Closed consultation

Pharmacy supervision

Published 7 December 2023

Foreword

Message from the 4 chief pharmaceutical officers of the UK

There is a clear ambition across the UK to maximise the contribution pharmacists, pharmacy technicians and wider team members can make to address the challenges faced by the NHS. Recognising and more effectively utilising the skills of every member of the pharmacy team will enable pharmacists to spend a greater proportion of their time delivering patient-facing clinical services – using their training and expertise, including prescribing, to release capacity in the wider NHS. This will also improve career progression and job satisfaction for the whole team.

The legal requirement for supervision of activities (the preparation, assembly, dispensing, sale and supply of medicines) taking place in pharmacies in the community and in hospitals defines how pharmacy services are currently provided. However, there is a need for greater clarity about how and when the current requirements apply, and a need to ensure they continue to be fit for purpose today and in the future. Reform of supervision has been an ongoing topic of debate for some time, and we are grateful to the Pharmacy Supervision Practice Group for their collaborative effort to produce a consensus position and report to inform this consultation.

Given the shared desire to fully realise the potential of pharmacy professionals, it is imperative we address common misconceptions, provide clarity and assurance as to what the government and pharmacy regulators (General Pharmaceutical Council (GPhC)) in Great Britain and the Pharmaceutical Society of Northern Ireland (PSNI) in Northern Ireland) are, and are not, aiming to achieve through reforms. For community pharmacy, we continue to believe firmly that there should be a pharmacist responsible for every pharmacy premises and a registered pharmacy professional responsible for the dispensing of medicines.

These principles are fundamental to realising the ambitions we have for the expanded delivery of clinical services from community pharmacies and these proposals will not change that. However, we must enable pharmacists to spend less time on activities that can be safely delegated, more time on providing clinical services, and provide clarity both on how the legal framework applies, and the accountability between professionals for tasks undertaken at the pharmacy.

These proposals will put in place a legal framework for delegation within a pharmacy or pharmacy service, they are enabling not prescriptive, and the intention is to release time for pharmacists to spend more of their time with patients, not less. These proposals will enable pharmacists to authorise pharmacy technicians to undertake tasks that would otherwise need to be performed by, or under the supervision of, a pharmacist and for pharmacy technicians to supervise other members of the pharmacy team. The proposals will also provide for pharmacy technicians to take primary responsibility for the preparation and assembly of medicinal products in hospital aseptic facilities operating under a new parallel exemption to the ‘section 10’ exemption of the Medicines Act 1968.

These proposals are not a move towards allowing pharmacists to remotely supervise a community pharmacy. Physical presence of the responsible pharmacist in a retail pharmacy as the default is enshrined in primary legislation that is not being changed as part of this reform.

Changing legislation is the important first step in creating a framework in which pharmacists, pharmacy technicians and the wider pharmacy team can thrive. Legislation will be underpinned by regulatory rules and standards, and professional guidance to ensure good governance safely supports the implementation of this legislation in practice.

We fully support and endorse these proposals, as do ministers in the UK and devolved administrations. We urge you to consider the legislative proposals in the context of the ambition for, and changing nature of, practice, the aspirations of current and future pharmacy professionals, and the work proposed for the regulators and professional leaderships bodies that will underpin the changes in law. This is an issue of critical importance for pharmacy, the NHS, patients, and communities accessing these services. We encourage everyone to engage with the consultation and share their views.

Introduction

This consultation seeks views on proposals to modernise medicines legislation governing what tasks must be undertaken by a pharmacist, or under the supervision of a pharmacist. This work is part of a series of reforms to make full use of registered pharmacy technicians’ knowledge and skills and free-up pharmacist time to deliver more clinical services.

Government and NHS systems across the UK have an ambition to maximise the use of the skill mix in pharmacy teams, enabling them to better meet the health needs of their communities. By utilising the skills of the whole pharmacy team, pharmacists in community pharmacy will be enabled to deliver more patient-facing clinical services - improving access to care for patients and releasing capacity in the wider NHS. Across other clinical settings this proposal will enable pharmacy technicians to maximise the contribution they make within multi-professional teams, through more effective use of their skills and expertise in pharmaceutical care.

Medicines legislation requires that the preparation, assembly, dispensing, sale and supply of pharmacy and prescription-only medicines must be undertaken by a pharmacist, or under the supervision of a pharmacist. To enable greater delegation by pharmacists to pharmacy technicians, who are competent to undertake many of these activities without direct supervision, and to provide for greater flexibility in relation to final supply in retail settings once medicines have been dispensed, we are proposing to introduce a new, additional method of delegation termed ‘authorisation’, into pharmacy practice.

Our proposals will enable pharmacists to authorise (without directly supervising) registered pharmacy technicians to perform tasks that would otherwise need to be performed by or under the supervision of pharmacists – and for registered pharmacy technicians to take primary responsibility for the preparation and assembly of medicinal products in hospital aseptic facilities, and in doing so, supervise non-registered members of staff. These proposals are designed to allow pharmacists to spend less time on tasks that can be safely delegated to pharmacy technicians, who are registered and regulated health professionals in Great Britain – capable of working more autonomously, referring to a pharmacist only where necessary.

We also propose that checked and bagged prescriptions should be allowed to be handed out in a retail pharmacy in the absence of a pharmacist - where the pharmacist has authorised this. This package of proposals is designed to enable a broader range of pharmaceutical services to continue safely while pharmacists are engaged delivering clinical services or temporarily absent from the premises.

Unless specified, the proposals apply to pharmacy technicians in Great Britain only, as pharmacy technicians are not currently a registered health profession in Northern Ireland. Following a public consultation in March 2022, the Department of Health is taking forward a work programme to progress the statutory registration and regulation of pharmacy technicians in Northern Ireland, in partnership with PSNI. Should the proposals in this consultation be taken forward, these will be applied in Northern Ireland when possible, once statutory registration and regulation of pharmacy technicians is in place.

Extensive pre-consultation has been conducted with the sector and profession to inform these proposals, including with the Pharmacy Supervision Practice Group, national Chief Pharmaceutical Officer group and others. Furthermore, these proposals have been developed with the full support of all 4 nations across the UK, where the future ambitions for the pharmacy technician profession and making better use of the skill-mix, are addressed in the documents below.

In England, the proposals support the delivery of the NHS Long Term Plan, the NHS Long Term Workforce Plan and the Delivery plan for recovering access to primary care.

In Scotland, the proposals support the future vision for pharmacy in Achieving excellence in pharmaceutical care and the Scottish government’s workforce strategy.

In Wales, the proposals support the achievement of ambitions set out in Pharmacy: Delivering a Healthier Wales and A New Prescription (Presgripsiwn Newydd).

In Northern Ireland, the proposals support the commitment to develop the capacity and capability of the pharmacy workforce, and regulation of the pharmacy technician profession in the Pharmacy Workforce Review 2020 and Introduction of Statutory Regulation of the Pharmacy Technician Workforce.

Types of pharmacy services covered by this consultation

The proposed changes relating to preparation, assembly and dispensing, cover:

• hospitals
• community pharmacies
• some types of health centres
• clinics
• care homes and similar institutions

Additionally, the proposed changes relating to final supply, cover:

• community pharmacies (including hub pharmacies)
• other registered pharmacies (including some hospitals)

GP practice dispensaries (dispensing doctors) generally fall outside the scope of this consultation. In these locations, the dispensing of medicines is done under the authority of a doctor, rather than a pharmacist. The scope of this consultation is further set out in Annex A.

