Sense about Science, a charitable trust that equips people to make sense of scientific and medical claims in public discussion, have published a new guide entitled, Making Sense of Drug Safety Science: Investigating the science of side effects.
The guide was produced in collaboration with the Medical Research Council (MRC) Centre for Drug Safety Science with support from the MRC.
Sense about Science want patients and their carers, as well as medical professionals to know about this guide, which is free.
I can make sense of the science but it still defeats me as to why the bio equivalent study that FDA did on bioavalibilty was changed to an upper limit of 105 from 110 but lower limit of 90 was left where it was. They mentioned that there were unlikekly to be adverse clinical outcomes for being too low on thyroxine but there would be on too high eg. Heart etc. Until someone really pushes the issue of quality of life really affecting the health care budget for increased GP appointments and that it can have a clinical outcome for example hypothyroid patients being prescribed anti depressants when really if we were optimised the symptoms that are costing healthcare for all the further investigations would reduce. Not to mention the number of boxes that are stacked up in local chemists which aren't air conditioned. So frustrating. Sorry bit of a rant there....
Though the USA's FDA did change the lower level to 95% - it is the UK's MHRA which did not change the lower limit.
There was also a clear shift in stated policy that overage would not longer be tolerated. (The idea of making medicines deliberately over-potent on the assumption that they would lose some of that before being taken.)
I entirely agree about air conditioning in pharmacies. It strikes me that some of the smaller ones might be locked up from Saturday lunch through to Monday morning, weekend after weekend, during the summer - allowing the medicines to 'cook'. The saving grace is possibly the low levels of stock most usually hold. It is somewhat good that if you read about the pharmaceutical distributors, they have put a lot of effort into maintaining acceptable environments within their vehicles.
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Making sense of my results
