EMR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-22 for EMR manufactured by Cerner Corporation.

Event Text Entries

[176402522] The following issue occurs in cerner emr. I suspect it can occur with any emr that uses multum as their formulary service vendor. Multum does a very poor job with distinguishing multiple non ab rated branded extended release products. This impacts which representative ndc is selected during eprescribe. This then causes downstream impact in the receiving retail pharmacy which can lead to a medication error. The specific case mentioned here is with metformin 500 mg extended release but applies with many other medications as well. There are 3 different metformin 500 mg extended release products on the market that are not interchangeable and not bioequivalent. In all cases when there are multiple non ab rated branded extended-release products on the market it is advisable to use one of the branded product listings (based on their intended medication) instead of the generic listing. Having the provider enter the prescription as either "glucophage xr 500 mg oral tablet, extended release", "fortamet 500 mg oral tablet, extended release" or "glumetza 500 mg oral tablet, extended release" based on intent will yield much better results than using the generic listing of "metformin 500 mg oral tablet, extended release" all 4 of these are main multum drug code 8177 which points to 6 different rxnorm codes. Three of these are branded (sbd semantic branded drug) and 3 are generic (scd semantic clinical drug) rxnorm does a much better job of distinguishing these. This is the root of the issue as cerner eprescribe can pull any representative ndc that is neither obsolete nor repackaged. Once again i'd suggest our providers use the intended branded listing to prevent this issue. This would prevent the 'rolling of the dice' that is happening by using the generic listing. Ln the specific case brought to my attention it is pulling the first ndc under mmdc 8177 that happens to be 00378-6002-91 which is a generic equivalent of fortamet, which explains why they're seeing 'osmotic' in the retail pharmacy and sent the request for prior approval. I've made suggestions with cerner about this issue and provided thoughts on how they resolve/mitigate by leveraging rxnorm data but they have not moved at all. Hence i'm trying to get ismp's assistance with this safety issue. Feel free to contact me for additional information if needed. (b)(6). Access number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5092411
MDR Report Key9621814
Date Received2020-01-22
Date of Report2020-01-22
Date Added to Maude2020-01-23
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameEMR
Generic NameMEDICAL DEVICE DATA SYSTEM
Product CodeOUG
Date Received2020-01-22
Device Availability*
Device Sequence No1
Device Event Key0
ManufacturerCERNER CORPORATION

Device Sequence Number: 101

Brand NameMETFORMIN HCL EXTENDED RELEASE, METFORMIN ER
Product Code---
Date Received2020-01-22
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-22

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