Patient Group Direction For The Administration Of Rotavirus Vaccine Rotarix By Nurses, Midwives and Health Visitors Working Within.

Transcription

1 NHS Grampian Patient Group Direction For The Administration Of Rotavirus Vaccine Rotarix By Nurses, Midwives and Health Visitors Working Within NHS Grampian Lead Author: Consultation Group: Approver: Medicines Management See relevant page in the Medicine Guidelines and Specialist Nurse PGD Policies Group Signature: Signature: rialorrert f; [U..40 Identifier: NHSG/PGD/rotaV/ MGPG932 Review Date: February 2020 Expiry Date: February 2021 Date Approved: February 2018 NHS Grampian have authorised this Patient Group Direction to help patients by providing them with more convenient access to an efficient and clearly defined service within the NHS Board. This Patient Group Direction cannot be used until Appendix 1 and 2 are completed. Uncontrolled when printed Version 3 This Patient Group Direction has been adapted from the Health Protection Scotland template by NHS Grampian in order to meet local clinical governance arrangements for Patient Group Directions.

2 Revision History: Date of change November 2017 November 2017 Approval date of PGD that is being superseded June 2015 June 2015 Summary of Changes 2 Yearly update to new PGD template. Updated in-line with HPS national PGD. Section heading NHS Grampian Identifier: NHSG/PGD/rotaV/MGPG932 Replaces: NHSG/PGD/rotaV/MGPG740, Version 2.3 Keyword(s): PGD Patient Group Direction, Rotarix, Rotavirus, Nurse, Midwife, Health Visitor, Vaccine Policy Statement: It is the responsibility of individual nurse, midwife, or health visitor and their line managers to ensure that they work within the terms laid down in this PGD and to ensure that staff are working to the most up to date PGD. By doing so, the quality of the services offered will be maintained, and the chances of staff making erroneous decisions which may affect patient, staff or visitor safety and comfort will be reduced. Supervisory staff at all levels must ensure that staff using this PGD act within their own level of competence. The lead author is responsible for the review of this PGD and for ensuring the PGD is updated in line with any changes in clinical practice, relevant guidelines, or new research evidence. Review date: The review date for a PGD needs to be decided on a case-by-case basis in the interest of patient safety. The expiry date should not be more than 3 years from the date the PGD was authorised. Document: Drafted: November 2017 Completed: February 2018 Approved: February 2018 (published March 2018) UNCONTROLLED WHEN PRINTED Review Date: February 2020 Identifier: NHSG/PGD/rotaV/MGPG932 - i -

3 PGD Rotavirus vaccine, Live (Rotarix ) Authorisation This specimen Patient Group Direction (PGD) template has been produced by Health Protection Scotland to assist NHS Boards. NHS Boards should ensure that the final PGD is considered and approved in line with local clinical governance arrangements for Patient Group Directions. The qualified health professionals who may administer Rotavirus vaccine, live (Rotarix ) under this PGD can only do so as named individuals. It is the responsibility of each professional to practice within the bounds of their own competence and in accordance with their own Code of Professional Conduct and to ensure familiarity with the marketing authorisation holder's summary of product characteristics (SPC) for all vaccines administered in accordance with this PGD. NHS Board governance arrangements will indicate how records of staff authorised to operate this PGD will be maintained. Under PGD legislation there can be no delegation. Administration of the vaccine has to be by the same practitioner who has assessed the patient under the PGD. This PGD has been produced for NHS Grampian by Designation Name Signature Date Signed Doctor Diana Webster Sit/abed, March 2018 Pharmacist Ann Smith. March 2018 Nurse Fiona Browning c,s alitkill4 March 2018 Organisational Authorisation This PGD is not legally valid until it has had organisational authorisation NHS Grampian Designation Name Signature Date Signed Medical Director Nick Fluck ZU c March 2018 Director of Pharmacy David Pfleger W March 2018 Director of Nursing, Midwifery and Allied Healthcare Professionals Amanda Croft 0. L_ Cnz.ft March 2018 UNCONTROLLED WHEN PRINTED Review Date: February 2020 Identifier: NHSWPGD/rotaV/MGPG932 - II - PGD For The Administration Of Rotavirus Vaccine Rotarixt By Nurses, Midwives and Health Visitors Working Within NHS Grampian Version 3 Template Version 1.2

