effectiveness of this additional collected via these minimisation risk minimisation measure for channels will be activities. This is these ongoing safety concerns reported to the TGA due to the under will be measured, the criteria through established reporting and used to verify success and how reporting the lack of the results of such testing will mechanisms if reliable be reported to the TGA. required.” The exposure Section 3: of the ASA updated ASA states: (usage) data ‘RMP’ should be revised accordingly. diligently associated with “Allergan monitors AEs (related spontaneous to injection reporting procedure). The systems, not to overall AE profile, mention the reporting rate, as well information as the type and gained from frequency of injection adverse reaction procedure related reporting is adverse events will all often be used as a measure incomplete. of effectiveness of Consequently these educational this materials.” remains outstanding and should be adequately addressed preferably before this application is approved. In addition the sponsor stated that educational materials were attached as Appendix 1 to the updated ASA. However, it appears that the patient educational materials have not been so attached. The sponsor should correct this oversight. A table summarising the The sponsor states: This is “A pharmacovigilance and risk table listing all acceptable. minimisation activities for all proposed of the specified ongoing safety Pharmacovigilance concerns and missing activities (Table 2 1)
effectiveness of this additional risk minimisation measure for these ongoing safety concerns will be measured, the criteria used to verify success and how the results of such testing will be reported to the TGA. Section 3: ‘RMP’ of the ASA should be revised accordingly. collected via these channels will be reported to the TGA through established reporting mechanisms if required.” The updated ASA states: “Allergan diligently monitors AEs (related to injection procedure). The overall AE profile, reporting rate, as well as the type and frequency of injection procedure related adverse events will all be used as a measure of effectiveness of these educational materials.” minimisation activities. This is due to the under reporting and the lack of reliable exposure (usage) data associated with spontaneous reporting systems, not to mention the information gained from adverse reaction reporting is often incomplete. Consequently this remains outstanding and should be adequately addressed preferably before this application is approved. In addition the sponsor stated that educational materials were attached as Appendix 1 to the updated ASA. However, it appears that the patient educational materials have not been so attached. The sponsor should correct this oversight. A table summarising the pharmacovigilance and risk minimisation activities for all of the specified ongoing safety concerns and missing The sponsor states: “A table listing all proposed Pharmacovigilance activities (Table 2 1) This is acceptable.
auspar-dexamethasone-161025.docx