Introduction

Amendments to the Human Medicines Regulations 2012 (HMR 2012) came into effect from 26 June 2024. These amendments enable suitably trained and supported dental hygienists and dental therapists to personally supply and administer specified medicines without requiring a patient specific direction (PSD) from a dentist, or a patient group direction (PGD).

This amendment applies throughout the UK and affects both NHS dental contractors and private dental practice owners. The purpose of this guidance is to support NHS dental contractors to determine whether they wish to implement this in their practice and outlines the clinical governance structures required to ensure patient safety.

What do these amendments mean in practice?

These amendments enable dental hygienists and dental therapists to lawfully sell, supply and/or administer to patients the medicines listed in the legislation without needing a PGD or PSD. It should be noted that the amendments do not allow independent prescribing.

This increase in autonomy is expected to empower the workforce and, as noted in the consultation outcome, the potential benefits of this amendment are:

• better quality of care for patients
• improved efficiency
• more prevention of oral health disease
• increased patient safety
• a positive impact on vulnerable people (such as older people living in care homes and the community), for example, by allowing a dental hygienist or dental therapist to supply certain medications without requiring a dental prescription form signed by a dentist

Dental hygienists and dental therapists working to exemptions are recommended to have completed suitable training before starting to do so and should only administer and supply the listed medicines that are within their competence. For example, medicines that they have regular experience with and are confident in using.

Delegation of the administration or supply of a medicine from a dental hygienist or dental therapist working under these exemptions to another member of the dental team is not permitted. For example, asking a dental nurse or a dental practice receptionist to give a pack of sodium fluoride toothpaste to a patient is not permitted.

Which medicines are approved for supply and administration?

These medicines are listed in the HMR 2012 (Schedule 17 Parts 2, 3 and 4) and are:

Medicines for administration only:

• 2% lidocaine with 1:80,000 adrenaline
• 4% articaine hydrochloride with 1:100,000 adrenaline
• 4% articaine with 1:200,000 adrenaline
• 3% mepivacaine hydrochloride
• 3% prilocaine with 0.54 µg/mL felypressin
• 2.5%/2.5% lidocaine and prilocaine (periodontal gel)
• sodium fluoride varnish, 50 mg/mL (2.26%) dental suspension (containing 22,600 ppm fluoride)
• 2% minocycline periodontal gel
• 15% lidocaine, 0.15% cetrimide oromucosal spray

Medicines for supply:

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

These lists will be updated as appropriate to reflect changes in clinical practice.

What to consider when deciding if working to exemptions is desirable in your practice

The decision to work to exemptions should be reached collaboratively between the dental hygienist or dental therapist and the NHS contractor or practice owner on whose behalf they are delivering services. There is no requirement for dental hygienists and dental therapists to work to exemptions.

PSDs are written instructions to administer a medicine to a list of individually named patients where each patient on the list has been individually assessed by a dentist. If PSDs are working well, the practice may conclude that working to exemptions has no benefit for patient care or clinical efficiency.

PGDs are written instructions drafted by a multidisciplinary group to help dental hygienists and dental therapists supply or administer medicines to patients in planned circumstances. PGDs should only be used where no other suitable mechanism for administration and supply of medications exists within legislation. The introduction of exemptions means that PGDs should not be used for the supply or administration of the listed medicines. Where PGDs are currently used to supply and administer such medicines, contractors and private practice owners should put a plan in place to transition to working under PSDs or the exemptions.

PGDs cannot be renewed or replaced for those medicines listed in the exemptions once they have expired (maximum of 3 years from authorisation).

Practices providing NHS or private care may wish to consider working to exemptions where they can identify potential patient care and/or clinical efficiency benefits from this. For example, if:

• the use of PSDs is significantly delaying patient care
• hygienists and therapists do not always have easy access to a dentist to complete a PSD
• in an assessment of intended and unintended consequences, the benefits to patient care outweigh any risks

Training recommendations

Dental hygienists and dental therapists

While the ability to work to exemptions will be vested in individuals at the point of registration with the General Dental Council (GDC), the responsibilities around the supply and administration of the medicines listed above are not currently covered in undergraduate training. Therefore, it is strongly recommended that all current dental hygienists and therapists wishing to work to exemptions undertake further training that complies with the curriculum contained in Annex A. This has been developed by NHS England, the Department of Health and Social Care (DHSC), The British Society of Dental Hygiene and Therapy and The British Association of Dental Therapists.

Dental hygienists or dental therapists undertaking this training may require additional in-practice support, the level of which will likely vary between individuals and should be determined on an individual basis.

