Thoughts.

When medicines are first introduced to market, although there has been extensive research done in a clinical environment, it’s known that only the more common adverse events are likely to have presented themselves due to the small sample size.

Signal management is a key activity in pharmacovigilance, allowing the identification of new risks associated with a medicine. Manufacturers of medicines and regulatory agencies are constantly managing signals. But what is a signal and how are they managed?

Reporting adverse events is crucial in identifying potential safety issues and relevant risks in drug administration. An adverse event (AE) is any untoward occurrence that is experienced by a person following administration of a medicinal product or a medical intervention to that person. An adverse reaction is an AE that is suspected of being related to that product or intervention.

Patient safety is defined as the avoidance of unintended or unexpected harm to people during the provision of health care (NHS, 2022). The idea was first pioneered by Florence Nightingale, who used charts and other figures such as graphs to show relationships between hygiene and patient outcomes.

As part of Med Safety Week, the focus for this year is on promoting patient safety and a topic highlighted in this year’s theme is adverse drug reactions (ADRs), including raising awareness of potential ADRs and the importance of reporting these events.