Given these differences in The sponsor states: This approach is registration details it would overall AE reliant upon “The also be expected that the reporting rate, as well data from sponsor will conduct a as the injection spontaneous AE physician survey in Australia procedure related reports which to assess the effectiveness of adverse trial rate, will are unlikely to the prescriber educational be used as a measure be sufficient in materials as a measure to of effectiveness of measuring the reduce all the specified these educational effectiveness of important identified risks. materials. A decrease these proposed Consequently the sponsor in overall reporting additional risk should provide to the TGA for rate, as well as minimisation review the details of the frequency and activities. This is nature (quantitative) and severity of injection due to the under content of the survey testing to procedure related reporting and be conducted in Australia, adverse events, will the lack of including the specific review be considered as reliable period, the criteria used to verification of the exposure verify success and how the success of the (usage) data results of this testing will be educational associated with reported to the TGA. Section 3: materials.” spontaneous of the ASA should be reporting ‘RMP’ revised accordingly. 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. It would appear that no The sponsor This approach is information detailing how the capturing reliant upon “proposes patient educational materials data on identified data from as a measure to reduce the risks through the spontaneous AE important identified risks: targeted reports which IOP, glaucoma, questionnaire and are unlikely to ‘Increased ocular hypertension’ and spontaneous AE be sufficient in (infectious/ reporting to measuring the ‘endophthalmitis non-infectious)’ has been Allergan’s effectiveness of provided. Consequently the pharmacovigilance these proposed sponsor should state how the department. Data additional risk
Given these differences in registration details it would also be expected that the sponsor will conduct a physician survey in Australia to assess the effectiveness of the prescriber educational materials as a measure to reduce all the specified important identified risks. Consequently the sponsor should provide to the TGA for review the details of the nature (quantitative) and content of the survey testing to be conducted in Australia, including the specific review period, the criteria used to verify success and how the results of this testing will be reported to the TGA. Section 3: ‘RMP’ of the ASA should be revised accordingly. The sponsor states: “The overall AE reporting rate, as well as the injection procedure related adverse rate, will be used as a measure of effectiveness of these educational materials. A decrease in overall reporting rate, as well as frequency and severity of injection procedure related adverse events, will be considered as verification of the success of the educational materials.” This approach is reliant upon data from spontaneous AE reports which are unlikely to be sufficient in measuring the effectiveness of these proposed additional risk 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. It would appear that no information detailing how the patient educational materials as a measure to reduce the important identified risks: ‘Increased IOP, glaucoma, ocular hypertension’ and ‘endophthalmitis (infectious/ non-infectious)’ has been provided. Consequently the sponsor should state how the The sponsor “proposes capturing data on identified risks through the targeted questionnaire and spontaneous AE reporting to Allergan’s pharmacovigilance department. Data This approach is reliant upon data from spontaneous AE reports which are unlikely to be sufficient in measuring the effectiveness of these proposed additional risk trial
auspar-dexamethasone-161025.docx