[Advanced therapy medicinal products' (ATMP) pharmaceutical circuit in France: Current situation and outlook]

Abstract

Objectives: Advanced therapy medicinal products' reconstitution is an innovative pharmaceutical activity. The purpose of this work is to evaluate the current situation in France within hospital pharmacies.

Methods: An electronic questionnaire (90 questions) was sent to previously identified French pharmaceutical teams exploring advanced therapy medicinal products' reconstitution process in its various aspects.

Results: Thirty-eight pharmacists completed the survey. The ATMPs reconstitution is very largely carried out by pharmaceutical teams in charge of other activities, even if dedicated teams are beginning to appear. Gene therapy represents majority among advanced therapy medicinal products. The premises are very often shared, especially the controlled atmosphere areas. These vary greatly in nature, as do facilities used. The ultra-low temperature storage is most frequently used and the nitrogen equipment of hospital pharmacies is yet observed and tends to expand. Simple reconstitution processes (thawing, dilution) are mostly carried out in hospital pharmacies. The traceability still largely relies on different software and/or the use of paper formats. The reconstitution process needs devoted pharmaceutical time according to the active queues, sometimes exceeding 200 patients per year.

Findings: If the hospital pharmacists is going to take charge of this activity on a constant basis, the regulatory context and the increase in active queues will require a real investment plan from the public authorities in this activity to effectively implement ATMPs reconstitution to the greatest benefit of patients.

Keywords: Advanced therapy medicinal products; Current situation; France; Médicaments de thérapie innovante; Reconstitution; État des lieux.