and Australia’ in the ASA to believes that a provide a justification line indication in regarding the difference in the Australia is indication sought in Europe acceptable, will be (second line indication) and evaluated by the Australia (first line clinical evaluator. indication). 4. As the product will be RMP evaluator’s comment: The The sponsor’s provided in ready to use sponsor has provided a detailed response has been devices (pen or pre-filled response to this recommendation, and noted. syringe), and there is limited states that it is not considered In the majority of information available about appropriate to add error’ ‘medication cases included in the the safety of this product in a as missing information to the RMP. described studies, the home treatment setting, The sponsor refers to the following: 1.) subject were trained errors’, which ‘Medication Appropriate wording is included in the in the use of the should include medication PI to ensure that physicians product (self-injecting errors in a home treatment patients in the administration devices) prior to first setting should be added as a technique, 2.) Appropriate instructions using the product. potential risk. are provided in the Instructions for Overall, the sponsor It is considered appropriate Use Document, 3.) Two clinical studies relies heavily on that errors’, during which patient’s ability to use ‘Medication patient’s training which should include the product for self-administration conducted by medication errors in a home was assessed, 4.) Human factor studies treating physician to treatment setting, be added as during which patient’s ability to use ensure safe use of the missing information in the the product for self-administration product by patients in table of ongoing safety was assessed. a home treatment concerns. Overall, the sponsor concludes that a setting. high of successful In the RMP was detected. evaluator’s opinion, it Further detail was provided in the cannot be guaranteed sponsor’s response document. that a thorough training of the use of the product, and a thorough assessment of the patient’s ability for will be conducted in busy daily clinical practice. Consequently, the RMP evaluator maintains the opinion that ‘Medication errors’, which should include medication error in a home treatment setting, should be added as potential risk to the table of ongoing safety concerns. Risk-minimisation and pharmacovigilance activities should be
and Australia’ in the ASA to provide a justification regarding the difference in the indication sought in Europe (second line indication) and Australia (first line indication). believes that a line indication in Australia is acceptable, will be evaluated by the clinical evaluator. 4. As the product will be provided in ready to use devices (pen or pre-filled syringe), and there is limited information available about the safety of this product in a home treatment setting, ‘Medication errors’, which should include medication errors in a home treatment setting should be added as a potential risk. It is considered appropriate that ‘Medication errors’, which should include medication errors in a home treatment setting, be added as missing information in the table of ongoing safety concerns. RMP evaluator’s comment: The sponsor has provided a detailed response to this recommendation, and states that it is not considered appropriate to add ‘medication error’ as missing information to the RMP. The sponsor refers to the following: 1.) Appropriate wording is included in the PI to ensure that physicians patients in the administration technique, 2.) Appropriate instructions are provided in the Instructions for Use Document, 3.) Two clinical studies during which patient’s ability to use the product for self-administration was assessed, 4.) Human factor studies during which patient’s ability to use the product for self-administration was assessed. Overall, the sponsor concludes that a high of successful was detected. Further detail was provided in the sponsor’s response document. The sponsor’s response has been noted. In the majority of cases included in the described studies, the subject were trained in the use of the product (self-injecting devices) prior to first using the product. Overall, the sponsor relies heavily on patient’s training conducted by treating physician to ensure safe use of the product by patients in a home treatment setting. In the RMP evaluator’s opinion, it cannot be guaranteed that a thorough training of the use of the product, and a thorough assessment of the patient’s ability for will be conducted in busy daily clinical practice. Consequently, the RMP evaluator maintains the opinion that ‘Medication errors’, which should include medication error in a home treatment setting, should be added as potential risk to the table of ongoing safety concerns. Risk-minimisation and pharmacovigilance activities should be