Presentation Overview. Pharmaceutical Waste in the News. Pharmaceutical Waste Management Writing A Prescription for Compliance

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1 Presentation Overview AHMP 2011 National Conference Technical Session Bob Doyle, CHMM Management Writing A Prescription for Compliance Background What is? Regulations in FL & MI Management Options Update on EPA s Proposed Rule to Regulate as Universal Waste in the News US Geological Survey Study ( ) 139 water stream sampled in US found 80% contained organic contaminants, many were common prescription medication and OTC products AP investigation of drinking water supplies (March 2008) Pharmaceuticals detected in the drinking water supplies of 24 major metropolitan areas across the country EPA Health Services Industry Study August 2008 Detailed study of pharmaceutical waste management practices at hospitals and LTCF across the country Healthcare Waste Management Challenges 24/7/365 operation Complex systems with multiple waste streams Large volume of waste generated Multiple State and Federal regulations apply to operation Decentralized service model On-site and off-site Healthcare Waste Management Risks/Rewards Risks Poor Management EOC compromised Non-compliance enforcement (up to $32,500 per day/violation) Employee health and safety exposure Negative publicity Negative environmental impact Rewards Proper Management Safe working environment Compliance Efficient use of resources Positive public image Positive environmental impact Background Complicated Regulatory Issue Multiple agencies/jurisdictions with requirements RCRA, DOT, DEA, State regulations Operational Challenges Lack of regulatory knowledge Historically poor management practices sewering, landfill, medical waste incinerator Training, space, cost constraints

2 Regulatory Background All RCRA regulations apply to pharmacies/ hospitals P-listed, U-listed, D-Listed & Characteristic Expired and unopened or unused drugs are typically collected by a reverse distributor Opened and partially dispensed hazardous drugs should not be disposed of through a reverse distributor RD s do not want to be haz waste generators What is? 1 st Define Pharmaceutical (FDA) any chemical product, vaccine or allergenic (including any product with the primary purpose to dispense or deliver a chemical product, vaccine or allergenic), intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or injury in man or other animals or is intended to affect the structure or function of the body in man or other animals. not containing a radioactive component 2 nd Define Waste (Solid Waste) 40 CFR Discarded material which is abandoned or recycled or inherently waste-like. What is? Pharmaceutical waste can be: Non-hazardous solid/liquid normal saline, dextrose, electrolytes, acetaminophen, salicylic acid Hazardous solid/liquid 31 commercial chemical products listed on RCRA s P- and U-lists that have pharmaceutical uses Depending on the concentration in different pharmaceutical preparations, pharmaceuticals may also exhibit the ignitability, corrosivity, reactivity or toxicity What is? Pharmaceutical waste can be: DEA Regulated Schedule II-V RCRA and DEA Regulated Chloral hydrate - U034/Schedule IV Dual Waste Infectious and Hazardous Limited disposal options, costly State specific regulations apply (MI and FL Universal Waste) What is? Pharmaceutical waste can be: Multiple P or U listed chemicals in a formulation NIOSH Hazardous Drug Alert Appendix A OSHA Technical Manual Section 6, Chapter 2, Appendix 6, 2-1 US Department of Health and Human Services National Toxicology Program s Report on Carcinogens (11 th Edition) Chemotherapy agents not listed on RCRA Additional drugs meeting NIOSH and OSHA criteria Drugs with LD50 at or below 50mg/kg Endocrine disruptors Antibiotics Determination A pharmaceutical is considered waste at the time and place the decision is made to discard it FL When the decision is made that the pharmaceutical is no longer viable A waste determination must be conducted on a discarded pharmaceutical to determine if it is hazardous waste Spilled, damaged or broken product no longer useable for the intended purpose An item used in cleaning spills (dry absorbent, paper towels, etc.) must be determined and managed as either hazardous or non-hazardous waste Formulary Review

3 in FL & MI Pharmaceutical waste in Florida & Michigan can be regulated as universal waste Implications: Eliminate hazardous waste generator responsibilities Accumulation; Storage; Record Keeping; Labeling (reduced); Training; Security; Response to releases Streamline management practices for generators of hazardous pharmaceutical waste EPA proposed a draft rule to add pharmaceutical waste as universal waste on 11/20/2008 in FL & MI On-site Storage and Labeling Comingled collection of compatible hazardous pharmaceutical wastes with appropriate label Universal Waste Pharmaceuticals or Universal Pharmaceutical Waste Container should remain closed, structurally sound Handler demonstrate accumulation time MI Liquid industrial waste regulations Training in FL & MI Off-site shipment Waste can be shipped to a universal waste handler or disposal destination as universal waste IN FLORIDA & MICHIGAN Note: If the universal waste meets requirements of a DOT HM under DOT 49 CFR , the waste must be properly packaged, labeled, marked and placarded and must have appropriate proper shipping papers Six DOT Shipping Categories: Pharmaceuticals, liquids (Metals), Toxic Pharmaceuticals, Liquids, Flammable 3 Pharmaceuticals, Solids, Toxic, Listed Waste 6.1 Pharmaceuticals, Aerosols 2.1 Pharmaceuticals, Alkaline 8 Pharmaceuticals, Un-used Injectible 3 (6.1) Option #1 Management Options Comingle all waste pharmaceuticals into containers at the point of generation Record detailed inventory of contents for each container to determine proper offsite shipment requirements Option #2 Comingle all waste pharmaceuticals into containers at the point of generation Separate waste streams by DOT categories prior to off-site shipment Management Options Option #3 Collect waste pharmaceuticals by DOT HM category at the point of generation Requires multiple containers, proper labeling of pharmaceuticals Option #4 Comingle all waste pharmaceuticals with sharps Send material off-site as duel waste for incineration Management Options Reverse Distribution Returned for documented credit through the pharmaceutical reverse distribution system to a manufacturer, wholesaler or reverse distributor due to an; oversupply, expiration of the recommended shelf life, manufacturer recall, product received as a result of a shipping error, or product is damaged. Donated to a charitable organization as described in the Internal Revenue Code No role in the decision to discard Not a management option for the disposal of pharmaceutical waste

