PATIENT GROUP DIRECTION. Oral (live attenuated) Typhoid Vaccine (Ty21a) (Vivotif )

Transcription

1 PATIENT GROUP DIRECTION Administration of: Oral (live attenuated) Typhoid Vaccine (Ty21a) (Vivotif ) By: Practice Nurses In: General Practice It is the responsibility of the professional working under this PGD to verify that the patient fulfils the stated criteria for supply or administration of the treatment concerned. It is not appropriate to have a PGD in place that is infrequently used by healthcare professionals because of progressive unfamiliarity with its contents. Any healthcare professional that works to a PGD infrequently should consider whether to cease doing so. This PGD will be reviewed every 3 years, or sooner in light of new guidance. Review date: March 2018 PGD Oral Typhoid (Vivotif) v2.docx Page 1 of 6

2 1. Reason for introducing PGD Immunisation 2. Clinical Condition or situation to which this PGD applies 2.1 Define condition/situation Active immunisation against Salmonella typhi 2.2 Criteria for inclusion Adults and children from the age of 6 years Advised for: Travellers to areas of poor sanitation Workers handling specimens from suspected cases 2.3 Criteria for exclusion Children under 6 years old. Patients with congenital or acquired immune deficiency including those who are taking Immunosuppressant s immunosuppressed individuals may have a sub-optimal immune response. The importance of scrupulous attention to personal, food and water hygiene must be emphasised for immunosuppressed persons travelling to endemic areas. Hypersensitivity to any component of the vaccine or the enteric-coated capsule. Confirmed anaphylactic reaction to a preceding dose of a Ty21a vaccine or enteric-coated capsule, including gelatin. Immunisation should be postponed in patients with acute febrile illness/infection or acute gastrointestinal illness. Individuals who have received another live vaccine within four weeks. However, other live vaccines can be given concomitantly. Individuals who have received immunoglobulin within three months. 2.4 Cautions [to include consideration of concurrent medication] 2.5 Patient consent [verbal, written, implied] In the event of gastrointestinal illness, vaccination with this vaccine should be postponed until after recovery. This vaccine should not be commenced within three days of completing any antibacterial agent, and similarly, antibacterial therapy should not commence within 3 days after the last dose of the vaccine. There is no safety data for this vaccine in pregnancy or during lactation. It is not known if this vaccine can cause foetal harm when administered to a pregnant woman or affect the ability to reproduce. If the risk of typhoid is high, vaccination should be considered. Refer patient to Doctor. Informed consent as stated in the local consent policy Parent/guardian consent to be given, where necessary PGD Oral Typhoid (Vivotif) v2.docx Page 2 of 6

3 2.6 Action if patient excluded Advise on the importance of being immunised. Advise on when the subject can be vaccinated, and by whom, where applicable. Advise on potential disease complication Re-assure and provide any practical advice 2.7 Action if treatment declined by patient, parent, or guardian 3. Characteristics of Staff 3.1 Class of healthcare professional for whom PGD is applicable & Professional qualifications required 3.2 Additional requirements/specialist qualifications required. 3.3 Continued training requirements 4. Description of treatment. 4.1 Generic name of medicine and form (e.g. tablets) 4.2 Legal status POM/P/GSL Licensed or unlicensed use [If unlicensed state rationale for use] Advise on the importance of being immunised Advice about protective effects of the vaccine and the risks of infection and disease complications Document advice given Inform or refer to GP as appropriate Registered Nurse, RN This PGD will only apply whilst you are employed or contracted/working at the time for a Dudley CCG GP practice. Competent to undertake immunisations under this PGD Specific training in vaccine administration, the immunisation programme and having up-to-date knowledge Has undertaken training and is competent in the recognition and treatment of anaphylaxis, including practical training in Basic Life Support (annual practical update session to be undertaken). Three-yearly update in immunisation and vaccination, and annual update in the management of anaphylaxis and CPR The practitioner should be aware of any change to the recommendations for the medicine listed. It is the responsibility of the individual to keep up-to-date with continued professional development and to work within the limitations of individual scope of practice. Oral (live attenuated) typhoid vaccine (Ty21a) (Vivotif ) in an enteric-coated capsule POM Licensed - See under Criteria for Inclusion PGD Oral Typhoid (Vivotif) v2.docx Page 3 of 6

