Hostname: page-component-cd9895bd7-lnqnp Total loading time: 0 Render date: 2024-12-22T17:27:48.307Z Has data issue: false hasContentIssue false
  • English
  • Français

Public Acceptance of Peramivir During the 2009 H1N1 Influenza Pandemic: Implications for Other Drugs or Vaccines Under Emergency Use Authorizations

Published online by Cambridge University Press:  17 April 2015

Sandra Crouse Quinn ,
Karen Hilyard ,
Nestor Castaneda-Angarita  and
Vicki S. Freimuth
Sandra Crouse Quinn*
Affiliation:
Department of Family Science, School of Public Health, University of Maryland, College Park, Maryland
Karen Hilyard
Affiliation:
School of Public Health, University of Georgia, Athens, Georgia
Nestor Castaneda-Angarita
Affiliation:
Department of Politics and International Relations, University of Southampton, Southampton, United Kingdom
Vicki S. Freimuth
Affiliation:
Southern Center for Communication, Health, and Poverty, University of Georgia, Athens, Georgia
*
Correspondence and reprint requests to Sandra Crouse Quinn, PhD, Department of Family Science, School of Public Health, University of Maryland, 2242K SPH Building #255, College Park, MD 20742-2611 (e-mail: [email protected]).
Get access Rights & Permissions [Opens in a new window]

Abstract

Objective

The Centers for Disease Control and Prevention estimated that up to 88 million H1N1 influenza cases, 398,000 hospitalizations, and up to 18,050 related deaths, including significant racial and ethnic disparities, occurred between April 2009 and March 13, 2010. The Food and Drug Administration (FDA) approved emergency use authorizations (EUAs), which allowed the distribution of unapproved drugs or the off-label use of approved drugs. In late 2009, peramivir was granted an EUA for patients with severe disease. This study examined factors associated with willingness to take peramivir.

Methods

In 2010 we conducted a nationally representative survey with 2079 respondents randomly drawn from the Knowledge Networks research panel. Our completion rate was 56%. Respondents received information about peramivir from a fact sheet and then answered questions about their willingness to take the drug.

Results

Overall, 48% of participants indicated that they would probably or definitely take peramivir. Seventy-nine percent definitely would take the drug if their doctor recommended it and there were no alternative treatments. There were significant racial differences in willingness. The term experimental to refer to the drug decreased willingness to accept peramivir among both whites and blacks.

Conclusions

Trust in the FDA was important for peramivir acceptance. Particular care must be taken to ensure that patients and their families understand the complex nature of EUA drugs. Lessons learned can inform communication about future EUAs. (Disaster Med Public Health Preparedness. 2015;9:166-174)

Keywords

communicationpublic healthvaccines
Type
Original Research
Information
Disaster Medicine and Public Health Preparedness , Volume 9 , Issue 2 , April 2015 , pp. 166 - 174
Copyright
Copyright © Society for Disaster Medicine and Public Health, Inc. 2015 

