Hazardous Drug Rules amp Updates for Pharmacy Buyers Katrina Kagler Harper PharmD MBA BCPS Learning objectives Explain the risk of hazardous drug exposure for healthcare workers Summarize updates to ID: 1036577
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1. National Institute for Occupational Safety & Health (NIOSH) Hazardous Drug Rules & Updates for Pharmacy BuyersKatrina Kagler Harper, PharmD, MBA, BCPS
2. Learning objectivesExplain the risk of hazardous drug exposure for healthcare workersSummarize updates to the National Institute for Occupational Safety and Health (NIOSH) Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Healthcare SettingDiscuss effects of USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings regulations on processes and procedures for receipt, storage, and ordering of hazardous drugsDiscuss barriers that prevent compliance with hazardous drug handling standards and ways to remove those barriers2Vizient Presentation │ 2017 │ Confidential Information
3. USP General Chapter <800>: Hazardous Drugs – Handling in Health Care SettingsThe newest chapter in USP Compounding CompendiumDescribes practice and quality standards for handling hazardous drugs (HDs)To promote patient safety, workersafety and environmental protectionApplies to all health care personnel who handle HDsAll entities that store, prepare, transport or administer HDs Entities that handle HDs must incorporate the standards into their occupational safety planVizient Presentation │ 2017 │ Confidential Information 3
4. Protecting health care workersEight million U.S. health care workers are potentially exposed to HDsConcern of cancers and reproductive hazardsA 2010 study results (McDiarmid et al) show significantly higher rates of chromosome 5 and 7 abnormalities among health care workers handling anti-neoplastic medications.A 1999 study (Valanis et al) compared pregnancy outcomes in 2,976 nurses, pharmacists, and pharmacy technicians with outcomes in 4,118 pregnancies among women who were not health care workers. The risk of spontaneous abortion or stillbirth was 40 percent higher in women handling hazardous drugs during pregnancy.California, Washington, Maryland, and North Carolina standardsNew chemotherapy safety standards from ASCO and ONSVizient Presentation │ 2017 │ Confidential Information 4
5. Occupational exposure to hazardous drugsVizient Presentation │ 2017 │ Confidential Information 5
6. Knowledge of hazardous drug risk61960sReports inthe medicalliterature1976Resource Conservation and Recovery Act list developed1980sFirst ASHP TechnicalAssistance Bulletin(TAB) on handlinghazardous drugs2004National Institute for Occupational Safety and Health (NIOSH) alert on preventingoccupationalexposure to HDs2010201220142016Revisions to NIOSH alert on preventingoccupationalexposure to HDs2016USP chapter <800> finalized1986OSHA guidelines published 1970sQuestions ofoccupationalexposureVizient Presentation │ 2017 │ Confidential Information 60s70s90s2000s10s80s2018USP chapter <800> becomes official
7. NIOSHNational Institute for Occupational Safety and Health U.S. Centers for Disease Control and PreventionU.S. Department of Health and Human ServicesFederal research agencyFocused on the study of worker safety and healthEmpowering employers and workers to create safe and healthy workplacesMaking recommendations for the prevention of work-related injury and illnessArea of focusHazardous drug exposures in health carePublicationNIOSH Alert: Preventing Occupational Exposures to Antineoplastic and other Hazardous Drugs in Healthcare Settings Vizient Presentation │ 2017 │ Confidential Information 7
8. NIOSH AlertPreventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings, 2004Identified a sample list of major hazardous drugsRecommendationsNIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016Latest updated list of hazardous drugsVizient Presentation │ 2017 │ Confidential Information 8
9. Defining hazardous drugsNIOSH list of anti-neoplastic and other hazardous drugs in health care settings cdc.gov9CharacteristicDescription Carcinogenic A substance or agent that can cause cancerTeratogenic or developmental toxicity A substance or agent capable of producing fetal malformationReproductive toxicityAdverse effects on the male and/or female reproductive systems caused by exposure to a toxic substance or agentOrgan toxicity at lowdoses Toxicity of an organ by a pharmaceutical when it is administered in low dosesGenotoxicA substance or agent causing deleterious action on a cell's genetic material affecting its integrity; the degree to which something causes damage to or mutation of DNASimilar drugs New drugs whose structure and toxicity are similar to existing drugs determined hazardous by the above criteriaVizient Presentation │ 2017 │ Confidential Information
10. ClassificationGroup 1: Anti-neoplastic drugs (AHFS classification 10:00) [ASHP/AHFS DI 2016]Group 2: Non-anti-neoplastic drugs that meet one or more of the NIOSH criteria for a hazardous drugGroup 3: Drugs that primarily pose a reproductive risk to men and women who are actively trying to conceive and women who are pregnant or breast feeding, because some of these drugs may be present in breast milkVizient Presentation │ 2017 │ Confidential Information 10NIOSH [2016]. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings, 2016. By Connor TH, MacKenzie BA, DeBord DG, Trout DB, O’Callaghan JP. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication Number 2016-161 (Supersedes 2014-138).
