of syringes. The stability was studied after freezing for 8 days at - 20°C, defrosting at room temperature and storage for 8 hours at 2-8°C. Samples were analysed by a stability-indicating highperformance liquid chromatographic method using a reversedphase
column, a mobile phase consisting of phosphate buffer 10 mM pH 6,5, and detection wavelenght at 200 nm. Visual inspection was also performed.

Results: No modification of suspension or coloration was visually observed in any syringes. Azacitidine concentrations we degradation products were observed at the beginning of the study. They represented approximately 5 % of the total of the peaks surfaces. At the end of the study, only one degradation product has slightly increased and no other degradation products appeared after 8 days of freezing.

Conclusion: Azacitidine suspension 25 mg/mL was stable for 8 days at -20°C. After thawing at room temperature, suspension was stable for 8 hours at 2-8°C. Azacitidine syringes can be prepared in advance.

Reference: Poster in: 16th Congress of EAHP. 30 March-01 April 2011, Vienna, Austria

Livro Manual de Drogas Injetáveis

2ª Edição 2012
Livraria e Editora Medfarma
ISBN: 978-85-89248-07-5
Nº de páginas: 412
Formato: 16 x 23 cm
Capa dura

De forma prática e concisa o Manual de Drogas Injetáveis apresenta importantes informações a médicos, enfermeiros e farmacêuticos que atuam em Unidade Central de Misturas Intravenosas, tais como: Descrição do produto, nome comercial, posologia, alertas, reconstituição, concentração após a reconstituição, vias de administração, diluentes, volume final para infusão, compatibilidade, incompatibilidade e estabilidade de medicamentos injetáveis para 175 medicamentos: pH dos produtos farmacêuticos: capítulo com cálculos e fórmulas, capítulo sobre administração de medicamentos injetáveis e capítulo com lista de abreviaturas e siglas. A descrição de cada medicamento está de acordo com a nova norma da ANVISA, com o Sistema Fechado, a RDC 45.

Conteúdo
Sumário
Nota
Agradecimentos
Prefácio
Apresentação
Introdução
Lista de abreviaturas e siglas
Cálculos e fórmulas

Informações básicas
Reconstituição de pós injetáveis
Misturas intravenosas
Cálculos e fórmulas
Cálculos de velocidade de infusão
Cálculo do gotejamento
Método prático
Infusão em gotas
Infusão em microgotas
Cálculo para infusão intravenosa do medicamento
Cálculo da velocidade de gotejamento com equipo de bureta
Cálculo de mL/h para uso em bomba de infusão contínua (BIC)
Cálculo da concentração do medicamento
Cálculo da concentração do medicamento em porcentagem
Cálculo da concentração do medicamento na forma diluída
Cálculo da dose para medicamentos em g/mL, mg/mL ou mcg/mL
Cálculo de mL/h para uso em BIC em gotas/min
Resumo de cálculo para gotejamento
Unidades de medida
Questões para autoavaliação
Respostas do teste

Administração de medicamentos injetáveis

Introdução
Terapia intravenosa
Injeção intravenosa direta
Infusão intravenosa intermitente
Infusão intravenosa contínua 40
Injeção intramuscular
Injeção subcutânea
Injeção subcutânea contínua
Via intra-arterial
Via intratecal
Via intraperitoneal
Outras vias
Equipos para infusão
Sistema fechado de infusão
Bombas de infusão

Medicamentos Injetáveis: Monografias

ACETILCISTEÍNA
ACICLOVIR
ÁCIDO AMINOCAPRÓICO
ÁCIDO ASCÓRBICO
ÁCIDO TRANEXÂMICO
ADENOSINA
ALBUMINA HUMANA
ALFAINTERFERONA 2b RECOMBINANTE
ALFENTANILA
ALPROSTADIL
ALTEPLASE
AMICACINA
AMINOFILINA
AMIODARONA
AMOXICILINA + CLAVULANATO DE POTÁSSIO
AMPICILINA
AMPICILINA + SULBACTAM
AMRINONA
ANFOTERICINA B
ANFOTERICINA B COMPLEXO LIPÍDICO
ANFOTERICINA B LIPOSSOMAL
ANIDULAFUNGINA
ATRACÚRIO
ATROPINA
AZITROMICINA
BENZILPENICILINA POTÁSSICA
BICARBONATO DE SÓDIO
BROMOPRIDA
BUPIVACAÍNA
CALCITRIOL
CASPOFUNGINA
CEFAZOLINA
CEFEPIMA
CEFOTAXIMA
CEFTAROLINA
CEFTAZIDIMA
CEFTRIAXONA
CEFUROXIMA
CETAMINA
CETOPROFENO
CETOROLACO DE TROMETAMOL
CIPROFLOXACINO
CISATRACÚRIO
CLARITROMICINA
CLINDAMICINA
CLONIDINA
CLORETO DE POTÁSSIO
CLORETO DE SÓDIO
COMPLEXO VITAMÍNICO B
CLORPROMAZINA
DALTEPARINA
DANTROLENO
DAPTOMICINA
DESFERROXAMINA
DESLANOSÍDEO
DESMOPRESSINA
DEXAMETASONA
DEXMEDOTIMIDINA
DIAZEPAM
DICLOFENACO DE SÓDIO
DILTIAZEM
DIMENIDRINATO
DIPIRONA
DOBUTAMINA
DOLASETRONA
DOPAMINA
DORIPENEM
DROPERIDOL
EFEDRINA
ENOXAPARINA
EPINEFRINA
ERTAPENEM
ESCOPOLAMINA
ESMOLOL
ESOMEPRAZOL
ESTREPTOMICINA
ESTREPTOQUINASE
ETILEFRINA
ETOMIDATO
FENILEFRINA
FENITOÍNA
FENOBARBITAL
FENTANILA
FITOMENADIONA
FLUCONAZOL
FLUMAZENIL
FOSFATO DE POTÁSSIO
FUROSEMIDA
GENTAMICINA
GLICOSE
GLUCAGON
GLUCONATO DE CÁLCIO
GRANISETRONA
HALOPERIDOL
HEPARINA
HIDRALAZINA
HIDROCORTISONA
IBUPROFENO
IMIPENEM + CILASTATINA
IMUNOGLOBULINA ANTITETÂNICA
IMUNOGLOBULINA ANTITIMÓCITO
IMUNOGLOBULINA HUMANA ENDOVENOSA
INDOMETACINA
INSULINA HUMANA REGULAR
LANSOPRAZOL
LEVOBUPIVACAÍNA
LEVOFLOXACINO
LIDOCAÍNA
LINEZOLIDA
MANITOL
MEROPENEM
METADONA
METARAMINOL
METILPREDNISOLONA
METOCLOPRAMIDA
METOPROLOL
METRONIDAZOL
MICAFUNGINA
MIDAZOLAM
MILRINONA
MONONITRATO DE ISOSSORBIDA
MORFINA
NALBUFINA
NALOXONA
NEOSTIGMINA
NIMODIPINO
NITROGLICERINA
NITROPRUSSIATO DE SÓDIO
NOREPINEFRINA
OCITOCINA
OCTREOTIDA
OMEPRAZOL
ONDANSETRONA
OXACILINA
PALONOSETRONA
PANCURÔNIO
PANTOPRAZOL
PARECOXIBE SÓDICO
PENTOXIFILINA
PETIDINA
PIPERACILINA + TAZOBACTAM
POLIMIXINA B
PROMETAZINA
PROPOFOL
PROPRANOLOL
PROTAMINA
RANITIDINA
REMIFENTANILA
ROCURÔNIO
ROPIVACAÍNA
SACARATO DE HIDRÓXIDO FÉRRICO
SALBUTAMOL
SOMATOSTATINA
SUFENTANILA
SUGAMADEX
SULFAMETOXAZOL + TRIMETOPRIMA
SULFATO DE MAGNÉSIO
SUXAMETÔNIO
TEICOPLANINA
TENOXICAM
TERBUTALINA
TICARCILINA + CLAVULANATO DE POTÁSSIO
TIGECICLINA
TIOPENTAL
TIROFIBANA
TRAMADOL
TREPROSTINIL
TROPISETRONA
VANCOMICINA
VASOPRESSINA
VECURÔNIO
VERAPAMIL
VORICONAZOL
ZIDOVUDINA

A pilot study of pharmacist initiated interventions in drug therapy in a Danish university hospital

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A pilot study of pharmacist initiated interventions in drug therapy in a Danish university hospital

J. Carlsson1, T. Villumsen1, B.R. Olesen

RAP, Clinical pharmaceutical services, Copenhagen OE, Denmark

Background: The aim of this pilot study was to identify possible drug interventions which can be related to the use of the Electronic Patient Medications Module (EPM). The study was based on reviews of prescriptions from the EPM.

Methods: A total of 1003 patient medications were reviewed during 23 consultations with the EPM. The study was executed at 3 different departments with similar medical specialization. Identified interventions were divided into 12 categories, dosage
inappropriate, contraindicated drug, incomplete prescription, inappropriate dose frequency, drug duplication, no administration or dispensing of drug, inappropriate drug formulation, drug-drug interaction, inappropriate route of administration, optimisation of drug therapy, non-approved prescription in the EPM and other.

Results: During this study a number of 1365 interventions were identified. The identified interventions showed the following distribution between the 12 categories. Dosage inappropriate (0.7%), contraindicated drug (0.3%), incomplete prescription (4.9%), inappropriate dose frequency (2.6%), drug duplication (0.3%), no administration or dispensing of drug (47.3%), inappropriate drug formulation (0.5%), drug-drug interaction (24.5%), inappropriate route of administration (0.4%), optimisation of drug therapy (3.3%), non-approved prescription in the EPM (14.9%), other (0.2%). The most commonly identified intervention was ‘no administration or dispensing of drug’ (47.3%). Either the patient did not get the prescribed medication or there was a lack of documentation in relation to the medical administration. The severity of the drug-drug interactions (24.5%) was ranged as major, moderate and minor. 32.2% of the identified drug-drug interactions were recognized as major, 57.9% were recognized as moderate and 9.9% were recognized as minor.

Conclusions: This pilot study showed a potential for pharmacist initiated
interventions to optimise drug therapy in the EPM, especially regarding drug-drug interactions, medical administration and dispensing. This study underlines the benefits of having a clinical pharmacist contributing with scientifically valid
information and advice regarding safe, appropriate and costeffective use of medication.

References: EAHP Congress Barcelona 2009.

