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Pharmaceutical Waste Management


 
 

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):
  1. Carcinogenicity
  1. Teratogenicity
  2. Fertility impairment
  3. Serious organ toxicity at low doses
  4. Genotoxicity
 

      NIOSH criteria: 2004: ASHP��s criteria plus

      ��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: 

    Two primary ways drug waste is hazardous 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?
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