1. PATIENT GROUP DIRECTIONS (PGDs)
Medicines Optimisation
Hira Singh
Medicines Optimisation Pharmacist

2. What will we cover today?
Legal background to PGDs
Your responsibilities
NICE Competency Framework
Current Influenza PGD through case studies

3. Quiz PGD Quiz Sept 2014.doc PGD Quiz Answers.doc

4. 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 legal framework to protect patients
Reduce delays in treatment
Maximise the use of the skills of a range of health professionals

5. Definition
“a written direction relating to the supply or administration of a named medicine in an identified situation.
It applies to group of patients (rather than named patients) who may not necessarily be individually identified prior to presentation for treatment.”
PGD’s reserved for limited situations where: -
advantage for patient care
does not compromise patient safety
consistent with professional relationships and accountability.
The supply and administration of medicines is controlled by The Medicines Act 1968 and controlled drugs (CDs) are regulated by The Misuse of Drugs Act and Misuse of Drugs Regulations 1985.
Following a parliamentary review these were amended to allow for the supply and administration of medicines, without the need for an individual prescription, by a defined group of health professionals under Patient Group Directions (PGDs).
The Health Service Circular 2000/026 (9th August, 2000) Patient Group Directions (PGDs), subsequent amendments and more recently PGD guidance issued by the Medicines & Healthcare Regulatory Agency (MHRA), detail the legislation and guidance governing the development, implementation, use and review of PGDs within the NHS and other organisations providing health care services.

6. In an identified clinical situation (subject to specific exclusions)
Or more simply:
They are written instructions relating to:
Supply, sale &/or admin
Of a named medicine
To a group of patients
In an identified clinical situation (subject to specific exclusions)
Signed by a doctor or dentist & by a pharmacist
In existence since Aug 2000
They are not a form of prescribing

7. PGD Legislation
The Health Service Circular (HSC) 2000/ (9th August, 2000) Patient Group Directions,
The Medicines & Healthcare Regulatory Agency (MHRA) &
PGD NICE guidance (2013)
- These detail legislation and guidance governing the:
development
implementation
use & review of PGDs
(within the NHS and other organisations providing health care services).
The Health Service Circular 2000/026 (9th August, 2000) Patient Group Directions (PGDs), subsequent amendments and more recently PGD guidance issued by the Medicines & Healthcare Regulatory Agency (MHRA), detail the legislation and guidance governing the development, implementation, use and review of PGDs within the NHS and other organisations providing health care services.

8. PGD Legislation The HSC 2000/026 & MHRA – defines PGD content
such as: -
Period PGD is valid;
Patient details
The clinical situations to which the PGD relates
The clinical criteria under which a person shall be eligible for treatment
Treatment / medicine allowed via PGD & its specifics
Staff details (who can use the PGD)
Management of PGD / Authorisations (signatures) Etc….
NICE Guidance 2013 – includes competencies of all involved with PGDs
The supply and administration of medicines is controlled by The Medicines Act 1968 and controlled drugs (CDs) are regulated by The Misuse of Drugs Act and Misuse of Drugs Regulations 1985.
Following a parliamentary review these were amended to allow for the supply and administration of medicines, without the need for an individual prescription, by a defined group of health professionals under Patient Group Directions (PGDs).
The Health Service Circular 2000/026 (9th August, 2000) Patient Group Directions (PGDs), subsequent amendments and more recently PGD guidance issued by the Medicines & Healthcare Regulatory Agency (MHRA), detail the legislation and guidance governing the development, implementation, use and review of PGDs within the NHS and other organisations providing health care services.

9. Patient Group Directions (PGDs)
The PGD forms the legal entitlement for health care professionals (HCP) named within it
to take a decision
to supply and/or administer
an identified POM
to defined patient groups,
with an identified clinical condition, without the patient needing to see a prescriber.
PGDs were introduced as a facilitative measure to allow non-prescribing health care professionals to take a decision to supply and/or administer an identified POM to a patient with an identified clinical condition, without the patient needing to see a prescriber.
This could be useful in services where assessment and treatment follows a clearly predictable where a practice nurse has the experience and knowledge to make decisions on appropriate treatment (e.g. immunisation, family planning and travel clinics).

