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Protocol For Registered Rheumatology Nurses To

Administer Subcutaneous Methotrexate And To

Educate Patients And Carers In The

Self-Administration Of Subcutaneous Methotrexate

CATEGORY: / Procedural Document
CLASSIFICATION: / Clinical
PURPOSE / This protocol supports the administration, by registered rheumatology nurses, of subcutaneous methotrexate, (a cytotoxic agent) for patients with rheumatic disease. In addition it supports registered nurses to educate, support and monitor the patient and carers’ self-administration of methotrexate.
Controlled Document Number:
Version Number:
Controlled Document Sponsor:
Controlled Document Lead: / Rheumatology Nurse Consultant
Approved By: / Rheumatology Nurse Consultant
Clinical Service Lead
On: / November 2008
Review Date: / October 2011
Distribution:
  • Essential Reading for:
  • Information for:
/ All registered rheumatology nurses who currently undertake this practice and all registered rheumatology nurses who wish to expand their practice to include this skill.
All registered clinical staff

EVIDENCE FOR PRACTICE

The efficacy of oral methotrexate in rheumatology is well established (Maini, 2003) and is recognised as the gold standard for treating people with a range of rheumatological disorders.

Currently inflammatory joint disease is being treated earlier and more aggressively with optimisation of the methotrexate dose in order to control symptoms and disease progression (Porter et al 2003). This approach can be limited due to poor tolerability of the oral form of the drug. Giving methotrexate by the subcutaneous route improves drug tolerability and therefore patients who could not otherwise be treated can benefit.

Patients with a variety of rheumatological conditions attend rheumatology nurse led clinics to be taught how to self-administer their own subcutaneous methotrexate. When patients prefer not to self-administer the therapy a carer can be taught to administer the injection. Although the quantities of methotrexate used in rheumatology practice are small, methotrexate is a cytotoxic drug. Therefore, registered nurses, patient and carersrequire appropriate training to ensure safe administration (Hiley et al 2008)(Appendix 3).This includes handling of accidental spillage, and injection technique.Appropriate follow up and telephone support are also required.

Some GP’s are reluctant to engage in prescribing and supervising the treatment because of a lack of knowledge in this specialist area and concerns about cytotoxic drugs and their disposal.

Experience of training patients/ carers to administer methotrexate by the subcutaneous route at University Hospital Birmingham NHS Foundation Trust (UHB),has enable more patients able to receive therapy, has reduced the number of hospital visits for the individual patient and patients have become more involved in their care.

Initially aregistered rheumatology nurse competent in the administration of subcutaneous methotrexate will initially administer the injections to the patient in the rheumatology outpatient clinic as prescribed. Patients/carers will receive written information devised to support this document and the arthritis research campaign and these will be discussed with the patient.

Patients are followed up on a regular basis until stable on treatment. Blood monitoring is carried out in accordance with the hospitals monitoring protocols.

CONSENT
  1. Although formal written consent is not required for minor procedures, verbal consent for the procedure must be obtained where possible and this must be documented on the patient’s record.
  1. If the patient is unable to give their consent, the registered practitioner must act in accordance with the Mental Capacity Act (2005) and document in the patient's notes why they believe the procedure to be in the patient's best interests, including any involvement from other health professionals, family or carers in reaching that decision.

INDICATIONS

  1. An independent non medical prescriber who is providing nurse led care for the patient will prescribe licensed subcutaneous methotrexate for the patient and adjust the methotrexate dose in accordance with the local hospitals monitoring protocol.
  1. The referral criteria for patients who may be considered suitable for self-administration of subcutaneous methotrexate include:
  • Inefficacy of oral methotrexate at a dose of up to 20mgs per week
  • Loss of efficacy of oral methotrexate at a dose of up to 20mgs per week
  • Evidence of mucosal irritation and gastrointestinal side effects such as nausea and diarrhoea caused by oral methotrexate
  • Where efficacy is not established following a prior trial of oral methotrexate and there is a likelihood that the patient may require the use of anti-tumour necrosis factor therapy.
  1. Following referral, patients and carers will be assessed and where appropriate selected for training to follow a programme of tuition for self/carer injection of subcutaneous methotrexate at home. This will involve assessing the patient or carer’s:
  • Willingness to administer injections
  • Ability to administer injections
  • Ability to safely store and transport injections
  • Knowledge of reasons for the therapy, how to administer the injections subcutaneously, recognition and action when experiencing side effects, attendance for monitoring and follow up, dealing with spillage, disposal of sharps and waste and self care whilst at home. See patient/carer education package and competencies (Appendix 3)
  1. The registered rheumatology nurse will assess the patient’s/carer’s understanding of the process by discussing the training programme with them (Appendix 3)

