Controlling Health Costs: Limit Off-Label Drug Use

Whatever a person’s opinion about the nation’s current healthcare debate, one thing seems certain; Medicare and Medicaid budgets are currently stretched to the breaking point. The programs need to find some way to ease the fiscal tension.

One research-based suggestion has been to curtail or eliminate off-label usage of antipsychotic medications. Off-label use is the practice of prescribing and using drugs for non-FDA approved treatment. Limiting the use of antipsychotics to the treatment of only those conditions for which the FDA has given approval could create some financial slack for over-stretched government subsidized health programs.

Researchers who sifted through Medicaid and Medicare data compiled in 2003 found that in that year 372,038 patients were dispensed antipsychotic drugs. A recent article made note of the fact that close to 58 percent of those patients did not have conditions for which the FDA had approved antipsychotic therapy. In 2003 these medications were only approved for treatment of bipolar disorder and schizophrenia. By 2009, sales of antipsychotic medications totaled more than $14.5 billion. If the same 60 percent of those sales were for non-FDA approved use, costs could be trimmed by nearly $9 billion.

Prescribing medication for off-label use is fairly common practice among physicians who encounter conditions which are resistant to standard care. Doctors who feel they have exhausted the recommended tools at their disposal reach out to find other medications which may prove effective. Though antipsychotics appear to be used for off-label purposes most frequently, they are not the only drugs so used. Doctors also prescribe heart medications, asthma remedies and anti-convulsant medications for off-label use.

Since 2003, antipsychotics have been FDA approved for treatment of specific problems relating to autism along with particularly hard to treat depression. This demonstrates that when research proves the efficacy of a drug therapy, the FDA will broaden its approval.

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