proposed usp 800 - safely handling hazardous drugs
TRANSCRIPT
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.
Proposed USP 800 - Safely Handling Hazardous DrugsPharMEDium Lunch and Learn Series
ProCE, Inc.www.ProCE.com 2
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. . . ?
Proposed USP 800 - Safely Handling Hazardous DrugsPharMEDium Lunch and Learn Series
ProCE, Inc.www.ProCE.com 3
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
Proposed USP 800 - Safely Handling Hazardous DrugsPharMEDium Lunch and Learn Series
ProCE, Inc.www.ProCE.com 4
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
Proposed USP 800 - Safely Handling Hazardous DrugsPharMEDium Lunch and Learn Series
ProCE, Inc.www.ProCE.com 5
Is There a Cost to Improved Care?
9
USP <800>: A Decade of Progress Toward Hazardous Drug Safety
2014
2004
10
Proposed USP 800 - Safely Handling Hazardous DrugsPharMEDium Lunch and Learn Series
ProCE, Inc.www.ProCE.com 6
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
Proposed USP 800 - Safely Handling Hazardous DrugsPharMEDium Lunch and Learn Series
ProCE, Inc.www.ProCE.com 7
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
Proposed USP 800 - Safely Handling Hazardous DrugsPharMEDium Lunch and Learn Series
ProCE, Inc.www.ProCE.com 8
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
Proposed USP 800 - Safely Handling Hazardous DrugsPharMEDium Lunch and Learn Series
ProCE, Inc.www.ProCE.com 9
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
Proposed USP 800 - Safely Handling Hazardous DrugsPharMEDium Lunch and Learn Series
ProCE, Inc.www.ProCE.com 10
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.
Proposed USP 800 - Safely Handling Hazardous DrugsPharMEDium Lunch and Learn Series
ProCE, Inc.www.ProCE.com 11
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
Proposed USP 800 - Safely Handling Hazardous DrugsPharMEDium Lunch and Learn Series
ProCE, Inc.www.ProCE.com 12
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
Proposed USP 800 - Safely Handling Hazardous DrugsPharMEDium Lunch and Learn Series
ProCE, Inc.www.ProCE.com 13
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
Proposed USP 800 - Safely Handling Hazardous DrugsPharMEDium Lunch and Learn Series
ProCE, Inc.www.ProCE.com 14
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
Proposed USP 800 - Safely Handling Hazardous DrugsPharMEDium Lunch and Learn Series
ProCE, Inc.www.ProCE.com 15
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
Proposed USP 800 - Safely Handling Hazardous DrugsPharMEDium Lunch and Learn Series
ProCE, Inc.www.ProCE.com 16
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
Proposed USP 800 - Safely Handling Hazardous DrugsPharMEDium Lunch and Learn Series
ProCE, Inc.www.ProCE.com 17
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
Proposed USP 800 - Safely Handling Hazardous DrugsPharMEDium Lunch and Learn Series
ProCE, Inc.www.ProCE.com 18
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
Proposed USP 800 - Safely Handling Hazardous DrugsPharMEDium Lunch and Learn Series
ProCE, Inc.www.ProCE.com 19
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
Proposed USP 800 - Safely Handling Hazardous DrugsPharMEDium Lunch and Learn Series
ProCE, Inc.www.ProCE.com 20
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
Proposed USP 800 - Safely Handling Hazardous DrugsPharMEDium Lunch and Learn Series
ProCE, Inc.www.ProCE.com 21
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
Proposed USP 800 - Safely Handling Hazardous DrugsPharMEDium Lunch and Learn Series
ProCE, Inc.www.ProCE.com 22
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
Proposed USP 800 - Safely Handling Hazardous DrugsPharMEDium Lunch and Learn Series
ProCE, Inc.www.ProCE.com 23
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
Proposed USP 800 - Safely Handling Hazardous DrugsPharMEDium Lunch and Learn Series
ProCE, Inc.www.ProCE.com 24
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
Proposed USP 800 - Safely Handling Hazardous DrugsPharMEDium Lunch and Learn Series
ProCE, Inc.www.ProCE.com 25
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
Proposed USP 800 - Safely Handling Hazardous DrugsPharMEDium Lunch and Learn Series
ProCE, Inc.www.ProCE.com 26
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
Proposed USP 800 - Safely Handling Hazardous DrugsPharMEDium Lunch and Learn Series
ProCE, Inc.www.ProCE.com 27
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
Proposed USP 800 - Safely Handling Hazardous DrugsPharMEDium Lunch and Learn Series
ProCE, Inc.www.ProCE.com 28
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
Proposed USP 800 - Safely Handling Hazardous DrugsPharMEDium Lunch and Learn Series
ProCE, Inc.www.ProCE.com 29
USP <800> -- Comment Period Ended July 31, 2014
57
58