1. Treatment and Disposal Options for
Pharmaceutical Waste

2. What is the Definition of the Wastes that we are Concerned With ?
PHARMACEUTICAL WASTES includes expired, unused, spilt and contaminated pharmaceutical products, drugs, vaccines and sera that are no longer required and need to be disposed of appropriately. The category also includes discarded items used in the handling of pharmaceuticals, such as bottles or boxes with residues, gloves, masks , connecting tubing and drug vials
GENOTOXIC WASTES is highly hazardous and may have mutagenic, tertogenic or carcinogenic properties. It raises serious safety problems both inside the Hospitals and after disposal and should be given special attention
CHEMICAL WASTES is hazardous if it contains one or more of the following properties : Toxic, corrosive, flammable, reactive and genotoxic.

3. Chemotherapy Waste
Most common genotoxic products used in health care classified as carcinogenic
Chemicals: benzene
Cytotoxic and other drugs: azathioprine, chlorambucil, chlornaphazine, ciclosporin, cyclophosphamide, melphalan, semustine, tamoxifen, thiotepa, treosulfan
Classified as possibly or probably carcinogenic
Cytotoxic and other drugs: azacitidine, bleomycin, carmustine, chloramphenicol, chlorozotocin, cisplatin, dacarbazine, daunorubicin, dihydroxymethylfuratrizine ,doxorubicin, lomustine, methylthiouracil, metronidazole, mito- mycin,nafenopin, niridazole, oxazepam, phenacetin, phenobarbital, phenytoin,procarbazine hydrochloride, progesterone, sarcolysin, streptozocin,trichlormethine

4. Chemotherapy Waste
Harmful cytostatic drugs can be categorized as follows:
alkylating agents: cause alkylation of DNA nucleotides, which leads to cross- linking and miscoding of the genetic stock;
antimetabolites: inhibit the biosynthesis of nucleic acids in the cell;
mitotic inhibitors: prevent cell replication.
Cytotoxic wastes are generated from several sources and can include the following:
Contaminated materials from drug preparation and administration, such as syringes, needles, gauges, vials, packaging;
outdated drugs, excess (leftover) solutions, drugs returned from the wards;
urine, faeces, and vomit from patients, which may contain potentially hazardous amounts of the administered cytostatic drugs or of their metabolites and which should be considered genotoxic for at least 48 hours and sometimes up to 1 week after drug administration.
In specialized oncological hospitals, genotoxic waste (containing cyto-static or radioactive substances) may constitute as much as 1% of the total health-care wastes.

5. What are the Environmental and Public Health Problems of Pharmaceutical Waste ?
HOLD Wastage of Raw Materials from Manufacturing Process
Wastage / Expiry at the Distributor / Pharmacy / Healthcare Facility / Consumer Level
Problem with Metabolites Entering Environment

6. Where Have Waste Drugs Gone in the Past ?

7. Where Have Waste Drugs Gone in the Past ?
Primarily concerned with rendering drugs unrecoverable
Not in dumpsters, municipal trash
Made slurries, sewered
Burned in hospital incinerators
No training in pharmacy curriculum on Environmental regulations

8. Where are Waste Drugs Going Today ?
Sewer System
Unused, partial IVs, including antibiotics
Compounding residues
Liquids
Yellow Infectious Waste Sharps Containers, Bags
Yellow Chemotherapy Sharps Containers, Bags

9. Contents of Current Pharmaceutical Waste Streams
CHEMO WASTE
CONTAMINATED
MUNICIPAL WASTE
SEWER SYSTEM
CHEMO WASTE
INFECTIOUS WASTES & SHARPS
• Vials
- Empty (trace)
- Partial (residue)
• Syringes/Needles
- Empty
- Unused, partial
• IV’s
• IV’s eg NaCl
• Non hazardous
substances?
Other substances
– antibiotics etc?
• Gowns
• Gloves
• Goggles
• Tubing
• Wipes
• Spill clean up
• Packaging
• Empty glass bottles
• Empty plastic bottles
• Paper
• Plastic
• Food waste, etc.
Vials /
Syringes/Needles
Pre -Shredding
WASTE
TREATMENT PLANT
MUNICIPAL LANDFILL
AUTOCLAVE/
MICROWAVE
MEDICAL WASTE INCINERATOR
Ash
Leachate into
ground water or
air emissions
Discharge to
surface waters
NON-HAZARDOUS LANDFILL
Copyright © 2004 by RAE Training & Environmental Consultants
Leachate