Types of medicine covered by this consultation

The proposals relating to preparation, assembly and dispensing relate to all medicines. These are classified as ‘prescription-only medicine’ (POM) and ‘pharmacy medicines’ (P medicines), and products subject to general sale or ‘general sales list’ (GSL) medicines. The ordinary presumption is that these have to be supplied in their original packaging and only with their original labelling – and ordinary processes of preparation, assembly and dispensing will cut across this. The proposals relating to final supply only apply to POMs and P medicines. GSL medicines, such as small packets of paracetamol or allergy tablets, are outside the scope of these proposals, as these medicines can be sold or supplied without the supervision of a pharmacist and from ordinary retail locations, such as supermarkets, newsagents and petrol stations.

The proposals also do not apply to pharmaceutical services (for example, blood pressure checks) that do not involve the sale or supply of POM or P medicines.

The meaning of ‘supervision’

Currently, medicines legislation requires that, subject to exceptions, the final sale and supply of POM and P medicines (Regulation 220 of The Human Medicines Regulations 2012) and the preparation, assembly and dispensing (section 10(1) of the Medicines Act 1968) of medicines in certain settings must be undertaken by a pharmacist, or under the supervision of a pharmacist.

As supervision is not defined in legislation, and there is relevant case law in this area, it is recognised that there is some disagreement as to what the law currently requires in terms of ‘supervision’. While adding ‘authorisation’ as a new form of delegation into pharmacy practice will provide a clear route to delegation, we also recognise the importance of providing more clarity on what ‘supervision’ means. The explanation given in this consultation document details the relevant legislation, case law and professional guidance and gives an overview of why practice has emerged as it has.

In summary, Annex B details 2 particularly relevant pieces of case law, one (Roberts v Littlewoods Mail Order Stores Ltd [1943]) that has led to the view that the law requires direct supervision of each individual transaction, and another (Summers v Congreve Horner [1992]) that concluded that supervision was “…a matter of degree…” and would vary depending as to what the profession deemed best practice. This verdict allows for a body such as the Royal Pharmaceutical Society (RPS) or PSNI to provide guidance as to what is good practice in the profession.

The Royal Pharmaceutical Society of Great Britain (RPSGB - the precursor to the Royal Pharmaceutical Society (RPS)) and GPhC issued guidance in 2005 which stated:

If a pharmacist is involved in a consultation with a patient in a private area or room of a registered pharmacy premises, pharmacy medicines may be sold, and dispensed prescriptions that have been checked for clinical appropriateness and accuracy may be supplied, provided that robust standard operating procedures (SOPs) are in place.

The pharmacist will still have professional responsibility for any sales or supplies of medicines that take place while they are involved in the consultation and it is essential that the SOPs clearly identify when a pharmacists’ intervention in such medicine sales or supplies is required and that systems provide for this intervention.

DHSC and the devolved administrations support the RPSGB approach and welcomes the commitment from RPS to update this guidance following this consultation.

Summary of proposals

A draft statutory instrument has been included alongside this consultation and is summarised below.

Proposal 1: introducing authorisation of a pharmacy technician by a pharmacist

Currently section 10(1) of the Medicines Act 1968 and Regulation 220 of the Human Medicines Regulations 2012 (HMR) enables the preparation, assembly, dispensing, sale and supply of medicines by a pharmacist, or under the supervision of a pharmacist - in specified settings. These proposals will enable these activities to be done by, or under the supervision of, a pharmacy technician with the authorisation of a pharmacist.

Under these proposals, subsection (1A) and section 10A will be inserted into the Medicines Act (1968) and Regulation 220A will be added to the HMR (2012). This will enable a pharmacist to authorise a registered pharmacy technician to either carry out tasks relating to the preparation, assembly, dispensing and sale or supply of medicines - or with the authorisation of the pharmacist, to supervise others to carrying out these tasks. Limiting these forms of ‘authorisation’ to pharmacy technicians is a patient safety measure designed to ensure that the legislation starts from the premise that a registered pharmacy professional, who is accountable for their practice to the regulator, is going to be doing or supervising the preparation, assembly, dispensing and sale and supply of medicines.

Our proposal states that an authorisation given to a pharmacy technician can be expressed in either specific or general terms (for example, relating to particular transactions or orders for medicines, or in general terms, potentially covering a range of prescriptions or categories of medicines). An authorisation can be given orally or in writing, may be subject to conditions or restrictions and may be varied or withdrawn by the pharmacist by whom it is given. In giving authorisation, a pharmacist must have due regard to patient safety and failure to comply with that requirement may lead to professional fitness to practice proceedings. This places an emphasis on professional regulation, rather than the criminal law.

This wording is intended to be enabling and sets a broad framework. This means pharmacies will be able to continue to operate as they do now after the changes come into force and to introduce changes in their practice later or not at all (recognising this will mean those pharmacies forego the benefits of the changes). Government legislation will not set out practice matters (for example, who is competent to perform specific tasks, using professional judgement to determine if a task is within their scope of practice, the keeping of records concerning an authorisation, expectations around reviewing authorisations and so on). This allows for the pharmacy regulators to consult on and set out the detail in their rules, regulation and/or standards. Professional bodies can then support with associated guidance.

These new arrangements will only apply in Great Britain as pharmacy technicians are not currently a regulated profession in Northern Ireland. Our aim is to apply this legislation in Northern Ireland once possible.

Proposal 2: the handing out of pre-checked and bagged medicines to patients in the absence of a pharmacist

Under these proposals, Regulation 220B will be inserted into the HMR (2012), which will enable pharmacists to authorise any member of the pharmacy team to hand out dispensed prescriptions, which have been checked for clinical appropriateness and accuracy, in the pharmacists’ absence (for example, when the pharmacist is not interruptible in a consultation room or temporarily absent from the premises).

Authorisation under this proposal is intentionally broader than the authorisation under proposal 1, as any member of the pharmacy team can be authorised. The law currently allows pharmacy staff to give a delivery driver medicines to take to the patient, or to place a medicine in an automated collection locker for collection by the patient or their representative, but a pharmacist needs to be in a position to supervise a member of staff if they were to pass out the same medicine on a registered pharmacy premises. This restriction has led to patients experiencing delays in receiving medicines when a pharmacist is absent from the pharmacy. Our proposal will bring arrangements in community pharmacies in line with arrangements for automated lockers, collection points and home deliveries.

In authorising these types of transaction, the pharmacist can specify any conditions or restrictions they deem appropriate. We would expect that pharmacy standard operating procedures and sale of medicines protocols would include clear instructions on the conditions under which a sale or supply should not go ahead, for example, if a patient presents with information that they have been prescribed a new medicine, report side-effects from taking their medicines, or has so called ‘red-flag’ symptoms which suggest more severe illness.

Again, as for proposal 1, practice matters will not be set out in government legislation (for example, record keeping of authorisation), implementing this legislation in practice will require these to be set out by pharmacy regulators and professional bodies.

These proposals will apply to Great Britain and Northern Ireland.

