Consultation outcome

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

Updated 28 March 2024

Executive summary

The Secretary of State, in relation to England, Wales and Scotland, and, in relation to Northern Ireland, jointly with the Department of Health for Northern Ireland, held a public consultation from 18 August to 15 September 2023 to amend the Human Medicines Regulations 2012 (HMRs) to enable dental hygienists and dental therapists to supply and administer specific medicines under exemption.

The consultation sought views on the proposal to allow dental hygienists and dental therapists to lawfully supply and/or administer specified prescription-only medicines (POMs) to be listed within the HMRs, as well as pharmacy or general sales list medicines in the practitioner’s scope of practice, without the use of a patient specific direction (PSD) or patient group direction (PGD). Under current legislation, dental hygienists and dental therapists can supply or administer the proposed medicines through PSDs or PGDs.

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.

The proposed policy builds on the NHS Long Term Workforce Plan by allowing dental hygienists and dental therapists to provide direct care for their patients and help free up dentists to provide more NHS dental services. The Long Term Workforce Plan states that:

by the end of the modelling period, the plan aims to deliver 15% of dental activity through dental therapists and dental hygienists, as opposed to the current estimate of 5%. A national Return to Therapy programme is being developed to enable dental therapists working as hygienists to fulfil their full scope of practice.

As well as all medicines licensed in the UK as general sales list (GSL) and pharmacy (P) medicines that fall within their scope of practice, we are considering exemptions to allow dental hygienists and dental therapists to supply specified 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

The consultation also sought views on how the use of exemptions by dental hygienists and therapists should be regulated, proposing that it be governed by arrangements captured in professional registration with the General Dental Council (GDC).

Introduction

The HMRs set out a comprehensive regime for the authorisation of medicinal products, including the sale, supply and administration of medicines. The powers that 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.

Regulated healthcare professionals have been able to take on further 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.

The Department of Health and Social Care (DHSC) is working with NHS England 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.

Between 15 October and 10 December 2020, NHS England held a public consultation on enabling dental hygienists and dental therapists to supply and administer a number of specific medicines under exemptions. Since this consultation took place, the Medicines and Medical Devices Act 2021 (MMD Act) brought in new requirements for consulting on proposed changed to the HMRs, which is why the DHSC has consulted again.

In 2021, the Commission on Human Medicines (CHM) considered the proposals presented by NHS England and provided advice to ministers that the HMRs be amended to allow dental hygienists and dental therapists to supply and administer medicines under exemptions.

The Secretary of State, in relation to England, Wales and Scotland, and, in relation to Northern Ireland (NI), jointly with the Department of Health for Northern Ireland, sought views of the public and stakeholder organisations on these proposals through this public consultation, which ran from 18 August to 15 September 2023.

The following section of this document discusses the analysis of the consultation responses in detail.

Summary and evaluation of responses

Approach to analysis

DHSC and the Department of Health NI have analysed the responses and considered the feedback received. In doing so, we looked at the responses given to each of the questions posed as well as the information responders provided in the ‘free text’ sections of the consultation response survey, where people could share their views in their own words.

Key themes or topics in the responses were identified across each of the questions asked by the consultation.

Overview of the respondents

A total of 2,743 responses were received, all through the GOV.UK page, and one which came via email.

73% of responses were from individuals sharing their professional views, 24% from individuals sharing their personal views and experiences, and 3% were on behalf of organisations.

48% of respondents stated that they were responding as a dental hygienist or dental therapist. 25% stated that they were responding as a patient and 15% as a dentist.  

Themes common across the responses

The consultation asked 2 key policy questions to seek views on the proposal itself and the way the policy is to be regulated. The most common theme that came through from respondents was that this proposal would be beneficial for patients, the professions and the NHS. This included a clear belief that the patient journey would be improved because the treatment process would become more efficient, reducing delays and freeing up dentist appointment time.

