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USP <800> and the Expected
Impact on Health Systems
Firouzan “Fred” Massoomi, Pharm.D., FASHP
Nebraska Methodist Hospital
Omaha, Nebraska
USMP/MG1/14-0221 07/14
USMP/MG1/14-0221 07/14 2
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USMP/MG1/14-0221 07/14 3
Disclosure
� The content of this presentation was created by the
presenters and does not necessarily reflect the views
of Baxter Healthcare Corporation.
� Our speakers have accepted an honorarium from
Baxter for this presentation.
USMP/MG1/14-0221 07/14 4
About Our Speaker
Firouzan “Fred” Massoomi, Pharm.D., FASHP
� Pharmacy Operations Coordinator – NE Methodist Hospital 1996 to Current
� Primary research interest in protecting healthcare providers who handle hazardous
drugs
USMP/MG1/14-0221 07/14 5
Objectives
� Introduce the proposed standards for the newest
USP Chapter, <800> Hazardous Drug- Handling in
Healthcare Settings.
� Describe the differences between
recommendations, standards, and regulatory
management of hazardous drugs.
� Discuss barriers that prevent compliance with these
standards and ways to remove the barriers.
� Identify gaps that are unmet with meeting the
proposed standards.
USMP/MG1/14-0221 07/14 6
Source Year
ASHP 1982, 1984, 1990, 2006
OSHA 1986, 1995, 1999
AMA Council on Scientific Affairs 1985
Oncology Nursing Society 1988, 2003, 2010
NIOSH Alert 2004, 2010, 2012, 2014
HOPA 2009
UHC’s Guidelines 2009, 2010 published in AJHP
ISMP 2012
USP <797> 2004, 2008
USP <800> 2014 (for comment)
40 years of Safe Handling Guidelines
USP 800
The Next Step Towards Safety1
USMP/MG1/14-0221 07/14 7
Drivers of USP <797> Compliance2
Data from 2013 USP Chapter <797> Compliance Survey
USMP/MG1/14-0221 07/14 8
State Boards of Pharmacy
� State regulations for compounding3
• Board of Pharmacy or Health Departments
• Most States have USP 797 specific regulations
� Specific Hazardous Drug Compounding
regulations4-6
• California in 2013
• North Carolina in process
• Maryland in process
o Maryland Board of Pharmacy since 2010
• “Closed system vial transfer devices (CSTD) are employed
when handling cytotoxic drugs COMAR 10.34.19.12(17)”
USMP/MG1/14-0221 07/14 9
The Joint Commission
Is Concerned7
“
“
USMP/MG1/14-0221 07/14 10
“The objective of this chapter is to
protect personnel and the
environment when handling
hazardous drugs (HDs)”8
Sterile and non-sterile products
USMP/MG1/14-0221 07/14 11
USP 800
Chapter Sections8
USMP/MG1/14-0221 07/14 12
Visual Hazard Mapping Tool 9,10
USMP/MG1/14-0221 07/14 13
USP 800
Hazard Communication Standard8
� “Right to Know Standard”• Standard (29 CFR part 1910 – 1200)
� A safe and healthful workplace.
� Know about hazardous chemicals.
� Complain or request hazard correction from employer.
� Hazard exposure and medical records.
� File a complaint with OSHA.
� Be free from retaliation for exercising safety and health rights.
