HAZARDOUS WASTETHE PHARMACY PURCHASING

PROFESSIONAL’S ROLE

Kathy Pflaum, Inventory Control Coordinator, Pharmacy

Speaker Disclaimer

Kathy Pflaum is an employee of St. Francis Hospital in Topeka, Kansas and has nothing else to disclose

Today’s Objectives – Hazardous Waste- It Affects You

Describe the pharmacy purchasing role regarding the identification and disposal of hazardous waste

Define the Resources Conservation & Recovery Act of 1976 (RCRA) and the effects on Pharmacy

Reverse distribution selection processes

Why Do We Care About Hazardous Waste?

What You Don’t Know May Cause Harm

How much hazardous waste is generated by your facility?

What happens to the current sharps and red bag waste?

Who are the responsible parties in your hospital to ensure proper handling and disposal of hazardous pharmaceutical waste?

Why do you care?*

* Managing Hazardous Pharmaceutical Waste, Pilot Project of North Memorial Medical Center, Robbinsdale, MN Pilot Project Presentation

Pharmacy Purchasing Professional – What Can You Do?

Be observant and document the observations Always ask questions Probe the entire pharmacy and everywhere

pharmaceuticals are used or stored Understand the equation between what is purchased

and how the product is used Have a plan for an unidentified delivery

Effecting the Purchase of Pharmacy Items

How Can You Effect The Purchasing?

Develop and enforce a policy that states that no medications are accepted into the Pharmacy with less than 1 year dating– Medications are purchased with the least amount of

packaging– Select medications without preservatives whenever

possible*

*These opportunities and further discussion can be found at www.h2e-online.org.

Minimize waste wherever possible– Look for opportunities to change the size or style

bought– Controlled substances are especially difficult to

waste* Inventory controls can be tightened on many

medications thus reducing waste

How Can You Effect the Purchasing?

*These opportunities and further discussion can be found at www.h2e-online.org.

Selection of the Reverse Distribution Vendor

Pharmaceutical Reverse Distribution - Who Selects This Vendor at Your Facility?

Proper permits are required of Reverse Distribution and you have the right to ask for copies of these and other permits that may be required by the state:

• DEA Registration

• State Board of Pharmacy

• EPA Waste ID

• Local Solid Waste Permit

• Local Medical Waste Permit

For all hazardous waste disposal, the reverse distributor should provide the site information to which it will be delivered.

ALL HAZARDOUS WASTE IS “CRADLE TO GRAVE”

The facility owns the waste even in the landfill.

All applicable fines for improper waste disposal belongs to the facility.

Pharmaceutical Reverse Distribution - Who Selects This Vendor at Your Facility?

What to Know When Choosing a Reverse Distribution Company

Does the reverse distributor have all the proper permits? Where does the hazardous waste go from the reverse

distributor? What are the charges for disposal of hazardous and non-

hazardous waste per pound? Is there a processing fee? Who pays the freight from the facility to the reverse

distributor facility? Off site/On site processing fee?

What is a Hazardous Waste?

The EPA* defines a hazardous waste as:

…a waste with properties that make it dangerous or potentially harmful to human health or the environment. The universe of hazardous wastes is large and diverse. Hazardous wastes can be liquids, solids, contained gases, or sludges. They can be the by-products of manufacturing processes or simply discarded commercial products, like cleaning fluids or pesticides.

*EPA web site www.epa.gov/epaoswer/osw/hazwaste.htm

RCRA Law is Administered by EPA

Resources Conservation and Recovery Act of 1976*– Protect human health and the environment from the

potential hazards of waste disposal– Conserve energy and natural resources– Ensure that wastes are managed in an environmentally

sound manner

*EPA web site www.epa.gov/epaoswer/osw/hazwaste.htm

Categories of Hazardous Waste

Hazardous waste is regulated under the Resource Conservation and Recovery Act (RCRA) Subtitle C

Waste is categorized as hazardous if it appears on a hazardous waste list*– F-list– D-list– K-list– P-list– U-list

*EPA web site www.epa.gov/epaoswer/osw/hazwaste.htm

“D” listed Pharmaceuticals*– Barium D005– Lindane D013

“U” listed Pharmaceuticals*– Acetone U002– Cyclophosphamide U058– Lindane U129– Phenol U188

“D” LIST and “U” List Examples

*EPA web site www.epa.gov/epaoswer/osw/hazwaste.htm

“P” Listed Waste Effects Pharmacy

Listed below are a few examples of “P” listed Pharmaceuticals:– Epinephrine* P042– Nicotine P075– Nitroglycerin (weak)** P081– Physostigmine P204– Warfarin (greater than 0.3%) P001

*Epinephrine salts have been federally excluded effective October 16, 2007. States may or may not have adopted this federal stance.

