P218: A Comparison of Instructions for Use (IFU) and Manufacturer Produced Administration Video Consistency for Biologic Products
Pharmacovigilance and Risk Management Fellow
Butler University United States
Compare and contrast IFU and manufacturer produced administration videos for biologic products to verify if they are highly similar or different. Identify differences between the two that can lead to medication errors/patient harm and possible solutions to optimize safety.
We screened 139 biologic products for having both an IFU document and product administration video. Differences between each biologic IFU and video were noted and categorized by importance and how likely it would cause patient harm. Strategies were discussed based off differences observed.
Of the 139 biologic products screened, 51 had an IFU and manufacturer produced administration video available for evaluation. They were primarily made of pre-filled pens (25) and pre-filled syringes (19). Of this group, we found that 11 had no differences between the IFU and video while the other 40 had at least 1 or more identifiable differences. We identified 90 differences between all the IFU documents and manufacturer produced administration videos for each respective biologic product. As part of a qualitative and quantitative assessment, these 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 biologic and found an average of 2 differences per video (IQR 1-3).
Various differences have been identified between FDA approved IFU documents and respective manufacturer produced administration videos than can possibly lead to patient harm. Differing word choice and supplemental information in videos may be less likely to lead to medication errors since they are likely not going to change how the patient is taking the medication. However, missing information in videos and unaligned directions between IFU and video may lead to confusion and medication errors since they are more likely to change how the IFU and/or video are interpreted. We suggest when sponsors create or update manufacturer produced administration videos, to focus on how it aligns with the IFU for that respective biologic product. Furthermore, healthcare providers should take into consideration these findings when training patients and considering the use of an IFU document and/or manufacturer produced administration video. In conclusion, we believe that it is possible for manufacturer produced administration videos to potentially reduce medication errors as a non-text-based media form when aligned appropriately with its respective IFU.
Vraj Patel, PharmD;
Kellie Taylor, PharmD, JD;
James Schlick, RPh, MBA;
John Hertig, PharmD, MS, CPPS, FASHP