CONTRAINDICATIONS

  1. The patient is under the age of 16
  1. The patient refuses treatment/the training programme
  1. Patients and carers will be excluded from self-administration if they:
  • Are unable to administer the injection because of poor dexterity as indicated in a practical demonstration to the rheumatology nurse
  • Show poor concordance with attendance and monitoring
  • Are unable to safely store the methotrexate injections at home or are unable to demonstrate an understanding of the need for safe storage (including that the drug, syringes & needles must be kept where children cannot access them)
  • Demonstrate a lack of understanding of the safety and self care requirements

4.If, in the registered rheumatology nurse’s professional opinion, the patients’ condition requires that the injection should not be administered. (E.g., skin rashes, infection, neutropenia, leucopenia, thrombocytopenia, abnormal liver function tests, pregnancy, breast-feeding and planning to conceive) the registered rheumatology nurse willseek a medical opionion.

LIMITATIONS TO PRACTICE

The patient will be referred for a medical opinion if they:

  1. Develop a new health problem
  1. Existing health problems require medical supervision
  1. Have poorly controlled side effects
  1. Have evidence of developing a blood dyscrasia
  1. Have failed to respond to treatment and there is evidence of disease progression
  1. Have toxicity related to methotrexate therapy

CRITERIA FOR COMPETENCE

1.Registered rheumatology nurses will attend an initial Trust in-house course on chemotherapeutic agents and attend an update bi-annually.
  1. Evidence of satisfactory supervised practice must be provided by the registered rheumatology nurse and witnessed by a practitioner who is already competent in the administration of subcutaneous methotrexate(Appendix 2).
  1. The number of supervised practices required will reflect the individual registered rheumatology nurse’s learning needs.
  1. Evidence of competence must be provided and a copy kept in the registered rheumatology nurse’s personal file and in the department where the skill is practiced. (Appendix 1)
5.Registered rheumatology nurses working in HOB musculoskeletal and rheumatology service who are responsible for teaching patients and carers to administer subcutaneous methotrexate, must be fully conversant with the Trusts’ policy on handling, spillage and administration of cytotoxic drugs.
6.Evidence of continuing professional development and maintenance of skill level will be required and checked on an annual basis by the registered rheumatology nurse’s line manager.
7.A practitioner who is already competent in the administration of subcutaneous methotrexate and theteaching of patient’sto administer subcutaneous methotrexate, will assess registered rheumatology nurses new to the Trust, who have been administering and teaching and carers to administer subcutaneous methotrexate elsewhere. This will include:
Introduction to the Trust’s protocol, standards of care and training requirements
  • Attendance on the a course course on chemotherapeutic agents
Provision, by the registered nurse, of evidence of satisfactory education, supervised practice and competence
A formal, practical assessment of the registered rheumatology nurse in the administration of subcutaneous methotrexate and in the ability to teach and monitor patients and carers.

PROTOCOL AND SKILLS AUDIT

The rheumatology nurse consultant,will lead the audit of the protocol with support of the clinical governance department. The audit will be undertaken in accordance with the review date.

The audit will include:

  1. Adherence of staff to the protocol
  2. Untoward incidences and adverse events arising from the administration of subcutaneous methotrexate administered by nurses in the department and by patients and carers at home and in the hospital setting Eg. allergy, inoculation injury, spillage etc.
  3. Details of those patients declining treatment and those referred for a medical assessment

4. Any adverse drug reactionswith methotrexate that are reported on a yellow report card and forwarded to the centre for adverse drug event reporting

5.Any identified problems relating to patients/carers ability to obtain injections, giving injections, spillage, local skin irritation and disposal of sharps

6.Patient satisfaction with:

  • The teaching procedure and information for patients/carers (Appendices 2 & 3)
  • Giving the injections
  • Theservice provided by the rheumatology nursing team

All audits will be logged with the Clinical Governance Support Unit.

CLINICAL INCIDENT REPORTING AND MANAGEMENT

Any untoward incidentsand near misses should be dealt with by the appropriate management team. An incident form must be completed. The risk management team must be notified by telephone of any serious untoward incidents.

A list of registered rheumatology nurses competent to perform this skill will be kept by the rheumatology nurse consultant.

REFERENCES

Hiley J, Homer D, Clifford C (2005)Patient self-injection of methotrexate for inflammatory arthritis: a study evaluating the introduction of a new type of syringe and exploring patients’ sense of empowerment. Musculoskeletal Care 6(1):15-30

Maini RN, Ferdinand CB, Kalden JR Smollen JS, Davis D, Macfarlane JD, Elliott MJ, Woody JN, Schaible TF, Feldmen M (1998) Therapeutic efficacy of multiple intravenous infusion of anti-tumour necrosis factor alpha monoclonal antibody combined with low dose weekly methotrexate in rheumatoid arthritis. Arthritis and Rheumatism41(9):1552-1563.