The pre-registration training that dental hygienists and dental therapists must undertake was mentioned frequently by respondents in a supportive manner for both questions. It was stated that professional qualifications would give the practitioners a good grounding in the use of exemptions and the medicines being proposed. 

Many respondents also mentioned Direct Access, where patients have the option to see a dental hygienist or dental therapist without having to see a dentist first. It was suggested that the proposed use of exemptions would allow these practitioners to fully utilise Direct Access and treat their patients to the full scope of their practice, while doing things that they are trained, competent and indemnified to do.

Consideration of responses to individual questions

Use of exemptions

The consultation proposed that the HMRs should be amended to allow dental hygienists and dental therapists to supply or administer specific POMs via exemptions, as well as all GSL and P medicines within their scope of practice.

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?

Of the respondents to this question:

• 2,651 agreed
• 71 disagreed
• 21 said they didn’t know

Feedback from responses

97% of respondents agreed with the proposal to amend the HMRs to enable dental hygienists and dental therapists to supply and administer specific medicines under exemptions. 2% disagreed and 1% didn’t know.

Of those who responded, most said that enabling dental hygienists and dental therapists to supply and administer medicines would improve the quality of care for patients. It was noted that patients are currently struggling to access suitable dental services and, under this proposal, patients would have better access to healthcare professionals who will be able to work to their full scope of practice, allowing for a ‘one-stop service’.  Patients would have better access to the medicines they need and be seen more quickly, which will ultimately reduce waiting times rather than waiting for treatment to be signed off.

A common theme among the respondents was that this would increase autonomy, which will result in workforce empowerment. It was considered a step towards increased effectiveness and service optimisation.

The majority of the responses from organisations stated the potential benefits of the proposal to be:

• better quality of care for patients
• improvements in efficiency
• improving the prevention of oral health disease
• increased patient safety
• having a positive impact on vulnerable people (such as older people living in care homes and the community)

Some organisations had concerns that the proposal did not refer to the need for dental hygienists and dental therapists to have “appropriate indemnity cover” and, while they agreed with the proposal, strongly recommend that it makes reference to this.

A few stated that dental hygienists and dental therapists are already trained to administer and advise on the use of medicines, but will lose these skills if they are unable to utilise them.   

Quotes from organisations

The Community Pharmacy Northern Ireland said:

CPNI recognises that dental hygienists and dental therapists already supply and administer the proposed medicines to their patients in the course of their professional practice. They currently have to either ask dentists to prescribe the medicines or use a patient group direction (PGD) if one is available. In addition, such supply and administration under the exemptions would only be within the dental hygienists’ and dental therapists’ scope of practice. It is also noted that eligible dental therapists and hygienists would be required to undergo training and, as both are statutory regulated healthcare professions, they will be working to the standards set by the GDC.

The British Society of Paediatric Dentistry said:

The British Society of Paediatric Dentistry (BSPD) supports this proposal to enable dental hygienists and therapists to administer and/or supply specific medicines under exemption. BSPD strongly feel that hygienists and therapists have a key role in securing the oral health of children and young people. The medicines are currently prescribed by a dentist via a patient specific direction (PSD) or a patient group direction (PGD). This directive will therefore reduce this need, allowing dental hygienists and therapists to work in a more efficient, effective and patient-centred way. As part of their training, these professionals are already able to administer/supply these medicines. We believe that this proposal can only enhance the treatment that dental hygienists and therapists deliver and will improve autonomy and job satisfaction, leading to retention of these professionals in NHS services.

NHS England’s Workforce, Training and Education Directorate said:

NHS England’s Workforce, Training and Education (WTE) Directorate fully endorses amending the Human Medicines Regulations 2012 to allow dental hygienists and therapists to administer specified medicines. This change would enhance quality of patient care, operational efficiency, and workforce empowerment.

The British Dental Industry Association said:

The BDIA welcomes the proposal to enable dental hygienists and dental therapists to supply and administer certain medicines as per the proposal. We are supportive of the use of regulation to further enable the effective use of skills mix within the dental team. We believe that the proposed changes will facilitate the provision of timely and appropriate care to patients as well as contributing to overall system capacity and patient access within the dental sector.