Proposal 3: supervision by pharmacy technicians at hospital aseptic facilities

Under these proposals, inserting Regulation 4A in to the HMR (2012) would permit registered pharmacy technicians to supervise the preparation, assembly and dispensing of medicines in hospital aseptic facilities. This would enable suitably qualified and experienced pharmacy technicians to be responsible for a hospital aseptic facility without having to act under the supervision (or authorisation) of a pharmacist. To benefit from this provision, the pharmacy service must still be overseen by a chief pharmacist (or someone fulfilling the statutory functions of a chief pharmacist) who is responsible for ensuring the safe and effective running of the pharmacy service.

Pharmacy technicians are increasingly the most experienced professionals working in aseptic units with many suitably qualified and experienced to oversee aseptic production. The roles of pharmacists in hospitals are changing with more time spent in patient-facing clinical roles, this is expected to accelerate following the changes to pharmacist initial education and training which mean all newly qualified pharmacists will register as prescribers from 2026. This means pharmacy technicians are now often more experienced in aseptic production than some of their pharmacist colleagues. We are proposing enabling pharmacy technicians, in addition to pharmacists, to be allowed to supervise aseptic preparation activity, allowing optimal deployment of healthcare professionals and service delivery for patients.

Robust governance arrangements will be required to ensure safe implementation of these proposals into practice. As for proposals 1 and 2, practice matters will not be set out into legislation, such as the level of experience or qualifications a pharmacy technician must hold to fulfil these roles. These should be recognised for aseptic supervising and ‘accountable’ pharmacy technicians in Quality Assurance of Aseptic Preparation Services professional standards, published by RPS, and will be subject to separate consultation.

Regulation 4A expressly or impliedly restates the following important principles.

Hospital aseptic facilities that do not have a specials manufacturer’s licence are able to undertake preparation of what are known as magistral and officinal formula preparations (where a product can be made up on the basis of either a detailed product specification provided by the prescriber or by reference to detailed product specification in an official pharmacopoeia).

Accordingly, hospital aseptic facilities generally rely on medicinal products that are already on the market and sourced through approved routes to market, such as licensed medicines or specials, and the facility will then modify those products by processes of preparation or assembly to fulfil particular patient needs.

The modifications that they make to medicines already on the market are not, however, so significant that they create ‘new’ medicinal products.

Generally, hospital preparation should be preceded by the existence of a prescription or direction ordering the medicine, but there are some cases where this is simply not possible - for example certain preparations that are needed by A&E departments or operating theatre suites. Accordingly, the changes have been drafted with these existing practices for fulfilling clinical needs in mind as well.

The primary focus of this consultation is supervision and the related new concept of authorisation - and hospitals are not expected to change any practices about the sort of work that hospital aseptic facilities undertake simply because of a change of lead responsibility from a pharmacist to a pharmacy technician.

As pharmacy technicians are not a regulated profession in Northern Ireland, this provision will only apply in Great Britain. Our aim is to apply this legislation in Northern Ireland once possible.

Physical presence of a pharmacist in a retail pharmacy business

We are grateful for the work of the Pharmacy Supervision Practice Group (a group of community pharmacy, pharmacist, and pharmacy technician representative organisations), who have produced a report, Pharmacy Supervision Practice Group - Update and outcome, to inform this consultation. The group have made clear that the broad consensus of the sector is that physical presence of a pharmacist within a retail pharmacy is critical, and we have taken this into account when developing these proposals.

Although the presence of a pharmacist in retail pharmacy is not explicitly stated in law, section 70(2) of the Medicines Act 1968 requires that a responsible pharmacist must be in charge of what happens at a retail pharmacy. This means, in law, the ‘physical presence’ of a pharmacist is inferred by virtue of the specific rules regarding their absence. Therefore, it is neither necessary nor appropriate to restate a requirement for physical presence in the new provisions permitting delegation.

Currently, in accordance with The Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008, the responsible pharmacist may only be absent for up to 2 hours during pharmacy business hours (within a 24-hour period). The GPhC and PSNI have the powers to consult on and change this if future practice requires. The GPhC will take account of recommendations from the Supervision Practice Group as it develops standards and rules, including its recommendations in relation to responsible pharmacist absence from the premises and maintaining the current 2-hour limit.

Authorisation versus supervision

The proposed changes to legislation will not, in themselves, redefine ‘supervision’ - and supervision by a pharmacist will continue as before, to be one route to lawful preparation, assembly, dispensing and final sale or supply of medicines. Authorisation provides a new route to lawfully undertaking these activities, but supply by or under the supervision of a pharmacist will remain an option open to pharmacies, for example, where a pharmacy does not employ a pharmacy technician.

Annex B outlines the legislation, case law and professional guidance that has led to the current interpretation of supervision in practice (concerning the final supply of prescribed medicines or sale of P medicines) which requires a pharmacist to be on the registered premises and either directly aware of transactions or interruptible so as to be able to intervene in a sale or supply. Authorisation will enable a pharmacist to delegate the dispensing process (barring any clinical check required by professional standards or guidance) to a pharmacy technician. Extant professional guidance will continue to require some activities to be carried out by a pharmacist (for example, the clinical check). Pharmacy professionals need to be mindful of all layers of pharmacy governance, not solely what is stated in the criminal law. These proposals will enable a pharmacist to use their professional judgement to determine which activities can continue in their absence (for example, where they cannot be interrupted or are temporarily off the premises) by authorising a pharmacy technician to undertake them.

Workforce, education and training

The pharmacy technician workforce plays an essential role in realising the full potential of these proposals and we recognise the need to increase training and recruitment of pharmacists and pharmacy technicians across the NHS.

The NHS Long Term Workforce Plan, backed by over £2.4 billion to fund additional education and training places over the next 5 years, sets out the steps the NHS and education providers need to take to deliver an NHS workforce that meets the changing needs of the population over the next 15 years. The ambition is to increase training places for pharmacists by nearly 50% to around 5,000 by 2031 to 2032 and grow the number of pharmacy technicians.

Similarly, the Scottish government’s national workforce plan, and associated strategies such as increasing foundation year training places for pharmacists and offering a national Pre-registration Trainee Pharmacy Technician scheme to support the expansion of technical apprenticeships in pharmacy services, are seeking to expand and upskill the pharmacy workforce. A national pharmacy workforce forum has been established to set a strategic workforce plan for the pharmacy professions in Scotland.

In Wales, the Strategic Pharmacy Workforce Plan (2023) outlines actions to develop the pharmacy workforce to meet the ambitions set out in ‘Pharmacy: Delivering a Healthier Wales’, to transform pharmacy services by 2030. These include actions to enhance the services available to patients by increasing capability and consistency of skills within pharmacy teams.

The number of training opportunities offered annually in Wales has been increased in 2023 to 2024 by 20% (83 to 100) for pre-registration pharmacy technician training and 67% (30 to 50) for pharmacy technician training. In addition, the Welsh government is providing over £4 million in 2023 to 2024 through the Community Pharmacy Contractual Framework to a workforce development scheme to encourage community pharmacy contractors in Wales to realise the benefits of skill mix in community pharmacy through support for recruitment and training of pharmacy technicians.

In 2020, the Department of Health in Northern Ireland published the Pharmacy Workforce Review, which contained an analysis of the current pharmacy workforce in Northern Ireland, described a workforce model to support health and social care (HSC) transformation, and made recommendations regarding the commissioning of pharmacy pre-registration and post-registration training. The scope of the review included pharmacy practice in HSC settings, including community pharmacy, general practice and hospitals. A Pharmacy Workforce Review steering group has been convened to oversee implementation of the 17 key recommendations in the review.

