Download Sodium aurothiomalate - Wolverhampton Formulary

Royal Wolverhampton
NHS Trust
Wolverhampton City
Clinical Commissioning Group
Wolverhampton Shared
Care Agreement
Sodium aurothiomalate (Myocrisin®) – GP Monitored
ESCA: For the treatment of severe rheumatoid arthritis in adults and children
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:
01902 695736
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.
File copy in patient’s record and add read code 66S2 or XaK6z depending on GP clinical system.
BACK-UP ADVICE AND SUPPORT
Contact details
Telephone No.
Rheumatology Nurse Helpline
01902 695491
Rheumatology Secretaries
01902 695492
01902 695495
Hospital Pharmacy Department
Mrs S. Reed
01902 695136
Email address:
[email protected]
This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for sodium aurothiomalate
Date approved: May 2013
Expiry date: 31/12/2017
Royal Wolverhampton
NHS Trust
Wolverhampton City
Clinical Commissioning Group
Wolverhampton Shared
Care Agreement
Sodium aurothiomalate (Myocrisin®) – GP Monitored
ESCA: For the treatment of severe rheumatoid arthritis in adults and children
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
sodium aurothiomalare can be shared between the specialist and general practitioner (GP). GPs are invited to
participate. If GPs are not confident to undertake these roles, then they are 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 should
be explained to the patient by the doctor initiating treatment. It is important that patients are consulted about
treatment and are in agreement with it.
The doctor who prescribes the medication legally assumes clinical responsibility for the drug and the
consequences of its use.
RESPONSIBILITIES and ROLES
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Specialist responsibilities
Discuss the benefits and side effects of treatment with the patient. Check FBC (including numerical platelet
count) and plot readings before initiation. Also test urine for protein and check skin for rash.
Initiate treatment. 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.
Dose stabilisation: initial dosage adjustment until stable. Thereafter, during maintenance treatment, advice to
the GP on any further dose adjustments required.
Communicate promptly with the GP when treatment is changed.
Have a mechanism in place to receive rapid referral of a patient from the GP in the event of deteriorating
clinical condition.
Advise the GP on stopping treatment (if appropriate).
Report serious adverse events to the MHRA
Ensure that clear backup arrangements exist for GPs to obtain advice and support.
General Practitioner responsibilities
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.
Adjust the dose as advised by the specialist
Refer back to specialist if condition deteriorates.
Report adverse events to specialist and MHRA.
Check FBC (including numerical platelet count) and plot readings before each injection. Also test urine for
protein and check skin for rash.
Withhold until discussed with specialist team if WBC<3.5x109/l, platelets <150x109/l, neutropenic (<2.0x109/l) a
rash (usually itchy) or oral ulceration occur. If abnormal bruising or severe sore throat present, check FBC
immediately and withhold until results are available.
If 2+ proteinuria or more, check MSSU: If infection present treat appropriately. If sterile and 2+ proteinuria or
more persists, withhold until discussed with specialist team.
Stop treatment on advice of specialist.
Patient's role
Report to the specialist or GP if he or she does not have a clear understanding of the treatment.
Share any concerns in relation to treatment with sodium aurothiomalate
Report any adverse effects to the specialist or GP whilst taking sodium aurothiomalate
This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for sodium aurothiomalate
Date approved: May 2013
Expiry date: 31/12/2017
Royal Wolverhampton
NHS Trust
Wolverhampton City
Clinical Commissioning Group
Wolverhampton Shared
Care Agreement
Sodium aurothiomalate (Myocrisin®) – GP Monitored
ESCA: For the treatment of severe rheumatoid arthritis in adults and children
SUPPORTING CLINICAL INFORMATION
Indications
Sodium aurothiomalate is licensed for the treatment of rheumatoid arthritis, including paediatric conditions
Dosage and Administration
Sodium aurothiomalate should be administered only by deep intramuscular injection followed by gentle massage of
the area. The patient should remain under medical observation for a period of 30 minutes after drug administration.
Contraindications
Pregnancy
Myocrisin is contraindicated in patients with gross renal or hepatic disease, a history of blood dyscrasias, exfoliative
dermatitis or systemic lupus erythematosus.
