[Therapeutic drug monitoring to optimize psychopharmacotherapy in children and adolescents - Update and guidelines for practice]. / Therapeutisches Drug Monitoring zur Optimierung der Psychopharmakotherapie von Kindern und Jugendlichen.

Therapeutic drug monitoring to optimize psychopharmacotherapy in children and adolescents - Update and guidelines for practice Abstract. Despite the improved evidence base, many uncertainties remain in child and adolescent psychiatric pharmacotherapy about the efficacy and tolerability of drugs, which are often prescribed off-label or in combination therapy in this age group. Because medium- to long-term use is unavoidable in many cases, clinicians should minimize adverse drug reactions as far as possible and tailor an effective dosage to the individual characteristics of the patient. Not only are children and adolescents particularly vulnerable to certain adverse drug effects, they are also exposed to iatrogenic risks from dosing or application errors, which can lead to under- or overdosing with correspondingly negative effects on the success of the therapy. In addition to determining a strict indication, it is therefore essential to establish precise dosage and systematic monitoring of the safety of the psychopharmacotherapy. This article introduces therapeutic drug monitoring as a useful clinical tool and describes how its correct application in practice can improve the efficacy as well as the safety and tolerability of psychotropic therapy in children and adolescents for the immediate benefit of patients. Keywords: Psychopharmacotherapy, adverse drug reactions, pharmacovigilance, therapeutic drug monitoring, quality assurance.

[Vigilance for veterinary medicinal products: Reports of adverse reactions in the year 2017]. / Vigilance der Tierarzneimittel: Gemeldete unerwünschte Wirkungen im Jahr 2017.

INTRODUCTION: A total of 306 reports of adverse reactions to veterinary medicinal products were received during the year 2017 representing an increase of 21% compared to the previous year. The majority of these reports described reactions concerning companion animals (180 dogs and 59 cats) as well as cattle (38 reports) and horses (14 reports). Most of the reported reactions were linked to the use of antiparasitics (158 reports), hormone products (30 reports) and anti-inflammatory products (25 reports). 40 reports were generated from consultations with Tox Info Suisse in Zürich and mainly involved the excessive intake of flavoured tablets and, in some cases, the use of products under the cascade regulation (applied to another species than that authorized). Nine signals were identified from the reports, resulting in revisions of the product information in the sections addressing contra-indications or adverse reactions.

INTRODUCTION: En 2017, 306 annonces d'effets indésirables de médicaments vétérinaires ont été enregistrées, ce qui constitue une augmentation de 21% par rapport à l'année précédente. Des réactions ont principalement été rapportées chez les petits animaux (180 chiens et 59 chats), ainsi que chez les bovins (38 annonces) et les chevaux (14 annonces). Les groupes de médicaments les plus souvent concernés étaient, comme les années précédentes, les antiparasitaires (158 annonces), les préparations hormonales (30 annonces) et les anti-inflammatoires (25 annonces). Quarante cas ont été transmis par Tox Info Suisse, Zürich, qui concernaient principalement l'absorption en surdose de médicaments vétérinaires aromatisés ainsi que quelques cas de reconversions. Sur la base de l'ensemble des annonces, neuf signaux ont été identifiés qui ont conduit à l'adaptation des informations sur les produits dans les rubriques «effets secondaires indésirables¼ ou «contre-indications¼.

[Polypharmacy of psychotropic drugs in child and adolescent psychiatry in Germany - rather the rule than the exception]. / Polypharmazie in der Anwendung von Psychopharmaka in der deutschen Kinder- und Jugendpsychiatrie ­ häufiger Regel als Ausnahme.

