Q&A 346.2
Patient Group Directions in dental practice
Prepared by UK Medicines Information (UKMi) pharmacists for NHS healthcare professionals
Before using this Q&A, read the disclaimer at
Date prepared: August 2013
Summary
Patient Group Directions (PGDs) allow the sale, supply or administration of named medicines in an identified clinical situation.
Individuals who are allowed to supply or administer medicines under a PGD are specified ‘registered healthcare professionals’.
The Human Medicines Regulations 2012 allow dental hygienists and dental therapists to work under PGDs.
The Human Medicines Regulations 2012detail information that must be included in a valid PGD and the legal authority required to develop and authorise a PGD.
If a PGD has been approved, as set out in the legislation,dental hygienists and dental therapists are allowed to administer local anaesthetics and supply fluoride preparations directly to patients.
PGDs canbe used inNHS andprivate dental practices and clinics.
Resources are available for dental professionals who are considering developingPGDs in their area of practice. These include the national PatientGroup Directions websiteand the NICEPatient Group Directions: Good Practice Guidance.
Background
Patient Group Directions (PGDs) are written instructions allowing the sale, supply or administration of specified medicines by named, authorised, registered health professionals, to a pre-defined group of patients needing treatment in an identified clinical situation. Using a PGD is not a form of prescribing [1].
Dental therapists and dental hygienists (not dental nurses) have been recognised ‘registered healthcare professionals’ able to work under a PGD since 2010 [2]. The Human Medicines Regulations 2012 detailsthe individuals allowed to work under a PGD in Part 4 of Schedule 16 [3].
What role do dental therapists and dental hygienists have in dental practice?
Dental therapists and dental hygienists are trained to be competent to perform many tasks including the following [4]:
Dental hygienists
Scaling and polishing teeth,
Advanced periodontal therapy (supragingival and subgingival scaling, root debridement),
Administering infiltration and inferior dental block analgesia,
Applying appropriate anti-microbial therapy to manage plaque-related diseases,
Applying topical treatments and fissure sealants,
Taking radiographs,
Monitoring and screening procedures including intra and extra oral assessments,
Providing detailed oral hygiene and dietary advice,
Providing emergency temporary replacement of crowns or fillings,
Taking impressions,
Administering inhalational sedation.
Dental therapists
All the duties of dental hygienists (above) plus,
Direct restorations on permanent and primary teeth,
Extracting primary teeth,
Pulp treatments and placing preformed crowns on primary teeth.
What training do dental therapists and dental hygienists receive in using medicines?
The curriculum for training dental therapists and dental hygienists was developed by the General Dental Council and incorporates training in administering injectables, particularly administering local anaesthetics by infiltration and inferior dental regional block [4]. Dental therapists and dental hygienists also receive training in pharmacology, compatibility/incompatibility of medicines with local anaesthetics and use of antimicrobials and antibiotics (for systemic and local delivery in the periodontium).
Which medicines can dental therapists and dental hygienists supply or administer under PGDs?
The aims of introducing PGDs into dental practicewere to enable dental therapists and dental hygienists to administer local anaesthetics and to sell or supply fluoride supplements and high strength fluoride toothpastes without prescription by a dentist. However, legislation does not limit the medicines dental therapists and dental hygienists may sell/supply or administer. As long as the hygienist/therapist is assessed as competent in the use of a medicine and there is agreement between all signatories to the PGD, any licensed Pharmacy Medicine (P) or Prescription Only Medicine (PoM) can be included in a PGD. Particular caution should be exercised in any decision to draw up PGDs relating to antibiotics [1]. Microbial resistance is a public health matter of major importance and great care should be taken to ensure that inclusion of antibiotics in a PGD is absolutely necessary and will not jeopardise strategies to combat increasing resistance. A local microbiologist should be involved in drawing up any PGD which includes an antibiotic.
Is a PGD required for application of fluoride varnish?
Sodium fluoride varnish is available from different manufacturers as either a PoM or a medical device. A PGD is required for administration/application of a PoM but not for administration/application of a medical device. To check the classification of the product:
Medicines that are PoMs must display the letters PoM within a box on the packaging /Medical devices must display the CE mark logo on the packaging /
A PGD is not required for application of fluoride varnish by dental therapists or dental hygienists working to a protocol overseen by a consultant or registered specialist in dental public health [5]. Dental nurses may also apply fluoride varnish under the same protocols.
How should preparation of a PGD be approached?
PGD preparation requires significant resources and is time-consuming. Before embarking on the process, consider whether a PGD is necessary, safe and legal and whether there are clear governance arrangements and accountability. The national PGD website provides the following Q&As, which include algorithms to aid initial decision making [6]:
To PGD or not toPGD? - that is the question: A guide to choosing the best option for individual situations.
Is a PGD appropriate? A checklist to make sure that you have considered all the questions.
NICE guidance on PGDs includes a detailed approach to good practice and the legal requirements for PGD development [1] including an algorithm (Figure 1, on page 29).
