Protocol for the Administration of Inactivated Influenza Vaccine to. Adults by Registered Nurses via Patient Specific Direction

Transcription

1 This document has been reviewed in line with the Policy Alignment Process for Liverpool Community Health NHS Trust Services. It is a valid Mersey Care document, however due to organisational change this FRONT COVER has been added so the reader is aware of any changes to their role or to terminology which has now been superseded. When reading this document please take account of the changes highlighted in Part B and C of this form. Part A Information about this Document Protocol for the Administration of Inactivated Influenza Vaccine to Policy Name Adults by Registered Nurses via Patient Specific Direction Policy Type Board Approved (Trust-wide) Trust-wide Divisional / Team / Locality Action No Change Minor Change Major Change New Policy No Longer Needed Approval As Mersey Care s Executive Director / Lead for this document, I confirm that this document: a) complies with the latest statutory / regulatory requirements, b) complies with the latest national guidance, c) has been updated to reflect the requirements of clinicians and officers, and d) has been updated to reflect any local contractual requirements Signature: Date: Part B Changes in Terminology (used with Minor Change, Major Changes & New Policy only) Terminology used in this Document New terminology when reading this Document Vaccine Health Care Assistant Patient Specific Direction Specify Inactivated Influenza Vaccine Registered Nurse Fully defined Part C Additional Information Added (to be used with Major Changes only) Section / Paragraph No Outline of the information that has been added to this document especially where it may change what staff need to do All Clarification around definitions and roles Part D Rationale (to be used with New Policy & Policy No Longer Required only) Please explain why this new document needs to be adopted or why this document is no longer required To support Mersey Care staff to deliver contracted services within the community within a legal framework with regard to the National Vaccination program for Winter Pressures in a timely manner Part E Oversight Arrangements (to be used with New Policy only) Accountable Director Recommending Committee Approving Committee Next Review Date LCH Policy Alignment Process Form 1

2 SUPPORTING STATEMENTS This document should be read in conjunction with the following statements: SAFEGUARDING IS EVERYBODY S BUSINESS All Mersey Care NHS Foundation Trust employees have a statutory duty to safeguard and promote the welfare of children and adults, including: being alert to the possibility of child / adult abuse and neglect through their observation of abuse, or by professional judgement made as a result of information gathered about the child / adult; knowing how to deal with a disclosure or allegation of child / adult abuse; undertaking training as appropriate for their role and keeping themselves updated; being aware of and following the local policies and procedures they need to follow if they have a child / adult concern; ensuring appropriate advice and support is accessed either from managers, Safeguarding Ambassadors or the trust s safeguarding team; participating in multi-agency working to safeguard the child or adult (if appropriate to your role); ensuring contemporaneous records are kept at all times and record keeping is in strict adherence to Mersey Care NHS Foundation Trust policy and procedures and professional guidelines. Roles, responsibilities and accountabilities, will differ depending on the post you hold within the organisation; ensuring that all staff and their managers discuss and record any safeguarding issues that arise at each supervision session EQUALITY AND HUMAN RIGHTS Mersey Care NHS Foundation Trust recognises that some sections of society experience prejudice and discrimination. The Equality Act 2010 specifically recognises the protected characteristics of age, disability, gender, race, religion or belief, sexual orientation and transgender. The Equality Act also requires regard to socio-economic factors including pregnancy /maternity and marriage/civil partnership. The trust is committed to equality of opportunity and anti-discriminatory practice both in the provision of services and in our role as a major employer. The trust believes that all people have the right to be treated with dignity and respect and is committed to the elimination of unfair and unlawful discriminatory practices. Mersey Care NHS Foundation Trust also is aware of its legal duties under the Human Rights Act Section 6 of the Human Rights Act requires all public authorities to uphold and promote Human Rights in everything they do. It is unlawful for a public authority to perform any act which contravenes the Human Rights Act. Mersey Care NHS Foundation Trust is committed to carrying out its functions and service delivery in line the with a Human Rights based approach and the FREDA principles of Fairness, Respect, Equality Dignity, and Autonomy Page 2 of 18

