Black box warnings from the U.S. Food and Drug Administration are the most serious action that the federal agency can take against pharmaceuticals other than recalling a drug. They are meant to inform health care providers who would prescribe certain medications about potential risks connected to the drug. However, a new study shows that these labels have little impact on drug coverage provided through Medicare.
About Black Box Warnings
Black box warning labels are typically used when a drug is associated with the potential for a very serious adverse event. Approximately half of the warnings are used when there is a risk of drugs. They are intended to help people know of the potential risks of the drug before prescribing these medications to patients. Researchers recently conducted a study into the efficiency of these warnings because there is not consistent data to show whether these labels increase drug safety.
A Harvard Medical School study conducted in 2006 found that one in ten patients are prescribed a drug with a black box warning label.
About Drug Access
Drug access is primarily controlled through two distinct processes. The first is prior authorization in which a healthcare provider receives permission from a health insurance company before he or she prescribes a drug. Step therapy is the second process, which requires the patient to use a different drug before the health insurance company will cover a different one.
Insurer formularies are lists of drugs that an insurance company agrees to cover. They help manage how the drug is used and effectively control access to drugs. However, these formularies are not used to control safety of drugs.
About the Study
Researchers from the Yale-affiliated study evaluated whether serious drug safety warnings that were provided before and after the warnings were issued would change coverage of drugs under Medicare. They focused exclusively on Medicare formularies since it is the largest payer for healthcare in the nation.
Study Findings
Researchers found that the black box labels were ineffective, regardless of the type of drug involved or the warning’s content. Researchers found that formularies’ coverage of drugs only changed very modestly from 65% before drugs had a black box warning to 63% a year after the warning was issued. It slipped slightly lower to 62% after two years.
Researchers noted that the warnings could be used to improve drug safety. The study’s senior author said that the use of formularies is an underutilized strategy. He stated that current drugs with black box warning labels do not have increased restrictions. By limiting these prescriptions, safer prescribing may be possible. The researcher noted that even though these drugs should sometimes be prescribed, he believes that formularies should be used to promote safe access to drugs, such as prescribing a safer alternative before one with a black box warning label.
Researchers discussed their plan to continue to assess the effect of black box warning labels, including how they might impact the prices of drugs and commercial insurance coverage.
How to Improve Prescription Safety
The researchers said that more work needs to go into improving drug safety. They suggest that medical communities consider black box warning labels when establishing formularies. A few hundred people in the country determine which drugs should be on these lists. The researchers also say that the communication of these labels could be improved to further safe prescribing.
Individuals who are harmed by dangerous drugs may have valid legal claims against healthcare providers. They can discuss the possibility of making a claim with an experienced products liability lawyer.
