UNITYPOINT HEALTH - MARSHALLTOWN Marshalltown, Iowa PHARMACY POLICY AND PROCEDURE

Transcription

1 UNITYPOINT HEALTH - MARSHALLTOWN Marshalltown, Iowa PHARMACY POLICY AND PROCEDURE Subject: Hazardous Drugs and Chemicals IAC (10) (Formerly High Alert and Hazardous Medications MM ) (Formerly Admin Policy Pharmaceutical Waste Management #163) Purpose: The hospital safely manages high alert and hazardous medications Policy #: IAC (10) Procedure: 1) The hospital identifies, in writing, its high-alert and hazardous medications. a) See Appendix A - High Alert Medications (ISMP) b) See Appendix B - Safety/ Health Hazardous Medications (NIOSH) c) See Appendix C - Environmentally Hazardous/ Dangerous Medications (Stericycle) 2) The hospital has a process for managing high-alert and hazardous medications. a) High Alert Medications i) All high alert medications are identified with a High Alert sticker, placed by pharmacy ii) Key safety strategies for safeguarding high alert medications are implemented (ISMP) Table I b) Hazardous Medications i) All formulary drugs have an MSDS/SDS sheet available via the facility s intranet (pharmacy is responsible) (1) Identifies Health, Fire, Reactivity and Environmental hazards ii) All Antineoplastic and Other Safety/Health Hazardous Drugs are identified by a Hazardous Drug sticker, placed by pharmacy (NIOSH) iii) All Environmentally Hazardous/Dangerous Drugs have stickers that characterize proper disposal, placed by pharmacy (Stericycle) (1) Compatible Hazardous Rx Waste 1) Black Circle sticker (BKC) 2) Dispose empty, partial or unused in BLACK Stericycle Container 3) Ex. Insulin, trace elements, clindamycin, silvadene (2) Compatible Hazardous Rx Waste 1) Black Circle with P Sticker (PBKC) 2) Dispose medication and packaging in BLACK P Stericycle Container 3) Ex. Coumadin (and packaging), nicotine (and packaging) (3) Incompatible Hazardous Rx Waste 1) Black Circle with Orange Exclamation sticker (SP, SPC, SPO, SPLP) 2) Dispose empty, partial or unused in BLACK EXCLAMATION Stericycle Container 3) Ex. Aerosols - inhalers with canister, silver nitrate (4) Bulk and Trace Chemotherapy Rx Waste 1) Black Circle sticker (Chemo) 2) Bulk (i) Dispose partial or unused in BLACK CHEMO Stericycle Container (ii) Ex. IV s/ syringes/ vials with residual chemo agents, chemo spill cleanup debris 3) Trace (i) Dispose empty in YELLOW CHEMO Stericycle Container (ii) Ex. Empty iv s/ syringes/ vials/ tubing, gowns/ wipes/ gloves/ PPE (5) Hazardous and Infectious Rx Waste 1) Purple Circle sticker 2) Dispose empty, partial or unused in PURPLE Stericycle Container 3) NA c) Non-Hazardous Medications

2 i) All Non-Hazardous Drugs do not have stickers (1) Non-Hazardous Rx Waste 1) No Sticker 2) Dispose empty, partial or unused in BLUE Stericycle Container 3) Ex. Antibiotics, lidocaine, marcaine, heparin, contrast (2) Plain IVs 1) No Sticker 2) Dispose in SINK 3) Ex. solutions containing additives (potassium chloride, potassium phosphate, sodium phosphate, calcium, sodium bicarbonate) (3) Controlled Substances 1) No Sticker 2) Dispose in SINK/ TOILET/ CACTUS 3) Ex. ALL CII-CV substances (witness and waste) d) EMPTY Items i) No Sticker ii) Dispose in appropriate Stericycle container, regular trash or sharps container e) NOTE: If unused medications are intact and in their original, tamper-evident packaging they should be returned to Pharmacy/ AMDS instead of wasted (NEW 8/1/16) f) The Environmental Services Director has the overall responsibility for the Hazardous Waste Management Program (Stericycle) g) Personal Protective Equipment and Engineering Controls are followed when working with hazardous drugs (NIOSH) Table II h) Pharmacy should complete Storage, Handling and Disposal of Hazardous Drugs Written Assessment as part of their yearly competencies (APPENDIX D) i) See Stericycle Waste Disposal Quick Reference (Computer, X Drive, Pharmacy, 2016 P&P, Policy Procedures) 3) The hospital implements its process for managing high-alert and hazardous medications. 4) For hospitals that use Joint Commission accreditation for deemed status purposes: The hospital reports abuses and losses of controlled substances, in accordance with law and regulation, to the individual responsible for the pharmacy department or service and, as appropriate, to the chief executive. a) All abuses/ losses will be reported to the pharmacy director and, as appropriate, to the chief executive officer (CEO) b) Iowa registrants must complete and submit the DEA Form 106 Report of Theft or Loss of Controlled Substances to the Board within 14 days of discovery of theft or loss c) The registrant will maintain a copy of the report for two years Additional Information: 5) High-alert medications - those medications that bear a heightened risk of causing significant patient harm when they are used in error (ISMP) 6) Hazardous drugs - include those drugs that exhibit one or more of the following six characteristics in humans or animals: carcinogenicity, teratogenicity or other developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, structure and toxicity profiles of new drugs that mimic existing drugs determined hazardous by the above criteria (NIOSH) Closing Banner: Originated by: Pharmacy Department Effective date: 4/12 Authorized by: P&T Cmte/ Date: 1/27/15 Authorized by: Jessica Rosenhamer, Pharmacy Director Revision date: 1/15, 9/15, 7/16 Review date: 5/16, 7/17 References:

3 Iowa Pharmacy Law Joint Commission USP (high alert medication list) (safeguarding high alert meds) (hazardous medication list) (preventing occupational exposures) Stericycle - Waste Characterization Report (report of theft or loss of controlled substances) Key Strategy FMEA and Self Assessment Table I Key Safety Strategies for Safeguarding High Alert Medications Example NA Forcing Functions and Fail Safes Limit Access or Use Maximize Access to Information Constraints and Barriers Standardize Simplify *Use of oral syringes that cannot be connected to IV tubing ports (pediatric patients ONLY) *Use of epidural tubing without ports *Use of infusion pump sets with an automatic clamping mechanism to prevent free-flow if the tubing is removed from the pump *Engineering features that (soft) stop a process from moving forward or require the entry of key information before proceeding (weight, allergies) *Carefully select the drugs, concentrations and quantities of medications in floor stock/ AMDS *Establish parameters to change IV therapy to oral therapy as soon as possible to limit IV access *Limit the administration of certain medications unless certain criteria are met (Ofirmev) *Use of smart infusion pumps with dose checking software enabled *Use of concurrent data monitoring software systems that notify practitioners with critical monitoring information (labs) *Deploy clinical pharmacists in patient care units for immediate consultation when needed *Use of personal protective equipment to reduce employee exposure to hazards Use of a biologic safety cabinet to prepare chemotherapy *Use of a needleless system to administer medications and fluids, or for other procedures involving a potential risk of exposure from contaminated sharps (addease connectors) *Employ standard order sets *Standardize concentrations, container sizes and drugs used to treat specific conditions *Use commercially available products *Dispense oral and parenteral medications in the most ready-to-use form *CPOE *Dosing charts for calculation of infusion rates

4 Externalize or Centralize Error Prone Processes *Use commercially available products *USP 797 *External service for Mitomycin, PCAs

5 Table II Personal Protective Equipment and Engineering Controls for Working with Hazardous Drugs Formulation Activity Double Gloves Gown Eye Protection Respiratory Protection Ventilated Engineering Control Tab/ Cap cut/ crush/ prepack yes yes yes, if not done yes* Oral Liquid compound yes yes yes, if not done in a control yes, if not done yes* Topical compound yes yes yes yes, if not done yes* Ampoule open yes yes yes, if not done in a control yes, if not done yes SQ/ IM injection Preparation yes yes yes, if not done in a control yes, if not done yes IV solution Compound yes yes yes, if not done in a control yes, if not done yes Solution for irrigation Compound yes yes yes yes Powder/ Solution INH Inhalation yes yes yes yes yes, when applicable *For nonsterile preparations, an engineering control is sufficient. It is recommended that these activities be carried out, but it is recognized that under some circumstances, it is not possible. If the activity is performed in an engineering control that is used for sterile intravenous preparations, a thorough cleaning is required following the activity.

6 Appendix A High Alert Medications (ISMP) Epinephrine IV/ SQ, Phenylephrine IV, Norepinephrine IV Propranolol IV, Metoprolol IV, Labetalol IV Lidocaine IV, Amiodarone IV Warfarin, Lovenox, Heparin IV Fondaparinux Bivalirudin, Dabigatran Alteplase Eptifibatide Calcium Chloride Vial Potassium Chloride Vial, Potassium Acetate Vial, Potassium Phosphate Vial Sodium Acetate Vial, Sodium Bicarbonate INJ, Sodium Chloride Vial, Sodium Phosphate Vial Sodium Chloride 3% IV Magnesium Sulfate in Water IV Magnesium Sulfate Vial D20W, D25W, D30W, D50W, D70W Digoxin, Milrinone Amphotericin B Liposomal Succinylcholine, Rocuronium Amino Acids/ Dextrose, Intralipids, Amino Acids Sterile Water for INJ/ INH/ Irrigation (excluding pour bottles) in containers of >/=100ml Nitroprusside sodium INJ Promethazine IV Vasopressin IV *Efavirenz/ emtricitabine/ tenofovir, Lamivudine/ zidovudine, Zidovudine Metformin, Janumet, Glimepiride, Pioglitazone, Acarbose *Azathioprine, Cyclosporine, Tacrolimus Humalog, Novolog, Humulin, Detemir, Lantus, Novolin, and Mixes *Carbamazepine *Propylthiouracil *Chemotherapy - see Appendix B *Pregnancy Category D - see appendix B Radiocontrast IV, Narcotics/ Opioids, Pediatric Liquid Meds

