15 junho, 2014

POTENTIAL DRUG INTERACTIONS IN INTENSIVE CARE UNITS

ALINE TEOTONIO RODRIGUES, ALINE APARECIDA DA CRUZ, MÉCIA DE MARIALVA, ANTONIO LUIS EIRAS FALCÃO, PATRICIA MORIEL, PRISCILA GAVA MAZZOLA

Department of Clinical Patology - Faculty of Medical Sciences (FCM) - Unicamp, Pharmacy Service HC-Unicamp, Intensive Care Unit (ICU) HC-Unicamp

The level of technological complexity of this intensive care units (ICU), the elevated number of drugs used and the inherent difficulties in critical care are factors that highlight the need for an elaborated evaluation of drug-therapy used in intensive care medicine. The role of the clinical pharmacist, composed among other factors, by tracking and detecting potential drug interactions (PDI), can be seen as an important contribution to the quality and security of service in the ICU.

This study is based on the evaluation of a sample of medical prescriptions of ICU and aims to assess the incidence of potential drug interactions in prescriptions made in the Intensive Care Unit (ICU) of a public health hospital (Clinic Hospital - UNICAMP), to quantify and classify them according to their degree of severity, tracing with it a profile of present PDI in this setting.

From January to December 2011, prescriptions of 369 patients were evaluated, all over 18 years old, mean age of 57.03 ± 14.62, hospitalized for more than 24 hours in adult ICU. Two hundred and five different types of drugs were prescribed in the study period, average of 13.04 ± 4.26 per prescription.

 Among the evaluated prescriptions, 89% presented PDI, resulting in an average of 5.00 ± 5.06 per prescription. The 405 types of observed PDI in the prescriptions were classified using Micromedex ® database, highlighting the prevalence of moderate and severe PDI present in 74% and 67% of prescriptions, respectively. In addition to the data from the pharmacotherapeutic profile of the ICU under study, statistically significant correlation among PDI and duration of hospital stay in the ICU and the number of prescription drugs was observed in the survey. The results contribute to design the risk profile relative to PDI in intensive care, showing that there is a high incidence of moderate potential drug interactions in prescriptions of ICU.

Rev.Bras. Farm. – 94 (4); 2013

28 maio, 2014

EVALUATION OF THE EFFICACY AND SAFETY OF BEVACIZUMAB IN THE TREATMENT OF MACULAR OEDEMA SECONDARY TO RETINAL VEIN OCCLUSION

ER Alfaro Lara, FJ Bautista Paloma, C Vázquez Marouschek, S Flores Moreno, MA Pérez Moreno, A Villalba Moreno

Hospital Universitario Virgen del Rocio, Pharmacy, Seville, Spain; Hospital Universitario Virgen del Rocio, Ophthalmology, Seville, Spain

Background After evaluation of ranibizumab and bevacizumab by the Pharmacy and Therapeutics Committee of a tertiary hospital, for the treatment of macular oedema secondary to retinal vein occlusion (RVO), based on the available evidence, both drugs were considered equivalent therapeutic alternatives and ‘off label’ use of bevacizumab was approved. 1.25 mg intravitreal prefilled syringes are prepared by the Pharmacy department, administered every 6 weeks for four doses and repeated as required.

Purpose To evaluate the efficacy and safety of bevacizumab as an antiangiogenic drug in the treatment of macular oedema secondary to RVO.

Materials and methods Data were collected from patients diagnosed with macular oedema secondary to RVO from November 2012 to April 2013. For each patient, the following data were collected: age and gender, type of occlusion and adverse reactions detected. The variable used to evaluate the efficacy of the treatment was the improvement in the visual acuity, measured by the Snellen fraction adapted to decimal between 0.05 and 1.

Results 18 patients with macular oedema secondary to RVO were treated, with a total of 46 doses, and an average of 2.5 (1–5) doses/patient. The average age was 67 and 61% were women. In all cases we used intravitreal bevacizumab as the antiangiogenic drug. 14 cases were branch RVO and 4 cases were central RVO. 14 patients showed great improvement after being given the drug, 2 patients showed a slight improvement and the other 2 patients maintained the same visual acuity and continue with the treatment. No loss of visual acuity has been recorded in any patients. No adverse reactions have been reported.

