Claims for Patent: 8,626,531

Summary for Patent: 8,626,531

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 (Summit, NJ)
Application Number:	13/591,622
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,626,531
Patent Claims:	1. A system for communicating over a network with a pharmacist for authorizing delivery of a contraindicated drug to a patient, the patient pre-assigned to at least one risk group of a plurality of risk groups, the plurality of risk groups defined based on factors which indicate one or more risks of one or more adverse side effects if the patient receives the drug, the system comprising: a computer device including: a computer readable medium having stored therein the plurality of risk groups, the at least one risk group assignment, and registration information of the patient; the computer device configured to provide: an interface configured to receive an on-line transmission of a pharmacist prescription for the patient in order to dispense the contraindicated drug to the patient; a generator configured to generate a prescription approval code based on comparison of the on-line transmission of the pharmacist prescription for the patient with the registration information of the patient stored in the computer readable medium to confirm if the patient is registered, and based on comparison of the on-line transmission of the pharmacist prescription for the patient with the risk group assignment stored in the computer readable medium to determine if the patient is eligible to receive the contraindicated drug, such that the risk group assignment is based on a predefined set of risk parameters for the contraindicated drug; and an interface configured to send an on-line transmission to the pharmacist including the generated prescription approval code when the registered patient is eligible to receive the drug; wherein the pharmacist can proceed with dispensation of the drug to the patient on the basis of the generated prescription approval code once received. 2. The system of claim 1 further comprising the computer readable medium having stored thereon further information selected from the group comprising: registration of the pharmacist as qualified to fill a prescription for the drug and registration of a prescriber as qualified to prescribe the drug. 3. The system of claim 2, wherein the further information includes an informed consent of the patient for receiving the drug. 4. The system of claim 3, wherein the further information is compared with the drug request before generation of the prescription approval code. 5. The system of claim 4, wherein the patient registration information includes information selected from the group comprising: name; age; sex; mailing address; date of birth; specified prescriber for the drug; history of drug prescription; medical condition; medical patient history; and lifestyle. 6. The system of claim 4, wherein the drug is a teratogen intended for prescription for activity selected from the group comprising: disease diagnosis; disease cure; disease mitigation; disease treatment or prevention; and to affect the structure or function of the body of the patient. 7. The system of claim 4, wherein the one or more adverse side effects of the drug is selected from the group comprising: abnormality; defect; mutation; lesion; degeneration; and injury. 8. The system of claim 7, wherein an individual having the one or more risks of the one or more adverse side effects is selected from the group comprising: the patient, a foetus of the patient, and a foetus carried by a recipient of bodily fluid of the patient. 9. The system of claim 8, wherein the drug is one of a plurality of drugs available to the patient and the one or more risks of the one or more adverse side effects is defined in the risk group assignment as from a combination of the plurality of drugs. 10. The system of claim 1 further comprising additional communication over the network via on-line communication. 11. The system of claim 10 further comprising the interface including an integrated voice response system such that the network is a telecommunications network. 12. The system of claim 1 computer readable medium having stored thereon risk parameters assigned to the plurality of risk groups, such that the at least one risk group includes a risk parameter selected from the group comprising: female patients of child bearing potential; female patients of non-child bearing potential; sexually active male patients; sexually inactive male patients; patients to whom administration of the drug may be strictly contraindicated; factors influencing a likelihood that certain pre-existing conditions may exist; and factors indicating a likelihood of certain other drugs being used concomitantly with the drug. 13. The system of claim 12 further comprising the on-line transmission to the pharmacist such that the generated prescription approval code is omitted from the on-line transmission to the pharmacist and a request for additional information is included in the on-line transmission to the pharmacist, the additional information selected from the group comprising: a survey for a set of information to be collected from the patient that is probative of the one or more risks of the one or more adverse side effects to occur if the drug is provided to the patient; and a diagnostic test result associated with the patient. 14. The system of claim 13, wherein the diagnostic test result is selected from the group comprising: genetic test results; pregnancy test results; and evidence of use of another drug different from the drug of the on-line transmission of the pharmacist prescription. 15. The system of claim 13 further configured such that the least one risk group assigned to the patient defines the additional information for the request for additional information included in the on-line transmission to the pharmacist. 16. The system of claim 15, wherein the additional information is defined for updating parameters of the patient risk group assignment on a periodic basis. 17. The system of claim 16, wherein the providing of the additional information to the computer readable medium results in an update of the patient risk group assignment. 18. The system of claim 15 further comprising the interface configured for providing the generated approval code once the registered patient is deemed eligible to receive the drug in view of the update to the patient risk group assignment. 19. The system of claim 12, wherein the on-line transmission of the pharmacist prescription is selected from the group comprising: an initial prescription for the drug and a prescription refill for the drug. 20. The system of claim 19, wherein additional information when received by the interface in reply to the request for additional information is stored in the computer readable medium. 