Polypharmacy of psychotropic drugs in child and adolescent psychiatry in Germany - rather the rule than the exception Abstract. Background: Polypharmacy increases the risk of interactions and enhances the chance of adverse drug reactions (ADRs). Hence, child and adolescent psychiatrists generally try to avoid polypharmacy with psychotropic drugs. However, only little data regarding the frequency of polypharmacy in child and adolescent psychiatry are available. This study analyzes clinical data on polypharmacy and the possible association with a higher risk of ADRs in Germany, with a focus on antidepressants and antipsychotics. Methods: We investigated a total of 940 datasets from descriptive studies on therapeutic drug monitoring (TDM) of pediatric patients treated with different psychotropic drugs. Results: The frequency of polypharmacy ranged up to 45.6 % (escitalopram) and 72.1 % (olanzapine). In 17.4 % of the cases, polypharmacy consisted of four or more psycho-/neuropharmacological substances. No increased incidence of ADRs was reported with polypharmacy of antipsychotics compared to monotherapy. Polypharmacy with sertraline was associated with a higher number of ADRs. Discussion and Conclusion: There is a high prevalence of polypharmacy with psychotropic drugs in child and adolescent psychiatry in Germany. Conclusions concerning individual drugs should be drawn with care since the subsample sizes were relatively small. However, our results do provide an indication of the prevalence of polypharmacy, although the validity of the data is limited. There is an urgent need to analyze data from larger and more homogeneous groups under more controlled conditions.

[Does methylphenidate cause liver damage? An analysis of ad hoc reports to the "Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)"]. / Induziert Methylphenidat Leberschäden? ­ Analyse von Spontanmeldungen an das Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM).

Does methylphenidate cause liver damage? An analysis of ad hoc reports to the "Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)" Abstract. Ad hoc reports to the "Bundesinstitut für Arzneimittel und Medizinprodukte" (BfArM, the German Federal Institute for Drugs and Medical Devices) were analyzed concerning liver injuring stemming from therapy with methylphenidate (MPH). Clinical criteria were used to assess suspected cases of causal association. The BfArM database on adverse drug reactions (ADRs) recorded suspected cases from Germany over the period from 1 January 2006 to 23 May 2016. Using the Standardized MedDRA Queries (SMQ) search strategy, we searched the database for "MPH" and its potential ADRs "Hepatic Disorder." The ad hoc reports were checked for completeness and assessed clinically according to the Uppsala Monitoring Centre criteria. 60 suspected cases of liver damages by MPH were recorded in the database. In 15 thereof, an assessment was not possible because of insufficient documentation; in 25 cases, a link between the intake of MPH and the occurrence of liver injury was considered "unlikely." A "possible" causality was assessed in 11 cases, a "probable/likely" causality in 9 cases: 1 patient with fulminant hepatitis, 1 with increased size of benign liver tumor, and 18 cases of (reversible) hepatic enzyme elevation. According to our evaluation, MPH is well-tolerated with regard to liver and gall bladder diseases. For patients with hepatic impairment or other risk factors, regular monitoring of liver values is recommended.

[Vaccinovigilance: Adverse reaction reports of animal vaccines in 2020]. / Vaccinovigilance: Gemeldete unerwünschte Arzneimittelwirkungen immuno­logischer Tierarzneimittel im Jahr 2020.

INTRODUCTION: The aim of the vigilance system in Switzerland is the evaluation and classification of reported suspected adverse reactions of immunological veterinary medicines (IVMP), including suspected lack of expected efficacy. The Institute of Virology and Immunology (IVI) is the competent authority for marketing authorizations of immunological veterinary medicinal products in Switzerland and responsible for the vaccinovigilance system. In 2020, 130 adverse reaction reports were received (5% less compared to 2019). The reports mainly concerned dogs (41%) and cats (25%) followed by cattle (18%) and horses (7%). Many of the reports in dogs involved the application of combined vaccines against canine distemper, hepatitis, parvovirosis and parainfluenza in combination with canine leptospira components, in cats against cat flu and feline panleukopenia in combination with feline leukaemia virus infection. Causality assessments were done according to the international ABON system. In 27% of the reported cases, the causality assessments between the vaccination and the reaction described were evaluated as being probable (ABON A), in 44% as possible (ABON B).

