When Drugs and Devices Come Together, Safety Considerations Get More Complex

Dr. Khaudeja Bano, Vice President Combination Product Quality at Amgen, joined the Safety Signals Podcast to discuss the unique safety challenges posed by combination products that include both drugs and devices.

“The word ‘signal’ means nothing to my quality peers and the word ‘trend’ means nothing to my safety peers,” Dr. Bano says. “So some of our growing pains are around truly bringing the cross-functional team together to start speaking the same language.”

As a pioneer in combination product safety, Dr. Bano continues to shape the practice by coordinating pharmacovigilance and device risk management teams.

Combination products encompass everything that has a device and a drug–and/or a biologic–as constituent parts. Examples include auto injectors, prefilled syringes, pre-packaged first aid kits, and cross-label combinations such as a CT scanner and the isotope required to read the scanner’s images.

Prior to new FDA requirements established in July 2020, single-entity products like auto injectors and prefilled syringes were considered drug products, while the syringes and injectors were governed as container closures. Today, there are stricter standards that require a more rigorous investigation of the device component if something goes wrong.

Ten years ago, for example, if a syringe needle broke and a patient required surgery, documenting the adverse event would follow standard pharmacovigilance practice. Currently, if something like that happens “there are additional fields within the safety database that you have to complete with all the device information,” says Dr. Bano. These include the device lot number, device code, a narrative description of the incident, and follow up with the device supplier.

Dr. Bano says that supplier quality and vendor management is an area of “immense pain” for teams like hers. Because of new regulations, contracts with suppliers may have to be retrofitted to reduce risk, which can be difficult with products that have been made the same way for decades or when vendors consider you a “little fish” compared to other clients.

According to Dr. Bano, managing device risk and reporting problems requires detailed tracking and trending. “Everything that gets reported to us…any expression of a deficiency…is considered a complaint,” she says. “Within that bucket of complaints, you have to parse out adverse events and product complaints. When you look at your product complaints, you are expected to not just log them, evaluate them, and investigate them, but also monitor them with the expectation that you will do continuous improvement of your product.”

To reduce some of the complexity, Dr. Bano is on a mission to align quality and safety teams within pharma organizations. “There’s always been a kind of a barrier or a wall between the safety organization and the quality organization,” she notes. “We don’t talk the same language; we don’t use the same terminology.”

Dr. Bano is optimistic about how people from pharma, regulatory agencies, and technology providers are working together to make compliance with new regulations governing combination products easier. “This is the first time I’m seeing people talking to each other, sharing their experiences, learning from each other, just so we can do an effective job, and have regulators help us,” she says. “We need to collaborate as much as possible, within organizations, across organizations, across peers, and across different modalities of this industry.”

This collaboration will become increasingly important as combination products become more widely administered by patients themselves, and as science paves the way towards personalized therapies that Dr. Bano says can “target organs digitally, intervening in people’s DNA. That’s the level of discussions we are hearing.”

With so much going on in the world of combination products, Dr. Bano believes that automation and analytics technologies will play a bigger role in safety and quality investigations. She is looking forward to integrating those technologies into the field and we hope to have her on the podcast again in the future to share her experiences with digital transformation.

This post is based on an episode of the Safety Signals podcast. To hear more, check us out on Apple Podcasts, Spotify, or on our website.

The views of the hosts and guests featured on Safety Signals are their own and do not necessarily reflect the views of Saama or the individual companies for which the guests may work.