07/10/2010. Objectives Of Presentation. The Good Ol e Days. Agents. Classes of Disinfectants. Agents

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1 Objectives Of Presentation Decontamination Of Chemotherapy Preparation Area: Sunnybrook s Journey To Get Clean Mari Culotta-MascioliCo-ordinator I.V. and Chemotherapy Training and Certification Program, Safe Handling of Cytotoxic/Hazardous Drug Odette Cancer Centre Sunnybrook Health Sciences Centre Recall past standards Review the Isopp Hierarchy of Protection Establish where exposure occurs Review acceptable cleaning agents by today's standards and how they differ from past agents Share Sunnybrook s experience to get clean Facilitate a better understanding for developing work place policy and procedure for cleaning chemotherapy preparation areas The Good Ol e Days Biological Safety Cabinet Chemo prep room cleaned the same way as regular IV rooms and with the same agents. Chemo room and the IV admixture room were often one and the same Agents Cleaning Agent remove residue that may harbor microbes and inactivate sanitizing agent Sanitizing Agents result in 99.99% reduction of bacteria; requires pre-cleaned surfaces 2008, Baxa Corporation All rights reserved Agents Classes of Disinfectants Common Cleaning program agents Disinfectant Kill 100% of vegetative bacteria, target viruses and target fungi Sporicidal Agents Kill all vegetative bacteria as well as fungal and bacterial spores Chemical Isopropyl Alcohol* Phenolics Quaternary ammonium Classification General purpose disinfectant General purpose disinfectant, sanitizer, cleaning agent General purpose disinfectant, sanitizer, cleaning agent 2008, Baxa Corporation All rights reserved Chlorine (sodium hypochlorite) Iodophors Hydrogen peroxide Sporicidal agent General purpose disinfectant Sporicidal agent *Sterile 70% IPA must be used 2008, Baxa Corporation All rights reserved 1

Cleaning Agents & Methods The agents of choice Quaternary ammonium coumpounds Quaternary ammonium The Quats Classes of Disinfectants Know for their mild antiseptic properties Good for their detergent

2 Cleaning Agents & Methods The agents of choice Quaternary ammonium coumpounds Quaternary ammonium The Quats Classes of Disinfectants Know for their mild antiseptic properties Good for their detergent properties General purpose disinfectant, sanitizer, cleaning agent Worked by actively removing soils and contaminants from surfaces Highly potent Low or no vapours Non corrosive The Quats Made them a likely choice for the type of cleaning required in an IV room Non Hazardous Clean Rooms Easy enough to deal with bio-burden given all the choices in cleaning agents and by following very specific directions fro USP 797 Fast Forward A Couple of Decades We see published studies showing evidence of: Cancer patients getting secondary cancers from their chemotherapy treatment Health care workers who handled, prepared or administered anti cancer drugs experiencing adverse health events Harsh reality Realization that our cleaning methods were not cleaning anti cancer drugs off work surfaces The quats were not the appropriate agents for chemotherapy prep rooms Evidence of sufficient amounts of contamination on work surfaces that allowed/s for human uptake of these agents 2

3 ISOPP What is ISOPP saying International Society of Oncology Pharmacy Practitioners Hierarchic Order in Protective Measures (5) ISOPP Hierarchy of Protection Levels of protection are not meant to be cherry picked over, rather followed from highest level (1) to lowest level (4) ISOPP Level 1 Eliminate, substitute, replace or change the hazardous product to another which is less or non toxic If this is impossible or insufficient then apply level 2 ISOPP Level 2 Isolate the hazard/contain the source By containing the hazard at its source the contamination of persons or materials is prevented. (e.g. closed system transfer/containment device) If impossible or insufficient apply level 3 ISOPP Level 3 Apply local and general ventilation or extraction in order to dilute the toxic product The Solution to Pollution is Dilution Eric Kastango 3

4 ISOPP Level 3 Any form of dilution will reduce the concentration of contamination e.g.opening a window/door to a patients room to allow ventilation and turn over of room air ISOPP Level 3B Administrative Controls/Organizational Measures Work should be organized in such a way that the duration of exposure is reduced and the number of employees exposed is reduced If not possible or insufficient apply level 4 e.g.bsc that extract air and move it into a space of greater dilution (outside) ISOPP Level 4 Personal Protective Equipment Gloves, gowns, goggles or face shields and other equipment create a temporary barrier between the contamination and the operator. Pharmacy Exposure Despite all the precautions being taken the possibility of exposure to cytotoxic contamination on work surfaces are still a reality Preparation ; oral, IV, vapour pressures Receiving; contaminated vials (broken or intact) Storing ; contaminated vials (manufacturer or partially used vial) Accidental spills Use of inappropriate cleaning agents Solution A comprehensive Cleaning Schedule and Vigilance Created by you For your own BSC, Cleanroom and Anteroom NIOSH Recommendation Clean work surfaces with an appropriate deactivation agent (if available) and cleaning agent before and after each acitivity and at the end of the work shift. Establish periodic cleaning routines for all work surfaces and equipment that may become contaminated, including administration carts and trays. NIOSH Alert September

