Adult Intrathecal Drug Delivery Service Guideline

• Summary
• Aims
• Background
• Diagnosis
• Assessment
  1. Referral and care pathway pre Implant
  2. Pump Implant
  3. ITDD Staff Training
  4. ITDD Drugs and Prescriptions
  5. Pump assessment, refill and adjustments
  6. ITDD Nurse Led Refill Service
  7. ITDD Adverse Events and Emergency SOPs
  8. Removal and Disposal of Intrathecal pump
• Contact details

Intrathecal Drug Delivery emergencies and urgent problems

ITDD Adverse Events and Emergencies

NB: For baclofen, refer to Intrathecal Baclofen use in adults (2020) Guideline to refer to any adult patients receiving Intrathecal baclofen

SOP for Intrathecal Drug Delivery Emergency/Urgent intrathecal pump problems (2021)
SOP - Intrathecal Drug Delivery Suspected Infection (2021)
SOP - Intrathecal Drug Delivery Suspected Granuloma (2021)
SOP - Intrathecal Drug Delivery- Managing complications when refilling Medtronic Synchromed II Intrathecal pumps (2021)

Summary

This guideline is to outline the patient care pathway and responsibilities of those involved in the care of adult patients with an Intrathecal Drug Delivery system at the LTHT under the management of Leeds Pain & Interventional Neuromodulation Service.
This document provides links to Clinical Forms, Standard Operating Procedures (SOP’s) and other relevant sources of information.

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Aims

To provide a comprehensive guideline for managing a safe and effective Adult Intrathecal Drug Delivery (ITDD) service
To outline the responsibilities of clinicians involved in the Adult ITDD Service
To provide access and links to documents to assist routine patient care and emergency patient treatment

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Background

Intrathecal drug delivery (ITDD) is the term used to describe the method of administering one or more prescribed drugs directly into the patients’ intrathecal space via an internally implanted pump at a specified rate determined by the prescriber.

LTHT Pain And Interventional Neuromodulation Service has an Intrathecal pump implantation and refill Service. Indications for the implantation of an Intrathecal pump within the service include Chronic Non-Malignant Pain, Malignant Pain and Chronic Spasticity. Drugs delivered via the intrathecal route by this service include Hydromorphone, Morphine Sulphate, Clonidine, Levobupivicaine, Bupivacaine, Ziconotide and Baclofen.

The pump consists of a programmable battery with a medication reservoir and a catheter implanted into the Intrathecal space. Once implanted the ITDD system is programmed with the drug concentration, the desired infusion rate and the reservoir volume.

The on-going care of a patient with an ITDD requires careful planning and monitoring.
The patients care will be managed in accordance with this Guideline, The Guideline for Intrathecal Baclofen Use in Adults, LTHT (2020) and Intrathecal Drug Delivery best practice guidance (BPS 2015, ITDD Polyanalgesic conference 2017). This document outlines the policy requirements for caring for a patient with an Intrathecal pump from referral to end of pump life within the LTHT.

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Diagnosis

Intrathecal drug delivery systems may be appropriate for patients with any condition with negative function impact from;

1. Chronic pain
2. Malignant Pain
3. Spasticity and / or Dystonia

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Assessment

Medical assessment of the patient must be undertaken by one of the implanting Pain or Neuro-Rehab Consultants to ascertain the suitability of ITDD for the individual patient.

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1.0 Referral and care pathway pre Implant

Referral for baclofen service as per Intrathecal Baclofen use in adults (2020) Guideline

Referral to the Adult Pain ITDD service

1.1 Patients with existing ITDD systems
Patients with ITDD systems implanted in other hospitals are referred to one of the Pain Consultants. The accepting consultant will refer the patients (if suitable) to the Nurse Led ITDD service. If possible, patients will be seen by the CNSs in outpatients prior to their next refill. The pump site, drugs and dosing schedules will be ascertained and their CMP and subsequent Intrathecal Prescription will be prepared.

1.2 New patients requiring ITDD systems
Patients deemed suitable for new ITDD implants should be reviewed by Pain Consultant and then referred to attend an information session provided by the CNSs. Depending on the condition to be treated, it may be necessary to apply for individual funding for the ITDD medication. Referral and care pathway as below.

1.3 Refer to Intrathecal pump care pathway.

1.4 Information Session
New patients are referred to the CNS’s for an ITDD information session. The information session forms the first part of the patients ITDD Care Pathway Document. This includes an explanation of the procedure, demonstration of the equipment to be used and the opportunity to discuss the risks, benefits and life style issues associated with implantation and on-going care. It also includes information regarding the prescribed medication that will be initiated on implantation. Patients’ physical and mental status and their suitability to proceed with the suggested ITDD procedure and subsequent medication with be assessed. The patient will then be given patient information leaflets relevant for them individually and contact details for the team if further advice/information is required.

