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POLICY FOR THE DEVELOPMENT, APPROVAL AND IMPLEMENTATION OF PATIENT GROUP DIRECTIONS
(PGDs)
Responsible Director: Sheila Dilks
Responsible Directorate:
Patient Care and Professions
Author: Lisa Meeks, Specialist Technician for Community & Support Services
Date Approved: 11th August 2010
Committee: Governance
Version: 1
Revision Date: 11th August 2013
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CONTENTS
Section Page 1 Introduction 4 2 Associated policies, procedures and guidance 4
3 Aims and objectives 5 4 Scope of the policy 5 5 Accountabilities and responsibilities 5
6 Foreword 6
7
CHOOSING THE MOST APPROPRIATE MECHANISM FOR THE SUPPLY/ADMINISTRATION OF MEDICINES
7.1 Definitions
7.2 When are PGDs not required?
7.3 Medicines which can and cannot be included in a PGD
7.4 Other methods of supply/administration of medicines
7 - 8
8
DEVELOPING PATIENT GROUP DIRECTIONS
8.1 Who should be involved?
8.2 Information that should be contained in the PGD
8.4 Example PGDs
9 - 10
9
APPROVAL AND IMPLEMENTATION
9.1 Review of PGDs
9.2 PGD amendments
9.3 Distribution of PGDs
9.4 PGD Review Group
9.5 Current List of PGDs
11 - 13
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RESPONSIBILITIES
10.1 Staff responsibilities
10.1.1 Health professionals
10.1.2 Team Leaders/Service Managers
10.1.3 Responsibilities of those authorising practitioners to work under PGDs
10.1.4 PCT Non Medical Prescribing Lead
14 - 16
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Section Page
11 Competency Framework 17 12 Audit 17
13 Equality Impact Assessment 17 14 Training Needs Analysis 17
15 References 17 - 18
Appendices 1 Flowchart for the Development of a New PGD
2 Proposal Form for the Development of a New or Extended Patient Group Direction
3 Checklist of Contents and Service Sign off Form
4 NHS Kirklees PGD Template 5 PGD Revision checklist
6 To PGD or Not to PGD 7 Glossary 8 Key stakeholders consulted in the development of this document 9 Equality Impact Assessment Tool 10 Dissemination sign off sheet
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Policy Statement
NHS Kirklees will endeavour to ensure the safe and secure handling of medicines to protect patients, staff and the public in accordance with current legislative requirements and best
practice.
This policy has been developed to ensure that NHS Kirklees complies with the requirements of Health Service Circular – HSC 2000/026, Patient Group Direction (England Only), which
outlines the legal position regarding Patient Group Directions and follows good practice guidance issued by the National Prescribing Centre.
1. Introduction
This document outlines the process to be followed within NHS Kirklees for the development of Patient Group Directions. It gives practical guidance on the development of Patient Group Directions, including details of criteria to be included, in order that the practice it supports is within the law and has the approval of the PCT. It also addresses the approval of PGDs developed by independent contractors / commissioned services providing NHS care. Those developing PGDs should take account of current PCT policies; guidelines and best practice and be aware of the PCT strategy for non-medical prescribing and PGDs.
2. Associated Policies, Procedures and Guidance
This policy should be read in accordance with the following PCT policies, procedures and guidance:
• Medicines Management Policy – A Guide to the Safe and Secure Handling of Medicines
• Non Medical Prescribing Policy and in conjunction with:
• The PGD guide published by the National Prescribing Centre, “A Practical Guide and Framework of Competencies for all Professionals using Patient Group Directions”, December 20091
Other Relevant Legislation The main relevant legislation covering the use of PGDs is found in:
• The Medicines Act 1968 as contained in the Prescription Only Medicines (Human Use) Amendment Order 2000 (SI 2000/1917)
• The Medicines (Sale and Supply) (Miscellaneous Provisions) Amendment (No 2) Regulations 2000 (SI 2000/1918)
1 Available at:
http://www.npc.co.uk/prescribers/resources/patient_group_directions.pdf
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• The Medicine (Pharmacy and General Sale - Exemption) Amendment Order 2000 (SI 2000/1919)
Further guidance is contained in Health Service Circular HSC 2000/026. The Prescription Only Medicines (Human Use) Amendment (No 2) Order 2004 (SI 2004/1189) covers additional professional groups: registered dietitians, registered occupational therapists, registered orthotists and prosthetists, registered speech and language therapists, who may supply or administer under a Patient Group Direction. All professions must act within their relevant Code of Professional Conduct.
3. Aims and Objectives
• To provide policy for the PCT covering the development, approval and implementation of PGDs.
• To provide staff with clear guidelines on the requirements for developing and reviewing PGDs within NHS Kirklees.
• To detail the responsibilities both of NHS Kirklees and of staff in respect of PGDs
• To provide a template proforma for developing PGDs.
• To provide a flow chart detailing the approval and implementation process within NHS Kirklees.
4. Scope of the Policy
All Trust employees including those on temporary or honorary contracts, bank staff and students who are involved in developing, reviewing or working under Patient Group Directions must follow the process set out in this document.
Independent Contractors are responsible for the development and management of their own Patient Group Directions and for ensuring compliance with relevant legislation and best practice guidelines. The Trust will provide such advice and support as required.
5. Accountabilities & Responsibilities
All activities within NHS Kirklees, which include the supply and administration of medicines to patients not covered by a prescription, patient specific direction or exemptions under the Medicines Act, MUST comply with the criteria set out in this policy. Any practice failing to comply with the criteria falls outside of the law and could result in criminal prosecution under the Medicines Act. This general policy outlines the responsibilities of authorised practitioners, professional groups, and NHS Kirklees with regard to Patient Group Directions and encompasses all the criteria required for their preparation.
All professionals are required to work within their Professional Code of Practice and terms of service.
