Key person ethical decision-making and substandard drugs rejection intentions.

Abstract

Substandard drugs are a major public health issue worldwide. Key person such as the Qualified Person in China and Europe is responsible for rejecting substandard drugs during the manufacturing stage. This study applies the Hunt-Vitell ethical decision-making model to study their rejection intentions on substandard drugs. Using the experimental vignette methodology, two scenarios were developed to represent different levels of deviation from regulations in pharmaceutical manufacturing. Responses from 204 Chinese key persons show a decline in deontology, ethical judgment, and rejection intention, and an increase in teleology in the minor deviation scenario, in comparison with the major deviation scenario. The results from the two scenarios show that the Hunt-Vitell ethical decision-making model is well fitted to explain substandard drug rejection intentions. Organizational and occupational commitments have a significant positive impact on deontological evaluation. Whereas, occupational commitments have a significant negative impact on teleological evaluation. This study suggests that strengthening occupational commitment can significantly affect key person's rejection intentions of substandard drugs.