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TOUGHER prescribing criteria for testosterone are a step in the right direction to address the massive growth in prescriptions for age-related testosterone decline, say experts ahead of the 1 April changes.
Brisbane GP Dr Justin Coleman said the more stringent Pharmaceutical Benefits Scheme (PBS) criteria were necessary to curb the “dangerously fast” increase in testosterone prescribing in Australia, which was unsustainable and probably harmful. (1)
Under the changes, GPs will have to consult with a specialist paediatric endocrinologist, urologist, endocrinologist or registered member of the Australasian Chapter of Sexual Health Medicine before they can prescribe testosterone for a patient.
"There’s little doubt that in Australia at the moment, there are at least some men getting testosterone that they don’t need, and for them it is causing more harm than good", Dr Coleman told MJA InSight.
He said the first port of call in addressing the issue should be GP education through organisations like NPS MedicineWise, but education alone was unlikely to temper testosterone prescribing practices.
“Unfortunately, the situation has burgeoned out of control, and there are plenty of market forces that stand to benefit if it remains out of control, so I guess that’s where some sort of regulation comes in”, said Dr Coleman, who is a spokesman for the No Advertising Please campaign, which encourages doctors to ban surgery visits by drug representatives.
GPs can seek an authority from the federal Department of Health to issue a prescription for testosterone after consulting with a specialist, a department spokesperson told MJA InSight.
“To meet the restrictions, a GP may contact the appropriate specialist by phone, email or fax”, the spokesperson said. Prescribing GPs could also inform the department that a patient had made an appointment with an appropriate specialist and this would be accepted by the department as meeting the PBS restrictions.
The threshold serum testosterone level to establish PBS eligibility would be reduced from 8 nmol/L to 6 nmol/L.
The spokesperson said the criteria for authority prescription excluded treatment for low serum testosterone due primarily to age, obesity, cardiovascular diseases, infertility or drugs as these indications had not been assessed for efficacy and cost-effectiveness by the Pharmaceutical Benefits Advisory Committee (PBAC). “The PBAC noted some safety concerns with testosterone, including possible increased cardiovascular risk in older men.”
In an Australian Doctor poll of 554 readers, GPs were divided on the issue. Almost half of respondents said testosterone was being prescribed appropriately and restrictions on GP prescribing were “outrageous”. (2)
Earlier this month, the US Food and Drug Administration (FDA) announced that warnings would have to be included with testosterone products of possible increased risks of heart attack and stroke, and that testosterone should not be used for low testosterone levels associated with ageing. (3)
In an editorial published in the Journal of the American Geriatric Society last week, Dr Thomas Perls of the Boston Medical Center and Australia’s Professor David Handelsman, applauded the FDA’s moves to address “disease mongering” of age-related declines in testosterone. (4)
Professor Handelsman, director of the ANZAC Research Institute, told MJA InSight that an overflow effect from international direct-to-consumer advertising and lax US and European prescribing guidelines had fuelled an accelerating increase in testosterone prescribing in Australia in the past two decades, as he had outlined previously in the MJA. (5)
Professor Handelsman, who is also professor of reproductive endocrinology and andrology at the University of Sydney, said although the increase in testosterone prescribing rates in Australia were not as extreme as in the US, Canada or most of the 41 countries analysed in his MJA research, Australia had paralleled the rapidly increasing North American prescribing trends.
He said tightening the PBS prescribing criteria was a step in the right direction and would have some beneficial effect on curbing inappropriate prescribing of testosterone for functional causes of low serum testosterone.
While much of the testosterone prescribing was well-intentioned, it was misguided, wasteful and unsound medicine that could potentially put patients at risk of harm, Professor Handelsman said.
A Therapeutic Goods Administration (TGA) spokesperson said the TGA was reviewing the available information about testosterone and the risk of adverse events.
