Q&A with Anne McDonnell, PharmD, BCOP;
Caryn Belisle, RPh; and Josephine Leung, PharmD, MBA
Brigham and Women’s Hospital, Department of Pharmacy
Pharmacy Purchasing & Products: What is the main challenge in managing IV chemotherapy workflow at your facility?
Anne McDonnell: The main challenge for managing intravenous chemotherapy workflow at Brigham and Women’s Hospital (BWH) in Boston is scheduling appropriately for busy, real-time preparation of chemotherapy products. Our sterile products room (SPR) is operational twenty-four hours a day and chemotherapy preparation is performed from 7am to 11pm spanning two shifts. Both shifts prepare chemotherapy as it is being activated and approved. Currently, we average a two-hour turnaround time for chemotherapy products, which requires the coordination of chemotherapy timing and approval by the unit pharmacists with the SPR pharmacists, physicians, and nurses. Physicians enter all of our inpatient chemotherapy orders through CPOE and unit-based pharmacists approve the orders after nurse activation.
PP&P: What were the primary safety concerns with a non-automated process for chemotherapy production?
McDonnell: Non-automated processes for chemotherapy production are rife with potential error points. Transcription errors in particular often lead to medication errors and misadventures. Fortunately, our current system provides prescribers with templates, which include default doses, frequencies, infusion rates, and administration times for chemotherapy preparation. By entering a patient’s height and weight, the template will populate the necessary dosage fields, thereby providing both pharmacists and nurses with clear, complete, and accurate chemotherapy order information. Although it is not an error-proof system, it is certainly safer than non-automated processes.
With automated functionality there are specific tasks we can afford to take for granted. For example, with our current chemotherapy order entry (COE) system, a physician will enter the patient’s current height and weight at the time of prescribing, often well in advance of the actual administration. Therefore, on the day of administration, two nurses will take the height and weight of the patient again. If there is a discrepancy between these numbers, and the resultant dose change is greater than 5%, the order will automatically be returned to the physician for authorization. In a more traditional, non-automated process, pharmacy must rely on clinicians to accurately transcribe height and weight values, as well as calculate dosages. Mistakes made at this stage can lead to significant errors downstream.
PP&P: Brigham and Women’s Hospital has a fairly advanced chemotherapy order entry system, how has this system matured since its inception?
McDonnell: Since adopting our COE system in 2009, we have become more skilled at setting realistic chemotherapy administration times. We also have developed standard administration times for many of our hematopoietic stem cell transplant (HSCT) regimens, as well as our supportive care medications. For example, all of our filgrastim orders are approved for a 5pm administration time; designating an administration time that is later in the day allows for therapeutic discontinuations (and therefore, less waste) based on laboratory results received in the morning.
These activities speak to the larger accomplishment of establishing an efficient and appropriate daily production schedule. Our chemotherapy patients have two different time clocks for medication administration. Non-chemotherapy medications are scheduled between 12am and 11:59pm, whereas the chemotherapy pharmacist schedules the chemo day according to the start time of the first chemotherapy administered. For example, if a patient is scheduled to receive chemotherapy every six hours and the first dose is due at 7pm, the chemo day would start at 7pm, and run to 6:59pm the following day. This process allows pharmacists to schedule a full, twenty-four hour day of chemotherapy without losing any doses.
Under our current COE system prescribers enter a chemotherapy order and nurses are permitted to activate that order. However, the system requires a minimum of two hours from the time of the request until the dose is available for administration. So, if a nurse activates a chemotherapy order at 10am, he or she may request that chemotherapy dose to be initiated any time after 12 noon.
PP&P: What are some other strategies for reducing wasted doses?
McDonnell: Reducing wasted chemotherapy has become an area of focus for our institution in recent years. Prior to the preparation of any high-cost or short-supply medication doses, the covering clinical pharmacist will confirm that timely administration of that dose will take place by reaching out to either the nurse or the physician caring for the patient. An additional step intended to reduce chemotherapy medication waste is to designate patients that have met specific laboratory values in order to be treated with certain chemotherapies. For a medication like arsenic trioxide, the chemotherapy pharmacist will check that the laboratory values for both potassium and magnesium are within the proper ranges before preparing the medications. In addition, the compounding pharmacist will also reach out to the administering nurse to confirm the patient is presenting appropriate cardiac parameters before preparing the medication.
Josephine Leung: Further to these operational activities, we also employ technology to assist with waste reduction and proper medication utilization. Medications used to make patient-specific doses are kept in a designated automated dispensing cabinet (ADC) located in the SPR. Par and reorder quantities are set within the ADC software and our purchasing department is automatically notified to reorder any medications that have fallen below established reorder quantities.
PP&P: How do your automated systems affect batch production and extended BUD?
Leung: At BWH, we produce all of our doses daily on a per-patient basis. We do not outsource any chemotherapy production at our institution and we do not use any extended use dating for our chemotherapy products either. However, we do perform batch production of high-use, non-chemotherapy items using robotic technology; roughly 60% of our batch production is robotic and our technicians produce the remaining 40%. We follow USP <797> guidelines for all BUDs and we only apply extended BUD to products for which samples have been sent in for sterility testing per USP <71>. We also have a quarantine program for all products that have an extended BUD. For example, furosemide bags are batched on a scheduled basis and assigned an expiration of 90 days. Once a batch of furosemide is compounded and verified by a pharmacist, the batch is held in a quarantine area for 14 days until sterility test results are released.
