1. Patient Group Directions (PGDs) August 2019
Beverley Baker
Non-medical Prescribing Lead, Medicines Optimisation

2. Topics covered Legal background to PGDs Prescribing, PGDs and PSDs
South West PGD update
NICE Competency Framework
Healthcare Professional Responsibility
Contact Details
Resources

3. Legislation
The Human Medicines Regulation 2012 does not permit non prescribing healthcare professionals to supply or administer prescription only medicine (POMs) unless one of three types of instruction is in place:-
Signed prescription
Patient Specific Direction (PSD)
Patient Group Direction (PGD)
Exemptions, e.g. Adrenaline, can be administered in an emergency for the purpose of saving life, without the direction of a prescriber
If non prescribing healthcare professionals administer medicine on the instruction of a GP the GP must be able to show that the health care professionals has authority for that administration via one of the above methods

4. Which Organisation? Commissioners NHS England CCGs Local Authorities
Providers
NHS Organisations
Non-NHS organisations providing public health or NHS commissioned services
Secure Environments/MOD
Arrangements vary
Local organisations structures
How services are commissioned and provided
What resources are available

5. Which bodies can authorise PGDs?
Those listed in the legislation as able to authorise a PGD in England are:-
Clinical Commissioning Groups
Local Authorities
NHS Trusts or NHS Foundation trusts
Special Health Authorities
NHS England
Public Health England
An authorised signatory from the organisation must sign the PGD

6. Complex Commissioning and PGDs
NHS and non-NHS commissioner/provider arrangements are becoming increasingly complex and varied and sub contracting/partnerships working are becoming more common
Increasingly local decisions will have to be made based on the `set up’ in place and considered on a case by case basis when determining who authorises a PGD
Memorandums of Understanding may need to be drawn up where multiple providers/commissioners are involved in services using PGDs.

7. Other things to consider
Need for a robust and transparent process-PGD Policy
Clear lines of accountability and governance
Planning-workload and resources needed to review a large number of PGDs can be significant

8. Patient Group Direction-What is it?
Background The PGD forms the legal entitlement for healthcare professionals named within it to take a decision to supply and/or administer an identified Prescription Only Medicines to a defined group of patients within an identified clinical condition, without the need for a patient to see a prescriber

9. Patient Group Direction-What is it?
Definition `Written instructions for the supply or administration of medicines to groups of patients who may not be individually identified before the presentation for treatment’

10. Background to PGDs 1999-Final Crown Report
2000-Changes in legislation PGDs established, Health Services Circular 2000/026
2002/2003-Supplementary prescribing
2006-Independent prescribing
2012-The Human Medicines Regulations and The Health and Social Care Act

11. Health Service Circular 2000/026

12. Health Service Circular 2000/0026
Must be signed by a senior Doctor (or, if appropriate, a dentist) and a Senior Pharmacist, both of whom should have been involved in developing the direction
Patient Group Direction must be authorised by the HA, SHA, NHS Trust, or Primary Care Trust or Primary Care Group (in its capacity as a sub-committee of the HA)
Clinical Governance Leads are best placed to do this

13. Patient Group Directions
The preferred method for patients to received the medicines they need is for a prescriber to prescribe for an individual patient on a on-to-one basis
PGDs are reserved for limited situations where:-
Advantage for patient care
Does not compromise patient safety
Consistent with professional relationships and accountability

14. Why use a PGD?
Deliver effective patient care in a pre-defined clinical situation without compromising patient safety
Improve access to medicines-improve uptake
Provide equity in the availability and quality of services when other options for obtaining medicines are not available
Provide a safe and legal framework to protect patients
Reduce delays in treatment
Maximises the use of skills of a range of health professionals

15. Who can use a PGD?
Only those qualified and registered health professionals listed in PGD legislation
The Healthcare Professional must be individually identified named and authorised to practice under the PGD
Must be registered members of their profession
Must act within their appropriate code of professional conduct
PGD use-does not remove professional obligation and accountability (as defined by their professional body)
Please note that a non-qualified Healthcare Assistant cannot use a PGD