USMP/MG1/14-0221 07/14 14
10 (N=2)18 (N=5)481N(pos)=7
0041Control
0341Nurse 2
0151Nurse 1
0091Technician 3
0061Technician 2
1881Technician 1
93101Pharmacist 2
0361Pharmacist 1
Positive IF samples
Positive CP samples
Urine samplesDaysWorker
Evidence of Exposure to Health Care Workers11
“There is no acceptable level of personnel exposure to HDs”
CP= cyclophosphamide, IF= ifosfamide
USMP/MG1/14-0221 07/14 15
Occupational Risks Due To Exposure to
Hazardous Drugs
� Kaiser Permanente Center for Health Research12
• 7,094 pregnancies of 2,976 pharmacy & nursing staff
o Increased risk for miscarriages (OR=1.5% CI, 1.3-1.9)
o Higher gravidity and history of prior adverse pregnancy outcomes
were associated with poorer outcomes
� Lawson Trial, December 201113
o 7,500 nurses
o Oncology nurses 2-fold risk of miscarriages
o 3.5 fold increase in miscarriage in nulliparous women
USMP/MG1/14-0221 07/14 16
Case Report of Employee Concerns 14
� CDC Case Report
� “Chemotherapy Drug Exposures of an Oncology
Clinic – Florida”
� Health Hazard Evaluation Report: HETA 2009-0148-
3158 June 2012
� At the request of an employee
� Site visit with follow-up visits for compliance
USMP/MG1/14-0221 07/14 17
The Contaminated Environment 15
• More than 70 published studies
Most surfaces that come in direct contact with hazards
Some with in-direct contact with hazards
USMP/MG1/14-0221 07/14 18
USP 800
Formulary Assessment of Hazards16
�NIOSH Appendix A
� Proposed stratification of Hazards� Antineoplastic non-Antineoplastic Reproductive
�Continuously stratify hazards and response
USMP/MG1/14-0221 07/14 19
#1 Safety Concern
The Source
� EVIDENCE: 11 Published studies17
� Drug vial exteriors
� Not due to damage during shipping & handling
USMP/MG1/14-0221 07/14 20
Vial Contamination Improved17
� Tested: MTX (60); 5-Fluorouracil (FU) (110); cisplatin (60)
� 2 out of 230 vials tested contaminated• 1 FU and 1 cisplatin vial
� Marked improvement
� NOTE: Highly Manufacturer Specific
USMP/MG1/14-0221 07/14 21
Totes from wholesaler
Gloves to handle
Drugs left in baggies
Removed in Isolator
USP 800
Segregated Handling of Vials8
Shall not
� Store
� Unpack
� Compound
� Manipulate
� Not a positive pressure area
• Equi-pressure
• Negative pressure
USMP/MG1/14-0221 07/14 22
www.cdc.gov/handhygiene
Training Documentation
No Make-up or Jewels
No Fake fingernails
No iPods
Hands & elbows scrubbed CDC
Hand hygiene document
Goal
Minimize Contamination
*From product to employee
and visa versa
Proper demonstrative use
USP 800
Personal Protective Equipment (PPE)8
USMP/MG1/14-0221 07/14 23Source: Taipei Veterans Hospital; Taipei, Taiwan
Garb-Off SequenceGarb-On Sequence
USP 800Documentation of Garb Competency8
USMP/MG1/14-0221 07/14 24
USP 800
Choosing the Right Glove8
USMP/MG1/14-0221 07/14 25
USP 797 vs. USP 8002
Hazardous Drug Compounding
No Hazardous Drug
Compounding - 30.4%
Hazardous Drug
Compounding - not
limited to Low Volume -
40.2%
Hazardous Drug
Compounding - Low
Volume - 29.4%
USMP/MG1/14-0221 07/14 26
Low Use Exemption8
� “If a CACI that meets the requirements of this
chapter is used outside of a buffer area, the
compounding area shall maintain a minimum
negative pressure of 0.01-inch water column and
have a minimum of 12 ACPHs.”
� “In facilities that prepare a low volume of hazardous
drugs, the use of two tiers of containment (e.g., CSTD
within a BSC or CACI that is located in a non-negative
pressure room) is acceptable.”
� Probably Going Away!
USMP/MG1/14-0221 07/14 27
Hazardous Compounding (NIOSH Listed)8
� ‘BSC or CACI shall be placed in an ISO Class 7 … area
� “physically separated (i.e., a different area from
other preparation areas)”
� “optimally has not less than 0.01-inch water column
negative pressure to adjacent positive pressure”
� “ISO Class 7 or better ante-areas, thus providing
inward airflow to contain any airborne drug.”