The responses from individuals were extremely supportive and provided evidence that included the same themes as above, including improvements to patient care, cost and efficiency savings, and qualifications that are embedded within the practitioners’ training.

Many said that the current system creates a barrier to getting prescriptions such as local anaesthetic and topical fluoride varnish, and that removing this barrier would improve patient access to treatment, reduce referrals and cancellations, and save time and money. 

Some respondents felt that dental hygienists and dental therapists are highly trained professionals with the same knowledge and experience as a dentist and, therefore, it would be appropriate to give them the same level of trust and allow them to supply and administer medicines under exemption as there is a risk of them losing these skills if they are not put into practice.

Very few respondents (2%) disagreed with the proposal. They were mainly concerned about practitioners lacking the knowledge and skills necessary to assess patients and ‘prescribe’ these medicines.

There was a general response around the difficulty of putting PGDs into place in dental practice and one respondent stated that having to pay for PGDs is discriminatory to the professions.

Quotes from individuals

One respondent said:

…this proposal would have a significant positive impact on my patient care. It would make treatment more efficient for patients and waste less clinical time. Administering local anaesthetics is a routine part of my working day.

One respondent said:

I manage a dental practice and this would make the treatment of patients much easier, freeing up dentists to treat more patients. I feel my therapist is qualified to carry this out.

One respondent said:

YES. I’m a dental hygienist, and there have been many occasions where I have seen patients who require periodontal therapy or PMPR on root and need local anaesthetic to ensure the care they require can be delivered without discomfort. When I look to obtain a PSD, their regular treating dentist might not be available on the same day, I am working and the other dentists have refused to provide me with a PSD because of not seeing the patient initially. Furthermore, remote prescribing is discouraged and so many times I have been unable to fulfil the patient’s care plan. Additionally, some of the PSDs received are brief with many dentists not fully understanding what should be enclosed in a PSD. Leaving me to go back and explain what I need - therefore, I am essentially telling them what to prescribe me because I know more than they do in terms of my scope and what I am able to administer. Appointments have been cancelled and rescheduled with dentists’ diaries used for writing a PSD when their, mine and our patients’ time could be better utilised. All this could be avoided if we were permitted to… administer autonomously and within our scope.

One respondent said:

Yes, it strikes a crucial balance between providing flexibility for practitioners and upholding regulatory integrity. This initiative holds the potential to enhance patient care, improve access to treatments.

One respondent said:

It would eliminate the current barrier in place for patients when having treatment with a dental hygienist/therapist when no prescription for local anaesthetic has been made (forgotten) by the referring dentist. It would save patients wasted appointment times and enable a more efficient way of working.

Proposed medicines for supply and administration under exemption

Responses to the public consultation and further informal consultation with stakeholders raised an issue with the proposed list of POMs for supply and administration under exemption. We consulted on the following list of POMs:

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

After analysing all responses and collating further information, we sought advice from Jason Wong, interim Chief Dental Officer for England, along with CDOs for NI, Scotland and Wales, and intend to make the following amendments:

• we will replace ‘2.5%/2.5% lidocaine with adrenaline’, which was an error in presentation, with ‘lidocaine 2% with 1:80,000 adrenaline’, the most commonly used dental local anaesthetic
• we will also add ‘articaine hydrochloride 4% with 1:200,000 adrenaline’, which is often preferred in patients very sensitive to the effects of adrenaline and patients who are pregnant or breastfeeding

Concerns were raised about ‘minocycline 2% periodontal gel’. While risks for topical antibiotics is low, recent periodontal S3 guidance from the British Society of Periodontology does not advocate for its use. It is also not indicated within the College of General Dentistry’s Antimicrobial prescribing in dentistry: good practice guidelines or in the National Institute for Clinical Excellence’s British National Formulary (BNF) Dental practitioners’ formulary. However, the risk they raise is, as far as we know, relatively low, and its inclusion could allow more independent practice for dental therapists and hygienists. As we do want to allow skill mix as much as possible and there is no evidence that dental hygienists and dental therapists are any less capable in using antibiotics in any form appropriately, it has been decided to keep minocycline on the list.

