2013 USP Chapter <797> Compliance Survey & Current Practice Standards

Transcription

1 2013 USP Chapter <797> Compliance Survey & Current Practice Standards Kenneth S. Latta, BS, RPh Gates Healthcare Associates, Inc Hillsborough, NC

2 We Welcome Your Questions You can submit questions throughout the webinar, using the form on your screen. If you experience any technical issues during the webinar, please use the help button shown on your screen. Download a PDF handout of the presentation on the PharmacyAdvisor.com web page where you clicked to join today s webinar. 2 Disclosure The content of this presentation was created by the presenters and does not necessarily reflect the views of Baxter Healthcare Corporation. Our speaker has accepted an honorarium from Baxter for this presentation. 3

3 About Our Speaker Kenneth S. Latta, BS, RPh Manager Duke Compounding Facility 2000 to Pharmacy Compounding Accreditation Board Present Surveyor Standards Committee PCAB Medisca Network 2006 Present Co-Writer for Non-Sterile and Sterile Compounding Courses; Facilitator for Non-Sterile and Sterile Courses. Gates Healthcare Associates, Inc Senior Associate Present. Visante; Visante UK Senior Consultant 4 Objectives Identify the top 10 underperforming standards from the 2013 USP Chapter<797> Compliance Study. Discuss barriers that prevent compliance with these standards and ways to remove the barriers. Discuss the new recommendations possibly incorporated in the Revisions to USP <797> and the upcoming USP <800> Hazardous Drugs Handling in Healthcare Settings. Identify resources that can be employed to assist pharmacists in meeting these standards. 5

4 Compliance Improvement? 2011, 12, and 2012 National USP Chapter <797> Studies showed work practice related deficiencies Could be remedied with little financial impact Provided with many free resources Demonstrated little to no improvement in deficiencies 6 Challenges to USP <797> Implementation 7

5 Drivers of USP <797> Compliance 8 Survey Dynamics versus SBOP Dynamics Hospitals were 76% of study population (790/1045) Alternate site provider 11% Hospital pharmacies do not control budget Compounding pharmacies control own budget Hospital pharmacies do not completely set priorities Compounding pharmacies can set priorities Survey possibly selected for higher performing facilities 9

6 Facility Design (Secondary Engineering Controls) 10 Buffer only For buffer areas not physically separated from the ante-areas, the principle of displacement airflow shall be employed. 2 This concept utilizes a low pressure differential, high airflow principle. 2 Using displacement airflow typically requires an air velocity of 40 ft per minute or more from the buffer area across the line of demarcation into the antearea USP 36 NF 31 May to July 2013 USP <797> Pharmaceutical Compounding Sterile Preparations 11

7 Primary Engineering Control Not in ISO 7 12 hour BUD Segregated Compounding Area LAFW or BSC must be certified per CETA Gowned and garbed Sterile gloves Cleaning and Disinfection of area - Documented Monthly - ceiling, walls and storage shelving Daily - floors, counters, and easily cleanable work surfaces PEC per standard protocol Surface Sampling & Viable Air Sampling in PEC and Area with identification during certification 2. USP 36 NF 31 May to July 2013 USP <797> Pharmaceutical Compounding Sterile Preparations 12 Compounding Aseptic Isolator in non-iso 7 Must be certified to CETA and USP standards 2 Viable Environmental Sampling Surface and Air 3 Compounding Chamber Pass Through Chambers Non-ISO room in which it is located Colony Forming Units must be identified Tested under Operational or Dynamic Conditions USP highly pathogenic organisms Gram Negative Rods Coagulase Positive Staphylococcus Molds and Yeasts 2. USP 36 NF 31 May to July 2013 USP <797> Pharmaceutical Compounding Sterile Preparations 3. CETA Certification Application Guide USP <797> Viable Environmental Sampling & Gowning Evaluation 13

8 CAI Certification Section Field Test Mandatory Airflow Test 2.02 Chamber Pressure Test 2.03 Site Installation Assessment Tests 2.05 HEPA Filter Integrity TEST Mandatory Operational or Dynamic Conditions 2.08 Airflow Smoke Pattern Test 2.09 Preparation Ingress and Egress Test 2.10 Non-Viable Particulate Testing 2.06 Particulate Containment Integrity and Enclosure Leak Test (CACI HD Only) 4. CETA Compounding Isolator Testing Guide 14 Airflow Smoke Pattern Test should be performed on all unidirectional airflow clean-zones to verify unidirectional airflow. 5 should be done under dynamic operating conditions 5 actual compounding personnel should conduct the actual operations that will be carried out in the areas being tested. 5 should be witnessed by the compounding facility supervisors so they can determine optimal operating set-ups based on airflow patterns within the space CETA Certification Guide for Sterile Compounding Facilities 15

9 Facilities 16 Low Use Exemption If a CACI that meets the requirements of this chapter is used outside of a buffer area, the compounding area shall maintain a minimum negative pressure of 0.01-inch water column and have a minimum of 12 ACPHs. In facilities that prepare a low volume of hazardous drugs, the use of two tiers of containment (e.g., CSTD within a BSC or CACI that is located in a non-negative pressure room) is acceptable. Probably Going Away! 2. USP 36 NF 31 May to July 2013 USP <797> Pharmaceutical Compounding Sterile Preparations 17

