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Guidelines and Standard Operating Procedures
Administration of Subcutaneous Methotrexate for Inflammatory Arthritis
in Children
2015
Amendments
Version No.
Amendments
1.1
Original policy adapted to include administration for adults as well. Administration of subcutaneous methotrexate - procedure now reflects use of the new, now licensed, Metoject® auto injector device General updating, references updated, pre-administration checklist added. Document takes account of Health and Social Services Department and General Practitioner related processes for managing patients on subcutaneous methotrexate. Document re-categorised as a clinical guideline and standard operating procedures. COSHH hazard assessment added.
Type i.e. Strategy, Policy,
Education Package etc. Clinical Guideline and Standard Operating Procedures
Name
Administration of Subcutaneous Methotrexate for Inflammatory Arthritis in Children
Category
i.e. organisational, clinical, Corporate, Finance etc
Clinical
Version
1.1
Author
Working Party
Approved by
i.e. Operational Governance Group
Chief Executive Officer – Julie Gafoor
Date Approved
11/08/15
Review Date
11/08/18
Person responsible for
review
Approved by
i.e.Sub Committee, H&SS
FAMILY NURSING & HOME CARE RATIFICATION FORM
Contents
Page 1 Introduction 1
1.1 Rationale 1 1.2 Scope 1 1.3 Principles 1 2. Guidance 1
2.1 Background 1 2.2 Action of Methotrexate 1 2.3 Benefits of Parenteral Methotrexate 22.4 Dosage 2 2.5 Monitoring 2 2.6 Side Effects 3 2.7 Child/Young Person/Parent/Carer training 4 2.8 Supply of Subcutaneous Methotrexate 5 2.9 Storage 5
2.10 Sharps 5 2.11 Control of Substances Hazardous to Health (COSHH) Regulations 2002 5
3. Standard Operating Procedures (SOPs) 6
3.1 Communication in the Shared Care of Subcutaneous methotrexate Administration
6
3.2 Preparing for the Administration of Subcutaneous Methotrexate 7 3.3 Giving the Injection - Metoject® auto-injector 8
3.4 Disposal of Equipment Following Subcutaneous Methotrexate Administration
10
3.5 Recording the Administration of Subcutaneous Methotrexate 11 3.6 Spillage of Subcutaneous Methotrexate 124 Quality Standards 13 5 Development and Consultation 13
5.1 Consultation Schedule 13 6 References 14 7 Bibliography 15 8 Appendices
Appendix 1 Subcutaneous Methotrexate Administration Checklist
Appendix 2 Staff Competencies programme
. 1
1. Introduction
1.1 Rationale Family Nursing and Home Care recognises the potential legal and clinical obligations of their staff’s involvement in the administration of subcutaneous methotrexate and adheres to the current versions of the Nursing and Midwifery Council’s (NMC) Standards for Medicine Management and the Royal College of Nursing’s (RCN) guidelines on administering subcutaneous methotrexate for inflammatory arthritis.
1.2 Scope This clinical guideline and Standard Operating Procedures (SOPs) applies to Nurses employed by Family Nursing and Home Care who may be required to administer subcutaneous methotrexate or support children/young people or parents/carers to administer this medication. This guideline and SOPs applies to children.
1.3 Principles Family Nursing and Home Care believes that all children/young people should receive the same standard of care regardless of who is administering the subcutaneous methotrexate.
Care should be based on current best practice and patient safety should be maintained at all times.
2. Guidelines
2.1 Background Methotrexate remains one of the most effective (non-biologic) Disease Modifying Anti-Rheumatic Drugs (DMARD) for rheumatoid arthritis available today (Bijlsma, 2012 cited in RCN, 2013) and its use is seen as a gold standard treatment for rheumatoid conditions (NICE 2009, BSPAR, 2010 cited in RCN, 2013).
Parenteral methotrexate can be given by intraveneous, intramuscular or subcutaneous injection. Subcutaneous methotrexate in a pre-dosed, auto injector device is now licensed for use in both adults and children for the treatment of rheumatoid conditions. This mode of delivery is used throughout the United Kingdom with great success in improving disease control. Subcutaneous injecting is usually less painful than intramuscular administration and allows patients to self administer this weekly therapy. Therefore, unless otherwise indicated, this is the recommended mode of administration and the mode of administration reflected in this document.
