Lec 4- Sterile Compounding Automation and Technology

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Questions and Answers

What is the primary purpose of compounding automation?

  • To complicate the labeling process
  • To reduce human interventions during compounding (correct)
  • To limit the number of medications available
  • To increase the cost of medication

What does compounding technology primarily apply to practical use?

  • Scientific knowledge (correct)
  • Traditional medicine
  • Ancient remedies
  • Herbal recipes

What is the main benefit of sterile compounding?

  • Identifying, reducing, or eliminating compounding errors (correct)
  • Increasing medication errors
  • Avoiding harm through automation
  • Eliminating compounding errors
  • Ignoring compounding errors

According to USP Chapter <797>, what is permitted regarding the use of technologies in sterile compounding?

<p>Technologies can be used if they are noninferior and validated. (A)</p>
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Barcode scanning verification should be incorporated into the workflow for what purpose?

<p>To verify base solutions and ingredients (D)</p>
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What kind of verification should be incorporated for quality control to ensure the weight of ingredients meets the expected weight for a given CSP?

<p>Gravimetric verification (B)</p>
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According to a 2023 survey, what percentage of pharmacies have adopted I.V. Workflow Management Systems?

<p>45% (A)</p>
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What do temperature monitoring systems in sterile compounding settings primarily do?

<p>Monitor and record temperature readings (B)</p>
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What is a key advantage of using automated compounding devices?

<p>Increased efficiency and accuracy (C)</p>
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What is one disadvantage of automated compounding devices?

<p>Inability to pump very small volume medications (C)</p>
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What is a notable advantage of using I.V. robots in compounding?

<p>Limiting hazardous drugs exposure (B)</p>
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Which of the following is a DISADVANTAGE of using I.V. robots for I.V. preparation?

<p>High cost to purchase (C)</p>
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What is the function of an automated medication tray and cart management system?

<p>To use radio-frequency identification (RFID) integrated tags for product labels (B)</p>
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What is a primary use for automated compounding devices?

<p>To transfer multiple ingredients into a single container (A)</p>
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What is a key component that I.V. Workflow Management Systems use to assist in the verification of components and preparation of CSPs?

<p>Barcode scanning (C)</p>
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Automated Compounding Devices are primarily used to prepare:

<p>Total parenteral nutrition formulations (A)</p>
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What is emphasized by ISMP and ASHP regarding the syringe pull-back method?

<p>Elimination of the method (C)</p>
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What is compounding automation?

<p>Technologies that reduce human interventions (C)</p>
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What is the purpose of gravimetric calibration in automated compounding?

<p>To ensure accuracy of programmed amounts (B)</p>
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The use of radio-frequency identification (RFID) integrated tags is part of which system?

<p>Automated Medication Tray and Cart Management System (C)</p>
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What is a primary advantage of utilizing automated compounding devices in pharmaceutical settings?

<p>Enhancing precision and efficiency in compounding processes. (B)</p>
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What is a limitation of automated compounding devices regarding the volume of medications they can handle?

<p>They cannot accurately pump very small volume medications. (D)</p>
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Which aspect of sterile compounding is directly enhanced by automatic calculations in automated compounding devices?

<p>Improved safety and risk reduction. (B)</p>
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What is a key benefit of incorporating robotic I.V. preparation devices into the sterile compounding process?

<p>Decreasing the exposure of personnel to hazardous drugs. (A)</p>
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What capability is enhanced when primary engineering controls camera systems interface with I.V. workflow management systems?

<p>Remote monitoring of compounding and verification by a pharmacist. (A)</p>
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Which of the following highlights a disadvantage of using I.V. robots in sterile compounding?

<p>They generally have high requirements for maintenance. (A)</p>
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What is a major advantage of using I.V. robots for sterile compounding in terms of contamination risk?

<p>Decreased contamination due to the closed system nature of the robots. (C)</p>
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How does gravimetric calibration contribute to the accuracy of Automated Compounding Devices?

<p>By ensuring accuracy within 5% of the programmed amount. (B)</p>
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How do automated compounding devices enhance safety in pharmaceutical compounding?

<p>By reducing labor and materials. (B)</p>
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In sterile compounding, what role do barcode scanners and readers play when integrated with I.V. workflow management systems?

<p>They verify base solutions and ingredients. (A)</p>
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What is a key function of I.V. Workflow Management Systems in the context of sterile compounding?

<p>Assisting in the verification of components and preparation of CSPs. (B)</p>
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In what specific scenario is gravimetric verification particularly recommended as a quality control measure?

<p>When preparing parenteral cancer chemotherapy or pediatric products. (B)</p>
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What is the primary role of temperature monitoring systems in sterile compounding environments?

<p>Documenting and alerting staff to out-of-range temperature readings. (D)</p>
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According to ISMP, what is the recommended alternative to the syringe pull-back method for ingredient and dose verification?

<p>An in-process check by a pharmacist. (B)</p>
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According to USP Chapter <797>, what is the key requirement for using technologies, techniques, materials, and procedures that are not explicitly described within the chapter for sterile compounding?