A summary of the various pharmacy roles is provided at Annex D.

Consequential changes

At or from

Linked to proposals 1 and 2, we are proposing to change, for the whole of the UK, the reference in Regulation 220 to supply needing to take place ‘on premises’ that are a registered pharmacy to ‘at or from’ such premises. This is a change that we have already generally made to equivalent references in the Medicines Act - in The Pharmacy (Responsible Pharmacists, Superintendent Pharmacists and so on.) Order 2022. It also reflects current practice, particularly where delivery services are used, which has led to strained readings of the legislation - including strained understandings of when supply takes place - in order to ensure that current standard practices are understood to have a proper legal base. This change may be made in other legislation in the pipeline, but in case it is not, the possibility of it being in this order has been provided for to ensure that regulation 220 is brought into line with the changes already made.

VAT

Expansion of the role of registered pharmacy technicians is underpinned by HM Revenue and Customs (HMRC) confirmation that services delivered by registered pharmacy technicians qualify for VAT relief. HM Treasury and HMRC have confirmed that medicines dispensed under the supervision of a pharmacy technician will also benefit from a zero rate of VAT. This will ensure there are no financial barriers for NHS pharmacy contractors implementing these changes. Our intention is to work with HM Treasury and HMRC to ensure any consequential changes to the VAT Act commence at the same time as the proposed changes to the Medicines Act 1968 and Human Medicines Regulations 2012.

Controlled drugs

The Misuse of Drugs Regulations 2001 and The Misuse of Drugs Regulations (Northern Ireland) 2002 specify that a pharmacist may manufacture or compound, supply or destroy any drugs subject to controls under Schedules 2 to 5 of the regulations. This includes drugs such as morphine, codeine and pregabalin.

To implement the proposals, consequential changes to the Misuse of Drugs Regulations 2001 are required to enable pharmacy technicians to undertake these activities across the pharmacy settings within the scope of this consultation.

Before changing the Misuse of Drugs Regulations 2001, the government will seek the views of the Advisory Council on the Misuse of Drugs, this will take place separately from this consultation. Our intention is to work with the Home Office to ensure changes to the 2001 Regulations commence at the same time as the proposed changes to the Medicines Act 1968 and Human Medicines Regulations 2012. Changes to the 2002 Regulations in Northern Ireland will not be required until pharmacy technicians become a registered healthcare profession in Northern Ireland.

NHS pharmaceutical contract regulations

England

Schedule 4, Part 2 of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 require that medicines must be ordered ‘either by or under the direct supervision of a registered pharmacist’. The 2013 Regulations will be reviewed in consultation with Community Pharmacy England, to ensure the regulations are aligned with the policy intent outlined in this consultation.

Wales

Schedule 5, Part 2 of The National Health Service (Pharmaceutical Services) (Wales) Regulations 2020 require that medicines must be ordered ‘either by or under the direct supervision of a registered pharmacist’. The 2020 Regulations will be reviewed in consultation with Community Pharmacy Wales, to ensure the regulations are aligned with the policy intent outlined in this consultation.

Scotland

Paragraph 7 of Schedule 1 of the National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009 require that the dispensing of medicines can only take place ‘either by or under the direct supervision of a pharmacist’. The 2009 Regulations as amended will be reviewed in consultation with Community Pharmacy Scotland, to ensure the regulations are aligned with the policy intent outlined in this consultation.

Northern Ireland

Schedule 2, Part 1, paragraph 5 of the Pharmaceutical Services Regulations (Northern Ireland) 1997 require that medicines must be supplied ‘either by or under the direct supervision of a pharmacist’. The 1997 Regulations will be reviewed in consultation with Community Pharmacy Northern Ireland, to ensure the regulations are aligned with the policy intent outlined in this consultation.

The role of legislation, regulations and guidance

The changes proposed in this consultation will enable new ways of working that will shape pharmaceutical care in the future. Changing legislation is the important first step, but these proposed changes will need to be underpinned by regulatory rules and standards to ensure good governance safely supports the implementation of the legislation in practice.

Over the past decade, the government has set a clear direction by moving pharmacy practice matters out of criminal law and inflexible primary legislation and into regulator rules, regulations and standards. The role of government legislation now is to set the broad framework and to be sufficiently ‘enabling’ so that the pharmacy regulators can then consult on and set out the detail in professional regulation, further supported by professional bodies providing associated guidance.

There are 5 layers of pharmacy regulation and governance:

• government legislation
• regulatory rules and standards
• professional standards
• other standards or professional guidance
• local governance policies and procedures

These underpin the safe and effective provision of pharmacy services and ensure patient and public outcomes and experience. The government’s role is to set the overarching legislative framework. The second phase, led by the pharmacy regulators and professional bodies, will set the detail of how this legislation will work in practice.

This consultation is the first phase of this work, which will be followed by separate consultations by the pharmacy regulators on regulatory standards for the roles of chief pharmacist, responsible pharmacist, superintendent pharmacist and rules (GPhC) and regulations (PSNI) to replace the Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008.

The pharmacy regulators have a statutory duty to consult with all key interested groups on these matters and in Great Britain will be subject to scrutiny by Parliament and agreement by the Privy Council. Separately, any regulations made by the council of the PSNI would require consultation of appropriate persons and consultation of and approval by the Department of Health in Northern Ireland.

The GPhC and RPS have produced a joint statement on using standards to help provide safe and effective care for members of the public. The regulatory standards produced by the GPhC for pharmacy professionals and pharmacies are statements of what people have the right to expect when they use pharmacy services. All standards set by the GPhC or PSNI, work to improve the quality and safety of services provided to patients and the public. The professional standards and guidance produced by the regulators provide a framework to support pharmacists and their teams, to develop their professional practice, improve services, shape future services, and deliver high quality patient care.

DHSC has worked closely with the regulators and professional bodies in developing these proposals to ensure there is a clear policy direction and that their consultations can proceed as quickly as possible to operationalise these new provisions. Any future standards or guidance issued by the regulator and/or the professional bodies would need to take account of both concepts of supervision and authorisation, and what is required or is best practice in terms of the safe and effective running of the pharmacy.

To provide a clear understanding of what matters will be subject to further consultation by the regulators, we have set out the high-level expectation of what the future consultations will cover.

Regulatory standards (GPhC or PSNI) for chief pharmacist, responsible pharmacist, superintendent pharmacist

We expect this to include (among other things):

• expectations of these professional roles in terms of education, training, conduct, performance, ethics and health
• expectations on using professional judgement when supervising or authorising the preparation, assembly, dispensing and sale or supply of medicine
• considering what needs to be taken into account when supervising or authorising, such as the appropriate skills of the pharmacy team
• regulators producing additional guidance about all or parts of the standards if necessary

Regulator rules and regulations concerning the responsible pharmacist

We expect this to include (among other things):

• rules around absence of the responsible pharmacist, including meeting legal requirements, and arrangements during absence
• record keeping requirements
• that the sale of general sale list medicines may continue at or from the premises during any period in which the responsible pharmacist is absent from the premises (which is a requirement of section 72A(7A))
• any exemptions from the rule that a pharmacist can only be a responsible pharmacist for one registered pharmacy

Guidance on hospital aseptic facilities

Professional standards for the quality assurance of aseptic dispensing services are published by RPS. Aseptic services operating under the section 10 exemption of the Medicines Act 1968 are audited against these standards to assure quality for NHS patients.

