PSS - NHSN Adverse Drug Event - Hypoglycemia Report

Response from Project Team: Response: Thank you for this important point; we agree wholeheartedly with it given the role nutritional interruption plays in contributing to hospital-associated hypoglycemia. We have updated the PSS (section 6h) to reflect this omission.

Response from Project Team: 

Response: There are several ways in which ADEs that would be reported through NHSN are distinct from those reported through the FDA Sentinel Initiative (SI), thus requiring a new IG. Adverse drug event reporting through CDC NHSN and through FDA SI serve fundamentally different purposes, support different public health questions, and utilize different data sources. This is reflected in this newly proposed PSS. NHSN plans to collect information on well-recognized ADEs from commonly used medications in U.S. hospitals to directly inform local (hospital-level) quality improvement (e.g., https://www.cdc.gov/nhsn/datastat/index.html) and benchmarking for one the most common iatrogenic harms in U.S. hospitals. In contrast, FDA SI is primarily focused on novel, previously unrecognized , under-studied, or rare ADEs that are informed by large dataset analysis (primarily administrative claims data), to inform nationwide regulatory decision-making--not local/hospital quality improvement. The PSS describes the intent for hospitals to report individual, patient-level blood glucose values drawn during a hospitalization and linked to a hospital medication administration event. These type of data are not traditionally available via FDA SI. The ADE data for NHSN are based on EHR (laboratory and eMAR) sources. The ADE data from FDA SI are traditionally based on administrative claims sources. The IG would reflect requirements that could ensure data can be calculated to generate local quality improvement metrics for hospitals and a proposed Centers for Medicare & Medicaid Services electronic clinical quality measure (eCQM), https://cmit.cms.gov/CMIT_public/ViewMeasure?MeasureId=6086, which would not be feasible using FDA SI ADE reporting standards.

Response from Project Team: Response: We appreciate the insight regarding alignment with eCQM as this was an important consideration for how the proposed NHSN ADE measures were constructed. A new IG would ensure that the data reported could be used to calculate the eCQM should the measure be incorporated into future hospital quality reporting/performance programs. We have responded to Dr McClay’s comments above regarding the need for a new IG and are happy to provide additional information to address any remaining concerns.