Sarasota Memorial Hospital Hazardous Drug List PHARMACY Handling Categories Category A1 (Low Risk): Primarily oral solids that are not anti-neoplastics. May be tubed and placed in Pyxis • Personal protective equipment not required for dispensing prepackaged intact drug product not requiring manipulation. • Oral solids requiring repackaging: Single pair of chemotherapy gloves. • Oral solids requiring cutting, crushing, or other manipulation will be considered a category B2 (medium risk) hazardous drug, requiring double pair of chemotherapy gloves and chemotherapy gown. Mask required if powder inhalation is a risk. Category A2 (Low-Medium Risk): Primarily anti-neoplastic oral solids - Hand delivered only/Not in Pyxis • Require the same precautions and personal protective equipment as Handling Category A1 above PLUS: • These agents will not be placed in Pyxis and cannot be delivered through the pneumatic tube system and must be hand carried. Category B1 (Medium Risk): Primarily oral liquids, topicals, and injections that are not anti-neoplastics- May be tubed and placed in Pyxis • Personal protective equipment not required for dispensing prepackaged or previously prepared intact product not requiring manipulation. • Drug product requiring repackaging, compounding, or manipulation: Double pair of chemotherapy gloves and chemotherapy gown. Mask required if sterile product or if powder inhalation is a risk. Category B2 (Medium Risk): Antineoplastic oral liquids, topicals, or injections not requiring manipulation and crushed/manipulated HD oral solids. Not tubed/Not in Pyxis • Personal protective equipment not required for dispensing prepackaged or previously prepared intact product not requiring manipulation. • Drug product requiring repackaging, compounding, or manipulation: Double pair of chemotherapy gloves and chemotherapy gown. Mask required if sterile product or if powder inhalation is a risk. Category C (High Risk): Primarily antineoplastic injections. Hand delivered only/Not in Pyxis • Double pair of chemotherapy gloves and chemotherapy gown are required. Outermost gloves must be sterile. • Must be compounded in a ventilated engineering control, utilizing hair/beard cover, mask, and double shoe covers. NURSING Handling Categories Handling Category A (Low Risk): ): Primarily oral solids • Single pair of chemotherapy gloves required. • Crushed tablets or opened capsules: Treat as Category B. Double pair of chemotherapy gloves and face protection (mask) required to avoid inhalation of powder. Crushing tablets or opening of capsules must be performed in pharmacy. Handling Category B (Medium Risk): Primarily oral liquids, injections, topicals, and crushed or manipulated oral solids • Double pair of chemotherapy gloves required. • Chemotherapy gown recommended if there is a splash potential or risk of spitting or vomiting of the dose after administration. Handling Category C (High Risk): Primarily antineoplastic injections • Double pair of chemotherapy gloves, and chemotherapy gown required (see also Nursing Procedure onc 01). Definitions (See Exposure Risk Information Section) • IARC: International Agency for Research on Cancer Antineoplastic: Inhibits or prevents the spreaD of tumors or malignant cells o Group 1: Carcinogenic to humans Black Box warning: The most significant warning for prescription drugs by the FDA when use of a drug has been o Group 2A: Probably carcinogenic to humans associated with serious harm o Group 2B: Possibly carcinogenic to humans Carcinogen: A substance capable of causing cancer in living tissue • NTP: National Toxicology Program classification Carcinoma: Cancer arising in the epithelial tissue of the skin or the lining of the internal organs o NTP** Known to be a human carcinogen Genotoxic: Able to cause damage to the genetic information within a cell o NTP*** Reasonably anticipated to be a human carcinogen Lymphoma: Cancer of the lymph noDes • FDA Pregnancy Categories: FDA Drug categorization baseD on risk of use During pregnancy Malignant: SpreaD of cancer to nearby tissues anD other areas of the boDy o Category A: Adequate human studies have not shown a risk to the fetus Neoplasm: New abnormal tissue growth, particularly relateD to cancer o Category B: Animal studies have not shown a risk to the fetus Teratogenic: Use has the potential for causing malformations to an embryo st nd rd o Category C: Animal studies have shown a risk to the fetus, human studies have not Trimesters: 1 : Initial 12 weeks of gestation; 2 : Time from 13 weeks to 27 weeks of gestation; 3 : Time from o Category D: Evidence of risk to the fetus; benefits of medication may outweigh the risks 28 weeks of gestation until Delivery o Category X: Evidence of risk to the fetus; risks of meDication clearly outweigh