DEVELOPING STANDARD PROCEDURES FOR SAFE HANDLING OF CYTOTOXIC DRUGS

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1 DEVELOPING STANDARD PROCEDURES FOR SAFE HANDLING OF CYTOTOXIC DRUGS HARBANS DHILLON Senior Pharmacist University Malaya Medical Centre Kuala Lumpur APOPC JAKARTA

2 OBJECTIVES Definition of cytotoxic drugs Who is at risk? Sources of contamination Routes of exposure Goals for safe handling of cytotoxic drugs Drug administration Waste disposal Developing standard procedures APOPC JAKARTA

3 DEFINITION OF CT DRUGS Therapeutic agents intended for but not limited to treatment of cancer rheumatoid arthritis multiple sclerosis auto-immune disorders Specific destructive action on cells that may be: Genotoxic damage DNA Mutagenic alter DNA Teratogenic malformation of embryo or fetus hazardous to cells Inhibit cell growth by affecting cell cycle resulting in a blockage of cell partition & multiplication. APOPC JAKARTA

4 DEFINITION OF CT DRUGS Affect all cells, but more on cells that divide rapidly or uncontrollably Cancerous cells Cells from the GI tract Hair follicles Early blood cells in bone marrow APOPC JAKARTA

5 LONG TERM EFFECTS OF CT DRUGS Small but significant numbers of patients treated successfully with aggressive cancer chemotherapy later present with secondary malignancies, often AML More commonly used MTX & cyclophosphamide to treat RA, MS & other non-malignant diseases APOPC JAKARTA

6 POTENTIAL EFFECTS OF EXPOSURE Cytogenetic abnormalities & mutagenic activity related to biological uptake by exposed Contact Alterations dermatitis to normal blood cell counts personnel Excretion of drug or metabolites in urine Abdominal pain, hair loss, nasal sores & vomiting Liver damage Foetal loss & malformations Guidelines for handling cytotoxic drugs and related waste in health care establishments Work Cover NSW Long term effects of occupational exposure to CT are inconclusive BUT not appropriate to wait for indisputable evidence of harm APOPC JAKARTA

7 SIGNIFICANT REPORTS OF OCCUPATIONAL EXPOSURE TO CT DRUGS: Falck 1979 mutagens in urine of nurses preparing CTX Neal 1983 CPM & FU aerosols in air of clinics Hirst 1984 CPM detected in blood of nurses Selevan 1985 foetal loss in exposed pregnant nurses Hemminki 1985 defects in offspring of exposed nurses Saurelle- Cubizolles 1993 factor in ectopic pregnancies Sessink 1994 skin contamination a major cause Valanis 1999 foetal loss, reduced fertility in males, females APOPC JAKARTA

8 EXPOSURE ASSESSMENT Identify path CT drugs follow from point of entry to exit as reconstituted product patient waste contaminated laundry contaminated equipment Includes: receiving transportation storage preparation administration waste handling APOPC JAKARTA

9 SAFE HANDLING Who is at risk? Where? How? APOPC JAKARTA

10 WHO IS AT RISK? Everyone involved in the handling Manufacturers & shipping Pharmacists & pharmacy assistants Physicians & nurses Housekeeping Family members & friends APOPC JAKARTA

11 SAFE HANDLING Who is at risk? Where? Sources of contamination What? APOPC JAKARTA

12 SOURCES OF CONTAMINATION? Vials and packaging surface contamination Leaks/spills Surface contamination on BSC, carts, tables, counters, equipment, wards, bedside Aerosol generation, spraying, splattering Withdrawing of needles from drug vials Use of syringes and needles or filter straws for transfer Opening of ampoules Expulsion of air from syringe when measuring the precise volume of drug Excreta of patients Surface contamination APOPC JAKARTA

13 SURFACE CONTAMINATION Slide courtesy of Thomas Connor ISOPP VIII Vancouver APOPC JAKARTA

14 SURFACE CONTAMINATION Slide courtesy of Thomas Connor ISOPP VIII Vancouver APOPC JAKARTA

15 SURFACE CONTAMINATION Slide courtesy of Thomas Connor ISOPP VIII Vancouver APOPC JAKARTA

16 MANUFACTURER Some vials have significant cytotoxic drug residue on vial surface exposure Plastic coated vials appear safest Plastic vials also appear safe Methods of packing for transit to be specified APOPC JAKARTA

17 Classify & segregate CT drugs Areas where drugs are received Quarantine packages with visual signs of damage Dedicated storage areas Use PPE when handling CT drugs Wash hands after handling CT drugs Spill kit available Proper waste disposal of damaged goods & PPEs Purchase of CT drugs designed to minimise risk of breakage unbreakable plastic material glass vials provided in specially designed outer plastic containers glass vials over-wrapped in plastic APOPC JAKARTA

