Connaître les attentes des pharmaciens hospitaliers sur le livret thérapeutique dématérialisé. Enquête nationale par un questionnaire de 26 items. Il a été obtenu 248 réponses. Le livret thérapeutique dématérialisé « idéal » pour les pharmaciens devrait contenir : le nom commercial, la dénomination commune internationale (DCI), la classe ATC, le statut, le prix et les modalités de conservation. Les fonctionnalités suivantes devraient être présentes : un lien vers une base de données sur le médicament, un moteur de recherche des équivalences thérapeutiques, des liens vers les recommandations de bon usage, la possibilité de télécharger des formulaires et un module de génération de messages d’alerte. Notre travail est la première étude sur ce sujet. To evaluate the expectations of pharmacists on the online drug formulary. A national study by a 26-item questionnaire. Two hundred forty-eight responses were obtained. The online drug formulary must contains, for each medicinal product, the trade name, the international non-proprietary name (INN), the ATC class, the status, the price and the conditions of conservation. The following features should be present: a link to a drug database, a therapeutic equivalency search engine, links to recommendations for proper use, possibility of downloading forms and an alert message generation module. Our work is the first study on this subject.

Les entretiens pharmaceutiques ont été mis en place en France en 2013 suite à la signature de l’avenant no 1 de la convention nationale des pharmaciens signée en 2012. Ces entretiens doivent être menés dans un espace de confidentialité en pharmacie ou au domicile du patient. Cette démarche a pour objectif de diminuer la fréquence des effets indésirables des traitements médicaux (anti-vitamines K, anticoagulants oraux directs et corticoïdes inhalés) et d’améliorer l’utilisation pour garantir la sécurité du patient. Cette mission valorise également l’expertise du pharmacien qui est rémunérée par les caisses primaires d’assurance maladie à hauteur de 50 euros par an et par patient. L’étude effectuée, sur la base d’un sondage et d’entretiens individuels, a permis dans un premier temps de faire un état des lieux de la mission sur la totalité du calvados. Cette étape a permis de relever que les entretiens pharmaceutiques étaient proposés par 40 % des pharmacies seulement ; une forte tendance à la baisse a aussi été observée dans 85 % de ces officines depuis 2013. Cependant, 8 pharmaciens sur 10 ont reconnu un réel bénéfice des entretiens pharmaceutiques pour leurs patients. De nouvelles initiatives sont prises et des entretiens non conventionnés sont également de plus en plus effectués (tabac, suivi de grossesse, diabète…). Ces constats nous ont encouragés à rechercher les causes de la non-pratique des entretiens pharmaceutiques. Elles ont été identifiées, quantifiées, analysées et classées pour permettre de proposer des axes d’optimisation à la fois adaptés et réalisables financièrement à court, moyen et long terme. Neuf propositions concrètes ont été exposées selon trois axes principaux d’amélioration : la communication, la rémunération et l’organisation.In 2012, a National Agreement of Pharmacists was initiated in France and then amended in 2013 to introduce the “Pharmaceutical consultation”. These consultations must be conducted by the pharmacist with the patient in a confidential area in pharmacy or patient residence. The objective is to decrease the frequency of negative side effects of the medical treatments (anti-vitamins k, direct oral anticoagulants and inhaled corticoid) and to improve the correct use of medication therefore assure the safety of the patient. This initiative also recognizes the expertise of the pharmacists who are remunerated with 50 euros per year and per patient from Social Security. This publication is based on a survey conducted in the whole Calvados area and it is based on several individual interviews. It gives a clear picture about how effective the practice has been so far. It shows that the “Pharmaceutical consultation” is currently only proposed to patients by 40% of pharmacists in this area, additionally the practice decreased by 85% in the pharmacies since 2013. However, 8 on 10 pharmacists recognized a real benefit for patients who subscribed for consultation. Independently, the number of non-subsidized conversation initiatives carried out by pharmacists (anti-tobacco, pregnancy, diabetes) are increasing. This finding leads to the investigation of the causes for not practicing the “Pharmaceutical consultation”. The causes for not carrying out the consultations were identified, quantified, analysed and classified with a view to proposing short, medium and long time actions to optimize the “Pharmaceutical consultation” in a financially feasible manner. Nine practical proposals were identified and groups in three areas of improvement: communication, remuneration and organization.

