Objectives. Objectives. Introduction. True or False? State and explain the New England Compounding and Ameridose investigations

Transcription

1 Sterile Compounding Updates for Pharmacy Technicians Objectives State and explain the New England Compounding and Ameridose investigations Demonstrate the use and need for an ongoing Quality Assurance Program Caryn Belisle, RPh Pharmacy Manager Sterile Products Service Department of Pharmacy Brigham and Women s Hospital Boston MA April 1, 2014 Illustrate the current Quality Assurance program at the Brigham and Women s Hospital Department of Pharmacy Objectives Identify and explain USP chapter <797> guidelines List the current metrics of compounding sterile products in the pharmacy department Illustrate the use of technology to assist with upholding USP regulations Introduction New England Compounding/Ameridose: -What s the story? Regulations: -USP <797> and others Quality Assurance: -Why do we need it? -How do we do it in the BWH Pharmacy? Technology: -Robots, workflow software True or False? Timeline of NECC and Ameridose Closures Ameridose and New England Compounding Center (NECC) are both compounding pharmacies that recalled sterile products contaminated with fungal meningitis. NECC is a compounding pharmacy responsible for the national fungal meningitis outbreak Ameridose is an i.v. admixture service and did not have any confirmed cases of contaminated products 1

2 True or False? Why use a compounding pharmacy? Currently fungal meningitis outbreak has affected 751 patients with 64 reported deaths through out the United States. TRUE Statistics as of October 23, 2013 All cases are associated with contaminated steroid injections from NECC USP 797 regulations forced some hospitals and clinics to outsource over upgrading facilities National drug shortages of FDA licensed products * Medication not available from FDA licensed manufacturer requiring non-sterile to sterile compounding (high-risk compounding) * Joint Commission requirements to have all nonurgent medications prepared in pharmacy has increased volume for ready to use (pre-mixed) medications * What did we do at BWH? True or False? All NECC and Ameridose products pulled from inventory BWH sent letters to any patient that received an injectable medication from NECC No patient at BWH or in the state of Massachusetts received the contaminated lot of steroid injection BWH Pharmacy to take-on sterile compounding of all items previously compounded by Ameridose with no additional FTEs or space Ameridose compounded approximately 260,000 doses per year for BWH Ameridose and NECC are both compounding pharmacies that convert non-sterile products into sterile products for their customers. NECC had licensure to compounded sterile products from non-sterile substances for patient specific prescriptions. Ameridose did not practice this technique. Gray Area More regulations -State -Federal More surprise visits What s Next? The Regulations: USP <797> Chapter 797 of the United Stated Pharmacopeia Prevent patient harm resulting from ingredient errors and microbial contamination Chapter includes: compounding personnel responsibilities training and evaluation requirements medication preparation sterility and accuracy verification classification of microbial contamination risk equipment and environmental quality and control requires all sterile products to be made in the pharmacy that are not urgent or have short stability 2

3 True or False? RISK: USP <797> As it pertains to USP <797>, the risk of a compounded sterile product means how dangerous a medication can become if a patient gets the wrong dose (i.e. insulin or heparin). Risk is measured by the likelihood of contamination based upon how the product is compounded! Low Risk single transfer Example: Withdrawing 5mL of drug into a NS bag Medium Risk multi-transfers Example: TPN, Multi-electrolyte solutions High Risk sterile to non-sterile Example: Converting non-sterile Glutamine powder into a sterile solution for use in a TPN solution. Can nurses or other providers compound a medication? True or False? YES! USP <797> allows for immediate use products to be made outside a clean room. Emergent Situations Short Stability example phenytoin To be used immediately and given a 1 hour beyond use date (BUD) USP < > concentrates on endotoxin testing of compounded sterile products. <USP 85> Endotoxin <USP 71> Sterility aerobic/anaerobic/fungal <USP 788> Particulate matter Quality Assurance Environmental Monitoring Diligence to assure quality and safety to our patients Contracted with outside testing agency Every 6 months Certified as ISO Class 5 devices Air volume and velocity profile HEPA filter integrity/leak test Airflow patterns and pressure differential Particle count monitoring Temperature and relative humidity monitoring 3

4 Continuous Quality Assurance Real Time Online Results Testing is performed by an outside laboratory All compounded sterile products sent to outside lab daily for test of end product sterility Staff - Aseptic sterile product technique tested twice yearly with growth medial fill -Gowning, garbing, fingertip testing -Annual written competency on USP <797> Notification of Test Completion Executive Monthly Reports Beyond Use Date Certification Printable Certificate Increase expiration dating to decrease cost of waste and increase operational efficiency End product testing of bulk preparations Testing performed by outside lab at designated time points with customer receipt of certified results Stability - potency/purity via HPLC Sterility <USP 71>: aerobic/anaerobic/fungal Endotoxin <USP 85> Particulate matter <USP 788> ph testing 4

5 What s in these bags? Evidence Demonstrating Concerns about Compounded Sterile Products Prepared by Healthcare Workers Parshuram CS, et al. Occurrence and impact of unanticipated variation in intravenous methotrexate dosing. The Annals of Pharmacotherapy. 2006;40(5):805. Anton C, et al. Medication errors detected in infusions. Arch Intern Med. 2003;163(8):982. Parshuram CS, et al. Discrepancies between ordered and delivered concentrations of opiate infusions in critical care. Critical care medicine. 2003;31(10):2483. Hayes BD, et al. Frequency of medication errors with intravenous acetylcysteine for acetaminophen overdose. The Annals of Pharmacotherapy: 2008;42(6):766. The Emily Jerry Story Why do We Need to Know What s in Our Compounded Sterile Products? Our Vision: The Sterile Products Room of the Future! Robots, Robots, Robots! Part of our strategic plan is to move toward a fully automated process using gravimetrics to compound all sterile products Process includes a combination of robotics and work flow software 5

6 Robots Provide Us With: Bar code verification Specific gravity and gravimetrics Optical scanning Central data storage High degree of accuracy and precision Efficient work flow Workload tracking Interfaces Removing part of the human element when compounding we are the primary source of contamination! i.v. Station How is it resourced 1 Pharmacy Technician 2 shifts, 7 days per week Batch production PAR level based Scheduled production runs Pros/Cons + Versatile in final product containers (syringe/bag sizes) + Expansive degree of safety features (gravimetric, barcode scanning, visual recognition) + Relatively small physical footprint - Drug shortages = suboptimal operation due to availability i.v. Station Onco i.v. Soft Assist Decrease exposure of carcinogenic medications to pharmacy technicians Must use bags, syringes, and needles specified by vendor One technician operates Checks stepwise human process by gravimetrics Interface via Worklist Not as product dependent as robotics Patient specific doses Vials/materials that do not meet robot specification Non-standard, non-premade doses Last one.true or False? Quality Assurance Technology enables us to do less QA testing as with manually prepared products. Technology does NOT replace the need for QA! Why QA when we have technology? 6

7 WE TEST OUR ROBOTS TOO! The Staff s Reaction.. In the beginning.some resistance: Don t you trust me? This is going to slow me down! How We Dealt with it.. Lean concepts STAFF DRIVEN Tabletop exercises STAFF DRIVEN Time and Motion Studies In Conclusion: NECC/Ameridose Only NECC responsible for meningitis outbreak Quality Assurance BWH Pharmacy has a fully compliant QA program to ensure sterility of all compounded sterile products The Regulations USP <797>, <71>, <85>, <788> Technology helps us adhere to the rules and ensures an accurate, sterile, and safe products to our patients! + We re Done! 7