Download Methotrexate Policy - Portsmouth Hospitals NHS Trust

Methotrexate Policy: Once a Week Dosing
(Oral and Subcutaneous Administration)
Version
3
Name of responsible (ratifying) committee
Formulary and Medicines Group
Date ratified
17th January 2014
Document Manager (job title)
Medication Safety Pharmacist, Rheumatology and
Medical Directorate Pharmacists.
Date issued
24th January 2014
Review date
January 2016
Electronic location
Clinical Policies
Related Procedural Documents
See section 8 of this policy
Key Words (to aid with searching)
Methotrexate; prescribing; administration; patient
information; monitoring; communication; dispensing
and storage; National Patient Safety Agency; NPSA;
Drug labelling; Drug therapy; Medication errors; Safety
standards; Patient safety
PHT Methotrexate Policy: Once a Week Dosing (Oral and Subcutaneous Administration)
24/01/2014
(Review date: January 2016)
Issue 3.
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Version Tracking
Version
Date Ratified
3
15.11.13
Brief Summary of Changes
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Author
Reference to s/c methotrexate.
Information about DoH ‘Never Events’.
Pharmacist must check the methotrexate prescription
before it is administered.
The patient should be asked to confirm dose and day of
administration.
Removed administration should be double-checked with a
suitably trained colleague.
Definitions supplied as a link to the medicines Policy
Appendices A-C: Re-organised description of the process
for the use of methotrexate in inpatient/outpatients, to the
procedure for prescribing/ screening & supply
/administration
Only hospital supplies to be used for administration in
hospital, and only one dose to be supplied at a time.
Information included about interactions
Information included about folic acid
Inserted alert poster for methotrexate in Appendix D and
Alert Card Appendix E
Updated developments in methotrexate personal care
plan /information and monitoring in rheumatology
References updated
PHT Methotrexate Policy: Once a Week Dosing (Oral and Subcutaneous Administration)
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CONTENTS
QUICK REFERENCE GUIDE....................................................................................................... 3
1.
INTRODUCTION.......................................................................................................................... 5
2.
PURPOSE ................................................................................................................................... 5
3.
SCOPE ........................................................................................................................................ 5
4.
DEFINITIONS .............................................................................................................................. 6
5.
DUTIES AND RESPONSIBILITIES .............................................................................................. 6
6.
PROCESS ................................................................................................................................... 7
7.
TRAINING REQUIREMENTS .................................................................................................... 11
8.
REFERENCES AND ASSOCIATED DOCUMENTATION .......................................................... 11
9.
EQUALITY IMPACT STATEMENT…………………………………………………………………….11
Appendix A: Safe Prescribing Checklist - Once a Week Methotrexate ………………………………12
Appendix B: Safe Practice Checklist- Clinical Check/Dispensing…………………………………… 13
Appendix C: Safe Practice Checklist –Administration of Once a Week Methotrexate…………...... 15
Appendix D: Methotrexate Alert Poster………………………………………………………………… 16
Appendix E: Methotrexate Dosage Chart…………………………………………………..….………. 17
Appendix F: Arthritis UK Methotrexate Patient Information Leaflet…………………………………. 18
Appendix G: Rheumatology Methotrexate Alert Card…………………………………………………. 18
Appendix H: Rheumatology Methotrexate Protocol……………………………………………………. 18
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PHT Methotrexate Policy: Once a Week Dosing (Oral and Subcutaneous Administration)
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QUICK REFERENCE GUIDE
The quick reference guide below is not a substitute for reading the full policy, it is meant as a
summary only.
1. Decision to treat with weekly oral or subcutaneous methotrexate is made by specialists
experienced in its use, i.e. rheumatologists, dermatologists and gastroenterologists.
2. The prescriber should ensure that the dose of methotrexate (in milligrams) is prescribed
clearly and correctly.
3. The route of administration should be clearly stated for each prescription (oral, s/c, or IM)
4. Prescriptions should clearly state “ONCE a WEEK” and preferably specify the day of the
week. This should not be abbreviated.
5. When prescribing weekly methotrexate on inpatient drug charts, the doctors must strike out
the six days of the week when a dose of methotrexate must not be administered. (See
Appendix A and D.
6. Only methotrexate 2.5mg tablets are stocked and dispensed in the PHT pharmacy and 10mg
tablets are not available in PHT.
7. Ward pharmacists should be informed of any methotrexate prescription, and the prescription
must be clinically checked by a pharmacist before administration. The pharmacist will supply
one dose of methotrexate at a time to reduce the chance of administration errors.
