Control system for control of distribution of medication

Abstract

A system of controlling distribution of a medication in the treatment or prevention of epilepsy is provided. A central controller of the system has a data store and one or more processors for reading and writing data to the data store. The data store comprises a database of patient records, each patient record having a medication authorization field. The central controller can output an authorization of a first prescription of epilepsy medication to a patient in dependence upon genetic test results for the patient and schedules a subsequent test for the patient prior to authorization of a subsequent prescription of epilepsy medication. Also provided are methods in which the subject systems find use. The systems and methods find use in the treatment of severe subtypes of epilepsy or refractory epilepsy, such as Dravet Syndrome.

1 .- 15 . (canceled) 
     
     
         16 . A method of treating a patient having Dravet Syndrome with fenfluramine or a pharmaceutically acceptable salt thereof, comprising:
 approving a prescriber by a process comprising the steps of:   ensuring the prescriber knows the cardiovascular risks of treating a patient with fenfluramine or a pharmaceutically acceptable salt thereof;   requiring the prescriber to agree to provide information regarding cardiovascular risks of treating a patient with fenfluramine or a pharmaceutically acceptable salt thereof to the patient;   requiring the prescriber to agree to provide information to the patient on the need to obtain an echocardiogram before initiating treatment with fenfluramine or a pharmaceutically acceptable salt thereof;   requiring the prescriber to agree to provide information to the patient on the need to obtain an echocardiogram of the patient's heart periodically during treatment with fenfluramine;   or a pharmaceutically acceptable salt thereof; and   requiring the prescriber to complete an enrollment form, the enrollment form including a certification by the prescriber that the prescriber:   knows the cardiovascular risks associated with treating a patient with fenfluramine or a pharmaceutically acceptable salt thereof;   will provide information regarding the cardiovascular risks of treating a patient with fenfluramine or a pharmaceutically acceptable salt thereof to the patient;   will provide information to the patient on the need to obtain an echocardiogram of the patient's heart before initiating treatment with fenfluramine or a pharmaceutically acceptable salt thereof;   will provide information to the patient on the need to obtain an echocardiogram of the patient's heart periodically during treatment with fenfluramine or a pharmaceutically acceptable salt thereof;   storing the prescriber enrollment form in a central database;   approving the patient by a process comprising the steps of:   requiring the patient to receive information regarding the cardiovascular risks of treatment with fenfluramine or a pharmaceutically acceptable salt thereof;   requiring the patient to receive information regarding an echocardiogram of the patient's heart prior to treatment with fenfluramine or a pharmaceutically acceptable salt thereof;   requiring the patient to receive information regarding a need to obtain periodically an echocardiogram of the patient's heart during treatment with fenfluramine or a pharmaceutically acceptable salt thereof;   requiring the patient to complete an enrollment form, the enrollment form including a certification by the patient that the patient will:   review information from the prescriber regarding the cardiovascular risks of treatment with fenfluramine or a pharmaceutically acceptable salt thereof;   obtain an echocardiogram of the patient's heart prior to treatment with fenfluramine or a pharmaceutically acceptable salt thereof;   obtain an echocardiogram of the patient's heart periodically during treatment with fenfluramine or a pharmaceutically acceptable salt thereof;   storing the patient enrollment form in a central database;   storing a physician's analysis from the echocardiogram of whether fenfluramine or a pharmaceutically acceptable salt thereof treatment presents acceptable risks in the central database; and   approving a patient only if the physicians' analysis from the echocardiogram concludes that treatment present acceptable risks;   approving one or more pharmacies by a process comprising the steps of:   requiring the pharmacies to complete an enrollment form, the enrollment form including a certification by the pharmacies that the pharmacies will only fill prescriptions from approved prescribers to approved patients who have received an echocardiogram prior to treatment; and   storing the pharmacies' enrollment form in a central database;   permitting distribution of fenfluramine or a pharmaceutically acceptable salt thereof from a pharmacy and prescribed by a prescriber to the patient having Dravet Syndrome by a process comprising the steps of:   querying the central database to determine if the patient is approved; querying the central database to determine if the prescriber is approved; querying the central database to determine if the pharmacy is approved; and only allowing distribution of fenfluramine or a pharmaceutically acceptable salt thereof from the pharmacy to the patient if in the central database, the patient is approved, the prescriber is approved and the pharmacy is approved.   
     
     
         17 . The method of  claim 16 , further comprising:
 re-approving a patient by a process comprising the steps of:   obtaining an additional echocardiogram of the patient's heart during treatment with fenfluramine or a pharmaceutically acceptable salt thereof;   obtaining an analysis of the echocardiogram of the patient's heart to confirm that the patient is suitable for further treatment with fenfluramine or a pharmaceutically acceptable salt thereof;   storing the analysis from the echocardiogram of the patient's heart in the central database;   permitting continued distribution of fenfluramine or a pharmaceutically acceptable salt thereof from a pharmacy and prescribed by a prescriber to the patient having Dravet Syndrome by a process comprising the steps of:   querying the central database to determine if the patient is approved; querying the central database to determine if the prescriber is approved;   querying the central database to determine if the pharmacy is approved; and   only allowing distribution of fenfluramine or a pharmaceutically acceptable salt thereof from the pharmacy to the patient if in the central database, the patient is approved, the prescriber is approved, and the pharmacy is approved.   
     
     
         18 . The method of  claim 16 , wherein:
 the central database comprises patient records including address details for the patient, each patient record having a medication authorization field for entering a first prescription of fenfluramine or a pharmaceutically acceptable salt thereof.   
     
     
         19 . The method of  claim 16 , wherein:
 the central database comprises one or more processors coupled to a communication network, coupled to a data storage facility to read and write data to the data storage facility via the communication network.   
     
     
         20 . The method of  claim 16 , wherein:
 the central database is programed to monitor drug inventory in a drug storage facility and further programed to control dispatch of fenfluramine or a pharmaceutically acceptable salt thereof from the drug storage facility.   
     
     
         21 . The method of  claim 16 , wherein:
 the central database controls transmission and receipt of data to and from the data storage facility via the network, and acts as a centralized pharmacy for the medication, and confirms receipt of the fenfluramine or a pharmaceutically acceptable salt thereof at the patient address.   
     
     
         22 . The method of  claim 16 , wherein:
 the central database is programed to output via the network a first authorization of a first prescription of fenfluramine or a pharmaceutically acceptable salt thereof to a specific patient previously subjected to a first echocardiographic imaging test;   wherein output of authorization is dependent upon results of the first echocardiographic imaging test.   
     
     
         23 . The method of  claim 16 , wherein:
 the central database is further programed to output a time period over which use of the fenfluramine or a pharmaceutically acceptable salt thereof by a patient is authorized and to schedule a subsequent echocardiograph imaging for the patient-which subsequent tests results for the patient are required to be received before authorizing additional fenfluramine or a pharmaceutically acceptable salt thereof for the patient.   
     
     
         24 . The method of  claim 16 , wherein:
 the central database is further programed to take an action dependent upon subsequent test results selected from authorizing an additional prescription, a change to the prescription and output of a proposal for cessation of the prescription.