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Getting started
with PSUR writing


October, 2018

Periodic Safety Update Reports require great precision and knowledge. A lot of organization and management goes into their composition. And you can achieve all that with good planning and preparation.

The quality of writing can depend on the quality of preparation

What is the point of PSURs, exactly?

In a way, PSURs are check-ups on a drug’s or substance’s safety. They round up the accumulated information on a given product and present it in a systematic order.

PSURs give clear and objective insight into a substance’s risks and benefits, while sustaining the relevancy and utility of a particular medicine.

Delegating tasks:
Teamwork vs. Doing it alone

The technique of PSUR composition varies. How does your department handle PSURs? Are they always written by a team, or do you prefer to be a lone wolf while composing them?

The downside of writing PSURs singlehandedly is obvious: you can be biting off more than you can chew. The job is extensive. Filling out each section with condensed research can take an overwhelming amount of time, even for veterans in the field.

However, there is an obvious plus side to it, too: a single writer produces a more coherent report. They have complete overview and control over each and every section.

Combine the best of both worlds

The benefit of writing coherent reports can also be applied to writing in a team. Slicing up tasks between numerous associates can increase the speed of PSUR preparation, but it could harm the report’s coherency. You can overcome this with appointing someone to act as a guiding axis that orchestrates everything.

Having one person be the master-composer of a PSUR can guarantee coherency, and snuffing out any mistakes or oversights. They have a perfect view of the bigger picture. All the other team members send their segments, and the master composer glues them together in the most sensible way.

In the end, the most important thing is that your PSUR is composed well. The sections have to be coherent and contain all necessary information.

Manage information on the right platform

It’s also important to use a software that lets you sort and manage all the information you’ve collected. We made Sympto® with that in mind.

You can group literature. You can enter all important findings while performing your weekly or monthly literature search and save them for future PSURs. Any time you enter a literature finding, you can link it to a case you’re working on. In a way, you’re making a neat net of information you can filter and extract in a click.

And, you can add comments for your coworkers or for yourself. You can inform others what to expect in a literature finding. You can instruct them to modify or check a specific case or report segment. You can leave notes for your future reference. It makes communication about specifics so much more direct. No more need to explain steps in detail through emails, just leave a comment to clear things up.

Also, Sympto® allows extraction of the necessary summary tabulation and line listing data which you can easily manipulate and use as appropriate. You can rely on Sympto® to lessen your workload and ease the need for immaculate data compilation.

How to achieve a good PSUSA verdict

Learn from feedback. Look through previous verdicts. What was omitted? What wasn’t included last time? What should you include from now on?

Screening PSUSA verdicts and already assessed PSURs is a good way to hone your judgment. Before your first PSUSA verdict, however, you have only your critical judgment and logic.

When preparing materials for PSUR writing, make sure to:

Gather information

PSUR composition doesn’t begin and end with writing. Actually, writing starts roughly in the middle of the whole process. As with anything else in life, preparation is king. You can’t simply pick up the information as you go.

So, read through your SmPC, read through findings, check what’s important and what’s not. Read and characterize everything you have on disposal. Then, go back and reread it.

Check MAH information

Before starting anything, if you work as a freelancer or in an outsourcing company, check if the respective Marketing Authorization Holder (MAH) delivered all the information you need for composing the PSUR.

Especially if they aren’t your regular client. This could save you from unnecessary delays and backtracking.

Understand PSUR sections

To get started, you have to understand what your assigned section depends on. Do you need to know the Data Lock Point (DLP)?

Does your work require other tasks to be finished before you start? Do you have to cooperate with others working on other sections?

Mark the date

Once a month, EMA issues the EURD list. It contains all reference dates for medicines and the frequency of their PSUR submission. These timelines are inflexible and reports can’t diverge from them.

Determine the report’s submission date, Data Lock Point (DLP) and writing period. In some cases, a substance is not on the EURD. These substances still follow old PSUR submission timelines, accessible on EMA’s webpage.

Group information

By this time, you will have an abundance of information. You have to put your organization skills to good use in order to deal with it all.

Organize and categorize everything you know. Group all relevant literature findings. It will make your information clear and easy to sort in PSUR sections.

Find your guiding principle

Understanding and organizing information will also give you a special edge: it will help you see the guiding principle behind the articles, and outline the backbone of your future PSUR.

See what’s your most important finding, and start with it. Check if certain groups of information connect with each other or imply something greater. This will help you clearly decide on the order of their presentation.

Always go back and check

In pharmacovigilance, you can’t simply do things from memory. When determining risks, always go back to consult section 4.8 of the SmPC, even if you’re sure you know an adverse reaction’s frequency.

Go back to a relevant finding to reread it and see if there is something omitted. Check if there is any other study you could include. When talking about drug safety, there is no such thing as too much caution.

These are the foundations on which good PSURs lie. You can read about the peculiarities of writing PSUR sections, such as Literature or Risks, in our next few articles.

Feel free to ask more about this topic.
And if you want to know more about Sympto®, we invite you to

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