The list below indicates the key legislation around handling medicines by hospital pharmacy services:
Medicines and medical device legislation:
The EU Medical Devices Regulation (2017/745) and in vitro Diagnostic Medical Device Regulation (2017/746) apply in Northern Ireland
*Comes into force on 1 December 2022.
Health and safety legislation
Confidentiality and data protection
Regulation of individuals
There are a number of key aspects of regulation relevant to the delivery of hospital pharmacy services. The following sections refer to generic resources and legislation only, and do not aim to cover the more specific requirements for services such as manufacturing, mental health legislation etc.
General Pharmaceutical Council (GPhC)
The General Pharmaceutical Council (GPhC) is the independent regulator for pharmacists, pharmacy technicians and pharmacy premises in Great Britain. All registered pharmacists and pharmacy technicians are required to comply with their Standards for pharmacy professionals (May 2017), in the course of their professional duties.
The GPhC states that as a pharmacy professional, you must:
- Provide person-centred care
- Work in partnership with others
- Communicate effectively
- Maintain, develop and use their professional knowledge and skills
- Use professional judgement
- Behave in a professional manner
- Respect and maintain the person’s confidentiality and privacy
- Speak up when they have concerns or when things go wrong
- Demonstrate leadership.
Pharmacy professionals are accountable for their practice and must use their professional judgement when deciding on a course of action.
Chief pharmacists (or equivalent) also have specific responsibilities in relation to delivering the pharmacy service and should take into account:
In September 2012, the GPhC published new standards for registered pharmacies. The Standards apply to all pharmacies registered with the GPhC. The GPhC has also provided additional information regarding which service models including those that involve hospital pharmacies require registration.
Pharmaceutical Society Northern Ireland
The Pharmaceutical Society Northern Ireland (PSNI) is the independent regulator for pharmacists, pharmacy technicians and pharmacy premises in Northern Ireland.
As a professional requirement of registration, all pharmacists in Northern Ireland are expected to abide by the Pharmaceutical Society NI Code (Professional standards of conduct, ethics and performance for pharmacists in Northern Ireland), which can be accessed here.
The Code details five mandatory principles that explain the required standards of professional behaviour.
- Principle 1: Always put the patient first
- Principle 2: Provide a safe and quality service
- Principle 3: Act with professionalism and integrity at all times
- Principle 4: Communicate effectively and work properly with colleagues
- Principle 5: Maintain and develop your knowledge, skills and competence.
Additionally, the following documentation should be taken into account:
Regulation of organisations
Regulatory standards that apply to hospitals are set by systems regulators across the United Kingdom. These regulate NHS and/or private providers and social care providers.
The main regulators in each country are:
The Care Quality Commission (CQC)
The CQC regulate both the NHS and independent providers of health and social care in England, to that ensure they comply with the Health and Social Care Act 2008 (Regulated Activities) Regulations 2010 and the CQC (Registration) Regulations 2009.
The CQC replaced their outcomes framework and introduced a new inspection framework in 2015. Pharmacy services are expected to comply with CQC "Fundamental standards" which replaced the previous "Essential standards".
CQC inspections are based on an assessment tool using Key Lines of Enquiry (KLOE) with a set of questions on five key components:
The CQC have provider handbooks on their approach to regulation for each of the sectors they regulate, including acute hospitals, ambulance trusts, community health services, mental health services and the independent sector.
NHS England publish a single oversight framework which covers five national themes. This framework has been designed to help NHS providers ensure alignment of priorities across the NHS and with wider system providers.
They are linked to CQC’s questions but are not identical:
- Quality of care, access & outcomes
- Preventing ill-health and reducing inequalities
- Finance and use of resources
- Leadership & capability.
Healthcare Inspectorate Wales (HIW)
HIW regulate both the NHS and independent providers of health care in Wales. The Health and Social Care (Community Health and Standards) Act 2003 (Part II, Chapter 4) gives HIW the power to carry out inspections, reviews and investigations of the NHS or services provided for the NHS. Whilst the Care Standards Act 2000 gives them the powers and responsibilities, on behalf of Welsh Ministers, for the registration and inspection of independent health care services in Wales.
HIW replaced their health standards framework in 2015. Pharmacy services in the NHS are expected to comply with the Welsh Government Health and Care Standards. Guidance on how HIW inspect NHS providers can be found here.
Independent healthcare providers are expected to comply with the standards as defined by the Care Standards Act 2000 (section 2) and the National Minimum Standards for Independent Healthcare Services in Wales (April 2011), the Care Standards Act 2000 and the Independent Health Care (Wales) Regulations 2011. Guidance on how HIW inspects independent providers can be found here.
Healthcare Improvement Scotland (HIS)
HIS regulate organisations in NHS Scotland and independent healthcare providers in Scotland, to ensure that they comply with standards and regulation. They were established as a health body by the Public Service Reform Scotland Act 2010 and the Public Bodies (Joint Working) Act 2014.
They inspect NHS services in acute hospitals against the Health and Social Care Standards (2017), HAI Standards (2015), the HIS Quality of Care Framework (2018) and any other standards that become relevant during the course of the inspection. Independent providers are also inspected against the HIS Quality of Care Framework (2018). Findings are reported under the Framework domains and quality indicators.
Regulation and Quality Improvement Authority (RQIA)
The RQIA is the independent body responsible for monitoring and inspecting the availability and quality of health and social care services in Northern Ireland and encouraging improvements in the quality of those services. The legislation under which RQIA was established is The Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003.
The Quality Standards for Health and Social Care set out the standards that people can expect from Health and Personal Social Services (HPSS). Guidance for different types of services providers can be found here.
