PATIENT GROUP DIRECTION (PGD) FOR THE ADMINISTRATION OF HEPATITIS A VACCINE (HAVRIX MONODOSE VACCINE) BY REGISTERED NURSES WORKING IN THE COMMUNITY SUBSTANCE MISUSE TEAMS Version Number : 2 Patient Group Direction drawn up by: Name Julie Barton Helen Manuell Dr Baier Title Community Psychiatric Nurse Clinical Pharmacist Consultant Psychiatrist, Substance Misuse Services Group direction authorised by: Medical Lead Executive Medical Director On behalf of the organisation Chief Pharmacist Executive Director of Nursing Dr Anthony Glasper Dr Tim Ojo Jed Hewitt Helen Greatorex Date Protocol agreed Proposed review date December 2012 Date Protocol expires July 2013 1
PLAN OF CARE Diagnosis/condition treated Symptom(s)/clinical criteria under which the patient will be eligible for treatment under the PGD Active immunization against hepatitis A virus for clients of the adult Community Substance Misuse Teams within Sussex Partnership NHS Trust and who are considered to be at high risk of contracting hepatitis A infection A client of the Community Substance Misuse Service who is identified as being at risk of contracting hepatitis A infection. This includes: Current injecting drug users Clients with chronic liver disease e.g. chronic hepatitis C Adults and adolescents 16 years of age and over able to give informed consent. In some cases there may be a degree of uncertainty about previous vaccinations. There is not thought to be a problem with administering extra doses of hepatitis A vaccine, as it is an inactive vaccine. Consideration can be given to accessing laboratory results and discussing with a doctor. The client should be informed of the effectiveness of the vaccine. In adults at risk, a protective efficacy is achieved in 99% of subjects 30 days after the first dose. Drug users who are likely to progress to injecting i.e. those who smoke heroin should be offered hepatitis B vaccination. Aims of treatment or care Active immunization against hepatitis A infection Criteria under which the patient will be excluded from care within the protocol including contraindications Actions to be taken for patients who are excluded from treatment under the protocol and arrangements for referral Client has previously had a severe adverse reaction to hepatitis A vaccine Client is knowingly allergic to the vaccine or any components of the vaccine or neomycin Client is acutely ill (minor infections without fever or systemic upset are not contraindications) Pregnancy and Breast feeding Any other individual who requests vaccination (and who is not a client of the Substance Misuse Services) should be referred to their own GP Service users only excluded because of an acute illness should be asked to return when better. Other service users excluded from receiving vaccination under this PGD should be given advice about prevention of hepatitis A and referred to other appropriate services such as their GP or clinic doctor Pregnant or breastfeeding clients should be offered Hepatitis B vaccination. A PGD is available for Hepatitis B vaccination. Refer to a doctor for Hepatitis A vaccination. 2
Actions to be taken for patients who do not wish to receive, or do not adhere to, care under the protocol and arrangements for referral Follow-up treatment and actions Clearly record the decision in the client s notes Refer to other appropriate services Patient to be counselled regarding the risks associated with contracting hepatitis-a infection and the potential sources of infection. To be counselled regarding needle-sharing etc. Advise on symptoms and complications of the disease Client s GP to be sent details of vaccination if appropriate Clients should be warned that vaccination may not provide protection in some people and counselled regarding the risks associated with contracting hepatitis-a infection and the potential sources of infection. To be counselled regarding needle-sharing etc Return for remainder of the course Evaluation of treatment/care Havrix confers protection against hepatitis A infection within 2-4 weeks. In clients who are undergoing haemodialysis or who have an impaired immune system, adequate anti-hav antibody titres may not be obtained after the first dose and so may require additional doses. 3
MEDICINE Generic name and form(s) Mode of action Storage of Vaccine Hepatitis A vaccine (Havrix Monodose vaccine) 1440 ELISA units/1ml suspension for injection The vaccine is presented in syringes for single use or vials. By stimulating production of antibodies and other components of the immune mechanism Fridge storage at between 2 o C and 8 o C. Not to be frozen - any frozen vaccine must be discarded. Upon storage the content of the vaccine may present a fine white deposit. This can be shaken into the liquid to leave a slightly opaque suspension suitable for injection. Legal status of medicine Potentially significant drug interactions (Adverse Reactions) Prescription Only Medicine (POM) Common: Hepatitis A vaccine (Havrix Monodose vaccine) is generally well tolerated and the most common adverse reactions are soreness, induration and redness at the injection site Less Common: Less common general complaints, not necessarily related to the vaccination, include headache, fever, malaise, fatigue, nausea, diarrhoea and loss of appetite and rash. Very rare: Arthralgia, myalgia, convulsions and allergic reactions including anaphylactoid reactions have been reported very rarely. Elevations of serum liver enzymes (usually transient) have been reported occasionally. However, a causal relationship with the vaccine has not been established. Serious suspected neurological reactions such as Guillain-Barre syndrome and transverse myelitis have extremely rarely been reported although a causal relationship with hepatitis A vaccine has not been established. Havrix Monodose vaccine may be administered at the same time as some other vaccines (using a different site), but must not be mixed in the same syringe. 4
