proposed usp 800 - safely handling hazardous drugs

Proposed USP 800 - Safely Handling Hazardous DrugsPharMEDium Lunch and Learn Series

ProCE, Inc.www.ProCE.com 1

Proposed USP 800Safely Handling Hazardous Drugs

LUNCH AND LEARN

August 8, 2014

Featured Speaker: Firouzan 'Fred' Massoomi, Pharm.D., FASHP

Pharmacy Operations Coordinator, Department of Pharmacy ServicesNebraska Methodist Hospital

1

CE Activity Information & Accreditation

ProCE, Inc. (Pharmacist and Tech CE)

1.0 contact hour

Funding: This activity is self‐funded through

2

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 received Grant and/or Research Support from ICU Medical, BD, Equashield, and Carefusion.



Submission of an online self‐assessment and evaluation is the

Online Evaluation, Self-Assessmentand CE Credit

Submission of an online self assessment and evaluation is the only way to obtain CE credit for this webinar

Go to www.ProCE.com/PharMEDiumRx

Print your CE Statement online

Live CE Deadline: September 5, 2014

CPE Monitor

3

– CE information automatically uploaded to NABP/CPE Monitor within 3 to 4 weeks of the completion of the self‐assessment and evaluation

Event Code

Code will be provided at the end of today’s activityEvent Code not needed for On‐Demand

Ask a Question

Submit your questions to your site manager.

Questions will be answered at the end of the presentation.

4

Your question. . . ?



Resources

Visit www.ProCE.com/PharMEDiumRx to access:

Handouts– Handouts

– Activity information

– Upcoming live webinar dates

– Links to receive CE credit

5

Proposed USP <800>:Safely Handling Hazardous Drugs

Firouzan “Fred” Massoomi, PharmD, FASHP

Pharmacy Operations CoordinatorNebraska Methodist Hospital

Omaha, Nebraska

[email protected]



What Is the Trend?

Source: WHO Globalcan 2013 7

Cancer Death Rates Drop in U.S.Age-adjusted cancer death rates, 1930-2007

Males

F l

Sources: USAToday; CDC 2012 8

Females



Is There a Cost to Improved Care?

9

USP <800>: A Decade of Progress Toward Hazardous Drug Safety

2014

2004

10



Guidelines for Hazardous Drugs

Source Year

ASHP 1982, 1984, 1990, 20069 , 9 4, 99 ,

Israel Ministry of Health 1984, 2000, 2002, 2004

OSHA 1986, 1995, 1999

AMA Council on Scientific Affairs 1985

Oncology Nursing Society 1988, 2003, 2010

NIOSH Alert 2004, 2010, 2012, 201414, , , 4

HOPA 2009`

USP <797> 2004, 2008

USP <800> 2014 (for comment)

Globally 42 years of Safe‐Handling Guidelines11

Critical Point of Safety: Defect Compounding Inconsistencies

DOES NOT:

Eli i t t• Eliminate waste

• Reduce costs

• Improve quality

• Delight customers

• Improve employee p p ysatisfaction

• Increase safety

12



Drivers of USP <797> Compliance

2

3Percentages Concern About State Board of

Pharmacy Sanctions ‐ 15%

C Ab O h R l

15

14

45

2 Concern About Other Regulatory Body Sanctions ‐ 14%

Publicity About Serious Sterile Compounding Errors/Incidents at Other Facilities ‐ 21%

Another Standard of Practice That Should Be Implemented ‐ 45%

21 Sterile Compounding Errors/Incidents in Organization ‐ 2%

Other ‐ 3%

Source: Douglass, K, et al. Pharmacy Purchasing & Products. October 2013:S1 –S2413

State Boards of Pharmacy

State regulations for compounding Board of Pharmacy or Health Departments

Most states have USP 797‐specific regulations

Specific Hazardous Drug Compounding regulations Washington 2013

California in 2013

North Carolina 2014

Maryland in process Maryland Board of Pharmacy since 2010 “Closed system vial transfer devices (CSTD) are employed when handling

cytotoxic drugs COMAR 10.34.19.12(17)”14



The Joint Commission Is Concerned

Source: TJC ECNews; March 2014:volume 7; issue3 15

“The objective of this chapter is to t t l d th protect personnel and the

environmentwhen handling hazardous drugs (HDs)”

