Background and importance The management of investigational health products (IHPs) is a major part of conducting clinical trials (CTs). It presents specific risks all along the circuit, with data integrity and patient safety issues. However, few standardised tools are available, and no national inventory has been conducted in hospital pharmacies.
Aim and objectives The aim of this work was to make an inventory of the current situation in our country, and then to prioritise risk reduction standardised tools to develop.
Material and methods A national survey was developed by a regional working group including four clinical research pharmacists (CRPs), a coordinating pharmacist and a pharmacy resident. The 76 questions dealt with the quality approach and the proposal of new tools. The online anonymous survey was emailed to CRPs in health facilities and activated for 2 months.
Results 94 pharmacists participated, allowing a response rate of 70%: 35 non-university hospitals, 25 university hospital centres, 12 private clinics, 11 cancer centres, 10 not-for-profit private hospitals and 1 academic cancer institute. The results regarding the features of quality approach were: documentation system (76/94), adverse drug event reporting system (77/94), prior risk assessment (24/94), training and empowering staff (42/94), using means of evaluation and monitoring (49/94, including 13 conducting internal audits) and ISO 9001 certification (10/94). All of these features were synthesised into an overall score: from I (basic quality approach) to IV (ISO certification). Score II was the most frequent (38/94). The score depends on the type of health facility (p<0.0005) and increases with the number of active CTs (p<0.0005). 88/94 pharmacists were interested in standardised tools. All nine proposed tools were useful for over two-thirds of pharmacists. Two tools with the highest utility scores were self-assessment (p<0.001) and the internal audit grids.
Conclusion and relevance All types of facilities conducting CTs were represented and the response rate suggested an overall interest in this topic of management of IHPs. The quality approach was heterogeneous in hospital pharmacies and depended on the level of activity. The needs identified justify prioritising the self-assessment and traceability audit tools which are being validated for dissemination. Such tools will help to harmonise practices in hospital pharmacies by identifying the specific risks and improving the circuit for IHPs.
Conflict of interest No conflict of interest
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