10. Who can use a PGD?
Chiropodists Podiatrists Dental hygienists Dieticians
Midwives Nurses Occupational therapists
Optometrists Orthoptists Orthotists & prosthetists
Paramedics Pharmacists Physiotherapists
Radiographers Speech & language therapists
The HCP must be individually named & 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 & accountability (as defined by their registering / professional body).

11. Important points to note
PGDs developed by a doctor, pharmacist, member of HCP
A PGD must be authorised (authorising bodies)
(AT’s, LA’s, Acute trusts, CCG’s)
Most licensed medicines can be used in a PGD
As PGDs provide a legal framework to practice within, stepping outside the set boundaries may represent a criminal act, e.g. giving an undefined dose of the medicines
Many Professionals
Nurses, Pharmacists, Optometrists, Dieticians
Midwives, Occupational therapists, Podiatrists,
Chiropodists, radiographers, physiotherapists & ambulance paramedics
Individual practitioners must be named
Must be registered members of their professions
Must act within their appropriate code of professional conduct

12. Important points to note
Own professional responsibility to ensure that understand the use, dose, adverse effects, cautions and contraindications for each medicine you administer.
Must use professional judgement in each individual situation
- a PGD may allow an action to occur, (it does not compel it to happen in every circumstance)
Patients must still give valid informed consent before care proceeds

13. What is the difference between prescribing & PGDs ?
Assess patient and diagnose
Medicine needed?
Issue prescription to a named individual
Pharmacist dispenses
Patients receives medicine
The HCP instructed to supply does not need to assess and diagnose patient
Patient presents directly to HCP using PGD
HCP assesses the patient fits the criteria in the PGD
Medicine needed?
HCP supplies or administers
Generally not suitable for long-term management of conditions
PGDs
Prescribing

14. General Principles (1)
PGDs should be reserved for limited situations where this offers an advantage to groups of patients without compromising safety
Usually for one-off treatment and not for long-term treatment
childhood vaccines
minor ailments
emergency contraception
ECPs' work
acute exacerbation of chronic conditions e.g. prednisolone for COPD
Use of a PGD should be consistent with the provision of healthcare by the individual service and professional involved

15. General Principles (2)
Supply or administration cannot be delegated to another person under a PGD
Separate PGD is needed for each individual medicine. Different presentations of the same med can be included e.g. liquid & tabs
If a patient is excluded it does not mean they can not have the medicine. It means that it can not be given via a PGD & the patient should be referred to a GP for further assessment

16. 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 for the PGD to be legal:
The date PGD begins & expires (authorised for a max of 2 yrs)
Description of medicine
Class of HCP who can supply/administer
Signature of senior doctor/dentist & pharmacist involved in its writing and a member of the profession to whom it relates.
Signature of appropriate organisation i.e. Clinical Governance lead or Medical Director (authorisation of organisation in which it operates)
Clinical condition or situation to which PGD applies
Criteria for inclusion & description of patients excluded.

17. What should be in a PGD?
Description of circumstances where further advice needed
Details of referral process (GP, 111, 999)
Details about: - dose, - max dose,
- quantity, - form & strength,
- route, - frequency
Relevant warnings including ADRs
Necessary follow up action

18. Your Responsibilities (1)
Carefully read & ensure you understand all sections
Ensure you meet the characteristics of staff section i.e. qualifications, experience & training required
PGD document
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 PGDs
Partners in improving local health

19. Your Responsibilities (2)
By signing - you agree to work within terms described in PGD
If you work outside these terms you are putting yourself and possibly the patient at risk
You are responsible for assessing the patients fit the inclusion criteria and be satisfied with info collected
You must work within your own clinical competency
It is your responsibility to be aware of changes to clinical practice

