Claims for Patent: 6,561,977

Summary for Patent: 6,561,977

Title:	Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated
Abstract:	Methods for delivering a drug to a patients in need of the drug, while restricting access to the drug by patients for whom the drug may be contraindicated are disclosed. The methods are of the type in which prescriptions for the drug are filled by a pharmacy only after a computer readable storage medium has been consulted to retrieve a prescription approval code. Embodiments are provided wherein the patients are assigned to risk groups based upon the risk that taking the drug will lead to an adverse 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:	09/965,155
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 6,561,977
Patent Claims:	1. A method for delivering a drug to patients in need of the drug while restricting access to the drug by patients for whom the drug may be contraindicated, said method comprising permitting prescriptions for the drug to be filled by a pharmacy only after the pharmacy has retrieved an approval code for the prescription from a computer readable storage medium, wherein generation of the prescription approval code comprises the following steps: a. defining a plurality of patient risk groups based upon a predefined set of risk parameters for the drug; b. defining a set of information to be obtained from a patient, which information is probative of the risk that an adverse side effect is likely to occur if the drug is taken by the patient; c. in response to the information set, assigning the patient to at least one of the risk groups and entering the patient, the information and the patient's risk group assignment in the medium; d. based upon the information and the risk group assignment, determining whether the risk that the adverse side effect is likely to occur is acceptable; and e. upon a determination that the risk is acceptable, generating the prescription approval code to be retrieved by the pharmacy before the prescription is filled. 2. A method according to claim 1 further comprising registering in the medium the physician who prescribed the drug. 3. A method according to claim 1 further comprising registering the pharmacy in the medium. 4. The method of claim 1 further comprising counseling the patient as to the risks of taking the drug and advising the patient as to risk avoidance measures, in response to the risk group assignment. 5. The method of claim 4 wherein the counseling comprises full disclosure of the risks. 6. The method of claim 5 wherein the prescription is filled only following the full disclosure and informed consent of the patient. 7. The method of claim 6 wherein the informed consent is registered in the computer readable storage medium prior to generation of the prescription approval code. 8. The method of claim 7 wherein the risk group assignment and the informed consent is transmitted to the computer readable storage medium by facsimile and interpreted by optical character recognition software. 9. The method of claim 1 wherein the set of information includes the results of diagnostic testing. 10. The method of claim 9 wherein the diagnostic testing comprises genetic testing. 11. The method of claim 9 wherein the diagnostic testing is probative of the onset of the adverse side effect. 12. The method of claim 9 wherein the diagnostic testing is probative of the presence of a condition or disease for which the drug is contraindicated. 13. The method of claim 1 wherein the side effect is likely to arise in the patient. 14. The method of claim 1 wherein the side effect is likely to arise in a foetus carried by the patient. 15. The method of claim 1 wherein the side effect is likely to arise in a recipient or a foetus carried by a recipient of the bodily fluid of the patient. 16. The method of claim 15 wherein the recipient is a sexual partner of the patient. 17. The method of claim 1 further comprising: f. defining for each risk group a second set of information to be collected from the patient at periodic intervals; g. obtaining the second set of information from the patient; and h. entering the second set of information in the medium. 18. The method of claim 17 wherein the second set of information comprises a survey regarding the patient's behavior and compliance with the risk avoidance measures. 19. The method of claim 18 wherein the survey is conducted telephonically using an integrated voice response system. 20. The method of claim 17 wherein the patient is a female of childbearing potential and the second set of information comprises the results of a pregnancy test. 21. The method of claim 18 wherein the periodic interval comprises about 28 days. 22. The method of claim 1 further comprising providing the patient with a contraceptive device or formulation. 23. The method of claim 1 wherein the adverse side effect comprises a teratogenic effect. 24. The method of claim 23 wherein the drug is thalidomide. 25. The method of claim 23 wherein the teratogenic effect is likely to arise in a foetus carried by the patient. 26. The method of claim 23 wherein the teratogenic effect is likely to arise in a foetus carried by a recipient of the bodily fluid of the patient. 27. The method of claim 26 wherein the recipient of the bodily fluid of the patient is a sexual partner of the patient. 28. The method of claim 23 wherein the set of information includes the results of a pregnancy test. 29. The method of claim 28 wherein the prescription is filled for no more than about 28 days. 30. The method of claim 1 wherein the adverse side effect is likely to arise in patients who take the drug in combination with at least one other drug. 31. The method of claim 30 wherein the set of information is also probative of the likelihood that the patient may take the drug and the other drug in combination. 32. The method of claim 30 wherein the set of information includes the results of diagnostic testing. 33. The method of claim 32 wherein the diagnostic testing comprises testing for evidence of the use of the other drug. 34. The method of claim 32 wherein the diagnostic testing comprises testing for evidence which is indicative of the onset of the adverse side effect.