Factors that Lead to Stagnation in Direct Patient Reporting of Adverse Drug Reactions: An Opinion Survey of the General Public and Physicians in Japan

• Published in: Therapeutic innovation & regulatory science Vol. 56; no. 4; pp. 616 - 624
• Main Authors: Kitabayashi, Aki, Inoue, Yusuke
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01.07.2022; Springer Nature B.V
• Subjects: Adverse Drug Reaction Reporting Systems; Attitudes; Data collection; Drug Safety and Pharmacovigilance; Drug-Related Side Effects and Adverse Reactions; Health Knowledge, Attitudes, Practice; Humans; Japan; Medical personnel; Medicine; Original Research; Patients; Pharmacotherapy; Pharmacovigilance; Pharmacy; Physicians; Public opinion surveys; Regulatory agencies; Side effects; Stagnation; Japan; Patient and public involvement; Physician–patient relationship; Questionnaire survey; Direct patient reporting; Adverse drug reactions
• ISSN: 2168-4790; 2168-4804
• DOI: 10.1007/s43441-022-00397-x

Objective Data collection from patients regarding adverse drug reactions (ADRs) in Japan have greatly stagnated. To examine the factors underlying this stagnation, we investigated the awareness of and opinions about the direct ADR reporting system among the general public and physicians. Methods We conducted questionnaire surveys of general citizens and physicians throughout Japan and included the following topics: (1) awareness of the direct patient ADR reporting system, (2) attitude toward this system, (3) reasons for negative opinions of this system, (4) awareness of the physician ADR reporting system, and (5) respondent demographics. Results Responses were received from 845 citizens and 300 physicians. Most citizens (83.7%) were unaware of the direct patient ADR reporting system. While many citizens supported the idea of the system, 26.7% expressed negative/hesitant opinions. Prominent reasons for negative/hesitant opinions included the patient burden for reporting their own ADRs and expectations that physicians would make reports. Among the general public, the physician reporting system was better known (43.6%). In contrast, many physicians were aware of the direct patient ADR reporting system (65.0%). However, only 46.7% of physicians had supported this system; prominent reasons for disapproval included skepticism toward patients’ judgment and the regulatory authorities’ assessment. Conclusion Our survey suggests that stagnation in the reporting system is affected by the attitudes of the general public and physicians. In addition to government measures to improve awareness and eliminate reporting hurdles, the involvement of medical staff in patient reporting needs to be improved.