NIOSH Recommendation Perform cleaning and decontamination in work areas that are sufficiently ventilated to prevent buildup of hazardous airborne drug concentrations.

5 NIOSH Recommendation Perform cleaning and decontamination in work areas that are sufficiently ventilated to prevent buildup of hazardous airborne drug concentrations. Develop protcols prohibiting the use of unventilated areas such as storage closets for drug storage or any tasks involving hazardous drugs. NIOSH Alert September 2004 The Appropriate Deactivator? Decontaminate all surfaces (of the BSC) with : Detergent or Hypochlorite solution and Neutralizer at the end of the batch, day, shift or as appropriate to the workflow. Buchanan CE, Schneider PJ. Compounding Sterile Preparations, Second Edition. American Society of Health-Systems Pharmacist Surface Safe The Appropriate Deactivator? Step 1 2% Sodium hypochlorite Step 2 1% Sodium Thiosulfate Action of Surface Safe Step 1 ( diluted bleach) Deactivates most chemo drugs. Step 2 Sodium Thiosulfate Neutralizes the bleach but also helps deactivate some of the chemo drugs that step 1 cannot. Oxidizing Agents Number of people have looked at oxidizing agents to deactivate chemotherapy Potassium Permanganate (KMnO 4 ) Sodium Hypochlorite (NaOCl) PUBLISHED STUDIES OF CHEMICAL DEGRADATION OF ANTICANCER DRUGS KMn0 4 Complete inactivation of: VP-16, bleomycin, mitomycin C Partial inactivation of cyclophosphamide Some drugs were chemically degraded, but mutagens increased (Connor et al: Env Mutat 6:383, 1984) NaOCl (Bleach) Complete loss of mutagenicity for cyclophosphamide, Melphalan, ifosfamide (S. Hansel: Int Arch Occup Envir Health 69:109,1997) Complete loss of mutagenicity for methotrexate (A. Wren: J Clin Pharm Ther 18:133, 1993) Dr Robert T.Dorr,PH.D.,R.Ph., Professor University of Tuscon Arizona, Cytotoxic Contamination

6 PRIOR STUDIES OF INACTIVATION OF CYTOTOIC ANTICANCER AGENTS IN VITRO CYTOTOIC AGENT INACTIVATION METHOD CHEMICAL INACTIVATION ACHIEVED MUTAGENIC ACTIVITY REMAINING Hypochlorite as an inactivator Cyclophosphamide Alkaline hydrolysis (dimethy/formamid) Acid hydrolysis the Alkaline KMnO 4 oxidation No Large number of companies that recommend hypochlorite for inactivation of their chemotherapy products on MSDS forms Cisplatin/ Carboplatin Etoposide/ Teniposide Diethyldithio-carbamate chelation KMn0 4 No No Mitomycin C Bleomycin KMn0 4 Partial Mitoxantrone Ca(OCI) 1 NL Methotrexate Sodium hypochlorite (NaOCI) Partial Anti Cancer drugs deactivated with hypochlorite Cyclophosphamide Cytarabine Dacarbazine Doxorubicin Epirubicin Fluorouracil Methotrexate Mitoxantrone Vinblastine HAZARDS OF UNDILUTED BLEACH FOR SURFACE DECONTAMINATION Splash onto skin or eyes is toxic Inhalation of vapours causes irritation May oxidize surfaces (metal, others) with prolonged contact Bleaching clothes, coloured surfaces Structure Na 2 S Active Form: Mechanism: Clinical Applications: SODIUM THIOSULFATE Same (sulphur is ionized in physiologic conditions) Bindings to alkyl ting groups and metals in inactive Cytotoxic species Local antidote to Mechlorethamine (HN 2 or nitrogen mustard) skin toxicity Cytoprotection from cisplatin (systemic, but especially renal) Used for extravasations for above drugs SODIUM THIOSULFATE Removes chlorine from solutions by two reactions (1) Na 2 S 2 O 3 +SCl+SH 2 O 2NaHSO 4 +8HCl left with Sodium sulfate and hydrochloric acid (2) Na2S2O3+2HCl 2NaCl+H 2 O+S=SO 2 Hydrochloric acid turned into Sodium chlorite (table salt), water and inorganic sulfite Dr Robert T.Dorr,PH.D.,R.Ph., Professor University of Tuscon Arizona, Cytotoxic Contamination

