POLICY DOCUMENT POLICY FOR PATIENT GROUP DIRECTIONS (PGD) Reference number Title: Policy for Patient Group Directions (PGD).

Transcription

1 POLICY DOCUMENT POLICY FOR PATIENT GROUP DIRECTIONS (PGD) Reference number Title: Version number 1 Policy approved by Date of approval Policy for Patient Group Directions (PGD). Medicines Management Committee 20 th November 2008 Date issued Review date November 2010 Document Author Lesley Gant Director Toby Sanders Director of Primary and Community Care

2 CONTENT PAGE 1. Version Control 2. Background 3. Policy Statement 4. Scope of Policy 5. Statutory Requirements 6. Roles and Responsibilities 6.1 Development Flow Diagram NHSLCC and NSHLCCHS 6.2 Development Process Assessment of Clinical Need for PGD Consultation Group Pharmaceutical and Legal Check Submission to Relevant Committees Medicines Management Committee Final Sign Off 6.3 Supply and Storage of Medicines 6.4 Patient Supply and Administration 6.5 Consultation Records 6.6 Risk Management 7. Format of PGD Document 8. Training Requirements 9. Independent Contractors 10. Monitoring and Audit Requirements 11. References 12. Appendices 12.1 PGD Template 12.2 Competency Assessment Template 13. Impact Assessment

3 1. Version Control and summary of changes Version Number Version 1 Draft 1 Version 1 draft 2 Version 1 draft 3 Date January 2008 October 2008 November 2008 Comments (Description change and amendments) Amendments in line with policy development document and comments from the PGD task and finish group (Lesley Gant Nirlas Bathia, Tejas Khatau, and Lindsey Wilkins) Comment from Tejas Khatau, appendix 1 not necessary as this is referenced in the document Policy for the development of Patient Group Directions (PGD) Page 3 of 23

4 2. Background 2.1. In 1997, the DH commissioned a Review of the Prescribing, Supply and Administration of Medicines. The Review Group, chaired by Dr June Crown CBE submitted its final report to the Secretary of State for Health in March The first report of the Review Group concerning the supply and administration of medicines by Group Protocol was published in April Recommendations from this report were circulated by the NHS Executive in the Health Services Circular (HSC 1998/051): Report on the Supply of Medicines under Group Protocols On 9 th August 2000 new legislation on the supply and administration of medicines came into effect. The legislation authorises the supply and/or administration of medicines, where the medicine is supplied for the purpose of being administered or is administered, in accordance with a Patient Group Direction (HSC/2000/026) Patient Group Directions (PGDs), in existence since August 2000, constitute a legal framework which allows certain health care professionals to supply and administer medicines to groups of patients that fit the criteria laid out in the PGD without the need for a prescription or an instruction from the prescriber 2.4. This policy has been developed to ensure that NHS Leicester City complies with the legal requirements of HSC 2000/026, 9 August 2000, Patient Group Directions (England Only) A Patient Group Direction (PGD) is a specific written instruction for the supply or administration of a named medicine in an identified clinical situation. The PGD should be locally developed by doctors, pharmacists and other appropriate professionals, and approved by the employer, advised by the relevant professional advisory committees 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 for patient care (without compromising patient safety), and where it is consistent with appropriate professional relationships and accountability. An example of this is the provision of immunisations and vaccinations 3. Policy statement This policy aims to deliver the following: 3.1 Define a consistent, safe and effective process to develop, implement and review Patient Group Directions within the law. 3.2 Define a method of joint working to reduce duplication of work. 3.3 Define health professional responsibility with respect to their role to develop and implement Patient Group Directions. 3.4 Define the responsibility of health professionals with respect to their role to supply and administer under Patient Group Directions. Policy for the development of Patient Group Directions (PGD) Page 4 of 23

