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Safe Handling of Hazardous Drugs: An Evolving Legislative and...
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Safe Handling of Hazardous Drugs: An Evolving Legislative and Regulatory LandscapePharMEDium Lunch and Learn Series
ProCE, Inc.www.ProCE.com 1
Safe Handling of Hazardous Drugs:An Evolving Legislative and Regulatory Landscape
LUNCH AND LEARN
August 14, 2015
Featured Speaker: Firouzan 'Fred' Massoomi, PharmD, FASHP
Pharmacy Operations CoordinatorNebraska Methodist Hospital
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CE Activity Information & Accreditation
ProCE, Inc. (Pharmacist and Tech CE)
1.0 contact hour
Funding: This activity is self‐funded through
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g y gPharMEDium.
It is the policy of ProCE, Inc. to ensure balance, independence, objectivity and scientific rigor in all of its continuing education activities. Faculty must disclose to participants the existence of any significant financial interest or any other relationship with the manufacturer of any commercial product(s) discussed in an educational presentation. Dr. Massoomi has no relevant commercial and/or financial relationships to disclose.
Safe Handling of Hazardous Drugs: An Evolving Legislative and Regulatory LandscapePharMEDium Lunch and Learn Series
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Safe Handling of Hazardous Drugs: An Evolving Legislative and Regulatory LandscapePharMEDium Lunch and Learn Series
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Safe Handling of Hazardous Drugs
An Evolving Legislative and Regulatory Landscape
Firouzan ‘Fred’ Massoomi, Pharm.D., FASHPPharmacy Operations Coordinator
Nebraska Methodist HospitalOmaha, Nebraska
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Safe Handling of Hazardous Drugs: An Evolving Legislative and Regulatory LandscapePharMEDium Lunch and Learn Series
ProCE, Inc.www.ProCE.com 4
Program Objectives Describe the technical differences between NIOSH,
USP<797> and USP<800> version 1 to 2 for handling h d dhazardous drugs.
Describe the cradle to grave process for assessing the hazardous drug process
Overview of points to consider when selecting devices for compounding hazardous drugs: closed-system transfer device(s); syringes; powder boxes
Discuss the importance of developing and maintaining a joint pharmacy-nursing dialog for implementation of USP<800>-related changes.
VIDEO: Ordering and Receiving of Hazardous Drugs
VIDEO: Spill management
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March 30, 31, April 1 2015 on PBS8
Safe Handling of Hazardous Drugs: An Evolving Legislative and Regulatory LandscapePharMEDium Lunch and Learn Series
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How believable are the risk?
Aust NZ J Med 1984;14(6):831‐4
Lancet 1979; June 9: 1(8128):1250‐1
J Pharm Practice 1991;4(1):72‐6
Eur J Clin Oncol 1986;22(12):1489‐95
J NCI 1993;85:1089‐90
NEJM 1985;313(19):1173‐8
BMJ Qual Saf published online August 16, 2011Scand J Work Environ Health 1994;20:22‐6
J Occup Environ Med 1997;39(6):574‐80
AJHP 1993; June 9: 1(8128):1250‐1
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Who is at Risk of Occupational Exposure? 8 million US healthcare workers at risk
o Pharmacy, nursing personnel, physicianso Operating room personnel,
Veterinary personnelo Veterinary personnel,o Shipping and receiving personnel,o Laundry workers, waste handlers, maintenance workers
Exposure is associated with adverse health outcomeso Acute symptomso Organ toxicityo Reproductive riskso Cancer
Source: NIOSH [2008]. NIOSH Workplace Solution: Personal Protective Equipment for Health Care Workers Who Work with Hazardous Drugs.
Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety
and Health, DHHS (NIOSH) Publication No. 2009–106.10
Safe Handling of Hazardous Drugs: An Evolving Legislative and Regulatory LandscapePharMEDium Lunch and Learn Series
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Public Policy
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Public Awareness
PBS Newshour.org August 5, 2010 NBCNews.com July 10, 2010
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Safe Handling of Hazardous Drugs: An Evolving Legislative and Regulatory LandscapePharMEDium Lunch and Learn Series
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Guidelines for Hazardous Drugs
Source Year
ASHP 1982, 1984, 1990, 2006
OSHA 1986 1995 1999OSHA 1986, 1995, 1999
AMA Council on Scientific Affairs 1985
Oncology Nursing Society 1988, 2003, 2010
NIOSH Alert 2004, 2010, 2012, 2014
USP <797> 2004, 2008
USP <800> 2014 (for comment)
33 years of Safe Handling Guidelines13
A Decade Towards Safety2004 2014
Source: US Pharmacopeial Convention. General Chapter<8OO> Hazardous Drugs-Handling in Healthcare Settings. http://www.usp.org/usp-nf/notices/compounding-notice. Accessed January 5, 2015
Source: CDC & NIOSH. Preventing occupational exposures to antineoplastic and other hazardous drugs in health care settings. www.cdc.gov/niosh/doc:;/2004-165/ Accessed January 5, 2015
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Safe Handling of Hazardous Drugs: An Evolving Legislative and Regulatory LandscapePharMEDium Lunch and Learn Series
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USP 800 Chapter SectionsUSP800
Source: US Pharmacopeial Convention. General Chapter<8OO> Hazardous Drugs-Handling in Healthcare Settings. http://www.usp.org/usp-nf/notices/compounding-notice. Accessed January 5, 2015
2014 Proposal 1 2015 Proposal 2
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USP 800 Chapter Differences
2014 Proposal 1
Shall = requirement
2015 Proposal 2
Must = requirement
USP800
Shall = requirement 193 main document
20 in ancillary
Should = recommendation 35 main document
Must = requirement 162 main document
6 in ancillary
Should = recommendation 33 main document
Source: US Pharmacopeial Convention. General Chapter<8OO> Hazardous Drugs-Handling in Healthcare Settings. http://www.usp.org/usp-nf/notices/compounding-notice. Accessed January 5, 2015 16
Safe Handling of Hazardous Drugs: An Evolving Legislative and Regulatory LandscapePharMEDium Lunch and Learn Series
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Proposed USP 800: Timeline
First Release March 2014
Comment Due Date July 31, 2014
USP800
y ,
Second Release December 2014
Comment Due Date May 31, 2015
Goal Publish Date February 2016
Official Compliance Date August 2016
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“The objective of this chapter is to t t l d th
USP800
protect personnel and the environment when handling
hazardous drugs (HDs)”
Sterile and non sterile productsSterile and non-sterile products
Source: US Pharmacopeial Convention. General Chapter<8OO> Hazardous Drugs-Handling in Healthcare Settings. http://www.usp.org/usp-nf/notices/compounding-notice. Accessed January 5, 2015 18
Safe Handling of Hazardous Drugs: An Evolving Legislative and Regulatory LandscapePharMEDium Lunch and Learn Series
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USP 800USP 800
Source: State of Compounding 2015: Pharmacy Purchasing and Products; May 2015
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Defect Legacy of Current Practices
Source: ASHP Study Guide: Safe Handling ofCytotoxic and Hazardous Drugs. 1990
Source: Bristol Meyers Squibb ONC CE 2001
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Safe Handling of Hazardous Drugs: An Evolving Legislative and Regulatory LandscapePharMEDium Lunch and Learn Series
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Defect Equipment Compliance
NIOSH Survey of Nursing Practices
Findings Findings Failure to wear nonabsorbent gown with closed front and tight cuffs (42%);
Potentially contaminated clothing taken home (12%);
Spill or leak of antineoplastic drug during administration (12%);
Failure to wear chemotherapy gloves (12%); Failure to wear chemotherapy gloves (12%);
Lack of hazard awareness training (4%).
