And there is no sign that the status quo is changing anytime soon, says an Aussie expert.
A leading Australian women’s health physician has taken a massive swipe at the TGA over “nightmare” prescription medicine shortages that she says are the worst she has seen in more than 40 years of medical practice.
Latest data from the TGA’s drug shortages database, accessed on 10 August, showed there were 452 current shortages, 92 anticipated shortages and 233 discontinuations of prescription medicines in Australia.
These include common antibiotics and other anti-infectives, and a range of contraceptives and MHT medications such as estrogen patches.
Dr Terri Foran, a Sydney-based sexual health physician with a special interest in contraception, menopause and STIs, said supply issues needed urgent attention from the TGA.
She said the shortage of menopause medications like patches was wreaking havoc on patients, doctors and pharmacists, and healthcare professionals were forced to spend large amounts of additional time trying to find alternatives for patients when their regular medications were unavailable.
“I simply do not remember in the whole time I’ve been practising that this has been an issue like it is now,” said Dr Foran, conjoint senior lecturer with the School of Women’s and Children’s Health at the University of NSW.
“The stuff that we really should have really access to, we’re just not getting and nobody’s talking about it. The TGA just puts out vast lists of stuff that’s not easy to get at the moment, but nobody’s doing anything about it.
“And it’s not just been the last year, it’s even before covid. Covid just made it completely untenable.”
She said Australians should have ready access to the medications that are on the PBS for the treatment of conditions like menopause.
“The last three-four years have been a nightmare for those of us working in women’s health,” she said.
“We’ve had contraceptive pills become unavailable for huge periods of time, we’ve had patches come in and out of our availability.
“Frankly I think it’s just another symptom of a health system that’s grinding to a horrible halt.”
Dr Foran said in the case of menopause symptom management, it could take time to establish patients on treatment regimens that work effectively and are well tolerated. And having to find alternatives could be problematic, she said.
“It’s the poor old GPs who have to do the hard yards […] when something that was working really well is just no longer available,” she said.
She said she knew of patients who tried to manage the shortage by halving their tablets and cutting their patches in half, but this was not recommended, and in some cases could even be dangerous.
“Certainly if you’re economising on the progestogen side of HRT, if you’re trying to spin that out, that’s actually inherently dangerous, because that dose is designed to protect the endometrium,” she said.
“And if you go down below that dose that might not offer the protection that’s required. So there are hazards in doing exactly that. But I have found patients who do it because they are just trying to make their supplies spin out just that little bit longer.”
Cutting back to half doses of other medications meant that a patient was only receiving half the required dose and that might not be enough to control menopause symptoms, Dr Foran said.
She said there were some practical things GPs could do to try and help patients affected by MHT/HRT shortages. The Australasian Menopause Society has a guide to equivalent MHT/HRT doses in Australia. The society is currently also reviewing this information.
She said GPs should also feel empowered to contact patients’ menopause clinicians to discuss alternatives.
“It’s much better to have a chat with your doctor about an alternative preparation, rather than to spin a patch or a medication out, it does require a conversation because it’s not quite as straightforward as it perhaps seems,” she said.
Dr Foran said there needed to be a wider and meaningful conversation about the problems around medicine supply in Australia as a matter of urgency.
“Australia’s at the end of the supply chain, generally, we don’t make very many drugs here, almost everywhere else in the world pays people more for drugs than we do,” she said.
“So basically, were on the end of on the end of the list when it comes to supply. So if there’s ever a shortage, we feel it first.”
A spokeswoman for the TGA told TMR that “the absolute number of shortages on the Medicine Shortage Reports Database is lower than previous years”.
“However, there are currently some very high-profile shortages, including of a number of antibiotics and menopausal hormone treatment (MHT),” she said.
“Some of these shortages are not limited to Australia. The number of medicine shortages reported, including critical medicine shortages, has been generally consistent since the mandatory reporting of medicine shortages started in January 2019, with an average of 446 shortages reported each month.”
She said shortages had a variety of reasons, including shortages of raw materials, batches of the medicine not meeting Australian specifications, or logistical delays including potential impacts of global events.
“Whilst pharmaceutical companies do their best to maintain supply through demand forecasting and stock control, situations can arise where a disruption to the supply of a medicine cannot be avoided,” she told TMR.