The government has laid out plans to “proceed to a formal, public consultation” on allowing pharmacists to substitute medicines this summer, after a toddler died when her pharmacist was unable to amend her out-of-stock prescription.
In January, Lancashire and Blackburn coroner Christopher Long reported that two-year old Ava Hodgkinson’s cause of death was sepsis from a Group A Streptococcus (strep A) infection.
Read more: Strep A: Toddler died after ‘delay’ in receiving out-of-stock antibiotics, coroner warns
The young girl had been prescribed an amoxicillin dose of 250mg/5ml – which was out of stock at her pharmacy – and the pharmacist was unable to prescribe the amoxicillin 125mg/5ml that was in stock due to dispensing restrictions.
Now in a response to the coroner, secondary care minister Karin Smyth has committed to “exploring new flexibilities” for pharmacists.
“Immediate clinical need”
In a letter sent on March 28, Smyth said that a “recent programme of engagement” has seen government officials, GP representatives, pharmacy bodies and patient groups discuss substitution changes “since December 2024”.
“The stakeholder feedback has been sufficiently positive that the government is minded – subject to the normal machinery of government clearance processes – to proceed to a formal, public consultation,” she added.
Read more: ‘Significant disappointments’: DH rejects generic substitution recs
She said that the consultation will seek views on granting pharmacists “the flexibility to supply an alternative dose and formulation to that specified in a prescription written by a prescriber”.
The consultation “should be limited to cases of immediate clinical need where it is impractical to obtain a prescription for the alternative medicine without undue delay”, she added.
“Subject to the normal clearances, my officials aim to publish this by summer 2025,” she said.
“Empowered”
Commenting on the announcement, Royal Pharmaceutical Society (RPS) president Professor Claire Anderson said that the body has “long called for changes to the law so that pharmacists can be empowered and supported to do the right thing for patients”.
“This would improve patients’ experience, use pharmacists’ expertise, and save time for GPs,” she added.
Read more: UPDATED - ‘Get a grip’: HSCC calls for rapid change to drug substitution rules
“These proposals have already been backed by patient groups, pharmacy bodies and GPs,” she said.
“I look forward to the Government consulting on this issue as soon as possible,” she added.
Substitution latest
The department of health’s (DH) announcement comes just months after it rejected the health and social care committee’s (HSCC) recommendation to introduce “generic substitution” in January.
In May 2024, the parliamentary committee’s pharmacy inquiry report urged the government to update regulations on “dose and formulation” substitutions within three months to address medicines shortages.
Community Pharmacy England (CPE) chief executive Janet Morrison deemed the decision to reject the recommendation a “significant disappointment” at the time.
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Meanwhile in February, a group of 45 cross-party MPs signed a letter to health secretary Wes Streeting calling for “an urgent review into ongoing medication shortages”.
“A review into the UK’s medicines supply chain and potential solutions is critical if we are to resolve this crisis,” the letter said, adding that “if action is not taken to properly understand the crisis we face, and explore potential solutions, it will worsen”.