1. Department of Health. Schedule of pharmaceutical benefits – summary of changes, March 2015
2. Australian Doctor, 13 March 2015
3. FDA. Drug safety communication, 3 March 2015
4. J Am Geriatric Soc 2015; Online 24 March
5. MJA 2013; 199: 548-551
(Photo: Diego Cervoi / shutterstock)
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I’m a patient – not a medical practitioner – who has been on testosterone replacement treatment for several years; 56 yo male generally healthy but with baseline T 6 – 6.3 Ng/m. Testosterone supplementation has transformed my life so I am able to function normally in the adult world rather than heading to the retirement village and sitting around with diminished brain function and no stamina. The most disappointing aspect of how the changes to testosterone prescribing guidelines have been made is that they don’t seem to have involved any consultation with actual patients and looking at their real health outcomes. If there is a genuine concern about increased risk of cardiovascular disease what better place to examine that than within the cohort of Australian men already being treated? I’m certain my tuned-in general practitioner who manages my testosterone supplementation takes a fair degree of care in constantly evaluating a range of risk factors, before continuing the treatment. I don’t accept that only an endocrinologist is able to make that call on my behalf.
I totally support the government’s objective of controlling the increasing cost of the PBS, and would be less upset about the changes to Tesosterone prescribing guidelines if they were simply justified on that basis. But the public announcement seems framed in ideological language, and without much reference to patients as real people and what their views or experiences are.
How disheartening to see the comments by Coleman and Handelsman regarding the use of testosterone (or other hormone) replacement in men. There are many articles describing the benefits of testosterone therapy in the literature that contradict the opinions of these gentlemen. Indeed, most of the commentary in this recent discussio0n in MJA InSight is in the form of opinion with little regard for facts. If the TGA, among other regulatory and authoritative bodies, relies on this ‘information’ to promote medical policy it is doing the men of Australia a grave disservice.
The idea that testosterone (or hGH) is a drug is in itself an absurdity. What is most disheartening is that the Medical Board among others, pressure doctors not to give men this beneficial treatment because of veiled threats to their license. This is the legacy of the US Senate investigations into sports doping where, a once freely prescribed substance, was classified as a mind-altering ‘drug’ and from that point nothing but ignorance and stupidity followed.
It would be refreshing to see some commonsense enter into this discussion: to view the increase in testosterone prescribing as ‘alarming’ is pure scientific ignorance. Practitioners faced with a patient asking for testosterone will frequently prescribe an SSRI, a situation I see on a regular basis, that is appalling even as it is ignorant!
If the gentlemen who so stridently make the case that testosterone is dangerous were to voluntarily undergo orchiectomy, they would at least have some moral authority. Meanwhile men in Australia are being treated sub-optimally to say the least. I remain, disgusted.
It’s not clear why Sue Ieraci raises the case of a successful prosecution of a doctor as an example of why additional restrictions are required. Surely the prosecution demonstrates that existing regulation is working?
Androgen deficiencies do not resolve, except through continued medication. Testosterone, when needed by people with intersex variations/differences of sex development, is necessary for life. The regulatory change creates a new and additional impost for people who may have decades of experience in taking testosterone, but who are still required to obain an “authority script” from a GP or specialist every 6 months. Combined with restrictions on renewal dates, and some State/Territory regulations (NSW insists that pharmacies keep scripts once presented), and so compliance and patient costs are real issues.
Some people with intersex variations/differences of sex developments are prescribed irreversible treatment without their prior fully informed consent (the PBS rules explicitly permit interventions on persons aged under 18). The issue of consent were examined by the Senate Community Affairs References Committee in the 2013 report, “Involuntary or coerced sterilisation of intersex people in Australia”. This issue has not been addressed in the current PBS change.
Other persons with, for example, Complete Androgen Insensitivity Syndrome (CAIS), or persons with an X gender marker, are unable to access testosterone on PBS as they are not male. This issue has not been addressd by the current change to PBS rules.
This is a disappointing change by the PBAS that does not address key issues for people with intersex variations/differences in sex development.
Through association with elderly men in the community and working as a RN in public hospitals and nursing homes, I’v seen the benefits of testosterone replacement over many years. I feel it’s unfair to compare them with body builders using it for other purposes. In my experience the use of testosterone in an elderly person who has a low level improves dramatically the quality of life, and probably helps to keep them out of nursing homes. I’v noticed how the mental capacity drops off with the testosterone level until their wives and family can’t look after them any more. In my mind it’s a false economic measure in a time of growing elderly populations to take away a GPs right to prescribe it as needed. The GP knows the patient personally where to a specialist you’re just another body. Surely it’s to all our benefits to keep the elderly as active as possible for as long as possible.
