Download SCP Penicillamine Oct 2012

Shared Care Protocol
Penicillamine 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 oral penicillamine. 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
Penicillamine is a disease-modifying anti-rheumatic drug.
For further information please click on the links below or visit;
British National Formulary
Summary of Product Characteristics
NICE Guidance
Licensed Indications
Severe active rheumatoid arthritis, including juvenile forms
Wilson's disease (hepatolenticular degeneration)
Cystinuria – dissolution and prevention of cystine stones
Lead poisoning
Chronic active hepatitis
Dose (posology & method of administration) (click here for details)
125mg to 250mg daily for the first month. Increase by the same amount every four to twelve weeks until
remission occurs. The usual maintenance dose is 500 to 750mg daily.
The minimum maintenance dose to achieve suppression of symptoms should be used and treatment
should be discontinued if no benefit is obtained within 12 months. Improvement may not occur for
some months.
Tablets should taken at least half an hour before meals. Indigestion remedies or products containing
iron or zinc should not be taken within 2 hours of the penicillamine dose.
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Contra-indications (click here for details)
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Hypersensitivity to penicillamine.
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Agranulocytosis, aplastic anaemia or severe thrombocytopenia due to penicillamine.
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Lupus erythematosus.
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Moderate or severe renal impairment
Special warnings and precautions for use (click here for details)
• Renal impairment (see also contraindications)
• Previous reaction to gold therapy
• Elderly – careful monitoring is essential, increased toxicity has been observed regardless of renal function.
• Patients with hypersensitivity to penicillin very rarely exhibit hypersensitivity to penicillamine.
• Pregnancy: men and women of child-bearing age must use a reliable method of contraception. When
planning a pregnancy it is important that both men and women on this drug discuss medication with the
rheumatology team (at least six months before conception) since all drugs can potentially affect the unborn
child.
Monitoring
Consultant monitoring
For patients commencing treatment with penicillamine : FBC, U&E, Creatinine, Urinalysis
prior to treatment
General practitioner monitoring
FBC
Weekly or fortnightly for the first 8 weeks. Monthly thereafter.
Urinalysis
Initially weekly and following each dose increase, then monthly.
Monitoring action and advice for the GP
Withhold treatment & liaise with Specialist team in charge of patient's treatment if:• Severe rash or bruising or ulceration of mucous membranes.
• Any unexplained illness occurs including nausea or diarrhoea
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• WCC falls <3.5 x 10 /l
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• Neutrophils <2.0 x 10 /l
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• Eosinophils >0.5 x 10 /l
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• Platelet count falls below <150 x 10 /l
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Interactions (click here for details)
• Analgesics: possible increased risk of nephrotoxicity with NSAIDs
• Antacids: absorption reduced by antacids
• Antipsychotics: avoid concomitant use with clozapine (increased risk of agranulocytosis)
• Cardiac glycosides: penicillamine possibly reduces plasma concentration of digoxin
• Gold: avoid concomitant use (increased risk of toxicity)
• Iron: absorption of penicillamine reduced by oral iron
• Zinc: penicillamine reduces absorption of zinc, also absorption of penicillamine reduced by zinc
Pregnancy and lactation (click here for details)
Adverse effects (click here for details)
Common/uncommon:
• Nausea, anorexia, fever and rash may occur early in therapy, especially when full doses are given from the
start. Rash occurs in up to 35% of patients. Taking medicine before bed may reduce nausea.
• Taste loss or metallic taste; may be transient for a few weeks.
• Thrombocytopenia
• Proteinuria occurs in up to 30% of patients and is partially dose-related.
• Bone marrow suppression, which may occur at any stage during treatment (this is sometimes triggered by
infection).
Drug Cost
(Drug tariff October 2012)
Penicillamine 125mg
Penicillamine 250mg
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56 / £12.95
56 / £20.96
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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:
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Decision to prescribe penicillamine.
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, serum creatinine and urinalysis. Copy test
results to GP.
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.
Issue the first prescription for 4 weeks supply
General Practitioner responsibilities:
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Accept clinical responsibility for the patient provided the above criteria have been met.
Repeat prescribing of oral penicillamine after communication with specialists regarding the need for
treatment.
Undertake monitoring of full blood count, U&Es, 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.
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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After counselling, to be willing to administer penicillamine as directed at home.
Report any concerns in relation to treatment with penicillamine.
Report any other medication being taken, including over-the-counter products.
Report any adverse effects or warning symptoms whilst taking penicillamine such as mouth ulcers, sore
throat, fever, epistaxis, rash, unexpected bruising or bleeding, and any unexplained illness/infection.
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 Distamine
http://www.medicines.org.uk/EMC/medicine/9211/SPC/Distamine+125mg+Filmcoated+tablets/#tableOfContents
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
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