Estabilidade após diluição: IRINOTECAN (CAMPTO®)

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ETUDE DE LA STABILITE DE LA SOLUTION COMMERCIALE D’IRINOTECAN (CAMPTO®) APRES PRELEVEMENTS REITERES DANS LE MEME FLACON

E. Huet, S. Roy, C. Hochart, A. Bellanger, R. Farinotti, C. Fernandez - Laboratoire
d’Analyse du Médicament – Unité de Pharmacie Clinique Oncologique - Service Pharmacie - GH Pitié Salpêtrière – 47 Bd de l’Hôpital – 75013 PARIS

Introduction: L’irinotécan, inhibiteur de la topoisomérase I, est indiqué dans le traitement du cancer colo-rectal localement avancé ou métastatique et en cours d’évaluation dans le glioblastome. Les posologies varient de 10 à 350 mg/m²selon les indications et les associations et la spécialité pharmaceutique CAMPTO®, laboratoire Pfizer, se présente sous forme prête à l’emploi (20 mg/ml), conditionnée sous azote et disponible en flacons de 40, 100 et 300 mg. Les unités de préparation centralisées, sous responsabilité pharmaceutique, ont dorénavant recours au dosage le plus élevé. Le reliquat, du fait des manipulations en atmosphère estérile, est susceptible d’être utilisé pour une préparation ultérieure. Cependant, aucune donnée sur la conservation de la solution commerciale à 20 mg/ml, après première utilisation du flacon n’a été communiquée par le laboratoire. L’objectif de ce travail est d’étudier la stabilité physico-chimique de la solution de CAMPTO® 20 mg/ml après prélèvements répétés dans le même flacon.

Matériel et méthode: Le dosage de l’irinotécan a été réalisé par HPLC selon une méthode développée et validée au laboratoire, conformément aux critères ICH. Dans un premier temps, afin de tester la spécificité de la méthode et de détecter les produits de dégradation, la solution a été soumise à une dégradation forcée (acide, base, oxydant, chaleur). Dans un deuxième temps, des prélèvements ont été réalisés pendant 8 jours dans le flacon à 20 mg/ml, sous hotte à flux d’air laminaire, dans des conditions d’asepsie et de protection du personnel strictes. Les flacons ont été conservés à température ambiante. La solution concentrée a été diluée au 1/10ème dans le glucose à 5% avant analyse. La solution a été déclarée stable aussi longtemps que la concentration en irinotécan (exprimée en IC95) était comprise entre 90 et 110% de la concentration initiale. Les essais ont été réalisés sur trois lots de la solution commerciale.

Résultats: La méthode développée, en phase inverse (phase mobile : tampon phosphate 0.05M/acétonitrile (72 : 28, v/v), phase stationnaire Curosil-PFP C18 4,6´250 mm, 5em) avec détection spectrofluorimétrique (355-550 nm), permet la séparation de l’irinotécan en 10 minutes. Aucun des produits de dégradation obtenus au cours des tests de dégradation forcée n’a été retrouvé lors de l’étude de stabilité. La concentration en irinotécan de la solution concentrée est restée stable pendant les 8 jours de l’étude.

Discussion/conclusion: Les résultats de nos essais ont montré que la solution prête à l’emploi d’irinotécan (CAMPTO® 20 mg/ml) peut être conservée à température ambiante dans son flacon d’origine pendant 8 jours après la première utilisation, sans risque de dégradation physico-chimique du principe actif. En pratique courante, cette durée de stabilité excède largement la durée de conservation du flacon entamé.

References: Congres 2009. SFPO. France

Fluorouracila colírio: formulação magistral

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Fluorouracila 150 mg/mL Injetável...............................................20 mL
Água Destilada para Injeção.....................................................23 mL
Cloreto de Sódio 0,9% q.s.p....................................................100 mL

Manipulação: Calcular a quantidade requerida de cada componente da formulação para o total de material a ser preparado. Este produto deve ser preparado em área com controle ambiental de forma a reduzir a introdução, a geração e a retenção de contaminantes em seu interior. Retirar o volume desejado de fluoruracila, seguindo protocolo para reconstituição de soluções de drogas citostáticas. Adicionar quantidade suficiente de cloreto de sódio e misturar bem, filtrando previamente a solução através de um filtro de membrana esterilizante de 0,22 micra para um frasco plástico âmbar estéril. Estocado em frasco de plástico âmbar na concentração de 1%. Para uso oftálmico. Estabilidade de 180 dias na temperatura ambiente

Referência: Fluorouracil 1% Ophthalmic Solution. IJPC. 2004; 8(3): 217

AVALIAÇÃO DA EFICÁCIA E SEGURANÇA CLÍNICA DE UM CREME A BASE DE VITAMINAS E ÓLEO DE ANDIROBA NA PELE IRRADIADA DE PACIENTES PORTADORAS DE CÂNCER MAMA

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AVALIAÇÃO DA EFICÁCIA E SEGURANÇA CLÍNICA DE UM CREME A BASE DE VITAMINAS E ÓLEO DE ANDIROBA NA PELE IRRADIADA DE PACIENTES PORTADORAS DE CÂNCER DE MAMA

Paiva JT, Pinezi JCD, Helfenstein T, Bezerril CM, Freitas NMA, Teixeira ST, Machado GDP.

Associação de Combate ao Câncer de Goiânia, Goiânia, GO
E-mail: storres@pharmanostra.com.br

RESUMO

Introdução: A radiodermatite é o efeito colateral mais comum em pacientes portadoras de tumor de mama submetidas à radioterapia e, dependendo do grau apresentado, pode afetar a efetividade do programa terapêutico. Alguns cuidados padrões são empregados para prevenir e/ou tratar as radiodermatites, dentre eles a hidratação da pele irradiada. Produtos naturais, como pomada de amêndoa, creme de camomila e Aloe vera, têm provado diminuir os sintomas da pele irradiada. Ora, já que a reação cutânea aguda à radiação se deve principalmente à produção insuficiente de células a partir da camada basal danificada, nutrientes revitalizantes, como vitaminas, ácidos graxos e proteína, tornam-se essenciais para a recuperação da pele lesada pela radioterapia. Um tratamento que se propõe a restabelecer a umidade e as condições fisiológicas da pele para a boa difusão de substâncias no meio celular por meio de componentes livres de efeitos colaterais é uma alternativa saudável aos tratamentos antiinflamatórios e esteroidais convencionais.

Objetivo: Avaliar e comparar a eficácia e segurança de um novo creme a base de vitaminas A e E e óleo de andiroba com um gel a base de Aloe barbadensis e ácido hialurônico de eficácia comprovada no tratamento da dermatite aguda causada pela radioterapia, além de verificar a melhor posologia para esse novo produto.

Método: Trinta e nove pacientes portadoras de tumor de mama a serem submetidas à radioterapia foram divididas em 3 grupos: Grupo 1: Fazendo uso do gel a base de Aloe barbadensis e ácido hialurônico três vezes ao dia (n=16); Grupo 2: Fazendo uso do creme a base de vitaminas e óleo de andiroba (Pharma Nostra Com. Ltda, Rio de Janeiro, RJ, Brasil) duas vezes ao dia (n=12); Grupo 3: Fazendo uso do creme a base de vitaminas e óleo de andiroba três vezes ao dia (n=11). As mamas das pacientes foram examinadas por apenas um observador. Foi avaliado o grau de evolução da dermatite segundo o RTOG.

Resultados: Nenhuma paciente do Grupo 2 evoluiu para dermatite seca, ao passo que 32% do Grupo 1 apresentou este sintoma (p=0,031). Não houve diferença entre os grupos em relação à evolução para dermatite úmida e RTOG (p>0,05). Quatro pacientes do Grupo 1 evoluíram para dermatite úmida, com uma suspensão. Dez das dezesseis pacientes com dermatite seca neste grupo evoluíram para grau 2, cinco foram suspensas, totalizando seis suspensões no Grupo 1. Duas pacientes do Grupo 2 evoluíram para dermatite úmida, com uma suspensão. Quatro das doze pacientes com dermatite grau 1 neste grupo evoluíram para grau 2.

Conclusão: O estudo em questão mostrou que o creme a base de vitaminas A e E e óleo de andiroba, aplicado 2 a 3 vezes ao dia, é seguro e eficaz na prevenção dos efeitos colaterais causados pela radioterapia. Ainda que o número de pacientes utilizado neste modelo tivesse sido pequeno, foi suficiente para demonstrar que o novo creme aplicado 2 vezes ao dia é mais eficaz na prevenção da dermatite seca do que o gel de Aloe barbadensis e ácido hialurônico.

Referência: trabalho apresentado no XI Congresso Congresso da Sociedade Brasileira de Radioterapia. 22 a 25 de junho de 2011. Rio de Janeiro - RJ

Amiodarona injetável: estabilidade após diluição

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Estabilidade da solução diluída: em soro fisiológico 0,9% e soro glicosado 5% na concentração de 2 mg/mL é estável para 32 dias em temperatura ambiente e sob refrige-ração em bolsa plástica Viaflex® para infusão via endovenosa. Uso injetável. (1)

Estabilidade da solução injetável não diluída: na concentração de 50 mg/mL é está-vel para 450 dias na temperatura ambiente em seringa plástica descartável estéril de polipropileno. Uso injetável. (2)

Referências bibliográficas:
1.Pramar YV. Chemical Stability of Amiodarone Hydrochloride in Intravenous Fluids. IJPC 1997;1(5):347-348.
2.Marcoz N, Ing H, Sautter AM, Saadi JF, Roulin MJ, Bonnabry P. Stabilite et Compatibilité de Solu-tions Injectables d’Amiodarone (Cordarone). Pharmacie. Soins Intensifs de Médicine. Hôpitaux Uni-versitaire de Genève (HUG). Suisse. Disponível em: http://www.hcuge.ch. Acesso em: 18 de dezembro de 2004.

Livro Manual de Drogas Injetáveis

Este livro apresenta 370 páginas, com 169 monografias de medicamentos injetáveis e sua descrição da forma farmacêutica, categoria terapêutica do fármaco, reconstituição, concentração após a reconstituição, estabilidade do produto reconstituído, vias de administração, diluente, volume final e tempo de infusão da solução injetável, compatibilidade, incompatibilidade, reconstituição e estabilidade em seringa plástica e em bolsas plásticas de PVC. O livro Manual de Drogas Injetáveis fornece informações práticas sobre administração, preparo, vias de administração, reconstituição, compatibilidade e estabilidade de medicamentos injetáveis.