Source: Boiano JM, Steege AL, Sweeney MH. Adherence to safe handling guidelines by health care workers who administer antineoplastic drugs. Journal of Occupational and Environmental Hygiene November 2014;11:728-40 21
Defect Compounding Inconsistencies
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Source: https://www.osha.gov/dep/enforcement/inpatient_insp_06252015.html23
Department of Labor is Concerned
Source: https://www.osha.gov/SLTC/hazardousdrugs/index.html 24
Safe Handling of Hazardous Drugs: An Evolving Legislative and Regulatory LandscapePharMEDium Lunch and Learn Series
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Hazard Communication Standard “Right to Know Standard” Standard (29 CFR part 1910 – 1200)
A safe and healthful workplace.
Know about hazardous chemicals
USP800
Know about hazardous chemicals.
Complain or request hazard correction from employer.
Hazard exposure and medical records.
File a complaint with OSHA.
Be free from retaliation for exercising safety andBe free from retaliation for exercising safety and health rights.
29 CFR 1903.2 (a)(1)Each employer shall post and keep posted……
Source: Occupational Safety and Health Administration. (1999). OSHAtechnical manual: Section VI, chapter 2.,from www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html, Accessed January 5, 2015 25
The Hazardous Drug Team
Primary Pharmacist Pharmacy technicians/interns
USP800
Pharmacy technicians/interns Pharmacy purchasing Nursing Surgical Services Risk management Employee health Environmental services
Secondary Administration Administration Safety officer Physician office managers Home Health managers
Primary Goal: Establish a hazardous drug safety program26
Safe Handling of Hazardous Drugs: An Evolving Legislative and Regulatory LandscapePharMEDium Lunch and Learn Series
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Visual Hazard Mapping ToolUSP800
• More than 70 published studiespMost surfaces that come in direct contact with hazardsSome with in-direct contact with hazards
Source: Nebraska Methodist Hospital Department of Pharmacy Services27
Environmental Quality Control ‘Routinely’ = every 6 months
Approximate cost is $250 to $400 per sample
USP800
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Safe Handling of Hazardous Drugs: An Evolving Legislative and Regulatory LandscapePharMEDium Lunch and Learn Series
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NIOSH Hazardous Drug ListProposed 2016 List available
2014 NEW Grouping Risk System
USP800
Group 1: Antineoplastic drugs 97 drugs listed
Group 2: Non-antineoplastic drugs 48 drugs listed
Group 3: Reproductive risk men and women
39 drugs listed
Guide to handling based on formulation
Source: Centers for Disease Control and Prevention, NIOSH List of Antineoplastic and OtherHazardous Drugs in Healthcare Settings, 2014. www.cdc.gov/niosh/doc/2014-138/. Published September 2014. Accessed January 5, 2015. 29
Formulary AssessmentApplication of NEW NIOSH of Hazards
Antineoplastic non-Antineoplastic Reproductive
Class 1 Class 2 Class 3
USP800
Continuously stratify with new formulary drugs
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Safe Handling of Hazardous Drugs: An Evolving Legislative and Regulatory LandscapePharMEDium Lunch and Learn Series
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#1 Safety Concern The SourceUSP800
EVIDENCE: 11 Published studies Drug vial exteriors Not due to damage during shipping & handling
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Wholesaler Process Limitations
Limitations on Hazardous Drugs Cytotoxic only
No NIOSH Stratification
Site Trick Set up “departments” within
Order based off the ‘department’ Antineoplastic HDAntineoplastic HD
Non-Antineoplastic HD
Reproductive HD
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Totes from wholesaler
Segregated Handling of Vials
MUST not
Good Distribution Practices
USP800
Gloves to handle
MUST not StoreUnpackCompoundManipulate
Drugs left in baggies
Removed in Isolator