10. How is Pharmaceutical Waste Generated at the Healthcare Facility ?
IV Preparation
General Compounding
Spills/Breakage
Partially Used Vials/Syringes
If Contaminated, Biohazardous
Discontinued, Unused Preparations
Unused Repacks (Unit Dose)
Discontinued Indated Pharmaceuticals
Patients’ Personal Medications
Outdated Pharmaceuticals

11. Pharmaceutical Waste : The Challenge to Improve
Where , How and What ??

12. Where is Pharmaceutical Waste Generated ?
Pharmacy
Patient Care Units
ER/OR
ICU/CCU/NICU
Oncology/Hematology and other outpatient clinics
Home Health Care Services

13. What Departments Get Involved in Generating and Managing Pharmaceutical Waste?
Pharmacy
Nursing
Infection Control
Environmental Services
Safety
Facility Management
Purchasing

14. Understanding the Classification / Definitions?

15. Characteristic of Ignitability
Aqueous Solution containing 24% alcohol or more by volume & flash point<140° F.
Rubbing Alcohol
Topical Preparation
Injections

16. Characteristic of Corrosivity
An aqueous solution having a pH < or = 2 or > or = to 12.5
Examples: Primarily compounding chemicals
Glacial Acetic Acid
Sodium Hydroxide

17. Characteristic of Toxicity
Approximately 40 chemicals which meet specific leaching concentrations
Examples of potential toxic pharmaceuticals:
Arsenic m-Cresol
Barium Mercury (thimerosal)
Cadmium phenylmercuric acetate)
Chloroform Selenium
Chromium Silver
Lindane

18. Examples of Pharmaceuticals Exhibiting the Characteristic of Toxicity

19. Characteristic of Reactivity
Meet specific criteria for identifying certain explosive and water reactive wastes e.g. Nitroglycerin formulations

20. Examples of P-Listed Pharmaceuticals
From the EPA perspective these are listed and defined as the most acutely hazardous toxic wastes, such as aresnic, cyanides salts and strychnine.

21. Examples of U-Listed Pharmaceuticals
These chemicals have lower risk to the human health and environment , but are still highly regulated based upon their toxicity, ignitability, corrosive or reactivity

22. Recommended Revised Pharmaceutical Waste Streams
HAZARDOUS WASTE
- IGNITABLE
HAZARDOUS WASTE
- TOXIC
CHEMO
WASTE
Others
NON-HAZARDOUS
SEWER
SYSTEM
CHEMO
WASTE
INFECTIOUS WASTE
MUNICIPAL
• Packaging
• Empty bottles
• Paper
• Plastic
• Vials
- Empty
• Syringes/Needles
• IV’s
All waste
pharmaceuticals
NOT hazardous
including
antibiotics, IV’s
• Non-chemo
vials
- Infectious waste
syringes/
needles
• IV’s
- NaCl
• Controlled
Substances?
• Ignitable
- Collodion
- Oxidizers
- Ignitable
compressed
gas
• Gowns
• Gloves
• Goggles
• Tubing
• Wipes
• Check with
municipal water treatment plant
for limits, recommendations
• Recycle as much paper, glass, plastic
as possible
MUNICIPAL WASTE TREATMENT
INCINERATOR
AUTOCLAVE/
MICROWAVE
APPROVED
HAZARDOUS WASTE
INCINERATOR (HIGH TEMPERATURE, SCRUBBERS)
MEDICAL WASTE INCINERATOR or SOLIDIFICATION ( Note )
Shredded - Note
Ash
Ash
Ash
LINED HAZARDOUS
WASTE LANDFILL
NON-HAZARDOUS LANDFILL
Copyright © 2004 by RAE Training & Environmental Consultants
Leachate

