Pharmacovigilance and Safety Reporting


1. Please select the BEST answer for each of the questions. 

2. After you have finished answering all of the questions, click the icon on the upper right corner and select "Finish course".

3. Enjoy learning! :)

Basics of Pharmacovigilance

Why is Pharmacovigilance important?

  • Otsuka is required by law to collect and evaluate them
  • To ensure patient safety
  • All the above
  • To protect the business

What is the purpose of Otsuka Pharmacovigilance Policy?

  • To protect patients
  • To ensure regulatory compliance
  • To protect business
  • To protect products throughout lifecycle

There is a need to continue surveillance of product _______ after approval of MA as part of Pharmacovigilance process.

  • Efficacy
  • Safety
  • Quality
  • None of the above

Safety Information

Which of the following is a safety information?

  • a. Dosage and Administration
  • b. Precaution
  • c. Drug-Food Interaction
  • d. Storage

Your 4-year old child has accidentally taken one of the drugs that you carry as a Physician’s sample. What type of safety information is this?

  • A. Pediatric Use
  • B. Accidental Exposure
  • C. Misuse
  • D. Off-label Use

Choose which statement is true or false.

  • All AEs are ADRs.
  • All ADRs are AEs.

A 42-year old man had severe headache for 4 days. He went to a doctor and was prescribed with Drug B. He went to the pharmacy and drank the medication. On his way home, he met a vehicular accident and was hospitalized. The scenario is an example of:

  • a. Serious Adverse Event
  • b. Adverse Event
  • c. Adverse Drug Reaction
  • d. None of the above

PV Reporting

The following fulfills the minimum criteria of valid safety report except:

  • Patient
  • Product
  • Drug Indication
  • Reporter

How soon should you report the case to OPPI-PV?

  • Within 24 hours
  • Within 48 hours
  • Within 7 days
  • Within 15 days

While you are browsing an online selling website, you noticed that a counterfeit Aminoleban Oral Sachet is being advertised. Should you report this to OPPI-PV?

  • Yes
  • No