Not a + pressure areaEqui-pressureNegative pressure
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Example As to Why Not Handle Vials
Broken Carmustine vial
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Training DocumentationGoal
Minimize Contamination
Personal Protective Equipment (PPE)USP800
• Methodist Notes Per Guidelines
– Hand washing technique
Minimize Contamination
*From product to employee
and visa versa
Proper demonstrative use of PPE
– No Make‐up
– No Jewelry
– No Fake fingernails
– No iPods or personal devices
No exemptions from garbing requirements35
Standards Differ
Source: http://www.discsci.com/blogs/high-performance-pharmacy-compounding-equipment-to-optimize-sterile-preparation-and-handling
Source: JAMA. 2003;290(7):875-877 36
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Doffing SequenceDonning Sequence
USP800 Donning and Doffing PPE
Source: Fred Massoomi visit Taipei Veterans Hospital; Taipei, Taiwan; 2012 37
Choosing the Right GloveUSP800
IMPORTANT: ASTM D6978 and not ASTM F739 due to permeability limits35.2° +2 C 25° C temperature delta
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Safe Handling of Hazardous Drugs: An Evolving Legislative and Regulatory LandscapePharMEDium Lunch and Learn Series
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Primary Engineering ControlsUSP800
Biological Safety CabinetClass II Type B2 BSC
Isolator Glove BoxCompounding Aseptic Containment
Isolator (CACI)
Total Exhaust
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Secondary Engineering Controls**Low Volume Compounding Exemption ELIMINATED from USP 797
USP800
The ROOM: Separate Room 12 ACPH ISO 7 Negative Pressure40
Safe Handling of Hazardous Drugs: An Evolving Legislative and Regulatory LandscapePharMEDium Lunch and Learn Series
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C-SCAContainment Segregated Compounding Area
Non-HEPA room 12 ACPH
USP800
Negative pressure
NO USP 797 dating Not for High Risk Max 12 hours dating
Line of demarkation Line of demarkation
PEC: Cabinet Dual HEPA
Source: UPS 800 Open Mic Session; February 2015 41
Are Syringes Designed For Drug Storage?
Source:http://www.ismp.org/newsletters/acutecare/articles/loss-of-drug-potency.aspx42
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Supplemental Environmental Controls Closed System Transfer Devices (CSTDs)
Compounding : Recommended
Administration : Required
USP800
PhaSeal EquashieldVialshield/Texium
Currently 8 US products
PhaSeal®: BD
VialShield® with Texium®: Carefusion:BD
On‐Guard®: B.Braun
Chemoclave® /Spiros®: ICU Medical
ChemoLock®: ICU Medical
Equashield®
On-GuardChemoLock
Equashield®
Halo®: Corvida Medical
All Devices FDA Cleared
Four have FDA ONB Code????????????
Halo 43
CSTD Attributes to Consider
Source: Massoomi. Pharmacy Purchasing Products 2015; February S1-S1244
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Compounding a basic dose: Unpacking, Setup, Transfer of Drug from Vial to a Syringe and into an IV Bag
Steps PhaSeal™ ICU ChemoLock® Genie® Vialshield® with Texium® Equashield®1 Unpack PhaSeal Protector (P50) Unpack ChemoLock Genie vial spike (CL77) Unpack Vialshield Vial Adaptor (MV0520) Unpack Equashield Vial Adaptor (VA20/2)2 Remove Green protective cap Remove the protective cap Attach Vial Adaptor to a 50ml vial Attach Vial Adaptor to a 50ml vial3 Place P50 on Vial Mounting device Attach Genie to a 50ml vial Remove the protective cap Remove the protective cap 4 Attach Protector to a 50ml vial Unpack a 60ml syringe Unpack the Texium 60mL pre-bonded syringe unit
(MY8060)Unpack Equashield 60ml Syringe Unit (SU-EZ60)
5 Unpack a 60ml syringe Unpack a ChemoLock with luer lock (CL2000S) Remove Texium protective cap. Connect the Syringe unit to the vial6 Draw 50ml of ambient air Remove the protective cap Connect the Syringe Unit to Vialshield Vial Adapter Invert vial and draw 50ml of liquid 7 Unpack Phaseal Injector (N35) Attach ChemoLock to syringe to form syringe
unitInvert vial and draw 50ml of liquid Disconnected Syringe Unit from vial