5 4. Scope of the Policy This policy applies to: 4.1 All qualified health professionals and directorates within NHS Leicester City (NHSLC) and/or Leicester City Community Health Services (LCCHS) who wish to develop Patient Group Directions for use in their own area of work. 4.2 All qualified health professionals who wish to supply or administer medicines under a Patient Group Direction in NHSLC and/ or LCCHS. 4.3 Managers, Medicines Management Committee and Clinical Governance Leads who are responsible for approval of the use of a Patient Group Direction in NHSLC and/ or LCCHS. 4.4 All qualified health professionals who are entitled to act under Patient Group Directions. 4.5 Health professionals can only act within the Patient Group Direction as named individuals and must act within their appropriate Code of Professional Conduct. 5. Statutory Requirements 5.1. HSC 2000/026 clarifies the legal position with respect to the use of group protocols recommended in the Report on the Supply and Administration of Medicines under Group Protocols The legal term for these protocols is Patient Group Directions (PGD) A Patient Group Direction is a written instruction to supply and or administer a medicine to groups of patients who may not be individually identified before presentation for treatment A Patient Group Direction must be signed by a Senior Doctor, a senior pharmacist and a senior nurse and be authorised for use by the PCT 5.5. Qualified health professionals who are entitled to act under Patient Group Directions include nurses, midwives, health visitors, optometrists, pharmacists, chiropodists, radiographers, orthoptists, physiotherapists and ambulance paramedics. They can only do so as named individuals Pharmacists Registered nurses Registered health visitors Registered midwives Registered dieticians Registered physiotherapists Registered occupational therapists Registered speech & language therapists Registered optometrists Policy for the development of Patient Group Directions (PGD) Page 5 of 23

6 Registered orthoptists Registered orthoptists and prosthetists State registered chiropodists (podiatrists) State registered physiotherapists State registered radiographers State registered paramedics or qualified ambulance paramedics 5.6. Legislation specifies that each PGD must contain the following information: The name of the business to which the PGD applies The date the direction comes into force and the date it expires A description of the medicines to which the PGD applies The class of health professional who may supply or administer the medicine Signature of a doctor, dentist, nurse where appropriate and a pharmacist Signature by an appropriate health organisation i.e. PCT, GP practices The clinical condition or situation to which the PGD applies A description of those patients excluded from treatment under the PGD A description of the circumstances in which further advice should be sought from a doctor (or dentist) and arrangement for referral Details of appropriate dosage and maximum total dosage, quantity, pharmaceutical form and strength, route and frequency of administration and a minimum and maximum period over which the medicine should be administered Relevant warnings, including potential adverse reactions Details of any necessary follow-up action and circumstances A statement of the records to be kept for audit purposes. Policy for the development of Patient Group Directions (PGD) Page 6 of 23

7 6. Roles and Responsibilities 6.1. Development Process Flow diagram for NHSLC and NHSLCCHS Need for PGD identified within a service Discussion with Medicines Management Pharmacist (NHSLC or LCCHS) Service writes PGD (with input from doctor(s) and other healthcare professionals) 1-2 months PGD distributed to Clinical and Quality Assurance Directorate for comment Discussion For all LCCHS services, PGD presented to LCCHS Clinical Governance Committee Legal and Pharmaceutical check of PGD by Medicines Management Team (NHSLC) PGD signed off by senior professional leads (Doctor, Nurse and Pharmacist, NHSLC) Formal review by service 1-2 months 1-2 months PGD presented to Medicines Management Committee for organisation approval. PGD IS LEGAL TO USE FROM THIS POINT Change in practice impacting on PGD or PGD expires (PGD expires in 2 years from date of approval so PGD should be reviewed by the service at least 3 months prior to expiry) Key: = Responsibility of NHSLC or LCCHS service = Responsibility of Medicines Management Team/Committee = Direction of work flow/discussion Policy for the development of Patient Group Directions (PGD) Page 7 of 23

