Method for distribution of a drug

Abstract

A method of providing an anti-VLA-4 antibody to a patient.

Description

[0001]The application claims priority to U.S. Provisional Application No. 60 / 836,530, filed Aug. 9, 2006, which is hereby incorporated by reference.BACKGROUND[0002]The invention relates generally to methods and systems for drug distribution.SUMMARY[0003]The invention features methods and systems for distributing or providing a therapy, e.g., a drug. The drug can be a VLA-4 blocking agent, e.g., an anti-VLA-4 antibody, e.g., TYSABRI® (natalizumab) or an equivalent or similar antibody. Methods and systems of the invention are particularly useful for drugs which may weaken the immune system. The drug can be administered to treat a patient for a disorder mediated by VLA-4. The drug can be used to treat a patient having multiple sclerosis (MS), Crohn's disease, or a fibrotic condition. In a preferred embodiment the patient has relapsing MS. Methods and systems can include one or more of the steps or elements described herein.[0004]Accordingly, in one aspect, the invention features, a met...

AI Technical Summary

Benefits of technology

[0047](c) Does the patient have an unwanted side effect of the drug, a contraindicated condition, or a contraindicated treatment that you have not already reported to the central administrator?

Problems solved by technology

In a preferred embodiment authorization is necessary but not sufficient for allowing administration of the drug.

In a preferred embodiment authorization and satisfaction of treatment site review are necessary but not sufficient for administration.

Indication of the authorization, e.g., an authorization form generated in (2), is necessary but not sufficient to allow treatment.

Thus, in addition to having a current authorization for treatment, a number of issues are resolved before the treatment site can treat the patient.

Entry of the correct response into a field is required—if such entry does not occur, the computer will not allow passage to the next field or phase of completion.

The patient and prescriber form may be defective because it lacks a relevant entry, e.g., the signature by the prescriber or patient, or because it includes additional information not requested by the queries on the patient and prescriber form.

As discussed above, if a field is not correctly filled out in the computer, the computer will not generate an authorization form, e.g., a Notice of Patient Authorization Form.

As will be clear from the following discussion, the patient enrollment number found on the authorization form is necessary but not sufficient to allow treatment.

Prescribers and their patients should know that TYSABRI® is associated with an increased risk of PML, which usually causes death or severe disability.

In addition, based on limited data, use of TYSABRI® in combination with antineoplastic, immunosuppressant or immunomodulatory agents may further increase the risk of PML compared to TYSABRI® monotherapy.

Failure to provide the requested information or otherwise comply with the requirements of the TOUCH Prescribing Program may result in discontinuation of TYSABRI® treatment for this patient and forfeiture of my authorization to prescribe TYSABRI®I have received educational materials regarding the benefits and risks of TYSABRI® treatmentI have, or another healthcare provider under my direction has, educated this patient on the benefits and risks of treatment with TYSABRI®, provided him or her with the Patient Medication Guide and Enrollment Form, instructed him or her to read these materials, and encouraged him or her to ask questions when considering TYSABRI®

By signing the Prescriber / Patient Enrollment Form, prescribers will acknowledge that a significant pattern of non-compliance with the requirements of the RiskMAP may result in his or her de-enrollment from the TOUCH Prescribing Program and forfeiture of authorization to prescribe TYSABRI®.

Significant non-compliance on the part of the infusion site may result in de-enrollment of the infusion site and forfeiture of the authorization to administer TYSABRI® (see Section 10.3.2 for De-Enrollment Process).

Significant non-compliance with these requirements on the part of the prescriber may result in de-enrollment of the prescriber and forfeiture of the authorization to prescribe TYSABRI®, after review by the TYSABRI® Compliance Review Committee (See Section 10.3.2).

Similarly, a persistent pattern of non-compliance on the part of the infusion site may result in de-enrollment of the infusion site and forfeiture of the authorization to administer TYSABRI®, after review by the Compliance Review Committee (described in Section 10.1 and 10.3.2).

Inventory Tracking logs must be kept for at least 5 years from the date of the final log entry.I understand that, per the requirements of the TOUCH Prescribing Program, this central pharmacy may be audited by the Food and Drug Administration (FDA), Biogen Idec, Elan Pharmaceuticals, Inc., and / or a third party designated by the FDA, Biogen Idec, or Elan Pharmaceuticals, Inc.Noncompliance with the requirements of the TOUCH Prescribing Program may result in de-enrollment of the central pharmacy and forfeiture of the authorization to dispense TYSABRI®

A significant pattern of non-compliance with these requirements on the part of the prescriber may result in de-enrollment of the prescriber and forfeiture to prescribe TYSABRI®, upon review by the Compliance Review Committee.

These infections are frequently severe, prolonged or disseminated.

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