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Considering the preferences in Shared Decision Making (SDM) of patients with Digestive Cancer (DC) is crucial to ensure the quality of care. To date, there is limited information on preferences in SDM of patients with DC. The objectives of this study were to describe digestive cancer patients’ preference for involvement in therapeutic decision-making and to identify variables associated with these preferences. An observational prospective study in a French university cancer center has been conducted. Patients completed two questionnaires to qualify and quantify their preference for involvement in therapeutic decision-making: the Control Preference Scale (CPS) and the Autonomy Preference Index (API), which is composed of the Decision Making (DM) score and the Information Seeking (IS) score. Associations between these scores and socio-demographic data, disease-related data, coping strategies (Brief-COPE), physical (QLQ-C30) and psychological (HADS) quality of life were tested. One-hundred fifteen patients returned the questionnaires. The majority of patients reported a passive (49.1%) or a collaborative (43.0%) CPS status. The mean DM score was 39.4 Variables associated with decision-making preferences were occupational status and time since diagnosis. The identification of variables associated with patients' preferences for involvement in decision-making can help make clinicians aware of patients' needs and wishes. However, it can only be determined by interviewing the patient individually.

Resume La maladie de Kawasaki est une maladie rare qui touche particulierement les nourrissons et les jeunes enfants decrite pour la premiere fois dans les annees 60. Il s’agit d’une vascularite aigue febrile qui affecte notamment les arteres coronaires. Elle represente la premiere cause de cardiopathie acquise chez l’enfant. En fonction de la combinaison des symptomes, on observe des formes completes ou incompletes de la maladie de Kawasaki. Le diagnostic de la maladie de Kawasaki etant uniquement clinique avec des symptomes non specifiques et sans marqueur biologique, on observe souvent un retard au diagnostic. La complication majeure et redoutee est une atteinte cardiaque par anevrisme des arteres coronaires alors qu’il existe un traitement diminuant le risque de survenue d’anevrisme coronarien. N’ayant aucune experience dans la conception d’un enseignement par le moyen du e-learning, l’objectif de cet article est de presenter les etapes de conception du e-learning sur la maladie de Kawasaki, les difficultes rencontrees et l’outil final afin de permettre a d’autres personnes d’utiliser ce nouvel outil de communication et methode pedagogique.

Resume But/objectif La notion du caractere photosensibilisant des dermocorticoides (DC) semble repandue chez les pharmaciens d’officine. L’objectif de cette etude etait d’evaluer la crainte des equipes officinales vis-a-vis d’une prescription de dermocorticoides dans la dermatite atopique (DA) et d’une exposition au soleil et son retentissement en termes de conseils d’utilisation. Materiels et methodes Un questionnaire a partir d’un « cas de comptoir » (ordonnance de dermocorticoides pour la DA d’un enfant de 18 mois) etait mis en ligne sur Facebook via des groupes de pharmaciens, preparateurs et etudiants. Les questions concernaient la personne sondee, sa reticence vis-a-vis des DC, les conseils associes, les craintes detaillees concernant l’association DC et soleil et les sources d’informations. Resultats Au total, 126 participants ont repondu (48 % pharmaciens, 41 % preparateurs, 10 % etudiants) : 12 % etaient reticents aux DC, 36 % etaient reticents aux DC et les estimaient photosensibilisants, et 51 % n’etaient pas reticents mais les jugeaient photosensibilisants. Le retentissement sur les conseils delivres lors dispensation etait : une suggestion d’arret du DC pendant toute la duree de l’exposition solaire (28 %), d’arret ou de limitation du DC independamment de l’exposition solaire (43 %). Les sources citees a l’origine de ces craintes etaient : les monographies des medicaments (54 %), Internet (6 %) et les cours theoriques (13 %). Conclusion La croyance fausse de l’incompatibilite DC/soleil dans la DA retentit sur les conseils delivres aux parents. Le role de l’equipe officinale lors de la dispensation des dermocorticoides est essentiel : la formation et l’information des professionnels permettent de lutter contre la dermocorticophobie.

Purpose Patient autonomy is a key concept in medical ethics, which consists of recognizing each person as a free individual capable of judging and determining for himself or herself. The objectives of this study were to describe digestive cancer patients’ desire for autonomy in therapeutic decision-making and to identify variables associated with these preferences. Methods An observational prospective study in a French university cancer center has been conducted. Patients completed two questionnaires to qualify and quantify their desire for autonomy in therapeutic decision-making: the Control Preference Scale (CPS) and the Autonomy Preference Index (API), which is composed of the Decision Making (DM) score and the Information Seeking (IS) score. Associations between these scores and socio-demographic data, disease-related data, coping strategies (Brief-COPE), physical (QLQ-C30) and psychological (HADS) quality of life were tested. Results One-hundred fifteen patients returned the questionnaires. The majority of patients reported a passive (49.1%) or a collaborative (43.0%) CPS status. The mean DM score was 51.5. Variables associated with decision-making preferences were occupational status and time since diagnosis. Conclusion The identification of variables associated with patients' preferences for autonomy and participation in decision-making can help make clinicians aware of patients' needs and wishes. However, it can only be determined by interviewing the patient individually.

