Question: How can prescribers satisfy requirements for reporting serious adverse drug reactions (SADR)?
Context: In a separate post, we describe how to report a patient safety event. Safety threats that specifically relate to serious adverse drug reactions are subject to federal (Health Canada) reporting requirements and so have unique supports within Connect Care.
To be "serious", an adverse drug reaction should cause or potentially cause a:
- hospitalization or prolongation of an existing hospitalization
- congenital malformation
- persistent or significant disability of incapacity
- life threatening situation or death
Answer: SADR events can be reported from within Connect Care. From within an opened patient chart, seek the "Serious Adverse Drug Reaction Form" activity or use Chart Search with "Serious" as a keyword before jumping to the SADR activity.
Note the "Adverse Drug Reaction Note" in the SADR navigator and create a note. A NoteWriter "SmartForm" will open to highlight the required reporting elements. Any clinician can initiate the SADR report. However, the patient's attending prescriber must complete the indicated section, with details about:
- The impact of the adverse drug reaction on the patient's health.
- Any comorbidities which may have affected the impact of the adverse drug reaction.
- The date on which health was restored (if applicable).
Once completed and signed, the report is automatically directed for review and reporting to Health Canada.