Continuous drug safety monitoring: PSPs and compliance management systems
AI-translated from the Chinese original · editorially reviewed
In the risk management of drugs and medical devices, ensuring safety and efficacy is paramount. Once a drug or device moves from R&D through the end of clinical trials, post-market surveillance activities and periodic safety reports become the most critical part of the risk management plan's lifecycle, providing continuous monitoring of drug safety. Safety monitoring is what determines whether a drug's marketing license remains valid.
Importance and challenges: why risk management for drugs and medical devices is essential
A Patient Support Program (PSP) is a framework that helps patients adhere to their medication. For pharmaceutical companies, supporting and monitoring post-market drug risk management plans is the core domain of a PSP. PSPs not only improve medication adherence but also build a seamless communication bridge between clinical staff and patients, opening up more supportive treatment opportunities — provided everything complies with the principles of drug safety monitoring.
Beyond that, the effectiveness, safety, and legality of PSPs face multiple challenges. First, they must meet ethical compliance requirements, including conflict-of-interest and anti-corruption rules, and must never influence physicians' prescribing. Second, privacy protection is critical: when running a PSP, the private information of patients and healthcare professionals must be properly safeguarded against leaks and misuse. Finally, in addition to maintaining an effective drug safety monitoring system, a sound feedback mechanism is needed to ensure the PSP's quality and patient satisfaction keep improving. Beyond the design of the PSP itself, what matters even more is an effective quality management system.
The role and contribution of Media-WIND Health Group (MWHG)
As a pioneer in healthcare services, Media-WIND Health Group (MWHG) plays an indispensable role in Taiwan's healthcare service ecosystem, particularly in PSPs. The Group began delivering physician-patient services in 2015, and by 2023 had partnered with more than 32 multinational pharmaceutical companies, benefiting over 10,000 families. Its subsidiary Media-WIND Health Strategies first earned SGS ISO 9001:2015 quality management certification for patient assistance program management in 2017. In response to changes in the international environment and regulations, it first passed SGS ISO 27001:2013 information security management system certification in 2021, and to protect the privacy of patients and healthcare professionals, it adopted and obtained SGS ISO 27701:2019 privacy information management system certification in 2022. Never content with the status quo, Media-WIND Health Group (MWHG) is pressing ahead with ethical and responsible procurement and plans to sign on to SBTi, aspiring to become a well-rounded, sustainably run social enterprise.
Vettius Yang, Manager, Compliance Center