Ethical, Regulatory, Legal Responsibilities

Limitations on safety profile in clinical trials: pregnant, pediatrics,

geriatrics not enrolled
Adverse Event: Any untoward medical occurrence in a patient,
clinical investigation subject, or consumer who administered an
Abbvie product, which could be a drug or medical device
An adverse event need not necessarily have a causal relationship
with the treatment or usage of an AbbVie product.
You need to report the adverse event even if the reporter thinks
the adverse event is unrelated to the AbbVie product.
Adverse Events: abnormal test findings (elevated liver enzyme),
clinical signs and symptoms (sneezing, coughing), changes in
physical exam findings (reduced body weight), hypersensitivity
(rashes due to drug allergy), worsening of underlying disease
(sudden surge in BP), death, hospitalization
An adverse event is considered serious if it results in death, is life
threatening, requires or prolongs hospitalization, results in
significant/persistent disability/capacity, is a congenital
anomaly/birth defect, medically significant requiring medical or
surgical intervention, elective abortion (AbbVie), miscarriage
(AbbVie)
15 calendar days for SARs and 7 days for fatal/life-threatening
events for report to regulatory agency
Valid adverse event: identifiable patient (initials, sex, age and age
group), reporter (contact info), adverse event/special situation
(confirm w HCP whether serious or not), AbbVie product (batch
number)
Special Situations (circumstances that may increase
patients risks of developing adverse events):

-Exposure during pregnancy/lactation: maternal exposure (during

or after use of AbbVie) or paternal exposure (prior to or around
time of conception, during partner pregnancy), obtain pregnancy
outcome
-Suspected Transmission of an Infectious Agent: contamination of
starting materials, during manufacture, inadequate inactivation
/attenuation of infectious agents (live vaccines)
-Misuse/Abuse/Overdose/Underdose: intentional or unintentional
-Lack of effect: therapeutic effect is diminished, the drug is not
working
-Off-label use with an adverse event: prescribe pharmaceuticals
outside the scope of the drugs approved label.
-Occupational exposure to the drug
-Medication errors (near miss): potential errors: no actual patient
has been involved, preventable event that may cause or lead to
inappropriate medication use or patient harm. Including
prescribing error, dispensing error, administration error, product
labelling, packaging and name confusion, wrong preparation and
expired products. Reportable even if it was corrected prior to the
administration of the product.
Other situations: adverse events already in label, occurred
weeks/months ago but just recently aware, AEs which HCPs
do not want to report, unexpected therapeutic or clinical
benefits, inadvertent or accidental exposure w or w/o AEs,
product complaints associated with an adverse event.
GSK products: Tracium, Ultiva, Mivacron