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1.
Soins Pediatr Pueric ; 44(335): 42-47, 2023.
Artigo em Francês | MEDLINE | ID: mdl-37980161

RESUMO

Between November 2020 and June 2021, twelve children were treated at a university hospital in western France for pediatric multisystem inflammatory syndrome (PIMS). While the clinical presentation may have been reminiscent of Kawasaki disease, PIMS, a new nosological entity, was mentioned in the media in the context of the Covid-19 pandemic. In 2023, research into this syndrome will continue in France and Europe.


Assuntos
COVID-19 , SARS-CoV-2 , Criança , Humanos , Pandemias , França
2.
Soins Pediatr Pueric ; 42(320): 41-47, 2021.
Artigo em Francês | MEDLINE | ID: mdl-34099237

RESUMO

Medications are an important source of intoxication or misuse in the pediatric population. It is therefore important to raise parents' awareness on this point. To do so, a team of professionals has set up an e-learning, presented in the form of a slide show. Nineteen cases were selected, then divided into three themes (administration error, danger and storage error) and in four rooms of the home (living room, bathroom, child's room and parent's room).


Assuntos
Pais , Criança , Humanos
3.
BMC Med Res Methodol ; 16: 36, 2016 Mar 29.
Artigo em Inglês | MEDLINE | ID: mdl-27025840

RESUMO

BACKGROUND: The ethical, methodological, and technical aspects of pediatric research, often results in complications and delays in implementation. Our objective was to identify factors associated with the implementation duration of hospital-based pediatric studies. METHODS: All hospital-based pediatric studies sponsored by AP-HP between 2002 and 2008 were retrospectively identified. Association of the funding mechanism and methodological factors with the implementation duration was assessed using a multivariable mixed linear model. Pharmaceutical factors were explored as part of a subgroup analysis restricted to the studies involving drug therapy. Given that we took an exploratory approach, factors associated with implementation duration with p < 0.10 were kept in the final models. RESULTS: A total of 139 studies were evaluated. The median implementation duration was 17.1 months (range: 0.9-55.3 months), and tended to increase over time (from 14.9 [25(th) percentile-75(th) percentile: 11.5-19.9] months in 2002 to 23.7 [15.2-31.0] months in 2008, p = 0.01). External (coefficient [95 % confidence interval]: -7.7 [-11.9;-3.5] months, p < 0.001) and internal funding (-5.3 95 % CI [-9.8;-0.8], p = 0.02) compared to governmental funding and number of centers (-0.1 95 % CI[-0.2;0.02] months for 1 center increase, p = 0.07) were associated with reduced duration, whereas interventional study (either involving drug therapy (6.0 95 % CI[0.7;11.3] months, p = 0.03 or not (3.5 95 % CI[-0.3;7.3] months, p = 0.06) was associated with increased duration compared to observational study. Regarding the 35 studies involving drug therapy, external funding decreased duration (-6.7 95 % CI[-13.2;-0.2] months, p = 0.05), whereas studies involving solely a pediatric population (7.8 95 % CI[1.1;14.5] months, p = 0.01) (compared to mixed adult-pediatric population), a placebo-controlled design (6.6 95 % CI[0.9;12.3] months, p = 0.01), and inappropriate drug formulation for at least one drug used in the study (6.9 95 % CI[-0.2;14.0] months, p = 0.06) were associated with increased duration. CONCLUSION: Implementation of hospital-based pediatric studies primarily faced delays when they were interventional and, in particular, when they involved drug therapy. Regarding the latter, difficulties that resulted in delayed studies arose with respect to the supply of drugs and placebo in age-appropriate dosages and route of administration. Therefore, difficulties related to the use of pharmaceuticals need to be anticipated earlier in order to avoid implementation delays.


