The sponsor considers that these measures, in addition to the gratuitous preparation and dosing instructions included in the PI, will provide sufficient guidance to healthcare professionals to mitigate the risk of medication errors occurring. The proposed risk minimisation activities include a Pharmacist Preparation Guide, Physician Educational Brochure, Nurse Educational Brochure and Patient (Caregiver) Educational Brochure. Recommendation 9: It is In the US, A REMS is The sponsor recommended that the sponsor implemented to inform proposes to amends the proposed Dear Health Healthcare providers about provide the Care Professional (DHCP) letter in the serious risks of cytokine educational Australia to closely the release syndrome, materials to content/elements with the Risk neurological toxicities, and health care Evaluation and Mitigation medication errors. The REMS professionals Strategy (REMS) in the US. A components consisted of: and to patients detailed outline of the DHCP via health care Blincyto REMS Letter for describing all relevant details and professionals. Healthcare Providers all educational materials to be They may also be used in Australia should be Blincyto REMS Letter for supplied by the attached to an updated ASA and Hospital and Home sponsor directly. will be reviewed. Healthcare Pharmacists In addition, Blincyto REMS Fact Sheet according to the for Healthcare Providers ASA, the sponsor proposes to In Europe, following the conduct a feedback received from the CHMP evaluation, the sponsor market research has proposed to distribute study to measure educational materials to the effectiveness address the risks of of the neurological events educational (physicians, nurses, patients program. The and caregivers) and sponsor has medication errors committed to (physicians, nurses, patients providing these and caregivers, pharmacists). results to the The educational materials TGA and should will include: do so as soon as Educational brochure for practical after physicians launch. Educational brochure for Should reports of nurses medication errors or Educational brochure for serious adverse patients and caregivers events occur, the sponsor will be
The sponsor considers that these measures, in addition to the gratuitous preparation and dosing instructions included in the PI, will provide sufficient guidance to healthcare professionals to mitigate the risk of medication errors occurring. The proposed risk minimisation activities include a Pharmacist Preparation Guide, Physician Educational Brochure, Nurse Educational Brochure and Patient (Caregiver) Educational Brochure. Recommendation 9: It is recommended that the sponsor amends the proposed Dear Health Care Professional (DHCP) letter in Australia to closely the content/elements with the Risk Evaluation and Mitigation Strategy (REMS) in the US. A detailed outline of the DHCP describing all relevant details and all educational materials to be used in Australia should be attached to an updated ASA and will be reviewed. In the US, A REMS is implemented to inform Healthcare providers about the serious risks of cytokine release syndrome, neurological toxicities, and medication errors. The REMS components consisted of: Blincyto REMS Letter for Healthcare Providers Blincyto REMS Letter for Hospital and Home Healthcare Pharmacists Blincyto REMS Fact Sheet for Healthcare Providers In Europe, following the feedback received from the CHMP evaluation, the sponsor has proposed to distribute educational materials to address the risks of neurological events (physicians, nurses, patients and caregivers) and medication errors (physicians, nurses, patients and caregivers, pharmacists). The educational materials will include: Educational brochure for physicians Educational brochure for nurses Educational brochure for patients and caregivers The sponsor proposes to provide the educational materials to health care professionals and to patients via health care professionals. They may also be supplied by the sponsor directly. In addition, according to the ASA, the sponsor proposes to conduct a market research study to measure the effectiveness of the educational program. The sponsor has committed to providing these results to the TGA and should do so as soon as practical after launch. Should reports of medication errors or serious adverse events occur, the sponsor will be
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