Pharmaceutical
Waste Management
Leslie
Durrant, R.Ph., BCPS, and Nancy Dietz, R.Ph., Ph.D.
Harry
S. Truman Memorial Veterans Hospital
Columbia,
Missouri
Harry
S Truman Memorial VA Hospital Columbia, Mo.
- 100 Inpatient
beds, 30,000 veterans
What is
a hazardous drug?
- ASHP
2004 TAB criteria for considering a drug hazardous (adopted by OSHA):
- Carcinogenicity
- Teratogenicity
- Fertility
impairment
- Serious
organ toxicity at low doses
- Genotoxicity
��Structure and toxicity profile
of new drugs that mimic existing drugs determined hazardous by above
criteria.��
NIOSH
- Now updating
their list of hazardous drugs. 59 proposed additions.
- Update is
controversial: some proposed drugs are toxic only after prolonged oral
usage such as divalproex, aripiprazole, amiodarone.
- ASHP proposes
further study on 40% of the proposed drugs before recommending handling
as ��hazardous drugs��.
Hazardous
Drugs:
- Each facility
should create its own list of ��hazardous drugs��
based upon criteria. NIOSH list may be useful in establishing a hospital
list. MSDS, literature very helpful.
Hazardous
pharmaceutical Waste
- Hazardous
pharmaceutical waste is NOT synonymous with hazardous pharmaceuticals.
- Some drugs
not considered hazardous drugs by NIOSH,OSHA and NIH are still regulated
as hazardous waste by EPA-RCRA.
- Some drugs
not considered hazardous waste under RCRA are probable environmental
hazards (some chemo).
Pharmaceutical
Waste:
- Two main
types of pharmaceutical waste: hazardous and non-hazardous.
- Hazardous
waste as defined by EPA RCRA is waste with properties making it
dangerous or potentially harmful to human health or the environment,
and includes chemicals and drugs.
Hazardous
Pharmaceutical Waste under RCRA:
- It contains
a ��P�� or ��U�� listed waste as the sole active
ingredient
- OR
- It exhibits
at least one ��Characteristic�� of a hazardous waste.
Hazardous
Pharmaceutical Waste under RCRA:
In addition to
exhibiting a ��characteristic�� or Listing as a P, or U, ��listed��
waste, three more requirements:
- It has
not been excluded by federal or state law, and
- It has
not been used for its intended purpose, and
- The decision
has been made to discard it.
EPA -
RCRA Listings
- RCRA, P,
U, lists originally developed for discarded commercial chemical products.
- Listings
only apply to pharmaceuticals that contain the listed drug as the ��sole
active ingredient��. E.g. – pharmaceuticals flavored by
saccharin with other ingredients added would NOT be considered hazardous
waste under RCRA.
P list – Acutely Hazardous
P001
Warfarin >0.3%*
P188
Physostigmine salicylate
P204
Physostigmine
P046
Phentermine
P081
Nitroglycerin*
P075
Nicotine
P042
Epinephrine*
P012
Arsenic trioxide
EPA HAZ WASTE #
NAME
P Listed
waste generation:
- Large qty
generator: produces more than 1 Kg (2.2 lbs) per calendar month.
- Small qty
generator: < 1 Kg/month.
- Conditionally
exempt small quantity.
- Most hospitals
fall into small or large quantity generator category.
To reduce
P waste generation:
- Practice
waste minimization: Minimize inventory, ��just in time�� ordering.
- Purchase
unit dose whenever possible on P listed items.
- Repackage
minimal amounts at a time.
- Encourage
patient to take home appropriately Rx labeled partial bulk containers.
Nitroglycerin:
Nitroglycerin
- Nitroglycerin
in finished dosage forms is exempt by EPA/RCRA (2001).
- Some states
have adopted this exemption, including Missouri, Iowa, and Alaska.
- Some states,
such as Michigan, have chosen not to adopt. Check with your state.
Epinephrine
Epinephrine
in syringes:
- Missouri
DNR Hazardous Waste Program: epinephrine in a discarded syringe is not
a P listed waste.
- Rationale:
once the syringe has been used for patient care, it has been used for
its intended purpose.
- Applies
to partially used epinephrine IV admixtures, also per Mo DNR.
- RCRA: applies
to any P or U listed drug in a syringe as waste, after patient use.
Epinephrine
in syringes:
- Epinephine
syringes after emergency use (e.g. Code Blue): discard in sharps container.
- EXPIRED
unused epinephrine STILL considered P listed waste.
Warfarin:
Warfarin:
- If present
in dosage forms over 0.3%, the whole preparation is a ��P�� listed pharmaceutical waste
when decision is made to waste.
- Tablet
weighings demonstrated that all of the common tablet strengths are >0.3%
warfarin, and therefore P waste when discarded.
- 5mg/210mg
(tablet weight) = 2.4%
Nicotine:
Nicotine:
- Patch dosage
forms: after patient use, consider ��used��? Or ��unused��?