Purpose This study aims to explore the experience of caregivers of patients with digestive cancer and to compare the perspectives of patients and caregivers. Methods This was a mixed-methods study on caregiver-patient dyads. Semi-structured interviews with caregivers and their patients were conducted to explore each perspective. Two questionnaires were distributed to caregivers, the Caregiver Reaction Assessment (CRA) and the Supportive Care Needs Survey for Partners and Caregivers (SCNS-PC). Results Thirty-two caregivers completed the questionnaires. The CRA showed great self-esteem (3.8 +/- 0.7) and the burden on schedule (3.3 +/- 1). The SCNS-PC showed a need for healthcare service and information (2.0 +/- 0.8). Ten dyads participated in semi-structured interviews. Three themes emerged from caregiver’s interviews: the illness is an upheaval; the feeling of loneliness and helplessness and its consequences; a natural role with positive outcomes. Four themes emerged from the patient's side: the caregiver naturally takes on this role and gets closer; the caregiver is the patient's anchor; the disruption of the caregiver's life; anxiety, guilt, and the desire to protect the caregiver. Comparison of the data identifies many similarities between patients and caregivers, as well as discrepancies with the main theme being their relationship. Conclusion This demonstrates the importance of caring for caregivers and considering them in the context of their relationship with the patient to better understand their experience.

Resume Introduction Les enfants ne sont pas des « adultes miniatures ». Les pharmaciens et les etudiants en pharmacie doivent y etre sensibilises pour developper des competences en pharmacie clinique pediatrique. Materiel et methodes Dans le contexte d’un diplome universitaire de pharmacie clinique pediatrique et de 6 e annee de filiere officine, nous avons developpe une nouvelle methode pedagogique de type classe inversee. Ce projet, initie en 2017 par deux etudiantes en pharmacie, les membres de la cellule TICE et deux pharmaciens et enseignants specialises en pediatrie a touche 30 pharmaciens et internes et 86 etudiants. Les themes choisis etaient « Le medicament pediatrique » et « La fievre chez l’enfant ». Resultats Au total, 4 videos ont ete creees. Apres visionnage, les participants devaient realiser une fiche synthese puis travailler sur des cas cliniques avec les intervenants des videos. Les participants ont ete satisfaits par ce nouvel outil V-Idee-Oh (96 %), par la vision de la video avant le cours (92 %). Concernant la preparation de la fiche, 81 % ont ete satisfaits par ce travail en amont. Discussion Nous avons teste cette annee une nouvelle methode pedagogique sur deux themes de base. Grâce aux commentaires recueillis, nous allons raccourcir la preparation des cours cas et nous elargirons cette methode pour d’autres themes pour les prochaines sessions. Conclusion Cette nouvelle methode pedagogique est attractive pour les etudiants et pour les enseignants. Cet article decrit ses modalites pratiques pour etre transposable dans d’autres universites et sur d’autres thematiques.

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).

Background and objectivePediatrics: 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.DesignA 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.SettingRobert-Debré Hospital (France) and Albaret community pharmacy (Seine and Marne).ParticipantsPatients 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 measuresPIM and PPO rate and risk factors.ResultsAt 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.ConclusionThis 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.

Summary Aims To analyze plasma-derived products (PD) traceability from donor selection to administration to patient. To compare PD recall legislations in France, United States (US), Canada and United Kingdom (UK) related to transmission of Creutzfeldt-Jakob disease (CJD). To develop a flowchart adapted to French context regarding information that should be given to patients. Method Literature research, consultation of national agencies and blood donation centers websites. Most recent laws and legislative texts were included. Results Twenty-five legislatives texts and 9 articles were retrieved. English donors and those who have stayed in UK more than 3 months (US) or 1 year (Europe) were excluded from plasma donations. In US and Canada, donors who lived during 5 years and more in France were also excluded. Europe and US recommended the recall of PD extracted from donors diagnosed with vCJD after donation. Recommendations concerning information to give to prescribers and patients were variable depending on the country analyzed.

