PHARMACY UPDATEDrug DisposalJohn Karwoski, RPh, MBAJDJ Consulting, LLC

FDA Unapproved DrugsIt 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)

Sally.Loewke@fda.hhs.gov

(301) 796-0710

DRUG DISPOSALWhere 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:

› 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 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…?

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 “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

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 LETTEROctober 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.”

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

rriedinger@devinespharmacy.com

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 CairnsBusiness Manager - PA/DEDaniels HealthcareTCairns@danielsinternational.com 267-788-0913

Alan AndersonBusiness Manager- NJDaniels HealthcareAAnderson@danielsinternational.com609-444-6025

Aspiration in the ASCAre 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, MBAJohn@JDJConsulting.net(609) 313-7572

Brittney Lodato, MPHBritt.JDJConsulting@gmail.com(609) 384-5620