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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

DC
  • US 6,869,399 B2
  • Filed: 01/22/2004
  • Issued: 03/22/2005
  • Est. Priority Date: 10/23/2000
  • Status: Expired due to Term
First Claim
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1. A method for treating erythema nodosum leprosum using thalidomide while restricting access to thalidomide for patients for whom thalidomide may be contraindicated, said method comprising permitting prescriptions for thalidomide to be filled by a pharmacy only after the pharmacy has received an approval code for the prescription from a computer readable storage medium, wherein generation of the prescription approval code comprises the following steps:

  • a. defining a plurality of patient risk groups based upon a predefined set of risk parameters for thalidomide;

    b. defining a set of information to be obtained from the patient, which information is probative of the risk that an adverse side effect is likely to occur if thalidomide is taken by the patient;

    c. in response to the information set, assigning the patient to at least one of the risk groups and entering the patient, the information and the patient'"'"'s risk group assignment into the medium;

    d. based upon the information and the risk group assignment, determining whether the risk that the adverse side effect is likely to occur is acceptable; and

    e. upon a determination that the risk is acceptable, generating the prescription approval code to be received by the pharmacy before the prescription is filled.

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