3 Title Protocol reference number Aim and purpose of protocol Author Protocol for the Administration of Inactivated Influenza Vaccine to Adults by Registered Nurses via Patient Specific Direction 176 To enable suitably trained Registered Nurses working for or on behalf of Liverpool and Sefton Community Divisions to administer Influenza vaccine to adults. Modern Matron (Trust Lead Physical Health/Influenza Lead) - Executive Nursing Department Medicines Management Pharmacist Type New Policy Reviewed Policy Review date NOVEMBER 2019 Person/group accountable for review Type of evidence base used ISSUE DATE Authorised by Clinical Standards Group Clinical Standards Group C: Evidence which includes published and/or unpublished studies and expert opinion (limited scientific evidence) NOVEMBER 2018 Agreement at Clinical Standards Group on 29/11/2018 for approval via Delegated Authority. Equality Analysis Undertaken Yes No x Evidence collated Yes No Page 3 of 18

4 Version Control Form Version Number: Ratified by: V1 Clinical Standards Group Date of Approval: Name of originator/author: Approving Body / Committee: Hillary Smith Medicines Optimisation and Safety Group Clinical Standards Group Date issued: November 2018 Review date: November 2019 Target audience: Name of Lead Director / Managing Director: Registered Nurses working for or on behalf of Mersey Care Community Divisions who have undertaken relevant training, to administer influenza vaccine to adults aged 16 years and over Executive Director of Nursing and Operations Changes / Alterations Made To Previous Version: Specified vaccine and target audience Expanded definitions This protocol has been approved at the Medicines Optimisation and Safety Group and agreed via Delegated Authority at Clinical Standards Group on 29/11/2018 Page 4 of 18

5 Contents Page 1 Purpose of Protocol 6 2 Rationale 6 3 Principles 7 4 Training / Skills Training programme Topics covered Continuing Training Requirements 9 5 Authority to proceed Consent Patient Identification Patient Specific Direction 9 6 Eligibility Criteria & Condition to be Treated Criteria for inclusion Criteria for exclusion & circumstances for further advice/ action Treatment, route of administration and legal status Special circumstances Record keeping and audit Significant Events 14 7 References National Guidance Mersey Care Policies 15 8 Appendices Vaccination & Immunisation Option Checklist Consent Process for Influenza Immunisation 16 Resuscitation Council UK Anaphylactic Reaction Initial Treatment 17 Vaccination Competencies 18 Page 5 of 18

6 1. Purpose of Protocol To enable Registered Nurses employed by Mersey Care and working in the Community Divisions who have undertaken relevant training (section 4), to administer inactivated Influenza vaccine to adults aged 16years and over. A single dose of vaccine would be administered as a duty authorised and delegated by a prescriber, either a GP or Non-Medical Prescriber, under a Patient Specific Direction (PSD). It will ensure that all staff employed by the Trust, provide optimal service delivery to this population group. The advice and guidance contained within this protocol is based upon the latest research-based evidence from the Department of Health, Immunisation Against Infectious Disease, The Green Book. National and local policy documents should be read in conjunction with this protocol. Please see References in section Rationale To ensure that patients receive the highest possible level of care during the administration of vaccines. To ensure that Registered Nurses are appropriately trained to deliver the vaccination program. To ensure that Registered Nurses are supported to undertake tasks when delegated via a Patient Specific Direction (PSD). To ensure that Mersey Care Community Divisions can demonstrate resilience when there is a requirement for increased immuniser capacity and the ability to mobilise staff to support the implementation of public health contingency plans during peaks of seasonal flu activity and for any future Flu pandemics. An essential element to the development of this protocol is to ensure Registered Nurses have access to specific guidance in vaccine administration. This protocol underpins a recognised set of competencies based PHE (2018) National Minimum Standards and Core Curriculum for Immunisation Training of Registered Practitioners.. Page 6 of 18

