Although barcode medication administration (BCMA) has already made its way into the majority of hospitals nationwide (Am J Health Syst Pharm 2013;70[9]:787-803), only a few hundred have incorporated barcode-assisted medication preparation (BCMP) into their medication-use processes. We anticipate, however, that this disparity will diminish before the end of the decade.

We recently researched BCMP technologies and conducted site visits for six months to create a report on these systems and variations. Our research showed that most technologies reside in hospital pharmacy cleanrooms to assist in preparing compounded sterile products (CSPs), but at least one is being used outside the cleanroom to prepare nonsterile, oral liquid products as well.
 
For inclusion in our report, systems had to include computerized workflow processes, which require barcode-scanning of CSP containers and ingredients to verify that they match orders, and produce barcode-labeled CSPs for scanning at the point of care. A dozen systems, on or soon to hit the market, met these criteria. Here are some of our findings and observations.
 
Categories
 
Semiautomated manual systems: People handle the products during the compounding process and barcode readers verify the accuracy of the selected products. The vast majority of BCMP implementations are semiautomated and are used to prepare virtually all of a hospital’s CSPs.
 
Highly automated robotic systems: Robotic arms perform most of the compounding activities, and internal readers verify product selection with barcode scans, confirm drug amounts with scales and capture images of critical steps for documentation purposes. Robotic systems fill limited formularies of sterile products (six to 12 at sites we visited), and in some cases, process hazardous drugs exclusively. Although they are capable of producing patient-specific doses, most robots are used to produce batches of their hospital’s highest moving CSPs, akin to small-scale manufacturing.
 
Pharmacy information system interfaces: All products are interfaced to hospital pharmacy information systems. Drug orders make their way to BCMP systems via direct HealthLevel 7 interfaces or print streams.
 
Compounding Tools
 
BCMP systems vary with the information and tools provided, and in most instances, hospital formularies must be cross-referenced to National Drug Code numbers. Some vendors use third-party databases to manage these files, whereas others rely on hospitals to build and maintain their own.
 
Most vendors offer customizable drug-recipe catalogues. Recipes may include formulas, ingredients, diluents, containers and final solutions, as well as beyond-use dating and special instructions for preparation and handling. Recipes assist in standardizing preparation processes, improving safety and efficiency and equipping pharmacies to meet state pharmacy board documentation requirements. A few BCMP systems provide dose-and-volume calculation utilities, as well as reference tools for permitted diluents, known stabilities and drug-storage conditions.
 
Remote Access
 
Most BCMP systems are Web-based, allowing users full or partial system access from anywhere via desktop computers, laptops, tablets and some smartphones. Direct computer interfaces, as well as Internet access, enable pharmacists to retrospectively verify CSP orders by viewing production images without having to enter cleanrooms. We expect the remaining systems to migrate to Web-based access in the near future.
 
Workflow 
 
Workflow software, the core of BCMP systems, guides users from one step to the next during the compounding process. Most versions include forcing functions, which prevent users from proceeding until particular steps are completed (barcode scans have verified products and/or scales have verified weights). Robot algorithms include internal forcing functions, which do not allow CSP production to continue should scanning and/or weighing fail to confirm the right containers, drugs and volumes. During the checking process, pharmacists compare orders with multiple production images to verify accuracy—what we think of as an enforcing function.
 
Labels
 
All BCMP systems produce barcoded labels for application to final IV products, which may be used for tracking CSPs en route to points of care and for scanning at the points of administration. Most systems only use one barcoded label, which is applied to containers at the beginning of the process, scanned during various preparation steps and finally at the point of care. One semiautomated system uses two barcode labels; one during the preparation process, and another after orders have been satisfactorily completed and approved by a pharmacist. This serves as a forcing function to prevent incomplete or inaccurate CSPs from being administered to patients.
 
Code Readers
 
All BCMP systems use imagers for reading multidimensional, as well as linear barcodes on containers, syringes, diluents and drugs.
 
Images
 
Most BCMP systems use cameras for capturing images of compounding activity. Semiautomated systems capture images at various user-determined stages in the preparation process. Pharmacists can thus check completed orders remotely instead of gowning up and entering cleanrooms. Likewise, robotic systems capture images of critical steps during the compounding processes, which are archived for future reference. Although pharmacists, by law, must inspect CSPs, they do not routinely have access to robot-captured images when verifying compounding accuracy and must trust the robots to have fulfilled their tasks correctly.
 