- Expired
unused may be returned to reverse distributor for credit.
- Patient
home disposal not regulated by RCRA.
U List – Toxic Wastes
U089
Diethylstilbestrol
U248
Warfarin <0.3%
U237
Uracil Mustard
U205
Selenium sulfide
U206
Streptozocin
U202
Saccharin
U010
Mitomycin C
U201
Resorcinol
U150
Melphalan
U200
Reserpine
U059
Daunomycin
U187
Phenacetin
U058
Cyclophosphamide
U132
Hexachlorophene
U035
Chlorambucil
#
NAME
#
NAME
D list:
Characteristic waste
- Waste exhibits
one of 4 characteristics of hazardous wastes:
1. ignitability –
2. corrosivity –
3. reactivity -
4. toxicity –
if concentration of chemical above regulatory level in mg/L.
Characteristic
Waste:
- The generator
(the hospital) is responsible for deciding if a drug product that is
being discarded exhibits a characteristic.
- Decision
is based upon testing or knowledge of the drug product properties.
- MSDS, pharmacy
references and literature can help determine this.
Characteristic
waste: Toxicity
5 mg/L
D011
Silver
0.2 mg/L
D009
Mercury
0.4 mg/L
D013
Lindane
200 mg/L
D024
M-Cresol
6 mg/L
D022
Chloroform
1 mg/L
D006
Cadmium
100 mg/L
D005
Barium
5 mg/L
D004
Arsenic
REG.LEVEL
EPA #
NAME
Toxicity
characteristic
- Mercury:
most vaccines reformulated and now preservative free.
- Silver:
present in silver sulfadiazine cream, silver nitrate sticks.
- Barium:
in contrast media. Radiology is a satellite accumulation point.
Chemotherapy
- Only seven
chemotherapy drugs on the U list. However, RCRA was enacted in 1976
and the list has not been updated since then.
- Most hospital
consider all cytotoxic chemotherapy to be hazardous waste, including
our VA hospital.
Putting
it all together:
- Receipt
into pharmacy: As the medication order received is sorted, medications
that could become hazardous wastes are placed into specially labeled
bins:
Repackaging:
- As drugs
that could become hazardous waste are repackaged, a code is included
on the label for Nursing notification: ��HW-P list��
Re-packaged
drug:
- ��HW-P List��: text chosen to alert Nurse,
but not alarm Veteran:
Dispensing:
Before dispensing,
a drug that could
become hazardous waste
Has the code included
on
the barcode label:
Patient
discharge:
- Partial
bulk medication that could become hazardous waste, if prescribed at
discharge, is re-labeled and given to the patient during discharge
counseling by the Pharmacist.
Reverse
Distributors
- Receive
outdated drugs (��products��) from pharmacies and ship
to manufacturer for credit.
- Outdates
not meeting manufacturer��s policy become ��waste��
once the RD makes the decision to discard.
- EPA supports
this practice as long as it is not the sole waste management practice.
Disposal:
P,U, or D listed items
Drug
with ��P,U��
Or ��D��
Listed
ingredient
Bulk:
at discharge
If ordered,
Give
to pt.
Expired
unused:
Reverse
Distributor
for
credit
Not
suitable
For
R.D.:
��P�� ,��U��,
Or ��D��
bucket
��P��
Bucket: Satellite accumulation
P,U, and
D buckets:
Satellite accumulation Point
- Pharmacy
satellite accumulation point:
Satellite
accumulation: List of all contents with dates required:
Satellite
Accumulation:
- Satellite
storage up to 1 year before sending to facility hazardous waste storage
area, unless > 1 quart of P listed or 55 gallons of hazardous waste.
- Industrial
Hygienist utilizes licensed hazardous waste contractor to pick up from
facility hazardous waste area.
Disposal:
Chemotherapy
Chemo ��U��
listed
OR cytotoxic
chemo:
Bulk: (>3%),
��hazardous
Waste��
BULK yellow
Chemo bucket
Trace:(<3%):
Empty vials,
Syringes,
gowns,
Yellow chemo
bucket
Chemo sharps:
Needles:
Yellow chemo
bucket
Trace
Chemo:
Bulk Chemo:
- Contains:
expired and partially used vials, IV bags.
- Grossly
contaminated items
- Spill clean
up material
- Must label
bucket as ��Chemotherapy�� AND ��Hazardous waste��.
Must include names of EACH drug within, and date 1st waste
placed. Keep closed!
Disposal:
non hazardous
pharmaceuticals:
Non-chemo
Non-cytotoxic
non-RCRA:
Expired:
Reverse
distributor
��plain�� IVS:
(NS,D5W,LR)
Sink
disposal
Controlled
Substances:
RD licensed
For
controlled
substances
Take home
points:
- Know P,
U, and D toxicity lists.
- Know State
law.
- Label all
P, U, and D drugs as ��HW�� all through chain from receipt
to final dispensing or segregation for pickup.
- Implement
safe handling practices and policies for hazardous drugs.
- Questions?
