Transcript Pharmaceutical Wastes Long Term Care Facilities

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
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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 173-303 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 1301.72 (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:
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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
[email protected]
(360) 778-7962