Risk Management System Authorization Code for Therapeutic Safety
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Solution Overview
Problem
There is a need for effective device-based risk management of therapeutics with known contraindications and/or side effects, particularly in outpatient settings where appropriate patient monitoring is lacking, leading to risks associated with medication use.
Innovation Solution
A risk management system (RMS) device that includes a processor and database, enabling enrollment of patients in a program for therapeutic agents, generating authorization codes based on diagnostic tests, and ensuring that prescribers and dispensers are certified, to safely manage and dispense medications.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If device-based risk management systems are implemented for therapeutics, then patient safety and risk mitigation are improved, but system complexity and operational burden increase
Solution Approach 1:
The patent introduces an intermediary authorization code system that mediates between the risk management system and the therapeutic dispensing process. The authorization code serves as a simplified interface that encapsulates complex risk assessment logic, allowing prescribers and dispensers to interact with the system through a straightforward authorization check rather than navigating complex risk management protocols directly.
Solution Approach 2:
The system performs preliminary risk assessment and authorization code generation before the therapeutic is dispensed. By conducting the complex safety evaluation, diagnostic test verification, and authorization code creation in advance, the system eliminates the need for real-time complex processing during dispensing, thereby improving patient safety while reducing operational complexity at the point of care.
2Reliability
If comprehensive patient monitoring and diagnostic testing are required, then medication safety is improved, but time consumption and operational efficiency deteriorate
Solution Approach 1:
The system requires diagnostic tests and patient monitoring to be completed before authorization code generation. By performing these safety checks preliminarily and storing the results, the system ensures comprehensive medication safety verification without requiring time-consuming checks at the moment of dispensing, thus reducing time loss while maintaining high safety standards.
Solution Approach 2:
The authorization code serves as a copy or representation of the comprehensive patient assessment results. Instead of requiring the original diagnostic tests and monitoring data to be present and re-evaluated during each dispensing event, the system creates an authorization code that encapsulates the safety verification, enabling rapid dispensing decisions while maintaining thorough safety checks.
3Measurement precision
If authorization codes and enrollment verification are implemented, then appropriate patient selection is improved, but operational complexity and processing requirements increase
Solution Approach 1:
The authorization code acts as an intermediary that simplifies the verification process. Instead of requiring operators to directly assess multiple patient criteria, enrollment status, and diagnostic results, the system uses the authorization code as a mediator that encapsulates all these verification elements, reducing operational complexity while maintaining precise patient selection.
Solution Approach 2:
The system extracts the complex patient selection logic and verification requirements into a separate authorization code generation process. By taking out the complex assessment criteria, enrollment verification, and safety checks from the main dispensing workflow and encapsulating them in an authorization code, the system achieves accurate patient selection without increasing the operational complexity of the primary dispensing process.
Data Source
AI summary
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.