LUNCH AND LEARN. Current Regulatory Landscape for Sterile Compounding: Part 1. June 8, 2018

Transcription

1 LUNCH AND LEARN Current Regulatory Landscape for Sterile Compounding: Part 1 June 8, 2018 Featured Speaker: Fred Massoomi, PharmD, FASHP Senior Director of Health system & Hospital Services Visante, Inc. Omaha, Nebraska CE Activity Information & Accreditation (Pharmacist and Tech CE) 1.0 contact hour Funding: This activity is self funded through PharMEDium. It is the policy of to ensure balance, independence, objectivity and scientific rigor in all of its continuing education activities. Faculty must disclose to participants the existence of any significant financial interest or any other relationship with the manufacturer of any commercial product(s) discussed in an educational presentation. Dr. Massoomi does not have any relevant commercial and/or financial relationships to disclose. 2 1

2 Online Evaluation, Self-Assessment and CE Credit Go to /PharMEDiumRx Login to CE Center Complete online self assessment and evaluation to obtain CE credit Live CE Deadline: July 6, 2018 CPE Monitor CE is uploaded to NABP/CPE Monitor upon completion of CE process (user must complete the claim credit step) Attendance Code Code will be provided at the end of today s activity Attendance Code not needed for On Demand 3 Ask a Question Submit your questions to your site manager. Questions will be answered at the end of the presentation. Your question...? 4 2

3 Resources Visit /PharMEDiumRx to access: Handouts Activity information Upcoming live webinar dates Links to receive CE credit 5 Current Regulatory Landscape Sterile Compounding: Part 1 Fred Massoomi, Pharm.D., FASHP Senior Director; Hospital and Health system Services Copyright Visante, Inc. All rights reserved 3

4 -Describe oversight of sterile compounding standards and regulations -Review USP inaugural meeting on sterile compounding -Compare cgmp to USP and the necessary integration of standards -Review FDA activity for sterile compounding oversight -Identify key FDA guidance documents for sterile compounding for 503A and 503B facilities -Theorize immediate future expectations for safe sterile compounding 7 7 Collaboration of Standards? 8 4

5 USP Announcements Source: usp.org/compounding/updates-on-standards 9 USP Compliance Timelines NOTE: Individual states may require compliance sooner Source: usp.org/compounding/updates on standards 10 5

6 Regulatory Activity NOTE: Not listed FDA activity on healthcare facilities Source: Pharmacy Purchasing and Products; State of Pharmacy Compounding 2018; 11 th Annual: April Compounding Inspections CMS Hospitals Clinics State Board of Pharmacy Hospitals Retail Pharmacy s Compounding Pharmacy s FDA Copyright Visante, Inc. All rights reserved

7 Surveying Bodies for Compounding TJC: The Joint Commission DNV Healthcare HFAP: AOA s Healthcare Facilities Accreditation Program ACHC: Accreditation Commission for Healthcare PCAB: Pharmacy Compounding Accreditation Board Copyright Visante, Inc The Joint Commission Source:

8 FDA USP FDA Policy goals Public health concerns Provide clarification Decrease regulatory burden 3 policy types Access Auality Necessity; must use FDA approved drugs FDA voluntary top recalls Sterility assurance Potency Labeling FDA Civil and Criminal Enforcement Medistate July 2017 Pharmakon pharmaceuticals 2017 Compounding Risk Alert System 2017 eye injection of a compounded drugs 43 patients; combo issues by a Texas compounding facility 017 one illness and one death turmeric and curium; non FDA USP registered products Finalization of cgmp for Outsourcing Manufacturers 15 PDA Update FDA Activities 503A B 73 Registered ALL have 483 s 9 warning letters 1 Consent Decree August 2016 to October warning letters 4 injunctions #1 Insanitary Conditions #2 Lack of sterility assurance Source: Compounding/ucm htm Source: PDA News UPDATE November, 2107; Lachman Consults.com( 16 8

9 Sterile Compounding Compliance Current Perception of Compliance 63% Not in full compliance Source: Pharmacy Purchasing and Products; State of Pharmacy Compounding 2018; 11 th Annual: April 2018 Copyright Visante, Inc

10 Source: Pharmacy Purchasing and Products; State of Pharmacy Compounding 2018; 11 th Annual: April Construction For Compliance Source: Pharmacy Purchasing and Products; State of Pharmacy Compounding 2018; 11 th Annual: April

