#PAGE_PARAMS# #ADS_HEAD_SCRIPTS# #MICRODATA#

Pharmaceutical Industry Off-label Promotion and Self-regulation: A Document Analysis of Off-label Promotion Rulings by the United Kingdom Prescription Medicines Code of Practice Authority 2003–2012


In a document analysis of legal cases, Shai Mulinari and colleagues characterize off-label drug promotion by pharmaceutical companies in the UK.


Vyšlo v časopise: Pharmaceutical Industry Off-label Promotion and Self-regulation: A Document Analysis of Off-label Promotion Rulings by the United Kingdom Prescription Medicines Code of Practice Authority 2003–2012. PLoS Med 13(1): e32767. doi:10.1371/journal.pmed.1001945
Kategorie: Research Article
prolekare.web.journal.doi_sk: https://doi.org/10.1371/journal.pmed.1001945

Souhrn

In a document analysis of legal cases, Shai Mulinari and colleagues characterize off-label drug promotion by pharmaceutical companies in the UK.


Zdroje

1. European Union. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use; Article 87. http://ec.europa.eu/health/files/eudralex/vol-1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_en.pdf. Accessed 28 July 2015.

2. Radley DC, Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians. Arch Intern Med. 2006;166(9):1021–6. doi: 10.1001/archinte.166.9.1021 16682577

3. Ratner M, Gura T. Off-label or off-limits? Nat Biotech. 2008;26(8):867–75.

4. European Federation of Pharmaceutical Industries and Associations (EFPIA). Promotion of off label use of medicines by European healthcare bodies in indications where authorised medicines are available. 2014. http://www.efpia.eu/uploads/Modules/Documents/efpia-position-paper-off-label-use-may-2014.pdf. Accessed 28 July 2015.

5. Mello MM, Studdert DM, Brennan TA. Shifting Terrain in the Regulation of Off-Label Promotion of Pharmaceuticals. New Engl J Med. 2009;360(15):1557–66. doi: 10.1056/NEJMhle0807695 19357413

6. Ventola CL. Off-Label Drug Information: Regulation, Distribution, Evaluation, and Related Controversies. P T. 2009;34(8):428–40. 20140107

7. Lenk C, Duttge G. Ethical and legal framework and regulation for off-label use: European perspective. Ther Clin Risk Manag. 2014;10:537–46. doi: 10.2147/tcrm.s40232 25050064

8. Medicines & Healthcare products Regulatory Agency (MHRA). The Blue Guide: advertising and promotion of medicines in the UK; 3rd Edition. 2014. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/376398/Blue_Guide.pdf. Accessed 28 July 2015.

9. Medicines & Healthcare products Regulatory Agency (MHRA). Memorandum of understanding between the ABPI, the PMCPA and the MHRA. 2005. http://www.abpi.org.uk/our-work/news/2011/Documents/Memorandum%20of%20Understanding%20between%20the%20ABPI,%20PMCPA%20and%20SFO%20Final%20April%202011.pdf. Accessed 27 July 2015.

10. Zetterqvist AV, Merlo J, Mulinari S. Complaints, complainants, and rulings regarding drug promotion in the United Kingdom and Sweden 2004–2012: A quantitative and qualitative study of pharmaceutical Industry self-regulation. PLOS Med 12(2): e1001785. doi: 10.1371/journal.pmed.1001785 25689460

11. Association of the British Pharmaceutical Industry (ABPI). Code of Practice for the pharmaceutical industry. 2014. http://www.pmcpa.org.uk/thecode/Documents/PMCPA%20Code%20of%20Practice%202014.pdf. Accessed 27 July 2015.

