Case scenario
Jimmy, a 36-year-old man, presents to the pharmacy with a new prescription for escitalopram 10 mg daily and diazepam 5 mg twice daily as required, prescribed by his GP. His medicine history includes topical corticosteroids for eczema. During the consultation, he asks whether dupilumab could be contributing to his recent low mood and increased anxiety. He reports that these symptoms started about 3 weeks after initiating dupilumab, prescribed by his dermatologist.
You explore his symptoms further and identify a potential temporal association with treatment initiation. While you consider the possibility of an adverse event (AE), Jimmy expresses reluctance to proceed with reporting, stating, ‘Please don’t report this,’ due to concerns about delays in seeing his specialist, potential loss of treatment access and the perceived benefit he has experienced from dupilumab for eczema.
Introduction
The World Health Organization (WHO) defines pharmacovigilance as ‘the science and activities related to detecting, assessing, understanding and preventing adverse effects and other medicine-related problems’.1 Closely linked to this is therapeutic risk management, a concept focused on maintaining a favourable benefit–risk balance throughout the medicine lifecycle.2 Risk is generally understood as the probability of an adverse outcome occurring and therefore requires continuous, proactive management.3
Pharmacovigilance and therapeutic risk management extend across the medicine lifecycle, from pre-market development and regulatory evaluation to post-market monitoring and safety surveillance. These complementary processes generate and provide safety evidence to support regulatory and clinical decision-making. A medicine is considered safe and acceptable when its expected benefits continue t
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