We expect these standards to be reviewed to describe how supervision by pharmacy technicians can safely operate in practice, including specifying the appropriate knowledge and competency requirements for supervising and ‘accountable’ pharmacy technicians or pharmacists.

Professional, civil and criminal liability

Registered pharmacists and registered pharmacy technicians are professionally accountable for the actions they take and the decisions they make. All healthcare workers are also accountable to the criminal and civil courts to make sure their activities meet legal requirements.

Regulators and professional leadership bodies are responsible for setting out what is professionally appropriate, and we would expect this to take account of a broad range of factors including, but not limited to, only delegating tasks to a person who is competent and making sure there is a clear framework in which to carry out a task or activity. Employers also have a role, for example, making sure that all members of the pharmacy team receive adequate training to perform the tasks they are expected to undertake, ensuring escalation policies are in place so that pharmacy professionals can raise areas of concern if asked to perform activities out of scope or training or in unsafe environments, and are supported to carry out their role to the best of their ability.

There is a continuing accountability where something is done with the authorisation of another person. It is not possible to have a delegatory relationship where the delegator can completely hand over accountability to the person they have delegated to. If something goes wrong, there may be shared accountability, and while there is a defence that something has occurred due to the fault of another person, the extent of accountability and liability will be fact-dependent and a matter for the regulators and courts to decide.

For example, if a pharmacist authorises a pharmacy technician to carry out dispensing activities and something goes wrong, both civil and criminal law have ways in which liability is only apportioned where it properly lies. Similarly, in a civil context, where a number of people are arguably at fault - which might include the pharmacy owner - the courts are highly experienced at apportioning blame where it truly lies - potentially in percentage terms. This will already be a live issue where someone acts under the supervision of a pharmacist and the supervised person is at fault, and what changes with authorisation may be the amount of blame that the courts might attach to the various people potentially at fault, but not the principle that the court may have to work out where blame truly lies.

The bottom line is that authorisation may make the pharmacist less at fault in a particular case (because they may have less to do with an individual transaction), but they may still be at fault - at some level (for example, because of a problem with the nature of the referral back arrangements). This will be for the courts to resolve, and insurers to take account of when assessing what cover to offer and the sort of practical scenarios in which the people they cover may be practising.

It is important to note that where a pharmacy technician breaches the terms of the ‘authorisation’, for example, a medicine is handed out to a patient against the agreed pharmacy protocols (with no extenuating circumstances), as a question of fact, they cease to be a person who ‘has the authorisation of a pharmacist’ and would therefore be in breach of criminal law and may risk professional misconduct proceedings. However, a person who acts outside the terms of the delegation under ‘authorisation’ faces the same jeopardy as the person who currently acts outside the terms of their delegation under ‘supervision’. So, the risk remains unchanged in this regard.

Transition periods

As this legislation is designed to be high level and enabling, we are proposing to build in a transition period to ensure any amendments to the law enter into force in a controlled and measured way, providing pharmacy regulators adequate time to consult on and develop rules, regulations, standards and guidance. This in turn provides the profession and employers adequate time to implement the changes safely and effectively into practice. The one exception to this is to bring in the provisions on handing out checked and bagged items in the absence of a pharmacist - where the pharmacist has authorised this - as soon as practically possible as this requires minimal change to practice.

Consultation questions

Proposal 1

Proposal 1 is to amend the Medicines Act 1968 and Human Medicines Regulations 2012 to enable pharmacists (should they wish) to authorise a registered pharmacy technician to carry out, or supervise another person to carry out, the preparation, assembly, dispensing, sale and supply of POMs and P medicines.

Question

Do you agree or disagree with proposal 1?

• Agree
• Neither agree nor disagree
• Disagree

If you have any additional information to support your answer, please provide details (maximum 350 words).

Proposal 2

Proposal 2 will enable a pharmacist to authorise any member of the pharmacy team to hand out checked and bagged prescriptions to patients or patient representatives. This is to align ‘bricks and mortar’ pharmacy premises with current practice for home delivery, locker box and other delivery services.

Question

Do you agree or disagree with proposal 2?

• Agree
• Neither agree nor disagree
• Disagree

If you have any additional information to support your answer, please provide details (maximum 350 words).

Proposal 3

Proposal 3 is to allow a registered pharmacy technician to be responsible for a hospital aseptic facility in the same way that a pharmacist is under the current law.

Question

Do you agree or disagree with proposal 3?

• Agree
• Neither agree nor disagree
• Disagree

If you have any additional information to support your answer, please provide details (maximum 350 words).

‘At or from’

We propose that Regulation 220 of the Human Medicines Regulations 2012 is brought into line with the changes already made to other legislation concerning the supply of medicines ‘at or from’ a registered pharmacy premises. This is to better reflect current practice, particularly in the provision of delivery services from a registered premises.

Question

Do you agree or disagree with this proposal?

• Agree
• Neither agree nor disagree
• Disagree

If you have any additional information to support your answer, please provide details (maximum 350 words).

Legislative barriers

Question

Do you think there any other barriers to modernising pharmaceutical practice in government legislation that we should consult on removing in the future?

• Yes
• No
• Don’t know

If you answered yes, please provide details of these barriers to support your answer (maximum 350 words).

Impact assessment

Question

If you have any further information to inform the consultation-stage impact assessment on the costs and benefits of each option, please provide it here (maximum 350 words).

Draft statutory instrument

Question

If you have any further comments on any aspect of the draft statutory instrument, please provide it here (maximum 350 words).

How to respond

The government invites responses on the specific questions raised.

Please respond through our online consultation survey.

If you have any queries on this consultation or require an alternative format please email pharmacy.supervision@dhsc.gov.uk. Do not send your consultation answers or any personal information to this email address.

If you do not have internet or email access, then please write to:

Department of Health and Social Care
Pharmacy and Eye Care Team
Department of Health and Social Care
39 Victoria Street
London
SW1H 0EU

The consultation is open for a period of 12 weeks. Please submit your responses to the questions by 11:59pm on Thursday 29 February 2024.

Annex A: legal basis and scope of consultation

Legal basis and scope

The subject matter of the Medicines Act 1968 and the Human Medicines Regulations 2012 are reserved to the UK government as regards Wales and Scotland but devolved as regards Northern Ireland. So, although these proposals are supported by the UK and the devolved administrations, the proposed changes are, formally, matters for the Secretary of State for Health and Social Care, in relation to England and Wales and Scotland, and the Department of Health in Northern Ireland in relation to Northern Ireland. However, they would be implemented by a statutory instrument under enabling powers in the Health Act 1999 - and section 60 of the Health Act 1999 provides powers for the Privy Council to make changes to the professional regulatory landscape through secondary legislation across the UK.

The minister putting the draft order for approval to the Privy Council would, in this instance, be the Secretary of State for Health and Social Care acting simply on his own authority - but before the Privy Council would, separately, commence any of the proposed changes to the Medicines Act or the Human Medicines Regulations as they apply in Northern Ireland, they will be required to obtain the agreement of the Department of Health in Northern Ireland (article 3(3) of the draft order), which is how the spirit of the devolution settlement is preserved in this particular context.

Pharmacy technicians in Northern Ireland are not yet a registered healthcare profession, therefore the amendments to the Medicines Act and Human Medicines Regulations in the proposals that solely apply to registered pharmacy technicians will not apply in Northern Ireland. However, once pharmacy technicians in Northern Ireland become a registered healthcare profession, a further amendment may be made to apply these changes to the whole of the UK. This position is reflected in the consideration that the UK and devolved administrations have given and will continue to give to these proposals in the context of their broader legal duties.

