usp, niosh, and osha oh, my! · 2015-11-14 · hazardous drugs: usp, niosh, and osha oh, my! thomas...

Hazardous Drugs: USP, NIOSH, and OSHAOh, My!

Thomas ConnorEric KastangoPatricia Kienle

Disclosures

The program chair and presenters for this continuing education activity have reported no relevant financial relationships, except:

Patricia C. Kienle – Employee, Cardinal Health; Author, ASHP

Learning Objectives

Identify the current state of compliance with hazardous drug (HD) safety requirements and recommendations

Summarize the key non‐compliant issues concerning HDs

Describe the similarities and differences among USP, NIOSH, OSHA, ASHP, and ONS documents

Outline actions to take to ensure compliance with updated NIOSH recommendations and OSHA Technical Manual requirements

Discuss the facility, personnel, environmental monitoring, and related issues required to be compliance with USP and related documents

Agenda

Announcements

Understanding where we are now

Coping with all the requirements

Caring enough to move forward with what needs to be done

Questions and answers

If I only had a brain … understanding where we are now

Eric Kastango, RPh, MBA, FASHPPresident/CEO

Clinical IQ, LLC and CriticalPoint, [email protected]

Hazardous Drugs: USP, NIOSH, and OSHA Oh, My! 2015 Midyear Clinical Meeting & Exhibition

© 2015 American Society of Health-System Pharmacists 1 of 13

Evidence‐Based Brutal Facts

What should we know and accept as self‐evident!

A number of health risks associated with healthcare workers’ exposure to antineoplastic drugs have been established since the 1970s [1].

Occupational exposure to these agents have led to a range of health outcomes reported in healthcare workers including acute effects [2], cardiotoxicity [3], reproductive toxic effects [4‐6], and chromosomal damage ‐ a precursor to cancer development [7,8].

Should we be concerned?

Yes and for several reasons

The use of antineoplastic drugs is growing because of the increasing incidence of cancer [9].

Existing safe drug handling practices may not effectively eliminate the risk potential as drug contamination of surfaces is prevalent in multiple departments within a hospital [10,11].

The number and variety of healthcare workers potentially exposed to antineoplastic drugs has increased because the use of these agents for treating nonmalignant diseases has expanded [1].

Should we be concerned?

Yes and for several reasons

After 40 years, NO occupational exposure limits have been established for these drugs by any of the recognized agencies that produce such exposure thresholds

• American Conference of Governmental Industrial Hygienists threshold limit values,

• German maximum workplace concentration.

Why should we be concerned?

No other industry comes close to healthcare regarding the number of hazardous agents handled by a variety of different professionals

• Known or suspected human and/or animal carcinogens, teratogens, mutagens

• Known or suspected human and/or animal reproductive toxicants

• Known or suspected drugs with effects on fertility

• Known human acute and/or chronic toxicants

Source: Connor TH‐HD presentation to ASCO, December 2014

Does your health‐system require employees to confirm in writing that they are aware of the risk of

handling hazardous drugs?

Yes

No



Used with permission Copyright © 2008‐2016 CriticalPoint, LLC™ ‐ All rights reserved

Hospital Compliance with Written HD Confirmation of Risk 2011 through 2015

24%

31% 31%

42%

37%

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

2011 2012 2013 2014 2015

This requirement, present since 2008, has not seen significant gains in improvement. When these data were published in 2011, CriticalPoint provided a template “Written Confirmation of Risk Form” and made it available for free download, which will be made available again this year.

It’s easy to see why there is little compliance with this requirement since the two items that measure HD employee training and competency continue to show less than 60% compliance and do not seem to be improving.

HD Residue

1999 study ‐ 3 drugs measured in 6 hospitals: 75% of the pharmacy wipes & 65% of the nursing wipes were contaminated

2010 study ‐ 5 drugs measured in 3 hospitals: 75% of the pharmacy wipes and 43% of the nursing wipes were contaminated

Connor TH. AJHP 7/1999; Connor TH. JOEM 10/2010

15

HD Work Practice Survey

Conclusions:

• Our results suggest that knowledge regarding risks associated with antineoplastic drugs can be improved, especially amongst job categories that are not tasked with drug preparation or drug administration.

• There is also a gap between knowledge and compliance with glove usage and hand hygiene.

• Training is also recommended to improve healthcare workers’ perceptions of the risks associated with antineoplastic drugs.

