Compliance with USP 800

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Laureen Gilbert
5 years ago
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2 Disclosure Patricia Kienle is an employee and stockholder of Cardinal Health She is an elected member and Vice Chair of the USP Compounding Expert Committee, but this talk is not endorsed by or affiliated with USP She authored the ASHP upcoming publication The 800 Answer Book and is a contributor to Competence Assessment Tools for Health System Pharmacies All Rights Reserved. 2

Neither PESG nor any accrediting organization supports or

4 Disclosure This continuing education activity is managed and accredited by Professional Education Services Group. Neither PESG nor any accrediting organization supports or endorses any product or service mentioned in this activity All Rights Reserved. 4

6 Learning Objectives At the conclusion of this activity, the participant will be able to: Discuss the three categories of hazardous drugs Describe elements of an Assessment of Risk Review facility design options for compounding hazardous drugs Discuss the garbing requirements and cleaning process when compounding hazardous drugs All Rights Reserved. 6

10 Preventing Occupational Exposure Warning! Working with or near hazardous drugs in health care settings may cause skin rashes, infertility, miscarriage, birth defects, and possibly leukemia or other cancers * NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings, All Rights Reserved. 10

11 Evidence: Health Effects 1960s 1970s 1980s 1990s Link between alkylating agents and leukemias Occupational exposure safety Antineoplastics and adverse reproductive effects Link of cancer in healthcare workers to exposure to antineoplastics All Rights Reserved. 11

12 Occupational Hazard Characteristics Genotoxicity (mutagenicity) Carcinogenicity in animal models Teratogenicity or fertility impairment Evidence of serious organ or other toxicity at low doses All Rights Reserved. 12

15 Current List of HD Criteria Carcinogens Genotoxins Teratogens Reproductive toxins Organ toxicity at low doses Types of HDs Structure or toxicity similar to other drugs classified as hazardous All Rights Reserved. 15

16 NIOSH Alert, 2004 Background Potential for worker exposure Conditions for exposure Exposure routes Evidence for worker exposure Evidence for health effects in workers Current standards and recommendations * 165/pdfs/ pdf All Rights Reserved. 16

20 Why <800>? Recognition that there is no federal standard that protects workers from hazardous drug exposure Professional organizational guidance documents are not regulations USP is recognized in the federal Food, Drug, and Cosmetic Act USP chapters numbered under <1000> are federally enforceable standards * Courtesy of United States Pharmacopeial Convention All Rights Reserved. 20

21 Development of USP <800> USP Compounding Expert Committee Subcommittee on Hazardous Drugs USP Expert Panel on Hazardous Drugs Pharmacy Nursing Medicine Engineering Industrial hygiene Certification All Rights Reserved. 21

22 USP <800> Handling Hazardous Drugs To promote patient safety, worker safety, and environmental protection when handling hazardous drugs (HDs) Addresses, but is not limited to Receipt Storage Compounding Dispensing Administration Disposal All Rights Reserved. 22

23 USP <800> Handling Hazardous Drugs (cont d) Applies to all healthcare personnel who handle hazardous drugs Applies to all healthcare entities that store, prepare, transport, or administer hazardous drugs Becomes federally enforceable on July 1, All Rights Reserved. 23

26 Major Components of USP <800> Facilities Assessment of risk Other elements Personnel acknowledgement Medical surveillance Education and training Personal Protective Equipment Use of closed system drug transfer devices (CSTDs) Environmental monitoring All Rights Reserved. 26

28 NIOSH List Disclaimer Some drugs defined as hazardous may not pose a significant risk of direct occupational exposure because of their dosage formulation (for example, intact medications such as coated tablets or capsules that are administered to patients without modifying the formulation). However, they may pose a risk if solid drug formulations are altered outside a ventilated cabinet (for example, if tablets are crushed or dissolved, or if capsules are pierced or opened) All Rights Reserved. 28

31 Your List All containment strategies in <800> API of any hazardous drugs on the list Antineoplastics you have to manipulate Items that don t fit your Assessment of Risk approach Alternative containment strategies Antineoplastics you only need to count or package Non antineoplastics Reproductive hazards All Rights Reserved. 31

32 Receipt of Hazardous Drugs Supplier should mark containers Can be received in either a neutral / normal or negative pressure area (NOT in positive pressure) Receiving personnel need to assess the integrity of the container You must provide: Chemotherapy gloves Chemotherapy spill kit All Rights Reserved. 32