USMP/MG1/14-0221 07/14 28
Biological Safety Cabinet
Isolator Glove Box
USP 800
Primary Engineering Controls8
Class II Type B2 BSC
Compounding Aseptic Containment
Isolator (CACI)
USMP/MG1/14-0221 07/14 29
USP 800
Secondary Engineering Controls8
Separate Room 12 ACPH ISO 7 Negative Pressure
USMP/MG1/14-0221 07/14 30
USP 800
Supplemental Environmental Controls8
� Closed System Transfer Devices (CSTDs)
� Compounding : Recommended
� Administration : Required
� Currently 6 US products
• PhaSeal® BD
• Smartsite ® /Texium® Cardinal
• On-Guard® or Tevadaptor® B.Braun
• ChemoClave® /Spiros® ICU Medical
• Equashield®
• Q-Flo® I3 Infusion Inovations
� All Devices FDA Approved
� Two have FDA ONB Code
USMP/MG1/14-0221 07/14 31
Uptake in closed system transfer device
use in the US18
0
5
10
15
20
25
30
35
Nursing Pharmacy
35%
101-200 bed hospitals
32%
USMP/MG1/14-0221 07/14 32
Specialized CSTD Kits
Mobius Therapeutics
USMP/MG1/14-0221 07/14 33
� NO secure bag spike system
� Dose size limitations: 2mL
� Ampule management
� Specialized routes of administration
o Intrathecal
o Irrigations
o ophthalmic
o topical
Known CSTD Gaps
USMP/MG1/14-0221 07/14 34
USP 800
Final Product Preparation8
� Pre-primed bags
• Line naïve fluid
� Proper labeling
• Clear instructions
• Warning labels
� Line labels
� Safety overbag
• Supplemental Engineering Control
USMP/MG1/14-0221 07/14 35
Sterility Testing Required if
BUD Exceeds 19
Risk Level Room Temperature Refrigerated Frozen
Low Risk 48 hrs 14 days 45 days
Medium Risk 30 hrs 9 days 45 days
High Risk 24 hrs 3 days 45 days
IMPORTANT to keep in mind with Vial Optimization Program proposals
USMP/MG1/14-0221 07/14 36
USP 800
Compounding Validation8
� ChemoChek®
• Nursing certification program
o Covidien and Kendall
� ChemoTEQ®
• Videos and training materials on line
• www.valiteq.com
USMP/MG1/14-0221 07/14 37
USP 800Non-Sterile Hazardous Drugs8
� Segregate from non-hazardous
� Non-Sterile characteristics
� Tablet, capsule, liquid
� Coated or punch tablet
� All manipulations in negative pressure room
� In a Powder Cabinet
� Crushing of product
� Liquid medication request process
� Compound into a topical
� NOT for automated packaging devices
USMP/MG1/14-0221 07/14 38
Oral Drug Formulary Assessment20
Currently: 32 orals for oncology
However: 68 orals are hazards
USMP/MG1/14-0221 07/14 39
USP 800
Hazardous Waste Management8
� NOTE: highest environmental concentrations
� Collaborative formulary assessment
• State and federal regulations
• Continuous assessment of risk and stream
DRUG - GENERIC (BRAND)
CLASS OF MEDICATION
ROUTES/ FORMS COMPANY
PREGNANCY CATEGORY MSDS BSC
HAZ CLASS
(1-4)WASTE STREAM
RCRA Y/N
Aldesleukin (Proleukin) ONC INJ Chiron C YES YES Class 1 YELLOW N
Alitretinoin (Panretin) RetinoidTOPICAL, GEL Ligand D YES
Yes, if altered Class 1 YELLOW N
Cyclophosphamide ONCINJ,ORAL Multiple D YES YES Class 1
RCRABLACK Y
USMP/MG1/14-0221 07/14 40
USP 800
Hazardous Drug Spill Kits/Policy 8
� Develop a collaborative policy
� Define volume limits
• Who is responsible
� Develop or purchase ‘spill kits’
• Location of kits
• Training on kits
• Dating on kits
� Drill Spills
USMP/MG1/14-0221 07/14 41
USP 800
Proper Workspace Preparation8
① Deactivation
-2% Sodium Hypochlorite solution
-Sodium Thiosulfate
② Decontamination
-Physical wiping of surface
③ Cleaning
-Tri or Quadra-valent detergent
-Peroxide
④ Disinfection
-Sterile Isopropyl Alcohol 70%
-UV light
USMP/MG1/14-0221 07/14 42
USP 800
Medical Surveillance Program 21
� Tier-One Education and Self Surveillance
� Tier-Two Employer/Supervisor Surveillanceo Annual reproductive questionnaire
o Trending of sick calls
� Tier-Three Comprehensive Medical Surveillance
o Hire and annually
o CBC, urinalysis, LFT’s
o Urine drug testing by www.exposurecontrol.nl
� Tier-Four Post-exposure Surveillanceo Notation in medical record with date and drug
USMP/MG1/14-0221 07/14 43
Baseline Employee Information
USMP/MG1/14-0221 07/14 44
GAP: Hazardous Drug Consideration
Specialized Patients and Procedures� Surgical
• Bladder installation
• HOT Chemo Bathso Hyperthermic Intraperitoneal Chemotherapy
• Ophthalmic surgery = TOPICAL
• Esophageal Strictures = TOPICAL
� Obstetrics• Ectopic pregnancy
� Rheumatology• Rheumatoid arthritis
• Lupus nephritis
� Neurology• Multiple sclerosis
USMP/MG1/14-0221 07/14 45
GAP: Hazardous Drug ConsiderationBacille Calmette-Guerin (BCG vaccine) & Ampules
� Indication: Bladder CA
� WARNINGS
• Live Biological Hazard
• BCG infections in healthcare workers
have occurred
• Case studies of deaths due to cross
contamination of TPNs
� Ampule management
• Cuts with Hazardous Drugs
• No known CSTD integration
USMP/MG1/14-0221 07/14 46
USP 800
Comment Period Up to July 31, 2014
Free Access to Proposed USP <800>
http://www.usp.org/usp-
nf/notices/compounding-notice
Submit Your Comments at:
USMP/MG1/14-0221 07/14 47
References
1. Power L, Polovich M. Safe handling of hazardous drugs: Reviewing standards for worker protection. Pharm Pract News.
2011;3:1-12.
