Do CMS' Medication Storage Guidelines Worsen Drug Shortages?

The Institute for Safe Medication Practices is conducting a survey of pharmacists and other healthcare practitioners on CMS' interpretive guidelines related to drug storage, stability and beyond use dating of injectable products, according to an ISMP Medication Safety Alert! newsletter (pdf).

ISMP claims CMS' interpretive guidelines may exacerbate drug shortages and waste by mandating drugs and biologicals be stored in accordance with only manufacturers' directions and state and federal requirements. ISMP says this guideline is "needlessly wasteful, particularly during an ongoing drug shortage crisis," for the following reasons:

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•    Complete information on dilution, compatibility with diluents, stability, storage and beyond use dating is often not provided by manufacturers in the official prescribing information.

•    Information from the innovator manufacturer is often not provided to the generic manufacturers.

•    For information on storage, compatibility, stability and beyond use dating, manufacturers often refer practitioners to official compendia such as the American Hospital Formulary Service Drug Information, Trissel's Handbook on Injectable Drugs and/or studies published in peer-reviewed journals.

•    Conflicts may exist between the manufacturer's directions in official labeling and more recent evidence-based compatibility/stability data and beyond use dating published in official compendia endorsed by pharmacy organizations.

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