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6. FOREWORD This policy incorporates the guidance provided in the 1998 Crown Report on the supply and administration of medicines under group protocol (the legal term for which is now Patient Group Direction); the legal requirements and guidance set out in HSC 2000/026: Patient Group Directions; and the National Prescribing Centre document, ‘Patient Group Directions A Practical Guide and Framework of Competencies for all Professionals using Patient Group Directions’. To meet the changes taking place within the NHS, it is desirable that highly trained health care professionals should be able to use their full range of skills in the interests of better patient care, the efficient use of resources and enhanced job satisfaction. It is essential, however, that the extension of professional roles is accompanied by clear arrangements for accountability. The extended role of health care practitioners must take into account the need to protect patient safety, ensure continuity of care and safeguard patient choice and convenience. It also has to be cost effective and bring demonstrable benefits to patient care. The majority of clinical care will continue to be provided on an individual, patient specific basis by a doctor, dentist or authorized non medical prescriber. Supply and administration of medicines under Patient Group Direction is reserved for those limited situations where advantages to patient care can be demonstrated (without compromising patient safety) and where it is consistent with appropriate professional relationships and accountability. Currently, the following health care professionals are permitted to supply or administer medicines under a Patient Group Direction:
• Pharmacists
• Registered nurses
• Registered Health Visitors
• Registered Midwives
• Registered Dieticians
• Registered Physiotherapists
• Registered Occupational Therapists
• Registered Speech & Language Therapists
• Registered Optometrists
• Registered Orthoptists
• Registered Orthotists and Prosthetists
• State registered Chiropodists (Podiatrists)
• State registered Physiotherapists
• State registered Radiographers
• State registered Paramedics or qualified Ambulance Paramedics The above professionals may only supply or administer medicines under a Patient Group Direction as named individuals. For further information: www.mhra.gov.uk
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7. CHOOSING THE MOST APPROPRIATE MECHANISM FOR THE SUPPLY/ADMINISTRATION OF MEDICINES The majority of clinical care should be provided on an individual, patient-specific basis. The supply and administration of medicines under Patient Group Directions should be reserved for those limited situations where this offers an advantage to patient care, without compromising patient safety, and be consistent with appropriate professional relationships and accountability. The decision on whether to use a PGD or other mechanism will depend on how an individual service is structured. Services in different organisations may choose, because of differences in the way their services are organised, to supply and/or administer medicines to their patients in different ways. For example, doctors referring patients to nurse-led clinics may write a Patient Specific Direction, (PSD – see ‘definitions’ below), in the patient’s notes for the nurse to supply and/or administer a particular medicine. Alternatively, the nurse-led clinic may have several PGDs which cover the patient groups likely to be seen in the clinic. It is important to ensure that a PGD is the most appropriate mechanism for delivery of the service in question and that all the options have been considered. For further guidance on deciding whether to use a PGD see ‘To PGD or not to PGD – that is the question’ (appendix 6) and ‘Option Appraisal – are PGDs the safest route for your service’ on the PGD website at: www.pgd.nhs.uk/
7.1 Definitions
A Patient Group Direction (PGD) can be defined as:
“a specific written instruction for the supply or administration of named medicines in an identified clinical situation. It is drawn up locally by doctors, pharmacists and other appropriate professionals, and approved by the employer, advised by the relevant professional advisory committees. It applies to groups of patients or other service users who may not be individually identified before presentation for treatment.”
A Patient Group Direction is NOT an authorisation to prescribe, but provides a legal authorisation for the supply and/or administration of medicines by a range of healthcare professionals within specified criteria.
A Patient Specific Direction (PSD) can be defined as:
“a written instruction from an independent prescriber (doctor, dentist or independent nurse/pharmacist prescriber), to another healthcare professional, to supply and/or administer a medicine directly to a named patient, or to several named patients.” 7.2 When are PGDs NOT Required?
A PGD is unnecessary if:
• An exemption exists under the Medicines Act for a podiatrist (chiropodist), paramedic or midwife to supply or administer the specified medicine. Full details can be found on the MHRA website at: www.mhra.gov.uk/howweregulate/medicines/index.htm
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• The medicine involved is classified as a General Sales List Medicine (GSL): Medicines legislation states that a PGD is not necessary to supply a GSL medicine, provided the supply takes place from lockable premises and the medicines are pre-packed and fully labelled. For services supplying GSL medicines in this way, good practice (from a clinical governance perspective) is to use a simple protocol.
• The medicine is exempt under the Medicines Act when used in an emergency, i.e. in a life threatening situation e.g. Adrenaline (epinephrine) – no prescription is required.
• Medical gas – as medical gases are not usually classified as prescription-only medicines
• Dressing, medical device or chemical agent – these are not legally classed as medicines
7.3 Medicines Which Can and Cannot be Included in a Patient Group Direction The following drugs should NOT be included in a PGD:
• Unlicensed medicines
• Controlled Drugs (except Diamorphine for treating cardiac pain following MI, Midazolam, part 1 Schedule 4 CDs and all drugs listed in Schedule 5)
In special circumstances the following medicines can be included in a PGD:
• Medicines used outside the terms of their license
• Recently licensed drugs under intensive monitoring and subject to special adverse drug reaction reporting requirements (‘Black Triangle Drugs’)
In both of the above cases such use is exceptional, and should be justified by current best practice e.g. NICE guidance, or recommendations of the Joint Committee on Vaccination and Immunisation (JCVI) for vaccine use. Each PGD should clearly state when the product is being used outside the terms of the Summary of Product Characteristics (SPC) and documentation should include the reasons why such use is necessary. A PGD can include a flexible dose range so the healthcare professional can select the most appropriate dose for the individual patient. Antimicrobials The inclusion of antimicrobial agents in a Patient Group Direction must be absolutely necessary and in line with current PCT antibiotic guidelines. A Consultant Microbiologist must be involved when developing any PGD that includes antimicrobial therapies. 7.4 Other Methods of Supply/Administration of Medicines This policy should be read in conjunction with the PCT Medicines Management Policy which gives full details on the different methods of supply / administration and prescribing of medicines.
8. DEVELOPING PATIENT GROUP DIRECTIONS
Refer to appendix 1 for a flowchart detailing the process for the development of a new PGD.2
For the development of a new or extended Patient Group Direction, the Service manager / clinical lead should complete a proposal form (appendix 2) and send to the Chair of the Non Medical Prescribing Committee for consideration at the next group meeting. The development of a new/extended Patient Group Direction should not be initiated until approval to proceed has been received. Following approval by the Non Medical Prescribing Committee the Specialist Technician for Community Services will enter the PGD onto the NHS Kirklees database of PGDs and allocate the PGD a number. The Service/Clinical Lead will then draft the Patient Group Direction using the PCT template, (appendix 4), and ensuring guidance contained within sections 8.1 and 8.2 (below) is followed. This draft document should then be sent for comments to:
• Representatives of any professional group expected to supply or administer medicines under the PGD.
• Relevant clinicians/health professional leaders
• A specialist if appropriate e.g. microbiologist. A consultant microbiologist must be involved in a PGD that includes an antimicrobial medicine.
The final draft must then be submitted to the Non Medical Prescribing Lead and Specialist Technician for Community Services, together with the Checklist of Contents and Service Sign Off Form (appendix 3). A peer review will then be undertaken by the Specialist Technician for Community Services/Non Medical Prescribing Lead and any comments fed back as necessary. The Specialist Technician for Community Services will then take the final draft document through the PCT’s approval and authorisation process (refer to section 9).
The PGD will be returned to the lead author with comments and appropriate support if not approved at any point of the process. It can be resubmitted once amendments have been made and agreed with all authors.
8.1 Who should be Involved?
Development of the Patient Group Direction is the responsibility of the Service/Clinical Lead, with pharmacist support from the Medicines Management Team.
A multidisciplinary group, including a doctor, a pharmacist, and a representative of the professional group involved in the specialist area concerned, should draw up the Patient Group Direction.
2 Development of vaccination and immunisation PGDs for NHS Kirklees are undertaken by the
PGD Review Group and do not follow this process – see 9.4
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Clear records of draft documents produced should be kept to show the comments and decisions made during preparation.
