promoting best practices for the safe ... bd safe...nebraska methodist hospital department of...

PROMOTING BEST PRACTICES

FOR THE SAFE HANDLING OF

HAZARDOUS DRUGS

A CONTINUING EDUCATION WEBINAR

PROMOTING BEST PRACTICES

FOR THE SAFE HANDLING OF

HAZARDOUS DRUGSFirouzan “Fred” Massoomi, PharmD, FASHP

Nebraska Methodist Hospital

Department of Pharmacy Services

Omaha, Nebraska 68114

[email protected]

Objectives

• Outline the latest policies and recommendations

about the safe handling of HDs

• Identify state legislation in regards to HD handling

• Explore the landscape changes for practice sites

and the need to meet identical standards

throughout

Who Is at Risk of Occupational

Exposure?•8 million US healthcare workers

o Pharmacy, nursing personnel, physicians

o Operating room personnel

o Veterinary personnel

o Shipping and receiving personnel

o Laundry workers, waste handlers, maintenance workers

NIOSH. http://www.cdc.gov/niosh/docs/wp-solutions/2009-106/pdfs/2009-106.pdf. Accessed April 14, 2015.

Risks of Hazardous Drugs Exposure

• 7,094 nurse and pharmacy personnel pregnancies– Compared to peers not at risk

• Observed risks to handling hazardous drugs Increased risk for miscarriages by 40%-50%

Increased risk for low birth weight by 17-fold

Increased risk for congenital malformations by 5-fold

Valanis B, et al. J Occup Environ Med. 1999;41(8):632-638.

10 (N=2)18 (N=5)48N(pos)=7

004Control

0341Nurse 2

0151Nurse 1

0091Technician 3

000061Technician 2

1881Technician 1

93101Pharmacist 2

0361Pharmacist 1

Positive IF

samples

Positive CP

samples

Number of

Urine samples

DayWorker

Quantifying Exposure

CP =cyclophosphamide; IF=ifosphamide

Wick, C, et al. Am J Health Syst Pharm. 2003;60(22):2314-2320.

Source: ASHP Study Guide: Safe Handling of Cytotoxic and Hazardous Drugs. 1990.

Legacy of Current Practices

Defect: Compounding Inconsistencies

Source: Nebraska Methodist Hospital Department of Pharmacy Services

A Decade Towards Safety2004 2014

CDC & NIOSH. http://www.cdc.gov/niosh/docs/2004-165/. Accessed April 1, 2015.

US Pharmacopeial Convention. http://www.usp.org/usp-nf/notices/general-chapter-hazardous-drugs-handling-

healthcare-settings. Accessed April 1, 2015

Guidelines for Hazardous DrugsSource Year

American Society Heath-System Pharmacists 1982, 1984, 1990, 2006

Occupational Safety Health Administration 1986, 1995, 1999

American Medical Association 1985

Oncology Nursing Society 1988, 2003, 2010

NIOSH* Alert 2004, 2010, 2012, 2014

Hospital Oncology Pharmacists Association 2009

United States Pharmacopeia <797> 2004, 2008

United States Pharmacopeia <800> 2014 (for comment)

*NIOSH = National Institute for Occupational Safety and Health

33 years of safe handling guidelines

Defect Compliance• NIOSH survey of nursing practices findings

• Failure to wear nonabsorbent gown (42%)

• Intravenous (IV) tubing primed with antineoplastic drug by

respondent (6%) or by pharmacy (12%)

• Potentially contaminated clothing taken home (12%)

• Spill or leak of antineoplastic drug during administration (12%)

• Failure to wear chemotherapy gloves (12%)

• Lack of hazard awareness training (4%)

Boiano JM, et al. J Occup Environ Hyg. 2014;11:728-740.

State Health Departments• State regulations for compounding

– Board of pharmacy or health departments

– Most states have USP 797 specific regulations

• Specific hazardous drug compounding regulations– Washington 2011(Bill 5594)

– California 2013 (Bill 1202)

– North Carolina 2014 (H644)

– Maryland 2014 (Bill 1108)– Michigan March 2015 (Bill 237)

-Washington State: http://search.leg.wa.gov/CombinedDocument.aspx.

-California: http://www.leginfo.ca.gov/pub/13-14/bill/asm/ab_1201-1250/ab_1202_cfa_20130422_121250_asm_comm.html.

-North Carolina http://www.ncleg.net/Sessions/2013/Bills/House/HTML/H644v0.html.

-Maryland: http://dhmh.maryland.gov/regs/Documents/SB1108%20-%20Safety%20Standards%20WG_

REVISED_Final%20Signed_12-16-14_OGA%201547.pdf.

