Medication Safety
Institute for Safe Medication Practice, Horsham, PA
Adalimumab is used for nine different autoimmune indications in both pediatric and adult populations and is available as many different prefilled syringe and pen carton configurations. The opportunity for mix-ups is high.
In addition to the brand name product Humira, 10 biosimilar and/or interchangeable adalimumab products have become available, each with one or more dosage forms and concentrations. As payors begin to select different biosimilar products for their formularies, pharmacies will need to stock more of these products. Confusion can arise with all of the adalimumab products having overlapping strengths/concentrations, and nonproprietary names that only differ by the added biosimilar suffix (some even have similar letters).
Specialty pharmacies have been reporting that the packaging of many of these products may also lead to product mix-ups. For example, a pharmacy shared that the cartons of Amjevita (adalimumab-atto) 40 mg/0.4 mL and Amjevita 40 mg/0.8 mL autoinjectors look similar and can be easily confused (Figure 1). While the Amjevita 40 mg/0.4 mL concentration is highlighted in yellow on its carton, the size and prominence of the 40 mg part of the concentration for both the 40 mg/0.4 mL and the 40 mg/0.8 mL cartons compared to the font size of the different volumes makes them look similar.
Some manufacturers are also producing both branded and unbranded versions of their adalimumab product. For example, Sandoz produces Hyrimoz (adalimumab-adaz) and the unbranded (i.e., no brand name) product adalimumab-adaz. While the products have different national drug code (NDC) numbers and pricing strategies, they both share the same nonproprietary name, adalimumab-adaz. The cartons for both the branded and unbranded 40 mg/0.4 mL prefilled pen devices look identical except for the different names and NDC numbers which are easy to miss (Figure 2). Dispensing the wrong NDC could result in billing errors as well as mislabeling.
Takeaways
To help intercept selection errors when retrieving one of these products from the refrigerator, it is critical to scan each carton during fulfillment. Ideally, pharmacy computer systems will prompt or require scanning of each carton to be dispensed. Avoid scanning one carton multiple times when dispensing more than one carton. Enhance the computer system to alert the pharmacist during product verification if barcode scanning was bypassed during fulfillment. Clearly label storage bins, and if space permits, use separate storage locations for the different adalimumab products.
Make sure staff are aware that the medications have been separated and where to locate them. Explore ways to differentiate the products to highlight critical information when they are received from the supplier. Educate staff on the different products and the potential for mistakes. At the point-of-sale, open the bag and have the patient check what has been dispensed to make sure it is correct. If the product is shipped to the patient, instruct them to carefully inspect the product upon receipt, comparing the product name and quantity to what is listed on the pharmacy label. Encourage patients to contact the pharmacy if they have any questions or concerns. ■