Assuntos
Centros Médicos Acadêmicos , Pesquisa Biomédica/estatística & dados numéricos , Implementação de Plano de Saúde , Pediatria/organização & administração , Pesquisa Biomédica/métodos , Feminino , França , Hospitais Pediátricos , Humanos , Modelos Lineares , Masculino , Análise Multivariada , Avaliação das Necessidades , Fatores de Risco , Fatores de Tempo
4.
Int J Clin Pharmacol Ther ; 52(11): 940-7, 2014 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-25161154

RESUMO

OBJECTIVE: Numerous studies have shown that the tolerance of children to fluoroquinolones (FQs) is satisfactory, and some indications have been recently agreed upon. However, vigilance is required when prescribing FQ to children. The aim of our study was to describe the prescription of FQs to children hospitalized in our hospital. MATERIALS AND METHODS: This is a chart retrospective observational study at the Robert-Debré teaching Hospital between January 2009 and December 2010. Data was collected about patients (name, sex, weight, age) and prescribed treatments (indication, international nonproprietary names, dose, number of doses per day, administration route). Quality of collected data was assessed by analyzing the clinical files of 32 randomly selected patients. RESULTS: We analyzed data for 397 patients (3 days - 18 years old and 640 g - 115 kg). Ciprofloxacin was prescribed for 382 patients (96%), ofloxacin for 10 patients (3%), and levofloxacin for 5 patients (1%). Febrile neutropenia was the most common indication (108 patients, i.e., 27%), followed by inflammatory bowel disease (50 patients, 13%). Doses conformed to recommendations for 88% of the patients. Analysis of the 32 cases indicated an overall compliance percentage of 94.4%. CONCLUSION: This is the first study to collect so much data on FQ prescriptions for hospitalized children. Use in practice went beyond the licensed indication. Doses were consistent with those for recommended indications.


Assuntos
Antibacterianos/uso terapêutico , Revisão de Uso de Medicamentos , Fluoroquinolonas/uso terapêutico , Adolescente , Criança , Pré-Escolar , Farmacorresistência Bacteriana , Neutropenia Febril/tratamento farmacológico , Feminino , Fluoroquinolonas/efeitos adversos , Humanos , Lactente , Recém-Nascido , Doenças Inflamatórias Intestinais/tratamento farmacológico , Masculino , Estudos Retrospectivos
5.
Basic Clin Pharmacol Toxicol ; 134(1): 28-38, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37276582

RESUMO

BACKGROUND: The prison environment is a place of high consumption of benzodiazepines (BZDs) due to the anxiety and sleep disturbances, mental disorders, detoxification and trafficking. OBJECTIVE: The study aims to explore experiences of health and social care professionals on the use of BZDs in prisons, as well as the barriers and enablers to their deprescribing. METHOD: Semistructured individual interviews with professionals working in a prison setting were performed between March and April 2022, based on an interview guide. They were recorded and transcribed using the NVivo software. A qualitative analysis using an inductive approach based on a thematic analysis was performed. RESULTS: Sixteen health professionals were interviewed, including psychiatrists, general practitioners, nurses, pharmacists, psychologists, musicologists and pharmacy technicians. The identified barriers to deprescribing BZDs were problems of coordination between prescribers, lack of time and alternatives. Concerning the enablers, therapeutic education groups, staff's awareness of the irrelevance of some medication and multi-professional advice were identified. DISCUSSION: This study highlights the similarities in deprescribing difficulties between prison and other settings. Some of the levers identified in our study have shown their effectiveness in different settings. CONCLUSION: Deprescribing is done most of the time in good conditions but requires an additional delay compared to the outside environment.


Assuntos
Desprescrições , Clínicos Gerais , Humanos , Prisões , Benzodiazepinas/efeitos adversos , Pesquisa Qualitativa
6.
J Pediatr Hematol Oncol ; 35(3): 188-92, 2013 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-23042014

RESUMO

INTRODUCTION: The patients receiving hematopoietic stem cell transplantation (HSCT) require routine management: the role of the pharmacist has not been extensively considered. This study had 2 aims: to explore the knowledge of community pharmacists relating to pediatric HSCT and to evaluate their expectations in terms of training needs. MATERIALS AND METHODS: We interviewed 40 community pharmacists in May and June 2010 in Paris (France) with a 3 parts questionnaire: information concerning the community pharmacy, analysis of 2 pediatric prescriptions and knowledge about HSCT and professional training. RESULTS: Twenty-nine (72.5%) of the 40 community pharmacies agreed to participate in the study. When asked what pharmacological advice they would give for an episode of fever, 13% of the pharmacists asked said that they would deliver acetaminophen without asking any further questions. Concerning hypertrichosis in patients treated with corticosteroids and ciclosporin, none mentioned the role of ciclosporin. The erroneous indications for HSCT given included road accidents (1 pharmacist; 3.4%) and hemophilia (3 pharmacists; 10.3%). Almost 80% of the pharmacists questioned considered their HSCT knowledge insufficient for their professional practice. An E-learning session adapted to their needs was of interest to almost three quarters of the pharmacists questioned.