8.2 Information that should be contained in a PGD
The Checklist of Contents (appendix 3) and PGD template (appendix 4) should be used together when writing a PGD. It is important to ensure all areas are completed in full as failure to do so may result in the PGD not fulfilling all the legal requirements, leading to unnecessary delay in the implementation and use of the PGD. The pre-populated information contained within the PGD template should not be amended unless absolutely necessary. Any changes must be brought to the attention of the Non Medical Prescribing Lead. All PGDs should be underpinned by the best possible evidence-base (e.g. clinical guidelines, consensus statements). These guidelines do not need to form part of the PGD but should be used as a basis for producing it and the PGD should contain relevant and most up-to-date references. For more information, the following may be of use:
� National PGD website - http://www.portal.nelm.nhs.uk/PGD/default.aspx
� MHRA: Patient Group Directions in the NHS -
http://www.mhra.gov.uk/index.htm search “PGD”
� DH: HSC 2000/026 - http://www.dh.gov.uk/en/Publicationsandstatistics/Lettersandcirculars/Healthservicecirculars/DH_4004179
� NPC: Competency framework for Healthcare Professionals -
http://www.npc.co.uk/prescribers/resources/patient_group_directions.pdf If the multidisciplinary working group developing a PGD have any doubts or difficulties when completing any section of the PGD, advice should be sought from the Non Medical Prescribing Lead or Specialist Technician for Community Services by contacting the Medicines Management Team on 01484 464281. 8.3 Example PGDs
Examples of NHS Kirklees approved PGDs can be viewed on the PCT website at:
http://nww.kirklees.nhs.uk/medicines-management/patient-group-directions/
Examples of PGDs from other organisations can be viewed on the national PGD website at:
http://www.nelm.nhs.uk/en/Communities/NeLM/PGDs/
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9. APPROVAL AND IMPLEMENTATION Each PGD must be approved by the PCT Medicines Management Committee and Clinical Executive Committee (CEC) for use within NHS Kirklees. The Specialist Technician for Community Services is responsible for ensuring the PGD goes through the correct approval process, which can take up to 2 months depending on timing of meetings. The procedure is outlined below:
1) Draft PGD(s) to be submitted to the first available Medicines Management Committee meeting for consultation and endorsement.
2) Draft PGD(s) to be sent electronically to all CEC members for consultation. 3) Following consultation, and if no comments are received, the draft PGD will be sent
to CEC for final ratification. 4) If at any stage approval is not obtained, the PGD will be returned to the
Service/Clinical Lead with an explanation as to why approval has not been granted. 5) Once ratified an organisational copy of the PGD is printed and forwarded to the
organisational leads for signing. For Kirklees PCT these signatories are: � Director of Patient Care and Professions (Lead Nurse) � Assistant Director of Prescribing and Medicines Management (Lead Pharmacist) � Medical Director � CEC Chair (Lead GP)
This final ratification of the PGD ensures that legal liability and hence indemnification of staff is given full consideration. The organisational copy is retained by the Medicines Management Team and copies sent out to the relevant individuals/teams. The PGD will also be made available on the Trust intranet/website. . Until final approval by CEC AND organizational ‘sign off’, a PGD, or amendment of
an existing PGD, is invalid. NHS Kirklees accepts no responsibility for an authorised practitioner who acts in accordance with a PGD that is not signed by the organizational leads listed above
(bullet 5). 9.1 Review of PGDs The content of a Patient Group Direction must be reviewed every two years, or earlier, if there are changes in clinical practice or updates to the Summary Product Characteristics. Six months prior to the expiry date of an individual PGD, the Specialist Technician for Community Services will inform both the service lead and Head of Integrated Governance and Quality, (Kirklees Community Healthcare Services), that the PGD requires reviewing.
The service/clinical lead should first consider whether the PGD is still required and that the PGD is still the most appropriate/safest route for the supply or administration of medicines in their service – refer to ‘To PGD or not to PGD’, appendix 6.
If the PGD will still be needed after the expiry date, it must be reviewed and re-approved for use before it expires.
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Before undertaking this review the PGD should be audited for its effectiveness in the practice environment for a period of 1 month (see audit of PGD on Revision Checklist, appendix 5).
The service lead is responsible for undertaking/initiating review of an existing PGD ensuring guidance contained within sections 8.1 and 8.2 is strictly adhered to.
Amended draft(s) must then be sent for comments to:
• Representatives of any professional group expected to supply or administer medicines under the PGD.
• Relevant clinicians/health professional leaders
• A specialist if appropriate e.g. microbiologist. A consultant microbiologist must be involved in a PGD that includes an antimicrobial medicine.
The final draft must then be submitted to the Non Medical Prescribing Lead and Specialist Technician for Community Services, together with the Revision Checklist (appendix 5). This must be no less than two months prior to the expiry date to allow time for peer review and final approval. A peer review will then be undertaken by the Specialist Technician for Community Services and the PGD taken through the approval process as described above. 9.2 PGD Amendments 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 service/clinical lead, (or another professional involved in the use of the PGD), should notify the Non Medical Prescribing Lead who will decide whether the PGD needs to be amended accordingly and submitted for re-approval, or whether another method of communication is appropriate.
Any proposed changes to an existing PGD must be actioned by following the process described in 9.1. The amended PGD must then be resubmitted to the Medicines Management Committee and Clinical Executive Committee in accordance with the original approval procedure described in section 9. Where there are significant changes to a PGD the document must go through the full application and approval process – see section 8. Until final approval by CEC, a PGD, or amendment of an existing PGD, is invalid. 9.3 Distribution of PGDs The original signed document will be held by the Medicines Management Team, and a copy sent to the Service Lead/Manager which should be used as a ‘master’ to prepare individual copies for staff. Immunisation and vaccination PGDs will be sent out to Practice Managers and Team Leaders as appropriate. Acknowledgement slips will be sent out when distributing Patient Group Directions and Service Leads/Managers must ensure that these are returned on receipt of the document(s).
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On receipt of a new Patient Group Direction:
• A senior practitioner in each professional group (usually the Service/Clinical Lead or GP for Practice Nurses) is designated the responsibility to ensure that only fully competent, qualified and trained professionals operate under the Patient Group Direction.
• The Patient Group Direction ‘master’ MUST be signed by all health care professionals who intend to work under it. This must also be signed by the authorizing manager to confirm that the health care professional has undertaken the necessary training and is competent to work under the PGD.
• Authorised staff should be provided with an individual copy of the PGD.
On receipt of updated/reviewed Patient Group Directions a new ‘master’ will be sent to the service lead/manager who is responsible for:
• Ensuring all copies of the previous PGD are removed from use. The ‘master’ should be stored safely away and retained. For adults, all PGD documentation should be kept for 10 years and for children until the child is 25 years old.
