consideration for applicability in the RMP for SB4. TGA recommendation 2: The sponsor has revised the The sponsor’s response is acceptable. The following statement in implementation plan of the ASA should be amended additional risk minimisation as highlighted: in Australia according to the ‘For additional risk TGA recommendation. minimisation, a format similar to the EU-RMP (such as the patient alert card [PAC] and educational programs) will be provided, with separate review and approval by the TGA’. TGA recommendation 3: The sponsor has revised the The sponsor’s response is The ASA states: order to plan to provide the acceptable. ‘In inform regarding the safe free demonstration device and proper use of the to clinicians for patient the sponsor will education purposes. The develop and implement an needle-free demonstration additional risk minimisation devices will now be made plan in the form of a training available to all relevant and educational program for healthcare professionals at patients, HCPs, and their practice sites, not only company staff, specifically to clinicians. In addition, the for the safe use of the sponsor has replaced the However, as term with ‘use’ ‘administer’ previously noted the ASA for clarity. The revised also states: of a statement is (changes ‘Availability needle free demonstration underlined): device: This device allows Potential for ‘3.2.1 patients to practice medication errors – injections prior to using the pen actual pre-filled Additional risk minimisation These devices have activities: Training program been made available to will be launched to avoid clinicians for training medication errors that can purposes in the clinician’s occur from auto-injectors office’. Given the existing and help HCPs and patients presence in the Australian to administer SB4 properly. market of the innovator administered presumably Availability of a needle via a different auto-injector demonstration device: This device, it is agreed that a device allows patients to range of HCPs, not just the practice injections prior to prescriber, will require an using the actual pre-filled educational program to be auto-injector. These devices able to inform patients on have been made available to the safe and proper use of all relevant HCPs for the auto-injector. This would include making the
consideration for applicability in the RMP for SB4. TGA recommendation 2: The following statement in the ASA should be amended as highlighted: ‘For additional risk minimisation, a format similar to the EU-RMP (such as the patient alert card [PAC] and educational programs) will be provided, with separate review and approval by the TGA’. The sponsor has revised the implementation plan of additional risk minimisation in Australia according to the TGA recommendation. The sponsor’s response is acceptable. TGA recommendation 3: The ASA states: ‘In order to inform regarding the safe and proper use of the the sponsor will develop and implement an additional risk minimisation plan in the form of a training and educational program for patients, HCPs, and company staff, specifically for the safe use of the However, as previously noted the ASA also states: ‘Availability of a needle free demonstration device: This device allows patients to practice injections prior to using the actual pre-filled These devices have been made available to clinicians for training purposes in the clinician’s office’. Given the existing presence in the Australian market of the innovator administered presumably via a different auto-injector device, it is agreed that a range of HCPs, not just the prescriber, will require an educational program to be able to inform patients on the safe and proper use of the auto-injector. This would include making the The sponsor has revised the plan to provide the demonstration device to clinicians for patient education purposes. The needle-free demonstration devices will now be made available to all relevant healthcare professionals at their practice sites, not only to clinicians. In addition, the sponsor has replaced the term ‘use’ with ‘administer’ for clarity. The revised statement is (changes underlined): ‘3.2.1 Potential for medication errors – pen Additional risk minimisation activities: Training program will be launched to avoid medication errors that can occur from auto-injectors and help HCPs and patients to administer SB4 properly. Availability of a needle free demonstration device: This device allows patients to practice injections prior to using the actual pre-filled auto-injector. These devices have been made available to all relevant HCPs for The sponsor’s response is acceptable.
auspar-etanercept-rch.docx