Therapie
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Pharmacovigilance aims to identify unknown adverse drug reactions once clinical development is complete, in order to promote improved use of drugs, and thus a reduction in risk for every exposed patient. We describe in this article the missions of French pharmacovigilance system, including French drug agency, Regional Centers of Pharmacovigilance, health professionals, pharmaceutical companies, patients and their associations. We also develop the French pharmacovigilance organization, its perspectives and challenges, both in French and European levels.
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The new European legislation that came into force in July 2012 reinforced the organisation of pharmacovigilance by setting up a committee in charge of risk assessment for medicines, the Pharmacovigilance Risk Assessment Committee (PRAC). The PRAC has a remit covering the assessment of all aspects of the safety and the risk management of medicinal products for human use in the European Union. It deals with issues regarding pharmacovigilance signals, the periodic evaluation of benefit/risk reports from marketing authorization holders (MAH), risk management plans, post-marketing studies, variations or renewals of marketing authorisations, management of under surveillance drugs lists, inspections for pharmacovigilance reasons and audits of pharmacovigilance systems. ⋯ The final decision, which applies to all Member States and to the concerned MAH, lies with the European Commission (EC). This decisional procedure thus rests on coordination involving the PRAC, the CHMP, the CMDh, the EC, the Member States and the pharmaceutical companies. In the 3 years from July 2012, the PRAC has processed nearly 4500 procedures and is still facing an increasing workload.
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The aim of this article is to discuss the contribution of pharmacoepidemiology to pharmacovigilance in the context of drug safety monitoring. Because this contribution requires a comparison of the approaches and a presentation of their respective merits, we have tried to show that this comparison did not necessarily mean opposing these methods, which would not serve any useful purpose. We wanted to underline the fact that the notion of contribution of one to the other implied a complementarity that we propose to demonstrate. ⋯ Pharmacoepidemiology for its part, through its population-related studies and the possible use of a comparison group, enables a quantification of risks that is impossible to carry out using spontaneous reporting alone. It also enables the highlighting and quantification of safety signals for events that are frequent and multifactorial, where the role of a drug in individual cases can be difficult to detect, and therefore difficult to identify from spontaneous reporting. All in all, this is the major contribution of pharmacoepidemiology to pharmacovigilance, where it can be said that it complements pharmacovigilance in drug safety monitoring but in no way could replace it.
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Comparative Study Observational Study
[Factors Associated with Direct Oral Anticoagulants versus Vitamin K Antagonists in Patients with Non-valvular Atrial Fibrillation].
Describing the factors associated with direct oral anticoagulants (DOA) prescription in patients with atrial fibrillation (AF). ⋯ DOA are less prescribed than VKA in patients treated with APA. DOA switch to VKA was not systematic in patients diagnosed for a long time. However, international normalized ratio (INR) values were stable in most of patients treated with VKA at the switching to DOA. A more powerful study would confirm the factors associated with DOA prescription.
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Elderly with several pathologies are usually treated with many drugs, and are exposed to a majored risk of drug-induced adverse effects. A network of local nursing homes (EHPAD) in the south Seine-Saint-Denis area (France) created a geriatric drug guidelines to improve the quality of the drugs prescriptions. This study assesses the conformity of prescriptions in elderly patients prior and after the distribution of the booklet. ⋯ This study shows that the drug geriatric guidelines does not improve prescription conformity and monitoring for high risk drugs, but it does significantly improve the median formal quality score.