NHS Grampian Patient Group Direction For The Pre-Exposure Prophylactic Administration Of Rabies Vaccine By Nurses And Pharmacists 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: SO CArearns4n Signature: /. s i/ Identifier: NHSG/PGD/Rabies/ MGPG854 Review Date: November 2018 Expiry Date: November 2019 Date Approved: November 2016 A Patient Group Direction is 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, approved by the employer and advised by the relevant professional advisory committees. In most cases, appropriate clinical care is provided on an individual basis by a specific prescriber to a specific individual patient. Patient Group Directions should only be considered where they offer a benefit to patient care without compromising patient safety in any way. Uncontrolled when printed Version 6.2 (Amended August 2018) Post exposure treatment is not covered by this PGD. Please refer all patients presenting post exposure to their GP or 00H Service.
This document is also available in large print and other formats and languages, upon request. Please call NHS Grampian Corporate Communications on (01224) 551116 or (01224) 552245. Revision History: Date of change September 2016 October 2016 October 2016 October 2016 November 2016 April 2017 April 2017 August 2018 Approval date of PGD that is being superseded September 2014 September 2014 September 2014 September 2014 September 2014 November 2016 November 2016 November 2016 Summary of Changes 2 yearly update to new PGD template Removed statement regarding preference for individual prescriptions for travel purpose from front page. Dose can be given at day 21 if there is insufficient time to complete course prior to travel added. Advice added regarding immediate wound care Please refer all patients presenting post exposure to their GP or OOH Service Amended following update in SPC for Rabipur. Timeframe changed from 3-5 years to 2-5 years. Information inserted regarding common anxiety reactions following vaccination as per SPC. Information regarding JCVI accelerated schedule added. Section heading Front page Duration of Treatment Advice to patient (Verbal) Front Page Route/ Method of administration Identifying and managing possible adverse reactions Route/Method of administration and Duration of Treatment Subject: Patient Group Direction Identifier: NHSG/PGD/Rabies/MGPG854 Version 6.2 Replaces: NHSG/PGD/rabies/MGPG854, Version 6.1 Keyword(s): PGD Patient Group Direction vaccine rabies rabipur prophylactic nurse pharmacist UNCONTROLLED WHEN PRINTED Review Date: November 2018 Identifier: NHSG/PGD/Rabies/MGPG854 - i -
Policy Statement: It is the responsibility of individual nurse or pharmacist 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: April 2005 Completed: February 2006 Approved: February 2006, February 2008, June 2010, August 2012, September 2014, November 2016 (December 2016) UNCONTROLLED WHEN PRINTED Review Date: November 2018 Identifier: NHSG/PGD/Rabies/MGPG854 - ii -
Patient Group Direction For The Pre-Exposure Prophylactic Administration Of Rabies Vaccine By Nurses And Pharmacists Working Within NHS Grampian Clinical indication to which this PGD applies Definition of situation/condition This Patient Group Direction (PGD) will authorise nurses and pharmacists to administer rabies vaccine to individuals for preexposure prophylaxis. 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 A full risk assessment must be carried out as the risk of rabies infection outweighs the risk of hypersensitivity where the risk of rabies is high. Pre-exposure immunisation with rabies vaccine should be offered to: Laboratory workers routinely working with rabies virus. Those who in the course of their work, regularly handle imported animals, for example at animal quarantine centres, zoos, animal research and acclimatisation centres where primates and other imported animals are housed, at ports, e.g. certain HM Revenue and Customs officers and at the premises of carrying agents authorised to carry imported animals. Veterinary and technical staff in the State Veterinary Service; the Department for Environment, Food and Rural Affairs; the Scottish Executive Environment and Rural Affairs Department. People who regularly handle bats in the UK. Those working abroad (e.g. veterinary staff or zoologists) who by the nature of their work are at risk of contact with rabid animals. Health workers who are about to be at risk of direct exposure to body fluids or other tissue from a patient with probable or confirmed rabies. UNCONTROLLED WHEN PRINTED Review Date: November 2018 Identifier: NHSG/PGD/Rabies/MGPG854-1 -
