Transcript VISN FL Meeting May 18, 2006 - Remote

Hazardous Drug Management
VA Pharmacy Informatics Conference
Pleasanton, CA Aug 2-5, 2011
George H. Knight, RPh.
VISN 2 Pharmacy Executive
PBM Manager
Syracuse, NY
Pharmacy Benefits Management
www.pbm.va.gov
1
Overview of Today’s Discussion

Why review VAMC Pharmaceutical Management
Practices and Why Now?

Pharmaceutical Management Objectives and Goals

Program Milestones and Timeline

What is meant by “hazardous pharmaceutical”?

Hazardous Pharmaceutical Handling and Use

Issues and Challenges * Warfarin containers

Leading Practices * Labeling * Containers

Recommendations
Pharmacy Benefits Management
www.pbm.va.gov
2
Why review Pharmaceutical Management
Practices and Why Now?
 Heightened levels of scrutiny in recent years by Federal
and state environmental regulators on the management
of pharmaceutical products and waste at health care
facilities
 To answer the overarching question, “Does VA have a
well-developed pharmaceutical management program in
place?
 To proactively identify and address gaps in VA’s current
pharmaceutical waste management practices
 To share leading practices and lessons learned with the field
Pharmacy Benefits Management
www.pbm.va.gov
3
Goals and Objectives of the VHA
Pharmaceutical Management Program
 The Pharmaceutical Management Program was
initiated to:

Maximize the efficiency of pharmaceutical management and
waste management policies and procedures within VA;

Promote and implement best practices for the handling and
administering of pharmaceuticals (both hazardous and nonhazardous) in compliance with Federal regulations and VA and
VHA policy; and

Promote the protection of the environment and VA staff, through
well-defined and properly implemented pharmaceutical waste
management processes.
Pharmacy Benefits Management
www.pbm.va.gov
4
Pharmaceutical Management Program
Timeline and Milestones
Project “Kickoff”
Meeting
Dec 08
Universal Waste
Rule (UWR)
Response
(Feb 09)
Jan 09
Pilot Site Visit
Assessor’s
Guide
(May 09)
Draft
Baseline
Report
(Mar 09)
Jun 09
Richmond
VAMC
(Jul)
Jul 09
Maryland
VAHCS
(Jul)
Finalized
Assessor’s Final Baseline
Guide
Report
(Oct 09)
(Nov 09)
Final
Guidance
Document EPA Letter
(Feb 11) (Mar 11)
Summary Site
Visit Report
(May 10)
Pharmaceutical
Management
Training Program
(Jun 11)
Conducted 2 Conducted 9 Site Visits
Draft
Pilot Site Visits
(Sept 09 – Mar 10)
Guidance Final VACO Coumadin
(Jul 09)
Document Summary Fact Sheet
(Mar 11)
(Jun 10) (Feb 11)
Lexington Phoenix
VAMC
VAHCS
(Sept)
(Nov)
Sep 09
Sierra
Nevada
VAHCS
(Nov)
Nov 09
Manchester
VAMC
(Nov)
Bay
Roseburg Pines
VAHCS
VAMC
(Feb)
(Jan)
Jan 10
Feb 10
Greater LA
VAHCS
(Jan)
Pharmacy Benefits Management
www.pbm.va.gov
Detroit
VAMC
(Mar)
Mar 10
Charleston
VAMC
(Feb)
5
What is meant by “hazardous pharmaceutical”?
 For the purpose of today’s discussion, it is important to understand
that there are two commonly confused working definitions of
hazardous pharmaceuticals:

Occupational Safety & Health Administration/
National Institute of Occupational Safety & Health
OSHA/NIOSH Hazardous (adverse health effects) Pharmaceuticals
 Carcinogenic, Corrosive, Toxic or Highly Toxic, Irritant, or Sensitizer

Resource Conservation & Recovery Act (Environmental Impact)
RCRA Hazardous (waste) Pharmaceuticals
 Listed Hazardous Waste (P- and U-listed)
 Characteristic Hazardous Waste (Ignitability, Corrosivity, Reactivity,
and Toxicity) D - Listed
Pharmacy Benefits Management
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6
Categories of RCRA Hazardous Wastes
 P-Listed