• All practitioners authorised under the previous PGD are advised of the changes and any additional training required under the new PGD is provided
• All practitioners are provided with a copy of the new PGD and sign a new agreement of authorisation as above
NHS Kirklees accepts no responsibility for an authorised practitioner who acts in
accordance with a PGD that has been superseded. 9.4 The PGD Review Group Vaccination and immunization PGDs for NHS Kirklees are developed, reviewed and updated by the PGD Review Group. The PGD Review group is a multidisciplinary working group and has membership drawn from clinicians belonging to the areas listed below: � Specialist Technician, Community and Support Services (Group Facilitator) � Pharmacists (Non Medical Prescribing Lead and Community Services Pharmacists) � GP (or other medic) � GP Practice Nurse � School Nurse � Immunisation Team Nurse � Children’s’ Community Matron � Deputy Director Infection Control 9.5 Current List of Patient Group Directions
• The current list, along with the archived documents, is kept by the Medicines Management Team.
• Current PGDs are published on the intranet at: http://nww.kirklees.nhs.uk/medicines-management/patient-group-directions/
10. RESPONSIBILITIES It must be acknowledged by all members of staff that the interests and safety of every patient are paramount. Patient Group Directions should specify clear arrangements for professional responsibility and accountability, and contribute to effective use of resources.
10.1 Staff Responsibilities
10.1.1 Health Professionals
• All authorised practitioners intending to supply or administer medicines under a PGD must first read it.
• All authorised practitioners supplying or administering medicines under PGDs MUST be named. Therefore all staff working under a PGD MUST sign the individual authorisation section on the service ‘master’, (near the back of the PGD document), and have it countersigned by their authorising manager BEFORE working under a PGD. This must be done for every PGD that they intend to work under. The ‘master’ PGD will be held by the Service Lead/Manager.
• Only health professionals who hold the relevant qualifications and have undertaken the specified training as stated under “Staff Characteristics” of the PGD must operate under it.
• Authorised practitioners MUST only undertake the extended role under a PGD in circumstances where they are competent to assess all relevant aspects of the patient’s clinical condition, take responsibility for supply and administration of the medicine and make related decisions.
• All authorised practitioners supplying or administering medicines under PGDs MUST be named and have written evidence of competence, training, knowledge, experience and continuing education relevant to the clinical condition/situation to which the PGDs apply. The practitioner must take personal responsibility for ensuring they maintain their competence and knowledge, and attend additional training when appropriate.
• No authorised practitioner should undertake any aspect of patient care for which they are not trained and which is beyond their professional competence. If the authorised practitioner is in any doubt about their competency they should not administer or supply in accordance with the PGDs and should seek advice.
• The authorised practitioner undertaking this extended role must do so in accordance with the appropriate current PGD.
• Practitioners should have a copy of the current PGD available for reference when supplying and/or administering a medicine.
• Practitioners should keep a record of the supply/administration made under a PGD, to be made available for audit purposes when necessary.
• Practitioners MUST act only in accordance with the PGD.
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• Where patients who require treatment according to recognised national or local guidance cannot be treated under the criteria of the PGD the health professional should refer the patient to a suitable prescriber to ensure treatment can be given. Refer to ‘action if patient declines or is excluded’ of the PGD.
• Any clinical incidents relating to the actions of a healthcare professional operating under a PGD must be reported as per local policy and procedure.
• An adverse drug reaction should be reported by the healthcare professional identifying it using the ‘Yellow Card’ scheme – www.mhra.gov.uk
NOTE: A practitioner authorized to work under a PGD cannot delegate the responsibility to another person NHS Kirklees accepts no responsibility for an authorised practitioner who attempts
to act under a PGD in an area of practice to which the PGD does not apply.
10.1.2 Team Leaders/Service Managers
• Are responsible for maintaining the ‘master’ file of PGDs currently in use by their service.
• Are responsible for ensuring that everyone using PGDs in their service/team has signed up to the service ‘master’ and are authorised by the relevant clinical team leader or clinical manager. This may be the team leader in most circumstances (see 10.1.3).
• Ensuring that PGDs currently in use have not passed their review dates.
• Are responsible for maintaining a file of all PGDs no longer in use which should be stored safely away and retained.3
10.1.3. Responsibilities of those Authorising Practitioners to Work under PGDs
Before any individual is allowed to work under a PGD it is essential that they are assessed as competent to do so. They should be familiar with the situation to which the PGD relates to and also be trained and possess the skills specified in the PGD to which they sign up to. These competencies should be assessed and agreed by the relevant clinical team leader or manager before the individual is signed off to work under a PGD. The clinical manager who assesses these competencies must be familiar with the situation and they must be deemed as competent to assess others.
For example:
A Community Nurse Practitioner expected to administer Influenza vaccine under the terms and conditions of a PGD could be assessed as competent by their team leader or clinical manager.
3 For adults, all PGD documentation should be kept for 10 years and for children until the child is 25
years old.
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A Contraception and Sexual Health (CaSH) nurse might have their competencies assessed by either their team leader or the CaSH Clinical Lead.
Those authorising practitioners to work under PGDs must ensure that:
• The authorised practitioner is trained and has the required skills as specified in the PGD to which they are signing up to.
• The authorised practitioner has received the necessary training and is competent to practice under the PGD.4
• They countersign the individual authorisation section on the service ‘master’ which confirms that they have assessed the practitioner as being competent to work under the PGD.
10.1.4 Responsibility of the PCT Non Medical Prescribing Lead
• The PCT Non Medical Prescribing Lead is responsible for ensuring that PGDs are developed in line with legislative requirements and provide advantages to patients without compromising safety. This includes ensuring that any relevant groups have approved its content.
4 There is currently no specific national training programme for healthcare professionals using
PGDs. However the competency framework for healthcare professionals using PGDs (NPC) may be useful: http://www.npc.co.uk/prescribers/resources/patient_group_directions.pdf
11. COMPETENCY FRAMEWORK All practitioners authorised to work to PGDs should understand the legal framework, have received the required training in the area covered by the PGD and maintain their competence. The National Prescribing Centre (NPC) has produced a competency framework for professionals using PGDs and copies can be downloaded from: http://www.npc.co.uk/prescribers/resources/patient_group_directions.pdf
12. AUDIT It is a legal requirement to keep records of administration / supply under PGD for audit purposes. Care provided under a PGD must be audited, as stated in HSC 2000/026. It is recommended that audit is undertaken annually as part of staff IPR.
For new staff, practice should be audited six months after commencing the post.
Audits on the use of PGDs will be initiated and carried out by service leads / managers to ensure compliance with procedures. The results of the audit should be shared within the service and made available to the Non Medical Prescribing Committee upon request.
13. EQUALITY IMPACT ASSESSMENT
This policy has been assessed for the potential adverse impact as set out in Appendix C. On initial screening no impact has been identified for this policy.
14. TRAINING NEEDS ANALYSIS
All practitioners who operate under a PGD should receive training prior to operating under a PGD. Training should include the legal aspects, practitioner responsibilities and specific information relating to the clinical indication being treated under the PGD.
All practitioners who operate under a PGD must ensure that they undertake CPD within the relevant therapeutic area and where refresher training is available; they should attend on a periodic basis.
