Working in pharmacovigilance, I understand the challenge of all the different reports you’re required to submit, from the DSUR, RMP and PBRER. They all have similar sections but address very different issues. I would like to focus particularly on the PBRER reports and some tips to make sure that you’re fulfilling the needs of the legislative requirements.
1. Do your homework
There is a lot of work that needs to be done upfront and doesn’t actually go into the body of the PBRER. Analysis of the data beforehand is extremely important to know what you need to cover within the PBRER. If the results aren’t adequately covered in the report, you will risk leaving the regulator blind and could end up with additional requests for analyses only because the data has not been described appropriately, which you will obviously wish to avoid!
One way to do this is to look at the raw data tables where cumulative and incident information is presented and assess those areas pointing towards an increase in the interval period. Focus on the analysis of these, even if you just have to add a sentence to the report for clarity. It shows the regulator you’ve done your homework! If there are events that look a bit strange as well or start to ring alarm bells such as Stevens-Johnson syndrome, make sure that you have looked at these events as well as they will be an alert for anyone reviewing the raw data.
2. Review your literature
Regularly review all your literature ensuring that all the important new safety information is included. It is also important to review the literature for your important risks and not just new safety information. For example you may come across an article on safe use of your product in cardiac patients, which may not be considered important new safety information, however if you have an important potential risk of use in patients with cardiac disorders this article may be relevant for this risk.
Be very clear as to what the process is within the organisation and especially the validation step and the mechanism you have for tracking these. Non-valid signals do not need to be added to the PBRER, but the validated signals that have been open, closed or are ongoing in the interval period need to be discussed.
Remember more detail on important risks needs to be included in the PBRER. If you are writing the report for the first time and don’t have an RMP then you will need to look through the CDS or SmPC to identify the important risks. If you downgrade a risk from important to non-important, you will need to justify your decision within the document and ensure that you have the appropriate tracking capabilities for these actions. There are sections for general updates on non-important risks but important risks need to be individually covered.
Often the benefit section is written by the medical department. Often you will come across articles or information when doing your homework from the risk perspective and its helpful to have an exchange of information with the person writing the benefit section. For older products the benefit section can be quite difficult to put together as often the documentation isn’t available from all those years ago. Often there is heavy reliance on the literature in these cases.
I hope these tips are useful in helping you prepare for writing a PBRER, what are your headaches when it comes to writing your pharmacovigilance reports? Let me know and we can cover these in the next update?
I’m running a webinar on 28th April at 11.00am BST about Top Tips for Report Writing, you can sign up for free here http://www.essjaysolutions.co.uk/events/webinar-top-tips-report-writing-pharmacovigilance/