PATIENT GROUP DIRECTIONS (PGDs)

Partners in improving local health NHS Confidential / Protect / Unclassified - Slide 1

PATIENT GROUP DIRECTIONS (PGDs)

Medicines Optimisation

Hira Singh

Medicines Optimisation Pharmacist

Partners in improving local health

What will we cover today?

• Legal background to PGDs• Your responsibilities• NICE Competency Framework• Current Influenza PGD through case studies


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

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 caredoes not compromise patient safetyconsistent with professional relationships and accountability.

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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


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).

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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

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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.

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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). 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

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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

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What is the difference between prescribing & PGDs ?

• 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

Prescribing

PG

Ds

• 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


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


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


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.


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


Your Responsibilities (1)

Sign the appropriate documentation and keep a copy for your records

PGD document

Carefully read & ensure you understand all sections

Ensure you meet the characteristics of staff section i.e. qualifications, experience & training required

Read any other documentation referred to e.g. BNF section, manufacturers SPCs

Clinical Leads – ensure you are aware of who has signed the PGDs


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

http://tidalseven.com/wp-content/uploads/2012/01/SquarePeg-RoundHole.jpg


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/

http://www.medicinesresources.nhs.uk/en/Communities/NHS/PGDs/

http://www.medicinesresources.nhs.uk/en/Communities/NHS/PGDs/


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



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.



• 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



Domain: The patient consultationCompetency area: KnowledgeHas up-to-date clinical, pharmacological and pharmaceutical knowledge relevant to the scope of the PGD.

Competencies Evidence / commentsUnderstands 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).


Domain: The patient consultationCompetency area: OptionsMakes 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).


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).


Domain: The patient consultation

Competency area: Shared decision‑makingEstablishes a relationship based on trust and mutual respect and recognises patients as partners in the consultation.


Takes confidentiality, dignity and respect into account when undertaking a patient consultation (recommendation 2.5.3).


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).


Domain: Safe and effective

Competency area: Safe - Is aware of own limitations and does not compromise patient safety.


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



Competency area: GovernanceEnsures practice is within the legal framework and follows local processes and governance arrangements.


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).


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).

http://publications.nice.org.uk/patient-group-directions-gpg2/introduction

http://publications.nice.org.uk/patient-group-directions-gpg2/appendix-a-glossary

http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_103643



Competency area: Always improvingActively participates in reviewing and developing current practice to optimise patient outcomes. Is self-aware and confident in own ability to use PGDs.

Competencies Evidence / commentsTakes responsibility for own learning and continuing professional development (recommendation 2.5.2).


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).


Domain: PGDs in context

Competency area: InformationAccesses relevant information and applies this in own practice.


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 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.


http://guidance.nice.org.uk/


Domain: PGDs in contextCompetency area: The healthcare systemEnsures practice is within national policies, systems and processes that impact on current practice. Sees how own practice impacts on the wider healthcare community.


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).


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).




http://www.nice.org.uk/

http://www.scottishmedicines.org.uk/Home

http://awmsg.org/

http://www.nice.org.uk/mpc/goodpracticeguidance/GPG1.jsp


Domain: PGDs in context

Competency area: CollaborationWorks in partnership with colleagues and collaborates with internal and external stakeholders for the benefit of patients.


Understands and works within local contractual requirements relating to PGDs (recommendations 2.8.1–2.8.3).


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.



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.

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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?



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

Yes

Yes

Yes

No

No

No

No

Yes



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.pdfNHS Confidential / Protect / Unclassified - Slide 36




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.pdfNHS Confidential / Protect / Unclassified - Slide 37




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





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





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





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





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



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



Thank you

• Any questions?



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


http://www.medicinesresources.nhs.uk/

PATIENT GROUP DIRECTIONS (PGDs)

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