The accurate and efficient management of chemotherapy is of the utmost importance for any facility that administers this treatment. Safety is always the top priority—utilizing automation and technology to optimize certain processes can help achieve this goal. Automating chemotherapy management is key to applying standardization that can increase both patient and provider safety throughout a facility.
Brigham and Women’s Hospital (BWH) is a tertiary academic medical center in Boston, Massachusetts, and is part of a joint venture with Dana Farber Cancer Institute (DFCI) to provide inpatient care to their patients. This joint venture involves a total of 150 inpatient oncology beds (30 DFCI, 120 BWH). BWH has an outpatient infusion clinic with 18 chairs for non-oncology chemotherapy infusions while all outpatient oncology infusion chair services are provided by DFCI. At BWH, automation and technology are used in many aspects of managing chemotherapy in order to increase patient and provider safety. Some of the ways we have incorporated technology in this process include computerized prescriber order entry (CPOE), automated inventory management systems, bar code scanning verification, IV workflow software, and robotics.
Computerized Provider Order Entry
When used in combination with an electronic health record (EHR) platform, electronic file systems can help standardize and track methods of treatment. At BWH and DFCI, we use the same EHR and inpatient chemotherapy is ordered using templated treatment plans through CPOE. Treatment plans are added to a patient’s chart using an electronic file system of treatment and therapy plans, which include standardized dosing buttons with parameters for treatment, pre-medications, fluids, and instructions on how to administer the chemotherapy.
Medication orders reside in the oncology EHR until clinical staff release the orders into an active encounter in the patient chart.
Access to the oncology EHR is granted at the user key level and is approved by the respective departments of the medical staff. Access can also be granted to oncology fellows, but any treatment plan they apply requires a co-signature by a fully privileged physician. Once the orders are signed and dated, they can be released into the active patient encounter by an oncology nurse. Upon release, these orders appear in the pharmacy order approval system. Two pharmacists independently verify chemotherapy orders.
Ambulatory outpatient chemotherapy for non-oncology use is also ordered using the templated therapy plans with default dosing buttons and default frequencies. While these templates require privileged user signoff, providers can sign one plan that can be used for multiple ambulatory encounters, allowing the patient to come to the infusion clinic for the same therapy at a fixed frequency.
Upon the patient’s arrival, the infusion clinic nurses release the orders into the active ambulatory encounter. Once released, the pharmacist verifies the orders for appropriateness and ensures lab value criteria are met prior to approval. When chemotherapy medication is being used for non-oncology indications, it does not require additional independent verification by two pharmacists. However, changes to the therapy plan, such as dose or frequency, can occur at any time and still require a privileged provider’s signature. Changes made and orders released are tracked and can be viewed through the treatment plan’s audit history.
When changes to a treatment plan occur before the orders are released, they are logged within a history tracker that can be viewed for changes, including dose modifications, medication changes, and additions to the treatment plans. The tracker displays the prior and new dose as well as the reason for the modification. The ability to make and validate an addition requires approval from subject matter experts and an exception order reason. Exception orders need to have a reference supporting the use of an additional agent for the diagnosis.
Bar Code Scanning Verification
Bar Code scanning verification technology can be incorporated at several steps in the chemotherapy process. Pharmacy staff at BWH use bar code scanning verification as an additional safety mechanism during chemotherapy preparation. To begin, the pharmacy technician scans the bar code on the patient specific label. A color-coded system is used to identify each item scanned:
Only products that are part of the order will be able to be scanned into the record of the preparation. A red scan should never be overridden.
Bar code verification scanning can also increase safety during chemotherapy administration. At BWH, this occurs on all chemotherapy and adjunctive medication prior to administration to the patient. Each dose of chemotherapy or adjunctive medication requires two nurses to independently verify the medication label with the active order as well as with the two patient identifiers on the wrist band. Following this bar code verification, each nurse must electronically sign off on the order.
Cleanroom Automation and Software
Hazardous compounding occurs in a negative pressure hazardous cleanroom. Hazardous drugs (HDs), including chemotherapy, are stored within the negative pressure cleanroom in an externally vented automated dispensing carousel. At BWH, the carousel contains the room temperature hazardous medications while maintaining remote inventory of the refrigerated hazardous medications, which are stored in a separate physical location in the hazardous cleanroom. Utilizing carousel storage with reporting both eliminates the need for the daily count of quantities on hand to determine how much to order and minimizes medication handling which reduces dropped vials and spills. The location of the carousel and the ability to limit authorized users restricts hazardous drug access to those who are permitted log-in access.