<p>They must be noninferior to those described and validated for the intended purpose. (A)</p>
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How do automated compounding devices help address labor and material costs in pharmaceutical compounding?

<p>By standardizing processes. (B)</p>
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What is a typical limitation regarding the types of final products that can be produced by I.V. robots?

<p>They have limited final products can they produce. (A)</p>
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Which of the following describes how compounding automation is best defined?

<p>The reduction of human interventions through the use of technologies. (C)</p>
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In what area do I.V. robots offer a distinct advantage over manual compounding regarding employee safety?

<p>Reduced repetitive motions improving employee comfort. (B)</p>
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What is the initial step in the implementation of automation and technology in sterile compounding?

<p>To understand the advantages and disadvantages of each automation device and technology. (A)</p>
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Within the framework of sterile compounding, how does gravimetric verification contribute to the overall quality assurance process when utilizing automated compounding devices?

<p>By validating that the weight of each ingredient dispensed aligns with the expected weight for the compounded sterile preparation (CSP). (A)</p>
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In the context of sterile compounding, what is the most significant implication of USP Chapter <797>'s allowance for the use of technologies, techniques, materials, and procedures not explicitly described in the chapter?

<p>It permits flexibility in adopting innovative solutions, contingent upon rigorous validation to ensure non-inferiority to established methods and suitability for the intended purpose. (B)</p>
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Considering the adoption rates of automation and technology in pharmacies, what strategic advantage does a pharmacy gain by implementing I.V. workflow management systems, compared to those that have not?

<p>Improved accuracy, enhanced safety, and increased efficiency in sterile compounding, positioning them as leaders in pharmaceutical care. (A)</p>
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How does the integration of radio-frequency identification (RFID) tags within automated medication tray and cart management systems most profoundly influence patient safety and medication management?

<p>By providing a robust, real-time tracking and verification mechanism that minimizes the risk of medication errors and ensures accurate inventory control. (C)</p>
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What is the most critical implication of ISMP and ASHP's recommendation to eliminate the syringe pull-back method of ingredient and dose verification in favor of an in-process check?

<p>A shift towards a more proactive, real-time verification process that enhances accuracy and minimizes the risk of errors in compounded sterile preparations (CSPs). (D)</p>
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Considering the limitations of I.V. robots in producing certain final products, what strategic decision must a pharmacy make to effectively integrate I.V. robotics into its sterile compounding operations?

<p>Carefully select the range of compounded sterile preparations (CSPs) to be produced by the robots, focusing on those compatible with the robot's capabilities, and maintain manual compounding for specialized preparations. (A)</p>
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What is the most significant factor to consider when evaluating the implementation of primary engineering controls camera systems that interface with I.V. workflow management systems?

<p>The system's capability to provide real-time, remote compounding verification by a pharmacist, ensuring accuracy and adherence to sterile compounding procedures. (C)</p>
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How do automated compounding devices primarily enhance patient safety, beyond the benefits of increased efficiency and accuracy in sterile compounding?

<p>By enabling a reduction in direct human contact with hazardous drugs, thereby lowering the risk of exposure for compounding personnel. (C)</p>
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How might the integration of bar code scanners and readers within I.V. workflow management systems most significantly reduce medication errors during sterile compounding?

<p>By ensuring correct drug and diluent selection, as well as accurate dose measurement, through real-time verification at each compounding stage. (B)</p>
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In what way do automated compounding devices contribute to lowering expenses linked to labor and materials throughout pharmaceutical compounding?

<p>By optimizing workflow and inventory management, decreasing waste, and reducing the need for manual labor. (A)</p>
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What is the primary advantage of utilizing automated compounding devices concerning the accuracy of sterile compounding?

<p>Automated Compounding Devices use programmed logic and precise measurements, decreasing variability and enhancing the accuracy of final product concentrations. (A)</p>
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How does temperature monitoring systems play a role in upholding the stringent quality standards required in sterile compounding environments?

<p>By continuously tracking and documenting temperature, ensuring it remains within defined parameters critical for maintaining the stability and sterility of compounded preparations. (B)</p>
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What is an operational hurdle presented by I.V. robots in the setting of sterile compounding when compared to manual compounding?

<p>I.V. robots require more space than manual compounding areas. (B)</p>
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In what specific way can I.V. robots reduce the risk of contamination during sterile compounding, compared to manual methods?

<p>By utilizing a fully enclosed, closed system design that minimizes human intervention and exposure of the preparation to the surrounding environment. (B)</p>
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What should a facility do before it integrates technology and automation into sterile compounding?

<p>They should make sure that the new technologies are noninferior to the existing manual standards. (A)</p>
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How do automation systems contribute to mitigation of the 'wrong drug' error within the pharmacy compounding environment?

<p>By using barcode scanning in conjunction with I.V. workflow systems. (A)</p>
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A gravimetric system that is off by 5% during automated compounding device calibration would lead to which situation?

<p>A compounding event with ingredients that could be outside of acceptable weight parameters. (A)</p>
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What is the most critical advantage of implementing automated compounding devices in sterile compounding facilities?

<p>More consistent results. (D)</p>
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What aspect of sterile compounding is greatly enhanced by automatic calculations within automated compounding devices?