8. Most patients taking regular weekly methotrexate will know their dose regimen. When
administering methotrexate, the patient should be asked to confirm they are expecting the
actual dose to be given and that the day of the week is correct, and withheld if there is any
other doubt concerning whether the dose should be given.
9. The supply of methotrexate is restricted and is not held as stock on any ward. Every effort
should be made for the drug dose to be prescribed safely and verified by a pharmacist to
avoid a missed dose. Methotrexate is given once weekly as the drug has long acting effects,
and whilst it is an important treatment, it is not clinically urgent. It can cause serious toxicity if
prescribed incorrectly, therefore is safer to omit the dose until the prescription can be verified
by a pharmacist prior to administration.
10. The pharmacist should check for any interactions particularly with respect to new medications
and alert the doctors and nurses accordingly.
11. The dosing instructions on the medication label must state that the dose is to be taken once a
week, or on a named day each week, and not ‘as directed’.
12. Remind patients to be alert for signs of adverse effects and they should be encouraged to
contact their prescribing department and given details of how to do so (e.g PHT
Rheumatology Department Methotrexate alert cards, Appendix E) if they have any concerns.
Patients should be reminded to ensure that they inform community pharmacists that they are
taking methotrexate when purchasing medications over the counter (OTC).
13. The Inappropriate administration of daily oral methotrexate is listed as a Department of Health
‘Never Event’. It is defined as:
Prescription, supply or administration of daily oral methotrexate to a patient for non-cancer
treatment, including supply to the patient with the instruction to take daily.
 Excludes cancer treatment with daily oral methotrexate.
 Excludes where the error is intercepted before the patient is supplied with the medication.
14. Methotrexate is classed as a cytotoxic agent and tablets and syringes are disposed of in the
appropriate cytotoxic disposal bin.
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1. INTRODUCTION
Methotrexate is a specific antagonist of folic acid. It is classed as a cytotoxic drug because, in high
doses, it inhibits the proliferation of malignant cells and has teratogenic properties and irritant effects
to the skin. However correctly used in lower non-cytotoxic weekly dosage regimens it can be used as
a safe and effective disease-modifying drug indicated for the treatment of:
 rheumatoid conditions
 connective tissue diseases
 dermatological diseases such as psoriasis
 inflammatory bowel disease (unlicensed indication)
For these conditions it is prescribed as a lower single dose e.g. 5mg - 25mg ONCE A WEEK.
Methotrexate may also be used in neoplastic disease using much higher doses according to a
specific protocol.
Methotrexate is a safe and effective medication if taken at the right dose and frequency with the
appropriate monitoring. However, errors involving daily oral administration have caused severe harm
and death. The National Patient Safety Agency (NPSA) found there had been 137 incidents in
England alone, over a 10 year period relating to oral methotrexate. These included 27 deaths and 26
cases of serious harm. As a consequence the NPSA recommended that NHS acute trusts take action
to reduce the harm caused by oral methotrexate, and in 2004 issued Patient Safety Alert PSA03
“Reducing the harm caused by oral methotrexate”. It included: prescribing, administration, patient
information, monitoring, communication, dispensing and storage. An updated Patient Safety Alert
(PSA13 “Improving compliance with oral methotrexate guidelines”) was published in 2006 providing
additional guidance, self-assessment tools and a core patient information leaflet and monitoring
document.
The inappropriate administration of daily oral methotrexate is considered by the DoH to be so
preventable that it is categorised as a ‘Never Event’ in the current DoH "Never Events" list 2012/13. It
is defined as prescription, supply or administration of daily oral methotrexate to a patient for noncancer treatment including supply to the patient with the instruction to take daily, excluding cancer
treatment with daily oral methotrexate or where the error is intercepted before the patient is supplied
with the medication. The methotrexate ‘Never Event’ is unusual in that it does not have to cause any
actual harm in order for it to be classed as a Never Event.
The PHT Policy on the Safe use of weekly dosing of oral and subcutaneous (s/c) methotrexate has
been developed based on these recommendations and updated to include the DoH ‘Never Event’
definition.
2. PURPOSE
This document outlines the policy to ensure the safe prescribing, administration, patient information,
monitoring, communication, dispensing and storage of regular weekly oral and subcutaneous
methotrexate (excluding use as part of a chemotherapy regimen, or use in maternity for ectopic
pregnancy).
This policy has been developed to manage and reduce the risk of harm to patients of incorrect
administration of oral and subcutaneous methotrexate, by improving the communication of
prescribing decisions, dose changes and monitoring, patient information and ensuring sound
processes are in place throughout the medication pathway, in accordance with the requirements of
the NPSA.
