A very testing condition


What role does pharmacy have to play in boosting the diagnosis and treatment of testosterone deficiency?

Men are, of course, roughly half of the population, but as everyone in health knows, they are the half that most often eludes the best efforts of the system.

Pharmacy, especially community pharmacy, is a particularly essential space for men’s health. The ability to see a health professional without a wait is appealing to many males.

However, the reluctance to talk openly about their concerns often remains, and this concern is particularly acute when it comes to matters relating to sexual health.

Testosterone deficiency, a condition that requires pathology diagnosis, and then steroid treatment, and crosses over into the territory of sexual health, is an area that is rife with difficult conversation.

But it is a condition that pharmacists need to know about, affecting one in 200 men aged under 60 years, with frequency increasing after this age.

On the lookout

Brad Butt, managing partner of Cooleman Court Pharmacy, has won a number of awards for his innovative work in the men’s health space.

He says that pharmacists should be alert for signs that men may have androgen deficiency, which is routinely undiagnosed, and “often goes unnoticed without active consideration”.

Mr Butt also says that pharmacists need to be aware of testosterone deficiency being caused by the genetic condition Klinefelter syndrome, “the leading cause of hypogonadism and contributing factor in male infertility”. (See ‘Four key points about testosterone deficiency’.)

“The symptoms of low testosterone will vary depending on the person’s stage of life,” he said.

“In infants and small children, it may manifest in a micro penis, and the testicles being quite small. In puberty it can see the boy go through puberty quite late, or have an abnormal puberty. Their size, and testicle & penis size can remain small, lack of facial and pubic hair, poor muscle development, and they can develop female-type breasts are also prevalent”.

“In adults the symptoms can include irritable mood, poor concentration, lethargy, low muscle strength and difficulties with getting and maintaining an erection,” he said. (See ‘What are the symptoms of testosterone deficiency?’)

“This is obviously an issue going to the heart of masculinity, and is going to be a difficult conversation, but it’s one that needs to be had,” Mr Butt said.

“Yes, it’s going to be difficult, but it’s important to be alert for any of the signs, to ask if they’ve had their testosterone levels tested, and to ask if they’ve had an erectile dysfunction.”

“You need to carefully consider how you’re going to approach them. Perhaps it could be done when dispensing, and going over, their medications. Many of them have probably had these symptoms for a while.”

“Approaching people with some knowledge and sensitivity is important. One particular example would be couples getting fertility medicines. Around 40% of infertility cases are related to the male, so this should be a red flag to inquire about testosterone deficiency,” he said.

Four key points about testosterone deficiency

By pharmacists Brad Butt and Tim Stewart

  • Androgen deficiency affects one in 200 men younger than 60.
  • Klinefelter syndrome is a genetic condition affecting one in 550 men and is the leading cause of hypogonadism and a contributing factor in male infertility.
  • Low testosterone often goes unnoticed without active consideration.
  • Know your patient resources including ‘Healthy Male’ and ‘Check Your Tackle’, as well as professional resources including the PBS website for prescribing requirements and Therapeutic Guidelines
Tim Stewart and Bradley Butt from Men's Health Down Under, Cooleman Court Pharmacy, ACT. Photo credit: Peter Dawn - Fifth Lane Photography Weston.
Tim Stewart and Bradley Butt from Men’s Health Down Under, Cooleman Court Pharmacy, ACT. Photo credit: Peter Dawn – Fifth Lane Photography Weston.

The issue with androgens

Androgens are a group of hormones, and include testosterone (the male sex hormone). At puberty, the testicles start to produce testosterone, signifying the onset of sexual maturity.

Low testosterone (or testosterone deficiency) is when the body isn’t able to make enough testosterone to work normally.

Because testosterone is the major androgen, it’s key not just for the physical changes that happen during puberty (like the development of the penis and testicles, and the growth of body hair), but for bone and muscles, sex drive, and general mood.

Testosterone levels are at their highest between the ages of 20 and 30. As men age, they experience a small, gradual drop in testosterone levels. A greater drop in testosterone levels may occur if a man is overweight or has other long-term medical problems.

Treatment in decline

In Australia, testosterone therapy is available as injections, gels, creams, patches and tablets, and generally works very well for men with testosterone deficiency, according to Healthy Male.

However, prescription treatment of all types of testosterone deficiency declined when, in 2015, the Pharmaceutical Benefits Schedule (PBS) tightened its prescription criteria.

These changes required GPs to consult with a relevant specialist or registered member of the Australasian Chapter of Sexual Health Medicine before they could prescribe the treatment. It also lowered the serum testosterone level to qualify for subsidised treatment from 8nmol/L to 6nmol/L.

The decision was underpinned by new evidence regarding the use of testosterone treatment, particularly in relation to older men.

In 2016, a review showed that the number of men initiated with PBS-subsidised testosterone replacement therapy was estimated to have halved.

The reviewers found, as reported by the AJP, that from a survey of 250 GPs, only 50% of patients with testosterone deficiency commenced therapy with PBS-subsidised treatment. Meanwhile 13% of patients access treatment on private prescription, while 24% of patients do not commence therapy due to the cost and/or inconvenience now involved.

The review authors concluded that the PBS restrictions were unnecessary and are leading to growing under-treatment, due to lengthy waiting periods to see specialists and associated costs, an unnecessarily restrictive testosterone threshold and the cost of private prescriptions.