The practitioner or service manager with responsibility for ensuring that ‘training records are up to date’ must review the PGDs being used by a health professional on a regular basis (e.g. current document), check that those named to operate under the PGD are trained and update training record accordingly.
15. REFERENCES
Statutory Instrument 2000 No. 1917, The Prescription Only Medicines (Human Use) Amendment Order 2000; http://www.opsi.gov.uk/si/si2000/20001917.htm Statutory Instrument 2000 No. 1918, The Medicines (Sale or Supply) (Miscellaneous Provisions) Amendment (No. 2) Regulations 2000; http://www.opsi.gov.uk/si/si2000/20001918.htm Statutory Instrument 2000 No 1919 The Medicines (Pharmacy and General Sale -Exemption) Amendment Order 2000; http://www.opsi.gov.uk/si/si2000/20001919.htm Health Service Circular HSC 2000/026 9 August 2003 Patient Group Directions http://www.dh.gov.uk/assetRoot/04/01/22/60/04012260.pdf Statutory Instrument 2004 No.1189, The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2004; http://www.opsi.gov.uk/si/si2004/20041189.htm
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National Prescribing Centre December 2009, Patient Group Directions – A Practical Guide and Framework of Competencies for all Professionals using Patient Group Directions; http://www.npc.co.uk/prescribers/resources/patient_group_directions.pdf
Southwark Primary Care Trust. Policy for the Development, Approval and Implementation of Patient Group Directions. February 2007.
Leeds Primary Care Trust. Policy for the Development and Review of Patient Group Directions. April 2007.
Appendix 1
FLOWCHART FOR THE DEVELOPMENT OF A NEW PGD
Draft PGD to be drawn up by Service/Clinical Lead, involving all relevant specialists. Follow PGD policy on how to write a PGD. Use appendix 3 as an aid to writing and the PCT template (appendix 4)
Determine if a PGD is the most appropriate method of supply/administration for your service.
Justify the clinical/organisational need – must be exceptional and lead to improvement in patient care.
Refer to ‘PGD or not to PGD’ via
http://www.portal.nelm.nhs.uk/PGD/viewRecord.aspx?recordID=422
Need for PGD identified
Complete ‘Proposal for the Development of a new PGD’ form (appendix 2) and submit to the PCT Non Medical Prescribing Committee for approval (this group meets bi-monthly).
Check by the Specialist Technician for Community Services
Final draft to be submitted to the to the Non Medical Prescribing Lead/Specialist Technician for Community Services WITH checklist of contents and service sign off form
Circulate draft for comments
Once approval has been received from the Non Medical Prescribing Lead
Submit to the PCT Medicines Management Committee (MMC) and CEC for consultation and endorsement by MMC
If any comments received from MMC/CEC, PGD to be returned to lead author for
further action/amendment
NHS Kirklees organisational leads to ‘sign off’ PGD
Submit to CEC for ratification
Endorsed by MMC
PGD distributed by Medicines Management Team
REMEMBER – THE SERVICE/CLINICAL LEAD IS RESPONSIBLE FOR THE REVIEW OF THE PGD, WHICH MUST BE REVIEWED EVERY 2 YEARS OR EARLIER IF REQUIRED.
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Appendix 2
PROPOSAL FORM FOR THE DEVELOPMENT OF A NEW OR EXTENDED PATIENT GROUP DIRECTION
The completed document should be submitted to the Non Medical Prescribing Lead for approval by the Non Medical Prescribing Committee prior to the development of the PGD.
PART 1 – (To be completed by proposer of the PGD)
PGD FOR ……………………………………………………….(insert name, strength and form of medicine)
� I/we have applied the flowchart ‘to PGD or not to PGD’,(available at: www.pgd.nhs.uk/), to this clinical situation and a PGD is the most appropriate route to provide this clinical activity.
NAME AND POSITION OF PROPOSER
Contact details (Tel No/Email)
NAME AND POSITION OF LEAD AUTHOR RESPONSIBLE FOR THE DEVELOPMENT OF THE PGD (if different to above)
Contact details (Tel No/Email)
DEPARTMENT
STATEMENT OF SUPPORT FROM PROFESSIONAL LEAD e.g. clinical/service lead
NAME, SIGNATURE AND POSITION:
………………………………. …………………………………………… ………………………..
Date:……………………………………
Appendix 2 Continued
23
Is this a new PGD or a revision of an existing one?
Proposed title of PGD Names, formulation and dosage of drug(s) to be supplied or administered.
What are the proposed indications for this PGD?
Please list local/national guidance which supports the use of this drug
Clearly describe –
Why there is a need for this PGD within your service.
What are the benefits to patients having a PGD?
What are the benefits to staff having a PGD?
Who is to use this PGD? What are the training implications?
Are there any resource implications? (e.g. cost of drugs/staff training)
What are the potential risks involved with this PGD – in developing or not developing it? Are there any financial or clinical risks involved?
NAMES OF ANTICIPATED PGD AUTHORS
JOB TITLE EMPLOYER CONTACT DETAILS
Doctor
Pharmacist
Rep(s) of professionals who will work to the PGD
Other parties
Please return to:
Lucianne Ricketts, Non Medical Prescribing Lead, Medicines Management Team, Broad Lea House, Bradley Business Park, Dyson Wood Way, Huddersfield.HD21GZ.
Appendix 2 Continued
Non Medical Prescribing Lead
Non Medical Prescribing Lead
PART 2 – (To be completed by the Non Medical Prescribing Lead following discussion at Non Medical Prescribing Committee)
PGD TITLE: ……………………………………………………….
SERVICE:……………………………………………………………..
This PGD was considered by NMPC on …………………….(insert date)
and was:
� Approved for development into Patient Group Direction on behalf of NHS Kirklees
…………………………………………………………………. Date………………………………
OR
���� NOT approved for development into Patient Group Direction on behalf of NHS Kirklees
…………………………………………………………………. Date………………………………
NUMBER ASSIGNED: ………………..
Non Medical Prescribing Lead to return to the proposer
COMMENTS
Appendix 3
25
CHECKLIST OF CONTENTS AND SERVICE SIGN OFF FORM
The following is a list of the elements, which must be included in any Patient Group Direction prior to it being submitted for approval to the Medicine Management Committee.
1. Clinical Condition or Situation to which the PGD Applies
� Clinical situation stated
� Objective of care defined
� Clinical condition or situation clearly defined
� Criteria for confirmation of the clinical condition defined
� Clinical criteria for inclusion of a patient in the PGD defined
� Clinical criteria for exclusion of a patient from the PGD defined
� Clinical criteria for situations where further advice must be sought
� Action to be followed for patients excluded from the PGD defined
� Action to be followed for patients who do not wish to receive, or do not adhere to, care under the PGD
2. Description of treatment available under the PGD
� Name of medicine to be supplied or administered.
� Legal status of medicine.
� The pharmaceutical form of the medicine.
� The dose which can be supplied or administered under the PGD.
