1. Delivery of Intrathecal Chemotherapy Kowloon Central Cluster 10Jan08

2. Background Inadvertent intrathecal administration of vincristine intended for intravenous administration have occurred in Hong Kong resulting in death Inadvertent intrathecal administration of vincristine intended for intravenous administration have occurred in Hong Kong resulting in death

3. Tolerance

4. HA Guideline on Safe Handling of Intrathecal Chemotherapy (18Sep07) Policy Policy Training and Competence Training and Competence Prescribing Prescribing Dispensing and Preparation Dispensing and Preparation Labelling, Packaging and Delivery of intrathecal chemotherapy Labelling, Packaging and Delivery of intrathecal chemotherapy Administration Administration Extra Precautions to avoid inadvertent administration of vinca alkaloids by intrathecal route Extra Precautions to avoid inadvertent administration of vinca alkaloids by intrathecal route

5. Policy Written Instruction Written Instruction Designated Officer Designated Officer Cross-check Cross-check

6. Designated Officer Assigned by COS Assigned by COS

7. Cross Check At least 2 persons At least 2 persons All specialty All specialty 3 Checks 5 Rights 3 Checks 5 Rights Documentation Documentation

8. Working Instruction Staff Staff Training Training Procedure Procedure Must not contravene HA guideline Must not contravene HA guideline

9. Working Instruction Not to disturb the routine Not to disturb the routine To reinforce the routine To reinforce the routine

10. Staff on list Medical and Nursing staff of Department Medical and Nursing staff of Department Trainee from other unit or hospital are not allowed unless approved by designated officer after proper training and assessment Trainee from other unit or hospital are not allowed unless approved by designated officer after proper training and assessment List of trained staff should be available and update regularly List of trained staff should be available and update regularly

11. Training and Competence Organized by designated officer of department on intrathecal chemotherapy Organized by designated officer of department on intrathecal chemotherapy Lecture & working instruction and assessment at bedside Lecture & working instruction and assessment at bedside At least yearly or after revision of instruction or new staff joining the department At least yearly or after revision of instruction or new staff joining the department

12. Procedure Prescribing Prescribing Dispensing and Preparation Dispensing and Preparation Labelling, Packaging and Delivery of intrathecal chemotherapy Labelling, Packaging and Delivery of intrathecal chemotherapy Administration Administration

13. Procedure Prescribing Prescribing Dispensing and Preparation Dispensing and Preparation Labelling, Packaging and Delivery of intrathecal chemotherapy Labelling, Packaging and Delivery of intrathecal chemotherapy Administration Administration

14. Procedure Prescribing Prescribing Dispensing and Preparation Dispensing and Preparation Labelling, Packaging and Delivery of intrathecal chemotherapy Labelling, Packaging and Delivery of intrathecal chemotherapy Administration Administration

15. Intrathecal Chemotherapy Agent Agent Indication Indication Route Route Protocol Protocol

16. Agent Methotrexate Methotrexate  50mg preparation Cytarabine ( Ara-C ) Cytarabine ( Ara-C )  100mg preparation  without benzyl alcohol solvent Hydrocortisone Hydrocortisone  100mg preparation

17. Indication CNS prophylaxis CNS prophylaxis  Burkitt lymphoma  Testicular lymphoma  Parameningeal extension  Acute Leukaemia Leptomeningeal disease Leptomeningeal disease  e.g breast or lung cancer

18. Route Lumbar puncture Lumbar puncture

19. Route Intrathecal port Intrathecal port

20. Route Lumbar puncture Lumbar puncture Intrathecal port Intrathecal port Ommaya reservoir Ommaya reservoir

21. Protocol SUMC ( Burkitt lymphoma ) SUMC ( Burkitt lymphoma ) q3wk q3wk MTX 12mg Day 1 & Day 10 MTX 12mg Day 1 & Day 10 Total 10 doses Total 10 doses

22. Protocol HyperCVAD ( Burkitt lymphoma ) HyperCVAD ( Burkitt lymphoma ) q3wk q3wk MTX 12mg Day2 + Ara-C 100mg Day7 MTX 12mg Day2 + Ara-C 100mg Day7 Total 16 doses Total 16 doses

