Proper Positioning of Pharmacy Label on Hospira PCA Vials Will Avoid Interference With Scanning

Problem: A 22-year-old male patient admitted to the hospital following a motor vehicle accident received an overdose of fentanyl and experienced respiratory arrest which, fortunately, was reversed with naloxone. The patient had been receiving fentanyl via a Hospira LifeCare patient-controlled analgesia (PCA) pump (see Figure 1). The overdose was unrelated to the way the drug was prescribed or any device malfunction. Instead, it was associated with the way pharmacy applied labels after preparing fentanyl PCA doses using the pump’s compatible empty sterile glass vials.

An important safety feature incorporated into the LifeCare PCA pump is a barcode scanner that identifies prefilled drug vials when loaded into the pump. Both morphine and meperidine are available for purchase in prefilled, bar-coded vials from Hospira. However, other commonly used PCA drugs, including fentanyl and hydromorphone, are not available from the manufacturer in prefilled, bar-coded glass vials because they have never been approved by the FDA for IV PCA use. In order to use fentanyl or hydromorphone with the LifeCare PCA pump, individual pharmacies must fill pump-specific, empty glass vials (available through the manufacturer) with the ordered medication, then affix a pharmacy label. The glass vials have a preprinted barcode that the pump recognizes, which enables it to start (see Figures 2 and 3), but it does not identify the specific analgesic that is contained inside the vial. An additional pharmacy label that contains the name of the drug and concentration must be placed in a very precise location on the vial or it may interfere with the pump’s scanner (see Figure 4). The pharmacy label cannot be angled, come too close to, or obscure the barcode on the vial because this could interfere with accurate scanning. Auxiliary labels can also interfere if not placed properly. It is possible and important to add a pharmacy generated barcode label to identify the drug, but the need to place the label in a precise location remains.  

Apparently, placement of the pharmacy label was an issue in this case. When the patient’s original drug vial emptied, a nurse removed a new pharmacy-prepared fentanyl vial from an automated dispensing cabinet and attempted to replace the patient’s empty vial with a full vial.

Unfortunately, she and a colleague were unable to get the pump to recognize the preprinted barcode on the vial. When the pump would not run, the nursing staff repeatedly manipulated the vial over the next 20 minutes or so, alternatively twisting and pulling on it, removing it and replacing it, while trying to move the pharmacy label away from the glass vial’s barcode to line it up with the scanner, all with no success. During this time, the tubing leading from the vial remained connected to the patient and no one pushed the slide clamp to pinch off the line. Although the tubing has an integrated anti-siphon device to protect against free-flow, the ongoing manipulation apparently was enough to force drug from the vial and overcome the pressures needed to bypass the valve. The full vial had 30 mL of fentanyl (50 mcg/mL) in it. Only about 5 mL remained in the vial at the time of the patient’s respiratory arrest. Prior to the manipulations that occurred during vial replacement, the patient had been alert and oriented and resting quietly in bed. The pump was checked by clinical engineering and was determined to be functioning properly.

Safe Practice Recommendations

Fentanyl and hydromorphone are common, efficacious parenteral analgesics. There is no doubt that commercially available premixed drug containers are important for patient safety. FDA and manufacturers should give priority to conducting whatever studies are needed to gain approval for producing commercially available premixed IV containers, including dosage forms for PCA use. If prefilled fentanyl vials were available from Hospira for use with the LifeCare PCA pump, it is highly unlikely that this event would have occurred. 

The pump needs to read and recognize a barcode in order to proceed. In the case above, pharmacy computer labels identifying the product and pertinent patient information were too close to the vial barcode and the pump was unable to recognize the product. This is the event that caused the nurses to manipulate the vial. We’ve heard the same problem from staff at another location, so it’s not a unique problem. While there is no commercial manufacturer of fentanyl or hydromorphone vials, companies such as Ameridose and PharMEDium provide outsourced pharmacy compounding of these drugs. Its labels are read directly by the LifeCare PCA as well as its predecessor, the Hospira PCA 3 pump (both have integrated barcode readers, but LifeCare PCA also offers MedNet dosage error reduction software to detect concentration programming errors, although this feature was not purchased in this facility). Ameridose and PharMEDium labels are properly positioned on the vial, have an NDC number, and do not expire as rapidly as hospital-prepared products.

When a pump malfunctions or difficulty is encountered setting up the pump or programming it, staff should be educated to first clamp the tubing to prevent accidental administration during manipulation of the pump, as recommended by the manufacturer. The pump has an anti-siphon device that protects against free-flow if the glass vial cracks, allowing entry of air, but uncontrolled flow is possible when manipulating the pump if the tubing is not clamped. It’s important to educate users about this problem, but that alone will not assure that the tubing will always be clamped when necessary, and the label on the vial will always be positioned properly. Hospira includes instructions for changing a vial in the pump’s operator’s manual and has a slide presentation on how to produce pharmacy generated barcodes and where to affix the label on the vial.