Cálculos e fórmulas, Cálculos de velocidade de infusão, Cálculo do gotejamento, Método prático, Infusão em gotas, Infusão em microgotas, Cálculo para infusão intravenosa do medicamento, Cálculo da velocidade de gotejamento com equipo de bureta, Cálculo de mL/h para uso em bomba de infusão contínua (BIC), Cálculo da concentração do medicamento, Cálculo da concentração do medicamento em porcentagem, Cálculo da concentração do medicamento na forma diluída, Cálculo da dose para medicamentos em g/mL, mg/mL ou mcg/mL, Cálculo de mL/h para uso em BIC em gotas/min, Resumo de cálculo para gotejamento, Unidades de medida

Monografias dos seguintes medicamentos injetáveis: Acetilcisteína, Aciclovir, Ácido Aminocaproico, Ácido Ascórbico, Ácido tranexâmico, Adenosina, Albumina humana, Alfainterferona 2b recombinante, Alfentanila, Alprostadil, Alteplase, Amicacina, Aminofilina, Amiodarona, Amoxicilina + clavulanato de potássio, Ampicilina, Ampicilina + sulbactam, Amrinona, Anfotericina B, Anfotericina B complexo lipídico, Anfotericina B lipossomal, Atracúrio, Atropina, Azitromicina, Benzilpenicilina potássica, Bicarbonato de sódio, Bromoprida, Bupivacaína, Calcitriol, Caspofungina, Cefazolina, Cefepima, Cefotaxima, Ceftazidima, Ceftriaxona, Cefuroxima, Cetamina, Cetoprofeno, Cetorolaco de trometamol, Ciprofloxacino, Cisatracúrio, Claritromicina, clindamicina, Clonidina, Cloreto de potássio, Cloreto de sódio, Complexo vitamínico B, Clorpromazina, Dalteparina, Dantroleno, Daptomicina, Desferroxamina, Deslanosídeo, Desmopressina, Dexametasona, Dexmedotimidina, Diazepam, Diclofenaco sódico, Diltiazem, Dimenidrinato, Dipirona, Dobutamina, Dolasetrona, Dopamina, Doripenem, Droperidol, Efedrina, Enoxaparina, Epinefrina, Ertapenem, Escopolamina, Esmolol, Esomeprazol, Estreptomicina, Estreptoquinase, Etilefrina, Etomidato, Fenilefrina, Fenitoína, Fenobarbital, Fentanila, Fitomenadiona, Fluconazol, Flumazenil, Fosfato de potássio, Furosemida, Gentamicina, Glicose, Glucagon, Gluconato de cálcio, Granisetrona, haloperidol, Heparina, Hidralazina, Hidrocortisona, Ibuprofeno, Imipenem + cilastatina, Imunoglobulina antitimócito, imunoglobulina humana endovenosa, Indometacina, Insulina humana regular, Lansoprazol, Levobupivacaína, Levofloxacino, Lidocaína, Linezolida, Manitol, Meropenem, Metadona, Metaraminol, Metilprednisolona, Metoclopramida, Metoprolol, Metronidazol, Midazolam, Milrinona, Mononitrato de isossorbida, Morfina, Nalbufina, Naloxona, Neostigmina, Nimodipino, Nitroglicerina, Nitroprussiato de sódio, Norepinefrina, Ocitocina, Octreotida, Omeprazol, Ondansetrona, Oxacilina, Palonosetrona, Pancurônio, Pantoprazol, Parecoxibe sódico, Pentoxifilina, Petidina, Piperacilina + tazobactam, Polimixina B, Prometazina, Propofol, Propranolol, Protamina, Ranitidina, Remifentanila, Rocurônio, Ropivacaína, Sacarato de hidróxido férrico, Salbutamol, Somatostatina, Sufentanila, Sugamadex, Sulfametoxazol + trimetoprima, Sulfato de magnésio, Suxametônio, Teicoplanina, Tenoxicam, Terbutalina, Ticarcilina + clavulanato de potássio, Tigeciclina, Tiopental, Tirofibana, Tramadol, Treprostinil, Tropisetrona, Vancomicina, Vasopressina, Vecurônio, Verapamil, Zidovudina

Risk of hypoglycemia in hospitalized patients prescribed a sulfonylurea.

***

Risk of hypoglycemia in hospitalized patients prescribed a
sulfonylurea.

Christina M. Hedrick, Pharm.D.1, Amy C. Donihi, Pharm.D., BCPS2,
Kim Coley, Pharm.D.2; (1)University of Pittsburgh Medical Center
Presbyterian, Pittsburgh, PA; (2)University of Pittsburgh School of
Pharmacy, Pittsburgh, PA

Purpose: To identify the incidence of and risk factors associated with
hypoglycemia in hospitalized patients taking sulfonylureas.

Methods: A nested case-control study of adult patients who received a
sulfonylurea while hospitalized at a tertiary care hospital between
November 1, 2008 and October 31, 2009 was performed. Case
patients included those who experienced hypoglycemia (BG <70
mg/dL) during sulfonylurea treatment. Control patients included those
who never experienced hypoglycemia. Controls were matched 1:1
with cases based on gender and number of days treated with a
sulfonylurea. Potential risk factors for the development of hypoglycemia,
including patient age, renal insufficiency, NPO status, concomitant use
of insulin and beta blockers, and hospital location were compared.
Covariates with p values ≤0.1 in univariate regressions were included
in a multivariate logistic regression model.

Results: Overall 16% of patients who received a sulfonylurea
experienced ≥1 episode of hypoglycemia. Cases (n=117) were more
likely than controls (n=117) to be ≥65 (74% vs 53%, p<0.001), have
renal insufficiency (18% vs. 7%, p=0.013), and receive basal insulin
(28% vs. 14.5%, p=0.012), and less likely to receive glipizide (44% vs
57%, p=0.05). Variables included in the multivariate regression were
age ≥65, renal insufficiency, and treatment with glipizide, glyburide,
or basal insulin. Age ≥65 (OR = 3.07, p<0.001), basal insulin (OR =
3.01, p=0.002), and renal insufficiency (OR = 3.64, p=0.006) were
predictors of hypoglycemia and use of glipizide (OR = 0.44, p=0.005)
was found to be protective in the multivariate logistic regression model.

Conclusions: These results can be used to identify hospitalized
patients for whom sulfonylurea agents should be avoided due to
their high risk for sulfonylurea-related hypoglycemia.

Presented at 29th Annual Eastern States Conference for Pharmacy
Residents and Preceptors, Hershey, PA, April 2010.

Zidovudina: estabilidade após diluição

***

. Estabilidade da solução diluída: em soro glicosado ou soro fisiológico 0,9% na concentração de 4 mg/mL é estável para 8 dias em temperatura ambiente e sob refrigeração em bolsa plástica de PVC para uso intravenoso. Para uso injetável

. Referência: Lam NP, Kennedy PE, Jarosinski PF, Galleli JF. Stability of zidovudine in 5% dextrose injection and 0.9% sodium chloride injection. Am J Hosp Pharm 1991;48:280-282

Omeprazol Suspensión 2 mg/mL en goma xantana

***

Omeprazol Base Fagron.......................0,2 %
Sodio bicarbonato...............................8,4%
Goma Xantan Sol. Acuosa al 1%..........50 mL
Esencia de Vainilla..............................0,5%
Sacarina Sódica..................................0,2%
Agua purificada c.s.p..........................100 mL

(*) Fórmula elaborada con materias primas Fagron; 56 dias en frigorífico. Envase bien cerrado. Oral. Agitar antes de administrar Ligeramente ácido. No amargo

Preparo:

1. Dispersar lentamente 0,5 g de goma xantan en 49,5 mL de agua. Agitar bien. Calentar a 50ºC (Fase 1)

2. Dispersar 8,4 g de bicarbonato sódico en el agua de la formula (P/V). Añadir la
sacarina sódica. Esta dispersión no queda disuelta ya que supera la concentración de saturación. (Fase 2)

3. Añadir la esencia de vainilla a la fase 1, bajo agitación suave.

4. Incorporar la solución nº1 (con la esencia) sobre la fase nº2.

5. Añadir el omeprazol base y homogenizar con un agitador de alta velocidad (tipo ultra-turrax). El aspecto final de la suspensión es blanco, homogéneo y viscoso, con un pH=9.

Referência: http://www.formulistasdeandalucia.es

Efectividad y seguridad de diltiazem 2 % tópico en fi sura anal

***


Efectividad y seguridad de diltiazem 2 % tópico en fisura anal

M.I. Fernández García*, R. Albornoz López, I. Pérez Rodrigo y J. Abellón Ruiz
Servicio de Farmacia, Hospital Universitario Reina Sofía, Córdoba, España


Introducción

La fisura anal es una grieta asociada a un intenso espasmo del esfínter anal interno, con una clínica de proctalgia y rectorragia, que conlleva una alteración de la vida sociolaboral del paciente junto con alarma y preocupación personales. Constituye uno de los problemas proctológicos más frecuentes en la población occidental. Su prevalencia es igual para ambos sexos, y se presenta principalmente en
pacientes jóvenes y adultos de edad media, aunque puede afectar a todas las edades. Su localización más frecuente (90 %) es la línea media en el plano posterior, y otra localización menos habitual (10 %) es la línea media anterior. Los síntomas clásicos son dolor anal, rectorragia y prurito anal. El dolor es de características l acerantes, a menudo intenso, y puede durar desde minutos a varias horas, durante y/o después de la defecación. La rectorragia suele ser un sangrado rojo, brillante, generalmente de escasa cuantía y no se mezcla con las heces. En la fase crónica de la lesión pueden aparecer prurito y/o secreción mucosa o mucopurulenta. Su diagnóstico es sencillo y se basa en la historia clínica: antecedentes, clínica y exploración. La fi nalidad del tratamiento consiste en reducir la hipertonía
con un descenso de presión en el conducto anal y mejorar la vascularización local, interrumpiendo el círculo vicioso de dolor anal, espasmo esfi nteriano e isquemia, permitiendo la cicatrización y curación de la fisura. El tratamiento ha presentado una evolución importante durante los últimos años, y hay diferentes opciones terapéuticas refl ejadas en la bibliografía, como las recomendaciones higienicodietéticas, los tratamientos quirúrgicos y los farmacológicos.

Efficacy and safety of topical diltiazem 2 % in anal fissure

Objectives: To evaluate the effectiveness and safety of 2 per cent diltiazem ointment in the treatment of anal fissure. To analyse the relationship between healing and diagnosis, and duration of the treatment and the number of applications.

Methods: A prospective observational study of all patients diagnosed with anal fi ssure that began treatment with topical diltiazem between January and June in 2007. Diltiazem ointment was prepared in the Pharmacy Service. Effectiveness and safety were assessed by a telephone survey conducted with each patient after 8 weeks of treatment, adding it to the patient’s clinical records. The variables that were analysed were healing, adverse effects, diagnosis, duration of treatment and number of applications, among others. Follow-up was carried out for up to one year until complete healing of the fi ssure. The data analysis was carried out by descriptive statistics, crosstabs and Chi-square.

Results: A total of 70 patients were included in the study and anal fi ssure healed in 48.6 % of them. Healing occurred in 54.5 % of patients with anal fi ssure and in 33.3 % of patients with anal fissure and haemorrhoids. Some adverse effects occurred in 30 % of patients. Therapy was abandoned due to adverse reactions for 5.7 %. The fi ssure was cured for 60 % of patients who underwent treatment for a month or more. More than twice-daily applications did not lead to improved healing. There were no signifi cant statistical differences in these results.

Conclusions: Despite not having found statistical differences between the analysed variables,treatment of anal fi ssures with 2 per cent diltiazem ointment has avoided surgery in nearly 50 % of patients, with few adverse effects.

