Device based risk management of a therapeutic

• US 10,412,089 B2
• Filed: 07/26/2016
• Issued: 09/10/2019
• Est. Priority Date: 01/29/2014
• Status: Active Grant

• Current Assignee: Otsuka Pharmaceutical Company Limited (Otsuka Holdings Company Limited)
• Original Assignee: Otsuka Pharmaceutical Company Limited (Otsuka Holdings Company Limited)
• Inventors: Czerwiec, Frank S., Freedman, Amy, Friend, Keith, O'Hara, Elaine A., Ostroff, Craig, De Freitas Santoro, Marcelo, Shiner, Charles, Watanabe, Takeshi, Yamamoto, Miho, Zimmer, Christopher A.
• Primary Examiner(s): Ouellette, Jonathan P
• Application Number:
  US15/219,866
• Publication Number:
  US 20160335411A1
• Time in Patent Office: 1,141 Days
• Field of Search: 705300, 705317, 705320, 705325, 705326, 705 11-912
• CPC Class Codes: G06Q 10/10 Office automation; Time management
• CPC Class Codes: G06Q 10/101 Collaborative creation, e.g. joint development of products or services
• CPC Class Codes: G06Q 10/105 Human resources
• CPC Class Codes: G06Q 50/265 Personal security, identity or safety
• 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 40/67 for remote operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment
• CPC Class Codes: H04L 63/10 for controlling access to devices or network resources

Abstract

A risk management system (RMS) device includes a RMS database and a RMS processor. The RMS processor includes a prescriber module to receive a request to enroll a patient in a RMS program of a therapeutic agent associated with multiple indications. The request includes a specification of at least one indication, and a confirmation of a diagnostic test conducted on the patient. The RMS processor also includes a patient module configured to generate a patient profile. The RMS processor also includes a database module configured to store the patient profile in the RMS database. The RMS processor also includes an authorization module configured to generate an authorization code indicating whether the patient is authorized to receive the therapeutic agent. The RMS processor also includes a communication module configured to transmit the authorization code to a pharmacy or a prescriber.

Claims

1. A risk management system (RMS) device, comprising:

an RMS database; and

an RMS processor,

the RMS processor configured to receive, via a communication network and from a compute device associated with a prescriber, a request to enroll a patient in an RMS program of a therapeutic agent associated with a plurality of indications, the request including;

a specification of at least one indication from the plurality of indications; and

a confirmation of a diagnostic test conducted on the patient, the diagnostic test associated with the therapeutic agent and associated with the at least one indication from the plurality of indications,

the RMS processor further configured, in response to the request, to identify a predetermined enrollment period based on the at least one indication from the plurality of indications and to generate a patient profile, the patient profile including the predetermined enrollment period, the predetermined enrollment period having a first duration when the at least one indication is a first indication from the plurality of indications, the predetermined enrollment period having a second duration different from the first duration when the at least one indication is a second indication from the plurality of indications;

the RMS processor configured to store the patient profile in the RMS database;

the RMS processor configured to generate a first authorization code, based on the predetermined enrollment period, authorizing a pharmacy or the prescriber to dispense the therapeutic agent to the patient and to generate a plurality of additional authorization codes, each additional authorization code from the plurality of additional authorization codes including an initial default instruction prohibiting the pharmacy or the prescriber from dispensing the therapeutic agent, the RMS processor configured to associate the first authorization code and the plurality of additional authorization codes with the patient profile; and

the RMS processor configured to transmit via the communication network the first authorization code to at least one of a compute device associated with the pharmacy or the compute device associated with the prescriber such that the therapeutic agent can be dispensed to the patient based on the first authorization code, the RMS processor configured to transmit each additional authorization code from the plurality of additional authorization codes and including the initial default instruction via the communication network to at least one of the compute device associated with the pharmacy or the compute device associated with the prescriber such that the pharmacy or the prescriber is prohibited from dispensing the therapeutic agent based on the plurality of additional authorization codes for a time period after receiving each additional authorization code including the initial default instruction.

