Medication shortages and the medico-legal risks of finding alternatives

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Australia faces ongoing shortages of many medications, especially antibiotics, resulting from the COVID-19 pandemic, and increased demand and supply chain challenges. The use of alternative medicines or treatments can raise potential medico-legal issues for practitioners.

We explore the current and evolving situation in Australia, how to protect yourself medico-legally, and provide some resources to assist you to navigate prescribing unfamiliar or sub-optimal alternatives.

What medications are currently in short supply?

Since January 2019, all suppliers of medications in Australia must notify the Therapeutic Goods Administration (TGA) if they believe there’ll be insufficient supply to meet demand over the next six months. In March this year, there were 380 medicines listed as being in short supply including approximately 60 antibiotics.

Availability of medications can be intermittent and vary across the country. You can visit the TGA website medicine shortage reports database for an up-to-date list of all medicines in short supply, and read current information and updates specifically related to antibiotic shortages

What is the medico-legal risks associated with medication shortages?

When patients are prescribed alternative medications which are less efficacious than the preferred unavailable medication, there is an increased risk of harm due to untended or unknown side effects or complications. This can lead to an increase in claims and complaints. For example, at the time of writing, there are currently shortages of certain strengths of Warfarin and switching brands may increase the risk of clots or bleeding. As you may be less familiar with substitute medications, including their side effect profiles, claims may also arise from allegations of failure to adequately warn patients about side effects or complications. 

 What can you do to mitigate the risks?

First, and most importantly, you should seek expert advice if you’re unsure what to prescribe as a substitute for any medication. This may include consulting clinical guidelines or speaking with other specialists or pharmacists. 

Second, you should familiarise yourself with the risks of substitute medicines so you can provide sufficient information to patients about any side effects or complications that may arise.

Third, if substitute medicines are less efficacious or increase the risk of complications, you may need to consider whether your patient should be followed-up, to ensure that they are closely monitored for side effects or complications. 

Finally, it’s essential that the circumstances in which substitute medicines are prescribed are clearly documented in the medical record. This is important if your records are scrutinised in response to a claim or complaint about a poor patient outcome and will assist you to recall why you prescribed what you did. 

For example, your record should clearly state the name of the preferred medicine and that it was unavailable at that time. The record should also state the basis upon which you prescribed the substitute medicine, any information provided to the patient about that substitute medicine, any specialists or guidelines consulted, and any information or agreed plans made with the patient about follow-up consultations.

In summary, medicine shortages regularly occurred before the pandemic and are likely to continue into the future. Knowing how to manage them, what to document and where to go for information and advice is critical. 

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