1.5 Test Dose
An intrathecal test dose will routinely be required prior to proceeding with the implant. This involves a specified bolus of the drug(s) which are intended to be used into the intrathecal space.
Patients will attend theatre to undergo this procedure and an overnight stay may be required.
The Consultant will then assess and review the outcome of the test dose. A successful outcome from a test dose is required for patients to proceed to the implantation of an ITDD.

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2.0 Pump Implant

2.1 ITDD Pump Implant
Following a successful test dose, the patient will be listed for insertion of ITDD system.
Insertion of an ITDD should be undertaken in accordance with the Intrathecal Drug Delivery Implantation of an ITDD system in theatre SOP

The follow up care and discharge will be managed and arranged by the implanting Consultant. The patient should be advised about wound care management, relevant medication advice post implant and follow up care prior to discharge, including contact details of the Service and emergency care and support.

Following implantation, the implanting consultant may refer the patient to the Nurse Led ITDD refill Service for ongoing refills (refer to section 6.0 below). The patient should be reviewed at least annually by their Consultant and have a Clinical Management Plan (CMP) (refer below).

2.2 IT Pump Revisions and Pump Replacements
Revision of an ITDD system or replacement of an IT pump should be undertaken in accordance with the Intrathecal Drug Delivery Implantation of an ITDD system in theatre SOP

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3.0 ITDD Staff Training

3.0. Training and Registration of Designated Personnel

3.1 There are 3 stages in training of designated personnel with regards to Intrathecal Pumps in LTHT:

• Stage One: Basic competency - IT pump programming.
• Stage two: Advanced competency – advanced IT pump programming, assessment and management of a patient with an IT pump and refilling of IT pumps.
• Stage 3: Theatre competency - Pump and catheter insertion or pump replacement programming.

3.2 Basic Programming
Basic programming is defined as interrogation of the IT pump and altering only the fluid volume. This applies at a routine refill and can be undertaken by two specialist trained CNS’s or a consultant and a specially trained CNS.

3.3 Refilling the IT pump
Refilling the IT pumps refers to the skill of using the specifically designed refill kits to access the pump chamber, removing the old drug and replacing it with the new drug.

3.4 Advanced Programming
Advanced programming refers to IT pump drug and dosing adjustments, Patient Therapy Manager (PTM) bolus dosing and Flex dosing

3.5 Implant Programming
Implant programming refers to the initial in theatre pump programming following new implant or IT pump revision.

At each stage, medical and nursing personnel involved in the reprogramming, refilling and implant/revision of the ITDD system must undergo the specific company ITDD Training and have completed the relevant competency booklet and Supporting Evidence for Demonstrating Competency and Adjustment to Scope of Professional Practice document. They must have demonstrated knowledge and competencies required.

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4.0 ITDD Drugs and Prescriptions

4.1 ITDD Drugs and Prescriptions
Only the following intrathecal drugs will be administered by the Adult ITDD service;
Hydromorphone, Morphine Sulphate, Clonidine, Levobupivacaine, Bupivacaine, Baclofen, Ziconotide, Water for injection, Sodium Chloride.
Intrathecal Drugs will only be prescribed on one of the LTHT ITDD pink Intrathecal Drug prescription charts.
Intrathecal drugs should only be prescribed by one of the Adult ITDD Consultants or Clinical Nurse Specialist (CNS) Independent Prescribers. The CNS role in prescribing will be for patients remaining on the same drug concentrations. It is the role of the Consultant to prescribe:
For new ITDD patients
Changes to drug combinations
Changes to drug concentration
Initiation of flex regime
Initiation of PTM bolus

4.2 Ordering the IT drugs
An Intrathecal prescription will be verified by a Pharmacist and then ordered through Aseptics. The IT drugs should be ordered at least 24 hours in advance of the intended refill. The IT drugs are then prepared by the LTHT Aseptic Department.
If the drug is a controlled drug, Aseptics will require a CD order for this as per LTHT CD policy.

4.3 Receiving and Storing the drugs
The IT drugs will usually be received and checked into the Refill Department the day before or on day of the clinic and will be stored in accordance with LTHT policy.

Prior to commencing the refilling procedure, the patients IT drug will be pre checked by the two CNS’s or CNS and Consultant using the prescription chart. Any errors found with IT drug should be referred immediately to the Aseptic department for clarification.

Controlled drugs will be checked in by 2 personnel as per LTHT controlled drug policy.