7 ADVANTAGES OF A TWO-STEP INACTIVATOR APPLICATION Hypochlorite 1) Contains chlorine oxidizing agent in recommended concentration for antimicrobial and antiviral activity (CRA test results) 2) Unlike alcohol, can also reduce mutagenicity of anticancer agents Thiosulfate 1) Inactivates chlorine to reduce chlorine exposure to skin and lungs 2) Can directly antagonize certain anticancer drugs (alkylating agents, platinum-containing drugs) To clean and inactivate most anticancer drugs Surface Safe has proven to effectively inactivate 1,2 Anthracyclines Anthracenes Alkylating Agents Antimetabolites Biologicals Miscellaneous compounds doxorubicin mitoxantrone mitomycin fluoroucil a-interferon paclitaxel daunorubicin bisantrene melphalan cytarabine interleukin 2 docetaxel epirubicin cyclophosphamide mercaptopurine tumor necrosis factor vinblastine ifosphamide G-CSF vincrisinte thio-tepa GM-CSF vindesine dacarbazine vinorelbine carmustine topotecan Cisplatin irinotecan carboplatin etoposide teniposide ansacrine(mamsa) dactinomycin bleomycin L-asparaginase Dr Robert T.Dorr,PH.D.,R.Ph., Professor University of Tuscon Arizona, Cytotoxic Contamination Dorr RT et al.data on file, Hospira 2. Data on file, Hospira SURFACE SAFE, A TWO-STEP INACTIVATOR APPLICATION PAD NO. ACTIVITY PAD CONTAINS EVALUATION OF SURFACE SAFE FOR DECONTAMINATION OF ANTINEOPLASTICS - BACKGROUND Goal: Test Surface Safe on stainless steel plates exposed to different anticancer drugs. Test site: Rod Larson, Ph.D., CIH, Larson International Birmingham, AL 1 Oxidizer in mild soap 7 ml of 2% w/v sodium hypochlorite (NaOCI) in 0.2% w/v sodium dodecylsulfate (SDS) Contractor: SuperGen, Inc., Dublin, CA Report Date: February 22, Inactivates Hypochlorite, Binds platinum, Other alkylators 9 ml 1% sodium thiosulfate (Na 2 S ) Dr Robert T.Dorr,PH.D.,R.Ph., Professor University of Tuscon Arizona, Cytotoxic Contamination 2010 STUDIES SHOWING EFFICACY OF HYPOCHLORITE / THIOSULFATE AS A CLEANING AGENT FOR ANTICANCER DRUGS ANTICANCER AGENT Cisplatin Cyclophosphamide Cytarabine Daunomycin REDUCED PARENT COMPOUND (BY HPLC OR OTHER ASSAY) REDUCED MUTAGENICITY BY AMES ASSAY HYPOCHLORITE / THIOSULFATE - SUMMARY Recent studies show broad surface contamination with antineoplastic agents in major centers No existing cleaning agents shown to inactive allanticancer agents (especially alcohol) Hypochlorite/Thiosulfate combines antiviral, antimicrobial and cancer drug cleaning activity Doxorubicin Etoposide (VP-16) 5-Fluorouracil Methotrexate Second (Thiosulfate) pad: Halts activity Reduces chlorine odour Reduces damage to surfaces Taxol VincristineVinblastine No other product has these properties Dr Robert T.Dorr,PH.D.,R.Ph., Professor University of Tuscon Arizona, Cytotoxic Contamination