23. Stabilisation / solidification

24. Landfill / liner
Improper management

25. Landfill Design

26. Single Lined and Double Lined Landfills

27. Advanced Technologies Available
Organics Recover / Reuse Technologies
Distillation / Steam stripping
Separation of volatile materials from less volatile materials by process of vapourisation and condensation
Freeze Crystallisation
As the temperature drops the difference between freezing points of wastewater components allow the formation of crystals at varying temperatures.
Membrane Filtration
Ie use of ultrafiltration/ nonofiltration or reverse osmosis , depending upon the pore size etc
Electrodialysis
This is a process whereby cations and anions are separated through the use of selective ion exchange and DC potential.

28. Advanced Technologies Available
Organics Destruction Technologies
Chemical Oxidation
Use of KMnO4,H202,Cl to oxidise the organic consituents to carbon dioxide and water to intermediate products that are more readily biodegradable or removable by adsorption.
Extraction – Solvent
Use of liquified gas to separate the organic constituents under critical operating conditions.
Adsorption - Carbon
Wet Air Oxidation
This is a liquid phase process which destroys organics and / or oxidizable inorganic components of a waste stream through thermal decomposition, hydrolysis and oxidation reactions. Is carried out at temperatures , 350 to 620 F and pressures up to 3,000 psig.

29. Advanced Technologies Available
Organics Destruction Technologies
HIGH ENERGY ELECTRON IRRADIATION
Using high voltage 1.5 Megavolts and electron treatment
SUPERCRITICAL OXIDATION
Oxidation of organic compounds is carried out above the critical point of water ( 374 Deg C and 218 atm ) At this point the water behaves as a polar organic liquid thereby increasing – increasing the solubility of organics and decreasing the solubility of inorganic salts in water.

30. Where Should Hazardous Waste Be Stored?

31. Where and How Should Hazardous Waste Be Stored?
Hazardous Waste Storage Accumulation Site:
Locked area as mercury, xylene, formaldehyde, lab chemicals
Suggested maximum storage time: 90 or 180 days based on generator status
Hazardous
Waste Label

32. Chemical Waste : Storage
Requirements:
Impermeable hard standing base with good drainage
Additional liquid and chemical proof chemical sump without drainage
Sub dividable in different sections
Fitted with a lock to prevent access by unauthorised persons
Lightening and very good ventilation (explosion proof !!!)

33. Chemical Waste : Storage
Separate from other buildings, in a lockable, special designed storage
The storage place fulfills the requirements of the local law and is equipped with all necessary safety equipment

34. Sample of Storage for chemical waste:
Necessary safety equipment
Different sections
Chemical waste is packed in suitable packing
Additional liquid and chemical proof chemical sump without drainage
All waste is labelled

35. How Should the Hazardous Pharmaceutical Waste Be Disposed?
Through contract with an approved hazardous waste transportation and treatment company
Note :
- Packing
- Manifest preparation

36. Jump-Starting the Process
Review
Review your drug formulary information , compare to
standard databases to identify the waste management properties of the waste ( ie MSDS )
On-site review
A one or two day visit to your facility followed by an Action Plan and Findings and Recommendations

37. How Can Hazardous Waste Generation Be Minimized?
Inherent limitations on substitution of a less hazardous drug since the hazardous nature of the chemical often provides the therapeutic effect
Tighter inventory control to reduce outdate generation, both original manufacturers’ containers and repacks
Single dose vials vs. multiple dose vials
Patient specific oral syringes vs. 10 cc. repacks (e.g. choral hydrate for pediatric use)
Reformulation of heavy metal concentration, especially mercury and m-cresol as preservatives

38. Benefits of a Comprehensive Hazardous Waste Disposal Plan
Environmental Care Performance Improvement Initiative
Standards – see both Medication Management and HCW
Reduces liability and risk exposure to a minimum
Protects employees and patients
Demonstrates responsible care in dealing with hazardous substances, hazardous wastes