Annex B: summary of applicable case law and interpretation of supervision

Locations covered by this consultation

The concept of ‘supervision’ by a pharmacist occurs at 2 places in the law regulating what happens at the very end of the medicines supply chain. These are:

• ‘supervision’ of preparation, assembly or dispensing of any medicine in a registered pharmacy, a hospital, a health centre or a Scottish care home service (section 10(1) of the Medicines Act 1968)
• ‘supervision’ of sale or supply of a POM or P medicine in a registered pharmacy (Regulation 220 of the Human Medicines Regulations 2012 (HMR))

This has important consequences.

The law, and therefore this consultation, treats the 2 potential stages of final supply separately, as follows:

• what happens when an order is received for a medicine to be supplied by way of readying that medicine for final supply
• the actual final supply itself

While the changes to the law that are proposed affect both of these stages, they only affect the particular avenues of preparation, assembly, dispensing, sale or supply in these particular provisions, not every potential avenue of final supply

So, for example, the changes relating to preparation, assembly and dispensing are unlikely to relate to GP practice dispensaries - notwithstanding the reference to ‘health centre’ in section 10(1) of the Medicines Act 1968. For its purposes, ‘heath centre’ only has a narrow meaning - relating to powers in NHS legislation that have historically been used to provide services such as walk-in centres for the homeless.

By way of a contrast, ‘hospital’ has a very broad meaning in the context of the relevant medicines’ legislation, and includes clinics, nursing homes and ‘similar institutions’.

The net result is that GP practices that do dispensing, which are generally practices in rural areas, need not employ a pharmacist in their dispensary. Instead, the dispensing that is done in GP practices dispensaries is done under the authority of a doctor in the practice, and from a legal perspective is done under the rules that apply to the concept of ‘agency’ rather than to the concept of ‘supervision’.

Therefore, GP practice dispensaries generally fall outside the scope of this consultation.

In the case of hospital dispensing, the position is more complicated. The preparation, assembly and dispensing of medicines in a hospital is covered by this consultation, but what happens after that, the final supply of medicines, is not covered - with one important exemption.

The exception relates to the fact that most supplies of medicines by a hospital pharmacy are not considered to be the sort of ‘retail’ supplies that would mean the hospital pharmacy department is considered part of a ‘retail pharmacy business’, which needed to be registered with either GPhC or PSNI.

There is a broad exception in Regulation 223(3) of the HMR to Regulation 220, which relates to final supplies “…in the course of a business of a hospital or health centre…”. There are hospital pharmacies that cannot rely on this exception - some hospital pharmacies do in fact provide a retail service for patients, and some hospital pharmacies supply to other hospitals under arrangements that are treated as retail supplies - but broadly, ordinary inpatient and outpatient final supplies of POMs and P medicines in hospitals are exempt from the requirements of Regulation 220 and therefore do not need to be made by or under the supervision of a pharmacist.

Therefore, hospital dispensaries come within the scope of this consultation as regards the preparation, assembly and dispensing that they do, but generally fall outside the scope of this consultation when it comes to the acts of final supply.

The position with regard to community pharmacies is straightforward. These are registered pharmacies and are impacted by this consultation both in the case of the preparation, assembly and dispensing of all medicines and in the case of the sale and supply of POM and P medicines.

Some community pharmacies use ‘hub’ pharmacies to share some of their dispensing activity. At the moment, such arrangements are limited to arrangements between pharmacies that are part of the same retail pharmacy businesses, but there are proposals that have been subject to consultation that may mean that these sorts of dispensing flexibilities will become possible between pharmacies that are part of different businesses.

Therefore, all community pharmacies, including ‘hub’ pharmacies come fully within the scope of this consultation.

Accordingly, the locations covered by this consultation are:

• most hospitals, some types of health centres, clinics, care homes and similar institutions, but only for the preparation, assembly and dispensing of medicines that they do, not for the final supplies that they make
• community pharmacies, and other registered pharmacies (including some hospitals), for the preparation, assembly and dispensing of medicines that they do, and also the final sale or supplies of medicines - specifically of POM and P medicines - at or from their premises

What is meant by ‘supervision’ by a pharmacist at these locations

This falls into 3 parts:

• what is meant by supervision of the preparation, assembly and dispensing at all the relevant locations
• what is meant by the supervision of the sale or supply of a POM medicine at a registered pharmacy
• what is meant by the supervision of the sale or supply of a P medicine at a registered pharmacy

The background in the case law

It is recognised that there is some disagreement as to what the law currently requires in terms of ‘supervision’ in this context. The explanation given in this consultation document is intended to give an overview of why practice has emerged as it has - which is based on a particular approach to the legal position - rather than giving a settled interpretation of the law, which would be for the courts.

Case law in this area is limited but there is common ground that the modern law on what is meant by ‘supervision’ of a pharmacist in a retail context goes back to an old case under the Pharmacy and Poisons Act 1933, Roberts v Littlewoods Mail Order Stores Ltd [1943] 1 All E R 271. Despite its antiquity, the Roberts case established what for many decades became the settled view of the proper interpretation of the ‘supervision’ requirement at the final stage of retail sale or supply. The case decided that there were 2 elements to the supervision obligation - the pharmacist needed to be:

• “….aware of what is going on at the counter…”
• “…in a position to supervise or superintend the activities…” of the person making the sale or supply

These requirements often led to a bell or buzzer being installed in a pharmacy so that it, if a patient was seeking supply of a P medicine, an assistant would ring the bell or buzzer to alert a pharmacist that a transaction was taking place.

Notwithstanding its antiquity, the Roberts approach represented a relatively settled view of how the supervision requirement was understood, sometimes characterised as ‘direct’ supervision, until 2005. From a practical perspective, however, the view came under increasing strain, in particular as the shift started towards pharmacists being asked to provide more in the way of clinical services.

It was also the case that the law on what amounted, more broadly, to supervision had changed - in particular following the case of Summers v Congreve Horner [1992] 2EGLR 152. The case was about surveyors rather than pharmacists, but the Court of Appeal established some general propositions in relation to the meaning of ‘supervision’ by a qualified person. These were that:

• supervision was “…a matter of degree…”. That is, there is no single approach to what is meant by supervision. It all depends on the context
• the general approach is to adopt what “….good practice in the profession…. would regard as necessary…”

What good practice would regard as necessary in the profession may of course change over time, as professional practice evolves. In a pharmacy context, this case supported the move, from the mid-1990s, towards the use of medicines sales protocols, where there was no direct involvement of a pharmacist at the pharmacy, in the sale - although views of the legality of this change differed.

The RPSGB 2005 guidance

An important milestone was reached when in 2005 RPSGB, which was then both the regulator and the professional body for pharmacists in Great Britain, adopted and then issued a law and ethics bulletin which provided qualified support for the sales protocols approach.

