Procedure Logs

C3.2 R5: Submit an ADR report to appropriate authority

One of the patients I followed had an ADR that was likely due to one of her medications and I used this as an opportunity to fill out an ADR form.

DD is a 24+4 GA baby born with extreme prematurity and a myriad of medical conditions and concerns including a patent ductus arteriosus. On day 11 of life 3 doses of indomethacin were used to pharmacologically close the PDA. The patient was also on concurrent vancomycin for rule out sepsis (with a trough level that came back on the higher end of range, 16mg/L [range: 5-15mg/L]). After the use of indomethacin DD started to experience acute kidney injury with elevated BUN, elevated SCr, decreased urine output (almost 1/2 of patient’s baseline amount), and decreased Na+. Though this eventually resolved (as only 3 doses of indomethacin were given), it required careful monitoring of the patient’s kidney function to ensure no further damage occurred.

By filling out the ADR report I tried to remain cognizant of who was reading the report I submitted. I wanted to ensure that the information I provided was understandable for a pharmacist who might not be as familiar with the NICU setting. Thus I tried to be as explicit as possible by providing doses in both mgs, and mg/kg. I also tried to add in what NICU ranges of normal are (e.g. for vancomycin trough) which may differ from adult ranges. Lastly, I followed the rules taught throughout undergrad and put units everywhere! This would allow me to ensure that whoever the recipient is, understands the exact situation that occurred, and to minimize any assumptions that would have to be taken.

This was an interesting experience, and not as painful as I thought it might be! A good reminder for myself to be sure to fill out the ADR vigilance forms when appropriate to ensure that we send Health Canada the “signals” if a product is causing any harm to patients!

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