Reform of early access program in France: impact on workload in a pharmacy and risk identification

Ann Pharm Fr. 2024 Feb 24:S0003-4509(24)00032-4. doi: 10.1016/j.pharma.2024.02.012. Online ahead of print.ABSTRACTThe reform of derogatory access authorisations (DAs) on 1st July 2021 has distorted the routine of the hospital pharmacists dealing with innovative medicines that are waiting for marketing authorization or approval. There are two distinct categories of DAs: Compassionate Access Authorisations (CAAs) are granted by the French National Agency for the Safety of Medicines (ANSM) while Early Access Authorisations (EAPs) are granted at the request of pharmaceutical companies by the French National Authority for Health (HAS). All AAPs and a majority of the AACs are supported by a Protocol for Therapeutic Use and Data Collection (PTU-DC). The aim of this study is to assess the impact of the reform on pharmacy process one year following its implementation, and to identify the risks related to the new circuits. The working group, composed of three pharmacists carried out an initial assessment of the effects first measured the impact of the reform on medicine processes in DAs. They performed a comparison of the changes in their management methods: 3 months prior to the reform (M0), and 3 months (M3) and 12 months (M12) post-reform. Risks analysis was conducted using the FMEA (Failure Modes, Effects and Criticality Analysis) method. The analysis was limited to the process steps specific related to DAs drugs were analyzed. The critical severity of the risk situations identifie...
Source: Annales Pharmaceutiques Francaises - Category: Drugs & Pharmacology Authors: Source Type: research