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New pharmacy regulator takes shape

Jackie Giltrow, Head of Regulatory Transition, Royal Pharmaceutical Society, discusses key points of the draft Pharmacy Order 2009 consultation

by Jackie Giltrow

Jackie Giltrow, Head of Regulatory Transition, Royal Pharmaceutical Society, discusses key points of the draft Pharmacy Order 2009 consultation

 

The proposals for pharmacy, contained in the February 2007 White Paper “Trust, assurance and safety — the regulation of health professionals in the 21st century”, passed a crucial milestone this week, with the launch of the draft Pharmacy Order 2009 consultation.

The Department of Health, on behalf of England and Wales, and the Scottish Government, are seeking comments between now and 9 March 2009 on the proposals contained within the draft Order, which will establish a new regulator for pharmacy — the General Pharmaceutical Council (GPhC).

The GPhC, which is expected to open its doors in 2010, will be responsible for the statutory regulation of pharmacists and pharmacy technicians, and the registration and inspection of pharmacy premises in Britain.

Why a new regulator?

The Government wants to harmonise the way that healthcare professions are regulated. In particular, it sees the new pharmacy regulator as:

  • offering a clear message that the quality and safety of patient care should be paramount
  • offering proportionate, risk-based regulation
  • giving accountability to the Westminster and Scottish Parliaments and independence of Government, professionals and all other interest groups
  • possessing agility — to have the ability to anticipate and respond to change
  • giving transparency and openness through increased involvement of lay people on the Council
  • providing a statutory framework for continuing professional development and standards for advanced levels of practice

To a large extent, this mirrors the Royal Pharmaceutical Society’s regulatory work now but, in the future, some of this work will be done differently.

The main changes in the thinking behind the new legislation relate to the link between standards of proficiency, and safe and effective practice. This link is not explicitly set out in the existing legislation and the Government wants to ensure that future regulation will focus on outcomes for users rather than process.

The major changes in the draft Order are outlined below:

Governance

The draft Order reflects the Government’s intention that councils of regulatory bodies must have, as a minimum, parity between lay and professional membership and that council members should be appointed, not elected.

Accountability

The GPhC will be required to submit to both parliaments a report on the exercise of its functions, including a description of arrangements relating to equality and diversity, as well as a statistical report on fitness to practise functions, and a strategic plan.

Fitness to practise

It is proposed that the number of statutory committees is reduced from six to three, reflecting general Government policy and is intended to prepare the GPhC for the eventual transfer of adjudication to the independent Office of the Health Professions Adjudicator, which should be established after the GPhC.

These three statutory committees are

  1. the Investigating Committee (as before)
  2. Fitness to Practise Committee (effectively the Health and Disciplinary Committees rolled into one)
  3. the Appeals Committee (to handle appeals relating to registration and accreditation)

Premises standards

Currently, there are few statutory standards for inclusion of registered pharmacies in the Register and, provided that the appropriate fee is paid and plans submitted, the Society has little choice but to enter premises in the Register.

The draft Order includes provisions to rectify this, by allowing the GPhC to make rules covering standards to be met by registered pharmacies, owners of pharmacies (including bodies corporate) and superintendent pharmacists.

The GPhC will also be able to set its own fees for premises registration (currently done by the DoH).

Emergency provisions

The draft Order contains provisions that would allow several of the requirements of the Medicines Act to be suspended for the duration of an emergency (eg, an influenza pandemic) and allow the Registrar to register a pharmacy or a group of pharmacies and impose any conditions necessary relating to the physical state, safety and security of the premises where medicines are stored.

Registers

It is proposed that the GPhC will have one Register that will be split into parts (eg, for pharmacists, pharmacy technicians and premises) and that there will no longer be a non-practising register for either technicians or pharmacists.

Anyone who is not on the GPhC Register will not be allowed to describe him- or herself as a pharmacist, registered pharmacist, pharmacy technician or registered pharmacy technician.

CPD

The draft Order includes broad provisions for the GPhC to adopt a statutory CPD framework, the key elements of which will be set out in legislation.

 

The Society is urging all pharmacists and pharmacy technicians to respond to the 13-week consultation, highlighting that it offers a once-in-a-lifetime chance to play a part in shaping the new pharmacy regulator.

To submit your views to the consultation, visit the DoH website

Frequently asked questions

Jackie Giltrow, Head of Regulatory Transition at the Royal Pharmaceutical Society, answers some frequently asked questions about the General Pharmaceutical Council. She is working with the Department of Health on the establishment of the GPhC.