8 6.2. Development Process steps Assessment of clinical need for a PGD The following information is essential reading to help answer the questions below To PGD or not to PGD? That is the question. Pharmacy Community Care Liaison Group NPC Patient Group Directions: A guide to good practice The individual manufacturers Summary of Product Characteristics (SPC), available on-line at The service wishing to produce a PGD must answer the following questions and document supporting evidence for the clinical need of a PGD Is a PGD the most appropriate method of providing treatment for the group of patients in the defined clinical situation? Is there a clearly defined gap in service that a PGD can address without compromising patient safety? Is the recommended use included in the PGD consistent with the Summary of Product Characteristics (SPC) and NICE and locally agreed guidance where available? If not then the PGD may not be a feasible option How will supplies be obtained? Is there a safe storage area for medicines? PGD discussion group A service wishing to develop a PGD is responsible for organising the appropriate discussion group, which should involve the following personnel A senior doctor A senior pharmacist A representative of the professional group expected to operate within the PGD Consultation with key stakeholders Policy for the development of Patient Group Directions (PGD) Page 8 of 23

9 Pharmaceutical and legal check The completed draft PGD should be forwarded to a Medicines Management Pharmacist for a pharmaceutical and legal check. The Medicines Management team is responsible for the final legal and pharmaceutical check of the PGD before approval and implementation Submission to relevant Committees The draft PGD should be submitted to the following committees for comment and approval Relevant clinical groups Medicines management Committee Clinical Governance Committee (LCCHS) Commissioning and governance committee Medicines Management Committee The draft PGD will be discussed and approved at Medicines Management Committee The Medicine Management committee meets once a month Contact a member of the Medicines Management team for dates and inclusion on the agenda Final sign off The PGD must be signed by the senior doctor, the senior pharmacist, senior nurse and the representative of the professional group/organisation involved in developing the direction From this point the PGD is a legal document 6.3. Supply and storage of medication The following should be in place for the PGD Arrangements for the security, storage and labelling of all medicines must be robust Medicines for supply for patients to take away should be available in pre-packs made up by a pharmacy The EC labelling and Leaflet Directive applies to all medicines supplied under the Patent Group Direction A patient information leaflet must always be supplied There must be a secure system to record and monitor medicines use so that it is possible to reconcile incoming and out-going stock on a patient by patient basis Patient supply and administration The service developing the PGD is responsible to ensure that supply and administration of medicines by PGD is: Within the law HSC2000/026 Policy for the development of Patient Group Directions (PGD) Page 9 of 23

10 Is the most appropriate method of providing treatment for the group of patients in the defined clinical situation? (Assessment of the Clinical need for a PGD) Includes the provision of Patient information leaflets (PILS) and additional specific information 6.5. Record of consultation Robust recording and monitoring procedures must be in place to provide a clear audit trail to allow identification of the following: Training and competency of staff skills including review (Kept by the Manager of the relevant service) The health professional administering treatment Patient treated Treatment provided (must include batch number.) Appropriate records/ systems in place to easily identify patients and their notes for audit purposes Records of training / competency assessment/ sign off 6.6. Risk Management The following areas of risk must be considered when developing a PGD Chaperoning guidelines Consent procedures Complaints, Incidents and Serious Adverse Events reporting protocol (in line with PCT Incident Reporting Process) Significant event auditing Infection control and sterilisation guidelines for primary care Confidentiality of patient data, adherence to Caldicott principles (1999) and data Protection Act (1998) Research Alliance approval for research activity Safeguarding Children procedures and guidelines Safeguarding Adult procedures and guidelines 7. Format of a PGD The format of the PGD must follow the template shown in appendix 1, which complies with legal documents that guide practice (HSC2000/026) and corporate requirements. 8. Training requirements 8.1. Clearly defined criteria for implementation, training and competency assessment must be produced to include: The Law relating to PGDs Professional accountability and code of conduct relevant to each healthcare profession Directions for use Differential diagnosis/patient assessment Dosages and frequency Contra-indications Interactions Side effects Policy for the development of Patient Group Directions (PGD) Page 10 of 23

