Managing Pharmaceutical Waste

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1 Managing Pharmaceutical Waste Marian M. Rhoads R.Ph, MS Director of Pharmacy Services Saint Joseph Medical Center Reading, PA

2 Disclaimer The information in this presentation conforms to Pennsylvania and local regulations. Other states may have more stringent rules. Individuals need to check their local and state regulations when comparing their requirements to this presentation. The transporter and receiving facility may also have regulations that vary from your state if the hazardous waste is going out of state for disposal.

3 Why a Pharmaceutical Waste Program? Reasons for a Pharmaceutical Waste Program Environment Regulations Elements of a Pharmaceutical Waste Program Characterization of Waste Waste Collection & segregation Waste transportation and Disposal

4 Concerns US Geological Water Survey findings: Organic Wastewater Contaminants(OWCs) were found in 80% of the streams tested 33% of OWCs were pharmaceuticals in Minnesota EPA Regulatory Visits October 2007 four hospitals visited unannounced by EPA Region 1 (Boston Area) Warnings issued Re-visit 1Q08 looking for waste implementation plan. The Joint Commission Standards involving Medication Management, Environment of Care, and Leadership

5 What Agencies are Involved? Environmental Protection Agency (EPA) Department of Transportation (DOT) The Joint Commission (TJC) Drug Enforcement Agency (DEA) Local & State Regulators

6 The Resource Conservation & Recovery Act (RCRA) of 1976 Controls the management and disposal of hazardous waste by the healthcare industry. Enforced by the Environmental Protection Agency (EPA). Defines hazardous waste as items so damaging that they must be set aside for special disposal and cannot be sent down the sewer or dumped in a landfill.

7 Hazardous Wastes Categories Listed Wastes F listed waste K listed waste P listed waste acutely hazardous U listed waste Characteristic Wastes exhibit hazardous properties Ignitability Corrosivity Reactivity Toxicity

8 . P- Listed Wastes A drug is placed on this list if the oral lethal dose is 50mg/kg (LD 50) or less. The LD 50 is the amount of material, given at once, causes the death of 50% of a group of animals. Drug Waste Code Drug Waste Code Arsenic Trioxide P012 Phentermine (CIV) P046 Epinephrine* P042 Physostigmine P204 Nicotine P075 Physostigmine P188 salicylate Nitroglycerin P081 Warfarin > 0.3% P001 Epinephrine salts were exempt from hazardous waste characterization in October 2007.

9 Two Necessary Conditions 1. The discarded drug waste contains the sole ingredient that appears on the P-list Therefore if the ingredient serves an ancillary function such as mobilizing or preserving the sole ingredient, it is not considered in this first condition. AND 2. It has been used for its intended purpose The second condition refers to the portion of the drug or dispensing instruments that have not been given to the patient and needs to be discarded.

10 Examples of P-Listed Waste Unit dose Coumadin tablets and packaging The patches and packaging of nicotine patches* The patches and packaging of nitroglycerin patches* Physostigmine vials and all syringes used to administer the drug. * Patches contain more than 20 times the normal amount of drug that will be absorbed during the time of administration so 95% of drug is left in the patches. Note there are no exclusions for dilutions or concentrations. For example if you add saline to a P-listed drug, additional P-listed waste is generated. Nitroglycerin is listed solely on the P-list for its reactivity. Nitroglycerin for medicinal uses was removed from the P-list at the federal level due to its low reactivity. However, more concentrated drips (> 5mg/ml may fail the ignitability characteristic).

11 Empty Containers of P-Listed Waste A container that has held P-Listed waste is not considered RCRA empty unless it has been: 1. Triple rinsed 2. The rinsate is handled as hazardous waste Since this is impractical in the hospital setting all vials, IVs, and other containers must be managed as hazardous waste regardless of whether or not all the contents are removed.

