Flexibility and Improvements

Every organization reaching a certain capability in processing reports will need to set up measures.

If you don't know what you are doing now, how will know what you'll be doing next?

It's very easy to account the reports ratio given by the number of staff you have and the number of reports you process. But this measure is very uneasy to analyze.

So now how do we handle that complexity? Pondering is the best way to go.

Every report has a certain number of data organized by categories: product, reporter, patient, etc.
Every category has structured data: Product's indication, product's dosage, patient's medical history.
Every structured data has more or less information (start/stop date partial or complete).

As you have defined the mandatory information, those are not accounted. This is key to make the measure really informative. What you're interested in are the information that will make the report more accurate, more difficult to process but more valuable for your analysis and organization. This will be the subject of our next post.

Why flexibility is now trendy in Pharmaco-Vigilance?

When one hears the word flexibility, the image coming to mind is the one of those acrobats bending and rolling over themselves.

In an organization, flexibility should be more like gearing up and down in a car depending on the road and the traffic's conditions.

Of course, every organization would like to be at full throttle.
This is not possible.
Why? As we all know organizations are based on individuals. Full throttle for an individual can not last long and the most important when dealing with PV is consistency.

Regulation, do not forget Pharmaco-Vigilance is a regulated activity, so regulation does not expect you to be good at 80% or 95%. Auditors, sent by management, or authorities, look for every single defect in your organization and they expect you to be at 100% compliance (reports on time). So if you want to be there, you need every one available and focused. You do not want exhausted individuals, painful meetings, passive-agressive approaches.

Question: How do you make your organization flexible enough to bend itself to outer constraints (regulation, compliance) inner constraints (data quality, team management) and achieving sustainability in the proceeding?

First Step: Closer is Better
Everyone agrees when it comes to information you need to be close to the source of it. Not only when people are using their own language it helps understanding the subtilitites )localization/translation) but it also insures you can provide protection under local laws to privacy.

Second Step: Doing good once better than doing several
Processing information must b an industrialized activity. Yes you may end up having queries (questions to the source of the information). Definitely if you control the quality of the data entered compared to the data given (called QC) you should do it once.

Third Step: Beat it when it's hot
When you have to correct/fix something you should do it as close to the step when this information/action was entered/done. More you wait, more expensive the fix will be.

Fourth Step: Empower thy users
You will have to build throughout your orgnization a structure/tool to enhance the knowledge about the defects/failures it achieved previously. If you know why somethign went wrong and if you describe it precisely, chances are you won't repeat it.

In a nutshell, you'll start being flexible when you'll be empowering sooner, closer and better. Giving power to users to make decisions, helping them to understand the failures, collecting the information where it should, doing things in order and once, that the first phase to gain flexibility.

The next one (in another post) will be adaptation.

PV Trends

When it comes to the future, Pharmaco-Vigilance is structured via the guidances and drafts provided by the agencies.

Now every department of every company gets its own dynamic.

The main reasons are varying. It can be a great team work, it can be a strong leadership. It might result from acquiring another company. Whatever, you name it.

• So what are the trends in PV now?
• Where are we?
• Where do we go?
• How fast will we be there?

In the next, posts I will detail what I feel are the most important results we will see in the near future.

Why I like it so far?

I've been working in PV for 30 months now.
I enjoyed it and I'm still learning.

Main aspect of this field:
The bar is getting higher.

As PV is mostly regrouping Mds and Phds from pharmacy to medecine, you have to deal with people used to facing more or less any kind of evolution (chemistry and biology are definitely challenging fields).
Second aspect of the job: people are open to new approaches.

As companies are distributing and sometime manufacturing, products all over the world, you are dealing with a mix of culture and positions that create wonderful teams.
Third aspect of the job: every team has its own dynamic.

Last but not least, you are dealing with a regulated (agencies/laws/auditors) environment where stakes are high.
Fourth aspect of the job: your decisions do matter.

So I do consider to be very lucky to have had the opportunity to get into this domain at a point in my career where I had definitely learned already from other fields and bringing something to the new one.