Hazardous Drugs Preparation and Handling - Exam Review PDF

*** Final exam review Preparation and Handling of Hazardous Drugs HAZARDOUS DRUGS Includes:  Chemicals  Cancer drugs (anti-neoplastic/cytotoxic)  Biologic agents  Antiviral agents  Hormones  Immunosuppressive agents...

*** Final exam review Preparation and Handling of Hazardous Drugs HAZARDOUS DRUGS Includes:  Chemicals  Cancer drugs (anti-neoplastic/cytotoxic)  Biologic agents  Antiviral agents  Hormones  Immunosuppressive agents  Toxic agents  Irritants  Corrosives ***Hazardous Drugs-Drugs that exhibit one or more of the following characteristics in humans or animal: 1. Carcinogenicity - the ability or tendency to cause cancer 2. Teratogenicity - may cause abnormal fetal development 3. Reproductive toxicity - can affect fertility 4. Organ toxicity at low doses 5. Genotoxicity (mutagenic) - may cause damage to DNA HAZARDOUS DRUGS Cytotoxic Drugs - Drugs that have harmful effects on living cells ‘anti-neoplastic’ - All cytotoxic drugs are hazardous, but not all hazardous drugs are cytotoxic - Preparation of ALL hazardous drugs must take place class 2 biological safety cabinet, by personnel trained to prepare and handle these drugs safely WHO IS AT RISK FOR EXPOSURE TO HAZARDOUS DRUGS? Healthcare professionals ✓ physicians ✓ nurses ✓ pharmacy staff Delivery personnel ✓ Porters ✓ delivery drivers Receiving ✓ inventory personnel Housekeeping staff Family members /friends WHEN CAN EXPOSURE OCCUR? ✓ Receiving inventory from suppliers ✓ Transportation from manufacturers doses delivered to patient care areas ✓ Storage of hazardous products ✓ Preparation of hazardous drugs ✓ Administration of chemotherapy ✓ Disposal of contaminated waste ✓ Clean up of hazardous spills ✓ Handling of contaminated patient urine and feces  ROUTES OF EXPOSURE*** DEFINITIONS and EXAMPLES PREVENTION SKIN ABSORPTION Main route of exposure ✓ Handwashing Direct contact with contaminated surfaces or objects ✓ Proper glove use ✓ Cleaning INGESTION Eating contaminated food ✓ Handwashing Putting contaminated fingers or objects in mouth ✓ Avoid food and drink in contaminated areas INJECTION Accidental needle stick injury ✓ Proper aseptic technique ✓ Use of items that reduce needle sticks (blunt needles, CSTD) INHALATION Breathing in contaminated particles from the environment Using a BSC Use of proper PPE PROTECTION FROM HAZARDOUS DRUGS General Considerations: AUDIT: ❑ equipment operation, practices and seek input from personnel affected by such products ❑ health and safety committee CONDUCT REGULAR TRAINING: ❑ review with all staff who are handling and being exposed to cytotoxic drugs WORKPLACE EVALUATION should include: ❑ Working environment: day-to-day operations ❑ Equipment ❑ Physical layout of work area ❑ Types/volumes/dosage formats of hazardous drugs to be handled ❑ Decontamination and maintenance procedures ❑ Waste management, containment & disposal ❑ Cytotoxic Spills – response and follow-up to spills SAFE HANDLING PROGRAM - Detailed procedures designed to keep staff safe from hazardous drug contamination Establish policies & procedures with respect to: ▪ Defining which products are hazardous (including oral and injectables) ▪ Labelling/auxiliary labelling ▪ Personnel training and expectations ▪ Standardized cleaning to decontaminate and disinfect areas contaminated by hazardous drugs ▪ Spill control MEDICAL SURVEILLANCE Should be part of any safe handling program Standard of occupational health practice for hazardous medications Exposure history, physical exams, lab tests, monitoring of urine Includes environmental sampling program when exposure is suspected and/or symptoms are evident  PROTECTION FROM HAZARDOUS DRUGS IN PHARMACY ❑ PPE (N95 masks, P100 respirators, chemotherapy gloves that comply with ASTM standard D-6978-05, chemotherapy tested gowns with protective outer layer) ❑ Rooms with 30 air changes per hour (ACPH) that are exhausted to exterior ❑ Use of Class 2 Type B II biological safety cabinet ❑ Negative pressure rooms and BSC ❑ Dedicated rooms for hazardous drug preparation ❑ Use of closed system transfer devices that protect compounder, environment and drug HANDLING OF HAZARDOUS DRUGS AS PHARMACY STAFF*** PRACTICE STANDARDS USP CHAPTER - Hazardous Drugs – Handling in Healthcare Settings ❑ purpose is to describe practice and quality standards for handling hazardous drugs in health care settings and help promote patient safety, worker safety, and environmental protection ❑ provides a framework to protect all workers, patients and the public who are accessing facilities where hazardous drugs are prepared ❑ processes intended to minimize the exposure to hazardous drugs in health care settings ❑ developed by USP Compounding Expert