8 HYPOCHLORITE/THIOSULFATE RECOMMENDED FREQUENCY OF USE FOR DRUG PREPARATION SURFACES On work surfaces exposed to chemotherapy drugs: At least once per shift for low-volume operations More frequently for high volume operations Immediately after any known minor spill or vial/ampoule leak Sunnybrook 2006 Re-evaluated safe handling practices campus wide Critical look at cleaning and decontamination procedures On surfaces adjacent to preparation area: drug cart, labelling countertop, floor around safety cabinets Dr Robert T.Dorr,PH.D.,R.Ph., Professor University of Tuscon Arizona, Cytotoxic Contamination 2010 NIOSH created a buzz for Surface Safe Unavailable in Canada Sunnybrook 2006 Trial Period Pharmacy Manufacturing department mixed 2% Sodium Thiosulfate using 5% household bleach Also manufactured 1% Sodium Thiosulfate Packaged in 500ml bottles The Trial for Odette Cancer Centre Pharmacy and The Sunnybrook Acute Care Pharmacy Clean the inside of the BSC at the end of shift with manufactered solutions Clean work surfaces in the chemotherapy prep room at the end of shift (counter tops only) Evaluate tolerance for bleach fumes Monitor all surfaces cleaned for degradation from bleach Trial Results The technicians overcome by the bleach fumes when submerged within the BSC for daily cleaning All of the staffed bothered by the fumes when counter tops were cleaned at days end Technicians experiencing bleaching of clothes from the hypochlorite despite the fact they were using full PPE Decision: Results To use the home made hypochlorite and thiosulfate only on counter tops To use the solutions only on Friday at the end of the day to allow the room to air out over the weekend To continue to use our detergent cleaning protocols on the hood until something better was available 8

Surface Safe @ Hospira 2008 Surface Safe became available in Canada Hospira the distributor Re-trial in both the Acute Care Pharmacy and Odette Manufacturer Recommendation Use one packet set (step 1

Contact time of 30 seconds for step 1 (hypochlorite towellete) Sunnybrook Implemented use of Surface Safe for the BSC Continue to use the homemade product for work surfaces Sunnybrook Staff not

9 Surface Hospira 2008 Surface Safe became available in Canada Hospira the distributor Re-trial in both the Acute Care Pharmacy and Odette Manufacturer Recommendation Use one packet set (step 1 and step 2) for a 2 x 2 sq ft area. For a 6 ft BSC = 8 packets. Contact time of 30 seconds for step 1 (hypochlorite towellete) Sunnybrook Implemented use of Surface Safe for the BSC Continue to use the homemade product for work surfaces Sunnybrook Staff not involved in cleaning but present during cleaning also use N95 respirator mask if bothered by the odour Implemented use of NIOSH rated N95 surgical respirator mask for cleaning the BSC Important Note for N95 mask Various Styles 0f Surgical Respirator N-95s N-95 respiratory mask = protection from airborne particulate N-95 surgical respiratory mask = protection from airborne particulates, gases, vapours and splash Good idea to check the models your institution carries to ensure proper protection 9

Surface Safe And Cleaning The BSC Odette Daily Cleaning of the BSC Daily cleaning: 3 packets, One for the back panel One for the work surface tray and airfoil One for both side panels It was decided

N-95 respirator mask Odette Pharmacy Daily Cleaning of the BSC Step 1: of surface safe bleach Step 2 : of surface safe thiosulfate Step 3 : Accel TB - Accelerated hydrogen peroxide/detergent Step 4 :

counter tops are cleaned with a 3 step procedure Step 5 Alcohol 70% Ethanol final rinse and sterilization Odette Weekly decontamination of the BSC 6 Packets of Surface Safe for weekly decontamination.

10 Surface Safe And Cleaning The BSC Odette Daily Cleaning of the BSC Daily cleaning: 3 packets, One for the back panel One for the work surface tray and airfoil One for both side panels It was decided by the group of techs that 1 packet was sufficiently saturated to spread across the full 6ft panel. N-95 respirator mask Odette Pharmacy Daily Cleaning of the BSC Step 1: of surface safe bleach Step 2 : of surface safe thiosulfate Step 3 : Accel TB - Accelerated hydrogen peroxide/detergent Step 4 : SWFI Rinse to get all residue from bleach, thiosulfate and detergent Odette Pharmacy Daily Cleaning of the BSC Cleaning occurs at the end of day (shift) on 2 BSC During the week Monday Thursday counter tops are cleaned with a 3 step procedure Step 5 Alcohol 70% Ethanol final rinse and sterilization Odette Weekly decontamination of the BSC 6 Packets of Surface Safe for weekly decontamination. 3 extra packets use for cleaning the underside of the BSC One packet for the underside of the work surface tray One for the foundation tray One for the floor of the BSC Odette Chemo Room Daily Cleaning Of The Counter Tops Step 1: Accel TB hydrogen peroxide/detergent Step 2 : SWFI rinse residue Step 3 : Alcohol- final rinse and sterilization No bleach on counter tops Monday to Thursday 10

Odette chemo room Friday decontamination (counter tops) Five Step Clean Step 1: bleach (from pharmacy manufacturing) Step 2 : thiosulfate (from pharmacy manufacturing) Step 3 : Accel TB - Accelerated

PPE required for BSC/work surfaces cleaning, including 2 pair of chemo rated gloves When using home made products of bleach and thiosulfate, solutions are poured onto 4 x 4 gauze pads for use.

