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|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)|
|Filing Date:||Mar 07, 2003|
|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.|
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