7 3. Principles Registered Nurses, employed by Mersey Care, who have completed the appropriate training for the administration of inactivated influenza vaccine to adults, can be delegated to deliver the service under a Patient Specific Direction (PSD). Registered Nurses will undertake bespoke training as developed by the Trust. Refer to section 4. A PSD is a written instruction signed by a doctor, dentist or non-medical prescriber (hereafter referred to as the prescriber ) for medicines to be supplied or administered to a named patient or patients after the prescriber has assessed the patient on an individual basis. The prescriber retains responsibility and included in that is being assured that the person to whom the task is delegated is competent to complete the task. It is a form of prescribing but is different to an FP10, which would normally be issued to the patient on an individual patient basis only to be dispensed at a pharmacy. A PSD allows the prescriber to manage a group of patients who have the same need. A PSD needs to be written a verbal instruction is not a valid PSD and needs to be signed by the prescriber. The PSD should specify the following: Name of patient and/ or other individual patient identifiers Name, form and strength of medicine Route of administration Dose Frequency Start and finish dates Signature of prescriber Example: a computer generated list of patient names who have been identified by the prescriber as requiring the vaccination, which has been titled with the name, form, strength and route of the single vaccination. It needs to be signed by the prescriber and the period during which he wants these patients to be targeted e.g. 1 October February 2019 These requirements need to be met before the trained registered nurse can proceed to follow this protocol. Page 7 of 18

8 4. Training & Skills 4.1 Initial Training Completion of Consent to Treatment training Completion of Basic Life Support training Completion of Infection Control training The above training will be completed as a pre-requisite to: Completion of trust training on administration of Influenza vaccine Completion of period of supervised practice and assessment against competencies as per National Minimum Standards and Core Curriculum for Immunisation Training of Registered Practitioners (2018) Training and competencies in the correct procedure of administering medication via intra-muscular injection - see Appendix 3 Training to include maintenance of patient/client privacy and dignity at all times and the demonstration at assessment of awareness of different possible injection sites if client has any physical disability e.g. amputation Basic Life Support recognition and treatment of anaphylaxis Knowledge of the management of anaphylaxis in the community. Refer to the green book The National Resuscitation Guidelines on Anaphylaxis, 2008 (annotated with NICE guidance July 2012) Access to and knowledge of the DH guidance Immunisation against infectious disease Green book 4.2 Topics covered Knowledge, skills and practical application relevant to Vaccination and Immunisation Patient / client communication - demonstrating an awareness of Equality & Diversity and access to publications in other languages Appropriate anatomy, physiology and immunology Correct procedure for the administration of the vaccine via intramuscular injection Vaccine delivery, storage and stock control requirements, maintaining the cold chain. Refer to Mersey Care Policy Cautions and side effects related to the administration of inactivated Influenza vaccination Correct disposal of waste. Documentation and policy including accountability and PSDs. Refer to National Guidance Legal aspects of drug administration including consent for further information. Refer to National Guidance Response and treatment of adverse reactions including anaphylaxis and Basic Life Support Access to and Knowledge of current infection control policies. Page 8 of 18

9 4.3 Continuing training requirements Annual update in Basic Life Support and treatment of anaphylaxis Demonstration of competence in relation to this medication within the Personal Development Plan (PDP) and appraisal process (Performance Development Review) Completion of e-learning/attendance at bespoke annual Vaccination & Immunisation update/ refresher as per Trust requirements Any relevant mandatory training introduced by the Trust The immuniser will in conjunction with this protocol refer to all current related Mersey Care policies as listed in Section 7 5. Authority to proceed 5.1 Consent Consent must be obtained prior to proceeding with vaccination. Refer to SD06 Consent to examination and treatment An adult must consent to their own treatment. The Mental Capacity Act 2005 sets out how treatment decisions should be made for people of 16years of age or older who do not have the capacity to make such decisions 5.2 Patient identification This is required prior to administration of a vaccine. Patient must confirm: Name, date of birth, and home address Registered Nurse must confirm that the patient is eligible to receive the vaccination under the PSD 5.3 Patient Specific Direction A Valid Patient Specific Direction (PSD) must be obtained. Page 9 of 18