11. NIOSH list 201611Group 1AfatinibEnzalutamideRegorafenibAxitinibHistrelinTrabectedinBelinostat*Ixazomib*Trametinib BosutinibPanobinostat*Trifluridine/tipiracil (combination only)*CabozantinibPertuzumabVismodegibCarfilzomibPomalidomide*Ziv-afliberceptDabrafenibPonatinibSource: cdc.gov pdf* Has manufacturers’ safe-handling guidelinesVizient Presentation │ 2017 │ Confidential Information
12. NIOSH list 201612Group 2Group 3MethimazoleClomipheneMipomersenEslicarbazepineOspemifeneLomitapidePaliperidoneMacitentanTeriflunomidePamidronateTofacitinibPasireotidePeginesatideRiociguatTemazepamVizient Presentation │ 2017 │ Confidential Information Source: cdc.gov pdf
13. Create hazardous drug listFacility-specific list of HDs Any HD stored, transported or otherwise handled in your facilityNon-formularyInvestigational drugsReviewed at least every 12 monthsContainment requirementsAny HD active pharmaceutical ingredient and any anti-neoplastic HD requiring manipulation must follow the requirements in USP chapter <800>All other HDs may follow all containment strategies defined in USP chapter <800> or an assessment of risk must be performed and implemented13Vizient Presentation │ 2017 │ Confidential Information
14. Development of standard operating procedures Vizient Presentation │ 2017 │ Confidential Information 14ReceiptPatient-care activitiesWasteStorageDispensingTransportSpillsCompoundingAdministration
15. Recommended standard operating procedures Hazard communication programOccupational safety programDesignation of HD areasReceiptStorageCompoundingUse and maintenance of proper engineering controls Hand hygiene and use of PPE based on activity Deactivation, decontamination, cleaning and disinfectionDispensingTransportAdministeringEnvironmental monitoring (e.g., wipe sampling)DisposalSpill controlMedical surveillance15Vizient Presentation │ 2017 │ Confidential Information
16. Pharmacy buyer dutiesVizient Presentation │ 2017 │ Confidential Information 16
17. Receipt and unpackingUSP Chapter <800> requirements17Anti-neoplastic HDs and all HD active pharmaceutical ingredient (API) must be unpacked in an area that isneutral/normal or negative pressure relative to the surrounding areas. HDs must not be unpacked from their external shipping containers in sterile compounding areas or in positive pressure areas.Storage of HDsAnti-neoplastic HDs requiring manipulation (including refrigerated anti-neoplastic HDs) and any HD API must be stored separately from non-HDs. These HDs must be stored in an externally ventilated, negative-pressure room with at least 12 air changes per hour (ACPH). Non-anti-neoplastic, reproductive risk only and final dosage forms of antineoplastic HDs may be stored with other inventory if permitted by entity policy. Nonsterile HD compounding Must follow standards in Pharmaceutical Compounding—Nonsterile Preparations <795>. A C-PEC is not required if manipulations are limited to handling of final dosage forms that do not produce particles, aerosols or gasses.Sterile HD compounding Must follow standards in Pharmaceutical Compounding— Sterile Preparations <797>. A laminar airflow workbench (LAFW) or compounding aseptic isolator (CAI) must not be used for the compounding of an anti-neoplastic HD. Vizient Presentation │ 2017 │ Confidential Information
18. OrderingHD identificationSeparated from non-HDs WholesalerSeparate purchase orderBest PracticeOuter container or toteSingle container if possibleEnclosed in impervious plasticAssessment of risk for Group 1 and 2 HDsVizient Presentation │ 2017 │ Confidential Information 18
19. ReceivingProtocolDesignated areaPressureAppropriate PPESupplies neededSpill kitInspect inventoryTransport to storage areaInventory into systemVizient Presentation │ 2017 │ Confidential Information 19
20. USP Chapter <800> summary of requirements for receiving and handling damaged HD shipping containersIf the shipping containerappears damaged• Seal container without opening and contact the supplier• If the unopened package is to be returned to the supplier, enclose the package in an impervious container and label the outer container "Hazardous"• If the supplier declines return, dispose of as hazardous wasteIf a damaged shippingcontainer must be opened• Seal the container in plastic or an impervious container• Transport it to a C-PEC and place on a plastic-backed preparation mat• Open the package and remove undamaged items• Wipe the outside of the undamaged items with a disposable wipe• Enclose the damaged item(s) in an impervious container and label the outer container "Hazardous"• If the supplier declines return, dispose of as hazardous waste• Deactivate, decontaminate, and clean the C-PEC (and discard the mat and cleaning disposables as hazardous wasteVizient Presentation │ 2017│ Confidential Information20
21. StoringIn containers that minimize the risk of breakage and leakageNon-sterile and sterile HDs may be stored togetherExcept HD storage in a sterile compounding buffer area shall be limited to HDs used for sterile compoundingAntineoplastic HDs requiring manipulation and any HD API must be stored separately Includes refrigerated HDsMust be stored in a room that hasNegative pressureAt least 12 air changes per hour (ACPH)Non-antineoplastic, reproductive risk only, and final dosage forms of antineoplastic HDs may be stored with other inventoryVizient Presentation │ 2017 │ Confidential Information 21
22. Other considerationsLabelingHDs requiring special handling precautions must be clearly labeled at all timesPackagingMaintain physical integrity, stability, and sterility during transport Packaging materialsProtect the HD from damage, leakage, contamination, and degradationProtect healthcare workers who transport HDsTransportIn containers that minimize the risk of breakage or leakagePneumatic tubes must not be used to transport any liquid HDs or any antineoplastic HDsDisposalVizient Presentation │ 2017 │ Confidential Information 22
23. Personnel trainingAll personnel who handle HDs must be trained based on their job functions. Training must occur before the employee independently handles HDs. The effectiveness of training for HD handling competencies must be demonstrated by each employee.Personnel competency must be reassessed at least every 12 months.All training and competency assessments must be documented.23Vizient Presentation │ 2017 │ Confidential Information
24. Personnel trainingOverview of facility-specific list of HDs and their risksReview of the entity's standard operating procedures related to the handling of HDsProper use of PPEProper use of equipment and devices Response to known or suspected HD exposureSpill managementProper disposal of HDs and trace-contaminated materials24Vizient Presentation │ 2017 │ Confidential Information
25. Questions?Vizient Presentation │ 2017 │ Confidential Information 25
26. Contact Katrina Harper at katrina.harper@vizientinc.comfor more information.