-Michigan http://legislature.mi.gov/documents/2015-2016/billintroduced/Senate/pdf/2015-SIB-0237.pdf.

-All accessed: Accessed 04/20/15

The Joint Commission Is Concerned

The Joint Commission. March 2014: volume 7; issue 3.

To reduce the incidence of hazardous drug contamination

by and exposure to workers, a health care organization

should have a comprehensive safety program.

Proposed USP 800: Timeline

• First Release March 2014

• Comment Due Date July 31, 2014

• Second Release December 2014

• Comment Due Date May 31, 2015

• Goal Publish Date February 2016

• Official Compliance Date August 2016

USP

800

Source: USP Open Mic Session; Open-Microphone Web Meeting for General

Chapter Hazardous Drugs – Handling in Healthcare Settings: February 20, 2015

“The objective of this chapter is to protect personnel and the

environment when handling hazardous drugs (HDs).”

Sterile and non-sterile products

USP

800

US Pharmacopeial Convention. www.usp.org/usp-nf/notices/general-chapter-hazardous-drugs-handling-

healthcare-settings. Accessed April 1, 2015.

The Hazardous Drug Team

• Primary– Pharmacist– Pharmacy technicians/interns– Pharmacy purchasing– Nursing– Surgical services – Risk management– Employee health– Environmental services

• Secondary– Administration– Safety officer– Physician office managers– Home health managers

Primary Goal: Establish a hazardous drug safety program

USP

800

Source: Nebraska Methodist Hospital Department of Pharmacy Services.

Visual Hazard Mapping Tool

Wholesaler Dock/Pharmacy

Receiving

$$

Waste Management

DeliveryPatient Unit

Delivery

Pharmacy

CompoundingPatientPackaging

Waste Hauler

Linen Haulers Linen Management

Nurse

Administration Housekeeping

Hazardous Drug Process

Pre-Hospital Hospital Post-Hospital

Delivery

RX Company

Hazardous Drug

NOTE: Red Indicates

Contamination points

Without a total hazardous drug safety

program in place the drug products, the

patient, the linen from patients, the

pharmaceutical wastes provides multi-

sourced contaminated risk to

healthcare providers.NIOSH Safety Alert 2004

Hazardous Drugs products should

always be considered contaminated on

the packaging and vials until properly

decontaminated.Connor T, et al. AJHP 2005;62:475-582

Massoomi©2012


USP

800

The Contaminated Environment

1. More than 70 published studies

2. Surfaces that come in contact with hazardsA. Primary engineering control spaces

B. Storage locations

C. Patient linen

3. Some with in-direct contact with hazardsA. Floors

B. Patient bed rails

C. IV ump buttons

Environmental Quality Control• ‘Routinely’ = every 6 months

• Approximate cost is $250 to $400 per sample


USP

800

NIOSH Hazardous Drug List

September 5, 2014

NEW

• 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

• 12 drugs removed from the 2004/12 lists

• Guide to handling based on formulation

CDC. http://www.cdc.gov/niosh/docs/2014-138/. Accessed April 1, 2015.

USP

800

Formulary AssessmentApplication of NEW NIOSH of Hazards

Antineoplastic Non-Antineoplastic Reproductive

Class 1 Class 2 Class 3

Continuously stratify with new formulary drugs

USP

800


#1 Safety Concern The Source

The Vial and Packaging

• EVIDENCE: 11 Published studies

• Drug vial exteriors

• Not due to damage during shipping & handling

USP

800


Wholesaler Process Limitations

• Limitations on hazardous drugs– Cytotoxic only

• No NIOSH stratification

• Site trick– Set up departments

– Order based off the department

Antineoplastic HD

Non-antineoplastic HD

Reproductive HD


Totes from wholesaler

Gloves to handle

Drugs left in baggies

Handle in compounding space

Segregated Handling of Vials

Shall not

• Store

• Unpack

• Compound

• Manipulate

• Not a + pressure area– Equi-pressure

– Negative pressure

Good Distribution Practices

USP

800


Source: US Pharmacopeial Convention. www.usp.org/usp-nf/notices/general-

chapter-hazardous-drugs-handling-healthcare-settings. Accessed April 1, 2015.

Training Documentation

• Methodist notes per guidelines

– Hand washing technique

– No make-up

– No jewelry

– No artificial finger nails

– No iPods or personal devices

Goal

Minimize Contamination

From product to employee

and visa versa

Proper demonstrative use of PPE

No exemptions from garbing requirements

Personal Protective Equipment (PPE)

USP

800


Source: Fred Massoomi visit. Taipei Veterans Hospital; Taipei, Taiwan: 2012.