11 Odette chemo room Friday decontamination (counter tops) Five Step Clean Step 1: bleach (from pharmacy manufacturing) Step 2 : thiosulfate (from pharmacy manufacturing) Step 3 : Accel TB - Accelerated hydrogen peroxide/detergent Step 4 : SWFI Rinse to get all residue from bleach, thiosulfate and detergent Step 5 Alcohol 70% Ethanol final rinse and sterilization Cleaning Procedure Continued Full PPE required for BSC/work surfaces cleaning, including 2 pair of chemo rated gloves When using home made products of bleach and thiosulfate, solutions are poured onto 4 x 4 gauze pads for use. All towelettes (Surface Safe ) and gauze used is discarded in chemo waste Bleach, thiosulfate and alcohol are never used on the plexiglass view screen of the BSC. See full procedures on handouts In The Acute Care Pharmacy Acute Care Chemo layout Counter Procedure are the same except for counter top decontamination 5 step clean occurs daily No issues with bleach Very small counter top See full procedures on handouts Acute Care BSC Setting your own policy and procedures Review the guidelines from multiple sources: ISOPP, NIOSH, ASHP, CSHP Determine the feasibility of complying with all, most or some of the guidelines Bring new procedures in slowly 11

12 Follow the Basics First Use appropriate deactivating agents if available. Use cleaning agents before and after each activity and at the end of shift Manufacturers recommends strong oxidizing agent and an alkaline detergent for hazardous drugs NOTE that any one product is incapable of decontaminating all hazardous drugs Follow the Basics First Perform cleaning and decontamination in work areas that are sufficiently ventilated to prevent build up of hazardous airborne drug concentrations. Cleaning materials (wipes, mops, disinfectants) for use in the clean room should be made of materials that generate low amounts of particles and be non shedding and dedicated to use in the clean room only ( buffer and ante in that order) Decontaminating Frequency Buffer Room Biological Safety Cabinet (daily clean) Beginning of shift After each use End of shift After a spill By the Pharmacy Tech Decontaminating Frequency Buffer Room Exterior Surfaces of the BSC: Weekly By The Rx Tech Work surfaces (counter tops, supply carts): Daily By Rx Tech???? Custodial Staff???? Decontaminating Frequency Buffer Room Storage and shelving: Weekly By whom???? Floors: Minimally daily Trained custodial staff following written procedures Ceiling and Walls: Monthly Trained custodial staff following written procedures Supply carts: Monthly By whom??? Equipment: Monthly By whom??? Decontaminating Frequency Ante room 12

13 Decontaminating Frequency Ante room Floors: Minimally weekly (recommendation) but perhaps daily is better. Trained custodial staff following written procedures Ceilings and Walls: Monthly Trained custodial staff following written procedures Decontaminating Frequency Recommendations are not always cut and dry when it comes to direction. Policies and procedures will be determined by you the pharmacy department Ensuring compliance of set policies will be up to the pharmacy to enforce Education and training is the key to compliance Education And Training Is The Key in understanding the whys and haws of cleaning and decontamination Education on cytotoxic risks and safe handling Basic pharmacology of cytotoxics agents Theory of aseptic technique Use of PPE Handling of cytotoxic waste Cytotoxic spills and accidental exposure clean up References and Interesting Reading 1. Conner Th, Anderson RW, Sessink PJ, et al. surface contamination with antineoplastic agents in six cancer centres in Canada and the United States. Am J Health Syst Pharm 1999;56: Falk K, Grohn P, Sorsa M et al. Mutagenicity in urine of nuses handling cytotoxic drugs. Lancet 1: , Hedmer M, Tinnerberg H, Axmon A, Jonsson BAG. Environmental and biological monitoring of antineoplastic drugs in four workplaces in a Swedish hospital.int Arch Occup Environ Health (2008) 81: Buchanan EC., Schneider PJ.,Second Edition Compounding Sterile Preparations. American Society of Health Systems Pharmacists Journal of Oncology Pharmacy Practice. Official Publication of the International Society of Oncology Pharmacy Practioners, Volume 13 Supplement NIOSH Alert: Preventing occupational exposures to antineoplastic and hazardous drugs in health care settings U.S. Department of Health and Human Services. Public Health Service, Centres for Disease Control and Prevention, National Institute for Occupational safety and Health DHHS (NIOSH) Publication No

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