benefits Generic Drug Name NIOSH Group Formulation Pharmacy Nursing Exposure Risk Information (Brand Name) Handling Handling NIOSH Supplemental Information Pregnancy Category Category Category Abacavir Non- Malignant tumors observeD in male anD female mice Oral SoliD A1 A C (Ziagen) Antineoplastic anD rats; genotoxic in in vivo micronucleus test Acitretin Reproductive Oral SoliD A1 A Black Box warning on severe reproductive effects X (Soriatane) Risk Altretamine Antineoplastic Oral SoliD A2 A D (Hexalen) Anastrazole Antineoplastic Oral SoliD A2 A X (ArmiDex) Arsenic Trioxide Antineoplastic Injection C C IARC Group 1 carcinogen; NTP** D (Trisenox) Azacitidine Antineoplastic Injection C C IARC Group 2A carcinogen; NTP*** D (ViDaza) Azathioprine Non- Oral SoliD A2 A IARC Group 1 carcinogen; NTP* D (Imuran) Antineoplastic Injection C C May cause teratogenicity anD/or embryo-fetal lethality Belinostat Antineoplastic Injection C C because it is a genotoxic drug and targets actively D (BeleoDaq) dividing cells Bendamustine Antineoplastic Injection C C D (TreanDa) Bicalutamide Antineoplastic Oral SoliD A2 A X (CasoDex) Bleomycin Antineoplastic Injection C C IARC Group 2B D (Blenoxane) Bortezomib Antineoplastic Injection C C D (VelcaDe) Bosentan Reproductive Oral SoliD A1 A Black Box warning on adverse reproductive effects X (Tracleer) Risk Busulfan Antineoplastic Oral SoliD A2 A IARC Group 1 carcinogen D (Myleran) Cabazitaxel Antineoplastic Injection C C D (Jevtana) Black Box warning for aplastic anemia; congenital Carbamazepine Non- Oral SoliD A1 A malformations in offspring of mothers who took Drug; D (Tegretol) Antineoplastic Oral LiquiD B1 B rapiD transplacental passage Carboplatin Antineoplastic Injection C C D (Paraplatin) Carfilzomib Special warnings on contraception while taking anD 2 Antineoplastic Injection C C D (Kyprolis) weeks post-treatment Generic Drug Name NIOSH Group Formulation Pharmacy Nursing Exposure Risk Information (Brand Name) Handling Handling NIOSH Supplemental Information Pregnancy Category Category Category Carmustine Antineoplastic Injection C C IARC Group 2A carcinogen; NTP*** D (BICNU) Chlorambucil Antineoplastic Oral SoliD A2 A IARC Group 1 carcinogen; NTP**. D (Leukeran) Chloramphenicol Non- Injection B1 B IARC Group 2A carcinogen; NTP*** D (Chloromycetin) Antineoplastic Cidofovir Non- Injection C C C (VistiDe) Antineoplastic Cisplatin Antineoplastic Injection C C IARC Group 2A carcinogen; NTP*** D (Platinol) Cladribine Antineoplastic Injection C C D (Leustatin) Clonazepam Reproductive IncreaseD risk of congenital abnormalities when taken Oral SoliD A1 A D (Klonopin) Risk in first trimester Published animal reproDuction anD Development Colchicine Reproductive stuDies inDicate it causes fetal toxicity, teratogenicity, Oral SoliD A1 A C (Colcrys) Risk anD altered postnatal Development at exposures within or above the clinical therapeutic range Cyclophosphamide Oral SoliD A2 A Antineoplastic IARC Group 1 carcinogen; NTP** D (Cytoxan) Injection C C Oral SoliD A1 A Cyclosporin Ophthalmic Non- B1 B (Neoral, SanDimmune, Drops IARC Group 1 carcinogen; NTP** C Antineoplastic Restasis) Oral LiquiD B1 B Injection B2 B Cytarabine (Cytosar-U, Depocyt) Antineoplastic Injection C C D Liposomal Cytarabine (Depocyt) Dacarbazine Antineoplastic Injection C C NTP*** C (DTIC) Dactinomycin (Cosmegen) Antineoplastic Injection C C D Daunorubicin (CerubiDine, Antineoplastic Injection C C IARC Group 2B, AKA daunomycin D Daumomycin, Daunosome) Generic Drug Name NIOSH Group Formulation Pharmacy Nursing Exposure Risk Information (Brand Name) Handling Handling NIOSH Supplemental Information Pregnancy Category Category Category Decitabine Antineoplastic Injection C C D (Dacogen) Degarelix Antineoplastic Injection C C X (Firmagon) SeconDary malignancies observed in patients treated long term with Razoxane (a racemic mixture Dexrazoxane Non- Injection B1 B containing Dexrazoxane); genotoxic in vitro anD in C (Totect, Zinecard) Antineoplastic vivo; in laboratory stuDies, testicular atrophy observeD at or below the human Dose Dinoprostone Reproductive Vaginal Insert B1 B HazarDous only for women in late pregnancy C (CerviDil, Prostin E2) Risk Oral SoliD A1 A Black Box warning for teratogenicity; tumors seen in Divalproex Non- Oral SoliD / laboratory stuDies at doses below the maximum D (Depakote) Antineoplastic A1 A Sprinkles recommenDeD human Dose Docetaxel Antineoplastic Injection C C D (Taxotere) Doxorubicin (ADriamycin, Doxil, LipoDox) Antineoplastic Injection C C IARC Group 2A carcinogen; NTP*** D Liposomal Doxorubicin (Doxil, LipoDox) DroneDarone Reproductive Oral SoliD A1 A Teratogenic in laboratory stuDies at ½ MRHD X (Multaq) Risk DutasteriDe Reproductive Oral SoliD A1 A Women warneD not to hanDle X (AvoDart) Risk