BEFORE USING THIS POLICY ALWAYS ENSURE YOU ARE USING THE MOST UP TO DATE VERSION Policy and Procedure for the Development, Approval and Implementation of Patient Group Directions in NHS Haringey Clinical Commissioning Group 1 SUMMARY 2 RESPONSIBLE PERSON: 3 ACCOUNTABLE DIRECTOR: 4 APPLIES TO: 5 GROUPS/ INDIVIDUALS WHO HAVE OVERSEEN THE DEVELOPMENT OF THIS POLICY: 6 GROUPS WHICH WERE CONSULTED AND HAVE GIVEN APPROVAL: This policy describes the process for developing, drafting, reviewing, approving and implementing Patient Group Directions in Haringey Clinical Commissioning Group. A Patient Group Direction is a written instruction for the supply or administration of medicines to specific groups of patients who may not be individually identified before presentation for treatment (i.e. without a prescription written by a doctor). Pauline Taylor, Head of Medicines Management, Haringey Jennie Williams, Executive Nurse and Director or Quality and Integrated Governance Individuals involved in the development and implementation of Patient Group Directions and primary healthcare professionals who may supply or administer medicines in accordance with them. Heads of Medicines Management of Camden, Islington, Haringey, Enfield and Barnet Clinical Commissioning Groups. Haringey Medicines Management Committee 30.1.13 Approved Haringey Quality Committee 29.1.13 Consulted Haringey Quality Committee 26.2.13 For approval Medicines Optimisation Committee 16.3.16 Reviewed 7 EQUALITY IMPACT ANALYSIS COMPLETED: Policy Screened March 2016 Template completed March 2016 8 RATIFYING COMMITTEE(S) & DATE OF FINAL APPROVAL: 9 VERSION: Haringey Quality Committee 14.12.2016 1.4 Page 1 of 17
10 AVAILABLE ON: Intranet Yes Website Yes 11 RELATED DOCUMENTS: 12 DISSEMINATED TO: 13 14 DATE OF IMPLEMENTATION: DATE OF NEXT FORMAL REVIEW: Heads of Medicines Management of Camden, Islington, Haringey, Enfield and Barnet Clinical Commissioning Groups. April 2016 April 2018 DOCUMENT CONTROL Date Version Action Amendments 21 Jan 2013 First draft with legislative amendments 1.0 incorporated Pauline Taylor 15 Feb 2013 1.1 Comments from Quality Committee Pauline Taylor incorporated. Separate the policy statements from the procedure. 1 March 2013 1.2 Further comments from Quality Committee Pauline Taylor 17 April 2013 1.3 Final amendments from Quality Committee Pauline Taylor 7 March 2016 1.4 Reviewed by Head of Medicines Management against NICE guidance (MPG2). Job titles and weblinks updated. Medicines Optimisation Committee role to include review of content and process added References to immunisations removed as now role of NHS England Pauline Taylor Contents Section Page Introduction 3 Definition of a Patient Group Direction 3 Professional groups who can use a PGD 4 Policy Statement 4 Appendix 1 Procedure to Develop a Patient Group Direction 5 1. How to develop a Patient Group Direction 5 2. Characteristics of staff authorised to take responsibility for the 6 supply or administration of medicines under a PGD 3. Review of a PGD, Expiry date and changes in practice 7 4. Auditing PGDs 8 5. References and other useful information 8 Appendix 2 Proposal for the Development of a Patient Group Direction 9 Appendix 3 Process of drafting & approving Patient Group Directions for 10 NHS Haringey Appendix 4 Local Contacts 13 Appendix 5 Example Haringey PGD Template 14 Page 2 of 17
Introduction Patients needs are at the centre of the NHS. The aim of providing prompt access to high quality care, within safe systems, is a key priority. Delivering effective care that is personal to individuals needs, providing choice in the way patients are treated and improving access are all key objectives. To achieve patient-focused services, healthcare professionals are finding ways to work more flexibly. One area in which significant changes have happened is the supply, administration and prescribing of medicines. The preferred way for patients to receive medicines is for prescribers to provide care for individual patients on a one-to-one basis. The legal framework that covers medicines usage reflects this principle and is based on the traditional model of prescribing by doctors and dentists. Following extension of prescribing responsibilities, a wide range of healthcare professionals including nurses, midwives, pharmacists, optometrists and some allied health professionals, can access additional training to qualify them to prescribe within their competence. This extension of prescribing responsibilities gives organisations more flexibility when designing their services, so that patients can have greater choice and access to high quality prescribing, when and where they need it. In addition, some long-standing exemptions in medicines legislation allow certain healthcare professionals to obtain, sell, supply and administer medicines in specific circumstances. There are also situations, not covered by these exemptions, where patients may benefit, without their safety being compromised, from having a medicine supplied and / or administered directly to them by a range of healthcare professionals. To enable this to happen, independent prescribers can give a documented Patient Specific