PATIENT GROUP DIRECTIONS (PGDs)

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

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

3. 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

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.

5. 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 Or more simply:

6. 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).

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

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.

9. 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 &authorisedto 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).

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

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 givevalidinformed consent before care proceeds

12. 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 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 PGDs Prescribing

13. 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

14. 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 General Principles (2)

15. 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?

16. 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 What should be in a PGD?

17. Sign the appropriate documentation and keep a copy for your records Carefully read & ensure you understand all sections Your Responsibilities (1) 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 Clinical Leads – ensure you are aware of who has signed the PGDs

18. 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 Your Responsibilities (2) • 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

19. 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/ The NICE PGD Competency Framework (1)

20. 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 & CPDas part of an appraisal process The authorising manager/line managercan complete the assessment or delegate this to an experienced and suitably qualified mentor It’s the authorisingmanager/line manager’s responsibilityto ensure staff meet the competencies PGD Competency Framework (2)

21. 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. PGD Competency Framework (3)

22. 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

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.

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?

34. Summary of process to identify patients who can be treated Stop & Refer No Yes No Yes Yes No No Yes

35. 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

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

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

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

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

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

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

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

43. Thank you • Any questions?

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