4 Management and Monitoring of Patient Group Direction PGD Consultative Group The consultative group is legally required to include a medical practitioner, a pharmacist and a representative of the professional group who will provide care under the direction Name: Frances Adamson Ann Smith Diana Webster Alison Work Fiona Browning Fiona Anderson Title: Lead Author: Medicines Management Specialist Nurse Pharmacist: H&SCP Lead Pharmacist Aberdeen City Medical Practitioner: Consultant in Public Health Public Health Team Leader Health Protection Nurse Specialist Health Visitor Team Leader UNCONTROLLED WHEN PRINTED Review Date: February 2020 Identifier: NHSG/PGD/rotaV/MGPG932 - iii -

5 Patient Group Direction For The Administration Of Rotavirus Vaccine Rotarix By Nurses, Midwives and Health Visitors Working Within NHS Grampian Clinical indication to which this PGD applies Definition of situation/condition This Patient Group Direction (PGD) will authorise nurses, midwives and health visitors to administer rotavirus vaccine Rotarix to patients to provide active immunisation against rotavirus in line with Scottish Government Health Directorate immunisation programme. This PGD should be used in conjunction with the recommendations in the current British National Formulary (BNF), British National Formulary for Children (BNFC), The Green Book and individual Summary of Product Characteristics (SPC). Inclusion criteria Infants from 6 weeks to 24 weeks (i.e. by 23 weeks and 6 days) as part of routine immunisation schedule. First dose should be given before 15 weeks of age. Valid consent has been given to receive the vaccine by the parent/guardian/person with parental responsibility. National recommendations advise Rotarix vaccination for all clinically stable preterm infants including those born before 27 weeks gestation, unless exclusion criteria apply. Exclusion criteria Confirmed anaphylactic reaction to a previous dose of rotavirus vaccine. Confirmed anaphylactic reaction to any component of the vaccine. Practitioners must check the marketing authorisation holder s summary of product characteristics (SPC) for details of vaccine components. Less than 6 weeks of age, over 24 weeks of age (i.e. older than 23 weeks and 6 days). Infants who have not received their first dose before 15 weeks of age (i.e. older than 14 weeks and 6 days). Known to have severe combined immunodeficiency disorder (SCID). Known to be immunosuppressed. Known to have previous history of intussusception. UNCONTROLLED WHEN PRINTED Review Date: February 2020 Identifier: NHSG/PGD/rotaV/MGPG

6 Known to have a malformation of the gastrointestinal tract that could predispose them to intussusception. Known to have rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucraseisomaltase insufficiency. Infants whose mothers have received immunomodulating biologics (such as monoclonal antibodies or receptor antagonists which interfere with the immune system, e.g. anti-tnf agents) in pregnancy. Acute severe febrile illness - postpone immunisation until patient has fully recovered. Acute diarrhoea or vomiting - postpone immunisation until patient has fully recovered. Precautions and special warnings Minor illnesses without fever or systemic upset are not valid reasons to postpone immunisation. If an individual is acutely unwell, immunisation may be postponed until they have fully recovered. Referral criteria Patients who fall into the categories detailed in the exclusion criteria. Action if excluded from treatment Specialist advice must be sought on the vaccine and circumstances under which it could be given. The risk to the individual of not being immunised must be taken into account. Infants with immunosuppression (other than SCID): there are limited data on the safety and efficacy of Rotarix. In such cases the infant s GP in collaboration with the clinician dealing with the child s underlying condition should assess the infant and consider vaccination. Temporary exclusion: In case of postponement due to acute severe febrile illness, arrange a future date for immunisation. Temporary exclusion: In case of postponement due to acute diarrhoea or vomiting, arrange a future date for immunisation. Medical advice should be sought refer to General Practitioner/Consultant (relevant medical practitioner). The reason why the patient was excluded under the PGD must be documented in the appropriate patient record. UNCONTROLLED WHEN PRINTED Review Date: February 2020 Identifier: NHSG/PGD/rotaV/MGPG