Pre-exposure immunisation is also recommended for some travellers, including: Those living in or travelling for more than one month to rabies-enzootic areas, unless there is reliable access to prompt, safe medical care. Health professionals can access the information at www.travax.nhs.uk. Consideration should be given to the activities being undertaken on the holiday, i.e. cycling, running. NB. Children may be at higher risk as they are less likely to be aware that they should avoid animals. Those travelling for less than one month to enzootic areas but who may be exposed to rabies because of their travel activities, or those who would have limited access to postexposure medical care. Any additional population which may be defined (in response to a UK rabies incident) by the NHSG Health Protection Team or by the Scottish Government Health Directorate. Exclusion criteria Known systemic hypersensitivity reaction to any component of Rabies Vaccine BP/Rabipur or after previous administration of the vaccine or a vaccine containing the same components as Rabies Vaccine BP/Rabipur. Patients should not be administered rabies vaccine under this PGD if they have had a confirmed anaphylactic reaction to: A previous dose of rabies vaccine. Eggs or ovalbumin as Rabipur contains inactivated rabies virus produced on purified chick embryo cells. A history of allergy to eggs or a positive skin test to ovalbumin does not necessarily indicate that a subject will be allergic to Rabipur. However, subjects who have a history of a severe hypersensitivity reaction to eggs or egg products should not receive this vaccine for pre-exposure prophylaxis. Any component of the vaccine, polygeline, amphotericin B, chlortetracycline, betapropiolactone or neomycin. Check individual Summary of Product Characteristic (SPC) for details. Vaccination must be postponed in case of febrile and/or acute disease. UNCONTROLLED WHEN PRINTED Review Date: November 2018 Identifier: NHSG/PGD/Rabies/MGPG854-2 -
Precautions and special warnings Minor illnesses without fever or systemic upset are not valid reasons to postpone immunisation. Patients who are acutely unwell should have vaccination deferred until fully recovered in order to prevent confusion of the symptoms of the illness with any adverse effects of the vaccine. Rabies vaccine may be used for pre-exposure prophylaxis vaccination during pregnancy and in women who are lactating if the risk of exposure is high and rapid access to post-exposure prophylaxis would be limited. Individuals with immunosuppression and HIV (regardless of CD4 count) should be given rabies vaccine but may not make a full antibody response. Administration of booster doses should be considered if the antibody titre is less than 0.5/international units (IU)/mL 2-4 weeks after the last injection of the primary course. Check individual SPCs. Discuss with a doctor. Referral criteria Patients who fall into the categories detailed in the exclusion criteria. Action if excluded from treatment Temporary exclusion In case of postponement due to acute severe febrile illness, advise when the individual can be vaccinated and ensure another appointment is arranged. Medical advice should be sought refer to General Practitioner/Consultant (relevant medical practitioner). The reason why the patient was excluded under the PGD will be documented in the patient s medical notes. Action if patient declines treatment Patient should be advised of the risks and consequences of not receiving treatment. Record outcome in Patient Medication Record if appropriate and refer the patient to their General Practitioner/Consultant (relevant medical practitioner). Consent Prior to the supply/administration of the drug, valid consent must be obtained. Consent must be in line with current NHSG consent policy. UNCONTROLLED WHEN PRINTED Review Date: November 2018 Identifier: NHSG/PGD/Rabies/MGPG854-3 -
Description of treatment available under the PGD Name of medicine Rabies Vaccine BP Rabipur Legal status Rabies Vaccine BP and Rabipur are Prescription-only Medicines (PoM). Form/Strength Rabies Vaccine BP 2.5 IU/mL, powder and solvent for suspension for injection. Rabipur 2.5 IU/mL, powder and solvent for solution for injection. Route/Method of administration Must not be given by intra-gluteal injection or subcutaneously. Primary pre-exposure immunisation Three doses of 1mL should be given to adults or children on days 0, 7 and day 28 by intramuscular (IM) injection in the deltoid region or anterolateral region of the thigh in small children. N.B. The third dose can be given from day 21 if there is insufficient time before travel. Accelerated Schedule: Following review by the Joint Committee on Vaccination and Immunisation an accelerated schedule is an option if there is insufficient time before travel to complete the 21-28 day course. Three doses of 1mL should be given to adults or children on days 0, 3 and day 7 by intramuscular (IM) injection in the deltoid region or anterolateral region of the thigh in small children. For those at continuous risk, serology should be undertaken at 6 monthly intervals and a single booster administered if the antibody titre falls below 0.5IU/mL. For those at frequent risk, a single reinforcing dose of vaccine should be given one year after the primary course has been completed. Further doses are given at two to five yearly intervals or guided by serology results. UNCONTROLLED WHEN PRINTED Review Date: November 2018 Identifier: NHSG/PGD/Rabies/MGPG854-4 -