Concerns were also raised about ‘nystatin oral suspension’ but a decision has been made to keep it on the list too. Health benefits to certain groups of patients were identified and it was made clear that there will be training associated with these medicines that will further provide patient safety for this and the other medicines.

The list of POMs to be listed in schedule 17 of the HMRs will therefore be:

• lidocaine 2% with 1:80,000 adrenaline
• articaine hydrochloride 4% with 1:100,000 adrenaline
• articaine hydrochloride 4% with 1:200,000 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
• sodium fluoride 0.619% (2,800ppm fluoride) dental paste
• sodium fluoride 1.1% (5,000ppm fluoride) dental paste
• nystatin oral suspension

Regulating use of exemptions

In the consultation, we proposed that, rather than the GDC keeping an annotated register of all dental hygienists and dental therapists who have completed additional training to be able to use exemptions, dental practitioners and their employer would be responsible for ensuring exemptions were only used by those that had completed the training. Regulation of exemptions would therefore be captured in the ongoing requirements of registration with the GDC.

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. Local clinical governance arrangements will provide day-to-day assurance and anyone who has concerns about a practitioner’s fitness to practise could raise these with the GDC.

The statutory instrument 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.

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

Of the respondents to this question:

• 2,303 agreed
• 135 disagreed
• 305 said they didn’t know

Feedback from responses

84% of respondents agreed with the proposal for regulating the use of exemptions. 11% stated that they didn’t know and 5% disagreed. Analysis of the responses has shown that the main themes in this area are registration with the GDC, training and qualifications, and patient safety.

Those agreeing indicated that registration with the GDC would provide the necessary level of regulation for the use of exemptions and included supportive points about fitness to practise, as well as professional accountability and the ongoing requirements of CDP. Some responses specifically noted that an additional annotation or list of qualified practitioners was unnecessary and would not hold any value for patients. Most respondents believed that the governance involved in GDC registration was important and sufficient.

The training and qualifications that registered dental hygienists and dental therapists must obtain was raised by many respondents. It was suggested that practitioners are trained to use the medicines and understand the risks involved. 

Quotes from organisations

The General Dental Council said:

Proposals align with our expectation that DT/DHs should consider whether any particular activity - in this case, use of exemptions - is in their individual scope of practice, based on their training, competence and indemnity cover. GDC registrants must follow GDC standards. Standard 1.9 is specifically referenced in proposals. Additionally, we would expect the overall effect of the principle to “put patients’ interests first” to be that professionals use exemptions only when in the patient’s best interests. GDC registrants must keep their professional knowledge and skills up to date through CPD, in line with GDC requirements. We would expect DT/DHs to consider their individual CPD needs around the use of exemptions, in the same way as they would around any other aspects of their professional practice.

The Specialist Pharmacy Service said:

As with all professionals working under exemptions, it is essential that dental hygienist/therapists only do so within their scope of practice and where they have the appropriate underpinning knowledge. Dental hygienist/therapists working under exemptions are accountable to both their employing organisation and professional body for their decisions to supply/administer medicines.

The British Dental Industry Association said:

…the proposed approach is proportionate and reflects the limited benefit that would be derived from development and implementation of a publicly available list. Both dental hygienists and dental therapists are already subject to professional regulation via the General Dental Council, and we believe that the existing ‘Standard for the Dental Team’ requirement for registrants to ensure that they are aware of, and in compliance with, applicable laws and regulations is sufficient.

