Beyond use dating
If information on storage, stability, and beyond use dating is not available in the manufacturer’s directions, CMS and The Joint Commission defer to recommendations available through nationally recognized sources.
We were specifically interested in learning about conditions that may result in unnecessary waste of drugs during the ongoing drug shortage crisis or waste of very expensive medications given the ever rising cost associated with healthcare. The Centers for Medicare & Medicaid Services (CMS) standard 42 CFR §482.25(b)(3) states that “Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use.” To avoid the use of outdated drugs, CMS requires pharmacists to follow the manufacturer’s directions regarding storage, stability, and beyond use dating in the official US Food and Drug Administration (FDA)-approved prescribing information (package insert) [§482.25(a)].
More than 80% of all the medications reported by respondents have been or are currently in short supply, further contributing to the alarming drug shortages in our country.
Specific differences in beyond use dating or lack of information by manufacturers on stability after dilution or withdrawal from the vial for several of these medications appear in Table 1.
The Joint Commission follows guidance from CMS on this issue, and surveyors from both agencies have cited organizations for not following the explicit directions in the manufacturer’s package insert when it comes to drug storage, stability, and beyond use dating.
Only following the manufacturer’s directions for injectable medications has proven difficult and wasteful in some situations for two primary reasons: 1) complete information on storage, stability, compatibility, and beyond use dating is often not provided in the official prescribing information, and 2) newer, evidence-based information on these matters can sometimes be found in peer reviewed journals and compendia fully endorsed by national pharmacy organizations.