For those at infrequent risk routine boosting is not recommended. For individuals, such as travellers, boosting with a single dose of vaccine can be considered in those who have had a primary course over 10 years ago and are travelling again to a high risk area. For individuals with a bleeding disorder, administration may be given by deep subcutaneous (SC) injection (refer to Green Book). Dosage/Total Dose 1.0mL Duration of treatment Three 1.0mL doses to be given on days 0, 7 and 28. N.B. Dose can be given at Day 21 if insufficient time to complete course prior to travel. Accelerated Schedule: Three 1.0mL doses to be given on days 0, 3 and 7. Reinforcing doses are dependent on serology. Storage requirements Store between +2C and +8C. Do not freeze. If frozen, the vaccine must be discarded. Follow-up (if applicable) Recipients of rabies vaccine 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 10 15 minutes. Patients should not leave if they are feeling at all unwell without speaking to the nurse or pharmacist first. If necessary a doctor or the patient's GP should be contacted for advice. When administration is postponed advise the individual/carer when to return for vaccination. Advice to patient (Verbal) Advice should be given on what to expect and what to do for major and minor reactions. Advise on immediate wound care/accessing medical attention and advice on post exposure treatment. UNCONTROLLED WHEN PRINTED Review Date: November 2018 Identifier: NHSG/PGD/Rabies/MGPG854-5 -
Advise to seek medical advice in the event of an adverse reaction. If treatment is deferred, explain why and arrange a new appointment. Advise when any subsequent vaccinations are due. Advice to patient (Written) It is recommended that patients be given a record of vaccination, a certificate, stamped vaccination booklet or equivalent. The Patient Information Leaflet (PIL) contained in the medicine(s) should be made accessible to the patient, parent, guardian, or 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 all medicines can be found at http://www.medicines.org.uk or http://www.mhra.gov.uk/spcpil/index.htm Concurrent Medications/Drug Interactions Patients who are immunocompromised, including those receiving immunosuppressive therapy, may not mount an adequate response to rabies vaccine. Therefore, it is recommended that serological responses should be monitored in such patients and additional doses given as necessary. Rabies vaccines can be given at the same time as other vaccines, including other travel vaccines. The vaccines should be given at separate sites, preferably in different limbs. If given in the same limb, they should be given at least 2.5cm apart. The site at which each vaccine was given should be noted in the individual s records. The vaccine must keep a record of the vaccine and regimen received as it will influence future post exposure treatment. Must not be mixed with any other vaccine in the same syringe. Identifying and managing possible adverse reactions Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress- related reactions, may occur in association with vaccination as a psychogenic response to the needle injection. It is important that procedures are in place to avoid injury from fainting. UNCONTROLLED WHEN PRINTED Review Date: November 2018 Identifier: NHSG/PGD/Rabies/MGPG854-6 -
Some reactions to vaccination are predictable (although it is not possible to predict who will be affected and to what extent), most are mild and resolve quickly, however some people will have a more severe reaction to the vaccine administered. Commonly reported symptoms: Pain, discomfort, redness, or swelling at the injection site. Stiffness in the muscle post injection. Low grade fever, headache, malaise, fatigue, irritability, rash, vomiting and diarrhoea. The above symptoms usually disappear within one to three days without treatment. This list is not exhaustive. Please also refer to current BNF/BNFC and manufacturers SPC for details of all potential adverse reactions. BNF: https://www.medicinescomplete.com/mc/bnf/current/ https://www.medicinescomplete.com/mc/bnfc/2011/ SPCs/PILs: https://www.medicines.org.uk/emc/ http://www.mhra.gov.uk/spc-pil/index.htm 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. https://yellowcard.mhra.gov.uk/ 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. (Refer to Patient Group Direction for the administration of adrenaline (epinephrine) in cases of suspected anaphylactic reactions by qualified health professionals) http://foi.nhsgrampian.org/globalassets/foidocument/foi-publicdocuments1---all-documents/pgd_adrenaline.pdf UNCONTROLLED WHEN PRINTED Review Date: November 2018 Identifier: NHSG/PGD/Rabies/MGPG854-7 -