Porter DR, Grigor C, Stirling A, Capell H (2003) A randomized controlled trial of a strategy of tight control of disease activity in rheumatoid arthritis: Outcome over 18 months: Glasgow: Gartnavel GeneralHospital and Glasgow Royal Infirmary.

UniversityHospitalBirmingham NHS Foundation Trust. Guidelines for the treatment and monitoring of methotrexate therapy. UniversityHospitalBirmingham NHS Foundation Trust, Birmingham.

BIBLIOGRAPHY

Arthur VAM, Jubb RW, Homer DC (2002) A study of parenteral use of methotrexate in rheumatic conditions Journal of Clinical Nursing11:256-263.

Arthur VAM, Jubb RW, Homer DC (2001) Self Injection of Gold and Methotrexate Journal of Rheumatology 28(1):212.

Arthur VAM, Jubb RW, Homer DC (2000) Study of parenteral use of methotrexate in rheumatic conditions Rheumatology Abstracts Supplement May P.167.

Brookes PJ, Spurill WJ, Parish RC and Birchmore DA (1990) Pharmokinetics of methotrexate administered by intramuscular and subcutaneous injections in patients with rheumatoid arthritis. Arthritis and Rheumatism; 33:91-95.

Dougherty, L. Lister, S. (2005) (Eds) The RoyalMarsdenHospital Manual of Clinical Nursing Procedures Sixth Edition. Blackwell Publishing, Oxford.

Nursing and Midwifery Council (2007) Standards for Medicines Management.Nursing and Midwifery Council,London.

RoyalCollege of Nursing (1998) Clinical Practice Guidelines: The administration of cytotoxic chemotherapy recommendations, Royal College of Nursing, London.

RoyalCollege of Nursing (2004) Administering subcutaneous methotrexate for inflammatory arthritis Royal College of Nursing, London.

Suarez-Almazor ME, Belseck E, Shea B, Wells G, Tugwell P (1997) Methotrexate for Rheumatoid Arthritis, The Cochrane Library, Systematic Review. November.

Wallace CA (1998) The use of methotrexate in childhood rheumatic diseases. Arthritis and Rheumatism 41; 3: 381-391

PROTOCOL SUBMISSION DETAILS

Protocol Reviewed by: University Hospital Birmingham NHS foundation Trust

Dawn HomerRheumatology Nurse Consultant

Emily HartwellAssociate Director of Pharmacy- Clinical Services

Dr JubbConsultant Rheumatologist

Elaine SpellmanLead Chemotherapy Nurse

Louise DennerPractice Development Nurse

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Protocol for registered rheumatology nurses to administer subcutaneous methotrexate and to educate patients and carers in the self administration of subcutaneous methotrexate.

Appendix 1

HOB PCT

CRITERIA FOR COMPETENCE

END COMPETENCE: PROTOCOL FOR REGISTERED RHEUMATOLOGY NURSES TO ADMINISTER SUBCUTANEOUS METHOTREXATE AND TO EDUCATE PATIENTS AND CARERS IN THE SELF-ADMINISTRATION OF SUBCUTANEOUS METHOTREXATE

Date(s) of Education and supervised practice: …………………………………………….

Name of Registered Rheumatology Nurse: …………………………………………….

Name of Supervisor: …………………………………………….

