Safe handling of cytotoxic drugs and cytotoxic waste ETLog GmbH Brunnenstraße Berlin Germany

Transcription

1 Cytotoxic Waste Management Safe handling of cytotoxic drugs and cytotoxic waste ETLog GmbH Brunnenstraße Berlin Germany

2 Safe Handling of Cytotoxic materials General ideas about types and hazards of cytotoxic drugs and waste Reconstitution and administration of cytotoxics Safe handling, storage, transportation Accidents and spillages Disposal of cytotoxic waste

3 Cytotoxic??? Cytotoxic materials and cytotoxic waste: Other name: antineoplastics, genotoxic or CMT materials (carcinogen, mutagen, teratogen waste) Cytotoxics are drugs used to block the growth of cancer cells. They achieve this by influencing cell metabolism during the cell cycle. Cancer cells do not differ from healthy cells! Due to this cytotoxic drugs can affect all dividing cells.

4 Types and hazards of cytotoxic materials Cytotoxic drugs Antiviral drugs Genotoxic Mutagen Carcinogen Teratogen Acute toxicity Local toxicity Cytotoxic materials can be absorbed through the skin or the respiratory tract!

5 Documented problems with cytotoxics Several evidences are documented for healthcare workers: Nausea, hair and eye lash loss Immunosuppression Detection of cytotoxic drugs in urine Mutagenic effects in the urine Personal involved in delivery, transport and disposal are also affected Environmental impacts Most cytotoxics are not biological degradable and will pass the waste water treatment plants and come in the groundwater Some will be adsorbed by the sewage and come in the soil!!! Long-term risk is not yet known!!!

6 Forms and types of cytotoxics About 50 different antineoplastics agents Solutions in Ampoules Powder in glass or plastic vials Solutions in glass vials in plastic bags plastic vials Special protected items (new)

7 Sources of cytotoxics waste in Pharmacy Surface contamination of the packing by manufacturing processes Surface contamination of the packing due to delivery accidents Contaminated material due to preparation Spillage on transportation to the wards Contaminated materials due to administration Contamination due to storage and disposal

8 Precautions around cytotoxic service The number of persons dealing with cytotoxic substances should be minimized Order and handle cytotoxics separately from other drug orders Separate storage places in the pharmacy Highly sophisticated, centralized preparation techniques by specially trained personnel Safety guidelines are needed Waste management procedures must be available If possible, pregnant women should avoid contact with cytotoxic drugs

9 Example: separate ordering and delivery Special care during handling of cytotoxic materials: Separate ordering from other pharmaceuticals Special care during loading, unloading, and storing to avoid possible glass breakage Precaution: wearing of gloves during unpacking

10 Example: problems during supply and storage Cytotoxic waste cause of unsuitable packaging by manufacturers: No unpacking only opening and control Detected broken deliveries are only to be handled in separate working areas by special trained personal

11 Transportation and storage Special care during transportation and storage: On-site transportation: separately from other drugs Storage: in the preparation area only one place in pharmacy

12 Reconstitution of cytotoxic drugs Reconstitution should be carried out in a special area in the pharmacy and be performed in a biological safety cabinet (BSC) Separate area for changing clothes outside of the reconstitution area Access to the reconstitution only for authorized, trained staff No food or drink must be consumed/stored, no smoking Cytotoxic drugs must stored separately in a well ventilated store (BSC)

13 Handling cytotoxic materials Training of employees: All employees handling cytotoxic drugs and waste must receive a training! Must be aware of hazards and know how to react in case of emergencies Practical training based on theoretical foundation Regularly retraining Documentation of training Personnel handling cytotoxic drugs should be examined regulary (annually)!

