| Substandard drugs have seriously endangered human health.In recent years,they have become a major public health problem and attracted worldwide attention.Substandard drugs mainly come from the manufacturing stage.Qualified person who is the key quality control person in the manufacturing stage.Improving the control ability of the qualified person can effectively reduce the release of substandard drugs.Ethical restraint is the basis for consciously following laws and regulations and has more extensive restraint scope than laws and regulations.The study object is qualified persons in drug manufacturing enterprises.Based on ethical restraints,two studies were conducted on the internal and external factors of the improvement of control ability in qualified persons.Study 1 focused on drug release tasks,explored the influence of the commitment of qualified persons on the decision-making in the task of drug release.This research adopted a combination of experimental vignette methodology and traditional survey.Controled the degree of deviation from law and regulations,deontological evaluation,teleological evaluation,ethical judgment,and ethical intention were measured.Conceptual model was evaluated using the structural equation method.The results of serious and minor deviation showed the reject intention was significantly affected by ethical judgment(.65***/.64***)and teleological evaluation(-.30**/-.28**).Ethical judgment was significantly affected by deontological evaluation(.43***/.59***)and teleological evaluation(-.55***/-.35***).Deontological evaluation was significantly affected by professional commitment(45***/.33***)and organizational commitment(.32**/.16*).Teleological evaluation was affected by professional commitment(-.32***/-.36***).Organizational commitment has no significant effect on teleological evaluation.The paired sample T test results showed that the two scenarios had significant variations（p<.001）in deontological evaluation,teleological evaluation,ethical judgment,and reject intention.There is no significant difference in rejection intention between qualified persons with different ethical positions when they were faced with substandard drugs with serious deviations.In cases of minor deviation,qualified persons’rejection intention was significantly different.Study 2 focused on the influence of the organization environmental factors.Based on the social information processing theory with the dual processing theory,explored how ethical leadership affected job anxiety,psychological safety,and job satisfaction of qualified persons.At the same time explore the moderating role of active personality.A questionnaire was used to measure variables including ethical leadership,job satisfaction,job anxiety,psychological safety,and active personality.Multiple regression methods were used to test the hypotheses.The results of Study 2 showed ethical leadership significantly reduced job anxiety(-.24***)and improved psychological safety(.43***).Job anxiety negatively affected qualified persons’job satisfaction(-.32***).Psychological safety positively affected qualified persons’job satisfaction(.36***).The active personality of qualified persons can adjust the relationship between moral leadership,psychological safety,and work anxiety.This study provides five main conclusions.First,the ethical decision-making model with commitment factor effectively explained the decision-making process of the qualified person at rejecting substandard drugs.Second,the degree of deviation of the manufacturing process of substandard drugs affected rejection intention of the qualified person.Compared with serious deviation,substandard drugs with minor deviation are at risk of being released.Third,qualified persons with different ethical positions have different rejection intentions.For example,situationists and absolutists have higher intentions in rejecting substandard drugs,especially in cases of minor deviation.Fourth,ethical leadership can affect job satisfaction through its impact on job anxiety and psychological safety.Fifth,the active personality of qualified persons can affect the relationship between moral leadership,psychological safety,and work anxiety.Based on ethical restraints,improvement suggestions were raised from three aspects:qualified persons,drug manufacturing enterprises,and drug management departments.This study enriches the research on the control of substandard drugs and combines different theories to explore the internal and external factors that affect the ability of qualified persons under ethical restraints.First,this study focused on the control of substandard drugs from the perspective of ethical restraint,and explored new research directions for controlling substandard drugs in China through the study of work behavior and attitudes of key personnel in the drug manufacturing process.Second,this study established a theoretical model and conducted empirical research on the release behavior of substandard drugs by qualified persons,which provides a theoretical basis and empirical evidence for the improvement of qualified person abilities in drug control.Third,by studying the influence of ethical leadership on the work attitude of qualified persons,the impact of important factors in the organizational environment on the control ability of substandard drugs is explored.At the same time,this study also enriches the empirical evidence of research related to organizational management in the pharmaceutical industry.Due to the space limitation and research purpose,there are some limitations and should be improved in future research.First,the number of qualified persons participating in the survey met the basic statistical requirements,however,the number of samples should be increased in future.Second,the survey data came from the same report source.Data should be collected from multiple sources in the future.Third,the H-V model pointed out that ethical behavior has a feedback mechanism,which is not covered in this study.In the future,a feedback mechanism can be added to enrich the research on ethical decision-making.Fourth,this study only focused on ethical leadership and did not consider other factors affecting the organizational environment. |
PDF Full Text Request