pLOG

2024-08-14

Execution of Patient Support Programs (PSPs) and Drug Risk Management Plans

A Drug Risk Management Plan (RMP) is a regulatory action coordinated with the FDA for specific marketed drugs, considering the management systems of advanced pharmaceutical countries like the U.S. and the EU. It balances drug safety with patient accessibility to medications. Depending on the drug's risk level, the drug manufacturer is required to implement risk control measures post-marketing, such as patient medication guides, healthcare provider education, and special risk prevention measures, and to regularly report to government authorities to effectively reduce medication risks.

Managing a Risk Management Plan falls under clinical medical management. Patients may need various tests according to the plan's content. Today, this can be integrated with Patient Support Programs (PSPs) to provide medical administrative management. Project health educators offer medication care and testing support during patient follow-ups, covering all stages of the patient's treatment journey. After being referred by the physician, patients receive assistance from health educators in arranging necessary tests before medication, such as screening for Hepatitis B, Hepatitis C, and tuberculosis, to assess the patient’s carrier status and medication risk. During the treatment period, project health educators also remind clinical staff to arrange regular tests to ensure medication safety.

PATIENTSFORCE, through the MediPASS “Medical Management System,” allows project health educators to manage cases, record patient progress at various stages of the treatment journey, including test dates, carrier status, and next scheduled test dates. The system will notify the next tasks according to the planned schedule, facilitating communication between project health educators and clinical physicians regarding test arrangements, and ensuring regular follow-ups for medication safety.

According to the risk management plan schedule approved by the Ministry of Health and Welfare, pharmaceutical companies must regularly provide performance reports. PATIENTSFORCE, in managing such PSPs, assists in systematically recording and compiling necessary information. Depending on the plan's requirements, this may include providing records of medication safety guidelines for physicians and patients or statistics on test quantities, disease carrier status, and adverse event reports, all managed by project health educators and the management team to ensure PSPs are executed according to the risk management plan’s requirements.

PatientsForce
Chen-Hsiu Kuo, Deputy Director
Nerrisa Kuo


Source:
https://www.cde.org.tw/drugs/med_explain?id=29