There is no requirement for a dental hygienist or dental therapist to have been in practice for a certain time before working to exemptions or for them to undertake a specific training course.

Postgraduate therapists and hygienists who do not routinely administer the medications listed above should undertake training to refresh their knowledge and skills before starting the training recommended to supply and administer medication under exemptions.

NHS England is keen to support dental hygienists and dental therapists to undertake training to work to exemptions, and the Centre for Pharmacy Postgraduate Education has been commissioned to produce an e-learning training module that aligns to the curriculum at Annex A. This should be available by November free of charge for dental hygienists and therapists providing NHS-funded care, but fees may apply for those working in the private sector within or outside the UK. Further information as to how to access this will be provided.

It is anticipated that this training and the associated learning outcomes will be integrated into the dental hygienists and dental therapists’ undergraduate curriculum, and with this, future clinicians will not need to undertake additional post qualification training.

Following completion of training, dental hygienists and dental therapists will need to demonstrate that they are maintaining their competence through continuing professional development (CPD) activities.

Indemnity

Dental hygienists and dental therapists and their employer or contractor will need to ensure they have adequate indemnity arrangements in place to cover the use of exemptions for their practice.

Supporting the wider team to understand this change

Guidance on building dental teams is given in Supporting the use of skill mix in NHS general dental practice.

Dental practice owners and contractors who are progressing towards working to exemptions should consider the need for wider practice team training and support. This should include:

• ensuring all practice staff understand how working to exemptions impacts on a clinician’s scope of practice
• developing protocols for the use of exemptions when care is delivered by NHS and private contractors, including providing a local formulary approved for use by each clinician this applies to, and the transportation of medications where appropriate.

Management and supply of medicines

The requirement for good medicines governance is common across all dental practices irrespective of whether they hold an NHS contract or not. Dental hygienists and dental therapists working to exemptions must follow all required safe custody and governance processes. Further information on this can be found in the Care Quality Commission’s Dental myth buster 35: Medicines management in dental practices.

Labelling requirements of prescription only medicines supplied under exemptions

Medication packs to be supplied when working to exemptions will need to be labelled with exactly the same information as if they were being dispensed against a prescription:

• name of the patient the medicine is being supplied to
• name and address of the supplying dental service
• date the medicine was sold or supplied
• name of the medicine
• directions for use of the medicine
• precautions relating to the use of the medicine
• warning label: ‘keep out of reach and sight of children’

In practice, medicines supplied for use under an exemption are often in packs that are pre-labelled by a licensed manufacturing unit. These labels meet all the standard labelling requirements, leaving a space for the patient’s name, date of dispensing and address of the supplying service to be added at the time of supply. This is sometimes known as over-labelling.

Please note: labels cannot be locally produced and attached to products within NHS or private dental practice as this is dispensing and is not legal practice.

Supply in NHS practices

DHSC and NHS England are currently considering how medicines for take-home use should be provided in NHS dentistry. In the meantime, it is recommended that patients requiring such medicines are issued a prescription in line with established processes.

The use of exemptions does not enable dental therapists or hygienists to prescribe. As such, in these circumstances a dentist will need to issue the patient with a prescription using an FP10D (dental prescription form). Patients will then need to follow the usual process for collecting prescriptions via an FP10D through a pharmacy, where the standard NHS prescription charge will apply.

Annex A: Curriculum for Human Medicines Regulations 2012 training

Qualifying criteria for dental therapist and dental hygienist registrants

Course participants will need to confirm the following pre-course application requirements. They must:

• be registered with the GDC as a dental hygienist and/or dental therapist
• under a PSD or PGD, be competent in the use of the medicines specified in the HMR 2012 exemptions, as would be expected of a dental therapist or dental hygienist working at full scope of practice
• be practising in an environment where there is an identified need for them 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, 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 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

Course providers should deliver the educational content with an emphasis on the responsibilities around supply and administration, rather than simply the management of HMR 2012 exempt medicines.

Learning outcomes

The learning outcomes from the training are expected to demonstrate that dental hygienists and therapists who have completed the recommended training are safe, effective and competent in the supply and administration of specific medicines within the legal framework, through:

• working within the registrant’s specific scope of practice and adhering to the current GDC standards for the dental team
• applying the legal and ethical aspects of medicines management, including the duty of candour and reporting of adverse effects
• applying the principles of safe and effective sale, supply and administration of medicines in accordance with national and local policies
• understanding of shared decision-making and respecting patient choice

Part 1: Patient management within the context of HMR 2021 exemptions

Assessing the patient

To supply or administer medicines to a patient under exemptions you must satisfy yourself that you have undertaken a full assessment of the patient.

