Patent attributes
A method for delivering a to a patient a medical therapy, which was previously characterized as a high-risk medical therapy, with restricted distribution or access under one or more restricted access programs, including programs with little or no restricted access. The medical therapy previously required a restricted distribution program that included registration of the physician, patient, or distributor in a computer readable medium prior to distribution. The method involves providing to a distributor or third party reviewer prescription data authorizing distribution of the medical therapy to a specific patient in need of the medical therapy and confirming the patient is eligible to receive the medical therapy and understands the risks associated with the medical therapy by the distributor or third party reviewer. The distributor or third party reviewer determines the qualified patient's eligibility for access to the medical therapy determines if the patient is eligible independent of requiring a registration of either the physician, patient, or distributor, in a computer readable medium, or a validation code. Over time, the patient's risk level may be reassessed by the patient's physician, a distributor, or a third party reviewer. In addition, the medical therapy itself may be re-characterized to a lower or higher risk level, requiring the adjustment of the previously required controls placed on the product.
