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Interets Et Limites De La Substitution Par Des Seringues Pre-Remplies (S2p) Des Ampoules Et Flacons

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Interets Et Limites De La Substitution Par Des Seringues Pre-Remplies (S2p) Des Ampoules Et Flacons http://portaildoc.univ-lyon1.fr Creative commons : Paternité - Pas d’Utilisation Commerciale - Pas de Modification 2.0 France (CC BY-NC-ND 2.0) http://creativecommons.org/licenses/by-nc-nd/2.0/fr GLEIZE (CC BY-NC-ND 2.0) UNIVERSITE CLAUDE BERNARD – LYON 1 FACULTE DE PHARMACIE INSTITUT DES SCIENCES PHARMACEUTIQUES ET BIOLOGIQES 2016 THESE n°79 T H E S E pour le DIPLOME D'ETAT DE DOCTEUR EN PHARMACIE présentée et soutenue publiquement le 21 juillet 2016 par M. GLEIZE Jean-Cédric Né le 13 janvier 1989 A Lyon ***** INTERETS ET LIMITES DE LA SUBSTITUTION PAR DES SERINGUES PRE-REMPLIES (S2P) DES AMPOULES ET FLACONS ADVANTAGES AND LIMITS OF THE VIAL TO PREFILL (V2P) STRATEGY ***** JURY M. HARTMANN Daniel, Professeur Mme. SCHWARZENBACH Florence, Docteur en pharmacie Mme. CORNU Catherine, Praticien Hospitalier GLEIZE (CC BY-NC-ND 2.0) 1 GLEIZE (CC BY-NC-ND 2.0) 2 GLEIZE (CC BY-NC-ND 2.0) 3 GLEIZE (CC BY-NC-ND 2.0) 4 GLEIZE (CC BY-NC-ND 2.0) 5 GLEIZE (CC BY-NC-ND 2.0) REMERCIEMENTS À la directrice de cette thèse, le Dr. Florence Schwarzenbach, pour m’avoir accueilli dans son équipe et dans la grande entreprise internationale qu’est BD. Merci d’avoir accepté d’encadrer mon travail de thèse d’exercice. Merci pour la confiance que tu m’as accordé et pour tous tes précieux conseils, suggestions et anecdotes professionnelles. Au Pr. Daniel Hartmann pour m’avoir fait l’honneur de présider le jury de cette thèse. Merci pour l’intérêt que vous avez porté à mes travaux, pour votre aide et votre confiance. Au Dr. Catherine Cornu de m’avoir fait l’honneur de faire partie du jury de cette thèse. J’espère que vous serez captivé par ce manuscrit qui marque la fin de mes études de pharmacie ainsi que le prolongement de mon master Eudipharm. À mes collaborateurs de BD, à Grenoble ou à Franklin Lakes, en particuliers à Orchidée Filipe Santos, Sophia Li et Steven Ren sans qui ces travaux n’auraient pas aboutis, mais également à tous les membres des Affaires Médicales et des Affaires Réglementaires pour leur bonne humeur et leur gentillesse. Au Dr Catherine Leger et à Muriel avec qui j’ai travaillé et évolué pendant deux ans de mes études à la Pharmacie Saint-Louis. Aux membres du CRCL pour leur aide, leurs conseils et leur bonne humeur. 6 GLEIZE (CC BY-NC-ND 2.0) Aux membres de PLH avec qui j’ai commencé ma vie associative et humanitaire de la plus belle manière. Aux anciens et aux nouveaux d’XLR Events, fruit de l’amour d’une poignée de futurs pharmaciens pour la musique électronique. À tous mes camarades de pharmacie, du master Eudipharm et du master GBCP mais également de médecine et d’odontologie. Je ne pourrais pas tous vous citer tellement j’ai eu la chance de faire tant de belles rencontres pendant ces neufs années d’études ! À tous ceux que j’espère recroiser le plus souvent possible et à ceux que je continuerai à fréquenter, je l’espère, toute ma vie. J’en place également une spéciale pour mes amis depuis bientôt 15 ans. À ma famille et en particulier mes parents qui m’ont façonné et qui m’ont permis de devenir l‘homme que je suis aujourd’hui. Merci d’avoir fait en sorte que je ne manque de rien et merci de m’avoir soutenu et poussé pendant toutes ces années et jusqu’à l’achèvement de cette thèse. À ma sœur qui a finalement fini ses études quelques semaines avant moi… Merci d’avance pour toutes les saveurs que tu me feras découvrir. Enfin, à Marion. Quel que soit mon futur parcours professionnel, t’avoir rencontré restera la plus belle raison pour moi d’avoir fait des études de pharmacie. Merci pour 7 GLEIZE (CC BY-NC-ND 2.0) l’amour que tu me portes chaque jour ainsi que pour ton soutien sans faille, notamment pendant la rédaction de cette thèse. 8 GLEIZE (CC BY-NC-ND 2.0) 9 GLEIZE (CC BY-NC-ND 2.0) TABLE DES MATIERES REMERCIEMENTS ........................................................................................................ 6 TABLE DES MATIERES ............................................................................................... 10 LISTE DES FIGURES .................................................................................................... 12 LISTE DES TABLEAUX ................................................................................................. 13 LISTE DES ABRÉVIATIONS ......................................................................................... 14 1. INTRODUCTION ........................................................................................... 16 2. CLINICAL AND INDUSTRIAL CONTEXT ......................................................... 22 2.1. INDUSTRIAL CONTEXT ................................................................................. 