Resume Objectif Face a la prescription hors AMM tres repandue en pediatrie, l’objectif de notre etude est d’identifier les experiences et attitudes des medecins face a la prescription hors AMM dans un centre hospitalier universitaire mere-enfant francais. Materiel et methode Questionnaire en ligne de 24 questions envoye par courriel a 409 medecins en fevrier 2013. Donnees : frequence de prescription hors AMM, sources d’information, pharmacovigilance et efficacite, devoir d’information et documentation hors AMM. Des mesures d’amelioration ont ete proposees. Resultats Au total, 80 medecins ont participe et 81 % etaient familiers avec le concept de prescriptions hors AMM. Ils estiment prescrire dans 74 % des cas pour un non-respect de la limite d’âge et pour 28 % dans une indication hors AMM. Ils (79 %) solliciteraient l’avis d’un collegue lors d’une prescription hors AMM. Les sources d’information utilisees etaient les publications (72 %), les recommandations internationales (62 %), le Vidal (56 %) et les recommandations nationales (46 %). Un tiers a dit avoir observe un evenement indesirable avec un medicament hors AMM. Deux tiers des repondants informeraient les parents. Pour la mention « hors AMM », 81 % des medecins disaient ne pas l’indiquer sur la prescription. Enfin 52 % etaient prets a mettre en place un observatoire local de suivi des prescriptions hors AMM. Conclusion Notre etude decrit les perceptions des medecins concernant la prescription hors AMM en pediatrie. L’information des patients et la documentation dans les dossiers medicaux sont incompletes. Un observatoire des prescriptions hors AMM va etre debute localement.

Resume Objectif L’erreur medicamenteuse est une des causes d’iatrogenie medicamenteuse chez les enfants. Notre objectif etait de developper un premier outil de detection des prescriptions medicamenteuses inappropriees ou des omissions de prescription en pediatrie a partir des recommandations francaises et internationales. Materiel et methodes Les themes abordes ont ete choisis selon la frequence des pathologies dans la population. Les criteres ont ete developpes a partir des recommandations des societes savantes et des instances nationales. La methode Delphi a ete utilisee afin de valider les propositions de l’outil. Le niveau d’accord et les propositions des professionnels de sante a ete note sur une echelle de Likert a 9 points. Resultats L’outil POPI comprend cinq categories (pathologie divers, digestif, oto-rhino-laryngologie/pneumologie, dermatologie et neuropsychiatrie). Tous les criteres ont ete argumentes par des references bibliographiques. Ils ont ete soumis a 16 professionnels de sante francais : 8 pharmaciens et 8 medecins (8 hospitaliers et 8 liberaux). Apres deux tours de Delphi, 101/108 criteres ont ete retenus (76 prescriptions inappropriees et 25 omissions). Conclusion POPI est le premier outil pediatrique pour la detection des prescriptions inappropriees et des omissions de prescription. Cet outil permettra d’estimer la proportion des prescriptions inappropriees et son impact devra etre evalue.

AimsChronic kidney disease is a major risk factor of vaccine preventable infectious diseases due to the altered immune system and the natural evolution of the disease. There are differences in the prescription of some vaccines for this population. The aim of this study is to elaborate a vaccination protocol for chronic kidney disease and haemodialysis patients for a better immunization coverage, care and prevention against preventable infectious diseases.MethodsThe study was conducted by a multidisciplinary team composed by pharmacists, infectious disease paediatrician and nephrology paediatricians. After a literature research (in Medline with MeSH terms: ‘Kidney Failure, Chronic’, ‘Renal Dialysis’ and ‘Vaccines’)1 2, we compared the French immunization schedule3 for the general population with patient with chronic kidney disease or haemodialysis patients and confront it to the physician practice in our nephrology unit. For each vaccine, we collected the following data: indication, any difference concerning dose, schedule, re-administration, antibody titration and reason for these differences.ResultsThe literature analysis showed disparate practices among countries and even medical centres. The most concerned vaccines were: hepatitis A and B virus vaccine, pneumococcal vaccine, flu and measles vaccines. The difference between vaccine scheduled concerned the indication (meningococcus A, B, C, Y and W135, papillomavirus), dose (hepatitis B), the schedule (hepatitis B, hepatitis A, pneumococcal, measles), re-administration (hepatitis B, varicella), antibody titration (hepatitis B, varicella). Patients with chronic kidney disease are more susceptible to develop hepatitis B infection. As for adult population, the haemodialysis patients are vaccinated with double dose4 of hepatitis B vaccine. The antibodies titration at our hospital is made twice a year and anti-HBs level needed are 30 to 50 UI/mL. Hepatitis A is a recommended vaccine for risk population including haemodialysis patients and chronic kidney disease patients. The vaccination schedule is the same for haemodialysis patients with two doses but the second dose is administered earlier, i.e. six months after the first with an antibody screening. For the pneumococcal vaccine, an additional dose is administered at 3 month of age for premature and at risk children and the conjugated vaccine potentiates the polyosidic vaccine. For measles, the second dose may be omitted if the antibody titration confirms the protection to allow the patient to be registered earlier on the renal transplant list. Flu vaccination is recommended with the same dose and schedule that the other patients, but tetravalent vaccines should always be chosen.ConclusionsChildren with chronic kidney disease or on haemodialysis are more at risk of vaccine preventable infectious diseases and should be vaccinated earlier before beginning dialysis. The specific immunization schedule will be presented and may be used by other hospital and countries for concerned patients.ReferencesBakkaloğlu SA, et al. Vaccination Practices in Pediatric Dialysis Patients Across Europe. A European Pediatric Dialysis Working Group and European Society for Pediatric Nephrology Dialysis Working Group Study. Nephron 2018;138:280–286.Costa NCP, da Canhestro MR, Soares CMBM & Rodrigues JS. Monitoring of post-vaccination anti-HBs titles vaccine in children and adolescents in the pre-dialysis of chronic kidney disease. Braz. J. Nephrol. 2017;39:296–304.DGS_Anne.M, DICOM_Jocelyne.M, DGS_Anne.M & DICOM_Jocelyne.M. Le calendrier vaccinal. Ministère des Solidarités et de la Santé (2019). Available at: https://solidarites-sante.gouv.fr/prevention-en-sante/preserver-sa-sante/vaccination/calendrier-vaccinal (Accessed: 28th June 2019)Misurac JM, et al. Immunogenicity of augmented compared with standard dose hepatitis B vaccine in pediatric patients on dialysis: a midwest pediatric nephrology consortium study. Clin. J. Am. Soc. Nephrol 2017;12:772–778.