Method or route of administration The vaccine should normally be given intramuscularly The injections should be given in the deltoid region. In clients with thrombocytopenia or bleeding disorder the vaccine should be given by deep subcutaneous injection to reduce the risk of bleeding. The vaccine should never be administered intravenously. Dose(s) and where a range criteria for deciding on a dose One dose (1440 ELISA units) in 1ml for each injection Frequency of administration Written/verbal advice to be given to the patient/carer on the identification and management of significant potential side effects Indications for follow up and actions to be taken 2 doses with second dose after 6-12 months The second dose may be delayed for up to 3 years to produce a similar effect. In addition It has been demonstrated that if the second dose is administered within 5 years of the first that this is sufficient to show a satisfactory antibody response. Clients presenting more than 5 years after the first dose should have 2 doses. Data available suggests the vaccination will last for 25 years after the vaccination course is complete; however until further evidence is available on the persistence of protective immunity, administer a booster at 20 years for those at ongoing risk. Prior to treatment the client should be given the Patient Information Leaflet (PIL) from the medicine and confirmation sought that they have read and understood the PIL and consent to treatment. It is recommended that the recipient of the vaccine remains on the premises for 15 minutes after vaccination to be observed for any immediate adverse reactions As vaccines are administered intramuscularly, the time of onset of anaphylaxis is variable and onset may be delayed for up to 72 hours. Clients should be advised to seek urgent medical attention if they develop early symptoms such as breathlessness, swelling and rash 5
AUDIT TRAIL Records required for a documented audit trail Hepatitis A vaccine administration form To be completed for each client Trust Incident Form To be completed in the event of a suspected adverse drug reaction. The incident must be reported immediately to the relevant doctor or pharmacist. Report on suspected Adverse Drug Reactions (Yellow form in back of the BNF) To be completed for a significant adverse event by the doctor or pharmacist. 6
COMPETENCY Designation (tick appropriate box) NMC Registered Nurse Competency/Qualifications (tick when checked) Professional qualification: NMC Registered Nurse At least 6 months post registration experience in a Community Substance Misuse Team Evidence of training in basic life support and anaphylaxis, and to remain updated annually Has attended the Trust's PGD foundation course Has successfully completed the 'Key topics of Pharmacy' questionnaire for hepatitis A vaccine (Havrix Monodose ) Evidence checked by: Name Designation Signature Review of competency 21 months or following a significant change in the patient group direction. Competency expires Two years or following a significant change in the patient group direction. 7
AUTHORISATION OF PROFESSIONAL TO USE THE PATIENT GROUP DIRECTION Date valid from: Date of expiry: This confirms that I: Name: understand the PGD have received the necessary education and training am of the opinion I am competent to implement the PGD effectively agree to work within the PGD Signature: Date: SIGNATURE OF SERVICE MANAGER Name: Date: SIGNATURE OF INTEGRATED TEAM MANAGER Name: Date: REFERENCES 1. BNF March 2010 2. Havrix Monodose vaccine and (GlaxoSmithKline UK) Summary of Product Characteristics April 2009 3. Immunisation against infectious disease. Department of Health 2006. 8
Hepatitis A Vaccine (Havrix Monodose ) administration form Designated Practitioner Patient s Name Injection site Batch number of product Expiry date of product I confirm verbal consent was obtained I confirm that the Client s GP has been informed of vaccination if appropriate I confirm that the client has been advised of the risks associated with contracting hepatitis-a infection and the potential sources of infection and counselled regarding needle-sharing etc. Record any adverse reactions Please initial If an adverse reaction has occurred I confirm that: o The details have been recorded in the client s notes o The details have been forwarded to the client s general practitioner 9
Signed by Date KEY ASPECTS OF PHARMACY QUESTIONNAIRE (To be completed without access to the PGD or drug text books, eg BNF.) Key aspects of pharmacy for Hepatitis A Vaccine (Havrix Monodose ) Professional's name: Job Title: 1. Symptoms/criteria under which the patient will be eligible for treatment under the PGD 2. Forms and strengths available 3. Mode of action 4. Exclusion criteria 5. Dose 6. Route of administration 7. What potentially significant side effects and drug interactions are there? 8. What written/verbal advice must be given to the patient/carer on the identification and management of significant potential side effects? I confirm that at the time of completion the answers provided showed an acceptable level knowledge. Name: Signature: 10
Designation: Date: 11