335
Views
2
CrossRef citations to date
0
Altmetric
Research Paper

Public engagement and the role of the media in post-marketing drug safety: the case of Eltroxin® (levothyroxine) in New Zealand

, ORCID Icon, , ORCID Icon, ORCID Icon, & show all
Pages 388-401 | Received 06 Nov 2016, Accepted 03 May 2017, Published online: 22 May 2017

References

  • Abraham, J. (2003). Learning from drug disasters and reforming medicines regulation. Critical Public Health , 13 , 269–279.10.1080/0958159032000114462
  • Abraham, J. , & Shepherd, J. (1999). The therapeutic nightmare: The battle over the world’s most controversial sleeping pill . Abingdon: Earthscan.
  • Akoorie, N. (2008, June 17). Woman blames drug for illness. Waikato Times .
  • American Thyroid Association, The Endocrine Society, & American Association of Clinical Endocrinologists . (2004). Joint Statement on the U.S. Food and Drug Administration’s Decision Regarding Bioequivalence of Levothyroxine Sodium. Retrieved from http://www.endo-society.org/advocacy/legislative/upload/Joint_Statement_Levothyroxine-Thyroxine.pdf
  • Avery, A. , Anderson, C. , Bond, C. , Fortnum, H. , Gifford, A. , Hannaford, P. , Hazell, L. , et al. (2011). Evaluation of patient reporting of adverse drug reactions to the UK ‘Yellow Card Scheme’: Literature review, descriptive and qualitative analyses, and questionnaire surveys. Health Technology Assessment , 15 , 1–234. doi:10.3310/hta15200
  • Backstrom, M. , Mjorndal, T. , Dahlqvist, R. , & Nordkvist-Olsson, T. (2000). Attitudes to reporting adverse drug reactions in northern Sweden. European Journal of Clinical Pharmacology , 56 , 729–732.10.1007/s002280000202
  • Banerjee, A. , Okun, S. , Edwards, I. R. , Wicks, P. , Smith, M. , Mayall, S. , … Basch, E. (2013). Patient-reported outcome measures in safety event reporting: PROSPER Consortium guidance. Drug Safety , 36 , 1129–1149.10.1007/s40264-013-0113-z
  • Basch, E. (2013). New frontiers in patient-reported outcomes: Adverse event reporting, comparative effectiveness, and quality assessment. Annual Review of Medicine , 65 , 307–317.
  • Blue, J. (2008a, September 8). Press release: Action on Eltroxin now urgent . Wellington: The National Party.
  • Blue, J. (2008b, August 22). Press release: Thyroxine concerns need sorting out . Wellington: The National Party.
  • Britten, N. , Stevenson, F. , Gafaranga, J. , Barry, C. , & Bradley, C. (2004). The expression of aversion to medicines in general practice consultations. Social Science & Medicine , 59 , 1495–1503.10.1016/j.socscimed.2004.01.019
  • Cumming, J. , McDonald, J. , Barr, C. , Martin, G. , Gerring, Z. , & Daubé, J. (2014). New Zealand health system review. Health Systems in Transition , 4 , 1–242.
  • Dew, K. , Stubbe, M. , Macdonald, L. , & Dowell, A. (2012). Side effects talk in general practice consultations. In B. Bates & R. Ahmed (Eds.), Medical communication in clinical contexts (pp. 95–126). Dubuque, IA: Kendall Hunt.
  • Edwards, I. R. , & Lindquist, M. (2011). Social media and networks in pharmacovigilance boon or bane? Drug Safety , 34 , 267–271.10.2165/11590720-000000000-00000
  • Faasse, K. , Cundy, T. , & Petrie, K. (2010). Thyroxine: Anatomy of a health scare. British Medical Journal , 340 , 20–21.
  • Faasse, K. , Gamble, G. , Cundy, T. , & Petrie, K. (2012). Impact of television coverage on the number and type of symptoms reported during a health scare: A retrospective pre-post observational study. British Medical Journal Open , 2 , e001607.
  • Gabe, J. , & Bury, M. (1996). Halcion nights: A sociological account of a medical controversy. Sociology , 30 , 447–469.10.1177/0038038596030003003
  • Gerken, S. (2008a, June 7). Changes to thyroid drug formula blamed for sickness. The Southland Times .
