EMR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-09 for EMR manufactured by Unk.

Event Text Entries

[145222918] Please note that this is a duplicate report, because i was not certain which entry portal is most appropriate to this situation. Thank you. Both my husband and i experienced medication errors in connection with electronic medical records and electronic prescription delivery. We had been living in another city/state for the previous 5 years and were pleased with the care provided by a renowned endocrinologist. So, we decided to keep our annual visits with him. Such was the case earlier this week. My husband's maintenance meds (synthroid, metanx) were renewed with dosage changes; my meds were also renewed without dosage changes. However, the route for my b-12 was changed. At the check-out point after the visit, we discussed med with the clerk (med-tech, secretary, nurse? Not sure about her credentials; not visible on her badge; that in itself could be problematic). We specifically discussed the route change for my med. I watched her as she entered info into a database. We verified the name and address of the pharmacy to which the prescriptions for both me and my husband were to be sent. She acknowledged that she understood where they were to be sent. From what i had witnessed and the questions she asked as she keyed things into the database, i expected the transmission to go smoothly. Not so; my husband's prescriptions for maintenance medications were sent to a local pharmacy in the city where the physician is located - a pharmacy that is not on our current health plan, but one we had used over 4 years ago. Bear in mind, please, that it has already been over a year since we moved from that city. Also please bear in mind that the carrier for our health insurance changed almost 4 years ago. That's not the only issue. When i went to pick up my medication at our local pharmacy (at least the prescriptions made it to the correct destination), i was shocked to see that i had been given a box of insulin syringes. I am not diabetic, nor do i use insulin syringes for b-12 injections. When i said that there was an error, the pharmacy tech insisted that they dispensed what had been ordered. That seems very peculiar to me, given the discussion i had with the clerk at the endocrinologist's office about the route change for the medication (to i. M. ). I believe that i personally witnessed her entering the info into the database. So how did the order go wrong? I believe the culprit may be a weakness in the emr. We did all we could to verify info and to see (literally) that this info was being entered into the emr correctly. So how did that happen? I suppose it is possible that the clerk may have entered incomplete info for the syringe order, and maybe the system or someone from the pharmacy kicked it back to the office and then someone in the office made the mistake of thinking "endocrinologist = diabetes care," perhaps someone in the office was in a major hurry and didn't bother to look at my chart in the emr and just gave a quick verbal to someone at the pharmacy? But, furthermore, how to explain the fact that my husband's prescription got sent to another city/state, different from mine? We verified the info with the clerk, and how is it that the emr clung to info over 4 years old? To make matters even more inconvenient, when my husband called the pharmacy with the misdirected prescription and asked them to forward it on to the one designated by our health plan, they refused. They said that they cannot do that and they put the burden on us to call the designated pharmacy and ask them to initiate the transfer. Where does the policy regarding misdirected electronic prescriptions originate? Is refusing to forward a prescription a matter of federal or state law or a corporate policy? More and more administrative tasks like these are being laid at pts' feet - with the risk of tripping them up. It has now become my responsibility to contact the physician and try to resolve the situation. Thank god that i am a nurse and that i knew i had been given the wrong syringes. What if i had lacked the requisite knowledge to differentiate between medication routes and types of equipment? I can even see the potential in this situation for a poorly educated pt to fall under the impression that he or she had become diabetic and that the healthcare providers had failed to communicate that adequately. Pts need a better form of concrete documentation of prescriptions that are sent electronically. They need something more than just a line of text on a discharge sheet that lists the medications and their doses. They should be given a print-out of a screen-shot that indicates what is sent and where the info is being or has been sent. There needs to be something akin to a receipt that pts receive that can be presented to a pharmacy to verify a prescription at the time of pick-up. As a matter of pt education, professionals should urge pts to always check their medications while they are still present in the pharmacy, so that errors can be identified before they leave the store. If an error is identified later, pharmacies don't ordinarily accept the drugs or merchandise and the pt and insurer are left holding the bag. In retrospect, i also find it peculiar that neither the pharmacist(s) nor techs at the pharmacy questioned an order for insulin syringes in the absence of an order for insulin. Yes, some physicians do suggest administering b-12 s. C. , but i don't believe that without an accompanying insulin order that it would be safe to be issuing insulin syringes without verifying the nature of their use. I believe that there is too much burden on retail pharmacists these days and don't believe that the use of techs has eased that burden nor increased safety for pts. Add'l comments: the emr has the potential to capture, cling to and perpetuate errors. With all the drawbacks to emr, do pharmacists even have time to review prescriptions anymore? Retail pharmacies, in general, do a poor job. They spend so much time dealing with insurance, it feels like they have to neglect even more important matters, like orders' surveillance. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5086553
MDR Report Key8600681
Date Received2019-05-09
Date Added to Maude2019-05-10
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameEMR
Generic NameMEDICAL DEVICE DATA SYSTEM
Product CodeOUG
Date Received2019-05-09
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-09

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