Claims for Patent: 6,315,720

Summary for Patent: 6,315,720

Title:	Methods for delivering a drug to a patient while avoiding the occurrence of an adverse side effect known or suspected of being caused by the drug
Abstract:	Improved methods for delivering to a patient in need of the drug, while avoiding the occurrence of an adverse side effect known or suspected of being caused by the drug are disclosed. The methods are of the type in which prescriptions for the drug are filled only after a computer readable storage medium has been consulted to assure that the prescriber, pharmacy and patient have been properly registered in the medium before the patient is approved to receive the drug. Embodiments are provided wherein the patients are assigned to risk groups based upon the risk that taking the drug will lead to the side effect, and certain additional information, such as periodic surveys and diagnostic tests probative of the ongoing risk of the side effect developing are obtained before prescriptions for the drug are approved.
Inventor(s):	Williams; Bruce A. (Flemington, NJ), Kaminski; Joseph K. (Hampton, NJ)
Assignee:	Celgene Corporation (Warren, NJ)
Application Number:	09/694,217
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 6,315,720
Patent Claims:	1. In a method for delivering a drug to a patient in need of the drug, while avoiding the occurrence of an adverse side effect known or suspected of being caused by said drug, wherein said method is of the type in which prescriptions for said drug are filled only after a computer readable storage medium has been consulted to assure that the prescriber is registered in said medium and qualified to prescribe said drug, that the pharmacy is registered in said medium and qualified to fill the prescription for said drug, and the patient is registered in said medium and approved to receive said drug, the improvement comprising: a. defining a plurality of patient risk groups based upon a predefined set of risk parameters for said drug; b. defining a set of information to be obtained from said patient, which information is probative of the risk that said adverse side effect is likely to occur if said drug is taken by said patient; c. in response to said information set, assigning said patient to at least one of said risk groups and entering said risk group assignment in said medium; d. based upon said information and said risk group assignment, determining whether the risk that said adverse side effect is likely to occur is acceptable; and e. upon a determination that said risk is acceptable, generating a prescription approval code to be retrieved by said pharmacy before said prescription is filled. 2. The method of claim 1 wherein, in response to said risk group assignment, said patient is counseled as to the risks of taking said drug and advised as to risk avoidance measures. 3. The method of claim 2 wherein said counseling comprises full disclosure of said risks. 4. The method of claim 3 wherein said prescription is filled only following said full disclosure and informed consent of said patient. 5. The method of claim 4 wherein said risk group assignment and said informed consent is verified by said prescriber at the time that said patient is registered in said computer readable storage medium. 6. The method of claim 5 wherein said risk group assignment and said informed consent is transmitted to said computer readable storage medium by facsimile and interpreted by optical character recognition software. 7. The method of claim 1 wherein said set of information includes the results of diagnostic testing. 8. The method of claim 7 wherein said diagnostic testing is probative of the onset of said adverse side effect. 9. The method of claim 7 wherein said diagnostic testing is probative of the concentration of said drug in a tissue of said patient. 10. The method of claim 7 wherein said diagnostic testing comprises genetic testing. 11. The method of claim 1 wherein said side effect is likely to arise in said patient. 12. The method of claim 1 wherein said side effect is likely to arise in a foetus carried by said patient. 13. The method of claim 1 wherein said side effect is likely to arise in a recipient or a foetus carried by a recipient of the bodily fluid of said patient. 14. The method of claim 13 wherein said recipient is a sexual partner of said patient. 15. The method of claim 1 further comprising: f. defining for each said risk group a second set of information to be collected from said patient on a periodic basis; g. obtaining said second set of information from said patient; and h. entering said second set of information in said medium before said patient is approved to receive said drug. 16. The method of claim 15 wherein said second set of information comprises a survey regarding said patient's behavior and compliance with said risk avoidance measures. 17. The method of claim 16 wherein said survey is conducted telephonically using an integrated voice response system. 18. The method of claim 16 wherein said patient is a female of childbearing potential and said second set of information comprises the results of a pregnancy test. 19. The method of claim 18 wherein said periodic interval comprises about 28 days. 20. The method of claim 1 further comprising providing said patient with a contraceptive device or formulation. 21. The method of claim 1 wherein said adverse side effect comprises a teratogenic effect. 22. The method of claim 1 wherein said drug is thalidomide. 23. The method of claim 21 wherein said teratogenic effect is likely to arise in a foetus carried by said patient. 24. The method of claim 21 wherein said teratogenic effect is likely to arise in a foetus carried by a recipient of the bodily fluid of said patient. 25. The method of claim 24 wherein said recipient of the bodily fluid of said patient is a sexual partner of said patient. 26. The method of claim 21 wherein said set of information includes the results of a pregnancy test. 27. The method of claim 26 wherein said prescription is filled for no more than about 28 days. 28. In a method for delivering a drug to a patient in need of the drug, while avoiding the occurrence of an adverse side effect known or suspected of being caused by said drug, wherein said method is of the type in which prescriptions for said drug are filled only after a computer readable storage medium has been consulted to assure that the prescriber is registered in said medium and qualified to prescribe said drug, that the pharmacy is registered in said medium and qualified to fill the prescription for said drug, and the patient is registered in said medium and approved to receive said drug, the improvement comprising: a. defining a plurality of patient risk groups based upon a predefined set of risk parameters for said drug; b. defining a set of information to be obtained from said patient, which information is probative of the risk that said adverse side effect is likely to occur if said drug is taken by said patient; c. in response to said information set, assigning said patient to at least one of said risk groups and entering said risk group assignment in said medium; d. based upon said information and said risk group assignment, determining whether the risk that said adverse side effect is likely to occur is acceptable; and e. upon a determination that said risk is acceptable, generating a prescription approval code to be retrieved by said pharmacy before said prescription is filled, wherein said adverse side effect is likely to arise in patients who take said drug in combination with at least one other drug. 29. The method of claim 28 wherein said set of information is also probative of the likelihood that said patient may take said drug and said other drug in combination. 30. The method of claim 28 wherein said set of information includes the results of diagnostic testing. 31. The method of claim 30 wherein said diagnostic testing comprises testing for evidence of the use of said other drug. 32. The method of claim 30 wherein said diagnostic testing comprises testing for evidence which is indicative of the onset of said adverse side effect.