HD Work Practice Survey

Boiano JM, Steege & Sweeney MH. (2015) Adherence to Precautionary Guidelines for Compounding Antineoplastic Drugs: A Survey of Nurses and Pharmacy Practitioners, Journal of Occupational and Environmental Hygiene, 12:9, 588‐602,

HD Work Practice SurveyBehavior Nurses

n=241Pharmacy practitioners

n=183

Not always wearing two pairs of chemo‐therapy gloves 85% 47%,

Not always even a single pair of chemo‐therapy gloves 8% 10%

Not always using closed system drug‐transfer devices 75% 53%

Not always wearing recommended gown 38%, 20%

I.V. lines sometimes/always primed with antineoplastic drug

19% 30%

Always using either a biological safety cabinet or isolator

9% 15%

They also reported lack of:

Hazard awareness training 9%, 13%

Safe handling procedures 20% 11%

Medical surveillance programs 61% 45%

Boiano JM, Steege & Sweeney MH. (2015) Adherence to Precautionary Guidelines for Compounding Antineoplastic Drugs: A Survey of Nurses and Pharmacy Practitioners, Journal of Occupational and Environmental Hygiene, 12:9, 588‐602,

Top Hazardous Drug Gaps:Results from the 2015 Compliance Study

Kate Douglass, MS, RN, APN,C, CRNIEric S. Kastango, RPh, MS, FASHP

Study Co‐Directors



Copyright © 2008‐2016 CriticalPoint, LLC™ ‐ All rights reserved

Hospital, 866Home Infusion/AIS,

[VALUE]

Prescriber, 7

Clinic, 27

Radiopharmaceutical, 5

Outsource/Central Fill, 6

FDA Registered, 4

Vet, 4

Community, 47

Other, 23

0 100 200 300 400 500 600 700 800 900

Number of Study Locations by Provider TypeN=1138

The distribution among provider types was similar to previous years:Hospital 71%Home Infusion/AIS 12%

Source: http://797study.criticalpoint.info/


2015 Hospitals by Bed SizeN=866

340

176

10887

53

102


Hospital Compliance with Hazardous Drug Items2011 versus 2015 Domain Items 2011 2015

Employees are not eligible for HD training or completion of the HD competency until they have successfully completed the three base competencies: 1) hand hygiene and garbing; 2) Cleaning and Disinfecting and 3) Aseptic Technique

88% 88%

Since you indicated that your organization uses a CACI for HD compounding, it is placed in a dedicated area that has not less than0.01 inches water column negative pressure and has at least 12 air changes per hour (ACPH).

80% 60%

The organization does NOT prepare hazardous CSPs in a laminar airflow workbench (e.g., LAFW) or other type of positive‐pressure primary engineering control (PEC).

67% 90%

The organization employs two tiers of containment (e.g., closed system transfer device (CSTD)) within a BSC or CACI. 88% 69%

The compounding location prepares hazardous CSPs in a BSC that is located inside of an ISO Class 7 area that is physically separate from other areas and has not less than 0.01 inches water column negative pressure to adjacent positive

62% 73%

Personnel who handle hazardous CSPs are fully trained in all of the following: safe aseptic manipulation; negative pressure techniques inside of BSC/CACI; correct use of CSTDs; containment, cleanup and disposal procedures for spills; treatment of exposed personnel and storage, handling and disposal of HDs as well as hazardous properties of existing and new CSPs prior to preparing or handling HDs.

73% 78%

Employees who handle, dispose or compound hazardous CSPs successfully complete a Hazardous CSPs Competency Assessment prior to working with hazardous CSPs and annually thereafter.

52% 55%

For each compounding employee, there is written documentation of training and successful completion of testing on hazardous drug preparation initially (prior to hazardous drug compounding) and annually thereafter.

57% 58%

Hazardous CSPs and HD wastes are disposed of in a manner that complies with local, state and federal regulations. 97% 99%

Personnel who compound hazardous CSPs use chemotherapy rated protective gowns, shoe covers (or dedicated shoes) and double gloving with sterile gloves in addition to standard garbing items and procedure.

76% 80%

The organization stores hazardous CSPs in a negative pressure room such as the HD compounding room. 57% 53%

The organization stores hazardous CSPs separately from other inventory in a manner that prevents contamination and exposure. 90% 85%

The storage area for hazardous CSPs has exhaust ventilation of at least 12 ACPH to dilute and remove potential airborne contaminants.

64% 55%

There is written confirmation by each compounding employee of reproductive age (male or female) that they understand the risk of handling hazardous CSPs.

