Identifying Psychological Disorders and Symptoms as AEs

As a healthcare provider, we interact with patients on a daily basis and capture AEs which we report to our pharmaceutical clients.

There isn’t much guidance on when a reported emotion/psychological symptom (i.e anxiety) is also reportable as an Adverse Event.

Would a normal emotional response, e.g. anxiety, to a situation (such as a delayed delivery of their medication) be reportable?

 

Please note, that the response to your query represents the opinions formed from a consensus of the PIPA Committee, but do not represent their employing companies. These responses are intended as guidance. Please also refer to pharmacovigilance regulatory legislation, guidelines and your own company procedures.

Dear Member,

Thank you for your enquiry regarding identifying psychological disorders and symptoms as AEs.

In response to your question, would a normal emotional response, e.g. anxiety, to a situation (such as a delayed delivery of their medication) be reportable?

There are a few factors to consider here and the below outlines what would and would not be considered reportable. Please do take these into consideration when assessing which situation this falls into.

The following situation is not deemed as reportable AE:

– If the anxiety is caused by waiting for a delivery

However the following situations are deemed as reportable AEs:

– Has the patient experienced anxiety or any other form of a psychiatric-related disorder from taking the prescribed medicine in question?

– How long has the delivery been delayed which could have resulted in the patient experiencing an AE from not taking their medication.

I do hope this has helped in responding to your query.

Kind regards

PIPA

 

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