2.2 Action of Methotrexate
Methotrexate is an anti-metabolite cytotoxic agent that competitively restricts/inhibits the action of an enzyme necessary for the synthesis of DNA and thus cell replication. The mode of action of methotrexate is immunosuppressive, the precise action is unclear but it is believed that the production of lymphocytes is inhibited thus restricting the amount of inflammation the body can produce.
A number of drugs have the potential to interact with and enhance the action of methotrexate or reduce its excretion and thus increase its toxicity (British National Formulary for Children (BNFC)). Drugs known to do this, for example, are salicylates, hypoglycaemics, sulphonamides, co-trimoxazole, probenecid, some diuretics, phenytoin and trimethoprim (full and comprehensive list of interactions available in the BNFC). Non-steroidal anti inflammatory drugs (NSAIDs) and corticosteroids are often used concomitantly and can potentially increase the risk of toxicity; so extra vigilance with blood monitoring is essential.
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Methotrexate is fertility impairing and embryotoxic (causing abortion and foetal defects) therefore, it is essential that young people (both sexes) of childbearing age use an effective contraceptive during treatment and for at least 3-6 months after treatment cessation. Those who are pregnant, particularly in the first trimester, should not handle or administer methotrexate (Dougherty and Lister, 2011)
2.3 Benefits of parenteral methotrexate Methotrexate can be taken orally however, escalation of the dose can be restricted due to the occurrence of gastrointestinal symptoms. Parenteral methotrexate has been shown to reduce the occurrence and severity of these undesirable effects whilst allowing patients to take a higher dose (Brooks et al 1990). Methotrexate absorption is saturable with absorption being erratic with oral doses in excess of 20mg, thus bioavailability is improved with parenteral methotrexate at doses over 20mg. Additionally it is thought that parenteral administration allows for a higher plasma concentration and bioavailability of the drug thus increasing efficacy (Bingham et al 2003).
Like oral methotrexate, there is usually a delay of at least 6 weeks before the joint symptoms start to improve however, benefit may occur up to 6 months after starting treatment. Treatment with non-steroidal anti inflammatory drugs (NSAIDs) and painkillers is usually continued.
2.4 Dosage Methotrexate must only be given in the exact dose as prescribed by the Paediatrician. It is given as a single injection once a week on the same day each week. The prescribing of folic acid supplementation is recognised as standard practice to reduce the risk or severity of any mucosal or gastrointestinal side effects, particularly in children (RCN, 2013). The dose and frequency can vary.
When converting from oral to parenteral methotrexate, the oral medication must be stopped for 7 full days prior to the first injection.
Please note, the change from oral to parenteral methotrexate is classed as a dose increase due to increased bioavailability.
2.5 Monitoring
Those receiving methotrexate must have regular monitoring of their bloods and urine. Monitoring guidelines should be provided by the clinician who refers the child/young person to FNHC. If it is not provided, a request for this information must be made. Where a self referral has been made, the monitoring regime must be requested from the child/young person’s responsible physician. Children/young people are usually monitored by their Paediatrician.
Current local monitoring guidelines should be known to staff and prior to administering subcutaneous methotrexate, nurses must confirm that the child/young person has had the appropriate tests undertaken at the recommended intervals and that there is no indication to withhold the administration of the subcutaneous methotrexate. This includes when supervising self-administration. If the responsible physician does not advise FNHC of the test results, the methotrexate must not be administered. The Nurse must contact the responsible physician (normally the Paediatrician) for this information.
In addition to confirming the test results, should the child/young person present with any of the following signs/symptoms, methotrexate must be withheld and advice must be sought from the responsible physician:
Severe sore throat or mouth
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Abnormal bleeding tendancy e.g. excessive bruising, blood spots, blisters on the skin or mouth
Rash
Mouth ulcers
Breathlessness or dry cough
Symptoms of shingles or chicken pox
An infection that is not improving
Pregnancy
A checklist is available to record pre-administration checks (Appendix 1).