11 Patient advice National and local guidance Position of direction in relation to patient s total care plan Specific training requirements Any additional requirements for the product 8.2 All staff must acknowledge that the interests and safety of every patient is paramount. 8.3 The role of the health professional in the use of Patient Group Directions is not compulsory. 8.4 Healthcare professionals have the ability to exercise personal and professional judgment as to whether to accept the responsibility that this role will place on them. 8.5 The health professional is responsible for ensuring that they are trained, confident and competent to operate under each PGD and for the patients to which the PGD applies. 8.6 Staff using a PGD must be competency assessed and signed off before using the PGD 8.7 Competency assessment can be in the form of: Role play, Multiple choice questions (MCQ,) Supervised practice 8.8 The preferred method of competency assessment is supervised practice. 8.9 Where supervised practice is not possible, the following methods should be considered: Role play between healthcare professional and assessor; Written test Before a healthcare professional can use a PGD, they must be individually listed and have signed the individual authorisation form attached to the end of each PGD Sign off is done after the healthcare professional has been deemed competent following training and assessment The clinical lead for a service is responsible for ensuring that all their staff have had a competency assessment and have been signed off on the individual authorisation form for each PGD before healthcare professionals attempt to use it The competency assessment must be documented and must occur at least every two years (in line with renewal of PGD). Policy for the development of Patient Group Directions (PGD) Page 11 of 23

12 8.14 The content of competency assessment is vital. The competency assessment must cover all the relevant areas of the drug (e.g. dose, side effects, and interactions) and disease (e.g. pathology, differential diagnosis) which the PGD is covering The PGD Competency Assessment Document in Appendix 3 has been designed to provide services with an outline of what needs to be covered in the competency assessment. Services should use the template to add in questions relevant to the drug and disease that the PGD is covering. 9. Independent contractors 9.1 Contractors wishing to use a PGD approved and adopted by the PCT in their own practice may do so 9.2 The PGD should be formally adopted and signed by their organisation. 9.3 Independent contractors adopting PCT PGDs should ensure adequate training and monitoring is completed and documented 10. Monitoring and audit requirements 10.1 Criteria for audit of PGD PGD is in date PGD available on premises All patients are in inclusion criteria Supply / administration of medication to patients in exclusion criteria Numbers of patients excluded Appropriate advice is given to patients Appropriate records are kept Medication is appropriately labelled Staff appropriately qualified and trained Policy for the development of Patient Group Directions (PGD) Page 12 of 23

13 11. References HSC 2000/026, 9thAugust 2000 Patient Group Directions (England Only). Department of Health Report on the Supply and Administration of Medicines under Patient Group Directions Crown Report April Department of Health (DoH), (1999). Review of Prescribing, Supply and Administration of Medicines, Final Report. Department of Health. London. Department of Health (DoH), (2000). Patient Group Directions (England only), HSC 2000/26 NHS Executive, London. Department of Health (DoH), (2001). Reference Guide to Consent for Examination or Treatment, DoH, London. To PGD or not to PGD? That is the question. Pharmacy Community Care Liaison Group ( British National Formulary (BNF), current edition. British Medical Association, Royal Pharmaceutical Society of Great Britain. London. NPC Patient Group Directions: A guide to good practice. The individual manufacturers Summary of Product Characteristics (SPC), available on-line at For nurses: Nursing and Midwifery Council (NMC), (2004). Code of Professional Conduct: standards for conduct performance and ethics (Ref: Standards 07.04) NMC. London. Nursing and Midwifery Council (NMC), (2007). Standards for Medicines Management (2007)NMC, London. For Pharmacists: Royal Pharmaceutical Society of Great Britain (RPSGB) 1st August Code of ethics for Pharmacists and Pharmacy Technicians. Royal Pharmaceutical Society of Great Britain (RPSGB) 1st August Professional Standards and Guidance document Policy for the development of Patient Group Directions (PGD) Page 13 of 23

14 Appendix 12.1 TEMPLATE PATIENT GROUP DIRECTION Reference number: Title: Patient Group Direction Version number: Policy Approved by: Date of Approval: Date Issued: Review Date: Document Author: Version Medicines Committee Management Director: Mandy Ashton, Director of Quality

