Abstract
A survey of the US public titled ‘Consumer Perceptions on Drug Safety’ was conducted in October 2006. The survey was undertaken at that time because of the heightened public awareness of drug safety concerns over rofecoxib (Vioxx®) and pediatric antidepressant use. The survey was designed with questions related to public perception of the pharmaceutical industry, the US FDA, Congress and whether the US public perceived there to be a safety crisis. The survey consisted of 1726 US men and women aged 18 years and over.
The survey results showed that the FDA, Congress and US pharmaceutical companies are perceived as having a notable amount of responsibility to ensure safety (by 75%, 41% and 70% of respondents, respectively). Additionally, 96% of the survey respondents indicated that they had some level of concern about adverse reactions to prescription drugs that are taken as directed. Seventy-six percent of the respondents were ‘fairly’ to ‘extremelyrs concerned about adverse reactions, while approximately 42% of the survey respondents’ opinions ranged from ‘somewhat distrusting’ to ‘strongly distrusting’ of the pharmaceutical companies that develop drugs. These findings are comparable to those in surveys conducted by the Kaiser Family Foundation in 2005 and PriceWaterhouseCoopers in 2007. These surveys suggest that about half the respondents believe there is both the need and desire for reform in drug safety by the pharmaceutical industry and the FDA.
In reports from 2006 and 2007, the Institute of Medicine challenges the healthcare system and the FDA to adopt the principles of the culture of safety. While there have been steps taken to address the recommendations of the reports, as exemplified by the FDA Amendment Act of 2007 and the Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium, true reform across the life sciences sector will only come through broad adoption of these principles. Thus, it is particularly important for individuals and healthcare providers to track and report safety-related events involving approved and unapproved indications and medication errors. Pharmacovigilance professionals provide the foundation upon which the principles of the culture of safety can be built.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
Food and Drug Administration, Center for Drug Evaluation and Research. Summary minutes of the CDER Psycho-pharmacologic Drugs Advisory Committee and the FDA Pediatric Advisory Committee, September 13–14, 2004 [online]. Available from: URL: http://www.fda.gov/ohrms/dockets/AC/04/minutes/2004-4065M1_Final.htm [Accessed 2009 Apr 30]
FDA’s role in protecting the public health: examining FDA’s review of safety and efficacy concerns in anti-depressant use by children. Hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives One Hundred Eighth congress, second session. Serial no. 108-125 [online]. Available from: URL: http://www.access.gpo.gov/congress/house/pdf/108hrg/96099.pdf [Accessed 2009 Apr 30]
FDA Public Health Advisory. Suicidality in children and adolescents being treated with antidepressant medications [online]. Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2004/ucm108363.htm [Accessed 2009 Aug 6]
FDA Public Health Advisory. Safety of Vioxx [online]. Available from URL: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm106274.htm [Accessed 2009 Aug 5]
US FDA. 2004 safety alerts for drugs, biologics, medical devices, and dietary supplements [online]. Available from URL: http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#drugs [Accessed 2009 Apr 30]
US FDA. 2005 safety alerts for drugs, biologics, medical devices, and dietary supplements [online]. Available from URL: http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm [Accessed 2009 Apr 30]
US FDA. 2006 safety alerts for drugs, biologics, medical devices, and dietary supplements [online]. Available from URL: http://www.fda.gov/medwatch/safety/2006/safety06.htm [Accessed 2009 Apr 30]
Harris Interactive. Large numbers of people are not very confident in their own knowledge and the safety of prescription medications and this often leads to non-adherence [online]. Available from URL: http://www.harrisinteractive.com/news/allnewsbydate.asp?NewsID=1206 [Accessed 2009 Aug 6]
Karacsony A, Rosenbaum J. Recapturing the vision: restoring trust in the pharmaceutical industry by translating expectations into actions [online]. Available from URL: http://www.pwc.com/extweb/pwcpublications.nsf/docid/E8A194168C19DE678525726100550B91 [Accessed 2009 Feb 16]
Kaiser HealthPoll Report. Views on prescription drugs and the pharmaceutical industry [online]. Available from URL: http://www.kff.org/healthpollreport/feb_2005/index.cfm [Accessed 2008 Apr 20]
Consumer Reports. Consumer Reports survey finds strong backing for drug reforms [online]. Available from URL: http://www.consumerreports.org/health/prescription-drugs/consumer-reports-survey-finds-strong-backing-for-drug-reforms-4-07/overview/consumer-reports-survey-finds-strong-backing-for-drug-reforms.htm?resultPageIndex=1&resultIndex=2 [Accessed 2008 Oct 29]
Baciu A, Stratton K, Burke SP, et al. The future of drug safety: promoting and protecting the health of the public. Washington, DC: The National Academies Press, 2007: 27
Aspden P, Wolcott J, Bootman JL, et al., editors. Preventing medication errors: quality chasm series. Washington, DC: The National Academies Press, 2006: 15
Bolger G, Mellman M. Prescription drug safety national survey [online]. Available from URL: http://www.dialogueondrugsafety.org/assets/files/AU%20Survey_Drug%20Safety_FINAL%209.20.pdf [Accessed 2008 Oct 29]
Löfstedt R. Risk communication and management in the twenty-first century. Int Public Manage Rev 2004; 5(2): 36–51
Commission of the European Communities. Summary of the impact assessment [online]. Available from URL: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SEC:2008:2671:FIN:EN:PDF [Accessed 2009 Feb 20]
European Medicines Agency. EMEA-coordinated PROTECT project has been accepted for funding by the Innovative Medicines Initiative Joint Undertaking. Doc. ref. EMEA/ 230677/2009 [press release; online]. Available from URL: http://www.emea.europa.eu/pdfs/human/phv/23067709en.pdf [Accessed 2009 May 1]
US FDA. Food and Drug Amendments Act 2007 [online]. Available from URL: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085.110 [Accessed 2009 Aug 6]
Department of Health and Human Services, FDA. Sentinel network to promote medical product safety: public meeting. Federal Register Vol. 72, No. 11 [online]. Available from URL: http://edocket.access.gpo.gov/2007/pdf/07-141.pdf [Accessed 2009 May 1]
Edwards B, Olsen AK, Whalen MD, et al. Guiding principles of safety as a basis for development of a pharmaceutical safety culture. Curr Drug Saf 2007; 2: 135–9
Acknowledgements
No sources of funding were used to assist in the preparation of this review. The authors have no conflicts of interest that are directly relevant to the content of this review.
The review is based, in part, on a Keynote address (22 May 2008) delivered at the Institute for International Research’s Drug Safety & Risk Management Conference, held in Washington, DC, USA. The Harris Interactive survey conducted in 2006 and cited in this review was supported by a grant from Quintiles, Inc.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Olsen, A.K., Whalen, M.D. Public Perceptions of the Pharmaceutical Industry and Drug Safety. Drug-Safety 32, 805–810 (2009). https://doi.org/10.2165/11316620-000000000-00000
Published:
Issue Date:
DOI: https://doi.org/10.2165/11316620-000000000-00000