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We described the safety profiles of all drug classes used for the treatment of advanced melanoma from the United States Food and Drug Administration Adverse Event Reporting System over the period 2008 to 2018. Adverse reactions reported in 25,900 pharmacovigilance cases were described for chemotherapies, immunomodulators, targeted therapies, and immunotherapies. There was a sharp increase in the number of cases over time, with peaks associated with the launch of new treatments. The adverse reactions diversified over time; notably, skin (alopecias, dermatitis) and retinal disorders were frequently associated with targeted therapies and endocrine disorders (hypothalamus, thyroid and adrenal dysfunctions) with immunotherapies. Less well-known reactions were also detected, such as neuropsychiatric disorders with targeted therapies and gastrointestinal ulcers, pneumothorax, and pleural effusions with immunotherapies. The findings highlight the need for various health professionals (including medical specialists or trained nurses) to enhance management of complications.

AIMS: Although medicine misuse is a public health issue, it has multiple meanings in the medical literature. This study aimed to characterize, classify and identify the most appropriate definitions of medicine misuse. METHODS: A systematic review was performed in Medline, ISI Web of Science, SocINDEX, PsycInfo, PsycArticles and Psychological and Behavioral Sciences Collection, using keywords related to "misuse", "appropriateness" and "medicine" between 1 November 2008 and 25 August 2020. Additional searches were conducted in websites of regulatory agencies and public health institutions. Two authors independently selected studies providing both definitions and examples of misuse, while a third resolved disagreements. Definitions were used to propose a hierarchical classification based on initiator, intent, purpose and context of medicine misuse. The study is registered on PROSPERO: CRD42018115789. RESULTS: Of 3404 identified records, 51 were included. A total of 71 definitions and 74 examples of misuse were retrieved. When the prescriber is initiator and according to intent, potential medicine misuse referred to "intentional or unintentional prescribing not in line with clinical evidence". Based on context, they could prescribe medicines not clinically justified, i.e. overprescribing, or prescribe indicated medicines incorrectly, i.e. misprescribing. Among other groups of definitions, those overlapping with drug abuse or medication use errors were considered out-of-scope. CONCLUSION: This systematic review provides a comprehensive overview of the terms and definitions used to characterize medicine misuse and could serve as a basis for a terminology that makes clear distinctions between misuse, abuse and errors.

Background Cognitive impairment is very common in late-life depression, principally affecting executive skills and information processing speed. The aim of the study was to examine the effect of antidepressant treatment on cognitive performances over a 10-year period. Methods The community-based cohort included 7381 participants aged 65 years and above. Five cognitive domains (verbal fluency, psychomotor speed, executive function, visuospatial skills and global cognition) were assessed up to five times over 10 years of follow-up. Treatment groups included participants under a specific antidepressant class at both baseline and the first follow-up and their follow-up cognitive data were considered until the last consecutive follow-up with a report of antidepressant use of the same class. Linear mixed models were used to compare baseline cognitive performance and cognitive decline over time according to antidepressant treatment. The models were adjusted for multiple confounders including residual depressive symptoms assessed by the Center for Epidemiologic Studies-Depression scale. Results At baseline, 4.0% of participants were taking antidepressants. Compared to non-users, tricyclic antidepressant users had lower baseline performances in verbal fluency, visual memory and psychomotor speed, and selective serotonin reuptake inhibitor users in verbal fluency and psychomotor speed. For the two other cognitive abilities, executive function and global cognition, no significant differences were found at baseline irrespective of the antidepressant class. Regarding changes over time, no significant differences were observed in comparison with non-users whatever the cognitive domain, except for a slight additional improvement over the follow-up in verbal fluency skills for tricyclic antidepressant users. Conclusions In this large elderly general population cohort, we found no evidence for an association between antidepressant use and post-treatment cognitive decline over 10 years of follow-up in various cognitive domains. Electronic supplementary material The online version of this article (doi:10.1186/s12916-017-0847-z) contains supplementary material, which is available to authorized users.

Potentially inappropriate prescriptions (PIPs) in the older population remain a growing public health concern due to the many associated adverse events increasing healthcare service use and health costs. This study aimed to assess the prevalence and direct costs of PIPs in older adults aged ≥65 years in France. A population-based cross-sectional study was conducted in 2017 using a representative sample of the French national healthcare reimbursement system database. PIPs were defined using the French REMEDI[e]S tool. Overall reimbursed direct costs and by PIP category were extrapolated to the French older population. The overall PIP prevalence was estimated at 56.7% (95% CI: 56.4–57.0). Medications with an unfavorable benefit/risk ratio had the highest prevalence (34.0%, 95% CI: 33.7–34.3). Direct costs associated with PIPs represented 6.3% of the total reimbursed medication costs in 2017 (€507 million). Drug duplications were the main contributors to these costs (39.2% of the total reimbursed PIP costs, €199 million) and among all PIPs, proton pump inhibitors (>8 weeks) were the most expensive PIPs (€152 million). PIP prevalence is still high among French older adults, with substantial direct costs. Large-scale interventions targeting the most prevalent and/or costly PIPs are needed to reduce their clinical and economic impacts.

Potentially inappropriate prescriptions (PIPs) in the older population remain a growing public health concern due to the many associated adverse events increasing healthcare service use and health costs. This study aimed to assess the prevalence and direct costs of PIPs in older adults aged ≥65 years in France. A population-based cross-sectional study was conducted in 2017 using a representative sample of the French national healthcare reimbursement system database. PIPs were defined using the French REMEDI[e]S tool. Overall reimbursed direct costs and by PIP category were extrapolated to the French older population. The overall PIP prevalence was estimated at 56.7% (95% CI: 56.4–57.0). Medications with an unfavorable benefit/risk ratio had the highest prevalence (34.0%, 95% CI: 33.7–34.3). Direct costs associated with PIPs represented 6.3% of the total reimbursed medication costs in 2017 (€507 million). Drug duplications were the main contributors to these costs (39.2% of the total reimbursed PIP costs, €199 million) and among all PIPs, proton pump inhibitors (>8 weeks) were the most expensive PIPs (€152 million). PIP prevalence is still high among French older adults, with substantial direct costs. Large-scale interventions targeting the most prevalent and/or costly PIPs are needed to reduce their clinical and economic impacts.