PATIENT GROUP
DIRECTIONS (PGDs)
Medicines Optimisation
Hira Singh
Medicines Optimisation Pharmacist
Partners in improving local health
NHS Confidential / Protect / Unclassified - Slide 1
What will we cover today?
•
•
•
•
Legal background to PGDs
Your responsibilities
NICE Competency Framework
Current Influenza PGD through case studies
Partners in improving local health
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
Partners in improving local health
NHS Confidential / Protect / Unclassified - Slide 4
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.
Partners in improving local health
5
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
Partners in improving local health
PGD Legislation
The Health Service Circular (HSC) 2000/026
(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).
Partners in improving local health
7
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
Partners in improving local health
8
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.
Partners in improving local health
9
Who can use a PGD?
Chiropodists
Midwives
Optometrists
Podiatrists
Nurses
Orthoptists
Paramedics
Radiographers
Pharmacists
Dental hygienists Dieticians
Occupational therapists
Orthotists & prosthetists
Physiotherapists
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).
Partners in improving local health
NHS Confidential / Protect / Unclassified - Slide 10
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
Partners in improving local health
11
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
Partners in improving local health
12
What is the difference between
prescribing & PGDs ?
• HCP assesses the
patient fits the criteria in
the PGD
• Medicine needed?
Prescribing
• Patient presents directly
to HCP using PGD
• Assess patient and
diagnose
• Medicine needed?
• Issue prescription to a
named individual
• Pharmacist dispenses
• HCP supplies or
administers
• Patients receives
medicine
• Generally not suitable
for long-term
management of
conditions
• The HCP instructed to
supply does not need to
assess and diagnose
patient
Partners in improving local health
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
Partners in improving local health
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
Partners in improving local health
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.
Partners in improving local health
What should be in a PGD?
• Description of circumstances where further advice needed
• Details of referral process (GP, 111, 999)
• Details about:
- dose,
- quantity,
- route,
- max dose,
- form & strength,
- frequency
• Relevant warnings including ADRs
• Necessary follow up action
Partners in improving local health
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
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
Partners in improving local health
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
• http://www.medicinesresources.nhs.uk/en/Communities/NHS/PGDs/
Partners in improving local health
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
Partners in improving local health
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.
Partners in improving local health
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;
1. Identify training needs
2. Facilitate continuing professional development
3. Establish training programmes
Partners in improving local health
NHS Confidential / Protect / Unclassified - Slide 23
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).
NHS Confidential / Protect / Unclassified - Slide 24
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. 2.5.3).
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).
NHS Confidential / Protect / Unclassified - Slide 25
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).
NHS Confidential / Protect / Unclassified - Slide 26
Domain: Safe and effective
Competency area: Safe - Is aware of own limitations and does not compromise patient safety.
Evidence / comments
Competencies
Is aware of how medicines are licensed, sourced, supplied and monitored, and the implications for
their own practice (recommendations 2.1.6, 2.1.7).
Knows about the common types of medication errors and how to prevent them
(recommendations 2.8.4, 2.8.5).
Knows how to identify and report patient safety incidents relating to the PGD, such as medication
errors, near misses and suspected adverse events (recommendations 2.8.5, 2.8.7).
Knows how to keep up to date with safety concerns related to the medicine(s) included in the PGD
(recommendation 2.6.9).
Understands the potential for misuse of medicines (recommendations 2.1.1, 2.1.9).
Understands antimicrobial resistance, healthcare-associated infections and the roles of infection
prevention and control, and antimicrobial stewardship (recommendation 2.1.10).
Understands the importance of robust medicines management systems supporting the use of PGDs,
such as the need for appropriately labelled packs, medicines procurement and safe storage
(recommendations 2.5.3–2.5.6).
Is able to assess the risk of, and deal with, adverse events after administration of a medicine,
including supportive measures for potentially life-threatening adverse events
(recommendation 2.5.3).
Is able to check doses and calculations to ensure accuracy and safety (recommendation 2.5.3).
Understands the need for accurate, clear and timely records and clinical notes
NHS Confidential / Protect / Unclassified - Slide 27
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,
2.8.2).
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,
2.5.1–2.5.7, 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).
NHS Confidential / Protect / Unclassified - Slide 28
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).
NHS Confidential / Protect / Unclassified - Slide 29
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).
Understands and applies the principles of evidencebased medicine.
User to make notes or provide evidence of
competency in these boxes.
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.
NHS Confidential / Protect / Unclassified - Slide 30
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
User to make notes or provide
Understands the benefits and risks of alternative options for supplying and/or
administering medicines, including independent prescribing, supplementary prescribing evidence of competency in these
boxes.
and Patient Specific Directions (recommendations 2.1.1–2.1.3).
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).
NHS Confidential / Protect / Unclassified - Slide 31
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.
NHS Confidential / Protect / Unclassified - Slide 32
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.
Partners in improving local health
33
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?
Partners in improving local health
NHS Confidential / Protect / Unclassified - Slide 34
Summary of process
to identify patients who can be treated
Patient presents
Do they have the condition in question?
No
Yes
Do they meet the inclusion criteria?
No
Yes
Do any exclusion criteria apply to this patient?
Yes
No
Do they wish to be vaccinated in this way?
Yes
Vaccinate as per PGD
Partners in improving local health
No
Stop
&
Refer
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 29 08 14.pdf
Partners in improving local health
NHS Confidential / Protect / Unclassified - Slide 36
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 29 08 14.pdf
Partners in improving local health
NHS Confidential / Protect / Unclassified - Slide 37
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 29 08 14.pdf
Partners in improving local health
NHS Confidential / Protect / Unclassified - Slide 38
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 29 08 14.pdf
Partners in improving local health
NHS Confidential / Protect / Unclassified - Slide 39
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 29 08 14.pdf
Partners in improving local health
NHS Confidential / Protect / Unclassified - Slide 40
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 29 08 14.pdf
Partners in improving local health
NHS Confidential / Protect / Unclassified - Slide 41
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 29 08 14.pdf
Partners in improving local health
NHS Confidential / Protect / Unclassified - Slide 42
PGD update – immunisation &
vaccines
• Influenza
– cohort expansion
– Anticoags/bleeding disorders
• Adrenaline
– Recommended doses (500mcg)
– Products available (Emerade – 500mcg auto injector)
Adrenaline PGD comm pharm 23 09 13 (amended 14.10.13).doc
Partners in improving local health
NHS Confidential / Protect / Unclassified - Slide 43
Thank you
• Any questions?
Partners in improving local health
NHS Confidential / Protect / Unclassified - Slide 44
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
www.medicinesresources.nhs.uk
• NICE medicines practice guidelines (MPG2) Patient Group
Directions August 2013 & associated resources
Partners in improving local health
NHS Confidential / Protect / Unclassified - Slide 45