Sensitive drug distribution system and method

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. 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 . (canceled) 
     
     
         2 . A method, using a computer processor and an exclusive computer database, to control the distribution of a prescription drug that has a potential for misuse, abuse or diversion, wherein the prescription drug is sold or distributed by a company that obtained approval for distribution of the prescription drug, comprising:
 receiving into the computer processor and the exclusive computer database of the company that obtained approval for distribution of the prescription drug, for any and all patients being prescribed the company's prescription drug, any and all prescriptions for the company's prescription drug with the potential for abuse, misuse or diversion;   entering into the computer processor and the exclusive computer database information sufficient to identify the any and all patients for whom the company's prescription drug is prescribed;   entering into the computer processor and the exclusive computer database information sufficient to identify any and all physicians or other prescribers of the company's prescription drug and information to show that the any and all physicians or other prescribers are authorized to prescribe the company's prescription drug; and   entering into and maintaining with the computer processor and the exclusive computer database any information that indicates that a patient or a prescriber has abused, misused, or diverted the company's prescription drug;   wherein the computer processor checks for abuse with the exclusive computer database by transforming prescription data, patient data, and prescriber data into one or more queries to access data in the exclusive computer database that relates to abuse, misuse, or diversion, the queries indicating whether investigatable abuse, misuse, or diversion has occurred; and   wherein the computer processor controls the distribution of the company's prescription drug based upon the transformation of the prescription data, patient data, and prescriber data in response to the checking for abuse, misuse, or diversion, and authorizes filling of a prescription for the company's prescription drug if there is no record of an incident that indicates abuse, misuse, or diversion by the patient and the prescriber, and if there is a record of such incident, the exclusive computer database indicates that such incident has been investigated, and the exclusive computer database indicates that such incident does not involve abuse, misuse or diversion.   
     
     
         3 . The method of  claim 2 , comprising delivering the prescription drug to the patient in order to treat the patient with the prescription drug. 
     
     
         4 . The method of  claim 2 , wherein a pharmacy enters data into the exclusive computer database. 
     
     
         5 . The method of  claim 2 , comprising selectively blocking shipment of the prescription drug to the patient. 
     
     
         6 . The method of  claim 2 , wherein an abuse pattern is associated with the patient, and shipment of the prescription drug is blocked based upon such association. 
     
     
         7 . The method of  claim 2 , wherein the prescription drug comprises a gamma hydroxy butyrate (GHB) drug product. 
     
     
         8 . The method of  claim 7 , wherein said GHB drug product treats cataplexy in the patient. 
     
     
         9 . A non-transitory computer readable medium comprising instructions to control distribution of a prescription drug that has a potential for misuse, abuse or diversion, wherein the prescription drug is sold or distributed by a company that obtained approval for distribution of the prescription drug, comprising:
 receiving into a computer processor and an exclusive computer database of the company that obtained approval for distribution of the prescription drug, for any and all patients being prescribed the company's prescription drug, any and all prescriptions for the prescription drug with the potential for abuse, misuse or diversion, the prescription drug sold or distributed under a single name in the United States;   entering into the computer processor and the exclusive computer database information sufficient to identify the patient for whom said prescription drug was prescribed;   entering into the computer processor and the exclusive computer database information sufficient to identify any and all physicians or other prescribers of said prescription drug and information to show that the any and all physicians or other prescribers are authorized to prescribe said prescription drug;   entering into and maintaining with the exclusive computer database any information that may suggest that the patient or the prescriber has abused, misused, or diverted said prescription drug; and   checking for abuse with the computer processor and the exclusive computer database by processing and tracking prescription data, patient data, and prescriber data to determine whether investigatable abuse, misuse, or diversion has occurred, and controlling the distribution of said prescription drug based upon the processing and tracking of the prescription data, patient data, and prescriber data and in response to the checking for abuse, misuse, or diversion, and authorizing filling of prescriptions for said prescription drug if there is no record of an incident that may suggest abuse, misuse, or diversion by the patient and the prescriber, and if there is a record of such incident, the computer database indicates that such incident has been investigated, and the computer database indicates that such incident does not involve abuse, misuse or diversion.   
     