Direction (PSD), which instructs another healthcare professional to supply or administer a medicine to a specified patient. Alternatively, a Patient Group Direction (PGD) is a legal mechanism that allows named registered healthcare professionals to supply and / or administer medicines to groups of patients that fit the criteria laid out in the PGD. So a healthcare professional could supply (e.g. provide an inhaler or tablets) and / or administer a medicine (e.g. give an injection or a suppository) directly to a patient without the need for a prescription or an instruction from a prescriber. Using a PGD is not a form of prescribing. Unlike prescribing, healthcare professionals entitled to work with a PGD require no additional formal qualification. However, for a PGD to be valid, certain criteria must be met, including; the information that it must contain, the patient group that the PGD can be used for and how the PGD itself is drawn up. Organisations also have a responsibility to ensure that only fully competent and trained registered healthcare professionals use PGDs. Definition of a Patient Group Direction The legal definition of a PGD is: a written instruction for the supply and/or administration of a licensed medicine (or medicines) in an identified clinical situation, signed by a doctor or dentist and a pharmacist. It applies to groups of patients who may not be individually identified before presenting for treatment. Page 3 of 17
This should not be interpreted as indicating that the patient must not be identified; patients within the group may, or may not be known to the service, depending on the circumstances. In simple terms, a PGD is the supply and/or administration of a specified medicine or medicines, by named authorised health professionals, to a well-defined group of patients requiring treatment for the condition described in the PGD. The health professional must be registered. The majority of clinical care should be provided on an individual, patient-specific basis. The supply and/or administration of medicines under PGDs 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. Professional groups who can use a PGD A list of the registered health professions able to use PGDs is available on the MHRA website www.mhra.gov.uk. Professionals using a PGD must be registered (or equivalent) members of their profession and act within their appropriate code of professional conduct. This differs from supplementary prescribers and independent prescribers who must also successfully complete specific prescribing training and be appropriately registered before they may prescribe. However, organisations using PGDs must designate an appropriate person within the organisation (for example, a clinical supervisor, line manager, General Practitioner) to ensure that only fully competent, qualified and trained healthcare professionals use PGDs. Individual practitioners using a PGD must be named Policy Statement All Patient Group Directions developed and used must comply with the law, HSC 2000/026 and with this policy and procedure. See the procedure below for notes on the development of PGDs. NHS Haringey delegates the clinical governance authorisation of PGDs to the CCG Director of Quality and Integrated Governance. Page 4 of 17
Appendix 1 Procedure to Develop a Patient Group Direction 1. Procedure to develop a Patient Group Direction 1. It should be carefully considered whether a PGD is required and is the most appropriate option for supply and/or administration of medicines. The flowchart To PGD or not to PGD http://www.medicinesresources.nhs.uk/en/communities/nhs/pgds/pgd-legislation- Guidance/PGD-Website-Tools/To-PGD-or-not-to-PGD-that-is-the-question/ and NICE NICE Patient Group Directions Guidelines 2013 https://www.nice.org.uk/guidance/mpg2 are useful guides or contact the Haringey Medicines Management Team (MMT) (see page 18 for contact details). The next step is to complete the pro forma Proposal for the development of a PGD appendix 2. Haringey MMT can provide the document as a word file. The pharmacist will know if a PGD is currently in use for this medication. If a new PGD is required, the applicant and a MMT pharmacist will discuss a drafting process. 1.2 Authorisation to proceed with a PGD should be obtained from the Head of Medicines Management, who can advise on the need for a PGD, provide the CCG proforma (Appendix 5) as a Word file and examples of existing approved PGDs to help with the drafting. 1.3 The PGD must be produced by a multidisciplinary group involving a doctor or dentist, a pharmacist and a representative of any professional group expected to supply and / or administer medicines under the PGD. The nurse(s), pharmacists and other health professionals involved in developing a PGD must complete the CCG pro forma to demonstrate compliance with the criteria specified in HSC 2000/026 (Appendix 2). If the PGD involves the supply of antimicrobials a local microbiologist must be involved in drawing up the PGD. The authors should ensure that any such PGDs are consistent with local policies and subject to regular external audit. 1.5 A clinician with relevant expertise must be involved in writing the clinical content of the PGD. S/he may be the doctor or dentist attached to the service or may be a local specialist in the CCG or a local acute trust as necessary. Before signing the PGD the clinician must be happy that it is safe and that in his/her expert opinion it describes practice of high quality. 1.6 A MMT pharmacist will be identified by the Head of Medicines Management to assist with the pharmaceutical content of the PGD. See Appendix 3 for a description of the process for drafting and approving PGDs. 1.7 The PGD must be signed by the senior doctor / dentist and senior pharmacist involved in developing the PGD. 1.8 Another MMT pharmacist will check the whole of the PGD when complete. Page 5 of 17
