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1 Update on Sterile Compounding in Health Systems: Opportunities and Challenges Louis S. Diorio, RPh, FAPhA Susan J. Schniepp Fred Massoomi, PharmD, FASHP Supported by an educational grant from PharMEDium Services, LLC. CE Activity Information Accreditation: 1.5 contact hours for pharmacists Proof of completion will be posted to your NABP CPE Monitor profile Funding: This CE activity is supported by an educational grant from PharMEDium Services, LLC. 2 1

2 Faculty Louis S. Diorio, RPh, FAPhA Principal LDT Health Solutions, Inc. Susan J. Schniepp Distinguished Fellow Regulatory Compliance Associates, Inc. Fred Massoomi, Pharm.D., FASHP Senior Director of Health system & Hospital Services Visante, Inc. Mr. Diorio is an employee and shareholder of LDT Health Solutions, Inc. and has served as a speaker for Grifols USA and Spectrum Pharmacy Products. Dr. Massoomi is an employee consultant for Visante, Inc. and has served as a speaker for Baxter, Equashield, Hospira, and ICU Medical, and as a writer for BD. Ms. Schniepp has served as a consultant for Regulatory Compliance Associates, as an auditor for NSF, and as a consultant for PharMEDium Services, LLC. Content review and conflict resolution conducted by James Dorociak, PharmD, MSc. Dr. Dorociak has no relevant financial relationships to disclose. 3 Improving the Safety of Compounded Sterile Preparations USP <797> Changes are coming How will this impact your practice? Lou Diorio, RPh, FAPhA Principal LDT Health Solutions, Inc. 2

3 Session Objectives Describe the current landscape of the United States Pharmacopeia (USP) Compounding Chapters Identify the environmental control requirements for sterile compounding Describe batch testing and the role batch testing can play to increase the safety of sterile compounding Discuss health system pharmacy accountability related to sterile compounding procedures Outline pharmacy leadership strategies for managing the increasing regulated environment while providing optimal patient care services 5 Acknowledgements The presenter would like to thank the following colleagues for their assistance & guidance in assembling these materials: Art Chaput, RPh, PharmD Patricia C. Kienle, MPA, BS Pharm, FASHP Eric Kastango, RPh, MBA, FASHP Dave Thomas, RPh, MBA 6 3

4 How Did We Get Here? 7 Can Tragedies Like NECC Be Prevented in the Future? The short answer is that there are NO Guarantees! Constant vigilance is in order! Know the limits of your Pharmacy Practice Act. Be familiar with all the moving parts: USP <71> [Sterility Testing] USP <85> [Endotoxin Testing] USP <795> [Non-Sterile Compounding] USP <797> [Sterile Compounding] USP <800> [Handling of HD in Healthcare Settings] DQSA [The Drug Quality & Security Act] NIOSH & OSHA regulation 8 4

5 Are You Comfortable Knowing How All the Pieces Fit Together? 9 Hospital Director of Pharmacy FOCUS The Balance of Priorities is KEY! DOH Compliance FDA Compliance TJC What are the Hospital Administration's Priorities? BOP Compliance Director of Pharmacy CMS Compliance DEA Compliance Individual Hospital Conditions Could Intensify Some of these Intersections 10 5

6 FDA Guidance on Compounding Since July 2014 the FDA has issued 27 Guidance documents or Regulatory Policy Statements impacting Pharmacy Practice Addressing the following topics: Insanitary Conditions at Compounding Facilities Pharmacy Compounding of Human Drugs / 503A 503B Outsourcing Facilities [Registration, Fees, General Facilities] Use of Bulk Drug Substances [A / B] Hospital & Health System Compounding Compounded Products that are Essentially Copies of Approved Drug Products [503A / 503B] Mixing, Diluting, or Repackaging of Biological Products Relevant FDA Guidance Documents FDA Compliance Program Guidance (CPGs) Insanitary Conditions at Compounding Facilities Guidance for Industry Draft Guidance (8.3.16) Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act - October Compounding and Related Documents (Revision 1) Sterile Drug Products Produced by Aseptic Processing Current Good Manufacturing Practice - Guidance for Industry (September 2004) Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act - Guidance for Industry - Draft Guidance (04/15/16) Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act - Guidance for Industry (PDF - 81KB) - Draft Guidance (04/15/16) Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act - Draft Guidance (04/15/16)