24% 37%

Domain Compliance 71% 81%

52%55%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

2011 2015

Employees who handle, dispose or compound hazardous CSPs successfully complete a Hazardous CSPs Competency Assessment prior to working with

hazardous CSPs and annually thereafter.


Where are your hazardous drugs prepared?

BSC/CACI in positive pressure cleanroom

BSC/CACI in negative pressure cleanroom

BSC/CACI in Segregated Compounding Area

Outside of a BSC/CACI

67%

90%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

2011 2015

The organization does NOT prepare hazardous CSPs in a laminar airflow workbench (e.g., LAFW) or other type of positive‐pressure primary engineering control (PEC).

2011 2015




57%

53%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

2011 2015

The organization stores hazardous CSPs in a negative pressure room such as the HD compounding room.


88%

69%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

2011 2015

The organization employs two tiers of containment (e.g., closed system transfer device (CSTD)) within a BSC or CACI.


64%

55%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

2011 2015

The storage area for hazardous CSPs has exhaust ventilation of at least 12 ACPH to dilute and remove potential airborne contaminants.


Key Takeaways

• We are still not where we need to be relative to compliance with the current hazardous drug requirements in USP Chapter <797> based on surveys done over the past 5 years.

• USP Chapter <800> release is expected soon

• What is necessary to move the occupational safety needle?

• The evidence‐based science is there about hazardous drugs and their respective health risks!

• Complying is not easy but it is necessary in order to protect ourselves, other healthcare professionals, patients and the environment.

References [1] Centers for Disease Control and Prevention ‐ National Institute for Occupational Safety and Health.

Preventing occupational exposure to antineoplastic and other hazardous drugs in health care settings 2004 [Internet]. Publication number 2004‐165, Cincinnati (OH). 2004 [cited 2011 Nov 30]. Available from: http://www.cdc.gov/niosh/docs/2004‐165/.

[2] McDiarmid M, Egan T. Acute occupational exposure to antineoplastic agents. J Occup Med 1988;30:984e7.

[3] Monica Lamberti, Giovane Giancarlo, Garzillo Elpidio M, Avino Franca, Feola Antonia, Porto Stefania, Tombolini Vincenzo, Di Domenico Marina. Animal models in studies of cardiotoxicity side effects from antiblastic drugs in patients and occupational exposed workers. Biomed Res Int 2014:1e8.

[4] Valanis B, Vollmer W, Labuhn K, Glass A. Occupational exposure to antineoplastic agents and self‐reported infertility among nurses and pharmacists. J Occup Environ Med 1997;39:574e80.

[5] Valanis B, Vollmer WM, Steele P. Occupational exposure to antineoplastic agents: self‐reported miscarriages and stillbirths among nurses and pharmacists. J Occup Environ Med 1999;41:632e8.

[6] George Dranitsaris, Johnston Mary, Poirier Susan, Schueller Trudi, Milliken Debbie, Green Esther, ZankeBrent. Are health care providers who work with cancer drugs at an increased risk for toxic events? A systematic review and meta‐analysis of the literature. J Oncol Pharm Pract 2005;11:69e78.

[7] Antonella Testa, Giachelia Manuela, Palma Selena, Appolloni Massimo, Padua Luca, Tranfo Giovanna, Spagnoli Mariangela, Tirindelli Donatella, Cozzi Renata. Occupational exposure to antineoplastic agents induces a high level of chromosome damage. Lack of an effect of GST polymorphisms. Toxicol Appl Pharmacol2007;223:46e55.

[8] McDiarmid MA, Oliver MS, Roth TS, Rogers B, Escalante C. Chromosome 5 and 7 abnormalities in oncology personnel handling anticancer drugs. J Occup Environ Med 2010;52:1028e34.

References [9] World Cancer Research Fund International. 2012 Cancer Statistics [Internet]. London (UK). 2012 [cited

2014 Mar 7]. Available from: http://www.wcrf.org/cancer_statistics/.

[10] Connor Thomas H, DeBord Gayle, Pretty Jack R, Oliver Marc S, Roth Tracy S, Lees Peter SJ, Krieg Jr Edward F, Rogers Bonnie, Escalante Carmen P, Toennis Christine A, Clark John C, Johnson Belinda C, McDiarmid Melissa A. Evaluation of antineoplastic drug exposure of health care workers at three university‐based US cancecenters. J Occup Environ Med 2010;52:1019e27.