15 PATIENT GROUP DIRECTION (PGD) (PGD) [NAME OF DRUG] FOR [CLINICAL CONDITION BEING MANAGED] POM/P/GSL FOR USE BY [BODY OF HEALTHCARE PROFESSIONALS] EMPLOYED BY/WORKING ON BEHALF OF [NAME OF SERVICE] Equality Impact Assessment Tool To be completed and attached to any procedural document when submitted to the appropriate committee for consideration and approval. 1. Does the policy/guidance affect one group less or more favourably than another on the basis of: Race Ethnic origins (including gypsies and travellers) Nationality Gender Culture Religion or belief Sexual orientation including lesbian, gay and bisexual people Age 2. Is there any evidence that some groups are affected differently? 3. If you have identified potential discrimination, are any exceptions valid, legal and/or justifiable? 4. Is the impact of the policy/guidance likely to be negative? 5. If so can the impact be avoided? 6. What alternatives are there to achieving the policy/guidance without the impact? 7. Can we reduce the impact by taking different action? Yes/No Comments If you have identified a potential discriminatory impact of this procedural document, please refer it to the Policy Administrator, 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 the Policy Administrator. Date approved: Review date: Ref : Page 2 of 23

16 PATIENT GROUP DIRECTION (PGD) (PGD) [NAME OF DRUG] FOR [CLINICAL CONDITION BEING MANAGED] POM/P/GSL FOR USE BY [BODY OF HEALTHCARE PROFESSIONALS] EMPLOYED BY/WORKING ON BEHALF OF [NAME OF SERVICE] YOU MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT Clinical Condition Describe condition/symptoms/presentation DEFINITION OF CONDITION/ SITUATION Inclusion criteria Condition/situation where treatment under this direction is permitted Define age range Define diagnostic criteria/outcomes of tests required (where appropriate) Ensure fits with local guidelines / protocols if appropriate Exclusion criteria Defined upper and lower age limit Contra-indications listed in the Summary of Product Characteristics Pregnancy (unless totally safe or appropriate for caution) Breastfeeding (unless totally safe or appropriate for caution) Known hypersensitivity to (drug name) or any other ingredient in the product List all major interactions which would be exclusions Consider its use in patients with varying degree of renal/hepatic insufficiency Situations which are exclusions in local guidelines Cautions Circumstances when further advice should be sought from a doctor (seek further advice from supervising doctor) Action if patient declines treatment or is excluded As per local referral guidelines Describe what documentation is required and where this should be written. Date approved: Review date: Ref : Page 3 of 23

17 PATIENT GROUP DIRECTION (PGD) (PGD) [NAME OF DRUG] FOR [CLINICAL CONDITION BEING MANAGED] POM/P/GSL FOR USE BY [BODY OF HEALTHCARE PROFESSIONALS] EMPLOYED BY/WORKING ON BEHALF OF [NAME OF SERVICE] Description of Treatment Name, form & strength of medicine(s) Route/Method administration of Dosage & frequency (including maximum total dose where necessary) Duration of treatment Maximum or minimum treatment period Quantity to supply/administer SPECIAL PRECAUTIONS FOR HANDLING, LABELLING AND STORAGE. SIDE EFFECTS e.g. oral, sub-cutaneous, intra-muscular. specify any reconsitution requirements before adninistration For antibiotics specify course e.g. storage in refrigerator, List side effects as described in the Summary of Product Characteristics/British National Formulary. List side effects in order with the most commonly occurring ones first Use the Yellow Card System to report adverse drug reactions (ADR s) directly to the Commission on Human Medicines. Guidance on the use of the Yellow Card System and Yellow Cards are available in the current BNF. Report all significant ADR s to patients own GP. Advice to patient/carer Advise patient on how to take the medication (e.g. take with/after food, avoid grapefruit juice, complete the course etc ) Counsel patient on the potential side effects Advise to patient on how to manage these side effects (where appropriate) What to do if condition/symptoms do not improve/worsen Give a patient information leaflet Follow up Follow up with another health care professional (e.g.gp) Specify timeframe for follow-up Referral arrangements Circumstances for further advice Date approved: Review date: Ref : Page 4 of 23

