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Archive for outubro \28\UTC 2010

New reports of ADEs appear in the medical literature each month. These publications can provide pediatric health care providers with valuable information to guide drug selection, dosing, and monitoring to avoid or reduce the potential for adverse events in their patients.

Adverse Events in Pediatric Intensive Care

A collaborative group of 15 PICUs published a retrospective evaluation of adverse events documented during the last four months of 2005. A total of 734 patient records were evaluated; 1,488 adverse events were identified, including 256 adverse drug events (ADEs). This resulted in a rate of 4.9 ADEs per 100 patient-days, or an adjusted cumulative risk for an ADE of 1.6% per PICU day. Surgical patients had a higher incidence of both adverse events and ADEs. There was also a relationship between the risk for ADEs and age, with a 4% increase in the adjusted ADE rate for every year increase in age. The authors suggest that these data may be useful in developing areas of focus for prevention strategies. Agarwal S, Classen D, Larsen G, et al. Prevalence of adverse events in pediatric ICUs in the United States. Pediatr Crit Care Med 2010; (epub ahead of print).

Analgesics and Anti-inflammatories in Sports

The June 2010 issue of Pediatric Clinics of North America includes an extensive review of the benefits and risks of analgesics and anti-inflammatory medications in young athletes. The authors describe the mechanism of action, pharmacokinetic and pharmacodynamic properties, and dosing recommendations for these drugs, as well as their adverse effect profiles. They include both oral agents and topical products. This article, with its extensive tables and bibliography, will be a useful reference for health care providers who provide care for adolescents with sports-related injuries. Feucht CL, Patel DR. Analgesics and anti-inflammatory medications in sports: use and abuse. Pediatr Clin N Am 2010;57:751–74.

Antiepileptic Safety Monitoring

Anderson and Choonara have studied the methods for ADE reporting during randomized controlled trials (RCTs) of antiepileptic drugs in children over the 10-year period from 1998 to 2007. Of the 29 RCTs identified, only three analyzed data from pediatric patients separately. Six of the trials (20%) described a standardized method for obtaining and documenting ADE information. Only three studies utilized an independent safety monitoring committee to ensure thorough, unbiased assessment of adverse event reports. Based on their assessment, the authors recommend significant changes in antiepileptic study design to improve safety monitoring and ADE reporting. Anderson M, Choonara I. A systematic review of safety monitoring and drug toxicity in published randomized controlled trials of antiepileptic drugs in children over a 10-year period. Arch Dis Child 2010; (epub ahead of print).

Guillain-barré Syndrome After H1cn1 Vaccine

Tremblay and colleagues describe a case of Guillain-Barré Syndrome (GBS) in an 11-year-old boy after administration of the H1N1 vaccine during the fall of 2009. The patient presented to the hospital with facial diplegia, abdominal, forehead, neck, and thigh pain 13 days after receiving a subcutaneous injection of the Arepanrix® H1N1 vaccine. Neurologic examination demonstrated symmetric paralysis of the eighth cranial nerve, along with proximal weakness of the shoulder and pelvis. After exclusion of alternative diagnoses and further investigation, the authors concluded that there was a probable relationship between the patient’s condition and the vaccine. While the CDC reports only 12 probable cases of GBS from approximately 46 million doses of vaccine administered during 2009 (MMWR 2009;58:1–6), this case serves as a reminder of the potential for this condition in children. Tremblay M, Closon A, D’Anjou G, et al. Guillain-Barré syndrome following H1N1 immunization in a pediatric patient. Ann Pharmacother 2010;44:1330–3.

 

Valproate-induced Metabolic Effects

Long-term use of valproate has long been associated with the potential for weight gain and insulin resistance in children with epilepsy. A two part study was recently conducted to address the mechanism for these adverse effects. The first part, a cross-sectional study of children previously diagnosed with epilepsy was designed to evaluate insulin sensitivity and weight gain. Patients were divided into 3 groups: those who had not yet received valproate, patients currently receiving treatment, and those who had discontinued valproate at least 1 year previously. The second part of the study was a prospective longitudinal follow-up of the children in the first group after they began treatment with valproate. Sixty children were enrolled, with 20 continuing on to the longitudinal portion of the study.