Conclusions In our group of patients, intravitreal bevacizumab was an effective and safe treatment of macular oedema secondary to RVO. The efficacy data obtained are consistent with the reported bibliography.

Eur J Hosp Pharm 2014:21(Suppl 1):A1–224

18 abril, 2014

ANALYSIS OF ANTINEOPLASTIC MEDICATION ERRORS IN A 500-BED TEACHING HOSPITAL

R Gavira Moreno, MT Moreno Carvajal, V González Rosa, F Gómez de Rueda, R Gázquez Pérez, JP Díaz López, P Gómez Germá, MA Almendral Vicente, MT Gómez de Travecedo y Calvo, M Lobato Ballesteros.

Hospital del SAS de Jerez, Farmacia, Jerez de la Frontera (Cádiz), Spain

Background Medication errors with antineoplastic drugs may be catastrophic due to the drugs’ high toxicity and narrow therapeutic index.

Purpose To assess antineoplastic medication errors in terms of frequency, type of error and severity for patients.

Materials and Methods A 1-year prospective study was conducted (2011) in order to identify the medication errors that occurred during cancer chemotherapy for patients in a 500-bed teaching hospital. Wards included both day care and inpatient units. All prescriptions and production forms were verifi ed by pharmacists. The different types of error were defi ned in a data collection form. For each medication error intercepted, the potential severity was evaluated according to the Ruiz-Jarabo 2000 version2 classification system.

Results During the study period, the pharmacy unit prepared 17241 distinct anticancer drugs. In total, 136 medications errors were detected throughout the medicines use process. Prescriptions errors represented 82% of errors, followed by pharmaceutical validation (7%) transcription (7%), preparation (2%) and administration errors (2%). The most common causal drug was carboplatin, which was involved in 25 cases, despite corresponding to only 2.8% of anticancer drugs prescribed at our institution. Overall, in 66 cases erroneous doses of the medicine were recorded (48.5%), 24 errors were linked to the choice of antineoplastic regimen (17.6%) while in 12 cases, erroneous duration of treatment was prescribed (8.8%). Of the 136 medication errors, 124 were intercepted prior to administration while 12 reached the patients (9%). Overall 66% of non-intercepted medication errors had no impact on the patient and only 3 cases required enhanced monitoring.

Conclusions In our study pharmaceutical validation mainly allowed us to identify prescription errors (82%), almost all errors were intercepted prior to administration to the patient. Wrong dose represented the most common type of error. Few pharmaceutical errors (transcription, validation, preparation) were detected. 

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

30 março, 2014


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

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

03 março, 2014

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

06 fevereiro, 2014

ASSESSMENT OF WARD-BASED CLINICAL PHARMACY SERVICES IN JIMMA UNIVERSITY SPECIALIST HOSPITAL, ETHIOPIA: THE CASE OF INTERNAL MEDICINE


A Berhane, E Ali, O Peggy, S Suleman.
University of Gondar, Clinical Pharmacy,Gondar, Ethiopia; Jimma University, Health Services Planning and Management,Jimma, Ethiopia; Washington, School of Pharmacy, Seatle, USA; Jimma University,School of Pharmacy, Jimma, Ethiopia.

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

Background Patient-centred clinical pharmacy practise has developed internationally to expand the role of a pharmacist well beyond the traditional roles of compounding, dispensing and supplying drugs, though it is poorly developed in Africa. Implementation of patient-centred practise is an important goal for maximizing the utility of the profession. But, studies on the work done by pharmacists in inpatient wards in resource-constrained settings are scarce.

Purpose To assess ward-based clinical pharmacy services in an internal medicine ward of Jimma University Specialist Hospital.

