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Delivery of Intrathecal Delivery of Intrathecal Chemotherapy Chemotherapy
Kowloon Central ClusterKowloon Central Cluster
10Jan0810Jan08
BackgroundBackground
Inadvertent intrathecal Inadvertent intrathecal administration of vincristine administration of vincristine intended for intravenous intended for intravenous administration have occurred in administration have occurred in Hong Kong resulting in deathHong Kong resulting in death
ToleranceTolerance
HA Guideline on Safe Handling of HA Guideline on Safe Handling of Intrathecal Chemotherapy Intrathecal Chemotherapy (18Sep07)(18Sep07)
PolicyPolicy Training and CompetenceTraining and Competence PrescribingPrescribing Dispensing and PreparationDispensing and Preparation Labelling, Packaging and Delivery of Labelling, Packaging and Delivery of
intrathecal chemotherapyintrathecal chemotherapy AdministrationAdministration Extra Precautions to avoid inadverteExtra Precautions to avoid inadverte
nt administration of vinca alkaloids bnt administration of vinca alkaloids by intrathecal routey intrathecal route
PolicyPolicy
Written InstructionWritten Instruction
Designated OfficerDesignated Officer
Cross-checkCross-check
Designated OfficerDesignated Officer
Assigned by COSAssigned by COS
Cross CheckCross Check
At least 2 personsAt least 2 persons All specialtyAll specialty 3 Checks 5 Rights3 Checks 5 Rights DocumentationDocumentation
Working InstructionWorking Instruction
StaffStaff Training Training ProcedureProcedure
Must not contravene HA guidelineMust not contravene HA guideline
Working InstructionWorking Instruction
Not to disturb the routineNot to disturb the routine
To reinforce the routineTo reinforce the routine
StaffStaff on liston list Medical and Nursing staff of Medical and Nursing staff of
DepartmentDepartment
Trainee from other unit or hospital Trainee from other unit or hospital are not allowed unless approved by are not allowed unless approved by designated officer after proper designated officer after proper training and assessmenttraining and assessment
List of trained staff should be List of trained staff should be available and update regularlyavailable and update regularly
Training and CompetenceTraining and Competence
Organized by designated officer of Organized by designated officer of department on intrathecal department on intrathecal chemotherapychemotherapy
Lecture & working instruction and Lecture & working instruction and assessment at bedsideassessment at bedside
At least yearly or after revision of At least yearly or after revision of instruction or new staff joining the instruction or new staff joining the departmentdepartment
Procedure PrescribingPrescribing
Dispensing and PreparationDispensing and Preparation Labelling, Packaging and Delivery of iLabelling, Packaging and Delivery of i
ntrathecal chemotherapyntrathecal chemotherapy
AdministrationAdministration
Procedure PrescribingPrescribing
Dispensing and PreparationDispensing and Preparation Labelling, Packaging and Delivery of iLabelling, Packaging and Delivery of i
ntrathecal chemotherapyntrathecal chemotherapy
AdministrationAdministration
Procedure PrescribingPrescribing
Dispensing and PreparationDispensing and Preparation Labelling, Packaging and Delivery of iLabelling, Packaging and Delivery of i
ntrathecal chemotherapyntrathecal chemotherapy
AdministrationAdministration
Intrathecal ChemotherapyIntrathecal Chemotherapy
AgentAgent
IndicationIndication
RouteRoute
Protocol Protocol
AgentAgent
MethotrexateMethotrexate 50mg preparation50mg preparation
Cytarabine ( Ara-C )Cytarabine ( Ara-C ) 100mg preparation100mg preparation without benzyl alcohol solventwithout benzyl alcohol solvent
HydrocortisoneHydrocortisone 100mg preparation100mg preparation
IndicationIndication
CNS prophylaxis CNS prophylaxis Burkitt lymphomaBurkitt lymphoma Testicular lymphomaTesticular lymphoma Parameningeal extensionParameningeal extension Acute LeukaemiaAcute Leukaemia
Leptomeningeal diseaseLeptomeningeal disease e.g breast or lung cancere.g breast or lung cancer
RouteRoute Lumbar punctureLumbar puncture
RouteRoute Lumbar punctureLumbar puncture Intrathecal portIntrathecal port
RouteRoute Lumbar punctureLumbar puncture Intrathecal portIntrathecal port Ommaya reservoirOmmaya reservoir
ProtocolProtocol
SUMC ( Burkitt lymphoma )SUMC ( Burkitt lymphoma ) q3wkq3wk MTX 12mg Day 1 & Day 10MTX 12mg Day 1 & Day 10 Total 10 dosesTotal 10 doses
