PATIENT GROUP DIRECTION PROCEDURE

PATIENT GROUP DIRECTION PROCEDURE Date approved 2 October 2015 Version 3 Approved by Yvette Oade, Chief Medical Officer Procedure Lead Clinical Governance Lead - Medicines Management Procedure Author Karen Feeney, Pharmacy Medicines Risk and Communications Coordinator Governance Group Medicines Risk Management Group Review Date 31 August 2018 Link to Policy Medicines Management Policy Patient Group Direction Procedure - Approved August 2015 1

1. PURPOSE To ensure compliance with legislation and NICE medicines practice guideline recommendations for the systems and processes used when considering the need for, developing, authorising, using and updating Patient Group Directions (PGDs). 2. SCOPE The document covers governance arrangements with the aim of ensuring quality of care, patient safety and timely access to medicines, in line with legislation. The majority of clinical care should be provided on an individual patient-specific basis. The supply and/or administration of medicines under a PGD should be reserved for those limited situations where this offers an advantage for patient care (without compromising patient safety) and where it is consistent with appropriate professional relationships and accountability. PGDs provide a legal framework that allows some registered health professionals to supply and/or administer a specified medicine(s) to a pre-defined group of patients, without them having to see a doctor (or dentist). PGDs are NOT intended as a substitute for individual prescribing where there is an opportunity in the care pathway for a medicine or medicines to be prescribed i.e. where an episode of care is planned. A PGD must only be written after careful consideration of all the available methods of administration and supply of medicines, including prescribing by medical or non-medical prescribers. Failure to comply with the law could result in a criminal prosecution under the Medicines Act. 3. DEFINITIONS/ ABBREVIATION PGD - Patient Group Direction MRMG - Medicines Risk Management Group SPC - Summary of Product Characteristics NICE - National Institute for Clinical Excellence LTH - Leeds Teaching Hospitals A&E - Accident and Emergency CSU - Clinical Service/Support Unit Patient Group Direction Procedure - Approved August 2015 2

4. PROCEDURE TO BE FOLLOWED 1. Considering the need for a PGD 1.1. Use the national PGD website tools to consider whether a PGD is necessary. Do not use PGDs for medicines when exemptions in legislation allow their supply and/or administration without the need for a PGD. 1.2. PGDs must be used only by named and authorised registered health professionals who can legally supply and/or administer medicines using a PGD. 1.3. PGDs must only include medicines with a UK marketing authorisation, in line with legislation. Unlicensed medicines cannot be administered under a PGD. 1.4. Medicines used outside the terms of their marketing authorisation (off-label use) may be included in PGDs provided such use is exceptional and clearly justified by current best clinical practice. Each PGD should clearly state when the product is being used outside the terms of the marketing authorisation and the documentation should include the reasons why, exceptionally, such use is necessary. 1.5. Black triangle medicines are those recently licensed and subject to special reporting arrangements for adverse reactions. They may be included in PGDs provided such use is exceptional and clearly justified by current best clinical practice. The PGD must clearly indicate the black triangle status of the product. Black triangle vaccines used in immunisation programmes may be included in PGDs, provided they are used in accordance with the schedules recommended by the Joint Group on Vaccination and Immunisation. 1.6. Ensure that a controlled drug is included in a PGD only when legally permitted and clearly justified by best clinical practice. The list of controlled drugs that can currently be included in a PGD can be found here. For an explanation of controlled drug schedules, refer to the LTH Medicines Code. 1.7. Microbial resistance is a public health matter of major importance and great care should be taken to ensure that the inclusion of antibiotics in a PGD is absolutely necessary and will not jeopardise strategies to combat increasing resistance. A local microbiologist must be one of the authors of the PGD. 1.8. Do not include a medicine needing frequent dosage adjustments or frequent or complex monitoring in a PGD (e.g. anticoagulants or insulin) 1.9. Do not make dose adjustments to a medicine supplied under a PGD when the medicine is already in the patient s possession. 1.10. Do not use PGDs for managing long-term conditions, such as hypertension or diabetes or when uncertainty remains about the differential diagnosis. 1.11. Outpatients, day case patients and A&E patients who normally pay for their prescriptions must pay a prescription charge for each medicine they are given to take away under a PGD. Medicines which are administered to patients on Trust premises do not incur a charge. Patient Group Direction Procedure - Approved August 2015 3

