safe handling of hazardous drugs: an evolving legislative and...

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.



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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

[email protected]

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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



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



Public Policy

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Public Awareness

PBS Newshour.org August 5, 2010 NBCNews.com July 10, 2010

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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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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



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



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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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



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



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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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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#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



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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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



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



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



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



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



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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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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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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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



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



“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

[email protected]

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safe handling of hazardous drugs: an evolving legislative and...

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