Nursing Essentials for Safe Handling of Hazardous Drugs - PowerPoint Presentation

Slide1

Nursing Essentials for Safe Handling of Hazardous Drugs

USP General Chapter <800>

Shawn Becker, MS, BSNSenior Director Healthcare Quality and SafetyUS Pharmacopeia

Slide2

Questions

True or False: USP is a government agency.

True or False: USP is a nonprofit organization.

USP sets standards to support

the

identity, quality, and purity of medicines, the identity, quality, and purity of food ingredientsthe identity, quality, and purity of dietary supplements safe compounding of drugs for human and animal patientssafe handling of hazardous drugs by healthcare workersa, c, e onlyAll of the aboveNone of the above

Slide3

About USP

USP’s Mission: To improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines & foods.

Founded in 1820

Non-profit, non-governmental international organization

Global organization >1000 employees worldwide

Mission: to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods.

Works with more than 900 scientists, practitioners, and regulators to revise standards that help protect public health

Slide4

What We Do Today

Establish and disseminate public written standards for the quality, purity, identity, strength, and labeling of medicines

Provide recommendations to practitioners on the safe use of medicines

Work with national and international health agencies to improve the quality of medicines worldwide

Educate practitioners and others seeking information and implementation of quality standards

About USP

Slide5

USP Healthcare Quality and Safety (HQS) supports the development and implementation of science-based standards and services to ensure accessibility and the informed, safe use of quality medicines for patients and healthcare providers.

Slide6



Safe Use of Medication &



Medication Errors

Errors caused by Drug Names / Pronunciation Unsafe sterile and nonsterile Compounding Practices Hazardous Drug Exposure to healthcare providers and patients Patient Health Literacy related to prescription drugs

Impact Across distribution channel and across the continuum of care Patients33M hospital admissions1.7M patients in SNF4B prescriptions Institutions 5,627 Hospitals 15,600 SNF 67,000 Pharmacies Healthcare Providers300K Pharmacists

380K Pharmacy techs

2.7M Nurses

1M MDs

Manufacturers

>200 Manufacturers

>40 new drugs approved/year

Healthcare Quality & Safety

Public Health Focus Areas

Slide7

Describe the development and scope of

USP

General Chapter <800>

Hazardous Drugs – Handling in Healthcare Settings

Identify which drugs are classified as hazardous drugs (HDs)Describe the sections within USP General Chapter <800>Identify resources to assist with implementing USP General Chapter <800> in your facility

Learning ObjectivesRemoved --- Perform a high level assessment of readiness to implement USP General Chapter <800>

Slide8

What is USP General

Chapter <800>?

Development and Scope of USP General Chapter <800>

Slide9

Approximately 8 million healthcare workers are potentially exposed to hazardous drugs (HDs) each year.

Pharmacy personnel

Nurses

Physicians

Operating room personnel

Environmental service workersWorkers in research laboratoriesShipping and receiving personnelVeterinary personnelExposure to Hazardous Drugs Source: http://www.cdc.gov/niosh/topics/hazdrug/

Slide10

Risks associated with HDs

Acute effects are increased in healthcare personnel exposed to HDs

(

Valanis

et al., 1993)1Nausea, rashes, hair loss, liver & kidney damage, hearing loss, cardiac toxicitiesLong-term effects documented in both patients and healthcare workersImpact on incidence of cancer (Hansen and Olsen, 1994)

2Impact on fertility and reproductive outcomes (Connor et al., 2014)3 Exposure to Hazardous Drugs 1. B Valanis et al., “Association of Antineoplastic," 455-62.2. Hansen and Jørqen, “Cancer Morbidity,” 22-26.3. Connor et al., "Evaluation of Antineoplastic,” 901-910.

Slide11

Activities that Expose Personnel to HDs

Activity

Potential Opportunity of Exposure

Receipt

HD residues on containers and work surfacesDispensingCounting or repacking tablets and capsulesCompounding and other manipulationCrushing tablets or opening capsulesWithdrawing doses of injectable productsAdministrationPriming intravenous lines

Patient-care activitiesHandling bodily fluidsSpillsSpill generation, management, and disposalTransportMoving hazardous drugs within a healthcare facilityWasteCollection and disposal of hazardous waste and trace contaminated waste

Slide12

NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings:

Link

ASHP Guidelines on Handling Hazardous Drugs:

Link

ONS Safe Handling of Hazardous Drugs: LinkJoint Statement of ONS, ASCO & HOPA: Link“Ensuring Health Care Worker Safety when Handling Hazardous Drugs”

Resources On Guidelines for HDsNIOSHNational Institute for Occupational Safety and HealthONSOncology Nursing SocietyASHP

American Society of Hospital Pharmacists

ASCO

American Society of Clinical Oncology

HOPA

Hematology/Oncology Pharmacy Association 

Slide13

Define practice and quality standards for handling HDs

Builds on existing science, guidelines and expertise

Promote patient safety, worker safety, and environmental protection when handling hazardous drugs (HDs)

Why USP General Chapter <800>?