ERRO MÉDICO E INTERAÇÕES NA ADMINISTRAÇÃO DE MEDICAMENTOS INJETÁVEIS NO CTI DE UM HOSPITAL UNIVERSITÁRIO

***

ERRO MÉDICO E INTERAÇÕES NA ADMINISTRAÇÃO DE MEDICAMENTOS INJETÁVEIS NO CTI DE UM HOSPITAL UNIVERSITÁRIO

GILBERTO BARCELOS SOUZA, JÚLIO FERNANDO CASCARDI DE BARROS, ROBERTA MENEZES BRANDÃO DE SOUZA, MARIA EMÍLIA DE CASTRO KLING FLEMING, LUANA RAPOSO DE MELO SOARES, LUIZ SÉRGIO DO CARMO

Serviço de Farmácia. Hospital Universitário Antonio Pedro. Universidade Federal Fluminense. Niterói. RJ

Introdução: A equipe de enfermagem é a responsável pela administração dos medicamentos aos pacientes em todas as instituições de saúde, sendo importante que durante a terapêutica medicamentosa injetável, observe o paciente quanto a possíveis erros médicos, interações e incompatibilidades medicamentosas, com o objetivo de minimizar os possíveis danos aos pacientes, tendo em vista que em unidades de terapia intensiva, nas quais é grande a complexidade e a freqüência dos procedimentos, a ocorrência de erros é maior.

Objetivos: Identificar os medicamentos envolvidos nas interações medicamentosas descritas nas prescrições médicas.

Método: A partir da análise das prescrições médicas de pacientes com mais de 5 medicamentos injetáveis por paciente, exceto para as soluções parenterais de grande volume (SPGV), admitidos no CTI do Hospital Universitário Antonio Pedro (HUAP), no período de fevereiro a abril de 2009, foram quantificadas as incompatibilidades na administração de medicamentos injetáveis.

Resultados e discussão: Analisamos 64 pacientes e 533 prescrições médicas, com uma média de 8 medicamentos IV por paciente. As seguintes interações medicamentosas foram encontradas: cefepima + vancomicina (0,19%), cefepima + fenitoína (0,38%), omeprazol + fenitoína (0,19%), imipenem + vancomicina (0,94%), tazobactama + vancomicina (0,38%), fenitoína + vancomicina (0,94%), cefepima + fenitoína (0,19%), vancomicina + anfotericina B (0,38%), vancomicina + dexametasona (0,19%). As incompatibilidades mais comuns foram identificadas com cefepima (33%) e vancomicina (66%) do total das interações descritas. No total encontramos 9 incompatibilidades de via, sendo que 3,76% das prescrições médicas do CTI, apresentaram incompatibilidades descritas na literatura médica.

Conclusão: A prevenção de erros deve basear-se na busca de causas reais. Erros devem ser aceitos como evidência de falha no sistema, e abordados como oportunidade de revisão do processo e aprimoramento da atenção farmacêutica ao paciente hospitalizado, tendo em vista, que a existência de interações e incompatibilidade de medicamentos injetáveis é um risco permanente em hospitais.

Trabalho aprovado:

III Fórum Internacional sobre Segurança do Paciente: Erros de Medicação

Data: 24 e 25 de setembro de 2010

Local: Ouro Preto, MG

Informações: ismp@ismp-brasil.org

Analysis and Stability of Deferoxamine and Hydrocortisone Admixtures

P. Yuan, N. U. Aigbogun1, C. Chamberlain, R. DeChristoforo, G. J. Grimes, G. K. Potti
National Institutes of Health

Purpose: Deferoxamine (DEF) is a chelating agent used to remove excess iron load from patients with sickle cell disease due to frequent blood transfusion to alleviate anemia. Common complaints with DEF infusions are redness, swelling, tenderness and pain at the site of the subcutaneous catheter. Hydrocortisone (HYD) is used as an immunosuppressive drug, given by injection in the treatment of severe allergic reactions such as anaphylaxis and angioedema or topically for allergic rashes. The admixture of DEF and HYD has been given to patients as one of the alternatives for reducing the inflammations. This combination has been in clinical use, however, no published studies indicate that the combination is stable. The purpose of this study is to see if the combinations are stable for up to seven days.

Methods: The admixtures of DEF/HYD were prepared at concentration of 250 mg/ml DEF/1 mg/ml HYD (A) and 100 mg/ml DEF/1 mg/ml HYD (B) (all base drug equivalent) and stored in 60 cc monoject syringes at room temperature. Stability of the drug
admixtures was followed by visual observation, pH testing, USP chelating UV assay on DEF and Optical Rotation analysis on HYD. In addition, a stability-indicating HPLC assay has been developed to test DEF and HYD together.

Results: Both (A) and (B) solutions are visually clear, no precipitation over the 7 days period. The pH values of the solution are 5.1 +/- 0.1 for (A) and 5.46 +/- 0.08 for (B), contents of DEF and HYD are above 98% relative to initial testing over the seven days period from our preliminary analysis using UV and OR. Both DEF and HYD would degrade when subject to high temperature, acidic and alkali conditions and with the presence of hydrogen peroxide. The degradation products were well
resolved from DEF and HYD in the chromatograms. Stability-indicating HPLC analysis of the drug admixtures is in progress.

Conclusion: The admixtures of DEF and HYD are stable at controlled room temperature for at least seven days

Reference: . Referência: Yuan P, Aigbogun NU, Chamberlain C, DeChristoforo R, Grimes GJ, Potti GK. Analysis and Stability of Deferoxamine and Hydrocortisone Admixtures. Disponível em: http://www.aaps.org/abstracts Acesso em: 04 de agosto de 2010

Livro de Oncohematologia

Cada monografia foi organizada em categoria pelo tipo de informação: reconstituição; compatibilidade com frascos e equipos; diluente, volume final e tempo de infusão; compatibilidade; incompatibilidade; sinonímia e outras denominações e finalmente, os estudos sobre a estabilidade da solução diluída.

O perfil de cada medicamento segue um esquema consistente e lógico, onde informamos a referência bibliográfica específica do estudo, incluindo informações sobre alguns parâmetros de estabilidade, como uma tabela de pH, critérios de armazenamento e estocagem de cada preparação realizada, temperatura de armazenagem, sinonímias do fármaco, tabela de compatibilidade e incompatibilidade dos medicamentos, glossário de termos técnicos aplicados na área, legislação farmacêutica específica e referências bibliográficas por medicamento.

Espero sinceramente que médicos, enfermeiros, farmacêuticos, veterinários, professores e estudantes da área da saúde considerem o livro como um recurso valioso de informações.

Este livro apresenta 256 páginas, com 132 monografias de princípios ativos e mais de 300 preparações extemporâneas de medicamentos injetáveis ou não de uso em oncologia, cuidados paliativos e em hematologia, assim como os medicamentos de suporte de uso em oncohematologia, com a respectiva estabilidade do produto reconstituído ou manipulado que foram preparados a partir de cápsulas, comprimidos, ampolas ou de outras formas farmacêuticas existentes, também descrevemos a estabilidade de líquidos orais fracionados e estocados em seringa dosadora oral âmbar, estabilidade de preparações dermatológicas, estabilidade de preparações oftálmicas, assim como o preparo, compatibilidade, reconstituição e estabilidade de medicamentos citostáticos injetáveis.

O livro Oncohematologia: Manual de Diluição, Administração e Estabilidade de Medicamentos Citostáticos é um livro que desejamos que funcione como um livro prático, de leitura fácil, simples e que seja objetivo para acompanhar a equipe multiprofissional dos serviços de terapia antineoplásica.

Abciximabe,Ácido Folínico, Ácido Zoledrônico, Aclarrubicina, Actinomicina D, Alemtuzumabe, Alopurinol, Amifostina, Amsacrina, Asparaginase, Azacitidina, Azatioprina, BCG, Bevacizumabe, Bleomicina, Bortezomibe, Bussulfano, Carboplatino, Carmustina, Cetamina, Cetuximabe, Ciclofosfamida, Cidofovir, Cisplatino, Citarabina, Citarabina Lipossomal, Cladribina, Clodronato, Clofarabina, Clorambucila, Codeína, Dacarbazina, Daclizumabe, Darbepoetina Alfa, Daunorrubicina, Daunorrubicina Lipossomal, Decitabina, Dexametasona, Dexrazoxano, Diamorfina, Dimetilsulfóxido, Docetaxel, Dolasetrona, Doxorrubicina, Doxorrubicina Lipossomal, Droperidol, Eculizumabe, Edrecolomabe, Epirrubicina, Eritropoetina Alfa-Recombinante, Estramustina, Estreptozocina, Etoposido, Fentanila, Filgrastima, Floxuridina, Fludarabina, Fluoruracila, Folinato de Cálcio, Folinato Dissódico, Fotemustina, Ganciclovir, Gemcitabina, Gemtuzumabe, Gemtuzumabe Ozogamicina, Granisetrona, Haloperidol, Hidromorfona, Hidroxiuréia, Idarrubicina, Idoxuridina, Ifosfamida, Infliximabe, Interferon Alfa-2b Recombinate, Interferon Alfa-2a, Interleucina, Irinotecano, Lenograstima, Mecloretamina, Melfalano, Mercaptopurina, Mesna, Metadona, Metilprednisolona, Metotrexato, Metronidazol, Mitomicina, Mitoxantrona, Mitramicina, Molgrastima, Morfina, Naloxona, Naltrexona, Nelarabina, Octreotida, Ondansetrona, Oxaliplatino, Oxicodona, Paclitaxel, Palonosetrona, Pamidronato, Panitumumabe, Pegaspargase, Pegfilgrastima, Pemetrexede, Pentostatina, Petidina, Procarbazina, Raltitrexede, Rasburicasa, Rituximabe, Saliva Artificial, Saliva Artificial com Lidocaína, Sargramostima, Solução Sedativa Oral, Sucralfato, Sunitibe, Temozolomida, Teniposido, Tintura de Ópio, Tioguanina, Tiotepa, Topotecano, Tositumomabe, Tramadol, Trastuzumabe, Treossulfano, Tropisetrona, Valrrubicina, Vidarabina, Vimblastina, Vincristina, Vindesina, Vinorelbina

Consequências dos erros de medicação em unidades de terapia intensiva e semi-intensiva

***

Maria Cecília Toffoletto (1); Kátia Grillo Padilha (2)

(1) Enfermeira. Mestranda do Programa de Pós-Graduação na Saúde do Adulto da Escola de Enfermagem da Universidade de São Paulo (EEUSP) mariacel@usp.br

(2) Professora Doutora do Departamento de Enfermagem Médico-Cirúrgica da EEUSP kgpadilha@usp.br

RESUMO

O estudo objetivou caracterizar erros de medicação e avaliar consequências na gravidade dos pacientes e carga de trabalho de enfermagem em duas Unidades de Terapia Intensiva (UTI) e duas Semi-Intensiva (USI) de duas instituições hospitalares do município de São Paulo. A amostra foi constituída por 50 pacientes e os dados obtidos por meio do registro de ocorrências e prontuários, retrospectivamente. A gravidade e carga de trabalho de enfermagem foram avaliadas antes e após o erro. Do total de 52 erros, 12 (23,08%) ocorreram por omissão de dose, 11 (21,15%) e 9 (17,31%) por medicamento e dose erradas, respectivamente. Não houve mudança na gravidade dos pacientes (p=0,316), porém houve aumento na carga de trabalho de enfermagem (p=0,009). Quanto ao grupo de medicamentos envolvidos, potencialmente perigosos e não potencialmente perigosos, não houve diferenças estatisticamente significantes na gravidade (p=0,456) e na carga de trabalho de enfermagem (p=0,264), após o erro de medicação.

