[Consensus update of the POPI tool]. / Mise à jour par consensus de l'outil POPI.

Medication errors are one of the causes of iatrogenic medication use in children. The POPI tool for detecting inappropriate drug prescriptions and prescription omissions in paediatrics was the first tool to be published in this field in 2014. Our aim was to update the POPI tool for French use based on current recommendations and practice. Criteria were removed, updated or added based on recommendations from learned societies and national bodies. The two-round Delphi method was used to reach a consensus of experts. The level of agreement of the healthcare professionals' proposals was rated on a 9-point Likert scale. In the first round, only proposals with a median agreement of 7 to 9 and an agreement of more than 65% were retained. In the second round, only those with a median agreement of 7 to 9 and over 75% agreement were retained. The POPI tool now includes eight categories (various, infectiology, gastroenterology, pneumonology, dermatology, neurology/pedopsychiatry, haematology and excipients). All the criteria were supported by bibliographical references. They were submitted to 20 French healthcare professionals: 9 pharmacists and 11 doctors (17 hospital-based and 3 self-employed). After two rounds of Delphi testing, 166 criteria were retained and validated (111 inappropriate prescriptions and 55 omissions). In conclusion, this study made it possible to update the POPI tool, which is still available for assessing paediatric prescriptions.

[Illustrated case study of a patient with pediatric multisystem inflammatory syndrome]. / Cas clinique illustré autour d'un patient atteint d'un syndrome inflammatoire multisystémique pédiatrique.

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.

[Medication and children: Practical situations to address the risks]. / Médicaments et enfants : approche des risques par des mises en situation pratiques.

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).

Academic pediatric clinical research: factors associated with study implementation duration.

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.

Fluoroquinolones in pediatrics: review of hospital prescription use over 2 years.

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.

Exploration of the barriers and enablers of benzodiazepines deprescribing in prisons: A qualitative study among health and social care professionals.

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.

Selection of a probiotic to prevent necrotizing enterocolitis for preterm infants in a French neonatology department.

Very premature and/or low-birth-weight infants are at risk of developing necrotizing ulcerative enterocolitis (NEC). Prophylactic use of probiotics would change the composition of the gut microbiota and thus reduce the risk of NEC. In order to choose a probiotic at the local level, international recommendations were compared, and the available specialties were listed. Discrepancies between the different recommendations appeared, and the great variability of infant specialties available, as well as their status, did not allow us to select one. The local objective will therefore be to participate in the discussion of this subject at a national level.

The role of community pharmacists in the management of hematopoietic stem cell transplant recipients: knowledge and training.

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.

Off-label prescriptions: how to identify them, frame them, announce them and monitor them in practice?

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.

Questions around a case of in utero thrombosis in a premature child, concerning the management of anticoagulant treatments.

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.

Observational and prospective study: evaluation of beliefs and representations of chronic treatments of polymedicated patients hospitalised in a vascular medicine and surgery department.

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.

The experience of being a caregiver of patients with digestive cancer, from patients and caregivers' perception: A mixed study.

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.

Factors influencing French community pharmacists' willingness to participate in research projects: a mixed method study.

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.

Safety and Efficacy of Ceftaroline in Neonates With Staphylococcal Late-onset Sepsis: A Case Series Analysis.

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.

International consensus validation of the POPI tool (Pediatrics: Omission of Prescriptions and Inappropriate prescriptions) to identify inappropriate prescribing in pediatrics.

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.

Retrospective study of irrational prescribing in French paediatric hospital: prevalence of inappropriate prescription detected by Pediatrics: Omission of Prescription and Inappropriate prescription (POPI) in the emergency unit and in the ambulatory setting.

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.

Interrater reliability of a tool to assess omission of prescription and inappropriate prescriptions in paediatrics.

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.

Program to monitor surface contamination by methotrexate in a hematology-oncology satellite pharmacy.

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.

[Pediatric medication errors and their prevention]. / Accidents médicamenteux en pédiatrie. Comment les limiter et les prévenir?

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.