• you should supply or administer medicines to a patient under exemptions only where you have relevant knowledge of the patient’s health and medical history commensurate with the medicines decisions you are taking
• you should ensure you have considered the patient’s current medication, including over-the-counter and herbal preparations, and any potential interactions with other medicines before supplying or administering medicines
• you should ensure you consider the effects of your patient’s lifestyle and socio-behavioural history on the safety of the medicines you supply or administer. This will include the effects of over-the-counter medicines including herbal preparations, and recreational or non-therapeutic use of medicines

Considering the options

• you should refer to an appropriate prescriber if you do not fully understand the implications of a medicine’s use, even though you may be able to take a thorough and appropriate history that leads to a diagnosis
• each patient must be assessed on an individual basis. You must only supply or administer medicines when you have assessed the patient and they have a genuine clinical need
• you should never supply or administer medicines for your own convenience or simply because a patient demands that you do so

Consent

• you should explain to the patient or their representative the role you play in their treatment and take appropriate informed consent
• you should provide your patient with sufficient information relating to the risks, benefits, possible side effects, possible costs and outcomes of the supply and administration of the medicines you are considering, as well as the comparative risks of alternative treatment options to medication that may be considered, so that the patient can give their informed consent to treatment
• you must ensure that patients (or their carers) understand the decisions they are being asked to make
• you should be aware, to the best of your ability, of the variety of social, cultural and religious factors that may affect the choices your patient makes in agreeing medicines decisions with you.
• the patient has the right to refuse to accept any medication you propose to supply and/or administer. If they do, you should explain the risks, benefits and outcomes of their decision and record that you have done so in the patient’s notes
• the patient should be provided with any relevant patient information to assist them in making an informed decision, either before administration within the clinical setting, or by giving them a patient information leaflet (PIL) about any medicine you propose to supply and for them to read outside the practice
• where the PIL is not routinely supplied, such as is the case with local anaesthetic, patients can request such information if they wish
• patients with visual impairment should be made aware that they can receive a large print, braille or audio version from the RNIB medicines leaflet line

Record keeping responsibilities

This guidance relates specifically to the record keeping of your supply and administration of medicines under exemptions. You should refer to other standards and guidance for information relating to clinical record keeping in general. Guidance can be found in the GDC standards for the dental team (principle 4).

• documentation of the supply or administration activity should be recorded in the clinical records at the time of administration or supply. It is not good practice to document medicines supply/administration after the event; for example, at the end of the clinic session or at the end of the day
• records must include details of the medicines supplied and/or administered, together with relevant details of the consultation with the patient

Use of exemptions as part of a team

• there is no statutory requirement for dental professionals to communicate with a patient’s medical practitioner when administering medicines for dental use. There are, however, occasions when this would be in the patient’s interest and such communication is encouraged
• it is good practice to inform the patient’s medical practitioner when you supply a medicine to a patient to take home
• you should communicate effectively, using the most appropriate medium, with other practitioners involved in the care of the patient. This includes communication across NHS/practice boundaries where necessary/possible, and communications can be in hard copy or electronic form depending on the practice

Part 2: Using medicines responsibly under the exemption mechanism

Antimicrobial stewardship

• when administering or supplying antimicrobials you should consider the requirements of antimicrobial stewardship, in line with national guidance, including Expert Advisory Committee on Antimicrobial Resistance and Healthcare Associated Infections (ARHAI), to ensure good infection prevention but also prudent antimicrobial use. Effective prevention of infection must be part of everyday practice for dental therapists and dental hygienists as this helps to reduce the need for antimicrobials
• you should follow local policies for antimicrobial use, which are required to be based on national guidance and should be evidence-based, relevant to the local healthcare setting and take into account local antimicrobial resistance patterns. They should cover diagnosis and treatment of common infections and prophylaxis of infection
• resources are available to inform dental hygienists and dental therapists about their role in the prevention of antimicrobial resistance including audit of their antimicrobial use, alternative treatments and accurate identification of need. Dental therapists and dental hygienists should undertake training to inform them of their responsibilities with regard to the use of antimicrobial medicines

Adverse events

• if you discover that you have made an error in supply or administration, you must take immediate action to prevent potential side effects to the patient and report the error as soon as possible according to local/practice policy
• if a patient experiences an adverse reaction to a medication, you should record this in their notes and notify the Medicines and Healthcare products Regulatory Agency (MHRA) via the Yellow Card Scheme as soon as possible. Yellow cards are found in the back of the British National Formulary (BNF) and online at yellowcard.mhra.gov.uk. You may also be required to report the incident through local incident reporting procedures
• you should also inform the patient that they can report adverse reactions independently to the Yellow Card Scheme using the BNF freephone service and MHRA regional centres.
• you can also report adverse reactions via the MHRA website and by following the guidance in the Patient Safety Incident Response Framework (PSIRF) which replaces the Serious Incident Framework (SIF) (2015). Incidents should now be reported to the Learn from patient safety events (LFPSE) service
• you should review incidents within your local team and/or medicines management committee (or equivalent) to enable learning and where necessary change practice

Delegation

• you cannot delegate the administration of a medicine to another healthcare worker or to the patient/their legal representative
• you should only use exemptions to supply or administer medicines to patients in your direct care. You must not use them for any patients for whom you have not undertaken an appropriate assessment
• you must not use exemptions for a patient unknown to you even when you are the only dental hygienist or dental therapist available with the qualification to use exemptions

Storage

This is in relation to both the dental practice and community settings.

• you should ensure all medicinal products are stored in accordance with the information in the Summary of Product Characteristics or PIL, or that on the label. Some medicines may require refrigerated storage
• when not in use, medicines should be stored in lockable containers or cabinets
• you must follow local protocols agreed by the governance lead for the practice/organisation for carrying medicines to various settings that are outside the clinical practice; for example, care homes, outreach centres
• all storage environments must meet the prevailing storage requirements and it is your responsibility to find out what these requirements are. You must ensure correct storage policies are in place and are being adhered to

Transportation

• you may transport medicines from the dental surgery to their place of use following local practice policies for safe and secure storage of the medicines during transit

Disposal

• you must be aware of and follow protocols for the safe disposal of used, partially used and unused medicines in accordance with current legislation and your local practice policy

Accountability

• you are professionally accountable for your decisions regarding the supply and administration of medicines under exemptions, including actions and omissions
• you must only supply or administer medicines under exemptions within your scope of practice and competence
• you should be aware of and understand the legislation that underpins the supply and administration of medicines, and how it relates to safe and compliant practice
• while you are legally permitted to supply or administer any of the approved medicines on the relevant exemptions list, as they fall within your individual area of competence and respective scope of practice, there may be further locally approved restrictions in place. For example, an employer may restrict dental therapists and dental hygienists to supply and administer only a number of the listed medicines. These restrictions would only apply to practice for that employer. You must work to such locally agreed written protocols and procedures at all times, in addition to the standards set by the regulator and any guidance provided by your professional body

Continuing professional development

• you must remain up to date with appropriate knowledge and skills to enable you to supply and administer medicines competently and safely within your scope of practice

Peer support

• you recognise the value of support from another dental hygienist or dental therapist who qualified and is using exemptions to supply and administer medicines, or from a dentist colleague who can advise and support

Clinical governance

• you must follow the governance arrangements related to medicines that are in place where you work
• clinical audit is an important part of clinical governance and you should be aware of local policies and audit your use of exemptions
• if you are working in private practice, clinical governance systems are expected to be equivalent to those in the NHS. For example, you need to be able to demonstrate how you keep up to date with current guidance, how you safeguard the patients in your care and work with the practice to ensure that the protocols are robust and adhered to
• you should ensure that you have information about national guidelines (for example, NICE guidelines, National service framework, BNF, BNF for children), local guidelines, local agreements and formularies to ensure you make the best decision for your patients

Frequently asked questions

1. Once working to exemptions do I need to submit my claims differently?

This change has no impact on the submission of FP17 claims.

Unique numbers can be generated for dental hygienists and dental therapists. This means these dental care professionals (DCPs) no longer require a dentist’s performer number to submit a claim where the DCP has independently carried out the entire course of treatment. However, the current process for DCPs when sharing courses of treatment with dentists will continue to apply, where FP17 claims must continue to be submitted with a dentist’s performer number and the GDC number of the DCP (even if the DCP has a personal number). Further information can be found in DCP changes – England providers.

2. Can dental hygienists and dental therapists work without assistance from another dental professional, especially under direct access?

Under the lone working arrangements for dental professionals, the GDC’s Standards for the dental team states all dental professionals must be appropriately supported, and work with another appropriately trained member of the dental team, when treating patients.

3. As a provider of a dental contract how would I know if a DCP has undertaken a recommended education programme that allows them to work under exemptions?

All education should be supported by a certificate as well as reflection for personal development. Therefore, the provider should ask for appropriate evidence of course completion, with the relevant aims and objectives set out clearly to assure that expected learning has taken place.

Publication reference: PRN01495