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.

RANITIDINE-INDUCED SYSTEMIC HYPERSENSITIVITY REACTION: A CASE REPORT

M Geneste, S Bourget, P Brun, I Dufrene, H Hida.

Hospital, Pharmacy, Valence Cedex 09, France; Hospital, Pneumology, Valence Cedex 09, France

Background Ranitidine is a histamine-2-receptor antagonist (antiH2) widely used with an excellent safety record. It’s a drug included in the premedication for several chemotherapy regimens.

Purpose To report a case of hypersensitivity to ranitidine.

Materials and Methods Case report, literature review. 

Results A 68-year-old man was being followed at hospital for management of metastatic lung carcinoma. A third-line treatment with weekly paclitaxel had been decided. The usual premedication includes intravenous ondansetron, ranitidine, dexchlorpheniramine and methylprednisolone. The patient’s anamnesis hadn’t reported any allergic events. During the fi rst course, the patient presented pruritus 5 minutes after ondansetron and ranitidine injections. Hypotension and warmth occurred despite the administration of dexchlorpheniramine. 120 mg of methylprednisolone resolved the hypersensitivity completely before the patient received paclitaxel, without further event. During the next course, ondansetron was replaced by metoclopramide. During the ranitidine infusion the patient presented sweats, hypotension and bronchospasm. Ranitidine infusion was stopped and methylprednisolone overcame the reaction. The patient’s condition allowed paclitaxel administration although he refused dexchlorpheniramine. The need for antiH2 and the most appropriate premedication for the next courses were discussed by the clinician and pharmacist. Hypersensitivity reactions are reported in ranitidine’s SPC with an estimated rare frequency and also in the literature review. A case also reported a cross-reaction between antiH2 and other antihistamines, while another author excluded it. As no allergic investigation has been performed, all antihistamines have been removed as a precaution. For subsequent courses the premedication included metoclopramide 10 mg and methylprednisolone 80 mg. No other incidents have been reported. This search didn’t formally establish the need for antiH2 in paclitaxel premedication. 

Conclusion: This case has been reported to the pharmacovigilance centre and reminds clinicians that even commonly used and generally well-tolerated substances can cause serious side effects. 

Reference: Eur J Hosp Pharm 2013;20(Suppl 1):A1–A238

CLINICAL RESEARCH IN FRANCE AND QUEBEC

A Guérin, C Tanguay, D Lebel, O Bourdon, JF Bussières.

CHU Sainte-Justine Pharmacy, Montreal, Canada; Hôpital Universitaire Robert-Debré, Pharmacy, Paris, France

Background Pharmacy practise is evolving in most countries. Hospital pharmacists are pivotal in the organisation and the support of clinical trials. We looked at the current state of pharmacy practise in
clinical research. 

Purpose To identify differences in clinical research organisation and pharmacy practise between France and Quebec (Canada).

Materials and Methods This is a descriptive study. A literature review was performed in order to describe the organisation of clinical research and the role of pharmacists in clinical research for both countries. Differences were identifi ed by a panel consisting of one French pharmacy intern, one French hospital pharmacist, one Quebec research assistant and two Quebec hospital pharmacists.

Results Fourteen differences relating to research organisation were identifi ed. France and Canada have different normative frameworks, regulatory authorities, authorization processes, delays and shutdown processes. While it is encouraged, clinical trial registration is not mandatory in Canada. Data needs to be archived for 15 years in France vs. 25 years in Canada. Institutional review boards (IRB) have different names, location, composition, nomination processes, mandate duration and informed consent processes for minors. Seven key differences in pharmacy practise were identified. There are different authorization processes for drug compounding and manufacturing. Pharmacy fees are based on a national reference in France, but not in Canada. Software for the computerization of pharmacy services for clinical trials is common in France. In addition to drug trials, French pharmacists also manage sterile medical devices and medicinal products derived from human blood. Canadian pharmacists offer decentralised pharmaceutical care to hospitalised patients. Canadian pharmacists can be principal investigators if a doctor is the qualifi ed investigator.

Conclusions Clinical research organisation is similar on many aspects, but 21 main differences were identifi ed. Comparisons between countries help identify best practise and may contribute to practise improvement.

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