In addition, all of the ingredients for each bag are scanned against the associated label to ensure the correct admixture is made during compounding as mentioned above. Closed system drug-transfer devices (CSTDs) are used for the safety of the compounding staff.
Each admixture is then placed separately in a bag marked chemotherapy to be delivered to patient specific chemotherapy bins in an automated dispensing cabinet (ADC) on the patient units. These chemotherapy admixtures are stored separately from the regular admixtures in the patient unit ADC. This separation prevents potential contamination and keeps any accidental spills contained.
IV Workflow and Robotics for Sterile Compounding
BWH has over a decade of experience using robotic technology and IV workflow technology to compound sterile products. We were one of the first institutions in the US to use robots to compound patient-specific doses of chemotherapy; our primary goal was to ensure a safe and effective compounding process. The original robots used specific gravity to determine the theoretical weight of the final preparation and compare that to the actual weight of the completed compounded product. The electronic record documents all the steps the robot took to make the product as well as the final weight and variance of the compounded product. The final compounded chemotherapy product passes if it is within +/- 5% of the theoretical weight.
BWH also has a long history with gravimetric IV workflow devices. This technology uses the same process and software as the robot, but to determine the accuracy of products compounded by a pharmacy technician or pharmacist. These devices typically utilize a small computer with a scale and camera. Both the robots and IV workflow devices were integrated in the EHR through an HL7 interface to avoid the possibility of any transcription errors. There were challenges in using robotic and workflow technologies, many of which had to do with both drug and diluent shortages as well as technology issues that early adopters often face.¹ It is also important to note that neither of the original devices were compatible with CSTDs, which were added to the bag or syringe after the preparation was complete. Any compounding automation must address the exposure risk to the operator. While the automated compounding devices and robotics are self-contained throughout the compounding process, the inner components of these devices are not a closed system; as such, the user can be exposed to chemotherapy residue when cleaning the internal surfaces.
It is imperative when incorporating technology that all users are thoroughly trained and maintain competency on all automation devices. Annual competencies are recommended in anticipation of upgrades to the software or other enhancements to the technology over time. It is also vitally important that both the pharmacist and pharmacy technicians do not rely so heavily on technology that they become complacent to noticing changes or potential errors. Implementing technology does not remove the importance of reading a label or paying attention to surroundings. Anything that seems out of the ordinary or looks questionable should be brought to the attention of the covering pharmacist for further discussion.
Opportunities for Improvement
Opportunities for technological improvement during the chemotherapy use process are complicated, as building of chemotherapy treatment and therapy plans must align with the timing of the protocols. When changes are needed on either the main chemotherapy medication or an adjunct medication, there is a trickle-down effect on all of the medications in those plans. Future improvements should be made to better customize the build of these complex plans and provide more flexibility in instances of drug shortages or changes in protocols. While bar code scanning verification is an established method for improving the safety of medication administration, there are additional opportunities to use radiofrequency identification (RFID) with inventory management systems. Although RFID can be a more costly endeavor, it may provide increased accuracy when maintaining inventory of expensive chemotherapeutic medications both while stored in the pharmacy and during preparation and transportation to the unit or clinic. Lastly, there are many opportunities to improve IV workflow assist devices and robotics, namely, by incorporating CSTDs into the processes. Furthermore, improvements in speed and accuracy are needed to better support busy outpatient clinic settings.
Future steps for BWH on the technology front include several options for improving automated inventory management systems, including refrigerator automation. A new IV workflow system will be adopted shortly to upgrade oversight of the compounding processes. In addition, BWH is working toward integrating the smart pump system and the EHR, which requires the standardization of admixtures and pump settings (ie, hard/soft limits) across the entire health system.
The chemotherapy use process is complex and requires multiple resources to build, support, and maintain. Incorporating technology and automation can increase the efficiency, quality, and safety of all aspects of the process including the prescribing, compounding, administration, and inventory management of chemotherapeutic agents.
Caryn Belisle, RPh, MBA, is the director of pharmacy regulatory compliance, quality, and safety at Brigham and Women’s Hospital (BWH) in Boston, Massachusetts. She has served as president of the Massachusetts Society of Health-System Pharmacists and presently serves on the House of Delegates for the American Society of Health-System Pharmacists.
Josephine H. Leung, PharmD, MBA, is the pharmacy manager of sterile compounding services and ambulatory infusion services at BWH. She received a PharmD from the University of Maryland, School of Pharmacy and an MBA from the University of Baltimore, Merrick School of Business.
Amy Ostrowski, RPh, is the senior oncology pharmacist at BWH.