Patent ID: 8719055

Claim:
A method for controlling a refilling of a drug to a patient to prevent off-label use of the subject drug comprising the steps of: (a) receiving a prescription for the drug for the patient, (b) entering information on the patient and the drug into a patient registry database, wherein the drug information comprises information sufficient to identify the drug and its labeler, strength and dosage form, (c) dispensing the drug in an N-of-1 test kit to the patient according to the prescription, (d) accessing an analysis report stored in the patient registry database, wherein: the analysis report is generated by a computer programmed to analyze data from the N-of-1 drug test kit stored in the patient registry database, the analysis report indicating whether the patient is receiving an intended labeled benefit from the drug specified by a manufacturer of the drug and by a government agency, (e) receiving a prescription for a refill of the drug, and (f) preventing off-label use of the drug by permitting dispensation of the refill to a patient who, based on the analysis report, is receiving the intended labeled benefit from the drug and restricting dispensation of the refill to a patient who, based on the analysis report, is not receiving the intended labeled benefit from the drug, wherein there are at least two patients, and at least one of the patients is engaging in off-label use, and not receiving the intended labeled benefit from the drug, and at least one of the patients is receiving the intended labeled benefit from the drug, and wherein the test kit and drug are associated by at least one identifying code number.