Acutely Hazardous

Sole Active Ingredient – Unused

Empty – Only if Triple Rinsed
 Rinse Solution is Hazardous
 Manage Un-rinsed Containers as Hazardous (Vials)
Pharmacy Benefits Management
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7
Categories of RCRA Hazardous Wastes
 P-Listed

Arsenic Trioxide (Chemotherapy)

Epinephrine (Excluded if in used syringe; may be discarded as
regulated medical waste) ** not EPI salts ** except MN

Nicotine (Patch backing but not wrappers)

Warfarin >0.3% (all Rx dosages)

Nitroglycerine (Excluded federally and some states if in final
dosage form)

Phentermine (1 of 3 controlled substances)
Pharmacy Benefits Management
www.pbm.va.gov
8
Categories of RCRA Hazardous Wastes
 U-Listed

Toxic – not as hazardous as “P”

Sole Active Ingredient – Unused

Empty Containers
 All contents have been removed through normal means and <3% by
weight remains = not hazardous
 Residues removed from containers must be managed as hazardous
waste
Pharmacy Benefits Management
www.pbm.va.gov
9
Categories of RCRA Hazardous Wastes
 U-Listed

Chloral Hydrate & Paraldehyde

Chlorambucil

Cyclophosphamide

Warfarin <0.3% (all Rx dosages exceed this percentage)

Selenium Sulfide (Selsun Blue)
Pharmacy Benefits Management
www.pbm.va.gov
10
Categories of RCRA Hazardous Wastes
 Characteristic (D-Listed): Pharmaceutical, chemical
formulations not on P-List or U-List, which exhibit one or
more of the following characteristics:
 Ignitability (nitroglycerine inj.)
 Toxicity (M-Cresol or thimerosal as a preservative – fluvax)
 Corrosivity (Zephiran solution 1:750)
 Reactivity (no examples on VANF)
Pharmacy Benefits Management
www.pbm.va.gov
11
Pharmaceutical Waste Management
Issues and Challenges identified through VAMC site visits
 Lack of guidance on hazardous waste identification and segregation beyond
the Pharmacy (e.g., Patient Care Wards, Oncology)
 Lack of containers for the accumulation of pharmaceutical hazardous waste
at or near the point of generation (e.g., Patient Care Wards, Oncology)
 Commingling of P-listed with U-listed and characteristic hazardous wastes in
a single container in the Pharmacy satellite accumulation area
 Expired drugs that are potentially hazardous waste (e.g., repackaged
Coumadin, flu vaccine, insulin) returned to VAMC Pharmacy from CBOC
 Reports and online tools from Reverse Distributors not fully leveraged
 Proper management of empty Coumadin stock bottles due to varying
regulatory interpretations (hazardous or non-hazardous waste?)
Pharmacy Benefits Management
www.pbm.va.gov
12
Pharmaceutical Handling and Use:
Issues and challenges identified through VAMC site visits
 Lack of “OSHA/NIOSH” Hazardous Drug List
 Absence of Written Hazardous Drug Programs
 Omission of pharmaceuticals from Hazard Communication Programs
 Limited participation in medical surveillance programs
 Limited Safety and Health Training on pharmaceutical waste disposal
procedures
 Limited availability of Industrial Hygienist (IH) support to perform Job Hazard
Analyses (JHA) and develop employee exposure control procedures
 Absence of “Standard Precautions” for handling and use of all
pharmaceuticals (hazardous, “non-hazardous”, and controlled)
 Establishment of VHA policies for safety and health regarding exposure to
pharmaceuticals
Pharmacy Benefits Management
www.pbm.va.gov
13
Pharmaceutical Handling and Use:
Leading practices identified through VAMC site visits
 Radiopharmaceutical Management
 All eleven facilities visited were determined to be effectively
managing radiopharmaceuticals
 Documented and fully implemented Chemotherapy
Training, Handling and Use Procedures
 Labeling
 Container Implementation
Pharmacy Benefits Management
www.pbm.va.gov
14
Pharmaceutical Waste Management
Recommendations based on environmental scan and
VAMC site visits
 Waste Identification and Segregation

