AE's 101
The year that the World Health Organization (WHO) was organized.
What was 1968?
Our AE Motto.
What is when in doubt, report it out?
Suicide and prevention hotline.
What is 988?
Examples of product quality.
What are damaged packaging, appearance/color, device malfunction or labeling/packaging error?
You must do this first before handling any calls or claims.
What is complete your training?
Reason we report an AE or PQC.
What is protecting the health and safety of our patients?
Key factor to experiencing an AE.
What is the patient must be taking the medication?
Examples of other safety information.
What are drug/food interactions, abuse/misuse (dependency), withdrawal/addiction, unexpected benefits and occupational exposure?
Examples of how to handle a medical information inquiry that is not listed in the FAQ's.
What is warm transfer directly to their Medical Information call center? Others may want the Medical Information Inquiries emailed or just refer back to their providers.
The the importance of reporting an adverse event, product complaint or other safety information.
What is: when you may be the first to become aware, allows drug manufacturers to best analyze and identify any potential risks related to their products/protects patients and lastly it is mandatory?
The drug that prompted leading to the establishing of the international drug monitoring program.
What was thalidomide?
Most common AE's reported.
What are rashes, fever, stomach ache and headache?
Examples of the most reportable Adverse Events.
What is hospitalization, up to and including death as well as pregnancy/breastfeeding?
The report received (oral, electronic or written communication) about an apparent or suspected deficiency or failure of a product where the product does not meet its specification or quality expectations (identity, durability, reliability, safety, efficacy or performance).
What is a Product Quality Complaint?
Sources or reportable information.
Who are patients, providers, caregivers/family/friends and pharmacists?
Timeframe for reporting AE/PQ complaints.
What is immediately or within 24 hours?
The timeframe that a person can experience an AE.
What are minutes, hours, days and even years after taking the medication?
Define Off Label use.
What is when the medication is utilized outside the Official Indication, or in an unapproved age group, dosage or route of administration, these are known as “Off Label” uses?
The question of a medical or scientific nature that pertains to a drug or combination drug/device.
What is a Medical Information Inquiry?
Define PREP.
What is the product info, the reporter, the event and patient info?
The true meaning of Pharmacovigilance.
What is drug safety?
Meaning of an Adverse Event.
What is any untoward medical occurrence associated with the use of drugs in a human, whether considered drug related or not?
The lack of effect or transmission of an infectious agent is always reported.
What is Other Safety Information as well as Product Quality Complaint?
Define a counterfeit or falsified medication.
What could be a wrong dosage, no active ingredient, manipulated expiration dates and/or toxic ingredients?
When we do NOT report the AE/PQC.
What is: discontinued the product or program and specific reason is not given/discontinued for financial reasons or due to a change in insurance coverage/Healthcare Provider changed them to another medication and specific reason was not given/Supply chain issues, drug shortages, or shipment problems/If patient has an AE experience as a result of the discontinuation - then you must report it?