Committee with the assistance of the USP Compounding with Hazardous Drugs Expert Panel and government liaisons from the U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC), including NIOSH (National Institute for Occupational Safety and Health) NAPRA Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations standards have been adapted from standards originally developed by the Ordre des Pharmacies du Québec standards reference USP Chapter and Chapter PERSONAL PROTECTIVE EQUIPMENT TYPE OF PPE WHEN TO WEAR DISPOSAL NOTES N95 MASK ▪ all times in clean room ▪ After leaving cleanroom ▪ Mask fitting ▪ When soiled moist or contaminated required ▪ Every 3-5 hours (NAPRA) ▪ Dispose as hazardous waste CHEMICAL CARTRIDGE ▪ cleaning and deactivating ▪ Clean and disinfect after each use wearing a gown and ▪ Mask fitting require RESPIRATOR BSC gloves ▪ cleaning spills ▪ Dispose of filters as hazardous waste TYPES OF PPE WHEN TO WEAR DISPOSAL NOTES BONNETT ▪ All times in cleanroom ▪ After leaving cleanroom ▪ Cover ears and hair ▪ Dispose as hazardous waste EYE PROTECTION ▪ Cleaning and deactivating BSC ▪ Clean and disinfect after each use ▪ No contact lenses ▪ Cleaning spills wearing a gown and gloves SHOE COVER ▪ 2 pairs at all times in cleanroom ▪ After leaving cleanroom ▪ Use dedicated shoes ▪ Cleaning spills ▪ After spill or contamination ▪ Use line of demarcation for ▪ Dispose as hazardous waste donning and doffing CHEMO GOWN ▪ At all times in the cleanroom ▪ After leaving work area ▪ Coated with impermeable outer ▪ Cleaning spills ▪ When soiled or contaminated layer ▪ Unpacking stock ▪ Every 2-3 hours (NAPRA) ▪ Dispose as hazardous waste GLOVES ▪ Two pairs (non-sterile/sterile*) while : ▪ After 30 min compounding ▪ Chemotherapy tested glove. ▪ Unpacking stock ▪ After tear or contamination Read glove contact time ▪ Cleaning and disinfecting controlled rooms and BSC ▪ Compounding hazardous preparations ▪ After cleaning BSC ▪ Inner glove under sleeve of gown ▪ Managing a spill ▪ Dispose as hazardous waste ▪ Outer glove over sleeve of gown ▪ Disposal of hazardous products  DEACTIVATION AND DECONTAMINATION Steps in addition to regular cleaning and disinfecting to help reduce risk of hazardous drug exposure to healthcare workers and patients Decontamination Deactivation Definition: Transfer of a hazardous drug contaminant from a fixed surface Treatment of a hazardous drug to create a less hazardous (for example: counter, bag of solution) to a disposable surface agent. One method is chemical deactivation (for example: wipe, cloth). The wipe is then contained and discarded as hazardous waste Examples: Wiping down a completed product before removing from BSC A step used in cleaning a BSC once weekly Examples of Sterile 70% isopropyl alcohol wipes Accelerated hydrogen peroxide 4.4% with peracetic acid solutions: 0.23% Sterile water on gauze Sodium hypochlorite 2% FACILITIES FOR PREPARATION OF STERILE HAZARDOUS PRODUCTS Limited access Separate from other area of STERILE product compounding 30 air changes per hour (ACPH) Negative Air pressure in relation to the surrounding areas Pressure for hazardous CLEANROOM should be NEGATIVE in relation to the ANTEROOM Pressure for ANTEROOM should be POSITIVE in relation to uncontrolled area Air and ventilation controls Pass-through windows Alarms to alert air pressure changes EQUIPMENT FOR PREPARING STERILE HAZARDOUS DRUGS (C-PEC) Class II, Type B Biological Safety Cabinet Contained in cleanroom ISO class 5 environment Negative pressure Uses vertical HEPA filtered air flow Meant to contain contamination in the cabinet External venting through HEPA filter Staff must be trained in proper use Cleaning twice daily like LAFH Deactivated weekly (2% hypochlorite) Cabinet is to be dedicated to preparing hazardous drug only no cross contamination  EQUIPMENT FOR PREPARING STERILE HAZARDOUS DRUGS (C-PEC) CLASS III BSC / ISOLATOR (CACI) Design reduces escape of contamination during compounding Air supply and exhausted air via HEPA filters ISO class 5 environment Contamination prevented with “ Pass through” windows PREPARING STERILE HAZARDOUS PRODUCTS Withdraw maximum limit of the syringe is 75% (3/4) of syringe capacity Needle hub should be clear of drug prior to removal from vial (using negative pressure) When dispensing in a syringe, use a protective Luer-Lok safety cap Use a closed-transfer system when applicable Before removing a sterile preparation from the BSC, decontaminate all surfaces of the container with sterile 70% IPA wipes After decontamination of sterile preparation label and place in a sealable plastic bag All final preparations must be marked “hazardous” or “cytotoxic” Any excess drug from an ampoule should be placed in an empty vial for disposal Any