Handling Potentially Flawed Carpuject Syringes
Hospira, a Pfizer company, released a letter last week, in coordination with the US Food and Drug Administration (FDA), detailing instructions for handling certain drugs and lot numbers of CARPUJECT glass syringes that may have cracked needle hubs and/or contain particulate matter. The list includes certain strengths and sizes of heparin, labetalol, LORazepam, morphine, and HYDROmorphone. The letter may not have been clear in stating that the cracked needle hubs and particulates are separate issues the company identified during routine inspection/quality checks. Still, a cracked hub could allow air to reach the outer cartridge (but not the solution inside). We confirmed with Hospira that none of the affected lot numbers are currently in the field. Although the company says the probability of a cracked hub is low, it was enough to hold up distribution until now. To help reduce critical drug shortages, the company has begun to release the affected lots, which should reach wholesalers by mid-June.
Providers are being asked to unpack the syringes and visually inspect the cartridges to confirm there are no cracks to the needle hub or visible particulate matter or discoloration. The letter includes photos that show what to look for. If cracks or particulates are observed, the syringes should be discarded. If not, photos show how to withdraw the medication from the Carpuject cartridges. The letter notes that the contents of all impacted Carpuject syringes should be filtered with a 5 micron filter needle to remove nonvisible particulates and prepare the drugs for administration.
ISMP believes that nurses should not be expected to inspect all syringes or use a filter needle to withdraw the Carpuject contents into another syringe. Using a cartridge as a vial is an unsafe practice that leads to unlabeled syringes and could impact sterility. It could also lead to the false assumption that the cartridges from other devices (e.g., pens) can be safely used as vials. We have heard from practitioners who are concerned about the letter recommending this practice. Although Hospira notes that using the Carpuject as a vial is not routine, the practice may be difficult to reverse once it is no longer needed. Furthermore, nurses are often not familiar with using filter needles to draw up products from Carpujects.
Instead, pharmacists should inspect the syringes. If no problems are visualized, staff should swab cartridge stoppers with alcohol (as with a vial), withdraw the contents per the company’s instructions, and then dispense properly labeled syringes with a beyond-use date. Any controlled substances should be handled the same as a compounded controlled substance (e.g., tracking chain of custody, capping with a secure tamper-evident cap). This interim process will take substantial pharmacy time and resources. However, these are extraordinary times, and critical drug shortages have left us with few safe options.
The root cause of the cracked needle hubs and particulate has been identified, and corrective and preventative actions are now in place. Hospira told us new product that may be used as normal will reach wholesalers in July.