Doffing SequenceDonning Sequence

USP

800

Donning and Doffing PPE

Choosing the Right Glove

IMPORTANT: ASTM D6978 and not ASTM F739 due to permeability limits

35.2° +2 C 25° C temperature delta

USP

800

US Pharmacopeial Convention. www.usp.org/usp-nf/notices/general-chapter-hazardous-drugs-handling-

healthcare-settings. Accessed April 1, 2015.

TJC is Concerned About the Glove

© Joint Commission Resources: (Environment of Care News). Oakbrook Terrace, IL: Joint Commission on

Accreditation of Healthcare Organizations (2014) Vol. 7, Issue 3. Reprinted with

Biological Safety Cabinet

Isolator Glove Box

Primary Engineering Controls

Class II Type B2 BSC

Compounding Aseptic Containment

Isolator (CACI)

Total Exhaust

USP

800


Secondary Engineering Controls

Attributes of the room: Separate Room

12 Air Changes Per Hour (ACPH)

HEPA filtered air to ISO 7 Standard

Negative Pressure to -0.01 to -0.03 inches of water column

• Low Volume Compounding Exemption ELIMINATED from USP 797

USP

800


C-SCA

Containment Segregated Compounding Area

• Non-HEPA room– 12 ACPH

– Negative pressure

• NO USP 797 dating– Not for high risk

– Max 12 hours dating

• Line of demarcation

• Primary Engineering Control: Cabinet– Dual HEPA

USP

800

US Pharmacopeial Convention.

http://www.usp.org/usp-nf/notices/general-chapter-hazardous-drugs-handling-healthcare-settings.

Accessed April 1, 2015

HEPA= High-efficiency particulate arrestance.

Supplemental Environmental Controls

Closed system transfer devices (CSTDs)

Compounding : Recommended

Administration : Required

Currently 7 US products

PhaSeal®: BD

VialShield®/Texium®: Carefusion: BD

On-Guard® : B.Braun

ChemoLock®: ICU Medical

ChemoClave®/Spiros®: ICU Medical

Equashield®

All devices FDA cleared

Four have FDA ONB device code

USP

800

Uptake in CSTD Use in US

CSTD Drug Incompatibilities

• N,N-Dimethylacetamide Amsacrine

VUMON® (teniposide)

BUSULFEX® (busulfan)

TREANDA® (Bendamustine)

• Listed CSTD– On-GuardTM

– ChemoClave®

– PhaSealTM

• CAUTION, no testing with others!

ISMP Medical Safety Alert. February 26, 2015.

FDA ALERT. March 10, 2015.

Users’ Comments on CSTDs

FDA. accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM. Accessed January 5, 2015.

Repetitive Strain Injury

19%

81%


Bacille Calmette-Guerin

(BCG vaccine)

• Indication: Bladder CA

• WARNINGS

– Live biological hazard

– BCG infections in healthcare workers

have occurred

– Case studies of deaths due to cross

contamination of Total Parenteral Nutritional

products

USP

800


Compounding Competency

• ChemoChek®

– Fluorescence test

– Nursing certification program

www.Covidien.com

• ChemoTEQ®

– Red dye and broth test

– Videos and training materials online

– www.valiteq.com

USP

800


Assuring Safety Compliance

• Compounding efficiency

• Protocol driven

• Remote verification

• ISMP highly recommends

Volumetric, gravimetric, barcode scanning

Final Product Preparation

• Pre-primed bags– Line naïve fluid

• Proper labeling– Clear instructions

– Warning labels

• Line labels– Not USP 800, but good practice

• Safety overbag

USP

800


Delivery of Hazardous DrugsYes to Hand Delivery NO to Pneumatic Delivery

USP

800


Hazardous Drug Spill Kits/Policy

• Develop a collaborative policy

• Define volume limits– Who is responsible

• DATE KITS!!!!!!!!!– We do 5 years on the date receipt

• Develop or purchase ‘spill kits’– Location of kits

USP 800: Warehouse

– Training on kits– Dating on kits

• Drill spills

USP

800


Proper Workspace Preparation

① Deactivation• 2% sodium hypochlorite solution

• Sodium thiosulfate

② Decontamination• Physical wiping of surface

③ Cleaning• Tri- or quadrivalent detergent

• Peroxide

④ Disinfection• Sterile isopropyl alcohol 70%

• UV light

USP

800


Medical Surveillance Program• First Step

– Work with Human Resources, Employee Health, and Legal

• Tier One: Education and Self Surveillance

• Tier Two: Employer/Supervisor Surveillance Annual reproductive questionnaire

Trending of sick calls

• Tier Three: Comprehensive Medical Surveillance At hire and annually

CBC, urinalysis, LFT

Urine drug testing by www.exposurecontrol.nl

• Tier-Four Post-exposure Surveillance Notation in medical record with date and drug

Massoomi F, et al. Implementing a personnel surveillance program for hazardous drug safety. Pharmacy,

Purchasing & Products. April 2008: 2-5.