7 When considering FDA Guidance Documents, which statement is TRUE? A. They do not establish legally enforceable responsibilities B. They reflect the Agency's current thinking of a topic C. Unless backed by a specific regulation, they are recommendations D. All of the above are TRUE 13 FDA 503A and 503B Pharmacy Top 25 Observations as of 4/30/2017 B01 Observation Occurences Percentage 1 Aseptic processing areas are deficient regarding the system for monitoring environmental conditions % 2 Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions % 3 Clothing of personnel engaged in the manufacturing, processing, packing, and holding of drug products is not appropriate for the duties they perform % 4 Procedures designed toprevent microbiological contamination ofdrug productspurporting to besterile arenot established, written, andfollowed % 5 Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process % 6 There is no written testing program designed to assess the stability characteristics of drug products % 7 Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity % and strength of each active ingredient prior to release. 8 There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the % batch has been already distributed. 9 Each batch of drug product purporting to be sterile and pyrogen free is not laboratory tested to determine conformance to such requirements % 10 Separate or defined areas to prevent contamination or mix ups are deficient regarding operations related to aseptic processing of drug products % 11 Aseptic processing areas are deficient regarding air supply that is filtered through high efficiency particulate air filters under positive pressure % 12 The labels of your outsourcing facility's drug products do not include the information required by section 503B(a)(10)(A)&(B) % 13 Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing % 14 Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions % 15 Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, % strength, quality or purity of the drug product. 16 Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test procedures designed to assure that drug products % conform to appropriate standards of identity, strength, quality and purity. 17 Routine calibration and inspection of mechanical and electronic equipment is not performed according to a written program designed to assure proper performance % 18 Batch production and control records do not include complete information relating to the production and control of each batch % 19 Drug product containers and closures were not clean and sterilized andprocessedto remove pyrogenic properties to assure that they are suitable for their intended use % 20 Buildings used in the manufacture, processing, packing, or holding of adrug product do not have the suitable size, construction, and location to facilitate cleaning, % maintenance, and proper operations. 21 There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport % or are represented to possess. 22 Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning % and maintenance. 23 The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed % 24 Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition % 25 Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product % Facilities: 328 Inspections: 420 Inspectiors: 320 States: 43 Districts: 20 Regions: 6 LDT Health Solutions, Inc Sunday, April 30,2017 Page 1of 1 7

8 FDA by the Numbers (as of ) Since the NECC tragedy the FDA has Visited at least 320 facilities Issued 420 FDA Form 483s to those facilities [From 20 different Field Offices in 43 States!] 15 FDA by the Numbers (as of ) Warning Letters Issued 168 in total To 151 different Facilities They were issued by FDA 48 days minimum 368 days on average 1,249 days maximum! 16 8

9 FDA by the Numbers (as of ) When the FDA walks in the door to inspect your pharmacy, you can expect Team will most likely be 2 agents They will stay about 6.8 days total They will write up 7.6 observations on the FDA Form 483 they leave behind! Compounders within the coverage areas of the Dallas, Los Angeles, Tampa & Nashville FDA Field Offices are more likely to be visited. 17 Since Hospitals are registered by their local Boards of Pharmacy, admittance of FDA to the establishment is voluntary. A. True B. False 18 9

10 USP Chapter <797> Sections Definitions Responsibilities of compounding personnel CSP microbial contamination risk levels Personnel training and evaluation in aseptic manipulation skills Immediate use CSPs Single-dose and Multiple-dose containers Hazardous drugs as CSPs Radiopharmaceuticals as CSPs Allergen Extracts as CSPs Verification of Compounding Accuracy and Sterility Environmental Quality and Control Suggested Standard Operating Procedures (SOPs) Elements of Quality Control Verification of Automated Compounding Devices (ACDs) for Parenteral Nutrition Compounding Finished preparation release checks and tests Storage and beyond-use-dating Maintaining Sterility, Purity, and stability of Dispensed and Distributed CSPs Patient or Caregiver training Patient monitoring and adverse event reporting The Quality Assurance (QA) Program Abbreviations and Acronyms Appendices I-V 19 Which of the following is NOT one of the central themes of USP <797>? A. Control of the compounding environment B. Control of the compounding personnel s actions C. Control of the compounding process D. ALL of the above are central safety themes of <797> 20 10

