A Mixed-Methods Evaluation to Identify Industry Knowledge Needs and Challenges in Health Product Defect and Recall...

Health product defects are complex issues affecting the quality standards of health products and indirectly impact public health outcomes. It is crucial for the pharmaceutical industry to be clear of the reporting and case management requirements for such issues. The Health Sciences Authority of Singapore used a mixed-methods evaluation strategy, combining an online questionnaire and face-to-face focus group discussions to identify areas for knowledge enhancement and challenges faced by the industry regarding product defect reporting and recall procedures. These findings were used to plan training workshops.

A self-administered online survey was emailed to representatives of all pharmaceutical companies with registered medicines and/or vaccines, or cell, tissue and gene therapy products (CTGTPs) in Singapore. The aim was to find out the challenges faced with product defect reporting and recall procedures. Two face-to-face focus group discussions were conducted with selected companies, specifically those that conducted product recalls between September 2022 and August 2024. A two-day online industry training workshop was held in October 2024. Pre- and post-workshop quizzes, including self-rating questions, were conducted to quantify the participants' baseline knowledge and what they gained from the workshop.

In total, 136 out of 463 individuals (29.4%) completed the online survey questionnaire for medicines and vaccines, while 24 out of 42 individuals (57.1%) completed the survey for CTGTPs. Seventeen industry professionals were invited for two focus group discussions. Participants provided feedback on existing processes, and requested clearer guidelines and examples on reportable defects, to aid their internal decision-making. The training workshop saw 318 and 271 industry professionals in attendance over two days, respectively, with 160 participating in both pre- and post-workshop quizzes. There was an improvement in average quiz scores ranging from 4.5% to 25.0% post-workshop. Participants' self-ratings also improved from a median of 3 (out of 5) to median of 4 from pre- to post-workshop.

The series of evaluations revealed an enhanced understanding of regulatory requirements in industry professionals through a combination of surveys, focus group discussions and tailored training workshops. These initiatives can equip the industry with knowledge to make informed decisions and enhance overall compliance with product defect reporting and recall procedures. The findings would be used to streamline our processes related to defect and recall.