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GPhC: overcoming the iceberg effect

There is an iceberg effect around the regulation of healthcareprofessionals: it is the disciplinary activities of regulation whichgenerally excite interest and generate news, yet these concentrateretrospectively on only a small minority of practitioners.Unfortunately looking from this perspective distracts us from theprimary purpose of professional regulation, which is enhancing patientsafety and confidence

by Peter Noyce

There is an iceberg effect around the regulation of healthcare professionals: it is the disciplinary activities of regulation which generally excite interest and generate news, yet these concentrate retrospectively on only a small minority of practitioners.

Unfortunately looking from this perspective distracts us from the primary purpose of professional regulation, which is enhancing patient safety and confidence.

Key principles

The overriding interest should be the safety and quality of care that patients receive from health professionals

  • Regulation needs to sustain the confidence of the public and professionals through demonstrable impartiality
  • Regulators need to be independent of Government, professionals and all other interest groups
  • Regulation is as much about sustaining, assuring and improving professional standards as it is about identifying and addressing poor practice and bad behaviour
  • Regulation should not create unnecessary burdens but be proportionate to the risk it addresses and the benefit it brings

The Government announced in its White Paper, “Trust, assurance and safety”, published in 2007, key principles for harmonising professional regulation (see Panel right).

It also indicated that a new regulator — the General Pharmaceutical Council (GPhC) — would be established for pharmacy.

Increasingly both pharmacists and policy-makers had recognised the fundamental incompatibility of having regulatory responsibilities and professional advocacy and development vested in a single institution, namely, the Royal Pharmaceutical Society.

The new arrangements will allow the GPhC to be established in a way that immediately meets the requirements for an independent and transparent regulator whose approach will be modern, responsive and proportionate.

To oversee the transitional process, ministers established a Pharmacy Regulation and Leadership Oversight Group (PRLOG), under the chairmanship of Ken Jarrold. This was informed by the Carter Report which envisaged the GPhC working in co-operation with a strong professional body bearing the hallmarks of a “royal college of pharmacy”. Now the prospectus for the new pharmacy professional body has been published.

Meanwhile the Society remains the pharmacy regulator, charged with regulatory implementation and development, and maintaining the registers of pharmacists, pharmacy technicians and pharmacy premises until the GPhC is established in 2010.

GPhC functions and challenges

The key functions of the General Pharmaceutical Council will include:

  • setting and securing standards for practice, education and training, continuing professional development and conduct for pharmacists and pharmacy technicians
  • registering qualified and competent pharmacists and pharmacy technicians
  • registering, regulating and inspecting pharmacy premises
  • operating fitness-to-practise procedures covering performance, health, and conduct
  • having enforcement responsibilities in relation to medicines and poisons legislation

The primary legislation establishing the GPhC received Royal Assent in July 2008 and the consultation on the draft Pharmacy Order 2009 covering the GPhC structures, functions and processes is imminent. There will then be a later consultation on the rules and standards to be adopted by the GPhC.

Modern regulation is focused around the notion of fitness to practise. This embraces the conduct, health and performance of healthcare professionals. In this regard, the GPhC will have the benefit of being able to build on the groundwork and early experience of the Society in implementing the Pharmacists and Pharmacy Technicians Order 2007.

In determining the standards for initial fitness to practise, or entry to the register, health regulators have oversight over the education of health professionals.

The GPhC will set standards for the education of pharmacists and pharmacy technicians, and will have powers more in keeping with those of the General Medical Council and General Dental Council in the regulation of pharmacy education.

Health regulators also have a responsibility to ensure registrants maintain their fitness to practise. Pharmacy is unusual among health professions in that there is still no legal requirement for practitioners to undertake CPD to remain on the professional register. That will change immediately with the establishment of the GPhC, and the Society is already preparing for this.

Subsequently CPD requirements will become part of the revalidation arrangements for practising pharmacists and pharmacy technicians, when they will have to demonstrate their capability to meet the contemporary standards for entry to their registers. So an early challenge for GPhC will be to establish the appropriate culture, competence and confidence of a modern health regulator.

The GPhC is the first new regulator to be established since the constitutional changes associated with the devolved administrations. Since it will include the regulation of pharmacy technicians (a profession brought into regulation after the devolution settlement), as well as pharmacists and premises, legislation establishing the GPhC will be considered by the Scottish and Westminster Parliaments.

In addition, because the jurisdiction of the GPhC includes England, Wales and Scotland, it is likely to have offices in each country to allow proper account to be taken of differing NHS legislation and service delivery models as they emerge in the three countries.

It is also the first new regulator to be informed by the recommendations of the White Paper specialist working groups on, for example, regulatory governance and regulation of extended practice.

For instance, the steer on regulatory councils is that they should be strategic, comparatively small and equally balanced in membership between lay and health professionals.

Perhaps the biggest challenge for the new GPhC will be to chart and reflect the changing roles and relationships between the pharmacy workforce and medicines, patients and other healthcare professionals.

It will need to be both sensitive and responsive to patients’ expectations, and developments in therapeutics and pharmaceutical sciences through developing its own horizon-scanning facility.

Its goal must be to provide a risk-based regulatory framework for a coherent clinical profession that embraces prescribing and practice in a range of specialist functions and professional levels. So the GPhC’s mission is pivotal to enhancing pharmacy’s contribution to patient care.

What will it mean?

What will pharmacy regulations meant o pharmacy professionals? The trite answer is “It depends who they are”. For practising pharmacists, it will mean that as long as they continue to meet the requirements of the pharmacy regulator and pay its annual fee, the will retain the privilege to practise as pharmacists.

However for pharmacy technicians a major transformation will occur. In future “pharmacy technician” will become a restricted title, and pharmacy technicians will also enjoy the status of becoming designated health professionals. (For pharmacy technicians in Scotland, this is currently the subject of regulatory consultation.)

Of course that means that in order to retain the right to practise technicians also will need to meet the specific conditions of the pharmacy regulator and pay an annual retention fee to retain the right to practise.

For patients and pharmacy users, it will mean that they can be confident that any pharmacist or pharmacy technician in England, Scotland or Wales who provides professional advice or services has the competence to do so and will act in their best interests.


Peter Noyce is professor of pharmacy practice and director of the Workforce Academy at Manchester University School of Pharmacy

Citation: The Pharmaceutical Journal URI: 10040537

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