Relevant to providers of pharmacy services in or to acute, mental health, private, community service, health and justice, hospice and ambulance settings.

Introduction/Background

The standards handbook is a supporting resource which has been updated and published online alongside the RPS professional standards for hospital pharmacy services.

We recommend that the handbook, the RPS Ultimate guide for Chief Pharmacist (or equivalent) and the newly developed case studies (continue to be evolved) are used in conjunction with the standards to provide you with useful signposting information to legislation and resources relevant to the standards and to help with the implementation of the standards in your organisation.


Regulation

There are a number of key aspects of regulation relevant to the delivery of hospital pharmacy services. The following sections refer to the key generic resources and legislation and do not aim to cover the more specific requirements for services such as manufacturing, mental health legislation etc.

General Pharmaceutical Council (GPhC) 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 Standards for pharmacy professionals (May 2017) in the course of their professional duties. The GPhC states that as a pharmacy professional, you must:

  1. provide person-centred care 
  2. work in partnership with others 
  3. communicate effectively 
  4. maintain, develop and use their professional knowledge and skills 
  5. use professional judgement 
  6. behave in a professional manner 
  7. respect and maintain the person’s confidentiality and privacy 
  8. speak up when they have concerns or when things go wrong 
  9. demonstrate leadership

Pharmacy professionals are accountable for their practice and must use their professional judgment when deciding on a course of action. Chief pharmacists also have specific responsibilities in relation to delivering the pharmacy service and should take into account:

(Please note: 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).

Regulation of Organisations

Regulatory standards that apply to hospitals are set by systems regulators across Great Britain. These regulate NHS and/or private providers and social care providers. The main regulators in each country are:

The Care Quality Commission (CQC) The Care Quality Commission (CQC)

CQC regulates both the NHS and independent providers of health and social care in England. They ensure that providers comply with the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 and the CQC (Registration) Regulations 2009.

The CQC have 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" and their 28 outcomes. CQC inspections are based on an assessment tool (using Key Lines of Enquiry, KLOEs) with a set of questions on 5 key components:

  • Safety
  • Effectiveness
  • Caring
  • Responsiveness
  • Leadership

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.

NHS Improvement has published a single oversight framework which covers 5 themes, they are linked to CQC’s questions but are not identical:
  • Quality of care (safe, effective, caring, responsive) 
  • Finance and use of resources 
  • Operational performance 
  • Strategic change 
  • Leadership and improvement capability

This framework has been designed to help NHS providers attain, and maintain, CQC ratings of ‘Good’ or ‘Outstanding’. The Framework doesn't give a performance assessment in its own right.

 

 

 

 

 

Health Inspectorate Wales (HIW) Health Inspectorate Wales (HIW)

HIW regulate both the NHS and independent providers of health care in Wales. In 2010 the Welsh Assembly Government launched a revised set of standards for health services Doing Well, Doing Better – Standards for Health Services in Wales in all settings. The standards provide a consistent framework that enables health services to look across the range of their services in an integrated way to ensure that all that they do is of the highest quality. In addition, independent healthcare providers are also 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),   which set out the requirements of what is expected of all health. Guidance on how the HIW inspect the NHS can be viewed here.

Healthcare Improvement Scotland (HIS) Healthcare Improvement Scotland (HIS)

HIS regulate organisations in NHS Scotland and independent healthcare providers, to ensure that they comply with the standards as set out in Standards: Healthcare Associated Infection (HAI) (March 2008) and Clinical Standards: Care of older people in hospital standards (June 2015)

The Scottish NHS consists of unified geographical NHS boards, which are responsible for delivering services across hospitals and in the community. In addition there are special NHS boards that have an NHS Scotland wide remit. Pharmacy in Scotland has developed in line with "The Right Medicine: A strategy for Pharmaceutical Care in Scotland (2006) national standards for procurement, specials manufacturing, dispensing, clinical pharmacy, aseptic dispensing and Chief Executive Letters from Scottish Government (CEL). Hospital Pharmacy standards are implicit in the generic clinical standards produced within Scotland and are measured within the context of the multidisciplinary team or through discrete audit or inspection programmes led by Healthcare Environment Inspectorate, Audit Scotland or the NHS Managed National Aseptic Dispensing Audit programme.