10 6. Eligibility Criteria and condition to be treated 6.1 Criteria for Inclusion Clinical condition to be treated Criteria for inclusion Active immunisation for adults against influenza disease Patient has been included in a valid PSD signed by the prescriber Aged 65 years and over by 31st of March in the relevant financial year Pregnant women at any stage of pregnancy All patients resident in long stay residential accommodation Any adult patient (16 years and over) who has a confirmed diagnosis of one of the following diseases: o Chronic heart (excluding uncomplicated controlled hypertension), renal, respiratory disease including asthmatics that requires repeated use of inhaled or systemic steroids or with previous history of hospital admissions due to asthma o Chronic neurological disease o Stroke, transient ischaemic attack o Diabetes mellitus o o o o Chronic liver disease Immunosuppression (due to treatment or disease including asplenia or splenic dysfunction and HIV infection at all stages refer to GP for individual assessment) Morbid obesity (class III obesity) adults with a BMI 40/kg/m² Main carer for elderly or disabled person A more in depth list of clinical risk factors can be found in the influenza section of the updated on line Green Book 6.2 Criteria for Exclusion and circumstances for further advice/action Criteria for exclusion Patients/ clients with any of the following: No valid consent Aged under 16 years Current acute febrile illness - immunisation should be postponed until recovered A confirmed anaphylactic reaction to a previous dose of vaccine containing the same antigens, including neomycin or gentamycin (discuss with clinician/gp). Page 10 of 18

11 Circumstances for further advice/action None of the influenza vaccines should be given to those who have had: a confirmed anaphylactic reaction to a previous dose of the vaccine, or a confirmed anaphylactic reaction to any component of the vaccine, (other than ovalbumin) see circumstances for further advice or action section below) Fit and well (no co-morbidities) adults under the age of 65yrs other than those stated above in inclusion criteria, for example main carer for an elderly relative or disabled person Individuals with an uncontrolled bleeding disorder i.e. haemophilia Patients with capacity declined. Counsel with regards to the risks of influenza infections and the protective effect of the vaccine. Document advice given If no capacity documented refer to prescriber for best interest decisions Severe reaction to any vaccine, or influenza vaccine or any vaccine component, including Neomycin or Gentamycin. Refer to prescriber Individuals who have egg allergy may be at increased risk of reaction to influenza vaccines. In recent years, inactivated influenza vaccines that have a very low ovalbumin content have become available with ovalbumin content less than 0.12 μg/ml (equivalent to 0.06 μg for 0.5 ml dose). Refer all patients who have a confirmed anaphylaxis to the prescriber for assessment for egg Pregnancy and breast feeding are not contraindications to receiving Flu vaccination. Pregnant women are in the clinical at risk criteria for Influenza infection; however pregnant women should be offered the opportunity to discuss their pregnancy with their clinician/gp/ registered nurse in relation to influenza infection and vaccination risks and benefits History of Guillain - Barre syndrome refer to prescriber (please note this is not a contra indication but will require a discussion with the prescriber) Acute febrile illness; rearrange vaccination at a later date Maintain all clients dignity at all times. If client is an amputee utilise available alternate limbs. If no alternative limb is available do not proceed. Seek advice from the Immunisation Lead /GP/ registered practice nurse as applicable Page 11 of 18

12 6.3. Treatment, route, administration and legal status Recommended treatment: Route and legal status Dosage Frequency of administration & maximum dosage Follow-up and advice Side effects & their management Inactivated Influenza vaccine to be administered by intramuscular injection into the deltoid muscle (for individuals with an uncontrolled bleeding disorder refer to GP/ registered nurse for subcutaneous vaccination) Prescription Only Medicine (POM) Adults 0.5mls Single administration via Patient Specific Direction (PSD) Seasonal flu vaccination is usually carried out between October and February of each year and it would be unusual to carry on vaccinating people, including pregnant women, after that date. Registered Nurses should seek advice from the Immunisation Lead or GP who can assess the needs of individual patients, taking into account the level of flu-like illness in the community and the fact that the immune response following flu vaccination takes about two weeks to develop fully Re -immunisation is not normally advised within a 12 month period: The patient/client should be referred to the prescriber for advice if re immunisation in the same year is required Follow any DH guidance during influenza pandemic Re-vaccination in 12 months with appropriate seasonal vaccine Local effects: Redness, swelling, hardness at injection site, pain, bruising. A small painless nodule (induration) may also form at the injection site Systemic side effects: Low grade fever recommended treatment with paracetamol. Pyrexia, headache, tiredness, muscle & joint pain Counsel patient that these reactions are rare and usually disappear within 1-2 days. If they do not, or more serious symptoms develop, then the patient should contact the GP. Extremely rare side effects: Immediate reactions e.g. Urticaria, angio-oedema, bronchospasm and anaphylaxis see protocol for treatment of anaphylaxis for appropriate management Neuralgia, paraesthesia, convulsions and transient thrombocytopenia have been reported rarely Page 12 of 18

