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Global trends in testosterone prescribing, 2000–2011: expanding the spectrum of prescription drug misuse

David J Handelsman
Med J Aust 2013; 199 (8): 548-551. || doi: 10.5694/mja13.10111

Summary

Objective: To provide the first multinational survey of temporal trends in testosterone prescribing, given that anecdotal evidence indicates that it is increasing in some countries, including Australia.

Design: Sales data for all testosterone products were obtained for 41 countries for each year from 2000 to 2011. For each testosterone product type (injectable, implantable, oral, transdermal), units sold were converted into defined monthly doses per year, reflecting total testosterone prescribing per product.

Main outcome measures: National testosterone prescribing rate overall and per product type on a per capita basis.

Results: For every region and 37 of 41 countries, there was a major and progressive increase in defined monthly doses per year per capita over the 11 years surveyed. In most countries, the increases were steeper for the last half of the survey period. The proportion of testosterone prescribing represented by transdermal testosterone products, a surrogate measure of prescribing for older men, increased even more than did the total usage of testosterone products.

Conclusions: In the absence of any new indications, off-label testosterone prescribing has increased in most countries in 2000–2011, especially over the last half of the period. The increased testosterone prescribing appears to be primarily for older men and driven by clinical guidelines that endorse testosterone prescribing for age-related functional androgen deficiency (andropause). By eliminating the fundamental distinction between pathological and functional androgen deficiency, these guidelines tacitly promote increased testosterone prescribing, bypassing the requirement for high-quality clinical evidence of safety and efficacy and creating dramatic increases in prescription of testosterone products.

  • David J Handelsman

  • ANZAC Research Institute, Concord Hospital, University of Sydney, Sydney, NSW.

Correspondence: djh@anzac.edu.au

Acknowledgements: 

I thank Lam Ly for his help with data management and Nicole Sweetman of IMS Health for providing the data.

Competing interests:

No relevant disclosures.