3. SCOPE
This policy and the associated safe practice checklists apply to the use of weekly oral and
subcutaneous dosing of methotrexate in Portsmouth Hospitals NHS Trust, and link to the shared care
guidelines within the Portsmouth and South East Hampshire health economy. It does not cover the
use of methotrexate when used as part of a treatment regimen in oncology or gynaecology, where
different dosages and frequencies may be used.
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‘In the event of an infection outbreak, flu pandemic or major incident, the Trust recognises that it may
not be possible to adhere to all aspects of this document. In such circumstances, staff should take
advice from their manager and all possible action must be taken to maintain ongoing patient and staff
safety’
4. DEFINITIONS
ALT: Alanine aminotranferase
DoH ‘Never Event’: Department of Health ‘Never Event’. This is the list of 25 incidents which are
considered to be unacceptable and eminently preventable in the NHS in 2012/13. One of these is the
inappropriate administration of daily oral methotrexate. This is defined as the prescription, supply or
administration of daily oral methotrexate to a patient for non-cancer treatment including supply to the
patient with the instruction to take daily.
 Excludes cancer treatment with daily oral methotrexate
 Excludes where the error is intercepted before the patient is supplied with the medication.
BSR: British Society for Rheumatology
CRP: C-reactive protein
BHPR: British Healthcare Professionals in Rheumatology
DAWN: Electronic blood results monitoring program for rheumatology patients on methotrexate
ESR: Erythrocyte sedimentation rate
FBC: Full blood count
HCSW: Healthcare Support Worker
HRCT: High Resolution Computed Tomography
HHR: Hampshire Health Record (GP summary care record)
LFTs: Liver function tests
NSAID: Non steroidal anti-inflammatory drug
PODs: Patient’s Own Drugs
RODP: Registered Operating Department Practitioner
U&Es: Urea and electrolytes tests
Please also refer to section 4 of the PHT Medicines Management Policy
5. DUTIES AND RESPONSIBILITIES
Doctors, Pharmacists and Nursing Staff are responsible for following this Policy ensuring that the
prescribing/ supply and administration of methotrexate is carried out safely. All staff are responsible
to ensure that methotrexate is not unnecessarily omitted.
They should be aware of the Methotrexate ‘Never Event’.
 Prescribers must ensure that they prescribe weekly methotrexate carefully considering the
points in the Safe Prescribing Checklist (See Appendix A)
 Pharmacists must clinically check that the methotrexate prescription is correct and
endorse the chart to enable a dose to be given (See Appendix B).
 Nursing staff must check that the pharmacist has endorsed the prescription as being
correct before administration. (See Appendix C)
For further information on Duties and Responsibilities, please refer to Section 5 of the PHT Medicines
Management Policy
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6. PROCESS
Clinical specialist areas where weekly oral or subcutaneous methotrexate therapy is initiated are:
 Rheumatology (including paediatric rheumatology)
 Dermatology
 Gastroenterology (unlicensed use)
6.1. Referral
The decision to treat with oral methotrexate is only made by specialists trained in the above
specialist areas of medicine.
6.2. Prescribing
See Safe practice checklist in Appendix A
6.3. Screening/ Dispensing
See Safe practice checklist in Appendix B.
6.4. Administration
See safe practice checklist in Appendix C.
6.5. Monitoring
Local specialty guidelines and shared care guidelines set out:
 Dosage schedule
 Monitoring
 Indications for stopping the drug/seeking advice
 Special notes
 Drug interactions
Standard Monitoring:
Baseline testing
FBC/ LFTs/ U&Es
ESR/ CRP
Chest X ray in preceding 6 months
Consider pulmonary function test or HRCT if pre-existing interstitial
lung disease
Monitoring in 1st FBC/ LFTs/ U&Es:
Every fortnight until stable for 8 weeks, Monthly thereafter
year of therapy
If stable monitoring and dose after 1 year consider reducing
After 1 year
frequency of monitoring (e.g.: in rheumatology patients may be
reduced to every 2 months).
For details regarding blood monitoring across all departments, please see the PHT shared care
agreement: Methotrexate Shared Care Guideline.
When first starting methotrexate, regular blood tests are needed every 2 weeks for the first 8
weeks and then monthly for the first year. After a year the responsible department may take the
decision to increase the monitoring interval on a case by case basis.
Copies of all blood test results are sent to primary care as lead prescriber as they cannot
prescribe methotrexate until they have seen safe and current blood test results.
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Indications for seeking advice/ withholding methotrexate
Monitoring
Indication for withholding dose
until discussed with specialist
FBC
Neutrophils
<2.0 x 109/L
White Cell count (WCC)
<3.5 x 109/L
Platelet Count
<150 x 109/L
Mean Cell Volume (MCV)
>105 fl (check serum B12, folate and thyroid function
LFTs
ALT
Rise above 2 x baseline levels
Albumin
Unexplained reduced albumin in absence of active
disease.
