This is a great start in this direction and it is one big task to find all the relative data to get down to perhaps even more drugs that could have off label use, something the FDA wants to be aware of since they are the agency who is there to approve and guide the citizens of the US for safe drug and food use.

Perhaps the new Sentinel data mining system being put in place at the FDA can be mined to also give additional information in this area as well.  With having access to Medicare and many other resources, it’s a process of some new algorithms to produce the data.  

From a prior post: 

The Sentinel System will enable FDA to conduct product safety queries proactively from multiple existing data sources from remote locations, such as electronic health record systems, medical claims databases, and possibly clinical trial databases if they overlap with those of marketed products. “Data sources will be maintained by their owners and will remain behind the firewall of the data owner. We are not creating one big database,” she says.

E-prescribing data could also be helpful here as well. They will be monitoring and querying drug side effects with the new system, so why not add a few more formulas and algorithms complete the reporting process.  Granted, this takes time to get all of this set up along with some extensive programming and security issues addressed, so it won’t happen overnight.  BD 

Physicians and policy-makers know that drugs are frequently prescribed to treat certain diseases despite a lack of FDA approval - a practice known as off-label prescribing. Yet they say the problem is so big they don't know how to begin tackling it. But a potential game plan now exists. In a paper to be published in the December issue of Pharmacotherapy, a group of researchers has developed a list of 14 widely prescribed medications most urgently in need of additional study to determine how effective and safe they are for their off-label uses. Antidepressants and antipsychotics are the most prominent classes of drugs on the list, which specifically targets drugs that have high levels of off-label use without good scientific backing.

He said that in addition to prompting the FDA and other government agencies to study the priority drugs on the list, he hopes the research spurs patients to ask their doctors why they are prescribing a particular drug. "A dialogue needs to occur more frequently between physicians and patients regarding the level of evidence that supports a particular use of a drug."

14 Drugs Identified As Most Urgently Needing Study For Off-label Use, Stanford Professor Says

Related Reading:

Sentinel Initiative Boosts FDA Safety Oversight

FDA, Military Health System tighten data sharing pact


Post a Comment

Google Analytics Alternative