21. A method for communicating over a network with a pharmacist for authorizing delivery of a contraindicated drug to a patient, the patient pre-assigned to at least one risk group of a plurality of risk groups, the plurality of risk groups defined based on factors which indicate one or more risks of one or more adverse side effects if the patient receives the drug, the method comprising the steps of: accessing, using a computer device, a computer readable medium having stored thereon the plurality of risk groups, the at least one risk group assignment, and registration information for the patient in computer readable medium; receiving, using the computer device, an on-line transmission of a pharmacist prescription for the patient in order to dispense the contraindicated drug to the patient; comparing, using the computer device, the on-line transmission of the pharmacist prescription for the patient with the registration information of the patient stored in the computer readable medium to confirm if the patient is registered, and comparing of the on-line transmission of the pharmacist prescription for the patient with the risk group assignment stored in the computer readable medium to determine if the patient is eligible to receive the contraindicated drug, generating, using the computer device, a prescription approval code based on comparison of the on-line transmission of the pharmacist prescription for the patient if confirmed the registered patient is eligible to receive the drug; and sending, sing the computer device, an on-line transmission to the pharmacist including the generated prescription approval code when the registered patient is eligible to receive the drug; wherein the pharmacist can proceed with dispensation of the drug to the patient on the basis of the generated prescription approval code once received. 22. The method of claim 21 further comprising the step of storing further information selected from the group comprising: registration of the pharmacist as qualified to fill a prescription for the drug and registration of a prescriber as qualified to prescribe the drug. 23. The method of claim 22, wherein the further information includes an informed consent of the patient for receiving the drug. 24. The method of claim 23, wherein the further information is compared with the drug request before generation of the prescription approval code. 25. The method of claim 24, wherein the patient registration information includes information selected from the group comprising: name; age; sex; mailing address; date of birth; specified prescriber for the drug; history of drug prescription; medical condition; medical patient history; and lifestyle. 26. The method of claim 24, wherein the drug is a teratogen intended for prescription for activity selected from the group comprising: disease diagnosis; disease cure; disease mitigation; disease treatment or prevention; and to affect the structure or function of the body of the patient. 27. The method of claim 24, wherein the one or more adverse side effects of the drug is selected from the group comprising: abnormality; defect; mutation; lesion; degeneration; and injury. 28. The method of claim 27, wherein an individual having the one or more risks of the one or more adverse side effects is selected from the group comprising: the patient, a foetus of the patient, and a foetus carried by a recipient of bodily fluid of the patient. 29. The method of claim 28, wherein the drug is one of a plurality of drugs available to the patient and the one or more risks of the one or more adverse side effects is defined in the risk group assignment as from a combination of the plurality of drugs. 30. The method of claim 21 further comprising additional communication over the network via on-line communication. 31. The method of claim 30, wherein the receiving of the on-line transmission of the pharmacist prescription is via an integrated voice response system such that the network is a telecommunications network. 32. The method of claim 21 further comprising the step of storing risk parameters assigned to the plurality of risk groups, such that the at least one risk group includes a risk parameter selected from the group comprising: female patients of child bearing potential; female patients of non-child bearing potential; sexually active male patients; sexually inactive male patients; patients to whom administration of the drug may be strictly contraindicated; factors influencing a likelihood that certain pre-existing conditions may exist; and factors indicating a likelihood of certain other drugs being used concomitantly with the drug. 33. The method of claim 32 further comprising the step of omitting the generated prescription approval code from the on-line transmission to the pharmacist and including a request for additional information in the on-line transmission to the pharmacist, the additional information selected from the group comprising: a survey for a set of information to be collected from the patient that is probative of the one or more risks of the one or more adverse side effects to occur if the drug is provided to the patient; and a diagnostic test result associated with the patient. 34. The method of claim 33, wherein the diagnostic test result is selected from the group comprising: genetic test results; pregnancy test results; and evidence of use of another drug different from the drug of the on-line transmission of the pharmacist prescription. 35. The method of claim 33, wherein the least one risk group assigned to the patient defines the additional information for the request for additional information included in the on-line transmission to the pharmacist. 36. The method of claim 35 further comprising the step of using the additional information obtained from the patient for updating parameters of the patient risk group assignment on a periodic basis. 37. The method of claim 36 further comprising the step of using the additional information to update the patient risk group assignment. 38. The method of claim 35 further comprising the step of providing the generated prescription approval code once the registered patient is deemed eligible to receive the drug in view of the update to the patient risk group assignment. 39. The method of claim 32, wherein the on-line transmission of the pharmacist prescription is selected from the group comprising: an initial prescription for the drug and a prescription refill for the drug. 40. The method of claim 39 further comprising the step of storing the additional information in the computer readable medium when received in reply to the request for additional information.