** Nitroglycerin has been excluded from the federal listing. States may or may not have adopted this federal stance.

EPA web site www.epa.gov/epaoswer/osw/hazwaste.htm

Other Categories of Hazardous Waste

Not all hazardous waste is on a “list” Can be considered a hazardous waste if it exhibits at

least one of four characteristics*– Ignitability– Corrosivity– Reactivity– Toxicity

*EPA web site www.epa.gov/epaoswer/osw/hazwaste.htm

Characteristics of Ignitability or Corrosivity

Ignitable* - Aqueous solution containing 24% alcohol or more by volume & flash point <140° F

– Dehydrated Alcohol <98% Ethyl Alcohol– Rubbing alcohol– Paclitaxel in Aqueous solution

Corrosive* - Aqueous solution having a pH ≤ 2

– Primarily compounding chemicals– Glacial Acetic Acid– Sodium Hydroxide

*EPA web site www.epa.gov/epaoswer/osw/hazwaste.htm

Characteristics of Reactivity or Toxicity

Reactivity* - meets eight separate criteria identifying certain explosive and water reactive wastes– Nitroglycerin formulations are excluded federally from

the P081 listing as non-reactive as of 8/14/2001 in FR:5/16/2001**

Toxicity* - examples include but are not limited to:– Arsenic– Lindane– Barium– Mercury (thimerosal)

• Cadmium• Chloroform• Silver• Chromium

*EPA web site www.epa.gov/epaoswer/osw/hazwaste.htm **FR, volume 6 #95 (May 16, 2001)

Don’t Just Consider the Chemical!

Hazardous waste (the initial chemical) combined with:– Personal Protective Equipment,

packaging and spill materials– Regulated Medical Waste– Sharps– Controlled Substances

All items MUST be part of the hazardous waste stream

What Areas Generate Hazardous Waste?

Emergency Room Home Health ICU Lab Long term care facilities

Maintenance Oncology/hematology Outpatient clinics Patient care units Pharmacy

Who Is Watching You?

Enforcement Agencies

The Joint Commission (TJC)

– Standards in the Environment of Care section 3.10 U. S. Environmental Protection Agency State Department of Health & Environment

The Joint Commission and Hazardous Waste

Future ramifications with TJC if an executed plan not in process

Surveys now include such questions as:– How do you separate your waste?– What is your plan to comply 100% with RCRA?– Do you waste medications down the drain?– How does hazardous waste leave the facility?– Where does the hazardous waste go after leaving the

facility?– Can you product the logs of hazardous waste that

have been transported out of your facility?

Additional Governing Regulations

Clean Air Act Clean Water Act Emergency Planning and Community Right To Know

Act (EPCRA) Toxic Substance Control Act Safe Drinking Water Act

EPA - Regions

The mission of the Environmental Protection Agency is to protect human health and the environment.

• http://www.epa.gov/

• Click on your region number for contact information

Health Care RCRA Violations from Region #2

Breakout of RCRA Violations from Hospital Disclosures

Accumulation Time1%

Manifest 5%

ID of HW 26%

Universal Waste20%

General Facility Standards10%

Container Management30%

UST 3% Generator

Requirements5%

Janet Bowen, EPA Region I 12/7/2006 presentation of Top Ten Compliance Pitfalls Based on Region II Audit Disclosure Data to SBEAP

Has Green Become A Color At Your Hospital?

This is Where the Rubber Hits the Road!

Be Part of the Solution

Three ways to sort pharmaceutical waste– Provide appropriate disposal containers through

out the facility– Centrally processed sorting of hazardous waste

and medication– Treat all pharmaceuticals as hazardous waste

Medical Waste vs. Hazardous Waste

Red containers are SHARPS containers – Not hazardous waste receptacles

Medical waste is defined as waste materials that are generated at health care facilities (hospitals, clinics, etc…)– 4 categories – infectious, hazardous, radioactive,

other*

*EPA web site www.epa.gov/epaoswer/osw/hazwaste.htm

Container Regulations That Apply

Most states require clear verbiage stating Hazardous Waste

There should be an accumulation start date Record log

Who is Disposing Of Your Hazardous Waste?

Has the contracted company provided– Proper licensing to haul hazardous waste? (vs.

medical waste)– “Bill of lading” documents to haul the waste? – Identification and proper documentation of disposal

site

Establish a Hospital Wide Hazardous Waste Committee

C-Suite Administrator Clinics Surgery Materials Management Infection Control Director of Safety Environmental Services

Risk Management Pharmacy Nursing Lab Radiology Education/Training Director

Potential Impact of Compliance

Financial Impact

– Training and development of staff– Increased waste costs– Additional styles of containers– Additional staff to handle the waste– Outside consultants to achieve compliance

Potential Impact for Non-Compliance

Fines up to $32,500 per day per violation Legal costs EPA scrutiny The Joint Commission - Requirement for Improvement

(RFI)

Pharmacy Purchasing Professional’s Challenge

Get involved Be proactive Become an expert in hazardous waste Be the “GO TO” person in the health care facility Show your leadership skills

Resources Used in this Presentation

http://h2e-online.org http://www.epa.gov Top Ten Environmental Compliance Pitfalls - presented by

Janet Bowen, EPA Region 1 12/7/2006 to SBEAP. NIOSH – National Institute for Occupational Safety & Health PharmEcology Associates, LLC - www.pharmecology.com Managing Hazardous Pharmaceutical Waste, Pilot Project

at North Memorial Medical Center, Robbinsdale, MN Presentation

Covidien (Kendall SharpSafety Division) “Managing Pharmaceutical Waste – What Pharmacists

Should Know”, Charlotte A. Smith, RPh, MS, Journal of the Pharmacy Society of Wisconsin, Nov./Dec. 2002, p. 17.

Questions?