     
         10 . The non-transitory computer-readable medium of  claim 9 , comprising instructions for delivering the prescription drug to the patient in order to treat the patient with the prescription drug. 
     
     
         11 . The non-transitory computer-readable medium of  claim 9 , comprising instructions for an exclusive central pharmacy to enter data into the exclusive computer database. 
     
     
         12 . The non-transitory computer-readable medium of  claim 9 , comprising instructions for selectively blocking shipment of the prescription drug to the patient. 
     
     
         13 . The non-transitory computer-readable medium of  claim 9 , comprising instructions for associating an abuse pattern with the patient, and comprising instruction for blocking shipment of the prescription drug based upon such association. 
     
     
         14 . The non-transitory computer-readable medium of  claim 9 , wherein the prescription drug comprises a gamma hydroxy butyrate (GHB) drug product. 
     
     
         15 . The non-transitory computer-readable medium of  claim 14 , wherein said GHB drug product treats cataplexy in said patient. 
     
     
         16 . A non-transitory computer-readable medium comprising instructions to control distribution of a prescription drug that has a potential for misuse, abuse or diversion, wherein the prescription drug is sold or distributed by a company that obtained approval for distribution of the prescription drug, comprising:
 receiving into a computer processor and an exclusive computer database of the company that obtained approval for distribution of the prescription drug, any and all prescriptions for the company's prescription drug from any and all patients being prescribed the company's prescription drug, wherein the company's prescription drug has been manufactured at a single manufacturing site, and wherein the company's prescription drug has the potential for abuse, misuse or diversion;   entering into the computer processor and the exclusive computer database information sufficient to identify the patient for whom the company's prescription drug was prescribed;   entering into the computer processor and the exclusive computer database information sufficient to identify any and all physicians or other prescribers of the company's prescription drug and information to show that the any and all physicians or other prescribers were authorized to prescribe the company's prescription drug;   entering into and maintaining with the computer processor and the exclusive computer database any information that may suggest that the patient or a prescriber has abused, misused, or diverted the company's prescription drug;   checking for abuse with the computer processor and the exclusive computer database by querying, monitoring, and verifying prescription data, patient data, and prescriber data to access relational data in the exclusive computer database relating to abuse, misuse, or diversion to determine whether investigatable abuse, misuse, or diversion has occurred, and controlling the distribution of said prescription drug based upon the querying, monitoring, and verifying of the prescription data, patient data, and prescriber data and in response to the checking for abuse, misuse, or diversion, and authorizing filling of the prescription for the company's prescription drug if there is no record of an incident that may suggest abuse, misuse, or diversion by the patient and the prescriber, and if there is a record of such incident, the computer database indicates that any such incident has been investigated and found not to involve abuse, misuse or diversion; and   providing the company's prescription drug to the patient in order to treat the patient with the company's prescription drug;   wherein the company's prescription drug that has the potential for misuse, abuse or diversion is a gamma hydroxybutyrate (GHB) drug product; and   wherein said GHB drug product treats cataplexy in said patient.   
     
     
         17 . The non-transitory computer-readable medium of  claim 16 , comprising instructions for an exclusive central pharmacy to enter data into the exclusive computer database. 
     
     
         18 . The non-transitory computer-readable medium of  claim 16 , comprising instructions for selectively blocking shipment of the prescription drug to the patient. 
     
     
         19 . The non-transitory computer-readable medium of  claim 16 , comprising instructions for associating an abuse pattern with the patient, and comprising instructions for blocking shipment of the prescription drug based upon such association. 
     