2. The RMS device of claim 1, wherein the RMS processor is further configured to:

receive, for the therapeutic agent, from the compute device associated with the pharmacy, a request to enroll the pharmacy in the RMS program;

transmit, to the compute device associated with the pharmacy, educational material associated with the RMS and the therapeutic agent;

transmit, to the compute device associated with the pharmacy, access to a test relating to the educational material for a user of the compute device associated with the pharmacy;

receive an identifier of a performance of the user of the compute device associated with the pharmacy on the test; and

generate a dispenser profile for the pharmacy if the identifier of the performance meets a performance criterion for the test,

the RMS processor further configured to store the dispenser profile in the RMS database as a new dispenser profile.

3. The RMS device of claim 1, wherein the RMS processor is further configured to:

generate, prior to lapse of the predetermined enrollment period, and after generating the patient profile, patient reenrollment information associated with;

(1) the RMS program, (2) the therapeutic agent, and (3) the first indication;

transmit the patient reenrollment information to the compute device associated with the prescriber; and

receive an indication of consent from the compute device associated with the prescriber in response to the patient reenrollment information,

the RMS processor further configured to update the patient profile in the RMS database in response to receiving the consent.

4. The RMS device of claim 1, wherein the RMS processor is configured to modify at least one additional authorization code from the plurality of additional authorization codes based on an event subsequent to the generation of the plurality of additional authorization codes such the at least one additional authorization code authorizes the pharmacy or the prescriber to dispense the therapeutic agent to the patient, the event including at least one of:

a receipt of a diagnostic test result,

a receipt of an adverse event report, or

a receipt of a dispensing request.

5. The method of claim 1, wherein the time period is a period of time between receipt of each additional authorization code including the initial default instruction and receipt of an additional authorization code that has been modified by the RMS processor such that the additional authorization code authorizes the pharmacy or the prescriber to dispense the therapeutic agent to the patient.

6. A risk management system (RMS) device, comprising:

a RMS database storing dispenser profiles, patient profiles, and prescriber profiles; and

a RMS processor,

the RMS processor configured to receive, for a therapeutic agent associated with a plurality of indications, a request from a compute device associated with a pharmacy to dispense a first quantity of the therapeutic agent to a patient, the RMS database including a dispenser profile for the pharmacy, the RMS database including a patient profile for the patient;

the RMS processor configured to receive a confirmation of a successful diagnostic test of the patient from a compute device associated with a prescriber, the RMS database including a prescriber profile for the prescriber;

the RMS processor configured to generate a first authorization code if the successful diagnostic test of the patient is associated with at least one indication from the plurality of indications and the confirmation of the successful diagnostic test of the patient was received within a first predetermined time period,

the RMS processor further configured to generate a second authorization code if at least one of;

(1) the successful diagnostic test of the patient is associated with the at least one indication, the confirmation of the successful diagnostic test of the patient was not received within the first predetermined time period, and the request from the compute device associated with the pharmacy is received within a second predetermined time period, or (2) a request is received from the compute device associated with the prescriber to dispense a second quantity of the therapeutic agent to the patient, the second quantity different from the first quantity,

the RMS processor further configured to generate a third authorization code if;

(1) the confirmation of the successful diagnostic test of the patient is not associated with the at least one indication or the confirmation of the successful diagnostic test of the patient was not received within the first predetermined time period, or (2) the request from the compute device associated with the prescriber to dispense the second quantity of the therapeutic agent is not received within a third predetermined time period; and

the RMS processor configured to transmit the first authorization code, the second authorization code, or the third authorization code to the compute device associated with the pharmacy such that the pharmacy is permitted to dispense the first quantity of the therapeutic agent if the compute device associated with the pharmacy receives the first authorization code, the pharmacy is permitted to dispense the second quantity of the therapeutic agent if the compute device associated with the pharmacy receives the second authorization code, and the pharmacy is prohibited from dispensing the first quantity and the second quantity if the compute device associated with the pharmacy receives the third authorization code.

7. The RMS device of claim 6, wherein the at least one indication includes at least one of hyponatremia or autosomal dominant polycystic kidney disease (ADPKD).

