Why We Are Unique?

When it comes to Mass Tort and Class-Action litigation, the early bird gets the worm. In order to be at the forefront of new developments, one must use a diverse array of both traditional and non-traditional research methods.

At The Drug Ref we know that your time is valuable, and that is why you want a researcher who is a licensed lawyer. We can separate the wheat from the chaff better than unlicensed legal researchers, saving you the time, money, and frustration.

Example 1: FAERS

History has shown that medicine has benefited from practically every step in technology – and today it is no different. The advent of the internet has completely changed the game; drug reactions that would have gone unnoticed for decades in times past are now detected within days. There are large and well-funded organizations like the FDA and the WHO (World Health Organization) eagerly collecting health data and using it to improve our lives. They compile drug data in order to detect things like unexpected reactions or interactions with other medicines. Like detectives, they comb through the information – finding the victims of pharmaceutical negligence.

What is FAERS?

The FDA Adverse Event Reporting System (FAERS) is a database containing information on ‘adverse event’ and ‘medication error reports’ submitted to the FDA. The database is designed to support the FDA’s post-marketing safety surveillance program for drug and therapeutic biologic products.

How Does the FDA Use the Information in FAERS?

FAERS is used by the FDA to detect safety concerns linked to a product, evaluate a manufacturer’s compliance to reporting regulations, and respond to outside requests for information. The reports in FAERS are evaluated by clinical reviewers in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) to monitor the safety of products after they are approved by the FDA.

Who Reports to FAERS?

Reporting of adverse events and medication errors by healthcare professionals and consumers is voluntary in the United States. The FDA receives adverse event and medication error reports by way of voluntary submissions; either from healthcare professionals (such as physicians, pharmacists, nurses and others) or from the consumers themselves (such as patients, family members, and lawyers.)

Healthcare professionals and consumers may also report adverse events and/or medication errors to the products’ manufacturers. If a manufacturer receives an adverse event report, it is required to send the report to the FDA as specified by regulations.

FAERS contains over four million reports of adverse events, and reflects data from 1969 to the present.

FAERS now has quarterly compiled data snapshots, dating back to 2004, available for download directly from its website.

 

Example 2: VigiBase™

What is VigiBase™?

VigiBase™ is the name of the WHO global ICSR database. This database contains over 7 million Individual Case Safety Reports (ICSRs) of suspected adverse drug reactions, submitted by national pharmacovigilance centres. VigiBase is updated with incoming ICSRs on a continuous basis. The WHO VigiBase is the largest and most comprehensive drug resource of its type in the world.

The VigiBase functions as a computerized pharmacovigilance system. Information is recorded in a structured, hierarchical form to allow for easy data retrieval and analysis. The case reports in the WHO database protect the identity of both patient and reporter. Their primary objective is to provide a mechanism with which medicine safety hazards might be detected.

How Does the Database Work?

VigiSearch, a search tool for VigiBase, makes it possible to find trends and patterns in international data. VigiSearch also enables review of individual case reports. It is currently only available to members of the WHO Programme for International Drug Monitoring, and the Uppsala Monitoring Centre staff.

In addition, individual case reports in VigiBase are available to anyone with a health professional degree-level education (physician, dentist, nurse, pharmacist), and can be ordered by request.

On April 2011, The WHO enacted a measure to make VigiBase accessible to the public.1

These databases are full of opportunities, but only for those who have the time and talent to use them.

The challenge of adapting to new research methods can be daunting for some researchers. They prefer to rely on methods they are familiar with, regardless of whether something better is out there. You want a research team that leaves no stone unturned. You want a research team that will be constantly evolving to stay one step ahead.

 

FAERS and VigiBase are merely two examples of non-traditional approaches to getting the jump on potential lawsuits.

You can feel confident that we will keep abreast of new developments, and as a result working with us, so will you.

 


1http://www.who-umc.org/graphics/26961.pdf

http://www.who.int/medicines/areas/quality_safety/safety_efficacy/recommendations.pdf