Testosterone treatment is clinically indicated when a patient presents with symptoms and signs and biochemical evidence of testosterone deficiency, ie, male hypogonadism. Laboratory confirmation of hypogonadism requires repeatedly low serum testosterone concentrations; between 8 am and 10 am on ≥ 2 separate occasions, and evaluation should include measurement of gonadotropin, follicle-stimulating hormone (FSH), and luteinizing hormone (LH) concentrations. If the diagnosis of hypogonadism is established, it is important to determine whether the etiology is due to a structural or congenital disorder of the hypothalamic-pituitary-testicular (HPT) axis (organic hypogonadism) or a comorbid condition that results in suppressed function of an intact HPT axis and that is potentially reversible or treatable (functional hypogonadism).1,2 Prior to initiation of treatment, clinicians should discuss potential benefits and risks of testosterone and monitoring during treatment, using a shared decision-making process with the patient.1
Recent studies have reported an increase in testosterone prescriptions and raised concerns regarding health care provider (HCP) prescribing practices despite current clinical practice guidelines from major societies, such as the Endocrine Society. In the US from 2001 to 2011, testosterone use among men aged ≥ 40 years increased more than 3-fold in all age groups.3 Subsequently in the years from 2013 to 2016, prescription rates declined perhaps due to the cardiovascular and stroke concerns.4
In the US Department of Veterans Affairs (VA), new testosterone prescriptions across VA medical centers increased from 20,437 in fiscal year (FY) 2009 to 36,394 in FY 2012. Yet only 3.1% of men who received testosterone therapy had 2 or more low morning total or free testosterone concentrations measured; LH and/or FSH levels assessed; and presence of contraindications to therapy documented. Remarkably, 16.5% of these veterans did not have a testosterone level tested prior to being prescribed testosterone. Among veterans who were prescribed testosterone, 1.4% had a diagnosis of prostate cancer, 7.6% had a diagnosis of obstructive sleep apnea (OSA), and 3.5% had elevated hematocrit at baseline.5 These findings raised concerns of whether the diagnosis and etiology of hypogonadism were appropriately established and risks were considered before testosterone treatment was initiated.5,6
To further understand VA prescribing practices of testosterone therapy, a 2018 VA Office of the Inspector General (OIG) report evaluated the initiation and follow-up of testosterone replacement therapy. The OIG randomly sampled and reviewed 1,091 male patients who filled at least 1 outpatient testosterone prescription from VA in FY 2014 and who did not have a prior testosterone prescription in FY 2013. Patients were followed through September 30, 2015. Within 1 year prior to initiating testosterone, only 1.5% had clinical signs and symptoms of testosterone deficiency documented prior to testosterone testing (76% within 18 months of starting testosterone); only 9.1% of veterans had the recommended measurements of 2 low morning testosterone levels; and only 12% had LH and FSH levels measured. Within 3 to 6 months after starting testosterone therapy, only 24% of veterans were assessed for symptom improvement, and 29% to 33% were evaluated for adverse effects, hematocrit levels and adherence to the therapy. The OIG report concluded that VA HCPs were not adhering to guidelines (referencing the Endocrine Society guidelines) when evaluating and treating veterans with testosterone deficiency.7
Considering the OIG recommendations and need to improve current practices among providers, VA Puget Sound Health Care System (VAPSHCS) in Washington established a multidisciplinary workgroup consisting of an endocrinologist, geriatrician, primary care provider (PCP), pharmacists, VA information technology (IT) specialist, and health products support (HPS) clinical team in the spring of 2019 to assess and improve testosterone prescribing practices.
Methods
A testosterone order template was developed, approved by VAPSHCS Pharmacy and Therapeutics Committee, and implemented on July 1, 2019, at VAPSHCS, a 1a medical facility caring for more than 112,000 veterans. Given its potential risks and the propensity for varied prescribing practices, testosterone was designated as a restricted drug requiring a prior authorization drug request (PADR) and required completion of the testosterone order template in the Computerized Patient Record System (CPRS).
Testosterone Order Template
The testosterone order template had 2 components. Completion of the template for new testosterone orders was required to initiate treatment unless the patient had known organic hypogonadism or was a transgender male. The template ensured documentation of defined symptoms and signs of testosterone deficiency; low serum testosterone levels on at least 2 occasions and LH and FSH concentrations; no contraindications to testosterone treatment; discussion of risks and benefits of therapy; and baseline hematocrit (Figure 1). Relevant educational content (eg, risks and benefits of testosterone) was incorporated in the template. The second template was required for the first renewal of testosterone to document adherence to or reason for discontinuation of testosterone; improvement of symptoms and signs; and confirm monitoring hematocrit and testosterone levels during treatment.