2. Obtaining agreement to develop and developing a PGD 2.1. Before the PGD is drafted the authors must submit a proposal to the Medicines Risk Management Group (MRMG) using the standard template. This must provide evidence that the delegation of administration and supply to approved practitioners will lead to improved patient care or organisational advantages without any reduction in patient safety or quality of care. The MRMG will consider whether a PGD is the best method for medicines supply or administration in the given circumstances and consider any risk issues. 2.2. Once support is given to the development of the proposed PGD the lead author will receive formal notification of support from the chair of the Medicines Risk Management Group and the PGD can be written. 2.3. When support for the proposal is given, write the PGD using the template supplied. PGDs must be written by a group of healthcare professionals. The lead author will normally be from the same professional group as the practitioners who will be working under the PGD. The authors must include a pharmacist and a doctor (or, if appropriate, a dentist). 2.4. All PGDs for antibiotics must be developed in association with a Consultant Microbiologist. The authors of PGDs for other groups of medicines should consider whether an appropriate expert prescriber should be involved. 2.5. The final PGD must be signed by: each author, to include a senior doctor (or dentist), senior pharmacist and senior professional as appropriate e.g. nurse, radiographer Lead Clinician Matron (or equivalent) An expert prescriber, if appropriate A Consultant Microbiologist, where the PGD involves an antimicrobial 2.6. A letter of support is required from: Clinical Director Head of Nursing (or relevant head of profession) Director of Medicines Management and Pharmacy Services 2.7. Use the quality checklist to ensure that all steps have been completed. 2.8. Send the final signed PGD (with the signed quality checklist) to the Medicines Risk Management Group for final registration. The clinical content of a PGD is the responsibility of the authors and the relevant Clinical Service Unit. 3. PGD Review 3.1. The registration process enables the use of a PGD for a maximum of three years from the date of registration. Alternative expiry dates may be set by the Medicines Risk Management Group (MRMG). After the review date a PGD is no longer valid unless it has been re-registered by the MRMG following audit and review by the authors. 3.2. An audit tool is available, which sets out the minimum requirements. Patient Group Direction Procedure - Approved August 2015 4

3.3. When reviewing the PGD, conduct an appropriate literature search to identify new evidence. Ensure this evidence is evaluated to assess its relevance and validity as detailed in the NICE Medicines Practice Guideline [MPG2] on Patient Group Directions. 3.4. When reviewing the PGD, determine whether the PGD remains the most appropriate option to deliver the service. 3.5. Link the findings from the audit and review to the revision of the PGD. 3.6. Submit the findings from the review of the PGD and proposed changes, if any, to the relevant CSU Governance Forum and obtain support for re-registration. 3.7. The PGD must be re-signed and new letters of approval obtained, even if no amendments are required. The signed PGD, signed and dated review section (page 4) from the audit tool and letters of approval must be sent to the Medicines Risk Management Group for review. If all the requirements are satisfied the authors will receive formal notification of registration from the Chair of the Medicines Risk Management Group following the next MRMG meeting. 3.8. If a PGD needs amending before the designated review date the Lead Author must discuss the proposed changes with the Professional Secretary of the Medicines Risk Management Group. Minor changes may be agreed following discussion with the Chair of the Medicines Risk Management Group. More extensive changes may require discussion at a Medicines Risk Management Group meeting. 3.9. By submitting a revised PGD the Lead Author and CSU provides assurance that an appropriate audit and adequate review of the PGD has taken place. Patient Group Direction Procedure - Approved August 2015 5

Flowchart summarising PGD development: Discuss the rationale and service implications with the relevant professional manager and Clinical Director. NOT APPROVED Complete the PGD proposal template and present this at a Medicines Risk Management Group meeting APPROVED Draft the PGD Send the draft PGD to key individuals outside the team to review e.g. Lead Clinician, Lead Pharmacist and practitioners working in similar clinical areas. Incorporate comments where appropriate. Send the final PGD with relevant signatures to the Clinical Director and Head of Nursing (or equivalent) and obtain letters of approval Send the final signed PGD and letters of approval (with checklist) to the Medicines Risk Management Group for registration Practitioners working under the PGD undergo education/training and declare competency Patient Group Direction Procedure - Approved August 2015 6