12. Casali PG. The off-label use of drugs in oncology: a position paper by the European Society for Medical Oncology (ESMO). Ann Oncol. 2007;18(12):1923–5. doi: 10.1093/annonc/mdm517 18083693

13. Levêque D. Off-label use of anticancer drugs. Lancet Oncol. 2008;9(11):1102–7. http://dx.doi.org/10.1016/S1470-2045(08)70280-8. doi: 10.1016/S1470-2045(08)70280-8 19012859

14. Anon. Off-label prescriptions: patient safety first. Lancet Oncol. 2011;12(9):825. doi: 10.1016/S1470-2045(11)70246-7 21875558

15. Martin-Latry K, Ricard C, Verdoux H. A one-day survey of characteristics of off-label hospital prescription of psychotropic drugs. Pharmacopsychiatry. 2007;40(03):116–20. 10. doi: 1055/s-2007-977713 17541887

16. Kaye JA, Bradbury BD, Jick H. Changes in antipsychotic drug prescribing by general practitioners in the United Kingdom from 1991 to 2000: a population-based observational study. Br J Clin Pharmacol. 2003;56(5):569–75. doi: 10.1046/j.1365-2125.2003.01905.x 14651732

17. Conroy S, Choonara I, Impicciatore P, Mohn A, Arnell H, Rane A, et al. Survey of unlicensed and off label drug use in paediatric wards in European countries. European Network for Drug Investigation in Children. BMJ. 2000;320(7227):79–82. 10625257

18. Conroy S, Newman C, Gudka S. Unlicensed and off label drug use in acute lymphoblastic leukaemia and other malignancies in children. Ann Oncol. 2003;14(1):42–7. doi: 10.1093/annonc/mdg031 12488291

19. Neubert A, Wong ICK, Bonifazi A, Catapano M, Felisi M, Baiardi P, et al. Defining off-label and unlicensed use of medicines for children: Results of a Delphi survey. Pharmacol Res. 2008;58(5–6):316–22. http://dx.doi.org/10.1016/j.phrs.2008.09.007. doi: 10.1016/j.phrs.2008.09.007 18852048

20. Culshaw J, Kendall D, Wilcock A. Off-label prescribing in palliative care: A survey of independent prescribers. Palliat Med. 2013;27(4):314–9. doi: 10.1177/0269216312465664 23175511

21. Pavis H, Wilcock A. Prescribing of drugs for use outside their licence in palliative care: survey of specialists in the United Kingdom. BMJ. 2001;323(7311):484–5. doi: 10.1136/bmj.323.7311.484 11532839

22. Walton SM, Schumock GT, Lee KV, Alexander GC, Meltzer D, Stafford RS. Prioritizing future research on off-label prescribing: results of a quantitative evaluation. Pharmacotherapy. 2008;28(12):1443–52. doi: 10.1592/phco.28.12.1443 19025425

23. Fugh-Berman A, Melnick D. Off-Label Promotion, On-Target Sales. PLOS Med. 2008;5(10):e210. doi: 10.1371/journal.pmed.0050210 18959472

24. Moja L, Lucenteforte E, Kwang KH, Bertele V, Campomori A, Chakravarthy U, et al. Systemic safety of bevacizumab versus ranibizumab for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2014;9:CD011230. doi: 10.1002/14651858.CD011230.pub2 25220133

25. National Institute for Health and Care Excellence (NICE). Evidence summaries: unlicensed or off-label medicines. 2014. http://www.nice.org.uk/about/what-we-do/our-programmes/nice-advice/evidence-summaries-unlicensed-or-off-label-medicines Accessed 27 July 2015.

26. Yank V, Tuohy CV, Logan AC, Bravata DM, Staudenmayer K, Eisenhut R, et al. Systematic Review: benefits and harms of in-hospital use of recombinant Factor VIIa for off-label indications. Ann Intern Med. 2011;154(8):529–40. doi: 10.7326/0003-4819-154-8-201104190-00004 21502651

27. Connolly HM, Crary JL, McGoon MD, Hensrud DD, Edwards BS, Edwards WD, et al. Valvular heart disease associated with fenfluramine–phentermine. New Engl J Med. 1997;337(9):581–8. doi: 10.1056/NEJM199708283370901 9271479

28. Ferriman A. UK licence for cisapride suspended. BMJ. 2000;321:259.

29. Matthews S. Pharma fines increase, but the pain is not felt on Wall Street. Nat Med. 2013;19(1):5. doi: 10.1038/nm0113-5 23295992

30. Kesselheim AS, Darby D, Studdert DM, Glynn R, Levin R, Avorn J. False Claims Act prosecution did not deter off-label drug use in the case of neurontin. Health Aff. 2011;30(12):2318–27. doi: 10.1377/hlthaff.2011.0370