Other
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Acute infection /sore throat
Acute breathlessness, (not chronic shortness of breath) Urgent referral advised.
Dry cough/ increasing breathlessness
Unexplained widespread rash/ oral ulceration
6.6. Communication and Record-Keeping
PHT Rheumatology patients are given a personalised care plan folder which incorporates
patient information and a monitoring log. Rheumatology specialist nurses will manage the
DAWN electronic blood monitoring system, which automatically monitors blood tests, enabling
patients to be highlighted and contacted if the results fall outside the normal range or if the
patient misses a blood test. The GP is kept informed by letter.
The Dermatology Department informs the patient’s GP if methotrexate is started and the patient
has a hand-held record of their dosage regimen available from the NPSA Methotrexate Alert 13
which can be used to document the most recent dosage and blood results, This should be used
unless the department has produced a suitable departmental version.
Gastroenterology: The patients hold an Oral Methotrexate Patient Information Leaflet and
Dosage Record Book which is completed with their most recent dosage and blood results and
holds all the necessary information about oral methotrexate. Within Gastroenterology, all
monitoring of patients is undertaken by the department and recorded in the Patient’s Record
Book.
6.7. Patient information
The prescriber will discuss treatment options with the patient in full and explain monitoring
procedures.
 Rheumatology patients prescribed methotrexate are:
* Referred to the Rheumatology Monitoring Clinic and will be entered onto the
DAWN database
* Given patient information leaflets available via the following links: Arthritis
Research UK: Methotrexate Patient Information Leaflet:
* Given a Methotrexate Alert card (Appendix G) proving details of access to a
Rheumatology Patient Advice and Information Line for queries relating to
treatment, Tel no: 02392 286935
* Provided with a personalised care plan folder when methotrexate is started.
 Dermatology patients prescribed methotrexate are:
* Monitored by the Dermatology Specialist Nurses
* Given an NPSA Oral Methotrexate Patient Information Leaflet and Dosage Record
Book available at NPSA Methotrexate Alert 13
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 Gastroenterology patients are:
o Given a NPSA methotrexate Patient Information Leaflet and Patient Record Book
o Are given the details of an Inflammatory Bowel Disease helpline
6.8. Storage
In pharmacy and outpatient clinical areas, methotrexate tablets and s/c injections will be stored
away from other medication in an area designated for cytotoxic medications. Methotrexate
should be kept in the original outer container to further distinguish them from other products.
On the ward, methotrexate should be kept in the patients own bedside medication locker.
Methotrexate PODs should not be used in hospital and only PHT supplies ordered after the
pharmacist has screened and checked the prescription. Methotrexate PODs should be stored
away in a bag in the POD locker and returned on discharge if appropriate.
6.9. Methotrexate strengths
All oral methotrexate doses will be supplied as multiples of 2.5mg tablets.
Methotrexate 10mg tablets are not stocked at PHT.
If the patient’s own methotrexate contains 10mg tablets the patient will be counselled on the
safety issues relating to confusion between strengths of tablets. The patient’s methotrexate
dose should be converted over to 2.5mg tablets, subject to their agreement, and the GP
informed verbally and in writing. If the patient requests to keep their 10mg tablets, they should
be informed that these will not be used during admission and the nursing staff will use 2.5mg
tablets for administration. The patient should be given the option of having their 10mg tablet
supply destroyed or returned home, or should be stored separately sealed in a bag in the POD
locker. The pharmacist should inform the nursing staff of this decision and document this in the
notes.
PHT subcutaneous methotrexate prefilled syringes from range from 5mg to 25mg (in 2.5mg
increments). Methotrexate (Metoject®) 50mg/ml prefilled syringes, are available in doses from
7.5mg to 30mg.
6.10. Stock holding, ordering and supply
Stock of methotrexate is restricted to pharmacy departments and methotrexate tablets are not
to be held as stock in any clinical area/department or in peripheral hospitals. Methotrexate
tablets or s/c injection will only be dispensed for individual patients against a valid, verified
prescription.
Every effort must be made to ensure that treatment with methotrexate should not be
unnecessarily interrupted or omitted.
When ordering for inpatients, only one week’s supply (one dose) is ordered and dispensed
per week for each individual patient and, if not due immediately, should be stored securely on
the ward, preferably in the patient’s POD locker.