USP

800

CBC=complete blood count, LFT=liver function. test

Direct

Contact with

Patient on

HD Therapy

Risk Stratification of Employees to HDs

Direct

Contact with

HD or

Wastes

Indirect HD contactor Hdrug patient contact

No Contact by position with HD

Or Patients on HD

No Contact allowed: Pregnancy,

Breast Feeding, Attempt atPregnancy


Pregnancy and Breastfeeding

USP 800

Gap

CFR Federal Register. Vol. 80. No. 15. Friday, January 23, 2015. Notices page 3601-3602.

Non-Sterile Hazardous Drugs

• Segregate from non-hazardous

• 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

USP

800


Hazardous Waste Management• Collaborative formulary assessment

– State and federal regulations

– Continuous assessment of risk and stream

DRUG - GENERIC

(BRAND)

CLASS OF

MEDICATION

ROUTES/

FORMS COMPANY

PREGNANCY

CATEGORY SDS BSC

HAZ

CLASS

(1-4)

WASTE

STREAM

RCRA

Y/N

Aldesleukin

(Proleukin®) ONC INJ Chiron C YES YES Class 1 YELLOW N

Alitretinoin

(Panretin®) Retinoid

TOPICAL,

GEL Ligand D YES

Yes, if

altered Class 1 YELLOW N

Cyclophosphamide ONC

INJ,

ORAL Multiple D YES YES Class 1

RCRA

BLACK Y

USP

800


SDS=Safety Data Sheet; BSC = Biological Safety Cabinet;

RCRA=Resource Conservation Recovery Act listed drug

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 ideo Training Program

– Kendall's Chemocheck

• NO secure bag spike system

• Dose size limitations: 1 mL

• Ampule management

• Specialized routes of administration Intrathecal Irrigations Ophthalmic Topical

Hazardous Drug Consideration

Known CSTD Gaps

USP 800

Gap


Hazardous Drug Consideration

Special Delivery Devices

USP 800

Gap

• Elastomeric pumps

• On-Q pumps

• Syringe pumps

• Implantable pumps

• New electronic patches

Hazardous Drug Considerations• Surgical

– Bladder installation

– HOT chemo baths

– Ophthalmic surgery = TOPICAL

– Esophogeal Strictures = TOPICAL

– Hyperthermic IntraperitonealChemotherapy

• Ophthalmology

• Obstetrics

– Ectopic pregnancy

• Rheumatology

– Rheumatoid arthritis

– Lupus nephritis

• Neurology

– Multiple sclerosis

USP 800

Gap


What Happens After Treatment?

• 35 and 16 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

Yuki M, et al. J Oncol Pharm Practice. 2012;19:208-217.

Hazardous Drug RoundsPreparation Administration Disposal


Additional Resources1. USP <800> Hazardous drugs—Handling in healthcare settings. Briefing. www.usp.org/usp-

nf/notices/compounding-notice. Accessed 04/09/2015.

2. NIOSH [2014]. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings

2014. 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. 2014-138 (Supersedes 2012-150).

3. Davis J, McLauchlan R, Connor T. Exposure to hazardous drugs in healthcare: an issue that

will not go away.

J Oncol Pharm Pract. 2011;17(1):9-13.

4. Centers for Disease Control and Prevention. Workplace Safety and Health. NIOSH ALERT.

Preventing occupational exposures to antineoplastic and other hazardous drugs in health

care settings. DHHS (NIOSH) Publication Number 2004-165. September 2004;1-50.

5. Connor TH and McDiarmid MA. Preventing occupational exposures to antineoplastic drugs

in health care settings. CA Cancer J Clin. 2006;56:354-365.

6. United States Department of Labor. Occupational Safety & Health Administration. Healthcare

wide hazards: Needlestick/sharps injuries. Available at

http://www.osha.gov/SLTC/etools/hospital/hazards/sharps/sharps.html.

7. Pines E, Smith C. The U.S. EPA, Office of Solid Waste and Emergency Response,

Innovation Initiative. Managing pharmaceutical waste: A 10-step blueprint for healthcare

facilities. 2008. http://www.epa.gov/osw/hazard/generation/pharmaceuticals.htm. Accessed

04/09/2015.

http://www.osha.gov/SLTC/etools/hospital/hazards/sharps/sharps.html

http://www.epa.gov/osw/hazard/generation/pharmaceuticals.htm

Thank you!