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WorksheetsPharmacovigilance
Total questions: 13
Worksheet time: 12mins
PV stands for
Physical Volume
Present Value
Pharmacovigilance
Photovoltaic
Choose the correct definition of Pharmacovigilance.
The science and activities relating to the detection, assessment, understanding and prevention of adverse events or any other food-related problem.
The science and activities relating to the hiding, assessment, understanding and prevention of adverse events or any other drug-related problem.
The science and activities relating to the detection, assessment, understanding and promoting of adverse events or any other drug-related problem.
The science and activities relating to the detection, assessment, understanding and prevention of adverse events or any other drug-related problem.
What are the purposes of Pharmacovigilance?
Define the safety profile & Prevent harm of a
product
Monitor the safety of a product and its effects when in widespread use in a diverse population
Evaluate benefit vs. risk to patients
Ensure compliance with worldwide regulations
Increase profit margin of a product
Below are the consequences of Non-Compliance to Pharmacovigilance, EXCEPT
Criminal prosecutions
Risk to patient safety
Withdrawal / batch recall of marketed drugs
Affects the registration status of the product(s)
Pricing up of the drugs
Pharmacovigilance is important to Protect the Patient, Protect the Government, and Protect Medispec.
True
False
Choose the correct definition for ADVERSE EVENTS.
Any untoward medical occurrence in a patient administered a medicinal product and which must have a causal relationship with this treatment.
Any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment.
Any untoward medical occurrence in a patient administered traditional herbs and which does not necessarily have to have a causal relationship with this treatment.
Any untoward medical occurrence in a patient administered traditional herbs and which must have a causal relationship with this treatment.
Death is not an example of Adverse Event.
True
False
Miscarriage and Toothache are not examples of Adverse Events
True
False
Choose the 4 minimum criteria of Pharmacovigilance needed to report an Adverse Drug Reaction.
Patient ID
Reporter
Event
Product
Issue
If you do not have all the 4 data elements (PREP), there is no need to share the information in hand with Medispec even though there is a Medispec medicinal product involved.
True
False
REPORTABLE EVENTS/OTHER SAFETY INFORMATION are not important as they do not meet the classic definition of AE (unintended or unintentional sign, symptom or disease)
True
False
For MEDICAL DEVICES reportable events, there is no need to report if the incident does not lead to death, but only near death.
True
False
The deadline to collect all the required information and send it to Medispec person-in-charge of PV will be within 3 days.
True
False
