pafolacianine, the first FDA‑approved fluorescent probe for intraoperative tumor detection, has entered clinical use at AdventHealth Celebration in Florida, where pharmacy staff have built a dedicated workflow to support its safe and timely administration.
How the drug works and its clinical impact
The agent is a folate molecule linked to a near‑infrared dye that binds to folate‑receptor–expressing cells with an affinity of about 1 nM. When exposed to light between 760 nm and 785 nm, the dye emits fluorescence at 790‑815 nm, causing cancerous tissue to glow against surrounding structures. The approved dose is 0.025 mg per kilogram given as a 60‑minute IV infusion in 250 mL of 5 % dextrose.
Phase‑3 trials have shown the probe can reveal additional malignant lesions in roughly a quarter of patients. In ovarian cancer, the study identified extra cancer in 26.9 % of participants and helped achieve complete R0 resections in about 62 % of cases. In the ELUCIDATE lung trial, 24 % of patients had clinically significant nodules detected only by fluorescence, with lesions found as deep as 38 mm.
Early real‑world data echo the trial results. A series of 39 minimally invasive lung resections reported that all fluorescence‑guided lesions were removed with negative margins on final pathology, supporting the agent’s role in improving nodule localization and enabling parenchymal‑sparing surgery.
Pharmacy‑driven implementation at AdventHealth Celebration
Implementation began with procurement through Cardinal Specialty Pharmacy, ensuring a reliable supply of the frozen biologic product. Pharmacy leaders coordinated with supply‑chain teams to set par levels matched to thoracic surgery block schedules, minimizing waste while keeping the drug available for elective cases.
Electronic health record integration followed. The medication was added to Epic with correct National Drug Codes, dosing logic, and infusion parameters. Compounding instructions were embedded in Baxter DoseEdge, the hospital’s IV workflow manager, and barcode‑enabled labels were created for bedside scanning, turning a theoretical therapy into a trackable order.
Storage requirements are strict: the single‑dose vial (3.2 mg/1.6 mL) must be kept at –25 °C to –15 °C in its light‑protective carton. Thawing takes at least 60 minutes at room temperature before dilution. Once thawed, the vial can be refrigerated for up to 30 days and refrozen three times. After dilution in 5 % dextrose, the infusion can be refrigerated for 24 hours, but must be administered within three hours of removal from the fridge.
Pharmacists conduct a structured clinical review before each dose. The checklist includes a negative pregnancy test, a 48‑hour hold on folate‑containing supplements, medication reconciliation, verification of the patient’s standing weight, and confirmation that premedications are ordered and timed correctly. Using the verified weight, the pharmacy calculates the exact drug volume and serves as the final safety gate before preparation.
Coordination with the operating‑room team relies on Microsoft Teams messaging. The pharmacy operational manager and the thoracic surgery service line coordinator exchange case schedules, patient readiness updates, and any changes to OR timing. This real‑time dialogue helps the pharmacy prepare the infusion within the required imaging window, reducing the risk of premature thawing or delayed surgery.
They found the data promising. The broader significance lies in how a targeted imaging agent reshapes perioperative practice. Fluorescence guidance adds a layer of molecular information that surgeons can act on instantly, potentially reducing the need for repeat operations. As more receptor‑specific probes enter development, the pharmacy’s role in building reliable medication‑use systems will become increasingly central to oncologic care, including oncology ai scheduling efficiency.
Preparation, administration, and monitoring
Once clinical and operational readiness is confirmed, the frozen vial is removed from the freezer and thawed in its original carton for at least an hour. The calculated dose is withdrawn and diluted into 250 mL of 5 % dextrose using a dedicated infusion line. The final solution should appear light blue‑greenish and remain protected from light throughout handling.
Administration occurs in the preoperative area on the morning of surgery, eliminating the need for evening admissions. A standardized premedication regimen—acetaminophen 1000 mg orally, diphenhydramine 25 mg IV, pantoprazole 40 mg IV, and ondansetron 4 mg IV—has been adopted to mitigate infusion‑related reactions, which affect about 17 % of patients and typically arise within the first 15 minutes.
During infusion, nursing staff monitor vital signs every 15 minutes for the first hour, treating the process with the same vigilance as a blood transfusion. Patients receive education on avoiding over‑the‑counter folic acid and are instructed to report any rash, flushing, chills, or pain immediately.
They addressed challenges by moving the infusion to the preoperative area, streamlining patient flow and aligning drug preparation more closely with surgical start times.
The pharmacy created a playbook outlining notification steps, thawing schedules, compounding duties, and escalation pathways for schedule changes. Ongoing post‑case reviews allow them to refine timing strategies and reinforce that fluorescence is an adjunct, not a substitute, for surgical judgment.
Future outlook
pafolacianine exemplifies a new class of receptor‑targeted intraoperative imaging agents that will require similar medication‑use system design. As comparable technologies emerge for breast, colorectal, and pancreatic surgeries, pharmacy departments are poised to lead procurement, inventory control, informatics integration, and compounding oversight, including medicare payment models and lung cancer rates.
Embedding pharmacists within perioperative governance and oncology service lines will support consistent clinical review, appropriate patient selection, and long‑term safety monitoring. Tracking utilization patterns, adverse events, and waste can help define best practices and enable scalable adoption of fluorescence‑guided surgery across the health system.
