Consultation outcome

Proposal to enable dental hygienists and dental therapists to supply and administer specific medicines under exemptions

Updated 28 March 2024

Introduction

Regulated healthcare professionals have been taking on responsibilities for prescribing, supplying and administering medicines for many years. This supports patients to receive the medicines they require from the professional who is appropriately qualified to help them and means they do not need to see additional professionals simply to access these medicines.

In 2020, NHS England (NHSE) held public consultations on proposals to extend medicines responsibilities to additional regulated health professions. This included enabling dental hygienists and dental therapists to supply and administer a number of specific medicines under exemptions. Following these consultations, the Commission on Human Medicines (CHM) considered the proposal presented by NHSE and provided advice to DHSC Ministers that the Human Medicines Regulations 2012 (HMRs) be amended to allow dental hygienists and dental therapists to supply and administer certain medicines under exemptions.

Since the 2020 consultations took place, the Medicines and Medical Devices Act 2021 (MMD Act) brought in new requirements for consulting on proposed changes to the HMRs. Due to the MMD Act requirements, the Department of Health and Social Care (DHSC) and the Department of Health in Northern Ireland are jointly consulting further on the dental proposals.

The Secretary of State for Health and Social Care, in relation to England and Wales and Scotland, and in conjunction with the Department of Health NI in relation to Northern Ireland (pursuant to Section 45(1) of the MMD Act), is seeking views on the proposal to amend the HMRs to allow dental hygienists and dental therapists to supply and administer certain medicines under exemptions. The proposed change will support dental hygienists and dental therapists in providing the right care to patients to reduce unnecessary delays where it is safe and appropriate to do so.

DHSC is working with NHSE and the dental sector to improve the use of skill mix in NHS dentistry to ensure the full dental team can be fully utilised to deliver care to patients. This is an important element in improving access to NHS dentistry, while also improving the job satisfaction these professionals have by enabling them to work to the full scope of their practice.

Regulations for dental hygienists and dental therapists

We are seeking views on the proposal to enable specific medicines to be administered and/or supplied to patients under exemptions. At the heart of the proposal is an aim to make it easier for patients to get the medicines they need when they need them, and avoiding having to see additional healthcare professionals just to receive medicines.

Many dental hygienists and dental therapists already supply and administer the proposed medicines to their patients in their professional practice. However, they currently have to either ask dentists to assess the patient and write a patient specific direction (PSD) or use a document called a patient group direction (PGD), if one is available, before they can supply or administer the medicine. This limits the full utilisation of these dental practitioners’ skills, as PGDs are often not suitable for use in dental practices and PSDs can lead to unnecessary delays and handovers in care.

The profession and regulation

Dental hygienists and dental therapists support patients to maintain their oral health by helping to prevent dental disease, treating periodontal (gum) disease and promoting good oral health practice. They carry out treatment for patients as part of a team, directly and under a written treatment plan from a dentist. Dental hygienists and dental therapists provide treatment to a wide range of patients of all ages for preventative advice and treatment. They can:

• carry out a clinical examination
• diagnose and plan treatment within their scope of competence
• justify, take and interpret radiographs in compliance with the Ionising Radiation (Medical Exposure) Regulations - IR(ME)R 2017 and the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018

There is a large overlap in the scope of practice of dental hygienists and dental therapists, and many are dual registered. In addition to the shared scope of practice described above, if registered as a dental therapist they may also carry out direct restorations (fillings) on primary and secondary teeth, pulpotomies (nerve treatments) on primary teeth and extract primary teeth.

Dental hygienists and dental therapists are statutory regulated healthcare professionals. Both professions have been registered with the General Dental Council (GDC) for over 50 years. The GDC is an independent regulatory body that holds the register of dental hygienists and dental therapists in the UK and is responsible for the regulation of the UK dental workforce. It is mandatory that all dental hygienists and dental therapists are registered with the GDC to practise in the UK.

The purpose of professional regulation is to protect the public. The GDC sets the standards that all dental hygienists and dental therapists must meet to stay registered, in relation to the education, performance, conduct and ethics relevant to their scope of practice. These are the standards that the GDC considers necessary for safe and effective practice.

Regulated healthcare practitioners, including dental hygienists and dental therapists, must meet the standards of practice required by their professional regulator in order to remain registered and lawfully practice regulated activities. They must also keep within their scope of practice at all times to ensure they are practising safely, lawfully and effectively. Statutory healthcare regulators protect the public by investigating concerns about registrants’ fitness to practice.

Legal routes to prescribe, supply and administer medicines

Many dental hygienists and dental therapists already supply and administer the proposed medicines through different medicines mechanisms. Dental hygienists and therapists have been able to use PGDs since 2010. PGDs provide a framework for allowing named, authorised and registered health professions to supply and/or administer specific medicines to a defined group of patients requiring treatment for a condition detailed in the PGD, without the need for a prescription or an instruction from a prescriber.

NHSE identified, through engagement with stakeholders, that PGDs have been difficult to develop in the dental primary care setting. This is primarily due to most dental hygienists and dental therapists working with dentists who are not directly employed in the NHS but under contract to deliver dental service. This means there is no readily accessible governance framework within which to develop and implement PGDs. Additionally, the national guidance on the writing and signing of PGDs requires the input of a senior pharmacist. Most dental services do not have access to this expertise.

PSDs are also used to administer and supply a variety of preparations for patients with gum disease and tooth decay. A PSD is a written instruction from an appropriate practitioner (who is an independent prescriber) to administer a medicine to a named patient. The practitioner, such as a dentist, must have assessed the patient on an individual basis before prescribing the medicine.

The use of PSDs has limitations as it requires direct input from a prescriber for each individual patient for a single course of treatment which can lead to delays to patient care.

Exemptions within the HMRs allow certain medicines, or classes of medicine (for example prescription-only medicines), listed in legislation to be lawfully sold, supplied and/or administered to patients by specific health professional groups without using a prescription, PGD or PSD. Patients who receive oral health treatment from dental hygienists and dental therapists through such exemptions would be able to receive all the treatment they need without additional appointments or having to see another dental professional to receive their medicines.

As well as all medicines licensed in the UK as ‘general sales list’ and ‘pharmacy medicines’ (that fall within their scope of practice), we are considering exemptions to allow dental hygienists and dental therapists to supply specific prescription-only medicines for:

• the administration of high strength fluoride treatments - for example, fluoride varnish treatments widely used for children and others at risk of decay to strengthen and reharden teeth
• the administration of topical and local anaesthetics - to make dental treatment more comfortable and effective
• treatment for oral candidiasis (thrush)
• topical antibiotics to address implant associated disease

Proposed medicines for supply and administration under exemption

Dental hygienists and dental therapists working under the proposed exemptions within the HMRs would only be able to supply or administer within the limitations of that exemption, as related to their registered profession. They would be legally permitted to supply or administer any of the approved medicines on the exemptions list, though there may be further locally approved restrictions in place, such as a limited formulary in a particular organisation. Delegation of the supply or administration of a medicine using exemption to another health professional not able to use the mechanism would not be permitted.

The specific medicines and their proposed uses are outlined below.

Medicines for administration only:

• 2.5%/2.5% lidocaine with adrenaline
• articaine hydrochloride 4% with 1:100,000 adrenaline
• 3% mepivacaine hydrochloride
• 3% prilocaine with 0.54 microgram/ml felypressin
• 2.5%/2.5% lidocaine and prilocaine (periodontal gel)
• sodium fluoride varnish, 50mg/ml (2.26%) dental suspension (containing 22,600ppm fluoride)
• minocycline 2% periodontal gel
• 15% lidocaine, 0.15% cetrimide oromucosal spray

Medicines for supply:

• sodium fluoride 0.619% (2,800ppm fluoride) dental paste
• sodium fluoride 1.1% (5,000ppm fluoride) dental paste
• nystatin oral suspension

In addition, the supply of all general sales list and pharmacy medicines licensed in the UK, within the dental hygienists and dental therapists’ scope of practice.

