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Patient Adverse Event Reporting Process

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Questions and Answers

What type of information is included in Safety Information?

Only reports of hospitalization and death

All reports of Adverse Events and pregnancies

Reports of medication errors and device failures

All of the above and more (correct)

What should the agent do as soon as an Adverse Event is identified?

Inform the patient's doctor

Call the Novo Nordisk hotline

Stop using the Drug Product

Fill the Novo Nordisk AE/PC reporting form (correct)

What is the purpose of the Novo Nordisk AE/PC reporting form?

To collect information about medication errors

To collect as much information as possible about the Adverse Event (correct)

To report device failures only

To collect information about off-label use

What type of exposure should be reported according to the Safety Information?

All of the above and breastfeeding exposure Signup and view all the answers

What should be reported in relation to pregnancies?

All reports relating to pregnancies, including the outcome Signup and view all the answers

What is an example of a Serious outcome?

Hospitalization Signup and view all the answers

What should be reported in relation to Medical Devices?

All device failures, even if no harm occurred Signup and view all the answers

What type of use should be reported according to the Safety Information?

Only off-label use Signup and view all the answers

What is the agent's responsibility in terms of collecting information about the Adverse Event?

To collect as much information as possible Signup and view all the answers

What is included in the category of Adverse Events?

All reports of Adverse Events, including overdose and drug abuse Signup and view all the answers