Sterile and non sterile productsSterile and non‐sterile products

Source: Proposed USP <800>; 2014 16



Protection Starts with aHazardous Drug Team

Primary Pharmacist

Ph h i i /I Pharmacy technicians/Interns

Pharmacy purchasing

Nursing

Risk Management

Employee health

Environmental services

Secondary Secondary Administration

Safety officer

Tertiary Customers

Primary Goal: Establish a hazardous drug safety program

Visual Hazard Mapping Tool

18



0361Ph i t 1

Positive IF samples

Positive CP samplesUrine samplesDaysWorker

Evidence of Exposure in Healthcare Workers

0151Nurse 1

0091Technician 3

0061Technician 2

1881Technician 1

93101Pharmacist 2

0361Pharmacist 1

10 (N=2)18 (N=5)481N(pos)=7

0041Control

0341Nurse 2

Wick et al. Am J Health‐Syst Pharm. 2003; 60:2314‐20

“There is no acceptable level of personnel exposure to HDs”

19

Occupational Risks Due To Exposure to Hazardous Drugs

Kaiser Permanente Center for Health Research1

7,094 pregnancies of 2,976 pharmacy and 7, 94 p g ,97 p y

nursing staff

Increased risk for miscarriages by 40 ‐ 50%

Increased risk for low birth weight by 17‐fold

Increased risk for congenital malformations by 5‐fold

NIOSH2 NIOSH2

7,500 nurses

Oncology nurses 2‐fold risk of miscarriages

2 out of 10 nurses lost pregnancy at week 20

20

1. J Occup Environ Med. 1999; 41(8):632‐8.2. Lawson et al. Am J ObstetGynecol. December 2012.



The Contaminated Environment• More than 70 published studies

Most surfaces that come in direct contact with hazardsSome with indirect contact with hazards

Source: B. Braun 21

Hazardous Drug Wipe Study

Testing takes approximately 10 minutes

22



USP <800>Formulary Assessment of Hazards

NIOSH Appendix A Proposed stratification of Hazardsp Antineoplastic non‐Antineoplastic Reproductive

Continuously stratify hazards and response

23

#1 Safety Concern: The Source

EVIDENCE P bli h d di

24

EVIDENCE: 11 Published studies• Drug vial exteriors • Not due to damage during shipping & handling



Vial Contamination Improved

Tested: MTX (60); 5FU (110); cisplatin (60)

2 of 230 vials tested were contaminated

1 FU and 1 cisplatin vialp

Marked improvement

NOTE: highly manufacturer‐specific

Source: Hospital Pharmacy 2014:49(4):355‐362 25

Look for Safety

26



Totes from wholesaler

USP <800>Segregated Handling of Vials

Shall not

Store

Gloves to handle

Store

Unpack

Compound

Manipulate

Not a positive‐pressure Drugs left in baggies

Removed in Isolator

27

Not a positive‐pressure area Equi‐pressure

Negative pressure

USP <800> -- Personal Protective Equipment : Training Documentation

Hands & elbows scrubbed CDC hand hygiene document

www.cdc.gov/handhygiene

GoalMinimize contamination from product to employee

& vice versa

Proper demonstrative use

No make‐up or jewels

No fake fingernails

No iPods

& vice versa

No exemptions from garbing requirements



Garb‐Off SequenceGarb‐On Sequence

USP <800> -- Documentation of Garb Competency

Source: Taipei Veterans Hospital; Taipei, Taiwan 29

USP <800> --Choosing the Right Glove

30



USP <800> --Primary Engineering Controls

Biological Safety CabinetClass II Type B2 BSC

Isolator Glove BoxCompounding Aseptic Containment Isolator

Total Exhaust

31

USP <800> --Secondary Engineering Controls

Separate Room 12 ACPH ISO 7 Negative Pressure

32



Closed-System Transfer Devices

Current Global Products®

Supplemental Environmental Controls

PhaSealSmartsite/Texium

PhaSeal® BD Tevadaptor®Teva ChemoLock®/Spiros® ICU Medical Equashield®

Chemoshield®/Smartsite® Carefusion Sure Connect® Baxa Q‐Flo® I3 Infusion Inovations

Equashield

On-Guard SureConnect Q-Flow

ChemoLock

33

Israeli Health Ministry Approved PhaSeal® BD Tevadaptor®Teva Equashield®

Vapor Control of Hazardous Drugs

Antineoplastic Drug

Mol. Weight

Vapor pressure (Pa) at 20°C

Max. concentration (mg/m3)

Carmustine 214 0.019 1.7

Cisplatin 300 0.0018 0.22

Cyclophosphamide 261 0.0033 0.36

Etoposide 289 0 0026 0 63Etoposide 289 0.0026 0.63

5-Fluorouracil 130 0.0014 0.08

Some antineoplastic drugs possess a low vapor pressure.

Protective clothes not designed to protect workers from vaporized drugs.

Source: Kiffmeyer et al., Pharm J 2002; 268:331‐7 34



Uptake in CSTD Use in the U.S.