line with drug should be primed into an empty bag, vial, needle or syringe to avoid aerosolization Non-sharps waste used in compounding must be placed in a sealable plastic bag before removal from BSC and discarded in hazardous waste container “Leftover hazardous drug in ampoule should be draw up “ WHAT IS NEGATIVE PRESSURE? Creating negative pressure in a vial pulls back fluid into a vial so minimal aerosols are released into the environment when removing a needle 1. Disinfect rubber stopper with sterile alcohol swab and let dry 2. Draw air equal or less than 50% of the fluid required into the syringe 3. Insert needle bevel up from 45 degrees to 90 degrees 4. Invert and withdraw some fluid into syringe, creating negative pressure in the vial 5. Use milking technique to draw solution to volume needed 6. Tap syringe lightly and gather small bubbles with larger air bubble, push air back into vial 7. Place vial on work surface, remove needle tip from fluid and draw back some air. Keep plunger extended until needle removed from vial 8. Recap needle and adjust, only allowing fluid to reach the hub of the needle CLOSED SYSTEM TRANSFER DEVICES (CTSD) CSTD limit potential for generating aerosols and exposing workers to sharps Evidence documents a decrease in drug contaminants inside a Class II BSC when a closed-system transfer device is used CSTD not a substitute for a BSC and must be used within a BSC Use appropriate PPE and work practices even when using CSTD BD PhaSeal SYSTEM How does PhaSeal keep pharmacy staff safe? Expansion chamber equalizes pressure in vial and seals in drug vapors Airtight, leak-proof Membrane to membrane reduces needle stick injuries Luer-lock fittings Repetive strain injuries Protects nursing during administration Protects products by preventing microbial contamination CYTOTOXIC AND HAZARDOUS WASTE Dry cytotoxic waste Wet cytotoxic waste Cytotoxic sharps Always wear double gloves when disposing of PPE IV bags Ampoules hazardous waste Drug packaging Tubing Needles Packaging from Empty drug Anything capable Properly labelled compounding vials of puncturing skin supplies Incinerated through proper waste management companies Follow local guidelines RECEIVING HAZARDOUS DRUG Unpacked outside the cleanroom or anteroom to limit particles from packaging Wear 2 pairs of chemo rated gloves (Nonsterile gloves) Always check for potential breakage or leaks before and during unpacking If product is potentially damaged, treat as a spill Any packaging materials in direct contact with vials are disposed of as hazardous waste STORAGE OF HAZARDOUS PRODUCTS Stored separately from non-hazardous drugs Labelled as hazardous or cytotoxic In externally vented, negative pressure room 12 air exchanges per hour In a controlled area to minimize breakage, spillage or contamination. Low traffic areas with limited access In sturdy bins on shelving which is no higher than counter-top level. Enclosed in cupboards if possible. Less than 25C for room temp Dedicated refrigerator 2C-8C TRANSPORTING HAZARDOUS PRODUCTS Transported in rigid container that minimizes risk of breakage Double bagged in sealed container (Cytotoxic transportation bags) Must be clearly labelled as hazardous/cytotoxic Must be transported by someone trained in hazardous spill clean up Pneumatic tubes cannot be used Must be transported following storage requirements Spill kit must be available  SPILL MANAGEMENT Policies and procedures must be in place to: Prevent spills Audit clean-up of spills Responsibility of spill management Size and scope of spill Disposal of spill material Worker contamination and medical support procedures Availability of signs warning of restricted access to the spill area Proper training of personnel to handle spills Mock spills for training purposes Isotonic eye wash supplies and soap should be available Spill kit should be readily available in all areas where hazardous drugs are stored, prepared and administered Spill kit should accompany delivery of a cytotoxic preparation to a patient area SPILL KIT *** ❑ Two hazardous waste bags ❑ Eye protection ❑ Chemo gown ❑ 2 pairs of gloves ❑ Shoe covers ❑ Absorbent sheets, powders or pads ❑ Scoop for broken glass ❑ Chemo spill warning sign Be sure to bring: ✓ Fit tested chemical cartridge respirator ✓ Approved cleaning solution ✓ Sharps container ✓ A friend to help QUALITY CONTROL PROGRAMS Process includes PERSONNEL SAFETY Personnel training, Establishment of a comprehensive Medical Surveillance Program to ensure personnel Audits of operator technique safety handling hazardous drugs Equipment maintenance Identification of potentially exposed workers and workers of higher risk to adverse health Environmental monitoring, housekeeping, effects exposed to