Supporting the execution of drug Risk Management Plans through PSP patient-testing management
AI-translated from the Chinese original · editorially reviewed
Overview of the Risk Management Plan
A Risk Management Plan (RMP) is a drug-management strategy that supports the TFDA's risk oversight actions for specific marketed drugs. Drawing on the management systems of advanced pharmaceutical nations such as the United States and the European Union, it balances medication safety and patient access to medicine. Based on a drug's risk level, the license-holding pharmaceutical company carries out risk controls after launch—such as patient medication guides, education for healthcare professionals on drug administration, and special risk-prevention measures at varying levels—and reports regularly to the competent government authority, in order to effectively reduce medication risk for the public.
Patient Support Programs and medication safety
The management work of a Risk Management Plan is part of clinical medical-affairs management. Patients may need to undergo various tests according to the plan's content, and this can now be combined with a Patient Support Program (PSP) to provide medical-affairs administration. Case education specialists provide medication care and testing support during patients' follow-up visits, covering every stage across the patient's entire treatment journey. After a patient is referred by a physician, the education specialist helps arrange the necessary tests before medication begins—such as screening for hepatitis B, hepatitis C, and tuberculosis—to determine the patient's carrier status and medication risk; during the course of treatment, the case education specialist is also responsible for reminding the clinical team to arrange periodic testing to ensure medication safety.
Systematic management and case follow-up
PATIENTSFORCE uses the "doctor-patient management system" of MediPASS for case education specialists to conduct case management, recording the progress of each stage of the patient's treatment journey—including the current testing date and carrier status—and noting the next expected testing date. The system will send notifications for the next task according to the scheduled plan, so the case education specialist and the clinical physician can coordinate on testing arrangements and thereby achieve periodic follow-up for medication safety.
Execution performance reports and data management
According to the Risk Management Plan schedule approved by the Ministry of Health and Welfare, pharmaceutical companies must provide execution performance reports periodically. In managing this type of PSP, PATIENTSFORCE helps record and compile the relevant necessary information in a systematic way. Depending on the different plan requirements, this may be records of medication-safety guidance for physicians and patients, or statistics on testing volumes at each hospital, disease carrier status, and adverse-event reporting. The case education specialists and management team ensure the PSP is executed in accordance with the requirements of the Risk Management Plan.
PatientsForce Media-WIND Health Group Associate Director Nerrisa Kuo