ISMP comments on BD syringe potency issue
It has been 4 weeks since we published an article about the loss of potency of certain medications when prepared in BD 3 mL and 5 mL syringes that are not administered shortly thereafter. According to a BD representative, this may be related to a problem with syringe plunger stoppers from a secondary supplier. Since our publication, BD and the US Food and Drug Administration (FDA) have issued communications that indicate the issue is more complicated than we initially realized. We thought that once the stopper situation was resolved, the problem would disappear. However, we now realize that these syringes were never cleared by FDA for use as a closed container storage system for drug products, and the suitability of these syringes for that purpose has not been established. This calls into question what hospitals have been doing for years—preparing unit dose syringes in the pharmacy in advance of anticipated use, or obtaining prepared syringes from outsourcers. These efforts take advantage of quality control mechanisms that exist in a pharmacy admixture program or outsourcing facility, and provide injectable medications in ready-to-use containers.
FDA has suggested that medications drawn into syringes should be “administered promptly.” This statement requires hospitals to decide what “promptly” means, although FDA, BD, and others are actively engaged in trying to determine how quickly a potency problem can develop in the syringes of concern. But we need to keep safety in balance.
It is important to consider the broader safety implications that can develop in response to this issue. Already, some have contemplated dispensing glass vials with exact doses so nurses can prepare syringes immediately before use. Breaches in aseptic technique and unlabeled syringes in patient care units could lead to contamination or medication errors. Other hospital pharmacies have started preparing and delivering prefilled syringes immediately before injection. But the resources associated with this are difficult to muster, and errors may increase if redeployed staff are taken away from normal safety functions.
The BD syringe issue also brings to light important information to consider when using syringes to store medications. Hospitals may be relying on literature to support the beyond-use dating of medications stored in syringes, or they may believe a beyond-use date of 24 hours or less is sufficient to ensure the products’ potency when stored in a syringe (as noted in the July 31 BD letter). However, to validate beyond-use dating for a product drawn up in syringes, testing would be needed to monitor drug potency over the period of time intended to store the product in the syringe, plus additional time for a margin of safety, for assurances about potency. Such testing may be beyond the capability of many hospitals to perform. However, outsourcers can be expected to supply assurances regarding stability data for the beyond-use date of available syringes and the drugs they hold, as they must follow FDA Current Good Manufacturing Practices (CGMPs).
You should bear in mind that syringe manufacturers can change components of their syringe, potentially rendering the stability information unreliable. Hospitals and compounding facilities that use syringes to store drugs should inform the syringe manufacturers, and syringe manufacturers should provide public notification when modifications are made that could affect the stability of drugs stored syringes.
We all need to work together to acquire information to better understand this issue, but for now, we cannot suggest that radical changes are warranted to what is currently the norm. Hospitals should try to limit drug exposure in plastic syringes by using them as promptly as possible after preparation in the pharmacy. Make sure that clinical staff are aware of the situation and know to report unexpected changes in drug effectiveness, such as a sudden loss of pain control, especially with infusions via a syringe pump. Monitor patients for signs of decreased efficacy when administering drugs that have been stored in syringes, and use caution when administering sequential doses to avoid a sudden increased effect that could occur when switching from a syringe of medication stored for a period of time to a newly prepared syringe. Assign staff to watch for new FDA, BD, ISMP, ASHP, or other alerts, because more information may become available. Also, work with BD to understand whether any syringes in your institution belong to lots that are affected by this issue. According to information on the ASHP website dated August 21, customers who want to know whether their BD general use syringes are affected with the secondary supplier’s stopper should contact the company at 201-847-4500 or via [email protected] and be prepared to state the lot number.