Objective To study reconstitution and preparation dosing errors of liquid oral medications given by caregivers to children. Methods A prospective observational study was carried out in the departments of general paediatrics and emergency paediatrics at the Robert-Debré Children's University Hospital. An interview with caregivers involved (1) practical reconstitution and preparation of an oral liquid medication from a prescription drawn at random (amoxicillin (Clamoxyl, dosing spoon) or josamycin (Josacine, dose-weight pipette)) and (2) a questionnaire about their use. Results One hundred caregivers were included. Clamoxyl and Josacine were incorrectly reconstituted in 46% (23/50) and 56% (28/50) of cases, respectively, with a risk of underdosing of Clamoxyl (16/23) and overdosing of Josacine (23/28). Dose preparation with the dosing spoon was incorrect in 56% of cases, and in 10% of cases with the dose-weight pipette. Female sex, native French speaker, and age were significantly associated with correct reconstitution. Male sex and medication were significantly associated with correct preparation. Conclusions This study highlights the high incidence of errors made by caregivers in reconstituting and preparing doses of these liquid oral medicines, which are associated with considerable risks of over- and underdosing. Factors associated with these errors have been identified which could help health professionals to optimise their strategy for educating families about the use of liquid oral medications and the need to check that they understand these instructions.

The lack of drugs specifically assessed for paediatric use results in a widespread off-label drug use. The aim of this work is to identify experiences and attitudes towards paediatrics off-label prescribing in a university teaching paediatric hospital.A questionnaire of 24 items was sent by email to 409 paediatricians in February 2013.frequency of off-label prescribing, sources of information, concern about safety and adverse events with off-label drug use, proportion of parents informed and order with "off-label" mention.Eighty questionnaires were returned. Over 81% of responders were familiar with the concept of off-label drugs prescribing. The most common reason given for off-label prescribing was for a younger age (74%) and for another indication (28%). They (79%) used a colleague's opinion and the most important sources of information used were the literature (72%), international guidelines (62%), the French National Formulary Vidal (56%) and national guidelines (46%). Although 54% of responders expressed concerns about safety about off-label prescription, only 29% had observed adverse event with off-label drug use. Two third of respondents informed the parents but off-label prescribing cannot be always explained to family. Many respondents (81%) did not write "off-label" mention on prescription. However, 52% stated that they would be willing to undertake off-label prescription monitoring with a local observatory.Our study describes the perceptions and attitudes of paediatrician's regarding off-label prescribing for children. Patient information and documentation in the patient file remain incomplete. The prospective collection of off-label prescription will locally be performed.

INTRODUCTION:We developed a training program for pharmacy students aiming at supporting patients receiving vitamin K antagonists (VKAs). The objective was to estimate how the program impacts VKA-treated patient knowledge acquisition and/or improvement on their anticoagulant treatment.METHOD:Using dedicated tools, pharmacy students received education on VKA treatment. Once appointed to clinical wards of Assistance publique-Hôpitaux de Paris, they were in charge of evaluating patient's knowledge on VKA treatment before and after training. Evaluation was conducted using a face-to-face standardized interview (14-item questionnaire). A global score was calculated for each patient. An univariate and multivariate analysis was performed to identify potential variables influencing score result.RESULTS:One hundred and seventy VKA-treated patients were recruited in seven hospitals for evaluation of their knowledge on VKA treatment and on clinical at risk situations. Before intervention, patients obtained an average score of 12.3±3.2 (maximum: 18). Factors significantly associated with the score were possession of a VKA information booklet, VKA treatment duration, treatment initiation and age. Fifty-two patients with a low score were further trained by the pharmacy student. After intervention, their initial score was improved significantly, from 9.9±3.3 to 13.5±2.3 (P<0.0001).DISCUSSION AND CONCLUSION:Increasing patient knowledge is a way to decrease the rate of adverse effects. This study demonstrates that patients with primary poor knowledge improved it significantly thanks to pharmacy students' intervention. This may contribute to lower the VKA-associated risk of adverse events and consequently to the improvement of patients quality of life and healthcare expenditures.