Each NHS organisation with responsibility for signing off PGDs (the PGD authorising body) should have a ‘PGD approval group’, a multidisciplinary group that considers proposals to develop a PGD to deliver a service. This group may be an established group e.g. the local medicines decision-making group, such as the drug and therapeutics committee.Development of a PGD should not proceed until the PGD approval group has formally agreed that a PGD is appropriate [1].
In private dental practices/dental organisations when PGDs are written by a non-NHS body and are being used outside the NHS, the practice/organisation is not required to inform local NHS bodies. NHS funding is not available for their implementation (e.g. writing, training, auditing). The private practice/dental organisation is responsible for ensuring that their PGDs are clinically sound, comply with legislation and professional standards, and that governance and audit procedures are in place.
What information must a PGD include?
The Human Medicines Regulations 2012specifies that each PGD must contain the following information [7]:
The date the PGD comes into force and the date it expires.
A description of the medicine (or class of medicine) to which the PGD relates.
The clinical situations for which medicines detailed in the PGD may be used.
Any restrictions on the quantity ofmedicinal product that may be sold or supplied on any one occasion.
The clinical criteria under which a patient is eligible for treatment.
A description of patients excluded from treatment under the PGD.
Details of circumstances in which further advice should be sought from a doctor or dentist.
Details of the pharmaceutical form or forms in which medicines are to be administered.
Details of the strength, or maximum strength, at which medicines are to be administered.
The applicable dosage or maximum dosage of the medicine.
The route of administration.
The frequency of administration.
Details of any minimum or maximum period over which the medicine should be administered.
Details of any relevant warnings.
Details of any follow up action to be taken and in what circumstances.
Arrangements for referral for medical advice if required.
Details of the records to be kept of the supply, or administration, of products under the PGD.
Who needs to be involved in writing and signing off dental PGDs?
Legislation requires that each dental PGD is approved and signed by [1,8]:
a dentist*who should have been involved in developing the directionAND
a pharmacist*who should have been involved in developing the directionAND
a representative* of alocal NHS body#for NHS patients OR
a representative* of the dental business registered with the Care Quality Commission for private patients AND
the manager of the dental clinic/practice.
Recommended, but not mandatory:
A senior dental therapist or hygienist should be involved in setting up the PGD who, if involved, must sign it.
* Advice on experience and competencies that are expected of PGD signatories can be found in the PGD website Q&AsWhat experience and competencies are expected of PGD signatories?and responsibilities of signatories ofPGDs and also in the NICE PGD guidance, Section 3.7 and Table 2 [1].
#From April 2013Clinical Commissioning Groups, local authorities and the NHS Commissioning Board Area Teams were given the powers required to authorise PGDs.Legislation also put in place transitional arrangementsallowing PGDs to remain legal after their original authorising body was abolished[9].
Additional requirements of PGD legislation [1]:
Individualsworking under a PGD must have written authorisation from a senior responsible person/manager within their practice/clinic/organisation.
PGDs can only be used for the sale/supply or administration of licensed medicines.
Asenior dentist/dental care professional should be givenresponsibility to ensure that only fully competent, qualified and trained professionals operate under PGDs.
Can PGDs be used in private dental practices?
England
Yes. Initially PGDs could only be used in NHS dental practices but The Human Medicines Regulations 2012allow non-NHS dental practices and clinics in England who are registered with the CQC for the treatment of disease, disorder or injury and/or diagnostic and screening procedures to treat patients under PGDs [10].
Wales
Yes.Initially PGDs could only be used in NHS dental practices but The Human Medicines Regulations 2012 allowstheir use in dental practices in which the individual dentists (not the practice) areregistered with Health Inspectorate Wales in accordance with the Private Dentistry (Wales) Regulations (2008) as providing private dental services [10].
Northern Ireland
Yes. Legal arrangements,predating The Human Medicines Regulations 2012,allowuse of PGDs in independent hospitals and clinics and cover private dental practices and clinics registered by the Regulation and Quality Improvement Authority (RQIA) [11].
Scotland
No.Until the Scottish legislative regime governing the regulation of care services is extended to include independent clinics and medical agencies, PGDs can only be set up for use in independent hospitals and hospices. Note that a PGD signed by a provider of an independent health care service registered in England or Wales cannot be used to authorise the supply or administration of medicines by its own staff in Scotland [12].
Are there any storage/supply requirements for medicines supplied under a PGD?
There must be comprehensive arrangements for security, storage and labelling of all medicines [13]. Medicines should be supplied either in the manufacturer’s original pack or in appropriately labelled pre-packs obtained from a licensed pre-packing unit. In particular there must be a secure system for recording and monitoring medicines use from which it should be possible to reconcile incoming stock and out-goings on a patient-by-patient basis. Names of the health professionals providing treatment, patient identifiers and medicine provided should all be recorded.
The Human Medicines Regulations 2012sets out labelling requirements that apply to all medicines, including those supplied under PGDs [14]. All PoM medicines issued under a PGD must be labelled as dispensed medicines What are the legal requirements for labelling a Prescription Only Medicine (POM) issued via a PGD before supply to the patient?[6]. For details of labelling dispensed medicines see UKMi Medicines Q&A Can dentists supply medicines [15].
