NHS Trust /
Wolverhampton Shared Care Agreement / Wolverhampton City
Clinical Commissioning Group
Black Country Cluster
Letrozole (Femara®)
ESCA: For the treatment of postmenopausal breast cancer
SECONDARY CARE SECTION TO BE COMPLETED BY INITIATING DOCTOR
Patient’s Name: / NHS Number:Date of Birth: / Date Treatment Started:
(Add Date)
One copy of information leaflet given to patient
One copy of agreement sent to general practitioner
One copy filed in patients notes
Name of Initiating Doctor:
Consultant:
Speciality:
Fax Number:
PRIMARY CARE SECTION TO BE COMPLETED BY GENERAL PRACTITIONER
I agree*/don’t agree* to enter into a shared care arrangement for the treatment of the above patient with this medicine (*delete as appropriate)GP Name:
Signature: / Date:
Once signed please detach this sheet and fax to the number shown above.
BACK-UP ADVICE AND SUPPORT
Contact details / Telephone No. / Bleep / Fax / EmailSpecialist:Dr Allerton / 695203 / 695624 /
Specialist: Dr H Khan / 695204 / 695624 /
Specialist: Dr Mehra / 695205 / 695624 /
Specialist: Dr D Tripathi / 695201 / 695624 /
Hospital Pharmacy Dept: Sandra Tang / 695139 / 1717 /
Patient’s Name: Date treatment commenced:
AREAS OF RESPONSIBILITY FOR THE SHARING OF CARE
This shared care agreement outlines suggested ways in which the responsibilities for managing the prescribing of letrozole for postmenopausal patients with early invasive or advanced breast cancer can be shared between the specialist and general practitioner (GP). GPs are invited to participate. If the GP is not confident to undertake these roles, then he or she is under no obligation to do so. In such an event, the total clinical responsibility for the patient for the diagnosed condition remains with the specialist. If a specialist asks the GP to prescribe this drug, the GP should reply to this request as soon as practicable.
Sharing of care assumes communication between the specialist, GP and patient. The intention to share care is usually explained to the patient by the doctor initiating treatment. It is important that patients are consulted about treatment and are in agreement with it. Patients with breast cancer are under regular specialist follow-up, which provides an opportunity to discuss drug therapy.
The doctor who prescribes the medication legally assumes clinical responsibility for the drug and the consequences of its use.
RESPONSIBILITIES and ROLES
Specialist responsibilities1. Initiate treatment and provide at least 28 days’ supply.
2. Discuss the benefits and side effects of treatment with the patient.
3. Ask the GP whether he or she is willing to participate in shared care, and agree with the GP as to who will discuss the shared care arrangement with the patient.
4. Supply GP with summary within 14 days of a hospital out-patient review or in-patient stay.
5. Monitor bone mineral density. Advise GP on need for subsequent treatment for osteoporosis.
6. Review the patient's condition and monitor response to treatment regularly where indicated.
7. Give advice to the GP on when to stop treatment.
8. Report adverse events to the CSM.
9. Ensure that clear backup arrangements exist for GPs to obtain advice and support.
General Practitioner responsibilities
1. Reply to the request for shared care as soon as practicable.
2. Prescribe letrozole at the dose recommended.
3. Refer promptly to specialist when any loss of clinical efficacy is suspected (e.g. worsening of disease-related symptoms, new symptoms suggestive of disease recurrence or progression) or intolerance to therapy occurs.
4. Liaise with specialist about need for osteoporosis treatment or prophylaxis.
5. Report to and seek advice from the specialist on any aspect of patient care that is of concern to the GP and may affect treatment.
6. Stop treatment on the advice of the specialist.
7. Report adverse events to the specialist and CSM.
Patient's role
1. Report to the specialist or GP if he or she does not have a clear understanding of the treatment.
2. Share any concerns in relation to treatment with letrozole.
3. Report any adverse effects to the specialist or GP whilst taking letrozole.
SUPPORTING CLINICAL INFORMATION
Indications
· First-line treatment in postmenopausal women with advanced breast cancer.
· Treatment of advanced breast cancer in postmenopausal women in whom tamoxifen or other anti-oestrogen therapy has failed.
· Pre-operative therapy in postmenopausal women with localised hormone receptor-positive breast cancer not originally considered candidates for breast-conserving surgery.
Dosage and Administration
The recommended dose of letrozole is 2.5 mg once daily. Following standard adjuvant tamoxifen therapy, treatment with letrozole should continue for three years or until tumour relapse occurs. In patients with metastatic disease, treatment should continue until tumour progression is evident.
No dose adjustment is required for older women, for patients with mild to moderate hepatic impairment (Child-Pugh grade A or B) or renal impairment (creatinine clearance 10ml/min).
Contraindications
Letrozole is contraindicated in pre-menopausal, pregnant or breast-feeding women, and patients with severe hepatic impairment.
Women with osteoporosis or at risk of osteoporosis should have bone mineral density assessed at the start of therapy and at regular intervals thereafter.
Side Effects
The most frequently reported adverse reactions (5-11%) were hot flushes, nausea and fatigue. Other common adverse events (1% to <10%) include anorexia, appetite increase, headache, dizziness, alopecia and musculoskeletal pain. Refer to the SPC for a full list of adverse effects.
Letrozole was launched in November 1996 and no longer has black triangle (▲) status. Serious suspected reactions (even if well recognised or causal link uncertain) should be reported to the CSM.
Monitoring
Parameter / Frequency of monitoring / Action
BMD with DXA scan / At commencement and regular intervals during therapy (depending on risk) / Treatment or prophylaxis for osteoporosis
Drug Interactions
There is no evidence from the clinical trial database of any clinically important interactions with commonly prescribed drugs.
Vaccination
The use of LIVE vaccine is not recommended during drug treatment with immunosuppressant drugs. This section may be excluded if the shared care agreement related to a drug which is not an immunosuppressant.
Acknowledgements
Refer to MTRAC VS 05/18.
Version Control
Version / Date of Issue / Author/s / Brief Description of Changes
1.0
1.1 / 25/06/2013 / R Eardley / Removal of pharmacy fax numbers
2.0 / 20/06/2016 / S Tang / Updated contact details and confirmed no changes to clinical content
This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for Letrozole (Femara)
Date approved: 30 Dec 12 Last Reviewed: June 2016 Expiry date: June 2019