[Pharmwaste] RE: Anyone using Cactus Sink?

[Bill Speenburgh]

Please post my response to the discussion on "Anyone using Cactus Sink? that
has recently circulated.

 

I am commenting on the discussion of the problem of how to legally dispose
of pharmaceutical waste generated by patient care operations.  

EPA and many states are disallowing the practice of flushing waste
pharmaceuticals down the toilet or sink.

The DEA requires dispensed controlled drugs to be deemed Unrecoverable and
Unusable with no guidance on what that means.  The industry thus is in a
holding pattern, waiting until DEA regulations are finalized and the term
Unrecoverable and Unusable is defined.   

Disposal facilities acceptance processes and operating permits require a
detailed characterization and inventory describing the wastes that will be
shipped 

EPA requires Generators to ensure Hazardous Waste are identified and
disposed of properly.  Mixing of just 1 warfarin tablet with unused patient
controlled drugs, even if it is rendered Unrecoverable and Unusable, makes
the mixture a Hazardous Waste.  If the mixture weighs more than 1 Kg., the
Generator is now considered a fully regulated Large Quantity Generator of
Hazardous Waste.  

 

Over the past several years, the healthcare industry has shown interest in a
product called the Cactus Sink.  Marketed as the ultimate answer to disposal
of pharmaceutical waste generated by hospitals, the Cactus Sink manufacturer
accurately describes its product as securely captures dispensed unused
pharmaceutical waste and renders it acutely "unrecoverable and unusable"
<through chemical fixation>  This is an effective collection system but it
has serious side effects with disposal abilities:

1.       If there is no inventory maintained as to the contents and, after
mixing, the contents cannot be verified.  This makes the filled canisters
very difficult, if not impossible to dispose of.

2.       How does the Hospital totally ensure that the device is used only
for distributed controlled drugs and never contains any hazardous waste? Or
DOT Hazardous Materials.  If the canister and contents weigh more than 1 Kg.
before being used, adding just 1 warfarin tablet (or other "P" Listed
product dose) makes the hospital a Large Quantity Generator of Hazardous
Waste

3.       There is yet to be a DEA approved method of making these controlled
drugs "unrecoverable and unusable". Thus the Cactus claim is pre-mature at
this time on stating their product does this. 

4.       For arguments sake, let's say a filled canister contains only
unrecoverable and unusable patient distributed controlled drugs and no
hazardous waste.  This is now a Solid Waste requiring shipment to a Solid
Waste Management facility.  Reverse Distributors do not typically have a
Solid Waste Management Permit and thus are prohibited from accepting Solid
Waste.  

5.       One of the main functions of Reverse Distributors is to arrange for
the destruction of DEA Controlled Drug Substances transferred from a DEA
Registrant's inventory.  Destruction requires approval for the waste by
Incinerator based on a detailed inventory.  Patient distributed controlled
drugs are not the same as inventoried Controlled Drug Substances and are not
accepted as they are already out of the pharmacy's inventory. 

6.       If a Reverse Distributor were to accept these canisters, what, if
any, disposal facility would accept them without an inventory of the
contents?  

7.       How would the Reverse Distributor accept the canisters and adhere
to their state's Solid Waste Management rules? 

8.       The canister can be used for liquids.  Many pharmaceutical
products, particularly liquid preparations, meet the definition of a DOT
Hazardous Material in Transportation (e.g. Excelon (rivastigmine) is DOT
Toxic and flammables, corrosives and oxidizers are quite common
pharmaceutical wastes ).  While these may be shipped as a Consumer commodity
ORMD as a medicine, there is no provision to mark those canisters that
contain Hazardous Materials as ORMD and misusing ORMD for non-hazardous is a
DOT violation too.  Are there compatibility issues (e.g. mixing flammable
and oxidizers) without proper classification by the user? 

I do not mean to be negative about this product but Hospitals and Pharmacies
are cautioned to be prudent in weighing these risks.  Legal, safety,
documentation and logistical requirements need to be in place before a
workable disposal process can be achieved.  The Cactus Sink is a great waste
collection system but needs considerable effort to make it a viable solution
for disposal of the wastes it collects. 

 

 

William G. Speenburgh

World Class Environmental Resources, LLC

 

(973) 770-2275 (Phone)

(973) 219-5720 (cell)

 

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