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10/1/2015
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© 2015 Lehigh Valley Health Network
Understanding USP <800> and the 2014 NIOSH List
The Lehigh Valley Health Network Journey
Janine Barnaby, RPh, BCOP
Kristin Held Wheatley, PharmD, BCOP
Cindy Mitman, PharmD, MBA
Rhonda Thomas, PharmD, MBA, BCPS
• 5 Campuses
• 1 Children’s Hospital
• 140+ Physician Practices
• 17 Community Clinics
• 13 Health Centers
• 11 ExpressCARE Locations
• 80 Testing and Imaging Locations
• 13,100 Employees
• 1,340 Physicians
• 582 Advanced Practice Clinicians
• 3,700 Registered Nurses
• 60,585 Admissions
• 208,700 ED visits
• 1,161 Acute Care Beds
Objectives
▪ Pharmacist
•Review proposed changes in USP <800> in
handling of hazardous medications.
▪ Pharmacy Technician
•Name 5 medications on NIOSH's 2014 List of
Hazardous Drugs
puppy : dog :: kitten :
A.cat
B. tiger
C.lion
D.bear
cat
tiger lio
nbear
25% 25%25%25%
Which 5 medications were added to the NIOSH 2014 List of Hazardous Drugs.
A. Carboplatin, cisplatin, cyclophosphamide, fluorouracil, and mitomycin
B. Tamoxifen, carbamazepine, tetracycline, divalproex, and aldesleukin
C. fosphenytoin, spironolactone, fluconazole, topiramate and warfarin
A. B. C.
33% 33%33%
What room requirements are needed for compounding antineoplastic agents,
based on USP <800>?
A. Biological safety cabinet in positive pressure ISO 7 cleanroom with 30 ACPH
B. Biological safety cabinet located in negative pressure (-0.01 to -0.03 inches WC), externally vented room with 12 ACPH
C. Negative pressure glove box located in cancer center pharmacy.
A. B. C.
33% 33%33%
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USP <800>
▪ Hazardous Drug (HD)- Handling in Healthcare Settings • Public review and comments closed on 5/31/15 for 2nd
revision
• Builds on existing chapters <795> and <797>
▪ Objective • Identify the requirements for receipt, storage,
compounding, dispensing, administration, and disposal of HDs to protect the patient, healthcare personnel, and environment.
▪ Designated individual to oversee handling of HD • Policy and procedures
• Entity compliance
• Environmental quality and control
• Competency of personnel
USP <800>: List of Hazardous Drugs
▪ National Institute for Occupational Safety
and Health (NIOSH) maintains a list of
antineoplastic and other HDs used in
healthcare
▪ An entity must maintain a list of HDs
•Reviewed at least annually, and when new
agent or dosage form is used
NIOSH List 2014 ▪ The most recent published update was 2014
•May 2015 announced a draft document for the 2016 list, comments closed on 7/27/15
▪ HD exhibit one or more of the following:
•Carcinogenicity
• Teratogenicity or other developmental toxicity
•Reproductive toxicity
•Organ toxicity at low doses
•Genotoxicity
•Structure and toxicity profiles of new drugs that mimic existing drugs determined hazardous by the above criteria.