  • Gerken, S. (2008b, September 23). Huge demand for alternative drug. The Southland Times .
  • Gerken, S. (2008c, August 27). NZ too small for drug says Ministry. The Southland Times .
  • Gerken, S. (2008d, August 22). Patient seek new safer pills. The Southland Times .
  • Gerken, S. (2008e, June 14). Thyroid drug users urged to contact centre. The Southland Times .
  • Gibbons, R. D. , Amatya, A. K. , Brown, C. H. , Hur, K. , Marcus, S. M. , Bhaumik, D. K. , & Mann, J. J. (2010). Post-approval drug safety surveillance. Annual Review of Public Health , 31 , 419–437. doi:10.1146/annurev.publhealth.012809.103649
  • Goffman, E. (2006). On face-work. In G. Massey (Ed.), Readings for sociology (pp. 105–114). New York, NY : W.W. Norton and Company.
  • Hall, M. (2008, September 9). The Eltroxin controversy: GlaxoSmithKline responds. The National Business Review .
  • Harrison-Woolrych, M. (2011). Patient reporting encouraged during monitoring of Dapoxetine in New Zealand. Drug Safety , 34 , 1115–1116.10.2165/11596010-000000000-00000
  • Hazell, L. , & Shakir, S. A. W. (2006). Under-reporting of adverse drug reactions – A systematic review. Drug Safety , 29 , 385–396.10.2165/00002018-200629050-00003
  • Hennessey, J. , Malabanan, A. , Haugen, B. , & Levy, E. (2010, February). Adverse event reporting in patients treated with Levothyroxine: Results of the Pharmacovigilance Task Force survey of the American Thyroid Association, American Association of Clinical Endocrinologists and The Endocrine Society. Endocrine Practice , 11 , 1–41.
  • Hodgetts, D. , & Chamberlain, K. (2006). An extended media research agenda for health psychology. Journal of Health Psychology , 11 , 317–327.10.1177/1359105306061190
  • Hooker, C. (2010). Health scares: Professional priorities. Health , 14 , 3–21. doi:10.1177/1363459309341875
  • van Hunsel, F. , Harmark, L. , Pal, S. , Olsson, S. , & van Grootheest, K. (2012). Experiences with adverse drug reaction reporting by patients an 11-country survey. Drug Safety , 35 , 45–60.10.2165/11594320-000000000-00000
  • Inácio, P. , Cavaco, A. , & Airaksinen, M. (2016). The value of patient reporting to the pharmacovigilance system: A systematic review. British Journal of Clinical Pharmacology , 83 , 227–246. doi:10.1111/bcp.13098
  • Jesson, J. , & Bissell, P. (2006). Public health and pharmacy: A critical review. Critical Public Health , 16 , 159–169.10.1080/09581590600825812
  • Kedgley, S. (2008, August 28). Press release: Situation critical for thyroid sufferers: Greens . The Green Party.
  • Kikuchi, T. , Suzuki, T. , Uchida, H. , Watanabe, K. , & Kashima, H. (2011). Subjective recognition of adverse events with antidepressant in people with depression: A prospective study. Journal of Affective Disorders , 135 , 347–353.10.1016/j.jad.2011.07.011
  • Kjellgren, K. I. , Svensson, S. , Ahlner, J. , & Saljo, R. (1998). Antihypertensive medication in clinical encounters. International Journal of Cardiology , 64 , 161–169.10.1016/S0167-5273(98)00038-2
  • Kmetz, J. (2011). Adverse event reporting in social media . Bellevue, WA : Visible Technologies.
  • Knezevic, M. , Bivolarevic, I. , Peric, T. , & Jankovic, S. (2011). Using facebook to increase spontaneous reporting of adverse drug reactions. Drug Safety , 34 , 351–352.10.2165/11590110-000000000-00000
  • Lazarou, J. , Pomeranz, B. H. , & Corey, P. N. (1998). Incidence of adverse drug reactions in hospitalized patients: A meta-analysis of prospective studies. Journal of the American Medical Association , 279 , 1200–1205.10.1001/jama.279.15.1200
  • Lopez-Gonzalez, E. , Herdeiro, M. T. , & Figueiras, A. (2009). Determinants of under-reporting of adverse drug reactions: A systematic review. Drug Safety , 32 , 19–31.10.2165/00002018-200932010-00002
