Abstract: A system and methods are provided for delivering to a patient a substitute medical therapy with restricted distribution or access. One example is a medical therapy provider, such as a pharmacist, receiving a prescription for a medical therapy for a patient and describing these procedures and the substitute medical therapy to the patient. The patient and patient's prescribing physician will determine whether the proposed substitute medical therapy is desired and would be indicated for this patient, including obtaining data and informed consent from the patient. The method also provides a distributor or third party reviewer the prescription and certification from a qualified patient's physician, data and consent from a qualified patient, including an authorization for the substitute medical therapy and confirming the informed consent from a qualified patient by the distributor or a third party reviewer.

Abstract: 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.

Abstract: A system and methods are provided for delivering to a patient a substitute medical therapy with restricted distribution or access. One example is a medical therapy provider, such as a pharmacist, receiving a prescription for a medical therapy for a patient and describing these procedures and the substitute medical therapy to the patient. The patient and patient's prescribing physician will determine whether the proposed substitute medical therapy is desired and would be indicated for this patient, including obtaining data and informed consent from the patient. The method also provides a distributor or third party reviewer the prescription and certification from a qualified patient's physician, data and consent from a qualified patient, including an authorization for the substitute medical therapy and confirming the informed consent from a qualified patient by the distributor or a third party reviewer.