Incidence des prescriptions hors autorisation de mise sur le marché en réanimation néonatale

Avenel, S.; Bomkratz, A.; Dassieu, Gilles; Janaud, Jean-Claude; Danan, Claude

doi:10.1016/s0929-693x(00)88083-5

Cited by 66 publications

(13 citation statements)

References 16 publications

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“…The use of off-label medications is associated with increased risk of AEs, particularly in sick hospitalized infants. 19–22 Neonatal medicine’s history is plagued with examples of SAEs with inadequate study and approval before widespread implementation of therapies. 23–26 While more evidence is required for safe use of diuretics in neonates, trials in this population are difficult.…”

Section: Discussionmentioning

confidence: 99%

Diuretic Exposure in Premature Infants from 1997 to 2011

et al. 2014

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Objective Diuretics are often prescribed off-label to premature infants, particularly to prevent or treat bronchopulmonary dysplasia (BPD). We examined their use and safety in this group. Study Design Retrospective cohort study of infants <32 weeks gestation and <1500 g birth weight exposed to diuretics in 333 neonatal intensive care units from 1997–2011. We examined use of acetazolamide, amiloride, bumetanide, chlorothiazide, diazoxide, ethacrynic acid, furosemide, hydrochlorothiazide, mannitol, metolazone, or spironolactone combination. Respiratory support and FiO2 on the first day of each course of diuretic use were identified. Results Thirty-seven percent (39,357/107,542) of infants were exposed to at least 1 diuretic; furosemide was the most commonly used (93% with ≥1 recorded dose), followed by spironolactone, chlorothiazide, hydrochlorothiazide, bumetanide, and acetazolamide. Seventy-four percent were exposed to 1 diuretic at a time, 19% to 2 diuretics simultaneously, and 6% to 3 diuretics simultaneously. The most common combination was furosemide/spironolactone, followed by furosemide/chlorothiazide and chlorothiazide/spironolactone. Many infants were not receiving mechanical ventilation on the first day of each new course of furosemide (47%), spironolactone (69%), chlorothiazide (61%), and hydrochlorothiazide (68%). Any adverse event occurred on 42 per 1000 infant-days for any diuretic and 35 per 1000 infant-days for furosemide. Any serious adverse event occurred in 3.8 for any diuretic and 3.2 per 1000 infant-days for furosemide. The most common laboratory abnormality associated with diuretic exposure was thrombocytopenia. Conclusion Despite no FDA indication and little safety data, over one third of premature infants in our population were exposed to a diuretic, many with minimal respiratory support.

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Section: Discussionmentioning

confidence: 99%

Diuretic Exposure in Premature Infants from 1997 to 2011

et al. 2014

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“…Several retrospective and prospective studies have been conducted in the United Kingdom (UK) [3–5], France [6], the Netherlands [7], Germany [8, 9], Switzerland [10], Finland [11, 12], Croatia [13], Italy [14], Portugal [15], across Europe [16], United States (US) [17], Brazil [18], Ireland [19], Israel [20], Malaysia [21] and Australia [1, 22, 23] in various hospital settings that have included Emergency Department patients, outpatients or inpatients (general and medical wards and paediatric and neonatal intensive care units). Most of the studies have been conducted over a period of weeks or months.…”

Section: Introductionmentioning

confidence: 99%

Clinical Setting Influences Off-Label and Unlicensed Prescribing in a Paediatric Teaching Hospital

et al. 2015

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PurposeTo estimate the prevalence of off-label and unlicensed prescribing during 2008 at a major paediatric teaching hospital in Western Australia.MethodsA 12-month retrospective study was conducted at Princess Margaret Hospital using medication chart records randomly selected from 145,550 patient encounters from the Emergency Department, Inpatient Wards and Outpatient Clinics. Patient and prescribing data were collected. Drugs were classified as off-label or unlicensed based on Australian registration data. A hierarchical system of age, indication, route of administration and dosage was used. Drugs were classified according to the Anatomical Therapeutic Chemical Code.ResultsA total of 1,037 paediatric patients were selected where 2,654 prescriptions for 330 different drugs were prescribed to 699 patients (67.4%). Most off-label drugs (n = 295; 43.3%) were from the nervous system; a majority of unlicensed drugs were systemic hormonal preparations excluding sex hormones (n = 22, 32.4%). Inpatients were prescribed more off-label drugs than outpatients or Emergency Department patients (p < 0.0001). Most off-label prescribing occurred in infants and children (31.7% and 35.9% respectively) and the highest percentage of unlicensed prescribing (7.2%) occurred in infants (p < 0.0001). There were 25.7% of off-label and 2.6% of unlicensed medications prescribed across all three settings. Common reasons for off-label prescribing were dosage (47.4%) and age (43.2%).ConclusionThis study confirmed off-label and unlicensed use of drugs remains common. Further, that prevalence of both is influenced by the clinical setting, which has implications in regards to medication misadventure, and the need to have systems in place to minimise medication errors. Further, there remains a need for changes in the regulatory system in Australia to ensure that manufacturers incorporate, as it becomes available, evidence regarding efficacy and safety of their drugs in children in the official product information.