NIOSH List 2014- con’t
▪ Three Groups of Hazardous Drugs •Antineoplastic Drugs
•Non-Antineoplastic Drugs that meet one or more of the NIOSH criteria for a hazardous drug
•Non-Antineoplastic drugs that primarily have adverse reproductive effects
▪ Guidance for Personal Protective Equipment and Engineering controls for working with hazardous drugs in healthcare settings
•Based on formulation (intact tablet, oral liquid, ampoule, intravenous solution, etc)
NIOSH List 2014- Additions
▪ Table 1 • abiraterone
• ado-trastuzumab emtansine
• brentuximab vedotin
• cabazitaxel
• crizotinib
• eribulin
• erlotinib
• vandetanib
• vemurafenib
▪ Table 2
• abacavir
• apomorphine
• deferiprone
• dexrazoxane
• fingolimod
• fosphenytoin
• liraglutide
recombinant
• nevirapine
• phenytoin
• propylthiouracil
• spironolactone
▪ Table 3
• fluconazole
• icatibant
• misoprostol
• topiramate
• ulipristal
• voriconazole
• warfarin
USP<800>: Assessment of Risk
▪ Any antineoplastic HD requiring manipulation and HD Active Pharmaceutical Ingredient (API) on the NIOSH list MUST follow the requirements of USP <800>
▪ Entities are able to perform an assessment of risk for NON-antineoplastic drugs and final dosage forms of antineoplastic drugs to determine alternative containment strategies and/or work practices
•Must consider the type of HD, risk of exposure, packaging, and manipulation
•Review annually and document
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USP <800>: Receipt and Storage
▪ Designated areas for receipt, unpacking, storage, and compounding of both sterile and non-sterile drugs
• Area must not be positive pressure relative to the surrounding areas
– Can be neutral/normal or negative pressure
– HD can not be unpacked from their shipping containers in sterile compounding areas
▪ Non-antineoplastic, reproductive risk only, and final dosage forms of antineoplastic HD may be stored with other inventory
▪ Antineoplastic HDs requiring manipulation and API must be stored separately and in a negative-pressure room with at least 12 air changes per hour.
• Sterile and non-sterile may be stored together, but only HDs used in sterile compounding may be stored in the negative pressure buffer room.
USP <800>: Compounding ▪ Containment Primary Engineering Control (C-PEC)
• Externally vented (redundant HEPA are acceptable for non-sterile)
• Examples: Powder Hoods, Biological Safety Cabinets, Isolators, robot
– For occasional non sterile HD compounding, the same C-PEC may be used, but must be decontaminated, cleaned, and disinfected before sterile compounding.
▪ Containment Secondary Engineering Control (C-SEC)
• Physically separated room, externally vented
• Negative Pressure (0.01-0.03 inches w.c.)
• Air exchanges per hour (>12 or >30)
• NO LOW VOLUME EXCEPTION
*w.c. – water column
USP <800>: Additional Compounding Requirements
▪ Sink for hand washing • Minimum of one meter from entrance of buffer room, reduces
potential for contamination
▪ Emergency access to water for removal of HD from eyes and skin
▪ If non-HD are prepared in the BSC or CACI which is used for HD compounding the non-HD must be labeled to require Personal Protective Equipment (PPE) handling precautions.
▪ Use commercially available products • Liquid formulation (even injectable) preferred over crushing tabs
or opening capsules – 6-MP oral solution
– Different concentration and expensive
▪ Dispense in final dose and form when possible
▪ Properly clean after compounding • Use dedicated or disposable equipment, if possible
– How do you clean the Mortar and Pestle after compounding HD?
USP <800> Wipe Studies
▪ Environmental wipe sampling • Initial and at least every 6 months
• Locations: – Inside C-PEC and equipment inside
– Staging area near C-PEC
– Area adjacent to C-PEC (floors)
– Patient administration areas
▪ There is no standard for acceptable limits for HD surface contamination.
• Common drugs sampled: – Cyclophosphamide, ifosfamide, methotrexate, fluorouracil, and
platinum-containing drugs
▪ If measurable amount found, then identify, document and contain the cause of the contamination.
• Repeat wipe sampling to validate that this was effective
▪ Multiple vendors available, cost ~$2500 for six samples, 2 weeks for results.
USP <800>: Personal Protective Equipment (PPE)
▪ Gloves • ASTM-tested chemotherapy gloves shall be worn for all handling of
HDs
• Two pairs for compounding, administering, managing a spill and disposal of HDs
• Change every 30 minutes or when torn, punctured or contaminated.