7 Action if parent/guardian/ person with parental responsibility declines treatment The parent/guardian/person with parental responsibility should be advised of the risks of not having the vaccination and given advice regarding minimisation of risk and where vaccination can be arranged. Refer to General Practitioner/Consultant (relevant medical practitioner). Record outcome in Patient Medication Record if appropriate, or relevant patient record. Consent Prior to the administration of the drug, valid consent must be obtained. Consent must be in line with current NHSG consent policy. Description of treatment available under the PGD Name of medicine Rotavirus vaccine, Live (Rotarix ). Legal status Rotarix is a Prescription-only Medicine (PoM). Form/Strength Oral suspension in a prefilled oral applicator or a tube. Route/Method of administration Oral use only. Rotarix must not be injected. If the infant spits out or regurgitates most of the vaccine, a single replacement dose may be given at the same vaccination visit. Dosage/Total Dose One single 1.5mL dose repeated after 4 weeks. Duration of treatment The course consists of two doses with an interval of at least four weeks between the doses. The recommended age for immunisation is the first dose at two months of age (approximately eight weeks) followed by the second dose at least four weeks after the first dose. UNCONTROLLED WHEN PRINTED Review Date: February 2020 Identifier: NHSG/PGD/rotaV/MGPG

8 It is preferable that the full course of two doses of Rotarix be completed before 16 weeks of age. Infants older than 15 weeks of age (i.e. older than 14 weeks and 6 days), who have not yet received their first dose of Rotarix, should not be commenced on Rotarix. Infants who receive the first dose before 15 weeks of age should complete the course by 24 weeks of age (i.e. by 23 weeks and 6 days). If the course is interrupted it should be resumed but not repeated, provided that the second dose can be given by 24 weeks of age (i.e. by 23 weeks and 6 days). Storage requirements Vaccine should be stored at a temperature of +2 to +8 C. If the vaccine has been frozen, it should be discarded. NHS Grampian guidance on Storage and Handling of vaccines must be observed. Follow-up (if applicable) Vaccine recipients should remain under observation until they have been seen to recover from the procedure. It is not possible to specify an exact length of time, but patients should remain on the premises for at least minutes. Patients should not leave if they are feeling unwell. Parent/guardian/person with parental responsibility should speak to the nurse or pharmacist first. If necessary a doctor or the patient s GP should be contacted for advice. Very premature infants (born 28 weeks of gestation) who are in hospital should have respiratory monitoring for hours when given their first routine immunisations, particularly those with a previous history of respiratory immaturity. If the child has apnoea, bradycardia or desaturations after the first routine immunisations, the second immunisation should also be given in hospital, with respiratory monitoring for hours. Give date for next vaccination. Advice to patient (Verbal) Advice should be given on what to expect and what to do for major and minor reactions. In the event of severe adverse reaction including infants with abdominal pain, vomiting and passing what looks like red currant jelly in their nappies parents/guardians should be advised to seek urgent medical advice. UNCONTROLLED WHEN PRINTED Review Date: February 2020 Identifier: NHSG/PGD/rotaV/MGPG