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.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.475 bed maternity-paediatric university hospital.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.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.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.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.

La Presse Medicale - In Press.Proof corrected by the author Available online since jeudi 5 fevrier 2015

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.

Objectives To compare pharmacy support for paediatric research services in France and Canada and to describe the perception of pharmacists and rank the paediatric clinical research issues. Methods This was a cross-sectional descriptive study. All paediatric hospitals from Canada and the main hospitals from France were contacted. A survey was conducted from May–September 2012. Descriptive statistics were performed. Key findings Results from 11 paediatric hospitals in Canada (11/12, 92%) and 11 (11/18, 61%) in France were obtained. There was a similar number of ongoing paediatric clinical trials per hospital in France versus Canada (38 (10–81) versus 20 (4–178)). A lower number of pharmacists per hospital was observed in France (17 (11.5–35) versus 45 (18.9–76.8)), but a similar number of pharmacists were assigned to clinical trials (1.5 (1–3) versus 1.9 (0.2–17.4)). Institutional protocols represented the majority of paediatric clinical trials in France (61% (14–100) versus 25% (0–100)). Similar pharmacy support services were offered, but the majority of French respondents also offered help for institutional protocol development (91 versus 50% P = 0.063). The main issues associated with paediatric clinical research were absence of financial interest from the pharmaceutical industry, prohibitive cost versus profit ratio, small patient cohorts and the non-availability of the appropriate drug formulations. Conclusions Difficulties related to pharmaceutical compounding were identified as the main hindrance to paediatric clinical research; particular attention should be paid to these details when setting up a paediatric trial.

Resume Objectifs L’evolution des strategies therapeutiques chez l’enfant depend de la sortie commerciale de medicaments avec une indication et une forme pediatrique. Les nouveautes therapeutiques different parfois entre les pays, notamment concernant la pediatrie. L’objectif de cette etude etait de comparer l’acces aux nouveaux medicaments pour les enfants entre la France (FR) et le Canada (CA). Materiels et methodes Etude retrospective comparant les medicaments nouvellement commercialises sur les marches francais et canadien du 1er janvier au 31 decembre 2009. Les donnees ont ete colligees grâce a des sources independantes (la Haute autorite de sante [HAS], Theriaque®, l’Agence nationale de securite du medicament et des produits de sante [ANSM] pour la FR et le conseil d’examen du prix des medicaments brevetes [CEPMB], la base de donnees sur les produits pharmaceutiques [BDPP] pour le CA). Resultats Respectivement 37 et 30 nouveaux medicaments ont ete commercialises en 2009 pour la FR et le CA. Ces medicaments avaient une indication pediatrique pour 38 % (n = 14) et 27 % (n = 8) d’entre eux respectivement. Pour 91 % (FR) et 95 % (CA) des molecules non indiquees en pediatrie, aucune etude clinique n’avait ete developpee dans ce but. La totalite des molecules a indication pediatrique presentait une posologie en fonction de l’âge ou du poids de l’enfant, mais deux medicaments n’avaient pas de forme galenique adaptable a l’enfant. Parmi ces nouveaux medicaments, 57 % etaient d’abord apparus sur le marche francais avec un delai median de 8,5 mois pour la sortie sur le marche canadien. Conclusions Cette etude souligne le manque de medicaments pediatriques contribuant aux nombreuses prescriptions chez l’enfant de medicaments hors autorisation de mise sur le marche (AMM), sans posologie et forme pharmaceutique adaptees.

