Risk control drives risk assessment and risk review: A cause and effect model of pharmaceutical drug recall on patient safety.

Background: Pharmaceutical drug recall is a relentless issue that is composed of multidimensional criteria. The distinct criteria that contributed to drug recalls have been identified in previous literature; however, there is limited information regarding the causal relationships between each criterion. Highlighting key influential aspects and criteria of pharmaceutical drug recall is critical in addressing this ongoing issue and promoting patient safety. Objective: The objective of this study is as follows: (1) identify critical criteria of pharmaceutical drug recalls for improvements, (2) determine the interrelationships among the criteria, and (3) define the causal relationships of pharmaceutical drug recall and provide theoretical insights and practice recommendations to minimize risks associated with pharmaceutical recalls and maximize patient safety. Design: This study proposes five aspects and 42 criteria to identify the impact of pharmaceutical drug recalls on patient safety by evaluating the interrelationships between the criteria by employing the fuzzy decision-making trial and evaluation laboratory method. Methods: A group of 11 professionals across the pharmaceutical industry, hospitals, ambulatory care, regulatory authority, and community care settings were selected for interviews. Results: Risk control is the influencing aspect of pharmaceutical drug recalls that has the most substantial impact on risk assessment and risk review; it generates medium effects on risk communication and technology. Risk assessment, risk communication, and risk review demonstrated comparative weak interrelationships, while risk communication exhibits a weak unidirectional effect on risk review. Finally, risk assessment exerts a weak influence on technology application and development. Product contamination, product subpotent or superpotent, injury to patients, product not sterile or impure, and system detectability of hazards have the strongest influence in the causal group of pharmaceutical drug recalls. Conclusion: The study shows that risk control drives risk assessment and risk review in the pharmaceutical industry manufacturing process. To achieve patient safety, this study suggests focusing on risk control strategies, as this aspect displays the most substantial effect on influencing other critical risk management aspects such as risk assessment and risk review.