Training

Eligible dental hygienists and dental therapists wishing to access exemptions in the HMRs would be required to gain entry to and successfully complete an approved training programme. They would also be required to undertake appropriate steps to maintain their skills and competence in keeping with the GDC Standards for the dental team.

The requirements and content of training was prepared by stakeholders including the GDC and College of General Dentistry (CGDent), and presented as part of the NHSE consultation in 2020. It was proposed that all dental hygienists and dental therapists wishing to enter an exemptions training programme would need to meet the following requirements:

• be registered with the GDC as a dental hygienist and/or dental therapist
• be practising in an environment where there is an identified need for the individual to regularly use exemptions to supply and administer the specific medicines in legislation
• be able to demonstrate that medicines and clinical governance arrangements are in place to support safe and effective use of exemptions
• be able to demonstrate support from an employer or, if self-employed, be able to demonstrate an identified need for the use of exemptions and that all appropriate governance arrangements are in place
• be able to demonstrate how they reflect on their own performance and take responsibility for their own continuing professional development (CPD)
• in England and Wales, provide a Disclosure and Barring Service (DBS) certificate; in Northern Ireland, an Access NI check within the last 3 years; in Scotland, be a current member of the Protecting Vulnerable Groups (PVG) scheme

A draft outline curriculum framework to prepare dental hygienists and dental therapists to use exemptions has been developed by the professional bodies in conjunction with key stakeholders, including the GDC. The draft framework is aimed at education providers that are intending to develop programmes for dental hygienists and dental therapists interested in qualifying to use exemptions. Training in the use of exemptions will initially be at post-registration, where criteria have been met. Not all dental hygienists and dental therapists would be expected to train to use exemptions as they may not meet all the entry criteria listed above.

In future, the GDC will consider if training can be embedded as part of dental professionals’ core training, pre-registration. Any changes to the training or entry requirements would be a matter for the GDC working with CGDent.

Human Medicines Regulations

The HMRs set out a comprehensive regime for the authorisation of medicinal products, including the sale, supply and administration of medicines. The powers which allow registered healthcare professionals to sell, supply and/or administer medicines to patients under exemptions are contained in regulation 235, when read with Schedule 17 of the HMRs.

Medicines regulation is a reserved matter (to the UK Parliament) in relation to Scotland and Wales. It is a transferred matter in Northern Ireland which is why changes to the UK-wide HMRs that affect Northern Ireland and made under the MMD Act 2021, are made by the UK and Northern Ireland ministers. This consultation is being conducted in the names of the Secretary of State for Health and Social Care (is so far as they relate to England, Wales and Scotland) and with the Department of Health in Northern Ireland (in so far as they relate to Northern Ireland).

Proposal for regulating use of exemptions

Dental hygienists and dental therapists must register with the GDC to practice. It is the case for some other registered health professions where post registration training and accreditation is a condition to the sale, supply and administration of medicines in reliance of exemptions as part of a professionals practice, an annotation is added to the register to indicate this. The GDC do not currently have powers in legislation to annotate the register to indicate that specific dental hygienists and dental therapists have completed the training.

Many dental practitioners already use these medicines during the course of their practice, through an alternative mechanism (PSD or PGD). We therefore think the value of a publicly available list in this context is limited, as patients receiving treatment are unlikely to be aware of the mechanism used to receive their treatment. As regulated health professionals, dental hygienists and dental therapists are already expected to work within their scope of practice and level of professional expertise and are accountable to their regulator for their actions. Dental practitioners and their employer would therefore be responsible for ensuring exemptions were only used by those that had completed training. Anyone who has concerns about a practitioner’s fitness to practice could raise these with the GDC.