31. Larkin I, Ang D, Avorn J, Kesselheim AS. Restrictions on pharmaceutical detailing reduced off-label prescribing of antidepressants and antipsychotics in children. Health Aff. 2014;33(6):1014–23. doi: 10.1377/hlthaff.2013.0939

32. Steinman MA, Harper GM, Chren MM, Landefeld CS, Bero LA. Characteristics and impact of drug detailing for gabapentin. PLOS Med. 2007;4(4):743–51. doi: 10.1371/journal.pmed.0040134

33. Lexchin J, Kohler JC. The danger of imperfect regulation: OxyContin use in the United States and Canada. Int J Risk Saf Med. 2011;23(4):233–40. doi: 10.3233/JRS-2011-0539 22156088

34. Kesselheim AS, Mello MM, Studdert DM. Strategies and practices in off-label marketing of pharmaceuticals: a retrospective analysis of whistleblower complaints. PLOS Med. 2011;8(4):e1000431. doi: 10.1371/journal.pmed.1000431 21483716

35. United States Government Accountability Office (GAO). FDA’s oversight of the promotion of drugs for off-label uses. 2008. http://www.gao.gov/assets/280/278832.pdf. Accessed 27 July 2015.

36. Landefeld CS, Steinman MA. The neurontin legacy—marketing through misinformation and manipulation. New Engl J Med. 2009;360(2):103–6. doi: 10.1056/NEJMp0808659 19129523

37. Kesselheim AS, Studdert DM, Mello MM. Whistle-blowers’ experiences in fraud litigation against pharmaceutical companies. New Engl J Med. 2010;362(19):1832–9. doi: 10.1056/NEJMsr0912039 20463344

38. Almashat S, Wolfe S. Public Citizen Report: Pharmaceutical Industry Criminal and Civil Penalties: An Update. 2012. http://www.citizen.org/hrg2073 Accessed 27 July 2015.

39. Steinman MA, Bero LA, Chren MM, Landefeld CS. Narrative review: the promotion of Gabapentin: an analysis of internal industry documents. Ann Intern Med. 2006;145(4):284–93. doi: 10.7326/0003-4819-145-4-200608150-00008 16908919

40. Ross JS, Hill KP, Egilman DS, Krumholz HM. Guest authorship and ghostwriting in publications related to rofecoxib: A case study of industry documents from rofecoxib litigation. JAMA. 2008;299(15):1800–12. doi: 10.1001/jama.299.15.1800 18413874

41. Congress of the United States. The Marketing of Vioxx to Physicians. 2005. http://democrats.oversight.house.gov/sites/democrats.oversight.house.gov/files/documents/20050505114932-41272.pdf. Accessed 27 July 2015.

42. Prescription Medicines Code of Practice Authority (PMCPA). AUTH/2572/1/13—Ex-employee v AstraZeneca. 2013. http://www.pmcpa.org.uk/cases/Pages/2572.aspx. Accessed 27 July 2015.

43. New Statesman. Ben Goldacre v the Association of the British Pharmaceutical Industry. New Statesman. 19 Oct 2012. http://www.newstatesman.com/sci-tech/sci-tech/2012/10/ben-goldacre-v-association-british-pharmaceutical-industry. Accessed 27 July 2015.

44. Berelson B. Content analysis in communication research. New York: Free Press; 1952.

45. Glaser BG, Strauss AL. The Discovery of Grounded Theory: Strategies for Qualitative Research. New York: Aldine de Gruyter; 1967.

46. World Health Organization (WHO). International Statistical Classification of Disease and Related Health Problems 10th Revision, ICD-10. 2015. http://apps.who.int/classifications/icd10/browse/2015/en. Accessed 27 July 2015.

47. Taxpayers Against Fraud Education Fund. Statistics. http://www.taf.org/resource/fca/statistics. Accessed 27 July 2015.