hazardous drugs Product stability and expiry dating Due to reproductive risks alternative duties should be offered to individuals who are Storage and handling pregnant , breast-feeding or attempting to conceive or father a child Checking final product WHAT IS CANCER? Abnormal and uncontrollable cell growth resulting in tumor formation Spreads and invades almost all areas of the body through the blood and lymphatic systems It is not a single disease, many types and forms of cancer Usually categorized or named based on the organs or cells it affects Example - Lung cancer - Squamous cell cancer (skin cancer) CANCER TREATMENT OBJECTIVE OF CANCER TREATMENTS: TREATMENT INCLUDES VARIOUS METHODS: Kill, shrink or slow the growth of the malignant tumor and/or cells Surgery minimize the adverse effects on normal non-cancerous cells of the individual Radiation treated Chemotherapy and/or combination of different methods CHEMOTHERAPY Some drugs used for cancer treatment may be referred to as: anti-neoplastic agents cytotoxic agents cancer chemotherapy agents Cancer cells divide rapidly Drugs can be non-selective and may destroy normal cells as well as abnormal (cancerous) cells hair loss mucositis ***CHEMOTHERAPY PROTOCOL (see textbook Chapter 7) a combination of 1 or more cytotoxic agents used to treat certain cancers protocol will outline all treatments that will be administered includes medications to treat side effects such as nausea, analgesics, antihistamines also includes IV fluid hydration, electrolytes Patient information: height-weight-BSA (m²) Medications ordered as mg/m² PHARMACOLOGIC CLASSIFICATIONS OF CANCER DRUGS Alkylating Agents Anti-metabolites carboplatin methotrexate cisplatin cytarabine cyclophosphamide Hormones and Antagonists Antibiotics medroxyprogesterone bleomycin megestrol doxorubicin Plant extracts vincristine vinblastine etoposide  Hazardous Spill Management What to do if you have a hazardous spill? 1. Collect a chemo spill kit, sharps container, water, detergent or Oxivir, Surface Safe 2 step packets and your P100 respirator. Bring a helper and have them bring full PPE 2. **Spill kits are located in staging, non-sterile hazardous room, anterooms and on a cart while transporting hazardous drugs** 3. Assess the spill. If we cannot manage the spill ourselves, call 5555 to report the spill and inform your manager or supervisor 4. Restrict access to the spill using the sign in your spill kit 5. Begin cleaning up working from area of least to greatest contamination -work in pairs, wear full PPE and two pairs of gloves Donning your PPE for a spill 1. Don inner pair of chemotherapy rated gloves 2. Chemotherapy protective gown 3. Fit tested P100 respirator and eye protection 4. Shoe covers 5. Outer pair of chemotherapy rated gloves over gown’s cuffs How to clean a hazardous spill FOR LIQUID SPILLS FOR POWDER SPILLS a) Lay chemo absorbs pads over the spill, shiny side up to absorb liquid ▪ Gently cover powder with water soaked spill towels b) Detach scoop from scraper and use both to pick up absorbent pads ▪ Lay chemo absorb pads over the spill towels and place into a chemo (red) waste bag-if there is any glass put into ▪ Detach scoop from scraper and use both to pick up absorbent pads your sharps container and towels then place in the red chemo waste bag c) Pick up remaining liquid with absorbent pads ▪ Wash area 3 times with hospital detergent (dish soap) or Oxivir and d) Wash area 3 times with hospital detergent (dish soap) or Oxivir and then twice with water then TWICE with water ▪ Wash the area with step 1 and step 2 surface safe packets and then e) Wash the area with surface safe, then rinse the area with water rinse with water Once the spill is cleaned Cleaning reusable PPE ✓ Remove your PPE in the following order: ▪ Don a pair of chemo rated gloves and clean chemo gown ◦ Shoe covers ▪ Place P100 respirator and eye protection on a clean chemo mat ◦ Outer gloves ▪ Remove P100 cartridges and discard as cytotoxic waste ◦ Gown ▪ Using water and a mild detergent, clean the inner and outer ◦ Eye protection – keep for cleaning surfaces of the respirator and eye protection ◦ Respirator – keep for cleaning ▪ Hang to dry ◦ Dispose of PPE in cytotoxic waste bag with items used for ▪ Store respirator and eye protection separately in clean re-sealable cleaning and tie up bags ◦ Double bag the cytotoxic waste bag and discard inner gloves in ▪ Attach cartridges to P100 respirator next time respirator is used the second bag ◦ Tie up outer bag and dispose of in a cytotoxic labeled box and seal all open edges with packing tape ◦ Wash your hands with soap and water ◦ Call housekeeping for a final rinse of the floor ◦ Complete a staff SOR for each staff member involved with a spill