Ghalib Abbasi, RPh, MS, PharmD Pharmacy Technology Consultant Florida, USA

Transcription

1 Ghalib Abbasi, RPh, MS, PharmD Pharmacy Technology Consultant Florida, USA

2 Disclosure Information IV Robotics and Workflow: Design and Integration with other Healthcare and Regulatory Components Ghalib Abbasi I have no financial relationship to disclose I will not discuss off label use and/or investigational use in my presentation.

3 Learning Objectives At the completion of this activity, you will be able to: Identify current IV compounding methods and list their associated benefits and risks. Define the terms IV robotics and IV workflow and identify their applicability. Describe the purpose of each of the IV workflow manager components. Descrbie the validation processes involved in designing sterile compounding devices and robotics. Identify planning and training components when implementing new IV technologies. Identify the various elements of pharmacy-related IT healthcare components in a hospital and illustrate the value of integration. Exemplify regulatory requirements and standards that may influence IV automation design and implementation.

4 Why to automate sterile compounding? Productivity the most labor-intensive part of pharmacy practice. Severity medication errors in this space have a higher frequency of sequelae. Documentation and process control Traceability and process improvement. Contamination The most significant source of contamination in IV admixtures is human touch. Accuracy the correct drug, amount, final volume, final concentration, and the correct patient.

5 IV Compounding Methods Manual Semi-Automated e.g. IV Workflow Manager Fully-Automated e.g. IV Robotics

6 IV Compounding Methods Compounding Earlier Method Benefits/advantages Manual - No additional upfront cost unless special environment is added (e.g. a glovebox) - Prevalent technique so plenty of resources. Semi-Automated - Barcode and gravimetric technologies to verify drugs/amounts - Standardized and customizable workflow - Remote verification possible Fully-Automated - Minimized user involvement and exposure. - Minimized waste. - Barcode/gravimetrics available and automated - Standardized and customizable workflow - Remote verification possible Risks/disadvantages - User exposure is higher, can be mitigated with enhanced environment (e.g. using a glovebox). - Higher risk for wrong drug/amount selection and labeling - Hard to standardize workflow - Technician/Pharmacist physical presence needed - Medium upfront costs - User involvement is still needed to perform the actual compounding - User perception of slowing down the compounding process - High upfront costs - Device size - ROI attained only if sufficient volume is produced

7 IV Workflow Definitions and Applicability IV Workflow: A process that involves dose routing, preparation, inspection, tracking, and reporting. IV Workflow Manager: A tool that consists of software and hardware components that facilitates the IV workflow process. Considered a semi-automated compounding method since user involvement is required. Applicability: IV admixtures IV syringes PN compounding Chemotherapy and cytotoxic compounding Other e.g. oral liquids.

8 IV Workflow Scheme Dose Routing Pharmacy Reporting Dose Preparation Dose Tracking Pharmacist Inspection 11/21/ For Internal Use Only

9 Automating IV Workflow - Dose Routing

10 Automating IV Workflow - Dose Preparation

11 Automating IV Workflow - Pharmacist s Inspection

12 Automating IV Workflow - Tracking & Reporting

13 IV Workflow Manager Design and Regulatory Compliance BUD assignment. Assists in assigning recommended BUDs for both in-process pharmaceuticals (sterility) and prepared doses (stability). Capable of assigning low, medium, and high-risk compounded sterile products with recommended BUDs. Storage profiles. Room Temperature, Refrigeration, and Freezing profile assignment. Hazardous drugs. Allows flagging of related doses so they re routed to the proper preparation area e.g. Compounding Aseptic Containment Isolator (CACI). Assists in displaying related precautions to the user preparing such doses.

14 IV Workflow Manager Design and Regulatory Compliance (cont.) IV preparation. Displays step-by-step instructions that assist in manipulating sterile products aseptically and labeling compounded sterile products (CSPs). Verification of compounding accuracy. Displays step-wise compounding instructions and utilizes barcode scanning to ensure that only the intended ingredients are being incorporated into the specific dose. Cleaning and Disinfecting the compounding area. Assists in providing a list of scheduled tasks to clean and disinfect the compounding area (e.g. compounding surface within the hood).

15 IV Workflow Manager Design and Regulatory Compliance (cont.) Inspection of solution dosage forms and review of compounding procedures. Retains images and procedure steps for the reviewing pharmacist before approving a dose. Packing and transporting CSPs. Assists in the efficient delivery of CSPs to external care or storage areas. Assists in creating appropriate labeling for handling specific doses e.g. auxiliary labels.

16 IV Robotics - Definition Earlier definitions implied mimicking human arms. Currently, a technology can be considered an IV robotic when it: Performs tasks that users would normally perform by hand and, thus, requiring little or no human input e.g. powder reconstitution; or Receives, queues, and prepares sterile doses with little or no human input Involves hardware and software components: Hardware: e.g. vial holders, injectors, storage bins, UV source. Software: e.g. formulary management, queueing, dose status.

