accidental exposure (with or without an AE) to study drug (non-marketed) by a non-subject

I would like to share with you this interesting topic.

Susanna Flores, Manager of Drug Safety at SuperGen asked the question and among the answers Bruce Graves Owner, Pharma GCP Support Services, Inc, Dr. Yeshpal Mathangi Clinical Data Reviewer at Clinnovo and Anuj Kapoor Medical Writer at Novartis provided great answers.

In a nutshell, this is a very rare situation, hence it won't require a SOP.

Without an AE, you should get as much as possible from the patient and supporting the investigator to make sure you collect the sequence of the event and save it into your database.

With an AE, you should report it as you'll do for events occuring during the study, making sure you clearly separate this single report from the rest of the study.

In the US, Poison Prevention Packaging Act (PPPA) administered by US Consumer Product Safety Commission is providing guidance on the situation.

CIOMS is working on the question too and Classify accidental exposure as an reportable event: Inadvertent or accidental exposure to study product with or without an ADR http://www.cioms.ch/march2008_pv_in_rpc_final_14dec2005.pdf.

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.

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.