PP&P: How do you manage the transition from IV to oral chemo?
McDonnell: Whenever there is a change in route of medication administration, our system requires the current order to be discontinued before the alternate route may be prescribed. Although we have very few patients transition from IV to oral chemotherapy, there are cases where we allow both intravenous and oral medications to be prescribed concurrently, but allow only one type to be administered. For example, a patient who is receiving anti-viral prophylaxis might have active orders for both oral acyclovir and intravenous acyclovir. Both medications can be approved and set for the same administration time. However, administration of either the intravenous or oral dosage form eliminates the option for the alternate dosage form in our system. For example, if a patient develops nausea or mucositis, the nurse may administer IV acyclovir, instead of the oral dosage form, without any delays in therapy.
PP&P: How does interconnectivity improve your processes?
Josephine Leung and Caryn Belisle: Our dose tracking, CPOE, pharmacy order approval system (POAS), and eMAR are all interconnected and communicate with each other. Patient-specific doses are documented in the eMAR as given or not given, and that information is linked to the order in the POAS, which can be queried. In our POAS, we are able to view information on whether a dose was prepared and sent to the patient. If we receive a call about a missing medication, we can see the time it was made across all shifts, who made it, and whether it should have been delivered to the floor. Our nurses also are able to view medication workflow through their computers. This ability to track medications from multiple points reduces calls regarding missing doses and streamlines the delivery process.
Leung and Belisle: Everything made in the SPR comes through the POAS and is listed on a computerized dashboard for verification. When a new order is received, a bar-coded order label is printed and the medication (along with its expiration date and lot number) and diluent are scanned into the dashboard. Once scanned, a preparation label prints out with information on how to prepare that specific bag. The order will be placed into the SPR intake window with the medication, diluent and preparation label. After the dose is made, the pharmacist will retrieve it from the SPR outtake window.
In addition, our robotic and IV workflow software allows us to track the times it was started, completed, and verified. The verifying pharmacist can see the exact quantity of medication in each preparation and determines the pass/fail status by comparing it to a theoretical weight based upon each drug’s specific gravity. The pharmacist scans a system-generated bar code and all the information about the preparation is displayed on a screen including who made it, the expected dose, the actual dose, and any percentage of error. These numbers are supported by photos of all medications used.
Pharmacist Checking and Verification
Leung and Belisle: We have dilution guidelines for all items prepared in the SPR, so when a pharmacist checks the dose, it is to make sure the dose was sent through the system following our dilution guidelines and was made correctly. After a visual check is performed, the pharmacist scans the bar code on the label to verify the order against the CPOE order and to ensure the label is appropriate. After these steps, the pharmacist verifies the dose electronically and that information is made available to the rest of the pharmacy system for dose tracking.
Data Management and Reporting
Leung and Belisle: Reports can be generated for various processes including those run through our compounding robots and IV workflow software, pharmacy verification system, and POAS. Information on medication lot numbers and expiration dates for products used to make each dose can be generated in the event of a recall or other issue. Our POAS allows us to track the entire medication use process from the time an order label prints in the pharmacy to the time the item is delivered to the patient.
Furthermore, all our robotic and hardware devices feed into reporting software that allows us to query production numbers and other specifics for every sterile product we prepare. The reporting software system combined with our robotic technology can tell us the number of passed and failed preparations in a given time frame, the standard deviation of the preparations that passed, and the amount of time it takes each robot or technician to prepare each preparation.
PP&P: How has the introduction of automated IV workflow impacted safety and efficiency in your SPR?
Belisle: Our pharmacy system allows us to see all pending, patient-specific medications that are due within four hours of administration time. This enables us to prepare, verify, and send medications up to the nurses for just-in-time dosing. Although waste is not completely eliminated, our waste has decreased 20% since we switched to an every-four-hour batch schedule. The enhanced safety is attributed to bar code scanning verification on all medications and diluents as well as verification via gravimetric control.
Anne M. McDonnell, PharmD, BCOP, is a clinical pharmacy specialist at Brigham and Women’s Hospital in Boston. She received a BS in pharmacy from Massachusetts College of Pharmacy and Health Sciences and a PharmD from the University of Arkansas for Medical Sciences. Anne completed an oncology pharmacy practice residency at the Medical University of South Carolina & College of Pharmacy.
Caryn Domenici Belisle, RPh, has been the pharmacy manager of sterile products and robotics at Brigham and Women’s Hospital for the past seven years. Her research focuses on the use of sterile products in the inpatient setting, new technological advances in health care, and adding newly approved agents to formulary.
Josephine H. Leung, PharmD, MBA, is a senior pharmacist at Brigham and Women’s Hospital. She received her PharmD from University of Maryland, School of Pharmacy and her MBA from University of Baltimore, Merrick School of Business. Josephine’s primary role for the last three years has been as the BWH ambulatory infusion clinic pharmacist. Her areas of expertise include rheumatoid arthritis, Crohn’s disease, and other immune-mediated diseases, as well as USP <797>.