Nous avons élaboré et déployé un programme « AVK Paris-Descartes » visant à former les étudiants en pharmacie 5AHU à l’accompagnement des patients traités par AVK en début d’année hospitalo-universitaire. L’objectif de notre étude a été d’évaluer l’impact du programme sur l’acquisition et/ou l’amélioration des connaissances des patients traités par AVK sur leur traitement anticoagulant. Les étudiants en pharmacie ont été formés à l’information des patients traités par AVK à l’aide d’outils spécifiques. Une fois habilité, l’étudiant était en mesure d’accompagner les patients traités par AVK dans leur service clinique d’affectation (Assistance publique–Hôpitaux de Paris). L’étudiant était chargé d’évaluer les connaissances des patients sur leur traitement à l’aide d’un questionnaire oral (14 items), puis calculait un score. En cas de connaissances insuffisantes, l’étudiant reprenait les points non acquis et répétait l’évaluation quelques jours plus tard. Un total de 170 patients a été recruté dans sept hôpitaux. L’évaluation des connaissances des patients avant intervention montre un score moyen de 12,3 ± 3,2 sur 18. Les variables significativement associées au score sont la détention d’un carnet AVK, la durée du traitement par AVK, l’instauration en cours d’hospitalisation et l’âge. Après intervention de l’étudiant auprès des patients dont les connaissances sont insuffisantes (n = 52), le score passe de 9,9 ± 3,3 à 13,5 ± 2,3 (p < 0,0001). Un étudiant en pharmacie formé à l’information des patients traités par AVK à l’aide d’un programme ciblé se révèle un professionnel adapté à l’amélioration de la connaissance des patients sur leur traitement, contribuant à minimiser la iatrogénie de ces médicaments. We developed a training program for pharmacy students aiming at supporting patients receiving vitamin K antagonists (VKAs). The objective was to estimate how the program impacts VKA-treated patient knowledge acquisition and/or improvement on their anticoagulant treatment. Using dedicated tools, pharmacy students received education on VKA treatment. Once appointed to clinical wards of Assistance publique–Hôpitaux de Paris, they were in charge of evaluating patient's knowledge on VKA treatment before and after training. Evaluation was conducted using a face-to-face standardized interview (14-item questionnaire). A global score was calculated for each patient. An univariate and multivariate analysis was performed to identify potential variables influencing score result. One hundred and seventy VKA-treated patients were recruited in seven hospitals for evaluation of their knowledge on VKA treatment and on clinical at risk situations. Before intervention, patients obtained an average score of 12.3 ± 3.2 (maximum: 18). Factors significantly associated with the score were possession of a VKA information booklet, VKA treatment duration, treatment initiation and age. Fifty-two patients with a low score were further trained by the pharmacy student. After intervention, their initial score was improved significantly, from 9.9 ± 3.3 to 13.5 ± 2.3 (P < 0.0001). Increasing patient knowledge is a way to decrease the rate of adverse effects. This study demonstrates that patients with primary poor knowledge improved it significantly thanks to pharmacy students’ intervention. This may contribute to lower the VKA-associated risk of adverse events and consequently to the improvement of patients quality of life and healthcare expenditures.

