Patient Group Direction (PGD) for the Administration of BCG Vaccine

Transcription

1 Patient Group Direction (PGD) for the Administration of BCG Vaccine Unlike most immunisations, which are administered either via the intramuscular/subcutaneous routes, or orally, BCG vaccine is administered intradermally. Only those healthcare professionals who have undertaken specialist training to administer BCG may use this PGD. Healthcare professionals using this PGD must sign the declaration at the end of this PGD to confirm that they have undertaken the necessary specialist training. This PGD must be read in conjunction with the core PGD (Reference: NHSE(LR)/Core PGD for Immunisations), which details information that is common to all of the immunisation PGDs. This PGD must only be used by registered healthcare professionals, working within, who have been named and authorised to practice under it. Version number: 1.1 The master copy for this PGD is held N:\2.0 Medical\Clinical Adviser Medicines\Patient Group Directions\Final Signed PGDs\Immunisation PGDs 2014 Change history Version Change details Date number 1.0 First version February Revision of content March 2014 Reference Number: NHSE(LR)/PGD/BCG v1.1 Page 1 of 8

2 PGD Development and Clinical Approval PGD Working Group This PGD was developed by a working group involving pharmacists from a number of Clinical Commissioning Groups across London, plus nurse representatives. Name and role Jonathan Mason Pharmacist and Lead Author Henrietta Hughes Doctor Eileen Bryant Nurse reviewer Nicola Pratelli Nurse Reviewer Thara Raj Public Health Specialist Nick Beavon Raana Ali Pauline Taylor Helen Tsang Dee Vadukul Seema Buckley Job title and organisation Clinical Adviser (Medicines) Medical Director North Central and East London Area Team Primary Care Nurse Adviser Population Health Practitioner Manager Immunisation South London Public Health Specialist (Immunisation) and Acting Public Health Consultant (Health in the Justice System) Chief Pharmacist Wandsworth Clinical Commissioning Group Senior Prescribing Adviser (Tower Hamlets) North and East London Commissioning Support Unit Head of Medicines Management Haringey Clinical Commissioning Group Practice Link Pharmacist North West London Commissioning Support Unit Senior Practice Pharmacist Richmond Clinical Commissioning Group Chief Pharmacist NHS Kingston Clinical Commissioning Group References: Summary of product characteristics for BCG Vaccine (accessed March 2014): 31/Discription%20of%20BCG%20Vaccine%20SSI.aspx Green Book chapter on Tuberculosis (accessed March 2014): 32 Reference Number: NHSE(LR)/PGD/BCG v1.1 Page 2 of 8

3 PGD for BCG Reference Number: NHSE(LR)/PGD/BCG v1.1 st Valid from: 1 April 2014 st Review date: 1 January 2016 st Expiry date: 31 March 2016 Page 3 of 8

4 PGD for the Administration of BCG Vaccine Clinical condition or situation to which this PGD applies Inclusion criteria Exclusion criteria For active immunisation against tuberculosis Infants (aged 0 to 12 months) living in areas of the UK where the annual incidence of TB is 40/100,000 or greater. Note: the whole of London is considered to be an area for this purpose; Infants (aged 0 to 12 months) with a parent or grandparent who was born in a country where the annual incidence of TB is 40/100,000 or greater; Previously unvaccinated children aged one to five years with a parent or grandparent who was born in a country where the annual incidence of TB is 40/100,000 or greater; Previously unvaccinated, tuberculin-negative children aged from six to under 16 years of age with a parent or grandparent who was born in a country where the annual incidence of TB is 40/100,000 or greater. These children should be identified at suitable opportunities, tuberculin tested and vaccinated if negative; Previously unvaccinated tuberculin-negative individuals under 16 years of age who are contacts of cases of respiratory TB (following recommended contact management advice); Previously unvaccinated, tuberculin-negative individuals under 16 years of age who were born in or who have lived for a prolonged period (at least three months) in a country with an annual TB incidence of 40/100,000 or greater; Unvaccinated, tuberculin-negative individuals at occupational risk aged under 35 years; Unvaccinated, tuberculin-negative individuals under 16 years who are going to live or work with local people for more than three months in a country where the annual incidence of TB is 40/100,000 or greater. As per the general exclusion criteria stated in the Core PGD, plus: Patients who have already had a BCG vaccination; Patients with a past history of TB; Post-exposure prophylaxis; Patients with an induration of 6mm or more following Mantoux (SSI) tuberculin skin testing Neonates in a household where an active TB case is Reference Number: NHSE(LR)/PGD/BCG v1.1 Page 4 of 8