Element of Competence To Be Achieved / Date Achieved / Registered Rheumatology Nurse Sign / Supervisor Sign
Discuss the rationale for the administration of subcutaneous methotrexate in rheumatic conditions in relation to the:
Indications for use
The classification of methotrexate as a cytotoxic agent
Effects of methotrexate on the cell cycle
The possible side effects, their likelihood and severity
Discuss contraindications for the administration of subcutaneous methotrexate as stated in the protocol
Discuss the referral criteria for patients with rheumatic conditions to receive a programme of self injection of subcutaneous methotrexate
Discuss the need for the adjustment or to the withholding of an existing methotrexate prescription in relation to
Side effects
Lack of efficacy
The patient’s current haematological results
The patient’s current health status
Discuss limitations to practice as stated in the protocol
Discuss the Trust Policy in relation to the following
Transportation of methotrexate between pharmacy and rheumatology outpatients
Storage of methotrexate in the outpatient clinic
Safe handling of methotrexate
Disposal of waste and equipment used during the administration
Element of Competence To Be Achieved / Date Achieved / Registered Rheumatology Nurse Sign / Supervisor Sign
Discuss accountability in relation to the administration of subcutaneous methotrexate
Demonstrate accurate record keeping in relation to subcutaneous administration of subcutaneous methotrexate
Discuss howmaintenance of competence will be ensured
Demonstrate the ability to organise the clinics, organise supplies of methotrexate and plan a programme of care for the individual patient
Demonstrate the following for patients referred for subcutaneous methotrexate:
Correct patient assessment and history taking
Appropriate selection of patients/carers for the self administration programme
Correct provision of written informed consent from the patient/ carer
Correct provision of information for patient/carers. This must include both verbal and written information on all aspects of the treatment, self care and action to be taken in the event of side effects
Correct documentation of evidence of training provided to the patient
Arranging appropriate follow up
Knowledge of the mechanisms by which the patient should contact the department/pharmacy/nursing team
Demonstrate safe administration of subcutaneous methotrexate
Demonstrate provision of correct patient information and education using the patient education pack (Appendix 3)
Demonstrate the actions to be taken in the following circumstances:
Skin, eye, or mucosal contamination with methotrexate
Spillage of methotrexate
Anaphylactic reaction
Discuss the rationale for folic acid supplementation in patients receiving subcutaneous methotrexate therapy.
Demonstrate adherence to the UHBFT infection Control policy throughout the procedure
Demonstrate knowledge of the UHBFT incident reporting process

I declare that I have expanded my knowledge and skills and undertake to practice with accountability for my decisions and actions.

I have read and understood the PROTOCOL FOR REGISTERED RHEUMATOLOGY NURSES TO ADMINISTER SUBCUTANEOUS METHOTREXATE AND TO EDUCATE PATIENTS AND CARERS IN THE SELF-ADMINISTRATION OF SUBCUTANEOUS METHOTREXATE

Signature of Registered Rheumatology Nurse: …………………………………………Print name:………………………………..

Date:………………………………………………

I declare that I have supervised this registered rheumatology nurse and found her/him to be competent as judged by the above criteria.

Signature of Supervisor:……………………………………………..Print name:………………………………..

Date: ……………………………………………..

A copy of this record should be placed in the registered rheumatology nurse’s personal file,a copy must be stored in the clinical area by the consultant rheumatology nurse and a copy can be retained by the individual for their Professional Portfolio.

Appendix 2

HOB PCT

EVIDENCE OF SUPERVISED PRACTICE

To become a competent practitioner, it is the responsibility of each registered nurse to undertake supervised practice in order toADMINISTER SUBCUTANEOUS METHOTREXATE AND TO EDUCATE PATIENTS AND CARERS IN THE SELF-ADMINISTRATION OF SUBCUTANEOUS METHOTREXATEin a safe and skilled manner.

Name of Registered Rheumatology Nurse: ………………………………………………….

DATE / DETAILS OF PROCEDURE / COMMENTS / OBSERVED BY / SIGNATURE AND DESIGNATION

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Protocol for registered rheumatology nurses to administer subcutaneous methotrexate and to educate patients and carers in the self administration of subcutaneous methotrexate.

Appendix 3

HOB PCT LOGO

HEART OF BIRMINGHAM PCT

MUSCULOSKELETAL AND RHEUMATOLOGY SERVICE

EDUCATION PACKAGE

INFORMATION FOR PATIENTS / CARERS

Patient Information: Methotrexate a therapy byunlicensed injection

Your rheumatologist has suggested that you try methotrexate to be given by injection subcutaneously (under the skin). This may be for one of the following reasons:

  • You are unable to tolerate methotrexate tablets due to side effects such as mouth ulcers, nausea, vomiting or diarrhoea.
  • You have already taken methotrexate tablets, which over a period of time have not improved your arthritis. Before completely stopping methotrexate it may be worth trying injections. Sometimes injections work better than tablets.

Methotrexate tablets have a license for the treatment of rheumatoid and psoriatic arthritis. However, at the moment only one type of subcutaneous methotrexate syringe (Metoject) has a license for the treatment of rheumatoid arthritis. Many specialists throughout the world use methotrexate injections for a variety of rheumatological conditions. It is unlikely that other companies who make methotrexate will apply for a license for giving methotrexate by injection becauseonly a small number of patients require injections with methotrexate.

  • Methotrexate has been prescribed and given by injection for many years with no apparent safety problems.
  • A Rheumatology specialist prescribes the drug for you. This doctor takes responsibility for your care, administration and supervision of the treatment. However the drug can only be safely used if you have regular blood checks and are able to attend either the rheumatology drug monitoring clinic or your GP practice nurse.

If you wish to know more please discuss it with your doctor, nurse or pharmacist. This information should be read in conjunction with the methotrexate leaflet provided by the Arthritis and Rheumatism Council (ARC).