Transcript PHARMACY UPDATEDrug Disposal

PHARMACY UPDATE
Drug Disposal
John Karwoski, RPh, MBA
JDJ Consulting, LLC
FDA Unapproved Drugs
It happens more often than you think…
FDA UNAPPROVED DRUGS INITIATIVE
In June 2006, the FDA announced a new drug safety
initiative to remove unapproved drugs from the market,
including a final guidance entitled "Marketed Unapproved
Drugs—Compliance Policy Guide (CPG)," outlining its
enforcement policies aimed at efficiently and rationally
bringing all such drugs into the approval process.
FDA DRUG APPROVAL
› The original Federal Food and Drugs Act of 1906 brought drug regulation
under federal law. That Act prohibited the sale of adulterated or
misbranded drugs, but did not require that drugs be approved by FDA.
› In 1938, Congress required that new drugs be approved for safety.
› In 1962, Congress amended the 1938 law to require manufacturers to
show that their drug products were effective, as well as safe.
› As a result, all drugs approved between 1938 and 1962 had to be
reviewed again for effectiveness. To be consistent with current
regulations and to ensure that all drugs have been shown to be safe and
effective, all new drugs are required to have an approved application for
continued marketing.
Unapproved Drugs:
Drugs Marketed in the United States that DO
NOT Have Required FDA Approval
The Orange Book:
Approved Drug Products with Therapeutic Equivalence
Evaluations
UNAPPROVED DRUGS
COORDINATOR ROLE
Sally Loewke, MD
Assistant Director for
Guidance and Policy
Office of New Drugs (OND)
Center for Drug Evaluation
and Research (CDER)
[email protected]
(301) 796-0710
DRUG DISPOSAL
Where does it go…?
DRUG DISPOSAL
› HAZARDOUS WASTE
– Must be properly disposed of in a hazardous waste container
– Can not go into the regular trash
– Includes:
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P-List, D-List, and U-List waste (EPA/ DEP)
Used Patches
Warfarin tablets
Inhalers
Epinephrine containers
Chemotherapeutic Agents/ containers
DRUG DISPOSAL
› NON-HAZARDOUS/ Non- Controlled Drugs
– Expired full vials
– Expired partial vials
– Partial wasted vials
Controlled Substance Disposal
…we’ll come back to this in a bit.
DRUG DISPOSAL
Disposal/ Dispose:
To refer generally to the wide range of activities that result in a
controlled substance being unavailable for further use or one
entity ridding themselves of such substances (e.g. retuns).
FR53547 col 2
A controlled substance can be “disposed of” by destruction,
return, recall, sale, or through the manufacturing process.
The new rule eliminates the authority of the SACs to individually
authorize disposal methods for non-practitioners, and retains
this option for practitioners (1317.05)
DRUG DISPOSAL
Destruction: (1317.90)
Must be rendered non-retrievable. Incineration is the
ONLY method currently accepted by the DEA. Sewering
and landfill disposal (mixing with kitty litter, coffee, etc) do
not meet non-retrievable standards (FR53547 col 3)
NON-RETRIEVABLE 1300.05
› Non-retrievable: the condition or state to which a
controlled substance shall be rendered following a
process that permanently alters that controlled
substance’s physical or chemical condition or state
through irreversible means and thereby renders the
controlled substance unavailable and ususable for all
practical purposes
› Cannot be transformed to a physical or chemical condition or
state as a controlled substance or controlled substance
analogue.
NON-RETRIEVABLE 1300.05
› This Means:
– Do not ‘shoot’ wasted controlled substances/ residual syringes
containing controlled substances into the sharps container
› A liquid mixture of controlled substances sits in the bottom of the container and
can be poured out
› This means it is retrievable
– Kitty Litter and/ or Coffee, etc, are NO LONGER considered nonretrievable methods of destruction and do not meet DEA standards by
the definition of “Non-Retrievable”
› Technically these substances could be consumed
› The chemical formula of the controlled substances has not been altered
› These are DEFINITIONS of what non-retrievable means.
what are you ALLOWED to do…?
But
METHODS OF DESTRUCTION
› Methods of Destruction (FR 53522 col 1): Intention to
allow public and private entities to develop a variety of
destruction methods that are secure, convenient, and
responsible. Must also meet all other applicable Federal,
State, tribal, and local laws and regulations. Once “nonretrievable”, the substance is no longer subject to DEA
Regulations
› What you should know about this rule: Even though it states
that they seek to determine a variety of destruction methods,
the only acceptable method for destruction at this time is
incineration
DOCUMENTATION IN THE ASC
› Wastage generated and destroyed in an institutional
setting (e.g. remaining substance in a vial, transdermal
patch, or syringe) must follow 1304.22 (c) but need not be
recorded on a DEA Form 41
› Number of units or volume dispensed/ administered, name of
patient, date, initials of personal dispensing/ administering,
etc.