The expert response

In its revised Position Statement following the PBS changes, the Endocrine Society of Australia stated that: “Testosterone replacement therapy is warranted in men with pathological hypogonadism, regardless of age.

“Currently, there are limited data from high-quality randomised controlled trials with clinically meaningful outcomes to justify testosterone treatment in older men, usually with chronic disease, who have low circulating testosterone levels but without hypothalamic, pituitary or testicular disease.

“Men with pathological hypogonadism should be identified and considered for testosterone therapy, while further research is needed to clarify whether there is a role for testosterone in these other settings,” the statement concluded.

Healthy Male issued advice that: “Clear-cut androgen deficiency due to established testicular disease or pituitary failure warrants testosterone treatment and has always been supported by the PBS and clinical practice guidelines. But there is a great deal of uncertainty about the significance of low testosterone levels in middle-aged and older men who do not have testicular disease or pituitary failure.

“While clinical guidelines provide some flexibility about the use of testosterone in men without established testicular disease or pituitary failure, it is not known if testosterone treatment in this setting is safe or effective,” it said.

“In this situation the PBS criteria reflect a more conservative approach to using public money for health interventions.”

Responding well

Despite the decline in treatment levels, most patients in whom therapy is initiated respond well and are positive about the treatment, says pharmacist Tim Stewart.

Mr Stewart, who works with Brad Butt in his Men’s Health Downunder pharmacy clinic, said the standard course of treatment is via intramuscular injection every 10–12 weeks.

“The men that we work with invariably say they are feeling a whole lot better after commencing treatment,” he said.

“If men are taking a home-based treatment, such as a gel, you should advise them to be cautious, as some are desperate and will be a bit over-zealous in their use of the therapy.

“You also, of course, need to be cautious given it is a steroid treatment, there’s always the risk of it being diverted. So I’d advise the usual checks when dispensing, such as eyeballing the patient, being aware of the dispense interval.”

Mr Stewart also advises that pharmacists shouldn’t be afraid to contact a GP or urologist to double check on patients they are concerned have not been corrected diagnosed, or who may not be compliant.

“I can’t emphasise too strongly the need for proper counselling on initial supply, as with any medicine, to ensure they’re fully compliant and aware of what to do. Also give them resources such as the Healthy Male website for more information.

pharmacy vector

A role for pharmacy

There’s room within the profession for pharmacies and pharmacists to specialise in niche areas such as men’s health, says Brad Butt.

“But there’s also a role for pharmacists with generalist-level knowledge,” he says. “People who know enough to be able to recognise someone who could be referred to a GP about specialist treatment in this area.

You won’t necessarily need to have absolute depth of knowledge, just awareness of the main symptoms, the prevalence, contributing factors such as Klinefelter’s. Really a lot of GPs also aren’t really knowledgeable in this area either”.

What are the symptoms of testosterone deficiency

as listed by Healthy Male (formerly Androgen Australia) 

Early childhood

  • Micropenis (penis does not grow to expected size)
  • Small testes

Early teenage years (puberty)

  • Late puberty or failure to go through full normal puberty
  • Small testes and penis
  • Poor development of facial, body or pubic hair
  • Poor muscle development
  • Voice does not deepen (larynx underdeveloped)
  • Gynecomastia (breast development)
  • Poor growth (height) surge

Adulthood

  • Mood changes (low mood and irritability)
  • Poor concentration
  • Low energy (lethargy, low stamina)
  • Reduced muscle strength
  • Increased body fat
  • Decreased libido (low interest in sex)
  • Difficulty getting and keeping erections (uncommon)
  • Low semen volume
  • Reduced beard or body hair growth
  • Gynecomastia (breast development)
  • Hot flushes, sweats
  • Osteoporosis (thinning of bones)

Later life (after 60 years)

  • Mood changes (low mood and irritability)
  • Poor concentration
  • Easily fatigued
  • Poor muscle strength
  • Increased body fat
  • Decreased libido (low interest in sex)
  • Difficulty getting and keeping erections
  • Gynecomastia (breast development)
  • Osteoporosis

What is Klinefelter Syndrome?

Klinefelter syndrome is a congenital genetic condition where you have an extra X chromosome. It is a common chromosomal disorder, affecting one in 550 men. However, many are never diagnosed.

It is the most common cause of hypogonadism, a condition that stops your body from producing sperm and testosterone.

Small testicles (about the size of a grape) after puberty are a strong indication of Klinefelter syndrome.

Other symptoms which sometimes occur, include:

  • Taller than average height
  • Reduced facial hair
  • Reduced body hair
  • Reduced muscle strength
  • Breast development (gynecomastia)
  • Osteoporosis
  • Feminine fat distribution (e.g. on thighs)
  • Varicose veins
  • Low energy (lethargy).

A diagnosis of Klinefelter syndrome is confirmed with blood tests. It can be diagnosed before or immediately after a child is born.

In other cases, Klinefelter syndrome is identified during childhood when learning or behavioural difficulties develop, or around the time of puberty when expected physical changes are delayed or don’t happen.

Because the symptoms aren’t always obvious, an adult might not be diagnosed until they seek medical help for infertility, a loss of sex drive, or a bone fracture. The majority of Klinefelter cases are diagnosed in adulthood.

Source: Healthy Male (Andrology Australia)

 

 

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