11 USP General Chapter <797> Is about 3 things CONTROL! CONTROL! CONTROL! Control of the compounding personnel Control of the compounding environment Control of the compounding processes 21 Personal Training and Evaluation in Aseptic Manipulation Skills Personnel who prepare CSPs shall be trained conscientiously and skillfully by expert personnel and through audio-video instructional sources and professional publications in the theoretical principles and practical skills of aseptic manipulations and in achieving ISO Class 5 environmental conditions before they begin to prepare CSPs. 1 USP<797> Pharmaceutical Compounding Sterile Preparations Revision Bulletin USP 22 11

12 The Responsibility of Compounding Personnel The need to maintain high standards for quality & control of processes, components, and environments and for the skill & knowledge of personnel who prepare CSPs. The USP is the National Standard, so compounding personnel must understand the legal risks of non-compliance. Especially for the Pharmacist-in-Charge / Manager of Record Focus for now should be USP 39 - NF 34! (current chapter) 23 Personal Training and Evaluation in Aseptic Manipulation Skills Aseptic training in pharmacy schools is inadequate or non-existent. Most training occurs OJT and by verbal tradition Training must include didactic instruction in theory and practice of sterile preparation before starting compounding and annually/semi-annually thereafter. Evaluations should include a formal written exam, motor-skills assessment and practical evaluation of aseptic technique using growth media. (c) 2017 LDT Health Solutions, Inc

13 Which of the following is part of a solid program for the provision of CSPs in Health Systems? A. Solid aseptic training B. Comprehensive gowning, gloving & garbing processes C. Standardized cleaning & disinfection of the controlled areas D. ALL of the above 25 Environmental Quality & Control Aseptic Processing areas must be of proper design - HEPA filtered air introduced at the ceiling Low wall returns Cleanable surfaces, able to stand up to repeated sanitizations Certification of the areas should follow CETA guidance Monitoring of Controls (Temperature / Humidity / Pressurization) Proper Environmental Monitoring semi-annually is NOT enough! Cleaning cycle must include a sporicidal agent. Responses to Viable & Non-Viable contaminations must be appropriate, swift, & measured

14 Cleanroom Cleaning & Disinfecting- for non-hd CSPs [USP <797>] SWFI 70% Sterile IPA Quat Ammonium Cleaner Sporicidal Agent 2% Sterile Bleach Per <797> when dissolution of messy spills is in order Per <797> this is the primary disinfect agent in your cleanroom Needed when a soap is indicated. Sticky spills etc. <797> Primary concern is Maintaining Sterility FDA is advocating the regular use of a sporicidal agent, regardless of ENV monitoring. POINTS to REMEMBERdilution strength & contact time. [as well as residues] A good economical disinfectant, especially if a large volume of solution is needed. Can be used to remove Sporicidal residues. OSHA Corrosive, S Steel could have issues (c) 2017 LDT Health Solutions, Inc. 27 Risk Levels of USP <797> Are you sure how to categorize any compounded, outsourced or contract compounded CSPs you provide to your patients? Low Risk Simple, single dose compounding Medium Risk Using multiple sterile components (i.e. Batch compounding) High Risk Beginning from non sterile components OR rendering sterile components nonsterile during manipulations NO Risk [Low Low Risk] RTU, Pre mixed, or UOU Commercial Doses (c) 2017 LDT Health Solutions, Inc

15 Beyond-Use Dating Applies once a manufacturer's container is opened and the drug product is transferred to another container for dispensing, repackaging, or compounding. The USP has developed recommendations for compounders to assign a BUD on the label of the new container. BUDs cannot exceed the manufacturer's expiration date and often may be much shorter. Unlike expiration dating, there is often little scientific basis for the assignment of BUDs. Theoretical dating periods exceeding 30 days must be supported by appropriate instrumental analysis. Compounders must have their BUD policies in writing! 29 Finding Balance: Chemical Stability vs Sterility Chemical Stability of the CSP Sterility of the Compounded CSP (c) 2017 LDT Health Solutions, Inc