1.9 The checked PGD is then approved by the Medicines Optimisation Committee and forwarded for clinical governance approval and signed by the CCG Executive Nurse and Director of Quality and Integrated Governance as described in Appendix 3. 2. Characteristics of staff authorised to take responsibility for the supply or administration of medicines under a PGD 2.1 The PGD must specify the qualifications, training, experience and competence considered necessary and relevant to the clinical condition to be treated. 2.2 The PGD must specify requirements for initial and for continued training or education for staff supplying or administering under the PGD. This will be considered this as part of the approval process. 3. Review of a PGD, review date and changes in practice 3.1 The review date on a PGD must be no longer than 2 years after the date it is approved for use. If it will still be needed after the review date, it must be reviewed and reapproved. After the review date the PGD is not valid; medicines must not be supplied or administered on the authority of an expired PGD. 3.2 Should there be a significant change in practice and/or a change in the Summary of Product Characteristics (SPC) during the life of an approved PGD, the Head of Medicines Management will decide whether the PGD needs to be amended accordingly and submitted for re-approval or whether another method of communication is appropriate. 3.3 A clinician with relevant expertise needs to be involved in reviewing the clinical content of the PGD. S/he may be the doctor or dentist attached to the service or may be a local specialist in the CCG or a local acute trust as necessary. 3.4 A MMT pharmacist will be identified by the Medicines Management Team to assist with reviewing the pharmaceutical content of the PGD. 3.5 A list of PGDs in operation, with details of their expiry dates will be maintained and held by the Head of Medicines Management. 4. Auditing PGDs 4.1 As stated in HSC 2000/026, care provided under a Patient Group Direction must be audited. 4.2 Practitioners must be able to access records of patients who have received medication under a PGD for audit purposes so that the appropriateness of the supply or administration (or of not supplying or administering a medicine) can be reviewed. 4.3 It is a requirement for antibiotics PGDs to be audited by an external reviewer. Page 6 of 17
5. References and other useful information 2. Review Team. Review of Prescribing, Supply & Administration of Medicines. A Report on the Supply and Administration of Medicines under Group PGDs. Department of Health, 1998 3. HSC 2000/026. Patient Group Directions. Issue date 9.8.00. Review date 9.8.03. 4. Patient Group Directions a practical guide and framework of competencies for all professionals using PGDs, December 2009. URL: http://www.npc.nhs.uk/non_medical/resources/patient_group_directions.pdf 5. Patient Group Directions NELM URL: http://www.nelm.nhs.uk/en/communities/nelm/pgds/ 6. NICE Patient Group Directions Guidelines 2013 https://www.nice.org.uk/guidance/mpg2 Page 7 of 17
Appendix 2 Proposal for the Development of a Patient Group Direction Considering the following points before completing the proposal for the development of a Patient Group Direction 1. Provide the majority of clinical care involving supplying and/or administering medicines on an individual, patient-specific basis. Reserve Patient Group Directions (PGDs) for limited situations in which this offers an advantage for patient care, without compromising patient safety, and where there are clear governance arrangements and accountability. 2. Explore all the available options for supplying and/or administering medicines in a specific clinical situation. Consider whether 1 option or a range of options is appropriate. 3. 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. 4. Consider investing in the training of additional non-medical prescribers to enable redesign of services if necessary, as part of a wider development or review of local medicines policy. 5. PGDs must be used only by named and authorised registered health professionals who can legally supply and/or administer medicines using a PGD. 6. PGDs must only include medicines with a UK marketing authorisation, in line with legislation. 7. Ensure that off-label use of a licensed medicine is included in a PGD only when clearly justified by best clinical practice. Clearly state that the medicine is being used outside the terms of the marketing authorisation on the PGD. Consider informing the patient or their carer that the use is off-label, in line with General Medical Council guidance. 