Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug

• US 20040152960A1
• Filed: 01/22/2004
• Published: 08/05/2004
• Est. Priority Date: 08/28/1998
• Status: Active Grant

• Current Assignee: Celgene Corporation (Bristol-Myers Squibb Company)
• Original Assignee: Celgene Corporation (Bristol-Myers Squibb Company)
• Inventors: Elsayed, Marc, Williams, Bruce
• Granted Patent: US 6,908,432 B2
• Time in Patent Office: Days
• US Class Current: 600/300
• CPC Class Codes: A61P 15/18 Feminine contraceptives
• CPC Class Codes: A61P 39/00 General protective or antinoxious agents
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 70/40 relating to drugs, e.g. their side effects or intended usage
• CPC Class Codes: Y10S 128/92 Computer assisted medical diagnostics

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.

Claims

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.

2. The method of claim 1 wherein said contraceptive device is a condom.

3. The method of claim 1 wherein said prescription is for no more than about 28 days.

4. The method of claim 1 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.

5. The method of claim 1 further comprising providing said patient capable of becoming pregnant with contraception counseling.

6. The method of any preceding claim, further comprising providing said patient with a contraceptive device or formulation.

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:

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.

8. The method of claim 7 wherein said contraceptive device is a condom.

9. The method of claim 7 wherein said prescription is for no more than about 28 days.

10. The method of claim 7 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.

11. The method of claim 7 further comprising providing said patient capable of becoming pregnant with contraception counseling.

12. The method of as in any one of claims 7, 8, 9, 10 and 11, further comprising providing said patient with a contraceptive device or formulation.