Warning

Introduction

In the UK there have been fatal errors associated with the administration of intrathecal drugs. Administration of the wrong drug or dose intrathecally is likely to be fatal.

Adherence to this document aims to minimise the risk to patients receiving intrathecal chemotherapy within the Borders General Hospital.

This policy complies with the Scottish Executive Health Department document "Guidance on the Safe Administration of Intrathecal Cytotoxic chemotherapy".

Policy

  • all relevant staff must be aware of this policy and understand its impact on practice. Relevant staff includes doctors, nurses and pharmacy staff who are involved in the prescribing, dispensing, checking, delivery and administration of intrathecal chemotherapy.
  • only medical staff expereinces in the field of intrathecal therapy may administer intrathecal drugs.

Definition

For the purpose of this policy an intrathecal drug is an agent given by intrathecal injection as part of a chemotherapy regimen (Methotrexate or Cytarabine). See Appendix 1 of this policy for a list of drugs and the doses, which may be used intrathecally at BGH.

Other drugs may also be administered intrathecally, eg in the management of CNS infection.
Although this policy does not specifically deal with these areas, the good practice points stated within should be considered relevant to the prescribing and administration processes involved.

Training

  • All medical, nursing and pharmacy staff, must receive training appropriate to their level of involvement in the prescribing, verification, handling, preparation, delivery and administration of intrathecal drug therapy. Training plans for all professions involved will be held locally.

  • As part of their training staff must be made aware of the dangers associated with the inadvertent  administration of intravenous drugs by the intrathecal route. It is essential that all staff are aware of the fatal  consequences associated with the inadvertent administration of Vinca alkaloids, intended for intravenous use, by the intrathecal route.

  • Trainer and trainee should formally document training. The training will cover theory and practice. Training  will be deemed complete when the trainee and senior member of staff have signed the appropriate  documentation. At this point the trainees’ name will be placed on the intrathecal register, and proof of their training held within the central register.

  • An up to date register of personnel authorised to be involved with intrathecal chemotherapy will be  maintained and held in pharmacy and on all areas where intrathecal chemotherapy is administered. The register must be subject to appropriate document control.

  • Training will be the responsibility of the medical director for doctors, chief nurse for nurses and chief  pharmacist for pharmacy staff. It may be appropriate to delegate this responsibility to a senior member of staff within each of the professional areas.

  • It is the responsibility of the above professional leads to ensure regular review and updating of the list of accredited intrathecal practitioners within their area of responsibility.

  • Personnel on the register must be re-accredited every 2 years.

Prescribing

  • Prescriptions for intrathecal drug therapy must be written by a doctor, who has undergone the NHS Borders intrathecal training, and whose name appears on the intrathecal register.  Only consultants will be on the register.

  • The prescription should clearly state the route of administration, i.e. INTRATHECAL should be written in full. Abbreviations are not acceptable.

  • Intrathecal injections and injections of other drugs by other routes must not take place at the same time.

  • In-patients must not be scheduled to receive intrathecal injections on the same day as intravenous bolus  chemotherapy.

  • Out-patients may be scheduled to receive intrathecal chemotherapy and intravenous bolus chemotherapy on the same day. However, pharmacy will only release intrathecal doses when confirmation that intravenous bolus chemotherapy has been administered is received, in the form of the signed chemotherapy  administration chart.

  • Intrathecal drugs should be prescribed on a Borders General Hospital intrathecal drug prescription chart, which contains no other drug prescription.

  • A clinical pharmacist must professionally check all doses of intrathecal chemotherapy, and sign the intrathecal drug prescription chart.

Preparation, Labelling & Packaging

Preparation

  • Intrathecal drugs must always be prepared in pharmacy.
  • Intrathecal drugs will be dispensed in a luer lock syringe.
  • The intrathecal drugs supplied by pharmacy will be pre-filtered and in a “ready to give” form. They should never by adulterated.

Labelling

  • All intrathecal drugs will be labelled “FOR INTRATHECAL USE”.
  • The labelling will be on the syringe and the outer, red over-wrap.
  • All medication for intrathecal use will be given a “use immediately” expiry.


Packaging

  • Intrathecal medication will be supplied in sealed red plastic bags to highlight the fact they are different from intravenous drugs.
  • Intrathecal injections will be packaged in separate transport containers from cytotoxic chemotherapy to be administered by other routes. The delivery box will be labelled “CONTAINS DRUGS FOR INTRATHECAL ADMINISTRATION”. No other drugs will be placed in this box.

