Legislation, regulation and professional guidance all play vital roles in protecting patients, maintaining professional standards and safeguarding public confidence in community pharmacy. But as the sector evolves, the approach to all three must evolve with it.
Much of the current legislative and regulatory framework was developed for a different model of pharmacy practice, when pharmacies and pharmacists played a greater role in preparing and compounding medicines and the risks associated with supply were materially different.
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Today, the volume of medicines supplied, by what is a shrinking network, has increased significantly. Medicines are overwhelmingly manufactured at scale to internationally recognised standards, while technology, automation and supply controls have significantly reduced many of the risks traditionally associated with routine dispensing.
This raises an important question: can a regulatory framework developed around traditional dispensing models adequately support a profession increasingly delivering clinical care?
Avoiding ‘blanket restrictions’
While regulation has to a certain extent moved towards a more outcomes-focused and risk-based approach, the profession is undergoing significant change. As pharmacists take on greater clinical responsibilities, including independent prescribing, the approach to regulation must keep pace without setting the direction of travel.
This means adopting a more proportionate, risk-based approach, where regulatory scrutiny and intervention are focused on areas of greatest concern.
Where professionals and providers meet the required standards and can demonstrate lower levels of risk, regulation should reflect this, allowing greater oversight to be focused where it is genuinely needed.
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This would enable regulators to use their very limited resources more effectively. They would be able to focus more on addressing poor practice and emerging risks while giving responsible professionals and providers the confidence and flexibility to innovate.
This is certainly not about lowering standards or reducing accountability. When poor practice occurs, regulators must be empowered to act, and to act fast, protecting patients and holding those who fall short accountable.
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However, the actions of a small minority should not result in blanket restrictions affecting the entire sector. Such an approach risks penalising responsible owners, superintendents and pharmacist, increasing bureaucracy and diverting valuable resources away from patient care.
More importantly, it risks limiting the sector’s ability to innovate and respond to changing patient needs.
Changing regulation for a changing sector
The expansion of clinical services, growing prescribing responsibilities, developments in digital and online pharmacy, and an increasing range of private healthcare services are transforming how community pharmacy operates.
The reforms to pharmacy supervision demonstrate the value of legislation that enables modern practice.
The CCA led action to update outdated requirements rooted in a time when pharmacies were more heavily involved in preparing and compounding medicines. The resulting reforms are a welcome recognition of how pharmacy has evolved, enabling pharmacy technicians to take on greater responsibility and freeing up pharmacists to deliver more clinical care.
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However, in my view, the General Pharmaceutical Council’s recent decision to change the initial education and training (IET) requirements for pharmacy technicians provides a contrasting example.
While raising standards is a noble ambition, additional requirements must be proportionate to the risks they seek to address. Without clear evidence of a risk that justifies this change, there is a danger of introducing unnecessary barriers without delivering meaningful improvements.
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What is a level 4 pharmacy technician going to do in a community pharmacy that cannot be safely delivered by a suitably trained and support level 3 pharmacy technician? By all means create headroom for professional development, but not at the expense of access to the profession in the first place.
Where supervision reform demonstrates how legislation and regulation can evolve to enable modern practice, the changes to IET risk inadvertently moving us in the opposite direction by trying to force change.
Enabling the future of community pharmacy
As community pharmacy takes on greater responsibility for delivering clinical care legislation, regulation and professional guidance must reflect both the realities of modern practice and the direction in which the sector is heading.
The UK government has explicitly asked regulators, including those operating in health and social care, to “support” economic growth alongside their core statutory objectives. Through the statutory “Growth Duty”, refreshed guidance and sector specific policy initiatives, healthcare regulators are now expected to take account of innovation, productivity and competitiveness when exercising their functions.
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There is a risk, however, that regulators may misinterpret this as a duty to drive growth and progress. The responsibility for driving the profession forward sits with the profession, and the sector, informed by both evolving patient need and how they choose to access their healthcare.
Regulatory frameworks must be sufficiently flexible to accommodate emerging technologies, evolving professional responsibilities and new approaches to patient care, while maintaining clear standards and robust safeguards.
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They must also be practical, recognising the operational realities of delivering healthcare in community pharmacy.
With the NHS increasingly looking to community pharmacy to take on a greater role in patient care, it is essential that regulation supports this ambition.
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Patient safety and innovation should not be competing priorities. A well-designed regulatory framework can, and should, deliver both.
The future of community pharmacy depends not only on expanding what the sector can do, but also on creating the conditions that allow it to do so.
The future of regulation must be an enabler of change, not a barrier to it.
Malcolm Harrison is chief executive of the Company Chemists’ Association.