Signed, sealed, delivered?

shutterstock_108481418In another of the series of legal articles from Dental Protection, Joe Ingham explains the current legal position of Patient Group Directions and how this affects those working with direct access – and those considering it.

Patient Group Directions (PGDs) are not well understood and, for some, they seemed to offer the means by which dental hygienists and therapists (DHTs) could prescribe local anaesthetic for their patients when no dentist is available to provide the prescription.

A PGD is a written instruction that allows listed healthcare professionals to sell, supply or administer named medicines in an identified clinical situation, without the need for a written, patient-specific prescription from an approved prescriber.

The Human Medicines Regulations 2012 require that both a dentist and a pharmacist must sign a PGD. For practices providing NHS primary dental services, the PGD must also be signed on behalf of the commissioning body. For private dental practices in England and registered with the Care Quality Commission (CQC), the PGD must be signed by a dentist and a pharmacist and by or on behalf of the registered provider and, if there is a relevant manager for the practice or clinic, by that manager. For private practices in Wales, the PGD must be signed by the private dentist who is treating the person, a pharmacist and, if there is a manager for the practice or clinic, by that manager.

The Human Medicines Regulations 2012 permit PGDs in respect of dental practices. Regulation 230 and Schedule 16 applies in respect of the supply or administration of a medicinal product by a DHT to assist a dentist in the provision of NHS Primary Dental Services. Regulations 232 and Schedule 16 provides the exemption for the sale or supply or administration by a DHT in a dental practice or dental clinic registered with the CQC in England in respect of the treatment of disease, disorder or injury and/or diagnostic screening procedures or in Wales by a DHT in a dental practice or clinic in which dental services are provided by private dentists registered with Healthcare Inspectorate Wales.

Regulations 230 and 232 set out the specific conditions that must be met.

The differences

Different conditions apply depending on whether the supply, etc, is in an NHS dental practice or a private practice. In both situations, the PGD must contain the particulars in Schedule 16 Part 1 of the regulations including:

  • The period during which the PGD is to have effect
  • The description or class of medicinal product to which it relates
  • The clinical situations which medicinal products of that description or class may be used to treat or manage in any form (except for administration PGDs only)
  • Whether there are any restrictions on the quantity of medicinal product that may be sold or supplied on any one occasion and, if so, what restrictions the clinical criteria under which a person is to be eligible for treatment and whether any class of person is excluded
  • The circumstances in which further advice should be sought from a doctor or dentist
  • The pharmaceutical form or forms in which the medicinal products of that description or class are to be administered
  • The strength or maximum strength at which the products can be administered, the applicable dosage or maximum dosage, the route and frequency of administration and the minimum or maximum period of administration
  • Relevant warnings
  • The circumstances in which any follow up action is needed
  • Arrangements for referral for medical advice
  • What records should be kept of the supply, or the administration, of products.

NHS

For NHS practices, the specific conditions in Regulation 230 are:

  • The PGD relates to the supply or administration of the medicinal product to assist the dentist in providing the services
  • The PGD has effect at the time at which the product is supplied or administered
  • The PGD contains the particulars in Schedule 16 Part 1
  • The PGD is signed by the dentist and a pharmacist and on behalf of the body commissioning the services
  • The individual supplying or administering the product is designated in writing by the dentist
  • The product has a valid marketing authorisation, Art 126 authorisation, certificate of registration or traditional herbal registration in force at the time of supply or administration.

Private

For private practices, the specific conditions in Regulation 232 are:

  • The product is sold or supplied for the purpose of being administered to a person in accordance with a PGD
  • The PGD relates to the sale or supply or administration of the medicinal product by the person by whom the product is sold or supplied or administered and has effect at the time
  • The PGD contains the particulars in Schedule 16 Part 1
  • It is signed by a dentist and a pharmacist and in England by or on behalf of the registered provider and, if there is a relevant manager for the practice or clinic, by that manager
  • In Wales, by the private dentist treating the person and manager for the practice, if there is one, and by a pharmacist
  • The person selling, supplying or administering the product is a registered DH&T and has been designated in writing for that purpose under the PGD
  • The product has a valid marketing authorisation, Art 126 authorisation, certificate of registration or traditional herbal registration in force at the time of supply or administration.

Is it valid?

Before administering drugs under a PGD, DHTs should be sure it is valid. This means checking they are named on the PGD; that the patient meets the clinical criteria; and that it applies to the prescription only medicine concerned. The DHT should be fully trained and competent to perform the procedure and is professionally accountable for their actions or omissions. They should also ensure they have adequate indemnity arrangements in place to cover the work they undertake.


A geography lesson

PGDs can be used by DHTs in:

  • NHS practices in England, Wales and Scotland and their equivalent in Northern Ireland
  • Private dental practices in England registered with the CQC
  • Private dental practices in Wales, providing the individual dentists are registered with the Health Inspectorate Wales
  • Private dental practices in Northern Ireland registered with the Regulation and Quality Improvement Authority

But

  • PGDs cannot currently be used in private dental practices in Scotland although this is due to change once there is a start date for their registration with Health Improvement Scotland

POMs away

  1. A local anaesthetic is a prescription only medicine (POM)
  2. A dentist has full prescribing rights – DHTs do not
  3. A dentist does not act as a pharmacist in relation to the parenteral administration of POMs
  4. Administration of a POM by a DHT without a patient specific direction or a patient group direction is a criminal offence
  5. The legislation is not open to interpretation

For more information please visit www.dentalprotection.org, call 0800 561 9000 or [email protected]

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