DEA CLARIFICATION LETTER
October 17, 2014
“…once a controlled substance has been dispensed to a
patient by an institutional practitioner on the basis of an
order for immediate administration to a patient at the
registrant’s registered location, the substance is no longer
in the practitioner’s inventory. For example, after a prefilled syringe or a single-dose vial or syringe is
administered to a patient, any remaining substance in the
syringe or vial IS NOT REQUIRED TO BE DESTROYED IN
ACCORDANCE WITH NEW PART 1317.”
http://www.deadiversion.usdoj.gov/drug_disposal/dear_practitioner_pharm_waste_101714.pdf
WASTAGE IN THE OR
It is still STRONGLY encouraged to maintain
double signatures for wastage and proper
disposal methods to discourage diversion.
This change is for DEA only and does not mean
that State, Local, or Accrediting bodies have
changed their stance on controlled substance
disposal.
WHAT ARE YOUR DISPOSAL OPTIONS?
› Wastage:
Since the controlled substance is no longer subject to DEA Part
1317, it is no longer subject to being deemed non-retrievable
– Continue to drain/ dispose is permitted by your state and local publically
owned treatment works (POTW)
– Select one of the devised being promoted to render the drugs difficult to
divert, e.g., Cactus SmartSink
– Do NOT dispose of any canisters or inner liners in the regular trash
– Must be disposed as non-hazardous pharmaceutical waste through
incineration (assuming there are no hazardous wastes involved e.g. chloral
hydrate)
› Expired Controlled Substances:
– Incineration:
› Reverse Distributor
› Take-back
› Buy-back
REVERSE DISTRIBUTE
› Reverse Distribute (1300.01): to acquire controlled
substances from another registrant or law enforcement
for the purpose of:
– Return to the registered manufacturer or another registrant authorized
by the manufacturer to accept returns on the manufacturer’s behalf
– Destruction
› Reverse Distributor (1300.01): a person registered with the
Administration as a reverse distributor
Devine’s Pharmacy, NJAASC Corporate member, is now a DEA
Registered Disposal Site.
Devine's Pharmacy is able to safely dispose of “drug wastage” as well
as expired medications.
For information please contact:
Robert Riedinger, RPh
732-549-7717
[email protected]
1949 Oak Tree Road, Edison, NJ 08820
Pharmaceutical Waste
Program
What you need to know…
Why is it important?
To date, scientists have identified numerous pharmaceutical compounds at discernible
concentrations in our nation’s rivers, lakes, streams and drinking waters. As a result, the
U.S. Environmental Protection Agency (EPA) initiated a study on unused pharmaceutical
disposal practices at health care facilities. Unused pharmaceuticals are dispensed
prescriptions that patients do not use and medications that have expired. For many
years, a standard disposal practice at many health care facilities was to flush unused
pharmaceuticals down the toilet or drain. EPA believes that facilities should not dispose
of their pharmaceuticals down the drain.
What makes it hazardous?
To be classified as a hazardous waste it must be listed in
EPA regulations or exhibit certain characteristics. Thus, a
pharmaceutical waste may be considered hazardous
under if the pharmaceutical or its sole active ingredient
is specifically listed on the P List or U List or if it exhibits
one or more hazardous waste characteristic such as
ignitability, corrosivity, reactivity, or toxicity.
Steps for managing unused pharmaceuticals
•Conduct an inventory of pharmaceuticals and unused pharmaceuticals to quantify the
amount of medication the facility is disposing of.
•Reduce unused pharmaceuticals by reviewing purchasing practices, using limited dose or
unit dose dispensing, replacing pharmaceutical samples with vouchers, and performing
ongoing inventory control and stock rotation.
•Properly manage unused pharmaceuticals by identifying types of pharmaceuticals and
any federal and state requirements; when possible: reusing or donating unused
pharmaceuticals, returning them to the pharmacy; sending them to a reverse distributor for
credit and proper disposal; and using EPA recommended practices to
dispose of pharmaceutical waste at the facility.
•Segregate waste for disposal to ensure regulations are met and to reduce
costs
•Train staff in proper disposal methods.
Sharps disposal guidelines
Pharmasmart containers are designed for the collection and
disposal of sharps and expired or residual pharmaceuticals that
require controlled disposal
Quick View Reference:
Loose sharps and
glass ampoules
Expired or unused
pharmaceuticals
Vials containing residual
pharmaceuticals
CONTACT US
Tim Cairns
Business Manager - PA/DE
Daniels Healthcare
[email protected]
267-788-0913
Alan Anderson
Business Manager- NJ
Daniels Healthcare
[email protected]
609-444-6025
Aspiration in the ASC
Are you tracking your rates?
ASPIRATION IN THE ASC
JDJ Consulting is currently researching prevalence of aspiration in
the ASC. If aspirations have occurred in your ASC within the last 5
years and would like to partake in this study*, please contact us.
We are investigating a potential link between antidepressant/
antipsychotic usage and aspiration.
*This is not a benchmarking study.
CONTACT US
John Karwoski, RPh, MBA
[email protected]
(609) 313-7572
Brittney Lodato, MPH
[email protected]
(609) 384-5620