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Regulatory requirements in the healthcare industry are increasingly placing stronger pressure on pharmaceutical organizations. For these businesses, it is becoming more challenging to remain in compliance in the face of advancing technology, process sophistication, and keeping operational costs low.
In our previous article, we elaborated on the importance of innovation in patient support programs (PSPs) in Asia. Here, let us zoom in on the practical side of things in getting PSPs to maintain compliance.
PSPs are much more sophisticated these days and with a larger emphasis on offering services to patients throughout their treatment plans enabling pharmaceutical companies to stay close to their clients. It includes aiding patients accurately in taking their prescription, improving adherence, better managing their disease, reducing complications, and providing financial assistance.
Among the practical ways these companies can innovate while remaining in compliance with laws, regulations, and standards include:
Due to the vast amount of patient safety data that can be acquired relative to the real-world use of medications, including adverse events, they have also become an important tool for pharmacovigilance.
At present, there is a lack of specific compliance guidelines on PSPs in Asia. In addition to the treatment, there is also a potential inducement in the form of financing or equivalent. This is an area of risk that requires raising the ethical bar.
While we are witnessing a surge in government enforcement, for example, Aegerion (2017) and United Therapeutics (2018), companies need to be aware of the consequences in the event of any compromises in ethics and compliance for PSPs. They include:
The purpose of implementing high ethical norms in the PSP process is to protect the patients, the company, and the physicians.
At DKSH, we set the compliance standards for patient support programs (PSPs) in Asia Pacific by ensuring that patient safety takes top priority, alongside data security and privacy. All interactions between patient and stakeholders, including benefits administered towards improving patient outcomes, are managed on the platform, allowing strict controls and seamless audits.
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Tal Freilich is a Senior Executive Manager at DKSH. He has over 10 years of experience as a compliance professional working for multinational companies. Tal specializes in generating tailor-made compliance programs to mitigate different business and compliance risks.