18 External transport from supplier Primary containers designed to minimise breakage use of parenteral grade polypropylene vials, resistant to breakage or reinforced plastic coated vials Packed in high impact resistant packaging material made from heavy duty corrugated cardboard & lined with moulded foam to prevent accidental damage to contents Internal transport of commercial product Internal transport of compounded admixture To prevent damage, pack in a labelled, sealed, leak-proof container, protected from light ISOPP Standards of Practice Section 5 APOPC JAKARTA

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20 SAFE HANDLING Who are at risk? Where? What? Routes of exposure APOPC JAKARTA

21 ROUTES OF EXPOSURE Inhalation of droplets or vapour during preparation or administration Ingestion surface contamination/substandard practices Topical contact spills or improper/inadequate PPE, conjunctival absorption Direct injection needle stick injury APOPC JAKARTA

22 Sources of Contamination 1 of 5 APOPC JAKARTA

23 Sources of Contamination 2 of 5 APOPC JAKARTA

24 Sources of Contamination 3 of 5 APOPC JAKARTA

25 ROUTES OF EXPOSURE Vials & packaging in which cytotoxic drugs are stored Leaks/spills surface contamination on BSC, carts, tables, counters, equipment etc Aerosolisation surface contamination on minibags, syringes, pumps Handling excreta & linen of patients APOPC JAKARTA

26 INHALATION OF DRUG VAPOUR Cytotoxic drugs evaporate at 23 C & 37 C Drug 23 C Drug 37 C Carmustine ++ Carmustine ++ Nitrogen mustard ++ Cyclophosphamide ++ Cyclophosphamide + Ifosphamide ++ Thiotepa ++ Nitrogen mustard ++ Fluorouracil? Fluorouracil? APOPC JAKARTA

27 Protect & secure packages of CT drugs Educate & train all involved personnel During manipulation, use of devices & negative pressure techniques Eliminate potential for exposure with CT drugs APOPC JAKARTA

28 Coverall or gown Disposable gown made of non-linting & non absorbent polyethylene-coated polypropylene material Head covering Closed footwear Gloves Protective eyewear/goggles double gloving (nitrile, neoprene latex) long enough to cover cuffs of gowns or coveralls changed every 30 minutes Respirator masks APOPC JAKARTA

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30 CT drugs should be handled & stored within the pharmacy by trained employees Preparation of parenteral CT drugs should be undertaken only by trained pharmacy personnel Reconstituted product should be protected against microbial, particulate & chemical contamination Operators should be protected against exposure to hazardous drugs. APOPC JAKARTA 2012 ISOPP Standards of Practice Section 3 30

31 Pharmaceutical analysis & QC implemented improves quality of preparation safety of patient is enhanced Economic benefits Location: Commonly pharmacy Sometimes - outpatient oncology department or close to inpatient ward Ease of transport Enhanced communication between pharmacy, medical & nursing staff Must be under control of pharmacist APOPC JAKARTA 2012 ISOPP Standards of Practice Section 6 31

32 Possess recognized qualification Received certified training in accordance with local regulations Assessment of practice undertaken on a regular basis Staff members should be evaluated on a regular basis to verify compliance with procedures Strict hygiene must be developed & followed No eating, drinking, chewing gum & application of cosmetics must be strictly prohibited No wearing of jewellery ISOPP Standards of Practice Section 3 APOPC JAKARTA

33 Appropriate staff chosen good work habits, teachable & fussy about cleanliness Personnel must be informed of known & potential hazards of CT drugs they are handling Document contents of training & the individual completion of training Worker right to know regulations Knowledge of & competence in procedures MUST be tested at the end of the training Re-test periodically every 6-12 months APOPC JAKARTA

34 Potential risks to exposure to CT agents Basic pharmacology of CT agents Theory of aseptic technique Use of PPE Theory of containment devices & barriers Theory of hierarchy of protection measures Handling of CT waste CT spills & accidental exposure Prescribing of CT agents Validation of CT prescriptions Hospital policies & procedures on CT management CT drug use processes drug selection prescription validation preparation dispensing drug administration & drug use evaluation 34 APOPC JAKARTA 2012 ISOPP Standards of Practice Section 4

35 Each institution should develop & maintain a procedure manual, detailing: policies & procedures for appropriate manufacture & administration of CT drugs aseptic techniques SOPs for reconstitution & administration cleaning procedures spill management transporting CT drugs health monitoring ISOPP Standards of Practice Section 4 APOPC JAKARTA