USP General Chapter <800> is created for the protection of Healthcare Workers, Patients and the Environment

Slide14

USP Healthcare Quality & Safety Standard-Setting Process

Slide15

Path to USP General Chapter <800>

1970s

European study found mutagenicity within urine of nurses. Beginning to evaluate occupational exposure in healthcare professionals

1960s

Reports in medical literature

1980sASHP published TAB (Technical Assistance Bulletin) regarding HDs, primary focused on chemotherapy agents2004NIOSH published Alert on preventing occupational exposure to HDs2011-2014Expert panel formed, , First and second versions both released for public comment

Feb 2016

USP General Chapter <800> published

1 Jul 2018

USP General Chapter <800> enforceable

Slide16

Scope of USP

General Chapter <800>

Scope of USP <800>

Healthcare Personnel

HospitalsPharmaciesVeterinary officesPhysician officesSkilled Nursing FacilitiesOutpatient clinicsOthersDrug Entire Life Cycle

PharmacistsPharmacy techniciansNursesPhysiciansVeterinary personnelEnvironmental ServicesOthersReceivingStoringCompoundingDispensingAdministeringDisposalAll Entities

Slide17

What are Hazardous Drugs (HDs)?

Identification of HDs

Slide18

Questions

Which of these drugs are

NOT

Hazardous Drugs?

Progesterone/

PrometriumMethotrexate/ TrexallOxytocin/PitocinClonazepam/KlonopinWarfarin/Coumadinb and e onlyAll of the aboveNone of the above

Slide19

Drugs that are hazardous to personnel

* Different from

Environmental Protection Agency (

EPA)-hazardous,

which are hazardous to the environment

As defined by NIOSH, a HD is any drug identified by at least one of the following criteria:What is an HD?CarcinogenicityTeratogenicity or other developmental toxicityReproductive toxicityOrgan toxicity at low dosesGenotoxicity Structure and toxicity profiles of new drugs that mimic existing drugs determined hazardous by the above criteria

Slide20

NIOSH categorizes HDs into 3 distinct groups

Antineoplastic drugs

Non-antineoplastic drugs

Non-antineoplastic drugs that primarily have adverse reproductive effects

2016 NIOSH List

- Updated every 2 yearsClassification of HDshttp://www.cdc.gov/niosh/topics/antineoplastic/pdf/hazardous-drugs-list_2016-161.pdf

Slide21

Overview of

USP

General Chapter <800>

Elements of

USP

General Chapter <800>

Slide22

Personnel

Facility & Equipment Requirements

Affected Practices

Documentation Requirements

Clean-up & MonitoringOverview of USP General Chapter <800>

Slide23

Responsibilities

Training Requirements

Personal Protective Equipment (PPE)

23

Personnel

Slide24

Designated person is responsible for the oversight of handling HDs within the facility

Develop policies and procedures

Oversight of facility compliance

Ensure personnel are trained and competent

Provide continuous monitoring of the facilityAll personnel are responsible for understanding the practices and precautions involved in handling HDs, as well as continuously evaluating the facility’s proceduresPersonnel Responsibilities

Slide25

All personnel who handle HDs must receive training based on their job function

Competency must be demonstrated

Training must include:

Overview of the facility’s list of HDs and their risks

A review of the facility’s Standard Operating Procedures (SOPs)Proper use of PPEProper use of equipment and devicesResponse to known or suspected HD exposureSpill managementDisposal of HDs and trace contaminated materials

Training Requirements

Slide26

Questions

I take precautions when handling hazardous drugs?

Some of the time

None of the time

Always

I don’t know when I am exposed to hazardous drugs

Slide27

Protection against potential exposure

PPE includes

Gloves and Gowns

Head, Hair, Shoe, and Sleeve Covers

Eye and Face ProtectionRespiratory ProtectionType of PPE required depends on the dosage form of the HD handled as well as the activity being performed.Personal Protective Equipment

Slide28

Promote safe conditions:

Personnel and patient safety

Environmental protection

Designate HD handling areas:

Sign displayed at entranceAway from breakrooms and refreshment areasRestrict access:Authorized personnel

Facility & Equipment Requirements

Slide29

Engineering controls utilize mechanisms to minimize HD contamination and exposure

Separate, fixed walls

Negative pressure

External ventilation

Air Changes Per Hour (ACPH)Engineering ControlsContainment Primary Engineering Controls (C-PECS)Containment Secondary Engineering Controls (C-SECS)Supplemental Engineering Controls

Facility & Equipment Requirements

Slide30

Practices Affected

Slide31

List of HDs handled within facility

Standard Operating Procedures (SOPs)

Hazard Communication Policy

Medical Surveillance

Documentation Requirements & Medical Surveillance

Slide32

Entities must maintain a list of HDs that are handled within the facility.