10 Hazardous Compounding (NIOSH Listed) BSC or CACI shall be placed in an ISO Class 7 area physically separated (i.e., a different area from other preparation areas) optimally has not less than 0.01-inch water column negative pressure to adjacent positive pressure ISO Class 7 or better ante-areas, thus providing inward airflow to contain any airborne drug. 2. USP 36 NF 31 May to July 2013 USP <797> Pharmaceutical Compounding Sterile Preparations 18 Compounding Performed Outside of ISO 5 19

11 Environmental Monitoring in Hospitals 57% 53% 49% 38% 36% 30% 50% 50% 49% 20 Ongoing Gloved Fingertip Testing

12 Environmental Sampling Rationale Tool to measure effectiveness of: The Primary Engineering Controls The Secondary Engineering Controls Disinfecting Processes Work Practices Shows that the pharmacy is maintaining an adequate state of control. 1 In lieu of direct sterility testing of preparations; are important indicators that the final preparation may be sterile in the eyes of regulatory personnel. 22 Daily Air Pressure/Velocity Documentation 23

13 Rationale for Air Pressure/Velocity Marker for each facility to show ability to maintain a state of control Decreased particulates Decreased microbes Containment of NIOSH listed (Hazardous) Drugs USP <800> Hazardous Drugs Handling in Healthcare Settings Personal Protective Equipment for Health Care Workers Who Work with Hazardous Drugs o 2. USP 36 NF 31 May to July 2013 USP <797> Pharmaceutical Compounding Sterile Preparations 24 Filter Integrity Test Hospital Compliance 15.5% Overall Compliance 26.9% Mandatory test that indicates that the sterile filtration could possibly produce a sterile final preparation. Part of the overall picture that indicates that the facility design, cleaning and disinfecting processes, behaviors and components used could have resulted in a preparation that is sterile. Regulatory vision 2. USP 36 NF 31 May to July 2013 USP <797> Pharmaceutical Compounding Sterile Preparations 25

14 Line of Demarcation 42% of hospitals (n=70) are Non-Compliant 1 Costs no money Behavioral changes needed Effective way to reduce the introduction of particles and microbes into the compounding environment 26 Bacterial Endotoxin Testing 27

15 Bacterial Endotoxin Testing High Risk Compounding Non-sterile ingredients or components o Except those for inhalation and ophthalmic administration Required for > 25 items or Exposed longer than 12 2 C to 8 C or > 6hrs at > 8 C before they are sterilized Commercial Laboratory In House Gel clot Empiric methodology 2. USP 36 NF 31 May to July 2013 USP <797> Pharmaceutical Compounding Sterile Preparations 28 Sterility Testing Compliance Hospital compliance 25% 1 Overall compliance 31% 1 Required when Beyond-Use Date exceeds the storage times published in USP <797> High Risk CSPs prepared in batches >25 29

16 Sterility Testing Required if BUD Exceeds Risk Level Room Temperature Refrigerated Frozen Low Risk 48 hrs 14 days 45 days Medium Risk 30 hrs 9 days 45 days High Risk 24 hrs 3 days 45days 2. USP 36 NF 31 May to July 2013 USP <797> Pharmaceutical Compounding Sterile Preparations 30 USP <71> Compliant Membrane Filtration Membrane Filtration is used whenever the nature of the product permits. Method Suitability testing for each preparation Number of containers to be tested determined by volume of container, size of the batch and type of preparation Minimum of 1 ml from each container for each of the two test fluids 6. USP 36 NF 31 USP <71> Sterility Tests 31

17 Parenteral Containers per Batch Batch Size -2 ml or Greater Not more than 100 containers >100 to 500 containers 10 containers Minimum Number of Items to be Tested for Each Medium 10% or 4 Whichever is greater > 500 containers 2% or 20 containers, whichever is less Large Volume Parenterals Less than 2 ml Not more than 100 containers >100 to 500 containers 20 containers 2% or 10 containers, whichever is less 20% or 8 Whichever is greater > 500 containers 4% or 40 containers, whichever is less 6. USP 36 NF 31 USP <71> Sterility Tests 32 References 1. Douglass, K, et al. The 2013 USP Chapter <797> Compliance Survey Pharmacy Purchasing & Products. October 2013:S1 S USP 36 NF 31 May to July 2013 USP <797> Pharmaceutical Compounding Sterile Preparations. 3. CETA Certification Application Guide USP <797> Viable Environmental Sampling & Gowning Evaluation CAG Effective January 31, CETA Compounding Isolator Testing Guide CAG Revised December 8, CETA Certification Guide for Sterile Compounding Facilities CAG Revised January 31, USP 36 NF 31 USP <71> Sterility Tests. Baxter and Pharmacy Advisor are trademarks of Baxter International Inc. 33

18 We Welcome Your Questions You can submit questions throughout the webinar, using the form on your screen. If you experience any technical issues during the webinar, please use the help button shown on your screen. Download a PDF handout of the presentation on the PharmacyAdvisor.com web page where you clicked to join today s webinar. 34