Referência: Revista da Escola de Enfermagem da USP 2006;40(2):247-52

Topical cidofovir for the treatment of plantar warts: case report

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Topical cidofovir for the treatment of plantar warts: case report

Amelia Troncoso, Ramon Cuiña, Juliana Alvarez, Cristina Vazquez, Maria Teresa Inaraja, Francisco Allegue

Pharmacy, Hospital Meixoerio, Dermatology, Hospital Meixoeiro, Vigo, Spain

Background and Objective: Plantar warts are hyperkeratotic lesions on the plantar surface caused by infection with Human papillomavirus. Lesions caused by warts are commonly refractory to therapy and may become large and painful in immunodeficient patients. Cidofovir is a cytidine analogue with activity against a broad spectrum of DNA viruses. It is indicated for the treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome and without renal dysfunction. We describe a case of plantar warts that was treated with topical cidofovir in a highly immunodeficient patient.

Results: A 29 years old woman, who received kidney transplant in 1996, presenting plantar warts refractory to conventional therapy since last four years. She was treated with topical 3% cidofovir cream twice daily. The treatment was authorised as compassionate use by the national regulatory agency on drugs. The glomerular filtration rate (GFR) was monitored in order to detect nephrotoxicity due to cidofovir.

The 3% cidofovir ointment was compounded as follows:

– Cidofovir 75 mg/ml 5 ml vial .…….. 20 ml
– Anhydrous Lanolin ……………………….. 5 g
– Beeler base …..sufficient to produce 50 g

It was packaged and labelled in a light-resistant containers and we assumed an expiration date of 3 months based on the duration of treatment and published studies. The quality controls of organoléptics properties were made according to the Good Manufacturing Practice (GMP)

After 10 weeks of therapy the patient did not show any improvement and developed severe local erosion, so treatment with cidofovir was withdrawn. Two weeks later this local erosion disappeared spontaneously. No systemic side effects were observed. The colour, texture and smell organoleptics characters were complied with GMPs.

Conclusions: There are not formal studies of optimal formulations or treatment regimens and further studies are needed to elucidate the role of cidofovir in treatment of plantar warts. The immunodeficiency of the patient and the large wart area could be related with the failure to the treatment.

Reference Alonso Diez M, de Miguel Cascón M, Sánchez Moreno H, González Mielgo FJ. Cidofovir tópico para tratamiento de lesiones cutáneas por Molluscum contagiosum y Papilomavirus humano. XLIV SEFH Congress.1999; 156–57

Voriconazol colírio: estabilidade após a manipulação

***

Stability of extemporaneously prepared voriconazole ophthalmic solution

AL-BADRIYEH, DAOUD; LI, JIAN; STEWART, KAY; KONG, DAVID C. M.; LEUNG, LOK; DAVIES, GEOFFREY E.; FULLINFAW, ROBERT

Methods: Voriconazole solutions (2% and 1%) were reconstituted from the i.v. formulation. After thorough mixing, 3-mL samples of each of the resulting 2% and 1% solutions were filtered into eyedroppers. Three samples for both solutions were analyzed in triplicate at each time point. The 2% voriconazole ophthalmic solutions were stored at 2–8 °C, 25 °C, and 40 °C. The 1% voriconazole eye drops were stored at 2–8 °C. The 2% voriconazole solution samples were analyzed at time 0 and at weeks 1, 2, 4, 8, 16, and 32. The 1% solution samples were analyzed at time 0 and at weeks 6 and 14. Stability was measured using high-performance liquid chromatographic analysis.

Results: The 2% voriconazole ophthalmic solution demonstrated excellent stability at 2–8 °C and 25 °C for up to 16 weeks. The voriconazole solution displayed no significant change in pH at all time intervals. No change in visual appearance or clarity was observed in the 2% voriconazole eye drops at any point of the study for all study temperatures. Voriconazole 1% solution was stable at 2–8 °C for up to 14 weeks.

Conclusion: Voriconazole 2% (20 mg/mL) solution preserved with 0.01% benzalkonium chloride prepared as alternative antifungal eye drops was stable for 16 weeks when stored at 2–8 °C and 25 °C and for 8 weeks when stored at 40 °C, while voriconazole 1% solution was stable at 2–8 °C for up to 14 weeks.

Reference: American Journal of Health-System Pharmacy
Issue: Volume 66(16), 15 August 2009, p 1478–1483

Poor preservation efficacy versus quality and safety of pediatric extemporaneous liquids.

***

Ghulam A, Keen K, Tuleu C, Wong IC, Long PF.

The School of Pharmacy, University of London, London, England.

Background: Most medicines are available only as solid, adult-strength dosage forms from which oral extemporaneous liquids are often prepared for children. There are few comprehensive reference lists for the preparation of pediatric extemporaneous formulations. Some pediatric reformulations are made by diluting the suspending vehicle, and a shelf life of up to 3 months can be used without documented microbial stability. Although most commercially available ready-to-use vehicles are supplied as preserved formulations, it is still common practice in many European dispensaries to prepare and dilute these vehicles as required for specific prescriptions.

Objective: To determine what influence dilution of vehicles has on the preservation efficiency of extemporaneous formulations.

Methods: Suspending vehicles were made by diluting methylcellulose 1% and simple syrup, BP (British Pharmacopoeia) in ratios of 1:1 and 1:4. The efficacy of antimicrobial preservation was tested according to the 2007 standards required by the BP.

Results: Dilution in ratios greater than 1:1 failed the BP 2007 criteria. Such dilution represents a potential biohazard, especially to premature, newborn, or immunocompromised children, exposing them not only to possible organoleptic changes of the preparation, but also to ingestion of either dangerous numbers of microorganisms or medicines that may have undergone biotransformation, rendering them inactive or toxic.

Conclusions: Significant concerns have been raised regarding the quality of extemporaneous preparations. We call for further research in this neglected area to address issues of antimicrobial preservation, including revision of existing quality assurance monographs. Moreover, these monographs should take into account testing that simulates multiple dosing from a single storage container during the intended in-use shelf life of multidose extemporaneous preparations.

Reference: Ann Pharmacother. 2007 May;41(5):857-60. Epub 2007 Apr 17.

Stability of morphine sulphate and diamorphine hydrochloride in Intrasite gel

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Stability of morphine sulphate and diamorphine hydrochloride in Intrasite gel

Giovambattista Zeppetella G; Joel SP; Ribeiro MDC.
St. Clare Hospice, Hastingwood, Essex; Medical Oncology Department, St. Bartholomew's Hospital, London; Peace Hospice, Watford

Several studies have reported that opioids applied topically to painful ulcers produce an analgesic effect. It is unknown whether these opioids (usually mixed with hydrogels) are stable and, if so, for how long. We investigated the stability of morphine sulphate and diamorphine hydrochloride, each mixed with intrasite gel at a concentration of 1.25 mg/mL. Samples were prepared in the laboratory and then stored in plastic containers in the dark, at room temperature, in conditions of normal day/night at room temperature, and at 48C. Aliquots were collected from each container over a 28-day period and analysed using HPLC. No known degradation products were measured in the morphine–intrasite gel mixture stored for up to 28 days, irrespective of the temperature and whether or not samples were exposed to light, suggesting that morphine remains stable. Diamorphine, breaks down to morphine and no other degradation products are measurable.

Reference: Palliative Medicine, Vol. 19, No. 2, 131-136 (2005)

Efectividad y seguridad de diltiazem 2 % tópico

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Efectividad y seguridad de diltiazem 2 % tópico en fisura anal

M.I. Fernández García*, R. Albornoz López, I. Pérez Rodrigo y J. Abellón Ruiz

Servicio de Farmacia, Hospital Universitario Reina Sofía, Córdoba, España

Objetivo: Evaluar la efectividad y la seguridad de la pomada de diltiazem al 2 % en el tratamiento de la fi sura anal. Analizar la relación entre la cicatrización de la fi sura y diagnóstico, duración del tratamiento y número de aplicaciones.

Métodos: Estudio prospectivo observacional de todos los pacientes diagnosticados de fi sura anal que comenzaron tratamiento con diltiazem tópico entre enero y junio de 2007. La pomada de diltiazem al 2 % se preparó como fórmula magistral en el servicio de farmacia. La efectividad y la seguridad se evaluó mediante encuesta telefónica a cada paciente tras 8 semanas de tratamiento, completándose con la historia clínica del paciente. Las variables analizadas fueron cicatrización, efectos adversos, diagnóstico, duración del tratamiento y número de aplicaciones, entre otras. Se realizó seguimiento hasta resolución de la fi sura hasta un período de 1 año. El análisis de los datos se realizó mediante estadística descriptiva y frecuencia, tablas de contingencia y  2.

Resultados: Se incluyó a un total de 70 pacientes y se produjo cicatrización en el 48,6 % de éstos. Cicatrizó en el 54,5 % de los pacientes con fi sura anal y en el 33,3 % con fi sura anal y hemorroides. El 30 % experimentó efectos adversos. El 5,7 % abandonó el tratamiento por reacción adversa. La fi sura cicatrizó en el 60 % de los pacientes que estuvieron más de 1 mes en tratamiento. No hubo más cicatrización con más de 2 aplicaciones diarias. En ninguno de estos resultados hubo diferencias estadísticamente signifi cativas.

Conclusiones: A pesar de no encontrarse diferencias signifi cativas entre las variables estudiadas, el tratamiento de la fi sura anal con la pomada de diltiazem al 2 % ha evitado la intervención quirúrgica casi en un 50 % de los pacientes, con efectos adversos poco frecuentes.

Reference: Farm Hosp. 2009;33(2):80-8

Vancomycin: stability in syringes

***

Chemical stability and microbiological potency of intravenous
vancomycin hydrochloride in polypropylene syringes for use in
the neonatal intensive care unit

Study objectives : To determine the chemical stability and microbiological potency of “almost” ready-to-use vancomycin solutions in polypropylene syringes at a concentration of 5 mg/mL in both 5% glucose and 0.9% sodium chloride at 4°C and 25°C, for use in the neonatal intensive care unit.

