Policy for administration of intrathecal chemotherapy

3.1 The following staff must be aware of this policy and understand its impact on practice:

• All medical staff involved in the prescribing and/or administration of intrathecal chemotherapy
• All registered nursing staff involved in the checking of intrathecal chemotherapy
• All clinical pharmacists involved in screening and verification of intrathecal chemotherapy prescriptions
• All pharmacy staff working within the aseptic unit involved in the preparation and issue of intrathecal chemotherapy. As processes within the aseptic unit are identical within adult and paediatric practice these staff will only appear on the GG&C adult register

3.2 Register of Designated Personnel: 

• An up to date register of personnel authorised to be involved with intrathecal chemotherapy is maintained and accessible in all areas where intrathecal chemotherapy is administered. The adult register is held electronically on StaffNet.  The paediatric register is held within the “Sch dbs” shared folder.  It is maintained and updated by the Quality Manager/Unit Administrator upon receipt of completed documentation from the Lead Trainers for Medical and Nursing staff.
• The Head of the Women & Children’s Directorate, the Associate Medical Director, Lead Clinical Pharmacist, Head of Nursing for Women and Children’s Directorate and the Lead Clinician for Systemic Anti-Cancer Therapy Services for Paediatrics are all aware of the register and can request access where necessary. A copy of the paediatric register is emailed to key staff and also forwarded post each update to the Quality Assurance Support Officer for the Adult SACT team who uploads it to the Adult SACT webpage on Staffnet.  A hard copy of the list is visible in both the Ward 2A and 2B doctor’s office.
• It is the responsibility of the above named lead professionals to ensure the register is regularly reviewed and updated. This responsibility is delegated to the administrator of the register or their named deputies. To remain on the register, professional staff must demonstrate competency to fulfil their designated roles and be certified competent as such by an appropriate trainer for the administration of intrathecal chemotherapy, every two years.
• It is the responsibility of the Lead Pharmacist for Preparative Services for GG&C to ensure that staff working within pharmacy aseptic facilities are given appropriate training on this policy, are regularly reviewed and their details are updated on the GG&C adult register. To remain on the register, professional staff must demonstrate competency to fulfil their designated roles and be certified competent by their appropriate lead professional for the administration of intrathecal chemotherapy.

3.3 Education & Training:

• All medical, nursing, pharmacy and theatre nursing staff must receive training appropriate to their level of involvement in the prescribing, supplying, checking, and/or administration of intrathecal drug therapy. Completed training plans for all professions involved are held within the “Sch dbs” shared folder.
• 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 well documented and fatal consequences associated with the inadvertent administration of Vinca alkaloids.
• Both the trainer and trainee should formally document training. The training provided will be relevant to the individual’s involvement in the process. Once training has been successfully completed the lead for that speciality will formally communicate this to the administrator of the register.

3. 4 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 ensure that this policy is adhered to at all times. Deviations from this procedure 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 deemed necessary, further training will be provided.
• 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.

4.1 Intrathecal Chemotherapy Prescription Form.

4.2 Access to Adult & Paediatric Intrathecal Register

4.3 Personal Protective Equipment (PPE) –personal protective equipment/PPE should be worn for administration of all SACT. This includes:

• Sterile gloves
• Plastic apron
• Armlets
• Goggles/glasses/eye protection
• Face mask when opening capsules

PPE should also be worn when disposing of unused SACT in a purple sharps box which should be securely closed as per hospital policy in a yellow clinical waste bin held within the locked waste cupboard.

5.1 Prescribing:

• Registered medical practitioners of ST4 level and above, staff in a nonconsultant career grade and consultants, who are currently named on the register, can prescribe intrathecal chemotherapy.
• Chemotherapy must be prescribed on an NHS GG&C standardised preprinted or validated electronic intrathecal drug prescription chart. This chart must be completed legibly and be both signed and dated by the prescriber. Addressograph labels MUST be used on all copies of the prescription form.
• Dose variations are only permitted in line with detailed and authorised local or national protocols which are available within the unit.
• All prescriptions for intrathecal chemotherapy must be received by a chemotherapy competent pharmacist on the register before 3pm the day prior to the therapy being required. If prescriptions are not received prior to this time the procedure will require to be rescheduled.
• The intrathecal administration of chemotherapy must be scheduled to take place during the normal working day, ie between 10am and 5pm Monday to Friday. In the rare and exceptional clinical case where intrathecal chemotherapy is required out of hours or over a weekend or public holiday, the consultant in charge must make this request via the on-call pharmacist. No formal system is currently in place to allow this to happen, however, attempts will be made to contact the appropriate staff to try to facilitate this in life-threatening situations.

5.2 Preparation & Dispensing:

• All intrathecal prescriptions are screened and double-checked by chemotherapy-competent pharmacists named on the register to ensure an intrathecal chemotherapy preparation is indicated, the appropriate dose is prescribed and a doctor currently on the register has completed the prescription appropriately.
• Intrathecal chemotherapy is prepared in the pharmacy aseptic unit in the Royal Hospital for Children by trained pharmacy personnel named on the adult register and in accordance with all relevant procedures.