Introduction La crainte des dermocorticoides (DC) ou corticophobie repose sur une surestimation des risques d’effets secondaires reels et sur des croyances non fondees: parmi ces dernieres, la notion du caractere photosensibilisant des DC semble repandue chez les pharmaciens. L’objectif de cette etude etait d’evaluer la crainte des equipes officinales vis-a-vis d’une prescription de DC dans la dermatite atopique (DA) en periode estivale et son retentissement en termes de conseils d’utilisation des DC en ete. Materiel et methodes Un questionnaire a partir d’un « cas de comptoir » (presentation en ete d’une ordonnance de DC pour la DA d’un enfant) etait mis en ligne sur Facebook via des groupes de pharmaciens, preparateurs et etudiants; les questions concernaient – la personne sondee (âge, profession) – sa reticence vis-a-vis des DC en general et en cas d’exposition solaire, – son adherence a l’ordonnance proposee evaluee en termes de conseils lors de la dispensation, – les craintes detaillees concernant l’association DC et soleil, – les sources d’informations concernant ces risques. Resultats Cent vingt-six participants ont repondus (48,4 % pharmaciens, 40,5 % preparateurs, 10,3 % etudiants): 12 % etaient reticents aux DC en general, 36 % etaient reticents aux DC en general et les estimaient photosensibilisants, et 51 % n’etaient pas reticents mais les jugeaient photosensibilisants. Le retentissement sur les conseils delivres lors dispensation etait: une suggestion d’arret du DC pendant toute la duree de l’exposition solaire (28 %), d’arret ou de limitation du DC (quantite, duree) independamment de l’exposition solaire (43 %). Les craintes exprimees concernant l’association DC/soleil etaient: un risque vis-a-vis de rayons UV (46 %), un risque de depigmentation (27 %) ou d’hyperpigmentation (5,6 %), une aggravation de la DA (9,5 %). Les sources citees a l’origine de ces craintes etaient: les monographies des medicaments (54 %), les sites Internet (6,3 %) et les cours theoriques (13,5 %). Discussion Le caractere photosensibilisant des DC est un malentendu frequent dans les officines et retentit en termes de conseils lors de la dispensation, allant jusqu’a preconiser dans 1/3 des cas un arret total du traitement pendant l’ete, y compris chez les professionnels n’exprimant pas de reticence en general vis-a-vis des DC. Les risques evoques confirment le caractere multifactoriel de la corticophobie: mauvaise interpretation de la dyschromie post inflammatoire, craintes non fondees d’effets secondaires lies aux mesusage de DC, part d’irrationnel. L’origine de cette fausse information est inconnue: contrairement aux dires des participants, elle est bien sur absente des monographies et des recommandations en ligne des societes savantes. Conclusion La croyance fausse de l’incompatibilite DC/soleil dans la DA est bien ancree chez les pharmaciens et retentit sur les conseils delivres aux parents. Ce point doit donc etre aborde lors de l’education therapeutique.

Anti-inflammatory drugs have been suspected on several occasions to have promoted development of bacterial infection among varicella patients. Some countries have not implemented childhood varicella vaccination. Three cases in our hospital suggested the predisposing role of NSAIDs in varicella patient deterioration. Open access to these drugs widely increases their use and patient information should be continually provided in the medical offices and at dispensing pharmacy counters. Taking account of the benefit/risk balance and applying the simple precautionary principle, it would be appropriate to be cautious about the use of NSAIDs in the paediatric population.

Objectives: The main objective was to evaluate whether the level of agreement of oncology hospital pharmacists with statements on their impact is influenced by the presence or absence of evidence-based data. The secondary objective was to evaluate the relative importance of evidence-based data among factors that may have contributed to oncology pharmacy practice evolution. Methods: Oncology pharmacists’ answered a Web questionnaire to measure their level of agreement with statements regarding their impact. Respondents answered the questionnaire before (pre) and after (post) being informed whether supporting evidence was available for each statement. Respondents were also asked to rank all of the factors in order of their perceived contribution to oncology pharmacy practice evolution. Results: A total of 64 questionnaires were obtained. Respondents reported a high level of agreement with statements regarding their impact on oncology pharmacy practice (mean agreement of 95.9% pre vs 93.8% post). A statistically significant diminution in the level of agreement was observed for 3 statements after respondents were informed that no supporting evidence was available for these statements. Respondents assigned a high importance to factors related to the perception of positive outcomes of pharmaceutical activities on patient safety, health care costs, and clinical results but a low importance to the use of evidence-based data.

