Saturday, February 7, 2015

Adverse event reporting

During clinical trials and after a medication is approved, it is vital that adverse events experienced by patients are reported quickly and correctly to the correct government body and to the manufacturer. This way issues experienced by patients can be analyzed and dosage corrections or even recalls can happen. This is a critical part of taking medications.

Adverse events can range from short term reactions - rashes, vomiting, - or longer term ones such as - anorexia, hair loss, etc. Sometimes patients report the events themselves but more often they are reported by physicians. When not reported directly or without the correct tools, often they are under reported by as much as 50%. In Italy, they are developing some tools for the patients to report directly in language they understand. This is key, if the language used is in 'doctor-speak' a patient will struggle with completing the questions.

A second part of this issue is when the companies themselves fail to report the adverse events as required by governing bodies such as the FDA. In Japan, Novatis is facing suspension of their pharmaceutical facilities for under reporting adverse effects. So far there is no final ruling by in December the company admitted that their sales reps had failed to report over 3200 adverse events from 26 of their drugs.

So there are two parts of this issue in getting the adverse events from the patients. The first one is getting the doctors to report them and getting the tools to the patients so they can report themselves. To be fair to doctors, I am not sure they should be the only way patients can report adverse events. I think patients should be able to report directly. And the second part is getting the pharma companies to report them to the appropriate agency.

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