Download GRE - Flu Vaccination PGD

PATIENT GROUP DIRECTION
FOR THE
ADMINISTRATION
OF
INFLUENZA VACCINE BY COMMUNITY PHARMACISTS
Controls Assurance Statement
The aim of this Patient Group Direction is to ensure that the supply and
administration of medicines under a Patient Group Direction complies with the legal
requirements and guidance set out in HSC2000/026 (i) Patient Group Directions
(England Only). Failure to comply with the law could result in a criminal prosecution
under the Medicines Act.
Start date: September 2005
Expiry date: September 2006
Issued by: Primary Care Directorate
GREENWICH TEACHING PRIMARY CARE TRUST
PATIENT GROUP DIRECTION FOR THE ADMINISTRATION OF
INFLUENZA VACCINE BY COMMUNITY PHARMACISTS
1. Clinical Condition
1.1 Define clinical situation
Vaccination against influenza in accordance with the current national influenza
vaccination programme.
1.2 Inclusion criteria
 Patients aged 65 and over.
 Patients from the age of 18 years who are at risk from serious illness from influenza
who have:
Chronic respiratory disease
Chronic heart disease – including ischemic heart disease e.g. stroke.
Chronic renal disease
Chronic liver disease
Diabetes
Immunosuppression due to disease or treatment
 Patients in long stay residential care homes or other long-stay care facilities where
rapid spread is likely to follow introduction of infection and cause high morbidity and
mortality (this does not include prisons, young offenders institutions, university halls
of residence etc.).
 People who are the main carer for an elderly or disabled person whose welfare may be
at risk if the carer falls ill.
1.3 Exclusion Criteria
Vaccinations will not be offered
 To patients who are acutely ill on the day of the scheduled vaccination
 Where there are contraindications:
Hypersensitivity to eggs, chicken protein or any constituent of the
vaccine such as neomycin, thiomersal or polymixin B.
Previous severe reaction to influenza vaccination.
Latex allergy
 To patients who are pregnant.
 To patients who are not registered with a Greenwich GP.
If vaccine is withheld:
 Refer to general practitioner or reschedule as clinically indicated. If a patient has not
been given the vaccination because of an acute illness, the patient will be offered the
vaccination on recovery as soon as it is convenient.
1.4 Circumstances when to refer to a doctor
Where there is doubt whether to give the influenza vaccination, refer the patient to their
general practitioner.
Patients under the age of 18 years who are at risk
2. Characteristics of practitioners authorised to supply and administer
the influenza vaccine
2
Qualified pharmacists, currently registered with The Royal Pharmaceutical Society will
administer the vaccinations.
2.1 Requirements for training and continuing education
All pharmacists will have undergone both theory and practical training in immunisation
and vaccination. (See appendix 1 for details of training).
3. Description of treatment within the PGD
3.1 Name, pharmaceutical form, strength:
Influenza Vaccine.
Suspension for injection containing split virus or surface antigen of Influenza A and
Influenza B virus. The particular strains and strengths of the virus are recommended each
year by the World Health Organisation.
The strains of influenza virus recommended by WHO to be included in the components for
the 2005-06 vaccine are:
 An A/New Caledonia/20/99(H1N1)-like virus
 An A/California/7/2004(HMN2)-like virus
 A B/Shanghai/361/2002-like virus
3.2 Dose and frequency
0.5ml dose for adults over the age of 18 years, given yearly.
3.3 Route of administration
By intramuscular or deep subcutaneous injection
3.4 Maximum total dose
Single dose per year
3.5 Minimum or maximum period over which the medicine should be administered
Not applicable
3.6 Legal category
Prescription Only Medicine
3.7 Storage and handling requirements
2°C – 8°C. Do not freeze. Allow vaccine to reach room temperature before administration.
Shake gently before use.
4. Consent
The patient will be asked to sign that they consent to be vaccinated and that they have
received information about the influenza vaccine (appendix 2)
4.1 Action if the patient declines treatment
Advice should be given about the complications of the disease.
5. Follow-up treatment

Recipients of vaccines should be observed for adverse reaction and remain under
observation until they are seen to be in good health.
3

If an adverse reaction occurs, such as anaphylaxis, give immediate treatment and
inform the patient’s general practitioner as soon as possible.
6. Information to be given to the patient



The pharmacist will give the patient an information leaflet (PIL) accompanying the
vaccine, if available.
The pharmacist will advise the patient as to the possible local and systematic adverse
reactions and that these reaction will usually disappear within one or two days without
treatment:
Local reactions: redness, swelling, bruising, hardness at the site of injection.
Systematic reactions: fever, feeling of being unwell, shivering, fatigue,
headache, muscle ache.
The patient must be advised that if there are other unusual severe reactions such as
confusion or drowsiness, he or she should contact his or her general practitioner as
soon as possible.
7. Treatment records
7.1 Names of pharmacists administering influenza vaccination
As recorded in the pharmacist team record for each pharmacy or GP practice (appendix 3)
if appropriate.
7.2 Patient identifiers
Pharmacists administering influenza vaccine will maintain a list of patients who receives
the vaccine. The list will have the patients name, date of birth, address, GP, date and time,
brand name of vaccine and batch number (Appendix 4).
7.3 Treatment provided
The following will be documented in the patient’s form:
 Brand name of vaccine, batch number and expiry date
 Method and route of administration of vaccine
 Injection site.
The pharmacist will inform the GP of the above, by forwarding a copy of the patient form
within 48 hours of administration, so that his patient’s records can be updated.
8. Reporting of adverse reactions
Any serious adverse reactions, untoward incident/error will be reported to the general
practitioner immediately and if necessary, the clinical governance leads and documented
in the patients records.
9. Drug Alerts from the Medical Control Agency
Pharmacists will be informed of Drug Alerts through the Contractor Services, Greenwich
Teaching PCT. The pharmacists will co-ordinate the return of affected vaccines through
their supplier.
4
10. Facilities provided at the site of care
The following are required to be readily available:
 An in date anaphylactic kit
 A telephone must be available and working. Health and Safety policies
must be adhered to regarding the disposable of sharps.
11. Professional accountability
Each practitioner administering vaccines under this Group Direction is personally
accountable for his/her own actions as laid down by the RPSGB Code of Ethics.
12. Indemnification
The Trust will indemnify community pharmacists employed by the Trust against claims
for negligence relating to injuries or loss caused by their actions provided the pharmacists
have complied with the guidelines and requirements of this Patients Group Direction.
The pharmacists’ employers will indemnify the pharmacists employed by them against
claims for negligence relating to injuries or loss caused by their own actions provided the
pharmacists have complied with the guidelines and requirements of this Patient Group
Direction.
13. Management and monitoring of this Patient Group Direction
13.1 The authors of the Patient Group Direction are:
Dr Clow
Immunisation Lead
Signature
5
Date
Kuldeep Kaur
Community services Pharmacist
Denise Rabbette
Head of Medicines Management
Dr. John Livingstone
PEC Chairman
Signature
Date
Signature
Date
Signature
Date
13.2 Authorised on behalf of Greenwich Teaching Primary Care Trust
Hilary Shanahan
Signature
Chairman, Clinical Governance Subcommittee
Date
13.3 The managers responsible for the implementation and monitoring of the Patient
Group Directions are:
Kuldeep Kaur
Community Services Pharmacist
Signature
Date
14. References
Immunisation against infectious diseases. Department of Health, HMSO (2004). London
Influenza Immunisation Programme 2004/2005. From the Chief Medical Officer, the
Chief Nursing Officer and the Chief Pharmacist PL/CMO/2005/2, PL/CNO/2005/2,
PL/CPHO/2005/2.Department of Health, August 2005
Patient Group Directions (England Only) – HSC 2000 / 026, NHSE 9 August 2000
6
Code for Professional Practice. Nursing and Midwifery Council, 2002.
Guidelines for the Administration of Medicines. Nursing and Midwifery Council, 2002.
Guidelines for records and record keeping. Nursing and Midwifery council, 2002.
Reference Guide of Consent for Examination or Treatment. Department of Health, July
2001. www.doh.gov.uk/consent
Medicines, Ethics & Practice. A Guide for Pharmacists, July 2005, 29, RPSGB.
APPENDIX 1
Training requirements
Theory


All pharmacists will be familiar with the summaries of the vaccines characteristics
accompanying the influenza vaccines that they administer.
All pharmacists will have knowledge of the book, Immunisations Against Infectious
Diseases (DOH 2004) or subsequent editions, with particular reference to the chapter
on influenza.
7


All pharmacists will have read and adhere to the Trust Policy on vaccine handling and
storage with particular reference to the vaccine cold chain.
All pharmacists will be familiar with this Patient Group Direction for the
administration of influenza vaccine.
Practical
All pharmacists are accountable under the RPSGB guidelines to maintain safe practice.
They will also have an annual peer review. See below.
Requirements for training and continuing education
 All pharmacists will attend an annual update on anaphylaxis, vaccination and
immunisation.
 All pharmacists will attend an annual update on resuscitation.
 All pharmacists will attend a yearly peer review of competent practice of vaccinations.
APPENDIX 2
Greenwich Teaching Primary Care Trust
Preliminary check
Name ……………………………………………….
Address……………………………………………..
Date of Birth………………………………………..
Are you feeling well today?
Yes/No
Have you had a reaction to the flu vaccine
or any other injection before?
Yes/No
8
Are you allergic to eggs or egg products?
Yes/No
Are you taking steroids?
Yes/No
Have you recently had chemotherapy or radiotherapy?
Yes/No
Whilst you may not receive full protection you should still receive the vaccination
Are you pregnant? (For women under 55 years old)
Yes/No
Have you had a mastectomy?
Yes/No
(If the answer is yes, do not administer the injection on the arm on the same side)
Are you on any of the following medicines?
Antiepileptics
Yes/No
Warfarin or any other anticoagulants
(If yes, give by subcutaneous, not intramuscular, injection)
Yes/No
Theophylline
Yes/No
If the answer to any of the above is ‘yes’, influenza vaccine is not contraindicated but please counsel
patients according to information in ‘Interactions with influenza vaccine’. See appendix 6.
Consent to have influenza vaccination
The side effects of the vaccination have been explained to me I consent to receiving an influenza
vaccination.
Signature of patient…………………………………………….
Date……………………………………………………………..
For Vaccines administered outside the surgery
Name of patient’s GP…………………………..
Brand name of vaccine……………………………Batch Number……………
Expiry Date ……………….
Site of administration……………………………………………
Signature of pharmacist………………………………………………..
Print name………………………………………………………..
Appendix 3
PHARMACISTS TEAM RECORD
This patient group direction is to be read and signed by all the
pharmacists trained and competent to administer influenza vaccine.
Pharmacy ………………………………………………………
We have read and understood the Patient Group Direction for the administration of
the Influenza vaccine. We agree to comply with the conditions stated in it.
9
Staff name, designation
and signature:
Pharmacists
…………………………………………..
…………………………………………..
…………………………………………..
…………………………………………..
…………………………………………..
…………………………………………..
…………………………………………..
…………………………………………..
Date
…………………………………………..
10
Pharmacy Influenza Vaccination Scheme
Name (BLOCK CAPITALS)
GP Surgery
Address
DOB dd/mm/yy
Today’s Date dd/mm/yy
Reason for vaccination, please tick;
Aged 65 or over

At risk medical condition

Private - £12

Do you suffer from the following?
Yes
No
Panic attacks?


Fainting?