The draft statutory instrument (SI) will specify that the use of exemptions is for ‘Registered dental therapists or registered dental hygienists who are qualified to use the medicines specified in column 2’. Dental hygienists and dental therapists would be required to ensure they had the requisite training before using exemptions. Standard 1.9 of the GDC ‘Standards for the dental team’ states that “You must find out about laws and regulations that affect your work and follow them”. The standards set out what dental professionals must do to stay registered and able to work as a dental professional.

Dental practitioners and their employer would therefore be responsible for ensuring exemptions were only used by those that had completed training. Local clinical governance arrangements will provide day to day assurance, and anyone who has concerns about a practitioner’s fitness to practice could raise these with the GDC.

Legal duties

The general equality duty that is set out in the Equality Act 2010 requires public authorities, in the exercise of their functions, to have due regard to the need to:

• eliminate unlawful discrimination, harassment and victimisation and other conduct prohibited by the act
• advance equality of opportunity between people who share a protected characteristic and those who do not
• foster good relations between people who share a protected characteristic and those who do not

We do not believe that the proposal detailed here would have adverse or different impacts on individuals with protected characteristics. The proposal would support dental hygienists and dental therapists to provide certain treatment to patients directly. The reduction in unnecessary delays would benefit any patient attending a practice where dental hygienists and dental therapists have completed the required training.

The National Health Service Act 2006 contains a number of overarching duties on the Secretary of State for Health which apply to every action undertaken in relation to the NHS and public health. These duties include:

• the duty to continue to promote a comprehensive health service in England (section 1)
• the duty as to improvement in quality of services (section 1A)
• the duty as to reducing inequalities (section 1C)

The proposal supports the duty to promote a comprehensive service through enabling dental hygienists and therapists to provide an extended range of care directly to patients. The proposal could remove barriers to patients receiving the care and support they need which would represent an improvement in quality of services. We do not anticipate the policy having any equalities impacts, as the policy would benefit any patients where their dental hygienist or therapist has undertaken the training.

Consultation questions

Do you agree or disagree with the proposal to amend the Human Medicines Regulations 2012 to enable dental hygienists and dental therapists to supply and administer specific medicines under exemptions?

This would include specific prescription-only medicines, as well as all general sales list and pharmacy medicines in their scope of practice.

• Agree
• Disagree
• Don’t know

If you have evidence to support your answer, please provide details (maximum 150 words).

Do you agree or disagree with the proposal for regulating use of exemptions?

• Agree
• Disagree
• Don’t know

If you have evidence to support your answer, please provide details (maximum 150 words).

NI respondents: equality and rural screening

In Northern Ireland new policies must be screened under Section 75 of the Northern Ireland Act 1998, which places a statutory duty on public authorities, to mainstream equality in all its functions - so that equality of opportunity and good relations are central to policy making and service delivery. In addition, new or revised policies must be rural proofed in line with the Rural Needs Act (NI) 2016, which requires public authorities to have due regard to rural needs.

We do not consider that our proposals risk impacting different people differently with reference to their protected characteristics or where they live in Northern Ireland.

Do you think that our proposals will impact people with protected characteristics?

• Yes
• No
• Don’t know

Please explain your answer (maximum 150 words).

Do you think the proposal risks impacting people differently with reference to their (or could impact adversely on any of the) protected characteristics covered by the Public Sector Equality Duty set out in section 149 of the Equality Act 2010 or by section 75 of the Northern Ireland Act 1998?

• Yes
• No
• Don’t know

Please explain your answer (maximum 150 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 hrtppcenquiries@dhsc.gov.uk. Do not send your consultation answers or any personal information to this email address.

If you have tried to message the mailbox since Monday 11 September, please resend your message to hrtppcenquiries@dhsc.gov.uk.

