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 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 NAME EPA HAZ WASTE # Arsenic trioxide P012 Epinephrine* P042 Nicotine P075 Nitroglycerin* P081 Phentermine P046 Physostigmine P204 Physostigmine salicylate P188 Warfarin >0.3%* P001

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 NAME # Chlorambucil U035 Hexachlorophene U132 Cyclophosphamide U058 Phenacetin U187 Daunomycin U059 Reserpine U200 Melphalan U150 Resorcinol U201 Mitomycin C U010 Saccharin U202 Streptozocin U206 Selenium sulfide U205 Uracil Mustard U237 Warfarin <0.3% U248 Diethylstilbestrol U089

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 NAME EPA # REG.LEVEL Arsenic D004 5 mg/L Barium D005 100 mg/L Cadmium D006 1 mg/L Chloroform D022 6 mg/L M-Cresol D024 200 mg/L Lindane D013 0.4 mg/L Mercury D009 0.2 mg/L Silver D011

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

“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

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:

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?