Method for distribution of a drug

A computer-implemented method of treating a plurality of patients having multiple sclerosis (MS) with natalizumab, wherein each patient is authorized to receive treatment with natalizumab responsive to an indication that the patient has not had progressive multifocal leukoencephalopathy (PML) and/or responsive to an indication that the patient does not have a contraindicated medical condition and/or responsive to an indication that the patient has not taken a contraindicated medication and has not received a contraindicated treatment, the method comprising, at a treatment site at which administration of natalizumab to treat the patient is authorized, administering natalizumab to treat each patient having a current authorization generated by a distributed system for tracking administration of natalizumab to each of the plurality of patients, the distributed system comprising a centralized administration system including a centralized computer and a database of patients, prescribers and treatment sites relating to the administration of natalizumab, and, at each authorized treatment site, the centralized administration system further comprising a computer system adapted to process the authorized patient, generation of the current authorization comprising, for each of the plurality of patients, prescribers and treatment sites relating to the administration of the natalizumab:

• (i) the centralized computer storing, within the database, an indication that a treatment site is an authorized treatment site;
• (ii) the centralized computer storing, within the database, an indication identifying whether one or more healthcare providers at an authorized treatment site has been trained on known risks, potential benefits, and appropriate use of natalizumab;
• (iii) the centralized computer creating, within the database, a patient record for each patient that receives treatment with natalizumab;
• (iv) the centralized computer creating, within the database, a prescriber record, the prescriber record indicating that a prescriber consents to provide, to an identified patient, natalizumab;
• (v) the centralized administration system enrolling, each of the plurality of patients, responsive to storing patient and prescriber record information by the centralized administration system, wherein the patient record information indicates the patient's consent to receive treatment with the anti-VLA-4 antibody, and wherein the prescriber record information indicates the prescriber's consent to provide the patient with natalizumab;
• (vi) the centralized administration system generating an indication, within the database, of an authorization of the patient as an authorized patient for treatment with natalizumab, responsive to the central administration system confirming that each of the patient record information and the prescriber record information is complete with respect to the patient's consent and the prescriber's consent;
• (vii) responsive to a confirmation, the centralized administration system generating an authorization form and a unique patient identifier for the authorized patient in the database of the centralized administration system, wherein the authorization form is valid for a maximum of six months;
• (viii) the computer system confirming enrollment of the authorized patient identified by the unique patient identifier in the centralized administration system;
• (ix) confirm, by the computer system responsive to communication with the centralized administration system, the computer system confirming authorization of the authorized patient for treatment with natalizumab;
• (x) the computer system completing complete, on the computer system, a treatment site checklist;
• (xi) responsive to completion of the treatment site checklist, the centralized administration system providing an indication of authorization to administer natalizumab intravenously to the authorized patient by the one or more healthcare providers at the authorized treatment site;
• (xii) treating the authorized patient by administering natalizumab at the authorized treatment site;
• and
• (xiii) the distributed system tracking administration of the natalizumab to at least 1,000 patients as each patient is treated at one of the plurality of treatment sites.