In April 2017, the NHS Litigation Authority brought together their three main functions under the umbrella name, NHS Resolution.
NHS Resolution is an arm’s length body of the Department of Health and Social Care who provide expertise to the NHS on resolving concerns and disputes fairly, sharing learning for improvement and preserving resources for patient care.
The main functions are:
They provide indemnity through the Clinical Negligence Scheme for Trusts (CNST). In 2022, they published a new strategy for 2022 to 2025 which focuses on early intervention and avoiding unnecessary court action and other formal processes.
Organisations in England will find the Standards can help to support maintaining high professional standards.
Clinical Negligence and Other Risks Scheme (CNORIS)
CNORIS is the indemnity provider for NHS Scotland, run by a private provider. Its primary objective is to provide cost-effective risk pooling and claims management arrangements for Scotland's NHS Boards and Special Health Boards.
Hospitals in Scotland may find the Standards can help meet CNORIS risk requirements.
Welsh Risk Pool Services (WRP)
WRP is a support function for all health bodies in Wales and is part of the NHS Shared Service Partnership Legal and Risk service, providing indemnity for Trusts and Health Boards. Their emphasis is on improvement to patient safety and outcomes. The risk pooling scheme covers all risk relating to NHS activity.
Hospitals in Wales may find the Standards can help meet WRP risk requirements.
Each health and social care trust provides its own indemnity, which is funded by the Department of Health, Social Security and Public Safety.
Other useful resources relevant to the Standards
The following key reports support across all the domains, standards, descriptors and supporting statements:
- A healthier Wales: long term plan for health and social care, (2021)
- Achieving excellence in pharmaceutical care: a strategy for Scotland, (2017)
- Berwick report. A promise to learn – a commitment to act: improving the safety of patients in England, (2013)
- Care Quality Commission (CQC): Regulation 20 Duty of Candour. Information for all providers: NHS bodies, adult social care, primary medical and dental care, and independent healthcare, (2022)
- Cumberlege Report. First Do No Harm: The report of the Independent Medicines and Medical Devices Safety Review, (2020)
- Department of Health: The NHS Constitution, (2021)
- Francis report. Report of the Mid Staffordshire NHS Foundation Trust public inquiry,(2013)
- General Pharmaceutical Council: Keeping patients safe – being open and honest, (2022)
- General Pharmaceutical Council: Pharmacy team toolkit – learning from incidents, (2022)
- Gosport War Memorial Hospital. The Report of the Gosport Independent Panel, (2018)
- Joint statement from the Chief Executives of statutory regulators of healthcare professionals: Openness and honesty – the professional duty of candour, (2014)
- Making Life Better – A whole system strategic framework for public health in Northern Ireland, (2014)
- Medicines Healthcare Regulatory Agency (MHRA): The Yellow Card Scheme: guidance for healthcare professionals, (2015)
- Messenger Review: Health and social care review: leadership for a collaborative and inclusive future, (2022)
- NHS Long Term Plan, (2019)
- NHS People Plan (2020).
European Association of Hospital Pharmacists
The European Statements of Hospital Pharmacy express commonly agreed objectives which every European health system should aim for in the delivery of hospital pharmacy services. A self-assessment tool and evidence map have been developed to support implementation of the statements.
The Common Training Framework for the hospital pharmacy profession support the raising of standards in hospital pharmacy practice and thereby enhance the quality of, safety of, and equity of access to, patient care in every European country.
International Pharmacy Federation (FIP)
In 2015, FIP approved revisions to the Basel Statements: The future of hospital pharmacy practice. These list 65 statements which cover global standards of practice for hospital pharmacist. In addition, a self-assessment tool has been developed so that hospitals can measure how they align with the Statements and identify areas to focus efforts on improving alignment.
American Society of Health-System Pharmacists (ASHP)
ASHP have produced an international accreditation of hospital and health system pharmacy services. They have also developed a Practice Advancement Initiative 2030, which includes tool and resources aimed at advancing practice.
Society of Hospital Pharmacists of Australia (SHPA)
The SHPA have produced standards of practice for clinical pharmacy services. These aim to describe the activities delivered by pharmacists for patients to minimise the risks associated with the use of medicines and to optimise the use of medicines.
Hospital pharmacy benchmarking metrics
RPS through its Hospital Expert Advisory Group (HEAG) has developed a consensus on definitions for benchmarking metrics relevant to acute hospitals. The aim is to provide a consistent basis for the collection of data which will allow acute hospitals to benchmark performance against each other most effectively.
The NHS Benchmarking Network supports members to improve the quality of health and social care services through a benchmarking service. Pharmacy and Medicines Optimisation is a core project in the Acute sector theme. It aims to support Medicines Management teams by providing comparable data that can be used to inform decision making and evidence examples of effective medicines optimisation. Further details of this project can be viewed here.
NHS Model Health System (England only): The Model Health System is a data driven improvement tool that enables NHS health systems and trusts to benchmark quality and productivity. It is an easy-to-navigate tool that can be used by all NHS staff. The user can explore and compare productivity, quality and responsiveness data to identify opportunities to improve.
RPS Ultimate guide for Chief Pharmacists (or equivalents)
This ultimate guide has been developed offering practical support and comprehensive signposting to help with the roles and responsibilities of a Chief Pharmacist (or equivalent). The guide can be used by Chief Pharmacists already in the role, senior leaders, people who work with Chief Pharmacists who may be interested or want to know more about the role and the support available.
Got a useful resource that isn’t listed here? Let us know by emailing [email protected]