36 A training program in CT reconstitution should be developed & implemented Can be offered in-house or by an external training provider Training should be: tailored to specific needs of the individual ongoing with regular updates & information for any new procedures or products e.g. new hazardous drug introduced at workplace Include periodic tests of staff competencies Structured program which contains important elements ISOPP Standards of Practice Section 4 APOPC JAKARTA

37 Validation of processes to demonstrate processes used during & staff undertaking aseptic manipulation are capable of maintaining sterility of product media fill test is intended to simulate routine aseptic operations Validation of operator to demonstrate aseptic technique of operator is capable of maintaining sterility ensure operators do not contaminate themselves Validation of training ensure all staff have a satisfactory level of knowledge & competency Evaluation On-going feedback should be an integral part of the program Re-training Repeated every 2-3 years ISOPP Standards of Practice Section 4 APOPC JAKARTA

38 Need to ensure protection of product Aseptic techniques Microbial contamination Chemical contamination Centralised service Dedicated facilities APOPC JAKARTA

39 STORAGE - ROOM TEMPERATURE APOPC JAKARTA

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43 PRODUCT RECONSTITUTED APOPC JAKARTA

44 Protect handler of vial/ampoule Vials enclosed in plastic coating Protect operator during preparation Closed system in regards to microbiological & chemical contamination (leakproof, airtight device) Protect administrator during administration of CT drug Techniques to protect patient ISOPP Standards of Practice Section 7 APOPC JAKARTA

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46 AIRBORNE PARTICLE CLASSIFICATION 46

47 AIRBORNE PARTICLE CLASSIFICATION 47

48 AIRBORNE PARTICLE CLASSIFICATION 48

49 AIRBORNE PARTICLE CLASSIFICATION 49

50 DRUG PREPARATION WITH CLOSED SYSTEMS Slide courtesy of Thomas Connor ISOPP VIII Vancouver APOPC JAKARTA

51 Administered mainly by nurses Exposure due to surface contamination of products made by pharmacy, connection/disconnection during administration including oral products using oral liquid dispensing syringes Use PPEs when administering Remove IV bag intact or use contained systems Flushing Wash hands after administration Closed systems Excreta of patient as second dilution of drug Spill management Proper disposal of CT waste ISOPP Standards of Practice Section 12 APOPC JAKARTA

52 Double checking for correct patient, route, dose & regime Swabbing rubber bung Administering bolus doses Commencing administration Setting up the infusion 52

53 Do cut or crush tablets Use gloves when handling oral CT drugs Do not open capsules If necessary, dissolve in warm water Return excess drugs to pharmacy APOPC JAKARTA

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56 UNSAFE PRACTICES APOPC JAKARTA

57 Leak proof & puncture proof sharps containers Sharps container no more than ¾ full Waste tied up & removed after each shift APOPC JAKARTA

58 Waste bags made of polyethylene or polypropylene, purple in colour Segregated, packaged & disposed properly Use of dedicated hardwalled carts Undertake waste collection frequently Incineration at 1100 C APOPC JAKARTA

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61 Staff health monitoring exposure to CTs education & training validation Training file for each personnel! Facilities microbiological & contamination monitoring maintenance log pressure differentials temperature logs particle counts qualification & re-qualification ISOPP Standards of Practice Section 21 APOPC JAKARTA

62 Transport Outside & within the institution Cytotoxic spills Extravasation Cleaning BSC/isolator Sterile room Workload statistics Procedure manual Material safety data sheet (MSDS) ISOPP Standards of Practice Section 21 APOPC JAKARTA

63 CONTROL MEASURES Key risk controls include: Outsourcing CT drug preparation work Purchasing CT drugs in the safest form available Reviewing health & safety information about CT drugs Using facilities that meet recommended technical & safety standards Designing & laying out work area according to recommended standards Adopting closed system operations Providing employees with information & training Automation Guidelines for handling cytotoxic drugs and related waste in health care establishments WorkCover NSW APOPC JAKARTA

64 SAFETY IN HANDLING CT DRUGS Policies & procedures Minimum standards, ISOPP standards Root cause analysis for spills & needle stick injuries Maintain records Health surveillance Training & validation Retraining APOPC JAKARTA

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68 SAFETY IS IN YOUR HANDS APOPC JAKARTA

69 REFERENCES ISOPP Standards of Practice J Oncol Pharm Practice (2007) Supplement to 13: 1-81 Guidelines for handling cytotoxic drugs and related waste in health care establishments WorkCover New South Wales NIOSH Alert: Preventing occupational exposures to antineoplastic & other hazardous drugs in health care settings 2004 ASHP Guidelines on Handling Hazardous Drugs Am J Health-Sys Pharm. 2006; APOPC JAKARTA