4Why use a PGD?Deliver effective patient care in a pre-defined clinical situation without compromising patient safetyImprove access to medicines – improve uptakeProvide equity in the availability and quality of services when other options for obtaining medicines are not availableProvide a safe legal framework to protect patientsReduce delays in treatmentMaximise the use of the skills of a range of health professionals
5Definition“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.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.
6In an identified clinical situation (subject to specific exclusions) Or more simply:They are written instructions relating to:Supply, sale &/or adminOf a named medicineTo a group of patientsIn an identified clinical situation (subject to specific exclusions)Signed by a doctor or dentist & by a pharmacistIn existence since Aug 2000They are not a form of prescribing
7PGD LegislationThe 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:developmentimplementationuse & 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.
8PGD Legislation The HSC 2000/026 & MHRA – defines PGD content such as: -Period PGD is valid;Patient detailsThe clinical situations to which the PGD relatesThe clinical criteria under which a person shall be eligible for treatmentTreatment / medicine allowed via PGD & its specificsStaff details (who can use the PGD)Management of PGD / Authorisations (signatures) Etc….NICE Guidance 2013 – includes competencies of all involved with PGDsThe 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.
9Patient Group Directions (PGDs) The PGD forms the legal entitlement for health care professionals (HCP) named within itto take a decisionto supply and/or administeran identified POMto 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).
10Who can use a PGD?Chiropodists Podiatrists Dental hygienists DieticiansMidwives Nurses Occupational therapistsOptometrists Orthoptists Orthotists & prosthetistsParamedics Pharmacists PhysiotherapistsRadiographers Speech & language therapistsThe HCP must be individually named & authorised to practice under the PGDMust be registered members of their professionMust act within their appropriate code of professional conduct.PGD use does not remove professional obligation & accountability (as defined by their registering / professional body).
11Important points to note PGDs developed by a doctor, pharmacist, member of HCPA PGD must be authorised (authorising bodies)(AT’s, LA’s, Acute trusts, CCG’s)Most licensed medicines can be used in a PGDAs 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 medicinesMany ProfessionalsNurses, Pharmacists, Optometrists, DieticiansMidwives, Occupational therapists, Podiatrists,Chiropodists, radiographers, physiotherapists & ambulance paramedicsIndividual practitioners must be namedMust be registered members of their professionsMust act within their appropriate code of professional conduct
12Important 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
13What is the difference between prescribing & PGDs ? Assess patient and diagnoseMedicine needed?Issue prescription to a named individualPharmacist dispensesPatients receives medicineThe HCP instructed to supply does not need to assess and diagnose patientPatient presents directly to HCP using PGDHCP assesses the patient fits the criteria in the PGDMedicine needed?HCP supplies or administersGenerally not suitable for long-term management of conditionsPGDsPrescribing
14General Principles (1)PGDs should be reserved for limited situations where this offers an advantage to groups of patients without compromising safetyUsually for one-off treatment and not for long-term treatmentchildhood vaccinesminor ailmentsemergency contraceptionECPs' workacute exacerbation of chronic conditions e.g. prednisolone for COPDUse of a PGD should be consistent with the provision of healthcare by the individual service and professional involved
15General Principles (2)Supply or administration cannot be delegated to another person under a PGDSeparate PGD is needed for each individual medicine. Different presentations of the same med can be included e.g. liquid & tabsIf 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
16What 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 medicineClass of HCP who can supply/administerSignature 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 appliesCriteria for inclusion & description of patients excluded.
17What should be in a PGD?Description of circumstances where further advice neededDetails of referral process (GP, 111, 999)Details about: - dose, - max dose,- quantity, - form & strength,- route, - frequencyRelevant warnings including ADRsNecessary follow up action
18Your Responsibilities (1) Carefully read & ensure you understand all sectionsEnsure you meet the characteristics of staff section i.e. qualifications, experience & training requiredPGD documentRead any other documentation referred to e.g. BNF section, manufacturers SPCsSign the appropriate documentation and keep a copy for your recordsClinical Leads – ensure you are aware of who has signed the PGDsPartners in improving local health
19Your Responsibilities (2) By signing - you agree to work within terms described in PGDIf you work outside these terms you are putting yourself and possibly the patient at riskYou are responsible for assessing the patients fit the inclusion criteria and be satisfied with info collectedYou must work within your own clinical competencyIt is your responsibility to be aware of changes to clinical practice
20The NICE PGD Competency Framework (1) The PGD competency frameworkdeveloped as a tool to:support individual people andorganisations that are using PGDs.The full framework is available on the NICE website and included in the dedicated NHS PGD website
21PGD Competency Framework (2) It provides guidance on the competencies required to enable you to work safely and effectively with a PGDCan be used to identify training requirements & CPD as part of an appraisal processThe authorising manager/line manager can complete the assessment or delegate this to an experienced and suitably qualified mentorIt’s the authorising manager/line manager’s responsibility to ensure staff meet the competencies
22PGD Competency Framework (3) Covers: 3 Domains and 9 Competency areas(1) The patient consultationknowledge, options, shared decision making(2) Safe and effectivesafe, governance, always improving(3) PGDs in contextInformation, the Healthcare system, collaborationEach competency area includes:a statement that gives a general overview of what the competency area coversa list of individual competencies, referenced to relevant good practice recommendations, where applicable.
