OBJECTIVE: The objective was to identify the main texts applicable to the practice of pharmacy in Quebec, then count the specific number of recommendations and criteria and describe the evolution of the legal and normative framework.
METHODS: This is a descriptive and retrospective study of the main texts applicable to the legal and normative framework for the practice of pharmacy on January 1st, 2019.
RESULTS: A total of 107 texts relating to the practice of pharmacy in Quebec were identified. They come from the legislator (53.1 %), the Order of pharmacists (26.1 %) or other organizations (20.8 %). These were laws/regulations (n=59), contributing to the optimal use of drugs (n=18), relating to hospital pharmacy management (n=18), the provision of pharmaceutical care (n=11), drug preparation (n=3), oncology practice (n=2) or health and safety at work (n=1). Thirty-three texts were considered for enumeration of recommendations and explicit criteria, for a total of 235 recommendations and 3703 explicit criteria applicable to the practice of hospital pharmacy in Quebec.
CONCLUSIONS: There is a significant increase in the number of texts, recommendations and criteria applicable to the practice of hospital pharmacy in Quebec. Compliance with this legal and normative framework appears to be a considerable challenge for hospital pharmacists. It seems worthwhile to further promote discussion with text-issuing agencies in order to keep the search for compliance realistic.

Modern pharmacovigilance began in the 1960s, since when the subject has grown markedly, interest having particularly increased since 2010. One index of its success is the increasing speed with which serious adverse drug reactions are discovered after marketing of a medicinal product. However, the speed with which products have subsequently been withdrawn as a result of the discovery of serious adverse reactions has not consistently changed. This highlights problems that regulators and manufacturers face when serious reactions are discovered, with difficulties in deciding which of several consequent actions to take: to add specific warnings (cautions) or contraindications to the product label; to issue a Direct Healthcare Professional Communication; to allow informed patients to decide whether they will take the drug; or, in the most serious cases, to withdraw the product or revoke the licence. Conflicts of interest may inhibit decision-making. Recommendations that arise from these observations are that: health professionals and patients should be more vigorously encouraged to report suspected adverse drug reactions; regulatory authorities and drug manufacturers should take quicker confirmatory action when serious suspected adverse drug reactions are reported, even anecdotally, with formal studies to test for causality conducted sooner rather than later, applying lower than usual thresholds for suspicion; temporary suspensions or restrictions could be considered during such assessments; universal guidelines are needed for determining when a drug should be withdrawn if serious adverse drug reactions are suspected; there should be more rigorous monitoring and verification of deaths and reporting of reasons for drop-outs during clinical trials, with more transparency in reporting adverse events and ready access to premarketing clinical study reports; post-marketing drug monitoring systems and medicines regulation in low-to-middle income economies, especially in Africa, where withdrawals are fewer than elsewhere, should be strengthened.