Monitoring Drug Safety in the General Population

Festival of Genomics – Speaker Event: Pharma and the Growing Need for Patient Genetic Diversity

Part 3 – Monitoring Drug Safety in the General Population 

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So, because of these 2 issues , you have a safety system in place, which is phase 4. This is where there is monitoring of side effects/adverse events that may occur in the general public. Those adverse events are supposed to be reported to the MHRA and that allows the MHRA (the regulator) to build up a picture around whether a molecule/drug is safe and effective. If there are any safety signals, the license can be modulated or modified and in extreme cases, the drug can be withdrawn from the market. This reporting system is called the Yellow Card System and its voluntary for healthcare professionals and patients. It has been in place now for over 50 year, since 1964 when it was first bought in. In these last few decades, there has been evidence to show consistent under-reporting by healthcare professionals, which I will demonstrate through 2 examples. 

First, there was a publication in 2007 which is based on a review of the 2006 BMA report, which is based on data from 2004 from the NHS. What this showed was, there were a quarter of a million patients that were hospitalised because they had a prescription-only medicine that resulted in adverse events, which were so severe that they had to be hospitalised. Clearly, that has a negative impact on the patient and their families but also the NHS, in terms of cost and resources. Going back to the 2004, this cost the NHS just shy of half a billion pound a year. The members of the BMA (British Medical Association) reprimanded their own members by saying that the primary care trust should remind their doctors that they have a moral responsibility to report adverse events. Now we will move onto 2016, a published report based on reporting of adverse events in children under the age of 2 over the period of 10 years from 2000 to 2010.