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Pharmaceutical Waste Pharmaceutical Waste Management Management Luring Pollution Prevention into Luring Pollution Prevention into Compliance Assistance Compliance Assistance Sara Johnson, M.S. Sara Johnson, M.S. Pollution Prevention Program Pollution Prevention Program Environmental Summit – Providence, RI Environmental Summit – Providence, RI September 29, 2005 September 29, 2005

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Page 1: Pharmaceutical Waste Management Luring Pollution Prevention into Compliance Assistance Sara Johnson, M.S. Pollution Prevention Program Environmental Summit

Pharmaceutical Waste Pharmaceutical Waste ManagementManagement

Luring Pollution Prevention into Luring Pollution Prevention into Compliance AssistanceCompliance Assistance

Sara Johnson, M.S.Sara Johnson, M.S.Pollution Prevention ProgramPollution Prevention Program

Environmental Summit – Providence, RIEnvironmental Summit – Providence, RISeptember 29, 2005September 29, 2005

Page 2: Pharmaceutical Waste Management Luring Pollution Prevention into Compliance Assistance Sara Johnson, M.S. Pollution Prevention Program Environmental Summit

AgendaAgenda

Pollution Prevention = Compliance Pollution Prevention = Compliance AssistanceAssistance

Hospital’s Perspective of Managing Hospital’s Perspective of Managing Pharmaceutical WastePharmaceutical Waste

Compliance ConfusionCompliance Confusion Regulatory ResearchRegulatory Research

Page 3: Pharmaceutical Waste Management Luring Pollution Prevention into Compliance Assistance Sara Johnson, M.S. Pollution Prevention Program Environmental Summit

Pollution Prevention = Pollution Prevention = Compliance AssistanceCompliance Assistance

Innocent transitionInnocent transition– Waste reduction workshop (1998)Waste reduction workshop (1998)– Mercury workshop (2000)Mercury workshop (2000)– NH3E (2001)NH3E (2001)

Green cleaningGreen cleaning Green purchasingGreen purchasing Alternative technologiesAlternative technologies

– Dioxin workshop (2002)Dioxin workshop (2002) Hospitals for a Healthy Hospitals for a Healthy

EnvironmentEnvironment– Web conferencesWeb conferences

Pharmaceutical questionsPharmaceutical questions– Epi pens and epi vialsEpi pens and epi vials– Chemo wasteChemo waste

Page 4: Pharmaceutical Waste Management Luring Pollution Prevention into Compliance Assistance Sara Johnson, M.S. Pollution Prevention Program Environmental Summit

Pharma Waste = P2Pharma Waste = P2

Management of Pharmaceutical Management of Pharmaceutical waste is NOT pollution preventionwaste is NOT pollution prevention– Maybe on rare occasionsMaybe on rare occasions– Patient carePatient care– Purchasing contracts (Group Purchasing Purchasing contracts (Group Purchasing

Organizations)Organizations) Regulatory interpretation made at Regulatory interpretation made at

EPA HQsEPA HQs

Page 5: Pharmaceutical Waste Management Luring Pollution Prevention into Compliance Assistance Sara Johnson, M.S. Pollution Prevention Program Environmental Summit

Tectonic Plates ShiftedTectonic Plates Shifted

New Hampshire’s New Hampshire’s regulatory section regulatory section experienced staff experienced staff reductions.reductions.– Lost knowledge and Lost knowledge and

historyhistory– Can’t hold hospital’s Can’t hold hospital’s

handhand– Only 26 hospitals in New Only 26 hospitals in New

HampshireHampshire

Page 6: Pharmaceutical Waste Management Luring Pollution Prevention into Compliance Assistance Sara Johnson, M.S. Pollution Prevention Program Environmental Summit

Compliance Assistance Mud SlideCompliance Assistance Mud Slide

NH3E Quarterly meetingsNH3E Quarterly meetings– Roundtable discussionsRoundtable discussions– NH DES panel discussionsNH DES panel discussions

List serveList serve– H2E and NH3EH2E and NH3E

Regional EPA hospital workshopRegional EPA hospital workshop– While sponsored by P2 section, mostly While sponsored by P2 section, mostly

compliance.compliance.

Page 7: Pharmaceutical Waste Management Luring Pollution Prevention into Compliance Assistance Sara Johnson, M.S. Pollution Prevention Program Environmental Summit

Hospital’s Perspective: Hospital’s Perspective: Pharmaceutical Waste ManagementPharmaceutical Waste Management

Who is managing the Who is managing the waste?waste?– Environmental servicesEnvironmental services– Facility managerFacility manager– PharmacistPharmacist

Facility SizeFacility Size– Upper CT <40 bedsUpper CT <40 beds– Dartmouth >400 bedsDartmouth >400 beds

What are my chances What are my chances at being inspected?at being inspected?

Page 8: Pharmaceutical Waste Management Luring Pollution Prevention into Compliance Assistance Sara Johnson, M.S. Pollution Prevention Program Environmental Summit

Hospital’s Perspective: Hospital’s Perspective: Be SpecificBe Specific What color should the What color should the

buckets be and where to buckets be and where to purchase them?purchase them?