The RPSGB guidance explained its position on ‘supervision’ in the case of both the final supply of dispensed medicines and the sale of P medicines, where the pharmacist is involved in a private consultation with a patient. It did 4 things, as follows:

• it confirmed the need for the pharmacist to professionally assess every prescription. In practice, this check happens at the stage just before final supply - preparation, assembly and dispensing - and so relates to what is professionally necessary as part of ‘supervision’ in order to meet the requirements of section 10 of the Medicines Act 1968 in a retail context
• at the stage of final supply, in the case of dispensed medicines, where a pharmacist was tied up in a private consultation, it advised that the dispensed medicines could be handed over to the patient, provided the staff doing so were aware of the circumstances in which the final supply could not proceed without further intervention from the pharmacist
• also at the stage of final supply, where a pharmacist was engaged in a private consultation, it advised that sales of P medicines could go ahead if the pharmacist was satisfied that sufficiently robust systems were in place to ensure that patient safety would not be compromised
• nevertheless, it also confirmed that at the stage of final supply, the supervising pharmacist had to be on the premises and interruptible, both in the case of the supply of dispensed medicines and the sale of P medicines, even if application of the relevant procedures or protocols meant the supply could go ahead without the pharmacist being interrupted

What this has been interpreted as meaning, in practice, is that where such robust procedures or protocols are in place, final supply of a dispensed medicine or P medicine sale, can go ahead when a pharmacist is in a consultation room, so long as the pharmacist is interruptible (and interrupted if further intervention is required of them). If the pharmacist is not interruptible, the supply cannot proceed or will have to wait until the pharmacist is available.

What this means, when compared to the terms of the original Roberts definition of ‘supervision’ is as follows:

• in the case of a POM or P supply of a dispensed medicine:
  • as regards the ‘awareness’ requirement, the pharmacist will be aware of the supply (having done the earlier checks), but will not be aware of the actual supply at the moment to supply
  • the ‘in a position to intervene’ requirement is met by the pharmacist being on the premises and interruptible, and procedures or protocols ensuring that the supply will not ahead if the threshold for a pharmacist’s intervention is met but the pharmacist was not interrupted
• in the case of a P sale:
  • the ‘awareness’ requirement no longer applied because it was not considered professionally necessary
  • the ‘in a position to intervene’ requirement was again met by the pharmacist being on the premises and interruptible, and procedures or protocols ensuring that the supply will not go ahead if the threshold for a pharmacist’s intervention was met but the pharmacist was not interrupted

This clearly put most strain on the Roberts position in the case of supply of P medicines - because of the difficulty in arguing that a pharmacist was aware, in any but the most general terms, of the transactions in question. However, DHSC and the devolved administrations have supported the RPS approach, recognising that the approach taken by the Court of Appeal in Summers does allow for a body such as RPS or PSNI to provide what amounts to a determination of what good practice in the profession would regard as necessary - and the 2005 guidance amounts to a reasonable determination, updating Roberts, in this case.

That said, there are presumed limits to how far a professional body could go with issuing this sort of guidance, even though there are no legal bright lines to say when these limits would be reached. It is not thought that the proposals covered in this consultation document could not simply be achieved by RPS or PSNI simply issuing even more flexible guidance on the meaning of ‘supervision’, for example. Some consistency with the courts’ historic approach is necessary, even if the updating of that approach that has happened to date properly uses tools that the courts’ themselves have given to provide such an update.

That said, it is important to emphasise that the proposed changes to legislation will not, in themselves, redefine ‘supervision’ - and supervision by a pharmacist will continue as before as one route to lawful preparation, assembly, dispensing and final sale or supply. New routes to the lawful undertaking of these activities are being established, which add to what is there at the moment, but conventional supply by or under the supervision of a pharmacist will remain an option.

Annex C: legal duties

The Secretary for State for Health and Social Care and the Department of Health in Northern Ireland, as part of their work on policy formation in this area, have to consider a number of important duties, in particular their obligations under, respectively, the Equality Act 2010 and the section 75 of the Northern Ireland Act 1998 - and in the case of the Secretary of State, the government’s Environmental Principles Policy Statement under the Environment Act 2021. The UK and devolved administrations will also need to consider, when it comes to implementation of these proposals if enacted, what changes they may wish to make to their NHS arrangements to take account of them, and that will require consideration of their specific duties in relation to NHS provision.

While these matters have not been made the subject of consultation questions, due regard will continue to be had to them as the proposals develop and the outcome of this consultation is considered. If consultees have any specific questions or issues, these should be included in the response to the consultation.

Annex D: summary of pharmacy roles

Role of pharmacists

Section 72A of the 1968 Act provides that it is the duty of the responsible pharmacist at each retail pharmacy to secure the safe and effective running of the pharmacy business at that pharmacy regarding the retail sale and supply of medicinal products. Each retail pharmacy premises must have a responsible pharmacist on duty to lawfully operate - whether that is a community pharmacy or a registered pharmacy in a hospital. The proposals outlined in this consultation do not change this fact. The responsible pharmacist may only be responsible for one premises (which includes any associated premises), at any one time, and the pharmacy regulators have a power to introduce an exception to this rule. No provisions have been introduced to date to allow an exception.

The Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008, is the key piece of legislation that details the responsibilities of the responsible pharmacist. The regulations provide that the responsible pharmacist may only be absent for up to 2 hours during pharmacy business hours (within a 24 hour period).

The retail sale and supply of medicinal products on a general sale list may still take place from the premises during the period of absence of the responsible pharmacist. However, HMR 2012 (Regulation 220) provides the retail sale and supply of POM and P medicines may only lawfully take place if a person is lawfully conducting a retail pharmacy business, and the product is sold, supplied, or offered for sale or supply on premises that are a registered pharmacy, and the transaction is carried out under the supervision of a pharmacist.

Role of pharmacy technicians

Pharmacy technicians are involved in the procurement, storage, supply, preparation, and administration of medicines and medicinal products. They work as part of multidisciplinary teams across a range of settings. Pharmacy technicians are patient-facing and provide medicines optimisation services with clinical setting exposure from pre-registration training. These settings include:

• acute hospital pharmacy, wards, dispensaries, technical service (aseptic) units
• community pharmacy
• primary care - GP surgeries, care homes
• health and justice settings
• mental health settings
• community services

Professional regulation of pharmacy technicians

The term ‘pharmacy technician’ is a protected title by law in Great Britain. All pharmacy technicians, whether working in the NHS, private or voluntary sectors in England, Wales, and Scotland, must be registered with GPhC, the statutory regulator for pharmacy professionals in Great Britain. In February 2023, there were 25,191 pharmacy technicians registered with the GPhC, the vast majority of whom were employed in the community pharmacy sector.

Pharmacy technicians are not currently a registered health profession in Northern Ireland. Following a public consultation in March 2022, the Department of Health is taking forward a work programme to progress the statutory registration and regulation of pharmacy technicians in Northern Ireland, in partnership with PSNI.

Pharmacy technician education and training requirements

Pre-registration trainee pharmacy technicians undertake a 2-year training programme and must achieve GPhC approved education that meets the 2017 Initial Education and Training Standards. The underpinning curricula as a minimum includes:

• chemistry
• microbiology
• physiology
• action and uses of medicines
• law
• pharmaceutics
• dispensing
• pharmacy production
• professional practice
• ethical decision making
• medicines optimisation
• accuracy checking

Pharmacy technician training involves the completion of combined knowledge and competence-based qualifications or courses. The GPhC accredits and recognises these courses and qualifications which lead to registration. They may be delivered face-to-face or at a distance. Awarding bodies - Pearson or Edexcel, NCFE Council for Awards in Care, Health and Education, Open Awards, and the Scottish Qualifications Authority - approve courses delivered in further education colleges and NHS trusts or health boards as well as providing external verification and quality assurance of assessments.