When the children were divided into the 3 groups, there were no differences in age, or baseline glucose and insulin levels. There were, however, significant differences in body mass index (BMI) and measurements of insulin resistance. The group currently receiving valproate had a significantly higher BMI than the group who had not been treated (20.22±4.11 compared to 15.97±1.70, p = 0.0002). There was also higher insulin resistance in this group (1.67±1.08 versus 1.04±0.38, p = 0.003). No differences were found between the treatment group and those who had discontinued valproate. Significant correlations were found in the treatment group between the daily valproate dose and both insulin resistance (r = 0.663) and fasting insulin levels (r = 0.765). The longitudinal study revealed significant increases in fasting and post-glucose challenge insulin values at the one year follow-up, however the degree of insulin resistance eventually leveled off over time. The information gained from this study suggests a need for routine monitoring of weight and blood glucose values in children receiving long-term treatment.Masuccio F, Verrotti A, Chiavaroli V, et al. Weight gain and insulin resistance in children treated with valproate: the influence of time. J Child Neurol 2010; 25:941–7.

 

Fonte: Medscape Pharmacist

Anúncios

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Você é farmacêutico consultor da Casa da Melhor Idade, uma casa de saúde que abriga idosos. A
casa lhe envia um fax de uma cópia das prescrições médicas daquele dia de um dos internos, o Sr. Pedro de Alcântara, em que você lê atorvastatina. Você faz uma anotação para lembrar-se de avaliar a sitaução durante sua próxima sessão de revisão na Casa da Melhor Idade, que está planejando para a semana seguinte. Na revisão anterior você concluiu que a terapia medicamentosa atual do Sr. Pedro era segura e eficaz, e que ele estava, em geral, satisfeito com ela. Enquanto isso, você revê rapidamente o perfil atual do Sr. Pedro e anota o seguinte:

Medicação Posologia Indicações
Amiodarona 100 mg 1 cp. 1x ao dia Arritmia
Glimepirida 2 mg 1 cp. 1x ao dia Diabetes tipo 2
Atorvastatina 20 mg 1 cp. 1x ao dia Hiperlipidemia
Furosemida 40 mg 1 cp. 1x ao dia Hipertensão
Fluoxetina 20 mg 1 cáp. 1x ao dia Depressão
ASA/dipiridamol 25/200 1 cap. 2x ao dia Profilaxia de ataques isquêmicos transitórios
Losartana 50 mg 1 cap. 1x ao dia Hipertensão e diabetes tipo 2
Acetaminofeno 500 mg 2 cp. Se necessário Dor
Diazepan 2,5 mg 1 cp. 1x ao dia Ansiedade, insônia
Beclometasona 40 mcg 2 jatos, 2 x ao dia DPOC
Alergia Nenhuma alergia conhecida

Histórico do Sr. Pedro

Edema, arritmia, diabetes tipo 2, parada cardíaca congestiva, depressão, ataques isquêmicos transitórios, insônia, doença pulmonar obstrutiva crônica.

Alergias: nenhuma alergia conhecida

Histórico familiar/ histórico social: sem histórico

Informações objetivas:

Perfil lipídico (20/06): Colesterol total 188 mg/dL; LDL 88 mg/dL; HDL 44 mg/dL; TG 133 mg/dL.

Pressão sanguínea (21/09): 124/74 mmHg;  (14/09) 126/70 mmHg; (7/09) 118/50 mmHg.

Testes de função hepática (21/09) ALT 288 U/L, AST 302 U/L; Fosfatase alcalina 249 U/L.

Bilirrubina total 0,7 mg/dL; Tempo de protrombina 12 segundos.

Testes de função tireoidana (01/05) TS livre 1,2 ng/dL; TSH 3,3 mil?mL.

Glicose sanguínea (21/09) 204 mg/dL. Hemoglobina glicosilada 9,0.

Eletrólitos (21/09) Na 142 mEq/L; K 3,3 mEq/L; Cl 98 mEq/L; CO2 26 mEq/L.

BUN e creatinina (21/09) 22 mg/dL e 0,8 mg/dL, respectivamente.

Adaptado de Roovers e Currie, 2010.

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Despite farmacological equivalence, generic vancomycin preparations exhibited inferior antimicrobial activity compared with the brand product in an infection model.

Introduction

According to WHO regulations, generic versions of intravenous antibiotics are not required to demonstrate therapeutic equivalence with the brand product because therapeutic equivalence is assumed from pharmaceutical equivalence. Such practice is generally accepted worldwide. To test whether this assumption is justified for vancomycin, researchers compared the pharmacokinetic characteristics and antibacterial activity of the original Eli Lilly vancomycin (VAN-Lilly) with those of the competitor generic preparations marketed in Colombia between November 2002 and November 2009.

