Safety Handling of Cytotoxic Drug

1、Jane Jia 2011-7Safety Handling of Cytotoxic DrugWhat is Cytotoxic Drug? Cytotoxic drugs are toxic compounds and are known to have carcinogenic, mutagenic and/or teratogenic potential. With direct contact they may cause irritation to the skin, eyes, and mucous membranes, and ulceration and necrosis o

2、f tissue. *The toxicity of cytotoxic drugs dictates that the exposure of health-care personnel to these drugs should be minimized. At the same time, the requirement for maintenance of aseptic conditions must be satisfied. PPEHOODPERSONELPIVAS Pharmacy Intravenous Admixture ServicesLAMINAR FLOW BIOLO

3、GICAL SAFETY CABINETAll procedures involved in the preparation of cytotoxic drugs should be performed in a Class , Type A or Type B laminar flow biological safety cabinet.Switch on the blower, and turn on the UV lamp, allow it to operate for at least 30 minutes before use. Turn off the UV lamp after

4、 30 minutes.Step 1PREPARATION OF BIOLOGICAL SAFETY CABINETClean the surfaces of the cabinet using alcohol 75% with disposable non-linting wipes, cleans back to front, up to down.Step 2PREPARATION OF BIOLOGICAL SAFETY CABINETStep 3Place all cleaned materials in the cabinet before beginning work to av

5、oid interruption of laminar flow.(75%alcohol spray) PREPARATION OF BIOLOGICAL SAFETY CABINETStep 4Open the front window of the cabinet at the height of 180mm or less, then admixture well.PREPARATION OF BIOLOGICAL SAFETY CABINETStep 5Seals preparation in zip-lock bag and affixes appropriate labels be

6、fore pass out of HOOD.PREPARATION OF BIOLOGICAL SAFETY CABINETStep 6Clean again with alcohol 75%, back to front, up to down. At the end of work sessions, allow BSC to operate for at least 30 minutes more to purge the work zone of aerosols.PREPARATION OF BIOLOGICAL SAFETY CABINETPERSONAL PROTECTIVE E

7、QUIPMENT (PPE)Activity (when to wear)Protective EquipmentGloves(2 layers; must bechanged at leasthourly orimmediately ifcontaminated, tornor punctured)Wash hands withsoap and water afterremoval of glovesGownMoisture-resistantgown, long-sleevedwith cuffs andhood. Must bechanged daily,immediately ifco

8、ntaminated, andafter spill clean-upEye ProtectionChemical splashgoggles.Adequate eyewashfacilities must beprovidedMask N95Preparation(cytotoxic drugsreconstitution)AlwaysAlwaysAlwaysYesAdministrationAlwaysAlways If hazard of eyecontactNoSpill clean upAlwaysAlwaysAlwaysYesWaste disposalAlwaysIf waste

9、uncontainedIf wasteuncontainedNoPERSONAL PROTECTIVE EQUIPMENT (PPE) Personal protective equipment (PPE) must be worn whenever cytotoxic agents are handled (P&A)1 PPE must be changed immediately when contaminated or soiled.2Used disposable PPE must be handled as cytotoxic waste.3PPE must not be w

10、orn outside the preparation, administration or storage area.4EQUIPMENT large bore needles e.g.16 gauge or larger. The length of needles should preferably not be longer than the vial luer lock syringes to avoid spills due to accidental disconnection ； never be more than filled Add diluent slowly into

11、 vial. Do this by alternately injecting small amounts of diluent into the vial and allowing displacement of air into the syringe NeedlesSyringes Handling vials Vials containing drugs requiring reconstitution should be vented to reduce the internal pressure with a syringe. This reduces the probabilit

12、y of spraying and spillage.Tips A sterile alcohol pad should be carefully placed around the needle and vial top during withdrawal from the septum.TipsThe external surfaces contaminated with a drug should be wiped clean with an alcohol pad prior to transfer or transportTips When opening the glass amp

13、ule, wrap it and then snap it at the break point using an alcohol pad to reduce the possibility of injury and to contain the aerosol produced. Tips Avoid direct skin contact and avoid introduction of powdered drugs into the air when handling cytotoxic drugs in the form of tablets or capsules.Do not

14、crush any oral form of cytotoxic drugs Label all containers of preparations containing cytotoxic drugs with a prominent, distinctive warning label such as:“CYTOTOXIC 细胞毒性细胞毒性 handle with care” Pack all prepared cytotoxic drugs in sealed, leak-proof plastic double bags prior to leaving the preparatio

15、n area. They should be packaged in a unit-dose, ready-to-use form. Warning label must be clearly visible on the outside of the packaging bags. Clean up the cabinet with alcohol. At the end of work sessions, allow BSC to operate for at least 30 minutes more to purge the work zone of aerosols.Remove p

16、rotective clothing according to PPE instruction.Wash hands after removing protective clothing. Discard used gown as cytotoxic waste.Disposal of Cytotoxic Waste Cytotoxic waste is considered to be all those materials which have come into contact with cytotoxic drugs during the process of reconstituti

17、on and administration. materials from the clean-up of cytotoxic spills empty or partially used vials masks gloves syringes single use PPEneedles Expired drugDisposal of Cytotoxic Waste All sharps waste must be placed in puncture resistant containers （Sharp Box）.All cytotoxic waste must be placed in

18、secondary packaging and sealed to ensure that leakage cannot occur, and must be clearly labeled to indicate the presence of cytotoxic waste. This waste must be segregated, packaged, and disposed of in a way that personnel and the environment are not contaminated. Documentation All validation tests,