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5.0 Pump assessment, refill and adjustments

5.1 ITDD Patient Assessment
Prior to any ITDD adjustment or refill, the patient will be assessed as per their individualised CMP using the ITDD Assessment form. Any outlined indications for referral back to the consultant or red flags from the assessments may result in patients not receiving their intended refill or adjustment and they will be referred back to the Consultant at the earliest opportunity. (note: it may be necessary for patient safety reasons to refill the pump and then refer back to the consultant at the earliest opportunity)

Assessments for patients with Chronic Pain
Pain VAS Score
Pump site for any signs of infection / inflammation
Any new or changes in medical condition
Neurological / mood Status
Blood tests as appropriate

Assessment for patients with Spasticity & Dystonia
Ongoing achievement of set goals
Assessment of muscle spasticity (Modified Ashworth Scale)
PENN Spasm frequency Scale
Pump site for any signs of infection / inflammation
Any new or changes in medical condition

5.2 Pump Refill and adjustments

5.2 Intrathecal pump refill
With exception (in urgent circumstances for patient safety), patients Intrathecal pumps should be refilled with 2 trained and competent practitioners (refer training above - section 3.0).

The patients Intrathecal pump will be refilled following the refill SOP’s:
Intrathecal Drug Delivery - Routine refills not requiring any medication dose or concentration change
Intrathecal Drug Delivery - Non-Routine refills requiring any medication dose or concentration change
Managing complications when refilling Medtronic Synchromed II Intrathecal pumps

Each person will work within their own competency and will refer to others when practice or knowledge is outside of this. Where there is not local guidance, advice will be followed and adhered to as per current best practice (Deer et al, 2017, BPS, 2015)

In addition to the Intrathecal Drug Delivery - Non-Routine refills requiring any medication dose or concentration change (LINK TO)
When changing concentrations of a patients drug regime where a patient has a My PTM (bolus button), a bridge bolus is required, during this time the patient will not be able to use their my PTM. At this time, the Consultant will need to consider if a dose increase is required to the ‘Simple continuous’ regime during bridge bolus to reduce the risk of drug withdrawal or severe pain. The risk/benefit of this will need to be carefully considered and dose will need to be calculated using average daily bolus’ and prescribed on the pink prescription.
If the drug concentration change does not involve the primary drug (i.e. the second or third drug) then the Consultant may need to consider if the effect on the patient not being able to use their bolus button exceeds the risk of overriding the bridge bolus. Again the risk/benefit will need to be considered and decided by the Consultant and documented in the patient’s medical records.
NB: The pump doses are programmed using the primary drug. The concentrations programmed for the primary drug MUST be correctly programmed and a bridge bolus MUST be performed when changing the primary drug.

5.3 ITDD Refill Intervals
The intrathecal pumps will be refilled in accordance with the current best practice guidelines (BPS 2015, and Deer et al 2017 and latest drug evidence) as follows;

5.4 Intrathecal pump adjustments
There may be times in between Intrathecal pump refills where the patient requires a dose adjustment. This must either be prescribed on the pink Intrathecal prescription and/or agreed as per CMP/PPM+ record with the Consultant.
This will be carried out as per the following SOP:
Intrathecal Drug Delivery - Routine programming of ITDD pumps not requiring refilling

5.5 ITDD pump refills off site (not within LTHT)
Occasionally it will be necessary to undertake a pump refill at the patients home or in another environment such as another hospital or hospice. This is a typical situation when patients are nearing end of life. This will be agreed with the patients Consultant. Refer to SOP for Intrathecal Drug Delivery Refills out of LTHT
There is also a procedures for ordering and handling IT drugs for off site use (Supply of controlled drugs to LTH Pain Service practitioners for administration in locations other than LTHT SOP - http://lthweb.leedsth.nhs.uk/sites/medicines-management-and-pharmacy/medicines-advisory-service/controlled-drugs/cd-standard-operating-procedures/cd-sop-all-areas/sops-section-one/CDSOP1.18%20Review%20of%20Controlled%20Drug%20Procedures.pdf

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6.0 ITDD Nurse Led Refill Service

6.1 Nurse Led ITDD Refill Service
The Nurse Led ITDD Service is available for LTHT Pain, Neurosurgical and Neuro Rehabilitation Consultants to refer patients for on-going assessment, pump refills / adjustments and general ITDD management. The service includes the management of patient clinic appointments, the programming / refilling of IT pumps and providing patients with advice and support and attending MRI scans.

The CNS Service will cover the hours Mon-Fri 8-4 and patients will be able to contact the nurses for non urgent support and advice in relation to their Intrathecal pump within these hours. Due to nurses clinical commitments, the Service may not be able to respond immediately to calls and messages and therefore urgent problems may have to be dealt with as emergency/urgent SOP above.