2.6 Side effects The side effects of parenteral methotrexate are similar to that of the oral formulation:
Nausea, diarrhoea or occasionally abdominal pain may occur initially but these often settle after adjustment of dosage and are not usually serious. Nausea may be treated by the use of anti-emetics or increasing folic acid supplements always ensuring it is not taken on the same day methotrexate is injected.
Mouth ulcers may occur and may necessitate an adjustment of dose or increasing the frequency of folic acid supplementation to 6 days out 7 days (omitting on the day methotrexate is administered).
Stomatitis, dyspepsia and loss of appetite are very common undesirable effects.
Erythema, pruritis and exanthema are common side effects affecting the skin and subcutaneous tissue.
Headache, tiredness and drowsiness are also common side effects.
Methotrexate may reduce the number of white cells or platelets in the blood and the dose must, therefore, be individually adjusted. In rare severe cases these abnormalities might lead to severe infection or bleeding. Regular blood checks are therefore essential (refer to section 2.5 ‘monitoring’ and local monitoring regimes).
Severe adverse effects on the lungs or liver have rarely occurred which will require stopping methotrexate treatment altogether. Chest x-ray and pulmonary function tests will be arranged at the time of starting therapy (usually by the physician initiating treatment), but this is not generally required if oral methotrexate has preceded parenteral therapy.
Methotrexate can reduce fertility and may harm an unborn baby; it should NOT be taken during pregnancy. Whilst taking methotrexate and for 3-6 months after methotrexate is stopped, contraceptive precautions should be taken by males and females. Patients should not breast feed when taking methotrexate.
Methotrexate is immunosuppressant and increases the risk of infections, even with a normal blood count. Therefore, it is recommended that pneumococcal (pneumovax) and annual flu vaccines should be given whilst on this treatment. Vaccination should, ideally, be given at least 2 weeks prior to commencing immunosuppressive therapy (RCN, 2013) Children and young people commencing parenteral methotrexate normally will have been taking oral methotrexate so vaccinations should be up to date. However vaccination status should always be confirmed prior to therapy commencing by the physician
. 4
initiating this therapy. Due to the immunosuppressive action of methotrexate, “Live” vaccines should be avoided.
Loss of hair has been reported on very rare occasions.
2.7 Child/Young Person/Parent/Carer Training In the event of the child/young person self-administering subcutaneous methorexate or a parent/carer administering the medication, a competency based training/education programme will need to be undertaken.
The initial training/education of children/young people/parents/carers to administer subcutaneous methotrexate is not within the scope of this guideline and should not be undertaken by FNHC staff. It is usually the case that the initial training of the child/young person and parent is delivered off Island in the UK. However, in the event that the child/young person/parent/carer has undertaken a comprehensive, training/education programme and there is evidence of successful completion of such a programme, FNHC nurses can support their practice, until such time as they are confident to safely administer the subcutaneous methotrexate alone.
When supporting the child/young person and/or their parent/carer to administer subcutaneous methotrexate, the Nurse must confirm that they are aware that they must:
stop methotrexate and contact their Paediatrician or GP if any of the following develop:
o severe sore throat or mouth
o abnormal bleeding tendency (excessive bruising, blood spots or blisters on the skin or in the mouth)
o rash
o mouth ulcers
o breathlessness or dry cough
o symptoms of shingles or chicken pox
o an infection which is not improving
not take any new medication without checking with their Paediatrician/GP
only have alcohol in strict moderation due to the potential combined liver toxicity.
not handle or administer subcutaneous methotrexate if they are pregnant or pregnancy is suspected
not administer subcutaneous methotrexate to anyone who is pregnant or thinks they may be pregnant
contact their Paediatrician/GP urgently if they have contact with someone with either chicken pox or shingles. N.B unless the child/young person has definitely had chicken pox/shingles or is known to be immune from prior immunology, they need urgent (same day) varicella zoster serology carried out. If not immune, the on call Paediatrician/GP must be contacted.