Core Legislation

The list below indicates the key legislation around handling medicines by hospital pharmacy services:

General General

  • The Human Medicines Regulations 2012 (More information is available on the MHRA website).
  • POM Order (Human Use) (partially repealed by the Human Medicines Regulations 2012)
  • Medicines Act 1968 (partially repealed by the human medicines regulation 2012
  • Health Act 2006
  • Health and Safety at Work Act 1974
  • Control of Substances Hazardous to Health Regulations 2002
  • The Hazardous Waste (England and Wales) (Amendment) Regulations 2009
  • National Health Services Act 1977
  • The Regulation of Care (Scotland) Act 2001
  • The Health and Social Care Act 2008 (Regulated Activities) Regulations 2010
  • Care Quality Commission (Registration) Regulations 2009
  • Care Standards Act 2000 (section 2)
  • The Health and Social Care Act 2012 (parts of this are already in force, other parts will follow in due course, more information is available from Her Majesty’s Stationery Office (HMSO)

Controlled Drugs Controlled Drugs

Other useful resources Other useful resources

Medical Insurers

NHS Litigation Authority (NHS LA) NHS Litigation Authority (NHS LA)

In April 2017 NHS LA brought together their three main functions under the umbrella name, NHS Resolution. They are in the process of replacing the current NHS LA and NCAS websites with a new user-orientated website going live on resolution.nhs.uk  in early 2018.

The NHSLA is a special health authority in England that handles clinical negligence claims made against NHS organisations and works to improve risk management practices in the NHS. It manages a range of insurance schemes which all NHS organisations and non-NHS providers of NHS care in England can apply to. Organisations are expected to comply with the risk management standards NHSLA Acute, Community, MH&LD and Non-NHS Providers of NHS Care Standards - 2013/14 set by NHS LA in order to participate. 

Previously the NHS LA produced 6 risk management standards in total, incorporating organisational, clinical, and health & safety risks for each type of NHS healthcare organisation. Organisations providing acute services, community services, or a mix of acute and community services, were assessed against Standards 1 to 5. Organisations providing mental health & learning disability services only, were assessed against Standards 1 to 4 and Standard 6. In September 2013 NHS LA decided that it would no longer update their standards and there would be no further assessments from March 2014. The standards continue to be available as archived documents on the NHS LA website however they will not be updated from 2014 onwards. NHS LA has agreed for organisations to continue to use them provided that they inform and ask them for permission

Hospitals in England may find the RPS professional standards for hospital pharmacy services can help to meet the NHS LA risk requirements.

 

Clinical Negligence and Other Risks Scheme (CNORIS) Clinical Negligence and Other Risks Scheme (CNORIS)

CNORIS is a risk transfer and financing scheme 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.

We have been unable to review their risk assessment criteria at this stage. Hospitals in Scotland may find the professional standards can help meet CNORIS risk requirements.

Welsh Risk Pool Scheme (WRP) Welsh Risk Pool Scheme (WRP)

WRP  a mutual self assurance scheme for all health bodies in Wales. The risk pooling scheme covers all risk relating to NHS activity. The WRP is the Welsh Equivalent of the NHSLA in England although with a different payment and funding system, and they no longer compile risk management standards. More information is available on the WRP website. Hospitals in Wales may find the professional standards can help meet WRP risk requirements. 

Other useful resources relevant to the standards

Hospital pharmacy benchmarking metrics Hospital pharmacy benchmarking metrics

  • RPS through its Hospital Expert Advisory Group (HEAG) has developed a consensus on definitions for benchmarking metric 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’s Pharmacy and Medicines Optimisation project 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 Improvement Model Hospital (England only) : The Model Hospital is a digital information service designed to help NHS providers improve their productivity and efficiency. It is an easy-to-navigate tool that can be used by anyone in the NHS from board to ward. The user can explore and compare productivity, quality and responsiveness data to identify opportunities to improve. Access to the model hospital  is currently provided to NHS provider trusts only.

RPS Ultimate guide for Chief Pharmacists (or equivalents) 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.

Rebalancing Medicines Legislation Rebalancing Medicines Legislation

Through the Department of Health is the Rebalancing Medicines Legislation and Pharmacy Regulation Programme Board Rebalancing. The work of this group is to review pharmacy legislation and regulation. When this group reports it may require significant changes to the roles and responsibilities of Chief Pharmacists in trusts as well as having wider implications for the pharmacy services in hospitals.

 

International Hospital Standards NHS Benchmarking

  • European Association of Hospital Pharmacists

- 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.

European Statements of Hospital Pharmacy express commonly agreed objectives which every European health system should aim for in the delivery of hospital pharmacy services.

  •   International Pharmacy Federation (FIP)

- FIP have published global standards of practice for hospital pharmacist, which can be viewed here .

Illustrations of practice

We have developed a range of case studies to help with the implementation of the standards.

Standard 1 – Putting Patients First

Pharmacy services enable patients to be fully involved in their own care and to make shared decisions about their treatment and their medicines.

