Clinolipid container label issue

Supply chain issues are impacting the availability of many products, including fat emulsions for parenteral nutrition. A hospital pharmacist reported that she had recently switched from the pharmacy's usual supply of lipid injectable emulsion to Baxter's Clinolipid 20%. Although the hospital has not experienced any errors, a potential safety issue was identified that prompted proactive education of the pharmacy team and reporting to ISMP.

The total volume of the product is 250 mL, but the concentration that is most prominently displayed is 20 g/100 mL (see Clinolipid concentration). The product is often prescribed in terms of percent concentration (20%) and volume. However, the presentation could lead healthcare professionals to incorrectly assume that the bag contains a total volume of 100 mL and 20 g.

Displaying the total amount per total volume (for example, 50 g/250 mL) would minimize the risk of confusion and error. Incidentally, the label for the 1,000 mL Clinolipid container lists the amount per container volume (200 g/1,000 mL), not 20 g per 100 mL, so the concentration expression on the 250 mL bag is inconsistent. Baxter reports that its regulatory team has initiated a label change for the 250 mL bag with the US FDA.

Do not dilute gray-capped Pfizer-BioNTech COVID-19 vaccine

Concerns have been reported about accidental dilution of the new prediluted form (gray cap) of the COVID-19 vaccine from Pfizer-BioNTech. ISMP received a report citing a case wherein 0.9% sodium chloride solution was erroneously added to the gray-capped Pfizer-BioNTech COVID-19 vaccine vial. Fortunately, a pharmacist caught the mistake before syringes of the vaccine were dispensed from the pharmacy.

The purple-capped vaccine (available under an emergency use authorization [EUA] as Comirnaty) requires dilution prior to use. The prediluted form (gray cap) and the vaccine that requires dilution (purple cap) may be confused during preparation. This will result in erroneously diluting the gray-capped vaccine or not diluting the purple-capped vaccine.

To avoid dilution errors, ISMP recommends switching entirely to the gray-capped prediluted vaccine vials as soon as possible. Be sure that labels and preparation instructions do not provide directions to dilute the gray-capped vaccine. Do not store the gray- and purple-capped vaccines together in the refrigerator during or after thawing; use separate shelves instead. Require an independent double-check of the preparation process. Inform the pharmacy and vaccination staff of this type of error and provide those who prepare the vaccines with an updated Fact Sheet for the EUA vaccines (http://www.ismp.org/ext/842, http://www.ismp.org/ext/813) or the package insert for Comirnaty (http://www.ismp.org/ext/843). Also, verify the competency of each healthcare professional involved in vaccine preparation.

Tubing spikes drop from I.V. bags in use

QuVa and possibly other 503B outsourcers have been using Douglas Medical Products (DMP) I.V. bags to prepare medications as a replacement for other I.V. bags that are in short supply. ISMP and ECRI recently investigated a report about I.V. tubing spikes falling out of these bags (product code: DMP0150) or the bags leaking during infusions. The reporting facility revealed that this has happened on five occasions. In addition, a letter shared with QuVa customers reported that this has also occurred in other facilities. The problem appears to happen with a Baxter administration set (product code: 2C8541). Some of the QuVa bags impacted contained fentaNYL. This could lead to patients receiving the wrong amount of medication, infusion contamination from a loosely connected spike, and patient or staff exposure to hazardous medications. The problem has also led to drug waste, therapy interruptions, and controlled substance management issues.

QuVa has stopped using these bags, but unused and unexpired products may still be available in some facilities. If these products are available in your facility, inform nurses that the I.V. spike should always be inserted with a single motion that includes a firm, twisting action to achieve full insertion of the spike into the bag port. The spike should not be wiggled or removed and reinserted as this could loosen the connection.