19、cleaning, maintenance, installation and service activities should be documented and kept for reference. Ufhpekfs03bjudataPharmacyPublicBiological Hoodnew hope ouva管理表格 You may find the Blank Form in below:ExtravasationExtravasationExtravasationExtravasationExtravasationExtravasationAgentVesicant (V)

20、or Irritant (I) ClassificationExtravasationAntidoteBleomycin (Blenoxane)I (weak)DCarboplatin (Paraplatin)concentration greater than 10mg/mlI (weak)CCisplatin (Platinol)greater than 20 ml andconcentration greater than or equal to 0.5 mg/mlIADocetaxel (Taxotere)IDDoxorubicin (Adriamycin)VCEtoposide (V

21、P-16)I (weak)BFluorouracil (5-FU)I (weak)DIrinotecan (Camptosar, CPT-11)IFOxaliplatin (Eloxatin)IG Irritant: An agent which can cause aching, tightness and phlebitis at the injection site or along the vein, with or without inflammatory reaction Vesicant: A chemical compound that causes severe skin,

22、eye and mucosal pain and irritation. They are named for their ability to cause severe chemical burns, resulting in large, painful water blisters on the bodies of those affected. Vesicant is a chemotherapy drug that could potentially cause serious tissue damage if it leaked from the a vein into surro

23、unding tissues. A drug that is capable of causing a somewhat less severe reaction if leaked is called an Irritant.Antidote RegimenALeave needle in place. Remove as much chemo as possible. Remove needle.Apply cold compress for 15 to 20 minutes, every 2 hours, at least 4 times per day for 48 hours.3.

24、Keep extremity elevated as much as possible for 48 hours.4. Administer Sodium Thiosulfate (see preparation and administration guidelines).Antidote RegimenB1.Leave needle in place. Remove as much chemo as possible. Remove needle.Apply warm pack for 15 to 20 minutes, every 2 hours, at least 4 times pe

25、r day for 48 hoursKeep extremity elevated as much as possible for 48 hours.4. Administer Hyaluronidase (see preparation and administration guidelines).Antidote RegimenC1. Leave needle in place. Remove as much chemo as possible. Remove needle.Apply cold compress for 15 to 20 minutes, every 2 hours, a

26、t least 4 times per day for 48 hoursKeep extremity elevated as much as possible for 48 hours.4. Protect area from sunlight and heat.5. Administer DMSO (see preparation and administration guidelines).Antidote RegimenAntidote RegimenDLeave needle in place. Remove as much chemo as possible. Remove need

27、le.Apply cold compress for 15 to 20 minutes, every 2 hours, at least 4 times per day for 48 hours3. Keep extremity elevated as much as possible for 48 hours.Antidote RegimenAntidote RegimenELeave needle in place. Remove as much chemo as possible. Remove needle.Apply warm pack for 15 to 20 minutes, e

28、very 2 hours, at least 4 times per day for 48 hours3. Keep extremity elevated as much as possible for 48 hours.Antidote RegimenAntidote RegimenF Leave needle in place. Remove as much chemo as possible. Remove needle. Flush site with water. Apply cold compress for 15 to 20 minutes, every 2 hours, at

29、least 4 times per day for 48 hours4. Keep extremity elevated as much as possible for 48 hours.Antidote RegimenAntidote RegimenG Leave needle in place. Remove as much chemo as possible. Remove needle. Apply warm pack for 15 to 20 minutes, every 2 hours, at least 4 times per day for 48 hours3. Keep ex

30、tremity elevated as much as possible for 48 hours. Administer Sodium Thiosulfate (see preparation and administration guidelines).Antidote RegimenAntidote Preparation and Administration Guidelines DMSO 50% Solution Apply a small amount of DMSO (1 to 2 ml) with gauze, every 4 hours for 3 to 14 days. M

31、ay sting on application. Allow to air dry. Application may need to continue for 4 to 8 weeks per providers evaluation.Sodium Thiosulfate Mix 4 ml of Sodium Thiosulfate 10% with 6 ml of sterile water for injection (this is a 0.17moles/liter solution). Inject 5 ml subcutaneously into the extravasation

32、 site.Hyaluronidase Product: Vitrase 200 units/ml Withdraw 0.75 ml from a Vitrase vial, add 0.25 ml of 0.9% sodium chloride (final concentration = 150 units/ml) Inject subcutaneously or intradermally into the extravasation site using a 25 gauge needle(or smaller). Inject five 0.2 ml injections for a

33、 total of one ml. Change needle after each injection.SPILLLiquidSolidSPILL managementPowderGloves (2 pair) Safety gogglesRespiration maskSpill mats (2)Spill towels (2) Chemo-caution labelsPoly-Bags (2)Gown(1), Shoe coverings (1 pair).Spill kit contains:Small spills In Pharmacy HoodAny areas outside

34、the Hoodleave blower onPPE (Gown and glove)If liquid, clean up with absorbent mat. Be careful not to splash or spread liquid.If solid, cover and wipe with 75% Alcohol gauze place into plastic bag, seal, then put in chemotherapy disposal containers.Wipe Spill area with 75% Alcohol times 3. If it is necessary to raise shielded hood to clean spill, disposable mask must be worn.Mark and isolate spill to prevent contamination of other personnel.If HEPA Filter is contaminated, the Unit must not be used. Manufacturers representati