Worldwide saline shortage impacts GP IV iron

Healthed

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Healthed

Healthed

Ability to provide IV iron in primary care hampered by supply shortages — nearly one in 5 GPs are already affected

While most of the attention has focused on hospitals, 18% of GPs say their practice has been impacted by the shortage of fluids for intravenous infusions, according to Healthed’s 23 July survey of 1933 doctors.

Practices that offer intravenous iron infusions have been particularly impacted.

Healthed research last February found that 60% of GPs had prescribed IV iron in the previous week — with about half either doing it themselves or by another GP in their practice — suggesting the scope of the problem may be even bigger.

GPs in our latest survey commented that the backlog of cases had patients panicking, and many were rescheduling appointments or using stop-gap measures.

“We offer iron infusions and have had to triage our appointments for this. One time a nurse asked if she could use water for injection to flush a line. (Answer: no).”

Some have pressed pause on plans to offer the service; others noted they were only safeguarded from the shortage because they had previously purchased a surplus of stock.

Significant challenges for GPs

Clinical Associate Professor Pradeep Jayasuriya, a GP who heads up WA Iron Centre, says clinics that offer IV iron should have a policy on how they will handle escalating demand for IV iron and relative inaccessibility of infusion in hospitals, without compromising patient safety.

“The correct dilution of iron leads to less side effects and less adverse reactions,” he wrote in an editorial for Healthed this week. “It is tempting to alter the way the iron is diluted and delivered, but this would involve changing the clinical process which could increase the risk of clinical error.”

“Any available saline supplies will be prioritised to hospitals… General practice will be at the end of the queue when this issue is eventually resolved,” Clinical Associate Professor Jayasuriya says.

Why the lack of transparency?

The TGA finally publicly acknowledged shortages of saline and Hartmann’s solution last week, at least two months after the disrupted supply first became known, stating it was aware of shortages of multiple intravenous fluid products from all three Australian suppliers (Baxter Healthcare, B.Braun, and Fresenius Kabi).

It blamed “multiple factors including global supply limitations, unexpected increases in demand, and manufacturing issues.” But some are saying this explanation is too vague, and too long in coming.

“This is not good enough and we need more transparency on when this was known and what was done,” Clinical Associate Professor Jayasuriya wrote.

Evidence that the shortages have been known for months

In a 2 July letter reviewed by Healthed, the manufacturer Baxter advised its wholesale partners that “unprecedented demand” for sterile fluid products had outstripped the company’s capacity, noting that “as per guidance by the TGA, Baxter is obliged to ensure supply for the public and private hospital sector of Australia, followed by wholesalers.” As such, they warned that supply to wholesalers would continue to be irregular through the end of the year, “and should not be relied upon.”

Likewise, in June a patient safety alert from the Queensland government, intended for internal use only, informed Hospital and Health Services about disrupted supply of sodium chloride 0.9% (saline) for intravenous infusion and sodium lactate (Hartmann’s) solution for intravenous infusion and recommended risk mitigation strategies—explaining that a critical response working group had been established on 7 May — more than two months before the TGA publicly announced the shortages on its website on 25 July.

Yet general practice appears to have been left out of the loop.

The TGA reportedly told stakeholders it was aware of the shortages, but that “IV fluid products are not listed as reportable medicines,” and therefore the sponsors of these products are not required to notify the TGA of a shortage or discontinuation—and the shortages are not included in the TGA’s Medicine Shortage Reports Database. However, they have now issued updated alerts on the situation.

Global shortage has no immediate end

The shortage is expected to continue through the end of the year, according to the TGA. Meanwhile this week, NSW Health sent an internal memo to hospital medicos alerting them to an extreme risk of IV fluid shortages over the next few weeks due to shipping delays, the Sydney Morning Herald reported, explaining that staff have been asked to consider alternatives to IV for medicine and fluid replacement.

To improve supply in the interim, the government has approved multiple overseas-registered alternative brands – which do not have to go through the usual Australian quality control process.

Part of a broader issue

“On a bigger level, shortages are on the increase worldwide and something that will need confronting down the track. Because of the complexities and market power of the companies, governments are reluctant to pursue it in a substantive way,” Clinical Associate Professor Jayasuriya says.

How has your clinic been impacted by the shortages?

“It has crippled our plan to start iron infusion in the clinic.”

“I was unable to start IV fluids on a man who had early signs of sepsis who was waiting for an ambulance.”

“We’ve been limited to larger sized saline solution which is time consuming to adjust to correct volume for iron infusion.”

“Fortunately, we had and have significant in-date stock!”

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