New year, same old drug shortages

Australia has started off 2024 with almost 450 drugs in short supply, including a popular ADHD medicine.

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Patients with scripts for oxycodone, cefalexin or Vyvanse (lisdexamfetamine dimesilate, Takeda Pharmaceuticals) will face an uphill battle at the pharmacy for weeks or, in some cases, months.  

The TGA currently lists Vyvanse, which is typically used in ADHD management, as having limited availability in the 30, 50 and 60mg strengths until March or April.  

An overseas-registered alternative to the 30 mg strength is available thanks to a section 19A approval from the TGA, but that approval is slated to end on 29 February. 

This alternative is not PBS-subsidised.  

While the 20mg Vyvanse formulation also dipped into shortage in October last year, the TGA now reports that supply has returned to normal.  

The drug’s sponsor, Takeda Pharmaceuticals, told The Medical Republic at the time of the 20mg shortage that a spike in demand for ADHD medicines had caused manufacturing and supply issues worldwide. 

While the Vyvanse supply situation is expected to improve, people with morphine and oxycodone prescriptions won’t be so lucky.  

Pharmaceutical company Mundipharma withdrew its oral liquid morphine product, Ordine, from the Australian market in August and announced the discontinuation of OxyNorm (oxycodone hydrochloride), MS Mono (modified release morphine sulfate) and Sevredol (morphine sulfate) in late November. 

The last of the Ordine supply is set to be exhausted by May of this year. 

MS Mono and Sevredol are slated to be deleted from market in the second half of 2024. Lower strengths of Oxynorm will remain on the market until March 2025. 

Various other morphine sulfate pentahydrate and oxycodone drugs are either currently in shortage (Oxycodone Wockhardt, Wockhardt Bio) or are also in the process of being withdrawn from market (DBL Morphine Sulphate, Pfizer). 

While the TGA is reportedly working on section 19A exemptions for overseas-registered alternatives, Palliative Care Australia, the Australian and New Zealand Society for Palliative Medicine, the Society of Hospital Pharmacists of Australia and Palliative Care Nurses Australia have written to Health Minister Mark Butler calling for a new approach to managing medicine discontinuation.  

The peak palliative care sector organisations specifically recommended increasing the minimum reporting period of palliative care medicine shortages from six to 12 months, developing Australia’s opioid manufacturing capability and streamlining the PBS listing process for critical medicines.  

Australia, the organisations pointed out, is already the second-biggest global producer of the raw materials needed to manufacture opioid medicines. 

“The cost of alternatives sourced from overseas to replace locally registered medicines is almost always higher, and this can be a barrier for many people and health services,” SHPA president Tom Simpson said.  

“There have also been problems with labels written in foreign languages and the size of the deliveries we are receiving can make these alternatives hard to administer safely and cost-effectively.” 

This Saturday will mark one year since the commonly used antibiotic cefalexin went into shortage, although the TGA has somewhat optimistically pinned the expected end date as April. 

The story is no better for diabetes drug Ozempic (semaglutide, Novo Nordisk), which has officially entered its third calendar year of being in shortage. 

The regulator was markedly less optimistic about semaglutide’s return to shelves, which has sat at 31 December 2024 since September last year.  

Earlier this week, the PBAC rejected an application to subsidise alternative semaglutide formulation Wegovy (Novo Nordisk) as a treatment for severe obesity.  

Although Wegovy is approved in Australia, Novo Nordisk has not yet set a launch date for the product.