Assuntos
Serviços Comunitários de Farmácia/tendências , Educação Continuada em Farmácia , Conhecimentos, Atitudes e Prática em Saúde , Neoplasias Hematológicas/terapia , Transplante de Células-Tronco Hematopoéticas , Farmacêuticos , Competência Profissional , Humanos , Inquéritos e Questionários
7.
Therapie ; 68(4): 225-39, 2013.
Artigo em Inglês, Francês | MEDLINE | ID: mdl-23981260

RESUMO

Following the Mediator crisis and the passage of the Health and Safety Law of December 2011, off-label prescriptions are a real concern shared by all those involved in healthcare system. Off-label, in the strictest sense of the term, is defined as all prescriptions that do not correspond to the summary of product characteristics (SPC), particularly those that fail to comply with the indications and dosage regimens defined by the marketing authorization (MA) for clear safety reasons. There are various rasons for off-label prescriptions, both conscious and unconscious. They are intended to respond to unmet medical needs, the needs of poorly studied populations or not studied at all in trials, but in relation to whom it is reasonable to extrapolate that MA would be given (common-sense prescriptions) and, additionally, to urgent public health needs (such as baclofen, pregnant women, and HIV drugs). All these prescriptions would deserve to be studied for a potential MA. However, there are off-label prescriptions that need to be restricted or even penalized in the case of compassionate prescriptions or unjustified prescriptions or prescriptions not based on any scientific grounds. Off-label prescriptions are not easy to track down because if the prescriber has to write "off-label" on his prescription, then clearly, in practice, he will only do so in exceptional cases. Neither the pharmacists who dispense the drug nor the Social Security that reimburses it, have access to the diagnosis (or targeted indication). Thus, in order to identify the off-label prescription, we must be able to cross reference the available databases (such as pharmacovigilance database, medicalized information system program [programme de médicalisation des systèmes d'information, PMSI], hospital drug formularies, general sample of beneficiaries [échantillon généraliste de bénéficiaires, EGB] or national inter-regional Health Insurance Information System [système national d'informations inter-régions d'Assurance maladie, SNIIRAM], sales data, and data from market surveys). The shared computerized patient file may resolve this problem. The temporary use recommendation (TUR) proposed by the Drug Safety Law will only partially deal with this problem for recently marketed molecules. This temporary and exceptional mechanism will authorize a recognized off-label prescription, which may be reimbursed and monitored for 3 years. These TURs will only concern a small portion of "off-label" drugs having yet a positive risk/benefit ratio (conditional MA) but this is far from matching with majority of off-label prescriptions. As such, and in order to improve the use of drugs, it is important to propose a control system for all "off-label" prescriptions with a dedicated committee: the "off-label" committee which would determine the frame of the "off-label" prescriptions.


Assuntos
Monitoramento de Medicamentos , Uso Off-Label , Padrões de Prática Médica , Rotulagem de Medicamentos/métodos , Rotulagem de Medicamentos/normas , Monitoramento de Medicamentos/métodos , Monitoramento de Medicamentos/normas , Monitoramento de Medicamentos/estatística & dados numéricos , Prescrições de Medicamentos/normas , Prescrições de Medicamentos/estatística & dados numéricos , Feminino , Humanos , Uso Off-Label/ética , Uso Off-Label/legislação & jurisprudência , Uso Off-Label/normas , Uso Off-Label/estatística & dados numéricos , Padrões de Prática Médica/legislação & jurisprudência , Padrões de Prática Médica/estatística & dados numéricos , Gravidez
8.
Eur J Hosp Pharm ; 2023 Sep 29.
Artigo em Inglês | MEDLINE | ID: mdl-37775260

RESUMO

We report the case of a preterm infant presenting a thrombosis, discovered on ultrasound at 22 weeks of gestational age and confirmed at birth following additional examinations. We describe the anticoagulant treatment of this patient by intravenous enoxaparin, tinzaparin and rivaroxaban, from questioning to practice.