La pandémie due à SARS-CoV-2 est caractérisée par une haute contagiosité et une mortalité élevée chez les adultes à risque (âge supérieur à 65 ans, obésité, diabète, hypertension). Au décours d’une pneumonie virale, survient parfois une phase hyper-inflammatoire compliquée d’une défaillance multi-viscérale dont un Syndrome de Détresse Respiratoire Aiguë (SDRA). Contrairement à la majorité des virus respiratoires, les enfants apparaissent moins susceptibles à SARS-CoV-2 et développent généralement une forme peu sévère, avec une faible mortalité. Cependant, des cas groupés d’états de choc associés à des biomarqueurs cardiaques élevés et à une vasoplégie inhabituelle nécessitant un traitement par inotropes, vasopresseurs et un remplissage vasculaire ont été récemment décrits. Les symptômes cliniques observés (fièvre élevée et durable, troubles digestifs, rash cutané, injection conjonctivale, chéléite) et le profil biologique (CRP/PCT élevées, hyperferritinémie) évoquent un syndrome de Kawasaki atypique qui répond à un traitement par perfusion intraveineuse d’immunoglobulines complété si besoin par une corticothérapie et/ou une biothérapie anti-IL-1Ra ou anti-IL-6. La majorité des enfants guérit en quelques jours avec cependant une possible dilatation des artères coronaires. Ainsi, un nouveau syndrome inflammatoire multi-systémique associé à SARS-CoV-2 mimant un syndrome de Kawasaki a été récemment identifié chez l’enfant et aide à mieux comprendre la physiopathologie de ce syndrome d’étiologie restée jusqu’ici inconnue.SARS-CoV-2 pandemics is characterized by a high level of infectivity and a high mortality among adults at risk (older than 65 years, obesity, diabetes, systemic hypertension). Following a common viral pneumonia, a multisystem inflammatory syndrome sometimes occurs, including an Acute Respiratory Distress Syndrome (ARDS) carrying a high mortality. Unlike most common respiratory viruses, children seem less susceptible to SARS-CoV-2 infection and generally develop a mild disease with low mortality. However, clusters of severe shock associated with high levels of cardiac biomarkers and unusual vasoplegia requiring inotropes, vasopressors and volume loading have been recently described. Both clinical symptoms (i.e., high and persistent fever, gastrointestinal disorders, skin rash, conjunctivitis and dry cracked lips) and biological signs (e.g., elevated CRP/PCT, hyperferritinemia) resembled Kawasaki disease. In most instances, intravenous immunoglobin therapy improved the cardiac function and led to full recovery within a few days. However, adjunctive steroid therapy and sometimes biotherapy (e.g., anti-IL-1Ra, anti-IL-6 monoclonal antibodies) were often necessary. Although almost all children fully recovered within a week, some of them developed coronary artery dilation or aneurysm. Thus, a new ‘Multisystem Inflammatory Syndrome associated with SARS-CoV-2′ has been recently described in children and helps to better understand Kawasaki disease pathophysiology.

Background The role of a clinical pharmacist in providing and transmitting drug information to other health professionals varies greatly between countries. There is no consensus on the most efficient way to document and transmit interventions and its effect on the implementation of recommendations in practise. Purpose To describe and then compare the methodology of pharmacist’s interventions (PIs) in each of the following French-speaking countries: France, Switzerland, Belgium and Quebec. Materials and Methods 527 on-line questionnaires were distributed (276 in France, 47 in Switzerland, 92 in Belgium, and 112 in Quebec). They contained 36 questions about clinical pharmacy work, the ways of transmitting information and its documentation in the patient record. Results 160 hospitals answered (total 30.3%; France 33.7%, Switzerland 44.7%, Belgium 23.9%, Quebec 21.4%). In the Swiss hospitals, only 47.4% of pharmacists analysed pharmaceutical prescriptions while 97.4% did in France, 76.5% in Belgium and 100% in Quebec. The same trend could be seen while examining the pharmacist’s presence on the wards: 42.1% in Switzerland, 58.4% in France, 85.7% in Belgium and 88.2% in Quebec. Communications channels for PIs also differed depending on countries: Swiss pharmacists mainly used the phone (56.7% of the cases), followed by personal visits (30.7%). In France and Quebec the preferred methods were writing notes in the patient’s record in respectively 39.1% and 36.4% of the cases, followed by phone calls in 25.4% and 32.4%. In Belgium, the communication of PIs was most frequently done through personal visits (40%). Conclusions Pharmacist’s interventions in terms of ways of transmitting drug information and its documentation differ among the 4 countries. Differences in the pharmacist’s integration into the ward teams, access to the patient record file and to the medical prescription probably explain the heterogeneity of our results. No conflict of interest.

