Concerns Continue About Inappropriate Prescriptions
By Brenda L. Mooney
BEDFORD, MA — Testosterone prescribing at the VHA has followed national trends and increased substantially over the last decade. In fact, during fiscal years 2008-14, testosterone (“T”) was the 13th most commonly prescribed drug in the healthcare system, ranking slightly below cardiovascular medications, opioids, antidepressants and antipsychotics.
While marketing and direct-to-consumer advertising has increased prescriptions for “T,” reports—including those based on VA studies suggesting an increased risk of cardiovascular events in men taking the hormones—have stemmed the tide somewhat, according to a new report published in the Endocrine Society’s Journal of Clinical Endocrinology & Metabolism.1
Despite the slight decline in prescriptions, concerns continue on whether those prescriptions follow clinical guidelines and/or indications for which the pharmaceuticals have been approved.
A study team led by researchers from the Edith Nourse Rogers Memorial Veterans Hospital in Bedford, MA and Boston University School of Public Health took a close look at exactly what was going on at the VHA in terms of testosterone prescribing. The review pinpointed characteristics of clinicians more and less likely to prescribe the hormones.
They determined that providers ranging in age from 31 to 60 years, with less experience in the VA, and credentialed as medical doctors in endocrinology and urology were more likely to prescribe testosterone. On the other hand, older providers, providers of longer VA tenure, and primary care providers were less likely to do so. The researchers pointed out that, while VHA endocrinologists were more likely to prescribe testosterone, they also were more likely to obtain an appropriate workup before prescribing, compared to primary care providers.
Geographic variations also were identified. The study found that VA facilities located in the Northeast were more likely to appropriately check too low testosterone levels, as well as too low morning testosterone levels. On the other hand, patients receiving care at VA’s community-based outpatient clinics (CBOCs) were both more likely to receive testosterone and less likely to have received appropriate testing, in comparison with patients receiving care at the larger associated VAMC.
“Our study clearly shows that there is variation in both receipt of testosterone as well as guideline-concordant prescribing of testosterone in the VA,” explained lead author, Guneet K. Jasuja, PhD. “Provider’s age, number of years in practice and geographic area are all associated with variations in testosterone prescribing practices.”
The research examining provider and site characteristics associated with an initial testosterone prescription involved the entire VA, with the focus on patients receiving outpatient medications from Oct. 1, 2007, to Sept. 30, 2012. Included were 132,764 male patients who had at least one outpatient testosterone prescription, and 550,151 male patients who did not receive testosterone, receiving another medication instead.
“Our findings highlight the opportunity to intervene at the provider and local level to improve testosterone prescribing practices,” Jasuja noted. “The VA and other healthcare systems can use these insights to promote targeted efforts that can help decrease inappropriate prescribing of testosterone, while ensuring that those patients who can benefit the most can still receive it.”
The overall adjusted odds ratio (AOR) of the younger cohort of VHA physicians prescribing testosterone was less than two. It was as high as 3.86 for endocrinologist prescriptions and 1.50 for urologists, however.
Comparing sites in the West with those in the Northeast led to an AOR of 1.75, while care received at a CBOC, compared to a medical center also predicted testosterone prescription, with an AOR of 1.22.
“Our results highlight the opportunity to intervene both at the provider and the site level to improve testosterone prescribing,” study authors pointed out. “Beyond testosterone, this study provides a useful example of how to examine contributions to prescribing variation at different levels of the healthcare system.”
Safety and Benefits
What makes the situation so complex is that clinical trial results have been so mixed when it comes to the safety and benefits of “T” therapy.
Back in 2013, a VA-funded study found that testosterone replacement therapy increased risks of death, heart attack or ischemic stroke in veterans who had undergone coronary angiography. That study, published in the Journal of the American Medical Association, evaluated the association between the use of testosterone therapy and all-cause mortality, myocardial infarction and stroke among male veterans with low serum testosterone levels. It also looked at whether this association was modified by underlying coronary artery disease (CAD).2
Results indicated that 19.9% of patients who had not used testosterone replacement therapy experienced coronary events three years after angiography compared with 25.7% in the testosterone therapy group. At the same time, the article noted that an estimated 2.9% of U.S. men over 40 years old are prescribed testosterone therapy, despite the lack of an extensive randomized trial examining the long-term benefits and risks.
Numerous other studies have been published since then, included one from the Kansas City VAMC finding that some patients using “T” therapy could be at lower risk of cardiovascular events, not higher. That study, which appeared recently in the European Heart Journal, examined the effect of testosterone replacement therapy on cardiovascular outcomes by comparing incidents of heart attack, stroke and all-cause mortality among different sub-populations of treated and untreated patients.3
What is less under dispute is that many veterans receiving testosterone therapy might not actually need it.
