OP0328-PARE Patient safety in relation to biosimilars – how can we act as a patient organization?
Authors: LM Thomsen
Journal: Annals of the Rheumatic Diseases (2017)

<h3>Background</h3> During the last years two biosimilars has been approved by the national authorities in Denmark, and implemented in the treatment of patients with arthritis. When the first biosimilars were approved in 2015, the hospitals in Denmark decided to shift native patients from the original drug to the new biosimilar. This decision caused considerable insecurity among the patients, who were afraid of biosimilars and their effectiveness and safety profile. Therefore the Danish Rheumatism Association decided to implement an effort to create better patient information and safety for patients, who had to start with a biological drug or shift from one biological drug to another or to a biosimilar. <h3>Objectives</h3> The purpose of the effort was to increase patient safety and to ensure that patients received independent patient information within biological drugs. <h3>Methods</h3> First the Association conducted a small study of how the shift of drug had taken place in the different regions. Most patients experienced that they were told by the doctors to shift to biosimilars, and furthermore they experienced a lack of information about the new biosimilars. On a national level, nearly all patients on a biological drug are registered in a national database. It is registered in the database and hospital records which drug the patient are prescribed, but it is not registered on a batch-level. In order to change these conditions the Association started a dialog with the politicians and the authorities on a national level and the hospital-administrations on a regional level. The purpose was to improve the registration of the drugs on batch-level, to improve more independent patient information and to improve the involvement of the patient in the decision making process. The dialog was on a general level, but with several patient-stories from each region. <h3>Results</h3> A new national plan for better monitoring and information about biologic and biosimilars was launched in august 2015 and carried out in 2016. The plan consists of four parts: 1) Monitoring biological drugs and biosimilars on batch level, 2) Information campaign to health professionals and patients, 3) Digital solutions and easy reporting of side effects from health professionals and patients, 4) Focus on monitoring patient safety by the authorities. The Danish Rheumatism Association has participated in the work to implement the plan. In addition to the national plan the hospitals on a regional level, has invited the Rheumatism Association to participate with a representative in the working group, where national recommendations for the use of biological drugs are being made in an attempt to involve the patient perspective more. The content of the national plan and the involvement in the work with national recommendations, will be elaborated and discussed from the patients perspective throughout the presentation. <h3>Conclusions</h3> The implementation of biosimilars created great insecurity among patients. Therefore, the Danish Rheumatism Ass. decided to make an effort to create better patient information and safety for the patients. Through dialog with politicians, national authorities and hospital-administrations, we managed to get a national plan for better monitoring and information about biologic and biosimilars, and to be involved in the work with national recommendations for these drugs. The national plan and work with national recommendations will be elaborated in the presentation. <h3>Disclosure of Interest</h3> None declared