Control system for control of distribution of medication

• US 10,452,815 B2
• Filed: 09/28/2015
• Issued: 10/22/2019
• Est. Priority Date: 09/29/2014
• Status: Active Grant

• Current Assignee: Zogenix International Limited (UCB SA)
• Original Assignee: Zogenix International Limited (UCB SA)
• Inventors: Stewart, Richard Alistair Balfour, Clarke, Anthony
• Primary Examiner(s): Holcomb, Mark
• Application Number:
  US14/867,862
• Publication Number:
  US 20160092652A1
• Time in Patent Office: 1,485 Days
• Field of Search: 705 2- 4
• CPC Class Codes: G06F 16/24573 using data annotations, e.g. user-defined metadata
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/13 delivered from dispensers
• CPC Class Codes: G16H 20/70 relating to mental therapies, e.g. psychological therapy or autogenous training
• CPC Class Codes: G16H 40/20 for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
• CPC Class Codes: G16H 40/67 for remote operation

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.

Claims

1. A system for controlling distribution of a fenfluramine or pharmaceutical acceptable salt thereof for treating symptoms of a designated subtype of epilepsy, the system comprising:

a data storage facility comprising a database of 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;

a central controller having one or more processors coupled to a communication network, which central controller is coupled to the data storage facility to read and write data to the data storage facility via the network;

a drug storage facility having fenfluramine or a pharmaceutically acceptable salt thereof stored therein;

wherein the central controller of the system is programed to monitor drug inventory in the drug storage facility and further programed to control dispatch of fenfluramine or a pharmaceutically acceptable salt thereof from the drug storage facility; and

wherein the central controller 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,

the central controller being 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 the authorization is dependent upon the results of the first echocardiographic imaging test,

and wherein the central controller 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 test results for the patient are required to be received before authorizing additional fenfluramine or a pharmaceutically acceptable salt thereof for the patient,

and further wherein the central controller is 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.

2. The system according to claim 1,

wherein the central controller is programed to authorize prescription related information regarding dosage, volume, count, regime, concentration and intended time period of use by the patient for fenfluramine or a pharmaceutically acceptable salt thereof;

and further

wherein the central controller coordinates subsequent tests for the patient.

3. The system according to claim 2, wherein the central controller is programed to predict future test results and categorizes patient test data by reference to a predetermined model.

4. The system according to claim 1,

wherein the central controller is programed to prescribe a data format for test results for each patient, the data format being aligned with test data fields for each patient;

and further wherein the central controller is programed to log test results for each patient over time, and to generate a plot showing a trend for each patient.

5. The system according to claim 1, wherein the central controller is programed to

monitor a patient monitoring device;

collect data related to patient treatment;

analyze the data collected;

determine patient response to treatment; and

determine occurrence of and type of seizures.

6. The system according to claim 1, further comprising:

a portable electronic device carried or worn by the patient for monitoring patient health, the electronic device comprising a sensor for measuring information selected from the group consisting of blood pressure, electrocardiography (ECG), heart rate, blood oxygen, temperature, and lung function, and

wherein the electronic device is arranged to provide sensor readings in a format compatible with the central controller.

7. The system according to claim 1,

wherein an output from an electronic device is used by the central controller to determine at least one of a change to a scheduled medical test for the patient and a change to a medication prescription for the patient;

and further

wherein the central data storage facility comprises a database of authorized medical professionals, the central controller outputting authorization of one or more medical professionals upon completion of one or more data fields indicative of the reputation of the medical professional in the field of epilepsy.

8. The system according to claim 1, wherein the designated subtype of epilepsy is Dravet Syndrome.

9. A system for controlling distribution of a medication for treating symptoms of a designated subtype of epilepsy, the system comprising:

a data storage facility comprising a database of 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;

a central controller having one or more processors coupled to a communication network, which central controller is coupled to the data storage facility to read and write data to the data storage facility via the network; and

wherein the central controller 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,

the central controller being 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 the authorization is dependent upon the results of the first echocardiographic imaging test,

further programed to schedule a subsequent medical test for the patient prior to allowing entry of a subsequent prescription for fenfluramine or a pharmaceutically acceptable salt thereof in the medication authorization field, wherein the subsequent medical tests is an echocardiographic imaging test,

wherein the central controller is programed to output a time period over which use of the fenfluramine or a pharmaceutically acceptable salt thereof by a patient is authorized and beyond which subsequent test results for the patient are required to be received before authorizing additional fenfluramine or a pharmaceutically acceptable salt thereof for the patient,

wherein the central controller is 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,

a drug storage facility having fenfluramine or a pharmaceutically acceptable salt thereof stored therein;

wherein the central controller of the system is programed to monitor drug inventory in the drug storage facility and further programed to control dispatch of fenfluramine or a pharmaceutically acceptable salt thereof from the drug storage facility,

wherein the central controller is programed to authorize prescription related information regarding dosage, volume, count, regime, concentration and intended time period of use by the patient for fenfluramine or a pharmaceutically acceptable salt thereof;

wherein the central controller coordinates subsequent tests for the patient;

wherein the central controller is programed to prescribe a data format for test results for each patient, the data format being aligned with test data fields for each patient; and

further wherein the central controller is programed to log test results for each patient over time, and to generate a plot showing a trend for each patient.