▪ Gown • Disposable, long-sleeved and cuffed gown with a solid front and
closure in the back
• Made of polyethylene-coated polypropylene or other laminate material
• Change every 2-3 hours or immediately after a spill or splash
• Do not wear gowns in other areas in order to prevent spreading HD
▪ Head, Hair, Beard
▪ Shoe Covers • Add 2nd pair as you are entering into the HD compounding area, and
remove when leaving
ASTM – American Society for Testing and Materials
USP <800>: Additional PPE
▪ Eye and Face Protection • Not required for routine use with a C-PEC
• Required when manipulating HDs outside of C-PEC and working at or above eye level, cleaning a C-PEC or cleaning a spill. (shield and goggles)
▪ Respiratory Protection • Fit tested, surgical NIOSH certified N-95 respirator
(barrier to splash and airborne particles)
• Elastomeric half-mask with multi-gas cartridge and P100-filter for unpacking HD not contained in plastic
▪ Consider all PPE contaminated and dispose of properly
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USP <800>: Administration
▪ Closed System Transfer Devices (CSTD) Required • Many different ones available
– Pros and Cons of each
– Ability to disconnect, residual volume, number of pieces, cost, comparison studies
• Not available for all administration routes – Intra-cavitary
– Intramuscular
– Intrathecal
▪ Spike and prime IV tubing in C-PEC
▪ Use plastic sleeve to contain any dust or particles from crushing tablets
▪ Proper PPE • Gown, double gloves
• Eye protection when splashing is possible
▪ Proper disposal of PPE and supplies
USP<800>: Cleaning
▪ 1. Deactivate • Render compound inert or inactive
• Bleach or EPA-registered oxidizer
▪ 2. Decontamination • Removal of inactivated residue
• Sodium thiosulfate, sterile water, sterile alcohol, or peroxide
▪ 3. Cleaning • Remove organic and inorganic material
• Sterile water and germicidal detergent
▪ 4. Disinfection • Destroy microorganisms
• Sterile alcohol or EPA-registered disinfectant appropriate for use
USP<800>: Medical Surveillance
▪ Collecting and interpreting data to detect
changes in health status of employees
potentially exposed to hazardous
substances
▪ Baseline, annual, and as needed review.
▪ Appropriate to the exposure, and have a
follow-up plan
▪ Exit examination
LVHN Hazardous Drug Workgroup
▪ Members: • Pharmacy clinical Specialists, leadership, and home infusion
• Nursing educators and leadership from inpatient and outpatient departments both adult and pediatric
• Employee Health
• Safety Department
• Added as needed: Human resources, risk management, medication safety officer, materials management, supply chain, environmental services, infection control
▪ Tasks: • Review all policies related to HD
• Create and periodically update the network’s HD list
• Review and standardize Personal Protective Equipment (PPE)
• Create GAP analysis for handling HD in our network
• Develop ideal state
• Educate staff on correct PPE and procedures
LVHN HD Workgroup Process and Accomplishments
▪ Updated the Network’s Hazardous Drug list • Two categories
– Cytotoxic
– Hazardous
▪ Evaluated and standardized PPE to be used
▪ Created plan for building the new HD designation into the EMR (electronic medical record)
▪ Standardized labeling of medications
▪ Developed educational material to educate staff
▪ Ensured that we are following our surveillance policy when employees are working with HDs
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LVHN Future Considerations
▪ Labels for psych patient say Hazardous Drug!!
▪ Non negative pressure cleanroom at one site
▪ NIOSH certified N-95 mask • need for pharmacy employees to be fit tested
▪ Pneumatic tubes must not be used to transport any liquid or antineoplastic HD because of the potential for breakage and contamination
• megestrol suspension, fluconazole IV
▪ Tablets and capsule forms of HDs must not be placed in automated counting or packaging machines, which subject them to stress and may introduce powdered contaminants into the work area.
• Add to robot to decrease LASA- divalproex
Which 5 medications were added to the NIOSH 2014 List of Hazardous Drugs.
A. Carboplatin, cisplatin, cyclophosphamide, fluorouracil, and mitomycin
B. Tamoxifen, carbamazepine, tetracycline, divalproex, and aldesleukin
C. fosphenytoin, spironolactone, fluconazole, topiramate and warfarin A. B. C.
33% 33%33%
What room requirements are needed for compounding antineoplastic agents,
based on USP <800>?
A. Biological safety cabinet in positive pressure ISO 7 cleanroom with 30 ACPH
B. Biological safety cabinet located in negative pressure (-0.01 to -0.03 inches WC), externally vented room with 12 ACPH
C. Negative pressure glove box located in cancer center pharmacy
A. B. C.
33% 33%33%
Contact Information:
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