Pandemic disruption and a new MA code update; what for patient programs in this new era?

^{Posted on April 16, 2020}

COVID-19 has taught us that in times of uncertainty, people seek information and reassurance.

With everyone affected by the current pandemic, there are many people around Australia living with chronic and debilitating conditions, impacted by these unprecedented changes and requiring medicines and support for managing their illnesses. People are skipping appointments and missing crucial treatments, whilst communication and reassurance is more necessary than ever to continue keeping vulnerable people safe and well.

Amongst the distractions caused by this novel coronavirus, the long-awaited Medicines Australia (MA) Code Edition 19 was released. But what does this new edition mean for patient programs moving forward, and how can we continue to support patients in a time when they need information more than ever before?

1. Whilst Edition 19 moves towards a ‘principles-based’ approach (and incidentally a lot less pages!) there are still specific requirements MA members are required to uphold surrounding patient support and access programs.
2. Edition 19 still permits support for patients, albeit usually via third parties who provide patient services. There are a great many wonderful patient support services, and health consumer organisations operating in Australia today. The rapid uptake of technology and communication channels seen since self-isolation measures have been implemented will truly bring lagging demographics into the digital age and complement the many ways in which support and education can be delivered. Edition 19 now treats all channels (digital and traditional) with the same approach, no more distinctions between social or owned media.
3. A support program is still an activity to help patients get the maximum benefit of their therapy, aimed at improving outcomes via education of appropriate administration of treatment and condition or disease lifestyle management to aid compliance. In recent years patient programs have become more holistic and sophisticated, demonstrating measurable improved outcomes and integrating treatment and lifestyle advice seamlessly. We see these programs as more important now than ever before.
4. We won’t miss the terminology ‘PFP programs’ which is completely absent from Edition 19. That doesn’t mean familiarisation programs are no more, it means the formulaic requirements including how many patients can participate and the protocols are gone. Now referred to as ‘programs for the provision of medicines at no cost or reduced cost’ they still require a legitimate need and clear clinical rationale, and must withstand public scrutiny with regard to how long they run and how much stock is provided.
5. Third parties are still paramount in enabling companies to deliver services to patients, providing de-identified data on outcomes that improve compliance, and critically support ongoing Adverse Event monitoring for new medicines. Aligning your Medical Information and Pharmacovigilance requirements internally with the opportunity to provide patient programs will continue to be a pathway to successful access and support programs for patients in need, creating healthier outcomes for all.