A Guérin, C Tanguay, D Lebel, O Bourdon, JF Bussières.
CHU Sainte-Justine Pharmacy, Montreal, Canada; Hôpital Universitaire Robert-Debré, Pharmacy, Paris, France
Background Pharmacy practise is evolving in most countries. Hospital pharmacists are pivotal in the organisation and the support of clinical trials. We looked at the current state of pharmacy practise in
clinical research.
Purpose To identify differences in clinical research organisation and pharmacy practise between France and Quebec (Canada).
Materials and Methods This is a descriptive study. A literature review was performed in order to describe the organisation of clinical research and the role of pharmacists in clinical research for both countries. Differences were identifi ed by a panel consisting of one French pharmacy intern, one French hospital pharmacist, one Quebec research assistant and two Quebec hospital pharmacists.
Results Fourteen differences relating to research organisation were identifi ed. France and Canada have different normative frameworks, regulatory authorities, authorization processes, delays and shutdown processes. While it is encouraged, clinical trial registration is not mandatory in Canada. Data needs to be archived for 15 years in France vs. 25 years in Canada. Institutional review boards (IRB) have different names, location, composition, nomination processes, mandate duration and informed consent processes for minors. Seven key differences in pharmacy practise were identified. There are different authorization processes for drug compounding and manufacturing. Pharmacy fees are based on a national reference in France, but not in Canada. Software for the computerization of pharmacy services for clinical trials is common in France. In addition to drug trials, French pharmacists also manage sterile medical devices and medicinal products derived from human blood. Canadian pharmacists offer decentralised pharmaceutical care to hospitalised patients. Canadian pharmacists can be principal investigators if a doctor is the qualifi ed investigator.
Conclusions Clinical research organisation is similar on many aspects, but 21 main differences were identifi ed. Comparisons between countries help identify best practise and may contribute to practise improvement.
Reference: Eur J Hosp Pharm 2013;20(Suppl 1):A1–238
CHU Sainte-Justine Pharmacy, Montreal, Canada; Hôpital Universitaire Robert-Debré, Pharmacy, Paris, France
Background Pharmacy practise is evolving in most countries. Hospital pharmacists are pivotal in the organisation and the support of clinical trials. We looked at the current state of pharmacy practise in
clinical research.
Purpose To identify differences in clinical research organisation and pharmacy practise between France and Quebec (Canada).
Materials and Methods This is a descriptive study. A literature review was performed in order to describe the organisation of clinical research and the role of pharmacists in clinical research for both countries. Differences were identifi ed by a panel consisting of one French pharmacy intern, one French hospital pharmacist, one Quebec research assistant and two Quebec hospital pharmacists.
Results Fourteen differences relating to research organisation were identifi ed. France and Canada have different normative frameworks, regulatory authorities, authorization processes, delays and shutdown processes. While it is encouraged, clinical trial registration is not mandatory in Canada. Data needs to be archived for 15 years in France vs. 25 years in Canada. Institutional review boards (IRB) have different names, location, composition, nomination processes, mandate duration and informed consent processes for minors. Seven key differences in pharmacy practise were identified. There are different authorization processes for drug compounding and manufacturing. Pharmacy fees are based on a national reference in France, but not in Canada. Software for the computerization of pharmacy services for clinical trials is common in France. In addition to drug trials, French pharmacists also manage sterile medical devices and medicinal products derived from human blood. Canadian pharmacists offer decentralised pharmaceutical care to hospitalised patients. Canadian pharmacists can be principal investigators if a doctor is the qualifi ed investigator.
Conclusions Clinical research organisation is similar on many aspects, but 21 main differences were identifi ed. Comparisons between countries help identify best practise and may contribute to practise improvement.
Reference: Eur J Hosp Pharm 2013;20(Suppl 1):A1–238
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