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Pharmacovigilance

Pharmacovigilance is a set of procedures and activities aimed at the detection, evaluation, recording and prevention of adverse reactions, as well as any other problem related to medicines. Know the confidentiality policies.

Standard adverse event reporting form

    1. General information

    Type of report:

    May we contact you in the future for follow-up information?

    2. Patient details

    To whom does the report refer?

    *Complete Section 4: Parent information

    3. History / patient medical history

    Chronic illnesses:

    Other illnesses:

    Are you or have you ever been a smoker?

    Do you drink alcohol frequently?

    Do you use illicit drugs?

    4. Parent information

    Mother (complete this section for a child's report only)

    Father (complete this section for a child's report only)

    5. Pregnancy information

    Is the patient pregnant?

    Date of last menstrual period

    Pregnancy outcome (multiple selection allowed)

    Is the patient breastfeeding?

    If yes, please indicate

    In case of an abnormal result of the current pregnancy, complete section 7.

    6. Pregnancy history information (for previous pregnancies)

    Past pregnancy results (Number of pregnancies)

    Normal

    Abortion

    Birth defect / congenital anomaly

    Fetal death

    Other

    Is there a family history of birth defects / congenital anomalies?

    7. Details of adverse event / special situation during / after pregnancy

    Adverse event

    Start date

    End date

    Resultado*: (utilice la leyenda a continuación)

    Criterios de gravedad**:(utilice la leyenda a continuación)

    Reporter causality ***: (specify which of the medications used by the patient is related to the adverse event) (use legend below)

    *Result: Recovered, Recovering, Not recovered, Recovered with sequelae, Death, Unknown.

    ** Severity criteria: Death, Disability or permanent impairment, Major medical event, Life-threatening, Congenital anomaly/birth defect, Hospitalization.

    ***Causality: Possibly related, Unrelated, Not assessable, Not reported.

    8. Suspect drugs information

    *Trimester exposed: Stopped before conception, First Trimester, Second Trimester, Third Trimester (can be more than one trimester).

    **Action taken: Dose maintained, Drug discontinued, Dose increased, Dose reduced, Not applicable, Unknown.

    10. Details of concomitant medications / Used in the past

    11. Details of the adverse event occurring

    12. Linked Cases (i.e., mother-child, twins)

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