Where indicated, if the Nurse is administering subcutaneous methorexate to the child/young person, they must discuss any side effects, either observed or brought to their attention, with the relevant physician in a timely manner. Side effects should be documented in the child/young person’s nursing records.
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If, at any time, the Nurse deems that the child/young person/parent/carer’s practice falls below an expected level of competence, they should discuss this immediately with the physician responsible for the child/young person’s care.
2.8 Supplying of Subcutaneous Methotrexate Parenteral methotrexate is now available in a licensed, pre-dosed, pre-filled auto-injector format which can be obtained from either the Hospital Pharmacy or Community Pharmacies.
Children/young people/parents/carers are responsible for obtaining their own supplies of methotrexate.
2.9 Storage The storage of subcutaneous methotrexate should be in accordance with the manufacturer’s instructions as the shelf-life and storage conditions may vary between manufacturers. It should be stored in a safe place within the home, out of reach of children.
Nurses administering subcutaneous methotrexate should enquire about how the medication was stored prior to administration of the drug. Administration of the drug should not take place if there is concern about its storage conditions. Instead, additional advice from the supplying pharmacy should be sought and/or an alternative supply should be obtained.
Methotrexate is a yellowish, transparent solution and must be stored out of direct sunlight.
2.10 Sharps Injury If, during the administration of subcutaneous methotrexate, a ‘sharps injury’ is sustained, staff should follow the FNHC ‘Protocol for Sharps Injury and/or Blood/Body Fluid Exposure’.
2.11 Control of Substances Hazardous to Health (COSHH) Regulations 2002 As a cytotoxic medication, methotrexate is considered to be a hazardous substance and therefore comes under the remit of the COSHH regulations. COSHH requires Family Nursing and Home Care to undertake a hazard assessment (appendix 3) and take suitable precautions to protect those who could be harmed by this substance. It also requires the organisation to put methotrexate on the organisational COSHH Register.
3. Standard Operating Procedures
6
3.1 Communication with other Relevant Healthcare Professionals in Subcutaneous Methotrexate Administration
Purpose
To enable all relevant healthcare professionals to be aware of the involvement of Family Nursing and Home Care in the administration of subcutaneous methotrexate, so relevant information is shared appropriately and in a timely manner.
Scope
All staff required to administer subcutaneous methotrexate or supporting others to do this.
Core Requirements
Regardless of the origin of the referral, when a child/young person is accepted for the administration of subcutaneous methotrexate or support with the administration of subcutaneous methotrexate, both the GP and the Paediatrician must be informed by means of a liaison letter.
The referral letter should request a copy of the child/young person’s individual blood and urine monitoring regime. In addition, written authorisation to administer subcutaneous methotrexate on the appropriate FNHC medication documentation must also be requested.
Where timely confirmation of satisfactory test results is not received from the responsible physician, the Nurse must contact this person ahead of the day they are due to see the child/young person. Should this not be forthcoming, the Nurse must advise the responsible physician that they will not be able to administer/support the administration of the subcutaneous methotrexate. This action should be undertaken following discussion with the Operational Lead.
Where contraindications to the administration of methotrexate are identified, the responsible physician must be informed immediately and arrangements made for the child/young person to be reviewed by them. This should be followed up by a liaison letter to the responsible physician.
3. Standard Operating Procedures
7
3.2 Preparing for the Administration of Subcutaneous Methotrexate
Purpose To ensure that staff are appropriately prepared ahead of administering the injection and contraindications to the administration of subcutaneous methotrexate are identified and appropriate action taken Scope All staff preparing to administer subcutaneous methotrexate or supporting others to administer the medication Core Requirements
All staff required to administer sub-cutaneous Methotrexate should adhere to the most up to date version of the Royal College of Nursing’s guidelines “Administering subcutaneous methotrexate for inflammatory arthritis”.
“No specialist training is required for the administration of subcutaneous methotrexate by practitioners” (RCN 2013, p. 9, 24). However, all nurses should be competent in the safe use of the auto-injector device now available for subcutaneous methotrexate administration and in the subcutaneous injection technique. To develop their practice relating to the administration of subcutaneous methotrexate, nurses should complete the educational competencies programme detailed in Appendix 2.