Materials and Methods The study was carried out on the internal medicine ward from March to April, 2011 at Jimma University Specialist Hospital. It was a prospective observational study. Clinical pharmacy interns providing pharmaceutical care to inpatients twice per week over a 2-month period were documented. Interventions optimising rational drug use and their acceptance were recorded. The clinical signifi cance of interventions was evaluated by an independent team (1 internist, 1 pharmacologist). Results of the study were reported in the form of fi ndings and percentages.

Results A total of 149 drug-related interventions for 48 patients was documented. Of these, 133 (89.3%) were clinical pharmacy intern-initiated interventions and 16 (10.7%) were interventions initiated by another health care professional. The most frequent drug-related problems (DRPs) underlying interventions were unnecessary drug treatment 36 (24.2%), additional drug treatment needed 34 (22.8%) and noncompliance 29 (19.5%). The most frequent type of intervention was change of dose/instruction for use, 23 (15.4%). 68.4% of interventions were fully accepted and 29.3% were partially accepted. Interventions with major and moderate clinical significance numbered 46 (49.5%) and 25 (26.9%) respectively.

Conclusions A clinical pharmacist contributes to improved inpatient treatment, even with a modest contribution such as participation in the pre-round meeting and the ward round twice per week.

Category of drug-related problem* Interventions, n (% of total)

Unnecessary drug treatment 36 (24.2%)
Additional drug treatment 34 (22.8%)
Ineffective drug 4 (2.7%)
Dose too low 18 (12.1%)
Adverse drug reaction 16 (10.7%)
Dose too high 12 (8%)
Noncompliance 29 (19.5%)
Total 149 (100%)

15 janeiro, 2014

GLUCONATO DE CÁLCIO: EXTRAVASAMENTO



Descrição: solução injetável; ampola plástica de 10 mL de gluconato de cálcio 10%. Excipientes: água para injeção. A ampola de 10 mL contém 98 mg/mL de gliconato de cálcio monoidratado e 4,6 mg de sacarato de cálcio tetraidratado; pH 6,8-8,2. Estocar na temperatura ambiente, não congelar, proteger da luz.(1,3) 

Categoria: eletrólito; droga vesicante; indicado no tratamento da hipocalcemia aguda (tetania hipocalcêmica neonatal, tetania por deficiência paratireóidea); tratamento da depleção de eletrólitos; coadjuvante no tratamento da reativação cardíaca; tratamento da hiperpotassemia e hipermagnesemia.(1,3) 

Protocolo de extravasamento: interromper imediatamente a infusão do medicamento instalado, quando observar sinais e sintomas de extravasamento. Não retirar a agulha. Aspirar, pela agulha, a medicação extravasada residual o quanto puder. Retirar a agulha. Compressa quente por 20 minutos a cada 6 horas nas primeiras 24 horas. Aplicar hidrocortisona 1% creme a cada 6 horas durante 7 dias. Extravasamento confirmado de volume >5 mL: preparar 1.500 unidades de hialuronidase em 2 mL de água para injeção ou soro fisiológico. Aplicar injeções SC de 0,2 mL ao redor da área e massagear para dispersão. Compressa por 20 minutos. Repetir a compressa a cada 1 hora nas primeiras 4 horas, depois repetir a cada 6 horas durante 2 dias.(2) 

Protocolo de extravasamento: interromper imediatamente a infusão do medicamento instalado, quando observar sinais e sintomas de extravasamento. Não retirar a agulha. Aspirar, pela agulha, a medicação extravasada residual o quanto puder. Retirar a agulha. Compressa quente por 20 minutos cada 6 horas nas primeiras 24 horas, depois repetir a compressa a cada 6 horas durante 2 dias. Aplicar hidrocortisona creme 1% a cada 6 horas durante 7 dias.(4) 

Protocolo de extravasamento: interromper imediatamente a infusão do medicamento instalado,quando observar sinais e sintomas de extravasamento. Não retirar a agulha. Aspirar, pela agulha, a medicação extravasada residual o quanto puder. Retirar a agulha. Compressa quente na área afetada durante 20 a 30 minutos. Repetir a compressa, diariamente, a cada 6 horas durante 2 dias. Aplicar 100 mg de hidrocortisona IV + 4 mg de clorfeniramina VO. Aplicar hidrocortisona creme 1% a cada 6 horas durante 7 dias.(5) 

Monitorização do paciente: orientar o paciente a manter o membro elevado. Observar regularmente a presença de dor, eritema, enduração ou necrose. Documentar o tratamento: data, hora, local edispositivo inserido, seqüência de medicamentos, notificação do médico e tratamento de enfermagem. 

