1. PHARMACY UPDATE Drug Disposal
John Karwoski, RPh, MBA
JDJ Consulting, LLC

2. FDA Unapproved Drugs
It happens more often than you think…

3. 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.

4. 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.

5. 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

8. 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)
(301)

9. DRUG DISPOSAL
Where does it go…?

10. DRUG DISPOSAL HAZARDOUS WASTE
Must be properly disposed of in a hazardous waste container
Can not go into the regular trash
Includes:
P-List, D-List, and U-List waste (EPA/ DEP)
Used Patches
Warfarin tablets
Inhalers
Epinephrine containers
Chemotherapeutic Agents/ containers

11. DRUG DISPOSAL NON-HAZARDOUS/ Non- Controlled Drugs Expired full vials
Expired partial vials
Partial wasted vials

12. Controlled Substance Disposal …we’ll come back to this in a bit.

13. 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 ( )

14. DRUG DISPOSAL
Destruction: ( )
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)

15. NON-RETRIEVABLE
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.

16. 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 non- retrievable 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. But what are you ALLOWED to do…?

17. METHODS OF DESTRUCTION
Methods of Destruction (FR 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 “non- retrievable”, 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

18. 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 (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.

19. 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 pre- filled 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.”

20. 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.

21. 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

22. REVERSE DISTRIBUTE
Reverse Distribute ( ): 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 ( ): a person registered with the Administration as a reverse distributor

23. For information please contact:
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
1949 Oak Tree Road, Edison, NJ 08820

24. Pharmaceutical Waste Program
What you need to know…

25. What makes it hazardous?
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.

26. 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.

27. 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

28. CONTACT US Tim Cairns Alan Anderson Business Manager - PA/DE
Business Manager- NJ
Daniels Healthcare

29. Aspiration in the ASC
Are you tracking your rates?

30. 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.

31. CONTACT US John Karwoski, RPh, MBA John@JDJConsulting.net
(609)
Brittney Lodato, MPH
(609)