9.
BMJ Open ; 13(12): e073250, 2023 12 13.
Artigo em Inglês | MEDLINE | ID: mdl-38097247

RESUMO

OBJECTIVES: Today, the involvement of patients in their care is essential. As the population ages increases, the number of patients with chronic diseases is increasing. In the vascular medicine and surgery departments, patients are polymedicated and mostly suffer from several chronic diseases. Approximately 50% of patients with a chronic disease are not adherent. Among the factors that can influence therapeutic adherence are the beliefs and representations of patients.To evaluate the beliefs and representations of chronic treatments in patients with multiple medications and hospitalised in a vascular medicine and surgery department, and to evaluate the medication adherence, the knowledge and the importance patients attach to their treatments. DESIGN: Observational, prospective and a single-centre study. SETTING: The study was conducted in a French tertiary hospital centre of around 3000 beds in 9 institutions. PARTICIPANTS: Adult polymedicated (ie, minimum of five chronic treatments) patients hospitalised in a vascular medicine and surgery department were included after application of the exclusion criteria. METHODS: Patient interviews were carried out in the department and were based on three interviewer-administered questionnaires (a global questionnaire, the Belief Medical Questionnaire and the GIRERD questionnaire). RESULTS: Our study showed that patients perceived their treatments as beneficial rather than worrying. A correlation between medication adherence and beliefs was observed. 'Non-adherent'patients had a more negative overall view of medication than 'adherent' patients. The level of compliance and knowledge of our patients was low. Only 11% of the patients were 'good adherent', 16% of the patients could perfectly name their treatment and 36% knew all the indications. CONCLUSION: Knowledge of treatment representation and beliefs are central to understanding patient behaviour. Considering patients' representations will allow the identification of levers, and the development of actions and educational tools adapted to improve their adherence, their knowledge and therefore their drug management.


Assuntos
Cardiologia , Conhecimentos, Atitudes e Prática em Saúde , Adulto , Humanos , Estudos Prospectivos , Inquéritos e Questionários , Doença Crônica , Adesão à Medicação
10.
PLoS One ; 18(7): e0287335, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37478058

RESUMO

BACKGROUNDS: Caregivers are essential in the care of a patient with digestive cancer. Considering their experience and needs is crucial. OBJECTIVES: To explore the experience of caregivers of patients with digestive cancer and to compare the perspectives of patients and caregivers. METHODS: A mixed-methods study with a cross-sectional prospective and a comprehensive qualitative dimension was performed in a medical oncology unit in a French tertiary hospital. Dyads made of patients with digestive cancer and their caregiver were recruited. The Caregiver Reaction Assessment (CRA) and the Supportive Care Needs Survey for Partners and Caregivers (SCNS-PC) questionnaires were distributed to caregivers. The CRA was used to measure the caregiver burden and the SCNS-PC was used to identify the unmet supportive care needs of caregivers. Semi-structured interviews with the dyads were conducted. Qualitative interviews addressed various dimensions of the caregiver's experience from each dyad's member perspective. RESULTS: Thirty-two caregivers completed the questionnaires. Responses showed high self-esteem, schedule burden, and a need for care and information services. Ten dyads participated in the interviews. Three themes emerged from the caregiver's interviews: illness is an upheaval; loneliness and helplessness are experienced; caring is a natural role with positive outcomes. Four themes emerged from patient's interviews: the caregiver naturally assumes the role and gets closer; he is the patient's anchor; his life is disrupted; anxiety and guilt accompany the desire to protect him. In comparing patient and caregiver data, the main theme of disagreement was their relationship. CONCLUSIONS: Caregiver care does not appear to be optimal, particularly in terms of their need for information. Patients have a fairly good representation of their experience, but the caregivers' opinion need to be considered.


