Specialty Distributors' Role in Health Care Compliance: Natalie Bedford

As the health care landscape evolves, specialty distributors play a role in navigating complex regulations, adapting to increasingly stringent temperature requirements for medications and addressing the impact of changing legislation on pricing and market access, explained Natalie Bedford, senior vice president, US pharmaceutical distribution services, McKesson.

Transcript has been lightly edited; captions were auto-generated.

Transcript

How do specialty distributors support compliance in rapidly changing health care environments?

Specialty distributors clearly play a really critical role, and we like to call ourselves as those allies to our pharma partners and helping them navigate that complex. Let's start first with the core distribution pieces. We need to make sure that we're in compliance with good distribution practices. We also need to make sure that we are aligned with serialization. Think of that DSCSA [Drug Supply Chain Security Act] and the timelines that have been set for this year. There are things that we must do to ensure our pharma partners can get their products to market, ultimately, through downstream customers and patients.

I think another is thinking about how the temperature requirements for products are changing. Some data points or fun facts is that almost 50% of products on the market today require some level of refrigeration; almost 10% require frozen capabilities. As a result, we need to make sure that we're thinking about what the future landscape looks like, and how can we ensure not only we've got the right capabilities and temperature requirements to support that, but we need to make sure we've got the right processes to how we manage those capabilities, so that the product is safe and is not jeopardized another way.

I think another way that we need to do it is make sure that we think about all of the changing different legislations and how it impacts pricing models, go-to-market models, and make sure that we continue to protect all the different stakeholders in the ecosystem. I think one of the things that we hear often is that not one stakeholder can do it alone. How can we collectively work in this health care ecosystem where we're all impacted by regulatory changes that make defined mutual solutions that are going to mitigate or at least minimize the impact at the end of the day on the patient? Because that's what's most important.