13 6.4 Special Considerations Special considerations/ Concurrent medication Adverse reactions As above seek expert advice/ discuss if previous history of Guilllain Barre Syndrome. Influenza vaccination is not a contraindication in pregnancy. Patients may be referred to GP for advice. If available a thiomersal free vaccine should be used. Vaccine shortage may necessitate the need for prioritisation of influenza vaccination within the at risk groups. No drug interactions known. The immune response to influenza vaccination is reduced in those who are immunosuppressed or immunodeficient, including HIV patients. Patients should be individually assessed by the consultant team/gp in relation to the risk versus benefit of immunisation. Immunosuppressant therapy eg oral corticosteroids. Chemotherapy or radiotherapy may result in reduced antibody response. The benefits are such that immunisation should be considered. Refer to Clinician/GP or registered nurse immuniser for advice. Ensure that Anaphylactic shock pack is available If general adverse reaction occurs: Record in patient s notes Inform patient s GP as soon as possible. Local reactions should be referred to a practice nurse or GP Inform line manager and complete DATIX incident form If anaphylactic reaction occurs: Give treatment according to Trust policy on anaphylaxis in the community Record in patient s notes Inform patient s GP as soon as possible All suspected adverse reactions to vaccines occurring in individuals where vaccines are labelled with a black triangle ( ) and serious adverse reaction to vaccines should be documented and reported to the Medicines Healthcare products Regulatory Agency (MHRA) via yellow card system. Page 13 of 18

14 6.5 Record Keeping and Audit Items to be recorded in patient s notes Audit Please refer to the Trust Record Management Policy (IT04) and Health Records and Divisional Guidance (IT06) Name of drug, dose, route and site of administration Date of administration Legible batch number/s and expiry date (from outer vaccine box packaging) Printed name and legible signature of person administrating drug (written or electronic) and designation Contraindications checked Action taken if patient refuses vaccine Reactions to vaccination and action taken (see completion of yellow card in adverse reactions section). Registered Nurses will be expected to participate in audit/evaluation in relation to patient outcomes. The Trust will monitor adherence of Mersey Care Community Divisions staff to this Protocol during attendance at training that will include: Annual review with LCH Clinical Audit. Annual Update Q & A. Maintenance of database with record of training. Annual Review of Protocol. 6.6 Significant Events Significant Events (i.e. vaccine error, interruption of cold chain, and Near misses) Any significant event which occurs during or as a result of administration of a vaccine must be reported to the Clinical Lead. All Registered Nurses following this protocol will be expected to: Participate in audit in relation to patient outcomes and the development of this role according to local governance arrangements Comply with the requirements of all relevant Trust policies applicable to their area of operation and local governance arrangements Report and record incidents to the Clinical Lead. Report and record incident via the Trust DATIX reporting system Report and record all potential near misses or adverse incidents in line with Trust Risk Management policy following the protocol for vaccine error or interruption of the cold chain Page 14 of 18

15 7. References 7.1 National Guidance Green Book Royal College of Nursing ( 2015 ) Supporting the delivery of immunisation education.london: RCN Health Protection Agency (2005 )National Minimum standards and core curriculum of immunisation training of health care support workers. London: Public Health England (previous HPA) Available at Roach,M.S. (1984 )Caring: The Human Mode of Being, Implications for Nursing.Ottowa: The Canadian Hospital Association Press NMC Guidelines for Records and Record keeping 7.2 Mersey Care Policies IC01 Infection Control & Prevention SA03 Reporting, Management & Review of Adverse Incidents SA22 Waste Management SD06 Consent to Examination or Treatment SSCSD009 Resuscitation incorporating Anaphylaxis & Deteriorating Patient MM21 Storage, Ordering, Distribution & Administration of Vaccines (Cold Chain) Policy 9 Vaccination & Immunisation Page 15 of 18

16 8. Appendices Appendix 1 Page 16 of 18

17 Appendix 2 Page 17 of 18

18 Appendix 3