Patient’s own methotrexate that is brought into PHT will be assessed for re-use by a
pharmacist. If the patient brings in more than one week’s supply of methotrexate, the
pharmacist will explain the safety issues and suggest that excess tablets be destroyed or
returned home. Only methotrexate dispensed by the hospital pharmacy should be
administered in hospital- patient’s own methotrexate should be put sealed away in a
separate bag in their POD locker.
Supplies for outpatients would normally be restricted to one month once the patient is on a
maintenance dose. During titration of the patient’s dose longer supplies may be given. Syringes
are also supplied one month at a time to reduce waste.
This will reduce the availability of oral methotrexate in general circulation and reduce the risk of
inadvertent use.
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6.11. Pharmacist clinical check & supply before nursing administration
As a high risk medicine the registered nurse should always check that the prescription has
been endorsed as having been checked and supplied by a pharmacist prior to administration–
see Appendix D.
6.12. Out of hours/ missed doses
Oral methotrexate will not be available in the emergency supply cupboards. It should not be
necessary to obtain and administer oral or subcutaneous methotrexate out of hours. Since it is
a weekly dosage with a long half-life it is not critical if the dose is delayed and is given up to 48
hrs later than usual. For example if the normal administration day is Saturday, the dose can be
taken safely on Sunday or Monday to allow time for the pharmacist to check the prescription.
Every effort should be made for the drug dose to be prescribed safely and verified by a
pharmacist to avoid a missed dose. However, although methotrexate is an important
treatment, it is not clinically urgent and so it is safer to omit the dose until the dose can be
verified by pharmacy before administration.
Do not give the dose if it is 3 or more days late. A flare up of the disease would be unlikely in
this time. Take the next dose on the usual day the following week.
When a new patient on methotrexate is admitted, the patient should be highlighted to the ward
pharmacist to clinically check, endorse the prescription and provide a supply.
6.13. Interactions
See BNF Appendix 1 (link) for an up to date list.
Drug
Acetazolamide
Acitretin
Aspirin/
Non-steroidal anti-inflammatories
(NSAIDs)
Alcohol
Co-trimoxazole
Trimethoprim
Ciclosporin
Ciprofloxacin
Cisplatin
Clozapine
Digoxin
Doxycycline/ Tetracycline
Sulfonamides
Leflunamide
Neomycin
Nitrous oxide
Penicillins
Phenytoin
Probenecid
Proton pump inhibitors e.g.
Omeprazole, lansoprazole
Pyrimethamine
Theophylline
Effect
Excretion reduced in alkaline urine
Avoid: plasma concentration of methotrexate
increased and increased risk of hepatotoxicity
Excretion of methotrexate probably reduced. If aspirin or
NSAIDs are given concurrently the dose of methotrexate
should be monitored. Patients can be stabilised on long
term NSAIDs and methotrexate on advice of the
specialist prescriber.
Advise patients to stay within 4-6 units per week
Avoid: Increased risk of haematological toxicity
Monitor closely, risk of toxicity increased
Excretion reduced (increased risk of toxicity)
Increased pulmonary toxicity
Avoid: increased risk of agranulocytosis
Methotrexate may reduce absorption of digoxin tablets
Increased risk of toxicity
Increased risk of toxicity
Absorption of methotrexate reduced
Avoid: General antifolate effect increased
Excretion reduced (increased risk of toxicity)
Antifolate effect of methotrexate increased
Excretion reduced (increased risk of toxicity)
Excretion reduced (increased risk of toxicity/
pancytopenia)
Antifolate effect of methotrexate increased
Methotrexate may increase plasma level of theophylline
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6.14. Folic acid
Folic acid is used to reduce the possibility of side-effects associated with methotrexate. It is
normally given as folic acid 5mg once a week, taken on a different day of the week to the
methotrexate, to avoid reducing the efficacy. Frequency varies according to patient side effects
and concordance. The BSR/BHPR (2008) monitoring guidelines suggest that folic acid in doses
of 5mg per week (on a different day to the methotrexate) is adequate, although it may be taken
more frequently.
6.15. Adverse Incident Reporting concerning Methotrexate
Any clinical adverse incidents and near misses involving methotrexate therapy (prescribing,
administration errors or adverse reactions) MUST be reported on Datix-web and should be
investigated to determine the root cause of the error and ways of preventing further errors.
Consideration should be given as to whether the incident is a ‘Never Event’ and the Medication
Safety team contacted.
6.16. Surgery in patients taking methotrexate.
Methotrexate should not be stopped for routine elective orthopaedic surgery (or other clean or
minor surgery) and it has been found that the infection risk may actually increase if
methotrexate is stopped in these cases 9
However, if the surgery involved carries a high infection risk (e.g. undergoing dirty or infected
surgery) or if the patient is on antibiotics for an active infection, then the methotrexate should be
withheld. Please seek expert opinion of the original prescriber or department and/or the patient’s
surgeon if in doubt.