8. Ensure that a black triangle medicine is included in a PGD only when clearly justified by best clinical practice. Clearly indicate the black triangle status on the PGD. 9. Ensure that a controlled drug is included in a PGD only when legally permitted and clearly justified by best clinical practice. 10. Do not jeopardise local and national strategies to combat antimicrobial resistance and healthcare-associated infections. Ensure that an antimicrobial is included in a PGD only when: clinically essential and clearly justified by best clinical practice, such as Public Health England guidance a local specialist in microbiology has agreed that a PGD is needed and this is clearly documented use of the PGD is monitored and reviewed regularly Page 8 of 17
Do not include a medicine needing frequent dosage adjustments or frequent or complex monitoring in a PGD (for example, anticoagulants or insulin). 11. Do not make dose adjustments to a medicine supplied under a PGD when the medicine is already in the patient's possession. 12. Carefully consider the risks and benefits of including more than 1 medicine in a PGD on a case-by-case basis. Ensure all legal requirements are met for each medicine. 13. Do not use PGDs for managing long-term conditions, such as hypertension or diabetes, or when uncertainty remains about the differential diagnosis. Please complete and submit for approval by the Head of Medicines Management prior to the development of a full PGD. Title of PGD Name of Proposer Position Current Service Outline the case for a PGD Provide details of: Who will be working under the PGD How CCG services will improve Benefits to patient care Names of drugs to be supplied and/or administered Define inclusions Define exclusions Describe any potential risks of using this PGD Consequences of not having a PGD Page 9 of 17
Names of Author(s) and Clinical Checker Additional Information to support application PGD authorised for development by: Date Head of Medicines Management Timetable for Development Date Proposal received by Head of Medicines Management PGD authorised for development Final draft of PGD complete PGD ready for Clinical Governance Approval Signatures Page 10 of 17
Appendix 3 Process of drafting & approving Patient Group Directions for NHS Haringey CCG Author Checker Clinical Checker Head of Medicines Management Clinical Governance Approval (Medicines Optimisation Committee and Executive Nurse and Director of Quality & Integrated Governance) CCG Head of Medicines Management (for dissemination) For review and action Practitioners using the PGD Significant changes Title Author Qualificatio n Pharmacist And/or Lead Practitioner Role Task Designated Person if identified Accountable for content of the PGD Checker Pharmacist Responsibility for checking the accuracy of the PGD document against relevant references Clinical Checker And/or Specialist input where needed PGD dependent Accountable for checking appropriateness of clinical application of the PGD To draft document from relevant references into the agreed format To check content of PGD with references. To check document for clinical application, in particular inclusion & exclusion criteria Shared across 5 CCGs This will be shared out between CCG pharmacists PGD dependent May not be required if relevant clinician represented on the steering group. Page 11 of 17
Head of Medicines Management Medicines Optimisation Committee Clinical Governance Lead Practitioner GP/Employer/ Manager Pharmacist Clinical Governance Nurse or other Professional GP/Employer/ Manager Responsible for assuring the correct process has been followed for developing, authoring and checking the PGD. Ensures PGD is disseminated and on CCG intranet Accountable for reviewing the content and process Accountable for approving the process Accountable for practice of administration of drugs under a PGD Responsible for ensuring competence of the practitioner practising within a PGD Assurance that the appropriate individuals have followed the correct process Approving the PGD To review competence for practising within the parameters of the PGD in discussion with Manager. Alert Head of Medicines Management of any significant changes. To audit compliance with PGD To assess competence for practising within the parameters of the PGD in discussion with Practitioner Head of Medicines Management Executive Nurse and Director of Quality & Integrated Governance Every practitioner in the CCG GP lead for practice/ Manager of Service Page 12 of 17
Appendix 4 Medicines Management Team Contacts Name Title Telephone Number Pauline Taylor Head of Medicines Management 020 3688 2716 Efa Mortty Deputy Head of Medicines Management 020 3688 2760 Margaret Powell Prescribing Adviser 020 3688 2707 Roshan Prescribing Adviser 020 3688 2721 Jayaseelan Olya Modric Team Administrator 020 3688 2713 Page 13 of 17
