The UK has conducted three such contracts to date and has been successful in containing the overall costs of haemophilia therapy by using accurate data on the consumption of concentrates and the distribution of patients, and through the ability to monitor the adherence to any new contracts. This may be an attractive option for other registries to explore as financial constraints continue to be imposed on healthcare in many countries. At registration, medicines have to be shown to be efficacious and safe. Mandated

regulatory studies, however, tend to be small and are likely to identify only frequent adverse events. No other patient community has suffered as much as that of haemophilia patients in terms of treatment adverse events. Before 1985, a single exposure to selleck chemicals clotting factor concentrate had an almost 100% chance of transmitting the hepatitis C virus (HCV) to the recipient. It is obvious,

therefore, that effective pharmacovigilance is C59 wnt order critical to this community. Systems for reporting adverse events are available in many countries but, unfortunately, they are often not used for many reasons including lack of time to undertake reporting, belief that the event is already well known, uncertainty about the relationship of the event to treatment, and delaying until the treating clinician has published their own report on the case(s). EUHASS is a simple prospective adverse event reporting system set up in Europe with support from the European Commission and the pharmaceutical industry selleck chemicals llc [9]. The system started on 1 October 2008, and 75 sentinel haemophilia centres

from 26 European countries participated in the first 4 years of the project. The adverse events reported by the centres are as follows: Allergic or acute reactions Transfusion transmitted infections Inhibitors Thromboses New malignancies Deaths Unexpected poor efficacy (since 2012) Any other possible adverse event (since 2012). The EUHASS system is a secure web based system and patient details are reported anonymously. Events are reported at the time they occur or, at a minimum, at the end of each 3 month period. Centres not having any events to report still have to confirm this by signing off each quarter. Participating centres also have to provide, annually, the number of patients with bleeding disorders registered in their centre and how many of these received treatment with clotting factor concentrate or platelet transfusions (for inherited platelet disorders), in the preceding 12 month period. Furthermore, annually, centres provide information on how many patients in their centre received each clotting factor concentrate and how many of these individuals had a severe bleeding disorder.