16 Quality Assurance Program Requires formalized policies, controlled processes and clear procedures used in preparing CSPs One element of quality that is not routinely performed in pharmacies is documentation, or written proof that compounding is occurring properly. Photos LDT Health Solutions., Inc. 31 (c) 2017 LDT Health Solutions, Inc. Proposed USP <797> Changes Proposed Major Changes - 3 Risk levels changed to 2 categories distinguished by conditions under which they are made and time within which used Quarterly requirement for Personnel Monitoring (visual observation of hand hygiene and garbing, MFT and on-going GFS BUD and Storage times changes with a maximum BUD of 45 days regardless of sterility testing Removal of HD handling section and crossreference to USP <800> Monthly requirement for Viable Air sampling & Surface sampling Introduction of In-Use-time (time before which conventionally manufactured product or compounded dilution bag must be used after it is punctured) Master formulation and compounding records will be required for all batch and non-sterile compounding New placement requirements on use of isolators New guidance for sterility testing of CSP prepared in batch sizes of less than 40. (10% rule) Requirement for sterile gloves and sterile sleeves, sterile wipers and cleaning tools that need to be resterilized but not sterile disinfectants CHART Clinical IQ, LLC All rights reserved used by permission 32 16

17 Self-Assessment tools (SAT) or GAP Analysis Use a SAT or GAP Analysis to identify organizational points of compliance and operational gaps. High level situational analysis of current state of readiness. Should address- USP <71> <85> <795> <797> <800> FDA CPGs 503A & Hospital and Health System Compounding State and Local Regulation SAT or GAP Analysis will serve as a placeholder for regulatory and accreditation agencies. It is only a starting point! But the best place to start is at the beginning! 33 Developing an Action Plan Focus should be on: Changing the culture Controlled processes and documentation Competency Based Training and Education Compliance to Local, State, and Federal Regulations Patient Safety is always your goal! 34 17

18 Summary / Conclusions There is no substitute for constant vigilance on the part of any professional, compounder, or healthcare provider of CSPs. All professionals must be aware of ALL best practices & prevailing regulation! A comprehensive situational analysis of the compounders current state of compliance is a good first step in the determination of its longrange compliance plan. USP <797> is in place, the time to address the Chapter is NOW! 35 Quality Process Courtesy of LDT Personnel are capable and qualified to perform their assigned duties. Ingredients used in compounding have their expected identity, quality, and purity. Critical processes are validated to ensure that procedures, when used, will consistently result in the expected qualities in the finished preparation. The engineering controls and production environment is suitable for its intended purpose (addressing such matters as environmental cleanliness, control, monitoring, staff attire, and the setting of action limits, as appropriate). There is assurance that processes are always carried out as intended or specified and are under control. Appropriate stability evaluation is performed or determined from the literature for establishing reliable expiration dating to ensure that finished preparations have the expected potency, purity, quality and characteristics at least until the labeled expiration date. Appropriate release checks or testing procedures are performed to ensure that finished CSPs have their expected potency, purity, quality and characteristics at least until the labeled beyond use date. Preparation conditions and procedures are adequate for preventing mix-ups. There are adequate procedures and records for investigating the product, correcting failures or problems in preparation, testing, or in the preparation itself. (c) 2017 LDT Health Solutions, Inc