34 Engineering Controls Primary (PEC) Containment Ventilated Enclosure (CVE) Biological Safety Cabinet (BSC) Compounding Aseptic Containment Isolator (CACI) Secondary (SEC) The room in which the PEC is placed Supplemental Closed system drug transfer devices All Rights Reserved. 34

35 Hazardous Drug Storage and Compounding Contain the hazard Separate room with fixed walls Negative pressure Remove and dilute the hazard Vented to the outside Appropriate number of air changes per hour (ACPH) These are the minimum requirements All Rights Reserved. 35

36 Design for Non sterile Compounding Primary Engineering Control Containment ventilated enclosure ( powder hood ) Secondary Engineering Control Room that is separate from non hazardous drugs, and is under negative pressure, vented to the outside, and has at least 12 air changes per hour (ACPH) Occasional nonsterile compounding can be done in the sterile compounding area; details are in USP <800> All Rights Reserved. 36

37 Two Options for Sterile Compounding Cleanroom suite Positive pressure ISO 7 anteroom opening into externally vented, negative pressure ISO 7 buffer room with at least 30 ACPH and an externally vented PEC [either a biological safety cabinet (BSC) or a compounding aseptic containment isolator (CACI)] All Rights Reserved. 37

38 Two Options for Sterile Compounding (cont d) Containment Segregated Compounding Area Room that is separate from non hazardous drugs, under negative pressure, vented to the outside, with at least 12 air changes per hour (ACPH) and an externally vented PEC [either a biological safety cabinet (BSC) or a compounding aseptic containment isolator (CACI)] Limited to 12 hour beyond use time (BUD) NOTE: Not currently allowed by <797> Low volume exemption is no longer allowed All Rights Reserved. 38

39 Equipment Requirements Clean equipment should be dedicated for use with HDs and should be decontaminated after every use. Tablet and capsule forms of antineoplastic HDs must not be placed in automated counting or packaging machines, which subject them to stress and may create powdered contaminants All Rights Reserved. 39

40 Equipment Requirements (cont d) Disposable or clean equipment for compounding (such as mortars and pestles, and spatulas) must be dedicated for use with HDs. All areas where HDs are handled and all reusable equipment and devices must be deactivated, decontaminated, and cleaned. Additionally, sterile compounding areas and devices must be subsequently disinfected All Rights Reserved. 40

41 Personnel Acknowledgement of risk of handling hazardous drugs Training USP <795> for nonsterile compounding USP <797> for sterile compounding State Board regulations Proper use of equipment and devices Monitoring for sterile compounding Media fill test Gloved fingertip test * Acknowledgement form available at All Rights Reserved. 41

44 Eye protection Other Garb Issues BSC / CACI provide eye protection Use goggles when working outside a PEC Respirators Use when outside a PEC All garb is required when using a CACI All Rights Reserved. 44

45 Closed System Drug Transfer Devices CSTDs mechanically prohibit the transfer of environmental contaminants into the system and the escape of HD or vapor concentrations outside the system NIOSH has published a proposed performance protocol Photo courtesy of BD All Rights Reserved. 45

46 Cleaning Processes Deactivate Decontaminate Clean Disinfect Step Agent Properly diluted EPA approved oxidizer intended for use with hazardous drugs Germicidal detergent Sterile isopropyl alcohol All Rights Reserved. 46

48 Medical Surveillance Recommended by <800> Requirement to follow organizational policies Consider Health questionnaire History of exposure to HDs Record of acute exposure (spills) CBC with diff * solutions/ /pdfs/ pdf All Rights Reserved. 48

49 Environmental Monitoring <797> requires EM to detect microbial contamination <800> recommends wipe samples to detect rogue hazardous drug contamination Screenshot courtesy of ChemoGlo All Rights Reserved. 49

50 How <800> Differs from <795> Requirement of Primary Engineering Control Requirement of negative pressure Secondary Engineering Control Can be a containment segregated compounding area PEC may be either externally vented (preferred) or have redundant HEPA filters SEC must be externally vented All Rights Reserved. 50

51 How <800> Differs from <797> All compounding must be performed in negative pressure No exemption for low volume of CSPs mixed Requirement for Supplemental Engineering Controls for administration of hazardous drugs When the dosage form allows All Rights Reserved. 51

