Advertisement

International Journal of Clinical Pharmacy

, Volume 39, Issue 1, pp 78–87 | Cite as

Availability and quality of illegitimate somatropin products obtained from the Internet

  • Róbert György VidaEmail author
  • András Fittler
  • Ivett Mikulka
  • Eszter Ábrahám
  • Viktor Sándor
  • Ferenc Kilár
  • Lajos Botz
Research Article

Abstract

Background Growth hormones are widely available on the Internet for those who want to enhance their physical performance and improve body satisfaction. Illegitimate websites market somatropin injections without medical prescription and encourage misuse. Customers potentially put their health at risk when purchasing parenteral medications online. Objective The objective of our study was to evaluate the online market of no-prescription somatropin products and to analyse and document Internet pharmacy characteristics, distribution and pharmaceutical quality. Setting Websites indexed in Google promoting somatropin for sale direct to patients. Method Websites promoting the sale of growth hormone products were identified and analysed from June to August 2014. Internet vendor sites were evaluated to identify possible patient and medication safety concerns. Website characteristics, delivery time, storage conditions, packaging and attached product information were assessed. Investigation of the somatropin content was achieved using capillary electrophoresis with UV detection and electrospray ionization mass spectrometry. Main outcome measure Accessibility and quality of somatropin injections. Results Seventeen individual Internet vendor websites distributed somatropin products directly to patients, majority (94%) did not require a valid medical prescription before dispensing the products. Majority (70%) of Internet pharmacies displayed no medical information and none (0%) of the vendors displayed any regulatory body logo. All online samples had significantly (p < 0.001) lower somatropin concentration than labelled. Conclusion Our results clearly illustrate that prescription only biologic drugs are widely available online and can be easily accessed by anyone. Unprofessional distribution and handling is likely to cause degradation and possible patient safety concerns.

Keywords

Growth hormone Illegal medicines Internet pharmacy Medication safety Online medicines Somatropin 

Notes

Acknowledgements

The present scientific contribution is dedicated to the 650th anniversary of the foundation of the University of Pécs, Hungary.

Funding

This research received no external funding.

Conflicts of interest

The authors declare no conflict of interest.

Supplementary material

11096_2016_398_MOESM1_ESM.docx (305 kb)
Supplementary material 1 (DOCX 304 kb)

