effective shared care agreement (esca)

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WORKING IN
PARTNERSHIP WITH
EFFECTIVE SHARED CARE AGREEMENT (ESCA)
DRUG NAME: SULFASALAZINE TABLETS
INDICATION/S COVERED Chronic inflammatory conditions in adults as determined by the
appropriate hospital specialist
NHS West Sussex/NHS Brighton and Hove Traffic Light system classification: Amber
N.B. The eligibility criteria included here apply to new patients commencing treatment under this agreement and
not to existing patients whose treatment was initiated under the previous version. However, monitoring and
discontinuation criteria apply to all patients.
NOTES to the primary care prescriber
Amber drugs: Prescribing to be initiated by a consultant / specialist but with the potential to transfer to
primary care. The expectation is that these guidelines should provide sufficient information to enable
primary care prescribers to be confident to take clinical and legal responsibility for prescribing these drugs.
The questions below will help you confirm this:

Is the patient currently under your care? (e.g. Shared care should not be agreed if the patient is
currently in intermediate care following hospital discharge.)

Is the patient’s condition predictable?

Do you have the relevant knowledge, skills and access to equipment to allow you to monitor treatment
as indicated in this effective shared care agreement?

Have you been provided with relevant clinical details including monitoring data?
If you can answer YES to all these questions (after reading this ESCA), then it is appropriate for you to
accept prescribing responsibility. Sign and return a copy of the final page to the requesting consultant /
specialist. Until the requesting consultant / specialist has received a signed copy of the final page indicating
that shared care has been agreed all care (including prescribing) remains with the consultant / specialist.
If the answer is NO to any of these questions, you should not accept prescribing responsibility. You should
write to the consultant / specialist within 14 days, outlining your reasons for NOT prescribing. If you do not
have the confidence to prescribe, we suggest you discuss this with your local Trust/specialist service, who
will be willing to provide training and support. If you still lack the confidence to accept clinical responsibility,
you still have the right to decline. Your PCT pharmacist will assist you in making decisions about shared
care.
Prescribing unlicensed medicines or medicines outside the recommendations of their marketing
authorisation alters (and probably increases) the prescriber’s professional responsibility and potential
liability. The prescriber should be able to justify and feel competent in using such medicines.
The patient’s best interests are always paramount
The primary care prescriber has the right to refuse to agree to shared care, in such an event the total clinical responsibility will remain
with the consultant
Reason for update: NEW
Valid from:
1st August 2011
Version: 1
Review date:
1st August 2013
Supersedes
version: N/A
Prepared by: Dr Kelsey M Jordan/Dr Stewart Glaspole
Updated by:
Approved by (Specialist/consultant): Dr Kelsey M Jordan
Approved by (Chief Trust pharmacist): Jatinder Harchowal
Approved by (PCT pharmacist(s)):
Katy Jackson
Clare Andrews
Approved by NW Sussex Area Prescribing Committee on: 14th September 2011
Approved by NHS Brighton and Hove Medicines Management Committee on:23 rd August 2011
Information
This information sheet does not replace the Summary of Product Characteristics (SPC), which should
be read in conjunction with this guidance. Prescribers should also refer to the appropriate paragraph in
the current edition of the BNF.
1. Link to the relevant SPC website:
http://www.medicines.org.uk/EMC/medicine/10722/SPC/Salazopyrin+En-Tabs/#INDICATIONS
2. Background to use for the indication/s, including licence status
Sulfasalazine is used as a disease modifying agent to induce and maintain remission in several types of
rheumatic & gastrointestinal inflammatory diseases. It can reduce inflammation and affect the immune
system and is therefore used for a number of other conditions.
Sulfasalzine has marketing authorisation for use in ulcerative colitis, Crohn’s disease and rheumatoid
arthritis.
3. Dose & administration
500 mg/day orally increasing by 500mg weekly to 2.0–3.0 g/day.
Occasionally doses above 3.0 g/day are prescribed
4. Cautions (including for pregnancy & lactation where relevant)
Glucose-6-phosphate dehydrogenase deficiency (G6PD): May cause haemolysis. Seek specialist advice.
Renal impairment (GFR 10-20ml/min): May cause significant crystalluria and must ensure high fluid intake. In
case of severe renal failure (GFR <10ml/min) do not use.
Slow–acetylators of the drug: May cause drug-induced lupus-like syndrome. It is not necessary to assess
acetylator phenotype.
Pregnancy and Lactation
There are NO contra-indications to use in pregnancy or lactation
Doses  2g/day are recommended
Folic acid should be prescribed to those wanting to conceive and throughout the pregnancy, particularly those
with G6PD deficiency
5. Contraindications
Sulfasalazine is contra-indicated in those who are hypersensitive to sulphonamides / co-trimoxazole and
aspirin / NSAIDs
6. Side effects