� Route or method of administration defined
� Frequency of administration defined
� Total dose, number of times treatment can be administered or supplied, and over what period of time defined
� Follow-up treatment or review time defined
� Advice, verbal and written to be given to the patient or carer, before or after treatment, defined, including access to patient information leaflets
� Instructions on identifying and managing possible adverse outcomes included
� Arrangements for obtaining medical advice defined
� Records to be kept to enable a clear audit trail described
� Method of keeping a record of drugs supplied under PGD
� Details of any special considerations to be made for patients taking concurrent medications included
3. Characteristics of staff authorised to supply/administer medicines under the PGD
� Professional qualifications and/or registration details stated
� Specialist qualifications, training and experience stated
� System set up for continued training and education of staff involved in PGD
� System for recording names of individuals authorised to supply or administer drugs under the PGD described
Appendix 3 Continued
4. Records
� Details of the records to be kept following supply or administration via the PGD should be specified
5. Management and monitoring of the PGD
� Names, job titles and signatures of professionals drawing up the PGD included
� Includes date of PGD and the review date after which the PGD is no longer valid
6. References*
� A list of the reference sources used during the development of the PGD should be included
8. Agreement by authorised practitioner
� Authorisation/agreement form for authorised practitioner to acknowledge their responsibilities and manager to provide assurance of that practitioner’s competence to work under PGD
* References
Please state which reference sources have been used during the development of this PGD (please tick):
Current BNF � State the edition number here: ……………………
Summary Product Characteristics (SPC) � Date accessed: …………………………………………………
NICE guidance � Please state title and version no: ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………….
Other guidance � Please state title and version no: :……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… …………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
I confirm that the use of this medicine is consistent with the current edition of the BNF Y/ N
I confirm that the use of this medicine is consistent with the relevant SPC Y / N
I confirm that the use of this medicine is consistent with relevant NICE guidance Y / N
SIGNED:…………………………………………………..(Service/Clinical Lead)
NAME: ……………………………………………………… DATE: ……………………………………………………….
If the answer is N to any of
these questions please give a
brief explanation overleaf.
Appendix 4
BASIC TEMPLATE FOR DEVELOPING A NEW PGD
NB. Dark coloured font is standard wording which must be included.
Italic light font lists criteria to be included specifically for that PGD
Patient Group Direction (PGD) for the (state Supply or Administration) of:
NAME OF MEDICINE
Insert legal classification
of drug
YOU MUST BE AUTHORISED BY NAME UNDER THE CURRENT VERSION OF THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT
CLINICAL CONDITION OR SITUATION TO WHICH DIRECTION APPLIES
Indication A clear and unambiguous definition of the clinical condition/situation, including criteria for confirmation of condition/situation.
Inclusion Criteria
• Informed consent has been given in accordance with current PCT guidelines for the supply/administration of the medicine.
State here the characteristics of the patient population you wish to treat for the above condition. Use bullet points
• Who is eligible to receive drug
• Clinical criteria
• Relevant local/national policies/guidelines Consider such characteristics as: The age range of patients The sex of patients Diagnosis or assessment the patient must have received prior to treatment. “At risk” groups that the patient must fall into (reference to national guidance is acceptable).
Exclusion Criteria
• Informed consent has NOT been given in accordance with current PCT guidelines for the supply/administration of the medicine.
State here those characteristics or situations that would prevent treatment under this PGD. Use bullet points. For example:
• Age
• Concurrent conditions
• Concurrent treatment (contraindications and dangerous interactions with essential medication).
• Previous adverse reactions/hypersensitivity
• Other exclusions listed in the product SPC.
• Are there any exclusions published by NICE or other DH
27
publications such as the Green Book.
Please also see Cautions/Need for further advice section
Cautions/Need for
Further Advice
Use bullet points. These may not be exclusions but require further consideration and discussion with an appropriate clinician.
POTENTIAL DRUG INTERACTIONS
This list is not exhaustive. Concurrent medication MUST always be checked for interactions before supply under this PGD
List here (using bullet points) some of the more common drug, less serious drug interactions as listed in appendix 1 of the BNF. The more serious interactions should be listed in exclusions.
Action if Patient Declines or is Excluded
• Patients who are excluded from treatment under the contraindications identified above should be referred to an appropriate medical practitioner/prescriber. This should be documented clearly in the patient’s record.
• Where patients do not wish to receive treatment under this PGD, refusal and action taken should be documented in the patient’s record.
• Give information about risks of infection and benefits of treatment (where appropriate).
• Give information about how to recognise signs and symptoms of infection (where appropriate).
• Give information about when the medicine may be given.
DESCRIPTION OF TREATMENT
Name, Form & Strength of Medicine
State clearly in full using the generic name of the medicine. Only use brand names of the medicine if you are insisting that a particular brand is used. Include the ▼ symbol for black triangle drugs adjacent to the drug name.
State the formulation e.g. sterile suspension for injection.
State the strength including units.
Route/Method State the route and if necessary the preferred site of administration
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Dosage & Frequency State clearly in full.
Provide practical information where appropriate, e.g. with food and ensure the period in which the maximum dose can be administered is stated (where applicable).
A dosage range is permitted but the PGD must state how to calculate/decide which dose to use.
Duration of Treatment
Maximum or Minimum Treatment Period
State minimum and maximum treatment period
Quantity to
Supply/Administer
State here the number of doses or units to be supplied or administered in this course of treatment.
Licensing Information Include a statement that the drug is licensed for this condition in this patient group or if relevant, include a statement supporting use if used outside terms of licence. See below for example wording to be used in this instance.
‘Off-label’ Use of (insert name of drug)
Describe here the difference between the licensed use of the drug and its use in this PGD.
The use of INSERT NAME OF DRUG under this PGD is therefore outside the specifications in the manufacturer’s SPC and is classed as ‘off label’ use.
Medicines can be used outside their licensing indication and be given under a PGD if such use is exceptional, justified by best practice and the status of the product is clearly described. In addition, you should be satisfied that you have sufficient information to administer the drug safely and, wherever possible, that there is acceptable evidence for the use of that product for the intended indication. (NMC 2004).
This PGD follows INSERT guidance which differs from the product SPC.
29
Side Effects As a minimum, include here those all adverse reactions that may be observed at the time of administration, all common reactions that could be perceived by the patient within a few days of administration and any serious reactions that may be perceived by the patient. Always include drowsiness where this is a potential reaction
Where the listed adverse reactions are not comprehensive reference should be made to the summary of product characteristics using the standard wording below:
This list is not exhaustive. Please refer to current BNF and product SPC for full details.
The following statement should be included for ���� drugs:
Report all suspected adverse reactions, however minor, to the Medicines and Healthcare products Regulatory Agency (MHRA), Commission on Human Medicines using a Yellow Card or on-line via www.yellowcard.gov.uk. Report all suspected reactions even if they are listed above, in the BNF or in the Summary of Product Characteristics (product data sheet). Yellow Cards may be completed by a nurse, pharmacist, the patient or a doctor, but it is the responsibility of the health professional identifying the ADR to report it.