Flowchart summarising PGD review: PGDs should be reviewed in advance of their expiry date or sooner if problems are identified. Audit the PGD using the PGD audit tool provided and review its place in the service Use the findings from the PGD audit and service review to update the PGD Submit the results of the audit and its place in the service to the relevant CSU Governance Forum linked to any proposed changed Members of the CSU Governance Forum are to review the PGD audit and its place in the service with the suggested amendments If satisfied that the PGD has been appropriately audited and reviewed the Lead Clinician will inform the Lead Author of the CSU support Send the updated PGD with relevant signatures, the summary section of the PGD audit and letters of approval (using the standard letter template) to the Medicines Risk Management Group Ensure old copies are destroyed after review and only current copies are in use Patient Group Direction Procedure - Approved August 2015 7

4. Training and competency 4.1. Before using a PGD, it is the responsibility of each practitioner to ensure they are competent to deal with each patient under the terms of the PGD. If the practitioner is in any doubt as to their competency they should not supply or administer in accordance with the PGD but should seek advice. 4.2. A practitioner is not authorised to act under a PGD in an area of practice to which it does not apply. 4.3. Supply and/or administration of a medicine must not be assigned or delegated to any other person under a PGD, regardless of their professional group or level of training. 4.4. The practitioners working under the PGDs must have access to the approved PGDs and any related guidance within their clinical areas. The matron, or equivalent, is responsible for ensuring that the most up-to-date PGDs are used and that a register of staff names or grades competent to use the PGD is kept in the clinical area. 4.5. It is important that the use of any medicine is consistent with the Summary of Product Characteristics (SPC) for the relevant product and any relevant guidance from NICE. 4.6. A record of the supply or administration of medicines under a PGD must be made for every patient. Authors may decide where this record should be made. Such records must include the following: known medicine allergies, current medicines taken, any relevant contraindications or exclusion criteria, name of any doctor or pharmacist consulted, approved name of the medicine to be administered and/or supplied, details of the dose, frequency of the supply (if appropriate), quantity, route and site (if by injection) of administration (record the batch number and expiry if recommended by relevant national guidance e.g. vaccines), date and time of administration and/or supply, name and signature of the practitioner, a statement that supply or administration is by using a PGD. 4.7. Any medicines supplied under a PGD must be supplied as pre-packs made up by Pharmacy. Medicines pre-packs should be given out according to the most up to date Procedure for the Supply of Medicines. This includes a secure system for recording and monitoring medicines use from which it should be possible to reconcile incoming stock and out-goings on a patient by patient basis. 5. ROLES AND RESPONSIBILITIES PGD authors Core healthcare professionals involved with the PGD must include a doctor, pharmacist and other relevant healthcare professional. All the authors should be involved in developing the PGD. The lead author is named as the individual responsible for the PGD and is usually from the group of practitioners who will be working under the PGD. The role of lead author is assigned to a specific job role. 1. Obtain approval from the Matron or appropriate service manager and the Lead Patient Group Direction Procedure - Approved August 2015 8

Clinician. 2. Submit and present the PGD proposal to the Medicines Risk Management Group 3. Obtain copies of relevant PGDs from other areas inside/outside LTH. 4. Obtain the PGD template from the professional secretary to the MRMG. Following approval of the proposal, draft the PGD in accordance with the template and guidance 5. Draft education pack 6. Send to key healthcare professionals for comment on first draft to include the Lead Clinician, Lead Pharmacist (if not an author) and expert prescriber (if required). 7. Send the final document to the relevant Clinical Director and the Head of Nursing (or equivalent Head of Profession) and obtain written approval. 8. Send the final, approved, signed copy and completed checklist to the MRMG for registration. 9. Send an electronic copy of the approved PGD to the Professional Secretary of the MRMG for publication on the Trust Intranet. 10. Audit the PGD 3 years after approval (or sooner if problems are identified) using the PGD audit tool and review its place in the service. 11. Use the findings from the PGD audit and its place in the service to update the PGD if appropriate. 12. Liaise with the Lead Clinician to submit the PGD audit results to the relevant CSU Governance Forum along with any proposed changes. 13. Confirmation that the PGD has been supported for re-registration by the relevant CSU Governance Forum will be achieved by the Clinical Director signing and dating the PGD review section (page 4) of the audit tool. 14. Obtain written approval using the standard letter template from the Clinical Director and Head of Nursing (or equivalent Head of Profession). 15. Send the final, approved, signed PGD copy along with the signed and dated PGD review section (page 4) from the audit tool and letters of approval to the MRMG for re-registration. By submitting a revised PGD along with the signed PGD section of the audit tool the Lead Author provides assurance on behalf of the CSU that an appropriate audit and adequate review of the PGD has taken place. 16. Ensure that old copies are destroyed after review and only current copies are in use. Matron (or equivalent) 1. Ensures a register of staff names or grades competent to use the PGD is kept in the relevant clinical area. Each approved practitioner must have access to a copy of the document. 2. Should the lead author leave their post and not be replaced, the matron should Patient Group Direction Procedure - Approved August 2015 9