Measuring Methods
 
BCMP systems offer several methods for verifying the amount of drugs drawn and injected into infusion containers, such as image-assisted volumetric analysis and scale-assisted gravimetric analysis. Some systems offer both options.
 
Traditional pullback: Traditional volumetrics is commonly used when making CSPs. Preparers draw drugs into syringes and visually confirm amounts against markings on syringe barrels before injecting the contents into IV containers. They then “pull back” the syringe plungers to the previous volume marking, only using their memory, before placing the empty syringes with the drug vials for pharmacists to check.
We support the Institute for Safe Medication Practices warning, “While the ‘syringe pullback’ checking process is standard in many hospitals, it is less than ideal because the check is made post-preparation and is based on the preparer’s memory of how much product was added to the bag.”
 
Image-assisted volumetric analysis: Most BCMP systems add image assistance to the volumetric analysis process. During compounding, images of all drug containers used are captured, as well as images of corresponding drawn syringes before their contents are injected into IV containers. During the checking process, pharmacists visually verify images of drawn syringes taken before they are emptied into containers. Although preparers may still draw wrong amounts and proceed on, image-assisted checking serves as an enforcing function, mitigating opportunities for technician errors being missed.
This is a safer practice than the traditional pullback method. Nevertheless, it should be noted that even with image-assisted volumetric analysis, both compounding technicians and checking pharmacists are capable of visually misreading volumes ordered and/or actual volumes in syringes.
 
Scale-assisted gravimetric analysis: Gravimetric analysis is the process of determining drug amounts using scales and a drug’s specific gravities. Some semiautomated systems provide gravimetrics for determining the accuracy of doses drawn into syringes, removed from vials and injected into infusion containers. Weighing each before and after adding or removing substances, reveals exactly how much of each ingredient was added or removed with accuracy equal to or surpassing the International Organization for Standardization syringe tolerance of plus or minus 5%.
Weighing products adds time to the process and decreases throughput. However, it serves as a forcing function that prevents compounders from proceeding should they draw too much or too little of a product before it goes to a pharmacist for review. Because robotics replaces human eyes and hands, gravimetrics is the only way these machines can ensure that proper volumes of drugs have been drawn before being injected into containers and safeguard against wrong product amounts being injected.
 
Throughput
 
Semiautomated system throughput varies greatly depending on hospital policies, procedures and product configurations. Some pharmacies that have experienced increases in hood time have also experienced decreases in overall production times by avoiding preparation of discontinued doses and automating documentation.
 
Throughput for robots varies based on the number of ingredients per product and the availability of labor resources to attend to a robot's needs and pace. Inventory must be manually loaded and completed orders must be manually removed before robots can proceed. Robots have faster throughput when compounding batches than when filling patient-specific orders on demand. However, semiautomated systems produce significantly higher doses per hour than robots.
 
Space and Utility Requirements 
 
Existing pharmacy space may limit which products or devices will work in a given facility. Semiautomated systems may easily operate within spaces currently allotted for CSP preparation, however, robotic devices with larger footprints may require additional floor space for installation, operation and maintenance. Increasing load-bearing support may be requisite to installation. All systems require network access and some require additional utilities, such as upgrading electrical outlets and plumbing for water-cooling systems.
 
Potential Benefits
 
Hospitals using BCMP technologies say they have realized a return on their investments; Baxter reports that more than 5% of products prepared with its product identify and intercept errors in the compounding process. These systems are also protecting patients and caregivers from CSP compounding and dispensing errors. Of increasing importance is the documentation assistance these systems provide for hospitals in meeting regulatory compliance.
 
It is time for hospitals to apply the same barcode safety technologies to the medication preparation process as so many already have to the medication administration process. Given the high risks associated with IV medications, it could be argued that if a hospital had neither, the best place to start might be with BCMP.
 
 
Dr. Fahrni will be presenting on this subject at The unSUMMIT in New Orleans. Click here to register or for more information on the event: www.unsummit.com.