Pharmacists could make medicines substitutions amidst shortages, consultation states

The Government has launched a consultation on giving pharmacists more flexibility to dispense a different strength or formulation of medicine to help tackle medicine supply issues.

Pharmacy leaders had been campaigning for an update to the 2012 legislation after extra workload and patient safety issues created by ongoing medicine shortages.

A House of Commons Health and Social Care Committee report on pharmacy also recommended pharmacists should be able to make dose and formulation substitutions for out-of-stock items.

GP leaders have also been broadly supportive of such a move as long as the correct safeguards are in place.

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In an introduction to the consultation, the Government said: ‘We are not expecting this measure to resolve all the issues surrounding medicine supply difficulties, but it is another tool for pharmacists to improve patient access to their medicines.’

Under current regulations, pharmacists must dispense the exact product - strength, formulation and quantity - set out in a prescription with a small number of exceptions.

But increasingly pharmacists warn that patients are being put at risk because if they do not have the exact product in stock, the patient has to go back to the prescriber putting an additional burden on healthcare services and causing stress for patients.

Under the proposed changes, pharmacists would be able to provide an alternative in certain circumstances.

‘We have considered the impact on patient safety, the medicine supply chain and conflict of interest,’ the consultation states.

‘Balancing these with enabling pharmacists to provide improved person-centred care, the proposals are that pharmacist flexibilities are enabled when the pharmacy does not have the medicine in stock and the pharmacist has assessed that there is an “urgent need” to supply an alternative and it would be impracticable to obtain the product without undue delay.’

It sets out that an urgent need could include an acute medicine such as an antibiotic or where a delay would cause a serious inconvenience to the patient.

But when there are known shortages, the flexibilities will not apply in order to avoid knock on impacts.

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The rule changes do not cover pharmacist prescribing, generic substitution, pharmacists supplying an entirely different medicine and only apply to community settings.

Consultation questions include on whether prescribers would need to be notified of any substitutions or in what circumstances.

Professor Kamila Hawthorne, RCGP chair said: ‘As long as all the right safeguards are in place, the College is supportive of pharmacists being able to make minor alterations to prescriptions where appropriate.

‘In the case of medicines shortages, in particular, it’s highly frustrating for GPs and pharmacists alike – and concerning for patients – if they need to go back to the GP to get a new prescription, when a suitable alterative is available. As such, we’ll be making this case when we respond to the consultation.’

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Olivier Picard, chair of the National Pharmacy Association said: ‘We've long called for pharmacists to be able to make substitutions where a medicine is not in stock and it is safe to do so.

‘It is good the government have listened to the NPA and others and have launched a consultation on this issue.

‘It is madness to send someone back to their GP to get a prescription changed when a safe alternative is in stock. It risks a patient either delaying taking vital medication or forgoing it altogether, which poses a clear risk to patient safety.’