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

Prescribing Policy and Charges Team
Department of Health and Social Care
Floor 2, Area G, Quarry House
Quarry Hill
Leeds
LS2 7UE

The consultation is open for a period of 4 weeks. Please submit your responses to the questions by 11:59pm on 15 September 2023.

Annex A: legal basis and assessment of the matters set out in section 2 of the Medicines and Medical Devices Act 2021

The Medicines and Medical Devices Act 2021 (the act) came into force on 11 April 2021. We propose to make legislative changes using powers in Part 2 of the act, which provides powers to make, among other things, amendments to the HMRs.

This consultation is conducted in line with the consultation requirement in section 45(1) of the act.

Section 2 of the act provides that patient safety must be the overarching objective of the appropriate authority when making regulations. Section 2 requires that when assessing whether regulations would contribute to the objective of safeguarding public health, the appropriate authority must have regard to 3 factors:

1. the safety of human medicines and that the benefits of doing so outweigh any risks
2. the availability of human medicines
3. the likelihood of the relevant part of the United Kingdom being seen as a favourable place which to: - carry out research relating to human medicines - conduct clinical trials - manufacture or supply human medicines

As set out in section 2(3) of the act, where regulations under section 2(1) may have an impact on the safety of human medicines, the appropriate authority may make the regulations only if the authority considers that the benefits of doing so outweigh the risks.

The appropriate authority is the Secretary of State for Health and Social Care in relation to Great Britain and, in relation to Northern Ireland, the Department of Health NI, and the Secretary of State jointly. The consultation obligation applies to both the Secretary of State and Department of Health NI, and both will make the final decision on making any legislative changes under section 2(1).

Below we have assessed the proposal against each of the factors set out in section 2.

Safety

The proposals to allow dental hygienists and dental therapists to use exemptions are designed to ensure the highest levels of safety for patients when receiving their treatment. The likelihood of any increased risk in inappropriate administration of medicines is considered to be low, and extending access to medicines administration and supply mechanisms has the potential to improve patient safety by reducing delays in care, improving compliance with medicines and supporting clearer lines of professional responsibility.

The proposal would remove the framework provided by a PGD or for the clinical oversight of a prescriber in the patient’s care. PGDs provide a framework for allowing named, authorised, and registered health professions to supply and/or administer specific medicines to a defined group of patients requiring treatment for a condition detailed in the PGD. Under exemptions, the decision would be for the dental therapist or dental hygienists based on their training and knowledge. While they could seek advice from a dentist, exemptions remove the requirement for either a PGD to be in place or a dentist or other prescriber to be involved, thus establishing professional responsibility and continuity of patient care

We assess that the risk of inappropriate medicines supply or administration as a result of removing this layer of oversight is low. Many dental hygienist and dental therapists already safely use the proposed list of prescription-only medicines during their professional practice under a PSD or PGD. The CHM has determined that while there is a lack of evidence of the benefits and risks involved in the use of the medicines, commissioners agreed the risks are low. Dental hygienists and therapists would be working in the context and governance of a dental practice or service and would have received specific training for working under exemptions. The completion of appropriate training is a requirement to work under exemptions, and the proposed list of medicines is also modest.

Availability

The policy has the potential for individuals to receive the treatment they need faster than if they needed to wait for another healthcare professional to prescribe, supply or administer the medicine they require.

The proposed use of exemptions would make more effective use of staff resources by reducing the need for patients to attend additional appointments with the dental hygienist or dental therapist and/or to see a dentist just to access medicines needed; and allowing dental hygienists and dental therapists to have more availability to see more patients. Use of exemptions will also enable dental hygienists and dental therapists to undertake routine practice outside of the clinical setting and traditional hours because they will be able to administer and supply certain medicines as part of the clinical care they offer, without the need for access to a dentist. Community-based dental screening clinics in schools and residential homes undertaken by dental hygienists and dental therapists would allow improved access to dental services for patients, which would lead to timely diagnosis, treatment and prevention of dental diseases.

