Screening and Monitoring in Men Prescribed Testosterone Therapy in the U.S., 2001–2010

Abstract

Objectives. The Endocrine Society recommends testosterone therapy only in men with low serum testosterone levels, consistent symptoms of hypogonadism, and no signs of prostate cancer. We assessed screening and monitoring patterns in men receiving testosterone therapy in the U.S. Methods. We conducted a retrospective cohort study of 61,474 men aged ⩾40 years, and with data available in one of the nation's largest commercial insurance databases, who received at least one prescription for testosterone therapy from 2001 to 2010. Results. In the 12 months before initiating treatment, 73.4% of male testosterone users received a serum testosterone test and 60.7% received a prostate-specific antigen (PSA) test. Among men who were tested, 19.5% did not meet Endocrine Society guidelines for low testosterone. In the 12 months after initiating treatment, 52.4% received a serum testosterone test and 43.3% received a PSA test. Multivariable analyses showed that those seen by either an endocrinologist or urologist were more likely to receive appropriate tests. Conclusions. A substantial number of men prescribed testosterone therapy did not receive testosterone or PSA testing before or after initiating treatment. In addition, almost one out of five treated men had baseline serum testosterone values above the threshold defined as normal by the Endocrine Society. Men treated by endocrinologists and urologists were more likely to have been treated according to guideline recommendations than men treated by other specialties, including primary care.

Off-Label Use and Misuse of Testosterone, Growth Hormone, Thyroid Hormone, and Adrenal Supplements: Risks and Costs of a Growing Problem

“…In a study of men in the United States and United Kingdom, only 14% of men in the United Kingdom and 10% of the men in the United States had more than one testosterone test within 180 days of receiving a prescription for testosterone (28). Another study from the United States showed a similar result, with only 18% of men receiving at least two testosterone tests in the 12 months prior to initiating treatment (29).…”

“…Although testing is required for the diagnosis of male hypogonadism, several studies show that men are commonly prescribed testosterone without any laboratory testing at all (29,31). Or, testosterone is prescribed to men with baseline testosterone levels that are normal or even high, with rates of such prescriptions ranging from 4 to 9% up to 20% (29,31).…”

“…Although testing is required for the diagnosis of male hypogonadism, several studies show that men are commonly prescribed testosterone without any laboratory testing at all (29,31). Or, testosterone is prescribed to men with baseline testosterone levels that are normal or even high, with rates of such prescriptions ranging from 4 to 9% up to 20% (29,31). Primary-care providers, perhaps without training and expertise in the diagnosis of male hypogonadism, write the majority of prescriptions for testosterone in the United States; one study reported that, prior to starting testosterone, only 7% of users were seen by endocrinologists and 20% were seen by urologists (29).…”

Addressing the pressing issues related to testosterone administration to men with prostate cancer

“…This challenge is not unique to Canada. 16,17 The stated purpose of the survey is to eventually develop a Canadian registry of hypogonadal men with a history PCa and receiving testosterone treatment. It is evident that only a countrywide registry would provide the power to address some of the pressing issues related to testosterone administration to men with PCa.…”

Irrational Exuberance in Testosterone Prescribing

“…2,3 Such stunning increases (which exclude pharmacy compounding and illicit nonprescription sources) are inexplicable in the absence of any proven new indications or well-controlled interventional trials over this time. 4 Interestingly, although the increased testosterone usage is reflected in data originating from health sector third parties, such as insurance 5,6 or governmental health scheme 7,8 databases, those sources substantially underestimate the magnitude of the increase. This dichotomy points to the fact that most unjustified testosterone prescribing occurs via doctors not subjected to third-party scrutiny such as through formulary and/or reimbursement restrictions in the veterans administration system 6 or in the health systems of a Canadian province 8 and Australia.…”