Therapie最新文献

Objective: Metformin-associated lactic acidosis (MALA) is a rare but serious adverse drug reaction (ADR). The aim of the study was to identify clinical situations associated with the onset of MALA in patients hospitalised in the Nord Pas de Calais regional intensive care units (ICUs), and to assess its preventability.

Material and methods: We included all cases of MALA, identified by metformin accumulation >2.3mg/dL and lactate >2.2mmol/L, reported by the regional ICU physicians to the Regional Centre of Pharmacovigilance and registered in the French Pharmacovigilance Database between 1 January 2017 and 30 December 2018.

Results: One hundred and ninety-eight (198) cases of MALA were included. 38 patients died in direct association with MALA (19.2%). There was a correlation between metformin plasma accumulation and acute renal failure and with the severity of MALA (P<0.0001). All patients presented an acute intercurrent event favouring MALA, dehydration for 87 (43.9%) patients, severe infection for 65 (32.8%) patients. For 172 patients (86.7%), the prescription was not adapted to the intercurrent medical situation as recommended. Seventy (40.5%) patients consulted their general practitioner for the acute intercurrent event, 1 temporarily stopped metformin and 34.3% had been referred directly to hospital. The remaining 65.7% presented to the hospital around 4 days later due to worsening symptoms. MALA was identified as preventable in 160 patients (80.8%).

Conclusions: MALA in ICUs often follow acute dehydration or infection, and these high-risk situations must be signals to prevent this serious ADR. Specific education programmes for physicians and patients could also reduce this risk.

The drug authorization process is shifting towards a policy aimed at shortening time-to-market. While this policy facilitates early access to new treatments, it can also result in potentially insufficient knowledge of both efficacy and safety at the time of marketing. The latter is particularly true for long-term outcomes or in specific populations (e.g., children and the elderly). Yet, French pharmacoepidemiology is currently not designed to address these challenges, despite recognized expertise. In this context, we aim: (i) to define a strategy for strengthening pharmacoepidemiology in France; and (ii) to identify the associated human, technical, and financial requirements to ensure its success. In this paper, we present the French Pharmacoepidemiology Initiative (https://frenchpharmacoepi.org/), i.e. a network of independent academic teams to complement existing institutions. It will provide coordinated expertise and a workforce to meet national and regional needs for pharmacoepidemiological monitoring and drug-related decision-making. Leveraging the existing expertise of university hospital pharmacoepidemiology units would enable rapid operational deployment to inform the decisions and policies of national regulatory agencies.

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.