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Introduction: In October 2018, Canada legalized the nonmedical use of cannabis for adults. The aim of our study was to present a more recent temporal pattern of cannabis-related injuries and poisonings found in the electronic Canadian Hospitals Injury Reporting and Prevention Program (eCHIRPP) database and provide a descriptive summary of the injury characteristics of cannabis-related cases captured in a nine-year period., Methods: We conducted a search for cannabis-related cases in the eCHIRPP database reported between April 2011 and August 2019. The study population consisted of patients between the ages of 0 and 79 years presenting to the 19 selected emergency departments across Canada participating in the eCHIRPP program. We calculated descriptive estimates examining the intentionality, external cause, type and severity of cannabis-related cases to better understand the contextual factors of such cases. We also conducted time trend analyses using Joinpoint software establishing the directionality of cannabis-related cases over the years among both children and adults., Results: Between 1 April 2011, and 9 August, 2019, there were 2823 cannabis-related cases reported in eCHIRPP, representing 252.3 cases/100 000 eCHIRPP cases. Of the 2823 cannabis-related cases, a majority involved cannabis use in combination with one or more substances (63.1%; 1780 cases). There were 885 (31.3%) cases that involved only cannabis, and 158 cases (5.6%) that related to cannabis edibles. The leading external cause of injury among children and adults was poisoning. A large proportion of cannabis-related cases were unintentional in nature, and time trend analyses revealed that cannabis-related cases have recently been increasing among both children and adults. Overall, 15.1% of cases involved serious injuries requiring admission to hospital., Conclusion: Cannabis-related cases in the eCHIRPP database are relatively rate, a finding that may point to the fact that mental and behavioural disorders resulting from cannabis exposure are not generally captured in this surveillance system and the limited number of sites found across Canada. With Canada's recent amendments to cannabis regulations, ongoing surveillance of the health impacts of cannabis will be imperative to help advance evidence to protect the health of Canadians., Competing Interests: The authors have no conflicts of interest to declare.

Objectives: 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., Conclusion: 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., (Copyright © 2019 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.)

According to the Organization for Economic Co-operation and Development (OECD), drug expenditures account for about 20 % of all health expenditures in high-income countries. The increase of these drug expenditures which has been observed in all these countries over a long period is due to the combination of aging populations, changes in medical practices and the dynamics of the pharmaceutical market, in particular the hospital market. France is no exception. Its consumption of drugs (which accounted for 17.5 % of health expenditures in 2014), historically among the highest in volume, has grown slower in the last decade than in other OECD countries. However, the particularly rapid and wide adoption of pharmaceutical innovations, which has always characterized France, has had in recent years a very significant effect on the soaring drug expenditures covered by the social protection system (plus 1.1 billion in 2014, a year marked by the introduction of new therapies against hepatitis C). This significant effect should continue with the introduction of new and very expensive therapies, particularly in oncology., (© 2018 médecine/sciences – Inserm.)

In France, the Médiator(®) scandal and the trauma it has created, are the source of Law n° 2011-2012 of 29 December 2011 on strengthening safety of drug and health products, intended by the Ministry of Labour, Employment and Health, adopted by the National Assembly and promulgated in order to restore confidence and enhance safety of drug and health products. This new law affects all stakeholders and health professionals impacts key points in the life cycle of the drug: MA, reimbursement, advertising, promotion, distribution, prescription, dispensing, and pharmacovigilance. It also provides for financial, administrative or criminal penalties, which are intended deterrent. Beyond strengthening constraints on safety of health products, this new law in France foreshadowed a revolution in behaviour, attitudes and overall scenery of the health system and no one today knows exactly the outline., (© 2012 Société Française de Pharmacologie et de Thérapeutique.)

