Quiz on Benefit Risk and Pharmacovigilance

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Question 1 of 5

1. Question
Which of the following are the components of the four-fold model of benefit risk for the EMA?
- Favourable effects
- Unfavourable effects
- Uncertainty about favourable effects
- Uncertainty about unfavourable effects
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Question 2 of 5

2. Question
Which of the following are true regarding safety signals in adverse event reports?
- The presence of a safety signal does not directly mean that a medicine has caused the reported adverse event. An illness or another medicine taken by the patient could also be the cause.
- The assessment of safety signals establishes whether or not there is a causal relationship between the medicine and the reported adverse event.
- The evaluation of safety signals is part of routine pharmacovigilance and is essential to ensuring that regulatory authorities have the most up-to-date information on a medicine's benefits and risks.
- A safety signal is information on a new or known adverse event that may be caused by a medicine and requires further investigation.
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Question 3 of 5

3. Question
Which of the following are true regarding the signification of the black triangle?
- The black triangle appeared on 1 October 2013 in all EU Member States to identify medicines under additional monitoring.
- All medicines are carefully monitored after they are placed on the EU market. If a medicine is labeled with the black triangle, this means that it is being monitored even more intensively than other medicines.
- The black triangle is important when there is limited data on its long-term use of a medicine. It does not mean that the medicine is unsafe
- The black triangle is important because in a real-life setting, a larger and more diverse group of patients will use the medicine. They may have other diseases and they may be taking other medicines. Some less common side effects may only occur once a medicine has been used for a long time by a large number of people.
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Question 4 of 5

4. Question
What can you do if a drug reaction occurs months after you take a medication?
- If you suspect that you are experiencing a side effect you should consult a healthcare professional.
- Report it to Healthcare Professionals/Pharmacovigilance experts as there could be a trend that they need to map & the medicine could be withdrawn if there is enough evidence that these reactions are caused by the medicine.
- Keep prescriptions for your own medical history & enter treatment history & data, then join a report of medical history to drug reaction report when sending it.
- Side effects are usually reported by healthcare professionals, but increasingly, patients and consumers are able to report suspected side effects directly to national medicines regulatory authorities or marketing-authorisation holders through online patient reporting forms or by telephone.
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Question 5 of 5

5. Question
Can you report adverse reactions for a medicine that you are taking off label?
- Yes
- No
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Eurordis - Rare Disease Europe

Quiz on Benefit Risk and Pharmacovigilance

Quiz on Benefit Risk and Pharmacovigilance

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