  • MARC . (2008). Minutes of 135th Meeting held on 11 September 2008 . Wellington: Medicines Adverse Reactions Monitoring Committee.
  • Medawar, C. , Herxheimer, A. , Bell, A. , & Jofre, S. (2002). Paroxetine, Panorama and user reporting of ADRs: Consumer intelligence matters in clinical practice and post-marketing drug surveillance. International Journal of Risk & Safety in Medicine , 15 , 161–169.
  • Medsafe . (2008a, June 27). Press release: Eltroxin formulation change. Scoop media limited .
  • Medsafe . (2008b, October 23). Press release: Medsafe approves additional Levothyroxine products. Scoop media limited .
  • Medsafe . (2010). Eltroxin formulation change. Retrieved September 3, 2010, from http://www.medsafe.govt.nz/hot/alerts/EltroxinInfo.asp
  • Miller, G. C. , Britt, H. C. , Valenti, L. , & Knox, S. (2006). Adverse drug events: Counting is not enough, action is needed [Comment]. Medical Journal of Australia , 184 , 19.
  • Ministry of Health . (2008, September 11). Media Research: Eltroxin . Wellington: Ministry of Heatlh.
  • Mintz, M. (1985). At any cost: Corporate greed, women, and the Dalkon Shield . New York, NY : Pantheon Books.
  • Office of the Clerk . (2008, September 10). Press release: Questions and Answers: Wednesday. Scoop media limited . Retrieved from http://www.scoop.co.nz/stories/PA0809/S00234.htm
  • PHARMAC . (2008, September 30). Press release: Consultation on alternative thyroid treatment. Scoop media limited .
  • Saukko, P. (2009). Genetic risk online and offline: Two ways of being susceptible to blood clots. Health, Risk and Society , 11 (1), 1–16.10.1080/13698570802538894
  • Seale, C. , Chaplin, R. , Lelliot, P. , & Quirk, A. (2007). Antipsychotic medication, sedation and mental clouding: An observational study of psychiatric consultations. Social Science & Medicine , 65 , 698–711.10.1016/j.socscimed.2007.03.047
  • Silverstone, R. (1999). Why study the media? London: Sage.
  • Silverstone, R. (2007). Media and morality: On the rise of the mediapolis . Cambridge: Polity.
  • Smith, M. , & Benattia, I. (2016). The patient’s voice in pharmacovigilance: Pragmatic approaches to builing a patient-centric drug safety organization. Drug Safety , 39 , 779–785. doi:10.1007/s40264-016-0426-9
  • Smith, C. C. , Bennett, P. M. , Pearce, H. M. , Harrison, P. I. , Reynolds, D. J. M. , Aronson, J. K. , & GrahameSmith, D. G. (1996). Adverse drug reactions in a hospital general medical unit meriting notification to the Committee on Safety of Medicines. British Journal of Clinical Pharmacology , 42 , 423–429.10.1111/j.1365-2125.1996.tb00004.x
  • Southland Times . (2008, June 11). Hundreds more claim thyroid drug side effects. Southland Times .
  • Tatley, M. (2008). The Eltroxin formulation change: An analysis of reports received by CARM . Dunedin: New Zealand Pharmacovigilance Centre.
  • The National Business Review . (2008, August 28). Over 500 complain of side effects from drug. The National Business Review .
  • Wiktorowicz, M. , Lexchin, J. , & Moscou, K. (2012). Pharmacovigilance in Europe and North America: Divergent approaches. Social Science & Medicine , 75 , 165–170.10.1016/j.socscimed.2011.11.046
  • Williams, A. , & Donaghue, N. (2010). ‘Now that’s a fair dinkum academic debate, but this affects people’s lives’: A discursive analysis of arguments for and against the provision of warnings about potential side effects of SSRIs in a public debate. Critical Public Health , 20 , 15–24.10.1080/09581590802566446
  • World Health Organization (2006). Adverse drug reactions monitoring . Vol. 2006. Geneva: Author.
  • Wylie, K. (2008, August 29). Alternative drug sells out. The Press .

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.