distribution system should be included in the ASA. A condition of registration Actelion confirms that in This is acceptable was imposed on approval of addition to the PSUR, a regular from an RMP the Dupuytren’s indication in report pertaining to the success perspective. Australia that the sponsor of the controlled distribution was required to regularly system will be forwarded to the report to the TGA about the TGA. success of the controlled distribution system. It is recommended that a similar requirement be imposed by the Delegate for this indication. In the Dosage and The education and training will This is similar to Administration section of the what is in for be linked to a Prescriber PI it states that should Certification Program. the Dupuytren’s ‘Xiaflex be administered by a Prescribers will be Certified contracture physician appropriately after they have undertaken indication and is acceptable from an trained in the correct either a peer-to-peer training administration of the product session or satisfactorily RMP perspective. and experienced in the completed the Web-based diagnosis and treatment of training program. The male urological disease’. A controlled distribution system sponsor should provide will ensure that only Certified information in the ASA as to Prescribers will be able to how this will be ensured as receive product from Actelion’s part of the controlled authorised Distributor. The distribution system. pharmacy ordering process will be tailored to ensure that specific personal information on the prescriber is supplied by the ordering pharmacy at the time product is ordered from the Distributor. Every order received by the Distributor will be checked against the Certified Prescriber List database prior to shipping product to pharmacy. Product will only be shipped to prescribers whose name appears on the Certified Prescriber List. Where the prescriber’s name is not on the Certified Prescriber List, the Distributor will withhold shipment of product and notify the pharmacy that the prescriber needs to undertake Actelion’s education and training program to enable Certification and subsequent receipt of product.
distribution system should be included in the ASA. A condition of registration was imposed on approval of the Dupuytren’s indication in Australia that the sponsor was required to regularly report to the TGA about the success of the controlled distribution system. It is recommended that a similar requirement be imposed by the Delegate for this indication. Actelion confirms that in addition to the PSUR, a regular report pertaining to the success of the controlled distribution system will be forwarded to the TGA. This is acceptable from an RMP perspective. In the Dosage and Administration section of the PI it states that ‘Xiaflex should be administered by a physician appropriately trained in the correct administration of the product and experienced in the diagnosis and treatment of male urological disease’. The sponsor should provide information in the ASA as to how this will be ensured as part of the controlled distribution system. The education and training will be linked to a Prescriber Certification Program. Prescribers will be Certified after they have undertaken either a peer-to-peer training session or satisfactorily completed the Web-based training program. A controlled distribution system will ensure that only Certified Prescribers will be able to receive product from Actelion’s authorised Distributor. The pharmacy ordering process will be tailored to ensure that specific personal information on the prescriber is supplied by the ordering pharmacy at the time product is ordered from the Distributor. Every order received by the Distributor will be checked against the Certified Prescriber List database prior to shipping product to pharmacy. Product will only be shipped to prescribers whose name appears on the Certified Prescriber List. Where the prescriber’s name is not on the Certified Prescriber List, the Distributor will withhold shipment of product and notify the pharmacy that the prescriber needs to undertake Actelion’s education and training program to enable Certification and subsequent receipt of product. This is similar to what is in for the Dupuytren’s contracture indication and is acceptable from an RMP perspective.