4 4.3 Dose [Where a range is applicable include criteria for deciding on a dose] 3 capsules, 1 taken on days 0, 2, and 4. Repeat every 3 years for those with repeated or continuous exposure. For those travelling from a non-endemic area to an endemic area give annual booster of 3 capsules as above. Unless the immunisation schedule of three vaccine capsules is completed, an optimal immune response may not be achieved. Protection commences about 7-10 days after completion of the third dose. Vivotif may be administered concomitantly with yellow fever vaccine and oral polio vaccine [SPC]. If patient requires malaria prophylaxis they must wait at least 3 days from last dose of Vivotif to start treatment. The capsule should be taken approximately one hour before a meal with a cold or lukewarm drink. The vaccine capsule should not be chewed and should be swallowed as soon as possible after placing in the mouth. 4.4 Route / method of Oral administration. administration 4.5 Frequency See under dose 4.6 Total dose and number of See under dose times treatment can be administered; state time frame 4.7 Information on follow-up management Advise to seek medical advice if more severe reactions to oral vaccine occur 4.8 Written/verbal advice for patient/carer before/after treatment and management Explain to patient or their carer why treatment is required Provide patient information leaflet, if available. Advise on potential side-effects and what action to take if they occur. 4.9 Instructions on identifying, managing & reporting adverse drug reactions 4.10 Arrangements for referral for medical advice Advise on self-treatment for minor reactions. The most commonly reported adverse events are gastrointestinal upset, fever, flu-like illness and headache. Serious suspected adverse reactions to vaccines should be reported through the Yellow Card scheme. Yellow card and guidance on its use is available at or in the back of the BNF. Refer patients to the medical practitioner Contact emergency services for life-threatening reactions 4.11 Precautions, facilities & supplies Specify method of recording supply/administration, sufficient to enable audit trail. Store in a refrigerator between 2-8 o C. Store in original container and protect from light. Obtain supplies from pharmacy or wholesaler Clients notes (Manual, Computerised, Own Held): Name, address and DoB of patient PMH, allergies and vital signs Brand, batch number and expiry date Dose, route Date given and by whom PGD Oral Typhoid (Vivotif) v2.docx Page 4 of 6

5 Patient s GP Any current or previous adverse reactions Any reason for refusing treatment Advice given to patient or carer (including side effects) Record any referral arrangements 5. Audit Serious adverse reactions should be documented in the patient s health record and on their medical records. GP should also be informed The use of this PGD to be monitored by the service in which it is used. 6. Management 6.1 Reviewing authors Noel Aslett Karen Mander Prescribing Adviser, Dudley Office of Public Health Practice Based Pharmacist Dudley CCG Others Lesley Cliff Clinical Nurse Advisor-Immunisation, Dudley Office of Public Health 6.2 Authorisation This PGD has been approved on behalf of Dudley CCG by: Name Signature Date Specialist in Pharmaceutical Public Health (Pharmacist) CCG Clinical Lead Prescribing Dr D Jenkins Signed Dr PD Gupta Signed CCG- Clinical Lead Quality and Safety Dr R Edwards Signed Persons permitted to authorise staff they are responsible for to operate this PGD Clinical Leads in General Practice 7. References and Sources of Information NMC Guidelines for the administration of medicines NMC Code of Professional Conduct DoH 2006: Immunisation against infectious diseases CMO/CNO/CPO updates Immunisation Against Infectious Diseases (Green Book) British National Formulary 68 September 2014 March Summary of Product Characteristics for Vivotif accessed on 8 th January 2015 via PGD Oral Typhoid (Vivotif) v2.docx Page 5 of 6

6 PGD for administration of Oral Typhoid Vaccine (Ty21a) (Vivotif ) by Nurses within Dudley CCG GP practices It is the responsibility of the Authorising Person to keep this list up to date and in a safe place for reference. Any healthcare professionals who no longer meets the competency requirements or leave the service or practice must be removed from the list; likewise, any new healthcare professionals meeting the competency requirements have to be added to the list in order to work under the Patient Group Direction. The Authorising Person is only expected to confirm that the Healthcare Professionals meets the minimum training and competency requirements under this PGD. It is the responsibility of the Healthcare Professional, their Professional Body and the CCG that they are fit to practice. This Patient Group Direction is to be read, agreed to and signed by all healthcare professionals it applies to. One copy should be given to each nurse with the original signed copy being kept by the Authorised Person with responsibility for PGDs within the service or practice. I confirm that I have read and understood the content of this patient group direction and that I am willing and competent to work under it within my professional code of conduct. Healthcare Professionals permitted to supply or administer under this PGD Name of Healthcare Professional Signature Authorised Person with responsibility for PGDs Signature Date approved PGD Oral Typhoid (Vivotif) v2.docx Page 6 of 6