20. The NICE PGD Competency Framework (1)
The PGD competency framework
developed as a tool to:
support individual people and
organisations that are using PGDs.
The full framework is available on the NICE website and included in the dedicated NHS PGD website

21. PGD Competency Framework (2)
It provides guidance on the competencies required to enable you to work safely and effectively with a PGD
Can be used to identify training requirements & CPD as part of an appraisal process
The authorising manager/line manager can complete the assessment or delegate this to an experienced and suitably qualified mentor
It’s the authorising manager/line manager’s responsibility to ensure staff meet the competencies

22. PGD Competency Framework (3)
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.

23. PGD Competency Framework (3)
Intended to be a developmental tool to support individuals
Not to be used as a grading or assessment tool
It may help to;
Identify training needs
Facilitate continuing professional development
Establish training programmes

24. Domain: The patient consultation
Competency area: Knowledge
Has up-to-date clinical, pharmacological and pharmaceutical knowledge relevant to the scope of the PGD.
Competencies
Evidence / comments
Understands the clinical condition(s) being treated, their natural progress and how to assess their severity (recommendation 2.5.2).
User to make notes or provide evidence of competency in these boxes.
Understands different non-drug and drug approaches to modifying disease and promoting health, identifies and assesses the desirable outcomes of treatment (recommendation 2.5.2).
Recognises the potential for adverse events and how to avoid/minimise and manage them (recommendation 2.5.3).
Demonstrates an up-to-date knowledge about the medicine(s) included in the PGD, including its mode of action, pharmacokinetics, indication, contraindications, cautions and drug interactions (recommendation 2.5.2).

25. Domain: The patient consultation
Competency area: Options
Makes or reviews a diagnosis, generates management options for the patient and follows up management within the scope of the PGD.
Competencies
Evidence / comments
Knows how to take an appropriate medical history and medication history, including current and previously prescribed medicines in addition to non‑prescribed medicines, supplements and complementary remedies (recommendation 2.5.3).
User to make notes or provide evidence of competency in these boxes.
Is able to undertake an appropriate clinical assessment using relevant equipment and techniques (recommendation 2.5.3).
Is able to interpret relevant investigations and patient records (recommendation 2.5.3).
Understands the effect of multiple clinical conditions, existing medication, allergies and contraindications on management options (recommendation 2.5.3).
Is able to make, or understand, the diagnosis by considering and systematically deciding between the various possibilities (recommendation 2.5.3).
Knows when to consider alternative options for treating the patient’s condition, including no treatment, non-drug and drug interventions (recommendation 2.5.3).
Is able to select the most appropriate PGD for an individual patient (recom ).
Is able to select the most appropriate drug, dose and formulation for an individual patient (recommendation 2.5.3).
Understands how to assess and monitor the effectiveness of the patient’s treatment and potential adverse events (recommendation 2.5.3).

26. Competency area: Shared decision‑making
Domain: The patient consultation
Competency area: Shared decision‑making
Establishes a relationship based on trust and mutual respect and recognises patients as partners in the consultation.
Competencies
Evidence / comments
Takes confidentiality, dignity and respect into account when undertaking a patient consultation (recommendation 2.5.3).
User to make notes or provide evidence of competency in these boxes.
Is able to adapt consultations to meet the needs of each individual patient and respects their values, beliefs and expectations (recommendation 2.5.3).
Works with the patient to make an informed choice about their treatment and respects their right to refuse or limit treatment (recommendation 2.5.3).
Is able to explain the patient’s condition and the rationale behind the treatment options, including the risk of harm and potential benefit (recommendation 2.5.3).
Knows how to assess the patient’s understanding of, and commitment to, their treatment, monitoring and follow-up (recommendation 2.5.3).