The relative added value of a drug is currently evaluated in France by the Transparency Commission (TC) of the National Health Authority (HAS), by assigning a level of Improvement in Actual Benefit (IAB). IAB is based on two parameters, efficacy and safety of the product, in a defined target population, either as compared to one or more other drugs with similar indications, or within therapeutic strategy. The items used for evaluation, including the level of clinical effect, the relevance of the comparator, the choice of comparison criteria and the methodology used (indirect comparison, non-inferiority studies, etc.), have been reviewed by the working group in Giens with regard to an analysis of the opinion on TC issued between 2004 and 2007 in several therapeutic areas First of all, this attempt at rationalisation based on the criteria used to assess the relative added value demonstrated the rareness of direct comparative data, and was followed by a discussion on the possible broadening of the evaluation criteria. The group discussed taking into account the Public Health Impact (PHI), which has now been incorporated into the assessment of Actual Benefit (AB). The group believes that PHI seems to be more related to the notion of IAB than to that of AB. Indeed, it is frequently the relative added value of a new drug that produces an impact in public health. Conversely, considering the comparative evaluation criteria of PHI, which are not systematically taken into account in IMSR (such as improvement in the health of the population, meeting a public health need or impact on the healthcare system), PHI could legitimately be included in the assessment of the relative added value of a drug. Other parameters such as compliance or impact on professional practice have been considered. Thus, the notion of relative added value, evaluated at initial registration, could be based on an expected improvement in medical service. The notion of expected medical service leads to the requirement of producing additional data in real life (post-registration studies), which would support the definitive notion of improvement in actual benefit at the time of renewed registration, while taking into account the place occupied by the drug in the therapeutic strategy.

The charter of medicines promotion recently adopted by France intends to constrain information given by sales representatives to the field of good prescription practices. Over a 11 year period (1994 to end 2004), 362 interdictions of promotional supports have been decided by the director of the French Medicines Agency. This accounts for 0.5% of the about 80 800 promotional supports controlled during this period. A date base shows the representation of the justifications of these interdictions and the predominance of documentation given or showed to the physicians. A challenge for health authorities would be to assess the actual impact of ethical and non ethical promotion.

In accordance with the Regulation N 2309/93/EC, the Commission shall produce a synopsis of European registration operating procedures no later than 2001. On July 18, 2001, after a wide open consultation, the College of Commissioners adopted a Proposed Revision elaborated by the "DG Enterprises". This Proposed Revision was guided by the desire to facilitate access of citizens of the European Union to innovating and safe medications, to limit fragmentation of the interior market, prejudicial to the community pharmaceutical industry, and to prepare widening of the community. This synopsis focused essentially on registration procedures and pharmacovigilance, on patient information, on reform of the European agency for administrative protection of recorded data. The Proposed Revision is following the codecision procedure and should come into force, in a more or less amended form, at the end of 2004 at the latest.

The pharmacokinetic content of the drug registration file is now well standardized. The objectives of the pharmacokinetic documentation is to provide evidence supporting the dosing regimen in patients, to take into account the pathophysiological states of the populations at risk and to anticipate drug-drug interactions. Recommendations on study design and evaluation of parameters of interest are listed in various documents Issued by the Committee for Proprietary Medicinal Products and the International conferences on Harmonization, i.e. the Concept Papers, the Points to Consider and Notes for Guidance. The pharmacokinetic data of the registration file are used to document many sections of the Summary of the Product Characteristics.

The participants attending the 1999 French Clinical Pharmacological meeting in Giens eventually reached a consensus about the necessity to set up a clear policy regarding self-medication products in France. Despite a wish by French people to take more responsibility for their own health care, self-medication products' use and development in France have been held back for many years for the reasons reported below. However, self-medication could be developed while respecting or even improving public health care by applying the following key principles: (1) the acknowledgement of a consensual definition. 'A self-medication drug is a drug (the guarantees for which are provided by marketing authorization approval and dispensation and advice of a pharmacist) specifically suitable for use without any physician's prescription'; (2) the advertising of self-medication products to the general public is authorized; (3) the safe use of self-medication products is linked to the selected indications and the relevance of the information provided to the general public; (4) the self-medication drug approval procedure could be simplified, managed by a specific AFSSAPS unit; (5) the role of the pharmacist involved, as well as suitable pharmacovigilance, is mentioned; (6) more than 1000 previously marketed drugs without any clear status, the so called 'grey zone drugs', should be taken into consideration. According to the participants at the meeting, it is possible to set up a new clear and dynamic policy for self-medication products in France in conformity with EU requirements.

Safety pharmacology, a discipline unrecognized until the last few years, is now the subject of Japanese, American, European and ICH draft guidelines. The aim of these guidelines, either of a general nature or targeted at one particular organ, is to define the necessary pharmacology studies as well as the conditions in which these studies must be performed to ensure the safe use of new molecules when they are administered to man. This presentation attempts to give a comparative analysis of these documents and to place them in the context of future international harmonization.

Directive 97/55/EC of October 6, 1997 has just amended Directive 84/450/EEC concerning misleading advertising in order for it to encompass comparative advertising. The purpose is to harmonize regulations regarding comparative advertising. Although the basic terms of this Directive are very similar to those imposed in France by the law of January 18, 1992, its transposition should, however, require changes to be made to French law.