What will happen with my title and post nominals?

The use of the titles “pharmacist” and “pharmacy technician” will be dependent on an individual’s name appearing in the relevant part of the statutory Register of the GPhC.

Legislation on protected titles does not explicitly cover the use of abbreviations or post-nominals. In relation to the designatory letters MRPharmS or FRPharmS, this will be a matter for the new professional body.

Use of these designatory letters is likely to depend on a number of issues, including membership category, but it will not depend on registration with the GPhC.

Will I have to pay two different fees in the future for registration with the GPhC and membership of a professional body, and how much will I have to pay?

Yes, the GPhC and the new body will be two entirely independent organisations and will each charge a separate fee for registration or membership respectively.

Regulatory fees for pharmacists and pharmacy technicians are yet to be determined as are the fees for the new body.

It is hoped that the cost of registration with the GPhC and membership of the new body will be no more than what pharmacists pay currently through their annual retention fee to the Society — after allowing for inflation.

If I do not deal with patients, will I still have to undertake CPD if I am on the GPhC Register?

If you are on the Register of the GPhC, the public will expect that you are fit to practise in your chosen field. Part of the evidence that is required to establish fitness to practise is CPD.

You will still be required to complete CPD relevant to your field of practice and be able to demonstrate that you have done so (it is not anticipated that the GPhC will have a non-practising register).

What happens to the Society’s assets when the GPhC is established?

The draft Pharmacy Order 2009 contains provisions to cover the transfer of relevant staff, property, rights and liabilities to the GPhC. When the GPhC is established, eligible staff will transfer from the Society to the GPhC under the Transfer of Undertakings (Protection of Employment) Regulations.

The Society’s regulatory responsibilities are being transferred but the Society and its assets will continue to exist and will form the basis of the new body.

Some items relevant to the regulatory functions, such as databases and records, will need to be transferred to the GPhC to allow it to take over these functions but it is not anticipated that the Society’s buildings or other assets will be transferred to the GPhC.

What regulatory activities will be carried out in Scotland and Wales, or will there merely be a “token” presence in these countries?

It is not intended that a “token” regulatory presence will be established in these countries and there is a possibility that the GPhC could work closely with the other regulators of healthcare professionals in Scotland and Wales to maximise efficiency and effectiveness.

These details have yet to be decided and will be a matter for the chief executive [Registrar] and chairman of the GPhC once appointed in 2009.

The Society is working well, so why is change necessary?

The Government is harmonising the regulation of healthcare professionals according to a set of key principles. These were set out in the White Paper “Trust, assurance and safety — the regulation of health professionals in the 21st century” in February 2007, which stated that there needs to be a clear separation of regulation from professional leadership.

How will the independence of the regulator from Government be achieved?

To ensure that regulators are accountable to Parliament, there are provisions within the draft Order requiring the GPhC to produce a report on the exercise of its functions.

This includes a description of the arrangements that the GPhC has put in place to ensure that it adheres to good practice in relation to equality and diversity. It also includes a statistical report about its fitness to practise arrangements and a strategic plan to Privy Council which, in turn, will lay the reports before the relevant parliaments.

Why is a pharmacy inspectorate needed? None of the other healthcare professions’ regulators maintain an inspectorate.

The Society registers pharmacy premises and has enforcement responsibilities under the Medicines Act 1968 in respect of all retail pharmacy businesses providing NHS and non-NHS services, as well as the retail sale of general sales list medicines.

The inspectorate has a key role in ensuring the safe sale and supply of medicines and it will form part of the functions of the GPhC in respect of Great Britain. The closely integrated regulation of pharmacy professionals, premises and products is a great strength in ensuring patient safety.

Why are the adjudication functions of the GPhC not going to be transferred to the Office of the Health Professions Adjudicator?

Initially, the OHPA will have adjudication functions for those professions regulated by the General Medical Council and General Optical Council. Consideration will be given to transferring the adjudication of pharmacy fitness to practise cases to the OHPA after the GPhC has been established.

What will happen to my old Society certificate?

Any certificate issued by the Society will not be valid as proof of registration with the GPhC and will not confirm registration as a pharmacist or pharmacy technician. There are provisions within the draft Order that require the Registrar to issue a notice of registration, where an application for entry or for renewal of an entry in the Register is granted. Although it is unlikely that you will be required to return your old certificate, no decisions have been made on this so far. The notice of registration for the GPhC will be in a form agreed by the GPhC Council.

Further information

Further information can be found on the Society’s website

Citation: The Pharmaceutical Journal URI: 10041853

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