28. Competency area: Governance
Domain: Safe and effective
Competency area: Governance
Ensures practice is within the legal framework and follows local processes and governance arrangements.
Competencies
Evidence / comments
Understands and works within current medicines legislation relevant to PGDs, and understands how this applies in practice (recommendations 2.1.3, 2.1.5–2.1.9, 2.4.1, 2.4.3, 2.4.6, 2.5.3– 2.5.6, 2.8.7).
User to make notes or provide evidence of competency in these boxes.
Understands and works within relevant code(s) of professional conduct and organisational governance arrangements (recommendations 2.1.1, 2.5.1, 2.8.1, 2.8.4).
Understands and follows the local PGD policy and/or medicines policy (recommendations 2.5.1, ).
Understands and accepts personal responsibility for working within PGDs and understands the legal implications of doing so (recommendations 2.1.5, 2.4.9, 2.5.1–2.5.7).
Is aware of own role and responsibilities and lines of accountability (recommendations 2.1.1, –2.5.7, 2.8.1).
Makes ethical and/or clinical decisions based on the needs of patients, not personal considerations (recommendation 2.5.3).
Knows how to record relevant information to maintain an effective audit trail of documents and actions, including version control (recommendations 2.5.7, 2.8.7).
Understands the importance of patient confidentiality in line with regulatory standards and contractual requirements (recommendation 2.5.1).
Is familiar with patient consent in the context of PGDs, including Gillick competence and Fraser guidelines (recommendation 2.5.7).
Knows how and when PGDs need to be reviewed and updated (recommendations 2.6.1–2.6.9).

29. Competency area: Always improving
Domain: Safe and effective
Competency area: Always improving
Actively participates in reviewing and developing current practice to optimise patient outcomes. Is self-aware and confident in own ability to use PGDs.
Competencies
Evidence / comments
Takes responsibility for own learning and continuing professional development (recommendation 2.5.2).
User to make notes or provide evidence of competency in these boxes.
Knows the limits of their own knowledge, skills and experience and works within them (recommendation 2.5.2).
Shares and debates own and others practice, and acts upon feedback and discussion.
Recognises and deals with pressures that may result in inappropriate use of PGDs.
Develops and makes use of networks for support, reflection and learning.
Understands the need to monitor and evaluate PGDs and their use in practice (recommendations 2.6.4, 2.8.6, 2.8.7).

30. Domain: PGDs in context
Competency area: Information
Accesses relevant information and applies this in own practice.
Competencies
Evidence / comments
Is able to use standard software packages and the internet to search for relevant information (recommendation 2.5.3).
User to make notes or provide evidence of competency in these boxes.
Understands and applies the principles of evidence- based medicine.
Is able to interpret relevant medicines information, such as the summary of product characteristics and NICE guidance (recommendations 2.5.2, 2.5.3).
Understands the advantages and limitations of different information sources.
Applies information to the clinical context, linking theory to practice.

31. Competencies Evidence / comments
Domain: PGDs in context
Competency area: The healthcare system
Ensures practice is within national policies, systems and processes that impact on current practice. Sees how own practice impacts on the wider healthcare community.
Competencies
Evidence / comments
Understands the benefits and risks of alternative options for supplying and/or administering medicines, including independent prescribing, supplementary prescribing and Patient Specific Directions (recommendations 2.1.1–2.1.3).
User to make notes or provide evidence of competency in these boxes.
Understands the current service where the PGD is used and/or future service provisions for supplying and/or administering the medicine(s), including where the medicine(s) fits within the care pathway (recommendations 2.1.4, 2.6.4).
Understands the national frameworks for medicines use, such as NICE, SMC, AWMSG, and local medicines optimisation strategies.
Understands and works within local frameworks for medicines use that support the PGD, as appropriate, such as local formularies, care pathways, decision support tools, protocols and guidelines.
Understands and works within the NHS/organisational or other ethical code of conduct when dealing with the pharmaceutical industry.
Understands the legal requirements for the collection of appropriate prescription charges (recommendation 2.5.6).

