News
Garber Announces Advisory Committee for Harvard Law School Dean Search
News
First Harvard Prize Book in Kosovo Established by Harvard Alumni
News
Ryan Murdock ’25 Remembered as Dedicated Advocate and Caring Friend
News
Harvard Faculty Appeal Temporary Suspensions From Widener Library
News
Man Who Managed Clients for High-End Cambridge Brothel Network Pleads Guilty
Serious warnings on high-risk medications are inconsistently heeded by
doctors in ambulatory care settings, according to a study that a
Harvard researcher published Friday.
Anita Wagner, an assistant professor in the Department of
Ambulatory Care and Prevention at Harvard Medical School, led the
study, which examined patients who had received one of 19 drugs with
Black Box Warnings (BBW) to determine how doctors comply with
prescription warnings.
BBW’s are the strongest warning labels, given to high-risk
medications by the FDA. They are used to indicate drugs that are
associated with what Wagner described as “special problems,
particularly those that may lead to death or serious injury.” The
warnings themselves are printed in a black frame in a package insert
for the drugs. According to Wagner, these warnings are the FDA’s
primary means of communicating risks to prescribers.
During the study, which was published online in the Nov. 18
issue of Pharmacoepidemiology and Drug Safety, the researchers
collected information about 917,000 ambulatory-care patients from
across the country over a two-and-a-half-year period.
They found that 42 percent of these patients received
high-risk medications with BBW’s. The team of researchers looked at
219,000 patients who had received one of these drugs. The warnings
associated with the medications were classified into three groups:
drugs requiring laboratory monitoring, drugs that were unsafe to take
simultaneously with other medications, and drugs that were unsafe to
take while pregnant.
The study showed that there was significant variability in
the consistency with which these three types of warnings were heeded by
doctors. The highest adherence was linked to those drugs that indicated
they were unsafe to take while pregnant—only 0.3 percent of the
prescriptions may have been given to pregnant women.
For the group of drugs that were unsafe to take with other
medications, Wagner found that nine percent were prescribed on the same
day as drugs deemed unsafe to take simultaneously.
But the study’s most significant finding was the high level
of non-adherence to the warnings on drugs that required laboratory
monitoring upon dispensation—49.6 percent of these prescriptions were
not accompanied by lab tests or monitoring, even though the BBW
explicitly states this requirement.
Wagner noted that a significant number of these cases of
non-adherence were linked to drugs that required liver-function tests.
She suggested that the non-adherence may have to do with questions
regarding the need for these tests.
“There is quite a bit of debate as to whether liver-function
tests prevent liver injury from drugs, and physicians may just have
that lack of evidence in their minds,” she said.
The study sheds new light on the difficulties in communicating drug warnings to doctors and patients.
“One of the main things that I hope it does is alert us to the
fact that we don’t know how to communicate dangers to millions of
prescribers and patients,” Wagner said.
Wagner also found that the warnings that were most specific were also most effective.
Wagner emphasized that the drug prescription system needs a new
strategy to help improve the communication of risks to prescribers and
patients. She suggested an automated electronic notification system
that would alert physicians to specific drug warnings through their
computers at the point of prescribing.
“If the information is applicable to the patient they’re with
that moment, the likelihood that they would pay attention to it is much
larger,” Wagner said.
Want to keep up with breaking news? Subscribe to our email newsletter.