Source: Advisory Board: CSTD Utilization in Drug Vial Optimization and Beyond‐use Dating; Pharmacy Purchasing and Products : April 2014

35

A Leader In Safety. . .

Source: Mydesk.com document: 545302 36



Time and Motion Study of CSTDs

Compared 5 CSTDs to syringe/needle PhaSeal; ChemoClave; On‐guard; Equashield; Cardinal Texium

From Rx to RN 110 Pharmacy personnel and 120 nurses; 3 sites

Needle/syringe Average times: Rx 270 sec RN: 216 sec

CSTD CSTD Average times all 5: Rx 321 sec RN: 156 sec

Total time Needle/Syringe: 486 sec vs. CSTD average: 477 sec

Source: D. Greisen, 2012 Resident Project 37

Repetitive Strain Injury

19%

RSI‐type pain

No pain81%

Source: Abbot L, Johnson T. Minimizing pain resulting from the repetitive nature of aseptic dispensing. Hospital Pharmacist, March 2002

38



CSTD Ergonomic ConsiderationsCSTD Ergonomic Considerations

39

Final Product Preparation Pre‐primed bags Line‐naïve fluid

Proper labeling Clear instructions Warning labels

Line labelse abe s

Safety overbag Supplemental Engineering

Control

40



Compounding Competency ChemoChek® Fluorescence test Nursing certification Nursing certification

program www.Covidien.com

ChemoTEQ® Red dye and broth test Videos and training

materials on line www.valiteq.com

41

Lack of Competency Can Be Costly

Source: www.cbsnews.com/news/how‐cancer‐drugs‐doubled‐to‐10000‐per‐month/42



Tool for Protecting Personnel:Hazardous Drug Checklist

43

Hazardous Waste Management

How Is drug waste properly managed?

Continuous formulary assessment

Technion & Al Quds Universities Collaborate For Clean Water. April 29, 2013 44



USP <800>Hazardous Drug Spill Kits/Policy Develop a collaborative policy

D fi l li i Define volume limits Who is responsible

Develop or purchase “spill kits” Location of kits Training on kits Training on kits Dating on kits

Drill Spills

45

A Better Approach To Spills!

46



USP <800>Proper Workspace Preparation

1. Deactivation 2% Sodium hypochlorite solution Sodium thiosulfateSodium thiosulfate

2. Decontamination Physical wiping of surface

3. Cleaning Tri‐ or Quadra‐valent detergent Peroxide

4 Disinfection4. Disinfection Sterile isopropyl alcohol 70% UV light

47

USP <800>Medical Surveillance Program

Tier One: Education and Self Surveillance

Tier Two: Employer/Supervisor Surveillance Annual reproductive questionnaire

Trending of sick calls

Tier Three: Comprehensive Medical Surveillance Hire and annually

’ CBC, urinalysis, LFT’s

Urine drug testing by www.exposurecontrol.nl

Tier Four: Post‐exposure Surveillance Notation in medical record with date and drug

Massoomi F. Pharm. Purch Prod. 2008 48



Baseline Employee Information

49

Oral Hazardous Drugs

Segregate from non‐hazardous

Non‐sterile characteristics

Tablet, capsule, liquid

All manipulations in negative pressure room

Crushing of product

Liquid medication request process

Compound into a topical

NOT for automated packaging devices

50



Hazardous Drug ConsiderationSpecial Delivery Devices

51

Hazardous Drug Consideration:New Chemotherapy Patch

Novel, patent‐pending micropump for drug deliveryp p g y

Drug reservoir contains up to 3 chemotherapy drugs

Microneedle array for painless drug administration

Simple microcontroller‐based electronic circuit for complex programmable delivery scheduling

Source: create the future http://contest.techbriefs.com/2013/entries/medical 52



Hazardous Drug Consideration:Bacille Calmette-Guerin Vaccine

Indication: Bladder CA

WARNINGSWARNINGS

Live biological hazard

BCG infections in healthcare workers have occurred

Case studies of deaths due to cross contamination of TPNscross‐contamination of TPNs

53

“Hazardous Drug Rounds”Preparation Administration Disposal

54



Future Considerations

Disposable drug‐delivery devices Genotargeted drugs Micro‐robot delivery of drugs Nanotechnology drugs “Nanopills” “Nanotopicals” “Nano‐injections”

55

Sterile Compounding:The Future Is Now

Monster Robots on the Market

Intellifill IVBaxter

RIVA CytoCareMcKesson

Health RoboticsIV Station

ApotecaLoccioni

Make way for thenew micro‐robots

DianaICU Medical 56



USP <800> -- Comment Period Ended July 31, 2014

[email protected]

57

58



59

proposed usp 800 - safely handling hazardous drugs

Documents