Methods: Ten-millilitre syringes were filled using aseptic techniques with a solution of vancomycin, covering body weights of 500 g to 3 kg at a dosage of 15mg/kg, prepared by reconstitution and dilution of commercially available vancomycin hydrochloride powder (Vancocin) and kept at 4°C and 25°C, respectively. At various storage times, the chemical stability was determined using a high-performance liquid chromatography method and the microbiological potency was assayed according to the European Pharmacopoeia 2002. Arbitrarily, 56 day samples at 4°C were brought to 25°C and analyzed after 48 hours to simulate ward conditions. The standards were the T0 solution kept at -70°C and the International Vancomycin Reference Standard.

Results: The vancomycin was found to be chemically and microbiologically stable at 4°C for 6 months. Losses were important after 14 days at 25°C in both cases. The samples subjected to simulated ward conditions were stable for 48 hours at 25°C. A shelf life of 6 months was proposed.

Conclusions: Syringes of low dose vancomycin manufactured and supplied by the pharmacy can be stored in the neonatal intensive care unit refrigerator for use in emergency situations thus avoiding calculation and dilution errors and reducing the risk of bacterial contamination. The solution brought to 25°C must be used within 48 hours.

References: This work was presented as a poster at the 8th congress of the European
Association of Hospital Pharmacists, Florence, Italy, 2003.

Dr Pascal Bonnabry, Head of pharmacy, Pharmacy Department University Hospitals of Geneva (HUG). William Griffiths, PharmD, Jocelyne Favet, PhD, Ho Ing, PharmD, Farshid Sadeghipour, PhD, Pascal Bonnabry, PhD

Elaboración de mezclas intravenosas individualizadas

***

Elaboración de mezclas intravenosas individualizadas
como mejora de la seguridad del paciente

Gimeno MJ, Fernández J, Pinto C, Acosta P

Servicio de Farmacia. Hospital de Poniente. Almeria

Objetivo: Los errores relacionados con medicamentos constituyen la principal causa de eventos adversos en los hospitales. La elaboración de mezclas intravenosas individualizadas por parte del Área de Farmacia permite evitar errores de dosifi cación que puedan producirse durante la preparación de éstas en el área de hospitalización. El objetivo del presente trabajo es describir la actividad asistencial que se ha llevado a cabo desde la unidad de mezclas intravenosas durante el 2006.

Material y métodos: A partir de los datos de dispensación en dosis unitarias la unidad de mezclas intravenosas elabora de forma individualizada aquellos antibióticos cuya estabilidad sea mayor de 48 h. Se consideran mezclas intravenosas individualizadas aquellas cuya dosifi cación es diferente a la de las mezclas protocolizadas que se elaboran a modo de reposición de stock.

Resultados: En el 2006 se han elaborado 230868 mezclas intravenosas de las que 2217 fueron individualizadas (0,96% total). De éstas el 87,1% (1931) pertenecen al Área de Pediatría.

Conclusiones: La elaboración centralizada en el Área de Farmacia de los antibióticos descritos evita que el personal de enfermería de hospitalización tenga que realizar cálculos de dosifi cación a los que puede no estar habituado (p.e. no tener en
cuenta el aumento de volumen que se produce al reconstituir algunos antibióticos); facilita la administración del tratamiento ya que va correctamente identifi cado; y se asegura una elaboración en condiciones estériles al ser preparados en cabina
de fl ujo laminar horizontal.

Referência: IV Congreso de la Sociedad Andaluza de Farmacéuticos de Hospitales. Spaña. 2007

Aripiprazol, eficaz a largo plazo en el tratamiento del trastorno bipolar

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El trastorno bipolar es una enfermedad mental grave que provoca cambios extremos en el estado de ánimo, la energía y las habilidades de los afectados (se calcula que aproximadamente 2,4 millones de ciudadanos europeos padecen este tratorno).

Por ello, es especialmente importante que los tratamientos "sean eficaces y bien tolerados a largo plazo", según señala a CF Eduard Vieta, profesor de Psiquiatría de la Universidad de Barcelona y director del Programa de Trastornos Bipolares del Hospital Clínico de Barcelona.

Este experto ha dirigido un ensayo clínico presentado en el último congreso de la World Psychiatric Association (WPA), celebrado en Florencia, que ha demostrado que aripiprazol, un moderno antipsicótico, en combinación con los estabilizadores del ánimo (litio o valproato) es un tratamiento bien tolerado a largo plazo en pacientes con trastorno bipolar de tipo I y con respuesta inadecuada a la monoterapia con litio o valproato, terapias habituales en esta patología.

Según comenta Vieta, "ya se tenían datos previos positivos de aripiprazol en monoterapia, pero el nuevo estudio aporta valor añadido, al describir el comportamiento del fármaco en condiciones clínicas mucho más habituales en la clínica, como es el caso de la terapia combinada".

En este trastorno, explica, el fármaco proporciona un control rápido de los episodios maníacos, evita que aparezcan nuevos episodios y aporta un control continuado de la manía.

La eficacia y seguridad de aripiprazol, en combinación con litio o valproato, fueron investigadas en un estudio multicéntrico, doble ciego, randomizado y controlado con placebo de 6 semanas de duración, en el que participaron 348 pacientes.

Una vez finalizado, se ofreció a los participantes la posibilidad de continuar en una fase de extensión abierta de 46 semanas.

Referência: Correo Farmaceutico. Madrid: Apr 13, 2009.

Ketamina: estabilidade em seringas

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Development of ready-to-use ketamine hydrochloride syringes for safe use in post-operative pain

M Cyril Stucki, PharmD; Sandrine Fleury-Souverain, PhD; Anna-Maria Sautter, PhD; Farshid Sadeghipour, PhD; Pascal Bonnabry, PhD

ABSTRACT: Study objectives: To increase safety in use of ketamine. This would be achieved by introducing a ready-to-use (RTU) intravenous syringe of ketamine hydrochloride, which would be prepared under aseptic conditions in the hospital pharmacy, for post-operative pain.

Methods: The chemical stability of ketamine hydrochloride solution (1 mg/mL) in 0.9% sodium chloride was determined at 4°C, 25°C and 40°C by means of a stability-indicating capillary electrophoresis method. Changes in pH and the presence
of non-visible particulate matter were measured throughout the study. Sterility testing was performed to check the integrity of the syringes.

Results: The loss in potency was less than 8% after 12 months at the three temperatures, and no degradation products were detected. The pH values did not change appreciably and the syringe contents remained sterile throughout the study. Each syringe fulfilled all US Pharmacopeia criteria in terms of non-visible particles.

Conclusion: RTU syringes of ketamine hydrochloride with a shelf life of one year can be manufactured and supplied by the hospital pharmacy for use in post-operative pain. This product will help reduce the risk of dilution errors and lead to
significant economic advantages.

M Cyril Stucki, PharmD
Pharmacy Department
University Hospitals of Geneva
24 Rue Micheli du Crest
CH-1211 Geneva 14, Switzerland
Tel: +41 22 382 39 74
Fax: +41 22 382 39 40
cyril.stucki@hcuge.ch
www.hcuge.ch/Pharmacie

Reference: EJHP Science • Volume 14 • 2008 • Issue 1 • P. 14-18

Bupivacaína + sufentanila: estabilidade em seringas

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Chemical stability of a solution of bupivacaine hydrochloride 0.125% and sufentanil citrate 0.5 μg/mL for filling syringes using a repeater pump.

Karin Janssen, PharmD; René Wisselo, B App Sci; Charles Geerlings, PharmD; Jan Pieter Schouten, PharmD, MBM

ABSTRACT: Study objective: In Sint Franciscus Gasthuis, Rotterdam, The Netherlands, syringes filled with bupivacaine hydrochloride 0.125% and sufentanil citrate 0.5 μg/mL are administered epidurally during post-operative analgesia. These syringes are filled in the pharmacy using a Baxa Repeater pump. The suitability of the filling method and the shelf-life of the solution in the syringes were investigated.

Methods: During the filling process six samples were taken. Three syringes were stored at room temperature and three in the refrigerator. Samples were taken on days 4, 7, 14 and 28. High performance liquid chromatographic (HPLC) methods were used to measure the concentrations of both drugs in the samples.

Results: No loss of drugs was observed during the filling process. After 28 days at room temperature and in the refrigerator, the concentration of bupivacaine hydrochloride was 97.4 ± 0.9% and 97.9 ± 1.0% respectively, and that of sufentanil
citrate was 95.6 ± 4.2% and 99.2 ± 1.4%.

Conclusion: The filling method used with a Baxa Repeater pump is acceptable. Bupivacaine/sufentanil solution in syringes is chemically stable for at least 28 days in the refrigerator.

Contact: Karin Janssen, PharmD
Apotheek Zuwe Hofpoort Ziekenhuis
2 Polanerbaan
3447 GN Woerden, The Netherlands
Tel: +31 348 427385
Fax: +31 348 427489
kjanssen@zuwe.nl

Reference: EJHP Science • Volume 15 • 2009 • Issue 1 • P. 11-14

Osmolalidade e pH: metotrexato, citarabina e tiotepa.

Evaluation of osmolality and pH of various concentrations of methotrexate, cytarabine, and thiotepa prepared in normal saline, sterile water for injection, and lactated Ringer's solution for intrathecal administration.

Background: Neurotoxicity of intrathecal (IT) chemotherapy has been variously attributed to the preservatives, volume, osmolality, and pH of the preparations. There has been little evaluation of how different drug concentrations or diluents can affect the osmolality and pH of the final solution. We conducted a three-part study: survey of cancer centers regarding the drug concentrations and diluent used in preparing IT chemotherapy; review of the literature on common practice of preparing IT chemotherapy; evaluation of the pH and osmolality of commonly used chemotherapy preparations for IT.

Method: We surveyed selected cancer centers to provide information on their standard volume, drug concentrations, and choice of diluents. MEDLINE was searched for clinical reports using the MeSH terms of 'cytarabine,' 'methotrexate,' or 'thiotepa' with the subheading 'Cerebrospinal fluid' and combined with 'intrathecal' in all database fields. Data retrieved included the choice of diluent, volume, and/or drug concentration. We evaluated the pH and osmolality of methotrexate (1, 2, 5, and 10 mg/mL), cytarabine (2, 5, 10, and 25 mg/mL), and thiotepa (1, 2, and 5 mg/mL) in normal saline, sterile water for injection (SWFI), and lactated Ringer's solution.

Results: Nine centers were surveyed (seven in Canada, one in Australia, one in United Kingdom). Most centers used 5mL of preservative-free normal saline, irrespective of the drug or drug concentration used. Forty-four reports in the literature were reviewed. Most reported 5mL of preservative-free normal saline. Most information on drug concentrations was provided for methotrexate, with an average concentration of about 1-2.5 mg/ mL. Cytarabine 0.4-20 mg/mL and thiotepa 1 mg/mL were also reported. In our in vitro evaluation, there was a trend of increased pH associated with increasing concentration of methotrexate and cytarabine. There was no apparent impact of thiotepa concentration on the pH values of the final preparations, irrespective of the diluent used. Except for cytarabine 10 and 25 mg/mL, all the tested solutions have pH within 10% of the physiologic range of CSF. There was a concentration-dependent change in osmolality with methotrexate and cytarabine preparations. Osmolality was increased with increased concentrations in all except methotrexate mixed in SWFI and thiotepa mixed in normal saline and lactated Ringer's solution. Except for some thiotepa solutions, all the tested solutions have osmolality within 10% of the physiologic range of CSF.