18 PATIENT GROUP DIRECTION (PGD) (PGD) [NAME OF DRUG] FOR [CLINICAL CONDITION BEING MANAGED] POM/P/GSL FOR USE BY [BODY OF HEALTHCARE PROFESSIONALS] EMPLOYED BY/WORKING ON BEHALF OF [NAME OF SERVICE] Records and Audit Records Patient s name, address, date of birth and consent given Contact details of GP (if registered) Diagnosis Name of drug, dose and form given/administered Batch and expiry date details Advice given to patient (including side effects) Signature/name of staff who administered or supplied the medication, and also, if relevant, signature/name of staff who removed/discontinued the treatment Details of any adverse drug reaction and actions taken including documentation in the patient s medical record Follow-up arrangements Audit Ensure appropriate records/system are in place to easily identify patients and their notes for audit purposes. An audit should be conducted at least annually by services to ensure that they are complying with the requirements of this PGD. Staff Characteristics QUALIFICATIONS Registered professional [appropriate qualification to be listed] with a current [professional] registration SPECIALIST COMPETENCIES QUALIFICATIONS OR 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. References/Resources and comments British National Formulary Summary of Product Characteristics Any local or national guidelines (e.g. NICE, Clinical Knowledge Summaries) Date approved: Review date: Ref : Page 5 of 23

19 PATIENT GROUP DIRECTION (PGD) (PGD) [NAME OF DRUG] FOR [CLINICAL CONDITION BEING MANAGED] POM/P/GSL FOR USE BY [BODY OF HEALTHCARE PROFESSIONALS] EMPLOYED BY/WORKING ON BEHALF OF [NAME OF SERVICE] 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 Name of Author Directorate responsible for reviewing Organisation NHS Leicester City Authorisation LEAD DOCTOR NAME: AZHAR FAROOQI Position: Professional Executive Committee Chair Signature: Date: LEAD NURSE/ALLIED HEALTH PROFESSIONAL NAME: MANDY ASHTON Position: Director of Quality /Deputy Chief Executive Signature: Date: LEAD PHARMACIST NAME: SUSANNA TAYLOR Position: Assistant Director Medicines Management PGD reviewed by Signature: Date: Patient Group Direction Peer Reviewed by Name POSITION DATE Date approved: Review date: Ref : Page 6 of 23

20 INDIVIDUAL AUTHORISATION 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. Note to Authorising Managers: authorised staff should be provided with an individual copy of the clinical content of the PGD and a photocopy of the document showing their authorisation. Healthcare Professional s Declaration: I have read and understood the Patient Group Direction and agree to supply/administer this medicine only in accordance with this PGD. Authorising Manager s Declaration: I have assessed the knowledge and competencies of the healthcare professionals listed below in accordance with the requirements of the PGD. Name of Health Care Professional Signature of Health Care Professional Authorising Manager s Signature Date

21 Appendix 12.2 Competency Assessment Document (insert name of PGD here) Name of HCP Line Manager Job Title Date Knowledge/Competency being assessed Understanding of general principals of PGD use and legalities Questions/Statement to assess knowledge/competency Examples of suitable questions: A black-triangle drug can be put on a PGD Unlicensed medicines can be put on a PGD A PGD needs to be signed only by a doctor for it to be legal A PGD needs to be reviewed yearly HCPs must be competency assessed for each PGD before they can use it A PGD can only be used by independent prescribers Knowledge/competency shown? (or HCP to answer True or False if written test Relevant training Examples of suitable questions: Is the HCP up-to-date with CPR training? Is the HCP up-to-date with anaphylaxis training? Understanding of disease or condition to be managed by the PGD Insert questions to test HCP s understanding of: Disease/condition Disease progression Differential diagnosis Danger/warning signs

22 Knowledge/Competency being assessed Understanding of drug contained in the PGD Questions/Statement to assess knowledge/competency Insert questions to test HCP s understanding of: mechanism of action of drug dose side effects interactions cautions Contra-indications Knowledge/competency shown? (or HCP to answer True or False if written test Understanding of specific PGD Insert questions to test HCP s understanding of:: inclusion criteria exclusion criteria when to refer advice to give documentation Final Mark:..

23 To be used by the assessor only List below actins taken where a gap in the HCP s knowledge/competency has been identified: Gap in Knowledge/Competency Action(s) taken (e.g. discussion, reading etc.) Name of Assessor: Job Title: Date: