SHARED CARE AGREEMENT
1. REFERRAL CRITERIA
· Shared Care is only appropriate if it provides the optimum solution for the patient.
· Prescribing responsibility will only be transferred when it is agreed by the rheumatology and gastroenterology consultant and the patient’s GP. This agreement is reached by the GP completing and returning the form provided.
· When transfer is agreed the patient will be issued with four weeks supply.
2. AREAS OF RESPONSIBILITY
GP responsibilities
/Consultant responsibilities
a) Respond promptly to the shared care request.b) Monitor the patient’s overall health and well-being and ensure compatibility with other concomitant medication.
c) Arrange on-going monitoring as agreed with the specialist.
d) Raise any concerns or changes in the patients’ physical health with the specialist.
e) Re-affirm the use if contraception.
f) Prescribe the dose as advised by the hospital specialist.
g) Monitor U&E, FBC, LFTs and ESR / CRP at recommended frequencies and refer if abnormal.
h) Update ‘Patient Record Booklet’ issued by specialist.
i) Stop treatment on the advice of the specialist or immediately if any urgent need to stop treatment arises.
j) Ensure the patient is offered an annual flu vaccination and a one off pneumococcal vaccination on a priority basis.
k) Report any adverse events to the hospital specialist and the MHRA yellow card scheme.
l) Ensure the patient receives NO live vaccinations which includes the shingles vaccination.
m) Seek advice if patient travelling to a country where live vaccinations are required.
n) In the GP clinical system use the appropriate read code to denote the patient is receiving treatment under a shared care agreement. In Emis 8BM5, System One XaB58.
o) If patient fails to attend more than 2 monitoring visits it is not safe to continue treatment – contact the specialist for advice. / a) Discuss diagnosis, treatment options and agree care package with patient.
b) Discuss potential benefits and adverse effects of proposed treatment and ensure compatibility with other concomitant medication.
c) Undertake baseline tests including FBC, LFTs, U&Es, and where appropriate CRP, ESR and TPMT.
d) Provide baseline test results.
e) Provide Azathioprine prescriptions until a stable dose is reached.
f) Titrate dose to a therapeutic level before seeking shared care prescribing ensuring patient is stable.
g) Request shared care via clinic letter supplying a copy of this shared care agreement.
h) Recommend dose of Azathioprine and frequency of monitoring.
i) Supply patient with a copy of this shared care agreement.
j) Review patient periodically (no less than annually) and advise when to adjust the dose, stop treatment or consult with the specialist.
k) Provide and update patient with Azathioprine treatment booklet and update at each assessment.
l) Communicate with GP promptly when treatment changes.
m) Ensure a mechanism is in place to address clinical queries or concerns from GPs relating to this agreement in a timely manner.
n) Provide and update Burton Hospitals Patient Record Booklet.
o) Report adverse events to MHRA Yellow card scheme and GP.
p) Ensure a nurse advice line is available for GP to contact department if necessary and respond promptly to messages left by GPs on the nurse advice line.
Patient responsibilities
a) To take the prescribed dose as recommended by the specialist.b) To attend all appointments with specialist and GP for all monitoring, bringing ‘Patient Record Booklet’.
c) Inform specialists and GP of any other medication being taken including over the counter products.
d) Report any concerns of adverse effects to GP or consultant promptly. Do not wait for routine appointments.
3. CLINICAL INFORMATION
i. PrescribedIndications
Note:
This agreement is only for shared care requests from rheumatology and gastroenterology consultants. / Licensed indications
· Rheumatoid arthritis
· Dermatomyositis and polymyositis
· Autoimmune hepatitis
· Pemphigus vulgaris
· Polyarteritis nodosa / Unlicensed indications
· Vasculitis
· Psoriatic arthritis
· Autoimmune bullous disorder
· Systemic lupus erythematosus
· Ulcerative Colitis and Crohn’s disease
· Inflammatory Bowel Disease (IBD)
· Cutaneous lupus
· Asthma
· Severe eczema
· Autoimmune interstitial lung disease
· Sjögren's syndrome
· Scleroderma
ii. Therapeutic summary / Azathioprine is an immunosuppressive drug which is effective in controlling several inflammatory and autoimmune diseases.
Azathioprine should be considered for IBD patients who; require two or more courses on corticosteroids within a 12 month period; those who relapse when steroids are reduced below 15mg; those who relapse within 6 weeks of stopping or for post-operative prophylaxis of complex IBD.
For rheumatoid disease improvement may take 2 to 3 months to occur.
iii. Dose & Route of administration / Azathioprine
Autoimmune Conditions – Doses for autoimmune conditions will range between 1-3mg/kg, typically between 1.5 – 2.5mg/kg. Starting at 1mg/kg and increasing after 4 to 6 weeks to 2-3mg/kg/day according to response.
When therapeutic response is evident, consideration should be given to reducing the maintenance dosage to the lowest level compatible with the maintenance of that response.
IBD
Initially 50mg once daily for 2 weeks and then gradually increased by 50mg increments every 2 weeks up to 2 – 2.5mg / kg.
iv. Duration of treatment / Indefinite but may be withdrawn after a prolonged period of disease remission in selected cases.
v. Adverse effects
See BNF / SPC for full list / Undesirable effects may vary in their incidence depending on the indication.
Side Effects
Hypersensitivity reactions: including malaise, dizziness, vomiting, diarrhoea, fever, rigors, nephritis – requires immediate withdrawal.
Dose related bone marrow suppression, liver impairment, cholestatic jaundice, hair loss, increased susceptibility to infections, nausea, mouth ulcers, pancreatitis (rare), pneumonia, hepatic veno-occlusive disease.
Skin Care: There is an increased risk of skin cancer. Patients should be aware of the need for adequate sun protection measures. This risk is greater in patients who have a history of previous treatment with PUVA.
vi. Monitoring
Requirements / Pre-treatment assessments
· FBC
· U&E
· Creatinine
· LFTs
· TPMT assay
Monitoring continues as the responsibility of the specialist in accordance with local protocol until the patient is on a stable therapeutic dose.
Ongoing monitoring
· FBC’s and LFT’s fortnightly for the first 2 months of treatment, then monthly for 2 months, then 3 monthly unless toxicity noticed. If a dose change occurs repeat FB C’s and LFT’s 2 weeks after dose change then as above.
· U & E and Creatinine should be repeated 6 monthly.
· CRP / ESR as required to assess response to treatment (this is not for dermatology patients).
Responding to abnormal results
Please note that a rapid fall or consistent downward trend in any value should prompt caution and extra vigilance.
WBC <3.5 x 109 /1 / Withhold until discussed with specialist team
Neutrophils <2.0 x 109/l / Contact hospital specialist
Neutrophils <1.5 x 109/l / Withhold until discussed with specialist team
Platelets <120 x 109/ / Contact hospital specialist
>2 fold rise in AST, ALT
(from upper limit reference range) / Contact hospital specialist
>4 fold rise in AST, ALT
(from upper limit reference range) / Withhold until discussed with specialist team
Rash or oral ulceration / Contact hospital specialist
MCV> 105fl / Withhold until discussed with specialist team
Check serum folate and B12 & TSH. Treat any underlying abnormality. If results normal discuss with specialist
Abnormal bruising or severe sore throat / Withhold until FBC results available & discuss with the specialist team
CRP/ESR / Measured to allow disease activity evaluation
vii. Clinically relevant drug interactions
For a full list of interactions please refer to the BNF / · Avoid prescribing Allopurinol as this may lead to Azathioprine toxicity. If co-prescription is unavoidable reduce dose of Azathioprine by 50%.
· Increased risk of life threatening haematological toxicity with Co-Trimoxazole and Trimethoprim.
· Anticoagulant effect of coumarin anticoagulants may be inhibited by Azathioprine.
· Azathioprine may reduce the absorption of: Phenytoin, Sodium Valproate and Carbamazepine.
· Avoidance of Azathioprine with Febuxostat is advised by manufacturer.
· Co-prescription of ACE inhibitors may cause anaemia in frail elderly and renal function impaired patients.
· Aminosalicylates (Mesalazine, Sulfasalazine etc) may contribute to bone marrow toxicity.
· Patients should avoid live vaccines but an annual flu vaccine is recommended.
· Avoid co-prescribing with Clozapine due to an increased risk of agranulocytosis
viii. Contraindications and cautions / Contraindications
Immunisation:
· Patients receiving Azathioprine must not receive live immunisations. An inactivated form of polio is readily available.