Conclusions: There is limited published literature on the potential impact of diluent and drug concentration on the pH and osmolality of IT chemotherapy preparation. Most cancer centers conventionally prepare IT chemotherapy with 5mL of preservative diluent normal saline, irrespective of the specific drug or dose used. The conventional practice means that most methotrexate preparations are likely to have comparable pH and osmolality to CSF. In contrast, cytarabine preparations may show significantly higher pH than the CSF, while thiotepa preparations generally have lower osmolality than the CSF.

Reference: Lemos et al. Evaluation of osmolality and pH of various concentrations of methotrexate, cytarabine, and thiotepa prepared in normal saline, sterile water for injection, and lactated Ringer's solution for intrathecal administration. Journal of Oncology Pharmacy Practice; Mar 2009, Vol. 15 Issue 1, p 45-52

Chemical stability of a solution of bupivacaine hydrochloride 0.125% and sufentanil citrate 0.5 μg/mL

***

Chemical stability of a solution of bupivacaine hydrochloride 0.125% and sufentanil citrate 0.5 μg/mL for filling syringes using a repeater pump

Karin Janssen, PharmD; René Wisselo, B App Sci; Charles Geerlings, PharmD; Jan Pieter Schouten, PharmD, MBM

ABSTRACT: Study objective: In Sint Franciscus Gasthuis, Rotterdam, The Netherlands, syringes filled with bupivacaine hydrochloride 0.125% and sufentanil citrate 0.5 μg/mL are administered epidurally during post-operative analgesia. These syringes are filled in the pharmacy using a Baxa Repeater pump. The suitability of the filling method and the shelf-life of the solution in the syringes were investigated.

Methods: During the filling process six samples were taken. Three syringes were stored at room temperature and three in the refrigerator. Samples were taken on days 4, 7, 14 and 28. High performance liquid chromatographic (HPLC) methods were used to measure the concentrations of both drugs in the samples.

Results: No loss of drugs was observed during the filling process. After 28 days at room temperature and in the refrigerator, the concentration of bupivacaine hydrochloride was 97.4 ± 0.9% and 97.9 ± 1.0% respectively, and that of sufentanil
citrate was 95.6 ± 4.2% and 99.2 ± 1.4%.

Conclusion: The filling method used with a Baxa Repeater pump is acceptable. Bupivacaine/sufentanil solution in syringes is chemically stable for at least 28 days in the refrigerator.

References: EJHP Science • Volume 15 • 2009 • Issue 1 • P. 11-14

Jarabe de Paracetamol

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Jarabe de Paracetamol

Fórmula:
Paracetamol ............................................................. 1 % p/v
Propilenglicol ......................................................... 25 % v/v
Agua purificada..........................................................35 % v/v
Esencia de fresa.................................................................c.s.
Colorante hidrosoluble........................................................c.s.
Conservante......................................................................c.s.
Jarabe simple c.s.p........................................................ 100 mL

Tecnica: En un vaso de precipitado, se disuelve el paracetamol en el agua. Se añade el propilenglicol y se homogeneiza. Esta mezcla se vierte en una probeta graduada y se completa hasta la cantidad a elaborar, con jarabe simple. Finalmente, se vierte el contenido de la probeta al vaso de precipitado, se añaden la esencia, el conservante y el colorante y se mezcla todo bien hasta obtener un sistema
homogéneo.

Envasado: El jarabe se envasa en un frasco de cristal topacio, de capacidad adecuada a la cantidad de fórmula a dispensar; acompañado de jeringa.

Usos y Aplicaciones: Se utiliza como analgésico y antipirético

Conservación y Estabilidad: Se conserva a temperatura ambiente y protegido de la luz.

Referência: UNIVERSIDAD DE SEVILLA, FACULTAD DE FARMACIA, DEPARTAMENTO DE FARMACIA Y
TECNOLOGÍA FARMACÉUTICA

Stability of high dose melphalan in saline solution.

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Stability of high dose melphalan in saline solution

M.T. Baylatry, D. Geay, C. Guntz, J.L. Prugnaud, A.C. Joly
Saint-Antoine Hospital, Pharmacy, Paris Cedex 12, France

Background: Melphalan is an effective anticancer drug used in high doses as preparative regimen for haematopoietic stem cell transplantation (off-label indication). In Saint-Antoine hospital, melphalan concentration for chemotherapy infusion bag, in this indication, is between 0.8 mg/mL and 1.6 mg/mL. In melphalan
summary of product characteristics, the recommended maximum concentration is 0.45 mg/mL and the stability at this concentration in infusion bag is reported to be 90 min at room temperature. A chemical stability assay of high dose melphalan has been developed firstly to validate the safety of this unlicensed preparation and then to make possible melphalan centralized preparation and storage.

Methods: A liquid chromatographic UV method was used. The evaluation of stability (International Conference on Harmonization guidelines) and the accelerated degradation (temperature) were performed. The stability was established as the 95% of initial concentration. Melphalan solution in saline (0.9% NaCl) infusion bags were assessed at room temperature (average: 28°C) for 0.3 mg/mL (n=3) and 1.6 mg/mL (n=3) concentrations and at + 4°C for 0.8 mg/mL (n=3) and 1.6 mg/mL (n=3). Samples were collected at different times from 0h to 24h. Visible particulate formation or colour change were also evaluated.

Results: Melphalan solutions were degraded at room temperature within 2 hours (76% and 78% of initial concentration respectively for 0.3 mg/mL and 1.6 mg/mL). At + 4°C, melphalan concentrations (0.8 mg/mL and 1.6 mg/mL) remained above 95% for 3 hours. No color change or visible particulate formation were observed.

Conclusions: High dose melphalan is not degraded rapidly in saline solution. This study allows to prepare high dose melphalan infusion bags without recurring to high volumes of saline solution which may expose patients to hydric overload. The 3 hour stability of melphalan at + 4°C is compatible with an anticancer drug centralized preparation in Pharmacy department in order to avoid an extemporaneous preparation by nurses in Haematology department and improve their safety.

References: 14th Congress of EAHP. Barcelona. 2009

Tamiflu (oseltamivir): preparation and stability of extemporaneous oral liquid formulations of oseltamivir using commercially available capsules.

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Preparation and stability of extemporaneous oral liquid formulations of oseltamivir using commercially available capsules.

Winiarski AP, Infeld MH, Tscherne R, Bachynsky M, Rucki R, Nagano-Mate K.

Professional Product Information, Roche Laboratories, Nutley, NJ 07110-1199, USA. aleksander.winiarski@roche.com

OBJECTIVES: To develop a simple, standardized method for the extemporaneous compounding of an oral liquid form of oseltamivir from commercially available Tamiflu 75 mg capsules (Roche Pharmaceuticals) and to determine the stability of oseltamivir in this preparation.

***

INTERVENTION: Extemporaneous oral liquid formulations of oseltamivir (15 mg/mL) were prepared in Cherry Syrup (Humco) and Ora-Sweet SF (Paddock Laboratories) using methods consistent with current compounding practice in a pharmacy setting. Preparations were stored in amber glass and amber polyethyleneterephthalate bottles at 5 degrees C +/- 2 degrees C (41 degrees F +/- 4 degrees F) and 25 degrees C +/- 2 degrees C (77 degrees F +/- 4 degrees F) at 60% +/- 5% relative humidity (RH) for 35 days and 30 degrees C +/- 2 degrees C (86 degrees F +/- 4 degrees F) at 65% +/- 5% RH for 13 days.

***

RESULTS: The Cherry Syrup preparation, in either bottle type, was stable for up to 35 days under refrigeration (5 degrees C) and up to 5 days at room temperature (25 degrees C). It was not stable when stored at 30 degrees C for 5 days. The Ora-Sweet SF preparation was stable for up to 35 days at 5 degrees C or 25 degrees C and for up to 13 days at 30 degrees C in either bottle type. Both preparations maintained microbiologic stability for 35 days.

***

CONCLUSION: Both preparations are stable under the described conditions and may provide an option in situations where the marketed suspension is unavailable.

Reference: J Am Pharm Assoc (2003). 2007 Nov-Dec;47(6):747-55.

Formulation and stability evaluation of bromhexine hydrochloride for veterinary use

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Formulation and stability evaluation of 1% w/v oral solution of Bromhexine hydrochloride for veterinary use

Purpose: The aim of this study is to develop bromhexine hydrochloride 1 %w/v oral solution for veterinary use and to evaluate its stability.

Methods: Solutions of Bromhexine hydrochloride (1%w/v) were prepared by dissolving bromhexine hydrochloride in benzyl alcohol at 50 °C then alcohol 96 % v/v; Tween 80 and purified water were added. The obtained solution was filled in amber glass bottles, and the solution was stored at 25 °C/60 % relative humidity (RH) and at 40 °C /75% RH. The strengths of bromhexine hydrochloride were determined by High performance liquid chromatographic assay at 0, 2, 4, 6, 8, 10, 12, 16, 20 and 24 months. The concentrations of the drug were directly related to the peak area. pH, odor, color and crystal formation was also monitored.

Results: The degradation of bromhexine hydrochloride 1% w/v oral solution was faster at 40 °C/75% RH than at 25 °C /60% RH. No significant differences were found between the initial and final pH value for the solution at the studied conditions. No detectable changes in color, odor or precipitations were observed for the solutions stored at the upper conditions.

Conclusions: Bromhexine hydrochloride 1% w/v oral solution could be formulated and remains stable for at least 2 years when is stored at 25°C /60% RH and for 16 months when stored at 40 °C /75% RH.

Reference: The Islamic University Journal (Series of Natural Studies and Engineering), Vol.15, No. 1, pp 13 -22 , 2007

GEL DE CLORIDRATO DE DILTIAZEM

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ESTABILIDADE QUÍMICA, FÍSICA E MICROBIOLÓGICA DE UM GEL DE CLORIDRATO DE DILTIAZEM

Ana C. Salgado, Marina Lobo Alves, Fátima Falcão, João F. Pinto.