5.3 Labelling, Packaging & Storage in the Pharmacy:

• All intrathecal chemotherapy is labelled with the route of administration ‘FOR INTRATHECAL USE ONLY’ clearly displayed.
• All intrathecal chemotherapy is packaged individually inside a sealed, red cytotoxic bag clearly marked for INTRATHECAL PRODUCTS ONLY. The outside of the bag will be labelled with an individual patient label.

5.4 Issue of Drugs from Pharmacy:

• Intrathecal chemotherapy will be issued from the pharmacy aseptic unit at the Royal Hospital for Children. These will be issued individually with the appropriate prescription and as a separate item. The details on both the product and the prescription must be checked by the issuer and collector and the appropriate documentation completed. Intrathecal chemotherapy must NEVER be issued with chemotherapy for any other route. When a designated intrathecal theatre list is being performed, the intrathecal chemotherapy can be collected for all patients named on the theatre list, however, each patient’s treatment must be checked off separately as above.
• Intrathecal chemotherapy will only be issued to medical staff named on the register and this must be the individual who is administrating the intrathecal chemotherapy. For the purposes of training staff both the trainee and the supervisor must sign for the issue.

5.5 Timing of Issue from the Pharmacy: 

• For outpatients only; if both intrathecal and intravenous bolus chemotherapy are scheduled on the same day, they must not be given at the same time or within the same designated patient area. Only when the pharmacy staff within the aseptic unit receive written confirmation that the intravenous drug(s) has been given, i.e. a copy of a signed prescription confirming the administration of the intravenous bolus dose, will the intrathecal drug(s) be released for that patient.
• Inpatients must be scheduled to receive all intravenous bolus chemotherapy and all intrathecal chemotherapy on different days.
• Intrathecal chemotherapy and any Vinca Alkaloid chemotherapy must be administered on the same day.

NB: Any out-patient having a bone marrow aspirate MUST be given any scheduled intravenous bolus chemotherapy prior to theatre. Inpatients MUST be scheduled to have intravenous bolus chemotherapy on a different day from the bone marrow aspirate.

5.6 Patient Review:

• An appropriately trained medical professional or advanced nurse practitioner must review the patient prior to the administration of intrathecal chemotherapy. They must ensure the patient is fit for treatment, correct investigations have been conducted and reviewed and the appropriate arrangements have been organised to allow the therapy to be administered.
• Consent must be obtained from parent/carer/patient (as appropriate) ensuring they are aware of the nature of the procedure, route of administration and the drug being given.

5.7 Administration of Drug(s):

• Patients must only receive intrathecal chemotherapy in designated areas where staff are routinely involved in the administration of drugs by the intrathecal route.
• Designated areas within the Royal Hospital for Children for intrathecal chemotherapy are:
  
  • The ward treatment room in ward 2A(Schiehallion ward) – SCH-079
  • Treatment Room 1 in the Ward 2B (Schiehallion Day Care Unit)
  • Areas where general anaesthesia is being administered to the patient, i.e. theatre suite, MRI, PICU and interventional radiology.
• Intrathecal chemotherapy and intravenous bolus chemotherapy should never be administered at the same time or within the same designated area.
• Only a doctor at ST4 level or above, staff in a non-consultant grade and a consultant whose name appears on the intrathecal register, may administer intrathecal chemotherapy.
• For administration of intrathecal chemotherapy, the only syringes in the operating field of the patient are those containing intrathecal chemotherapy. Where local anaesthetic is given the administering syringes and needles must be removed from the field prior to the spinal needle being placed in the patient.
• Intravenous and/or subcutaneous infusions may be left in progress during the procedure. These must not be manipulated in any way while performing the lumbar puncture.
• Within paediatric practice many patients will receive intrathecal chemotherapy under general anaesthesia and, therefore, an exception must be made for drugs used to induce and maintain anaesthesia. Anaesthetists, however, must ensure all drug syringes are away from the sterile field prior to the administration of the intrathecal chemotherapy.
• Only a registered nurse, whose name appears on the intrathecal register, can check intrathecal drugs.
• Checking of intrathecal chemotherapy must be carried out as detailed in the “Safe & Secure Handling of Medicines in Hospital Ward, Theatres & Departments” policy.
• The intrathecal register must be available in all areas where intrathecal chemotherapy is administered.
• Any intrathecal cytotoxic drugs which are not administered to a patient must be discarded in a cytotoxic sharps box in the clean utility on Ward 6A or the clean utility room (shared with adults) on Ward 4B at QEUH; this must be documented and witnessed on the appropriate intrathecal prescription form which should then be returned to the Pharmacy Office near Ward 6A (POD 36).
• The aseptic unit must also document the destruction of any intrathecal products which are not collected and ensure a copy of this destruction is returned to the Pharmacy Office near Ward 6A (POD 36).
• The completed intrathecal chemotherapy prescription forms must be filed appropriately in the patient’s case records and subsequently scanned onto the patient’s electronic record.

This SOP will be reviewed every two years.

This procedure is subject to external audit under the Intrathecal Cytotoxic Chemotherapy Administration checklist contained within the CEL 2009 (21) guidance. Audits are normally performed every 3 years.

There are no exceptions to this SOP and deviations are not acceptable.

For further information contact:

Dr Nicholas Heaney
Royal Hospital for Children, Glasgow
Tel: 0141 201 0000, Page 8116 9.