325
Views
34
CrossRef citations to date
0
Altmetric
Commentary

Post-marketing surveillance: a UK/European perspective

Pages 565-570 | Accepted 09 Apr 2005, Published online: 18 Apr 2005

References

  • The Association of the British Pharmaceutical Industry. http//www.abpi.org.uk/statistics/intro.asp [last accessed 4 March 2005]
  • DiMassi JA, Hansen RW, Grabowski HG. The price of innovation: new estimates of drug development costs. J Health Econ 2003;22:151–85
  • New prescribing advice for the 40mg dose of Crestor (rosuvastatin) http://medicines.mhra.gov.uk/ [last accessed 4 March 2005]
  • Merck. Merckannounces voluntary worldwide withdrawal of VIOXX®. http://www.vioxx.com/vioxx/documents/english/vioxx_press_release.pdf [last accessed 4 March 2005]
  • Martin K, Begaud B, Latry P, Miremont-Salame G, Fourier A, Moore N. Differences between clinical trials and post-marketing use. Br J Clin Pharmacol 2003;57:86–92
  • Schmucker DL, Vesell ES. Underrepresentation of women in clinical drug trials. Clin Pharmacol Ther 1993;42(Suppl):11–5
  • Bugeja G, Kumar A, Banerjee AK. Exclusion of elderly people from clinical research: a descriptive study of published reports. Br Med J 1997;315: 1059
  • The yellow card scheme: how the yellow card scheme protects patients. https://www.mhra.gov.uk/medicines/safety/yellowcard/howprotects.htm [last accessed 4 March 2005]
  • Monitoring the safety and quality of medicines; new drugs under intense surveillance. http://medicines.mhra.gov.uk/ourwork/ monitorsafequalmed/newdrugs/newdrugs.htm [last accessed 4 March 2005]
  • Heeley E, Riley J, Layton D, Wilton LV, Shakir SAW. Prescription- event monitoring and reporting of adverse drug reactions. Lancet 2001;358:1872–7311.
  • Smith CC, Bennett PM, Pearce HM, et al. Adverse reactions in a hospital general medical unit meriting notification to the Committee on Safety of Medicines. Br J Pharmacol 1996;42:423–9
  • Mittmann N, Knowles SR, Gomez M, Fish JS, Cartotto R, Shear NH. Evaluation of the extent of under-reporting of serious adverse drug reactions: the case of toxic epidermal necrolysis. Drug Safety 2004;27:477–87
  • Begaud B, Martin K, Haramburu F, Moore N. Rates of reporting of adverse drug reactions in France. J Am Med Assoc 2002;288:1588
  • Backstrom M, Mjorndal T, Dahlqvist R. Under-reporting of serious adverse drug reactions in Sweden. Pharmacoepidemiol Drug Saf 2004;13:483–7
  • Guidelines for company-sponsored Safety Assessment of Marketed Medicines (SAMM) guidelines. Medicines Control Agency, Committee on Safety of Medicines, Royal College of General Practitioners, British Medical Association and association of British Pharmaceutical Industry (November 1993). Br J Pharmacol 1994;2: 95–7
  • Pharmacovigilance medicinal products for human and veterinary use, vol. 9: Section 1.5. Company-sponsored post-authorisation studies. http://www.eudravigilance.org/human/docs/Vol9en.pdf [last accessed 4 March 2005]
  • ICH harmonised tripartite guideline. Pharmacovigilance planning E2E. http//www.fda.gov/cder/guidance/6002dft.pdf [last accessed 4 March 2005]
  • Mehran R, Leon MB, Feigal DA, et al. Post-market approval surveillance: a call for a more integrated and comprehensive approach. Circulation 2004;109:3073–7
  • BMA fees guidance schedule, Section 6, April 2003 http://www/ bma.org.uk [last accessed 4 March 2005]
  • Guidance on the use of glitazones for the treatment of type 2 diabetes. http://www.nice.org.uk/pdf/TA63_Glitazones_Review_Guidance.pdf [last accessed 4 March 2005]
  • Department of Health. Research for Patient Benefit Working Party. Final report 2004. http://www.dh.gov.uk/assetRoot/04/08/26/75/04082675.pdf [last accessed 4 March 2005]
  • Work programme for the European Medicines Agency 2005. http://www.emea.eu.int/pdfs/general/direct/emeawp/13835104en.pdf [last accessed 4 March 2005.

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.