INTRODUCTION: L'objectif du système de vaccinovigilance en Suisse est l'évaluation et la classification des effets indésirables suspectés signalés en rapport à des médicaments vétérinaires immunologiques, y compris le manque présumé d'efficacité attendue. L'Institut de virologie et d'immunologie (IVI) est l'autorité compétente pour les autorisations de mise sur le marché des médicaments immunologiques vétérinaires en Suisse et est responsable du système de vaccinovigilance. En 2020, 130 déclarations d'effets indésirables ont été reçues (5% de moins par rapport à 2019). Les signalements concernaient principalement les chiens (41%) et les chats (25%) suivis des bovins (18%) et des chevaux (7%). Chez les chiens, ces annonces impliquaient principalement l'application de vaccins combinés contre la maladie de Carré, l'hépatite, la parvovirose et la parainfluenza en combinaison avec la leptospirose, chez les chats contre le coryza et la panleucopénie féline en association avec la leucose féline. Les évaluations de causalité ont été effectuées selon le système international ABON. Dans 27% des cas rapportés, les évaluations de causalité entre la vaccination et la réaction décrite ont été évaluées comme probables (ABON A), dans 44% comme possibles (ABON B).

[Vaccinovigilance: Reports of adverse reactions in the year 2019]. / Vaccinovigilance: Gemeldete unerwünschte Wirkungen immunologischer Tierarzneimittel im Jahr 2019.

INTRODUCTION: The registration of adverse events after the use of immunological veterinary medicinal products (IVMP) is the aim of the vigilance reporting system in Switzerland. Adverse events comprise suspected adverse reactions and lack of expected efficacy. Since the Institute of virology and immunology (IVI) is the competent authority for the regulation of immunological VMP in Switzerland, the reporting system is administrated by the IVI. In 2019, 137 reports concerning authorized immunological VMP were received (15% less compared to 2018). While most of the reports were submitted by the marketing authorization holders (56%), practicing veterinary surgeons contributed to the reporting system, too (40%). This corresponds to an increase of 22% of reported adverse events by the practicing veterinary surgeons compared to the previous year. Private persons (4%) submitted five reports. In comparison to 2018, in 2019 79% of the adverse events were reported by marketing authorization holders and 18% by veterinarians. Dogs (55%) and cats (20%) were mainly affected. Further reports were related to cattle (13%) and horses (5%). Recently, the numbers of reports concerning dogs (+12%) and cats (+4%) have considerably increased. Most of the reports were based on the application of vaccines against canine distemper, hepatitis, parvovirosis and parainfluenza in combination with leptospirosis in dogs as well as cat flu and feline panleukopenia in cats. In 34% of the submitted cases, the causality assessment between the vaccination and the reaction described was evaluated as probable.

INTRODUCTION: L'enregistrement des effets indésirables après utilisation de ­médicaments vétérinaires immunologiques est l'objectif du système de notification de vigilance en Suisse. Les effets indésirables comprennent les effets indésirables suspectés et le manque quant à l'efficacité attendue. L'Institut de virologie et d'immunologie (IVI) étant l'autorité compétente pour la réglementation des produits vétérinaires immunologiques en Suisse, le système de déclaration est administré par l'IVI. En 2019, 137 rapports concernant des produits vétérinaires immunologiques autorisées ont été reçus (15% de moins par rapport à 2018). Alors que la plupart des rapports ont été soumis par les titulaires de l'autorisation de mise sur le marché (56%), les vétérinaires en exercice ont également contribué au système de déclaration (40%). Cela correspond à une augmentation de 22% des effets indésirables rapportés par les vétérinaires en exercice par rapport à l'année précédente. Des particuliers (4%) ont soumis cinq rapports. Par rapport à 2018, en 2019, 79% des effets indésirables ont été signalés par les titulaires d'AMM et 18% par des vétérinaires. Les chiens (55%) et les chats (20%) ont été principalement concernés. D'autres rapports concernaient des bovins (13%) et des chevaux (5%). Récemment, le nombre de signalements concernant les chiens (+12%) et les chats (+4%) a considérablement augmenté. La plupart des rapports étaient basés sur l'application de vaccins contre la maladie de Carré, l'hépatite, la parvovirose et la parainfluenza en association avec la leptospirose chez le chien ainsi que contre la grippe et la panleucopénie féline chez le chat. Dans 34% des cas soumis, l'évaluation de la causalité entre la vaccination et la réaction décrite a été jugée probable.