Pharmacy Benefits Management www.pbm.va.gov

Hazardous Drug Management

VA Pharmacy Informatics Conference Pleasanton, CA Aug 2-5, 2011

George H. Knight, RPh.VISN 2 Pharmacy ExecutivePBM ManagerSyracuse, NY

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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

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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

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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 non-hazardous) 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.

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Pharmaceutical Management Program Timeline and Milestones

Dec 08

Project “Kickoff” Meeting

Universal Waste Rule (UWR) Response (Feb 09)

Jun 09Draft Baseline Report (Mar 09)

Pilot Site Visit Assessor’s Guide (May 09)

Conducted 2 Pilot Site Visits (Jul 09)

Finalized Assessor’s Guide (Oct 09)

Conducted 9 Site Visits (Sept 09 – Mar 10)

Summary Site Visit Report

(May 10)

Draft Guidance Document(Jun 10)

Jan 09

Final Baseline Report (Nov 09)

Maryland VAHCS

(Jul)

Phoenix VAHCS

(Nov)

Sierra Nevada VAHCS

(Nov)

Greater LA VAHCS

(Jan)

Bay Pines

VAHCS (Feb)

Richmond VAMC

(Jul)

Lexington VAMC (Sept)

Manchester VAMC (Nov)

Roseburg VAMC (Jan)

Charleston VAMC (Feb)

Detroit VAMC (Mar)

Nov 09 Sep 09 Jul 09 Jan 10 Mar 10 Feb 10

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Final Guidance Document (Feb 11)

Final VACO Summary (Feb 11)

EPA Letter (Mar 11)

Coumadin Fact Sheet(Mar 11)

Pharmaceutical Management

Training Program (Jun 11)

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

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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)

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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)

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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

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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)

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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)

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Pharmaceutical Waste ManagementIssues 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?)

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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

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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

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Pharmaceutical Waste ManagementRecommendations 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

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Pharmaceutical Waste ManagementLeading 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)

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Pharmaceutical Waste ManagementLeading Practices identified through site visits

Appropriate containers available for any given hazardous waste category (P-listed, U-listed, characteristic)

Training provided to nursing staff regarding pharmaceutical hazardous waste identification and segregation

Providing containers for the management of non-hazardous pharmaceuticals, trace chemotherapy and bulk chemotherapy waste

Hazardous Waste (Bulk Chemotherapy)

Non-Hazardous Pharmaceutical Waste

Trace Chemotherapy Waste

Acute Hazardous Waste

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Pharmaceutical Waste ManagementRecommendations 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 U-list or that exhibit a hazardous characteristic from the non-hazardous drugs, prior to adding to the reverse distribution holding area

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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.

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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.

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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).

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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 triple-rinsing.” (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.

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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?

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Acknowledgements to: The Pharmaceuticals Management Task Group

Paul CarnesChief of PharmacyLebanon, PA

Donald HorningEnvironmental Protection Manager Long Beach, CA

George KnightVISN 2 Pharmacy/PBM ManagerSyracuse, NY

William KulasVISN 1 Environmental Protection ManagerAugusta, ME

Jody McClarinNational GEMS Program ManagerSt. Louis, MO

Pamela RussellIndustrial Hygiene Manager, EngineeringMinneapolis, MN

Jack StaudtEnvironmental EngineerWashington, DC

Vaiyapuri SubramaniamAssociate Chief Consultant, Pharmacy Benefits Management Washington, DC

Robert Van ArsdalePharmacy ChiefColumbia, MO

Booz Allen Hamilton

Steve BuchananSenior AssociateMcLean, VA

Janet GagnonSenior AssociateRockville, MD

Timothy Killian AssociateMcLean, VA

Tom PapeAssociateRockville, MD

Veterans Health Administration

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Questions?

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