4 Reverse Distribution 21 CFR Parts All reverse distributors must be registered with the DEA. The term means a registrant who receives controlled substances (schedule II V) acquired from another DEA registrant for the purpose of i) returning unwanted, unusable, or outdated controlled substances to the manufacturer or ii) where necessary, processing such substances or arranging for processing such substances for disposal Reverse Distribution implications Making determinations as to whether pharmaceuticals are viable EPA Guidance: RDs cannot be used to relieve generators of the responsibility for making determinations about the discarding of materials as waste Reverse Distribution Requirements Registration (Different states also have specific regs.) Records and reports Inventory requirements Procedures for disposal Security Form 222 (Sched. 2) and Form 41 Inventory of Drugs must be completed for every shipment Shipments can be made USPS certified mail, other common carrier with chain of custody, or own fleet Controlled Substances Schedule 1 - Illicit drugs and some research drugs (Most RD s cannot accept these) Schedule 2 - Narcotics and highly addictive compounds (i.e., morphine) Schedule 3-5 Drugs with decreasing abuse potential (i.e., tranquilizers, sedatives, cough suppressants w/ codeine) DEA Regulation Overview U.S. DOJ DEA Office of Diversion Control 21 CFR Sec (c) Procedure for disposing of controlled substances Sec Power of attorney Sec &.72 Security requirements Sec (multiple sub-sections) Recordkeeping requirements Streams Pharmaceutical Waste Type Non-Regulated, DEA Controlled Substance Non-Regulated; Non-DEA Controlled Substance RCRA Regulated; Non-DEA Controlled Substance RCRA Regulated; DEA Controlled Substance Requirements DEA Form 222, DEA Form 41, Witness to Count Non-Regulated Waste Manifest Hazardous Waste Manifest, LDR Hazardous Waste Manifest, LDR, DEA Form 222, DEA Form 41, Witness to Count Services Support Waste Characterization Review formulary Determine non-hazardous, hazardous (by regulation) and best practice management wastes Support Operational Waste Identification Label Pharmaceuticals for proper disposal Disposal Offer Containerization Options Tailored to the Operation Provide On-Call or Scheduled Pickups Offer Non-Landfill Solution for Non-Hazardous Waste Pharmaceuticals DEA Registered

5 Haz Waste & RD Facility DEA approved Reverse Distributor Customer request process Mail-back program Truck transportation program In-bound receipt process Controlled substances stored in vault & safe Witness incineration at local facility In-Bound Receipt Containers arrive; inspected for tampering Only qualified/approved employees can handle/process the material Items are counted to ensure inventory matches shipping documents If discrepancy, must resolve with customer Barcode process, Info entered into database for receipt/tracking purposes Storage Controlled substances stored in vault & safe Safes - Schedule 2 substances MUST be in safe Security Enclosed vault Safes with 5 way combination Door trip alarms Motion sensor alarms Update on EPA s Proposed Rule EPA proposed rule December 2, 2008 Extended Comment Period January 30, 2009 Comments were due 3/4/09 Rule Highlights: Streamlines management requirements universal waste rules Defines pharmaceutical waste Seeks understanding on reverse distribution system for pharmaceuticals Does not modify any existing requirement to off-site shipments of universal waste Update on EPA s Proposed Rule Regulation is less stringent than existing rule so States are not required to adopt the new rule HealthCare Distribution Management Association commented on DOT requirements for universal wastes meeting DOT HM Recommends using ORM-D designation on return shipments Update on EPA s Proposed Rule Comments submitted: Healthcare Distribution Management Association (HDMA) States Waste Management Service Providers Pharmacy & Nursing Associations Retail Stores Wal-Mart, Walgreens, CVS Go to Regulations.gov Docket: EPA-HQ-RCRA entries regarding proposed rule Summer 2011 Rule delayed due to other priorities; EPA addressing comments

6 Management Resources H2E - Managing : A 10-Step Blueprint for Health Care Facilities in the United States. RCRA On-Line: : DEA Orange Book Swedish Study Stockholm County Council, Environmentally Classified Pharmaceuticals 2009 Thank You! Bob Doyle Marketing & Communications Manager EQ The Environmental Quality Company (734) bob.doyle@eqonline.com