17 IV Robotics - Applicability Several examples are currently available: IV admixing Syringe filling Powder reconstitution PN compounding Chemotherapy and cytotoxic compounding The ultimate goal behind implementing an IV robotic is enhancing efficiency and safety for both the patients and users. IV robotics used in compounding chemotherapy are normally designed to ensure full containment of vapors and particles released from such drugs.

18 IV Robotics Manufacturing the Device Pre-validation and Design Building and Testing the Device Post-validation

19 Pre-Validation and Design Choose materials commonly used or pre-validated by the manufacturer for use in medical devices. Pick tubing, plastics, etc. that are Relatively medically inert so that they won t leach or extract from the fluids going through them in any significant way Have no allergens e.g. Latex. The packaging for the material product is then selected to create the sterile barrier.

20 Building and Testing the Device Once specific design decisions are made, the next step is to build up a statistically significant number of packaged test product in a controlled environment (clean room). The Clean room is regularly tested for Bacteriologic burden e.g., Limulus Amebocyte Lysate (LAL) Particulate matter Bio-burden assessments in the manufacturing environment.

21 Testing the Product Test product is then sent to test labs for ISO testing ISO testing Pyrogen testing Other particulate testing e.g., USP <788> Transportation testing Accelerated aging Other product is set aside for real time aging. At the end of this testing, product is then tested for functionality.

22 Functional Testing Performed for both the device and packaging This particularly involves testing for leaks, which would indicate a breach of the fluid pathway or sterile barrier. Involves microbial challenge of the device and the fluid path. Involves mechanical calibration (e.g., balance).

23 Validating the Sterilization Procedures As each new product is developed, a protocol is established to specify a full suite of sterility testing per product. This includes the specification of minimum dose, bacteriostasis and fungistasis, etc. This testing is performed on a production-equivalent product i.e. a product built in a way to mimic the expected build and packaging.

24 Validating the Sterilization Procedures PCDs (process challenge devices) and steri-dots (as applicable) are placed in each load of product to verify that the sterilization of that load was in the defined range. The sterilization process is revalidated every two years.

25 Post-Validation Internal procedures to check readiness of the manufacturing environment e.g., cleaning, production equipment maintenance, etc. Use of production equipment is validated through: Installation Qualifications (IQ) testing Operational Qualifications (OQ) testing Process Qualifications (PQ). This validates the ability for reproducibility.

26 Post-Validation That all paints the desired picture of being able to reliably build safe and effective products when used according to their instructions and labeling.

27 User Validation and Regulatory Components Device placement according to USP <797> Electrical, Air, Telephone, Network connections Operating space around device Lighting, HVAC, Traffic Quality Control testing e.g., Endotoxin testing per USP <85> Periodic maintenance

28 Planning for new automation in the pharmacy Does the vendor provide help/templates? What pharmacy policies and procedures need to be created/driven? Address principal issues Calibration Infection control Any work process with a high likelihood of user error

29 Training on new automation Does the vendor provide materials? Who is allowed to operate the device? What training is required of whom? Levels of operators Even non-operators need to know about the device Training documentation

30 Planning and Training General Recommendations Automated systems must be used as they were designed to be used. Automated systems must be set up and maintained only by properly trained personnel. Automated systems should be operated only by properly trained personnel. Training must include what to do and why to do it.

31 Integration Sample Dose Lifecycle Order Entry Order Verification ADC Robotics Delivery CSPs, UD solids, etc. IV Workflow Manager Tube CSP Chemo Oral Liquid Premix TPN Delivery Hand ADC Patient Bin Reuse Administer Discard Return to Rx Nurse Retrieval

32 Integration Healthcare IT Components Components can be integrated using streams such as HL7 or print feed. Dispensing Cabinets Robotics CPOE Pharmacy Information System IV workflow Infusion Pumps Compounders

33 Value of integrating a hospital s healthcare IT components - examples Interface PIS-Robotics PIS-ADC PIS-IV Workflow ADC-Robotics CPOE-Infusion Pumps PIS-CPOE Example Value Dose processing, batches/cartfill Profiled order verification/monitoring, billing IV dose processing, tracking, routing Cabinet replenishment BCMA order recognition and matching, I&O recording Paperless pharmacy order processing

34 Regulatory Impact: The New England Compounding Center (NECC) Tragedy in 2012 Fungal Meningitis outbreak from contaminated steroid injections 64 deaths and 751 people sickened in 20 states Healthcare facilities in at least 24 states received 3 recalled lots of methylprednisolone acetate from NECC on September 26, 2012 Reaction: US Drug Quality and Security Act (DQSA) signed into law Nov 2013 to further control compounding practices. New State Board regulations in CA, TX, TN, GA, MN, MA and others

35 Other Applicable Regulatory Components Depending on the country, regional, or local jurisprudence, IV automation may need to prove compliance with one or more of the following requirements and standards: USP cgmp GAMP GS-1 and Supply chain traceability OSHA - minimizing user exposure Remote pharmacist verification Positive ID requirements Other