And for all other drugs:
Report all serious suspected adverse reactions (ADRs) in adults and all serious and minor reactions in children (under 18 years), to the Medicines and Healthcare products Regulatory Agency (MHRA) using a yellow card (located at the back of the BNF) or on- line via www.yellowcard.gov.uk.
Report serious suspected reactions 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 or prolong hospitalisation and/or are medically significant.
Yellow cards may be completed by a nurse, pharmacist, the patient or a doctor, but it is the responsibility of the health professional identifying the ADR to report it.
Special Considerations/Additional Information
• Immediate access to adrenaline/epinephrine for treatment of anaphylaxis.
• Access to a telephone
• State the storage requirements Include any other details considered important.
30
Advice to Patient/Carer
• Explain the treatment, why it is needed, and further action where required.
• Provide the product patient information leaflet and advise the patient to read it.
• The patient should be warned to discontinue treatment immediately and seek medical advice if hypersensitivity reactions occur. If severe drug reaction occurs advise to attend Accident and Emergency. (See side effects).
Consider:
Advice on reactions and their management (always include advice on driving, or activities requiring a high level of concentration for medicines that may cause drowsiness).
Advice specific to the condition being treated.
Advice on the expected outcome of treatment.
Advice on how the treatment is to be used if it is supplied rather than administered on site.
Advice that is specific to the service such as future access to the service
Advice on how the treatment will be followed up and by whom including when to make a future appointment.
Advice on where to seek further advice or discuss concerns etc.
Indicate whether this advice will be given verbally or in writing (or other presentation) or both.
Follow Up Advise patient to seek further medical advice if:
• The condition worsens, does not improve, or they have not fully complied with treatment.
• They experience any hypersensitivity reaction
State any other requirements for follow up specific to your service
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REFERRAL ARRANGEMENTS AND AUDIT TRAIL
Referral Arrangements • Referral arrangements (including self-care) to be documented in patients notes.
• If patient is excluded from this PGD refer to an appropriate medical practitioner/prescriber. Patients should be either referred, as appropriate, to an independent prescriber, the GP, clinic doctor, Local Care Direct or A&E for further assessment and advice.
Records/Audit Trail The following information must be documented in records which should be stored appropriately and can be easily retrieved where necessary:
• Patient’s name, address, date of birth and consent given. If consent is either refused or withdrawn, this decision should also be documented.
• Diagnosis
• Contact details of GP if applicable
• Dose supplied and route
• Duration of treatment
• Indication that the patient was treated under PGD (including PGD number if practicable).
• Batch number, expiry date, manufacturer and brand name.
• Advice given to patient (including side effects)
• Date supplied
• Name of staff who supplied the medicine
• Where applicable, details of any subsequent adverse drug reaction and actions taken including referral arrangements. This MUST be documented in the patient’s medical record.
• Current medication
• Known allergies
• Referral arrangements (including self-care) State any additional service specific records here.
32
STAFF CHARACTERISTICS
Qualifications All nurses with valid Nursing and Midwifery Council (NMC) registration working within NHS Kirklees. (Use here the equivalent statement for other professions the PGD applies to). Also include any additional requirements you would expect. E.g. “holding a nurse practitioners qualification” or “who can demonstrate competence in following PGDs” or “holds a diploma or certificate in first contact medicine” or “working in the PCT managed CaSH service” etc.
Specialist Competencies or Qualifications
• Has undertaken appropriate training and successfully completed the competencies to undertake the clinical assessment of patient leading to diagnosis that requires treatment according to the indications listed in this PGD
• Has undertaken appropriate training and is competent for working under PGDs for the supply and administration of medicines
• Has undertaken training appropriate to this PGD – e.g. understanding concepts of antimicrobial resistance and appropriate use of antimicrobials
• Has undertaken training and is competent in resuscitation skills.
• Has undertaken training and is competent in the recognition and treatment of anaphylaxis
• Accepts personal responsibility for working within the PGD, understands the legal implications of doing so and works within the scope of the PGD.
State any additional service specific competencies here.
Continuing Training & Education
• 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 and to work within the limitations of their scope of practice.
• Practitioner should have access to current BNF and updated DH advice where appropriate.
• Attends updates in administration of medicines through the use of Patient Group Directives at recommended intervals including mandatory annual updates on Anaphylaxis and Resuscitation.
• Keeps undated via departmental updates and meetings.
State anything specific to your service here.
References & Resources Include all references that have been source material for the PGD e.g. BNF, SPC and any references that form the basis of the treatment being “best practice” such as NICE guidance, other national guidance or published evidence.
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PATIENT GROUP DIRECTION FOR THE SUPPLY AND/OR ADMINISTRATION OF
(INSERT NAME OF MEDICINE)
**This PGD has been developed/updated for use by the individuals listed below:
OR **This PGD replaces: state title and number, and has been prepared by:
NAME DESIGNATION POSITION SIGNATURE DATE
Doctor
Pharmacist
Service Manager/Clinical
Lead
**Delete as appropriate
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Individual Authorisation for the Supply/Administration of (INSERT NAME AND STRENGTH OF DRUG) by (INSERT WHO CAN WORK TO THIS PGD) Working at NHS Kirklees (INSERT
NAME OF SERVICE)
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 the Patient Group Direction and agree to supply/administer this medicine only in accordance with this PGD. In signing this declaration the healthcare professional is willing to be professionally accountable for this work as defined in their Code of Professional Conduct.
Authorising Managers
For PCT staff this will be the team leader, or relevant clinical manager.
Authorised staff working at a fixed base should have access to the signed PGD held at the base. Authorised staff who may supply/administer medicines away from the base should have an individual copy of the relevant signed PGD with them when supplying/administering the medicine.
Name of Professional Signature Authorising Manager Date
Staff who are no longer required to administer under this PGD should be removed from it. This can be
done by crossing through the relevant name, adding date and initials.
CONSULTATION PROCESS ADOPTED IN DEVELOPING THIS PATIENT GROUP DIRECTION
TITLE OF DOCUMENT: PGD for NUMBER: New Document (Y/N) Review of Document (Y/N) Revised Document (Y/N) If revised – what revisions were required?
See appendix 5
Director Lead
(Name and job title)
Author
(Name and job title)
List of persons involved in developing/updating PGD (include job titles)
List of persons involved in consultation process (include job titles)
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AUTHORISATION
This patient group direction must be agreed to and signed by all health care professionals involved in its use. The NHS Trust should hold the original signed copy. The PGD must be easily accessible in the clinical setting
ORGANISATION KIRKLEES PRIMARY CARE TRUST
Director of Patient Care & Professions
Name: Sheila Dilks
Signature: Date:
Assistant Director of Medicines Management and Prescribing
Name: Neill McDonald
Signature: Date:
Medical Director Name: Dr Judith Hooper
Signature: Date:
PEC Chair Name: Dr David Anderson
Signature: Date:
Appendix 5
PATIENT GROUP DIRECTION – REVISION CHECKLIST
(To accompany an existing PGD that has been reviewed and revised)
PGD Title
Existing PGD Number
Have you considered alternative mechanisms for supplying/administering this drug in your service?
