Risk minimisation activities The sponsor proposes routine and additional risk minimisation activities (development and distribution of educational materials to Consumers and Healthcare Professionals prepared in accordance with Medicines Australia Code of Conduct Guidelines) for all the ongoing safety concerns. The sponsor’s evaluation of the need for risk minimisation activities was considered to be satisfactory. Reconciliation of issues outlined in the RMP report Table 8 summarises the OPR’s first round evaluation of the RMP, the sponsor’s responses to issues raised by the OPR and the OPR’s evaluation of the sponsor’s responses. Table 8. Reconciliation of issues outlined in the RMP report Recommendation in RMP Sponsor’s response OPR evaluation report evaluator’s comment abuse in weight loss’ RMP has been updated regarding The sponsor’s ‘Drug has been listed as an abuse in weight loss’. Based response was ‘Drug identified safety risk in the on estimated patient exposure of considered to pharmacovigilance and approximately 224 million be acceptable. risk minimisation plan in patient-years for the 100 the proposed RMP. The microgram daily dose and 148 sponsor should include million patient-years for the 150 this risk in the microgram daily dose for the ‘Summary of Safety Concerns’. post-authorisation period, and the potential for drug abuse with levothyroxine is considered to be low. Hence all reference to drug abuse in weight loss has been removed from the RMP. The sponsor proposes a The following 2 ICSR Follow-Up The sponsor’s specific adverse reaction response was Questionnaires had been agreed form for the identified and were submitted to the TGA. considered to risks order to gather be acceptable. ‘in Cardiac Adverse Events more accurate information Potential Hypo- or on patient status, change of – Thyroidism or Treatment dosage, change of brand, Imbalance. latest hormonal levels, new concomitant drugs’, the sponsor should provide a sample of such form to the TGA for evaluation. The evaluator agrees that The risk of medication errors can The sponsor’s the introduction of more be reduced by packaging with the response was strengths will help judicious use of different colours considered to minimise the potential for to distinguish different strengths be acceptable. some medication errors as on the carton pack and inclusion the sponsor has stated. of unique embossing on each and However, eleven different every strength of the tablet.
Risk minimisation activities The sponsor proposes routine and additional risk minimisation activities (development and distribution of educational materials to Consumers and Healthcare Professionals prepared in accordance with Medicines Australia Code of Conduct Guidelines) for all the ongoing safety concerns. The sponsor’s evaluation of the need for risk minimisation activities was considered to be satisfactory. Reconciliation of issues outlined in the RMP report Table 8 summarises the OPR’s first round evaluation of the RMP, the sponsor’s responses to issues raised by the OPR and the OPR’s evaluation of the sponsor’s responses. Table 8. Reconciliation of issues outlined in the RMP report Recommendation in RMP evaluation report Sponsor’s response OPR evaluator’s comment ‘Drug abuse in weight loss’ has been listed as an identified safety risk in the pharmacovigilance and risk minimisation plan in the proposed RMP. The sponsor should include this risk in the ‘Summary of Safety Concerns’. RMP has been updated regarding ‘Drug abuse in weight loss’. Based on estimated patient exposure of approximately 224 million patient-years for the 100 microgram daily dose and 148 million patient-years for the 150 microgram daily dose for the post-authorisation period, and the potential for drug abuse with levothyroxine is considered to be low. Hence all reference to drug abuse in weight loss has been removed from the RMP. The sponsor’s response was considered to be acceptable. The sponsor proposes a specific adverse reaction form for the identified risks ‘in order to gather more accurate information on patient status, change of dosage, change of brand, latest hormonal levels, new concomitant drugs’, the sponsor should provide a sample of such form to the TGA for evaluation. The following 2 ICSR Follow-Up Questionnaires had been agreed and were submitted to the TGA. Cardiac Adverse Events Potential Hypo- or – Thyroidism or Treatment Imbalance. The sponsor’s response was considered to be acceptable. The evaluator agrees that the introduction of more strengths will help minimise the potential for some medication errors as the sponsor has stated. However, eleven different The risk of medication errors can be reduced by packaging with the judicious use of different colours to distinguish different strengths on the carton pack and inclusion of unique embossing on each and every strength of the tablet. The sponsor’s response was considered to be acceptable.
auspar-thyroxine-sodium-140612.docx