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Master Thesis

Management du circuit des produits de santé expérimentaux dans les pharmacies hospitalières : état des lieux au niveau national et proposition d'outils standardisés

Abstract : The management of investigational health products (IHPs), by hospital pharmacists, is a major part of conducting clinical trials (CTs). This work aims to draw up an inventory of the current situation in France, then to prioritise the development of standardised risk reduction tools, according to the needs of hospital pharmacies managing IHPs. A survey of 76 questions was disseminated for 2 months. 94 clinical research pharmacists participated, 88 of whom are interested in standardized tools. The score for the implementation of a quality approach depends on the type of health facility (p<0,0005) and increases with the number of active trials (p<0,0005), particularly in Cancer Centres and University Hospital Centres (documentation system, risk management, outpatient dispensing, staff training, monitoring-evaluation). All 9 proposed tools are useful for over 2/3 of pharmacists, but the development of self-assessment and traceability audit tools has been prioritised. Indeed, only 26% of the hospital pharmacies carry out a prior risk assessment and 14% carry out internal audits. The first round of proofreading of both grids, by 16 and 14 pharmacists respectively, led to a consensus on 86% (57/66) and 89% (67/75) of the criteria, which were considered relevant, clear and assessable. After this validation phase, the dissemination of these interactive and complementary tools will enable to identify the specific risks on the whole circuit in order to improve the management of IHPs by hospital pharmacies.
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Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-03073761
Contributor : Ufr Santé Unicaen <>
Submitted on : Wednesday, December 16, 2020 - 11:31:20 AM
Last modification on : Friday, January 29, 2021 - 12:51:18 PM
Long-term archiving on: : Wednesday, March 17, 2021 - 6:58:27 PM

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  • HAL Id : dumas-03073761, version 1

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Élodie Delavoipière. Management du circuit des produits de santé expérimentaux dans les pharmacies hospitalières : état des lieux au niveau national et proposition d'outils standardisés. Sciences pharmaceutiques. 2020. ⟨dumas-03073761⟩

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