Antidepressants are highly prescribed in youth although most products have not been approved for use in this population. Furthermore, regulatory warnings have led to changes in antidepressant use that might have differed across various countries. Our study aimed at determining factors associated with antidepressant prescribing practices and at assessing trends in use from 1997 to 2005 in Quebec youth.A retrospective cohort study was conducted through claims databases of the Quebec public health care program (RAMQ). The study included 5094 children (age 2-14) and 11,121 adolescents (age 15-19) who were incident users of antidepressant between 1997 and 2005. The characteristics of users and prescribers were the main independent variables.Tricyclics were the most frequently dispensed products among children (50.9%) and selective serotonin reuptake inhibitors among adolescents (58.8%). Selection of an antidepressant class was associated with patient characteristics and with prescriber specialty. The number of antidepressant users increased from 1997 until 2001 then decreased thereafter.The selection of an antidepressant class was associated with clinical and non-clinical characteristics. Although antidepressant use decreased after regulatory warnings, there appears to be a care gap between the evidence generated by efficacy studies and the products prescribed in a real-life setting.
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http://dx.doi.org/10.1016/j.psychres.2010.06.007 | DOI Listing |
J Antimicrob Chemother
December 2024
Infection Science, North Bristol NHS Trust, Bristol, UK.
Introduction: Fluoroquinolones are important antibiotics but have associations with a number of adverse outcomes. A recent (January 2024) decision by the UK drug regulator, the Medicines and Health Regulatory Authority (MHRA), restricted systemic use of these antibiotics to when 'absolutely necessary'. One stated reason for the ban was the failure of previous guidance (2019, 2023) to reduce prescribing, with the MHRA stating there had been 'no change in prescribing' of fluoroquinolones in relation to guidance.
View Article and Find Full Text PDFJ Chem Phys
December 2024
Joint Research Centre on Medicine, the Affiliated Xiangshan Hospital of Wenzhou Medical University, Ningbo, Zhejiang 315700, People's Republic of China.
Drug Test Anal
December 2024
Service Medicines and Health Products, Scientific Direction of Chemical and Physical Health Risks, Sciensano, Brussels, Belgium.
A new nicotine delivery system in the form of tobacco-free nicotine pouches was introduced in Europe in 2019. These nicotine bags did not fall under the Tobacco Products Directive (TPD) II, which brought forward regulatory requirements for both cigarettes, related products, and e-liquids. As these pouches did not fall under the scope of the TPD, it was up to the member states to decide which action to be taken if any.
View Article and Find Full Text PDFNPJ Digit Med
December 2024
Center for AI and Data Science for Integrated Diagnostics, University of Pennsylvania, Philadelphia, PA, USA.
Current regulatory frameworks for artificial intelligence-based clinical decision support (AICDS) are insufficient to ensure safety, effectiveness, and equity at the bedside. The oversight of clinical laboratory testing, which requires federal- and hospital-level involvement, offers many instructive lessons for how to balance safety and innovation and warnings regarding the fragility of this balance. We propose an AICDS oversight framework, modeled after clinical laboratory regulation, that is deliberative, inclusive, and collaborative.
View Article and Find Full Text PDFClin Pharmacol Ther
December 2024
Department of Clinical Medicine (Pharmaceutical Medicine), Graduate School of Pharmaceutical Sciences, Kitasato University, Minato-ku, Japan.
Drug labels summarize essential safety information for healthcare professionals and patients. However, studies have reported a discordance of safety information in drug labeling among countries/regions. We aimed to identify the characteristics of adverse events associated with discordant safety warnings during the initial labeling of new drugs approved at approximately the same time in Japan, the United States, and the European Union.
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