Voluntary (or "spontaneous") adverse drug reaction reports may be submitted at any time, whether or not the suspected reaction results in a change in HIV medications.
DOWNLOAD: Antiretroviral Adverse Drug Reaction Report form
Who can report: Any health care provider or patient
What to report: Any symptoms or abnormal test results you believe might be caused by an antiretroviral medication. It is important to report reactions that are:
- severe (prevent the patient from carrying out usual daily activities)
- potentially life-threatening or requiring a hospital visit
- unexpected (the reaction may not have been reported before, or is considered to be rare)
How to report: Complete an Antiretroviral Adverse Drug Reaction Report form and fax or mail it to the address shown on the form. Do NOT use e-mail to send any information containing patient identifiers (such as name or Personal Health Number).
Completing an Antiretroviral Adverse Drug Reaction Report Form
Minimum information required for an adverse drug reaction report:
- Patient first and last name, age, and sex
- Name of the HIV medication(s) that you think might be the cause of the reaction
- Brief description of the reaction or problem
- Reaction onset date (estimated or exact date when the reaction was first noticed)
- Action taken: status of HIV medication at the time the report was completed (Medication stopped? Dose changed? Treatment continues?)
Note: An adverse drug reaction report cannot be processed without the above information.
Valuable additional information for a complete adverse drug reaction report:
- Patient height and weight
- Details about start date, dosage regimen of suspected HIV drug and other concurrent HIV medications
- Other medical conditions or medications which may have contributed to the reaction
- Reaction details, including: relevant lab test results, symptom progression, whether or not the reaction has resolved
- Reaction severity (severity scale is shown on page 2 of the report form)
- Specific treatment information, including whether or not hospitalization was required
- Reporter information
Note: The above information helps Pharmacovigilance Program personnel: a) evaluate the relationship between the reaction and the HIV drug; and b) characterize patterns of drug toxicity.
