Non-chemotherapy Intrathecal Drug Protocol

• Aims
• Background and indications for protocol
• Procedures

Aims

To minimise the risks associated with the prescribing, preparation, supply and administration of non-cytotoxic intrathecal and intraventricular injections.

Background and indications for protocol

The preparation and administration of all intrathecal and intraventricular injections are high risk processes and potentially associated with serious safety risks.

The intrathecal and intraventricular route should only be used where there is a clear evidence of efficacy.

The administration of intrathecal and intraventricular drugs must only be undertaken by staff that have undergone appropriate training and are assessed competent to participate in the process by the nominated lead. This will be documented in the pathway for each service registered with the CSU.

The guidance applies to all members of staff working within Leeds Teaching Hospitals NHS Trust who are involved in prescribing, preparation, supply and administration of non-cytotoxic intrathecal and intraventricular injections. This includes infusions for refilling implantable pumps.

This does not cover routine intrathecal spinal anaesthesia and analgesia.
This does not cover intrathecal chemotherapy.

This should be read in conjunction with the Injectable Medicines Policy and the Medicine Policy.

Definitions

Non-cytotoxic intrathecal injection - an injection of a non-cytotoxic drug into the intrathecal space surrounding the spinal cord.

Non-cytotoxic intraventricular injection - an injection of a non-cytotoxic drug for diffusion through the ventricular and subarachnoid space by means of a ventricular puncture.

All references to an intrathecal medicines/route in the following paragraphs should be read as equally applicable to intraventricular medicines/route.

Procedures

Prescribing

• Intrathecal and intraventricular medication must only be prescribed by a consultant or Specialist Registrar.
• The word  “intrathecal” or “intraventricular” must be written in full on the drug chart, anaesthetic chart or highlighted on eMeds and must not be abbreviated.

All prescribing of Intrathecal and intraventricular medication should be performed within the working hours of 7am-7pm. Except in exceptional circumstances.

Preparation

• Risks associated with the intrathecal route of administration should be considered when deciding the most appropriate location for preparation.
• Preparation in Pharmacy Aseptics will be the most appropriate location for preparation in the majority of cases.
• Preparation of Intrathecal and intraventricular medication should be performed within the working hours of 7am-7pm. Except in exceptional circumstances.

Pharmacy Aseptics

• All infusions for refilling implantable pumps must be made by Pharmacy Aseptics
• Preparation of non-cytotoxic intrathecal bolus injections whenever possible should be by Pharmacy Aseptics
• All bespoke requests for non-cytotoxic intrathecal infusions should be received in pharmacy 48 hours in advance for planned procedures, except in exceptional circumstances.
• All requests should be ordered on standard Pharmacy Aseptics ordering forms, with the route written in full.
• Clinical and compatibility checks should be performed for all requests before preparation. The clinical validation is carried out by the ward pharmacist and aseptics verification by the Pharmacy Aseptics team.
• Non-cytotoxic intrathecal medicines prepared by pharmacy will be pre-filtered and in a “ready to administer” form. They should not be tampered with.

Clinical area

• On the rare occasions where a preparation of an intrathecal bolus injection within the clinical are has been deemed necessary, the preparation and administration must always be performed by or under the direct supervision of a consultant/Specialist Registrar who is competent in the technique.

Labelling

• Labels on individual doses of intrathecal medication must show clearly the
• Patients full name
• Name of the product
• Dose
• The route of administration clearly printed and in bold
  “FOR INTRATHECAL USE ONLY”
• Negative labelling must never be used
• It must remain in the outer bag until immediately prior to administration

Packing

• Non-cytotoxic intrathecal medication must be packaged and transported separately from treatments which are to be administered by other routes.

Transportation and Storage

• Intrathecal medication should be transported from pharmacy in sealed bags/containers which are distinct from bags/containers used for any other purposes.
• All bespoke non-cytotoxic intrathecal medication received on the ward should only be used for the named patient.
• If the non-cytotoxic intrathecal drugs unavoidably requires storage for a short period this should be done within the outer plastic bag and kept in a separate designated area.

Administration

• Only Consultants and specialist registrars (or a trainee under direct supervision) may administer a non-cytotoxic intrathecal injection. Nurse practitioners who have been appropriately trained, and are on the trust register may refill an intrathecal drug pump reservoir.
• The healthcare professional preparing to administer a non-cytotoxic intrathecal must verify details to ensure that the correct medicines and the correct dose are given to the correct patient by the correct route at the correct date and time.
• The details must be verified by an appropriate (as determined by the CSU) second person and checks must be recorded (this includes checking the setting of the refill programmer for intrathecal pumps).
• When refilling pumps print a copy of programming details and place in the patients records.

• Administration of the intrathecal non-cytotoxic should, whenever possible, be in designated areas where staff is routinely involved in the administration of drugs by the intrathecal route. Currently these are:
  • Non-cytotoxic intrathecal medication must be administered at a distinctly different time to that of other concomitant injectable medication.
  • Wherever possible non-cytotoxic intrathecals must be prepared and administered within normal working hours.
  • If the patient is seriously ill or in isolation to avoid infection, they may not be able to be moved to a designated area for intrathecal administration. The responsible consultant must in these circumstances directly authorise the administration of the product in the most suitable area for the patient. The responsible consultant must ensure that safeguards are undertaken to ensure that this process closely managed and all risks are assessed. This must be documented in the patients notes.
  • Individual departmental procedures must be followed (e.g. for refill of pumps).
  • The NPSA has issued a Patient Safety Alert which required that from 1 April 2011 all spinal (intrathecal) bolus doses are performed using syringes, needles and other devices with connectors that do not all connect with intravenous Luer connectors.

Education and Training
All staff involved in the prescribing, preparation, supply, collection and administration of non-cytotoxic intrathecal medication must be suitable trained and deemed competent to carry out the relevant task.

• Speciality specific guidelines must be produced for the use of non-cytotoxic intrathecals. The local guideline should be readily accessible for all healthcare professionals involved in the process.
• Medical, nursing, pharmacy and all other relevant staff must receive appropriate training to their level of involvement in the process
• Staff programming and/or checking the intrathecal pump programmer must ensure they have undergone the relevant training for the device used.
• Training for all professionals involved will be coordinated by the Nominated Lead individual for each clinical area. The training for each area will be specified in the clinical areas review of their area.
• All staff transferring to the Trust must be inducted and assessed as competent by the appropriate nominated lead individual(s).
• It is the responsibility of each practitioner to ensure that as part of their Continuing Professional Development/Appraisal they maintain practical experience.
• All near misses and incidents relating to non-cytotoxic intrathecals must be recorded via the Trusts DATIX system.

References
The Prevention of Intrathecal Medication Errors - A Report to the Chief Medical Officer - Department of Health 2001

Guidance on the Safe Handling of Intrathecal and Intraventricular Injections - HDL (2006) 11 issued by the Scottish Executive Health Department

Safer practice with epidural injections and infusions - National Patient Safety Agency 2007

Intrathecal drug delivery for the management of pain and spasticity in adults; recommendations for best clinical practice - The British Pain Society - August 2008

Associated documentation

• Medicines Policy
• Injectable Medicines Policy
• Intrathecal Cytotoxic Chemotherapy Policy