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Methods For Delivering A Drug To A Patient While Restricting Access To The Drug By Patients For Whom The Drug May Be Contraindicated

  • US 20110082707A1
  • Filed: 12/13/2010
  • Published: 04/07/2011
  • Est. Priority Date: 10/23/2000
  • Status: Active Grant
First Claim
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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:

  • (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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