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|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)|
1. A method of treating a male patient having a disease or condition responsive to a teratogenic drug comprising permitting prescriptions for the drug to be filled by a pharmacy
only after the pharmacy has retrieved an approval code for the prescription, wherein the generation of the prescription approval code comprises the following steps: (a) via a computer readable storage medium, registering a prescriber and the pharmacy
with a distributor of a teratogenic drug; (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 the drug 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) via a computer readable storage medium, registering the patient with the distributor; and (g) upon obtaining the acknowledgement and registrations, generating via
a computer readable storage medium the prescription approval code to be retrieved by the pharmacy before the prescription is filled; and (h) upon retrieving a prescription approval code, administering the drug 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 the drug 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 the drug 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 the drug; (g) that the semen or blood must not be donated during the drug treatment; (h) that all of the patient's inquiries regarding the drug 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 drug 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 the drug, 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 prescription approval code is retrieved from a computer readable storage medium.
6. The method of claim 1, wherein the acknowledgement is a written informed consent.
7. The method of claim 6, wherein the written informed consent is registered in the medium prior to generation of the prescription approval code.