Provide guidance or tools to assist staff with proper waste identification
(e.g., stickers, labels, posters, BCMA)

Provide containers for the management of hazardous pharmaceutical
waste to the medication or patient care rooms on the wards

Until a VAMC receives documentation from the state hazardous waste
regulatory authority that dictates otherwise, empty stock bottles or
containers of Coumadin® or warfarin should be managed as acute
hazardous waste (P001)
 Hazardous Waste Accumulation

Pharmacy should have at least two separate containers for the
accumulation of hazardous pharmaceutical waste; one container should
be dedicated for P-listed waste only
Pharmacy Benefits Management
www.pbm.va.gov
15
Pharmaceutical Waste Management
Leading Practices identified through site visits
 pharmaceuticals as they enter Pharmacy to identify those that should be
managed as hazardous waste Use of colored stickers on
 Containers at Satellite Accumulation Areas clearly labeled to indicate what
hazardous waste should be placed therein (P-listed, U-listed, characteristic)
Pharmacy Benefits Management
www.pbm.va.gov
16
Pharmaceutical Waste Management
Leading Practices identified through site visits
 Appropriate containers
Acute Hazardous Waste
Non-Hazardous
Pharmaceutical Waste
available for any given
hazardous waste category (Plisted, U-listed, characteristic)
 Training provided to nursing
staff regarding pharmaceutical
hazardous waste identification
and segregation
 Providing containers for the
Hazardous Waste (Bulk
Chemotherapy)
Trace Chemotherapy
Waste
management of non-hazardous
pharmaceuticals, trace
chemotherapy and bulk
chemotherapy waste
Pharmacy Benefits Management
www.pbm.va.gov
17
Pharmaceutical Waste Management
Recommendations based on environmental scan and
VAMC site visits (continued)
 Expired Drugs at CBOCs

Drugs that become hazardous waste upon expiration should be
managed as waste from CBOC or returned to VAMC Pharmacy
before expiration
 Reverse Distribution

Use the data made available in reports and tools from Reverse
Distributor to identify those drugs that are consistently wasted and
divert them from the reverse distribution channel and manage them
as waste from Pharmacy

Remove those drugs that have sole active ingredients on the P- or Ulist or that exhibit a hazardous characteristic from the non-hazardous
drugs, prior to adding to the reverse distribution holding area
Pharmacy Benefits Management
www.pbm.va.gov
18
Pharmaceutical Handling & Use: Recommendations
based on environmental scan and VAMC site visits

VHA Formulary Review



VHA facilities need to identify (list) pharmaceuticals in the formulary that are
hazardous chemicals (or hazardous drugs) for OSHA compliance.
A national level review should be conducted to identify drugs against both OSHA’s
definition of “hazardous chemical“ and the Environmental Protection Agency’s
(EPA) definition of “hazardous waste.”
Local Policies/Practices



Facilities should develop and implement an action plan with milestones for each of
the elements of the recommended VHA hazardous drug management policy.
Facilities should report the implementation status of each of the elements and
progress should be monitored yearly using the Annual Workplace Evaluation
(AWE).
VHA should add hazardous drug management as an annual mandatory review
item in the AWE.
Pharmacy Benefits Management
www.pbm.va.gov
19
Pharmaceutical Handling & Use: Recommendations
based on environmental scan and VAMC site visits
(continued)

Hazardous Drug Communication Program



A National Hazardous Drug HAZCOM Plan should be developed and implemented
consistently across the VHA and should incorporate the requirements of the
HAZCOM rule.
“Fact Sheets” for each hazardous drug or drug class could be developed. These
fact sheets would convey essential information such as physical state, summary
health hazard information and required engineering controls, administrative
controls, and PPE.
Training