Equipment Ensure all the equipment required is ready and available and the procedure can be carried out with no interruptions or distractions
Written authorisation from a Registered Prescriber to administer subcutaneous methotrexate
Subcutaneous Methotrexate Administration Checklist (Appendix 1)
Methotrexate pre-dosed, pre-filled auto-injector device (Metoject® range)
Cytotoxic sharps bin (these are obtained from Robin Ward by the community children’s nurses (agreed by ward sister)).
Disposable gloves (ideally latex free) and apron
Gauze swabs or tissues
Spill kit (ideally)
Healthcare professionals or non-patient injectors must wear gloves and an apron however, a child/young person injecting themselves is not required to wear personal protective equipment.
Nursing staff must have written authorisation from a Registered Prescriber prior to administering subcutaneous methotrexate.
Complete the pre-injection checklist (appendix 1 – Subcutaneous Methotrexate Administration Checklist). In addition, check and confirm that no changes have been made to the dosage. Where a discrepancy is found, immediate advice must be sought from the responsible medical clinician.
Confirm that the medication had been stored appropriately
3. Standard Operating Procedures
8
3.3 Giving the Injection - Metoject® auto-injector
Please note, those who are pregnant should not handle or administer methotrexate.
Purpose
To enable the safe administration of subcutaneous methotrexate
Scope
All staff administering methotrexate subcutaneously to a child/young person with inflammatory arthritis.
Core Requirements
Wash and dry hands thoroughly.
Put on the gloves and apron
Check the following: child/young person’s name on pharmacy label, drug name, dose, route, expiry date and the colour (it should be yellow but transparent). Check details against the medication authorisation. Also check that the medication has been stored appropriately. If there is a discrepancy, please do not proceed; contact the dispensing pharmacy.
Remove Metoject® pen device from the packaging. The packaging can go in the normal household waste.
Check that the pen is undamaged by looking through the viewing window. An air bubble should be visible.
Remove yellow protection cap by pulling it downwards. This will reveal the needle shield. Do not twist or bend the protection cap
Identify the site you are to inject remembering to ensure site rotation each week. Appropriate sites to use are the standard subcutaneous sites; abdomen, thighs and upper arms (not for self administration and only if there is a sufficient subcutaneous layer). If the abdomen is used avoid the 5cm diameter around the umbilicus.
Do not try to eject any air that may be in the auto-injector device. It is purposefully present, harmless and absorbed easily.
Ensure the skin is clean and dry at the site you are about to inject (alcohol swabbing is not essential if skin is socially clean)
Gently grip the skin at the injection site and maintain throughout the injection process
Place pen at a 90° angle to the skin and push firmly against the skin until the needle shield slides fully into the viewing window. This action will then unlock the yellow release button.
To start the injection, press the yellow release button with your thumb. A clicking sound will then be heard.
Wait 5 secords until all the medicine is injected (observe this through the viewing window) – Do not remove the auto–injector device during injection.
Once the auto–injector device is empty, release the skin and remove the device.
3. Standard Operating Procedures
9
Put directly into the cytotoxic sharps bin
If there is a small amount of leakage from the injection site, dab with cotton wool/swab/tissue
Gloves and apron worn during the procedure should be disposed of in the sharps bin along with the cotton wool/swab/tissue
Wash and dry hands thoroughly (Medac, 2014)
Links to Metoject® information:
Adult and Adolescent – http://metoject.co.uk/wp-content/uploads/2014/03/Medication-is-changing-Adult-WEB.pdf
Parent and Child - http://metoject.co.uk/wp-content/uploads/2014/03/Medication-is-changing-Parents-WEB.pdf
Patient Frequently Asked Questions - http://metoject.co.uk/wp-content/uploads/2014/03/Patient-FAQs.pdf
3. Standard Operating Procedures
10
3.4 Disposal of Equipment Following Subcutaneous Methotrexate Administration
Purpose
To enable the safe disposal of equipment used in the administration of subcutaneous methotrexate
Scope
All staff administering methotrexate subcutaneously to a child/young person with inflammatory arthritis or supporting others to do this.
