Читать книгу Clinical Pharmacology and Therapeutics - Группа авторов - Страница 134

There is now a greatly increased obligation on pharmaceutical companies to set up risk‐management plans. In Europe, the EMA launched EudraVigilance in 2017 which is a system for managing and analysing suspected adverse reactions to medicines that have been authorised or are being studied in clinical trials. The aim is to support safe and effective use of medicines by sharing safety reports across Europe, allowing early detection and evaluation of safety signals and providing better product information for medicines authorised in Europe. The system is obligatory for clinical trial sponsors and marketing authorisation holders in Europe.

Following marketing approval and granting of a product licence for a new drug, observational Phase IV studies will often be performed either by the pharmaceutical company or professional organisations. This could involve implementation and analysis of databases or registries surrounding use of the medication in a real‐world setting. For example, the UK GP database was used to confirm a link between the oral contraceptive and the risk of deep vein thrombosis, while pharmaceutical companies that manufacture direct oral anticoagulants have conducted observational Phase IV studies to assess if the benefits that were observed compared to warfarin in Phase III trials remain evident when studied in real‐world populations.

If observational studies or meta‐analysis of randomised control trials raise concern about a particular medication, the options are for the company to withdraw the drug or the regulatory authorities to suspend the licence until the concern is investigated further. In the UK, a drug is marked with a black triangle in the BNF if it is thought to cause concern and prescribers are encouraged to report any problems through the yellow card scheme.