Overview of the risk management plan
The Risk Management Plan (RMP) is a drug management strategy that takes into account drug safety and patient accessibility in line with the risk supervision actions of the Food and Drug Administration for specific marketed drugs, with reference to the management systems of advanced pharmaceutical countries such as the United States and the European Union, and the implementation of risk control by the licensed pharmaceutical companies after marketing according to the risk level of the drug, such as patient medication instructions, drug administration education for medical personnel, special risk prevention measures, etc. And regularly report to the competent government departments to effectively reduce the risk of drug use by the Chinese people.
Patient support programs and medication safety
The management of risk management plans is part of clinical medical management, and patients may undergo various tests according to the content of the plan, and can now also be combined with Patient Support Programs (PSPs) to provide medical administration, and the drug care and testing support provided by the project health teachers cover all stages of the patient’s treatment journey. After the patient is referred by the doctor, the health teacher will assist in arranging the necessary pre-medication tests, such as hepatitis B, hepatitis C and tuberculosis tests, to determine the patient’s carrier status and drug risk. During the course of treatment, the project health teacher is also responsible for reminding the clinic to arrange regular check-ups to ensure the safety of medication.
Systematic management and case tracking
PATIENTSFORCE uses MediPASS’s “Medical and Patient Management System” to record the progress of each stage of the patient’s treatment journey, including the date of the examination, the original situation, and the estimated date of the next examination, and the system will notify the next work according to the estimated schedule, so that the project health teachers can communicate with the clinicians about the testing arrangements, so as to achieve regular tracking of medication safety.
Perform performance reporting and data management
According to the schedule of the risk management plan approved by the Ministry of Health and Welfare, pharmaceutical companies are required to provide regular implementation effectiveness reports, and PATIENTSFORCE will assist in recording and aggregating relevant necessary information in a systematic manner when managing this type of PSPs, and according to the requirements of different plans, it may be necessary to provide records of medication safety guidelines for physicians and patients, or the number of tests conducted by each hospital, the cause of disease and adverse event notification statistics, etc., and the project health teachers and management team will ensure that the PSPs are implemented in accordance with the requirements of the risk management plan.
Nerrisa Kuo, Associate Director, PatientsForce Healthcare Integration Group
Data source: https://www.cde.org.tw/drugs/med_explain?id=29