16. Who can use a PGD? Chiropodist Midwife Optometrist Paramedic
Radiographer
Podiatrist
Nurses
Orthoptist
The Future-2019/20-OPDs, clinical scientists, biomedical scientists
Pharmacists
Speech and Language Therapist
Dental Hygienist
Dietician
Occupational Therapist
Orthotist and Prosthetists
Physiotherapist
The Future-20??-Physician Associates/Nursing Associates

17. Caution with professions listed v job title
PGD cannot refer to `Emergency Care Practitioner (ECP)’ to cover a range of professionals employed in this role-ECP is not a protected title and is not within PGD legislation
PGD must refer to those registered professionals who have the role of an ECP e.g. registered nurse, registered paramedic
Employer must assure themselves that the person is currently registered and has declared that they are competent to carry out the provisions of the PGD

18. What should be in a PGD?
A PGD sets out specific details for a number of criteria
The key areas in a PGD are listed below, all must be present in the PGD to be legal
The date the PGD begins and expires (authorised for a maximum of 2 years)
Description of medicines, dose, max dose, strength, form, route, quantity, frequency
Class of Healthcare Professional who can supply/administer
Signature of senior Doctor/Dentist and Pharmacist involved in its writing and a member of the profession to whom it relates
Signature of appropriate organisation i.e. clinical governance lead
Clinical condition or situation to which the PGD applies
Criteria for inclusion and description of the patients excluded
Any warnings or Adverse Drug Reactions
Follow up details, referral details

19. General Principles
PGDs should be reserved for limited situations where this offers an advantage to groups of patients without compromising safety
Usually for one off treatments:-
Childhood vaccines
Minor Ailments
Emergency contraception
Emergency Care Practitioners work
Acute exacerbation of chronic conditions e.g. prednisolone to COPD
Use of a PGD should be consistent with the provision of healthcare by the individual service and profession involved

20. General Principles
Supply or administration cannot be delegated to another person under a PGD
Separate PGD is needed for each individual medicines. Difference presentations of the same medicine can be included e.g. liquid and tablets
If a patient is excluded it does not mean they can not have the medicines. It means that they cannot be given via a PGD and the patient should be referred to a GP for further assessment

21. General Principles
`Patients who may not be individually identified before presentation for treatment’
The intended meaning is that patients may/or may not be identified, depending on the circumstances
May not be identified, urgent care, immunisation clinics
May be identified; repeat supply of contraception where patients may be known to the services from a previous episode of care

22. Is a PGD legal?
PGDs must only include medicines with a UK marketing authorisation
Some restrictions on what can be included in a PGD
Controlled drugs restrictions
Other legal requirements also apply to PGDs
Labelling of medicines
Provision of a manufacturers patient information leaflet
Prescription charges and exemptions

23. Controlled Drugs and PGDs
Currently the following controlled drugs can be included on PGDs:-
Schedule 2-Morphine and Diamorphine (only registered nurses or paramedics for the immediate necessary treatment of a sick or injured person
Schedule 2-Ketamine
Schedule 3- Midazolam
Schedule 4- All drugs except anabolic steroids and injectables used for treating addiction
Schedule 5- All drugs

24. Difference between PGD and Prescribing
Patient directly presents to HCP
HCP assesses the patient fits the criteria in the PGD
Medicines needed?
HCP supplies or administers
Generally not suitable for management of long term condition
Prescribing
Assess patient and diagnose
Medicine needed?
Issue prescription to a named individual
Pharmacist dispenses
Patient received the medicine
The HCP instructed to supply does not need to assess and diagnose the patient

25. Patient Specific Direction
Definition
A Patient Specific Direction (PSD) is a written and signed instruction, given by a Doctor, Dentist, or Non-medical prescriber to another professional to supply and/or administer medicine(s) to a named person. The person must have been individually assessed by the prescriber.