Delivery & Administration

Delivery

  • Intrathecal doses should be issued directly to a consultant or nurse who is on the NHS Borders register. This person will collect the medication from pharmacy. They must not collect any other items at the same time.
  • If the patient has received intravenous cytotoxic medication the consultant or nurse must produce a signed copy of the prescription to show that all bolus intravenous cytotoxic medication has been administered or intravenous infusions have been commenced before the intrathecal medication is released from pharmacy.
  • The member of pharmacy staff issuing the medication and the consultant or nurse collecting it will sign the prescription.
  • Intrathecal chemotherapy will only be collected from pharmacy when required for administration; intrathecal chemotherapy will not be stored in any clinical area.
  • If there is a delay the intrathecal chemotherapy must be immediately be returned to pharmacy for safekeeping until such time that the procedure can go ahead.
  • If the procedure is cancelled the intrathecal chemotherapy must immediately either be returned to pharmacy or put into sharps bin for destruction.

Administration

  • Patients must only receive intrathecal chemotherapy in designated areas where staff are routinely involved in the administration of drugs by the intrathecal route.

  • No other syringes containing bolus doses of any drug should be within the area where the intrathecal chemotherapy is being administered. It is however permissible to continue intravenous or subcutaneous infusions which are already connected.

  • Only a consultant whose name appears on the intrathecal register, may administer intrathecal drugs. Medical staff not on the register must not administer intrathecal drugs. The intrathecal register will be available in all areas where intrathecal chemotherapy is administered.

  • Scheduling of intrathecal therapy must take into account the availability of the above trained staff. If for any reason, the required trained personnel are unavailable, the administration of intrathecal drugs should be delayed.

  • Prior to administration, patients and/or carers should be explicitly told the nature of the procedure, route of administration and drug being given.

  • Prior to administration the doctor must verify the prescription, and complete the administration checklist on the intrathecal drug prescription chart with a chemotherapy trained staff nurse whose name appears on the intrathecal register. The doctor and nurse must tick off the checks when they are made and initial that the administration checklist has been completed. The doctor and nurse must then sign the prescription chart in the “administered by” and “checked by” sections respectively. The nurse must witness the intrathecal injection being administered.

  • Intrathecal administration of chemotherapy must be scheduled to take place during the normal working day. 

  • Ensure FBC checked within 24 hours of administration and that platelet count is >50 (10˄9/l) prior to procedure.

  • Ask patient to lie in the left lateral position with their knees bent up to their chest, exposing the area from the lower ribs to mid-buttock. Using a non-touch technique open the equipment and drop onto the sterile dressing sheet. 

  • Once complete as the patient to lie supine for 30 minutes following the procedure in order to minimise
    the risk of post lumbar puncture headache.

  • See appendix 2 for list of equipment required.

Policy for Vinca alkaloids

Due to the fatal consequences associated with the inadvertent administration of Vinca alkaloids by the intrathecal route in the past, the following policy will apply.

  • Vinca alkaloid doses will be labelled:
    “FOR INTRAVENOUS USE ONLY – FATAL IF GIVEN BY OTHER ROUTES”.

  • All adult Vinca alkaloid doses will be diluted to a minimum volume of 50ml in an infusion bag

Professional Responsibility

Intrathecal administration of drugs is an extremely high-risk procedure. This policy must be adhered to at all times. All staff involved in the care and treatment of patients receiving intrathecal chemotherapy must be encouraged to ensure that this policy is adhered to at all times. Deviations from protocol are not acceptable.

If any member of staff has any doubts regarding their responsibilities they should immediately contact their line manager to seek clarification and, if necessary, further training.

Any member of staff who judges that the policy is not being adhered to or who considers that the actions of an individual may cause potential risk to a patient, must challenge that individual in order to ensure patient safety & the procedure should be suspended until any deviations have been rectified.

Appendix 1- Commonly used Intrathecal Drugs and Doses within Borders General Hospital

Drugs Prescribed by the Intrathecal Route as part of Chemotherapy
Regimens within Borders General Hospital
  Usual Dose Range
Methotrexate 12.5-15mg
Cytarabine 40-70mg

Appendix 2 - Equipment required for procedure

  • Spinal needle x 2 (22GA – 0.7 x 90mm)
  • 5ml sterile syringe
  • 10ml sterile syringe
  • 21G sterile needle
  • 25G sterile needle
  • Sterile dressing pack
  • Unisept sterile solution
  • 10ml of 2% Lignocaine
  • Sterile gloves
  • Blue underpad
  • Mepore
  • 3 Sterile universal containers

Appendix 3 - Borders General Hospital Intrathecal Chemotherapy Assessment Questions (Core & Nursing)

Core Questions

1.  What was the main instigator for the development of strict intrathecal chemotherapy
     guidelines within the NHS?

  1. It is in line with new health and safety recommendations
  2. Fatalities caused by the accidental administration of intravenous vincristine by the intrathecal route.
  3. Someone felt like forming another committee
  4. Accidents involving the administration of intrathecal drugs by the intravenous route.