19 Reading List / Bibliography General Chapter USP <795> <797> <800> Controlled Environmental Testing Association (CETA) Centers for Disease Control & Prevention Pharmacy Purchasing and Products Magazine FDA Website NECC FDA form M pdf Drug Quality & Safety Act OSHA / NIOSH Resources HD Drug list 161/default.html NIOSH Drug Alert 165/default.html Workplace Solutions PPEs solutions/ /pdfs/ pdf DONNING & DOFFING (videos) training/ CSTD (Draft for comment) (c) 2017 LDT Health Solutions, Inc. 37 Reading List / Bibliography Pharmacy Purchasing and Products FDA Website NECC FDA form ORAElectronicReadingRoom/UCM pdf Drug Quality & Safety Act - /ORA/ORAElectronicReadingRoom/UCM pdf Drug Quality & Safety Act - htm Guidance Pharmacy Compounding Guidance Insanitary Conditions Draft August pdf Guidance Aseptic Processing- Guidance-Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry Draft Guidance 04/15/16 Guidance- Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act Guidance for Industry Draft Guidance 04/15/16 Guidance- Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 244KB) Draft Guidance 04/15/

20 Batch Release Testing Why do we do it? What does it mean? Susan Schniepp Distinguished Fellow Regulatory Compliance Associates, Inc. Discussion Topics Batch Release Testing Requirements Regulations Analytical Chemistry Testing Identity Potency Microbiology Testing Sterility Endotoxin Activities Supporting Batch Release Media Fills & Smoke Studies Environmental Monitoring Gowning Air Quality Customer Impact Interpreting the CoA 40 20

21 Regulations Food, Drug, and Cosmetic Act Under section 501(a)(2)(B) of the FD&C Act, a drug is deemed to be adulterated if: the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess Regulations (cont ) Guidance Current Good Manufacturing Practice Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act July 2014 Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act April 2016 Insanitary Conditions at Compounding Facilities August

22 Regulations (cont ) Batch Release Testing Requirements 43 Appropriate specifications must be established for each drug product (see (b)). Specifications must address those attributes necessary to ensure the quality of the finished drug product (see (b)) and should include at a minimum: Identity of the active ingredient Strength of the active ingredient Sterile drug products: Limit for visible particles Statement of Sterility Limit for bacterial endotoxins What batch test requirements are measured using chemistry? A. Identity B. Potency C. ph D. Sterility E. A and B are both correct 44 22

23 Batch Release Testing Chemistry Testing Potency: Measure of the amount of the active ingredient(s) in a particular dosage form Typical Specification Range: 90%-110% (USP) Identification: Definitive Confirmation of the presence of the active ingredient(s) in the dosage form Typical Specification: Conforms to Standard

24 What batch test requirements are measured using microbiology? A. Endotoxin B. Sterility C. Environmental Monitoring D. Media Fills E. A and B are both correct 47 Batch Release Testing Microbiology Testing Sterility: The absence of microbial contamination (pathogens) in the dosage form Typical Specification: Absence of Salmonella, E. coli, etc. Endotoxin: Identification of the level of fever causing microbial by products present in the dosage form Typical Specification: < 0.25 EU/mL 48 24

25 49 Batch Release Testing Other Activities Supporting Batch Release 50 Media Fills & Smoke Studies demonstrates the capability of the process to maintain aseptic conditions during manufacturing Environmental Monitoring ongoing assessment of the facility to maintain an environment conducive to product manufacturing Gowning Monitoring ongoing assessment of the human element and their ability to manufacture while maintaining an environment conducive to aseptic processing Air Quality Part of the EM program monitoring viable and non-viable particulates potentially affecting product quality 25

26 Summary Batch release testing reflects a snapshot of the quality attributes required for product release Although sterility testing is required, the true sterility of a batch is assessed through: Sound environmental/personnel monitoring program Robust cleaning, disinfection & sanitization processes Strong manual aseptic processing technique Bioburden reduction measures Effective gowning procedures 51 Hazardous Drug Handling USP <800> & Beyond Fred Massoomi, Pharm.D., FASHP Senior Director Healthcare & Hospital Services Visante, Inc. 26

27 Source: LA Times; January 24, Trending Now 54 27

28 Hazardous Drug Compounding USP <800> First Release March 2014 Comment Due Date July 31, 2014 Second Release December 2014 Comment Due Date May 31, 2015 Approved February 1, 2016 Official Compliance Date July 1, USP <800> Compliance 57 Chart Ref: State of Pharmacy Compounding 2017; Pharmacy Purchasing and Products; Supplement April 2017, pg