Assuntos
Cuidadores , Neoplasias Gastrointestinais , Humanos , Masculino , Estudos Transversais , Estudos Prospectivos , Percepção , Qualidade de Vida
11.
BMC Prim Care ; 24(1): 229, 2023 11 03.
Artigo em Inglês | MEDLINE | ID: mdl-37919662

RESUMO

BACKGROUND: French community pharmacists are facing an increasing demand to provide a wider range of services to meet the needs of the population. These new missions must be evaluated by primary care research studies. This study aims to explore the factors that influence French community pharmacists' willingness to participate in research projects. METHODS: A mixed-method design was adopted for this study, comprising an initial quantitative online survey followed by semi-directed interviews. The investigation was conducted at two French faculties of pharmacy, Angers and Nantes, involving students in their 6th and final year of pharmacy education, and their community pharmacist tutors. The survey items were based on a study by Saini et al. and participants responded using five-point Likert scales. The semi-directed interviews were conducted after the quantitative analysis, only with volunteer and already graduated community pharmacists. RESULTS: A total of 131 people participated in the quantitative analysis, comprising 75 students and 56 pharmacists. Pharmacists and students agreed on the significance of two key aspects: the research must possess a clear and meaningful purpose, and researchers must keep the pharmacists informed about the study's results. Among the 27 proposed items, only three showed significantly different results between students and pharmacists. Moreover, 11 semi-structured interviews were conducted. Research in the community pharmacy domain is relatively new for many pharmacists. Despite limited training, their willingness to participate is contingent on being actively involved from the outset, receiving appropriate support and training. However, the research should be seamlessly integrated into their daily practice, without being too time-consuming and administratively burdensome. Time constraints emerged as the main obstacle, along with concerns about the availability of human resources. Pharmacists expressed strong motivation driven by the research topic's relevance, and its potential impact on patients or the profession. While financial compensation is desirable, it did not appear to be the main criterion for participation in a study. CONCLUSIONS: French pharmacists are willing to participate in research projects to improve patient care and develop the profession. Research teams must guide and involve from the project's inception.


Assuntos
Serviços Comunitários de Farmácia , Farmácias , Farmácia , Humanos , Farmacêuticos , Inquéritos e Questionários
12.
Pediatr Infect Dis J ; 42(10): 888-892, 2023 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-37463358

RESUMO

Treatment of late-onset neonatal staphylococcal sepsis is sometimes challenging with feared side effects of vancomycin, increasing minimal inhibitory concentrations and questions about catheter management. In case of failure, ceftaroline was administered as a compassionate treatment in 16 infants (gestational age of less than 32 weeks and less than 28 postnatal days), whose first-line treatment failed. We report 11 successes and no severe adverse drug reactions. Larger data are required to confirm these encouraging results.


Assuntos
Bacteriemia , Sepse Neonatal , Sepse , Infecções Estafilocócicas , Recém-Nascido , Lactente , Humanos , Antibacterianos/efeitos adversos , Infecções Estafilocócicas/tratamento farmacológico , Vancomicina/efeitos adversos , Bacteriemia/tratamento farmacológico , Sepse Neonatal/tratamento farmacológico , Sepse/tratamento farmacológico , Ceftarolina
13.
PLoS One ; 15(10): e0240105, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33017423

RESUMO

INTRODUCTION: While drug prescription should be based on established recommendations stemming from clinical trials but in pediatrics, many drugs are used without marketing authorization. Consequently recommendations are often based on clinical experience and the risk of inappropriate prescription (IP) is high. A tool for detecting IP in pediatrics-called POPI (Pediatrics: Omission of Prescriptions and Inappropriate prescriptions)-has been developed in France. However the relevance of its use at an international level is not known. Our aim has been to adapt POPI for a worldwide use. MATERIAL AND METHOD: A two-round Delphi online questionnaire was completed and validated by international experts to identify consensual items. They were asked to rate the validity of each items taking into account the recommendations and practices in their countries. Only propositions obtaining a median score in the upper tertile with an agreement of more than 75% of the panel-for the first round-and 85%-for the second round-were retained. RESULTS: Our panel included 11 pharmacists (55%) and 9 physicians (45%). The panelists came from 12 different countries: England, Belgium, Brazil, Canada, China, Ivory Coast, Ireland, Malaysia, Portugal, Switzerland, Turkey and Vietnam. At the end of the first round, of the 105 items of the original POPI tool, 80 items were retained including 16 items reworded and 25 items were deleted. In the second round, 14 experts participated in the study. This final international POPI tool is composed of 73 IP and omissions of prescriptions in the fields of neuropsychiatry, dermatology, infectiology, pneumology, gastroenterology, pain and fever. DISCUSSION AND CONCLUSION: This study highlights international consensus on prescription practice in pediatrics. The use of this tool in everyday practice could reduce the risk of inappropriate prescription. The impact of the diffusion of POPI tool will be assessed in a prospective multicentric study.