Characteristics of staff authorised to supply/administer medicine under PGD Professional qualifications Registered Nurses as recognised by the NMC and Pharmacists whose name is currently on the register held by the General Pharmaceutical Council (GPhC). Specialist competencies Be competent to assess the patient, parent, guardian, or person with parental responsibilities capacity to understand the nature and purpose of the administration in order for the patient to give or refuse consent. Has undertaken appropriate training to carry out clinical assessment of patients leading to a diagnosis that requires treatment according to the indications listed in the PGD. Be aware of current treatment recommendations and be competen to discuss issues about the drug with the patient. Is competent in the administration of the vaccine. Ongoing training and competency Have attended basic life support training which is required to be updated annually. Have undertaken the NHS e-anaphylaxis training session (and annual updates) which covers all aspects of the identification and management of anaphylaxis. This can be accessed via eksf, or the AT Learning tool. Maintain their skills, knowledge and their own professional level of competence in this area according to their individual Code of Professional Conduct. The practitioner must be familiar with the SPC for all medicines supplied 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. UNCONTROLLED WHEN PRINTED Review Date: November 2018 Identifier: NHSG/PGD/Rabies/MGPG854-8 -
Documentation Authorisation of administration Nurses working within NHS Grampian can be authorised to administer the drug specified in this PGD by their Nurse Manager /Consultant/GP. Pharmacists working within NHS Grampian can be authorised to administer the drug specified in this PGD by the Director of Pharmacy. All authorised staff are required to read the PGD and sign the Agreement to administer Medicines under PGD (Appendix 1). A certificate of authorisation (Appendix 2) signed by the authorising doctor/manager should be supplied. This should be held in the individual practitioners records, or 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: Name and address of patient Patient CHI No and date of birth Details of parent/guardian, or 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). UNCONTROLLED WHEN PRINTED Review Date: November 2018 Identifier: NHSG/PGD/Rabies/MGPG854-9 -
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. For 17 years and over retain for 6 years after last date of entry, for 3 years after death, or in accordance with local policy, where this is greater than above. 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. References Electronic Medicines Compendium http://www.medicines.org.uk Rabipur Date of revision of text 21/12/15, accessed 15/09/16 British National Formulary https://www.medicinescomplete.com/mc/bnf/current/ accessed 15/09/16 British National Formulary for Children https://www.medicinescomplete.com/mc/bnfc/2011/ accessed 15/09/16 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. Frances Adamson Fiona Browning Dr Carole Close Charles Michie Rhainnon Sharp Lead Author: Medicines Management Specialist Nurse Health Protection Nurse Specialist Medical Professional: Speciality Doctor GO Health Pharmacist: Community Pharmacist Lead Travel Nurse UNCONTROLLED WHEN PRINTED Review Date: November 2018 Identifier: NHSG/PGD/Rabies/MGPG854-10 -
Authorising Managers Dr Nick Fluck Medical Director, NHS Grampian Mr David Pfleger Director of Pharmacy and Medicines Management, NHS Grampian Professor Amanda Croft Director of Nursing, Midwifery and AHPs, NHS Grampian UNCONTROLLED WHEN PRINTED Review Date: November 2018 Identifier: NHSG/PGD/Rabies/MGPG854-11 - POD for the administration of rabies vaccine by nurses and pharmacists Version 6.2
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 Pre-Exposure Prophylactic Administration Of Rabies Vaccine By Nurses And Pharmacists 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: November 2018 Identifier: NHSG/PGD/Rabies/MGPG854-12 -
Appendix 2 Certificate Of Authorisation To Administer Medicines Under Patient Group Direction This authorises: Working within: e.g. H&SCP, Practice To administer medicines under the following Patient Group Direction Patient Group Direction For The Pre-Exposure Prophylactic Administration Of Rabies Vaccine By Nurses And Pharmacists Working Within NHS Grampian The above named person has satisfied the training requirements and is authorised to administer medicines under the above Patient Group Direction. The above named person has agreed not to act beyond their professional competence nor outwith the recommendations of the Patient Group Direction Signed: Authorising Manager/Doctor Print Name: Date: UNCONTROLLED WHEN PRINTED Review Date: November 2018 Identifier: NHSG/PGD/Rabies/MGPG854-13 -