Pharmavigilance Case Study

Pharmacovigilance is the process of examining the safety of medicines and taking action to reduce risks to public health (4) . While it is the purpose of a medicinal product to reduce pain, relieve symptoms and prolong life, it is important to evaluate the risk of such products throughout its lifecycle to ensure it poses minimal risk and side effects to the patient. Given the scope of drugs available on the market today which can greatly impact a person e.g Anti Depressants, Chemotherapy, Antibiotics, Steroids it is vital to ensure there is adequate traceability and all potential side effects associated with the product have been identified and assessed. The introduction of Pharmacovigilance legislation was based on the observation that
The objective of the monitoring system has been introduced in order to increase the accountability which healthcare professionals and patients play in the reporting of medicinal side effects(4). Medicines displaying an inverted black triangle on the Patient Information Leaflet (PIL) and in the summary of product characteristics (SmPC) for medical professionals, indicating that the medication is subject to additional monitoring(6). This purpose of this symbol is to ensure that patients and medical professionals are conscious of drugs which require further monitoring, in the hopes that they can be more assertive in detecting and reporting adverse side effects the producer may not be aware of(6). The black triangle will always be accompanied by a clear, concise statement which states 'this medicine is subject to additional monitoring' . The different classes of medicinal products which require additional monitoring