Personnel should be trained on the proper use and handling of hazardous drugs.
A HAZCOM training module should be developed at the national level and
included in LMS. The training should educate personnel on hazardous drug topics.
Pharmacy Benefits Management
www.pbm.va.gov
20
Pharmaceutical Handling and Use:
Recommendations based on environmental scan
and VAMC site visits (continued)

Medical Surveillance and Recordkeeping



An action plan with milestones should be required of all facilities that have not
effectively implemented medical surveillance.
Goals should be established for identifying and successfully inviting or recruiting
employees who handle hazardous drugs into program.
Work with NIOSH to conduct health hazard evaluations of processes that are
known to create potential long-term, low-level exposures to hazardous drugs or
exposures to drugs with synergistic effects.
 Hazard/Exposure Controls

Standard precautions should be developed for the use and handling of
pharmaceuticals similar to the universal precautions used for bloodborne pathogen
control (i.e., using gloves whenever contact with drugs or drug residues is
expected, using eye protection when sprays or splashes are possible, and
reinforcing hand and workplace hygiene practices when working with or around
pharmaceuticals).
Pharmacy Benefits Management
www.pbm.va.gov
21
Waste Management: Should empty Coumadin®
stock bottles be managed as hazardous waste?
 State interpretations vary significantly

Kentucky: The wrappers or vials that held P-listed drugs (e.g., warfarin or nicotine
patches) are considered P-listed hazardous waste

Michigan: Vials that do not meet the empty pharmaceutical container rule and had
contained drugs on the “P” hazardous waste list in must be managed as either a
universal waste or hazardous waste unless the vial had been triple rinsed

Washington: Any container that held a warfarin tablet that is administered would
not carry the RCRA listed waste codes since the tablet is removed as a product
 In the Universal Waste Proposed Rule, Federal EPA states that “[i]f a
chemical is listed on the P-list, then its container must also be managed as a
hazardous waste, unless it has been declared ‘‘RCRA empty’’ via triplerinsing.” (73 FR 73520; December 2, 2008)
 It is VHA’ s position that until a VAMC receives documentation from the state
hazardous waste regulatory authority that dictates otherwise, empty stock
bottles or containers of Coumadin® or warfarin should be deemed to have
contained P001 waste.
Pharmacy Benefits Management
www.pbm.va.gov
22
Waste Management: Should empty Coumadin® stock
bottles be managed as hazardous waste? (continued)
 VHA has developed a fact sheet entitled,
Proper Management of Empty Coumadin®
Containers that addresses:




What is “RCRA-empty”?
Interpretations Regarding Empty Coumadin®
Bottles
VHA Position on Empty Coumadin® Containers
Counting the Weight of the Container
 VHA is requesting an opinion letter from EPA
regarding:


Should empty Coumadin® stock bottles be
managed as hazardous waste?
Is the weight of the Coumadin® stock bottle or
only the warfarin residue therein counted
toward the monthly generator status and/or
quantity limits at a satellite accumulation area?
Pharmacy Benefits Management
www.pbm.va.gov
23
Acknowledgements to: The Pharmaceuticals Management
Task Group
Veterans Health Administration
Paul Carnes
Chief of Pharmacy
Lebanon, PA
Donald Horning
Environmental Protection Manager
Long Beach, CA
George Knight
VISN 2 Pharmacy/PBM Manager
Syracuse, NY
William Kulas
VISN 1 Environmental Protection
Manager
Augusta, ME
Booz Allen
Hamilton
Pamela Russell
Industrial Hygiene Manager,
Engineering
Minneapolis, MN
Steve Buchanan
Senior Associate
McLean, VA
Jack Staudt
Environmental Engineer
Washington, DC
Janet Gagnon
Senior Associate
Rockville, MD
Vaiyapuri Subramaniam
Associate Chief Consultant,
Pharmacy Benefits Management
Washington, DC
Timothy Killian
Associate
McLean, VA
Robert Van Arsdale
Pharmacy Chief
Columbia, MO
Tom Pape
Associate
Rockville, MD
Jody McClarin
National GEMS Program Manager
St. Louis, MO
Pharmacy Benefits Management
www.pbm.va.gov
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Questions?
Pharmacy Benefits Management
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25