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“…Consensos de especialistas, esConsensos de especialistas, estudos observacionais, assim como o uso de preparações magistrais, são estratégias que têm sido empregadas para lidar com essas limitações. (Avenel et al, 2000, Santos, Coelho, 2004, Stepheson, 2006. A carência de evidências seguras e de formulações padronizadas afeta, principalmente, crianças hospitalizadas, particularmente aquelas em unidades de tratamento intensivo, colocando em risco a eficácia e a segurança dos tratamentos.…”

Section: Introductionunclassified

“…A carência de evidências seguras e de formulações padronizadas afeta, principalmente, crianças hospitalizadas, particularmente aquelas em unidades de tratamento intensivo, colocando em risco a eficácia e a segurança dos tratamentos. (Conroy, Mcintire, Choonara, 1999;Avenel et al, 2000;Conroy et al, 2000, Carvalho et al, 2003Santos, Coelho, 2006;Pandolfini, Bonati, 2005).…”

Section: Introductionunclassified

Prescrição e preparo de medicamentos sem formulação adequada para crianças: um estudo de base hospitalar

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2009

Braz. J. Pharm. Sci.

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Este trabalho teve como objetivo identificar medicamentos cuja forma ou formulação farmacêutica representa um problema em pediatria (Medicamento Problema -MP), bem como analisar as estratégias empregadas pelos médicos, para sua utilização nas crianças e os riscos envolvidos. Trata-se de um estudo descritivo, que tem como base um inquérito com pediatras de um hospital de referência do SUS em Fortaleza-Ceará, conduzido para identificação dos MPs em julho-agosto de 2004; uma análise das prescrições contendo adaptação de formas sólidas e uma observação direta do preparo dos medicamentos, que foram conduzidas em dezembro de 2004 e janeiro de 2005, respectivamente. Os medicamentos foram agrupados pela classificação ATC e pelo cálculo de frequências das variáveis. Os pediatras (N=48, 98%) identificaram: 16 produtos sem forma injetável, 32 injetáveis necessários em concentrações menores e 30 MP sem formulação líquida para uso oral. Foram analisadas 89 prescrições contendo adaptação de formas sólidas, envolvendo 119 itens de medicamentos; todas continham inadequações, sendo a principal a partição de comprimidos. As doses prescritas corresponderam ao preconizado em 33,6% dos casos. Adaptações foram realizadas em local inadequado, por profissional não qualificado e sem as boas práticas. Concluindo, a carência de formulações apropriadas ao uso pediátrico repercute na prática médica e é agravada pela inexistência de condições adequadas para a manipulação de medicamentos por farmacêuticos, nos hospitais brasileiros.Unitermos: Prescrição pediátrica. Formulações farmacêuticas/adaptações para uso pediátrico. Medicamentos/uso pediátrico. Farmácia hospitalar.This work aimed to identify medicines whose form or pharmaceutical formula presents a problem to pediatrics (Problem Medication -PM), the strategies employed by doctors to use them in children, and the potential risks involved. Descriptive study: based on a survey with pediatricians from a SUS (Public Health System) reference hospital in Fortaleza-CE (Northeastern Brazil), in order to identify PMs, from July to August 2004; an analysis of prescriptions containing modification of medicines in the solid forms; and a follow-up of medicinal preparations, developed in December 2004 and January 2005, respectively. The medications were grouped by an anatomic, therapeutic and chemical classification and by means of a calculation of variables frequency. The pediatricians (N=48, 98% of the total) identified as PMs: 16 products without an injectable form; 32 in an injectable form that should be presented in lesser concentrations; and 30 without a liquid formula for oral use. Eighty two (82) prescriptions containing modifications of solid forms, involving 111 medicinal items were analyzed, all of which contained inadequacies; the main one being the partition of pills. In 33.6% of the cases, the prescribed doses were in accordance with that generally recommended. The modifications were carried out in inadequate places, by nonqualified professionals and without the use of best practices. Th...

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Incidence des prescriptions hors autorisation de mise sur le marché en réanimation néonatale

Cited by 66 publications

References 16 publications

Diuretic Exposure in Premature Infants from 1997 to 2011

Diuretic Exposure in Premature Infants from 1997 to 2011

Clinical Setting Influences Off-Label and Unlicensed Prescribing in a Paediatric Teaching Hospital

Prescrição e preparo de medicamentos sem formulação adequada para crianças: um estudo de base hospitalar

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