Olsetamivir prophylaxis for care home residents PGD by dfhrf555fcg

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									                                         Brighton and Hove City Teaching PCT




PATIENT GROUP DIRECTION
 Oseltamivir for prophylaxis of influenza for
 residents of care homes
For the Supply of Oseltamivir
by Registered Community Pharmacists
to Residents of Care Homes in Brighton and Hove City Teaching Primary
Care Trust.

Direction no:        BH 2005 11

Valid from:          October 2005

Supercedes:          All PGDs for oseltamivir for prophylaxis of influenza for
                     residents of care homes issued prior to October 2005

Review date:         31st April 2007

Expiry date:         October 2007




BH 2005 11                          Page 1 of 7          Valid until October 2007
Oseltamivir for prophylaxis of influenza for residents of care homes
                                           Brighton and Hove City Teaching PCT

 1.      Clinical condition or situation to which the direction applies.
                             Post Exposure Prophylaxis of influenza:
Indication
                             Oseltamivir is licensed for patients in one or more ‘at risk’ groups,
                             and living in a care home where a resident or staff member has an
                             influenza-like-illness (ILI), whether or not they have been vaccinated
                             against influenza.
                             This PGD will only come into force following notification from the
Criteria for inclusion
                             PCT.

                             Patients must:
                              Be a resident in a care home
                              Have been exposed to a patient, carer or nurse within the home
                                 who is exhibiting ILI symptoms
                              Be 65 years and over, or 16 – 64 years and in one of the defined
                                 risk groups below:
                                  Risk groups for patients aged 16 – 64 years:
                                   - Chronic respiratory disease (including COPD, 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)
                                   - Significant heart disease (including ischaemic heart
                                      disease, congenital heart disease, heart failure and
                                      hypertensive heart disease requiring regular medication
                                      and follow-up, but excluding uncomplicated controlled
                                      hypertension
                                   - Diabetes mellitus
                                   - Immunosuppression due to disease or treatment, including
                                      asplenia or splenic dysfunction, and also including
                                      systemic steroids equivalent to 20mg prednisolone daily for
                                      more than 2 weeks
                                   - Chronic liver disease
                              Be able to begin treatment within 48 hours of exposure
                                Be willing and able to consent to treatment from a pharmacist




 BH 2005 11                          Page 2 of 7          Valid until October 2007
 Oseltamivir for prophylaxis of influenza for residents of care homes
                                             Brighton and Hove City Teaching PCT

                               Patients will not be considered for prophylaxis with oseltamivir if the
Criteria for exclusion
                               following criteria apply
                                Not a resident in a care home
                                Already exhibiting symptoms of an ILI which may indicate
                                    oseltamivir should be supplied for treatment and not
                                    prophylaxis.
                                Patients has unstable or severe medical conditions.
                                Patient is less than 16 years of age
                                Patients not in an ‘at-risk’ group
                                Known allergy to oseltamivir phosphate or any of the excipients
                                    in the ‘Tamiflu®’ preparation
                                Has chronic renal disease
                                Are taking other drugs with clinically significant drug interactions
                                    e.g. chlorpropamide, methotrexate, phenylbutazone and
                                    probenecid
                                Exposure to ILI was more than 48 hours before treatment could
                                    start
                                Pregnant or breast-feeding women.
                                Severely debilitated patients
                                   Unwilling and / or unable to consent to treatment from a
                                    pharmacist
Action if excluded             Any resident in a care home excluded under this PGD should be
                               referred to GP for advice without delay. Some patients excluded
                               under this PGD may be suitable for post exposure prophylaxis if
                               prescribed by their GP.
                               Inform care home manager and refer to GP without delay.
Action if patient declines
treatment

Reference to national /           BNF – March 2005 edition
local policies or guidelines      Summary of Product Characteristics – Tamiflu® (Roche)
                                   www.medicines.org.uk
                                  NICE guidelines on the use of oseltamivir and amantadine for
                                   the prophylaxis of influenza Technology Appraisal No. 67
                                   www.nice.org.uk
                                  Royal Pharmaceutical Society Code of Ethics (Medicines, Ethics
                                   and Practice Guide 2004) www.rpsgb.org.uk
                                  CMO Letter July 2005 The Influenza Immunization Programme
                                   www.dh.gov.uk
                                  Royal Pharmaceutical Society of Great Britain- Patient Group
                                   Directions: A resource pack for pharmacists www.rpsgb.org.uk




 BH 2005 11                          Page 3 of 7          Valid until October 2007
 Oseltamivir for prophylaxis of influenza for residents of care homes
                                         Brighton and Hove City Teaching PCT

2.     Description of Treatment
                            Oseltamivir (Tamiflu®)
Name, strength &
formulation of drug
                            Oseltamivir 75mg capsules. One box contains 10 capsules,
                            sufficient for a full course of treatment.

                            Powder for oral suspension. After preparation yields 75ml
                            suspension with concentration of 12mg oseltamivir per ml.

Legal status                POM - Prescription only medicine

Dose / Dose range           For adults and adolescents 16 years and over a dose of 75mg
                            daily for at least 7 days for post exposure prophylaxis
Labelling Requirements      Oseltamivir is to be labelled as for any other dispensed medicine,
                            (including batch number and expiry date) and records of supply
                            maintained on the pharmacy computerised patients medication
                            record (PMR).
                            Post exposure prophylaxis should be initiated as soon as
Frequency of
                            possible within the first two days (48 hours) of exposure to
administration
                            influenza.
                            For adults and adolescents (16 years and over): the
                            recommended oral dose is 75mg oseltamivir (one capsule) daily
                            for 10 days.
                            The dose for the suspension is 1 x 30mg dose plus 1 x 45mg
                            dose both together once a day for 10 days. The suspension is
                            supplied with a calibrated dropper.
Identification &            Frequently reported adverse reactions include;
Management of Adverse        Nausea
Reactions                    Vomiting
                             Abdominal pain
                            Other commonly reported adverse reactions include;
                             Bronchitis
                             Dizziness
                             Fatigue
                             Headache
                             Insomnia
                            Patients should be advised that the majority of these adverse
                            reactions were found to occur on the first or second treatment
                            day and resolved spontaneously within 1-2 days. However, if
                            symptoms persist patients should consult a healthcare
                            professional.
                            Patients should be advised not to discontinue treatment without
                            consulting GP or pharmacist.




BH 2005 11                          Page 4 of 7          Valid until October 2007
Oseltamivir for prophylaxis of influenza for residents of care homes
                                          Brighton and Hove City Teaching PCT

Patient advice /Follow up      Discuss potential side effects
                               Advise patient to seek advice if common side effects do not
treatment
                                spontaneously resolve 48 hours after presentation
                               Promote bed rest, fluids and symptomatic remedies such as
                                analgesics
                               Patients should be referred to GP if breathing difficulties
                                develop or if general health rapidly worsens

                            It is recommended that the patient and /carers/nurses/officer in
                            charge read and understand the relevant oseltamivir key points
                            leaflet (Appendices 2 & 3) which should be given at the time of
                            supply.
Reporting procedure of      Any adverse reaction to the product should be documented in
Adverse Reactions           the medical records via the GP.
                            Pharmacists who become aware of any patient experiencing an
                            adverse drug reaction to oseltamivir should complete a yellow
                            card report and send to the CSM, oseltamivir is a black triangle
                            drug.

Special Considerations /       Oseltamivir is not recommended for post-exposure
Additional Information          prophylaxis, or treatment of otherwise healthy individuals with
                                influenza.
                               Use of oseltamivir is not a substitute for influenza
                                vaccination. The protection against influenza lasts only as
                                long as oseltamivir is administered.
                               Oseltamivir may be given to those with renal impairment
                                however dose adjustment is required. These patients should
                                be referred to their GP.
                               Patients aged 13-15 years in the ‘at risk’ groups although
                                excluded from this PGD should be referred to their GP
                                without delay as they may still receive treatment outside this
                                PGD.

                            Patient information relating to the supply of oseltamivir under
                            PGD may be passed to other health service organisations, such
                            as a patient’s GP or the local NHS commissioning body, for a
                            variety of purposes such as audit or payment.




BH 2005 11                          Page 5 of 7          Valid until October 2007
Oseltamivir for prophylaxis of influenza for residents of care homes
                                          Brighton and Hove City Teaching PCT

Records                     Data must be collected for the Pharmacist Consultation Record
                            and other relevant documentation and will include:
                               Patient’s name, address, date of birth and GP with whom
                                registered
                               Manufacturer of product, batch number and expiry date of
                                product
                               Quantity supplied and recommended dose
                               Date supplied and by whom
                               Details of any adverse drug reaction and action taken


                            Clinical records must be kept for at least 8 years following
                            completion of treatment. In patients who are aged under 17
                            years, clinical records must be kept until the patient’s 25th
                            birthday, or for 8 years following a child’s death.
                            Data must be stored in accordance with Caldicott guidance and
                            the Data Protection Act.




BH 2005 11                          Page 6 of 7          Valid until October 2007
Oseltamivir for prophylaxis of influenza for residents of care homes
                                            Brighton and Hove City Teaching PCT


  3.     Characteristics of Staff

  Qualifications required          Registered Pharmacist

  Additional requirements          Has undertaken appropriate training for working under
                                    PGD for supply of medicines

                                   Has undertaken training appropriate to this PGD

                                   Has been authorised as an approved practitioner within
                                    the terms of this patient group direction

  Continued training               Participation in CPD
  requirements


  4.    PGD Development

Developed & produced by:            Name                    Signature                 Date


Senior Pharmacist            Kirstie Denley


Authorising Doctor           Dr Susan Mills


  This patient group direction has been approved on behalf of Brighton and
  Hove City Teaching PCT by:

Approved by:                 Name                   Signature                  Date
The Medicines
Management Committee


Clinical Governance Lead     Dr Tom Scanlon




  BH 2005 11                          Page 7 of 7          Valid until October 2007
  Oseltamivir for prophylaxis of influenza for residents of care homes

								
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