References

  1. 1.
    McVeigh J, Evans-Brown M, Bellis MA. Human enhancement drugs and the pursuit of perfection. Adicciones. 2012;24(3):185–90.CrossRefPubMedGoogle Scholar
  2. 2.
    Fittler A, Bősze G, Botz L. Evaluating aspects of online medication safety in long-term follow-up of 136 Internet pharmacies: illegal rogue online pharmacies flourish and are long-lived. J Med Internet Res. 2013;15(9):e199.CrossRefPubMedPubMedCentralGoogle Scholar
  3. 3.
    Graham MR, Ryan P, Baker JS, Davies B, Thomas NE, Cooper SM, et al. Counterfeiting in performance- and image-enhancing drugs. Drug Test Anal. 2009;1(3):135–42.CrossRefPubMedGoogle Scholar
  4. 4.
    Jiang H, Wu SL, Karger BL, Hancock WS. Mass spectrometric analysis of innovator, counterfeit, and follow-on recombinant human growth hormone. Biotechnol Prog. 2009;25(1):207–18.CrossRefPubMedGoogle Scholar
  5. 5.
    Sheridan C. Bad medicine. Nat Biotechnol. 2007;25(7):707–9.CrossRefPubMedGoogle Scholar
  6. 6.
    United States Pharmacopeia. Somatropin for injection. In United States Pharmacopeia 37, National Formulary 32. Rockville: United States Pharmacopeial Convention Inc.; 2014. p. 4730–2.Google Scholar
  7. 7.
    European Pharmacopoeia, 7.0-1 ed. Somatropin for injection. Supplement 535th ed.; 2005. p. 3619–21. European Directorate for Quality of Medicines and Health Care. Strasbourg, France; 2014.Google Scholar
  8. 8.
    Catai JR, Sastre Toraño J, Jongen PM, de Jong GJ, Somsen GW. Analysis of recombinant human growth hormone by capillary electrophoresis with bilayer-coated capillaries using UV and MS detection. J Chromatogr B Biomed Sci Appl. 2007;852(1–2):160–6.Google Scholar
  9. 9.
    Arcelloni C, Fermo I, Banfi G, Pontiroli AE, Paroni R. Capillary electrophoresis for protein analysis: separation of human growth hormone and human insulin molecular forms. Anal Biochem. 1993;212(1):160–7.CrossRefPubMedGoogle Scholar
  10. 10.
    Orizio G, Merla A, Schulz PJ, Gelatti U. Quality of online pharmacies and websites selling prescription drugs: a systematic review. J Med Internet Res. 2011;13(3):e74.CrossRefPubMedPubMedCentralGoogle Scholar
  11. 11.
    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. http://ec.europa.eu/health/files/eudralex/vol-1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_en.pdf Accessed 21 Aug 2016.
  12. 12.
    Malik NN, Khan Y. Personalized medicine: potential impact on the biopharmaceutical industry. Drug Discovery Today. 2010;15(21–22):881–3.CrossRefPubMedGoogle Scholar
  13. 13.
    IMS Institute for Healthcare Informatics. Increasing numbers of innovative new medicines and orphan drugs are expected to be launched. In: The Global Use of Medicines: Outlook through 2017. IMS Institute for Healthcare Informatics. 2017. https://www.imshealth.com/files/web/IMSH%20Institute/Reports/The_Global_Use_of_Medicines_2017/global%20use%20of%20meds%202017%20right5%20Global_Models_New_Molecular_Entities.pdf Accessed 21 Aug 2016.
  14. 14.
    Kinch MS, Haynesworth A, Kinch SL, Hoyer D. An overview of FDA-approved new molecular entities: 1827–2013. Drug Discovery Today. 2014;19(8):1033–9.CrossRefPubMedGoogle Scholar
  15. 15.
    Foster KA. Biologics: a new approach needed? Drug Discovery Today. 2010;15(3–4):81–3.CrossRefPubMedGoogle Scholar
  16. 16.
    Tsiftsoglou AS, Ruiz S, Schneider CK. Development and regulation of biosimilars: current status and future challenges. BioDrugs. 2013;27(3):203–11.CrossRefPubMedGoogle Scholar
  17. 17.
    Gohil K. Long-acting therapies will expand growth hormone deficiency market. Pharm Ther. 2015;40(11):772–3.Google Scholar
  18. 18.
    Høybye C, Cohen P, Hoffman AR, Ross R, Biller BM. Christiansen JS; Growth Hormone Research Society. Status of long-acting-growth hormone preparations—2015. Growth Hormon IGF Res. 2015;25(5):201–6.CrossRefGoogle Scholar
  19. 19.
