This appeared today:
‘Havoc’ for patients as hundreds of medicines in short supply
By Mary Ward and Amber Schultz
May 26, 2024 — 5.01am
Hundreds of key medicines are in short supply in Australia as experts warn the problem is putting lives and livelihoods at risk.
The Therapeutic Goods Administration (TGA) lists more than 420 medicines as being in shortage, 20 of which are at critical levels, including blood thinners, antibiotics and hormone replacement therapy medication.
Royal College of Australian General Practitioners president Dr Nicole Higgins said Australia had faced an ongoing medicine shortage since COVID-19 but the problem was getting worse.
“Some critical medication shortages impact people’s immediate health, and others impact their ability to function,” she said.
As an example, Higgins said the shortage of five-milligram doses of blood thinners meant people had to use smaller tablets to get the same dose, and this could increase bleeding, side effects and complications.
“What shortages mean for patients is that at best, it’s inconvenient, at worst, it can be very dangerous,” she said.
Federal Health Minister Mark Butler referred questions to the TGA, which said managing medicine supply was a priority for the Australian government.
“The number of shortages appearing on the TGA’s Medicine Shortage Reports Database has been relatively consistent since the introduction of mandatory reporting in January 2019. The TGA receives an average of 120 notifications of new medicine shortages every month, with 12 of these having a critical impact rating,” a spokesperson said.
“Medicine shortages can arise for many reasons, ranging from shortages of raw materials, natural disasters, logistical difficulties, batches of the medicine not meeting applicable specifications, or increased demand.”
Pharmaceutical Society of Australia spokesperson and Melbourne pharmacist Peter Guthrey said the shortages were challenging for pharmacists, who must send women back to their GP for scripts for alternative hormone treatments in stock at their pharmacy, resulting in additional gap fees and time.
“A number of women have expressed frustration that there hasn’t been a resolution to this issue by now, and that they believe a similar issue affected medicines predominantly for men wouldn’t be allowed to go on unresolved for so long,” he said.
David Heffernan, president of the NSW branch of the Pharmacy Guild, said shortages resulted from supply chain issues that had been evident even before the pandemic.
“When one brand of drug goes out, that means there’s double the use of the other,” he said.
Australian Medical Association vice president Dr Danielle McMullen said the shortages had been “frustrating”, obliging doctors and patients to devise workarounds. Altered management strategies then had an impact on the time and energy that patients spend running around different pharmacies.
From July 2023, the Medicines Supply Security Guarantee was introduced, requiring manufacturers to hold a minimum of four or six months’ stock in Australia for key medicines. McMullen said there needed to be greater enforcement of these stockpiling requirements.
Among the 423 medicines currently in shortage in Australia are several treatments used by menopausal women to manage symptoms such as hot flushes and night sweats.
Menopause hormonal therapy (MHT) – also known as hormone replacement therapy (HRT) – refers to a range of patches, creams, tablets and devices to replace oestrogen, which declines with age.
The treatments, particularly in patch form, have soared in popularity in the past five years after a 2019 Lancet paper largely dispelled previous concerns about breast cancer risk.
Of the nine brands of HRT patches available in Australia, eight are in short supply and the other is not available on the Pharmaceutical Benefit Scheme (PBS).
Over several years, there have been occasional shortages of the patches. However, Vicki Doherty, executive director of the Australian Menopause Society, said the current shortage was the longest run to date in Australia.
She said it was particularly frustrating that the predicted dates for a return to normal supply – provided by the medicines’ sponsors to the TGA – had been repeatedly pushed back. For most MHT brands, return to normal supply is estimated between mid-June and the start of August.
“I have heard stories of women going to multiple pharmacies, getting very frustrated and upset,” Doherty said. “Our member doctors are telling us they’re spending their whole lunchbreak trying to find suppliers for their patients.”
Doherty believes the MHT shortages are the result of a “perfect storm”, the combination of increased demand thanks to studies showing the efficacy of MHT, the discontinuation of popular brands including Climara and the supply chain and market issues.
“It can create havoc for women, this really does impact their quality of life,” she said.
The TGA was unable to provide data on MHT prescriptions made in Australia.
Submissions to a coming federal senate inquiry on menopause from several healthcare organisations, published last month, raised concerns about the availability and cost of MHT.
The submissions supported MHT as an effective treatment for menopause symptoms. Most menopause treatments developed in the past 15 years are not subsidised in Australia and cost women $50 a month, while treatments listed on the PBS cost about $25 a month.
Here is the link:
I know I will be seen as a ‘old male white dude’ for wondering but I found it rather odd that with lots of different categories of seriously life-saving drugs apparently in short supply the second half of the article was devoted to hormonal medications which are some-what more optional – and certainly not life-saving in the short term!
Be that as it may be – we, as a nation, need to work to break our dependence on importation of major critical medicines – by fostering a more robust local pharmaceutical manufacturing industry – and making sure we can manufacture the basic WHO list of essential medications on shore – for national security reasons at least.
The WHO list is found here:
https://www.who.int/publications/i/item/WHO-MHP-HPS-EML-2023.02
WHO Model List of Essential Medicines - 23rd list, 2023
26 July 2023 – 67 Pages
Overview
Essential medicines are those that satisfy the priority health care needs of a population. They are selected with due regard to disease prevalence and public health relevance, evidence of efficacy and safety and comparative cost-effectiveness. They are intended to be available in functioning health systems at all times, in appropriate dosage forms, of assured quality and at prices individuals and health systems can afford.
The WHO Model List of Essential Medicines and Model List of Essential Medicines for Children are updated and published every two years, intended as a guide for countries or regional authorities to adopt or adapt in accordance with local priorities and treatment guidelines for the development and updating of national essential medicines lists. Selection of a limited number of essential medicines as essential, taking into consideration national disease burden and clinical need can lead to improved access through streamlined procurement and distribution of quality-assured medicines, support more rational or appropriate prescribing and use and lower costs for both health care systems and for patients.
---- End Quote
It would be fascinating to know how
much of this list can presently be make locally – does anyone know? I reckon we should nationally aim for self-sufficiency in the 'essentials list;!
Any input welcome!
David.
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