Contaminação acidental: as áreas afetadas do corpo devem ser lavadas imediatamente com bastante água durante 20 a 30 minutos. Se derramar na bancada de trabalho: lavar as áreas contaminadas com detergente e água para injeção. Limpar o interior e a superfície do trabalho com álcool a 70%. Deixar secar na ventilação. Terminada a descontaminação colocar todos os materiais e esponjas num saco plástico, selar e rotular como "RESÍDUOS DE MEDICAMENTOS" e incinerar. 

Conduta na superdose: anorexia, náusea, vómitos, obstipação, dor abdominal, poliúria, polidipsia, desidratação, fraqueza muscular, dor óssea, calcificação renal, entorpecimento, sonolência, confusão, hipertensão, arritmia cardíaca, parada cardíaca e coma. Infusão rápida pode causar sintomas de hipercalcemia, sensação de gosto calcário, afrontamentos e hipotensão. Tratamento: reduzir as concentrações séricas de cálcio, rehidratação e, na hipercalcemia grave: soro fisiológico para expandir o fluido extracelular; administrar calcitonina para diminuir as concentrações séricas elevadas de cálcio. Para aumentar a excreção de cálcio, pode administrar-se furosemida, mas os diuréticos tiazídicos devem ser evitados uma vez que podem aumentar a absorção renal de cálcio. Hemodiálise ou diálise peritoneal poderão ser utilizadas. Monitorização dos eletrólitos séricos.(1,3) 

Referências:
1.Gluconato de cálcio. Disponível em: http://www.diagnosia.com. Acesso em 04 de outubro de 2012.
2.Greater Manchester & Cheshire Cancer Network. NHS Management of extravasation policy. Disponível em: http://www.gmccn.nhs.uk. Acesso em 15 de janeiro de 2012.
3.Micromedex®. Disponível em: http://www.periodicos.capes.gov.br. Acesso em 20 de janeiro de 2013.
4.The Children’s Hospital at Westmead. Practice guideline: IV extravasation management – CHW. Disponível em: http://www.chw.edu.au. Acesso em 12 de fevereiro de 2013. 
5.Extravasation policy for all drugs, chemotherapy & non-chemotherapy. NHS Tayside. Disponível em: http://www.nhstayside.scot.nhs.uk/. Acesso em: 19 de fevereiro de 2013.

14 dezembro, 2013

Epinefrina: estabilidade em seringa.



Sinonímia (s):  epinefrina, cloridrato de epinefrina, cloridrato de adrenalina

Forma Preparada:  solução injetável

A Partir de:  solução injetável

Nome Comercial:  Epinefrina® (Cristália)

Concentração:  7 mg/mL

Estabilidade: 56 dias em seringa plástica descartável estéril de polipropileno

Modo de Preparo: Calcular a quantidade requerida de cada componente da formulação para o total de material a ser preparado. Este produto deve ser preparado em sala limpa, por um profissional qualificado em manipulação asséptica. Sala limpa: área com controle ambiental definido em termos de contaminação por partículas e microbiana, projetada e utilizada de forma a reduzir a introdução, a geração e a retenção de contaminantes em seu interior. Trabalhar em capela de fluxo laminar utilizando técnicas assépticas. Utilizar seringas e agulhas diferentes para cada componente. Na capela de fluxo laminar, preparar assepticamente os componentes da manipulação. Diluída em água destilada para injetáveis.

Estocagem:  TEMPERATURA AMBIENTE

Etiqueta:  Para Uso Injetável e Proteger da Luz

Referência da Estabilidade:

1. Trissel LA. Trissel’s Stability of Compounded Formulations, 2nd ed. Washington, DC: American Pharmaceutical Association; 2000