29 Roadmap to Safety Introduction and scope List of Hazardous Drugs Types of exposure Responsibilities of handling HDs Facilities and engineering controls Environmental quality and control Personal protective equipment Hazard communication program Personnel training Receiving Labeling, packaging, transport & disposal Dispensing final dosage forms Compounding Administering Deactivating, decontaminating, cleaning, & disinfecting Spill Control Documentation and standard operating procedures (SOPs) Medical surveillance 58 Compounding Hierarchy Professional Best Practices Industry Best Practices United States Pharmacopeia <800> United States Pharmacopeia <797> & <795> Regulatory Line State Boards of Health &/or Pharmacy Centers for Medicaid & Medicare Services Food and Drug Administration 59 29

30 Hazardous Drug Safety Paradigm OSHA USP 800 Employee Safety USP 797 USP 800 FDA Patient Safety EPA / DOT Public Safety 60 Surveying Bodies for Compounding State Boards of Pharmacy FDA: Food and Drug Administration CMS: Centers for Medicare/Medicaid Services TJC: The Joint Commission DNV Healthcare HFAP: AOA s Healthcare Facilities Accreditation Program ACHC: Accreditation Commission for Healthcare PCAB: Pharmacy Compounding Accreditation Board 61 30

31 Inspecting for <797> Compliance Chart Ref: State of Pharmacy Compounding 2017; Pharmacy Purchasing and Products; Supplement April 2017, pg Surveying Bodies for Compliance Physician Owned Offices If registered as a pharmacy = subject to pharmacy board regulations California, Florida & Texas register if they compound sterile drugs 64 31

32 Introduction & Scope Pharmacists, pharmacy technicians, nurses, physicians, physician assistants, home healthcare workers, vets, and vet technicians Not listed: Manufacturers; Wholesale personnel; Researchers; Family nf/notices/general chapter hazardous drugs handling healthcare settings Copyright 2017 Firouzan Massoomi, 65 Albarello, LLC. All Rights Reserved. Which statement best describes the NIOSH hazardous drug list? A. mirrors the FDA s list of HD s B. is updated approximately every two years C. is divided into different formulations of drugs D. includes all research drugs with potential hazards 66 32

33 List of Hazardous Drugs Must have a list (USP; TJC; NIOSH) Type of HD: antineoplastic; non-antineoplastic; reproductive risk Risk of exposure Updated every 2 years Copyright 2017 Firouzan Massoomi, 67 Albarello, LLC. All Rights Reserved. Types of Exposure Routes of unintentional entry Dermal Mucosal absorption Inhalation Injection Ingestion 69 33

34 Facilities & Engineering Controls Designated areas must be available for HDs: Receipt & unpacking Storage Non sterile compounding Sterile compounding Example: Signage 70 Receipt HDs must be unpacked in designated area Neutral/Negative pressure Storage Must store in manner to prevent spillage/breakage Externally vented, Negative pressure to.01 to 0.03 inch column height 12 air changes per hour (ACPH) 71 34

35 Compounding Containment Primary Engineering Controls (C PEC) Biological Safety Cabinet Class II BSC types A2 or B2 Containment Aseptic Compounding Isolator (CACI) 72 Compounding Containment Secondary Engineering Controls (C SEC) C SEC = The Room Externally vented Physically separated Negative pressure 0.01 and 0.03 inches water column 73 35

36 Close System Transfer Devices (CSTDs) are required for handling hazardous drugs during A. Pharmacy compounding B. Nursing administration C. Both A & B D. Neither A or B 74 Compounding Supplemental Engineering Controls Closed System Transfer Devices CSTDs Pharmacy Compounding: Should Nursing Administration: Must 75 36

