The General Pharmaceutical Council’s (GPhC) proposed new supervision standards “could undermine patient safety” unless “significantly revised”, the PDA has warned.
In its response to the GPhC’s consultation on the draft standards, the trade union said the proposed changes risk “blurring statutory roles, weakening accountability and enabling unsafe models of practice”.
The consultation, which ran from December to March, sought views on its proposed standards for responsible and superintendent pharmacists - as well as new rules for responsible pharmacists - ahead of new legislation on authorisation that came into effect in January.
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The PDA said it “supports reform that genuinely improves patient care and professional practice”.
But “commercial pressures, workforce shortages or funding constraints cannot justify lowering safety standards or reducing patient access to pharmacists”, it added.
And it stressed that pharmacy’s growing clinical role means “the need for pharmacists to be present, supported and properly governed has never been greater”.
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The union also set out the “three core principles” of its position:
- Statutory roles must remain distinct and clearly defined
- System, governance and premises accountability must rest with pharmacy owners and superintendent pharmacists, rather than being dispersed or obscured
- Pharmacists must be present and able to intervene at the point of care
Distinct roles
The PDA stressed that “safe and effective pharmacy practice relies on two distinct but complementary statutory roles”.
It said superintendent pharmacists have “continuous, overarching responsibility for governance, systems, staffing and safety across the pharmacy business”.
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Responsible pharmacists, it continued, are “accountable for the safe and effective running of an individual pharmacy” and “must be free to exercise independent professional judgement without commercial pressure”.
The union said that the GPhC’s proposed changes to the standards for these roles “risk blurring responsibility for authorisation, decision‑making and accountability”.
“When lines of responsibility are unclear, patient safety is compromised,” it added.
Superintendent pharmacists
The PDA said in its response that it welcomes role-specific standards for superintendent pharmacists “in principle”, but stressed that these pharmacists must be “senior leaders with genuine authority, not nominal appointees”.
It suggested there should be a “minimum eligibility criteria before appointment” and protections to stop “non‑patient‑facing managers overruling professional clinical judgement”.
And it added that superintendent pharmacists should have “clear accountability” for “staffing levels, skill‑mix, training, systems, technology, wellbeing and safe working environments”.
Remote supervision
The union said it continues to oppose responsible pharmacists being allowed to “supervise multiple pharmacies or operate remotely”.
It stressed that standards facilitating “remote or quasi‑remote supervision in any form” are “unacceptable”.
And it added that “poorly defined authorisation arrangements risk enabling routine pharmacist absence, reduced access to clinical expertise and increased patient harm”.
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The PDA also said it “strongly supports the retention of the existing two‑hour maximum absence rule for responsible pharmacists”.
It argued that the “case for weakening this protection has diminished, not increased”, as pharmacies deliver “an expanding range of complex clinical services including independent prescribing”.
“Any extension of absence arrangements would reduce access to pharmacists and increase clinical risk. This is a clear red line for patient safety,” it added.
Revision of standards?
The PDA called for a “decisive revision of the draft standards”, adding that “patient safety must come first”.
“That requires pharmacists to be present and supported in every pharmacy, under regulatory arrangements that ensure accountability is clear and appropriately held,” it said.
Read more: RPS calls for ‘greater clarity’ in GPhC’s draft standards
It comes after the NPA warned in March that increasing the “maximum two-hour absence period” could “lead to remote supervision and reduce patient access to a pharmacist”.
And it follows the RPS calling for “greater clarity” in the draft standards, and warning that there is a “regulatory conflict” between the legislation on authorisation and the permissions granted in the GPhC’s proposals.
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Meanwhile, the CCA has argued that the “safe and effective running of a pharmacy should not be dependent on the physical presence of a responsible pharmacist”.
In its response to the GPhC’s consultation, the body said that “continued reliance on a fixed, time-limited absence rule is increasingly misaligned with modern pharmacy practice and the way professional responsibility is exercised”.