    Navarro R, Dunn JD, Lee PA, Owens GM, Rapaport R. Translating clinical guidelines into practice: the effective and appropriate use of human growth hormone. Am J Manag Care. 2013;19(15 Suppl):s281–9.PubMedGoogle Scholar
  20. 20.
    Jung FM. Counterfeit protein drugs: how to discover and how to prevent? Eur J Hosp Pharm Pract. 2007;13(3):61–3.Google Scholar
  21. 21.
    Casali PG. Executive Committee of ESMO. 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.CrossRefPubMedGoogle Scholar
  22. 22.
    Generali JA, Cada DJ. Recombinant human growth hormone: HIV-related lipodystrophy. Hosp Pharm. 2014;49(5):432–4.CrossRefPubMedPubMedCentralGoogle Scholar
  23. 23.
    U.S. Food and Drug Administration. Drug database. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm Accessed 21 Aug 2016.
  24. 24.
  25. 25.
    National Institute of Pharmacy and Nutrition. Drug database. https://www.ogyei.gov.hu/drug_database/ Accessed 21 Aug 2016.
  26. 26.
    Hardin DS. Treatment of short stature and growth hormone deficiency in children with somatotropin (rDNA origin). Biologics. 2008;2(4):655–61.PubMedPubMedCentralGoogle Scholar
  27. 27.
    Svensson J, Johannson G. Long-term efficacy and safety of somatropin for adult growth hormone deficiency. Treat Endocrinol. 2003;2(2):109–20.CrossRefPubMedGoogle Scholar
  28. 28.
    Holt R, Erotokritou-Mulligan I, Sönksen PH. The history of doping and growth hormone abuse in sport. Growth Hormon IGF Res. 2009;19(4):320–6.CrossRefGoogle Scholar
  29. 29.
    Samaras N, Papadopoulou MA, Samaras D, Ongaro F. Off-label use of hormones as an antiaging strategy: a review. Clin Interv Aging. 2014;23(9):1175–86.CrossRefGoogle Scholar
  30. 30.
    Dresser R, Frader J. Off-label prescribing: a call for heightened professional and government oversight. J Law Med Ethics. 2009;37(3):476–86, 396.Google Scholar
  31. 31.
    Rennie MJ. Claims for the anabolic effects of growth hormone: a case of the emperor’s new clothes? Br J Sports Med. 2003;37(2):100–5.CrossRefPubMedPubMedCentralGoogle Scholar
  32. 32.
    Liu H, Bravata DM, Olkin I, Nayak S, Roberts B, Garber AM, et al. Systematic review: the safety and efficacy of growth hormone in the healthy elderly. Ann Intern Med. 2007;146(2):104–15.CrossRefPubMedGoogle Scholar
  33. 33.
    Cittadini A, Berggren A, Longobardi S, Ehrnborg C, Napoli R, Rosén T, et al. Supraphysiological doses of GH induce rapid changes in cardiac morphology and function. J Clin Endocrinol Metab. 2002;87(4):1654–9.CrossRefPubMedGoogle Scholar
  34. 34.
    Birzniece V, Nelson AE, Ho KK. Growth hormone and physical performance. Trends Endocrinol Metab. 2011;22(5):171–8.CrossRefPubMedGoogle Scholar
  35. 35.
    Krug O, Thomas A, Walpurgis K, Piper T, Sigmund G, Schänzer W, et al. Identification of black market products and potential doping agents in Germany 2010–2013. Eur J Clin Pharmacol. 2014;70(11):1303–11.CrossRefPubMedGoogle Scholar
  36. 36.
    Kimergård A, McVeigh J, Knutsson S, Breindahl T, Stensballe A. Online marketing of synthetic peptide hormones: poor manufacturing, user safety, and challenges to public health. Drug Test Anal. 2014;6(4):396–8.CrossRefPubMedGoogle Scholar
  37. 37.
    Perls TT, Reisman NR, Olshansky SJ. Provision or distribution of growth hormone for “antiaging”: clinical and legal issues. J Am Med Assoc. 2005;294(16):2086–90.CrossRefGoogle Scholar
  38. 38.
    Perls TT. Anti-aging quackery: human growth hormone and tricks of the trade—more dangerous than ever. J Gerontol A Biol Sci Med Sci. 2004;59(7):682–91.CrossRefPubMedGoogle Scholar

Copyright information

© Springer International Publishing 2016

Authors and Affiliations

  1. 1.Department of Pharmaceutics and Central Clinical Pharmacy, Faculty of PharmacyUniversity of PécsPecsHungary
  2. 2.Institute of Bioanalysis and Szentágothai Research Centre, Medical SchoolUniversity of PécsPecsHungary

Personalised recommendations