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Rationale
Q. The RPSGB is working well, so why is change necessary?
Q. Do we need more regulation? It's all becoming a burden for your average pharmacist and pharmacy technician?
Q. What will be the relationship between the regulator and primary care trusts (PCTs) given the provisions relating to standards in the Health Bill 2009?
Q. Won't pharmacy owners have to register their pharmacies with the Care Quality Commission (CQC) and the local primary care organisation (PCO) as well?
Q. We hear a lot about patient safety, but what's in these changes for pharmacists and pharmacy technicians?
A. The Government is harmonising the regulation of health 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' (Department of Health, February 2007), which aimed to deal with public perceptions that:
- regulatory bodies are overly sympathetic to the professionals they regulate, and
- there needs to be a clear separation of regulation from professional leadership.
As the pharmacy profession takes on an increasing clinical role, it is important that there is a clear patient/public focus in order to maintain public confidence and safety.
There is no intention to change those parts of regulation that work well, but the opportunity has been taken in the Pharmacy Order 2010 to take into account best regulatory practice, based on the advice of the Council for Healthcare Regulatory Excellence on the establishment of the GPhC.
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A. The GPhC will need to use its resources well to ensure it operates efficiently and effectively. The intention is to set up a new style of regulator where, rather than creating unnecessary burdens, regulation will be designed to be proportionate to the risks it addresses and the benefits it brings. The aim is to provide the GPhC with broad and flexible regulation to ensure that it can be nimble and responsive to innovation or changes in practice.
It is also expected that the GPhC will work closely with the policy makers within GB Governments to ensure that duplication of regulation and inspection is kept to a minimum. The GPhC also has a duty to co-operate with stakeholders when exercising its functions, including registrants and those concerned with the employment of registrants, so their views will be taken into account.
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A. The Health Act 2009 contains measures to improve the quality of NHS care, the performance of NHS services, and to improve public health. The Act also reforms current arrangements for pharmacies applying to provide NHS services and how performance meets required standards to ensure they are providing high quality services responsive to local needs. Guidance has been produced on pharmaceutical needs assessments (PNAs) that shows how PNAs can be used to support the provision of existing pharmaceutical services and extending the services that are provided by pharmacies. Amongst other matters, the guidance covers specific criteria and indicators of performance levels for the world class commissioning competencies particularly relevant for PNAs
The GPhC will need to work closely with all those responsible for setting standards for community pharmacy to ensure that the standards it sets work across England, Scotland and Wales and both the NHS and private sector. As a regulator, the GPhC will have the power to set minimum standards for entry and retention of pharmacies on the register.
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A. All pharmacies currently registered with the RPSGB will need to be registered with the GPhC instead, as this will be required by the amendments to the medicines legislation. The transfer of all pharmacies currently registered with the RPSGB will be automatic once the GPhC takes over the regulatory functions.
There may also be, in the future, a requirement for pharmacists who wish to assist in the provision of NHS pharmaceutical services in primary care in England to be registered with a PCT on a ‘supplementary list’.
In England, a decision to extend supplementary lists to cover all primary care community pharmacists was deferred in 2006 to take account of a review of the current arrangements for the performers’ list system for primary care professionals. [Scotland and Wales do not have supplementary lists].
In England, providers of pharmaceutical services (i.e. pharmacy contractors) are already required to be registered with a PCT.
The Care Quality Commission will be responsible for the registration of certain health and social care services (in England only). Only providers of regulated activities will need to be registered with the Care Quality Commission. It is not anticipated that pharmacies in England will routinely need to be registered with the Care Quality Commission.
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A. According to the White Paper Trust, Assurance and Safety, regulation is as much about sustaining, assuring and improving professional standards, as it is about identifying and addressing poor practice or bad behaviour. Under the GPhC, regulation will be designed to support and enable the working lives of pharmacists and pharmacy technicians, and open up pathways to a satisfying career, rather than purely a means of discipline. It will provide standards and a framework for continuing professional development for both pharmacists and pharmacy technicians. It is intended that regulation should not create unnecessary burdens, but be proportionate to the risk it addresses and the benefits it brings.
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