<p>Reduction of transcription errors. (C)</p>
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How does the implementation of automated compounding devices influence the dynamics of labor and material expenses within pharmaceutical compounding?

<p>By optimizing workflow and inventory management, decreasing waste, and reducing the need for manual labor. (A)</p>
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Flashcards

Automated Compounding Devices

Automated compounding devices are technologies designed to reduce human intervention in the sterile compounding process.

Advantages of Automated Compounding Devices

Automated compounding devices can increase efficiency, accuracy, and safety. They also provide automatic calculations and remote verification.

Disadvantages of Automated Compounding Devices

Drawbacks of automated compounding devices include the inability to pump small volumes, cost, and space requirements.

IV Robotics

IV robotics refers to the use of robotic systems in the preparation of intravenous medications to automate compounding processes.

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Advantages of IV Robotics

Advantages of IV robotics include accuracy, reduced preparation time, limited hazard exposure, and decreased contamination risk.

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Disadvantages of IV Robotics

Disadvantages include large size, high cost, required maintenance, and limitations in starting containers and final products.

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Compounding Automation

Technologies that reduce human intervention during compounding, labeling, packaging and verification.

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Compounding Technology

Applying scientific knowledge to solve problems during compounding with tools like barcodes and gravimetric scales.

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USP <797> and Technology

While not mandated, USP Chapter <797> allows new technologies if non-inferior/validated.

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ISMP Guidelines (2016)

Guidelines that recommend tech in I.V. admixture for enhancing safety.

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I.V. Workflow Systems

These systems help verify components and preparations, reducing errors.

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I.V. Workflow Features

Includes barcode scanning, ingredient checks, gravimetric verification and image capture during the I.V. process.

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Automation Tech Tools

Tools include automated compounding devices, I.V. robots and workflow management systems for sterile compounding.

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Infusion Pumps

Tools such as general infusion pumps for inpatient settings and PCA pumps for pain management in sterile compounding.

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PEC Camera Systems

Camera-based systems that allow remote monitoring for compounding/verification by a pharmacist.

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Automated Compounding Device Advantages/Disadvantages

Automated compounding devices use technology to minimize manual steps in preparing medications. What are their benefits and potential drawbacks?

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IV Robotics Advantages/Disadvantages

IV robotics automates the preparation of intravenous medications. What are the benefits and potential drawbacks?

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Study Notes

  • Automated compounding devices and IV robotics are designed to improve the sterile compounding setting through automation and technology.

Automated Compounding Devices

  • Automated compounding devices enhance efficiency and accuracy during sterile compounding.
  • These devices automate calculations using software-driven systems, improve safety, and allow remote verification.
  • Labor and material costs are reduced.
  • Automated devices usually cannot pump very small volumes of medications, typically those less than 0.2 mL.
  • The initial cost to purchase and the space they occupy in the hood can be considerable.
  • Baxter ExactaMix®, Kapsum NutriMix®, and Baxter Repeater® Pump are products available.
  • Used to transfer multiple ingredients into a single container, with 12 to 24 ingredient ports.
  • Use gravimetric calibration and are accurate to within 5% of the programmed amount.
  • Barcode scanning, patient specific labels, software interfaces, and volumetric/gravimetric checks are utilized.
  • Specific gravity of ingredients is required.
  • Mostly used to prepare TPN formulations, multi-ingredient solutions, and batching products.

IV Robots

  • IV robots automate compounding processes to achieve consistent standards and checks.
  • Advantages include accuracy in volumes and drugs, shorter IV preparation times, and reduced exposure to hazardous drugs.
  • Contamination risk is decreased due to closed systems.
  • Can reduce repetitive motion injuries and decrease outsourcing.
  • Disadvantages include large size, high purchase cost, and required maintenance.
  • Only certain starting containers like ampules, glass bottles, IV bags, syringes, and vials can be handled.
  • Can only produce limited final products like elastomeric pumps, glass bottles, IV bags, medication cassettes, syringes, and vials.

Automation and Technology

  • Automation refers to reduce human interventions during compounding, labeling, packaging, and verification.
  • Technology applies scientific knowledge to solve problems.
  • Used to identify, reduce, or eliminate compounding errors, thus preventing potential harm.

Minimum Standards

  • Current USP Chapter <797> does not prohibit alternative technologies if they are noninferior and validated.
  • Minimum practice standards don't require compounding technology, but emphasize manual processes.

Best Practices

  • ISMP advises that facilities offering IV admixture services utilize technology.
  • At a minimum, barcode scanning should verify base solutions and ingredients.
  • Gravimetric verification for cancer chemotherapy or pediatric products ensures correct ingredient weight.

Adoption Rates

  • As of a 2023 survey, the adoption rates for automated compounding devices, IV robots, and IV workflow management systems are 28%, 10%, and 45% respectively.
  • IV Workflow management systems appear to be a key automation and technology tool for pharmacies.

Additional Tools

  • Other tools are temperature monitoring systems, automated medication tray and cart management, and barcode scanners integrated with workflow management.
  • Infusion pumps (general, PCA, syringe, elastomeric), and primary engineering controls camera systems improve automation.

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