[11] Hon C‐Y, Teschke K, Chu W, Demers P, Venners S. Antineoplastic drug contamination of surfaces throughout the hospital medication system in Canadian hospitals. J Occup Environ Hyg 2013;10:374e83..



If I only had courage… coping with all the requirements

Thomas H. Connor, PhD

Research Biologist

Centers for Disease Control and Prevention

National Institute for Occupational Safety and Health

Division of Applied Research and Technology

[email protected]

The findings and conclusions in this report are those of the author and do not necessarily represent the views of the National Institute for Occupational Safety and Health (NIOSH). Mention of any company or product does not constitute endorsement by NIOSH. In addition, citations to Web sites external to NIOSH do not constitute NIOSH endorsement of the sponsoring organizations or their programs or products. Furthermore, NIOSH is not responsible for the content of these Web sites. All Web addresses referenced in this document were accessible as of the publication date.

NIOSH Disclaimers Current Hazardous Drug Guidance

American Society of Health‐System Pharmacists (ASHP)

National Institute for Occupational Safety and Health (NIOSH)

Occupational Safety and Health Administration (OSHA)

Oncology Nursing Society (ONS)

US Pharmacopeia (USP)

~OR~ASHPNIOSHOSHAONSUSP, for short

American Society of Health‐System Pharmacists

American Society of Hospital Pharmacists. ASHP technical assistance bulletin on handling cytotoxic and hazardous drugs. Am J HospPharm. 1990; 47:1033‐1049.

American Society of Health‐System Pharmacists. ASHP Guidelines on Handling Hazardous Drugs: Am J Health‐Syst Pharm. 2006; 63:1172‐1193.

National Institute for Occupational Safety and Health

Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings www.cdc.gov/niosh/docs/2004‐165/

Currently being updated (2016)

Reviewing ~400 new publications



Occupational Safety and Health Administration

OSHA [1999]. OSHA technical manual, TED 1‐0.15A, Sec VI, Chapt II: Categorization of drugs as hazardous

Currently being updated

Oncology Nursing Society

Polovich M, Bolton DL, Eisenberg S, Glynn‐Tucker EM, Howard‐Ruben J, McDiarmid MA, Power LA and Smith CA. Safe handling of hazardous drugs. Oncol Nurs Society. Second Edition. February, 2011

Currently being updated (2016)

US Pharmacopeia

USP 797: Guidebook to pharmaceutical compounding: sterile preparations. Rockville, MD: United States Pharmacopeia

USP 800: Hazardous Drugs—Handling in Healthcare Settings.Rockville, MD: United States Pharmacopeia

How do I cope with all these recommendations?

? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?

How do I cope with all these recommendations?

Look at the big picture!

NIOSH Hierarchy of Controls

All the recommendations follow these same principles



NIOSH Hierarchy of Controls

Typically do not apply to healthcare

All the recommendations follow these same principles

All the Recommendations Strive for the Same Goals

Protect the drug/patient

Protect the healthcare worker

Protect the environment

Protect the Drug/Patient

As required, assure that the drug is prepared aseptically

• Cleanroom technology

• Biological Safety Cabinet (BSC) or Compounding Aseptic Containment Isolator (CACI)

• Robotic systems

• Supplemented with a Closed System Drug‐Transfer Device (CSTD)

• Sterile chemotherapy gloves

• Proper aseptic technique

Does your facility use CSTDs for preparation/administration of

hazardous drugs?

Preparation

Administration

Both

Protect the Healthcare Worker

Protect the healthcare worker from undue exposures to hazardous drugs

• The same approaches that protect the drugs also protect the workers

• Include proper work practices as part of administrative controls

Protect the Environment

Limit contamination of the workplace

Clean/decontaminate equipment and surfaces

Clean up spills

Dispose of hazardous waste according to local, state, and federal regulations



How do Recommendations Differ?

ASHP (2006)

• Detailed information about drug preparation (IV and oral)

• Information about engineering controls, PPE etc.

• A good resource for specific procedures

ONS (2011/2016)

• More focus on drug administration and patient care

• A good resource for nursing personnel


OSHA (1999/201?)

Webpage will be updated in 2015/2016

• Currently based on 1995 OSHA recommendations

• No CSTDs

• No CACIs

• No robotics

• Minimal number of hazardous drugs


USP 800

• Describes what you should do or must do in order to protect drugs, workers, and the environment

• Enforceable by State‐Boards‐of Pharmacy

NIOSH (2004/2016)

• Not as detailed as ASHP or ONS, but describes the evidence and rationale behind the recommendations

• Has been adopted by three states and under consideration by several others

What recommendations does your facility adhere to most?

