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In fact, 36% reported that following the CMS regulation often results in unnecessary waste, and 43% said it always results in waste, thus contributing to the drug shortage crisis.Sixty-one percent of respondents said they feel compelled to discard injectable medications according to the package insert, knowing it differs from information in national compendia.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.With a typical dose of 1.3 mg/m2, unused portions of drug in these vials may be discarded unnecessarily.A serious medication safety issue was also mentioned by respondents.
Very few (7%) said they never follow compendia recommendations if they differ from the manufacturer’s directions.We conducted the survey to learn more about what resources pharmacists rely on to guide drug storage, stability, and beyond use dating.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 The Centers for Medicare & Medicaid Services (CMS) standard 42 CFR §482.25(b)(3) states that “Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use.” To avoid the use of outdated drugs, CMS requires pharmacists to follow the manufacturer’s directions regarding storage, stability, and beyond use dating in the official US Food and Drug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)].They remarked that, once a drug has been approved, the company may have little incentive to conduct additional testing on its products because the results may lead to required, costly labeling (package insert) changes and a reduction in sales if the beyond use dating is extended.In communications with FDA, we’ve learned that the agency does not routinely require manufacturers to update stability and compatibility data. A vast majority of respondents (97%) feel the CMS regulation and interpretive guidelines that require strict adherence to the manufacturer’s directions for storage, stability, and beyond use dating increases waste and contributes to the drug shortage crisis when evidence-based compendia information recommends a longer beyond use dating.
Given these circumstances, it is not surprising that practically all (98%) respondents felt that national compendia should be used to supplement the manufacturer’s directions, even when the directions conflict.