[Monitoring the safety of drugs and COVID-19 vaccines by the French Pharmacovigilance Centers during the pandemic: a win-win bet with Health Authorities!] / Pharmacovigilance des médicaments et des vaccins contre la COVID-19 durant la pandémie : comment le Réseau français des centres régionaux de pharmacovigilance a relevé le défi ?

The pandemic subsequent to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus resulted, for the French institutional pharmacovigilance, in a "health crisis" in 2 phases: the coronavirus disease 2019 - "COVID-19" phase during which the missions of the Regional Pharmacovigilance Centres (RPVC) were to detect a possible impact of drugs on this disease, as whether existed a possible aggravating role of certain drugs, or the safety profile of drugs used for the management of COVID-19 could evolve. The second phase followed the availability of COVID-19 vaccines, during which the RPVCs' missions were to detect as early as possible any new serious adverse effect, source of a potential signal that would modify the benefit/risk ratio of a vaccine and require the implementation of health safety measures. During these two periods, signal detection remained the core business of the RPVCs. The RPVCs had to organize themselves to handle an historical surge of declarations and requests for advice, whereas the RPVCs in charge of monitoring vaccines had to deal with an extraordinary dense activity over a long period of time, in order to produce in real time and on a weekly basis, a summary of all the declarations and an analysis of safety signals. The national organization put in place made it possible to meet the challenge of real-time pharmacovigilance monitoring of 4 vaccines with conditional marketing authorizations. Short-circuit efficient exchanges with the French Regional Pharmacovigilance Centres Network was paramount for the French National Agency for medicines and health products (Agence nationale de sécurité du médicament et des produits de santé) to develop an optimal collaborative partnership. The RPVC network has shown agility and flexibility, has been able to adapt swiftly and demonstrated its effectiveness in the early detection of safety signals. This crisis confirmed the superiority of manual/human signal detection as the most effective and powerful tool to date, to rapidly detect a new adverse drug reaction and enable to elaborate rapid measures of risk reduction. In order to maintain the performance of French RPVCs in signal detection and to monitor all drugs as they should and as expected by our fellow citizens, a new funding model correcting the inadequacy of RPVCs' expertise resources in relation to the volume of reports should be considered.

Improving safety of preparation and administration of medicines and enteral nutrition in a neonatal care unit: Global risk analysis.

OBJECTIVE: To date, few adapted pharmaceutical forms are available for infants leading to multiple steps of preparation and medicines dilution before administration. The main purpose of this study was to assess the risks on the steps of preparation and administration of medicines in a neonatal care unit and to propose corrective actions to ensure the medicines safety. METHODS: A global risk analysis was performed, conducted by a multidisciplinary working group of 9 experts, that is 9 meetings. RESULTS: We identified 57 scenarios: 59,6% of scenarios had an initial criticality C1, 31,6% C2 and 8,8% C3. The most risky phases were phases of needs identification including the step of doses calculation and phases of preparation. The strategic management together with the human factor were the most risky dangers. Nineteen corrective actions were proposed. After implementing those actions, 82,5% of scenarios had residual criticality C1, 17,5% C2 and no scenario had residual criticality C3. Follow-up actions have been implemented to control the residual risk as in service training. CONCLUSION: Neonatal unit care is a risky service and should be a priority in the risk management policy. This analysis joins the quality policy implemented in the hospital and similar risk analysis is on process.

[Interventions and treatments of farm animals by non-veterinarians: quo vadis?] / Eingriffe und Behandlungen von Nutz­tieren durch Nicht-Tierärzte: quo vadis?

INTRODUCTION: The increasing professionalization and the cost pressure on farms combined with a decreasing availability of veterinary expertise procures the demand for treatments and interventions performed by non-veterinarians. A current survey resulting in 56 responses of food animal practitioners showed that a majority delivered pour-on anthelmintics, drugs for oral application and ointments after respective instruction to farmers. Udder injectors, antimicrobials and vaccines were handled more restrictively, but even hormones were committed by more than half of the veterinarians to livestock owners. In respect to interventions, most practitioners supported that farmers perform functional foot trimming, administration of boli, inseminations, dehorning and castrations of calves. By contrast, many veterinarians refused that farmers apply intravenous injections, insert a trocar or treat sole ulcers. In respect to the future development, implications of non-veterinarian interventions on animal welfare, consumer protection and drug safety have to be considered. Indispensable are qualification and skills of the person performing interventions which can be acquired by certificated training courses. Moreover, a basic conception and taking responsibility in particular for application of veterinary drugs is mandatory - in this respect, at present marked deficits exist among many farmers. Based on the current legal situation, several interventions can be delegated to non-veterinarians, but the technical responsibility for the proper implementation is due to the veterinarian. This includes an evaluation of interventions and treatments on a regular basis together with the farmer. On this basis, the assessment of clinical symptoms as well as the initial treatment can be useful and appropriate to ensure a rapid therapy especially in animals suffering from factorial diseases. Having in mind profound differences in respect to the competence of non-veterinarians, general procedures to deliver drugs and to delegate interventions have to be rejected. Advanced diagnostic procedures and the prescription of veterinary drugs remain an exclusive mission of the veterinarian.

