A Comparison of Instructions for Use Documents and Manufacturer Produced Administration Videos for Biological Products

• Published in: Therapeutic innovation & regulatory science Vol. 57; no. 4; pp. 646 - 652
• Main Authors: Patel, Vraj, Taylor, Kellie, Schlick, James, Hertig, John
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01.07.2023; Springer Nature B.V
• Subjects: Analytical Report; Aortic Aneurysm, Abdominal; Biological Products; Drug Safety and Pharmacovigilance; Errors; Humans; Medical errors; Medicine; Pharmacotherapy; Pharmacy; Syringes; Time Factors; Video; Biological products; Medication errors; Instructions for Use; Product administration videos
• ISSN: 2168-4790; 2168-4804
• DOI: 10.1007/s43441-023-00516-2

Objectives To compare Instructions for Use (IFU) and Manufacturer Produced Administration Videos (MPAV) for biological products to describe if they are highly similar or different. To identify differences between the two that may lead to medication errors and to point out possible solutions to optimize safety. Methods We screened 139 biological products having both an IFU and a MPAV. Differences between the IFU and MPAV of each biological product were noted and categorized by importance and how likely it would cause harm to patients. Strategies were discussed based on differences observed. Results Of the products screened, 51 had an IFU and a MPAV available for evaluation. They were primarily made to support the use of auto-injectors ( n  = 25) and pre-filled syringes ( n  = 19). Of this group, we found that 11 had no differences between the IFU and MPAV, while the other 40 had at least one or more identifiable differences. Differences were stratified into the following sub-categories from most to least prevalent: word choice differences, supplementary information, missing information, and unaligned directions. We looked at the distribution of differences per biological product and found an average of two differences per MPAV (IQR 1–3). Conclusion We suggest that when sponsors create or update MPAVs, to focus on aligning critical content between the respective IFU and MPAV. We believe that it is possible for MPAVs to potentially reduce medication errors as a non-text-based media form and that care should be taken to avoid substantial differences in critical content between the IFU and MPAV.