Resume A la suite de l’affaire Mediator, et de la loi de securite sanitaire de decembre 2011, la prescription hors-autorisation de mise sur le marche (AMM) est une reelle preoccupation partagee par tous les acteurs de sante. Le hors-AMM au sens le plus strict est defini par toutes les prescriptions qui ne correspondent pas au resume des caracteristiques du produit (RCP), en particulier celles qui sont en dehors des indications et des posologies definies par l’AMM, pour des raisons evidentes de securite. Les raisons de la prescription hors-AMM sont diverses, conscientes comme inconscientes, elles ont pour objectif de repondre d’une part aux besoins medicaux non couverts, a ceux des populations peu ou pas etudiees dans les essais mais chez lesquelles une extrapolation de l’AMM est raisonnable (prescriptions de bon sens), et d’autre part a des besoins de sante publique urgents (baclofene, femmes enceintes et medicaments du virus de l’immunodeficience humaine…). Toutes ces prescriptions meriteraient d’etre etudiees en vue d’une AMM. Par contre, il existe des prescriptions hors-AMM qu’il faut limiter voire sanctionner quand il s’agit de prescriptions compassionnelles, de complaisance et/ou ne reposant sur aucun fondement scientifique. Les prescriptions hors-AMM ne sont pas faciles a depister car si le prescripteur est tenu d’ecrire la mention « hors-AMM » sur son ordonnance lorsqu’il se livre a ce type de prescription, force est de constater qu’en pratique il ne le fait qu’exceptionnellement. Les pharmaciens qui delivrent le medicament tout comme les caisses d’assurance maladie qui le remboursent, n’ont pas acces au diagnostic (ou l’indication visee) ; il faut donc, pour les identifier, avoir recours au croisement des bases de donnees a notre disposition (pharmacovigilance, programme de medicalisation des systemes d’information [PMSI], livret therapeutique hospitalier, echantillon generaliste des beneficaires de l’Assurance maladie [EGB] ou systeme national d’information inter regions [SNIIRAM], donnees de ventes, d’etudes de marche…). Le dossier patient informatise partage par tous resoudra possiblement cette problematique. Le dispositif de recommandation temporaire d’utilisation (RTU) propose par la loi de securite du medicament ne repondra a cette problematique qu’en partie pour les molecules recemment commercialisees (extension d’indication). Ce dispositif derogatoire et transitoire autorisera une prescription hors-AMM reconnue, possiblement remboursee et surveillee pendant 3 ans. Ces RTU concerneront la faible partie du « hors-AMM » qui dispose de preuves d’une balance beneficerisque positive (AMM conditionnelle anciennement protocole therapeutique temporaire [PTT]) mais ceci est loin de viser la majorite des prescriptions hors-AMM. De ce fait et afin d’ameliorer le bon usage des medicaments, il apparait important de proposer un systeme d’encadrement de tout le « hors-AMM » a l’aide d’une commission dediee : la commission du « hors-AMM » qui permettra de conduire a des recommandations d’utilisation (RU) ou non.

We aim to describe the number of health care visits before and after pediatric emergency department (PED) visits for common illnesses in a French tertiary pediatric hospital. This was a prospective cohort study with 501 children under 6 years of age who were evaluated and discharged from a tertiary care PED. Enrollment occurred on eight randomly selected study days between November 2010 and June 2011. The caregivers were then contacted via telephone 8 days later to obtain follow-up data, including information about return visits to health care facilities. Multiple visits were made by 206 (41 %) children, previous visits had occurred for 139 (28 %) children, and return visits had occurred for 94 (19 %) children. Previous and return visits were made at the PED as well as in general practitioners’ offices and private pediatric offices. The median age of the subjects was 18 months. Fever was the most common complaint and was associated with more frequent multiple heath care visits. Conclusion: Multiple heath care visits for the same illness are frequent, especially for febrile children. Interestingly, this phenomenon concerns every type of health care facility, including the PED, general practitioners’ offices, and private pediatric offices. Further studies should be performed to achieve a better understanding of this phenomenon and to test specific interventions, such as parental education and improvement of the information system.