In vitro antibacterial effects, protein binding, and pharmacokinetic properties were similar between the generic vancomycin preparations and VAN-Lilly. However, in a Staphylococcus aureus neutropenic mouse thigh infection model, the antibacterial activity of the generic vancomycin preparations marketed between 2002 and November 2004 (when Eli Lilly sold its brand name and production secrets to several manufacturers worldwide) proved to be significantly inferior to that of VAN-Lilly. One generic could not even achieve bacteriostasis, and others showed a pronounced Eagle effect, with paradoxical bacterial growth at high antibiotic concentrations; VAN-Lilly exhibited bactericidal activity over a broad concentration range.

After November 2004, the production process of some generic vancomycin preparations was changed. Those produced according to the original Eli Lilly protocol showed in vivo antibacterial potency similar to that of VAN-Lilly; however, one other generic continued to have significantly poorer efficacy.

The major variations in in vivo antibacterial activity among the vancomycin preparations despite pharmacological and in vitro microbiological equivalency are astonishing. The authors noted that high concentrations of fermentation impurities in the generic products probably explain their impaired antibacterial activity and the Eagle effect.

At least for vancomycin, with its delicate production process, identical pharmacological profiles apparently do not predict similar antimicrobial activity. Whether this is true for other generic antibiotics is unclear. Given the broad use of generic antibiotics and the paramount importance of appropriate antimicrobial treatment in patients with life-threatening infections, more research on the efficacy of generic antibiotics is urgently needed.

 

 

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Sra Teodora Pinheiro foi admitida há duas semanas no Hospital Municipal de Maraíba do Sul, onde você trabalha como farmacêutico. Hoje, você está fazendo a primeira entrevista com a paciente e prestando atenção farmacêutica à ela. Você tem dados demográficos da Sra. Pinheiro, o perfil de medicação, e a lista de problemas médicos disponíveis na farmácia do hospital. Protocolos de admissão na casa exigem um perfil laboratorial básico, feito para cada interno.

Dados demográficos:

Data de nascimento: 8/8/1936

Alergias e sensibilidades: metformina (causou diarréia), pioglitazona (causou edema), fosinopril (causou hipercalemia)

Altura: 1,55m; 53 Kg.

Lista de problemas médicos

Diabetes mellitus Tipo 2

Nefropatia diabética

Hipertensão

Doença vascular periférica

Anemia por deficiência de ferro

Hiperlipidemia

Osteoporose

Medicamentos atuais

Sinvastatina 40 mg (uma vez ao dia)

HCTZ 25 mg (uma vez ao dia)

Gliburida 10 mg( duas vezes ao dia)

Cálcio de ostra 500 mg (duas vezes ao dia)

Alendronato de sódio 70 mg ( uma vez por semana, às segundas feiras)

Anlodipino 10 mg ( uma vez ao dia)

Nabumetona 500 mg (duas vezes ao dia)

Cianocobalamina  1000 mcg IM q (uma vez por mês)

Sulfato ferroso 325 mg (uma vez ao dia)

Loratadina 10 mg( uma vez ao dia)

Vacina contra gripe na admissão

Histórico médico

Sinais vitais: PA 138/80 mmHg; FC 100 bpm; FR: 12mpm; T: 36,8ºC

Lipídios: colesterol total: 190 mg/dL;  triglicérides 121 mg/dL; HDL 48 mg/dL; LDL 66 mg/dL.

Química: Na: 140 ,Eq/L; K 4,8 mEq/L; Cl 110 mEq/L; CO2 22 mEq/L; BUN (nitrogênio-uréia sanguínea) 21 mg/dL; Cr 1,4 mg/dL (calculado o clearance de creatinina 31 mL/min), glicose 138 mg/dL; Hemoglobina glicosilada 7,3 %; bilirrubina total 0,6 mg/dL; fosfatase alcalina 44 U/L, ácido úrico 6,4 mg/dL; proteína urinária 16 mg/dL; Ca 8,8 mg/dL; Mg 2,0 mEq/L; Fósforo 3,2 mg/dL; albumina 4,4 g/L.

Hematologia

Hemoglobina 10,2 g/L; Hematócrito 30,8, WBC 5600/mm3; 70% neutrófilos, 26% linfócitos, plaquentas 168.000/ mm3; ferro sérico 48 mcg/dL; capacidade total de absorção de ferro 460 mcg/dL; volume médio corpuscular 90 fL.

Baseado em Rovers e Currie, 2010.

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