Download SCP Sodium Aurothiomalate Oct 2012

Shared Care Protocol
Sodium aurothiomalate (Myocrisin) in rheumatology patients
The full Shared Care Protocol can be found on
the NHS Somerset Prescribing & Medicines
Management intranet site
This shared care protocol (SCP) sets out details for the sharing of care for patients prescribed intramuscular Sodium
aurothiomalate. It should be read in conjunction with the Summary of Products Characteristics (SPC, available at
http://www.medicines.org.uk/emc/)
As outlined in NHS Circular 1992 (Gen 11), when a consultant considers a patients’ condition is stable he/she may seek
the agreement of the patients’ GP to “share” the patients’ care. This document provides information on drug treatment for
the shared commitment between the consultant and GP concerned. GPs are invited to participate. If the GP is 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. The doctor who prescribes the
medication has the clinical responsibility for the drug and the consequences of its use.
Introduction
Gold injection is a disease modifying anti-rheumatic drug. It is a long term treatment, the earlies initial response
is at 6 – 12 weeks.
For further information please click on the links below or visit;
British National Formulary
Summary of Product Characteristics
NICE Guidance
Licensed Indications
Myocrisin is used in the management of active progressive rheumatoid arthritis and progressive juvenile
chronic arthritis especially if polyarticular or seropositive.
Dose (posology & method of administration) (click here for details)
An initial test dose of 10 mg should be given in the first week followed by weekly doses of 50 mg until signs of
remission occur. At this point 50 mg doses should be given at two week intervals until full remission occurs.
With full remission the interval between injections should be increased progressively to three, four and then,
after 18 months to 2 years, to six weeks.
Administration: should only be administered by deep intramuscular injection followed by gentle massage of the
injection area.
Contra-indications (click here for details)
 Pregnancy
 Myocrisin is contraindicated in patients with gross renal or hepatic disease, a history of blood
dyscrasias, exfoliative dermatitis or systemic lupus erythematosus.
 The absolute contraindications should be positively excluded before considering gold therapy.
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Special warnings and precautions for use (click here for details)
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As with other gold preparations, reactions which resemble anaphylactoid effects have been reported.
These effects may occur after any course of therapy within the first ten minutes following drug
administration (see administration). If anaphylactoid effects are observed, treatment with Myocrisin
should be discontinued.
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
Monitoring
Consultant monitoring
For patients commencing treatment with Sodium aurothiomalate : FBC, U&E, LFT, Creatinine, Urinalysis, skin inspection for rash
prior to treatment
General practitioner monitoring
FBC, urinalysis, skin inspection for rash
at the time of each injection (the results of the FBC need
not be available before the injection is given but must be
available before the next injection is given i.e. it is
permissible to work one FBC in arrears)
Monitoring action and advice for the GP
WBC<4.0x10^9/l
withhold until discussed with
rheumatologist
Neutrophils<2.0x10^9/l withhold until discussed with
rheumatologist
Platelets<150x10^9/l
withhold until discussed with
rheumatologist
>1+ proteinuria on >1
withhold until discussed with
occasion
rheumatologist
Rash or oral ulceration withhold until discussed with
rheumatologist
Abnormal bruising or
withhold until FBC result available
sore throat
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Interactions (click here for details)
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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 angiotensinconverting enzyme inhibitors due to an increased risk of severe anaphylactoid reaction in these patients
Pregnancy and lactation (click here for details)
Adverse effects (click here for details)
Common/uncommon:
• Mouth ulcers, metallic taste
• Rash – mild scaly rash to severe dermatitis; may not necessitate withdrawal of drug. Significant skin
complications are almost exclusively pruritic.
• Hypersensitivity reactions
• Bone marrow suppression
• Proteinuria
Drug Cost
(BNF October 2012)
0.5 ml (10mg) = £3.80
100mg/ml 0.5ml (50mg) = £11.23
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Shared Care Responsibilities
Sharing of care assumes communication between the specialist, GP and patient. The intention to share care
should be explained to, and accepted by, the patient. This provides an opportunity to discuss drug therapy.
The clinician who prescribes the medication has the clinical responsibility for the drug
and the consequences of its use.
