[Evaluation of pharmaceutical practice in hospitals: An exploratory study comparing processes in France and Quebec]. / Évaluation de la pratique pharmaceutique en établissement de santé : une étude exploratoire comparant les processus en France et au Québec.

CONTEXT: To ensure compliance with the legal and normative framework, the professional orders, which supervise the practice of pharmacy have established a professional inspection process. In addition to this process, other external organizations also require an accreditation, authorization, certification or validation process for professional practices. OBJECTIVE: The main objective is to identify and compare the methods of evaluating pharmaceutical practice in hospitals in France and Quebec. RESULTS: In order to identify and compare the methods of evaluating pharmaceutical practice in hospitals in France and Quebec, our approach allowed us to identify more organizations in France (i.e., High Authority of Health, Regional Health Agencies, the National Order of Pharmacists, the Nuclear Safety Agency, the Biomedicine Agency and the National Agency for the Safety of Medicines and Health Products) than in Quebec (i.e., Accreditation Canada, Ordre des pharmaciens du Québec and Health Canada). The study highlights the legal framework and applicable standards, the surveyors, the evaluation methods and the particularities for the evaluation of the hospital, the pharmacy department and the members of the department. CONCLUSIONS: This study highlights the evaluation processes of pharmaceutical practice in hospitals. In France, as in Quebec, we recognize the importance of the drug circuit in the hospital, the development and operation of a pharmacy department and the practice of pharmacy. While there are more similarities for the assessment of the drug circuit in hospitals and pharmacy department, important differences are observed for the assessment of individuals. We believe that the publication of a comparative analysis can contribute to discussions and exchanges to benefit from the best practices of each country.

Biosimilars, generic versions of the first generation of therapeutic proteins: do they exist?

This contribution describes the present regulatory status in the EU of biosimilars, the generic versions of the first generation of therapeutic proteins. It points out why and where recombinant protein molecules and low-molecular-weight drugs differ in their behaviour and why biosimilars should be handled differently than generic low-molecular-weight drugs. This information is important for practitioners (pharmacists and physicians) while selecting the best supplier of a therapeutic protein.