The refill service will be carried out following the Guidance in 5.0 above. Currently it is provided on 1-2 days per week with additional clinic sessions as required to meet patient demand.

The Nurse led ITDD Service is undertaken by the LTHT Chronic Pain CNS’s specifically trained to manage ITDD systems (training as section 3.0 above). Non-Medical Prescribers (NMP) CNS’s are able to titrate IT drugs as required within the agreed limits of the patients individual Clinical Management Plans with a second checker. Other trained CNS’s (who are not NMP) are able to re-program and refill pumps as per training 3.0/patient prescription.

Either two specially trained CNS’s or one pain team Consultant and/or one specially trained CNS will be available at all times where a ITDD is refilled or re programmed

An active data base of all patients currently receiving ITDD will be maintained by the CNS’s on a shared drive for access across the service. Details of the patients Consultant, primary drug, alarm date and refill date, equipment serial numbers and CMP renewal date will be recorded.

6.2 Clinical Management Plans (CMP)
On referring patients to the Nurse Led Service, the patient should have an individual CMP. The CMP will be discussed and agreed with the patient and signed by them, the Consultant and CNS. Copies should then be given to the patient and in the medical notes. The Consultant is responsible for reviewing the patient and CMP at least annually.

6.3 ITDD - MRI
The CNS’s also provide a post MRI check service. The following SOP will be followed for this:
SOP for patients requiring an MRI scan who have a Medtronic Syncromed II Intrathecal Drug Delivery pump implanted

6.4 Criteria for inclusion in the Nurse Led Refill Service
To be eligible for inclusion in the Nurse led Service, patients must:

• Be referred by one of the Pain team or Neuro Rehabilitation Consultants who have accepted overall ongoing clinical responsibility for the patient
• Have a completed signed Clinical Management Plan (CMP)
• Be on a stable dose of intrathecal medication or on an acceptable titration schedule

6.5 Criteria for exclusion from the Nurse Led Refill Service

• Patients who do not have a CMP
• Patients who refuse the service
• Intrathecal drugs required other than those listed in this Guideline

6.6 Criteria for referral back to the Consultant

• Patient refusal to have their pump refilled / adjusted
• Patient request to see consultant
• Uncontrolled pain or spasticity
• Outside titration limits
• Assessment flags of concern and Adverse Drugs Reactions
• Any specific circumstances documented in patients CMP

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7.0 ITDD Adverse Events and Emergency SOP’s

The following SOP’s will be followed for emergencies and urgent procedures

Intrathecal Drug Delivery Emergency/Urgent intrathecal pump problems (Out of hours, A&E attenders, inpatients in LTHT with an intrathecal pump)
Intrathecal Drug Delivery Suspected Infection
Intrathecal Drug Delivery Suspected Granuloma
Intrathecal Drug Delivery Managing complications when refilling Medtronic Synchromed II Intrathecal pumps
Intrathecal Baclofen Use in adults Guideline (2020)

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8.0 Removal and Disposal of Intrathecal pump

Removal and disposal of Intrathecal pump

NB: If a patient has died and is to be cremated, the pump must be removed before cremation.

Catheters can be disposed of in a large sharps bin for incineration.

Synchromed pumps must not be disposed of in yellow waste bags, as they cannot be incinerated.

Any explanted devices should be double bagged and sent to CSSD with an accompanying dated proforma.

The devices will then be cleaned and sterilised by ethylene oxide. Once they are returned with their accompanying certification they may be shipped to Medtronic/given to the rep for disposal.

Audit and Monitoring Compliance

NB: There is a separate Intrathecal Baclofen use in adults (2020) Guideline to refer to any adult patients receiving Intrathecal baclofen.

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Intrathecal Drug Delivery Service Contact Details

For Intrathecal Drug Delivery advice Mon-Fri 8-4:
Chronic Pain Nurse Specialists - 0113 3922178, 0113 3922446, 07766 360404 - Team Leader Jenny Jennings
Pain Consultants - Dr Sheila Black, Dr John Titterington (via switchboard)
For baclofen ITB pumps- Neuro-Rehabillitation Consultants - Dr Kanch Devinuwara, Dr Rory O’Connor (via switchboard) or Neurosurgeon Mr Sivakumar (implants baclofen pumps)

Out of Hours or urgent problems (or unable to contact above)
On-call Chronic Pain Consultant (via switchboard)
For baclofen ITB pumps-On-call Neuro-Rehabillitation Consultant (via switchboard)
On-call Neuro-surgical Team (via switchboard)

Medtronic Tech Team - 01923 201 805