9 Advise parent/guardian/person with parental responsibility that contacts of infants who have had Rotarix vaccine should observe good personal hygiene, e.g. wash their hands after changing vaccinee s nappies. Advice to patient (Written) The Patient Information Leaflet (PIL) contained in the medicine(s) should be made accessible to the parent/guardian/person with parental responsibility. Where this is unavailable, or unsuitable, sufficient information should be given in a language that they can understand. Copies of PIL and SPCs for medicines can be found at or Concurrent Medications/Drug Interactions Rotarix can be given at the same time as the other vaccines administered as part of the childhood immunisation programme including BCG. Rotarix and BCG can be given at any time before or after each other. Identifying and managing possible adverse reactions The most common adverse reactions observed after administration of Rotarix vaccine are diarrhoea and irritability. Other reactions commonly reported are vomiting, abdominal pain, flatulence, skin inflammation, regurgitation of food, fever and loss of appetite. As with all vaccines there is a very small possibility of anaphylaxis and facilities for its management must be available. This list is not exhaustive. Please also refer to current BNF/BNFC and manufacturers SPC for details of all potential adverse reactions. BNF: SPCs/PILs: If an adverse reaction does occur give immediate treatment and inform relevant medical practitioner as soon as possible. Report the reaction to the MHRA using the Yellow Card System. UNCONTROLLED WHEN PRINTED Review Date: February 2020 Identifier: NHSG/PGD/rotaV/MGPG

10 Medical advice in cases of anaphylaxis Injections of IM adrenaline/epinephrine 1:1000 must be available to treat an anaphylactic reaction should this occur. Medical advice must be sought as soon as possible from a doctor if any patient develops any signs of hypersensitivity. If there is a delay in medical support arriving and the condition of the patient is deteriorating then an emergency ambulance must be called on 999 or direct via ambulance control or dial 2222 (hospital internal) according to local procedure, or seek urgent medical advice. Facilities and supplies required The following should be available at sites where the medication is to be administered: Pharmaceutical refrigerator (or a validated cool box for storing vaccine if mobile unit). An acceptable level of privacy to respect patient s right to confidentiality and safety. Resuscitation equipment. Immediate access to Epinephrine (Adrenaline) 1 in 1000 injection. Access to medical support (this may be via the telephone). Approved equipment for the disposal of used materials. Clean and tidy work areas, including access to hand washing facilities. Copies of the current PGD for the medicine specified in the PGD. Characteristics of staff authorised to administer medicine under PGD Professional qualifications Registered nurses, midwives and health visitors as recognised by the Nursing and Midwifery Council (NMC). Specialist competencies Aware of current treatment recommendations and be competent to discuss issues about the drug with the parent/guardian/person with parental responsibility. Competent in the administration of the drug. Ongoing training and competency All professionals working under this PGD must; UNCONTROLLED WHEN PRINTED Review Date: February 2020 Identifier: NHSG/PGD/rotaV/MGPG

11 Have attended basic life support training which is required to be updated annually. Have undertaken the NHS e-anaphylaxis training session or equivalent (including annual updates) which covers all aspects of the identification and management of anaphylaxis. This can be accessed via eksf, or the AT Learning tool/learnpro. Maintain their skills, knowledge and their own professional level of competence in this area according to their Code of Professional Conduct. Must be familiar with the SPC for all medicines administered in accordance with this PGD. Professional managers/lead Nurses will be responsible for: Ensuring that the current PGD is available to staff providing care under this direction. Ensuring that staff have received adequate training in all areas relevant to this PGD and meet the requirements above. Maintain up to date record of all staff authorised to administer drug specified in PGD. Documentation Authorisation of administration Nurses, midwives and health visitors working within NHS Grampian can be authorised to administer the drug specified in this PGD by their Clinical Manager/Consultant/practice GPs. All authorised staff are required to read the PGD and sign the Agreement to Administer Medicines Under PGD (Appendix 1). This should be held in the individual practitioners records, or as agreed locally. A Certificate of Authorisation (Appendix 2) signed by the authorising doctor/manager and staff working to the PGD, should be held as agreed locally. Record of administration/ supply An electronic or paper record for recording the screening of patients and the subsequent administration of the drug specified in this PGD must be completed in order to allow audit of practice. This should include: UNCONTROLLED WHEN PRINTED Review Date: February 2020 Identifier: NHSG/PGD/rotaV/MGPG

