Presentation on theme: "Pharmaceutical Waste June 2010 Wendi Shafir Environmental Protection Agency Region 9 415-972-3422"— Presentation transcript:
Pharmaceutical Waste June 2010 Wendi Shafir Environmental Protection Agency Region
Key Issues to Cover Today Pharmaceuticals in the Environment US Geological Survey Study How do they get there ? Health /Environmental Impacts Current Requirements for Managing Pharms What is pharmaceutical waste? Regulations Identification Management Resources
3 Pharmaceuticals in the News Medical facilities making uncontrolled releases of controlled drugs into water By JEFF DONN | AP National Writer 12:36 PM EDT, September 14, 2008 MINNEAPOLIS (AP) _ In a frustrating quirk in government policy, the most tightly controlled drugs — like painkilling narcotics prone to abuse — are the ones that most often elude environmental regulation when they become waste.
Drugs in Water In surface and ground sources of drinking water Endocrine disruptors found in waterways receiving wastewater Detrimental effects on aquatic species May have an impact on human health Antibotic resistance Water quality degradation
Nationwide survey 139 streams in 30 states, analyzed for 95 compounds 86% of compounds in at least one stream sample Widespread: One or more found in 80% of stream samples 13% of streams had more than 20 compounds *
How do they get into the water? Sewers Excretion Flushing unwanted medicines “Wasting” meds into sinks Landfills – thrown in trash Leachate goes to wastewater plants, released to rivers, ocean Animal waste flows into waterways Industrial discharge
So, what’s the problem? Endocrine Disruptors – act at very low dose Antibiotic Resistance Toxicity Environmental Degradation Lack of confidence in water supply
8 Sources of Endocrine Disrupting Chemicals (EDCs) Industrial chemicals Personal care products Pesticides, herbicides, fungicid es Pharmaceuticals Synthetic and natural hormones Endocrine Disrupting Chemical s
What are Endocrine Disruptors ? Any chemical –- that disrupts (or mimics) the normal balance of hormones, with particular focus on estrogen Interfere with normal function of the endocrine system (thyroid, adrenals, ovaries, testes) Affect reproduction, development, and behavior Active at VERY low dose Multi-generational effects
Antibiotic Resistance 1999: Ampicillin-resistant bacteria found in every U.S. river tested Samples containing the highest levels of antibiotics also contained bacteria with greatest resistance DNA that helps make germs resistant to medicines increasingly appearing as a pollutant in the water, even treated drinking water Decreases effectiveness of antibiotics
What is Pharmaceutical Waste?
May include, but is not limited to: expired drugs; patients’ personal medications; waste materials containing excess drugs ( IV bags, tubing, vials, etc.) drugs that can no longer be used; containers that held drugs; drugs that are intended to be discarded; and contaminated garments, absorbents and spill cleanup material.
How is it regulated ? Resource Conservation & Recovery Act- RCRA, mostly Enforced by EPA, state and local agencies Federal regulation - hazardous waste disposal Encourages minimization of waste generation Defines “hazardous waste” “Cradle to Grave” tracking of hazardous waste Households are exempt Not all pharms are hazardous waste
Understanding the Regulations Defining Hazardous Wastes: Listed (F, K, P and U)- lists of actual wastes – includes some meds Characteristic Waste: exhibit these characteristics Ignitability Corrosivity Reactivity Toxicity Also Radioactives – other reguations
Pharm Waste in California Proper pharmaceutical waste management is a highly complex new frontier in healthcare Hospital pharmacies typically stock between 2,000 and 4,000 different items Very difficult to correctly identify and manage waste California Only pharmaceuticals handled under MWMA
What can we do? Pollution Prevention Control at source Can implement & reduce loading in near term Product stewardship
Overview of Pharmaceutical Disposal: Hospitals Radioactives special handling RCRA hazardous waste must be hauled off as hazardous waste California Only pharmaceuticals handled under MWMA Solid Waste – not hazardous as defined by regs some flexibility May be best to dispose of as hazardous waste
Minimizing Pharm Waste - examples Minimize inventory Rotate inventory - use oldest stock first Centralized disposal of physician’s samples Prevent free samples- use voucher option Avoid unnecessary prescriptions, especially antibiotics-Note pharmacy has very little control Use pharmacy reverse distribution
Managing Pharm Waste Sewering Hazardous Chemo Radioactive MUST Develop Comprehensive System
Managing Pharmaceutical Waste A 10-Step Blueprint for Healthcare Facilities Revised August, 2008 Good reference – to develop plan California version available
Green Team Pharmacy Environmental Nursing Administration Safety Education Purchasing Risk Management
Recommended Disposal Strategy Everything Else RCRA Hazardous Waste RCRA Hazardous Sewer IV bags with salts/nutrients Medical Waste
What Pharms Can Be Sewered? Up to individual POTWs – sewer authority Generally okay to sewer solutions in IV bags containing only: saline solution lactate (i.e, Ringer’s) nutrients such as glucose (I.e., D5W) vitamins potassium other salts and electrolytes
Reverse Distribution For pharmaceuticals – not available for most other hazardous substances "Reverse distribution" - expired pharms can be returned to the manufacturer for credit by pharmacies, not by consumers Not to be used as a “waste management system.” Exclusion applies only to bona fide returns for credit, and not to broken containers, spilled contents, compounding leftovers, unused IVs, etc.
Take Home Messages Pharmaceuticals at detectable levels in many U.S. surface waters! First manage for P2, then dispose of properly. Pharmacists not always conversant in waste regulations (and may need support). EPA Resource Conservation & Recovery Act regulations carry significant liability, comparable to Drug Enforcement Administration
Resources NIOSH Hazardous Drug Alert ASHP Guidance on Handling Hazardous Drugs OSHA Technical Manual Step Blueprint for Health Care Facilities Pharmaceutical waste U.S. Geological Survey Classifying Pharmaceutical Waste at California Healthcare Facilities alinformation.pdf alinformation.pdf
Resources Classifying Pharmaceutical Waste at California Healthcare Facilities sposalinformation.pdf sposalinformation.pdf