Include nausea, diarrhoea, dizziness, headaches and rashes. Body fluids may turn orange/yellow with
discolouration of contact lenses
Uncommonly, leucopoenia, anaemia, liver function disturbance, hypersensitivity reactions & oligospermia
7. Interactions
Combination therapy with azathioprine may contribute to bone marrow toxicity.
Cardiac glycosides – possibly reduces the absorption of digoxin.
Prescribers are advised to check the BNF or ask a pharmacist for advice where required.
8. Criteria for use
Chronic inflammatory conditions unresponsive to first line therapy as determined by the appropriate hospital
specialist.
9. Any further information (e.g. supporting therapies)
N/A
10. References
N/A
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RESPONSIBILITIES and ROLES
Consultant / Specialist responsibilities
1
2
3
4
5
6
7
8
Identify patients requiring sulfasalazine and counsel patients appropriately
Undertake pre-treatment blood tests (FBC, U&E, LFT)
Adjust dose during initial monitoring period
Monitor according to speciality guidelines during first 3 months and until stable
Provide patient with hand-held information on sulfasalazine including a monitoring booklet and explain to the patient / carer
their roles
Review efficacy of treatment at regular intervals and ensure drug treatment changes are communicated to the patient and
GP. This would include a yearly review in stable patients.
Report any adverse events to the CSM and GP
Explain to the patient / carer their roles
Primary care prescriber responsibilities
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2
3
4
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Return a signed copy of the shared care invitation to the hospital team
Subsequent prescribing of sulfasalazine 500mg tablets at the dose recommended.
Monitoring of FBC, LFT & Creatinine 3 monthly for one year. If stable, reduce monitoring to each 6-12 months
Prescribe any change in sulfasalazine dose as advised by the hospital team
Monitor for adverse effects throughout treatment and check for drug interaction on initiating new treatments
Record results, when possible, in a patient held record book
Report adverse events to the CSM and hospital team
Ensure that if care of the patient is transferred to another prescriber that the new prescriber is made aware of the ESCA.
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2
3
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Monitor FBC, LFT and Creatinine 3 monthly for one year. If stable reduce to 6-12 monthly monitoring
WBC < 3x109/L and/or Neutrophil < 1.5x109/L : Withhold and discuss with hospital team
ALT / AST > 2.5 X upper limit of normal: Withhold and discuss with hospital team
Sore throat, significant oral ulceration, significant bruising: Check FBC and withhold until FBC result available
New or increasing dyspnoea or cough: Assess chest and withhold treatment until discussed with hospital team
Significant deterioration in renal function: Reduce dose (discuss with hospital team)
If urinary dipstick is 2+ send an MSU. If infection, treat appropriately. If sterile proteinuria seek advice
Monitoring requirements and appropriate dose adjustments (if relevant to specific drug)
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2
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Patient's / Carer’s role
Ask the consultant / specialist or primary care prescriber for information, if any aspects of treatment are not
fully understood
Share any concerns in relation to treatment with sulfasalazine
Tell the consultant / specialist or primary care prescriber of any other medication being taken, including overthe-counter products.
Read the patient information leaflet included with the medication and report any side effects or concerns to
the consultant / specialist or primary care prescriber.
Bring any hand held shared care monitoring booklet to consultant/specialist and GP appointments
BACK-UP ADVICE AND SUPPORT
Name / position
Telephone
Specialist /
Consultant:
Alternative
specialist (e.g.
departmental
contact or Shared
care co-ordinator):
Hospital Pharmacy:
Out of hours (e.g.
medical team on
call):
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Email
EFFECTIVE SHARED CARE AGREEMENT (ESCA)
DRUG NAME: SULFASALAZINE TABLETS
INDICATION:
Agreement for transfer of prescribing to PRIMARY CARE PRESCRIBER
Patient details:
Name:
Address:
DoB:
NHS No:
Hospital No:
Drug name and strength:
The following tests and investigations have been carried out:
Date treatment initiated:
At the last patient review the drug appeared to be effectively controlling symptoms / providing benefit:
Yes/No
The patients has now been stabilised on a dose of:
I will arrange to review this patient regularly. Date of next clinic appointment:
Consultant/specialist:
Agreement to shared care, to be
signed by primary care prescriber
and consultant/specialist.
Address:
Consultant/specialist signature:
Contact Number:
Date:
Primary care prescriber:
Primary care prescriber signature:
Address:
Contact Number:
Date:
Main Carer:
If shared care is agreed and the
primary care prescriber has signed
above please return a copy of this
page to the requesting
consultant/specialist or alternatively
fax to:
(please insert
appropriate fax number).
Contact Number:
Key worker if appropriate:
Contact Number:
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