Managing Hazardous Pharmaceutical Waste

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1 Managing Hazardous Pharmaceutical Waste

2 Environmental Consequences Why the growing concern? Discovery of pharmaceuticals in surface, ground and drinking waters of the U.S. Small concentrations of endocrine disruptors showing harm to aquatic life Increase in used of potent pharmaceuticals and increase amount of pharmaceutical waste generated in by healthcare facilities

3 Managing pharmaceutical waste is not new either are the hazardous waste rules. Hospitals have tended to focus on management of chemotherapy drugs More recent focus on managing other types of hazardous pharmaceutical waste Regulatory agencies paying more attention to hospitals and management of hazardous waste, including pharmaceutical waste

4 Frequently used pharmaceuticals (epinephrine, warfarin, and nine chemotherapeutic agents are currently regulated under the Resource Conservation and Recovery Act (RCRA) Failure to comply with these regulations by improperly managing and disposing of these wastes can result in fines and penalties.

5 Case Study Large regional healthcare system Infectious waste inspection Hazardous Waste inspection Development of comprehensive hazardous waste management plan, development of pharmaceutical waste management system and training of all affected staff.

6 What is a hazardous waste? Hazardous waste falls into two categories: Listed hazardous waste (it appears on one of four lists found in federal/state hazardous waste rules F, K, P or U) Characteristic hazardous waste exhibits one or more hazardous characteristics flammability/combustible; corrosivity; reactivity and toxicity.

7 Pharmaceutical Waste Pharmaceuticals are found on two of EPA s lists the P list and the U list. This listing refers to unused commercial chemical products (CCPs).

8 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Partially Used Syringes/IVs Discontinued, Unused Preparations Unused Repacks (Unit Dose) Patient Personal Medications Outdated Pharmaceuticals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 P Listed Pharmaceuticals P-listed waste are CCPs that are acutely hazardous. Examples include: Arsenic trioxide Nicotine Phentermine P012 P075 P046 Physostigmine Salicylate P188 Warfarin >0.3% P001

10 Examples include: U Listed Pharmaceuticals Chloral Hydrate (CIV) U034 Chlorambucil U035 Daunomycin U059 Diethylstilbestrol U089 Melphalan U150 Mitomycin C U010 Streptozotocin U206 Lindane U129 Saccharin U202 Selenium Sulfide U205 Warfarin <0.3% U248 Pharmaceuticals in italics refer to chemotherapy drugs

11 When must a P and U listed pharmaceutical be managed as hazardous waste? Two conditions must be met: The discarded drug waste contains a Sole Active Ingredient that is on the P or U list AND, The drug has not been used for its intended purpose (this means the drug and its associated container or dispensing instrument has not been given to a patient). The Sole Active Ingredient refers to the chemically active component that performs the function of the drug (this is key when determining if a discarded, unused CCP is a P or U listed hazardous waste).

12 Characteristic Hazardous Waste Drugs that exhibit one or more of the following characteristics must be managed as hazardous waste when discarded: o Ignitability easily combustible or ignitable. e.g. - some nitroglycerin vials, erythromycin gel 2%, flexible collodian o Corrosivity ph < 2 or > 12.5 e.g., acetic acid otic, robinul o Reactivity unstable or causes violent chemical or physical reaction e.g., silver nitrate applicators; cyanide antidote kit o Toxicity contains specific constituents above specific limits e.g., barium sulfate; m-cresol (insulins); vaccines containing mercury; silver- containing creams or ointments

13 Empty Containers RCRA Empty rule: Applies to containers such as IV bags and tubing, bottles, ampoules, 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) and No more than 1 inch of material remains or no more than 3% by weight remains in the container (in Ohio, see OAC rule ). Empty is similar to trace amount (not defined in the hazardous waste rules) but means less than the amount that can be pulled into a syringe or the residual that remains in a completely infused IV bag and tubing. Containers that held a P-listed waste should be managed as hazardous waste regardless of whether all contents have been removed (under empty rule, these must be triple-rinsed with rinsate managed as hazardous waste).

14 Syringes Based on U.S. EPA interpretation, after the proper dose has been administered to a patient, EPA considers residues remaining in the syringe to have been used for their intended purpose. Therefore, the syringe is not a hazardous waste and can be discarded in a sharps container.

15 Hazardous Waste Determination Determine if the waste is hazardous (is it listed or characteristic)? See OAC for waste evaluation requirements). To determine if a discarded drug is a characteristic hazardous waste, the generator must test the material or use its knowledge about the drug (e.g., MSDS, information about ingredients, etc) If hazardous waste, manage according to hazardous waste rules. Be aware of how much hazardous waste is being generated on a monthly basis at the facility this dictates whether the facility is a conditionally exempt small quantity generator, a small quantity generator or a large quantity generator (different requirements apply).

16 Identifying HW Pharmaceuticals Identify the chemical name of the drug or drug ingredients (not the same as the trade name). Find the Chemical Abstract Service Number (CAS Number) use Merck Index, MSDS or other supplier information and compare to EPA list (40 CFR Part 261).

17 Managing Specific Pharmaceuticals* Nitroglycerin Although nitroglycerin is a P listed chemical (P075), EPA excludes medicinal nitroglycerin as a P-listed waste, because it is weak, non-reactive form of nitroglycerin. Some formulations can exhibit the characteristic of ignitability, such as a 5 mg/ml vial formulation. *based on Ohio EPA Guidance November 2010

18 Managing Specific Pharmaceuticals Epinephrine is a P-listed chemical (P042), however, epinephrine salts do not meet the listing description and would not be a hazardous waste. The listing applies only to epinephrine with CAS Number

19 Managing Specific Pharmaceuticals Coumadin (warfarin) empty dose wrappers and soufflé cups If no residue is visible, no waste is present (the container is empty ) and the wrapper or cup can be discarded in regular trash.

20 Managing Specific Pharmaceuticals Used and Unused dermal patches In Ohio, unused nicotine patches and gum that contain nicotine as the sole active ingredient are listed hazardous waste (P075). Used patches and gum do not carry the listing and are therefore not hazardous waste.

21 Managing Specific Pharmaceuticals Thimerosal (vaccines) Due to mercury content, many thimerosalcontaining vaccines exhibit the characteristic of toxicity. For a vaccine containing mercury above the regulatory limit of.20 mg/liter, any unused vaccine (a non-empty container) must be managed as hazardous waste.

22 Managing Specific Pharmaceuticals M-Cresol (Insulin) Appears on list of chemicals that, when discarded, exhibit the characteristic of toxicity. For concentrations exceeding 200 mg/l of m- cresol, if the container is not RCRA empty, the waste must be managed as hazardous waste.

23 Chemotherapy Waste Trace means less than the amount that can be pulled into a syringe or the residual that remains in a completely infused IV bag). Typically managed in yellow buckets. Bulk - greater than trace amounts need to be managed as hazardous waste (other hazardous waste container).

24 Management Options Manage hazardous waste pharmaceuticals according to applicable hazardous waste rules and a hazardous waste management plan (various container/labeling options are available) Develop/implement best management practices for other types of pharmaceuticals (e.g. those not regulated under RCRA) Reverse distribution/crediting Drain disposal may violate the Clean Water Act. Become familiar with local sewer authority requirements, which may require permission before discharging to the sewer.

25 Questions? Julie Reese Environmental, Health and Safety Professional Frost Brown Todd LLC 201 E. Fifth St. Cincinnati, OH /

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