8. A method, comprising:

receiving, at a host device of a risk management system (RMS) for a therapeutic agent associated with a plurality of indications, from a compute device associated with a prescriber, a request to enroll the prescriber in the RMS;

enrolling, at the host device, the prescriber in the RMS if the performance of the prescriber meets a performance criterion for the test,

receiving, at the host device, from a compute device associated with the prescriber, a request to enroll a patient in the RMS, the request including a specification of at least one indication from the plurality of indications and a confirmation of a diagnostic test conducted on the patient, the diagnostic test associated with the therapeutic agent and associated with the at least one indication from the plurality of indications;

identifying, in response to receiving the request, a predetermined enrollment period based on the at least one indication from the plurality of indications, the predetermined enrollment period having a first duration when the at least one indication is a first indication from the plurality of indications, the predetermined enrollment period having a second duration different from the first duration when the at least one indication is a second indication from the plurality of indications;

generating a first authorization code based on the predetermined enrollment period authorizing a pharmacy or the prescriber to dispense the therapeutic agent to the patient;

generating a plurality of additional authorization codes, each additional authorization code from the plurality of authorization codes including an initial default instruction prohibiting the pharmacy or the prescriber from dispensing the therapeutic agent,

associating the first authorization code and the plurality of additional authorization codes with a patient profile; and

transmitting the first authorization code at least one of a compute device associated with the pharmacy or the compute device associated with the prescriber such that the therapeutic agent can be dispensed to the patient based on the first authorization code.

9. The method of claim 8, wherein the enrolling includes authorizing the prescriber to prescribe the therapeutic agent.

10. The method of claim 8, wherein the enrolling includes enrolling the prescriber for a predetermined time period, the method further comprising:

providing, after the enrolling and to the prescriber, prior to lapse of the predetermined time period, reenrollment information associated with the RMS and with the therapeutic agent;

receiving consent from the prescriber in response to the reenrollment information; and

reenrolling, at the host device, the prescriber in the RMS in response to receiving the consent.

11. A method, comprising:

receiving, at a host device of a risk management system (RMS) for a therapeutic agent associated with a plurality of indications, a request from a compute device associated with a pharmacy enrolled in the RMS to dispense a first quantity of the therapeutic agent to a patient enrolled in the RMS, the request including a specification of at least one indication from the plurality of indications;

generating a first authorization code if a confirmation of a successful diagnostic test of the patient was received from a prescriber enrolled in the RMS within a first predetermined time period, the successful diagnostic test associated with the at least one indication from the plurality of indications, the first authorization code authorizing the pharmacy to dispense the first quantity of the therapeutic agent to the patient;

generating a second authorization code if at least one of;

(1) the confirmation of the successful diagnostic test of the patient was not received within the first predetermined time period, and the request from the compute device associated with the pharmacy is received within a second predetermined time period;

or (2) a request is received from a compute device associated with the prescriber to dispense a second quantity of the therapeutic agent to the patient, the second quantity different from the first quantity, the second authorization code authorizing the pharmacy to dispense the second quantity to the patient;

generating a third authorization code if the confirmation of the successful diagnostic test of the patient was not received within the first predetermined time period and if the request from the compute device associated with the prescriber to dispense the second quantity of the therapeutic agent is not received within a third predetermined time period, the third authorization code prohibiting the pharmacy from dispensing the therapeutic agent to the patient; and

providing the first authorization code, the second authorization code, or the third authorization code to the compute device associated with the pharmacy.

12. The method of claim 11, wherein the first quantity is a standard quantity.

13. The method of claim 11, wherein the second authorization code authorizes the pharmacy to dispense the second quantity of the therapeutic agent to the patient without the confirmation of the successful diagnostic test.

14. The method of claim 11, further comprising transmitting, from the host device to the prescriber, a request for the confirmation of the successful diagnostic test, the confirmation received in response to the request for the confirmation.

15. The method of claim 11, further comprising:

receiving, at the host device of the RMS, the confirmation of the successful diagnostic test, the confirmation of the successful diagnostic test associated with a patient test result meeting a dispensation criterion for the at least one indication from the plurality of indications.

16. The method of claim 11, further comprising:

conducting a diagnostic test associated with the at least one indication from the plurality of indications to determine whether the diagnostic test is successful based on whether a patient test result meets a dispensation criterion for the at least one indication from the plurality of indications; and

sending the confirmation of the successful diagnostic test of the patient to the host device of the RMS if the patient test result meets the dispensation criterion.