Waiver for nitroglycerine?Waiver for nitroglycerine?– Should I just wait for the rule Should I just wait for the rule

change and hope for the best?change and hope for the best? What do we do with the What do we do with the

items that are not listed?items that are not listed?– EPA list not current, new EPA list not current, new

pharmaceuticals are more pharmaceuticals are more toxictoxic

Page 9: Pharmaceutical Waste Management Luring Pollution Prevention into Compliance Assistance Sara Johnson, M.S. Pollution Prevention Program Environmental Summit

Sector Specific QuestionsSector Specific Questions

Every scenario under the Every scenario under the sun.sun.– Mainly mixture questionsMainly mixture questions

P-list with a U-listP-list with a U-list P-list with another pharmaP-list with another pharma U-list with another pharmaU-list with another pharma Chemo cocktailChemo cocktail

– Spills versus splattersSpills versus splatters– Used versus unusedUsed versus unused

Page 10: Pharmaceutical Waste Management Luring Pollution Prevention into Compliance Assistance Sara Johnson, M.S. Pollution Prevention Program Environmental Summit

Hospitals Are Different Aren’t They?Hospitals Are Different Aren’t They?

The dilution rate is The dilution rate is different.different.– Healthcare is different Healthcare is different

from manufacturing. We from manufacturing. We should have different should have different rules.rules.

Epinephrine is naturally Epinephrine is naturally occurring substance.occurring substance.– Rinse the bottles and then Rinse the bottles and then

manage the rinsate?manage the rinsate?

Page 11: Pharmaceutical Waste Management Luring Pollution Prevention into Compliance Assistance Sara Johnson, M.S. Pollution Prevention Program Environmental Summit

Compliance ConfusionCompliance Confusion

Waste streams are generated Waste streams are generated throughout facilitythroughout facility

Wastes are not one “type”Wastes are not one “type”– Chemotherapy waste can be infectious, Chemotherapy waste can be infectious,

hazardous and/or solid waste.hazardous and/or solid waste.– Safety concernsSafety concerns

Page 12: Pharmaceutical Waste Management Luring Pollution Prevention into Compliance Assistance Sara Johnson, M.S. Pollution Prevention Program Environmental Summit

Compliance DenialCompliance Denial

Go to numerous Go to numerous workshops to try get a workshops to try get a different answer.different answer.

““Expert” adviceExpert” advice– Reverse distributorsReverse distributors– Group purchasing Group purchasing

organizationsorganizations– OSHAOSHA– Healthcare corporationsHealthcare corporations– Waste vendorsWaste vendors

Page 13: Pharmaceutical Waste Management Luring Pollution Prevention into Compliance Assistance Sara Johnson, M.S. Pollution Prevention Program Environmental Summit

Regulatory ResearchRegulatory Research Web pageWeb page

– Multiple guidance documentsMultiple guidance documents– FAQs – pharma wasteFAQs – pharma waste

Very time consumingVery time consuming– P2 is non-regulatoryP2 is non-regulatory– Must get approval from regulatory programsMust get approval from regulatory programs– Everyone has a sayEveryone has a say– Can’t seem to keep things simpleCan’t seem to keep things simple

Worth whileWorth while– Answer is now written downAnswer is now written down– Available to the public (share with others)Available to the public (share with others)

Page 14: Pharmaceutical Waste Management Luring Pollution Prevention into Compliance Assistance Sara Johnson, M.S. Pollution Prevention Program Environmental Summit

Current Hot TopicCurrent Hot Topic

Reverse DistributorsReverse Distributors– Mailing everything Mailing everything

IV bagsIV bags““empty” vialsempty” vials

– Received invoice of hazardous wasteReceived invoice of hazardous waste– No tracking or manifestNo tracking or manifest– No determination at point of generationNo determination at point of generation– No addition to generator statusNo addition to generator status

Page 15: Pharmaceutical Waste Management Luring Pollution Prevention into Compliance Assistance Sara Johnson, M.S. Pollution Prevention Program Environmental Summit

Time is MoneyTime is Money

Since 1999, the Healthcare project Since 1999, the Healthcare project has been funded through P2 grant.has been funded through P2 grant.

20 to 30% of my time spent on 20 to 30% of my time spent on healthcarehealthcare– 3 FTE = actual P2 work3 FTE = actual P2 work

Healthcare sectorHealthcare sector– Acute and specialty hospitals, home Acute and specialty hospitals, home

health care, eye physicians, nursing health care, eye physicians, nursing homes, and mental health clinicshomes, and mental health clinics

Page 16: Pharmaceutical Waste Management Luring Pollution Prevention into Compliance Assistance Sara Johnson, M.S. Pollution Prevention Program Environmental Summit

Future of Compliance Assistance Future of Compliance Assistance with Healthcare Facilitieswith Healthcare Facilities

Actively pursuing self-Actively pursuing self-efficiencyefficiency

H2E grant with DartmouthH2E grant with Dartmouth NH3E meetingsNH3E meetings Discussion through NH3E Discussion through NH3E

list servelist serve Committing to the phrase Committing to the phrase

“NO MORE” or “Keep me “NO MORE” or “Keep me out of this”out of this”

Page 17: Pharmaceutical Waste Management Luring Pollution Prevention into Compliance Assistance Sara Johnson, M.S. Pollution Prevention Program Environmental Summit

Sara Johnson, M.S.Sara Johnson, M.S.Hew Hampshire Pollution Prevention Program Hew Hampshire Pollution Prevention Program

Healthcare Project CoordinatorHealthcare Project Coordinator603-271-6460603-271-6460

www.des.nh.gov/nhppp/Healthcare_P2/default.aspwww.des.nh.gov/nhppp/Healthcare_P2/default.asp