Assuntos
Prescrição Inadequada , Pediatria , Adulto , Criança , Técnica Delphi , Prescrições de Medicamentos/estatística & dados numéricos , França , Humanos , Prescrição Inadequada/estatística & dados numéricos , Pessoa de Meia-Idade , Pediatria/estatística & dados numéricos , Farmacêuticos , Médicos
14.
BMJ Open ; 9(3): e019186, 2019 03 20.
Artigo em Inglês | MEDLINE | ID: mdl-30898791

RESUMO

BACKGROUND AND OBJECTIVE: Pediatrics: Omission of Prescription and Inappropriate prescription (POPI) is the first detection tool for potentially inappropriate medicines (PIMs) and potentially prescribing omissions (PPOs) in paediatrics. The aim of this study was to evaluate the prevalence of PIM and PPO detected by POPI regarding prescriptions in hospital and for outpatients. The second objective is to determine the risk factors related to PIM and PPO. DESIGN: A retrospective, descriptive study was conducted in the emergency department (ED) and community pharmacy (CP) during 6 months. POPI was used to identify PIM and PPO. SETTING: Robert-Debré Hospital (France) and Albaret community pharmacy (Seine and Marne). PARTICIPANTS: Patients who were under 18 years old and who had one or more drugs prescribed were included. Exclusion criteria consisted of inaccessible medical records for patients consulted in ED and prescription without drugs for outpatients. PRIMARY AND SECONDARY OUTCOME MEASURES: PIM and PPO rate and risk factors. RESULTS: At the ED, 18 562 prescriptions of 15 973 patients and 4780 prescriptions of 2225 patients at the CP were analysed. The PIM rate and PPO rate were, respectively, 2.9% and 2.3% at the ED and 12.3% and 6.1% at the CP. Respiratory and digestive diseases had the highest rate of PIM. CONCLUSION: This is the first study to assess the prevalence of PIM and PPO detected by POPI in a paediatric population. This study assessed PIMs or PPOs within a hospital and a community pharmacy. POPI could be used to improve drug use and patient care and to limit hospitalisation and adverse drug reaction. A prospective multicentric study should be conducted to evaluate the impact and benefit of implementing POPI in clinical practice.


Assuntos
Serviço Hospitalar de Emergência , Prescrição Inadequada , Erros Médicos , Pediatria , Farmácias , Criança , Pré-Escolar , Serviço Hospitalar de Emergência/normas , Serviço Hospitalar de Emergência/estatística & dados numéricos , Feminino , França/epidemiologia , Humanos , Prescrição Inadequada/prevenção & controle , Prescrição Inadequada/estatística & dados numéricos , Masculino , Erros Médicos/prevenção & controle , Erros Médicos/estatística & dados numéricos , Conduta do Tratamento Medicamentoso/normas , Segurança do Paciente/normas , Pediatria/métodos , Pediatria/normas , Farmácias/normas , Farmácias/estatística & dados numéricos , Lista de Medicamentos Potencialmente Inapropriados , Padrões de Prática Médica/normas , Padrões de Prática Médica/estatística & dados numéricos , Prevalência , Melhoria de Qualidade/organização & administração , Estudos Retrospectivos , Fatores de Risco
15.
Int J Clin Pharm ; 41(3): 734-740, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30972535

RESUMO

Background Potentially inappropriate medication (PIM) and potential prescription omission (PPO) are common issues in pharmacotherapy in vulnerable populations. A first tool to assess PIM's and PPO's targeting pediatric populations: POPI «Pediatrics Omission of Prescriptions and Inappropriate Prescriptions¼ was created in 2014. Objective This study aimed to evaluate inter-rater reliability between healthcare professionals who apply POPI. Setting: Mother and child emergency ward of a university hospital. Method Twenty cases with or without PIM or PPO were identified in a previous retrospective PIM-PPO prevalence study on 15,973 patients. One doctor and one pharmacist, who participated in the creation of POPI tool, identified PIM and PPO ("gold standard response"). These cases were reviewed independently by eleven clinicians (generalists, pediatricians, pharmacists, residents), with no previous experience of this tool. Interrater agreement was calculated by using the Kappa agreement test. Main outcome measure: Inter-clinician agreement. Results A high level of agreement of PIM and PPO detection was recorded (PIM: median = 0.80; PPO: median = 0.71). Conclusion POPI demonstrated a good interrater reliability. This validation by many clinicians proves that POPI is a reliable tool. Other multicenter and prospective studies should be conducted to evaluate economical and clinical impacts of POPI.