5 suspected or confirmed; Patients who are immunocompromised by virtue of disease or treatment, including: o Patients receiving corticosteroid, or other immunosuppressive treatment, including general radiation. Inhaled steroids are not a contraindication; o Patients suffering from a malignant condition such as lymphoma, leukaemia, Hodgkin s disease or other tumour of the reticuloendothelial system; Patients who are, or are suspected to be HIV-positive, regardless of clinical status. Where vaccination is indicated, for example infants born to HIV-positive mothers, this can be administered after two appropriately timed negative postnatal PCR tests for HIV infection; Pregnancy. Cautions including any relevant action to be taken No further immunisation should be given in the arm used for BCG immunisation for at least three months because of the risk of regional lymphadenitis; The patient must always be advised of the normal reaction to the injection and about caring for the vaccination site. The expected reaction to successful BCG vaccination, seen in 90 to 95% of recipients, is induration at the injection site followed by a local lesion, which starts as a papule two or more weeks after vaccination. It may ulcerate and then slowly subside over several weeks or months to heal, leaving a small, flat scar. It may also include enlargement of a regional lymph node to less than 1cm; It is not necessary to protect the site from becoming wet during washing and bathing. The ulcer should be encouraged to dry, and abrasion (by tight clothes, for example) should be avoided. Should any oozing occur, a temporary dry dressing may be used until a scab forms. It is essential that air is not excluded. If absolutely essential (e.g. to permit swimming), an impervious dressing may be used but it should be applied only for a short period as it may delay healing and cause a larger scar. Reference Number: NHSE(LR)/PGD/BCG v1.1 Page 5 of 8

6 Details of the medicine Name, form and strength of medicine Route/method of administration BCG Vaccine SSI is supplied in a glass vial containing the equivalent of 10 adult or 20 infant doses, fitted with a bromobutyl rubber stopper, which does not contain latex. The powder must be reconstituted with 1mL of the diluted Sauton SSI diluent which is supplied separately For intradermal injection only Inject into the lateral aspect of the left upper arm at the level of the insertion of the deltoid muscle (just above the middle of the left upper arm the left arm is recommended by WHO). Sites higher on the arm, and particularly the tip of the shoulder, are more likely to lead to keloid formation and should be avoided. Jet injectors and multiple puncture devices should not be used; The upper arm should be positioned approximately 45 to the body. This can be achieved in older children and adults if the hand is placed on the hip with the arm abducted from the body, but in infants and younger children this will not be possible. For this age group, the arm must be held firmly in an extended position; If the skin is visibly dirty it should be washed with soap and water; The vaccine is administered through either a specific tuberculin syringe or, alternatively, a 1ml graduated syringe fitted with a 26G 10mm (0.45mm 10mm) needle for each individual; The correct dose (see below) of BCG vaccine should be drawn into the tuberculin syringe and the 26G short bevelled needle attached to give the injection. The needle must be attached firmly and the intradermal injection administered with the bevel uppermost; Stretch the skin between the thumb and forefinger of one hand and with the other slowly insert the needle, with the bevel upwards, about 3mm into the superficial layers of the dermis almost parallel with the surface. The needle can usually be seen through the epidermis; A correctly given intradermal injection results in a tense, blanched, raised bleb, and considerable resistance is felt when the fluid is being injected. A bleb is typically of 7mm diameter following a 0.1mL intradermal injection, and 3mm following a 0.05mL intradermal injection; If little resistance is felt when injecting and a diffuse swelling occurs as opposed to a tense blanched bleb, the needle is too deep. The needle should be withdrawn and reinserted intradermally before more vaccine is Reference Number: NHSE(LR)/PGD/BCG v1.1 Page 6 of 8

7 Dose given. Infants under 12 months: 0.05ml Children aged 12 months or older and adults: 0.1ml Frequency Quantity Adverse effects Single dose Single dose As detailed in the core PGD, plus: enlargement of a regional lymph node to greater than 1cm and which may ulcerate. Refer to SmPC for complete list. Reference Number: NHSE(LR)/PGD/BCG v1.1 Page 7 of 8

8 Healthcare Professional s Agreement to Practise and Practice/Pharmacy/Local Organisation Authorisation PGDs DO NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR ACCOUNTABILITY. IT IS THE RESPONSIBILITY OF EACH PROFESSIONAL TO PRACTISE ONLY WITHIN THE BOUNDS OF THEIR OWN COMPETENCE AND IN ACCORDANCE WITH THEIR OWN CODE OF PROFESSIONAL CONDUCT. DECLARATION by healthcare professional: I have read and understand this PGD; I have been appropriately trained to understand the criteria listed, and the techniques and record-keeping required to administer BCG vaccine in accordance with this PGD; The training has included both the theoretical and practical aspects of the techniques required to administer BCG vaccine by intradermal injection; I confirm that I have been assessed for my knowledge and clinical competency, and EITHER am experienced in administering vaccines in the past 12 months, OR I have been observed administering vaccines in practice; I confirm that I am competent to undertake administration of this vaccine; I confirm that I will ensure that I remain up to date in all aspects of the administration of this vaccine. Healthcare Professional s Name:. Registration Number:. Expiry Date:. Signature:.... Date:. Declaration by Authorising Manager * : Managers should only authorise staff who have received the required training and are competent to work to this PGD. Each authorised member of staff should be provided with an individual copy of the PGD, which they should also sign to declare themselves competent. A copy of the signed document should be kept by the individual staff member. The authorising manager should retain a copy of the signed individual authorisation page. I have read and understood the PGD and authorise the staff member named above to operate in accordance with this PGD. Authorising Manager s Name:.. Signature:.... Date:. * The term manager refers to the person taking responsibility for authorising healthcare professionals to operate under the terms of this PGD, and includes lead GPs, nurse managers, pharmacy managers etc. Reference Number: NHSE(LR)/PGD/BCG v1.1 Page 8 of 8