The Department of Health and Social Care (DH) today (September 18) launched the much-anticipated consultation on granting pharmacists “flexibility when dispensing medicines”.
This will allow them, in certain circumstances, to “supply a different strength or formulation” of the same medicine originally prescribed, it said.
The proposals aim to “improve patient access to medicines”, “reduce the burden on healthcare systems” and “improve person-centred care”, it added.
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The DH is “not expecting this measure to resolve all the issues surrounding medicine supply difficulties”, it said, but noted that it is “another tool for pharmacists to improve patient access to their medicines”.
The consultation will run until 11:59pm on December 11 and is intended to “seek views” on whether respondents agree with the proposals, the government said.
It will also allow the DH to “assess any measurable impacts, risks and benefits before deciding whether to proceed with legislative change”, it added.
DH “considered various options”
According to the government, the consultation proposes to amend the Human Medicines Regulations 2012 to help community pharmacists deal with medicine shortages and supply issues and avoid possible “negative” impacts on a patient’s health.
“The DH has considered various options on when pharmacist flexibilities could be enabled – from enabling it in very restricted circumstances to enabling it in any circumstance,” it said.
And it today proposed 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”.
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It stressed, however, that the flexibilities will not apply – “except in limited exceptions” – when there is “a known serious shortage of the medicine prescribed or the alternative to be supplied”.
“This is to avoid the risk of causing knock-on shortages and disruption to the medicine supply chain,” the government said.
One “exception” to this, it noted, is where a medicine supply notification (MSN) or an alert through the central alerting system (CAS) “has specifically allowed the use of pharmacist flexibilities to manage a particular shortage”.
“Dangerous” status quo
The DH called for evidence on how often pharmacists are dealing with “minor amendments” and “referring patients or prescriptions to prescribers to have strength and formulation changes”.
And it also asked for examples of “delays to treatment that could have been avoided by allowing supply of a different formulation or strength to achieve the same dosage”.
National Pharmacy Association (NPA) chair Olivier Picard said that “it is good the government has listened to the NPA and others and have launched a consultation on this issue”.
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“The current status quo is not only frustrating for patients, it is also dangerous,” he said, adding that it is “madness to send someone back to their GP to get a prescription changed when a safe alternative is in stock”.
Picard stressed, however, that “any changes introduced must be simple and provide genuine flexibility to pharmacists”.
“They should not just be an extension of existing out of date systems that do not help pharmacists adequately manage systemic and sporadic medicine shortages,” he said.
“Improve” outcomes
Company Chemists’ Association (CCA) chief executive Malcolm Harrison also welcomed the consultation, arguing that it would “improve patient experience and outcomes”.
But he said that the proposals would not “resolve the issue of national medicine shortages”, noting that “continued underfunding of the medicines supply chain must be addressed so that the UK remains an attractive market for global manufacturers and suppliers”.
Today’s announcement comes after the government laid out plans in March 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.
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Meanwhile, the pharmacy all-party parliamentary group (APPG) called for “immediate and coordinated action” in July following its findings that “persistent disruptions” to supply chains were placing an “unsustainable burden on community pharmacy teams”.
And last month a House of Lords committee announced the launch of a “medicines security” inquiry to look into the “UK’s ability to predict and prevent medicine supply issues”.