     
         20 . A method, using a computer processor and an exclusive computer database, to control distribution of a single prescription drug that has a potential for misuse, abuse or diversion, comprising:
 receiving into the computer processor and the exclusive computer database of a company that obtained approval for distribution of the single prescription drug and storing in a computer memory of the company that obtained approval for distribution of the single prescription drug, any and all prescriptions for the single prescription drug received at a pharmacy and sold or distributed by the company that obtained approval for distribution of the single prescription drug, the single prescription drug having the potential for abuse, misuse or diversion, wherein the pharmacy is permitted to distribute the single prescription drug based on two or more of the following: processing of a prescription enrollment form for the single prescription drug; agreeing to document adverse events relating to the single prescription drug; providing educational materials relating to the single prescription drug; and verifying that the single prescription drug is medically necessary;   entering into the computer processor and the computer memory information sufficient to identify the patient for whom the single prescription drug is prescribed;   entering into the computer processor and the computer memory information sufficient to identify any and all physicians or other prescribers of the single prescription drug and information to show that the any and all physicians or other prescribers are authorized to prescribe the single prescription drug, including verifying that the any and all prescribers' drug enforcement agency (DEA) number and state license are current and that there are no pending disciplinary actions against the any and all prescribers;   verifying two or more of the following with the computer processor prior to providing the single prescription drug to the patient: patient name; patient address; that the patient has received educational material regarding the single prescription drug; a quantity of the single prescription drug; and dosing directions for the single prescription drug; and   entering into and maintaining with the computer processor and the computer memory any information that indicates that the patient or a prescriber has abused, misused, or diverted the single prescription drug;   wherein the computer processor checks for abuse with the computer memory by processing and tracking prescription data, patient data, and prescriber data in the exclusive computer database relating to abuse, misuse, or diversion to determine whether investigatable abuse, misuse, or diversion has occurred; and   wherein the computer processor controls the distribution of the prescription drug based upon the processing and tracking of the prescription data, patient data, and prescriber data and in response to the checking for abuse, misuse, or diversion, and authorizes filling of the prescriptions for the single prescription drug if there is no record of an incident that indicates abuse, misuse, or diversion by the patient and the prescriber, and if there is a record of such incident, the computer memory indicates that such incident has been investigated, and the computer memory indicates that such incident does not involve abuse, misuse or diversion.   
     
     
         21 . The method of  claim 20 , comprising delivering the single prescription drug to the patient in order to treat the patient with the single prescription drug. 
     
     
         22 . The method of  claim 20 , wherein there is an exclusive central pharmacy that enters data into the computer memory. 
     
     
         23 . The method of  claim 20 , comprising selectively blocking shipment of the single prescription drug to the patient. 
     
     
         24 . The method of  claim 20 , wherein an abuse pattern is associated with the patient, and shipment of the single prescription drug is blocked based upon such association. 
     
     
         25 . The method of  claim 20 , wherein the single prescription drug comprises a gamma hydroxy butyrate (GHB) drug product. 
     
     
         26 . The method of  claim 25 , wherein said GHB drug product treats cataplexy in said patient. 
     
     
         27 . The method of  claim 2 , comprising identifying, with the computer processor, information relating to the prescriptions and the information relating to the patient, and using the information for reconciling inventory for the company's prescription drug before shipments for a time period are sent. 
     
     
         28 . The method of  claim 2 , wherein the exclusive computer database is associated with an exclusive central pharmacy, wherein inventory of the prescription drug is owned by the company, and wherein the inventory is consigned to the exclusive central pharmacy and managed by the exclusive central pharmacy. 
     
     
         30 . The method of  claim 2 , comprising generating periodic reports to evaluate potential diversion patterns. 
     
     
         31 . The method of  claim 2 , wherein the exclusive computer database of the company that obtained approval for distribution of the prescription drug is the only database in existence for the company's prescription drug, such that all prescriptions for the company's prescription drug are processed only by the exclusive computer database of the company. 
     
     
         32 . The method of  claim 2 , comprising determining that a patient is unable to pay for the prescription drug, and determining whether third party funds are available to pay for the prescription drug.