Well, well, I have been doing a lot in 2011, but not contributing there much.
I'm going to address few of my peeves in the next posts. I swear. It will be fun. I promise.
Showing posts with label PV. Show all posts
Showing posts with label PV. Show all posts
Tuesday, February 21, 2012
Wednesday, July 29, 2009
Long Time
I have been very busy lately and I did not had time to write here. Shame on me.
Thru those last months, I have faced many times the same situation again: users and managers are loosing the business focus and get an IT-Database approach that is always the low road.
If you want to aim high, pharmacovigilance should always be first about business (as in business process).
As an example, an organization tried to get the events in a case re-ordered after the case was medically evaluate. The reason was they thought using a dedicated procedure capability in their software will help supporting it.
I had to detail why they were wrong. I have not detailed it from an IT perspective (the call they wanted to use was supposed to be a function and not a data updating feature), I took the business road: why is it done AFTER the medical evaluation and not BEFORE?
By putting the discussion on the right level (business) I put them back on the road they should not have left. My approach was acknowledged as the safest (audit anyone?) and the technically meaningful (updating data when you're allowed to).
I hope you will remember that the next time you talk about a software capability in your pharmacovigilance system.
Thru those last months, I have faced many times the same situation again: users and managers are loosing the business focus and get an IT-Database approach that is always the low road.
If you want to aim high, pharmacovigilance should always be first about business (as in business process).
As an example, an organization tried to get the events in a case re-ordered after the case was medically evaluate. The reason was they thought using a dedicated procedure capability in their software will help supporting it.
I had to detail why they were wrong. I have not detailed it from an IT perspective (the call they wanted to use was supposed to be a function and not a data updating feature), I took the business road: why is it done AFTER the medical evaluation and not BEFORE?
By putting the discussion on the right level (business) I put them back on the road they should not have left. My approach was acknowledged as the safest (audit anyone?) and the technically meaningful (updating data when you're allowed to).
I hope you will remember that the next time you talk about a software capability in your pharmacovigilance system.
Tuesday, April 28, 2009
B.3.1e: Interesting case
I was answering today a question on lab test result and I refer to the EMEA documentation to see what was the situation.
As often when I have to look in detail to the guidance, I'm discovering little surprises.
As you might know or not, the European MEdicine Agency is promoting guidance to use at best the electronic transmission of safety information including individual cases.
For that puprose EMEA with other agencies set forth a standard. The standard is divided in various section one of which is E2b (Efficacy guidelines section b of to make it simple).
Each section follows a certain series of updates and the latest one is EV 7.1 (EV stands for Eudravigilance which covvers all the resources involved in monitroing health situation in European Economic Area).
The description of what you should put in the electronic information sent is very detailed and B3.1e (lab test unit) element is mandatory if lab test result (B.3.1d) is provided.
If you fail providing the two fields together, your information is rejected.
The interesting piece is that the authority gives answers thru a working group to the industry now and then (more or less every quater we have updates). Since December 2007, the answer given to one question about B.3.1 element is not compliant with the standard provided by EMEA.
The test is related to Blood Glucose and the result is increased. the working group suggests that you send it as two fields B.3.1c (test name) and B3.1.d (result) without the B3.1.e unit.
I will be amused if one tries to send this to the agency and get the case rejected. If you do, let me know.
Monday, December 29, 2008
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.
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.
Sunday, December 28, 2008
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.
In the next, posts I will detail what I feel are the most important results we will see in the near future.
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.
What do you learn from PV?
When you are prescribed drugs, even when you take them over the counter without a prescription, the benefits and the risks associated with this drug are monitored.
Not only by the doctors in universities or in centers doing medical research, but by yourself. Getting a rash or a painful throat after taking a drug will lead yo to call the 800 number printed on the box. From there people will process the information and eventually this call will end up being declared to authorities like FDA in the US.
Whomever is calling , whether a nurse, a physician or yourself, will help the manufacturer of the drug to better understand how this active product is behaving in the field.
Even after years in service, someone taking a drug may describe something never seen before.
Don't be mislead, this will not bring any reward to you or the manufacturer. It will cost a lot of time and money to every one involved. Nevertheless, it will guarantee for future patients that we know how things are away from the labs.
Not only by the doctors in universities or in centers doing medical research, but by yourself. Getting a rash or a painful throat after taking a drug will lead yo to call the 800 number printed on the box. From there people will process the information and eventually this call will end up being declared to authorities like FDA in the US.
Whomever is calling , whether a nurse, a physician or yourself, will help the manufacturer of the drug to better understand how this active product is behaving in the field.
Even after years in service, someone taking a drug may describe something never seen before.
Don't be mislead, this will not bring any reward to you or the manufacturer. It will cost a lot of time and money to every one involved. Nevertheless, it will guarantee for future patients that we know how things are away from the labs.
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