2. Douglass K, Kastango E, Cantor P. The 2013 USP Chapter <797> compliance survey. Pharm Purch Prod. 2013;10(10):S1 –
S24.
3. Douglass K, Kastango E, Cantor P. State regulations impact USP 797 compliance. Pharm Purch Prod. 2012;4(4):S18 –S21.
4. California Legislative Information Website.
http://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=201320140AB1202&search_keywords=%22hazardous+
drug%22. Accessed June 15, 2014.
5. North Carolina General Assembly website. http://www.ncleg.net/Sessions/2013/Bills/House/PDF/H644v1.pdf. Accessed
June 15, 2014.
6. Maryland hospitals for a healthy environment (MD H2E). http://mdh2e.org/2013/08/20/public-meeting-to-address-
occupational-exposure-to-hazardous-drugs./. Accessed June 15, 2014.
7. The Joint Commission. Menacing Meds. How to safely manage hazardous drugs in the health care environment. ECNews.
2014;17(5):8-10.
8. USP 40 N 3 Proposed USP <800> Hazardous Drugs- Handling in Healthcare Settings. Proposed.
www.usp.org/sites/default/files/usp_pdf/EN/m7808.pdf. Accessed June 15, 2014.
9. Connor TH, Sessink PJM, Harrison BR, et al. Surface contamination of chemotherapy drug vials and evaluation of new vial-
cleaning techniques: Results of three studies. Am J Health-Syst Pharm. 2005;62(5):475-484.
10. National Institute for Safety and Occupation (NIOSH) Alert Preventing Occupational Exposures to Antineoplastic and
Other Hazardous Drugs in Health Care Settings; DHHS (NIOSH) Pub No. 2004-165, September 2004.
11. Wick C, Slawson MH, Jorgenson JA, Tyler L.. Am J Health-Syst Pharm. 2003;60(22):2314-2320.
12. 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(8):632-638.
13. Lawson CC, Rocheleau CM, Whelan EA, et al. Occupational exposures among nurses and risk of spontaneous abortion. Am
J Obstet Gynecol. 2012;206(4):327.e1-8.
USMP/MG1/14-0221 07/14 48
References
14. Couch J, West C. Chemotherapy drug exposures at an oncology clinic – Florida. . The National Institute for Occupational Safety
and Health (NIOSH) website. http://www.cdc.gov/niosh/hhe/reports/pdfs/2009-0148-3158.pdf. Accessed May 28, 2014.
15. Center for Disease Control. Occupational exposure to antineoplastic agents.
http://www.cdc.gov/niosh/topics/antineoplastic/sampling.html. Accessed May 28, 2014.
16. Badry N, Fabbro J, de Lemos ML. Hazards in determining whether a drug is hazardous. J Oncol Pharm Pract. Aug 20 2013.
17. Power LA, Sessink PJM, Gresy K, Charbonneau F. Hazardous drug residue on exterior vial surfaces: evaluation of a commercial
manufacturing process. Hosp Pharm. 2014;49(4):355–362
18. Pharmacy Purchasing and products. Market trends in closed system transfer devices. Pharm Purch Prod. 2014;4(4):S8.
19.American Society of HealthSystem Pharmacists. ASHP guidelines on compounding sterile products. Am J Health-Syst Pharm.
2014;71(2)145-166.
20. The National Institute for Occupational Safety and Health. NIOSH List of Antineoplastic and Other Hazardous Drugs in
Healthcare Settings 2012. http://www.cdc.gov/niosh/docs/2012-150/pdfs/2012-150.pdf. 2012.
21. Massoomi F, Neff W. Implementing a personnel surveillance program for hazardous drug safety. Pharm Purch Prod.
2008;5(4):205.
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USMP/MG1/14-0221 07/14 49
We Welcome Your Questions
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webinar, using the form on your screen.
� If you experience any technical issues during the
webinar, please use the help button shown on your
screen.
� Download a PDF handout of the presentation on the
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