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Claims for Patent: 6,561,976

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Claims for Patent: 6,561,976

Title: Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug
Abstract:Novel methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug. Embodiments are provided in which the involved prescribers, pharmacies and patients are registered in one or more computer databases. Embodiments are also provided in which registered patients receive counseling information concerning the risks attendant to foetal exposure to the drug. Male patients and female patients who are not pregnant may, in certain circumstances, receive the drug.
Inventor(s): Elsayed; Marc (Bridgewater, NJ), Williams; Bruce (Flemington, NJ)
Assignee: Celgene Corporation (Warren, NJ)
Application Number:09/964,068
Patent Claims: 1. A method for distributing a teratogenic drug to a patient in need of the drug while preventing foetal exposure to the drug, said method comprising: a. registering in a computer readable storage medium physicians permitted to prescribe said drug; b. providing said patient with counseling information concerning the teratogenic risks attendant to foetal exposure to said drug; c. obtaining the informed consent of said patient to receive said drug despite said risks; d. registering said patient in said medium, including information concerning the ability of said patient to become pregnant or to impregnate a female; e. upon a determination that said patient is capable of becoming pregnant, determining that said patient is not currently pregnant, and registering same in said medium; f. permitting said patient access to said drug only after consulting said medium to verify that said patient is either incapable of becoming pregnant or is not currently pregnant.

2. The method of claim 1 wherein said drug is thalidomide.

3. The method of claim 1 wherein said access to said drug is provided in the form of a prescription.

4. The method of claim 3, wherein said prescription is for no more than about 28 days.

5. The method of claim 3, wherein, before said prescription is refilled, said method further comprises: g. obtaining additional information regarding the likelihood that said patient may have become pregnant, and, based upon said additional information determining whether said patient could have become pregnant during the previous 28 days; and h. upon a determination that said patient could have become pregnant, administering a pregnancy test to verify that said patient is not currently pregnant, before said prescription is refilled.

6. The method of claim 1, further comprising providing said patient with contraception counseling.

7. The method of any one of claims 1-6, further comprising providing said patient with a contraceptive device or formulation.

8. A method for distributing a teratogenic drug to a patient in need of the drug while preventing foetal exposure to the drug, said method comprising: a. registering in a computer readable storage medium physicians permitted to prescribe said drug; b. providing said patient with counseling information concerning the teratogenic risks attendant to foetal exposure to said drug; c. obtaining the informed consent of said patient to receive said drug despite said risks; d. registering said patient in said medium, including information concerning the ability of said patient to become pregnant or to impregnate a female; e. upon a determination that said patient is capable of becoming pregnant, determining that said patient is not currently pregnant; f. permitting said patient access to said drug only after verifying that said patient is either incapable of becoming pregnant or is not currently pregnant.

9. The method of claim 8 wherein said drug is thalidomide.

10. The method of claim 8 wherein said access to said drug is provided in the form of a prescription.

11. The method of claim 10, wherein said prescription is for no more than about 28 days.

12. The method of claim 10, wherein, before said prescription is refilled, said method further comprises: g. obtaining additional information regarding the likelihood that said patient may have become pregnant, and, based upon said additional information determining whether said patient could have become pregnant during the previous 28 days; and h. upon a determination that said patient could have become pregnant, administering a pregnancy test to verify that said patient is not currently pregnant, before said prescription is refilled.

13. The method of claim 8, further comprising providing said patient with contraception counseling.

14. The method of any one of claims 8-13, further comprising providing said patient with a contraceptive device or formulation.

15. A method for distributing a teratogenic drug to a female patient in need of the drug while preventing fetal exposure to the drug, said method comprising: a. authorizing one or more pharmacies to fulfill prescriptions for said drug only after confirming that the patient is eligible to receive said drug, b. registering physicians authorized to prescribe said drug in a computer readable storage medium; and c. registering said patient in said computer readable storage medium; wherein said patient is deemed to be eligible to receive said drug if: 1. the patient has been counseled as to the danger of exposing a foetus to the teratogenic drug, and has given her informed consent to receive said drug; 2. the patient has been counseled to use at least two forms of birth control for at least about 4 weeks prior to initiation of treatment with said drug, and throughout the course of treatment; 3. the patient has tested negative for pregnancy for the month before, and for each month during treatment with said drug, and; 4. the prescription is for no more than about 28 days supply of said drug, and was written no more than about 7 days prior to being presented for fulfillment.

16. A method according to claim 15, wherein said teratogenic drug comprises thalidomide.
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