Sensitive drug distribution systems and methods

Abstract

A drug distribution system and method utilizes a central pharmacy and database to track all prescriptions for a sensitive drug. Information is kept in the database regarding all physicians allowed to prescribe the sensitive drug, and all patients receiving the drug. Abuses are identified by monitoring data in the database for prescription patterns by physicians and prescriptions obtained by patients and/or caregivers. Further verification is made that the physician is eligible to prescribe the drug by consulting a separate database, and optionally whether any actions are taken against the physician. Multiple controls beyond those for normal drugs are imposed on the distribution depending on the sensitivity of the drug.

1 . A computer-implemented system for distribution of a prescription drug that has a potential for abuse, misuse, or diversion, comprising:
 one or more computer memories for storing a central computer database and for receiving prescriptions from any and all patients being prescribed the prescription drug, said central computer database having a database schema that contains and interrelates prescription fields, patient fields, caregiver fields, and prescriber fields;   said central computer database being distributed over multiple computers;   said prescription fields, contained within the database schema, storing prescriptions for the prescription drug with the potential for abuse, misuse, or diversion;   said patient fields, contained within the database schema, storing information sufficient to identify a patient for whom the prescription drug is prescribed;   said caregiver fields, contained within the database schema, storing information sufficient to identify a caregiver associated with the patient;   said prescriber fields, contained within the database schema, storing information sufficient to identify any and all physicians or other prescribers of the prescription drug and information to show that the physicians or other prescribers are authorized to prescribe the prescription drug;   one or more data processors for processing one or more database queries that operate over data related to the prescription fields, prescriber fields, patient fields, and caregiver fields;   said one or more database queries checking for abuse, misuse, or diversion within the central computer database, wherein the filling of the prescriptions is authorized for the prescription drug only if there is no record of incidents that indicate abuse, misuse, or diversion by the patient, caregiver, or prescriber, and if there is a record of such incidents, the central computer database indicates that such incidents have been investigated, and the central computer database indicates that such incidents do not involve abuse, misuse or diversion.   
     
     
         2 . The computer-implemented system of  claim 1 , wherein the prescription drug is sold or distributed by a company that obtained approval for distribution of the prescription drug. 
     
     
         3 . The computer-implemented system of  claim 1 , wherein the one or more database queries are processed by the one or more data processors for identifying that the patient or the caregiver associated with the patient is a cash payer and for identifying a physician that is interrelated with the patient through the schema of the single computer database; and
 wherein said identifying that the patient or the caregiver associated with the patient is a cash payer indicates potential abuse, misuse, or diversion by the patient or the caregiver associated with the patient and is used to notify the physician that is interrelated with the patient through the schema of the single computer database.   
     
     
         4 . The computer-implemented system of  claim 1 , wherein the one or more database queries operate over all data relating to said prescription fields, prescriber fields, patient fields, and caregiver fields over the multiple computers. 
     
     
         5 . The computer-implemented system of  claim 1 , wherein the central computer database is used to identify a current pattern or an anticipated pattern of abuse, misuse; or diversion of the prescription drug; and
 wherein the current pattern or the anticipated pattern is identified using periodic reports generated on a regular basis from the central computer database.   
     
     
         6 . The computer-implemented system of  claim 1 , wherein current inventory is cycle counted and reconciled with database quantities before shipments for a day or other time period are sent. 
     
     
         7 . The computer-implemented system of  claim 1 , wherein the one or more data processors are operable to communicate with a computer processor of a drug dispensing device, and wherein the one or more data processors and the computer processor of the drug dispensing device exchange data relating to the prescriptions, the prescription drug, the patient, the caregiver, the physicians, the prescribers, prescription refills, and the one or more database queries relating to the abuse, misuse, or diversion. 
     
     
         8 . The computer-implemented system of  claim 7 , wherein the communication from the one or more data processors comprises a signal to control a locking mechanism on the drug dispensing device. 
     
     
         9 . The computer-implemented system of  claim 7 , wherein the communication from the one or more data processors comprises dosing information that can be stored in the dispenser. 
     
     
         10 . The computer-implemented system of  claim 7 , wherein the communication from the one or more data processors comprises a signal to control an indicator on the drug dispensing device. 
     
     
         11 . The computer-implemented system of  claim 7 , wherein the communication from the one or more data processors comprises a signal to control removal of an objectionable compound from the prescription drug by the drug dispensing device, including one or more of a date and a time of day during which the objectionable compound can be removed from the prescription drug. 
     
     
         12 . The computer-implemented system of  claim 7 , wherein the communication from the one or more data processors comprises a signal to control when a dose can be removed from the drug dispensing device. 
     
     
         13 . The computer-implemented system of  claim 7 , wherein the communication from the one or more data processors comprises a signal to control an alarm associated with the drug dispensing device to signal to the patient that it is time to take a second dosage of the prescription drug. 
     
     
         14 . The computer-implemented system of  claim 7 , wherein the communication from the one or more data processors relates to a registration of the drug dispensing device by the patient, and a tracking of usage of the drug dispensing device by the patient. 
     
     
         15 . The computer-implemented system of  claim 1 , wherein the one or more database queries determine that the patient is not associated with any caregiver, or that the patient is no longer associated with any caregiver; and preventing shipment of the prescription drug to the patient based on the determination. 
     
     
         16 . The computer-implemented system of  claim 15 , wherein the one or more database queries access the central computer database to determine if the patient has transitioned to a new caregiver; and restarting shipments to the patient when the patient has transitioned to the new caregiver. 
     
     
         17 . The computer-implemented system of  claim 1 , wherein the one or more database queries selectively block shipment of the prescription drug to the patient and the caregiver associated with the patient based on a determination of potential abuse by the patient or the caregiver associated with the patient. 
     
     
         18 . The computer-implemented system of  claim 1 , wherein the patient and the caregiver associated with the patient are residents of a same household, and wherein the computer processor associates potential abuse of the prescription drug with the same household. 
     
     
         19 . The computer-implemented system of  claim 1 , wherein the one or more database queries determine that potential abuse is associated with a formulation from a brand manufacturer or a formulation from a generic manufacturer. 
     
     
         20 . The computer-implemented system of  claim 1 , wherein the one or more database queries probe the caregiver fields associated with the caregiver associated with the patient upon a refill request, and counseling the caregiver associated with the patient, or other contact with the caregiver associated with the patient, to verify that the caregiver associated with the patient is still acting as the caregiver for the patient; and when the caregiver associated with the patient is no longer acting as the caregiver for the patient, selecting a new caregiver for the patient before the refill is filled.