Regulations & Reality Long Term Care & DEA’s New Rule for Controlled Substances June 26, 2013 NAHHMA Conference Mindy Collins, Local Source Control Specialist City of Bellingham, Washington

City of Bellingham Pharmaceuticals Take-Back Program Launched April 2010 Nearly 7000 lbs of waste meds collected to date!

Businesses Local Source Control Specialists – SQG waste management and pollution prevention – Regulatory assistance Pharmaceuticals can be especially problematic Veterinarians, medical clinics, dentists, pharmacies and long term care facilities generate pharm waste

Long Term Care? A home where you can live and get help with care in a community setting Adult Family Homes – up to 6 individuals in home setting Boarding Homes “Assisted Living” – 7or more residents, meals, laundry, and varying levels of assistance. Nursing Homes – 24 hour supervised nursing care

Long Term Care Waste Medications When regulations are confusing conscience dictates disposal methods Send back to pharmacy for disposal or credit Cut up fentanyl patches with scissors Add to sharps Burn in burn barrel Hospice… witnessed disposal down drain

Long Term Care Waste Medications When regulations are confusing conscience dictates disposal methods Dissolve in water, vinegar, bleach Mix with kitty litter or coffee Sludge goes in sharps container or garbage Use water for happy plants!

Regulations Federal: Centers for Medicare & Medicaid Services “CMS Rules” (Federal rules, delegated to DSHS) EPA Hazardous Waste Regulations, RCRA Subtitle C DEA Controlled Substances Act Title 21 State Dangerous Waste Regulations, WA Chapter WAC Local Ordinances prohibiting down the drain disposal

CMS Rules (Centers for Medicare & Medicaid Services) LTC Survey Guide Emphasis on patient care Describes federal requirements and management practices scrutinized during on-site surveys by delegated state agencies (WA DSHS) Medications must be counted, tracked, secured; timely disposal, & documentation of destruction method used

State & Federal Waste Regulations EPA: Pharmaceutical Waste: A 10-Step Blueprint for Healthcare Facilities in the U.S.; August 2008 –proposed rule in August 2013 WA Dangerous Waste Regulations – toxicity & persistence

Proposed DEA Rule Disposal of Controlled Substances 21 CFR Parts 1300, et.al: Secure and Responsible Drug Disposal Act 2010 Until rule is finalized, the Controlled Substances Act: Permits only DEA registrants to return controlled substances via reverse distributors Ultimate users are NOT DEA registrants

Proposed DEA Rule: Continues to: Govern disposal of controlled substances by ultimate users and DEA registrants Allow law enforcement to sponsor take-back events

New Rule & Long Term Care Intent is to address needs of non-registrants who “own” the medicines Gives authority to LTC staff to dispose of decedent’s property on their behalf Expands authority of retail pharmacies to maintain collection receptacles at LTC facilities

New Rule Mail-Back Option Authorizes: Retail pharmacies, manufacturers, distributors, and reverse distributors to administer mail-back programs

How Does the New CSA Rule Work? Models most take-back programs Managed by pharmacy staff at LTC facility Locked steel bin secured to floor or wall Lockable chute at top, with “inner liner”

Inner liner Specs: Waterproof, tamper evident, tear resistant Removable and sealable without emptying Contents not viewable Size clearly marked on outside Bear permanent unique I.D. # for tracking

How It Works Controlled substances must be transferred to collection receptacle within 3 days of discontinuation of use Inner liner cannot be removed or accessed by LTC staff Two authorized employees of retail pharmacy “collector” must remove inner liners or supervise removal of inner liner by reverse distributor

Destruction Promptly destroy sealed inner liners and contents on site per Subpart C of part 1317 Or Promptly deliver by common or contract carrier to reverse distributor’s registered location or be picked up by reverse distributor for destruction (“common carrier” is not well defined in rule) Two employees of reverse distributor must accompany waste from receipt to destruction Destruction must occur within 14 days of receipt by authorized collector (timing is unclear in rule)

Destruction Two employees of reverse distributor must accompany waste from receipt to destruction Destruction must occur within 14 days of receipt by authorized collector (timing is unclear in rule) Destruction method not specified in rule

Storage & Security Inner liner must be stored as Schedule II drugs per 21 CFR (e.g. morphine, cocaine, oxycodone), if it contains controlled substances Safe or steel cabinet, bolted or cemented, equipped with an alarm system or a vault of substantial construction and alarmed, etc…. This is not practical for multiple packages awaiting pickup by reverse distributors.

Mail Back Option Mail back may be conducted by: Law enforcement, registered manufacturers, distributors, reverse distributors, and retail pharmacies IF they are 1)authorized collectors, 2)have on-site destruction capabilities LTC staff cannot use mail-back

Considerations Staff are permitted to turn over medications to patients for mail-back (not really feasible) LTC staff count & document everything they waste. Compliance with other regulations is achievable Log sheets might be necessary for other regulations (i.e., to confirm CESQG status or complete manifests) Pills are already being removed from external packaging for wasting so collected volume is reduced

LHWMP King County, Comments: Clarify process for designation as authorized collector Non-registrants such as MRW’s cannot be collectors Law enforcement requirements for officers too restrictive Two full time pharmacy staff to remove full liners Two full time employees to transport & witness destruction Storage of full inner liners as Schedule II drugs is excessive Mail-back only accepted at point of destruction – need to allow storage point LTC specific – clarification of facility type needed Flushing/sewering does not meet non-retrievable standard RCRA wastes require haz waste incineration for >CESQG Define on-site destruction methods allowed Registered hospitals cannot be collectors Economic impact – costs & sustainability need to be considered

Thank you! Mindy Collins, Local Source Control Specialist City of Bellingham, Washington (360)