Tecnologia Farmacêutica, Faculdade de Farmácia, Universidade de Lisboa; Serviços Farmacêuticos Hospital São Francisco Xavier

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Resumo: A fissura anal é um problema comum que afecta ambos os sexos. A hipertonia do esfíncter anal é o principal factor fisiopatológico que condiciona a cicatrização. É mais frequente em doentes com obstipação crónica. É caracterizada por dor e hematoquezias. O índice de cicatrização não ultrapassa os 65 a 70%, independentemente da utilização dos tratamentos médicos disponíveis, obrigando frequentemente ao recurso a procedimento cirúrgico. A utilização do cloridrato de diltiazem por via tópica constitui uma nova abordagem terapêutica das fissuras anais. O objectivo deste trabalho é o desenvolvimento de um gel de cloridrato de diltiazem a 2% e o estudo da sua estabilidade química, física e microbiológica. O protocolo de estabilidade adoptado obedeceu, nos aspectos relevantes, às normas em vigor para estudos de estabilidade de especialidades farmacêuticas.Para o efeito, foram produzidos três lotes de gel de composição idêntica que foram armazenados durante 93 dias, em frascos de vidro incolor, a 22±3ºC e protegidos da luz. A intervalos de tempo apropriados foram colhidas amostras e analisados os seguintes parâmetros: aspecto, viscosidade, doseamento do cloridrato de diltiazem (HPLC) com pesquisa de produtos de degradação e controlo microbiológico (realizado segundo a FP VII para preparações líquidas para uso oral). O método de doseamento da substância activa foi devidamente validado quanto à sensibilidade, linearidade, exactidão e precisão. A estabilidade do gel foi definida como a retenção de um teor em cloridrato de diltiazem ³95% sem alterações significativas nos restantes parâmetros analisados. Os resultados indicam que o gel de cloridrato de diltiazem a 2% armazenado à temperatura ambiente (22±3ºC) é estável química, física e microbiologicamente durante todo o tempo do estudo (93 dias).

Referência: 5º Congresso Nacional da APFH. Lisboa. 2007

Creme de metadona 0,1%, lidocaína 2% e metronidazol 5% para el tratamiento de úlceras tumorales dolorosas.

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Crema de metadona 0,1%, lidocaína 2% y metronidazol 5% para el tratamiento de úlceras tumorales dolorosas

M.C. Dávila Pousa, L. Herrero Poch y G. Piñeiro Corrales
Complexo Hospitalario de Pontevedra. Pontevedra.

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Introducción: El alivio del dolor y la eliminación del mal olor causado por microorganismos anaeróbios, es uno de los objetivos principales del tratamiento de las úlceras tumorales dolorosas en una unidad de cuidados paliativos. La asociación de metadona a formulaciones tópicas con metronidazol y lidocaína podría estar valada por la existencia de receptores opiodes periféricos y por sus propiedades de liposolubilidad y elevada vida media.

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Objetivo: Protocolización de una fórmula magistral con metronidazol lidocaina y metadona para el tratamiento tópico de ulceras tumorales dolorosas.

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Material y método: Se realizó una busqueda bibliografica en PubMed y google sobre la utilización y dosificación de metadona, lidocaína y metronidazol por vía tópica en el tratamiento de ulceras tumorales. Se analizaron las características físico-químicas de los tres principios activos en Index merck y en el proveedor de materias primas: www.acofarma.com y las características farmacocinéticas en la base de datos de Micromedex. Se revisaron las fórmulas por vía tópica del formulario nacional, formularios de reconocido prestigio y la base de datos del Consejo General de Colegios farmacéuticos que incluyesen alguno de los tres componentes , para seleccionar les excipientes mas adecuados. También se revisaron las concentraciones y composición de los preparados comerciales con metronidazol y/o lidocaína.

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Resultados: Según los datos recogidos, para los principios activos se establecieron las siguientes concentraciones: metadona Cl H 0,1%, lidocaína ClH 2% y metronidazol 5%. Como base se utilizó una crema emoliente O/W compuesta por los siguientes excipientes: Tween 80 2,5%, Alcohol cetílico 15%, vaselina filante 10%, propilenglicol c.s, solución concentrada de hidroxibenzoatos 1% y agua purificada como vehículo. La experiencia de uso por parte del personal médico y de enfermería de la unidad de cuidados paliativos ha resultado muy satisfactoria.

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Conclusiones: La fórmula establecida se ha mostrado eficaz en el tratamiento del dolor y reducción del mal olor de úlceras tumorales. La utilización de metadona por vía tópica ha permitido en algunos pacientes una reducción de la dosis de opioide administrado por vía sistémica. La elaboración de formulas magistrales en una unidad de cuidados paliativos es una buena alternativa para cubrir aquellas lagunas terapéuticas que no proporciona la industria farmacéutica.

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Referência: 53º Congreso Nacional de la Sociedad Española de Farmacia Hospitalaria. Valencia. 21-24 de octubre de 2008

Errores de prescripción de antineoplásicos en pacientes oncohematológicos

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Errores de prescripción de antineoplásicos en pacientes oncohematológicos

Garzás-Martín de Almagro MC, López-Malo de Molina MD, Abellón Ruiz J, Fernández García I, Isla Tejera B.

Servicio de Farmacia. Hospital Universitario Reina Sofía. Córdoba (España)

Objetivo: Detectar los distintos tipos de error de prescripción de citostáticos en pacientes hematológicos y de Oncohematología pediátrica de nuestro hospital, identificar las posibles causas que los originan y proponer medidas de mejora.

Métodos: Estudio observacional longitudinal prospectivo en el que se validaron todas las prescripciones de antineoplásicos procedentes de los servicios de Hematología y Oncohematología pediátrica durante un período de 15 meses (en los años 2006-2007). Se clasificaron los tipos de error atendiendo a la terminología y taxonomía publicadas por Otero y cols en el documento “Errores de medicación: estandarización de la terminología y clasificación,”recogiéndose 11 variables. Entre otros parámetros se determinaron: %error global, % error por tipo de prescripción, % error por servicios, % intervención farmacéutica y su grado de aceptación.

Resultados: Se detectaron un total de 92 errores correspondientes al 1.4% del total de prescripciones, siendo los de mayor relevancia: dosificación incorrecta(28.2%), duración incorrecta (21.7%), volumen y/ó vehículo inadecuado (16.3%) y omisión (13.0%). Además se detectó una órden de tratamiento de un paciente pediátrico alérgico al citostático prescrito. El 81.8% de órdenes con error se prescribieron de forma manual. Para Hematología se obtuvo un 0.9% de error y un 3.5% para Oncohematología pediátrica. Tanto el índice de intervención farmacéutica como su grado aceptación fue del 100%.

Referência: Revista de la OFIL 2007,17;4:29-34

Perfil de consumo de antineoplásicos injetáveis em um Hospital Universitário

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Perfil de consumo de antineoplásicos injetáveis em um Hospital Universitário

Márcia Dias (1,2); Natalia Bousquet (1,2); Manuela Pedroza (3); Araken Caldas (2)

(1) Curso de Especialização Treinamento em Serviços para Farmacêuticos Hospitalares, nos moldes de Residência. Rua Mário Viana, 523 – CEP 24241-000 – Niterói (RJ)
e-mail: marciadias_35@yahoo.com.br, nataliabousquet@gmail.com

(2) Hospital Universitário Antônio Pedro (HUAP)
Rua Marquês de Paraná, 303 - CEP 24030-210 – Niterói (RJ)
e-mail: apcaldas@gmail.com

(3) Centro Universitário Plínio Leite (UNIPLI)
Av. Visconde do Rio Branco, 123 - CEP 24020-000 - Niterói (RJ)
e-mail: manu_pedroza@yahoo.com.br

Introdução: A Política Nacional da Assistência Farmacêutica juntamente com a Política Nacional de Medicamentos constituem um dos elementos fundamentais para a implementação de ações de melhoria das condições de assistência à saúde da população. A atenção farmacêutica envolve vários componentes inclusive o registro sistemático das atividades e avaliação de resultados.

Objetivo: Estimar o perfil de consumo de medicamentos antineoplásicos na central de quimioterapia do HUAP.

Método: As prescrições médicas de serviços ambulatoriais e de internação foram analisadas entre o período de abril a julho de 2008, considerando os antineoplásicos injetáveis padronizados e o número de manipulações deste período.

Resultados: Os medicamentos 5-fluorouracil (5-FU), citarabina (ARA-C), doxorrubicina (DOXO) e etoposido (VP16) apresentaram maior perfil de consumo nos meses estudados, acima de 100 frascos. O número de manipulações feitas no hospital no período foi em média aproximadamente 1140 por mês.

Discussão e Conclusão: Apesar de não ser um hospital especializado em oncologia, a crescente demanda de serviços em quimioterapia vem levando o staff farmacêutico hospitalar a determinar o perfil de consumo destes medicamentos para programar de forma correta a aquisição destes e assim, evitar tanto a demanda reprimida quanto a interrupção do tratamento.

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A partir da média mensal de manipulações de um período de quatro meses, foi possível determinar os antineoplásicos de maior consumo médio dentre os padronizados, cujo consumo em conjunto gira em torno de 63% do total de manipulações do período estudado. Nosso trabalho demonstra a importância do ciclo da atenção farmacêutica, em especial a programação, para a correta alocação de recursos públicos hospitalares.

Referência: 1º Congresso de Farmácia Hospitalar em Oncologia do INCA. Rio de Janeiro. 2008

Analysis of pharmaceutical interventions: Hospital Garcia de Orta

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Santos A, Rodrigues C, Alcobia A. Pharmacy Department, Hospital Garcia de Orta, EPE, Almada, Portugal. farmaceuticos@hgo.min-saude.pt

Background: A systematic record is made by the pharmacist of interventions to medical prescriptions in a unit dose drug distribution system. This is a practical method that enables communication between health professionals and allows the detection and resolution of drug-related problems, so enhancing clinical activity. The main objective of this study was to quantify and characterise the pharmaceutical interventions made in some wards of the hospital.

Methods: Prospective observational study of the pharmaceutical interventions that were made during review of the drugs prescribed from January to June 2006 in the gastroenterology, infectious diseases, rheumatology, neurology and vascular surgery departments.

Results: During the study period, 510 interventions were made in the following categories: 259 (51%) nonhospital formulary drugs, 58 (11%) drug substitution, 55 (11%) therapeutic drug monitoring, 54 (11%) antibiotic justifications, 34 (7%) wrong dosage, 16 (3%) drug stability, 9 (2%) drug information, 8 (2%) duplicate therapeutics, 8 (2%) drug interactions, 7 (1%) change from intravenous to oral administration and 2 (<0.5%) wrong indication. Of the 76 drugs studied, those that generated most interventions were: bisoprolol, valsartan, piperacillin–tazobactam, meropenem and vancomycin. All interventions mentioned previously were accepted by the medical staff, as were the suggested courses of action related to interventions.

Conclusions: Adjustment of dosage, drug monitoring and drug stability are just some of the interventions that result in improvements to the care provided to patients, as well as a better management of the available resources. The prevention of these problems must be a priority for the pharmacy department, whose main goal is to ensure the safety and efficacy of the drugs administered in the hospital environment. The next step will be to create a computerized record to classify these interventions and determine the clinical and economic impact of drug-related problems.

Reference: 13th Congress of the European Association of Hospital Pharmacists. 2008