11 Source: chapter Sterile Compounding Evolution

12 Compounding Standards Drug Quality & Security Act NAPB Model Rules for Sterile Pharmaceuticals USP <797> Pharmaceutical Compounding Sterile Preparations USP <1074> Dispensing Practices for Sterile Drug Products Intended for Home Use ASHP TAB Quality Assurance for Pharmacy Prepared Sterile Products USP <1206> Sterile Drug Products for Home Use USP <800> Hazardous Drugs Handling in Healthcare Settings NCCLVP Recommendations Best Practice Recommendations Federal Standards Copyright Visante, Inc. All rights reserved 23 Differing Standards? This interim guidance reflects FDA s intent to recognize the differences between compounding outsourcing facilities and conventional drug manufacturers. Maintaining the minimum standards necessary to protect patients from the risks of contaminated or otherwise substandard compounded drug products. Copyright Visante, Inc. All rights reserved

13 Differences between cgmp & USP <797> Crosswalk of USP Chapter <797> and cgmp (21 CFR 211): 187 individual cgmp requirements specifically examine 20 are fully covered in USP Chapter <797> 127 requirements of cgmp are not covered by USP Chapter <797> Copyright Visante, Inc. All rights reserved 25 Key Revisions to USP 797 Proposed revision to USP 797 is a complete re-write of 2008 chapter Compounded Sterile Products Categories nomenclature OLD: Immediate use; Low-risk; Medium-risk; High-risk NEW: Urgent use; Category 1; Category 2 REMOVAL of hazardous drugs section= USP 800 REMOVAL of Radiopharmaceuticals = USP 825 In-Use-Time = time a CSP must be used after it has been opened or punctured Sterility testing sampling for batching <40 (Test 10% of the batch size) Allergens no longer exempted Source:

14 Key Revisions to USP 797 Proposed revision to USP 797 is a complete re-write of 2008 chapter Monthly viable air sampling Monthly viable surface sampling Quarterly media fill test Quarterly finger glove tip test Room temperature Humidity Was every 6 months Was periodic Was annually Was annually 20 C or cooler Below 60% at all times Garbing and Cleaning - Sterile gloves and sterile sleeves or gowns - Sterile wipes and cleaning equipment Source:

15 Hazardous Drug Handling USP <800> Handling Hazardous Drugs in Healthcare Settings BTW: Also, includes 503B Facilities Copyright Visante, Inc Current Perception of Compliance 92% Not in full Compliance Source: Pharmacy Purchasing and Products; State of Pharmacy Compounding 2018; 11 th Annual: April

16 NOTE: Individual states may require compliance sooner Washington California North Carolina New Jersey Source: chapter hazardous drugs handling healthcare 31 Road Map 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 32 16

17 Scope 33 The Source Photo: Firouzan Massoomi, Pharm.D, FASHP NEVER touch boxes or vials with bare hands! Source: sectioncode=editorial&templatecode=single&user=

18 Types of Exposure Dermal Mucosal Inhalation Injection Ingestion Copyright Visante, Inc. All rights reserved 35 List of Hazardous Drugs Must have a Hazardous Drug list USP 800 The Joint Commission Occupational Safety & Health Admin. Type of Hazardous Drugs antineoplastic non antineoplastic reproductive risk Risk of exposure considerations Continual and annual update 36 18

19 Risk Stratifying Handling 37 Facilities & Engineering Controls Must Have Designated Areas Receipt & unpacking Storage Non sterile compounding Sterile compounding Example: Signage 38 19

20 Receiving & Storage Must be unpacked in marked area Neutral/Negative pressure MUST CLEANABILITY 39 Personal Protective Equipment Head covers Beard covers Eye protection Face mask Disposable Gowns Polyethylene or laminate Closed in the back ASTM 6978 Shoe Covers: x

21 Personnel & Training All personnel who handle HDs must be trained based on their job functions Must be assessed every 12 months Must be trained on new HDs and equipment Must document competencies 41 Deactivation Breaking chemical bonds 2% Sodium Hypochlorite Cleaning Remove dirt, oils, residue, etc. Tri or Quadra-valent detergent 5 cidal notably: Sporicidal Decontamination Physical wiping of surface Peroxide RTU Disinfecting Reduce bioburden Sterile Isopropyl Alcohol 70% UV-C light 42 21

22 These Do Not Clean Hazardous Drug Spills Copyright 2017 Firouzan Massoomi, Albarello, LLC. All Rights Reserved. 43 Safe Disposal of Waste 44 22

23 Outsourcing Drug Quality and Security Act 2013 The Drug Quality and Security Act (DQSA) signed into law on November 27, 2013 Public Law New Law Consists of Two Sections Title I: Compounding Quality Act Title II: Drug Supply Chain Security Act Drug pedigree through distribution channel Manufacturer to the pharmacy 46 23

