For most of recorded history, drug therapy was primarily conducted based on traditional beliefs and anecdotal reports with agents that were often ineffective, frequently not expensive and frequently fairly innocuous. This changed dramatically with the Therapeutic Revolution when the discovery in 1935 that bacterial infection could be cured with specific therapy produced paradigm changing effects on health care and medical practice. 1 The excitement over the use of sulfanilamide therapy was however soon muted with the Elixir of Sulfanilamide Tragedy. 2 Over the following decades, as the benefits of drug therapy have increasingly evolved, so has our appreciation of the potential for drug harms (Figure 1).Given that new opportunities and challenges in drug safety field are constantly arising, some current insights and future directions deserve to be outlined according to the evidence-based medicine approach. Data arising from meta-analyses of observational studies reported that 5%-10% of hospital admissions were caused by adverse drug reactions and that approximately half of those hospitalizations could be prevented. Thus, in this issue of the British Journal of Clinical Pharmacology, we are considering the theme of drug safety with a number of manuscripts exploring drug harms and their detection.An already well-established but still growing area in drug safety is pharmacogenetics (PGx), which has the potential as a component of Not applicable.