64 Each Room Has its own designation of tasks Room 300: Any research materials, formulation development, MD calls, etc. is done here Rx checking is done here Most of paperwork is kept out of the lab and stored / done here to create a clutter free environment & decrease dust / detritus in lab Room 400 Gowning, garbing as well as de garbing from non NIOSH compounding All Rights Reserved. 64

65 Each Room Room 600 Boxes of incoming chemicals are opened & invoiced here Boxes are broken down and disposed of in appropriate trash containers here (NIOSH, non NIOSH) immediately after invoicing is done Inventory is invoiced in The Compounder, barcodes are generated, and quarantine happens here, as well as unopened bulk chemical storage and expired raw ingredients / compounds bins Vented to outside after air passes through a HEPA filter Room 700 Non NIOSH open bottle storage and compounding All Rights Reserved. 65

67 Room 800 Separated from Room 700 by a medical grade sliding glass door Seals perfectly all around Non touch (motion sensor pad for hand motion) to open Emergency open by pushing door out if in 800 room to escape More negative than 700 room When door opens, nothing gets out, air from 700 room will be sucked into 800 room All air is vented out after passing through HEPA filter All Rights Reserved. 67

70 Room 800 Contains duplicate filler ingredients Microcrystalline cellulose, capsules, bases, etc. that are used only in compounding with NIOSH listed medications All open containers of NIOSH listed chemicals are stored in this room Any solid dosage forms (tablets) that are NIOSH rated and used in compounding are stored in this room All Rights Reserved. 70

71 Room 800 (cont d) All equipment is duplicated and specifically marked for utilization only in this room Mortars, pestles, spatulas, etc. are marked with red electrical tape or some red marking that is as permanent as possible and not impacting compounding (this included chemicals / drugs) EMP, hoods, balances, etc. are dedicated to this room they are not used for any other compounding, nor are they moved between rooms for use (maintenance is acceptable) All Rights Reserved. 71

72 Cleaning Room 800 All equipment that is used is sprayed down with 70% IPA prior to being removed from hood, and excess material is wiped off Equipment is then placed in a bleach / water mixture (no defined ratio per USP, but is a required decontamination step bleach or peroxide) in black tubs All Rights Reserved. 72

73 Cleaning (cont d) Room 800 Tubs are removed from Room 800 at the end of the day and cleaned in a sink with separate sponge / cleaning materials Not washed at the same time as non NIOSH related items Washed after non NIOSH related items have been cleaned Dishwasher is NOT utilized for NIOSH related item cleaning All Rights Reserved. 73

74 Cleaning (cont d) Room 800 Room 800 is cleaned stem to stern once a month with sanitizing agents, as is the rest of the lab (Cidecon & acidified bleach rotated each month) Weekly cleaning all vertical surfaces, trash bins, etc. are cleaned with 70% IPA all areas of lab All Rights Reserved. 74

75 Garbing Room 800 Dressing for primary garb (Room 700 standard garb) is done in Room 400 Booties, hair net, disposable gown, N 95 (R 95 is optional) facemask, long cuff gloves worn over gown cuff, goggles when applicable All Rights Reserved. 75

76 Room 800 Garbing (cont d) Upon entering Room 800, a second layer is donned Step onto dedicated floor space marked by green electrical tape, closest to cabinets Second gown, non absorbent, chemo rated, rear fastening is donned on top of primary gown 2 nd set of booties placed on feet Second set of gloves placed on hands, chemo rated, over cuffs of second gown All Rights Reserved. 76

78 Room 800 Gowning While someone is compounding in Room 800, they are to be disturbed as least as possible, whether over the phone system or by entering the room Before leaving the room, outer garb (potentially contaminated) is removed and disposed of in NIOSH trash All Rights Reserved. 78

79 Room 800 (cont d) Trash Is in dedicated bins, lined with biohazard trash bags, which are goose necked prior to removal from the room, and stored in cardboard containers in the basement (clearly marked, dedicated by the removal company) and picked up by a hazardous waste company which generates an EPA required form for disposal of boxed trash All Rights Reserved. 79

Improving the Safety of Compounded Preparations - USP <800> Compliance in Every Day Practice

Improving the Safety of Compounded Preparations - USP Compliance in Every Day Practice PSSNY Annual Convention, Westchester Hilton, Rye Brook, NY Sunday, June 25th at 9:00 AM Lou Diorio, RPh, FAPhA