referred to their general cardiovascular risks practitioner. associated with it. Pharmacists and nurses outside of One such mechanism haematology and oncology units could be the patient will have limited interactions with alert card, which the these patients, and all educational patient can present sessions to pharmacists and to any HCP during a nurses will be focused on the consultation (see personnel working at specialty point 5 in this table). hospitals and clinics only. Therefore, the sponsor proposes the following distribution plan in order to ensure initial and continued awareness of important safety issues associated with Iclusig. The exact format of the information is yet to be confirmed, but the sponsor can affirm that the content will include as a minimum all the information that are included in the HCP educational brochures that will be distributed in the EU. At launch: 1) Distribution of the educational materials (both electronically and as hard-copies) to all potential prescribers of Iclusig. This will include approximately 400 specialist haematologists, haematologists/oncologists and haematology registrars (Note: It should be recognized that trial the small patient population and therefore a relatively discrete number of specialists/haematologists managing these patients, the sponsor will provide additional focus on liaising with the CML and Ph+ALL treating physicians). 2) Communication/distribution of the educational materials to all relevant heads of departments at major haematology hospitals 3) Communication/distribution of the educational materials to all presidents of relevant professional organisations in this field. After launch: 1) Face-to-face visits by STA52F representatives to all prescribers to specifically discuss and distribute the safety educational
referred to their general practitioner. Pharmacists and nurses outside of haematology and oncology units will have limited interactions with these patients, and all educational sessions to pharmacists and nurses will be focused on the personnel working at specialty hospitals and clinics only. Therefore, the sponsor proposes the following distribution plan in order to ensure initial and continued awareness of important safety issues associated with Iclusig. The exact format of the information is yet to be confirmed, but the sponsor can affirm that the content will include as a minimum all the information that are included in the HCP educational brochures that will be distributed in the EU. At launch: 1) Distribution of the educational materials (both electronically and as hard-copies) to all potential prescribers of Iclusig. This will include approximately 400 specialist haematologists, haematologists/oncologists and haematology registrars (Note: It should be recognized that the small patient population and therefore a relatively discrete number of specialists/haematologists managing these patients, the sponsor will provide additional focus on liaising with the CML and Ph+ALL treating physicians). 2) Communication/distribution of the educational materials to all relevant heads of departments at major haematology hospitals 3) Communication/distribution of the educational materials to all presidents of relevant professional organisations in this field. After launch: 1) Face-to-face visits by STA52F representatives to all prescribers to specifically discuss and distribute the safety educational cardiovascular risks associated with it. One such mechanism could be the patient alert card, which the patient can present to any HCP during a consultation (see point 5 in this table). trial