Therapie最新文献

Medical analysis laboratories play an essential role in medical diagnosis, with their results influencing up to 70% of decisions. This means that the quality of laboratory services is a key factor in the quality of medical care. However, certification and accreditation are not yet compulsory in Morocco, and only the Guide to the Good Execution of Medical Biology Analyses (GBEA) published in 2011 governs the organisation of laboratories. The Blood Transfusion and Hemovigilance Service (STSH) at the Ibn Sina University Hospital (CHUIS) in Rabat has embarked on an ISO 9001:2015 certification process, with the aim of improving its performance and satisfying its interested parties. This process, which was launched in 2018, was carried out in two main phases. The first phase consisted of complying with current regulations, while the second phase involved an evaluation based on the ISO 9001:2015 standard. In accordance with the logic of the Deming wheel, the department developed its quality policy, set its objectives, and undertook staff training and awareness activities. The processes, along with the associated risks and opportunities, have been identified and represented. The documentation system, as well as the system for reporting and handling non-conformities, has been implemented and dematerialised. Performance and activity indicators have been defined for each process. Finally, the customer feedback system has been expanded to include all interested parties, thus allowing for an evaluation of their perceptions and the identification of areas for improvement. Despite the global pandemic of COVID-19, this work has successfully integrated ISO 9001:2015 into STSH's practices, with compliance being declared by a certification body in 2022.

Since the beginning of the century, the USA have been experiencing an opioid epidemic characterised by high levels of prescription opioid use. While extensive North American literature on the topic has been published and several public health measures implemented attempting to address the problem, in Europe addiction research, especially literature focusing on misuse of medicines, lags far behind. France is an exception: it is the only European country that has established a nationwide specific system to monitor misuse of legal and illegal psychoactive substances, an activity that has been named addictovigilance. Thanks to the combined use of several data sources, the French addictovigilance system has, in its three decades of existence, proven to be effective in the early identification and assessment of addictovigilance signals, providing real-world evidence to support the conception and monitoring of public health measures to minimise the health risks posed by psychoactive substance misuse in France.

The opioid epidemic has emerged in the USA in the late 1990s and widespread to Canada, Australia, and the UK to a lesser extent in the more recent years. At the European level, several studies performed in different European countries have highlighted that prescription opioid use increased substantially over the last decade, and several proxies for misuse show a parallel increasing trend. The French addictovigilance experience on opioid analgesics is a good example of a specific dedicated monitoring, taking into account in a global and multisource perspective, patterns of utilization, population involved in problematic use, ways of acquisition and health complications. The added value of this data triangulation is illustrated by the recent data on tramadol and oxycodone. The addictovigilance monitoring is particularly relevant to identify early signals of potential problematic use and to assess the impact of campaigns for opioid analgesics rational use and regulatory changes.

In March 2020, World Health Organization recognized severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emergence as a public health emergency of international concern. One of the major preventative measures developed against coronavirus disease 2019 (COVID-19) was vaccines. To monitor their use and safety of vaccines from the first utilization in humans during clinical development phases to implementation for the general population, an enhanced national pharmacovigilance system was enabled by the French National Agency for Medicines and Health Products Safety in collaboration with the 30 Regional Pharmacovigilance Centres. Here, we review the significant outcomes from a 2-year collaboration experience between the French National Agency for Medicines and Health Products Safety, the 30 Regional Pharmacovigilance Centres, disease-related experts and the pharmacovigilance and risk assessment committee at the European medicine agency. In France, until January 2023, over 155 million doses of COVID-19 vaccines were administrated, and 190,000 adverse events following immunizations (25% classified as serious) were analysed. Altogether 53 potential safety signals were reported to the Pharmacovigilance and Risk Assessment Committee at the European Medicine Agency by the French National Agency for Medicines and Health Products Safety: 13 were confirmed, 24 are still under investigation and 16 were not confirmed. The enhanced national PV system contributed actively better to define the safety profile of the newly developed vaccines, and the French National Agency for Medicines and Health Products Safety continues to monitor the benefit and risks of the COVID-19 vaccines.