The VA began pushing back against overuse of testosterone replacement therapy, especially after the FDA changed labels on those products to caution about cardiovascular side effects, as well as to emphasize the specific conditions testosterone is approved to treat.
More than 85,000 veterans receive testosterone supplements through the VA, according to 2015 statistics.
Noting that personal characteristics such as gender, age and ethnicity influence clinicians decision-making process, the authors of the most recent study said, “Therefore, it is unsurprising that we found that younger provider age and less number of years practicing in the VA were associated with more testosterone prescribing. While this study does not provide direct insight into why these patterns emerged, there are some likely explanations. For example, providers with fewer years in practice in the VA could be prescribing testosterone more often because they may be less fully acculturated to the generally parsimonious prescribing norms in the VA system, including the use of drug detailing, prior authorization requests, etc. which focus on evidence for benefit, rather than cost per se.”
The researchers emphasized, however, that while younger providers were more likely to prescribe testosterone, they also were more likely to document low testosterone levels before prescribing—as were providers with more experience in the VA system. “This could be based on the fact that providers trained more recently may be more aware of clinical practice guidelines and the principles of evidence-based medicine,” they wrote. “Our finding of younger provider age as a determinant for guideline-concordant prescribing echo those of other studies which have evaluated the relationship between clinical experience (defined as physician age and time in practice) and performance. These previous studies suggested that older physicians are less likely to adhere to appropriate standards of care, and may also have poorer patient outcomes.”
In terms of regional variation, the researchers posited, “It is possible that these geographic differences reflect cultural factors, which in turn may impact the propensity of patients in the West and Southeast to request testosterone or provider comfort with discussing it. Our results are consistent with published findings on outpatient antibiotic prescribing in the VA, which have observed substantial variation in the levels of antibiotic dispensing across regions.”
Suggesting that CBOC healthcare providers might be less current on medical knowledge because of their remoteness from academic medical center, the study authors also suggested that “this medical center-CBOC divide has been mitigated to some extent over the years with the availability of on-line educational resources as well as the provision of electronic consultations of academic and specialty expertise to providers throughout the VA including CBOCs.”
“To the extent that individual providers and sites vary in their decision-making regarding testosterone prescribing, our results highlight the opportunity to intervene both at the provider and the site level,” the researchers concluded. “A variety of interventions in the literature have been used to improve and standardize provider prescribing practice, such as mailed educational materials, educational programs, audit and feedback, and academic detailing. Through such efforts, providers’ knowledge of how to manage male hypogonadism could be increased, which could help promote adherence to existing clinical practice guidelines for testosterone prescribing.”
The report also recommended that facilities use their electronic medical report to offer decision support on testosterone prescriptions or to empower pharmacists to ensure appropriate documentation before a testosterone prescription is filled.
As for the most difficult dilemma faced by physicians and other prescribers—patients specifically requesting a prescription – study authors recommended a “non-prescription” pad.
“Using a similar tool here could help empower providers to offer an alternative to testosterone therapy for patients who want to feel ‘peppier,’ such as advice about improving diet, exercise, or sleep,” they wrote. “Such an approach is likely to simultaneously address patients’ symptoms and expectations. However, even with the benefit of such approaches, changing provider prescribing practices and behavior is a challenging task.”
- Jasuja GK, Bhasin S, Rose AJ, Reisman JI, Hanlon JT, Miller DR, Morreale AP, Pogach LM, Cunningham FE, Park A, Wiener RS, Gifford AL, Berlowitz DR. Provider and Site-Level Determinants of Testosterone Prescribing in the Veterans Healthcare System. J Clin Endocrinol Metab. 2017 Sep 1;102(9):3226-3233. doi: 10.1210/jc.2017-00468. PubMed PMID: 28911150.
- Vigen R, O’Donnell CI, Barón AE, Grunwald GK, Maddox TM, Bradley SM, Barqawi A, Woning G, Wierman ME, Plomondon ME, Rumsfeld JS, Ho PM. Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels. 2013 Nov 6;310(17):1829-36. doi: 10.1001/jama.2013.280386. PubMed PMID: 24193080.
- Sharma R, Oni OA, Gupta K, Chen G, Sharma M, Dawn B, Sharma R, Parashara D, Savin VJ, Ambrose JA, Barua RS. Normalization of testosterone level is associated with reduced incidence of myocardial infarction and mortality in men. Eur Heart J. 2015 Aug 6. pii: ehv346. [Epub ahead of print] PubMed PMID: 26248567.
While implantable devices have shown promise in reducing rehospitalization for heart failure (HF), VA researchers sought to determine if options that are less expensive and non-invasive would have comparable results.
Legislation to prevent VA from outsourcing creation of its drug formulary and to require more input from medical professions is being considered in Congress.