these proposed additional risk assessment, were considered minimisation activities. This is due adequate for monitoring the safety to the under reporting and the lack concerns. As a consequence the of reliable exposure (usage) data tools and the plan to provide a associated with spontaneous specific 6 monthly safety focused reporting systems, not to mention report as a measure of their the information gained from effectiveness, no longer form part adverse reaction reporting is often of the EU RMP. To align with the incomplete. Consequently the EU-RMP (v 4.1), the AUS-RMP sponsor should plan appropriate (v1.3) has been updated and alternative methods to assess the reference to the proposed tools educational materials for HCPs and measures of effectiveness and patients as a measure to have also been removed from the reduce risk of medication errors ASA (v1.3). In Australia the tools and include such detail in a revised will be made available to ASA. For example periodic market healthcare professionals and research of the Australian target patients as part of the standard audience of the educational educational materials delivered at materials could be planned for the time of product launch to ensure post market period for as long as Quality use of Medicines.” these additional risk minimisation activities are still considered necessary and therefore continue to be implemented. Advice from the Advisory Committee on the Safety of Medicines (ACSOM) advice was not sought for this submission. Key changes to the updated RMP In their response to the TGA request for information the sponsor provided an updated (Version 4.1, dated 14 November 2014) with an updated ASA (Version 1.3, dated December 2014). Key changes from the versions evaluated at Round 1 are summarised in Table 8. Table 8. Key changes in the updated RMP Document Changes implemented EU-RMP The potential risks: error (unnecessary re-calculation of the units needed)’, ‘Medication error (inappropriate use, i.e. extraction of insulin from the pen using a ‘Medication syringe)’ and error (substitution with product with inadequate concentration ‘Medication dispensed) were added. No additional risk minimisation activities were deemed necessary for any of the by the CHMP. Consequently the additional risk minimisation activities previously proposed for the important identified risk: errors (insulin mix-ups)’ and for the ‘Medication important potential risk: error (inappropriate dose injected, following needle ‘Medication blocked in absence of compliance with instructions for use)’ were removed.
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 the sponsor should plan appropriate alternative methods to assess the educational materials for HCPs and patients as a measure to reduce risk of medication errors and include such detail in a revised ASA. For example periodic market research of the Australian target audience of the educational materials could be planned for the post market period for as long as these additional risk minimisation activities are still considered necessary and therefore continue to be implemented. assessment, were considered adequate for monitoring the safety concerns. As a consequence the tools and the plan to provide a specific 6 monthly safety focused report as a measure of their effectiveness, no longer form part of the EU RMP. To align with the EU-RMP (v 4.1), the AUS-RMP (v1.3) has been updated and reference to the proposed tools and measures of effectiveness have also been removed from the ASA (v1.3). In Australia the tools will be made available to healthcare professionals and patients as part of the standard educational materials delivered at time of product launch to ensure Quality use of Medicines.” Advice from the Advisory Committee on the Safety of Medicines (ACSOM) advice was not sought for this submission. Key changes to the updated RMP In their response to the TGA request for information the sponsor provided an updated (Version 4.1, dated 14 November 2014) with an updated ASA (Version 1.3, dated December 2014). Key changes from the versions evaluated at Round 1 are summarised in Table 8. Table 8. Key changes in the updated RMP Document Changes implemented EU-RMP The potential risks: ‘Medication error (unnecessary re-calculation of the units needed)’, ‘Medication error (inappropriate use, i.e. extraction of insulin from the pen using a syringe)’ and ‘Medication error (substitution with product with inadequate concentration dispensed) were added. No additional risk minimisation activities were deemed necessary for any of the by the CHMP. Consequently the additional risk minimisation activities previously proposed for the important identified risk: ‘Medication errors (insulin mix-ups)’ and for the important potential risk: ‘Medication error (inappropriate dose injected, following needle blocked in absence of compliance with instructions for use)’ were removed.