Has this PGD been audited for
effectiveness?**
Date of Review
Reason(s) for revision
List of persons/groups
involved in revising PGD
(including job titles)
Pharmacist Reviewer
Doctor Reviewer
List of persons/groups
involved in consultation
process
(including job titles)
**Audit of PGD
Key aspects for audit of the effectiveness of a PGD should include:
• That the patients treated under the PGD have met the stated inclusion criteria.
• Any adverse reactions that have been noted
• Patients that have been exclude and why
• Circumstances where further advice/referral has been required.
Appendix 5 Continued
25
• Minimum and maximum doses of medication.
• Documentation in the patients records (record keeping)
• Where the PGD is for the supply of medicines, that receipts and outgoings of medicines can be reconciled.
• The storage facilities and security of medicines
References
Please state which reference sources have been used during the review of this PGD (please tick):
Current BNF � State the edition number here: ……………………
Summary Product Characteristics (SPC) � Date accessed: …………………………………………………
NICE guidance � Please state title and version no: ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………….
Other guidance � Please state title and version no: :……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… …………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
I confirm that the use of this medicine is consistent with the current edition of the BNF Y/ N
I confirm that the use of this medicine is consistent with the relevant SPC Y / N
I confirm that the use of this medicine is consistent with relevant NICE guidance Y / N
SIGNED:…………………………………………………..(Service/Clinical Lead)
NAME: ……………………………………………………… DATE: ……………………………………………………….
PLEASE COMPLETE THE RECORD OF CHANGES MADE, (NEXT PAGE), BEFORE SUBMISSION WITH THE REVISED PGD TO THE NON MEDICAL PRESCRIBING LEAD AND
SPECIALIST TECHNICIAN FOR COMMUNITY SERVICES
If the answer is N to any of
these questions please give a
brief explanation below
Appendix 5 Continued
Record of Changes made to Previous Version
SECTION EXPIRED VERSION REVIEWED VERSION Indication Inclusion Criteria Exclusion Criteria Cautions/Need for Further Advice
Action if Patient Declines or is Excluded
Name, Form and Strength of Medicine
Route/Method Dosage & Frequency
Duration of Treatment
Maximum of Minimum Treatment Period
Quantity to Supply/Administer
Licensing Information
Side Effects Special Considerations/Additional Information
Advice to Patient/Carer
Follow Up Referral Arrangements
Records/Audit Trail Qualifications Specialist Competencies or Qualifications
Continuing Training & Education
References & Resources
Appendix 6
25
Appendix 7
DEFINITIONS
Administer To give a medicine orally, by injection, by intravenous infusion, by suppository, pessary or by external application (e.g. cream/ointment/patch).
Authorised Practitioner A healthcare professional who has been given authorisation to work under a PGD
Black Triangle Drugs Newly-introduced drugs, still subject to special monitoring for potential side effects by the Medicines Control Agency (so called because they are identified by a black triangle symbol in the British National Formulary).
Clinical Responsibility Accountability for a particular aspect of the clinical assessment or management of a patient’s condition.
Controlled Drugs Narcotic drugs or other drugs liable to misuse, which are subject to special controls under the Misuse of drugs Act 1971.
Dispense To To make up or give out a clinically appropriate medicine to a patient for self-administration or administration by another, usually another professional. In the case of prescription only (POM) medicines, dispensing must be in response to a legally valid prescription. The act of dispensing is combined with advice on safe and effective use.
General Sales List (GSL) Medicine A medicinal product which can be sold or supplied direct to the public in an unopened manufacturer’s pack from any lockable business premises. Such products are listed in the Medicines (Products Other than Veterinary Drugs) (General Sales List) Order 1984.
Patient Group Directions Specific written instruction for the supply or administration of named medicines in an identified clinical situation. It is drawn up locally by doctors, pharmacists and other appropriate professionals, and authorised by the employer, advised by the relevant professional advisory committees. It applies to groups of patients or other service users who may not be individually identified before presentation for treatment.
Licensed Indication Treatment purpose for which a product may be used under the terms of the marketing authorisation
27
granted by the Licensing Authority.
Licensed Medicine A medicine which falls within the definition of a medicinal product and which is granted a marketing authorisation by the Licensing Authority when the safety, quality and efficacy of the product have been satisfactorily demonstrated by the License Holder (holder of marketing authorisation) in accordance with EC Directives 65/65.
Medicinal Product Any substance or combination of substances presented for treating or preventing disease in human beings or animals. Any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings or in animals is likewise considered a medicinal product (Article 1.2 EC Directive 65/65).
Pharmacy (P) Medicine Any medicinal product other than those designated as GSL or POM products. Pharmacy medicines can be sold or supplied only from a registered pharmacy by, or under the supervision of a pharmacist.
Prescription Only Medicine (POM) A medicinal product which may only be supplied against the signed prescription of an appropriate practitioner i.e. doctors, dentists, independent prescribers.
Summary Product Characteristics (SOP) A description of a medicine’s approved conditions of use.
Supply To provide a medicine directly to the patient or carer for administration
Key Stakeholders Consulted/Involved in the Development of the Document
28
Stakeholders name and designation
Date feedback requested
Detail of feedback received
Date feedback received
Action taken
Non Medical Prescribing Committee
22/6/10
Head of Integrated Governance and Quality to be notified in addition to Service Manager when a PGD is due for review.
21/7/10 Actioned
Medicines Management Committee
6/710
Clinical Executive Committee
7/7/10
Appendix C: Equality Impact Assessment Tool
To be completed and attached to any procedural document when submitted to the appropriate committee for consideration and approval.
Insert Name of Policy / Procedure
Yes/No Comments
1. Does the policy/guidance affect one group less or more favourably than another on the basis of:
• Race No
• Ethnic origins (including gypsies and travellers) No
• Nationality No
• Gender No
• Culture No
• Religion or belief No
• Sexual orientation including lesbian, gay and bisexual people No
• Age No
• Disability - learning disabilities, physical disability, sensory impairment and mental health problems
No
2. Is there any evidence that some groups are affected differently?
No
3. If you have identified potential discrimination, are any exceptions valid, legal and/or justifiable?
NA
4. Is the impact of the policy/guidance likely to be negative?
No
5. If so can the impact be avoided? NA
6. What alternatives are there to achieving the policy/guidance without the impact?
NA
7. Can we reduce the impact by taking different action?
NA
If you have identified a potential discriminatory impact of this procedural document, please refer it to [insert name of appropriate person], together with any suggestions as to the action required to avoid/reduce this impact.
For advice in respect of answering the above questions, please contact [insert name of appropriate person and contact details].
Appendix D Sign Off Sheet regarding Dissemination of Procedural Documents
To be completed and attached to any document which guides practice when submitted to the appropriate committee for consideration and approval.
Title of Document:
Lead Director:
Date Approved:
Where approved:
Dissemination Lead:
Placed on Website:
Review Date:
