METHOD FOR DISTRIBUTION OF A DRUG

• US 20110184747A1
• Filed: 08/09/2007
• Published: 07/28/2011
• Est. Priority Date: 08/09/2006
• Status: Abandoned Application

• Current Assignee: Biogen MA Inc. (Biogen, Inc.)
• Original Assignee: Biogen MA Inc. (Biogen, Inc.)
• Inventors: Gill, Erika M., Bozic, Carmen, Francer, Jeffrey K., Kalinowski, Anissa
• Application Number:
  US12/376,697
• Publication Number:
  US 20110184747A1
• Time in Patent Office: Days
• US Class Current: 705/2
• CPC Class Codes: G06Q 10/083 Shipping
• CPC Class Codes: G06Q 50/22 Social work or social welfare, e.g. community support activities or counselling services
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 20/00 ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 70/40 relating to drugs, e.g. their side effects or intended usage
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

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

Claims

1. A method of providing an anti-VLA-4 antibody to a patient having relapsing MS comprising:

(1) collecting patient and prescriber information;

(2) reviewing said information or enrollment form, entering information into a record system, and generating an authorization;

(3) communicating the authorization generated in (2) to a treatment site; and

(4) conducting a treatment site review of a patient including

i. determining if the treatment site has a current authorization for treatment of the patient;

ii. confirming that the treatment site does not have notice that the patient is no longer authorized

iii. providing the patient with information about the drug;

iv. asking the patient if symptoms have worsened;

v. asking the patient if he/she has a contraindicated medical condition; and

vi. asking the patient if he/she has taken a contraindicated medication;

wherein an answer of no to iv, v, and vi allows administration of the drug to the patient and an answer of yes to one of iv, v, or vi requires prescriber override to administer the drug.

2. The method of claim 1, further comprising:

(5) upon expiration of an authorization, obtaining reauthorization for subsequent treatment prior to subsequent treatment, wherein reauthorization requires certification by the prescriber that

(a) the patient still under his/her care;

(b) the patient is alive;

(c) the patient has had no unwanted side effect of the drug, no contraindicated condition, or no contraindicated treatment that the prescriber has not already reported to the central administrator,

provided that if the prescriber reauthorizes the patient must still undergo the review in step (4) prior to receiving the drug.

3. The method of claim 1, wherein prior to each shipment of the drug, a distributor of the drug obtains a shipment authorization from the central administrator.

4. The method of claim 1, wherein said drug is shipped only to and administered only at authorized treatment sites.

5. The method of claim 1, wherein central pharmacies that dispense the drug to authorized treatment sites are enrolled in a tracking system.

6. The method of claim 1, wherein the central administrator systematically follows and actively solicits information on every patient that receives the drug regarding any adverse events.

7. The method of claim 1, further comprising administering said anti-VLA4 antibody.

8. The method of claim 1, wherein said anti-VLA4 antibody is natalizumab.

9. The method of claim 1, wherein the method is applied to at least 500 patients.

10. A system configured to allow the practice of the method of claim 1 comprising:

instructions for carrying out the method of claim 1;

a user interface for inputting a query; and

a processor for generating a query result.

11. The system of claim 10, wherein the method carried out by the system further comprises the following step:

(5) upon expiration of an authorization obtaining reauthorization for subsequent treatment prior to subsequent treatment, wherein reauthorization requires certification by the prescriber that

(a) the patient still under his/her care;

(b) the patient is alive;

(c) the patient has had no unwanted side effect of the drug, no contraindicated condition, or no contraindicated treatment that the prescriber has not already reported to the central administrator,

provided that if the prescriber reauthorizes the patient must still undergo the review in step (4) prior to receiving the drug.

12. The system of claim 10, wherein the method carried out by the system further requires that prior to each shipment of the drug, a distributor of the drug obtains a shipment authorization from the central administrator.

13. The system of claim 10, wherein the method carried out by the system further requires that said drug is shipped only to and administered only at authorized treatment sites.

14. The system of claim 10, wherein the method carried out by the system further requires that central pharmacies that dispense the drug to authorized treatment sites are enrolled in a tracking system.

15. The system of claim 10, wherein the method carried out by the system further requires that the central administrator systematically follows and actively solicits information on every patient that receives the drug regarding any adverse events.

16. The system of claim 10, wherein said anti-VLA4 antibody is natalizumab.

17. The system of claim 10, wherein said method is applied to at least 500 patients.

18. A computer program product tangibly embodied in an information carrier and comprising instructions that when executed by a processor provide for performance of the method of claim 1.

19. A database which includes a record all of the forms and information referred to in the method of claim 1 for a patient.

20. The database of claim 19, having records for at least 100 patients.