7. TRAINING REQUIREMENTS
The importance of weekly dosing of methotrexate therapy is specifically included in the doctors’
induction and online training package, and in nurse training and induction “Setting Direction”
sessions for nurses, midwives, RODPs and HCSWs. The training also covers the significance
of errors with methotrexate dosing and the definition of the DoH ‘Never Events’
Methotrexate is covered with the Rheumatology department’s annual in-house nurse’s training
day.
The Safe Practice checklists will support consistent service provision and will be distributed
widely via bulletins and posted on the Trust’s intranet. Alerts in the form of posters will be
distributed via email to doctors, practice educators and pharmacists and placed on all wards,
see Appendix D.
The Trust will continue to develop ways to increase awareness about the safety of and weekly
dosing of methotrexate.
8. REFERENCES AND ASSOCIATED DOCUMENTATION
1. NPSA Patient Safety Alert PSA03: Reducing the harm caused by oral methotrexate: NPSA,
2004.
2. NPSA Patient Safety Alert PSA13, 1/6/2006. Improving compliance with oral methotrexate
guidelines.
3. Department of Health 2012: The "Never Events" list 2012/13.
4. NPSA. Oral methotrexate pre-treatment information leaflet.
5. NPSA. Patient-held blood monitoring and dosage record booklet.
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6. Royal College of Nursing RCN Guidance Administering subcutaneous methotrexate for
inflammatory arthritis (second edition) 2013
7. British Society for Rheumatology (BSR) and the British Health Professionals in Rheumatology
(BHPR) guidelines and standards issued for the safe prescribing and monitoring of
methotrexate for inflammatory arthritis (BSR/BHPR) 2008
8. Arthritis Research UK: Methotrexate Patient Information Leaflet: Sept 2011. Available at link
9. Grennan DM, Gray J, Loundon J et al. Methotrexate and early postoperative complications in
patients with rheumatoid arthritis undergoing elective orthopaedic surgery. Ann Rheum Dis
(2001) 60: 214-217
9. EQUALITY IMPACT STATEMENT
Portsmouth Hospitals NHS Trust is committed to ensuring that, as far as is reasonably
practicable, the way we provide services to the public and the way we treat our staff reflects
their individual needs and does not discriminate against individuals or groups on any grounds.
This policy has been assessed accordingly
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Appendix A
Safe Prescribing Checklist
Prescribing Once a Week Methotrexate
Before prescribing
Methotrexate is a potent immunosuppressant. When writing up a drug chart, always consider whether it is
appropriate to continue treatment or withhold it.
 If the patient has severe active infection requiring IV antimicrobials, then methotrexate should be
withheld.
 Consider whether the reason for admission could be related to methotrexate intolerance or toxicity.
(e.g. leucopenia, thrombocytopenia, LFT abnormalities, rashes, pneumonitis, renal impairment).
Symptoms such as acute breathlessness, dry persistent cough, vomiting, diarrhoea, sore throat, mouth
ulcers, easy bruising or bleeding may be related to methotrexate.
 Check if renal / liver function has changed which may mean treatment needs to be reviewed. Patients in
acute kidney injury should have methotrexate withheld and patient referred to their initiating consultant.
 Drug interactions should be considered. Check if the patient may have taken other medications
recently which may interact with methotrexate or predispose to toxicity. Significant interactions include
co-trimoxazole, trimethoprim, Acitretin, clozapine. See BNF for more details.
 When patients are admitted for surgery, generally patients do not need to stop methotrexate for
planned surgery, but it may need to be withheld if there is a high infection risk e.g. gastroenterology
surgery. It may be necessary for the prescriber to discuss the infection risk depending on the type of
surgery with the consultant who initiated methotrexate and/or the patient’s surgeon.
If methotrexate is to be withheld, this should be clearly documented in the notes and on the drug chart to
ensure that it is not given unintentionally. It should also be made clear how long it should be withheld for and
when the methotrexate should be restarted.
Confirm dose & route
 The current dose/ route (e.g. 5-25mg once a week) should be confirmed by asking the patient (or their
carer). The patient may have a patient-held record booklet/personalised care plan and/or the actual
tablets in a labelled container or a current medication list from the GP. Many GP records can be
accessed by using the Hampshire Health Record.
 If the patient is unable to confirm the dose or there is any doubt about the dose, it should NOT be
prescribed until the dose can be confirmed by contacting the GP or consultant who initiated the
treatment. Contact the ward pharmacist for advice.
