Statistics from Altmetric.com
“The test of morality of a society is what it does for its children” is a famous quote from the German philosopher, Dietrich Bonhoeffer. Yet we struggle to deliver appropriate medicines to our children on so many levels. With a lack of studies being performed on both the medicines and the formulations that we are using, it is a wonder that we ever have any good treatment outcomes. How is it possible then, that when we do have treatments that can be used almost overnight the medicine that we were using can just disappear from the market?
The situation was highlighted in 2012 in the USA when Jennifer LaCognata tried to sue Hospira for removing Vitamin A injections from the market. She had started to have night blindness and was relieved to find there was a simple treatment in the form of an injection. Soon after starting treatment, Hospira ceased manufacture and there was a worldwide shortage. With no alternative product in place, her sight deteriorated and she became blind in one eye and began to lose her sight in the other. She lost the case as it was judged that the medicines industry has no duty to ensure continuity of supply. This story and others like it moved the US government to allow the Food and Drug Administration more power to try to prevent shortages. While these moves have only been partially successful, they are still better than the lack of control we have in Europe. The European Medicines Agency (EMA) approves medicines but has only very limited strategies in place to address shortages. There is no coordinated approach to shortages in place and industry is not even obliged to inform the EMA if they know that a shortage is likely.
So when we are looking at the complex …