​If you work in drug safety you will know that all marketed drugs require an assessment of the need for a risk management plan, the first step of which is to conduct a risk assessment.  If there are no important potential risks found as a result, then it is acceptable to perform only routine pharmacovigilance.  If the assessment finds either important potential risks, or some missing information, then it becomes necessary to perform either a risk minimisation action, or conduct further studies to find the absent data respectively.

So far, so routine.  But are you aware of the extra layer of complexity that new regulations require?  From now on all pharma companies conducting risk minimisation actions on marketed drugs are required to prove their effectiveness. 

Is this news to you? Well, wait until you have heard the next bit.  Although the regulators are seeking enforcement options, including fines, to punish those companies who don’t implement their planned risk management actions, there are no set or recommended models for how companies should satisfactorily achieve or report this.

So, how do you go about tackling this new requirement?  Nostrapharmus is not entirely convinced that the agencies appreciate the full extent of what they are asking for yet, and feels at this stage there is only so much that companies can do.  However, the first step is surely to look at the different ways to minimise risk and to set the safety objectives for each of them.  If, for example, you identified a potential risk to either pregnant women or their foetus, your safety objective would be to prevent pregnant women from using the drug.  Your risk minimisation actions might include putting a specific warning advising against this type of patient on the label, setting up an education programme with the pharmacists and physicians who would advise them, an action to make the patient requirements stiffer (‘Do not prescribe this drug unless a pregnancy test has been conducted’), or in the case of higher potential risk, setting up a restricted distribution programme.

To read the article in full, please click on the pdf link below:

New regulations require new proof of your risk effectiveness.pdf

or to read the magazine, please click on the link below, the article can be found on pages 57-58

http://viewer.zmags.co.uk/showmag.php?mid=sgfgh#/page56/

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