Results of ISMP's Survey on Drug Storage, Stability, Compatibility, and Beyond Use Dating

ISMP Medication Safety Alert 

In This Article

Survey Background

The Centers for Medicare & Medicaid Services (CMS) standard 42 CFR §482.25(b)(3) states that "Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use." To avoid the use of outdated drugs, CMS requires pharmacists to follow the manufacturer's directions regarding storage, stability, and beyond use dating in the official US Food and Drug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)]. 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. These compendia, which are widely used by pharmacists and drug information vendors, include the American Hospital Formulary Service (AHFS) Drug Information, Trissel's 2 Clinical Pharmaceutics Database (electronic), Trissel's Handbook on Injectable Drugs, and the King Guide to Parenteral Admixtures. Pharmacists should be able to use evidence-based criteria from the compendia and peer reviewed journals as long as they conform to sterility standards published in the United States Pharmacopeia (USP) Chapter 〈797〉.

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. But CMS is confronted with a dilemma if the official, FDA-approved manufacturer's directions differ from newer, evidence-based recommendations in national compendia. CMS is reviewing this matter further. We are hoping the results of our survey, as described below, provide CMS with some baseline information to support its review process.


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