Assuntos
Prescrições de Medicamentos/normas , Prescrição Inadequada/prevenção & controle , Erros Médicos/prevenção & controle , Lista de Medicamentos Potencialmente Inapropriados/normas , Criança , Pré-Escolar , Estudos de Coortes , Feminino , Humanos , Lactente , Masculino , Reprodutibilidade dos Testes , Estudos Retrospectivos
17.
Am J Health Syst Pharm ; 64(5): 531-5, 2007 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-17322167

RESUMO

PURPOSE: The results of contamination monitoring during a one-year pilot period are described. SUMMARY: A hematology-oncology satellite pharmacy conducted contamination monitoring for one year, using methotrexate as the index marker. From January 12, 2005, to December 21, 2005, 40 sampling sessions occurred during which 238 wipe samples (excluding positive controls) were collected. Each week, seven wipe samples were prepared by pharmacy technicians. Samples were obtained from the blank reference (site 0), the external metallic window frame of the main biological safety cabinet (BSC) (site 1), the back of the phone receiver (site 2), the external surface of an i.v. solution bag that was inside the BSC the previous hour (site 3), a working surface used for the final packaging and labeling (site 4), and the floor of the preparation room (site 5). The sixth sample was a positive methotrexate control. The methotrexate was detected by a high-performance liquid chromatograph with a fluorometric detector. Five samples tested positive for methotrexate-two from site 1, one from site 2, one from site 4, and one from site 0 (the blank); the last finding was thought to have most likely been the result of an error or sample mix-up during the wipe-sampling procedures. Despite differences in the sampling methods used, the type of wetting solution used, and the volume of desorption solution, the results were consistent with the literature in terms of few positive results. CONCLUSION: A program was developed to monitor surface contamination by methotrexate in a hematology-oncology satellite pharmacy.


Assuntos
Antimetabólitos Antineoplásicos/análise , Monitoramento Ambiental/métodos , Metotrexato/análise , Exposição Ocupacional/análise , Cromatografia Líquida de Alta Pressão , Composição de Medicamentos , Contaminação de Equipamentos , Serviço de Farmácia Hospitalar , Controle de Qualidade
18.
Bull Acad Natl Med ; 189(8): 1711-9; discussion 1719, 2005 Nov.
Artigo em Francês | MEDLINE | ID: mdl-16737096

RESUMO

Two investigations, one carried out throughout France (PediAD) and the other exclusively in Robert Debré pediatric hospital (PediEM), focus on the difficulties encountered by nursing staff when administering drugs to children, and the risk of medication errors. Medication errors can arise from dysfunctions at all stages of the drugs circuit, and may involve doctors, pharmacists or nursing staff. In pediatric hospitals they are mainly related to the lack of commercial products specifically designed Jor children. In Robert Debré Hospital, only one-third of commercial products in stock are authorized for pediatric use with no age limit. Thus, even in a hospital where drug distribution is entirely computerized (PCS Patient Care System software), where dispensing is based on the DIP system (daily, individual, and personal) but is not con trolled, and where almost all requirements for sterile and non sterile preparations are met but where validation is only partial, the system is far from being error-free. Two major improvements are planned. First, dispensing will be automated in 2006. With the current shortage of pharmacy technicians, this will securitize drug dispensing and provide for therapeutic and economic traceability. Second, integration of a pharmacist within each medical team is being compared with validation of prescriptions by a pharmacist in the hospital pharmacy.


