Patient Group Directives

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1 Patient Group Directives David Young BDS (Lond), LDS RCS (Eng), BA, MDent Sci, FHEA

2 Learning outcomes Understand how DCPs can supply, and administer POMs Explain the basics of how patient group directive (PGD) are produced Recognise key people involved and important things to include in a PGD

3 Hygienists and therapists often say My dentist doesn t prescribe LA! My dentist prescribes saying treat with LA if required Do dentists write prescriptions with please give the patient antibiotics if required - No! To comply with law the drug needs to be prescribed (POM) not the procedure Drug, dose, route, no of cartridges etc required PGD may be logical way forward

4 Current situation For a dental hygienist or dental therapist to administer an LA or apply topical fluoride, a prescription is required or a patient group direct (PGD) needs to be in place This is essential to comply with law, because they re prescription only medicines

5 Law and the evolution of PGDs Medicines Act 1968 defines POM The traditional medical model changed following a report in 1999 to allow services to be redesigned to allow more flexibly for the benefit of patients Modifications allowing PGD in: Prescription Only Medicines (Human Use) Amendment Order 2000 Medicine (Pharmacy and General Sale Exemption) Amendment Order 2000 Medicines (Sale and Supply) (Miscellaneous Provisions) Amendment (No2) Regulations HSC 2000/026

6 HSC 2000/026 Patient Group Directions (PGDs) are documents permitting the supply of prescription only medicines (POMs) to groups of patients without individual prescriptions Healthcare workers using PGDs should be sufficiently trained and competent to be able to supply and administer POMs.

7 HSC 2000/026 The qualified health professionals who may supply or administer medicines under a patient group direction are: Nurses Midwives Health visitors Optometrists Pharmacists Chiropodists Radiographers Orthoptists Physiotherapists Ambulance paramedics

8 August 2009, the MHRA and the DoH issued consultation about expanding the scope of PGDs to allow POMs to be sold, supplied and administration by dental hygienists and therapists. The proposals was about allowing hygienists and therapists to administer LA and to sell or supply fluoride supplements and toothpastes with high fluoride content e.g. 2,800 and 5,000 ppm F. The legal change came into place on 1 June The relevant Statutory Instrument is SI 2010/ 1136 The Human Medicines Regulations Act 2012 (part 4 of schedule 16) specifies dental hygienists and dental therapists can work under PGD

9 PGD applicable in all the areas below: NHS practices in England, Wales and Scotland and their equivalent in Northern Ireland Private dental practices in England registered with the Care Quality Commission 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 PGDs cannot currently be used in private dental practices in Scotland although this is due to change with registration to Health Improvement Scotland

10 NICE April 2013 Consultation on PGD good practice guidance oupdirectionsdraftforconsultation.pdf Explains the purpose and procedure for writing and setting them up

11 Key people involved with PGDs Dentist Pharmacist A representative of the commissioning NHS body or for private patients a representative of the dental business registered with the CQC The dental therapist or hygienist involved in setting up the PGD The individuals working under the PGD must be named within the PGD A dentist/dcp designated with the responsibility to ensure that only competent, trained professionals operate within PGD

12 Legislation requires that PGD must contain the following information The period during which the direction is to have effect The description of the medicine or drug The clinical situations where the drug can be used Any restrictions of sale, supply or administration Criteria for inclusion and exclusion

13 Legislation requires that PGD must contain the following information The applicable dosage and maximum dosages The form and route of administration and frequency Relevant warnings to note Arrangements for referral for dental/medical advice Details of the records to be kept

14 Record keeping Date of supply and/or administration Patient details, name, dob, allergies, previous adverse events Details of medicine, dose, frequency, route of administration. The batch number and expiry date A statement that the drug is administered under a PGD Name and signature of the health professional Relevant information, that was provided to the patient or their carer

15 DCPs responsibility DCPs who are eligible to work under a PGD have a professional responsibility to work within their competency and undertake appropriate professional development in order to work safely.

16 Review The Health Service Circular (HSC 2000/026) states that generally, a direction should be reviewed every two years

17 AN EXAMPLE

18 PGD Lidocaine

19

20

21 Fluoride varnish

22

23 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 the signatories to the PGD, any licensed Pharmacy Medicine (P) or Prescription Only Medicine (PoM) can be included in a PGD. NW Medicines information centre

24 Summary For POM medicines to be dispensed or administered DCPs must have by law a prescription or PGD PGD can increase DCPs autonomy but it requires defined parameters being set, so it means good teamwork and communication with colleagues is essential

25 Teamwork

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