  • 1. Hamilton JB. Treatment of sexual underdevelopment with synthetic male hormone substance. Endocrinology 1937; 21: 649-654.
  • 2. David K, Dingmanse E, Freud J, Lacqueur E. [Uber krystallinisches mannliches Hormon aus Hoden (Testosteron), wirksamer als aus Harn oder aus Cholestrin bereites Androsteron] [German]. Zeischrift Physiologische Chemie 1935; 233: 281-282.
  • 3. Ruzicka L, Wettstein A. [Uber die krystallische Herstellung des Testikelhormons, Testosteron (androsten-3-on-17-ol)] [German]. Helv Chim Acta 1935; 18: 1264-1275.
  • 4. Handelsman DJ. Androgen therapy in non-gonadal disease. In: Nieschlag E, Behre HM, editors. Testosterone: action, deficiency, substitution. 4th ed. Cambridge: Cambridge University Press, 2012: 372-407.
  • 5. Liverman CT, Blazer DG, editors. Testosterone and aging: clinical research directions. Washington, DC: The National Academies Press, 2004.
  • 6. Handelsman DJ. Trends and regional differences in testosterone prescribing in Australia, 1991–2001. Med J Aust 2004; 181: 419-422. <MJA full text>
  • 7. Handelsman DJ. Pharmacoepidemiology of testosterone prescribing in Australia, 1992–2010. Med J Aust 2012; 196: 642-645. <MJA full text>
  • 8. Bhasin S, Singh AB, Mac RP, et al. Managing the risks of prostate disease during testosterone replacement therapy in older men: recommendations for a standardized monitoring plan. J Androl 2003; 24: 299-311.
  • 9. Baillargeon J, Urban RJ, Ottenbacher KJ, et al. Trends in androgen prescribing in the United States, 2001 to 2011. JAMA Intern Med 2013; Jun 3 [Epub ahead of print]. doi: 10.1001/jamainternmed.2013.6895.
  • 10. Nigro N, Christ-Crain M. Testosterone treatment in the aging male: myth or reality? Swiss Med Wkly 2012; 142: w13539.
  • 11. Gan EH, Pattman S, Pearce S, Quinton R. A UK epidemic of testosterone prescribing, 2001-2010. Clin Endocrinol (Oxf) 2013; Mar 10 [Epub ahead of print]. doi: 10.1111/cen.12178.
  • 12. Hernandez SH, Nelson LS. Prescription drug abuse: insight into the epidemic. Clin Pharmacol Ther 2010; 88: 307-317.
  • 13. Ranji SR, Steinman MA, Shojania KG, Gonzales R. Interventions to reduce unnecessary antibiotic prescribing: a systematic review and quantitative analysis. Med Care 2008; 46: 847-862.
  • 14. Andrews T, Thompson M, Buckley DI, et al. Interventions to influence consulting and antibiotic use for acute respiratory tract infections in children: a systematic review and meta-analysis. PLOS One 2012; 7: e30334.
  • 15. Altschule MD, Tillotson KJ. The use of testosterone in the treatment of depressions. N Engl J Med 1948; 239: 1036-1038.
  • 16. Shores MM, Kivlahan DR, Sadak TI, et al. A randomized, double-blind, placebo-controlled study of testosterone treatment in hypogonadal older men with subthreshold depression (dysthymia or minor depression). J Clin Psychiatry 2009; 70: 1009-1016.
  • 17. Pope HG Jr, Amiaz R, Brennan BP, et al. Parallel-group placebo-controlled trial of testosterone gel in men with major depressive disorder displaying an incomplete response to standard antidepressant treatment. J Clin Psychopharmacol 2010; 30: 126-134.
  • 18. Kanayama G, Hudson JI, Pope HG Jr. Illicit anabolic-androgenic steroid use. Horm Behav 2010; 58: 111-121.
  • 19. Bhasin S, Cunningham GR, Hayes FJ, et al. Testosterone therapy in adult men with androgen deficiency syndromes: an endocrine society clinical practice guideline. J Clin Endocrinol Metab 2006; 91: 1995-2010.
  • 20. Nieschlag E, Swerdloff R, Behre HM, et al. Investigation, treatment and monitoring of late-onset hypogonadism in males: ISA, ISSAM, and EAU recommendations. Int J Androl 2005; 28: 125-127.
  • 21. Bhasin S, Cunningham GR, Hayes FJ, et al. Testosterone therapy in men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2010; 95: 2536-2559.
  • 22. Wang C, Nieschlag E, Swerdloff R, et al. Investigation, treatment, and monitoring of late-onset hypogonadism in males: ISA, ISSAM, EAU, EAA, and ASA recommendations. J Androl 2009; 30: 1-9.
  • 23. Braun SR. Promoting “low T”: a medical writer’s perspective. JAMA Intern Med 2013; Jun 3 [Epub ahead of print]. doi:10.1001/jamainternmed.2013.6892.
  • 24. Handelsman DJ. Androgen physiology, pharmacology and abuse. In: DeGroot LJ, Jameson JL, editors. Endocrinology. 6th ed. Philadelphia: Elsevier Saunders, 2010: 2469-2498.
  • 25. Swerdlow AJ, Higgins CD, Schoemaker MJ, et al. Mortality in patients with Klinefelter syndrome in Britain: a cohort study. J Clin Endocrinol Metab 2005; 90: 6516-6522.
  • 26. Bojesen A, Juul S, Gravholt CH. Prenatal and postnatal prevalence of Klinefelter syndrome: a national registry study. J Clin Endocrinol Metab 2003; 88: 622-626.
  • 27. Herlihy AS, Halliday JL, Cock ML, McLachlan RI. The prevalence and diagnosis rates of Klinefelter syndrome: an Australian comparison. Med J Aust 2011; 194: 24-28. <MJA full text>
  • 28. Mulligan T, Frick MF, Zuraw QC, et al. Prevalence of hypogonadism in males aged at least 45 years: the HIM study. Int J Clin Pract 2006; 60: 762-769.
  • 29. Araujo AB, O’Donnell AB, Brambilla DJ, et al. Prevalence and incidence of androgen deficiency in middle-aged and older men: estimates from the Massachusetts Male Aging Study. J Clin Endocrinol Metab 2004; 89: 5920-5926.
  • 30. Orwoll E, Lambert LC, Marshall LM, et al. Testosterone and estradiol among older men. J Clin Endocrinol Metab 2006; 91: 1336-1344.
  • 31. Haring R, Ittermann T, Völzke H, et al. Prevalence, incidence and risk factors of testosterone deficiency in a population-based cohort of men: results from the study of health in Pomerania. Aging Male 2010; 13: 247-257.
  • 32. Wu FC, Tajar A, Beynon JM, et al. Identification of late-onset hypogonadism in middle-aged and elderly men. N Engl J Med 2010; 363: 123-135.
  • 33. Basaria S, Coviello AD, Travison TG, et al. Adverse events associated with testosterone administration. N Engl J Med 2010; 363: 109-122.
  • 34. Handelsman DJ. An old emperor finds new clothing: rejuvenation in our time. Asian J Androl 2011; 13: 125-129.
  • 35. Xu L, Freeman G, Cowling BJ, Schooling CM. Testosterone therapy and cardiovascular events among men: a systematic review and meta-analysis of placebo-controlled randomized trials. BMC Med 2013; 11: 108.

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