12 Name and address of patient Patient CHI No and date of birth Details of parent/guardian/person with parental responsibility where applicable Consultant/General Practitioner details Risk group, if appropriate Findings of physical examination, if appropriate Exclusion criteria, record why the drug was not administered Reason for giving Consent to the administration (if not obtained elsewhere) Drug manufacturer, batch number and expiry date (Vaccines and injectable medicines) Site where drug administered, dose and route of administration Signature and name in capital letters of practitioner who administered the drug Date drug given Record of any adverse effects (advise patient s doctor) If vaccines are given information regarding this administration must be provided to the General Practice and Practitioner Services Division (PSD) for inclusion on the Scottish Immunisation Recall System (SIRS). Depending on the clinical setting where immunisation is undertaken, the information should be recorded manually or electronically, in one (or more) of the following systems, as appropriate: GP practice computer Individuals GP records Child Health Systems (e.g. SIRS) Personal Held Child Record (red book) These records should be retained: For children and young people, retain until the patient's 25th birthday or 26th if the young person was 17 at the conclusion of treatment. Audit All records of the drug specified in this PGD will be filed with the normal records of medicines in each practice/service. A designated person within each H&SCP/practice/service will be responsible for auditing completion of drug forms and collation of data. UNCONTROLLED WHEN PRINTED Review Date: February 2020 Identifier: NHSG/PGD/rotaV/MGPG

13 References Electronic Medicines Compendium Rotarix Tube Date of revision of text 30/06/17, accessed 29/11/17. Rotarix Oral Applicator Date of revision of text 28/04/17, accessed 29/11/17. British National Formulary accessed 29/11/17. British National Formulary for Children accessed 29/11/17. Immunisation against Infectious Disease [Green Book] Rotavirus chapter 27b UNCONTROLLED WHEN PRINTED Review Date: February 2020 Identifier: NHSG/PGD/rotaV/MGPG

14 Appendix 1 Health Care Professional Agreement to Administer Medicines Under Patient Group Direction I: (Insert name) Working within: e.g. H&SCP, Practice Agree to administer medicines under the direction contained within the following Patient Group Direction Patient Group Direction For The Administration Of Rotavirus Vaccine Rotarix By Nurses, Midwives and Health Visitors Working Within NHS Grampian I have completed the appropriate training to my professional standards enabling me to administer medicines under the above Patient Group Direction. I agree not to act beyond my professional competence nor outwith the recommendations of the Patient Group Direction. Signed: Print Name: Date: Professional Registration No: UNCONTROLLED WHEN PRINTED Review Date: February 2020 Identifier: NHSG/PGD/rotaV/MGPG

15 Appendix 2 Health Professionals Authorisation to Administer Medicines Under Patient Group Direction The lead nurse/professional of each clinical area is responsible for maintaining records of their clinical area where this PGD is in use, and to whom it has been disseminated. The manager who approves a healthcare professional to supply and/or administer medicines under the patient group direction, is responsible for ensuring that he or she is competent, qualified and trained to do so and for maintaining an up-to-date record of such approved persons in conjunction with the Head of Profession. The healthcare professional who is approved to supply and/or administer medicines under the direction is responsible for ensuring that he or she understands and is qualified, trained and competent to undertake the duties required. The approved person is also responsible for ensuring that administration or supply is carried out within the terms of the direction, and according to his or her code of professional practice and conduct. Patient Group Direction For The Administration Of Rotavirus Vaccine Rotarix By Nurses, Midwives and Health Visitors Working Within NHS Grampian Local clinical area(s) where these healthcare professionals will operate under this PGD: Name of Healthcare Professional Signature Date Name of Manager Signature Date UNCONTROLLED WHEN PRINTED Review Date: February 2020 Identifier: NHSG/PGD/rotaV/MGPG

16 Patient Group Direction For The Administration Of Rotavirus Vaccine Rotarix By Nurses, Midwives and Health Visitors Working Within NHS Grampian Local clinical area(s) where these healthcare professionals will operate under this PGD: Name of Healthcare Professional Signature Date Name of Manager Signature Date UNCONTROLLED WHEN PRINTED Review Date: February 2020 Identifier: NHSG/PGD/rotaV/MGPG