A healthcare organization’s ability to manage drug shortages and reduce waste may be compromised by the way the Centers for Medicare & Medicaid Services (CMS) and Joint Commission surveyors apply statements in CMS interpretive guidelines (www.cms.gov/manuals/Downloads/som107ap_a_hospitals.pdf) related to stability, expiration dating, and storage of parenteral medications before and after they are manipulated to prepare injections. On the one hand, the interpretive guidelines associated with CMS standard §482.25(a) state, in part, that accepted professional principles must be followed as well as standards or recommendations promoted by nationally recognized organizations like FDA, the National Institutes of Health, the American Society of Health-System Pharmacists, and others. In conflict with these statements, the interpretive guidelines also state, “Drugs and biologicals are stored in accordance with manufacturer’s directions and State and Federal requirements.” Strict adherence to this means that professional standards or official compendia recommendations for stability information do not apply.
There are several factors that make following only the manufacturer’s directions difficult and needlessly wasteful, particularly during an ongoing drug shortage crisis:
-----Complete information on dilution, compatibility with diluents, stability, storage, and beyond use dating (BUD) 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 BUD, manufacturers often refer practitioners to official compendia such as the American Hospital Formulary Service (AHFS) 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 BUD published in official compendia endorsed by pharmacy organizations.
Examples of injectable drugs with evidence-based extended dating not mentioned in the manufacturer’s labeling include: succinylcholine (vial), LORazepam (vial), niCARdipine (IV admixture), famotidine (IV admixture), and norepinephrine (IV admixture). Hospitals may unnecessarily discard these drugs, all subject to recent shortages, when following the manufacturer’s directions in order to comply with CMS rules.
According to a recent analysis by Shane et al. at Cedars-Sinai Medical Center in Los Angeles (personal communication), among 50 randomly selected drugs on the current national drug shortage list, the package insert for only 68 % of them included information on compatibility with diluents, and only half provided information on stability, storage, and BUD after dilution of the drug to a final form. When the manufacturers were contacted, half referred practitioners to published compendia for needed storage and information on BUD.
We would like to hear from pharmacists and other healthcare practitioners about their experiences with this issue. We urge hospital pharmacists to complete a short ISMP survey at www.surveymonkey.com/s/ismp-bud so we can learn more about any unintended consequences of the CMS directive. If change is warranted, we plan to further pursue the issue with CMS officials.