14 Handling cytotoxic materials To be provided operation procedures: Hazards for humans and environment General handling Emergency response First aid Spill clean-up Waste disposal

15 Preparation and transportation Reconstitution should be carried out centrally in the pharmacy Delivering of the to be administered drugs to the ward For transport, liquid proof, shatterproof, easy to clean containers should be used Containers should be labeled according to the hazards

16 Waste segregation of cytotoxic waste Waste from cytotoxics preparation and handling Household (domestic) waste (Trace contaminated waste e.g. empty items and items have been in contact with cytotoxics like gloves) Cytotoxic waste (bulk contaminated waste e.g. US: > 3% drugs remaining in the waste, Germany 20 ml of cytotoxic drugs)

17 Waste segregation at the reconstitution area Non hazardous waste: 1. Plastics 2. Recyclable cardboards 3. General waste Glass bottles (beyond hoods)

18 Samples of trace contaminated waste Typical trace waste from reconstitution: Empty vials / ampoules Used compresses Used syringes Used mats Used trays Should be double packed: 1. Packing plastic bag 2. Packing plastic bag/bin

19 Trace contaminated waste from wards Trace waste: empty syringes empty infusion solutions infusion lines gloves, masks

20 Samples of bulk contaminated waste Typical bulk waste: Expired drugs Residues of drug solutions Filled syringes

21 Cytotoxic bulk waste back from the wards Not administered preparations in syringes or infusion bags Accidentally perforated infusion bags prior to administration Accidents during storage or transportation

22 To be disposed of bulk cytotoxic waste From hoods / pharmacy Expired, unused drugs Spillages From wards Non empty syringes/ infusions got back from wards Leakages back from wards From supplier By manufacturer contaminated vials Damaged during transportation from manufacturer to pharmacy

23 Spillage kit for cytotoxic waste Should contain: Two pairs of protective gloves Liquid proof gown Safety goggles Respirator mask (high-efficiency particulate HEPA) Overshoes Sufficient quantity of absorbents Small plastic scoop and tongs to collect glass Disposal bags Hazard signs

24 Clean up after spillages and accidents Recommended proceedings: Isolate the affected area Use hazard sign as spillage warning Get the spillage kit Collect glass fragments Whipe up spilled liquids with dry cellulose (Avaoid splashes). Use damp cellulose for spilled powder Clean with celloulose soaked in 70% Alcohol and afterwards with cellulose soaked in a soap solution Dispose of the waste

25 Possible cytotoxic waste disposal Back to supplier! Chemical destruction Amsacrin 260 Mitoxantron 800 Cisplatin Anthracyclines ca. 800 Dacarbazin 500 Melphalan 500 Idarubicin 700 Incineration a) Regional policies b) High Temperature: o C

26 Cytotoxic waste disposal options Back to supplier!? Chemical destruction solid compounds glassware aqueous solutions (ampoules, vials) inject able pharmaceutical preparations spills - solid compounds - aq. solutions and preparations

27 WHO recommended chemical destruction Commonly used reagents: H 2 SO 4, KMnO 4 NaOH /KMnO 4 HCl/ Na 2 S 2 O 5 Zn/H 2 SO 4 or Al/HCl NaOH/DMF NaOCl Neutralization: Na 2 S 2 O 3 NaOH Ascorbic Acid Drugs VCR, VBL, 6-TG, 6-MP, Procarbacin MTX CTX Cisplatin, Carboplatin CTX, IFO MTX Examples

28 Chemical destruction methods Apparatus: high quality standard laboratory equipment Methods: magnetic stirring or refluxing Surrounding: safety cabinet 1.Well founded chemical knowledge 2. In hospitals only at pharmacy 3. Residual solutions must be free from remaining mutagenicity

29 Sample: chemical destruction NaOCl 5,25% H 2 O 2 30% Fenton's Reagent or 15% (FeIICl 2 3% in H 2 O 2 30%) 10ml Prepn ml Reagent in an Erlenmeyer flask for 1-3 hrs at room temp. Neutralization ( ice-bath) with Na2SO3 and 12M-HCl. using Fenton's Reagent take Erlenmeyer flask with 5 times the Preparation/Reagent-Volume. Int.Arch Occup Environ Health (1997) 69: