|Title:||Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug|
|Abstract:||Novel methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug. Embodiments are provided in which the involved prescribers, pharmacies and patients are registered in one or more computer databases. Embodiments are also provided in which registered patients receive counseling information concerning the risks attendant to foetal exposure to the drug. Male patients and female patients who are not pregnant may, in certain circumstances, receive the drug.|
|Inventor(s):||Elsayed; Marc (Bridgewater, NJ), Williams; Bruce (Flemington, NJ)|
|Assignee:||Celgene Corporation (Summit, NJ)|
1. A method of treating a male patient having a disease or condition responsive to a teratogenic drug comprising (A) permitting the drug to be distributed by a pharmacy only
after the pharmacy has received a prescription and (B) administering the drug to the patient, wherein the generation of the prescription 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 to be retrieved by the pharmacy before the drug is distributed.
2. The method of claim 1, wherein the acknowledgement requires the patient's acknowledgement of one or more of the following: (a) the understanding that the drug must not be taken if unprotected sex cannot be avoided; (b) the understanding of potential birth defects; (c) that the patient has been advised of the need for barrier contraception by the prescriber; (d) the obligation to inform the prescriber if the patient's sexual partner is suspected of becoming or being pregnant; (e) that the drug is solely for the use of the patient himself and must not be shared with any other person; (f) that the patient has read the information brochure or viewed the information film on the drug; (g) that the semen or blood must not be donated during the drug treatment; (h) that all of the patient's inquiries regarding the drug treatment have been answered by the prescribing physician; or (i) the patient's understanding that participation in a survey and patient registry is required during the drug treatment.
3. The method of claim 1 further comprising obtaining a written authorization by the prescriber.
4. The method of claim 1, wherein the acknowledgement is a written informed consent and wherein the pharmacy fills the prescription only upon patient's presentation of the written informed consent to the pharmacy.