INTRODUCTION: La professionnalisation progressive et la pression des coûts sur les exploitations agricoles, combinées à une disponibilité d'expertise vétérinaire décroissante au moins au niveau régional, font que de plus en plus de traitements et d'interventions sur le bétail peuvent être effectués par des non-vétérinaires. Une enquête récente portant sur les réponses de 56 cabinets pour animaux de rente a révélé que la plupart d'entre eux remettent des anthelminthiques pour-on, des médicaments à administrer par voie orale et des onguents aux propriétaires d'animaux. On est plus restrictif avec les injecteurs intra-mammaires, les antibiotiques et les vaccins, mais même des hormones sont remises aux agriculteurs après instruction par plus de la moitié des vétérinaires. En termes d'interventions, la majorité des praticiens soutiennent la réalisation de soins fonctionnels des onglons, l'administration de boli, l'écornage des veaux, la castration et l'insémination par des non-vétérinaires. En revanche, la plupart des praticiens considèrent que les injections intraveineuses, la mise en place d'un trocart et le traitement d'un ulcère de la sole doivent être effectués par des vétérinaires. En ce qui concerne l'évolution future, il est important de prendre en compte les implications pour le bien-être des animaux, la protection des consommateurs et la sécurité en matière de médicaments. Il est essentiel que l'exécutant ait la compétence nécessaire ainsi que la capacité de prouver qu'il possède une expertise. En outre, une compréhension de base du sujet et la prise de responsabilité, notamment en ce qui concerne l'utilisation de médicaments vétérinaires, sont nécessaires. Bien que le vétérinaire puisse déléguer des actes en raison de la situation juridique actuelle, il assume ensuite la responsabilité professionnelle de la qualité des interventions réalisées. En outre la délégation nécessite impérativement une évaluation rétrospective régulière du type et du nombre des traitements ainsi qu'un contrôle du bon usage des médicaments vétérinaires conformément à l'Ordonnance sur les médicaments vétérinaires. Sous cette prémisse, le recueil des commémoratifs dans un cadre clairement défini et conformément aux exigences légales avec un traitement initial par l'agriculteur peut être, dans la pratique, judicieux, en particulier dans les maladies factorielles pour assurer le traitement le plus rapide possible des animaux malades. Compte tenu des différences considérables en termes de compétence professionnelle parmi les non-vétérinaires, des réglementations forfaitaires devraient être rejetées. Les diagnostics plus approfondis et la prescription de médicaments vétérinaires doivent en principe rester une tâche exclusive du vétérinaire.

Editorial: Medicines pricing, access and safety in Morocco.

Unregulated supply of medicines compromises quality assurance and risks patient safety. The emergence of illegal medicines trafficking in Morocco presents a major health threat, which highlights the need for region-wide alignment in policies to drive stringent regulatory enforcement and robust health systems that ensure population- wide access to safe medicines. Herein, we draw on insights from a situational analysis in Morocco, as a lower- middle income setting, to present access to medicines through regulated supply procedures as a vital prerequisite for quality assurance and patient safety.

L'approvisionnement non réglementé en médicaments compromet l'assurance qualité et la sécurité des patients. L'émergence du trafic illégal de médicaments au Maroc constitue une menace majeure pour la santé, ce qui souligne la nécessité d'un alignement régional des politiques pour une application stricte de la réglementation et des systèmes de santé robustes garantissant l'accès de la population à des médicaments sûrs. Nous nous inspirons d'une analyse situationnelle menée au Maroc, en tant que pays à revenu moyen-inférieur, pour présenter l'accès aux médicaments par le biais de procédures d'approvisionnement réglementées, prérequis indispensable à l'assurance qualité et à la sécurité des patients.