Review at least every 12 months

Two approaches to HD handling

Facility HD List

Slide33

SOPs are required for entities that handle HDs

Must be reviewed at least every 12 months (review must be documented)

Any changes must be communicated to all personnel involved in handling of HDs

USP <800> includes a list of recommended topics to be included within a facility’s SOPs

Standard Operating Procedures (SOPs)

Slide34

OSHA Hazard Communication Standard (HCS), otherwise known as HAZCOM

Ensures information about hazards and protective measures are distributed

Hazard Communication Program

Hazardous Drugs

Communication

Plan Facilities that handle hazardous chemicals must develop a written hazard communication plan to describe how the standard is implemented within the facility.

Slide35

Recommendation rather than a requirement of USP General Chapter <800>

Complements engineering controls, safe work processes, and PPE

Resource

NIOSH Medical Surveillance publication

Medical Surveillance

Slide36

Deactivation, decontamination, cleaning, disinfection

Spill Control

Environmental Monitoring

Clean-Up and Monitoring

Slide37

HD handling areas and reusable equipment/devices must be deactivated, decontaminated, and cleaned.

Disinfection is required for sterile areas/equipment.

Entities must have written procedures, including agents used, dilutions, frequency of actions, and any documentation requirements

Entities must also comply with USP General Chapters <795> and <797> cleaning processes for nonsterile and sterile compounding

Deactivation, Decontamination, Cleaning, Disinfection

Slide38

All personnel who may be required to clean up a spill of HDs must receive proper training in spill management

Personnel and spill kits must be available at all times that HDs are being handled

Spill Control

Slide39

Environmental monitoring in USP General Chapter <800> describes surface sampling to determine presence of HD contamination

*This is different from environmental monitoring for microbial contamination in USP General Chapter<797>

Recommendation rather than requirement of USP General Chapter <800>

Environmental Monitoring

Slide40

Assessing Readiness

Applying USP General Chapter <800>

Slide41

Questions

How frequently do you look up the hazards a drug may pose to

you?

Never - Do not research drug information

Once a month

Once a weekOnce a dayMore than one time per day

Slide42

Questions

Rate your confidence in receiving adequate information about the hazardous drugs you are handling.

Not Confident At All

Neutral (Neither Confident Nor Unconfident)

Confident

Slide43

Does USP General Chapter <800> apply?

If your facility performs any of these activities, then USP General Chapter <800> applies.

Refer to

NIOSH List of HDs

Receiving

Storing

Compounding

Dispensing

Administering

Disposing

Slide44

Assessing Readiness

Elements

of USP General Chapter <800>

Assessment

Does facility have list of all HDs handled within the facility?

Has the list been reviewed in the previous 12 months?

Does facility

have written SOPs for handling HDs?

Do the SOPs include all activities in handling HDs?

Have the SOPs been reviewed in the previous 12 months?

Have all personnel

involved in handling HDs received training?

Is training based on job function?

Has personnel competency been demonstrated within the previous 12 months?

Is

PPE being used?

Does PPE meet requirements within USP General Chapter <800> and NIOSH?

Is appropriate PPE being used for all activities of HD handling?

Are engineering controls being used?

Do engineering controls meet minimum requirements of USP General Chapters <795>, <797>, and <800>?

Have engineering controls been certified to ensure proper functioning?

Slide45

Additional Resources

Implementing USP General Chapter <800>

Slide46

Additional Resources

1

USP Compounding Compendium

USP General Chapter <800> FAQs

2

NIOSH Alert

2004 NIOSH Alert

2016 NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings

OSHA Hazard Communication Standard

OSHA HAZCOM

3

USP Essentials for Safe Handling of HD

On demand/remote education

1 contact hour

USP General Chapter <800> eLearning Course provides

E Learning Interactive Modules

6.5 contact hours

Education.USP.org

USP

Resources

Alerts

USP

Education

Slide47

Summary

Slide48

USP General Chapter <800> was developed to protect healthcare workers by describing practice and quality standards for handling hazardous drugs

The final version was published and will become official and enforceable on July 1, 2018

NIOSH maintains an updated list of HDs

USP General Chapter <800> covers the entire life cycle of handling HDs, from receiving to administration or disposal

Facilities that handle HDs should assess readiness to comply with USP General Chapter <800>

Additional resources are available to support implementation of USP General Chapter <800> in your facility. Summary

Slide49

Connor, Thomas H., D. Gayle

DeBord

, Jack R. Pretty, Marc S. Oliver, Tracy S. Roth, Peter S. J. Lees, Edward F. Krieg, Bonnie Rogers, Carmen P. Escalante, Christine A.

Toennis

, John C. Clark, Belinda C. Johnson, and Melissa A. McDiarmid. "Evaluation of Antineoplastic Drug Exposure of Health Care Workers at Three University-Based US Cancer Centers." Journal of Occupational and Environmental Medicine 52, no. 10 (2010): 1019-027.Johnni Hansen, and Jørqen H Olsen. "Cancer Morbidity among Danish Female Pharmacy Technicians." 

Scandinavian Journal of Work, Environment ＆ Health 20, no. 1 (1994): 22-26.Valanis, B., W. Vollmir, K. Labuhn, and A. Glass. "Association of Antineoplastic Drug Handling with Acute Adverse Effects in Pharmacy Personnel." American Journal of Hospital Pharmacy 50, no. 3 (1993): 455-62.Bibliography