All those commenters who are so confident that GPs don’t prescribe to body builders much have missed this news story about an “anti-ageing” doctor who was prosecuted in the medical tribunal for her prescribing practice: http://www.smh.com.au/nsw/antiageing-doctor-julie-epstein-found-guilty-of-misconduct-20150401-1mcrcv.html?stb=twt.
Quoting from the story: “Some of these patients had a known history of abusing steroids and testosterone, including body builders, bouncers, boxers, a former Mr Universe and a former SAS member who had been injured during service. However Dr Epstein ignored or “turned a blind eye”.”
Quoting David Handelsman, in regard to men […In the interim, testosterone prescribing for functional AD (androgen deficiency), notably among older men without pathological hypogonadism, should be confined to well controlled and adequately powered clinical trials that aim to determine the efficacy and safety of testosterone prescribing for andropause….]. If they are not going to treat so called ‘functional AD’ perhaps they may not want to treat subclinical hypothyroidism either.
At the PBS someone has noticed this twelve fold increase in prescribing. While for many of us this might represent a successful medication that has been well received by the consuming public, they appear to have concluded that it is another case of overprescribing. I say ‘appear’ as it would seem that there has been no official communique to the prescribing doctors as yet about a change in the rules if not a moving of the goalposts. These new criteria (if they actually exist) are not going to affect prescribing but increase costs to sometimes impoverished communities.
They do appear to have entirely missed that testosterone administration is central to the success of the emerging transman; these folk often have no money and precious little time to go running round specialists. Their lives hang literally in the balance with the increased risk of suicide RR 2.2: not to mention the tyranny of distance. Their lives depend on testosterone as does a diabetic’s life depends on insulin. The irony may be that the transmen join the menopausal ciswomen who have historically been denied the use of testosterone that improves the quality of their lives and may reduce their risk of early onset breast cancer.
A bit of honesty would help. If there is convincing medical evidence of adverse response to physiological androgen replacement therapy, then present it. GPs prescribing to body builders – rubbish. Anyone seeking super-therapeutic androgen cycles will not get the combinations of androgens +/- anastrozole from the GP. They are available at the gym. This is pure and simple an attempt to reduce PBS costs. It represents gender prejudice. Will women have to see a specialist to get HRT, therapy with proven adverse outcomes and doubtful preventive health benefits? This is all about money and should not be presented any other way. Will long term testosterone prescribing reduce? Will androgen abuse reduce? Will androgen uptake reduce? Betcha they will not.
On what is meant by the term ‘Cisgender’: “The opposite of transgendered, someone who is cisgendered has a gender identity <http://www.urbandictionary.com/define.php?term=gender+identity> that agrees with their societally recognized sex <http://www.urbandictionary.com/define.php?term=sex>.
“Many transgender people prefer “cisgender” to “biological”, “genetic”, or “real” male or female because of the implications of those words. Using the term “biological female” or “genetic female” to describe cisgendered individuals excludes transgendered men, who also fit that description. To call a cisgendered woman a “real woman” is exclusive of transwomen, who are considered within their communities to be “real” women, also.”
Have they considered rural areas where access to specialists is difficult, there are very few endocrinologists and the wait in private practice is over 6 months, it’s even difficult getting dabetics into a public endocrinologist in a timely fashion. By all means tighten the criteria, but do not restrict those who really need it, eg, hypophysectomy patients, klinefelter syndrome, etc. If “cigender” ( whatever that is) and more likely the body builders are getting their androgen on the PBS I am all in favour of tightening the restrictions. If doctors are prescribing inappropriatey then some kind of audit and education needs to be done. If there is abuse of the PBS for gain then that needs to be investigated
The prescribing of testosterone may well be a problem amongst the cisgender population. Unfortunately, the tougher criteria will affect a section of the population in a way that may decrease their already fragile health status; trans* men rely on testosterone to strengthen and maintain the levels of testosterone in their changing bodies. For the majority of people who pursue sex reassignment surgery, Gender dysphoria is known to improve/dissipate through hormonal therapies in this population, and by putting an extra hurdle in their already hurdle lain progress through their transition will only add extra unnecessary burdens which may affect mental health outcomes in the negative. This already vulnerable population will only suffer as a result. A radical rethink is required.
From what I understand, a GP would still be able to prescribe Testosterone as a private script without reference to a specialist?