Specialist responsibilities: Decision to prescribe gold injection (sodium aurothiomalate).
 Discuss benefits and side effects of treatment with patient or patient’s carers including, where
appropriate the risks associated with pregnancy and need for reliable method of contraception.
 Refer patient to specialist nurse service where appropriate (e.g. new patient) for advice on
taking the drug, its cautions, side effects associated with treatment, monitoring requirements
and the timing of re-assessment and by whom.
 Ascertain immune status by enquiring about history of chickenpox. Measurement of antibodies
to varicella-zoster virus is not recommended.
 Issue a booklet for recording test results to patient.
 Conduct baseline tests including full blood count, U&Es, LFTs, creatinine and urinalysis. Copy test
results to GP.
 Specify review dates.
 Prompt verbal communication followed up in writing to GP of changes in treatment or
monitoring requirements, results of monitoring, assessment of adverse events or when to stop
treatment. Urgent changes to treatment should be communicated by telephone to GP.
 Reporting adverse events to MHRA.
 Administer a test dose – observe patient for one hour. Take appropriate action if the patient develops a
rash.
General Practitioner responsibilities: Accept clinical responsibility for the patient provided the above criteria have been met.
 Repeat prescribing of intramuscular sodium aurothiomalate after communication with specialists
regarding the need for treatment.
 Check patient for rash and ask about mouth ulceration before subsequent doses. Observe patient for
30 minutes after each dose, check for rash. Take appropriate action if symptoms reported.
 Undertake monitoring of full blood count, U&Es, LFTs, creatinine and urinalysis as
specified. Review results and take any necessary action.
 Take appropriate action if patient reports sign(s) or symptom(s) specified under Monitoring.
 Be aware of criteria for referral to Rheumatology team.
 Respond to advice from secondary care on dose changes and frequency of monitoring.
 Report to and seek advice from specialist on any aspect of patient care of concern to GP which
may affect treatment. Prompt referral to specialist if there is a change in patient’s health status.
 Report adverse events to specialist.
 Stop treatment in case of a severe adverse event or as per shared care guideline.
Patient/carer responsibilities
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Report any adverse effects or warning symptoms whilst taking Sodium aurothiomalate such as pruritus,
mouth ulcers, sore throat or tongue, bleeding gums, fever, metallic taste, epistaxis, rash, unexpected
bruising or bleeding, menorrhagia, diarrhoea and any unexplained illness/infection. Breathlessness or
cough must also be reported.
Report any other adverse effect to their GP and / or specialist whilst being treated with gold injection.
Ensure they have a clear understanding of their treatment.
Report any concerns in relation to treatment with Sodium aurothiomalate.
Ensure that they attend for monitoring requirements.
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Further support
• Medicines Information department, Musgrove Park Hospital:
01823 342253
• Medicines Information department, Yeovil District Hospital:
01935 384327
• Prescribing & Medicines Management Team, NHS Somerset: 01935 384123
•
Version:
Approved by:
Written by
Review required by:
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Somerset Prescribing Forum, NHS Somerset
Drug & Therapeutics Committee, Taunton & Somerset NHS FT
Drug & Therapeutics Committee, East Somerset NHS FT
Drug & Therapeutics Committee, Somerset Partnership NHS FT
Jill Moore, Prescribing Support Pharmacist, NHS Somerset
Date
June 2012
June 2014
References:
BNF No. 63 March 2012
http://www.medicinescomplete.com/mc/bnf/current/64249.htm
Summary of Product Characteristics Myocrisin
http://www.medicines.org.uk/EMC/medicine/18613/SPC/Myocrisin+100mg+ml+Solution+for+Injection/#tableOf
Contents
British Society for Rheumatology Quick reference guideline for monitoring of DMARD therapy
http://www.rheumatology.org.uk/includes/documents/cm_docs/2009/d/dmard_grid_november_2009.pdf
NICE CG 79 RA http://www.nice.org.uk/CG79
Musgrove Park Hospital DMARD monitoring: Sodium aurothiomalate
http://www.tsft.nhs.uk/OurServices/Rheumatology/InformationforGPs/DMARDMonitoring/Sodiumaurothiomalat
eMyocrisin/tabid/1655/Default.aspx
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