Introduction : L’allaitement maternel exclusif est recommande pendant les six premiers mois de vie. La prise de medicaments pendant cette periode peut etre soit a l’origine d’arrets injustifies d’allaitement soit d’effets indesirables chez l’enfant. Objectifs : Le but de cette etude est de definir les besoins educatifs des femmes en post partum au CHU Robert Debre afin de pouvoir mettre en place un programme d’education adapte aux besoins de ces femmes sur cet aspect. En effet, il n’existe pas a notre connaissance de programme de ce type pour les meres. Nous avons donc explore la connaissance des medicaments, la comprehension des risques lies aux medicaments et les difficultes des meres liees a la prise de medicaments pendant l’allaitement au cours d’entretiens semi-directifs. Methodes : L’etude a consiste a croiser les besoins percus aupres de 19 meres allaitantes et de 12 professionnels de sante. Une analyse thematique des entretiens a ensuite ete realisee. Resultats : Les principaux besoins educatifs exprimes a la fois par les femmes et par les professionnels ont ete : connaitre les traitements appropries pour les pathologies courantes benignes, comprendre la physiologie du passage des medicaments dans le lait et le type de repercussion pour l’enfant, connaitre les medicaments utilisables et les questions a se poser avant leur prise. Des divergences entre les deux populations ont ete mises en evidence, notamment sur les connaissances necessaires aux femmes. Conclusion : Cette etude va permettre l’elaboration d’un programme d’education qui prendra place pendant le sejour des femmes en complement des actions d’aide a la pratique de l’allaitement deja mises en place a l’hopital Robert Debre.

Resume Introduction Le lorazepam injectable disponible en France sous autorisation temporaire d’utilisation nominative est commercialise dans de nombreux autres pays. L’objectif de cette etude est de faire un etat des lieux des disparites de statut et d’utilisation du lorazepam injectable en pediatrie au sein des hopitaux du Reseau mere–enfant de la francophonie (RMEF). Methodes Les criteres d’inclusion ont ete : premierement, l’appartenance de l’hopital au RMEF (29 hopitaux) ; deuxiemement, un seul site choisi par ville ; troisiemement, tous les hopitaux de l’AP–HP membres du RMEF. Apres un recrutement telephonique, un questionnaire a ete envoye par courriel a chaque centre hospitalier. Les donnees collectees concernent le nombre de lits de l’hopital, le statut officiel du lorazepam injectable, sa place dans la strategie therapeutique, la consommation de l’hopital en 2008 et les alternatives therapeutiques. Resultats Parmi les 18 hopitaux selectionnes, 17 hopitaux ont pu etre contactes et 12 hopitaux (70 %) ont repondu. Le lorazepam injectable n’est pas commercialise en Tunisie et au Liban. En Suisse, Canada et Belgique, le lorazepam injectable est commercialise et utilise dans tous les centres hospitaliers sondes (6,2 a 48,0 mg par lit d’hospitalisation). En France, seul l’hopital Robert-Debre l’utilise (3,2 mg par lit d’hospitalisation). Dans les pays ou il est commercialise, le lorazepam injectable est prescrit en premiere intention. Dans les autres pays, la premiere ligne de traitement proposee est le diazepam injectable (six sur huit centres hospitaliers). Discussion/conclusion La France est le seul pays ou le lorazepam injectable est disponible sans etre commercialise. Les donnees pharmacocinetiques sont en faveur de l’utilisation du lorazepam injectable par rapport a sa principale alternative therapeutique (diazepam injectable), mais aucune donnee actuellement disponible ne conclut a la superiorite du lorazepam injectable dans le traitement de l’etat de mal epileptique. L’indication officielle du lorazepam injectable en France (derniere intention) est en contradiction avec son utilisation dans les pays ou il est commercialise et les donnees de la litterature qui favorisent la premiere intention.

Objective: The aim of our study was to describe a cohort of pediatric glaucoma patients in Quebec. Design: This study was a retrospective medical record review. Participants: The study included patients younger than 18 years who were diagnosed with glaucoma between 1980 and 2000 and monitored at the Ophthalmology Clinic of the Sainte-Justine University Hospital Centre (Centre Hospitalier Universitaire Sainte-Justine) and had ocular hypertension or glaucoma in at least 1 eye. Methods: The data gathered concerned patients' information, the surgical procedures performed post diagnosis associated with the glaucoma diagnosis, and the drugs prescribed. Results: The study included 163 patients (254 eyes), a total of 374 surgical procedures, and the use of 2885 antiglaucoma drug therapies. For the 4 most frequent pathologies, patients were monitored for 8.4 (SD 4.2) years for aphakic glaucoma/pseudophakic glaucoma, 10.0 (SD 5.5) years for congenital glaucoma, 9.0 (SD 5.2) years for Axenfeld-Rieger syndrome, and 7.5 (SD 3.4) years for uveitic glaucoma. In total, 113 patients had at least 1 surgical procedure (69.3%). Before 1985, only timolol, pilocarpine, epinephrine, acetazolamide, and dipivefrin were used. Other beta blockers then appeared (betaxolol, levobunolol between 1985 and 1990, and the timolol-pilocarpine association between 1990 and 1995). After 1995, we saw the arrival of a new class of prostaglandin F2 alpha analogues, with latanoprost and other carbonic acid anhydrase inhibitors such as dorzolamide and brinzolamide. Conclusions: This study illustrates the great variety of glaucoma diagnostic subgroups and the use of surgery and drug therapies.