ProtocolProtocol HyperCVAD ( Burkitt lymphoma )HyperCVAD ( Burkitt lymphoma ) q3wkq3wk MTX 12mg Day2 + Ara-C 100mg Day7MTX 12mg Day2 + Ara-C 100mg Day7 Total 16 dosesTotal 16 doses
ProtocolProtocol
Acute Acute LeukaemiaLeukaemia
ProtocolProtocol Leptomeningeal diseaseLeptomeningeal disease MTX 12mg + Ara-C 100mg MTX 12mg + Ara-C 100mg 2 times per wk till CSF negative then weekly2 times per wk till CSF negative then weekly
VincristineVincristine
Fatal if given intrathecallyFatal if given intrathecally
Pre-printed MAR-ITCPre-printed MAR-ITC MAR-IT-MTXMAR-IT-MTX
MAR-IT-ARACMAR-IT-ARAC
MAR-IT-LMMAR-IT-LM
PrescriptionPrescription
One of the medical staff involved One of the medical staff involved ( prescription / verification ) must be ( prescription / verification ) must be specialistspecialist
Label with patient particular
5/11 6/11
6/11
S1
S2
Dispensing , Preparation, Dispensing , Preparation, Packaging and Delivery of DrugPackaging and Delivery of Drug
All intrathecal chemotherapy must All intrathecal chemotherapy must be prepared by Aseptic Dispensing be prepared by Aseptic Dispensing Unit QEHUnit QEH
MAR-ITC should be sent to ADU MAR-ITC should be sent to ADU one day before the injectionone day before the injection
QEH pharmacy policies in safe QEH pharmacy policies in safe administration of intrathecal administration of intrathecal chemotherapy for further detailschemotherapy for further details
AdministrationAdministration
Within normal working hour and day ( Monday to Within normal working hour and day ( Monday to Saturday 12pm )Saturday 12pm )
Should not be initiated at the same time with other Should not be initiated at the same time with other intravenous drugintravenous drug
Trained staff or trainee under direct supervision of Trained staff or trainee under direct supervision of trained stafftrained staff
Staff & patient should not be distracted during the Staff & patient should not be distracted during the procedureprocedure
In protected area with “sign of intrathecal In protected area with “sign of intrathecal chemotherapy in progress” hanged on after checkchemotherapy in progress” hanged on after check
Check patient record & chemotherapy protocolCheck patient record & chemotherapy protocol
Follow the step on MAR-ITCFollow the step on MAR-ITC
AdministrationAdministration
Last check should be the most Last check should be the most important checkimportant check
DocumentationDocumentation
Last check should be the most Last check should be the most important checkimportant check
6/11
6/11
6/11
S3
S4
S5
DocumentationDocumentation
Label with patient particular
5/11 6/11
6/11
S1
S2
S4
Call for helpCall for help
Lumbar punctureLumbar puncture Access to intrathecal portAccess to intrathecal port
Must follow the checking step Must follow the checking step before injecting drugbefore injecting drug
CautionCaution
Injecting substance without Injecting substance without labelinglabeling
Additional measures for vinca alkaloidsAdditional measures for vinca alkaloids
All intravenous doses of vinca alkaloids must be dAll intravenous doses of vinca alkaloids must be diluted in at least 50ml infusion minibags for adults iluted in at least 50ml infusion minibags for adults and 10-20ml syringe for paediatrics to distinguish and 10-20ml syringe for paediatrics to distinguish them from intrathecal drugs.them from intrathecal drugs.
All dispensed vinca alkaloids must be clearly labelAll dispensed vinca alkaloids must be clearly labelled on the bag and on the outer container with a wled on the bag and on the outer container with a warning “For Intravenous Use only. Fatal if given by arning “For Intravenous Use only. Fatal if given by other routes”. Negative labels, such as “Not for Inother routes”. Negative labels, such as “Not for Intrathecal Use” must not be used.trathecal Use” must not be used.
Procedures should be in place for monitoring, preProcedures should be in place for monitoring, preventing and treating extravasation of vinca alkaloiventing and treating extravasation of vinca alkaloids diluted in minibags.ds diluted in minibags.
Extravasation KitExtravasation Kit
Dimethylsulphoxide solution 99% 100ml Dimethylsulphoxide solution 99% 100ml (DMSO – US pharmaceutical grade) x 1 (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 Treatment protocol (basic treatment and
individual drug management) individual drug management) Extravasation report form x 1 Extravasation report form x 1