The British Society of Paediatric Dentistry said:

The British Society of Paediatric Dentistry (BSPD) supports the regulations laid out in the proposal. All dental hygienists and therapists must be registered with the General Dental Council (GDC) and are required to maintain continuing professional development (CPD). The GDC set the professional standards they must meet within their scope of practice. Dental hygienists and therapists have been regulated this way for decades and are well used to working effectively within their scope of practice. From the proposal, dental hygienists and therapists must be trained and competent to administer/supply medicines under exemption. The requirements and content for this training has already been prepared by stakeholders and, from the information given in the proposal, BSPD believes this would be more than sufficient to protect patients.

We noted some minor data quality concerns, where a response to the initial question (agree or disagree) did not align with the comments received from the respondent. In these instances, the respondent had ‘disagreed’ with the proposal, but their comments expressed support for the proposals. As such, it is important to clarify the position that there will be no additional regulatory requirements placed on professionals beyond what is already expected of them to attain and maintain their GDC registration.

Quote from an individual

One respondent said:

I see the need for post-registration certified training in order for a DTH to be able to administer medicaments under exemptions, but not the need for this to be highlighted on the GDC register. If this was the case, it could create two tiers of clinicians. Any member of the public who understood what the annotation on the register means, could ask to see only a clinician with this annotation as they may have the perception that this clinician is more highly qualified, and this would not be the case. However, it is my belief the majority of the public would not understand what the annotation would mean, therefore it is likely to be referred to mostly by dental professionals. If dental professionals wanted to know if a DTH had completed the postgraduate training, this could easily be proved by asking for a copy of the training certificate. If DTHs were able to give the stated medicaments without a prescription, the public would be protected in the normal way through the regulatory process. It is up to each DTH to demonstrate they work within their scope of practice and, if they administered the stated medicaments without completing the training and no prescription, that would be considered working outside their scope of practice, which is a regulatory issue. I do not see the point of the extra workload on the GDC when the public would be protected through the normal regulatory process, as they have been over the last 10 years.

Generally, responses from individuals were very positive. There was agreement that the proposal covered all the needs of regulation, with GDC registration acting as the foundation for a practitioner’s fitness to practise. It was felt that additional training, where required, and ongoing CPD would ensure that all practitioners have the skills and knowledge to use exemptions.

Those that disagreed (5%) with the proposal for regulation raised concerns about patient safety and did not agree that all P medicines should be in scope.

Quotes from individuals

One respondent said:

This measure demonstrates a proactive approach towards maintaining the highest standards of safety and efficacy in healthcare practices. It strikes a crucial balance between providing flexibility for practitioners and upholding regulatory integrity.

One respondent said:

Dental hygienists and therapists should not need further regulation past their own self-awareness and individual employers, as they are taught to high standards on programmes which are heavily regulated by the General Dental Council.

One respondent said:

Like many other areas covered by GDC as mandatory, it should be the responsibility of dental hygienists/therapist to take the appropriate training and keep records of that and submit the documents only if they were asked to.

Next steps

Following the analysis of consultation responses and the overwhelming support for the proposal and its regulation, we will progress work to amend the HMRs to allow dental hygienists and dental therapists to supply or administer medicines using exemptions.

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 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.

Several respondents to the consultation also noted that this proposal would improve access to medicines and dental treatment in rural areas, care homes and for vulnerable patients. It has the potential to reduce inequalities in these underserved areas where access to a dentist may prove difficult. This, in turn, would improve patient’s oral health with dental hygienists and dental therapists working to their full scope of practice.

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 (MMD 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:

• the safety of human medicines and, where there is an impact on safety, that the benefits of making the regulations outweigh the risks
• the availability of human medicines
• the likelihood of the relevant part of the United Kingdom being seen as a favourable place in 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 Secretary of State jointly.

We assessed the above proposals against each of the factors set out in section 2 for the public consultation exercise and our assessments essentially remain the same. We intend to amend the list of medicines as detailed in the ‘Proposed medicines for supply and administration under exemption’ section above, which will improve patient safety and ensure that the right medicines are available for use by dental hygienists and dental therapists in order to provide the best care for their patients.