There are limited published data on the labelling of single unit dose packages in hospitals.The study was conducted in three large hospitals (two adult and one paediatric) in the metropolitan Montreal area, Quebec, Canada.The objective is to evaluate the labelling of commercial oral single solid unit dose packages available in Canadian urban hospital pharmacy practice.The study endpoint was the labelling conformity of each unit dose package for each criterion and overall for each manufacturer. Complete labelling of unit dose packages should include the following information: (1) brand name, (2) international non-proprietary name or generic name, (3) dosage, (4) pharmaceutical form, (5) manufacturer's name, (6) expiry date, (7) batch number and (8) drug identification number. We also evaluated the ease with which a single unit dose package is detached from a multiple unit dose package for quick, easy and safe use by pharmacy staff. Conformity levels were compared between brand-name and generic packages.A total of 124 different unit dose packages were evaluated. The level of conformity of each criterion varied between 19 and 50%. Only 43% of unit dose packages provided an easy-to-detach system for single doses. Among the 14 manufacturers with three or more unit dose packages evaluated, eight (57%) had a conformity level less than 50%.This study describes the conformity of commercial oral single solid unit dose packages in hospital pharmacy practice in Quebec. A large proportion of unit dose packages do not conform to a set of nine criteria set out in the guidelines of the American Society of Health-System Pharmacists and the Canadian Society of Hospital Pharmacists.

RESUME Deux enquetes, l’une menee au plan national (PediAD) l’autre a l’hopital mere-enfant Robert Debre (PediEM) ont montre les difficultes rencontrees par le personnel infirmier lors de l’administration des medicaments a l’enfant quelle que soit la voie, et le risque d’erreurs medicamenteuses induites. En realite l‘accident medicamenteux n’est pas limite a l’administration du medicament mais peut resulter du dysfonctionnement de n’importe quelle etape du circuit du medicament, impliquant medecins, pharmaciens et infirmiers. Il est avant tout lie, en hopital pediatrique, a la carence de specialites pediatriques. L’analyse recente du livret therapeutique de Robert Debre a montre que seul 1/3 des specialites en stock ont une AMM pediatrique sans aucune limite d’âge. Il s’avere que meme dans un hopital, comme Robert Debre, entierement informatise des l’ouverture (logiciel PCS®, Patient Care System), dans lequel la dispensation est en DJIN (journaliere, individuelle et nominative) mais non controlee, ou la quasi-totalite des besoins exprimes en preparations steriles ou non est couverte mais ou la validation n’est que tres partielle, le zero defaut est loin d’etre atteint. Deux evolutions sont en cours. L’automatisation de la dispensation est inscrite au plan 2006 ! Elle devrait, dans un contexte de penurie de preparateurs, securiser cette etape tout en assurant une tracabilite therapeutique et economique des medicaments. L’integration d’un pharmacien au sein d’une equipe medicale. Nous avons etudie son impact et l’avons compare a celui d’un pharmacien validant les ordonnances depuis la PUI. L’analyse exhaustive de cette experience est en cours, elle ouvre de nouvelles perspectives d’organisation ciblant les professionnels sur les tâches a forte valeur ajoutee et de nouvelles relations entre les acteurs de sante.

We report 6 pediatric cases of tuberculosis caused by Mycobacterium tuberculosis and treated them with levofloxacin or moxifloxacin in the mother-child unit of a university hospital in France between 2005 and 2011. We assess the clinical efficacy and safety of fluoroquinolones and the benefit-risk ratio for their use as second-line antituberculosis drugs in children and adolescents.

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.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.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.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.

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. Ma- terials and methods: This is a chart retrospec- tive observational study at the Robert-Debre teaching Hospital between January 2009 and December 2010. Data was collected about pa- tients (name, sex, weight, age) and prescribed treatments (indication, international nonpro- prietary names, dose, number of doses per day, administration route). Quality of collect- ed 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%), ofloxa- cin 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 dis- ease (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 in- dication. Doses were consistent with those for recommended indications.