26. Medicines Entitlements of HCPC Professions

27. South West PGD website

28. South West PGDs PGD section Immunisation by vaccination
School Age immunisations
Adult Immunisations
Individuals at risk
Seasonal Influenza
Emergency Preparedness
Local
Pharmacy First PGDs, Chloramphenicol 0.5 % eye drops, Fusidic Acid 2% Cream, Nitrofurantoin Capsules and Timodine Cream

29. PGD Virtual Review Panel (PGD VRP)
Role is to advise the NHS Devon CCG in relation to PGDs across the organisation
Meet monthly
Terms of Reference for the Group
Members, Deputy Director of Nursing, Deputy Director for Medicines Optimisation and Pathology Optimisation, Head of Pharmacy and Controlled Drugs Accountable Officer, Medicines Optimisation Pharmacist x2, Non-medical Prescribing Lead
Authorising organisation for PGDs in
Devon Doctors Ltd
Livewell Southwest
Exmouth Minor Injury Unit
Pharmacy First PGDs

30. FAQ-Can I write my own PGD?
Governance processes in place
Service has to be commissioned
Only certain organisations can authorise PGDs
PGD group, which includes a terms of reference, and includes Doctor, Pharmacist, Healthcare Professional
Memorandum of Understanding between the provider and the CCG
Additional assurance documents:-
PGD policy
Medicines policy
NMP policy
Workplan
Minutes of PGD meetings
Supporting protocols
Index list/database

31. FAQ-Retention of documents?
8 years after the expiry date of the PGD relates to adults only
10 years if relates to implant
25 years after the expiry date of the PGD if relates to children

32. FAQ-Formulary ?

33. NICE MPG 2 (2017) Medicines Practice Guidelines
These detail legislation and guidance governing:-
Development
Implementation
Use and review of PGDs
within the NHS and other organisations providing healthcare services

34. Competency Framework

35. The NICE PGD competency framework
Developed as a tool to:-
Support individual people
Support organisations that are using PGDs
The full framework is available on the NICE website

36. The NICE PGD Competency Framework
It provides guidance on the competencies required to enable you to work safely with a PGD
Can be used to identify training requirements and CPD as part of an appraisal process
The authorising manager/line manager can complete the assessment or delegate this to an experienced and suitable qualified mentor
It’s the authorising manager/line managers responsibility to ensure staff meet the competencies

37. The NICE PGD Competency Framework
Covers 3 domains and 9 competency areas
1.The patient consultation
Knowledge, Options, Shared Decision Making
2.Safe and Effective
Safe, Governance, always Improving
3.PGDs in context
Information, the Healthcare System, Collaboration
Each competency area includes
A statement that gives a general overview of what the competency area covers
A list of individual competencies, referenced to relevant good practice recommendations, where applicable

38. The NICE PGD Competency Framework
Intended to be developmental tool to support individuals
Not to be used as a grading or assessment tool
Identify training needs
Facilitate Continuing Professional Development
Establish training programmes

39. Competency Framework

40. Healthcare Professional Responsibilities
Carefully read and ensure you understand all sections
Ensure you meet the characteristics of staff section i.e. qualifications, experience and training required
Read any other documentation referred to e.g. BNF section manufacturers SPCs
Sign the appropriate documentation and keep a copy for your records
Clinical Leads ensure you are aware of who has signed the PGD

41. Healthcare Professional Responsibilities
By signing you agree to work within terms described in the PGD
You are responsible for assessing the patient fits the inclusion criteria and be satisfied with the information collected
You must work within your own clinical competency
It is your responsibility to be aware of changes in clinical practice
It is your responsibility to be aware of updated versions of PGDs

42. Summary PGDs provide a legal framework to practice
PGDs developed by a Doctor, Pharmacist and member of the Healthcare Profession
A PGD must be authorised by an organisation listed in legislation
Own professional responsibility to ensure understand the use, dose, adverse effects, cautions and contraindications for each medicine you administer
Must use professional judgement in each individual situation
Patients must give valid informed consent before care proceeds

43. Contact Details England.southcentral-pgd@nhs.net
Immunisation on website
South West Screening and Immunisation Team
Non-medical Prescribing Lead

44. Resources
Department of Health (2000) HSC 2000/026 Patient Group Directions
Her Majesty’s Government (2012) The Human Medicines Regulations 2012
Medicines and Healthcare Products Regulatory agency (MHRA) (2010) Patient Group Directions in the NHS

45. Resources https://www.nice.org.uk/Guidance/MPG2/Resources
NICE Medicines Practice Guidelines (2017) (MPG2) Patient Group Directions and associated resources
Specialist Pharmacy Service Patient Group Directions
NHS England South West PGDs

46. Questions ?