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Claims for Patent: 7,959,566

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Claims for Patent: 7,959,566

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 (Warren, NJ)
Application Number:11/437,551
Patent Claims: 1. A method of treating a male patient, suffering from erythema nodosum leprosum, with thalidomide, by permitting prescriptions for thalidomide to be filled by a pharmacy only after the pharmacy has retrieved a prescription approval code for the prescription, comprising the following steps: (a) via a non-transitory computer readable storage medium, registering a prescriber and the pharmacy with a distributor of thalidomide; (b) determining whether the patient is able to understand and carry out instructions; (c) upon determination that the patient is able to carry out the instructions, providing verbal and written warnings of the hazard of taking thalidomide and exposing fetus to the drug; (d) further providing verbal and written warnings of the risk of possible contraception failure and of the need to use barrier contraception when having sexual intercourse with women of child bearing potential; (e) obtaining acknowledgement of said warnings from the patient; (f) providing the prescription for thalidomide to the patient from the prescriber; (g) via a non-transitory computer readable storage medium, registering the patient with the distributor; (h) upon obtaining the acknowledgement and registrations, generating the prescription approval code, and via a non-transitory computer readable storage medium, retrieving the prescription approval code by the pharmacy before the prescription is filled; and (i) upon retrieving the prescription approval code, administering thalidomide to the patient.

2. The method of claim 1, wherein the acknowledgement requires the patient's acknowledgement of one or more of the following: (a) the understanding that thalidomide must not be taken if unprotected sex cannot be avoided; (b) the understanding of potential birth defects; (c) that the patient has been advised of the need for barrier contraception by the prescriber; (d) the obligation to inform the prescriber if the patient's sexual partner is suspected of becoming or being pregnant; (e) that thalidomide is solely for the use of the patient himself and must not be shared with any other person; (f) that the patient has read the information brochure or viewed the information film on thalidomide; (g) that the semen or blood must not be donated during the thalidomide treatment; (h) that all of the patient's inquiries regarding thalidomide treatment have been answered by the prescribing physician; or (i) the patient's understanding that participation in a survey and patient registry is required during the thalidomide treatment.

3. The method of claim 1 further comprising providing the patient, prior to generation of the approval code, with warnings of the side effects associated with administration of thalidomide, wherein said side effects are non-teratogenic side effects.

4. The method of claim 1 further comprising obtaining a written authorization by the prescriber prior to generation of the approval code.

5. The method of claim 1, wherein the acknowledgement is a written informed consent.
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