Download SCP S/C Methotrexate Injection Nov 2014

Somerset Healthcare Community
Shared Care Protocol Sub-cutaneous
methotrexate injection in
dermatology/gastroenterology/rheumato
logy patients
This shared care protocol (SCP) sets out details for the sharing of care for patients requiring
subcutaneous methotrexate injection. 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.
Shared Care Protocol
Atomoxetine for Attention Deficit
Hyperactivity
Disorder
(ADHD)
Methotrexate
is a folic
acid antagonist
and is classified as an antimetabolite cytotoxic agent. It is
Introduction
used in low doses in the treatment of severe, active rheumatoid arthritis; severe, uncontrolled
psoriasis; Crohn’s disease; and to produce regression in a wide range of neoplastic conditions.
It is administered via the sub-cutaneous route if the patient has had a good response to oral lowdose methotrexate but suffers severe GI side-effects, or has had a poor response to the oral
methotrexate due to suspected reduced absorption, or would have poor absorption owing to
disease state.
For further information please click on the links below or visit;
British National Formulary
Summary of Product Characteristics
Licensed Indication
Severe, active rheumatoid arthritis in adult patients where treatment with disease modifying
antirheumatic drugs (DMARD) is indicated.
Unlicensed indication
•Severe, uncontrolled psoriasis (acute, generalised or pustular psoriasis; psoriatic erythroderma;
extensive chronic plaque psoriasis), unresponsive or intolerant to conventional therapy.
•Unresponsive or chronically active Crohn’s disease.
•Dermatomyositis; psoriatic arthritis; connective tissue disease (SLE, myositis and
vasculitis); blistering conditions; sarcoidosis; lymphomatoid papulosis.
Dose (posology & method of administration)
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Methotrexate dose is usually titrated at regular intervals until target dose / response is achieved.
Maximum weekly dose should not exceed 25mg unless prior agreement between consultant and
GP.
Methotrexate must be used with caution in renal failure or hepatic impairment; elderly patients
should be given a smaller test dose and titrated at a slower rate.
Folic acid tablets 5mg to be taken once EACH WEEK on the day before or the day after
methotrexate to limit side effects,
e.g. gastrointestinal and haematological toxicity.
Contra-indications (click for details in SPC)
Special warnings and precautions for use (click for details in SPC)
CSM advice; in view of reports of blood dyscrasias (including fatalities) and liver cirrhosis with lowdose methotrexate, the CSM has advised:
 Full blood count; renal and liver function tests before starting treatment and repeated weekly
until therapy stabilized, thereafter patients should be monitored every 2-3 months
 Patients should be advised to report all symptoms and signs suggestive of infection, especially
sore throat
Interactions (click for details in SPC)
Pregnancy and Lactation (click for details in SPC)
Adverse effects (click for details in SPC)
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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:1. Assess the need for methotrexate.
2. Comply with NPSA Alerts for methotrexate.
3. When initiating treatment give counseling in verbal and written form.
4. Provide and complete the initial Methotrexate patient information and monitoring
booklet.
5. Complete relevant baseline investigations if the patient is commencing methotrexate
treatment
6. Follow the patient’s response to treatment at the out-patient clinic.
7. Communicate advice to the patient’s GP regarding monitoring requirements.
8. Issue the first prescription for 4 weeks supply and request GP to continue/commence
monitoring.
9. Request GP to monitor as required in the monitoring section of this protocol.
10. Advise GP regarding any concerns about monitoring or adverse effects at any stage.
11. To exercise caution when initiating methotrexate in patients with impaired renal function.
Consultant monitoring
For patients commencing treatment with methotrexate: FBC, U&E, LFTs
prior to treatment
Urinalysis
prior to treatment
General Practitioner responsibilities:1. Comply with NPSA Alerts for methotrexate.
2. Prescribe weekly dose, under the shared care of the hospital consultant.
3. Prescribe weekly folic acid dose (5mg orally).
4. Pause treatment with Methotrexate if eGFR <35 due to increased risk of toxicity. Before reinitiating treatment seek advice from specialist if eGFR remains <35.
5. Discuss any important test abnormality with the consultant before continuing treatment
6. Ensure that the patient has received counseling in verbal and written form.
7. Provide subsequent Methotrexate patient information and monitoring booklet
8. Report any suspected adverse reactions to the hospital
9. Report any significant events relating to methotrexate therapy to the PCT
10. Liaise with the hospital consultant regarding any complications of treatment
11. Monitor the general health of the patient and specific side effects as detailed in the
‘Monitoring’ section.
