Patient Drug Safety Reporting: Diabetes Patients’ Perceptions of Drug Safety and How to Improve Reporting of Adverse Events and Product Complaints

• Published in: Therapeutic innovation & regulatory science 2018-03, Vol.52 (2), p.236-243
• Main Authors: Patel, Puja, Spears, David, Eriksen, Betina Østergaard, Lollike, Karsten, Sacco, Michael
• Format: Article
• Language: English
• Subjects: Communication; Diabetes Mellitus - drug therapy; Drug Industry; Drug Safety and Pharmacovigilance; Drug-Related Side Effects and Adverse Reactions; Female; Germany; Health Knowledge, Attitudes, Practice; Humans; Italy; Legislation, Drug; Male; Middle Aged; Patient Participation; Perception; Pharmacotherapy; Pharmacy; Product Safety: Original Research; Product Surveillance, Postmarketing; United Kingdom; United States
• ISSN: 2168-4790; 2168-4804
• DOI: 10.1177/2168479017723398

Background: Global health care manufacturer Novo Nordisk commissioned research regarding awareness of drug safety department activities and potential to increase patient feedback. Objectives were to examine patients’ knowledge of pharmaceutical manufacturers’ responsibilities and efforts regarding drug safety, their perceptions and experiences related to these efforts, and how these factors influence their thoughts and behaviors. Data were collected before and after respondents read a description of a drug safety department and its practices. Methods: We conducted quantitative survey research across 608 health care consumers receiving treatment for diabetes in the United States, Germany, United Kingdom, and Italy. This research validated initial, exploratory qualitative research (across 40 comparable consumers from the same countries) which served to guide design of the larger study. Results: Before reading a drug safety department description, 55% of respondents were unaware these departments collect safety information on products and patients. After reading the description, 34% reported the department does more than they expected to ensure drug safety, and 56% reported “more confidence” in the industry as a whole. Further, 66% reported themselves more likely to report an adverse event or product complaint, and 60% reported that they were more likely to contact a drug safety department with questions. The most preferred communication methods were websites/online forums (39%), email (27%), and telephone (25%). Conclusions: Learning about drug safety departments elevates consumers’ confidence in manufacturers’ safety efforts and establishes potential for patients to engage in increased self-monitoring and reporting. Study results reveal potentially actionable insights for the industry across patient and physician programs and communications.