The government is considering enabling pharmacists to substitute a different dose or formulation in specified circumstances, it has confirmed.

This comes as a coroner has raised concerns around the death of a child who was delayed in obtaining antibiotics as prescribed.

Two-year-old Ava Hodgkinson died on 14 December 2022, 'from natural causes due to overwhelming sepsis caused by Streptococcus A infection', according to the coroner.

She had been examined by a GP and while 'no infection was found', antibiotics were prescribed.

It was highlighted that Ava had been delayed by a day in obtaining the antibiotics because the pharmacy did not have the prescribed dose in stock.

This came during a time of higher and earlier than usual rates of strep A, increased demand due in part to a lower prescribing threshold, and difficulties for pharmacies getting hold of supplies.

The coroner noted that the GP had prescribed amoxicillin 250mg/5ml, which the pharmacy did not have in stock.

The pharmacy did have amoxicillin 125mg/5ml in stock, which in theory could have been administered in 10ml doses to meet the required strength, the coroner suggested.

But the pharmacy could not issue this 'as restrictions currently in place prevent a pharmacist issuing any different strength of medication without an amended prescription'.

'This led to a delay in Ava receiving antibiotics,' coroner Christopher Long said in a prevention of future deaths report, highlighting the concern to the Department of Health and Social Care (DHSC).

He added: 'Evidence from the Department of Health and Social Care included that this issue was being actively considered but it was explained the issue was complex and any change was likely to need public consultation and ministerial support.

'It was also explained that it was not possible to provide any timeframe for any appropriate steps to be taken to consider changing the restrictions preventing pharmacists from issuing medication where they can provide the same dosage of the same medication in a different denomination.'

In response to the coroner's prevention of future deaths report, a DHSC spokesperson said it was 'committed to learning lessons to prevent tragedies like this in the future', and would 'consider the coroner’s report closely'.

'Our deepest sympathies are with Ava’s family and loved ones in this tragic case,' they said.

The government confirmed it was currently considering enabling pharmacists to substitute to a different dose or formulation, under specified circumstances, where such a substitution might be both urgent and safe, and that further details would be set out in due course.

It also noted that the coroner had concluded there were no findings that anything relating to the provision of antibiotics contributed to Ava’s death, and that there were no system failings on the part of the state.

DHSC: 'There may be occasions where it is appropriate to enable further flexibility'

Last week, the government 'partially accepted' a parliamentary recommendation that regulations be updated promptly 'to allow pharmacists in community settings to make dose and formulation substitutions for out-of-stock items, subject to the safeguards set out in the Royal Pharmaceutical Society’s Medicines Shortage Policy'.

In response to that recommendation, the government said that requiring pharmacists to supply exactly what was written on the prescription 'works well as prescribers have certainty of what their patient is receiving; the clear separation of roles, prescribing and dispensing, supports patient safety, with a double clinical check on dose and interactions; and patients have consistency as to their dosing regimen'.

And it warned that 'allowing pharmacists to take local action to alter prescriptions and supply an alternative without an SSP in place and without the full oversight of supply issues that the DHSC Medicines Supply Team has, could have the effect of creating a "knock-on" shortage of the alternative and could thereby have the potential to exacerbate rather than mitigate a supply problem'.

But it said that it did recognise 'there may be occasions where it is appropriate to enable further flexibility to supply an alternative dose or formulation to what was prescribed without going back to the prescriber'.

'We are currently examining options with stakeholders, to assess where and how this could be appropriate, and how any associated risks could be managed,' the government said in its response to the health and social care select committee report, published last week.

In April 2024, The Pharmacist reported that the chief executive of the pharmacy regulator had met with DHSC to discuss whether pharmacists could be allowed to make substitutions or minor amendments to prescriptions in the case of medicines shortages.

The government had previously said it had ‘no plans’ to allow community pharmacists to amend prescriptions, in a written answer from then pharmacy minister Dame Andrea Leadsom in February 2024.

She said: ‘Allowing pharmacists to take local action to alter prescriptions could have adverse impacts on patients, because pharmacies will not know the reasons why a medicine has been prescribed, or in what particular way.

‘Supplying an alternative without full oversight of supply issues could also create a knock-on shortage of the alternative and could thereby have the potential to exacerbate rather than mitigate a supply problem.’

The following month, then health secretary Victoria Atkins said that DHSC had ‘not made a decision’ on whether it would allow pharmacists to supply alternative medicines in the case of a shortage.

But Sir Chris Wormald, permanent secretary at DHSC, queried whether pharmacists have the ‘skill sets’ and adequate access to a patient’s medical history to make the ‘carefully balanced clinical judgment’ needed to safely supply an alternative medicine.

'Pressing need' to fix medication supply chain

Yesterday, The Pharmacist reported on another recent prevention of future deaths report, in which a patient died after his pharmacy was unable to supply his epilepsy medication.