Development of self - administered cytotoxic therapy progromme

Category:          Evidence-Based Practice/Evidence-Based Research

Name:               Gail Burbage

Job Title:           Rheumatology Specialist Nurse

Organisation:    Sherwood Forest Hospitals NHS Trust

Email:                gail.burbage@sfh-tr.nhs.uk

Telephone:        01623 676002

Key team:          Rheumatology Mutli-disciplinary Team - Consultants, OPD Staff, OT, Physio, Ward Staff And Specialist Registrar.

Title:               Development of a patient self-administration programme to administer subcutaneous methotrexate (cytotoxic therapy)

The efficacy of oral methotrexate (cytotoxic therapy) in Rheumatology is well established. Recent research has highlighted the need to rapidly increase dosages, however this approach has been limited by drug toxicity and poor efficacy. The rationale for administration of methotrexate by the parentral route was based on:

•  Improved bio-availability and tolerance of methotrexate
•  Reducing the side effect profile of oral administration
•  Sustaining treatment with methotrexate to extend the time before
•  More costly therapies  need to be introduced (biologics)

Intramuscular administration of methotrexate was introduced in our department 5 years ago. Patients attended weekly, many via hospital transport leading to increased cost and workload within the nurse led monitoring clinic. We undertook a retrospective analysis of the clinical and patient experience with intramuscular Methotrexate focusing on efficacy and side effects as well as patient satisfaction. There was a statistical significant reduction in disease activity. The qualitative arm of our review confirmed the finding of previously identified studies on compliance, inconvenience and cost on time but patients were happy to attend weekly for injection as they experienced significantly improved quality on life. This prompted us to explore the use of subcutaneous methotrexate.

Recent literature indicates that subcutaneous and intramuscular administration is interchangeable; subcutaneous is well absorbed, well tolerated and less painful, allowing a natural progression to self-administration. The improved efficacy on this modality is leading to recommendations for parentral methotrexate to be used prior to biologic agents.

The perceived benefits were to:

• Provide a less painful parental route for administration
• Develop patient self-administration at home
• Improving patient satisfaction
• Increase patient choice and independence

The evidence for subcutaneous methotrexate was presented to the patients user group who agreed that the option to self-administer methotrexate after completion of a training programme would benefit the patients and service.

A thorough risk assessment and literature search was undertaken prior to amending the scope of professional practice to enable the nursing staff to administer s/c methotrexate within the clinic, once the amended document had been approved training of staff and assessment of competence commenced. A clear explanation of the reasoning for change from intramuscular to subcutaneous administration was given to all patients within the clinic. The consultants and patients group provided invaluable assistance in the development of this initiative.

Prior to initiating self-administration a clear protocol was developed identifying inclusion and exclusion criteria and a training package for the patients with clearly identified assessment criteria that included risk assessment and manual dexterity. A pilot study took place with randomly selected patients enabling further risk assessment and ensured operational systems functioned safely before approval for this imitative was obtained form the Trust. Patients were then offered the option of training to self-administer methotrexate at home.

The multidisciplinary team and patients group agreed that in light of the evidence subcutaneous administration should be adopted within the unit. Implementation was governed by local trust policy and adherence to the Code of Professional Conduct (NMC 2002) and the Scope of Professional Practice (UKCC 1992). Agreement of hospital management and the consultants who are responsible for the care of these patients was sought based on the evidence. Consultation with the pharmacy department and the health and safety officer ensured a comprehensive risk assessment was undertaken and incorporated into both the protocol and revised Scope of Professional Practice document.

We have had an excellent uptake and established a waiting list for wishing to commence training.  An audit of clinical and patient experience focussing on efficacy, side effects and satisfaction was completed to evaluate the impact of this initiative.

The main challenges were:

Ensuring the training pack was user friendly. The patient’s group involvement was essential in this process.

the trust raised some concerns about patient self-administering a cytotoxic drug at home. A thorough risk assessment and pilot study undertaken evaluated prior to implementation.

The evaluation of this initiative found:

• Clinically acceptable and safe
• Greatest satisfaction from patient self-administering
• Improved efficacy via subcutaneous route in comparison to oral and Intramuscular.

The work undertaken within our department has been identified as good practice and led to involvement in the Royal College of Nursing working party   to develop a national guidance document on subcutaneous methotrexate and self-administration.  This document will be launched at the British Society for Rheumatology Annual Conference (BSR) in April 2004.