Drug Safety 2005; 28 (5): 379-386

The WHO World Alliance on Patient Safety is a new, all encompassing project Abstract to improve medical care. Individual patients are the focus and all countries are encouraged to develop systems in which medical error, therapeutic accidents and failures are minimised. The potential for adverse events is present at all levels of healthcare and in all disciplines. One working group in the Alliance is charged with promoting and developing a ‘reporting and learning’ culture for adverse events in all areas of medical care. Central to current thinking for this group is a no-fault approach and to report near misses. The aim is not to provide certainty over the individual events, but rather to draw attention to possible improvements in systems that may prevent future problems. Adverse events relating to drug therapy have been reported for decades to national pharmacovigilance authorities, but this is aimed at finding problems with the drugs themselves as early as possible. The Alliance approach in the area of drug safety, by contrast, has a greater focus on safety in the systems of drug provision (including prescription and dispensing) and other systematic issues relating to safe drug provision, such as fraudulent drugs. Thus, current pharmacovigilance can be seen as representing a part of the reporting and learning envisaged by the Alliance. The two approaches are also complementary, but there are practical and philosophical areas of overlap in which difficulties may occur, such as anonymised reporting in a no-fault system and consequent impossibility for follow-up. In pharmacovigilance follow-up for more information is regarded as essential. Whether pharmacovigilance broadens into the area of patient safety or the latter involves completely new systems to do its work will be a matter for each country to consider. One thing is certain, working together both systems will improve patient care, but without cooperation more bureaucracy will take valuable health professional time with a lesser result.