Favourability

These provisions have the potential to have a positive impact on the UK being seen as a favourable place to supply medicines. They would demonstrate that the UK has the adaptability to ensure that medicines can be supplied, where necessary, to ensure patient safety and timely access to medicines. By removing any barriers or delays to treatment and allowing for the supply and administration of certain drugs under exemptions by dental hygienists and dental therapists, we believe that these proposals will influence the likelihood of the UK being seen as a favourable place in which to supply human medicines.

Privacy notice

Summary of policy

The Department of Health and Social Care is proposing to amend the Human Medicines Regulations 2012 to enable dental hygienists and dental therapists to supply and administer certain prescription-only medicines via exemptions. This will also include all pharmacy and general sales list medicines in the scope of their professional practice. The proposed change will support dental hygienists and dental therapists in providing the right care to patients without unnecessary delays and will add capacity in dental care teams. The overarching policy objective is to enable patients to safely receive their medicines from an appropriate practitioner without unnecessary delays.

Data controller

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

What personal data we collect

We will collect the following personal information:

• information relating to the individual’s physical or mental health condition
• job title
• name of organisation
• area UK respondent is based in
• email address

How we use your data (purposes)

The answers provided will help us to gather more information on key aspects of the proposed introduction of secondary legislation. The anonymised data will be analysed, collated and aggregated by DHSC, and the summarised results and outputs published as part of the government’s response to the consultation.

Legal basis for processing personal data

Under Article 6 of the General Data Protection Regulation (GDPR), the lawful basis we rely on for processing this information is:

• (e) Necessary task in the public interest or controller’s official authority

Special category data is processed under Article 9(h) of the GDPR: Health or social care.

Data processors and other recipients of personal data

The data mentioned above will be shared with Department of Health NI except email addresses. These will be replaced with a response identifier so that the Northern Ireland dataset is anonymous. The data processor will be SurveyOptic.

International data transfers and storage locations

Information will only be kept within the UK.

Retention and disposal policy

We manage the information you provide in response to this consultation in accordance with the DHSC’s data protection policy. We will retain your data for 12 months after the consultation closes.

How we keep your data secure

DHSC uses appropriate technical, organisational and administrative security measures to protect any information we hold in our records from loss, misuse, unauthorised access, disclosure, alteration and destruction. We have written procedures and policies which are regularly audited and reviewed at a senior level.

Your rights as a data subject

By law, data subjects have a number of rights and this processing does not take away or reduce these rights under UK data protection law. The Data Protection Act 2018 applies.

These rights are:

• the right to get copies of information - individuals have the right to ask for a copy of any information about them that is used
• the right to get information corrected - individuals have the right to ask for any information held about them that they think is inaccurate, to be corrected
• the right to limit how the information is used - individuals have the right to ask for any of the information held about them to be restricted, for example, if they think inaccurate information is being used
• the right to object to the information being used - individuals can ask for any information held about them to not be used. However, this is not an absolute right, and continued use of the information may be necessary, with individuals being advised if this is the case
• the right to get information deleted - this is not an absolute right, and continued use of the information may be necessary, with individuals being advised if this is the case

Comments or complaints

Anyone unhappy or wishing to complain about how personal data is used as part of this programme, should contact data_protection@dhsc.gov.uk in the first instance or write to:

Data Protection Officer
1st Floor North
39 Victoria Street
London
SW1H 0EU

Anyone who is still not satisfied can complain to the Information Commissioners Office. Their address is www.ico.org.uk and their postal address is:

Information Commissioner's Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

Automated decision-making or profiling

No decision will be made about individuals solely based on automated decision making (where a decision is taken about them using an electronic system without human involvement) which has a significant impact on them.

Changes to this policy

This privacy notice is kept under regular review, and new versions will be available on our privacy notice page on our website. This privacy notice was last updated on 18 August 2023.