The Wild West of Off-Label Use

Contrary to pop culture, off-label use has nothing to do with “dry cleaning versus machine wash”. It is the use of prescription or OTC drugs for an unapproved indication, dosage, administration, age group, etc. This use is legal, but it can be risky, ineffective, and expensive.

We periodically chronicle penalties assessed against Big Pharma for illegally promoting the off-label use of their products. The latest is Wyeth Pharmaceuticals who just paid a $491 million settlement and even pled guilty to criminal violations concerning what a US Attorney called “a systemic, corporate effort to seek profit over safety.”

At OMCA, our enhanced UR monitors inappropriate use of off-label drugs. Many times these are expensive narcotics developed for late stages of cancer pain, but end up being administered for low back and other similar chronic pain symptoms. Our UR professionals and physician advisors evaluate the off-label use by assessing the following:

• Safety/Side-effects

• Proven Effectiveness

• Less Costly Alternatives

• Extent/Duration

• Dispensing Agent

When dealing with Big Pharma and the Wild West environment, it’s good to know there’s a new sheriff in town.