The Life and Times of Managing Hazardous Pharmaceutical Waste

1. The Life and Times of Managing Hazardous Pharmaceutical Waste Pamela Hale CPhT, BBA Mercy Health Partners Southwest Ohio

2. Overview • Managing pharmaceutical waste is not new – neither are the hazardous waste rules. • Focus has typically been on management of chemotherapy drugs • More recent focus on other types of hazardous pharmaceutical waste • Regulatory agencies paying more attention to hospitals and management of hazardous waste, including pharmaceutical waste

3. Background • Why is Mercy concerned about Hazardous Waste Pharmaceuticals? • Hospitals inspected by Ohio EPA’s Division of Hazardous Waste; Notices of Violation for failure to properly evaluate and manage hazardous wastes; Enforcement Action taken by Ohio EPA – mandated development of a regional Hazardous Waste Management Plan • Hazardous Waste Management Plan - the Plan is designed to ensure proper management of all hazardous waste generated at the five Mercy hospitals.

5. Responsibilities • Administration - ensure the Plan is fully implemented at all hospitals • Site Safety Officers –oversee implementation of the Plan at their hospital • Department Managers - implement the Plan as it applies to their department • Employees – implement the Plan as applicable to their specific job duties.

6. What is a “waste”? If you are unable to use a chemical for its intended purpose and you plan to throw it away, it is a waste.

7. What is a hazardous waste? A waste is considered hazardous if: • It is not excluded from regulation under federal or state hazardous waste rules and meets one of the following criteria: • It is listed in applicable federal or state hazardous waste rules; • It exhibits a characteristic of hazardous waste; or • It is a mixture of a waste and a hazardous waste.

8. Pharmaceutical Waste Pharmaceutical Waste – How is it generated in hospitals? • IV Preparation • General Compounding • Spills/Breakage • Partially Used Vials • Partially Used Syringes/IVs • Discontinued, Unused Preparations • Unused Repacks (Unit Dose) • Patient Personal Medications • Outdated Pharmaceuticals

9. Characteristics of Hazardous Waste • Does the waste exhibit any of the four characteristics of a hazardous waste? • Ignitability – easily combustible or ignitable. e.g. – some nitroglycerin vials, erythromycin gel 2%, flexible collodian. • Corrosivity – pH < 2 or > 12.5 e.g., acetic acid otic, robinul • Reactivity – unstable or causes violent chemical or physical reaction e.g., silver nitrate applicators; cyanide antidote kit • Toxicity – contains specific constituents above specific limits e.g., barium sulfate; m-cresol (insulins); vaccines containing mercury; silver- containing creams or ointments

10. Listed Pharmaceutical Waste P-listed pharmaceutical waste is regulated as UNUSED discarded commercial chemical products. P-listed waste is “acute” hazardous waste. Examples include: • Arsenic trioxide P012 • Nicotine P075 • Physostigmine Salicylate P188 • Warfarin >0.3% P001

11. Acetic Acid Barium Sulfate Chloral Hydrate (CIV) U034 Collodion Cyclophosphamide U058 Dermoplast Dimethyl sulfoxide Eythl alcohol Ferric Subsulfate Influenza Leukeran Measles Vaccine (including MMR) Mitomycin C U010 Neomycin/Polymixin/Gramicdin Opth Ocufen Phenol Selenium Sulfide U205 Silver Sulfadiazine Talc Warfarin <0.3% U248 Anesthesia Gases (Forane, Suprane, Ultane) Benzoin Chlorambucil U035 Cortisporin Opth and Otic Cyanide Diethylstibestrol U089 Epinephrine (only Epi-pens) Ethyl Chloride Glycopyrrolate Insulins Lindane U129 Melphalan U150 Mutamycin Nicotine Paclitaxel Physostigmine Silver Nitrate Tetanus Toxoid (including DPT, Adacel) Listed Pharmaceutical WasteU-listed pharmaceutical waste is regulated as UNUSED discarded commercial chemical products.

12. What is NOT a hazardous waste? Examples: • IV solutions such as normal saline, dextrose, Lactated Ringers solution, electrolytes – these can be placed into sewer and the bag and tubing placed in regular trash. • Caps from vials • Outside baggies • Drugs not labeled with “black bucket waste” stickers

13. Chemotherapy waste Trace amounts of chemotherapy waste are managed in yellow buckets (“TRACE” means less than the amount that can be pulled into a syringe or the residual that remains in a completely infused IV bag). Bulk amounts of chemotherapy waste (greater than trace amounts) are managed as hazardous waste

14. Syringes According to EPA, a syringe is a delivery device, not a container. Any residue remaining in a syringe in which the proper dose has been administered to a patient is considered to have been used for its intended purpose and is not a hazardous waste. Unused syringes (in which a listed drug or drug exhibiting a characteristic of hazardous waste has not been fully administered to the patient) shall be managed as hazardous waste.

15. Empty rule: • Applies to containers such as IV bags and tubing, bottles, ampules, etc. • “EMPTY” means all the contents have been removed by normal means (fully administering the contents of an IV bag, pulling back all contents of a vial into a syringe). This is same as “trace” – less than the amount that can be pulled into a syringe or the residual that remains in a completely infused IV bag and tubing.

16. Regular Trash • EMPTY IV bags and tubing, bottles or other container. “EMPTY” means all the content have been removed by normal means (fully administering the contents of an IV bag, pulling back all contents of a vial into a syringe).

17. Disposing of Pharmaceutical waste Yellow Bucket • Trace chemotherapy waste (includes IV bags, tubing, syringes, gloves, supplies used to administer chemotherapy drugs). “TRACE” means less than the amount that can be pulled into a syringe or the residual that remains in a completely infused IV bag

18. Disposing of Pharmaceutical waste Sharps Container • Empty syringes of medications. “EMPTY” means the dose has been fully administered to the patient.

19. Disposing of Pharmaceutical waste Black Bucket (Hazardous Waste) • PHYSOSTAGMINE SALICYLATE AND COUMADIN IV VIALS - EMPTY OR FULL. • All partially filled vials, IV bags, bottles or other containers. • Partially filled syringes • Bulk chemotherapy – includes incomplete chemotherapy infusions, syringes containing unused chemotherapy drug, and all items used in cleanup of chemotherapy drug spills. • PPE and other items contaminated from cleanup of spills involving hazardous waste drugs.

20. Disposing of Pharmaceutical waste White Bucket (Hazardous Waste) • All Black Bucket waste that is also considered infectious waste this includes partially filled vials, IV bags, bottles or other containers

21. Disposing of Pharmaceutical waste • Specific Wastes not mentioned: • Nicotine – USED nicotine gum and patches are NOT hazardous waste. Place used nicotine patches, gum and wrappers in regular trash.

22. Specific Wastes not mentioned • Pharmacy will provide Nursing personnel with information (label) to assist with proper designation for drugs that are dispensed to the nursing units. • Black buckets will be available in med rooms on patient care units • Environmental Services will pick up buckets when full for transportation to hazardous waste holding area.

24. Questions