Methods For Delivering A Drug To A Patient While Restricting Access To The Drug By Patients For Whom The Drug May Be Contraindicated
First Claim
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 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 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.
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Accused Products
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.
30 Citations
7 Claims
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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:
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(a) via a 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 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. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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Specification