Background The Total Parenteral Nutrition (TPN) production facility of our children’s hospital produces around 20,000 units per year with 2 Baxa EM2400 compounders. In June 2012, a shortage of the calcium source (10% sterile solution of calcium gluconate in 500 mL bottles) occurred. To overcome this problem, we first tried to import an alternative source but the administrative delay was too long. The only sources available within a month were 10 mL plastic or glass ampoules. The estimated consumption was around 300 ampoules per production day. To maintain efficiency and safety in the TPN facility, it was decided to produce calcium gluconate bags from 10 mL ampoules by sterilising filtration to maintain the safety of preparation. Purpose To evaluate the additional cost incurred by setting up this production and the increased time required. Materials and Methods The pharmacy prepared calcium gluconate bags (250 mL) from plastic ampoules after filtration (0.22 µm philtres (Sterivex Millipore), using a Repeater Pump (Baxter), in a laminar air flow cabinet. The cost of setting up a new procedure and of the compounding was evaluated in different categories (materials, checking, staff). Results 228 bags were produced during the 20 days on which we could not obtain the 500 mL bottles (19 batches of 12 bags). The cost of one 250 mL compounded bag was €44.23 (materials: 25.5, checking: €5.73, staff: €13). In addition, developing the system cost €4,237.72. The overall additional cost was therefore €155.22/L. Conclusions Despite a major additional cost, compounding calcium gluconate bags has ensured the continued production of TPN. From a risk assessment point of view, identification of several suppliers and increasing our stocks of the raw materials would make out-of-stock situations easier to manage in future. No conflict of interest.

PURPOSE:The lack of drugs specifically assessed for paediatric use results in a widespread off-label drug use. The aim of this work is to identify experiences and attitudes towards paediatrics off-label prescribing in a university teaching paediatric hospital.METHODS:A questionnaire of 24 items was sent by email to 409 paediatricians in February 2013.DATA COLLECTED:frequency of off-label prescribing, sources of information, concern about safety and adverse events with off-label drug use, proportion of parents informed and order with "off-label" mention.RESULTS:Eighty questionnaires were returned. Over 81% of responders were familiar with the concept of off-label drugs prescribing. The most common reason given for off-label prescribing was for a younger age (74%) and for another indication (28%). They (79%) used a colleague's opinion and the most important sources of information used were the literature (72%), international guidelines (62%), the French National Formulary Vidal (56%) and national guidelines (46%). Although 54% of responders expressed concerns about safety about off-label prescription, only 29% had observed adverse event with off-label drug use. Two third of respondents informed the parents but off-label prescribing cannot be always explained to family. Many respondents (81%) did not write "off-label" mention on prescription. However, 52% stated that they would be willing to undertake off-label prescription monitoring with a local observatory.CONCLUSION:Our study describes the perceptions and attitudes of paediatrician's regarding off-label prescribing for children. Patient information and documentation in the patient file remain incomplete. The prospective collection of off-label prescription will locally be performed.