12 Constituent of Concern U-Listed Wastes * Waste Code Constituent of Concern Waste Code Chloral hydrate (CIV) U034 Paraldehyde (CIV) U182 Chlorambucil U035 Phenol U182 Cyclophosphamide U058 Reserpine U200 Daunomycin U059 Resorcinol U201 Dichlorodifluoromethane U075 Saccharin U202 Diethylstilbestrol U089 Selenium sulfide U205 Hexachlorophene U129 Streptozotocin U206 Lindane U129 Trichloromonofluromethane U121 Melphalan U150 Uracil Mustard U237 Mercury U151 Warfarin < 0.3% U248 Mitomycin U010 * Managing Pharmaceutical Waste, A 10-Step Blueprint for Health Care Facilities in the United States.

13 U-Listed Waste Same two characteristics as P-listed waste apply and there is no concentration limit or dilution exclusion. 1. Sole active ingredient and 2. It has been used for its intended purpose

14 Empty Containers of U-Listed Waste 1. All the contents have been removed using normal means (pouring, pumping, aspirating, and draining ) and 2. No more than 3% by weight remains If both of these criteria are not met, the container must be managed as hazardous waste. If both criteria are met, they can be disposed of as RMW

15 Characteristic Hazardous Waste Ignitability Aqueous drug formulations(50% water by weight) containing 24% or more alcohol by volume and have a flashpoint of less than 140 degrees F or 60 degrees C. Erythromycin Gel 2% Taxol Injection Liquid drug formulations, other than aqueous solutions, containing less than 24% alcohol, with a flashpoint of less than 140 degrees F or 60 degrees C Flexible Collodion Oxidizers or materials that readily supply oxygen to a reaction in the absence of air. Amyl Nitrite inhalers Silver nitrate applicators Bulk chemicals potassium permanganate Flammable aerosol propellants Various pressurized inhalers

16 Characteristic Hazardous Waste Corrosivity Any waste with a ph of less than or equal to 2 (highly acidic) or greater than or equal to 12.5 (highly basic) Examples: Strong acids such as glacial acetic acid and strong bases such as sodium hydroxide.

17 Characteristic Hazardous Waste Reactivity Wastes that are unstable under normal conditions. They cause fumes, gases, or vapors when heated, compressed, or mixed with water. Nitroglycerin is the only drug is potentially reactive but remember there is an exclusion for medicinal nitroglycerin so this does not apply( Exception patches are black bucket waste).

18 Characteristic Hazardous Waste Toxicity There are 40 chemicals in this list. The following table lists the products found in the hospital and their concentrations that should not be exceeded:

19 Ingredient Waste Code Regulatory Level (mg/l) Drug Formulations Arsenic D004 5 Arsenic trioxide (also P- Listed Barium D Barium Sulfate (used in radiology) Cadmium D006 1 Multiple mineral preparations Chromium D007 5 Multiple mineral preparations M-creosol D Preservative in human insulins Mercury D Vaccines with thiomersal Selenium D010 1 Dandruff shampoos, multiple vitamin preps Silver D011 5 Silver sulfadiazine cream Reprinted from Managing Pharmaceutical Waste, A 10-Step Blueprint for Health Care Facilities in the United States.

20 Contaminated Personal Protective Equipment (PPE) and Spill Materials If gloves or gowns have been contaminated with P-Listed or U-Listed waste, it must be managed as hazardous waste. If it does not appear to have come in contact with the hazardous waste, it can be discarded as trace chemotherapy waste (yellow bucket) if used with chemo agents, or in the trash as solid waste for non-chemo agents.

21 Controlled Substance Waste There are three controlled substances that need to be handled as hazardous waste: Chloral Hydrate Paraldehyde Phentermine All other controlled substance waste requires two witnesses and drain disposal.