Guidance supporting the standards Guidance supporting the standards

Useful resources Useful resources

- Phone interpreting services       

- Face to face interpretation    

NHS Choices Other language resource

- Online language translating services (Please note the RPS does not endorse any of the these services) e.g. Written Medicinetranslabel.co.uk ,Google Translate, etc ( useful BMJ article on "Use of Google Translate in Medical Communication: Evaluation of Accuracy ").

 

 

 

 

Standard 2 – Episode of Care

Patients’ medicines requirements are regularly assessed and responded to in order to keep patients safe and to optimise thier outcomes from medicines.

Guidance supporting the standards Guidance supporting the standards

Useful resources Useful resources

Commercial Medicines Unit: (2011) More guidance and resources on Homecare

Supporting/Relevant regulation Supporting/Relevant regulation

Standard 3 - Integrated Transfer of Care

Health and social care practitioners receive and share relevant information about the patient and their medicines when a patient transfers from one care setting to another.

Guidance supporting the standards Guidance supporting the standards

Useful resources Useful resources

• Commercial Medicines Unit (CMU): Guidance and resources on Homecare on CMU website

Standard 4 - Medicines Governance

Pharmacy expertise is available seven days a week to support the safe and effective use of medicines. The pharmacy team leads a multidisciplinary approach to safe medication practices.

Guidance supporting the standards Guidance supporting the standards

Useful resources Useful resources

Supporting/Relevant Legislation Supporting/Relevant Legislation

  • General Pharmaceutical Council (GPhC) : Pharmacist independent prescriber must complete a GPhC-accredited programme. On successful completion of the programme, they are eligible to apply for annotation on the register and may prescribe autonomously for any conditions within their clinical competence.

Standard 5 - Efficient Supply of Medicines

Medicines are available or can be readily made available to meet patients' needs whenever the patient needs them.

Guidance supporting the standards Guidance supporting the standards

• Audit Commission, (Nov 2001): A Spoonful of Sugar, Medicines Management in NHS Hospitals

• Department of Health, (2013): Health Building Note 14-01 – Pharmacy and Radiopharmacy Facilities

• Department of Health, (2008): Pharmacy in England. Building on strengths-delivering the future

• Department of Health, (2006): Improving Patients’ Access to Medicines: A Guide to Implementing Nurse and Pharmacist Independent Prescribing within the NHS in England

• Health

he following resources developed by Medicines and Healthcare products Regulatory Agency (MHRA) support standard "5.3(a) Use of any type of unlicensed medicine, including those that are aseptically or extemporaneously prepared is clinically justified and consistently in line with regulatory requirements, adhering to the principles of risk benefit to the patient and using licensed medicines wherever possible" :

care Commission, (Jan 2007): The Best Medicine, management of medicines in acute and specialist trustsTicines and Healthcare products Regulatory Agency (MHRA), ( 2014 ):  Guidance for pharmacists on the repeal of Section 10(7) of the Medicines Act 1968

• NHS Scotland, (2010): The Healthcare Quality Strategy for NHS Scotland

• Royal Pharmaceutical Society (RPS), (December 2015): Professional Guidance for the Procurement and Supply of Specials

• Royal Pharmaceutical Society (RPS): Medicines Ethics and Practice: The Professional Guide for Pharmacists, edition 41 , July 2017

• The Royal Pharmaceutical Society of Great Britain (2005): The Safe and Secure Handling of Medicines: A Team Approach (currently being updated)

• Scottish Executive Health Department (2007). Safer Management of Controlled Drugs: Guidance on Strengthened Governance Arrangements

Useful resources Useful resources

• Audit Scotland (2005). A Scottish prescription: Managing the use of medicines in hospitals

  

Standard 6 - Leadership

Pharmacy has strong professional leadership, a clear strategic vision and the governance and controls assurance necessary to ensure patients are safe and get the best from their medicines.

Guidance supporting the standards Guidance supporting the standards

Useful resources Useful resources

Standard 7 - Systems Governance and Financial Management

Safe systems of work are established and pharmacy services have sound financial management.

Guidance supporting the standards Guidance supporting the standards

Useful resources Useful resources

 

Standard 8 - Workforce

The pharmacy team has the right skill mix, capability and capacity to provide safe, quality services to patients.

Guidance supporting the standards Guidance supporting the standards

Useful resources Useful resources

Supporting Regulation Supporting Regulation

Details
 

PROVISO

  • We have tried to list key, generic regulatory requirements that are relevant to the overarching professional standards however these may not be applicable to all types of care settings.
  • It is helpful to bear in mind that the current professional standards are overarching professional standards, of which some are based on good /advanced practice, and therefore supporting /relevant regulation may not exist in every case.
  • We welcome any additions /amendments to this list.
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