Core Requirements
With the exception of the outer packaging of the auto-injector device, all materials used during the administration should be disposed of in the cytotoxic sharps bin.
The Nurse administering the cytotoxic medication will be responsible for the removal from the child/young person’s home of the sharps bins used. These should be returned to Le Bas
If the child/young person or parent/carer are administering the medication, they should be encouraged to follow the procedure for disposal of equipment that was agreed during their training.
3. Standard Operating Procedures
11
3.5 Recording the Administration of Subcutaneous Methotrexate
Purpose
To enable the administration of subcutaneous methotrexate to be recorded in line with local policy and the Nursing and Midwifery Council’s standards for medicine administration.
Scope
All staff administering methotrexate subcutaneously to a child/young person with inflammatory arthritis or supporting others to do this.
Core Requirements
The administration of subcutaneous methotrexate, as prescribed by the Registered Prescriber, must be documented in the appropriate place/s in the child/young person’s nursing records.
3. Standard Operating Procedures
12
3.6 Spillage of Subcutaneous Methotrexate
Purpose
To enable staff to safely deal with any spillage of subcutaneous methotrexate.
Scope
All staff required to deal with a spillage of subcutaneous methotrexate or supporting others to do this.
Core Requirements
Refer to the COSHH hazard assessment (Appendix 3)
In the event of a spillage, put on gloves and apron before dealing with it as follows:
Clothes/surfaces – mop up any spillage with absorbent disposable towels. Clothes should be removed and washed separately from other washing in the hottest possible washing cycle and the individual should shower thoroughly (also see information below re skin contact). Wash surfaces thoroughly with plenty soap and water. NB if the spillage is on carpet, do not use carpet cleaner on it as chemical reactions may be a further potential hazard. (RCN, 2004)
Skin – methotrexate can be a potential irritant to the skin. In the event of spillage on to the skin, it should be washed with plenty soap and water for a couple of minutes, before drying thoroughly. Note, do not scrub the skin. Monitor the affected area for 1 week and if the area is not improving/healing or if it is deteriorating, seek further medical advice.
Eye – methotrexate can potentially irritate the eye. In the event of eye contamination, the eye should be flushed thoroughly with 0.9% sodium chloride or cold tap water for at least 15 minutes. Seek medical attention.
Inhalation – methotrexate can potentially cause irritation of the airways. In the event of inhalation occurring, move to an area of fresh air. If irritation or breathing difficulties, seek medical attention
Ingestion – methotrexate is classified as toxic or harmful if ingested. In the event of this happening, rinse out mouth, give plenty of water to drink and seek urgent medical attention.
Dispose of all paper towels, gloves and other materials used to deal with the spillage in the cytotoxic sharps bin.
Finally, wash hands thoroughly after you have dealt with the spillage.
NB The spillage must be reported using the ‘Assure’ incident reporting system.
Ideally, nurses administering subcutaneous methotrexate should carry a small spillage kit, for home use.
13
4. Quality Standards This guideline and standard operating procedures (SOPs) links to the following Quality Assurance Framework (QAF) quality standards:
1) Care and welfare of people who use the service
3) Management of medicines
5) Respecting and involving people who use the services
8) Co-operating with other providers
9) Requirements relating to workers
11) Cleanliness and infection control
13) Safe, available and suitability of equipment
14) Consent to care and treatment
15) Records
16) Supporting workers
5. Development and Consultation
5.1 Consultation Schedule
The following staff were consulted during the development of these guidelines and SOPs
Name Title
Lindy Henesy Team Leader Children’s Community Nursing Team
Julia Foley Team Leader District Nurse – Town Team
Terena Biddulph Team Leader District Nursing Clinics
Phil Romeril Pharmacist
Gareth Hughes General Practitioner
Julie Le Sueur (HSSD) Rheumatology Clinical Nurse Specialist
Jane Abraham (HSSD) Rheumatology Clinical Nurse Specialist
Nicky Austin (HSSD) Pharmacist
Sharon Dean (HSSD) Oncology/Haematology Department Manager
This document has been reviewed by the following groups
Name of Committee/Group Date of Committee/Group
Operational Governance Group 21st May 2015
Operational Governance Group 16th July 2015
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6. References:
Bigham S J, Buch M H, Lindsay S, Pollard A, White J, and Emery P (2003) Parenteral methotrexate should be given before biological therapy. Rheumatology: 42 pg 1009-1010.