24 Compounding Quality Act FDA Hospitals and Clinics Pharmacy Compounding Under Section 503A Per prescription Outsourcing Manufacturers Voluntary Guidance for Industry Current GMP Compounding Outsourcing Facilities Under Section 503B of the FD&C Act State Boards of Pharmacy CMS FDA USP A + State Regulations + FDA Guidance Food & Drug Administration State Boards of Pharmacy Current cgmp Section FDA Guidance 1. Accessed 11/23/ Accessed 11/23/ GAO report: Drug Compounding: FDA has taken steps to implement compounding law, but some states/stakeholders reported challenges 47 Source:

25 Outsourcing Facility Requirements Licensed pharmacist has direct oversight Compound only drugs from bulk ingredients that appear on a list developed by the Secretary Register as an outsourcing facility Report to the Secretary upon registering, every 6 months Be inspected by FDA Report serious adverse event experiences within 15 days Label products with a statement identifying it as a compounded drug Source: Public Law Drug Quality and Security Act publ54/pdf/PLAW 113publ54.pdf. Accessed May 15, 2015 Copyright Visante, Inc. All rights reserved 49 Outsourcing Facility Requirements An outsourcing facility MUST NOT: Compound drugs removed from the market for safety and effectiveness reasons Compound copies of marketed FDA approved drugs except in the case of a drug shortage Sell to Wholesalers/Distributors, and all must be labeled not for resale. Source: Public Law Drug Quality and Security Act publ54/pdf/PLAW 113publ54.pdf. Accessed May 15, 2015 Copyright Visante, Inc. All rights reserved

26 Accountability

27 Reliance On Outsourcing Source: Pharmacy Purchasing and Products; State of Pharmacy Compounding 2018; 11 th Annual: April Outsourced Compounding Looking forward, most facilities expect to continue outsourcing much of the same product mix That they currently rely on their vendors to supply. State of Pharmacy Compounding. Pharm Purch Prod

28 Outsourcing Assessment From a legal and The Joint Commission perspective Hospitals are responsible for the services provided to patients from an outsourced vendor 55 Key Safety Elements People Processes Products Skills set Aptitude Training Math skills Environmental monitor Clean environment Ingredient standards Trustworthy Reliability Compounding skills Continuous education Consistency Documentation of processes Documented training Operator testing Re-training process Stability Sterility Labeling Appropriate dating Reduce contamination Consistency Recall process VALIDATION Copyright Visante, Inc. All rights reserved

29 Proper Room for Compounding Copyright Visante, Inc. All rights reserved 57 Proper Room Controls ISO 7: HEPA Ceiling Temperature Humidity Positive Pressure Copyright Visante, Inc. All rights reserved

30 The Proper Work Area ISO 5 Compounding Aseptic Isolator ISO 5 laminar Flow Cabinet ISO 5 HEPA Compounding Space Copyright Visante, Inc. All rights reserved 59 Effective Training? 60 30

31 Acceptable? Source; E.Kastango Source; F. Massoomi Source; F. Massoomi

32 Proper Technique Copyright Visante, Inc. All rights reserved 63 Proper Cleaning Copyright Visante, Inc. All rights reserved

33 Copyright Visante, Inc. All rights reserved 65 Copyright Visante, Inc. All rights reserved

34 67 Checking Outsourcing Compliance Source: Accessed May 15,

35 Understanding Outsourcing Issues 69 Evaluating Product Safety 2 nd Consensus Development Conference Safety of Intravenous Drug Delivery System Participants ranked products based on safety (highest=7 lowest=1): Manufacturer ready-to-use (6.0) Point-of-care activated (4.6) Outsourced ready-to-use (4.5) Pharmacy compounded (4.2) Non-pharmacy compounded at point of care (1.8) Sanborn MD, Moody ML, Harder KA et al. Second Consensus Development Conference on the Safety of Intravenous Drug Delivery Systems Am J Health-Syst Pharm. 2009; 66:

36 ISMP Sterile Compounding Summit ISMP Summit 2011 When available commercially manufactured premixed IV products Use over manually compounded sterile products Source: Guidelines for the Safe Preparation of Sterile Compounds: Results of the ISMP Sterile Preparation Compounding Safety Summit of October Rich S, et al. Hosp Pharm 2013;48(4): , Missing in the Equation 72 36

37 Seeing the Unseen Glass Precipitant Filaments Coring G. L. Shearer, Taking a Closer Look at Parenteral Contaminants," Pharmaceutical Technology 40 (9) Thank you. Fred Massoomi, Pharm.D., FASHP Senior Director Visante, Inc. Copyright Visante, Inc. All rights reserved 37