Appendix 5 Header on each page: NHS Haringey CCG xxxx Patient Group Direction (PGD) HAR XXX v1 NHS Haringey PATIENT GROUP DIRECTION (PGD) For the supply and administration of xxxxx in General Practice or designated Community Pharmacies This PGD prepared by: Name Job title Signature Organisation Date This PGD approved by: Clinical Governance Lead Name Job Title Signature Organisation Date Executive Nurse and Director of Quality & Integrated Governance Expiry date: NHS Haringey Clinical Commissioning Group The master copy of this PGD is held by the NHS Haringey CCG Medicines Management Team The electronic copy of this PGD can be accessed through the NHS Haringey CCG intranet or through the Head of Medicines Management/ Footer on each page: Date approved: Review date: Expiry Date: Patient Group Direction: HAR xxx v1 Page 14 of 17
PATIENT GROUP DIRECTION (PGD) For the supply and administration of xxxx in General Practices or designated Community Pharmacies THIS DOCUMENT MUST BE READ IN CONJUNCTION WITH THE LOCAL ANTICOAGULANT AND STROKE PREVENTION SERVICE SPECIFICATION 2012. YOU MUST BE AUTHORISED BY NAME, AND MUST MEET AND COMPLY WITH THE REQUIREMENTS STIPULATED WITHIN THE CURRENT VERSION OF THE PGD AND THE LOCAL SERVICE SPECIFICATION BEFORE YOU PROVIDE ANY TREATMENT UNDER THIS PGD. 1. CLINICAL SITUATION TO WHICH THE PGD APPLIES Clinical Indication: Inclusion criteria Exclusion criteria Action if excluded Cautions and referral criteria 2. DESCRIPTION OF TREATMENT Name, form & strength of medicine Legal status (POM/P/GSL) Dosage Frequency Route Storage Follow up Patient advice (Verbal or written) Side effects Reporting procedure for adverse reactions and errors All adverse reactions (actual and suspected) will be documented and reported to the GP. Where appropriate, a Yellow Card Report will be sent to the Medicines and Healthcare Products Regulatory Agency (MHRA). A supply of these forms can be found at the rear of the British National Formulary. Alternatively, a report can be submitted electronically via http://yellowcard.mhra.gov.uk/ Page 15 of 17
Record Special considerations and additional information Records Appendix 1 should be completed for all administration and a copy included in the patient notes or stored securely Details of any adverse drug reactions should be documented in the patient's medication record or medical notes A copy of the details should be forwarded to the patient's registered GP within 3 days of the administration Audits All providers will co-operate with any audits set by NHS Haringey CCG which encompass the operation of this Patient Group Direction. 3. AUTHORISATION OF STAFF Professional Qualifications For authorised staff Registered nurse or pharmacist with a current registration with the appropriate professional board commissioned by Haringey CCG. A pharmacist registered with General Pharmaceutical Council (GPhC) A nurse registered with the Nurse and Midwifery Council (NMC) The registered nurse/pharmacist must complete the declaration of the PGD Training Continuing Professional development Pharmacists and Nurses practicing under this PGD must ensure they can provide evidence of appropriate qualifications and their competence to practice in the following areas: Knowledge of the principles governing supply of medication following a PGD Knowledge of the medication to which this PGD applies The practitioner should be aware of any change to the recommendations for the medicine listed It is the responsibility of the individual to keep up-to-date with continued professional development (CPD) and to work within the limitations of individual scope of practice 4. REFERENCES References used: Page 16 of 17
PGDs are legal documents and may be required to be viewed as evidence. Obsolete/out-of date signed copies of PGDs must be archived, according to local Policy. The master copy of this PGD is held by the NHS Haringey CCG Medicines Management Team for 25 years after its expiry. This patient group direction must be agreed to and signed by all health care professionals involved in its use. The PGD must be easily accessible in the clinical setting. Individual Authorisation Record. This PGD applies to Health Care Professionals holding current registration and employed in area of NHS Haringey CCG PGDs DO NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR ACCOUNTABILITY It is the responsibility of each professional to practice only within the bounds of their own competence and in accordance with their own Code of Professional Conduct. I have read and understood this guidance and agree to administer medicines only in accordance with the Core PGD and the specific PGD for which the medicine applies. Health Care Professional Name: NMC/GPhC number: Signature: Date: Authorising Professional Manager / Senior Practitioner* Name: Signature: Date: [If employed in more than one Practice/clinical area, a PGD must be signed for each area] Authorizing professional would normally be the individual s line manager or employing GP. *Note to Authorising Professional Managers/Senior Practitioners: The authorising professional should only sign the PGD after ensuring that the health professional is trained and competent to supply/administer the named medicine. Authorised staff should be provided with an individual copy of the PGD showing their authorisation. Page 17 of 17