22 Trace vs. Hazardous Chemotherapy Waste Trace chemo waste includes: RCRA empty vials, syringes, IV bags, and tubing Gowns, gloves, wipes and other paraphernalia associated with routine handling, preparation and administration of chemo

23 * Managing Pharmaceutical Waste, A 10-Step Blueprint for Health Care Facilities in the United States. Hazardous Chemo Waste* Constituent of Concern Product Name Arsenic Trioxide Trisenox P012 Chlorambucil Leukeran U035 Cyclophosphamide Cytoxan, Neosar U058 Daunomycin Daunorubicin, Cerubidin, DaunoXome, Rubidomycin Waste Code U059 Diethylstilbestrol DES, Stilphostrol U089 Melphalan Alkeran, L-PAM U150 Streptozocin Mitomycin, Mutamycin U010 Mitomycin C Streptozocin, Zanosar U206 Uracil Mustard No longer in active use U237

24 Non-RCRA Hazardous Common Chemo Wastes Bevacizumab (Avastin) Carmustine (Bicnu) Irinotecan Hydrochloride (Camptosar) Doxorubicin Hydrochloride (Doxil) Oxaliplatin (Eloxatin) Classification Non-RCRA Hazardous Non-RCRA Hazardous Non-RCRA Hazardous Non-RCRA Hazardous Non-RCRA Hazardous

25 Generator Status Large quantity generators generate greater than 2,200 pounds/calendar month or greater than 1 kg (2.2 lbs) of acutely hazardous waste (P-listed waste) per calendar month. Small quantity generators generate between 220 lbs and 2,200 lbs per calendar month and generate no more than 2.2 lbs of acutely hazardous waste and accumulate less than 13,200 lbs of hazardous waste at any time. Conditionally exempt small generators - generate less than 100 kg of hazardous waste per calendar month and no more than 1 kg of acutely hazardous waste per calendar month.

26 Common EPA Violations Hazardous waste determinations not done or incorrect. Labeling of hazardous waste not done or incorrect Improper disposal of chemotherapy drugs Inadequate training of employees in HW management Not conducting proper weekly inspections of HW storage No or inadequate HW manifests Improper management of expired pharmaceuticals Lack of emergency contingency plan

27 TJC Accreditation Issue MM EP 4 The hospital minimizes risks associated with managing hazardous medications. EC EP 8 The hospital minimizes risks associated with disposing hazardous medications. LD EP2 The hospital provides care, treatment and services in accordance with licensure requirements, laws, rules and regulations.

28 Storage Requirements The black buckets must be kept closed at all times because they contain hazardous waste. If an area generates a large quantity of black bucket waste, the buckets can be kept in the soiled utility room.

29 Identification of RCRA Waste Pyxis cubie pocket will have a static cling which states to dispose of contents in black bucket waste.

30 Black hazardous waste buckets will be placed on the Pyxis machines for packaging and waste disposal. The top must be closed after each use.

31 For areas that generate a large amount of black bucket waste, closure devices with a foot pedal are available for automatic closure of the waste receptacle.

32 Pharmacy Department Designation All black bucket waste will have the HW sticker placed on the shelf or unit dose bin to denote that it is hazardous waste.

33 Pyxis Clinical Data Category Log in to the Pyxis as usual Choose your patient Choose your medication If the medication requires special handling then an alert message will pop up and you will be required to acknowledge it. It will indicate that the drug and packaging needs to be disposed of in the black buckets.

34

35

36 Meditech Applications

37 MAR Designation P- listed Waste U-listed Waste

38 Syringe Label & Bag

39 P and U-listed Waste Labels

40 Accumulation Storage Shed Hazardous waste black buckets are stored on site for up to 180 days (small quantity generator status)

41 Accumulation Storage Shed (Inside View)

42 References Hospital Accreditation Standards 2009.Accreditation Policies, Standards, Elements of Performance, and Scoring. Pines, Eydie and Smith,C. Managing Pharmaceutical Waste, A 10-Step Blueprint for Health Care Facilities in the United States. In Hospitals for a Healthy Environment. April PP Memorandum from Matt Hale. Scope of Hazardous Waste Listing P042(Epinephrine). EPA Office of Solid Waste and Emergency Response, Washington, DC. October 15, 2007.

43 On-line Formulary Contact Information: Sheryl Wamsley, PharmD Pharmacy Clinical Coordinator

44 Questions?????????

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