23. Protocol Acute Leukaemia Acute Leukaemia

24. Protocol Leptomeningeal disease Leptomeningeal disease MTX 12mg + Ara-C 100mg MTX 12mg + Ara-C 100mg 2 times per wk till CSF negative then weekly 2 times per wk till CSF negative then weekly

25. Vincristine Fatal if given intrathecally Fatal if given intrathecally

26. Pre-printed MAR-ITC MAR-IT-MTX MAR-IT-MTX MAR-IT-ARAC MAR-IT-ARAC MAR-IT-LM MAR-IT-LM

27. Prescription One of the medical staff involved ( prescription / verification ) must be specialist One of the medical staff involved ( prescription / verification ) must be specialist Label with patient particular 5/116/11 S1 S2

28. Dispensing, Preparation, Packaging and Delivery of Drug All intrathecal chemotherapy must be prepared by Aseptic Dispensing Unit QEH All intrathecal chemotherapy must be prepared by Aseptic Dispensing Unit QEH MAR-ITC should be sent to ADU one day before the injection MAR-ITC should be sent to ADU one day before the injection QEH pharmacy policies in safe administration of intrathecal chemotherapy for further details QEH pharmacy policies in safe administration of intrathecal chemotherapy for further details

29. Administration Within normal working hour and day ( Monday to Saturday 12pm ) Within normal working hour and day ( Monday to Saturday 12pm ) Should not be initiated at the same time with other intravenous drug Should not be initiated at the same time with other intravenous drug Trained staff or trainee under direct supervision of trained staff Trained staff or trainee under direct supervision of trained staff Staff & patient should not be distracted during the procedure Staff & patient should not be distracted during the procedure In protected area with “sign of intrathecal chemotherapy in progress” hanged on after check In protected area with “sign of intrathecal chemotherapy in progress” hanged on after check Check patient record & chemotherapy protocol Check patient record & chemotherapy protocol Follow the step on MAR-ITC Follow the step on MAR-ITC

30. Administration Last check should be the most important check Last check should be the most important check      

31. Documentation   6/11 S3 S4 S5

32. Documentation Label with patient particular 5/116/11 S1 S2 S4

33. Call for help Lumbar puncture Lumbar puncture Access to intrathecal port Access to intrathecal port Must follow the checking step before injecting drug Must follow the checking step before injecting drug

34. Caution Injecting substance without labeling Injecting substance without labeling

35. Additional measures for vinca alkaloids All intravenous doses of vinca alkaloids must be diluted in at least 50ml infusion minibags for adults and 10-20ml syringe for paediatrics to distinguish them from intrathecal drugs. All intravenous doses of vinca alkaloids must be diluted in at least 50ml infusion minibags for adults and 10-20ml syringe for paediatrics to distinguish them from intrathecal drugs. All dispensed vinca alkaloids must be clearly labelled on the bag and on the outer container with a warning “For Intravenous Use only. Fatal if given by other routes”. Negative labels, such as “Not for Intrathecal Use” must not be used. All dispensed vinca alkaloids must be clearly labelled on the bag and on the outer container with a warning “For Intravenous Use only. Fatal if given by other routes”. Negative labels, such as “Not for Intrathecal Use” must not be used. Procedures should be in place for monitoring, preventing and treating extravasation of vinca alkaloids diluted in minibags. Procedures should be in place for monitoring, preventing and treating extravasation of vinca alkaloids diluted in minibags.

36. Extravasation Kit Dimethylsulphoxide solution 99% 100ml (DMSO – US pharmaceutical grade) x 1 Dimethylsulphoxide solution 99% 100ml (DMSO – US pharmaceutical grade) x 1 Hyaluronidase (1500units injection) x 1 Hyaluronidase (1500units injection) x 1 Hydrocortisone (100mg injection) x 2 Hydrocortisone (100mg injection) x 2 Hydrocortisone 1% cream x 1 Hydrocortisone 1% cream x 1 Sodium bicarbonate 8.4% injection x 1 Sodium bicarbonate 8.4% injection x 1 Sodium thiosulphate 25% injection x 1 Sodium thiosulphate 25% injection x 1 Water for injections 20ml x 2 Water for injections 20ml x 2 Treatment protocol (basic treatment and individual drug management) Treatment protocol (basic treatment and individual drug management) Extravasation report form x 1 Extravasation report form x 1