Top 3 Best Practices for Complying with the Development Safety Update Report (DSUR)



Andrea Charles
01/06/2011

Pilar Carrero, Director of Safety Medical Writing at Novo Nordisk, joined Pharma IQ to discuss the impact social media has had on drug safety and risk management and the dawn of a new era for pharmacovigilance. To listen to the podcast go to Message from the Regulators: Pharmacovigilance to Move Heavily into Risk-Benefit Assessment.

Pharma IQ:
What regulatory concerns are pharma currently facing?

P Carrero: Many, I would say. From my perspective, at least, the main thing is the lack harmonisation between the different regulatory agencies; that creates redundant work for us and very unclear directions of how to approach our deliverables for them. There are a number of other concerns with privacy data; now they also want to make our information more accessible to patients and that can create a number of issues. So yes, in general, the lack of harmonisation; I think it creates confusion and redundant work.

Pharma IQ: What are the challenges of complying with the Development Safety Update Report (DSUR)?

From my point of view, I think, again, is the lack of harmonisation. So far only the European authorities have adopted ICH E2F. FDA considers it a guideline but has not pronounced itself about what to do. And Japan has said absolutely nothing. So the principle of ICH is very good; to have one document that will inform all authorities globally. However, when it comes to reality that is not the case; the agencies cannot really make it happen. So that's going to be a challenge, again, because, most likely, for a period we are going to be producing a number of documents for the different agencies.

Pharma IQ: How do think that DSUR will change with the EU Pharma package?

P Carrero: Well, we don't know because the DSURs will be implemented next year, by September 2011 and there is no... we don't know if with the Pharma package, they would like us to make these documents public or write some parts of it at least in lay language so patients can understand the information that the document contains. At the moment it's a big question mark, I would say.

Pharma IQ: What would be your top three tips for the best practice strategy to complete the DSUR?

P Carrero: I would say, the very first one, based on our own experience is that any pharmaceutical company needs to have a very good IT strategy. All the databases containing all the relevant information in the different areas of the company need to be thought through very well so the information is not sitting in too many different systems. That creates a very complicated process to put it together. That would be the first one, the IT strategy. Number two; have a very clear starter project that will help establish in a robust process well ahead of implementation of the document. And number three; have a very good communication and rollout strategy within the company and the organisation since this document is very cross functional.

Pharma IQ:
What would you say are the key steps necessary to optimise your pharmacovigilance activities?

P Carrero: Once again, IT systems. I think most large pharmaceutical companies have developed over time a number of IT systems that don't necessarily talk to each other, and that creates already complicated processes. And definitely we need to become a lot more proactive in our activities instead of just trying to react when the problems arise. We need to use the risk management plans as a tool for our pharmacovigilance activities and not just as a bureaucratic tool.

Pharma IQ: What impact, would you say, has the rise of social media had on drug safety and risk management?

P Carrero: A very big one because companies don't know what to do about it. If we become aware of the side-effects of our drugs in these social media, we need to report them to authorities. However, social media also contains very unspecific information so the quality of those cases is, I would say, very questionable. I think that it can blur the picture more and can create a lot of noise in the databases. And the authorities at the same time are asking us to provide very good safety information in our cases. So, the two things don't go hand-in-hand together. And that is one of the main challenges; should we be screening for everything and then, if we do, what's the value of it?

Pharma IQ: How do you see pharmacovigilance changing after 2012 and do you think we are entering a new era of drug safety?

P Carrero: Absolutely, I think it's quite clear. From the regulatory agencies the message is very clear; pharmacovigilance is going to move heavily into risk-benefit assessment instead of just pure description of the side-effects we receive. So we will have to do a much more proactive approach to pharmacovigilance, use risk management during our development programme as a tool to develop our development programme, and also to create comprehensive post-authorisation commitments that would give us the information we need to ensure the safe use of the drugs. So, definitely... I believe we are entering a new and exciting era. 

Interview conducted by: Andrea Charles