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Safe administration & preparation of cancer chemotherapy by irene weru

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Kesho Conference 2014

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Safe administration & preparation of cancer chemotherapy by irene weru

  1. 1. Safe Administration & Preparation of Cancer Chemotherapy KESHO Conference 2014 Irene Weru Oncology Pharmacist KNH
  2. 2. Irene Weru 2 Introduction  Anticancer Medicines are hazardous  They have a narrow therapeutic index  Classified as high alert medicines (HAMs)  Many are metabolized by the Cytochrome P-450 – interactions / alterations in concentrations  Drug sequencing may increase or decrease the antitumour effect or impact the severity of toxicities  Calculation and manipulation of the actual dose to be administered is based on many factors including
  3. 3. Introduction  Safety considerations :  Personnel & Care givers  Patients  Environment Irene Weru 3
  4. 4. Safety of Personnel & Environment
  5. 5. Modes of Contact for Drug Exposure Irene Weru 5  Dermal  Ingestion  Inhalation  Injection
  6. 6. ISOPP* Standards of Practice Irene Weru 6  Know Your Risk  Staff Training  Levels of Protection *ISOPP =International Society of Oncology Pharmacy Practitioners J Onc Pharm Pract 2007; 13 Suppl.
  7. 7. Levels of Protection – Top to bottom  Level 1 – Elimination/substitution/replacement  Level 2 – Isolation of the hazard/source containment  Level 3 – Engineering controls/Proper ventilation  Level 3b – Administrative controls/ Organization measures  Level 4 – Personal protective equipment (PPE) Irene Weru 7
  8. 8. Personnel at work in KNH Irene Weru 8
  9. 9. Safe handling during reconstitution  Reconstitution has to take place in designated rooms  Appropriate protective Gear MUST be worn before start of Irene Weru 9 procedure  Gloves should be changed every 30 minutes.  In case of visible contamination, gloves must be changed immediately  Ventilation slots should be left uncovered  Work surfaces MUST be cleaned with water and afterwards with 70% alcohol.  All waste MUST be put in the appropriate waste reservoirs  After completing procedure, and removing protective equipment, staff should thoroughly wash hands and face
  10. 10. Safe handling during administration and nursing of patients receiving cytotoxics  Appropriate protective Gear MUST be worn before start of procedure. Cover skin completely  Use swab or cotton pad when injecting into a cytotoxic Irene Weru 10 drug solution  When the application is finished, infusion system should not be removed or broken off the bottle  Contaminated linen should be put immediately into the laundry bag  Protective clothing should be worn when handling excreta
  11. 11. Storage of cytotoxic medicines  There should be designated areas for storing cytotoxic Irene Weru 11 medicines.  These designated areas will have clearly visible labels  The refrigerators for storing cytotoxic medicines will be those that are easy to clean
  12. 12. Handling spillages  After spillage of cytotoxic drugs, the contaminated area should be isolated and cleaned immediately  PPE should be worn during the cleaning  Spilled substances should be soaked up with sufficient quantities of absorbent material  Contamination of shoes and clothing should be Irene Weru 12 avoided  The spill kit should be replaced immediately after use
  13. 13. Safe handling of orally administered cytotoxic drugs  All packages containing cytotoxic drugs should carry clearly visible warning label  Powder free gloves should be worn while counting Irene Weru 13 tablets  A dedicated counting tray and disposable tongue depressor should be used  When tablets have to be broken, a plastic bag should be used  Counted tablets should be placed in a separately labeled dosage box  Tweezers should be used for administration
  14. 14. Waste Disposal & Management  Cytotoxic waste includes all those materials which have come into contact with cytotoxic drugs during the process of reconstitution and administration  Cytotoxic waste must be segregated, packaged, and disposed of in a way that personnel and the environment are not contaminated.  Cytotoxic waste must be collected in clearly marked dedicated containers made from hard, robust material, which is shock-resistant and can withstand external pressure during transportation. Irene Weru 14
  15. 15. Waste Disposal & Management (2)  The containers should be of a dedicated colour and display a recognizable symbol for cytotoxics.  All sharps waste must be placed in puncture resistant containers.  All cytotoxic waste must be placed in secondary packaging and sealed to ensure that leakage cannot occur, and must be clearly labelled to indicate the presence of cytotoxic waste.  Cytotoxic waste should be clearly labelled & stored in easily identifiable and dedicated storage area (awaiting incineration)  Cytotoxic waste must be incinerated in a facility approved for the destruction of cytotoxic waste. Irene Weru 15
  16. 16. Patient Safety
  17. 17. Introduction The overarching principle in medication use should be to ensure:  patients receive medications appropriate to their clinical needs  in doses that meet their own individual requirements  for an adequate period of time  at the lowest cost to them and their community —WHO Conference of Experts Nairobi, 1985 Irene Weru 17
  18. 18. Safety for the Cancer Patients  Chemotherapy – high alert medicines  Medicine doses may vary based on diagnosis and protocol  May have comorbid conditions  Complex Regimen / Protocols  Elderly and Young Irene Weru 18
  19. 19. Factors to consider for specific medicines  Cumulative doses  Route of administration  Regimen  Sequence of administration  Other treatments (e.g radiation recall with doxorubicin)  Renal & hepatic function  Other Laboratory and Diagnostic results  Compatibilities with infusion fluids and other medicines  Pre - medication  Side effects / adverse effects Irene Weru 19
  20. 20. The Swiss Cheese Model Irene Weru 20
  21. 21. Study – March to Dec 2010 13% 7% 3% 77% Dispensing Prescribing Preparation Administration Irene Weru 21
