Reflections
Thoughts on a shared journey to make drug use safer
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Be prepared - being read to be ready Cancer risk. New study reveals drug X causes cancer. After news like this the office feels like a hornets nest in which a big stick has been poked. As the buzzing becomes deafening the safety team must find that inner peace and composure that allows it to manage the situation constructively and in a levelheaded way. This is easier said than done. It is said that many a match is decided before the players walk onto the pitch. How fit the players are, how well they play with one another and the game strategy are preconditions that are set before the umpire blows the whistle for the first time. The situation in managing safety is similar. The most important asset in managing safety well is "being ready to be ready". Easy to say, not so easy to do. Knowing what to do and how to do it before it needs to be done. Baden Powell crafted the motto "be prepared" which is engraved on the belts of the boy scouts uniform. If drug safety officers were to wear uniforms this motto would be equally appropriate.
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Stepping back to see better A meal is never eaten as hot as it is cooked. So goes a German saying. Wisdom to guide safety professionals. Protecting patients from unnecessary harm is a serious matter. All the while the universe is probabilistic. Always and never are rare exceptions. Uncertainty is a steady companion. Evidence is usually incomplete and preliminary, rarely definitive and conclusive. Furthermore, safety data is often subject to biases and confounding. When facing a safety finding finding it can be helpful to keep this in mind and take a big step back to see the forest for the trees. Clinical safety information is often fraught with noise and to hear a discernible message requires careful listening. Three techniques can be helpful in separating the wheat from the chaff. 1) Statistical methodology. This is explicitly designed to help appreciate and account for random events. Estimates of confidence intervals can offer invaluable orientation. 2) Visualisation. Lengthy tabulations can be difficult to read. When the same information is provided in a well-designed figure understanding becomes intuitive. 3) Conditional probabilities. Suspected adverse reactions do not occur in all patients all the time. Rather there are factors that lead to their appearance in a given patient at a given time. Safety is always to be seen in the context of dispositions or tendencies that are associated with specific constellations of circumstances.