Generated: April 30, 2017
|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 fetus 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 fetal 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 distributing a drug to a patient comprising identifying that the patient has disease or condition responsive to a drug that is contraindicated for fetal exposure
and permitting the drug to be distributed to the patient by a pharmacy only after the pharmacy has received a prescription wherein 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 a teratogenic drug; (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 contraception by the prescriber; (d) the obligation to inform the prescriber if the patient or patient's sexual partner is suspected of becoming or being pregnant; (e) that the drug is solely for the use of the patient 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.
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.