  22. 22. Irene Weru 22 2 5 5 6 11 19 19 25 28 48 51 60 50 40 30 20 10 0 1 Type of error Number No Dose BSA calculation Wrong route Interaction Contraindication Required med not prescribed Wrong Medicine / Regimen Premeds missing Lower doses Higher doses Frequency / duration
  23. 23. Medication Safety Self Assessment for Oncology – ISMP
  24. 24. Areas covered:  Patient information  Drug information  Communication of drug orders & other drug information  Drug labeling, Packaging & Nomenclature  Drug Standardization, Storage & distribution  Medication device acquisition, Use and monitoring  Environmental factors, workflow design & staffing patterns  Staff competency & education  Patient education  Quality processes & Risk management Irene Weru 24
  25. 25. Patient Information  Essential Patient Information is obtained, readily available, in useful form and considered when prescribing, dosing, scheduling, dispensing, administering and monitoring chemotherapy, biotherapy and treatment related medicines Irene Weru 25
  26. 26. Patient Information - 2  First & last name, DOB, Medical record number or other unique identifier  Cancer diagnosis (including stage) & Therapeutic goal, Comorbid & Chronic Conditions, Performance status  Allergies, Adverse Reactions history, Immunization status  Medication reconciliation  Weight & Height  Patency of access devices  Informed consent Irene Weru 26
  27. 27. Patient Information - 3  Essential patient information is used to monitor & manage the effects of chemotherapy, biotherapy & Treatment related medicines & to adjust the treatment plan when indicated by evidence – based practices Irene Weru 27
  28. 28. Patient Information - 4  Easy access of laboratory values by authorized personnel  Electronic Medication order entry interfaced with laboratory  Baseline diagnostic & Laboratory tests – General & Treatment specific  Current laboratory values before each cycle  Communication of relevant patient information  Standardized toxicity grading scale  Dose modification guidelines  Documentation of lifetime cumulative doses Irene Weru 28
  29. 29. Medicine Information  Essential drug Information is obtained, readily available, in useful form and considered when prescribing, dosing, scheduling, dispensing, administering and monitoring chemotherapy, biotherapy and treatment related medicines Irene Weru 29
  30. 30. Medicine Information - 2  Standard references with annual renewal  Internally developed tools  Standardized protocols, guidelines, dosing formulae, maximum dose recommendations, checklists  Orders screened for contraindications, interactions, appropriateness of doses  Dose range checks  Route of administration checks Irene Weru 30
  31. 31. Medicine Information - 3  A controlled medicine formulary incorporates specific requirements, restrictions & considerations for chemotherapy, biotherapy & treatment related drugs ; driven by evidence based treatment algorithms, strength of evidence compedia & protocols  Formal process for formulary inclusion  Ability to monitor & manage adverse events of a medicine by organization  Safety enhancements  Use of Non Formulary  Investigational medicines Irene Weru 31
  32. 32. Communication of Drug orders & Other Drug Information  Methods of communicating chemotherapy, biotherapy and treatment related medication orders and other drug information are standardized & Automated to minimize the risk of error Irene Weru 32
  33. 33. Communication of Drug orders & Other Drug Information - 2  Basic information  Timing of prescription writing  Prescribing module interfaced with pharmacy, Nursing, Laboratory  Standard order sets  sequence of critical information (Drug, dose, route, infusion rate, total volume and duration)  Verbal/telephone orders  Who orders / prescribes chemotherapy (initial, subsequent, change)  Guidelines for evaluating patient at predetermined intervals  Use of generic prescribing Irene Weru 33
  34. 34. Communication of Drug orders & Other Drug Information - 3  Look alike names: vinCRIStine / vinBLAStine; CISplatin / CARBOplatin  Acronyms are defined  Specific days are written explicitly e.g Day 1, 2, 3 NOT Day 1- 3  Order sets  Documentation of cycle number e.g cycle of 1 of 6  Verification of interval/ rest period  Follow up of patient who miss scheduled sessions  Clalculations before each cycle e.g BSA, Creatinine clearance,  Trailing zeros never used e.g 10mg NOT 10.0mg  Leading Zeros always used e.g 0.1mg NOT .1mg  Dosing should be written for each day NEVER the entire dosing for the course  Standardized dose rounding procedures  Processes for oral chemotherapy Irene Weru 34
  35. 35. WHO safety strategies for vinCRIStine & other vinca alkaloids  Dispensing in minibags NEVER in syringes  Prominent label “FOR INTRAVENOUS ROUTE ONLY – FATAL IF GIVEN BY OTHER ROUTES”  Presence of vinCRIStine is prohibited in areas where intrathecal medications are administered or stored Irene Weru 35
  36. 36. Drug Labeling, Packaging & Nomenclature  Well Designed , readable labels that clearly identify medications as chemotherapy / biotherapy are present on all medication containers up to completion of drug administration  Typed / computer generated  Auxiliary labels  Standardized labels  Strategies are established to minimize the possibility of errors in the chemotherapy / biotherapy acquisition Irene Weru 36
  37. 37. Drug Standardization, Storage & Distribution  Strategies to minimize the possibility of errors in the chemotherapy / biotherapy and treatment related medicines acquisition, storage , production and distribution process Irene Weru 37
  38. 38. Drug Standardization, Storage & Distribution - 2  Preparation  Authorized distributors  Storage  Investigational medicines  Radio - labelled Medicines  Look - Alike / Sound - Alike  Non – Standard concentrations Irene Weru 38
  39. 39. Drug Standardization, Storage & Distribution - 3  Provision of medicines in a safe secure manner & available for administration within a timeframe that meets the patients needs  Delivery from Pharmacy  Timeframes established & followed  Prevention & Management of extravasations  Prevention & Management of Emergencies Irene Weru 39
  40. 40. Look - alike Medicines Irene Weru 40

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