Implementing USP 800 ASHLEY DUTY, PHARMD, MS JOANNA ROBINSON, PHARMD, MS

Transcription

1 Implementing USP 800 ASHLEY DUTY, PHARMD, MS JOANNA ROBINSON, PHARMD, MS

2 Disclosure Ashley Duty has no conflicts of interest to disclose Joanna Robinson has no conflicts of interest to disclose

3 Objectives 1. Understand the purpose of USP Describe how to engage key stakeholders and implement the required elements of USP Explain what resources are available to implement USP 800 standards

4 Overview Background Basic definitions Gap analysis Assessment of risk Non-Sterile Compounding

5 Background Awareness of risk Per the CDC, 8 million healthcare workers are potentially exposed 1 Presence of chemotherapy in urine of healthcare workers 2 Long-term repercussions of hazardous drug exposure Guidance documents previously released: Oncology Nursing Society (ONS) in 1984 Occupational Safety and Health Administration (OSHA) in 1986 American Society of Health-System Pharmacists (ASHP) in Hazardous Drug Exposures in Health Care. Centers for Disease Control and Prevention. 15 Sept Web. 20 Feb Sorsa M, Anderson D. Monitoring of occupational exposure to cytostatic anticancer agents. Mutation Research 355 (1996):

6 Background Release of the USP 800 chapter is a call to action Enforceable standard State BOP and other regulatory bodies can require compliance 6

7 Background- Scope of USP 800 Receiving Storage Manipulating Administration Disposal 7

8 Background- USP 800 Timeline March 2014 Chapter first published for public comment December 2014 Revisions published, round 2 of public comment February 2016 Final version published in USP-NF July 1, 2018 Federally enforceable 463 Days

9 Background USP 800 Chapter Overview List of Hazardous Medications Personal Protective Equipment (PPE) Facilities Design Handling Hazardous Medications Cleaning Medical Surveillance 9

10 Basic Definitions Acronym in USP 800 CPEC CSEC CSCA Should Shall or Must Definition Containment Primary Engineering Control Containment Secondary Engineering Control Containment Segregated Compounding Area What it really means The hood The room the hood is in Segregated area, no requirement for ISO classification Recommendation Requirement

11 CPEC: Types of hoods Laminar Airflow Workbench (LAFW) Horizontal Airflow Most common hood found in IV rooms Can NOT be used for HD compounding Biological Safety Cabinet (BSC) Vertical Airflow Often referred to as a Chemo hood Classes and Types with % air recirculation Glove boxes Compounding Aseptic Isolator (CAI)- POSITIVE pressure Compounding Aseptic Containment Isolator (CACI)- NEGATIVE pressure 11

12 CPEC: Sterile Compounding of HDs Must be performed in a CPEC within a separate room with ISO Class 5 air Laminar airflow workbench (LAFW) or Compounding Aseptic Isolator (CAI) can NOT be used for compounding HDs

13 Changes from <797> Elimination of low-volume exemption currently in <797> All HDs must be compounded in BSC or CACI in a negative pressure room Allowance for CSCA Storage under negative pressure 13

14 Gap Analysis 14

15 Conducting a Gap Analysis Compare the best practices with the processes currently in place in your organization Determine the gaps between your organization s practices and the identified best practices Select the best practices you will implement in your organization Get organized! 15

16 Conducting a Gap Analysis Example Current State 65% of hospitalized patients have received the influenza vaccine for Desired State 100% of hospitalized patients have received the influenza vaccine for Identified Gap 35% of hospitalized patients need to receive the influenza vaccine for Barriers to Implementation Misconceptions about vaccination Appropriate documentation about vaccination history Vaccine supply issues 16

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18 Hazmedsafety.com 18

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20 Hazmedsafety.com 20

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22 Hazmedsafety.com 22

23 800gaptool.com 23

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26 800gaptool.com 26

27 Gap Analysis at Children s Mercy Analyzed USP <800> by section to identify actionable items Created spreadsheet for each item with notes on Necessary changes Responsible individuals Policies that need updated Status Update frequently based on new information and item completion 27

28 Gap Analysis at Children s Mercy 28

29 What a Gap Analysis Cannot Do Show all complexities of the problem that may exist Implementation work Education to staff Minimize barriers to compliance 29

30 Completing an Assessment of Risk 30

31 NIOSH List National Institute for Occupational Safety and Health Updated every two years Three classifications oantineoplastic onon-antineoplastic oreproductive only 31

32 Everything must follow all USP 800 rules Complete an assessment of risk 32

33 Consider Colchicine Fluconazole Paroxetine 33

34 What Qualifies? NIOSH TABLE 1: ANTINEOPLASTIC Requires manipulation Ex: crushing methotrexate tablets Must follow all USP 800 precautions Final dosage form with no manipulation Ex: counting methotrexate tablets Perform assessment of risk for these agents NIOSH TABLE 2 AND 3: NON-ANTINEOPLASTIC AND REPRODUCTIVE ONLY Can perform an assessment of risk for all items Unless using active pharmaceutical ingredients (API) 34

35 Use NIOSH list to create a facility list of hazardous drugs Incorporate into hazardous drug policy and get approval through organization s policy process Review at least annually Separate into two categories API or antineoplastics requiring manipulation Everything else Determine strategies to minimize exposure to employees Evaluate current policies to ensure congruence Create a form to evaluate each dosage form in the everything else list and perform assessment Performing an Assessment of Risk Improving Safe Handling Practices for Hazardous Drugs. Joint Commission Resources

36 Consider These Actions Receipt from wholesaler Transport to storage Storage Transport to and from Compounding areas (sterile and nonsterile) Dispensing area Prepacking area Administration area Offsite area Deactivating, decontaminating, and disinfecting compounding and administration areas Including spills Administration Disposal Education of staff Improving Safe Handling Practices for Hazardous Drugs. Joint Commission Resources

37 Children s Mercy Assessment of Risk NIOSH list evaluated by pharmacists Two classification of drugs Cytotoxic Hazardous Upgrades Asparaginase Isotretinoin Historical items Alemtuzumab Rituximab Pentamidine Update list in Handling Cytotoxic and Hazardous Agents policy Nursing Practice Council P&T Committee Hospital executives 37

38 Children s Mercy Assessment of Risk Collaboration with Children s Hospital Association members Creation of Access database Meet with Nursing and Environmental Services to discuss proposed handling rules 38

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40 Tips Prioritize your concerns and implement those first Respectfully remind other departments that USP 800 is not a pharmacy issue Be reasonable when deciding how to handle items on Table 2 and Table 3 40

41 Non-Sterile HD Compounding 41

42 Non-Sterile HD Compounding Definition of Compounding: United States Pharmacopeia Chapter 800- Hazardous Drugs- Handling in Healthcare Settings

43 Repackaging USP 800 eliminates the ability to repackage tablets in packaging machines Risk of crushing and exposure Cytotoxic vs. hazardous Assessment of risk Buy unit dose Blister packaging 43

44 It s not just cleaning anymore Deactivate Renders the compound inert or inactive Decontaminate Inactivating, neutralizing, or physically removing hazardous residue Cleaning Process to remove contaminants from objects and surfaces using water, detergents, surfactants, solvents Disinfect Inhibiting or destroying microorganisms 44

45 Closing Thoughts USP 800 is a minimum requirement It is a supplement to USP 795 and 797 and does not replace it Sensitivity of messaging 45

46 Questions 46