If a General Sales List or a Pharmacy medicine is supplied under a PGD, the medicine does not need to be over-labelled if an original pack is issued, as long as the dose on the PGD is the same as the dose on the original pack. See Questions about labelling of P and GSL medicines on the PGD website [6].
A patient information leafletmust legally accompany a medicine issued to a patient to take home using a PGD, even when the medicine is being used off-label[1,16].It is also good practice to provide a patient information leaflet when a medicine is administered using a PGD, although this is not a legal requirement[1].
Should patients be charged for medicines issued under a PGD?
Yes. Standard prescription charge rules and exemptions apply to all patients issued a medicine to take home under a NHS PGD [1,17].
Can PGDs be used by dental therapists and dental hygienists treating patients via Direct Access?
Yes. Dental therapists and dental hygienists do not have prescribing rights and can only use medicines if they have been prescribed by a dentist or they are working under a PGD [18].
Does PGD legislation mean dental hygienists and therapists can supply Duraphat® toothpaste directly to patients but NHS dentists cannot?
Yes. High strength fluoride toothpastes (Duraphat® 2800 and 5000) are PoMs. Dentists have full prescribing rights and when treating NHS patients must issue a prescription for PoMs, including high strength fluoride toothpaste, and not issue them directly to the patient [15]. However, when working under a relevant PGD dental therapists and dental hygienists can issue high strength fluoride toothpaste (2800 and 5000 ppm fluoride) directly to the patient.
N.B. Dentists treating patients privately are still allowed to issue medicines directly to patients [15].
What resources are available to help dentists, dental therapists and dental hygienists understand and prepare PGDs?
The following information resources are freely available:
- Patient Group Directions website. [6].
The aim of this website is to provide, or signpost to, tools and resources to guide organisations and practitioners in England$ through the complex legal framework and associated processes of developing and approving PGDs. The website includes many documents helpful to new and established PGD users, including:
To PGD or not to PGD? - that is the question: A guide to choosing the best option for individual situations.
Is a PGD appropriate - questions you should consider, andsupporting resourcesyou should refer to,BEFORE you start developing a PGD.
So you think you need a PGD? How to prepare your PGD – flow diagram.
Questions about signatories of PGDs.
What are the responsibilities of signatories of PGDs?.
$Resources in Scotland are available from the NES PGD Website (Prescribing and Patient group Directions)
- Patient group directions: good practice guidanceNICE, August 2013 [1].
The guidance aims to provide good practice recommendations for systems and processes used when commissioners and providers of NHS services are considering the need for developing, authorising, using and updating PGDs. It also covers governance arrangements to ensure patients receive safe and appropriate care and timely access to medicines, in line with legislation.
- Patient Group Directions. A practical guide and framework of competencies for all professionals using patient group directions. (National Prescribing Centre – NPC, 2009) [19].
This is a practical guide for all professionals involved in setting up and using PGDs. The document provides information and guidance to organisations developing, authorising and using PGDs. It also provides a competency framework for all healthcare professionals entitled to work with PGDs and includes answers to frequently asked questions.
[Note: Changes to Medicines legislation have been made since the publication of this document; it should not be used in isolation. Electronic access to the document may cease in the future.]
- Medicines Matters: a guide to mechanisms for the prescribing, supply and administration of medicines (Department of Health, 2006) [20].
Medicines Matters is a brief guide for staff working in NHS trusts and other health and social care organisations, describing the mechanisms available for the prescribing, supply and administration of medicines which help to support the development of new/enhanced roles or service redesign.
[Note: Changes to Medicines legislation have been made since the publication of this document; it should not be used in isolation.]
References
1. NICE. Patient Group Directions: Good Practice Guidance. August 2013 (Accessed via August 2013).
2. Statutory Instrument 2010 No. 1136.The Medicines for Human Use (Miscellaneous Amendments) Order 2010 (Accessed via 2013).
3. The Human Medicines Regulations 2012. SCHEDULE 16, Patient group directions,PART 4 Classes of individuals by whom supplies may be made. (Accessed via 2013).
4. General Dental Council. Scope of Practice, Guidance for Dental Professionals. January 2009
(Accessed via August 2013).
5. NHS Primary Care Commissioning. The use of fluoride varnish by dental nurses to control caries. July 2009 (accessed via August 2013).
6. Patient Group Directions website. (Accessed via 2013).
7. The Human Medicines Regulations 2012. SCHEDULE 16, Patient group directions, This schedule has no associated Explanatory MemorandumPART 1 Particulars to be included in a patient group direction (Accessed via 2013.
8.The Human Medicines Regulations 2012. PART 12, Chapter 1, Interpretation. (Accessed via 2013).
9. The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013. (Accessed via August 2013).
10. The Human Medicines Regulations 2012. PART 12, CHAPTER 3, Exemptions relating to supply in specific circumstances,Exemption for supply etc under a PGD by dental practices and clinics: England and Wales Regulation 232. Accessed via July 2013.
11. The Regulation and Quality Improvement Authority. Regulation of Private Dental Treatment in Northern Ireland. February 2011. Accessed via July 2013.
12. MHRAPatient Group Directions in the private, prison and police sectors (Accessed via June 2013).