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 of treatment of a patient with 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, using a computer processor, into a 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, using the computer processor, into the computer database, information sufficient to identify the any and all patients for whom the company's prescription drug is prescribed;   entering, using the computer processor, into the 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;   entering and maintaining, using the computer processor, in the computer database, information that indicates that a patient or a prescriber has abused, misused, or diverted the company's prescription drug; and   checking for abuse, using the computer processor and the computer database, and authorizing 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 computer database indicates that such incident has been investigated, and the 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 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 method of treatment of a patient with 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, using a computer processor, into a 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 trademark;   entering, using the computer processor, into the computer database, information sufficient to identify the patient for whom said prescription drug was prescribed;   entering, using the computer processor, into the 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 were authorized to prescribe said prescription drug;   entering and maintaining, using the computer processor, in the computer database, information that may suggest that the patient or the prescriber has abused, misused, or diverted said prescription drug;   checking for abuse, using the computer processor and the computer database, 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 method of  claim 9 , comprising delivering the prescription drug to the patient in order to treat the patient with the prescription drug. 
     
     
         11 . The method of  claim 9 , wherein a pharmacy enters data into the computer database. 
     
     
         12 . The method of  claim 9 , comprising selectively blocking shipment of the prescription drug to the patient. 
     
     
         13 . The method of  claim 9 , wherein an abuse pattern is associated with the patient, and shipment of the prescription drug is blocked based upon such association. 
     
     
         14 . The method of  claim 9 , wherein the prescription drug comprises a gamma hydroxy butyrate (GHB) drug product. 
     
     
         15 . The method of  claim 14 , wherein said GHB drug product treats cataplexy in said patient. 
     
     
         16 . A method of treatment of a patient with 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, using a computer processor, into a 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, using the computer processor, into the computer database, information sufficient to identify the patient for whom the company's prescription drug was prescribed;   entering, using the computer processor, into the 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 and maintaining, using the computer processor, in the computer database, information that may suggest that the patient or a prescriber has abused, misused, or diverted the company's prescription drug;   checking for abuse, using the computer processor and the computer database, 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 method of  claim 16 , wherein a pharmacy enters data into the computer database. 
     
     
         18 . The method of  claim 16 , comprising selectively blocking shipment of the prescription drug to the patient. 
     
     
         19 . The method of  claim 16 , wherein an abuse pattern is associated with the patient, and shipment of the prescription drug is blocked based upon such association. 
     
     
         20 . A method of treatment of a patient with a single prescription drug that has a potential for misuse, abuse or diversion, comprising:
 receiving, using a computer processor, into a computer database of a company that obtained approval for distribution of the prescription drug and storing in a computer memory of the company that obtained approval for distribution of the 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 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, using the computer processor, into the computer memory, information sufficient to identify the patient for whom the company's prescription drug is prescribed;   entering, using the computer processor, into the computer memory, 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, 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 using 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;   entering and maintaining, using the computer processor, in the computer memory, information that indicates that the patient or a prescriber has abused, misused, or diverted the company's single prescription drug; and   checking for abuse, using the computer processor and the computer memory, and authorizing filling of the prescriptions for the company's 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 a pharmacy 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, using 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.