MAUDE Adverse Event Report: ELEKTA, INC. MOSAIQ; ACCELERATOR, LINEAR, MEDICAL

Device Problems Communication or Transmission Problem (2896); Compatibility Problem (2960); Protective Measures Problem (3015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Description

Different drug interaction databases screen for drug interactions as there seems to be a lot of variability and inaccuracies.Ultimately, we rely on the pharmacists as the clinical experts to determine if the interaction is clinically appropriate in some cases.We recently had a patient who was on an (b)(6) medication and prostate cancer medication in which "xxxxxxxxxx" ((b)(6) specific) catches the medication and (b)(6) (database we use) caught the interaction, but the multiple systems we utilize (rx30 (pharmacy dispensing}, (b)(6) (oncology)), clinical pharmacology does not flag the drug-drug interaction.This spurred some great discussion on best practices for using the specific drug interaction and how we implement best safety practices given our resources available.Here are the additional details on the scenario with (b)(6) and xtandi (enzalutamide) as the medications that were involved.I've attached screenshots removing phi which has the variability in the interaction between databases.As you can see, there is much variability as this is just one scenario.I believe there are more scenarios where there is variability among the di screenings and tools that we use, but we were also more curious on how other institutions and (b)(6) addresses the problem.I have attached an interesting reference which graded the most common drug interactions as lexi-interact and micromedex showed the best performances in drug,­ drug interactions.The di vendor that health systems use is normally it's based off cost and contracts.A comparison of five common doi software programs regarding accuracy and comprehensiveness hnrsjlpubmed.Ncbi nlm nih.Gov/27843962/ lbnp ubmed.Ncbi.Nlm.Nih.Gov/27843962/) (reporting from a health system specialty pharmacy).Contraindicated with concurrent drug therapy: drug interaction communication, poor/lacking (nonspecific) prescription processing software, omission from reference material electronic drug reference products.(b)(6).Submission id: (b)(4).

• Brand Name: MOSAIQ
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA, INC.
• MDR Report Key: 12877977
• MDR Text Key: 281585795
• Report Number: MW5105585
• Device Sequence Number: 2
• Product Code: NEP
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 06/28/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/24/2021
• Patient Sequence Number: 1