|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 (Summit, NJ) |
1. A method for treating a patient having a disease or condition which is responsive to thalidomide while restricting access to thalidomide for patients for whom thalidomide may
be contraindicated, the method comprising permitting prescriptions for thalidomide to be filled by a pharmacy only after the pharmacy has become aware of the generation of a prescription approval code for thalidomide for the patient from a computer
readable storage medium, the generation of said prescription approval code comprising 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, 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; c. 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 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 before the prescription is filled.
2. A method according to claim 1 further comprising registering in the medium the physician who prescribed said thalidomide.
3. A method according to claim 1 further comprising registering the pharmacy in the medium.
4. The method of claim 1 further comprising counseling the patient as to the risks of taking the drug and advising the patient as to risk avoidance measures, in response to the risk group assignment.
5. The method of claim 4 wherein the counseling comprises full disclosure of the risks.
6. The method of claim 5 wherein the prescription is filled only following said full disclosure.
7. The method of claim 6 wherein the fact of said full disclosure is registered in the computer readable storage medium prior to generation of the prescription approval code.
8. The method of claim 7 wherein the risk group assignment and the fact of said full disclosure is transmitted to the computer readable storage medium by facsimile and interpreted by optical character recognition software.
9. The method of claim 1 further comprising: f. defining for each risk group a second set of information to be collected from the patient at periodic intervals; g. obtaining the second set of information from the patient; and h. entering the
second set of information in the medium.