delegate responsibility for the PGD to a new job role. 3. Ensures appropriate education and training for staff using the PGD. 4. Ensures the PGD is reviewed 3 years after approval or sooner if problems are identified. Lead Clinician 1. Signs off final PGDs before submission to the MRMG. This will include consideration of any financial implications. 2. Submits the results of the PGD audit and review of its place in the service and how it links to the proposed changes to the PGD to the relevant CSU Governance Forum. 3. Communicates the decision of the CSU Governance Forum to the Lead Author by means of the signed and dated PGD review section. 4. The Lead Clinician must hold copies of the approved PGDs in use in the clinical areas within their responsibility. CSU Governance Forum 1. Reviews the audit data and review of the PGD in the service along with the proposed changes to the PGD and if satisfied supports its re-registration by the Medicines Risk Management Group. 2. Clinical Director will sign the PGD review section to confirm the review has been taken place at the CSU Governance Forum 3. Register the audit on the Trust Audit Database Professional Secretary to the Medicines Risk Management Group 1. Supply template documents used in the PGD development process. 2. Maintain the master file and Intranet site. 3. Support authors in identifying outside organisations that may provide useful information for specific PGDs. 4. Send PGD proposals to the MRMG for review. 5. Send final PGDs to the MRMG for registration. 6. Archive withdrawn/expired PGDs. Medicines Risk Management Group 1. Reviews the PGD proposal to determine whether that approach is appropriate for the clinical situation and ensure that any risks are minimised. Patient Group Direction Procedure - Approved August 2015 10

2. Registers final, signed PGDs and reviewed PGDs and ensures that the requirements of the PGD procedure are met. 6. LINKS TO OTHER DOCUMENTS Medicines Management Policy 7. MONITORING ARRANGEMENTS The procedure will be monitored through the receipt of the PGD proposals and PGD documents by the Medicines Risk Management Group. The procedure, supporting processes and guidance will be reviewed and revised in line with future changes to the UK legislation relating to PGDs two years from the date of approval. 8. REFERENCES Crown J. A review on the supply and administration of medicines under group procedures, Department of Health, April 1998 HSC 2000/026 Patient Group Directions [England only], NHS Executive, August 2000 Statutory Instrument 2000a. The Prescription Only Medicines (Human Use) Amendment Order 2000 (SI 2000/1917) National Institute for Health and Care Excellence (2013). Patient Group Directions. Medicines Practice Guideline [MPG2]. http://www.nice.org.uk/guidance/mpg2/chapter/1-introduction Human Medicines Regulations 2012. No 1916, Schedule 16, Part 4 http://www.legislation.gov.uk/uksi/2012/1916/schedule/16/part/4/made Patient Group Direction Procedure - Approved August 2015 11

Appendix A. Patient Group Direction Proposal template Proposed content of PGD What medicines do you wish to administer/supply? List the name, form and strength of each medicine What indication/condition will the medicines be given for? Does the medicine have a licence for the proposed indication / age group (if to be given to children)? If the medicine is not licensed for the proposed indication / age group, state why no licensed alternative can be used. How will patients be identified? Will patients be given a supply to take home? How will supply or administration be recorded? Medicines storage and security What facilities are/will be available for the storage of the medicines? If medicines are to be supplied to patients to take away, how will supply be monitored? Medicines must be pre-labelled for issue to patients and staff are required to follow the standard pre-pack issue procedure. Staff and training In which department(s) or site(s) will the PGD(s) be used? Which staff groups will work under the PGD? What additional training and/or competencies will be needed? Who will provide the training and assess competency? How will practitioners access the PGD document(s)? Where will the documents be kept? Practitioners must have access to up-to-date PGD documents. Service provision How is this service provided now? Describe the current process for medicines administration / supply Why is a PGD the most appropriate means of providing the service? Explain why the PGD is needed and why other methods, such as obtaining individual prescriptions from doctors or non-medical prescribers, are not appropriate. What are the expected benefits of a PGD? PGD title:

Authorship and approval Who will be the authors? Name all the authors and identify the lead (this is usually from the group of practitioners who will be working under the PGD). The group must include a doctor and a pharmacist. Have you identified people to write and/or endorse this PGD? An expert prescriber may be needed and should be consulted early on in the production process. Do you have approval from your Matron (or equivalent) to develop a PGD? Changes in the provision of clinical services require the approval of the relevant Matron (or equivalent). Other responsibilities are outlined in the LTH PGD Procedure. Please provide a name and job title. Do you have approval from your Lead Clinician? The Lead Clinician will consider the financial implications of any change in service provision. Other responsibilities are outlined in the LTH PGD Procedure. Please provide a name and job title. Audit and review How will the PGD be audited? Please provide an audit form or agree to use the LTH PGD audit tool. Proposed by: Name Job title Date PGD title:

Appendix B. Patient Group Direction template Leeds Teaching Hospitals NHS Trust <Add Clinical Area> <Add CSU title> Patient Group Direction for the <Supply and/or Administration of medicine and condition> Reference number: (Pharmacy use) 1. Clinical condition 1.1 Definition of the clinical condition or situation Use the BNF/Summary of Product Characteristics (SPC). Take into account any clinical guidelines or policies that are available locally or nationally e.g. Trust guidance, NICE. If the medicine is to be used outside the terms of the SPC or if it is black triangle, there must be a clear rationale and authorisation for use, backed by information to support its use over licensed and more established treatments. 1.2 Criteria for confirmation of above Refer to department guidelines or procedures if appropriate and include a copy of these guidelines when submitting the PGD for approval. 1.3 Inclusion criteria Who is eligible to receive the medicine e.g. sex / age. Clinical criteria Must reflect local and/or national guidelines or policies where available. 1.4 Exclusion criteria Who is not eligible to receive the medicine? Reasons may include: Age Concurrent conditions Concurrent treatment Previous local or general reactions to the medicine Hypersensitivity Pregnancy and breastfeeding - explain reason for exclusion Anything else stated in the SPC 1.5 Cautions (including any relevant action to be taken) 1.6 Arrangements for referral for medical advice State the circumstances for referral e.g. lack of effect at maximum dose, adverse effects. 1.7 Action to be taken if patient excluded 1.8 Action to be taken if patient declines treatment PGD title and reference number: Version number:

2. Treatment available 2.1 Name, form and strength of medicine(s) State the medicine name, form and strength as listed in the BNF. 2.2 Legal category List the legal category e.g. CD, POM, P, GSL If the medicine has black triangle status or is being used for an unlicensed indication, state that here. 2.3 Indicate any off-label use (if relevant) 2.4 Method or route of administration State in full; avoid Latin or abbreviations. 2.5 Dose / dose range and frequency Include details of the dose to be used, expressed as seen on the pharmacy label e.g. one tablet to be taken three times a day. Do not use Latin or abbreviations. Where a range of doses is planned, detail how a dose will be chosen. 2.6 Maximum or minimum treatment period State if the patient will receive a single dose, or a course of treatment (specify length of course and number of repeats, if appropriate) 2.7 Quantity to be administered and/or supplied Liaise with the pharmacist author to ensure appropriately labelled medicine packs are available for supply to patients. 2.8 Procedure for supply Liaise with the pharmacist author to ensure that a procedure is in place for supply and stock control. 2.9 Prescription charges State how these will be collected and how exempt patients will be identified. 2.10 Specific procedures for the management of patients on concurrent medicines State how potential drug interactions will be identified and managed. 2.11 Adverse effects List the most common side effects and any potentially serious symptoms the practitioner or patient needs to look out for. Warn about potential adverse effects e.g. CSM advice. Include the standard text: This is not a fully comprehensive list of side effects for this medicine. Refer to the Summary of Product Characteristics for more information. 2.12 Specific procedures for the management of adverse effects State how adverse drug reactions will be identified and managed, e.g. patient advice, follow-up. Include the standard text: Report all serious suspected adverse drug reactions to the Committee on Safety of Medicines using a yellow card, even if they are listed above, in the BNF or in the product SPC. Serious reactions are those that are fatal, life-threatening, disabling, incapacitating or which result in prolonged hospitalisation and/or are medically significant. PGD title and reference number: Version number:

2.13 The facilities and supplies which must be available at sites where care is provided e.g. pre-packed, pre-labelled medicines, resuscitation facilities. 2.14 Record keeping State what patient-specific information will be recorded and where this information will be documented. The following details must be recorded as a minimum requirement: Date and time of administration and/or supply Known medicine allergies Current medicines Any relevant contraindications or exclusion criteria Name of any doctor or pharmacist consulted Approved name of medicine in BLOCK CAPITALS and strength Details of the dose, frequency, quantity, route and site (if by injection) of administration Record the batch number and expiry date for vaccines, blood-derived products and other medicines if recommended by relevant national guidance Statement supply and/or administration is by PGD Name and signature of health professional supplying or administering the medicine 2.15 Patient follow-up Will other healthcare professionals be informed? If so, how? 2.16 Advice to be given to patients State what information will be given to patients and in what form, i.e. verbal and / or patient information leaflet. 3. Staff authorised to use the PGD 3.1 Professional qualification State the professional qualification required by practitioners working under this PGD. 3.2 Specialist qualifications, training or experience required Include details of qualifications, training, experience and competence in relation to the clinical context of the PGD and for the use of the specified medicine(s). 3.3 Details of continued training or education required Use the standard text below (further detail may be added if required): Practitioners using this PGD acknowledge the need to maintain the knowledge and skills required for practice. Training or education will be provided as a result of on-going audit and following any amendment to the PGD. Practitioners are expected to undertake training in relation to the legal and administrative requirements of the PGD and demonstrate an understanding of the drug action, administration, side effects and monitoring requirements. This will be determined at local level by senior staff. 3.4 The practitioner responsible for ensuring that only qualified competent individuals work under this PGD State the name and job title of the senior practitioner (for each relevant profession) who is responsible for ensuring that only fully competent and trained professionals operate within PGDs and that the register of authorised staff is maintained PGD title and reference number: Version number:

3.5 The register of staff authorised to work under this PGD This may be supplied as an appendix and is not required for the purposes of registration. A list of signatures must be kept in the relevant clinical area. 4. Audit and review 4.1 Details of audit mechanism Outline how use of the PGD will be audited. The standard audit tool may be used or added to. Include the standard text: Any adverse incidents relating to use of this PGD will be reported to the matron (or equivalent) and recorded on an online Incident Reporting form. 4.2 Arrangements for review Name the individual responsible for reviewing the document. PGD development and authorisation - one author must be named as Lead Author Name Job title Signature Date Senior doctor or dentist (author) Senior pharmacist (author) Senior nurse or other relevant professional (author) Lead Clinician Matron (or equivalent) Change history Version number Change details Date Change history (for office use only) Version number Ratification date Review date Date of approval Usually 3 years from the approval date PGD title and reference number: Version number:

Authorised Supply and Administration of Medication under Patient Group Direction Registered and Enrolled Nurses as outlined in 4.1, 4.2, 4.3 and 4.4 of the Patient Group Direction Procedure should read and sign the declaration below. I have read and understood the Patient Group Direction for <insert title of PGD>. Having undertaken appropriate training and education, and subject to approval, I am now ready and willing to accept full responsibility and accountability for this area of practice PRINT NAME SIGNATURE DATE PGD title and reference number: Version number:

Appendix C. PGD Quality Checklist To be completed by the lead author: Content The medicine will be used in accordance with the licence or clinical guideline The PGD matches the medicine s summary of product characteristics with regards to contraindications, precautions and side effects. The references used during the production of this PGD are the most up-to-date available at this time and are referred to in the document. The use of the PGD(s) by other departments has been considered and the appropriate people consulted. The document has been checked for spelling and typing errors. Framework The practitioners working under this PGD understand the Yellow Card Scheme for the reporting of adverse drug reactions. A list of competencies for practitioners working under the PGD has been produced. The PGD(s) will be audited on a tri annual basis (or before). Confirmation of the audit will be submitted to the Medicines Risk Management Group when the PGD is reviewed. I understand my responsibilities as set out in the PGD Procedure and notes for approval. The relevant clinical areas will have access to the most recent version of the PGD. Approval The PGD has been signed by the authors and relevant clinical managers. The PGD has been reviewed and signed by an expert prescriber where appropriate (e.g. a consultant microbiologist for antibiotics) A letter of approval has been received from the Clinical Director, the Head of Nursing (or equivalent) and the Director of Medicines Management and Pharmacy Services. Signature Print name Job Title Date PGD title and reference number: Version number:

