Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug
First Claim
1. A method for treating erythema nodosum leprosum using thalidomide while preventing foetal exposure, the method comprising permitting access to thalidomide only after becoming aware of approval of a prescription for thalidomide for the patient from a computer readable storage medium, the generation of the prescription approval comprising the following steps:
- a. registering in a computer readable storage medium physicians permitted to prescribe thalidomide;
b. providing said patient with counseling information concerning the teratogenic risks attendant to foetal exposure to thalidomide;
c. obtaining the informed consent of said patient to receive thalidomide 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 or capable of impregnating a female, determining that said patient is not currently pregnant or counseling said patient capable of impregnating a female to use a contraceptive device or formulation when engaging in sexual intercourse with a female, and registering same in said medium; and
f. permitting said patient access to thalidomide only after consulting said medium to verify that said patient is either incapable of becoming pregnant or is not currently pregnant, or if capable of impregnating a female, has been counseled to use a contraceptive device or formulation when engaging in sexual intercourse with a female.
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Accused Products
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.
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Citations
12 Claims
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1. A method for treating erythema nodosum leprosum using thalidomide while preventing foetal exposure, the method comprising permitting access to thalidomide only after becoming aware of approval of a prescription for thalidomide for the patient from a computer readable storage medium, the generation of the prescription approval comprising the following steps:
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a. registering in a computer readable storage medium physicians permitted to prescribe thalidomide;
b. providing said patient with counseling information concerning the teratogenic risks attendant to foetal exposure to thalidomide;
c. obtaining the informed consent of said patient to receive thalidomide 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 or capable of impregnating a female, determining that said patient is not currently pregnant or counseling said patient capable of impregnating a female to use a contraceptive device or formulation when engaging in sexual intercourse with a female, and registering same in said medium; and
f. permitting said patient access to thalidomide only after consulting said medium to verify that said patient is either incapable of becoming pregnant or is not currently pregnant, or if capable of impregnating a female, has been counseled to use a contraceptive device or formulation when engaging in sexual intercourse with a female. - View Dependent Claims (2, 3, 4, 5, 6)
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7. A method for treating a patient having a disease or condition which is responsive to thalidomide while preventing foetal exposure, the method comprising permitting access to thalidomide only after becoming aware of approval of a prescription for thalidomide for the patient from a computer readable storage medium, the generation of the prescription approval comprising the following steps:
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a. registering in a computer readable storage medium physicians permitted to prescribe thalidomide;
b. providing said patient with counseling information concerning the teratogenic risks attendant to foetal exposure to thalidomide;
c. obtaining the informed consent of said patient to receive thalidomide 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 or capable of impregnating a female, determining that said patient is not currently pregnant or counseling said patient capable of impregnating a female to use a contraceptive device or formulation when engaging in sexual intercourse with a female, and registering same in said medium; and
f. permitting said patient access to thalidomide only after consulting said medium to verify that said patient is either incapable of becoming pregnant or is not currently pregnant, or if capable of impregnating a female, has been counseled to use a contraceptive device or formulation when engaging in sexual intercourse with a female. - View Dependent Claims (8, 9, 10, 11, 12)
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Specification