48. Mulinari S. Regulating drug information in Europe: a pyrrhic victory for pharmaceutical industry critics? Sociol Health Illn. 2013;35(5):761–77. doi: 10.1111/j.1467-9566.2012.01528.x 23094890

49. Jack A. Letting the sunshine in on doctor-pharma relationships. BMJ. 2011;343:d6459. doi: 10.1136/bmj.d6459 21990283

50. Herxheimer A, Collier J. Promotion by the British pharmaceutical industry 1983–8 –a critical analysis of self regulation. BMJ. 1990;300(6720):307–11. 2106963

51. Zetterqvist AV, Mulinari S. Misleading advertising for antidepressants in Sweden: a failure of pharmaceutical industry self-regulation. PLOS One. 2013;8(5). e62609 doi: 10.1371/journal.pone.0062609

52. Lexchin J. Enforcement of codes governing pharmaceutical promotion: What happens when companies breach advertising guidelines? CAMJ. 1997;156(3):351–6.

53. Medicines & Healthcare products Regulatory Agency (MHRA). Advertising complaint—Pradaxa (dabigatran), promotion of unlicensed indications to healthcare professionals. April 2009.

54. Medicines & Healthcare products Regulatory Agency (MHRA). Advertising complaint—Allergan Neurology Pharmaceutical Survey—Promotion of Botox (botulinum toxin type A) to doctors. March 2010.

55. British Medical Journal (BMJ). BMJ media pack 2015. http://www.bmj.com/company/wp-content/uploads/2014/06/Reaching-healthcare-professionals-June-2015.pdf. Accessed 27 July 2015.

56. Prescription Medicines Code of Practice Authority (PMCPA). Advertisements and public reprimands 2014. http://www.pmcpa.org.uk/cases/Pages/Advertisements-and-public-reprimands.aspx. Accessed 27 July 2015.

57. Davis C, Abraham J. Is there a cure for corporate crime in the drug industry? BMJ. 2013;346:f755. doi: 10.1136/bmj.f755 23390241

58. Gøtzsche PC. Big pharma often commits corporate crime, and this must be stopped. BMJ. 2012;345:e8462. doi: 10.1136/bmj.e8462 23241451

59. House of Commons Health Committee (2005) The Influence of the pharmaceutical industry: Health Select Committee Report Volume 2. London: The stationery office limited. 550 p. doi: 10.1016/j.plrev.2005.01.001

60. Chen DT, Wynia MK, Moloney RM, Alexander GC. US physician knowledge of the FDA-approved indications and evidence base for commonly prescribed drugs: results of a national survey. Pharmacoepidemiol Drug Saf. 2009;18(11):1094–100. doi: 10.1002/pds.1825 19697444

61. Mintzes B, Lexchin J, Sutherland J, Beaulieu MD, Wilkes M, Durrieu G, et al. Pharmaceutical sales representatives and patient safety: a comparative prospective study of information quality in Canada, France and the United States. J Gen Intern Med. 2013;28(10):1368–75. doi: 10.1007/s11606-013-2411-7 23558775

62. Avorn J, Soumerai SB. Improving drug-therapy decisions through educational outreach. A randomized controlled trial of academically based “detailing”. New Engl J Med. 1983;308(24):1457–63. doi: 10.1056/nejm198306163082406 6406886

63. van Eijk MEC, Avorn J, Porsius AJ, de Boer A. Reducing prescribing of highly anticholinergic antidepressants for elderly people: randomised trial of group versus individual academic detailing. BMJ. 2001;322(7287):654–7. doi: 10.1136/bmj.322.7287.654 11250852

Štítky
Interné lekárstvo

Článok vyšiel v časopise

PLOS Medicine


2016 Číslo 1
Najčítanejšie tento týždeň
Najčítanejšie v tomto čísle
Kurzy

Zvýšte si kvalifikáciu online z pohodlia domova

Aktuální možnosti diagnostiky a léčby litiáz
nový kurz
Autori: MUDr. Tomáš Ürge, PhD.

Všetky kurzy
Prihlásenie
Zabudnuté heslo

Zadajte e-mailovú adresu, s ktorou ste vytvárali účet. Budú Vám na ňu zasielané informácie k nastaveniu nového hesla.

Prihlásenie

Nemáte účet?  Registrujte sa

#ADS_BOTTOM_SCRIPTS#