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Introduction: Two off-label use of ketamine are framed by recommendations: in intractable pain in palliative situations or in postoperative pain. Ketamine is used in hospital but can also be used outside hospital with dispensations by hospital pharmacy to outpatients. Few data are available on ketamine use outside hospital. In this context, the French Addictovigilance Network has set up a study with hospital pharmacies., Materials and Methods: This survey assesses ketamine dispensations from 1 January to 30 April 2019, for patients who have an administration of ketamine outside hospital., Results: Sixty-five (65) hospital pharmacies have dispensed ketamine for 553 patients. Ketamine was indicated within non-palliative care in 86% of cases. Most of non-cancer pain were in fibromyalgia (44%) and neuropathic pain (29%). During the 4-month monitoring period, 1352 dispensations were analysed. The frequency of administration is daily in 91% of cases within palliative care whereas it is much more diverse within non-palliative care (33% daily, more than 15 different frequency in fibromyalgia). Within palliative care, ketamine is most administered intravenously or by Patient Controlled Analgesia or syringe pump (78% of cases) whereas in non-palliative care, ketamine is most used subcutaneously (44%), orally (32%) or both subcutaneously and orally (20%). A large number of ampoules could be dispensed (more than 30 ampoules for 10% of dispensations)., Conclusion: These data highlighted that recommendation in pain are not respected because most of ketamine is used within non-palliative care context and it should be noted a great heterogeneity of practice. This study underlines the urgency of targeted and clear information on certain off-label uses of ketamine for which no robust clinical studies are available and for which the risk of health complications like psychiatric (addiction), urologic and hepatologic complications is proven., (Copyright © 2022 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.)

Addictovigilance in the French Public Health Code, in the section related to poisonous substances, refers to a monitoring system developed since 1990: control of psychoactive substances and products, with medicinal use or not, was completed by a specific system focused on evaluation and information on pharmacodependance in 1999. The French medicines agency (Agence du médicament) created in 1993 was involved in this monitoring system; pharmacodependance evaluation was added by law to the missions of the agencies that followed: the Agence française de sécurité sanitaire des produits de santé missions (AFSSAPS, 1998) and the Agence nationale de sécurité du médicament et des produits de santé (ANSM, 2011). "Addictovigilance" first appears in French Law in 2017 whereas it was used by pharmacodependance centers and AFSSAPS since 2007. Legal definition of addictovigilance in the French Public Health Code testified to public authorities action against addictive behavior whatever products status, legal or not. The visibility of addictovigilance is growing on the Internet as well (ANSM website, web portal for reporting adverse health events)., (Copyright © 2018 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.)

The methods for causality assessment of adverse drug reactions were developed in the 1970s and 1980s, alongside the development of pharmacovigilance. The French method is one of the earlier of these, following on from the pioneering works by Irey and Karch and Lasagna. Initially published in 1978, it was updated in 1985, and again in 2011. The main alterations to the original method are presented in tables annexed to this paper. The successive versions improved the presentation, provided more formalised definitions of the criteria for assessing causality, while at the same time ensuring the method remained easy to use. Causality assessment enables the causal link between a drug and the occurrence of an adverse reaction to be formalised and explained. It contributes to diagnosis, and to determining the action to be taken in case of an adverse drug reaction. It can contribute to the quality and the relevance of the data stored in pharmacovigilance databases., (Copyright © 2016 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.)

Introduction: Acetazolamide is a carbonic anhydrase inhibitor used topically for local secondary treatment of posttraumatic or postoperative edema., Cases: Two women had contact dermatitis, secondarily extensive, after local cutaneous use of acetazolamide under a compression panty after liposuction. The eruption disappeared after acetazolamide was stopped and local treatment administered. Cutaneous tests were positive for acetazolamide., Discussion: Local allergic reactions are mentioned in the monograph on topical acetazolamide. Cases of contact dermatitis from this drug have not so far been published, but French adverse drug reaction reporting data include 10 other cases of eczema or rash at the application site. In one of these, a positive reaction was observed on readministration, and in 2 cases allergy skin tests were positive. The application of the drug under occlusion, which is contraindicated, may have contributed to spreading the lesions. Cases have also been described with another carbonic anhydrase inhibitor, dorzolamide, used in ophthalmology.

The prescription of antidepressants in the elderly has changed since the marketing of new antidepressants such as selective serotonin reuptake inhibitors (SSRIs). We analysed the adverse effects associated with antidepressants in subjects aged > or =75 years reported to the pharmacovigilance centres in France. Among the 2381 cases recorded between 1985 and 2001, the distribution of adverse effects may reflect sales figures: 1040 for SSRIs (44%), 586 for tricyclic and related antidepressants (25%), 46 for monoamine oxidase inhibitors (2%) and 654 for other antidepressants (27%). Adverse effect patterns differed according to antidepressant class. For SSRIs, hyponatraemia was predominant (30%), followed by psychiatric (13%) and nervous system (10%) effects. For tricyclic antidepressants, psychiatric effects (confusion, agitation) [21%] were the most frequent followed by cardiovascular effects (15%). However, the consequences of adverse effects such as hyponatraemia are far from negligible in the elderly.