Product Details
Vaccination dose & brand
Batch Number
Site
Expiry Date dd/mm/yy
Pharmacists’ Name (BLOCK CAPITALS)
Pharmacists’ Signature
Pharmacy Stamp
White Copy – Pharmacy
Yellow Copy – GP
Consent form completed and on file at Pharmacy
Office use only
Cost Centre
Cost Code
Voucher number:
APPENDIX 5

Pink Copy – PCT
Greenwich Teaching Primary Care Trust
Medical Direction for the Administration of Influenza Vaccine without a
Prescription for a Named Individual
I………………………….General Practitioner give authorisation on behalf of the
group practice for the named health care professionals who have signed this protocol,
to administer influenza vaccine in accordance with current Department of Health
guidelines to the patients registered with this practice.
Signed……………………………………….
Practice Stamp
Appendix 6
Interactions with influenza vaccine
12
Date………………………..
The following interactions are not included in the manufacturers’ summaries of
products characteristics and thought not to be significant in clinical practice. There is
no contradiction to giving influenza vaccine to patients on the following medicines
mentioned. However, it is well to be aware of possible changes to the effects of the
medicines on patients because of the influenza vaccine.
1. Influenza vaccine with anticonvulsants
Influenza vaccine is thought to inhibit liver enzymes, which can reduce the
metabolism of phenobarbitone and increase its serum level.
Influenza vaccine can reduce, raise or have no effect on the levels of phenytoin.
Studies have shown that there is no effect of influenza vaccine on cabamazepine
levels in patients.
It is prudent to advise patients to see their GP if there is any change in their epilepsy
control or if they feel unusually drowsy or agitated or have insomnia.
2. Influenza vaccine with warfarin or any other anticoagulants
Administer the vaccine by subcutaneous, not intramuscular, injection.
Influenza vaccination in patients treated with warfarin is usually safe and uneventful.
There have been a very few reports of bleeding occurring unpredictably. The
mechanism of the interaction is not fully understood but it is to do with an alteration
in the synthesis of blood clotting factors.
Advise patients to report to their GPs if there is unusually easy bruising or bleeding
say, from the nose or when brushing teeth.
3. Influenza vaccine with theophylline
Influenza vaccination in patients on theophylline is usually very safe with no adverse
reactions. There have been a few reports of raised theophylline levels, possible due to
liver enzyme inhibition. One proposal may be due to the impurities in the vaccine but
with the purer vaccines now used; interactions will be very rare.
Advise patient to see their GP if they experience palpitations, tachycardie, nausea or
gastrointestinal upsets or headaches.
4. Influenza vaccine with steroids
Influenza vaccination in patients on steroids is usually very safe with no adverse
reactions. However, some immunocompromised patients may have a sub-optimal
response to the vaccine.
General Practitioners should report any adverse reactions and suspected interactions
to the MCA using the yellow forms at the back of the BNF
Reference
Stockley I, Drug interactions 4th Edition, Pharmaceutical Press, 1996
13
Appendix 7
Patients who fall within the ‘risk- groups’ category.
Chronic respiratory Disease, including asthma
This includes chronic obstructive pulmonary disease including chronic bronchitis and
emphysema, bronchiectasis, cystic fibrosis, interstitial lung fibrosis, pneumoconiosis,
asthma requiring continuous or repeated use of inhaled or systemic steroids or with
previous exacerbations requiring hospital admission.
Chronic Heart Disease
This includes chronic ischaemic heart disease, congenital heart disease and
hypertensive heart disease requiring regular medication and follow up (but excluding
uncomplicated controlled hypertension), and chronic heart failure.
Chronic Renal Disease
Including nephritic syndrome, chronic renal failure, and renal transplantation.
Diabetes
Diabetes Mellitus requiring insulin or oral hypoglycaemic drugs.
Immunosuppression
Due to disease or treatment, including asplenia or splenic dysfunction, and also
including systemic steroids equivalent to 20 mg prednisolone daily for more than 2
weeks. However, please note that some immunocompromised patients may have a
sub- optimal immunological response to the vaccine.
Vaccines covered under this PGD
All vaccines may have been exposed to latex in the manufacturing process so
patients who are allergic to latex should be referred to the GP.
Inactivated Influenza vaccine (Split Virion) Aventis Pasteur
Special warnings and precautions for use:
Not to be administered intravascularly.
Antibody response in patients with endogenous or iatrogenic immunosuppression may
be insufficient.
Can be used after the second trimester in pregnancy and during lactation.
Contraindications- hypersensitivity to the active substances, to any of the excipients,
to eggs, chicken protein, neomycin, formaldehyde and octoxinol 9
14