Prescribe weekly dose
 The frequency should be clearly stated as “ONCE A WEEK” and the day of the week should be stated.
 Ensure it can only be given once a week by crossing off the days where it should not be given so that
there is no confusion about which day that the methotrexate is due.

Ensure that methotrexate is prescribed once a week on the TTO / Electronic Discharge Summary
Monitoring
 The parameters to monitor may depend on the length of time the patient has been receiving
methotrexate and their current clinical condition (e.g. FBC, U&Es & LFTs: fortnightly for 8 weeks,
thereafter monthly)
 Inpatients: Check these on admission, then twice a week.
Folic acid
Folic acid is prescribed for many patients to reduce the side effects of methotrexate. It is usually prescribed
once a week but on a different day to the methotrexate
Frequency can be increased according to the severity of methotrexate side effects.
Interactions
Trimethoprim, co-trimoxazole, nitrous oxide, acitretin, clozapine. See BNF for full list of interacting drugs.
PHT Methotrexate Policy: Once a Week Dosing (Oral and Subcutaneous Administration)
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(Review date: January 2016)
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Appendix B
Safe Practice Checklist For Pharmacists
Clinical Screening and Supply of Once a Week Methotrexate
Provide advice / guidance to ward
Ensure the ward staff are familiar with the weekly dosing of methotrexate, and they are aware of and have
access to the policy/ alerts.
Check dose / day of administration
Inpatients: Methotrexate prescriptions must be clinically checked to verify the weekly dose (number and
strength of tablets) or s/c dose and day of the week for administration. The dose & route should be confirmed
with the patient (or their carer) if possible, and as part of medicines reconciliation confirm with two
information sources (e.g. PODs, GP Records). Any discrepancies or ambiguities should be queried and
resolved with the prescriber immediately.
When patients are admitted for surgery, generally patients do not need to stop methotrexate for planned
surgery, but it may need to be withheld if there is a high infection risk e.g. gastroenterology surgery. It may
be necessary for the prescriber to discuss the infection risk depending on the type of surgery with the
consultant who initiated methotrexate and/or the patient’s surgeon.
Take care to check that rewritten charts have been transcribed correctly. Endorse the correct prescription to
confirm that the dose can then be given.
The pharmacist will endorse the drug chart to confirm the weekly dose
Outpatients: When screening OPD scripts, ensure that the prescription is clear, including a WEEKLY
dosing interval/ route. A PHT Methotrexate medication chart (Appendix E) can be completed if the patient is
on an increasing dose.
Check for methotrexate toxicity
The pharmacist should check the reason for admission from the notes and if the symptoms could be due to
methotrexate toxicity. If there are any concerns the doctor should be contacted to check whether
consideration has been made to continue or withhold treatment. If a decision is made to withhold
methotrexate, the pharmacist should check that the prescription is cancelled so that it is not given
inadvertently.
Folic acid
Folic acid is usually prescribed weekly, although it may be more frequently. It should be taken on a different
day of the week to methotrexate, to avoid reducing the efficacy.
Monitoring
The parameters to monitor may depend on the length of time the patient has been receiving methotrexate
and their current clinical condition (e.g. FBC, U&Es & LFTs: fortnightly for 8 weeks, thereafter monthly). The
pharmacist should remind the multidisciplinary team if there are any concerns.
Interactions
The pharmacist should check the drug chart for any interactions with other prescribed medications
trimethoprim, co-trimoxazole, nitrous oxide, acitretin, clozapine (see BNF for full list of interacting drugs). Live
vaccines are contraindicated. Alert the doctors and nurses accordingly and annotate the drug chart. Contact
the patient’s doctor and document in the patient’s notes if the interaction could be clinically significant.
Concomitant NSAIDs in patients being monitored should not be stopped.
Supply
PHT Methotrexate Policy: Once a Week Dosing (Oral and Subcutaneous Administration)
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(Review date: January 2016)
Issue 3.
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

Only 2.5mg tablets of methotrexate are kept in PHT. Methotrexate is not kept as stock on any ward.
Inpatient supply: Ensure that the methotrexate is ordered to enable the dose to be given on the
appropriate day and avoid missed or delayed doses. Use an inpatient label and only supply sufficient for
one dose. PODs should not be used on the ward to make sure the prescription is screened by a
pharmacist before administration.
 TTO/ Outpatient prescriptions: the label should state the number of tablets to take ONCE A WEEK, OR
on a named day each week. Patients should be supplied with the manufacturer’s patient information leaflet
(PIL). One month’s supply should be given as a maximum.