These courses and their quality assurance arrangements are ‘recognised’ by the GPhC in contrast to programme providers (for example, delivered by Buttercups Training and the University of East Anglia) which are accredited directly by the GPhC. There are also approved apprenticeship pathways made up of qualifications and/or courses which are integrated in terms of the end point assessment requirement of the pharmacy technician apprenticeship standard.

Pre-registration trainee pharmacy technicians must provide evidence of having completed a minimum of 2 years relevant work-based experience in the UK as part of the GPhC registration criteria. This must have been under the supervision, direction or guidance of a pharmacist or pharmacy technician to whom they have been directly accountable for no less than 14 hours per week. During these 2 training years, they must have completed at least 1,260 hours of work experience (excluding sickness absence, maternity leave and holidays) and at least 315 hours of work experience in each year.

Providers of pharmacy technician training in Northern Ireland include further education providers and private organisations, with teaching methods ranging from classroom-based learning to distance learning. However, the current absence of registration and regulation of pharmacy technician in Northern Ireland can lead to a lack of clarity about their role and training requirements, particularly in the community pharmacy sector where staff may undertake many of the roles carried out by registered pharmacy technicians in Great Britain as outlined above, but without necessarily having formal qualifications that would meet the requirements for registration as a pharmacy technician with the GPhC. Work is underway to develop proposals for pharmacy technician education and training requirements that will inform future requirements for registration with PSNI.

Role of the pharmacy owner

The pharmacy owner is responsible for ensuring the safe and effective provision of pharmacy services from the registered pharmacy, or from each registered pharmacy, that is part of the pharmacy business, at all times. The advice from the pharmacy regulators is that they are expected to consider the range of services provided from the pharmacy, the skill mix and number of staff in the pharmacy team, and the needs of patients and people who use pharmacy services.

Owners should use the resources they have, including staff and their skill mix, to ensure safe and effective outcomes for patients. This includes ensuring that staff have the necessary training appropriate to their roles.

Other members of the pharmacy team

The composition of the pharmacy team will be different in each pharmacy business, and consists of registered pharmacist, supported by a range of support staff to assist in the dispensing of medicines and provide information and advice about medicines and pharmacy services. For example, this might include dispensing a prescription in a community pharmacy, making up specialised medicines in a hospital, or delivering pharmacy services to a care home.

First and foremost, alongside the registered pharmacist, is a pharmacy technician, which has been a regulated pharmacy profession since 2011. Other roles within the team typically consist of accuracy checkers (which may also form part of the role of the pharmacy technician), counter assistants or dispensing assistants, who are not registered with the pharmacy regulators, but are accountable to their employer for the performance of their role.

It is important all support staff should have the appropriate education and training and skills appropriate for the activities they perform and the setting in which they work, to ensure the supply of medicines to patients is safe and effective. This is vital for the whole pharmacy team to meet regulatory standards, and the pharmacy regulators set requirements for the education and training of pharmacy support to facilitate this.

Initial education and training reforms for pharmacists will see pharmacists become independent prescribers from the point of registration from 2026 onwards. As part of this reform, pharmacy technicians will be required to capitalise on their registered status and post-registration education to deliver a broader range of tasks, thus enabling independent prescribing pharmacists to deliver more clinically-orientated services, particularly in community pharmacy and general practice settings.

Initial education and training

Pharmacists

Pharmacists are clinically trained health professionals and must undertake a minimum of 5 years training. An individual must complete a 4-year GPhC or PSNI accredited Master of Pharmacy degree (MPharm). The undergraduate curriculum equips the students with the knowledge, professional behaviours and clinical skills required to practice safely and effectively as a pharmacist, including in pharmacology, therapeutics, public health practice and the preparation and assembly of medicines.

Undergraduate training is then followed by a foundation year (formerly pre-registration training year) - a period of paid employment in one or several sectors during which a trainee pharmacist is required to build up a portfolio of evidence and demonstrate their competence while being observed at work.

Once the foundation year has been completed, an individual must complete a registration assessment to legally practice as a pharmacist and is subject to annual re-validation.

From 2026, all newly qualified pharmacists will be independent prescribers from the point of registration, building greater capacity and capability within the NHS workforce to deliver clinical services.

Pharmacists can progress to advanced and consultant levels of practice through undertaking post-registration training aligned to the 4 pillars of practice:

• clinical practice
• leadership and management
• education
• research

There are post-registration development routes open to pharmacists in all sectors of practice and these equip them with further clinical and/or technical qualifications to effectively practice within multidisciplinary teams in highly specialised clinical areas for example, intensive care, paediatrics, renal medicine and HIV, advising on the optimal and safe use of medicines or to provide highly specialised technical services in aseptic or other production facilities.

Pharmacy technicians

Pre-registration trainee pharmacy technicians undertake a 2-year training programme and must achieve GPhC approved education that meets the 2017 Initial Education and Training Standards. The underpinning curricula as a minimum includes:

• chemistry
• microbiology
• physiology
• action and uses of medicines
• law
• pharmaceutics
• dispensing
• pharmacy production
• professional practice
• ethical decision making
• medicines optimisation
• accuracy checking

The GPhC accredits and recognises pharmacy technician courses and qualifications leading to registration which may be delivered face-to-face (mainly in further education colleges and NHS trusts or health boards), or at a distance. Three awarding bodies - Pearson, Edexcel, Open Awards, and the Scottish Qualifications Authority - approve courses delivered in further education colleges and NHS trusts or health boards as well as providing external verification and quality assurance of assessments. These courses and their quality assurance arrangements are ‘recognised’ by the GPhC in contrast to programmes of distance education (for example, delivered by the National Pharmacy Association and Buttercups Training) which are accredited directly by the GPhC.

In addition, pre-registration trainee pharmacy technicians must provide evidence of having completed a minimum of 2 years relevant work-based experience in the UK as part of the GPhC registration criteria. This must have been under the supervision, direction or guidance of a pharmacist or pharmacy technician to whom they have been directly accountable for no less than 14 hours per week.

During these 2 training years, they must have completed at least 1,260 hours of work experience (excluding sickness absence, maternity leave and holidays) and at least 315 hours of work experience in each year.

Initial education and training reforms for pharmacists will see pharmacists become independent prescribers from the point of registration from 2026 onwards. As part of this reform, pharmacy technicians will be required to capitalise on their registered status and post registration education to deliver a broader range of tasks, thus enabling independent prescribing pharmacists to deliver more clinical orientated services, particularly in community pharmacy and general practice settings.

Post-registration education is dependent on the sector of practice and areas of specialisms as pharmacy technicians advance their careers. Specific post-registration national frameworks for pre and in process checking, clean room supervision and final approval of products are available for those specialising in aseptic preparation. As well as qualifications in Qualified Persons and Quality Assurance. For other sectors of pharmacy post-registration, education reflects the scope of practice ranging from operational, leadership, educational supervision and clinical diplomas. Pharmacy technicians can also access a range of training for vaccinations, phlebotomy and administering medicines as other healthcare professionals do.

Privacy notice

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The Department of Health and Social Care (DHSC) is the data controller.

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We will collect the following types of personal information:

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Under the UK General Data Protection Regulation (GDPR), the lawful basis we rely on for processing this information is:

• Article 6(1)(e) UK GDPR
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Changes to this policy

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