2. Where can you check who is authorised to administer intrathecal chemotherapy within your
    Trust?

  1. The Trust intrathecal register of authorised personnel.
  2. The national intrathecal register
  3. Through the BMA
  4. By asking them

3. What grade(s) of medical staff, within the BGH, are authorised to prescribe to administer
     intrathecal
chemotherapy?

  1. Consultants only
  2. Senior registers and Consultants only
  3. SHO3s, Senior registrars, Associate specialists and Consultants
  4. Senior registrars, Associate specialists and Consultants

4. How frequently must staff demonstrate they are up to date with Trust intrathecal policies?

  1. Every year
  2. Every 2 years
  3. Bi-annually
  4. Once they are on the intrathecal register they don’t need to do any updates.

5. Intrathecal chemotherapy doses should be prepared where?

  1. Within a pharmacy aseptic unit
  2. On the ward
  3. In the pharmacy dispensary
  4. Can be done anywhere as long as aseptic technique is used.

6. In which clinical areas are copies of the Trust intrathecal register of authorised personnel kept?

  1. Pharmacy and all areas where intrathecal chemotherapy is routinely administered.
  2. All wards and department
  3. Pharmacy only
  4. Wards only.

7. Who is authorised to collect intrathecal chemotherapy from the pharmacy?

  1. a) Medical and nursing staff who are on the intrathecal register.
  2. b) Pharmacy, nursing, theatre and medical staff who are on the intrathecal register.
    c) Anyone, as long as they sign for receipt.
    d) No one – Pharmacy staff should deliver directly to ward.

8. Can intravenous bolus doses of chemotherapy and intrathecal chemotherapy be administered to
    the same patient on the same day?

  1. Yes
  2. No
  3. Yes, but only if they are an out-patient
  4. Yes, but only if they are an in-patient.

9. If the answer is yes to the above, what precautions must be made?

  1. Intravenous bolus will be supplied first and only when confirmation is received that they have been given, will be intrathecal doses be released from pharmacy.
  2. Intrathecal doses will be supplied first and only when confirmation is received that they have been given, will the intravenous bolus doses released from pharmacy.
  3. No precautions are necessary.
  4. The patient must be told of the risks involved.

10.Where can intrathecal drugs be stored on the ward?

  1. Intrathecal doses will never be stored on the ward.
  2. In the locked drug fridge
  3. In a separate lockable area specifically for intrathecal doses.
  4. On the bench in the treatment room.

11.What type of prescription chart must intrathecal chemotherapy be prescribed on?

  1. A fluid chart with no other drugs prescribed on it
  2. The once only section of the patient’s drug kardex
  3. The regular prescriptions section of the patient’s drug kardex.
  4. A Trust specific intrathecal drug prescription chart.

12.What members of staff must be involved in the administration checking procedure for
      intrathecal chemotherapy?

  1. A doctor whose name appears on the intrathecal register and any trained staff nurse.
  2. A consultant and chemotherapy trained nurse – both whom appear on the Trust register for intrathecal chemotherapy.
  3. A register and chemotherapy trained nurse.
  4. Anyone whose name appears on the Trust intrathecal register.

13.What information should patients and/or carers be given prior to the administration of
      intrathecal chemotherapy?

  1. The fact that they are about to receive an injection.
  2. The nature of the procedure, route of administration and drug being given.
  3. The route of administration and how it may feel.
  4. Nothing routine is necessary

Nursing Assessment Questions

1. What checks are required prior to administration of intrathecal drugs?

  1. No checks are required.
  2. Patient name only.
  3. Patient name, drug and dose, diluents, expiry date and time.

2. Which members of staff may check intrathecal chemotherapy prior to administration?

  1. Care assistant and doctor.
  2. Staff nurse and doctor, both of whom have undertaken cytotoxic training and whose names appear on the Trust intrathecal register.
  3. Any staff nurse and any doctor on the ward.

3. What details should be confirmed with the patient prior to administration of an intrathecal              drug? 

  1. No confirmation of any details required.
  2. Patients’ name to be confirmed with them.
  3. Confirm patients’ name, address and telephone number

4. Is it necessary for the nurse checking the intrathecal chemotherapy to observe it being given?

  1. No
  2. Yes
  3. It only has to be observed if the nurse is not familiar with the patient

 

 

Editorial Information

Last reviewed: 31/03/2023

Next review date: 31/03/2025

Author(s): Nicol E.

Version: Phar062/04

Author email(s): eileen.nicol@borders.scot.nhs.uk.

Co-Author(s): Gibson V.

Approved By: Borders SACT Group & Cancer Governance Group

Reviewer name(s): Nicol E.

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