Patient counselling
Prior to discharge or when screening the TTO on the ward or outpatient prescription the pharmacist should
ensure that the patient knows exactly what dose (i.e. the number of 2.5mg tablets) to take on which day of
the week. If the dose has changed, remind the patient to highlight the change to GP practice the next time
they order a repeat prescription as there may be a delay in information being received at the GP practice and
records updated.
Ensure that the patient has/ maintains their own personal care plan or record book containing dosage and
date of results of monitoring tests and that it is up to date. These can be obtained from the relevant speciality
if required.
Patients should be reminded to:
 Seek advice if they develop signs of intolerance or toxicity, sore throat, bruising, mouth ulcers.
 Tell the pharmacist that they are taking methotrexate when purchasing medicines OTC.
 Folic acid should be taken on a different day of the week to methotrexate.
 Keep alcohol to a minimum
Appendix C
PHT Methotrexate Policy: Once a Week Dosing (Oral and Subcutaneous Administration)
24/01/2014
(Review date: January 2016)
Issue 3.
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Safe Practice Checklist For Nursing Staff
Administration of Once a Week Methotrexate
Nursing staff should be familiar with the issues around weekly dosing and toxicity profile of methotrexate.
Treatment with weekly methotrexate is an important but not clinically urgent medication, so it is safer to
delay the dose until the dose and frequency has been checked by a pharmacist. The dose can be given
up to 48hrs after it is due, without having to change the day of the week it is routinely taken (e.g. if the patient
takes their methotrexate on Saturday, the dose can be delayed until it has been checked by a pharmacist and
then given on Monday).
Do not give the dose if it is 3 or more days late. A flare up of the disease would be unlikely in this time as
methotrexate has a long action, and the next dose should be taken on the next usual day of administration.
Methotrexate is not normally withheld before routine orthopaedic or clean surgery but may need to be withheld
if the surgery involves a significant infection risk.
Before administration
If the prescription has not already been seen by a pharmacist, the nurse should postpone administering any
methotrexate until the prescription has been clinically checked and endorsed by a pharmacist.
The administration box should be endorsed by the nurse as code ‘10’ on the drug chart recording on page 2
of the drug chart that the dose needs to be confirmed by the pharmacist.
The nurse should inform the ward pharmacist/ technician or pharmacy department that there is a
methotrexate prescription to be checked.
Supplies



Methotrexate is restricted and shall not be held as stock on any ward.
For oral dosing, only 2.5mg tablets are stocked at PHT.
If a patient requires methotrexate it will be ordered directly for that individual and only one dose at a
time will be dispensed each week.
 Please contact your ward pharmacist during the working week to check and supply doses of
methotrexate,
Administration
 The nurse should check that the prescription has been endorsed by the pharmacist before
administration.
 If the patient is able the nurse should confirm with the patient that the dose and day are correct
 If there are any concerns or change in the patient’s condition (e.g. acute infection) then the dose
should be withheld until it can be clarified by the pharmacist or prescriber.
Disposal of methotrexate
Methotrexate syringes are disposed of in a cytotoxic sharps bin and cannot be disposed of in clinical
waste bin. Methotrexate tablets should be disposed of in a cytotoxic/cytostatic purple bin. See PHT
Waste Policy for further information.
Patient counselling
Ensure that the patient has/ maintains their own record book or personal care plan containing dosage and
results of monitoring tests. These can be obtained from the relevant speciality if required.
Patients should be reminded to
 Seek advice if they develop signs of intolerance or toxicity, sore throat, bruising, mouth ulcers.
 Tell the pharmacist that they are taking methotrexate when purchasing medicines OTC.
 Folic acid should be taken on a different day of the week to methotrexate.
 Keep alcohol to a minimum
Further guidance on methotrexate administration is available from the BSR, BHPR and Royal College of Nursing
PHT Methotrexate Policy: Once a Week Dosing (Oral and Subcutaneous Administration)
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Appendix D
Methotrexate Fact Sheet
RISK DRUG!!!
PHT Methotrexate Policy: Once a Week Dosing (Oral and Subcutaneous Administration)
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(Review date: January 2016)
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Appendix E
PHT Methotrexate Dosing Chart
PHT Methotrexate Policy: Once a Week Dosing (Oral and Subcutaneous Administration)
24/01/2014
(Review date: January 2016)
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Appendix F
Methotrexate Patient Information Leaflet
Link: Arthritis UK Methotrexate Patient Information leaflet
Appendix G
Methotrexate Alert Card
PHT Methotrexate Policy: Once a Week Dosing (Oral and Subcutaneous Administration)
24/01/2014
(Review date: January 2016)
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