A bunch of people got COVID shots past their beyond-use dates: Here's what we can learn from such an incident

A healthcare organization in a small community administered COVID-19 vaccines to more than 50 people that were between four and 31 days past their beyond-use dates, according to a recent report from the Institute for Safe Medication Practices Canada. The issue was discovered when a new nurse reviewed the vaccines and discovered that the vaccine doses were all past their beyond-use date, and the organization did a review that showed that more than 50 people had gotten the outdated vaccines. The organization created an incident management team to determine the best response to the issue and consulted with the vaccine manufacturer, which the ISMP’s report highlighted as a solid strategy. But that process was time-consuming and challenging, the ISMP said, because getting the necessary information from the manufacturer was difficult. It ended up recommended that about 40% of the people who received the affected vaccines be re-vaccinated. Read: ISMP analysis highlights errors that can happen with look-alike high-alert medications The confusion came from the fact that the COVID-19 vaccines had three dates: The expiry date, a beyond-use date that was 30 days after the vaccine was put into a refrigerator and thawed, and a beyond-use date of six hours after the vial was punctured and diluent was added. The vaccine’s vials only included the expiry date and a space for the healthcare provider to write the date and time when the vial was punctured. But it had no place to put information about when the vaccine was thawed. The vials should have included details about the context of the expiry date (that it was only valid as long as the product was frozen) and had a space for documenting the beyond-use date on the individual vials, the ISMP said. Providing vaccines in pre-filled unit-of-use syringes when possible would have also helped avoid this issue. Read: Bivalent COVID-19 vaccines can be used for primary vaccination series: NACI Another factor that contributed to the misuse included that the local public health unit, which provided the vaccines to the healthcare organization, received the vaccines in bulk cartons in large quantities. That meant the public health unit had to repackage—and potentially thaw—the vaccines before distributing them to other healthcare organizations they were working with. When it repackaged the vaccines, the information about the beyond-use date was included on the storage container lid. But it wasn’t highlighted to give it more prominence than other information on the container, such as the number to call to return the container, and it wasn’t clear what the date given meant (it was the date the vaccines were put into the fridge and removed from the freezer). It also wasn’t put on the vials themselves. Being provided with smaller packages would have avoided the need for repackaging altogether. Labels should be designed so that important information is more prominent, through bold type or colour, the ISMP says, and labels with critical information should be attached to the product, not the package. Read: POP QUIZ: Primary immunization with bivalent COVID-19 vaccines The nurses at the healthcare organization who were in charge of vaccine inventory also had many other competing responsibilities. In addition, not all the nurses had experience with managing medication inventory or with vaccines. Further complicating matters was the fact that the COVID-19 vaccines had a more complex process than most vaccines, and the vaccine training didn’t include much information about beyond-use dates and expiry dates. The information about the vaccines was rapidly evolving, making it hard for organizations to keep up, and the info given to the nurses wasn’t “easily accessible or understandable,” the ISMP said. It recommends that concise practice aids and instructions, like checklists or one-pagers, be created to help frontline providers who are administering vaccines. In addition, vaccine inventory management should include a checklist of critical information such as beyond-use dates, and training should also cover this essential information. A record system should also be used to track vaccine inventory, and an independent double-checking process should be implemented. Other lessons learned include the importance of describing potential errors and how to avoid them in educational resources and other communications, having a process to escalate questions from healthcare providers so that they can receive timely answers, and creating FAQs from questions about new products. Read: 10 ways to make repackaged APIs safer: ISMP

A bunch of people got COVID shots past their beyond-use dates: Here's what we can learn from such an incident

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