Bijlsma, J.W. (2012) Is it time to optimise anchor therapy for rheumatoid arthritis? Rheumatology, 51 (4), pp. iv.1-2 cited in Royal College of Nursing (2013) Administering subcutaneous methotrexate for inflammatory arthritis, www.rcn.org.uk (accessed 4.12.14)
British Medical Association, Royal Pharmaceutical Society (2012) British National Formulary, 10.1.3. Methotrexate, Basingstoke, BMJ Group & Pharmaceutical Press
British National Formulary for Children 2009.
British Society for Paediatric and Adolescent Rheumatology (2010) Methotrexate use in paediatric rheumatology, St Albans: BSPAR cited in Royal College of Nursing (2013) Administering subcutaneous methotrexate for inflammatory arthritis, www.rcn.org.uk (accessed 4.12.14)
Brooks P J, Spruill W J, Parrish R C and Birchmore D A (1990) Pharmacokinetics of methotrexate administered by intramuscular and subcutaneous injections in patients with rheumatoid arthritis. Arthritis and Rheumatism: 33 pg 91-94
Dougherty, L. Lister, S. (Editors) (2011) ‘Cytotoxic Therapy in The Royal Marsden Hospital Manual of Clinical Nursing Procedures, (8th Edition), Oxford: Wiley-Blackwell http://www.rmmonline.co.uk/rmm8/chapter/15/ss6#ss7 (accessed 8.12.14)
Medac (2014) Metojec® is changing, available at http://metoject.co.uk/wp-content/uploads/2014/03/Medication-is-changing-Parents-WEB.pdf (last accessed 8.12.14)
National Institute for Health and Clinical Excellence (2009) Rheumatoid Arthritis: the management of rheumatoid arthritis in adults, London: NICE (CG79) available at www.nice.org.uk cited in Royal College of Nursing (2013) Administering subcutaneous methotrexate for inflammatory arthritis, www.rcn.org.uk (accessed 4.12.14)
Nursing and Midwifery Council (2007) Standards for Medicine Management, London: Nursing and Midwifery Council
Royal College of Nursing (2013) Administering subcutaneous methotrexate for inflammatory arthritis, www.rcn.org.uk (accessed 4.12.14)
Royal College of Nursing (2004) Administering subcutaneous methotrexate for inflammatory arthritis, (publication code 002 269)
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7. Bibliography
British Society for Paediatric and Adolescent Rheumatology (2013) Methotrexate use in paediatric rheumatology, Information for Health Professionals, https://www.bspar.org.uk/DocStore/FileLibrary/PDFs/BSPAR%20Guideline%20for%20Methotrexate%202013.pdf (last accessed 8.12.14)
Medac (2014) Metoject® summary of product characteristics, https://www.medicines.org.uk/emc/medicine/22145 (last accessed 8.12.14)
Appendix 1 Subcutaneous Methotrexate Administration Checklist
* if no educational/training programme has been undertaken, patient must be referred back to the referrer for this to happen. It is not the responsibility of FNHC staff to deliver this training programme
Has a competency-based education / training programme been undertaken by the patient/carer/parent? Yes / No* (delete as applicable)
Is a copy of the education programme available in the patient’s/child’s records? Yes / No (delete as applicable) If ‘no’, request this from the referrer
Who delivered this programme?