8 Attach Injector to syringe to form the Connect syringe unit to vial Disconnect syringe unit from Vial Adaptor Unpack Spike Adaptor (SA-1)*syringe unit
9 Connect syringe unit to vial Invert vial and draw 50ml of liquid Unpack Bag Spike Adaptor (10014881T) Attach Spike Adaptor to an IV bag*10 Inject 50ml of air into the vial Disconnect syringe unit from vial Attach Spike Adaptor to empty IV bag Connect Syringe Unit to empty IV bag11 Invert vial and draw 50ml of liquid Unpack ChemoLock Bag Spike (CL12)* Connect the syringe unit to Spike Adaptor. Inject 50ml of liquid into the bag12 Disconnect syringe unit from vial Attach ChemoLock Spike to empty IV bag* Inject 50ml of liquid into the bag Disconnect syringe unit from bag13 Unpack Infusion Adapter (C100)* Connect syringe unit to the bag Disconnect syringe unit from bag14 Attach Infusion Adapter to empty bag Inject 50ml of liquid into the bag15 Connect syringe unit to the bag Disconnect syringe unit from bag16 Inject 50ml of liquid into the bag17 Disconnect syringe unit from bag
TotalSteps 17 15 13 12Time 87.7 seconds 62.8 seconds 41.1 seconds 36.4 seconds
Source: Massoomi. Pharmacy Purchasing Products 2015; July S1-S1045
Looking for Efficiency
Source: Massoomi. Pharmacy Purchasing Products 2015; July S1-S10 46
Safe Handling of Hazardous Drugs: An Evolving Legislative and Regulatory LandscapePharMEDium Lunch and Learn Series
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Uptake in CSTD Use in US
Source: State of Pharmacy Compounding 2015; Pharmacy Purchasing and Products: May 2015
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CSTD Drug Incompatibilities
N,N-Dimethylacetamide Amsacrine
VUMEN (teniposide)
BUSULFEX (busulfan)
Treanda (Bendamustine)
Listed CSTD On-Guard
ChemoClave
PhaSeal
CAUTION, no testing with others!
Source: ISMP Medical Safety Alert: February 26, 2015Source: FDA ALERT: March 10, 2015 48
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Users Comments on CSTDs
Source: accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM, Accesed January 5, 2015
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Bacille Calmette-Guerin (BCG vaccine)
Indication: Bladder CA
USP800
WARNINGS
Live Biological Hazard
BCG infections in healthcare workers have occurred
Case studies of deaths due to cross contamination of TPNs
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Final Product Preparation
Pre-primed bags Line naïve fluid
USP800
Proper labelingClear instructionsWarning labels
Line labelsNot USP 800, but good practice
Safety overbag
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Delivery of Hazardous DrugsYes to Hand Delivery NO to Pneumatic Delivery
USP800
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Hazardous Drug Spill Kits/Policy
Develop a collaborative policy
D fi l li it
USP800
Define volume limits Who is responsible
Develop or purchase ‘spill kits’ Location of kits USP 800: Warehouse Training on kits Dating on kitsg
Drill Spills
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Proper Workspace Preparation① Deactivation
-2% Sodium Hypochlorite solution② Decontamination
-Physical wiping of surfaceS di Thi lf t
USP800
-Sodium Thiosulfate③ Cleaning
-Tri or Quadra-valent detergent-Peroxide
④ Disinfection-Sterile Isopropyl Alcohol 70%-UV lightg
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Safe Handling of Hazardous Drugs: An Evolving Legislative and Regulatory LandscapePharMEDium Lunch and Learn Series
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Medical Surveillance Program
First Step Work with Human Resources; Employee Health & Legal
Tier One Education
USP800
Tier-One Education
Tier-Two Employer/Supervisor Surveillance Annual reproductive questionnaire Trending of sick calls
Tier-Three Medical Surveillance Hire and annually CBC urinanalysis LFT’sCBC, urinanalysis, LFT s Urine drug testing by www.exposurecontrol.nl
Tier-Four Post-exposure Surveillance Notation in medical record with date and drug
Source: Massoomi F, Neff B. Implementing a personnel surveillance program for hazardous drug safety. Pharmacy, Purchasing & Products. April 2008: 2-5 55