ASHP

NIOSH

OSHA

USP

Current U.S. Recommendations for Safe Handling

Engineering Controls

BSCs/CACIs BSCs/CACIs BSCs BSCs/CACIs BSCs/CACIs

CSTDs Recommended Recommended N/A Recommended Recommended,Required for administration

PPE Double “Chemo‐therapy Gloves”

Double “Chemo‐therapy Gloves”

Double Gloves Double “Chemo‐therapy Gloves”

Double “Chemo‐therapy Gloves”

Medical Surveillance

Recommended Recommended Recommended Recommended Recommended

Alternative Duty

Recommended Proposed Recommended Recommended None

Key Takeaways

Engineering controls, administrative controls, and personal protective equipment work together to contain hazardous drugs

Five organizations provide guidance on handling hazardous drugs

All five organizational standards and guidance documents promote the same containment principles



If I only had a heart… caring enough to move forward with what needs to be done

Patricia C. Kienle, RPh, MPA, FASHPDirector, Accreditation and Medication SafetyCardinal Health Innovative Delivery Solutions

[email protected]

The Timeline …

1985

First Pharmacy Guidance

2004

USP <797>

2008

Revised USP <797>

… The Timeline

2014

Proposed USP <800>

2015

Revised Proposed USP <800>

2016

USP <800>

Other Documents

OSHA Technical Manual

• Controlling Occupational Exposure to Hazardous Drugs

ASHP Guidelines on Hazardous Drugs

NIOSH Alert and lists of hazardous drugs

• Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings

• 2014 List of Hazardous Drugs contains table of PPEs based on activities performed

ONS Safe Handling of Hazardous Drugs

Growing body of literature

Coordination

Requirements and recommendations

All work together

No confilcts



Degree of Difficulty

Harder to do

• Update facilities

Easier to do

• Identify HDs

• Revise policies

• Train personnel

• Use correct PPE

• Monitor environment

How much nonsterile HD compounding do you do?

Commonly done

A few times a year

None

At your health‐system, is any HD compounding done outside of a

negative pressure room?

Yes

No

Develop or Update Facilities

First decision

• Area for nonsterile HD compounding

• Cleanroom suite for sterile compounding

• Containment Segregated Compounding Area

All antineoplastic compounding MUST be done in a negative pressure room

• Pharmacy – Inpatient, Satellites, Ambulatory

• Oncology clinic

• Surgical services

• Urology clinic

• Physicians offices

Trace HD Meds in Your Health System

Receipt

Storage

MixingAdmin

Disposal

Transport

Get The Design Right

Identify what you need

Step through your workflow

Don’t believe: “We design cleanrooms all the time” without checking references

Involve staff in the design



Our newly‐designed IV room works well …

Yes

There are compliance issues

There are workflow issues

Identify the HDs You Handle

Drugs

Dosage forms

Manipulation required

Decide on your approach

• Treat all dosage forms of all HDs the same

• Perform an Assessment of Risk on selected dosage forms of specific HDs

www.cdc.gov/niosh/docs/2014‐138/pdfs/2014‐138.pdf

Develop Clear Policies and Procedures

Facilities

• Certification

Personnel

• Work practices

Closed‐system drug transfer devices

Spill management

• Spill drill

Establish a Robust Training Program

Personnel must be aware of the fact that they work with HDs

Document competency

Educate and monitor based on USP <795>, <797>, and upcoming <800>

Observe technique and practices

Be aware of HR’s medical surveillance policy

Use Correct Personal Protective Equipment

Gloves must be tested to ASTM 6978 standard

Gowns must be impervious and intended for use with hazardous drugs

Implement clear policies concerning PPE

• Receiving

• Nonsterile compounding

• Sterile compounding

• Administration

• Disposal

• Spill management

Monitor

<797> monitoring focuses on microbial contamination

<800> adds in information concerning HD contamination

Consider wipe samples

• Baseline

• Action based on results

• Periodic monitoring



Key Takeaways

This is not new information

• There have been guidance documents in the pharmacy literature for over 30 years

You need a proper facility

• All compounding of hazardous drugs must be done in a negative pressure room

There are things you can work on to improve personnel safety

• HD list, policies and procedures, personnel training and monitoring, and proper PPE can be implemented at every site now