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

REFERENCES

1. CDC Estimates of 2009 H1N1 Influenza Cases, Hospitalizations and Deaths in the United States, April 2009-March 13, 2010. Centers for Disease Control and Prevention website. http://www.cdc.gov/h1n1flu/estimates/April_March_13.htm. Accessed May 28, 2013.Google Scholar
2. Jain, S, Kamimoto, L, Bramley, AM, et al. Hospitalized patients with 2009 H1N1 influenza in the United States, April–June 2009. N Engl J Med. 2009;361(20):1935-1944.Google Scholar
3. Kwan-Gett, TS, Baer, A, Duchin, JS. Spring 2009. H1N1 influenza outbreak in King County, Washington. Disaster Med Public Health Prep. 2009;3(S2):S109-S116.CrossRefGoogle ScholarPubMed
4. Centers for Disease Control and Prevention. 2009. Pandemic Influenza A (H1N1) Virus Infections-Chicago, Illinois, April-July 2009. Morbid Mortal Wkly Rep. 2009;58(33):913-918.Google Scholar
5. Chitnis, AS, Truelove, SA, Druckenmiller, JK, et al. Epidemiologic and clinical features among patients hospitalized in Wisconsin with 2009 H1N1 influenza A virus infections, April to August 2009. WMJ. 2010;109(4):201.Google ScholarPubMed
6. Loganathan, R, Sitnitskaya, Y, Schori, M, et al. Urban Inner-City Minority New Yorkers Hospitalized with Novel Swine-Origin Influenza A H1N1 Virus Illness During the Pandemic of April-June 2009. Internet J Emerg Intensive Care Med. 2010;12(1). http://ispub.com/IJEICM/12/1/7091. Accessed March 2, 2011.Google Scholar
7. Dee, DL, Bensyl, DM, Gindler, J, et al. Racial and ethnic disparities in hospitalizations and deaths associated with 2009 pandemic influenza A (H1N1) virus infections in the United States. Ann Epidemiol. 2011;21(8):623-630.CrossRefGoogle ScholarPubMed
8. Interim Questions and Answers about Emergency Use Authorization. Centers for Disease Control and Prevention website. http://www.cdc.gov/h1n1flu/eua/. Accessed June 4, 2010.Google Scholar
9. Quinn, SC, Kumar, S, Freimuth, VS, et al. Public willingness to take a vaccine or drug under Emergency Use Authorization during the 2009 H1N1 pandemic. Biosecur Bioterror. 2009;7(3):275-290.CrossRefGoogle ScholarPubMed
10. Guidance Emergency Use Authorization of Medical Products. US Food and Drug Administration (FDA) website. 2007. http://www.fda.gov/RegulatoryInformation/Guidances/ucm125127.htm. Accessed May 28, 2013.Google Scholar
11. Nightingale, SL, Prasher, JM, Simonson, S. Emergency Use Authorization (EUA) to enable use of needed products in civilian and military emergencies, United States. Emerg Infect Dis. 2007;13(7):1046-1051.Google Scholar
12. Courtney, B. FDA Emergency Use Authorizations (EUAs): What are they and what do they mean for the H1N1 swine flu response? Biosecur Bioterror. 2009;7(2):211-213.Google Scholar
13. Termination of the Emergency Use Authorization (EUA) of Medical Products and Devices. Centers for Disease Control and Prevention website. http://www.cdc.gov/h1n1flu/eua/. Accessed May 28, 2013.Google Scholar
14. Emergency use authorization of Peramivir fact sheet for patients and parents/caregivers. US Food and Drug Administration (FDA) website. http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM187799.pdf. Accessed May 28, 2013.Google Scholar
15. FDA-issued Peramivir EUA letter. Centers for Disease Control and Prevention website. http://www.cdc.gov/h1n1flu/eua/EUA%20Peramivir%20Letter%20-%20Frieden.pdf. Accessed May 28, 2013.Google Scholar
16. Birnkrant, D, Cox, E. The Emergency Use Authorization of Peramivir for Treatment of 2009 H1N1 Influenza. N Engl J Med. 2009;361(23):2204-2207.CrossRefGoogle ScholarPubMed
17. Centers for Disease Control and Prevention. Influenza vaccination coverage-United States, 2000-2010. Morb Mortal Wkly Rep. 2011;60:38-41.Google Scholar
18. Quinn, SC, Parmer, J, Freimuth, V, et al. Exploring Communication, Trust in Government and Vaccine Intention Later in the 2009 H1N1 Pandemic: Results of a National Survey. Biosecur Bioterror. 2013;11(2):96-106.CrossRefGoogle ScholarPubMed
19. Advancing Regulatory Science at FDA: A Strategic Plan. US Food and Drug Administration website. 2011. http://www.fda.gov/downloads/scienceresearch/specialtopics/regulatoryscience/ucm268225.pdf. Accessed November 29, 2012.Google Scholar
20. Vaughan, E, Tinker, T. Effective health risk communication about pandemic influenza for vulnerable populations. Am J Public Health. 2009;99(S2):S324-S332. doi: 10.2105/AJPH.2009.162537.Google Scholar
21. Plain Writing Act of 2010. Government Printing Office (GPO) website. http://www.plainlanguage.gov/plLaw/. Accessed December 16, 2013.Google Scholar
22. Freimuth, VS, Quinn, SC, Thomas, SB, et al. African Americans’ views on research and the Tuskegee Syphilis Study. Soc Sci Med. 2001;52(5):797-808.CrossRefGoogle ScholarPubMed
23. George, S, Duran, N, Norris, K. A systematic review of barriers and facilitators to minority research participation among African Americans, Latinos, Asian Americans, and Pacific Islanders. Am J Public Health. 2014;104(2):e16-e31.Google Scholar
24. Questions and Answers for Hospitals and Healthcare Professionals Regarding Termination of the Emergency Use Authorization for Peramivir IV. US Food and Drug Administration website. June 22, 2010. http://www.cdc.gov/H1N1flu/EUA/pdf/Peramivir_Attachment_22Jun2010.pdf. Accessed May 28, 2013.Google Scholar