Medication Safety Alert! March 22, 2018
In this week's issue:
- US Food and Drug Administration (FDA) Guidance Needed to Assure Safe Labeling Practices by 503A and 503B Compounders
- FentaNYL - SUFentanil mix-ups during shortages
- StabilOx canister removed from Simplist opioid packages
- CycloSPORINE dispensing errors
Problem: Increasingly, ISMP has been receiving complaints and reports of errors, some serious, about prefilled compounded syringes that look alike. Drug shortages may be worsening the situation, as hospitals may be relying more on compounders they have not previously used to fulfill their needs. The US Food and Drug Administration (FDA) does not hold the labeling of drugs compounded or repackaged by pharmacies or outsourcing facilities to all of the same standards as FDA-approved products. For example, if certain conditions are met, federal law exempts compounded drugs from the requirement for...