12. Advise the patient to take any unused, not needed syringes to a community pharmacy for
safe disposal.
13. Do not co-prescribe Methotrexate with Trimethoprim or Co-trimoxazole (Septrin) due to it
causing severe blood dyscrasias.
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General Practitioner monitoring
NOTE: In most patients, subcutaneous methotrexate will replace current oral methotrexate
and monitoring should be continued as already being done by the GP without any change.
The monitoring for SC and oral methotrexate is the same (i.e. a straight switch from the current
monitoring)
Patients commencing treatment with methotrexate (usually methotrexate tablets):
FBC, U & E, LFTs: every 2 weeks until dose and monitoring within satisfactory parameters for 6
weeks
Thereafter, monthly until dose and disease is stable for 1 year.
Thereafter, frequency of monitoring may be decreased based on clinical judgment.
Chest X-ray, unless done in last 6 months. Pulmonary function tests in selected patients.
CRP Monthly at onset of disease (RA only).
Test prior to hospital appointments with Consultant or Specialist Nurse when notified.
Patients switching from oral to subcutaneous methotrexate: FBC, U & E, LFTs: monthly until dose and disease is stable for 1 year.
Thereafter, frequency of monitoring may be decreased based on clinical judgment.
Chest X-ray in selected patients, unless done in last 6 months. Pulmonary function tests in
selected patients
CRP Monthly at onset of disease (RA only).
Test prior to hospital appointments with Consultant or Specialist Nurse when notified.
Monitoring action and advice for the GP
WITHOLD METHOTREXATE and contact consultant if:








< 4 x109/L
< 2 x109/L
<150 x109/L
> 2 times upper limit of normal
(minor elevations are common in rheumatology patients)
Creatinine
> 2 times the baseline result
Acute infection; acute respiratory disease; acute renal insufficiency; folate deficiency
(MCV > 105 fl, check B12, folate, TFT)
Oral ulceration/sore throat, unexplained rash or unusual bruising
eGFR
>35
WCC
Neutrophils
Platelets
AST/ALT
Note: a rapid up or down trend in any values should prompt caution and extra vigilance.
Patient/carer responsibilities
1. After counselling, to be willing to administer the methotrexate as directed at home.
2. Report any concerns in relation to treatment with methotrexate
3. Be aware that taking OTC aspirin and NSAIDs in addition to methotrexate may interfere with
treatment.
4. Report any other medication being taken, including over-the-counter products.
5. Report any adverse effects or warning symptoms whilst taking methotrexate.
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6. Put used syringes and needles in a purple lidded waste container provided by rheumatology
and subsequently by Keir Waste Management services and dispose of in accordance with
local procedures.
7. Return any unopened syringes no longer required to a community pharmacy for safe
disposal in accordance with local procedures.
Drug cost
Medac October 2014
Formulation
Metoject™
PEN
Dose
7.5mg
10mg
12.5mg*
15mg
17.5mg*
20mg
22.5mg*
25mg
27.5mg*
30mg
Cost (single)
£14.85
£15.29
£16.50
£16.57
£17.50
£17.84
£18.45
£18.48
£18.89
£18.95
Dose
7.5mg every 7 days
10mg every 7 days
12.5mg every 7 days
15mg every 7 days
17.5mg every 7 days
20mg every 7 days
22.5mg every 7 days
25mg every 7 days
27.5mg every 7 days
30mg every 7 days
Further support
• Medicines Information department, Musgrove Park Hospital:
• Medicines Information department, Yeovil District Hospital:
• Prescribing & Medicines Management Team, NHS SomersetCCG:
Version:
Drawn up by:
Approved by:
Cost per 28 days
£59.40
£61.16
£66.00
£66.28
£70.00
£71.36
£73.80
£73.92
£75.56
£75.80
01823 342253
01935 384327
01935 384123
1.1
Version 1.0 by Nigel Ankcorn, Lead Pharmacist, MI,
Musgrove Park Hospital
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
Version 1.1 Shared Care Guideline version 1.0 put into
Somerset CCG shared care template by Helen Kennedy,
Prescribing Support Technician, Somerset CCG
Review required by:
Date
Aug 2011
Jan 2015
28th
November
2014
November
2017
References
• Summary of Product Characteristics, Metoject™ PEN Solutions for injection in pre-filled pen
(Medac)
last updated on the eMC: 19/06/2014
• British National Formulary, November 2014
• Somerset Primary Care Trust; Specification for a National Enhanced Service;
2.3 Provision of near–patient testing; Protocol Number SPCT5
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