Ask the Expert: Investigating Patient Complaints About Combination Products

Investigating Patient Complaints Involving Prefilled Syringes

In this episode of Ask the Expert, Susan J. Schniepp of RCA and Siegfried Schmitt of Parexel discuss the challenges of investigating patient complaints involving prefilled syringes (PFS) and combination products. The experts emphasize that marketing authorization holders (MAHs) remain ultimately responsible for product performance, even when purchasing commercial syringe components from external suppliers.

Investigations can be complicated by limited physical evidence, particularly when patients self-administer medications at home. Manufacturers must avoid prematurely attributing device failures to human error and ensure products are suitable for diverse patient populations, including elderly individuals and those with disabilities. Real-world complaints may reveal gaps in usability testing, device performance, or product design.

The experts also highlight the importance of clearly defined quality agreements, effective complaint handling procedures, and collaboration between drug manufacturers and component suppliers. Manufacturers should establish clear investigation responsibilities, adapt complaint processes to evolving distribution models such as direct-to-patient shipping, and ensure corrective actions and effectiveness checks can withstand regulatory scrutiny.

Watch the video: Investigating Patient Complaints Involving Prefilled Syringes

Link to the Video and Article on Pharmaceutical Technology