Background Lymphoma is one of the most frequent haemopathies among children and young adults. Anaplastic large cell lymphoma affects 15% of such children under 15 years old and 40% above 15 years old in France. Although the initial treatments are well codified and the efficacy of chemotherapy is well established in most patients, non-responses or relapses with these drugs are leading haemo-oncologists to look for new and effective therapeutic strategies. Thus, SGN35 or brentuximab vedotin is a monoclonal antibody drug conjugate (mADC). It combines an antibody that selectively targets CD30 expression in tumour cells and a cytotoxic drug derived from auristatin. This cell poison is delivered in situ and leads to apoptotic cell death. SGN35 activity is established in Hodgkin’s lymphoma and relapsed or refractory systemic anaplastic large-cell lymphomas that are CD30+. Purpose To report the use of brentuximab vedotin in a paediatric case study. Materials and Methods A literature search was undertaken about the use of brentuximab vedotin in paediatrics. The pharmacy undertook the administrative work to obtain the treatment for the patient. Results In July 2012, FDA licenced this ADC to treat CD30+ Hodgkin’s lymphoma and relapsed or refractory systemic anaplastic large-cell lymphoma in adults. It is currently awaiting conditional marketing authorization for adults in Europe. A Phase I/II study in paediatrics is at the moment recruiting. Brentuximab vedotin is administered every three weeks at 1.8 mg/kg (half-life ranges from 4 to 6 days and steady-state was achieved in 21 days for the ADC). Administration is possible in France, after the ANSM granted it temporary authorization on a named patient basis. An 8-year-old male child, with a diagnosis of anaplastic large-cell lymphoma, was treated according to the ALCL99 protocol. Two months after diagnosis the tumour grew under this first-line chemotherapy. A multidisciplinary group decided to start brentuximab vedotin treatment. A total of 5 courses spaced 3-weekly were scheduled combined with chemotherapy. Signs of the tumour disappeared, thorax imaging normalised, fever and pulmonary and mediastinum adenopathies decreased. Conclusions After the 4th dose of brentuximab vedotin, the treatment was well tolerated by the patient and the tumour regressed. Among adults, the median response is about 12 months. Thus, confirmation of efficacy still has to be evaluated. Further studies are required to establish the efficacy and safety profile in the paediatric population. No conflict of interest.

A188 Eur J Hosp Pharm 2013;20(Suppl 1):A1–A238 Purpose To evaluate the impact and quality of pharmaceutical interventions (PIs) issued over a period of 8 months. Materials and Methods All interventions are recorded and coded according to the criteria defined by the working group of the French Society of Clinical Pharmacy [1]. A note of the relevance is attributed by the pharmacist to each PI, according to Bayliff and Einarson’s scale [2]. Results In total, 1947 paper prescriptions were analysed. During this period, 980 patients were hospitalised, 133 (13.6%) were identified as having 209 PIs. Physicians accepted 168 interventions (80%), of which the pharmacist quantified the clinical relevance. A very significant clinical impact (level 2) was attributed to 36 PIs (21.5%), a significant clinical impact (level 1) to 77 (46%) and 54 PIs (32.5%) had an informative objective (level 0). No interventions had a vital clinical impact (level 3). For each level of relevance, the distribution of PIs was described according to the type of drug-related problems on the one hand and the type of pharmacists’ recommendations on the other hand. Highlighting the clinical impact of PIs increased the interest of physicians in pharmaceutical work. Consequently, they asked for pharmaceutical reports more frequently (twice a month instead of once a year). Conclusions The results reinforce the idea that a regular presence in care encourages collaboration between pharmacists and health care teams. References 1. Bedouch P, Charpiat B, Roubille R, et al, (2007). Site internet de la société française de pharmacie Clinique pour l’analyse des interventions pharmaceutiques: finalités, mode d’emploi et perspectives. J Pharm Clin 26(1), 40–4. 2. Bayliff CD, Einarson TR, (1990). Physician assessment of pharmacist’s intervention: a method of estimating cost avoidance and determining quality assurance. Can J Hospi Pharm 43(4), 167–7.