22 2.1.1. Expected impacts of V2P ................................................................. 23 2.1.1.1. For BD ........................................................................................ 23 2.1.1.2. For pharmaceutical laboratories .............................................. 24 2.1.1.3. For the buyers ........................................................................... 26 2.1.1.4. For the users.............................................................................. 27 2.1.1.5. For the patients ......................................................................... 28 2.2. INJECTION ................................................................................................. 29 2.2.1. The different routes of injection ..................................................... 30 2.2.2. The different injectable formulations.............................................. 34 2.2.3. The different injecting users ............................................................ 36 2.2.4. The different injection devices and packaging ................................ 37 10 GLEIZE (CC BY-NC-ND 2.0) 2.2.5. Regulatory considerations for prefilled syringes ............................. 42 3. METHODS .................................................................................................... 45 4. RESULTS ...................................................................................................... 47 4.1. SELECTED STUDIES .................................................................................... 47 4.2. SAFETY ASPECTS ........................................................................................ 52 4.2.1. Contaminations ................................................................................ 52 4.2.1.1. Micro-organisms ....................................................................... 52 4.2.1.2. Particles ..................................................................................... 59 4.2.2. Medical errors .................................................................................. 64 4.2.3. Needle-stick injuries ........................................................................ 71 4.2.4. Other safety considerations ............................................................ 73 4.3. EFFICACY .................................................................................................. 74 4.4 WORKFLOW .................................................................................................. 76 4.5. HEALTH ECONOMICS ..................................................................................... 78 4.5.1. Costs of medical errors ....................................................................... 78 4.5.2. Comprehensive unit price .................................................................. 81 5. DISCUSSION ................................................................................................. 88 6. CONCLUSION ............................................................................................... 91 BIBLIOGRAPHIE ......................................................................................................... 95 ANNEXE I: ETUDES INCLUES DANS LA META-ANALYSE .......................................... 105 11 GLEIZE (CC BY-NC-ND 2.0) LISTE DES FIGURES Figure 1: Photo d’une Syrette ................................................................................... 18 Figure 2: Photo du Tubex.......................................................................................... 19 Figure 3: The different players of the injection process. ......................................... 23 Figure 4: Example of dead space showing in red the remaining fluid after complete depression of the plunger. Bobashev, 2010. ........................................................................ 26 Figure 5: BD Uniject prefillable syringe components ............................................... 41 Figure 6: Meta-analysis study selection flowchart. .................................................. 48 Figure 7: Review study selection flowchart. ............................................................. 49 Figure 8: Meta-analysis quality assessment summary (Cochrane Collaboration’s tool for assessing risk of bias). ..................................................................................................... 51 Figure 9. Identification of glass particles in intravenous infusions by Scanning Electron Microscopy Coupled to Energy Dispersion Spectroscopy, Yorioka 2006. ............. 60 Figure 10: SEM images of vials and PFS after exposure to PH 11 gutaric acid at 40°C/75% relative humidity for 3 months. Zhao 2014. ........................................................ 63 Figure 11: Forrest plot comparing dose consistency. .............................................. 68 Figure 12: Ishikawa’s diagram illustrating
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