7 Appendix B Safety/ Health Hazardous Medications (NIOSH) Anastrozole Bicalutimide Erlotinib Exemestane Fulvestrant Hydroxyurea Letrozole Megestrol Methotrexate Mitomycin Tamoxifen Azathioprine Carbamazepine Cyclosporine Divalproex Estradiol, Conjugated Estrogen Fosphenytoin Leflunomide Liraglutide Medroxyprogesterone acetate Mycophenolate mofetil Oxcarbazepine Phenytoin Propylthiouracil Raloxifene Risperidone Spironolactone Tacrolimus Zidovudine Dutasteride (X) Finasteride (X) Clonazepam, Colchicine, Dinoprostone, Dronedarone, Fluconazole, Misoprostol, Oxytocin, Paroxetine, Topiramate, Valproate/ Valproic acid, Warfarin, Ziprasidone, Zoledronic acid

8 Appendix C Environmentally Hazardous/ Dangerous Drugs (Stericycle) Addamel N - BKC Advair HFA - SP Analgesic Grx - BKC Anti-diarrheal liquid - BKC Arimidex - Chemo Aromasin - Chemo Atrovent aerosol - SP Ayr Saline - BKC Bactroban cream - BKC Benzoin Compound Tincture - BKC Bicalutamide - Chemo Byetta Inj - BKC Cerovite liq - BCK Chlorhexidine Gluconate - BKC Clindamycin Phosphate Solution - BKC Coumadin - PBKC Cyanide Antidote - SPO Dehydrate Alcohol - BKC Digoxin Inj - BKC Doxycycline Inj - SPLP Drysol - BKC Dulera - SP Ethyl Chloride - SP Faslodex - Chemo First BXN Mouthwash - BKC Flovent aerosol - SP Flurbiprofen - BKC FML S.O.P. ointment - BKC Humalog - BKC Humalog Mix - BKC Hurricaine - SP Hydrea - Chemo Isopropyl Alcohol - BKC Kcentra BKC Lantus - BKC Lansinoh - BKC Letrozole - Chemo Levemir - BKC Mastisol - BKC Megestrol - Chemo Metoclopramide soln - SPC Mitomycin - Chemo MTV - BKC Multitrace Elements - SPC Neo-synephrine spray - BKC Neomycin/Polymyxin/Hyd Susp - BKC Neoral - BKC Nicotine - PBKC Nitroglycerin Inj - BKC Novolin - BKC Novolog - BKC Novolog Mix - BKC Ocuvite - BKC Permethrin Lotion - BKC

9 Phenol EZ swab - BKC Phenytoin Inj - BKC Physostigmine - PBKC Prosight - BKC Prostin VR Ped - BKC QVAR - SP Selenium Sulfide - BKC Silver Nitrate - SPO Silver Sulfadiazine - BKC Phenol Sore Throat Spray - BKC Symbicort - SP Tamoxifen - Chemo Tarceva - Chemo Thermazene - BKC TNKase - BKC Tri-Chlor - SPC Ventolin HFA - SP Viroptic - BKC Vision Blue - BKC Voltaren - BCK Xopenex Aeresol - SP Zantac Syrup - BKC

10 APPENDIX D Storage, Handling and Disposal of Hazardous Drugs Written Assessment 1) Hazardous drugs shall be stored separately from other inventory in a manner to prevent contamination and personnel exposure. a) true b) false 2) Hazardous drugs shall be handled with caution at all times using appropriate chemotherapy gloves during receiving, distribution, stocking, inventorying, preparing for administration, and disposal. a) true b) false 3) All Safety/Health Hazardous Drugs are identified by a Hazardous Drug sticker, placed by pharmacy (NIOSH) a) True b) false 4) Personal Protective Equipment (PPE) may include the following: a) double gloves c) gown b) eye protection d) all of the above 5) Primary engineering controls (i.e. biological safety cabinets) are used for: a) personnel protection c) all of the above b) exposure of critical sites d) none of the above 6) All Environmentally Hazardous/Dangerous Drugs have stickers that characterize proper disposal, placed by pharmacy (Stericycle) a) true b) false 7) Compatible Hazardous Rx waste (insulin, trace elements, clindamycin, silvadene) is characterized by a black circle sticker and is disposed of in a: a) black container c) black P container b) black exclamation container d) purple container 8) Compatible Hazardous Rx waste characterized by a black circle with P sticker and disposed of in a black P container includes: a) coumadin c) nicotine b) packaging d) all of the above 9) Incompatible Hazardous Rx waste (aerosols, silver nitrate) characterized by an orange exclamation sticker is disposed of in a: a) black container c) black P container b) black exclamation container d) purple container 10) EMPTY Schedules II-V vials and ampoules are disposed of in: a) appropriate Stericycle container c) regular trash b) sharps container d) all of the above Signature of Person Assessed Printed Name Date Signature of Qualified Evaluator Printed Name Date