FDA Adverse Event Other Summary report: N

THERAPYNOTES (ELECTRONIC HEALTH RECORD)

MDR report key: 24667985 · Received March 23, 2026

Report

Report Number
MW5185628
Event Type
Other
Date Received
March 23, 2026
Report Date
March 18, 2026
Manufacturer
UNKNOWN
Product Code
SAP
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
117
Health Professional
Yes

Narratives

Description of Event or Problem · 0

I AM REPORTING A HEALTH INFORMATION TECHNOLOGY? RELATED SOFTWARE ISSUE THAT PRESENTS A POTENTIAL PATIENT SAFETY RISK. I AM A PSYCHIATRIC NURSE PRACTITIONER REPORTING A PATIENT SAFETY CONCERN RELATED TO A RECENT SOFTWARE UPDATE IN THE THERAPY NOTES ELECTRONIC HEALTH RECORD (EHR) SYSTEM WITH INTEGRATED EPRESCRIBE (ERX) FUNCTIONALITY. PRIOR TO THE UPDATE, MEDICATIONS PRESCRIBED BY OUTSIDE PROVIDERS WERE DOCUMENTED IN A SECTION LABELED "PRESCRIBED BY OTHERS" AND WERE CONSISTENTLY CARRIED FORWARD INTO SUBSEQUENT CLINICAL NOTES. THIS ALLOWED FOR ACCURATE AND CONTINUOUS VISIBILITY OF ALL PATIENT MEDICATIONS, INCLUDING THOSE NOT PRESCRIBED WITHIN THE SYSTEM. FOLLOWING THE UPDATE, MEDICATIONS ENTERED AS "PRESCRIBED BY OTHERS" ARE NO LONGER CARRIED FORWARD INTO NEW NOTES OR REFLECTED IN THE ACTIVE MEDICATION LIST UNLESS THEY ARE MANUALLY RE-ENTERED INTO THE ERX SYSTEM. AS A RESULT, PREVIOUSLY DOCUMENTED MEDICATIONS DO NOT APPEAR IN CURRENT DOCUMENTATION UNLESS THE CLINICIAN ACTIVELY REVIEWS PRIOR NOTES AND RECONSTRUCTS THE MEDICATION LIST. THIS REPRESENTS A SOFTWARE-RELATED FAILURE THAT RESULTS IN LOSS OF CLINICALLY RELEVANT MEDICATION INFORMATION WITHIN THE ACTIVE RECORD. IN PSYCHIATRIC PRACTICE, PATIENTS ARE FREQUENTLY PRESCRIBED MULTIPLE MEDICATIONS BY OUTSIDE PROVIDERS. THESE MEDICATIONS ARE ESSENTIAL TO SAFE PRESCRIBING, AS THEY DIRECTLY IMPACT DRUG-DRUG INTERACTION SCREENING, CONTRAINDICATIONS, AND OVERALL TREATMENT PLANNING. WHEN THESE MEDICATIONS ARE NOT VISIBLE IN THE CURRENT RECORD, THERE IS A RISK OF PRESCRIBING ERRORS, INCLUDING HARMFUL DRUG INTERACTIONS OR CONTRAINDICATED TREATMENTS. THE VENDOR'S RECOMMENDED WORK AROUND IS TO MANUALLY RE-ENTER ALL EXTERNALLY PRESCRIBED MEDICATIONS INTO THE ERX SYSTEM. THIS APPROACH IS NOT CLINICALLY SAFE OR PRACTICAL, AS IT INTRODUCES SIGNIFICANT ADMINISTRATIVE BURDEN AND INCREASES THE RISK OF TRANSCRIPTION ERRORS. IT ALSO REQUIRES CLINICIANS TO RECONSTRUCT DATA THAT WAS PREVIOUSLY STORED AND FUNCTIONING CORRECTLY WITHIN THE SYSTEM. ADDITIONALLY, THE CURRENT ERX WORKFLOW DOES NOT PROVIDE A STRUCTURED OR PERSISTENT METHOD FOR CLEARLY IDENTIFYING THE ORIGINAL PRESCRIBING PROVIDER IN A WAY THAT CARRIES FORWARD INTO FUTURE NOTES, FURTHER REDUCING THE CLINICAL RELIABILITY OF THE MEDICATION RECORD. THE ISSUE HAS BEEN REPORTED TO THE VENDOR MULTIPLE TIMES. INITIAL RESPONSES ACKNOWLEDGED THE CLINICAL RISK AND INDICATED THAT A FIX WAS IN DEVELOPMENT. HOWEVER, AFTER MULTIPLE FOLLOW-UP ATTEMPTS OVER APPROXIMATELY TWO MONTHS, I WAS INFORMED THAT THE DEVELOPMENT TICKET HAD BEEN CLOSED AND THAT THE CURRENT BEHAVIOR IS CONSIDERED "WORKING AS INTENDED," DESPITE THE ONGOING SAFETY CONCERNS. THIS ISSUE CONSTITUTES A HEALTH INFORMATION TECHNOLOGY? RELATED SAFETY HAZARD IN WHICH PREVIOUSLY DOCUMENTED MEDICATION DATA IS NOT AVAILABLE IN THE ACTIVE CLINICAL WORKFLOW, CREATING THE POTENTIAL FOR ADVERSE DRUG EVENTS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
732628 THERAPYNOTES (ELECTRONIC HEALTH RECORD) COMPUTERIZED BEHAVIORAL THERAPY DEVICE FOR DEPRESSIVE DISORDERS. SAP UNKNOWN

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown Other