Medication Use Quiz

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Overdose refers to the administration of a quantity of a medicinal product given per administration or cumulatively, which is above the maximum recommended dose according to the authorised product information.

True

Misuse and abuse of a medicinal product have the same definition.

False

Primary sources' details, including their qualifications, should not be provided in the ICSR if they report information on the same case.

False

Occupational exposure refers to exposure to a medicinal product during the manufacturing process before its release as finished product.

False Signup and view all the answers

Misuse of a medicinal product refers to situations where it is intentionally and inappropriately used not in accordance with the terms of the marketing authorisation.

True Signup and view all the answers

Falsified medicinal product definition includes unintentional quality defects.

False Signup and view all the answers

What is the definition of a serious adverse reaction according to ICH-E2A?

Any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly/birth defect Signup and view all the answers

What is the difference between a life-threatening reaction and a reaction that hypothetically might have caused death if more severe?

A life-threatening reaction is one in which the patient was at risk of death at the time of the reaction, while a reaction that hypothetically might have caused death if more severe is not necessarily life-threatening Signup and view all the answers

What is the purpose of the IME list based on the Medical Dictionary for Regulatory Activities (MedDRA)?

To facilitate the classification of suspected adverse reactions that are serious Signup and view all the answers

Medication Use Quiz

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Questions and Answers

Overdose refers to the administration of a quantity of a medicinal product given per administration or cumulatively, which is above the maximum recommended dose according to the authorised product information.

Misuse and abuse of a medicinal product have the same definition.

Primary sources' details, including their qualifications, should not be provided in the ICSR if they report information on the same case.

Occupational exposure refers to exposure to a medicinal product during the manufacturing process before its release as finished product.

Misuse of a medicinal product refers to situations where it is intentionally and inappropriately used not in accordance with the terms of the marketing authorisation.

Falsified medicinal product definition includes unintentional quality defects.

What is the definition of a serious adverse reaction according to ICH-E2A?

What is the difference between a life-threatening reaction and a reaction that hypothetically might have caused death if more severe?

What is the purpose of the IME list based on the Medical Dictionary for Regulatory Activities (MedDRA)?

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