Assuntos
Erros de Medicação/prevenção & controle , Automação , Criança , França , Humanos , Sistemas de Medicação no Hospital/organização & administração , Equipe de Assistência ao Paciente , Farmacêuticos
19.
Int J Clin Pharm ; 37(6): 1222-7, 2015 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-26394784

RESUMO

BACKGROUND: Off-label or unlicensed medicine use is very common in paediatric practice, ranging from 11 to 80 %, and is one of the predisposing factors for adverse events (23-60 %). Medicine indications are the third leading reason for doctors to perform off-label prescriptions. OBJECTIVE: The aim of our study was to determine the prevalence and nature of off-label and unlicensed medicine prescriptions in children and propose methods for risk reduction and management. SETTING: 475 bed maternity-paediatric university hospital. METHOD: Retrospective cross-sectional study lasting 1 day on new prescriptions issued over the previous 24 h by departments using electronic prescribing. Age and indication were compared to those in the French independent formulary Thériaque(®) database. MAIN OUTCOME MEASURE: Number of off-label/unlicensed prescriptions, number of patients, proportion of off-label/unlicensed prescriptions by age group, treatment class and International Non proprietary Name (INN), using the established classification. RESULTS: A total of 315 prescription medicines were analysed for 120 patients, of average age 5.1 years old. For the classification of medicine utilisation, the majority of the medicines were prescribed as licensed (190/60.3 %), followed by off-label (115/36.5 %) and unlicensed (10/3.2 %) medicines. Alimentary tract, metabolic and nervous system medicines constituted the most widely prescribed ATC classes. At least 54 % of patients received an off-label/unlicensed medicine. The indications for these were mainly for off-label prescriptions (80/25.4 %) followed by medicines not evaluated for safety and regarding safety and efficacy in children (14/4.5 %). Pantoprazole was the most widely prescribed off-label INN for stress ulcer prevention (62 %). For risk reduction, we found esomeprazole being prescribed instead of pantoprazole; esomeprazole is indicated for children under a year old. CONCLUSION: This study reflects one given day: 36.5 % of off-label prescriptions and 3.2 % of unlicensed prescriptions in a paediatric setting. Few risk reductions for off-label number prescriptions have been found. This work confirmed the necessity of carrying out further studies in children.


Assuntos
Hospitais Pediátricos/estatística & dados numéricos , Hospitais Universitários/estatística & dados numéricos , Uso Off-Label/estatística & dados numéricos , Padrões de Prática Médica/estatística & dados numéricos , Adolescente , Fatores Etários , Criança , Pré-Escolar , Estudos Transversais , Prescrição Eletrônica/estatística & dados numéricos , França , Hospitais com 300 a 499 Leitos , Humanos , Lactente , Recém-Nascido , Prevalência , Estudos Retrospectivos
20.
J Eval Clin Pract ; 21(2): 262-70, 2015 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-25560989

RESUMO

RATIONALE, AIMS AND OBJECTIVES: High-alert medications (HAMs) are medications that are associated with a high risk of serious harm if used improperly. The objective of this study was to identify paediatric HAM used in our institution and to identify safety measures for their use. METHODS: The list of HAM and the list of safety measures that were introduced in our department were based on (1) a literature search; (2) a survey of health care professionals in our department including doctors, head nurses, nurses and pharmacists; and (3) the drug steering committee. RESULTS: We found four lists of HAM based on a literature search, including 27 classes of pharmaceutical agents, and 63 common drug names. The response rate of the survey was 20.7% (230 of 1113). Some of the HAMs included in our list were not identified by the literature search. These included neuroleptic drugs, anti-malarial agents, antiviral agents, anti-retroviral agents and intravenous acetaminophen. The drug steering committee selected 17 HAM and highlighted 53 safety measures involving seven broad aspects of pharmacological management. CONCLUSIONS: This project was part of the new safety strategies developed in a paediatric hospital. We set out to make a list of HAM relevant to paediatrics with additional safety measures to prevent medication errors associated and a 'joker' system. The various safety measures, such as double-checking of HAM prescriptions, should be reviewed during the year following their implementation. This list, which was developed in our hospital specifically for use in paediatrics, can be adapted for use in other paediatric departments.


Assuntos
Hospitais Pediátricos/organização & administração , Hospitais Universitários/organização & administração , Erros de Medicação/prevenção & controle , Segurança do Paciente , Medicamentos sob Prescrição/classificação , França , Humanos , Recursos Humanos em Hospital , Medição de Risco
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