Pregnancy and BreastfeedingUSP 800
Gap
Source: CFR Federal Register / Vol. 80, No. 15 / Friday, January 23, 2015 / Notices page 3601-2
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Safe Handling of Hazardous Drugs: An Evolving Legislative and Regulatory LandscapePharMEDium Lunch and Learn Series
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Risks of Hazardous Drugs Exposure7,094 Nurse & Pharmacy personnel pregnancies Compared to non-risk peers
Exposure of mother to handling hazardous drugs during pregnancy was associated with a significant increase risk for spontaneous abortion and stillbirth Increased risk for miscarriages by 40 - 50%Increased risk for miscarriages by 40 50%
Increased risk for low birth weight by 17-fold
Increased risk for congenital malformations by 5-fold
Source: Valanis B ; Vollmer WM ; Steele P. Occupational Exposure to Antineoplastic Agents: Self-Reported Miscarriages and Stillbirths Among Nurses and Pharmacists. J of Occupational and Environmental Medicine. 1999; 41(8):632-8
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Non-Sterile Hazardous Drugs Segregate from non-hazardous
USP800
NOT required: non-antineoplastic Simple transfers/counting
Unit dose formulations
Final product
Negative pressure room manipulations
NO automated packaging devices
YES to Automated Dispensing Cabinets
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Safe Handling of Hazardous Drugs: An Evolving Legislative and Regulatory LandscapePharMEDium Lunch and Learn Series
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Hazardous Waste ManagementContinuous formulary assessment State and federal regulations
USP800
DRUG - GENERIC (BRAND)
CLASS OF MEDICATION
ROUTES/ FORMS COMPANY
PREGNANCY CATEGORY MSDS BSC
HAZ CLASS
(1-4)WASTE STREAM
RCRA Y/N
Aldesleukin (Proleukin) ONC INJ Chrion C YES YES Class 1 YELLOW N
Alitretinoin (Panretin) RetinoidTOPICAL, GEL Ligand D YES
Yes, if altered Class 1 YELLOW N
Cychlophosphamide ONCINJ,ORAL Multiple D YES YES Class 1
RCRABLACK Y
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Hazardous Drug Training
Legacy
Home Grown
Commercially Available programs ASHP videos/print material
CriticalPoint Web-based training lessons
Covidien's ChemoPlus Training
Lab Safety Corporation/Valiteq
Pharmacy OneSource
Baxter's Blue Book (Training Manual for IV Admixture Personnel)
Germfree Video Training Program
Kendall's Chemocheck
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Compounding Competency
ChemoChek®
Fluorescence test
USP800
Nursing certification program www.Covidien.com
ChemoTEQ®
Red dye and broth test
Videos and training materials on line
www.valiteq.com
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Hazardous Drug Training
Source: http://www.criticalpoint.info/course/hazardousdrugs/ 62
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Hazardous Drug ConsiderationSpecial Delivery Devices
USP 800 Gap
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What Happens After Treatment?
42 Urine samples were collected from the three patients and their family members; ALL samples were positive for cyclophosphamide and 5-FU
Cyclophosphamide was detected at levels of 0.03–7.34 ng/cm2 in 8 of the 12 wipe samples obtained from the homes
Study demonstrated contamination of the home setting and exposure of family members
Source: J Oncol Pharm Practice 2012;19:208-1764
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“Hazardous Drug Rounds”Preparation Administration Disposal The Patient
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Safe Handling of Hazardous Drugs
An Evolving Legislative and Regulatory Landscape
Firouzan ‘Fred’ Massoomi, Pharm.D., FASHPPharmacy Operations Coordinator
Nebraska Methodist HospitalOmaha, Nebraska
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Safe Handling of Hazardous Drugs: An Evolving Legislative and Regulatory LandscapePharMEDium Lunch and Learn Series
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