Date programme completed
Date
Blood & urine monitoring checked and results confirmed to be within acceptable parameters yes/no
If test results are not within acceptable parameters, advice has been sought from the responsible clinician yes/no/n/a
Agreement to go ahead given yes/no
The patient is free of the following signs/symptoms:
Severe sore throat or mouth
Abnormal bleeding tendancy
Skin rash Mouth ulceration Breathlessness or dry
cough Symptoms of/contact with
shingles or chickenpox an infection that is not
improving yes/no
The patient is not pregnant yes/no ‘yes’ means the patient is NOT pregnant
Written authorisation to medicate available and the dosage confirmed as unchanged? yes/no
Correct medication available and in date yes/no
Medication has been stored appropriately yes/no
All necessary equipment available yes/no
Consent reaffirmed yes/no Checklist completed by:
(initial)
If the answer to any of the above questions is ‘no’ DO NOT administer methotrexate – seek medical advice
Sheet Number:
Name:……………………………………………………………… D.O.B:……………………………………………………………… URN:………………………………………………………………..
Or Affix Patient Label
Appendix 1 Subcutaneous Methotrexate Administration Checklist Continued from overleaf:
Date
Blood & urine monitoring checked and results confirmed to be within acceptable parameters yes/no
If test results are not within acceptable parameters, advice has been sought from the responsible clinician yes/no
Agreement to go ahead given yes/no
The patient is free of the following signs/symptoms:
Severe sore throat or mouth
Abnormal bleeding tendancy
Skin rash Mouth ulceration Breathlessness or dry
cough Symptoms of/contact with
shingles or chickenpox an infection that is not
improving yes/no
The patient is not pregnant yes/no ‘yes’ means the patient is NOT pregnant
Written authorisation to medicate available and the dosage confirmed as unchanged? yes/no
Correct medication available and in date yes/no
Medication has been stored appropriately yes/no
All necessary equipment available yes/no
Consent reaffirmed yes/no Checklist completed by:
(initial)
If the answer to any of the above questions is ‘no’ DO NOT administer methotrexate – seek medical advice.
Name:……………………………………………………………… D.O.B:……………………………………………………………… URN:………………………………………………………………..
Or Affix Patient Label
APPENDIX 2 – Staff Competencies Programme
19
Name of Practitioner...................................................................................................... Name of Supervisor.......................................................................................................
Element of Competence to be achieved Date of
achievement Signature of Practitioner
Signature of Supervisor
Discuss the rationale for the use of subcutaneous methotrexate in rheumatic conditions
Describe the physiological effects of methotrexate Discuss potential issues related to treatment including: screening of patients possible side effects or adverse events drug interactions contraindications to methotrexate therapy
Discuss the circumstances when subcutaneous methotrexate should not be administered
Describe interventions required to alleviate methotrexate induced side effects
Discuss the process for assessing the patient’s suitability for methotrexate therapy e.g. medical history, concomitant medications, allergies, level of disease activity, dexterity and attitude to treatment
Demonstrate the ability to check the validity of the current prescription. This includes expiry date, dose, route by which the drug is to be administered and the checking of the patient identification
Describe sites on the body that would be appropriate for subcutaneous methotrexate injection
Describe local health and safety guidelines and risk assessment required for providing a subcutaneous methotrexate service in the patient’s home. With particular relevance to: safe storage and handling handwashing dealing with spillage and disposal of cytotoxic waste the use of protective clothing ensuring a quiet and safe environment preventing unnecessary exposure to other people travelling and transporting methotrexate
Discuss the information/educational needs of the patient/carer in support of home administration of subcutaneous methotrexate therapy.
Discuss action to be taken if patient, parent/carer does not meet expected competencies level, when self administering.
Demonstrate the ability to maintain concise and accurate patient documentation and audit. These should include: nursing records medicine prescription/administration sheet helpline follow up
Demonstrate an understanding of the local monitoring requirements and follow up arrangements for subcutaneous methotrexate therapy and the actions that must be taken in the event of a blood dyscrasia.
Discuss accountability in relation to the administration of subcutaneous methotrexate
Identify the ways of maintaining current competency This programme was adapted from the Royal College of Nursing (2013) Administering subcutaneous methotrexate for inflammatory arthritis – guidance for nurses.
APPENDIX 3 COSHH Hazard Assessment
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