· Annual flu vaccination is recommended
In patients receiving azathioprine exposed to chickenpox or shingles, advice should be sought from specialists.
Pregnancy and breast-feeding:
Azathioprine should not be given to patients who are pregnant or likely to become pregnant in the near future without careful assessment of risk versus benefit.. Evidence of the teratogenicity of azathioprine in man is equivocal. As with all cytotoxic chemotherapy, adequate contraceptive precautions should be advised when either partner is receiving Azathioprine. Any mothers planning to breastfeed should seek advice from the specialist
TPMT Assay in secondary care:
Individuals with severely reduced TPMT activity and / or homozygous should not be prescribed AZATHIOPRINE as serious and fatal toxicity may occur within 6 weeks of starting the drug. For mild/moderate (heterozygous) deficiency serious adverse events may occur anytime and as late as 6 months after treatment commences. Serious Adverse Events can be exacerbated by minor infections or drug interactions (See Drug Interactions & contra-indications). Moderate deficiency and / or heterozygous individuals should be prescribed Azathioprine with caution and reduced drug dosage.
TMPT range can vary and is dependent upon hospital lab methodology.
Limited evidence suggests that Azathioprine is not beneficial to patients with hypoxanthine- guanine-phosphoribosyltransferase deficiency (Lesch-Nyhan syndrome). Therefore, given the abnormal metabolism in these patients, it is not prudent to recommend that these patients should receive Azathioprine.
Cautions:
· TPMT deficiency: may be associated with delayed haematoxicity including bone marrow toxicity (see above)
· Frail elderly persons with functional renal impairment
· Sunscreens and protective covering should be encouraged to reduce sunlight exposure
· Localised or systemic infection including hepatitis B or C and history of TB
ix. Supply, storage and reconstitution instructions / Not applicable.
4. COMMUNICATION AND SUPPORT
x. Hospital contacts:Burton Hospitals 01283 511511 / 566333
Rheumatology
Dr M Nisar ext 4111
Dr R Laximinarayan ext 4068
Clincial Rheumatology Nurse Specialist ext 4112
Bleep 274 available during office hours.
Gastroenterology
Dr Palejwala secretary ext 4221
Dr Watmough secretary ext 4008
IBD Nurse Specialist ext 5854
Dermatology
Dr Beswick and Dr Cartwight secretary ext 4061
Dr Elston and Dr Tudor secretary 5202 / xi. Out of hours contacts and procedures:
Burton Hospitals 01283 511511 / 566333 ask for on-call pharmacist via switchboard
Rheumatology
Messages can be left on the nurse advice line out of hours 01283 511511 ext 4112.
If the advice line is not staffed messages may be left 24 hours a day. The team aim to respond at latest within two working days. The specialist nurses may also be bleeped via switchboard for urgent enquiries.
xii. Specialist support/resources available to GP including patient information
Information issued by hospital to patient (rheumatology only MED/RHEU/0009/0615) –
xiii. Prepared by
In consultation with
Reviewed by
Date Prepared
Review date / Sam Hardy-Ainger – Interface Pharmacy Technician
Jane Whitmore - Lead Clinical Nurse Specialist Rheumatology
Dr M Nisar – Lead Consultant Rheumatology
Dr D Watmough – Lead Consultant Gastroenterology
APG Dec 2016
Dec 2016
Dec 2018
GP RESPONSE TO SHARED CARE
Shared care is produced by GPs and specialists knowledgeable in the field of that drug usage. This allows a more convenient service to the patient and cost effective use of NHS resources.
Patient: / NHS No:Consultant: / Medicine requested for shared care: Azathioprine
Current Dose: / Date last prescription was provided:
/ I agree to participate in this shared care agreement for the treatment of the above named patient with ………………… for ………………….
/ I will NOT be undertaking the GP responsibilities as described in the agreed shared care guideline. My clinical reasons for declining shared care for this patient are listed in the box below:
Yours sincerely
{GP name}
{Surgery}
Please send a copy of this response to:
1. The specialist / consultant requesting shared care.
2. It is the responsibility of the specialist / consultant requesting the shared care agreement to forward any declined responses to the Medicines Management Interface Technician, Pharmacy Department Burton Hospitals.
(Sending a copy of this form to the interface technician will help to identify the reasons shared care is not being undertaken allowing for changes to be made in future updates to improve patient care.)
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