Appendix D. Audit tool <Area or PGD(s)> LTHT Patient Group Directions (PGD) Audit Tool In accordance with the LTHT Patient Group Direction (PGD) Procedure an audit must be carried out before revalidation of PGD(s). This is required to demonstrate compliance with the PGD(s) and to ensure that the requirements of the service are met. Use the audit tool to review if the PGD is being used appropriately and use the questions at the end to help review if the PGD is still the most appropriate method of delivering the service. The person responsible for authorising staff to work under the PGD is responsible for ensuring that the audit is undertaken. The Lead Author must review the audit data and if required amend the PGD as part of the review. The audit data must be reported to the relevant Clinical Governance Forum and page 4 be submitted to the Medicines Risk Management Group for assurance. Name of practitioner responsible for authorising staff: Designation: Name of lead author: Designation: Date of audit: Question Tick as appropriate Yes No If no, state action required Are all the people who approved the PGD(s) still in post? Do the managers listed on the PGD(s) hold a current list of authorised staff? Are you confident that all medicines supplied or administered under the PGD(s) are stored according to the PGD(s) where this is specified? Does the staff working under the PGD(s) have a copy available for reference at the time of consultation? Where the medicine requires refrigeration, is there a designated person responsible for ensuring that the cold chain is maintained? 1

Audit of completion of Staff Records for (insert title of PGD) The staff records of authorisation to work under the PGD must be checked using this form. Where more than 5 members of staff are authorised to work under the PGD, then a minimum of 5 and maximum of 10 records must be checked for each PGD. Otherwise, all staff records must be checked. For PGDs in use on multiple sites then an audit of each site must be undertaken. Review date of PGD(s): Manager responsible for authorising staff, and for audit: Date of audit: NB: Answers to all questions except the first and last are Yes / No i.e. no details are required. Staff initials or identification number Is their name on the master list of staff authorised to work under the PGD? Is this authorisation dated? Has the manager responsible for authorising staff signed the master list? Is training specific to the PGD(s) up to date? Comments 2

Audit of completion of Patient Records for (insert title of PGD) A sample of 10 sets of patient records for each PGD must be checked using this form. This sample must relate to at least 4 different dates on which the PGD was used, and if applicable where 3 or more members of staff are working under that PGD. For PGDs in use on multiple sites then an audit must be undertaken on each site. Review date of PGD(s): Manager responsible for authorising staff, and for audit: Date of audit: NB: Answers to all questions except the first are Yes, No, not known (NK) or not applicable (NA) i.e. no details are required. Was the date of supply / administration recorded? Was patient consent obtained? Was allergy status recorded? Were the patient s concurrent medicines listed (if applicable)? Was the medicine given in accordance with the inclusion criteria? For injections, was the site, route, and batch number recorded? Has the practitioner signed the entry in the patient s notes? Was an up-to-date patient information leaflet supplied? Has the stock record been completed? 1 2 3 4 5 6 7 8 9 10 3

PGD review Is the PGD being used appropriately? Describe any areas of non-compliance found during the audit and detail the action required to remedy this. Include the person responsible for implementing the action and the proposed date for completion. Is the PGD still the best way to provide for the patient group and pathway? Is the PGD still needed or has the delivery of the service changed e.g introduction of non-medical prescribers. Has the patient group and licensed indications for the medicine been reviewed? Consider if the patient group has been expanded. Has the SPC been updated to include new indications that could impact on the inclusion criteria? Describe how the findings from the review link to the amendment of the PGD See example Example PGD (title) Ref No Amendment(s) Reason Clotrimazole 500mg pessary and Clotrimazole 1% cream 149 1.1 Clinical condition expanded to include using cream to treat men 1.2 References refer to the most up to date guideline Service review has shown more men presenting with genital candidiasis. Review of SPC of clotrimazole 1% cream indicates it is licensed to treat genital candidiasis in men. Changes improve patient s direct access to treatment 1.3 Inclusion criteria have been amended to include: Clinical features of genital candidiasis in men Removal of non offensive discharge As per SPC Currently only symptomatic patients are treated Additional information: Include any further details that are relevant to this review. Submit the audit to the relevant CSU Governance Forum for discussion and to obtain support. Once the information has been considered and the PGD supported for re-registration complete the following boxes and submit page 4 to the Professional Secretary of the Medicines Risk Management Group Date audit reviewed by CSU Governance Forum Signature of Clinical Director on behalf of CSU 4