23PGD Competency Framework (3) Intended to be a developmental tool to support individualsNot to be used as a grading or assessment toolIt may help to;Identify training needsFacilitate continuing professional developmentEstablish training programmes
24Domain: The patient consultation Competency area: KnowledgeHas up-to-date clinical, pharmacological and pharmaceutical knowledge relevant to the scope of the PGD.CompetenciesEvidence / 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).
25Domain: The patient consultation Competency area: OptionsMakes or reviews a diagnosis, generates management options for the patient and follows up management within the scope of the PGD.CompetenciesEvidence / commentsKnows 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).
26Competency area: Shared decision‑making Domain: The patient consultationCompetency area: Shared decision‑makingEstablishes a relationship based on trust and mutual respect and recognises patients as partners in the consultation.CompetenciesEvidence / commentsTakes 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).
28Competency area: Governance Domain: Safe and effectiveCompetency area: GovernanceEnsures practice is within the legal framework and follows local processes and governance arrangements.CompetenciesEvidence / commentsUnderstands 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).
29Competency area: Always improving Domain: Safe and effectiveCompetency 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.CompetenciesEvidence / commentsTakes 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).
30Domain: PGDs in context Competency area: InformationAccesses relevant information and applies this in own practice.CompetenciesEvidence / commentsIs 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.
31Competencies Evidence / comments 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.CompetenciesEvidence / commentsUnderstands 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).
32Competency area: Collaboration Domain: PGDs in contextCompetency area: CollaborationWorks in partnership with colleagues and collaborates with internal and external stakeholders for the benefit of patients.CompetenciesEvidence / commentsUnderstands 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.
33Vaccine storage/transport Storage as per manufacturer’s stateRefrigerated itemsUsually stored between +2°C to +8°CLockable, dedicated medication fridgeImportant not to over fill fridgeIntegrated / independent thermometer neededDaily temperature monitoring & recordingSOP for fridge monitoring (named persons responsibility)Transport – ensure cold chain maintained.
34Influenza PGD case scenarios Help illustrate the PGD in practiceFor 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?
35Summary of process to identify patients who can be treated Patient presentsDo 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 PGDStop&ReferNoYesNoYesYesNoNoYes
36Influenza PGD case scenarios Help illustrate the PGD in practiceCase 1The following patient requests Flu vaccination35 year old,Uses salbutamol & low dose BDP,Pregnant (1st trimester),sensitivity to nutsInfluenza PGD (com pharm) final pdfPartners in improving local health
37Influenza PGD case scenarios Help illustrate the PGD in practiceCase 2The following patient requests Flu vaccination79yr old maleCHD, AF,sensitivity to eggs,Has had shingles vaccine 4 weeks previousInfluenza PGD (com pharm) final pdf
38Influenza PGD case scenarios Help illustrate the PGD in practiceCase 3Following patient requests Flu vaccination59yr oldDiabetic type 2on warfarin (last INR 3.9 four weeks ago)Had Fluvirin last year and it gave him flu symptoms?Influenza PGD (com pharm) final pdf
39Influenza PGD case scenarios Help illustrate the PGD in practiceCase 4This patient requests Flu vaccination69 year oldHypertensive, MIKidney disease (CKD 3)Carries an adrenaline pen as has an allergy to eggsInfluenza PGD (com pharm) final pdf
40Influenza PGD case scenarios Help illustrate the PGD in practiceCase 5This patient requests Flu vaccination38 year oldHaemophiliacAllergy to gentamicinHad flu vaccine last year but missed flu clinic last weekInfluenza PGD (com pharm) final pdf
41Influenza PGD case scenarios Help illustrate the PGD in practiceCase 6This patient requests Flu vaccination32 year old, healthy person,Receives benefits as main carer for elderly mumMum is taking prednisolone and a DMARD for rheumatismInfluenza PGD (com pharm) final pdf
42Influenza PGD case scenarios Help illustrate the PGD in practiceCase 7This patient requests Flu vaccination22 year old,Works as a carer in a 10 bed residential care homeIn receipt of some benefits.Care home residents are all over 65 years old.Influenza PGD (com pharm) final pdf
43PGD update – immunisation & vaccines Influenzacohort expansionAnticoags/bleeding disordersAdrenalineRecommended doses (500mcg)Products available (Emerade – 500mcg auto injector)Adrenaline PGD comm pharm (amended ).doc
45Key resources available Department of Health (2000) HSC 2000/026 Patient Group DirectionsHer Majesty’s Government (2012) The Human Medicines Regulations 2012Medicines and Healthcare products Regulatory Agency (MHRA) (2010) Patient Group Directions in the NHSNational Patient Group Directions WebsiteNICE medicines practice guidelines (MPG2) Patient Group Directions August 2013 & associated resources