37 CSTD Adoption Are we all in? 77 Chart Ref: State of Pharmacy Compounding 2017; Pharmacy Purchasing and Products; Supplement April 2017, pg. 35 FDA Cleared Closed System Transfer Devices Device Manufacturer FDA Cleared FDA ONB BD Phaseal System Becton Dickenson and Company; Carmel Pharma, Inc. (original) Spiros ICU Medical, Inc Non-FDA Type 1998 * Containment Texium with SmartSite OnGuard with Tevadaptor Becton Dickinson and Company; CareFusion, Inc. (original) B. Braun Medical Inc. (U.S. distributor) TEVA Medical, Ltd. (manufacturer) 2006 Air Cleaning 2006 * Air Cleaning ChemoClave ICU Medical, Inc Containment & Air Cleaning Equashield Equashield, LLC; Plastmed, Ltd Containment (original) ChemoLock ICU Medical, Inc * Containment & Air Cleaning ChemoSafety Becton, Dickinson and Company; CareFusion, Inc. (original) 2013 Containment & Air Cleaning EquaShield II Equashield, LLC 2014 * Containment Halo Corvida Medical 2015 * Containment Source: BD & the Joint Commission Resources; Improving safe handling Practices for Hazardous Drugs. Toolkit

38 Drug Administration Must use CSTDs Must pre priming IV tubing with non HD solution Must wear PPE Must avoid manipulation Splitting, crushing, opening capsules Source: Used with permission Seth Eisenberg, RN 79 Noted Exposures Nursing Perspective Table 1. Hazardous Drug Exposure Reported by Nurses Drug Safe Handling Program Frequency Type of Exposure Time Frame 11% - 17% Dermal or eye exposure Previous year 12% - 26% HD spills Previous week 6 months 12% - 24% Took home potentially contaminated clothes No time frame 6% - 8% Sharps injury involving HDs Previous year Source: nurse/2017/march 2017/attitude shift making safe handling of hazardous drugs a priority 80 38

39 Non sterile Compounding Must follow USP <795> C PEC required for some manipulations Cutting Crushing 81 Environmental Quality & Control Recommended BEST PRACTICE every 6 months and following spills 82 39

40 Personal Protective Equipment Head covers Beard covers Eye protection for spill protection Face mask limited safety N 95 mask Disposable Gowns Polyethylene or laminate Close in the back Powered airpurifying respirator for spills 2 pairs Best Practice 2 pairs 84 Don 2 pairs prior to entry Remove outer when leaving Anti-skid Personnel & Training Must have a designated specialist Must be assessed every 12 months Must be trained on new HDs and equipment Must document competencies 85 40

41 Labeling, Packaging & Transport Labeling Precaution clearly labeled Transport Transport containers Must Not transport via pneumatic tubes any liquid HDs 86 Hazardous Waste Management Continuous formulary assessment State and federal regulations DRUG - GENERIC (BRAND) CLASS OF MEDICATION ROUTE/ FORMS COMPANY PREG CAT MSDS BSC HAZ CLASS (1-4) WASTE STREAM RCRA Y/N Cyclophosphamide ONC INJ, ORAL Multiple D YES YES Class 1 RCRA BLACK Y 87 41

42 Deactivation, Decontaminating, Cleaning & Disinfecting 88 Spill Control Must have proper training for spill management Must have spill kits readily available Must address size of spills Best practice Date kits 89 42

43 Nursing report spills occur most frequently in the following scenario? A. IV port/site leaks B. Spiking issues C. Tubing disconnects D. No spills noted in today's environment 90 Specific Spill Scenarios Nursing Perspective 91 43

44 Specialized Patients & Procedures Surgical Bladder installation HOT Chemo Baths Ophthalmic surgery = TOPICAL Esophageal Strictures = TOPICAL Obstetrics Ectopic pregnancy Rheumatology Rheumatoid arthritis Lupus nephritis Neurology Multiple sclerosis Hyperthermic Intraperitoneal Chemotherapy 92 Future Considerations Gene therapy delivery Virus & bacterial delivery Microrobot delivery of drugs Nanotechnology drugs 93 44

45 Evolution Towards Safety First and Second Generation Automation 94 Evolution Towards Safety Third Generation Automation 95 45

46 Educating Administration 1. USP <797> Pharmaceutical Compounding Sterile Compounds 2. USP <800> Hazardous Drug Handling in Healthcare Settings 3. MM Antibiotic Stewardship Standard A & 503B Compounding B Mega Guidance Withdrawn 96 Questions and Panel Discussion 46

47 Thank you To Receive CE Credit Complete the Post Test and Evaluation Score of > 70% is required to receive credit 98 47