Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated
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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
30 Claims
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1-19. -19. (canceled)
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20. A method of distributing a drug, comprising:
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a. receiving data from a prescriber for the drug, said data comprising information identifying a patient, the drug, and the prescriber;
b. entering the data into a computer database;
c. confirming the ability of the prescriber to prescribe the drug;
d. confirming that patient educational materials have been read;
e. generating periodic reports regarding distribution of the drug via the computer database; and
f. generating a prescription approval code for the drug comprising the following steps;
(i). defining a plurality of patient risk groups based upon a predefined set of risk parameters for the drug;
(ii). defining a set of information to be obtained from the patient, said set of information comprising the result of a determination of the ability of the patient to become pregnant and optionally comprising a determination that the patient is either (1) not currently pregnant or (2) currently pregnant;
(iii). in response to said information set, assigning the patient to at least one of said risk groups and entering the patient, the information and the patient'"'"'s risk group assignment into the database;
(iv). based upon the information and the risk group assignment, determining whether the risk that an adverse side effect is likely to occur is acceptable; and
(v). upon a determination that the risk is acceptable, generating the prescription approval code before a prescription is filled. - View Dependent Claims (21, 22, 23, 24, 25, 26, 27, 28, 29, 30)
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Specification