32. Competency area: Collaboration
Domain: PGDs in context
Competency area: Collaboration
Works in partnership with colleagues and collaborates with internal and external stakeholders for the benefit of patients.
Competencies
Evidence / comments
Understands and works within local contractual requirements relating to PGDs (recommendations 2.8.1–2.8.3).
User to make notes or provide evidence of competency in these boxes.
Thinks and acts as part of a multidisciplinary team to ensure that continuity of care is developed and not compromised.
Establishes relationships with colleagues and all relevant stakeholders based on understanding, trust and respect for each other’s roles.
Knows when to refer to, or seek guidance from, another member of the team or a specialist.
Provides support and advice to colleagues and all relevant stakeholders, when appropriate.

33. Vaccine storage/transport
Storage as per manufacturer’s state
Refrigerated items
Usually stored between +2°C to +8°C
Lockable, dedicated medication fridge
Important not to over fill fridge
Integrated / independent thermometer needed
Daily temperature monitoring & recording
SOP for fridge monitoring (named persons responsibility)
Transport – ensure cold chain maintained.

34. Influenza PGD case scenarios
Help illustrate the PGD in practice
For each case,
Think about the process you will follow.
Go through the influenza PGD using the clinical information provided.
What decisions you would make?
Why?
If you administer, what vaccine do you use?
What advice would you give?

35. Summary of process to identify patients who can be treated
Patient presents
Do they have the condition in question?
Do they meet the inclusion criteria?
Do any exclusion criteria apply to this patient?
Do they wish to be vaccinated in this way?
Vaccinate as per PGD
Stop
&
Refer No
Yes No
Yes
Yes No No
Yes

36. Influenza PGD case scenarios
Help illustrate the PGD in practice
Case 1
The following patient requests Flu vaccination
35 year old,
Uses salbutamol & low dose BDP,
Pregnant (1st trimester),
sensitivity to nuts
Influenza PGD (com pharm) final pdf
Partners in improving local health

37. Influenza PGD case scenarios
Help illustrate the PGD in practice
Case 2
The following patient requests Flu vaccination
79yr old male
CHD, AF,
sensitivity to eggs,
Has had shingles vaccine 4 weeks previous
Influenza PGD (com pharm) final pdf

38. Influenza PGD case scenarios
Help illustrate the PGD in practice
Case 3
Following patient requests Flu vaccination
59yr old
Diabetic type 2
on warfarin (last INR 3.9 four weeks ago)
Had Fluvirin last year and it gave him flu symptoms?
Influenza PGD (com pharm) final pdf

39. Influenza PGD case scenarios
Help illustrate the PGD in practice
Case 4
This patient requests Flu vaccination
69 year old
Hypertensive, MI
Kidney disease (CKD 3)
Carries an adrenaline pen as has an allergy to eggs
Influenza PGD (com pharm) final pdf

40. Influenza PGD case scenarios
Help illustrate the PGD in practice
Case 5
This patient requests Flu vaccination
38 year old
Haemophiliac
Allergy to gentamicin
Had flu vaccine last year but missed flu clinic last week
Influenza PGD (com pharm) final pdf

41. Influenza PGD case scenarios
Help illustrate the PGD in practice
Case 6
This patient requests Flu vaccination
32 year old, healthy person,
Receives benefits as main carer for elderly mum
Mum is taking prednisolone and a DMARD for rheumatism
Influenza PGD (com pharm) final pdf

42. Influenza PGD case scenarios
Help illustrate the PGD in practice
Case 7
This patient requests Flu vaccination
22 year old,
Works as a carer in a 10 bed residential care home
In receipt of some benefits.
Care home residents are all over 65 years old.
Influenza PGD (com pharm) final pdf

43. PGD update – immunisation & vaccines
Influenza
cohort expansion
Anticoags/bleeding disorders
Adrenaline
Recommended doses (500mcg)
Products available (Emerade – 500mcg auto injector)
Adrenaline PGD comm pharm (amended ).doc

44. Thank you
Any questions?

45. Key resources available
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
National Patient Group Directions Website
NICE medicines practice guidelines (MPG2) Patient Group Directions August 2013 & associated resources