Side Effects
Blood dyscrasias including thrombocytopenia, pancytopenia, agranulocytosis, aplastic anaemia, leucopenia &
neutropenia have been reported. Anaphylactic/Anaphylactoid reactions have been reported, symptoms of which may
include weakness, flushing, hypotension, tachycardia, dyspnoea, palpitations, abdominal pain, shock and possibly
collapse .Hepatotoxicity with cholestatic jaundice is a rare complication which may occur early in the course of
treatment. It subsides on withdrawing Myocrisin. A rare but severe form of enterocolitis has been described.
Diffuse unilateral or bilateral pulmonary fibrosis very rarely occurs. This progressive condition usually responds to
drug withdrawal and steroid therapy. An annual x-ray is recommended and attention should be paid to unexplained
breathlessness and dry cough.
Side effects may be largely avoided by the indicated careful titration of dosage. Minor reactions, usually manifest as
skin rashes and pruritus are the most frequent and commonly benign, but as such reactions may be the forerunners
of severe gold toxicity they must never be treated lightly. Other indicators of developing toxicity could be the
presence of albuminuria or an eosinophilia.
Severe skin reactions that have been reported include exfoliative dermatitis and bullous eruptions. Irreversible skin
pigmentation (chrysiasis) can occur in sun-exposed areas after prolonged treatment with Myocrisin. Rare reports of
alopecia exist. Nephrotic syndrome has been rarely reported.
Neurological manifestations of gold toxicity including very rare cases of peripheral neuropathy, Guillain-Barré
syndrome and encephalopathy have been observed.
Monitoring
Before starting treatment and again before each injection, the urine should be tested for protein, the skin inspected
for rash and a full blood count performed, including a numerical platelet count (not an estimate) and the readings
plotted. Blood dyscrasias are most likely to occur when between 400 mg and 1 g of gold have been given, or
between the 10th and 20th week of treatment, but can also occur with much lower doses or after only 2-4 weeks of
therapy. The British Society of Rheumatology advises that provided blood results are stable, the results of the FBC
need not be available before the injection is given, but must be available before the next injection.
The presence of albuminuria, pruritus or rash, or an eosinophilia, is indication of developing toxicity. Sodium
aurothiomalate should be withheld for one or two weeks until all signs have disappeared when the course may be
restarted on a test dose followed by a decreased frequency of gold injections.
A complaint of sore throat, glossitis, buccal ulceration and/or easy bruising or bleeding, demands an immediate blood
count, followed if indicated, by appropriate treatment for agranulocytosis, aplastic anaemia and/or thrombocytopenia.
Every patient treated with Myocrisin should be warned to report immediately the appearance of pruritus, metallic
taste, sore throat or tongue, buccal ulceration or easy bruising, purpura, epistaxis, bleeding gums, menorrhagia or
diarrhoea.
Drug Interactions
Concurrent gold administration may exacerbate aspirin-induced hepatic dysfunction. Caution should be exercised if
phenylbutazone or oxyphenbutazone are administered concurrently.
Caution is needed in patients treated concomitantly with sodium aurothiomalate and angiotensin-converting enzyme
This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for sodium aurothiomalate
Date approved: May 2013
Expiry date: 31/12/2017
Royal Wolverhampton
NHS Trust
Wolverhampton City
Clinical Commissioning Group
Wolverhampton Shared
Care Agreement
Sodium aurothiomalate (Myocrisin®) – GP Monitored
ESCA: For the treatment of severe rheumatoid arthritis in adults and children
inhibitors due to an increased risk of severe anaphylactoid reaction in these patients.
Vaccination
The use of LIVE vaccine is not recommended during drug treatment with sodium aurothiomalate.
Version Control
Version
Date of Issue
Author/s
Brief Description of Changes
25/06/2013
R Eardley
Removal of pharmacy fax numbers
1.0
1.1
References
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BSR/BHPR guideline for disease-modifying anti-rheumatic drug (DMARD) therapy in consultation with the British Association of
Dermatologists.BSR/DMARD guideline group April 2008, update November 2009.
Electronic Medicines Compendium. Summary of Product Characteristics: Sodium aurothiomalate. Surrey: eMC 2012. Available from
www.medicines.org.uk
This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for sodium aurothiomalate
Date approved: May 2013
Expiry date: 31/12/2017