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Warning Labels on High-Risk Drugs Inconsistently
Heeded by Doctors
Better means of communicating risks needed say
researchers
Nov. 18, 2005 A new study has found 42 percent of
ambulatory care patients received prescriptions for drugs with Black Box
Warnings (BBW), the Food and Drug Administration's strongest label for
high-risk medication. The authors suggest that better methods are needed
for ensuring the safe use of medications that carry serious risks.
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The survey covered approximately 930,000 ambulatory
care patients. The researchers were from the Department of Ambulatory
Care and Prevention (of Harvard Medical School and Harvard Pilgrim
Health Care).
In the categories studied, doctors' noncompliance
to BBWs ranged from 0.3 percent to 49.6 percent. These results are
reported online in the Nov. 18, 2005 issue of Pharmacoepidemiology and
Drug Safety. The highly variable physicians' compliance with the
recommendations of the BBWs led them to the suggestion that improvements
are needed to ensure safer use of these serious risk medications.
"In ambulatory care settings, approximately 1.4
billion prescriptions are written per year," said Anita Wagner,
assistant professor at DACP. "Until now, there has been no information
about how frequently doctors prescribe BBW drugs, nor whether
prescribing is consistent with the warnings. This study tells us that
these drugs are prescribed often and that in some categories,
prescribing is inconsistent with the warnings."
Wagner, Richard Platt (chairman of DACP and
principal investigator of the Agency for Healthcare Research and
Qualityfunded Prescribing Safety Study), and colleagues in HMOs across
the country conducted a retrospective study over two and a half years to
find out how many ambulatory care patients were prescribed drugs with
BBWs and to assess compliance to these warnings. BBWs are warnings
printed in a black frame in the package insert of a drug and are
intended to alert prescribers to the serious risks that may be
associated with certain drugs. They describe the drug's risks, can list
specific precautions for its use, and must appear on all promotional
materials.
Prescribing Practices
To examine prescribing compliance, Wagner and
colleagues examined approximately 217,000 enrollees who had received at
least one of 19 BBW drugs. The researchers considered BBWs that required
laboratory monitoring when a patient began taking the medication or for
the duration of the prescription; were unsafe to take with other
specific medications; or were unsafe to take while pregnant.
From this group, most noncompliance with BBWs
occurred when patients should have received lab tests as they began a
medication; 49.6 percent of all prescriptions that should have been
accompanied by a lab test at the onset of a prescription were not.
Recommendations for pregnancy tests were most frequently not observed
(for example, when women of childbearing age were given prescriptions
for acitretin, which treats severe psoriasis).
When patients needed lab monitoring while taking a
medication, there was no continued monitoring for 12.8 percent of
prescription times during which the BBW recommended a test.
Nine percent of prescriptions were dispensed on the
same day as a drug that is considered unsafe to take simultaneously. All
involved dispensing of methotrexate with non-steroidal anti-inflammatory
drugs (NSAIDS) or ketorolac with other NSAIDS (11 and 7.6 percent,
respectively).
Warnings that indicated a medication was unsafe to
take while pregnant had excellent compliance. Women of childbearing age
received almost 79,000 prescriptions for BBW drugs that should be
avoided during pregnancy. Only 95, or 0.3 percent, may have occurred
during pregnancy.
"We need several things to improve the
effectiveness of the warnings: to be clear about the magnitude of risk
that justifies a BBW and the evidence that underlies a recommendation,
to communicate warnings clearly to both clinicians and patients, and to
create systems that support doctors and patients in following the
recommendations," Wagner said. "We believe our data shed light on
adherence to BBW recommendations and provide a preliminary basis for
recommendations to improve communication about the risks of medicines."
For instance, it is possible that concise and
focused wording of a warning is more effective than less direct wording.
Patient-specific automated alerts to BBW drugs or recommendations at the
point of prescribing and dispensing may be more effective than BBWs in
package inserts. Designing such a system requires complete, consistent,
and current lists of BBW medicines and clinical circumstances associated
with risk of morbidity and mortality. The authors of this study
recommend that the FDA establish and maintain such a list.
"This will require new information about risks,
about the way drugs are used in everyday practice, about effective
methods of influencing clinicians' prescribing, and about ensuring that
patients understand how to use their drug as safely as possible," Wagner
said.
About the source:
This work was supported by a grant from the Agency
for Healthcare Research and Quality (AHRQ) to the HMO Research Network
Center for Education and Research on Therapeutics (CERTs). The mission
of the CERTs is to conduct research and provide education that advances
the optimal use of drugs, medical devices and biological products.
HARVARD
PILGRIM HEALTH CARE
http://www.hphc.org
Harvard Pilgrim Health Care is a not-for-profit health care plan
operating in Massachusetts, New Hampshire, and Maine with a network of
more than 22,000 doctors, 130 hospitals, and more than 900,000 members.
Harvard Pilgrim was the first New England health plan to establish a
non-profit foundation with the sole purpose of serving the community at
large. The efforts of the foundation reflect Harvard Pilgrim's mission,
which is to improve the health of its members and the health of society.
DACP is a unique partnership between HPHC and HMS, the nation's only
medical school department jointly sponsored by a health plan.
HARVARD
MEDICAL SCHOOL
http://hms.harvard.edu/
Harvard Medical School has more than 6,000 full-time faculty working in
eight academic departments based at the School's Boston quadrangle or in
one of 47 academic departments at 18 Harvard teaching hospitals and
research institutes. Those Harvard hospitals and research institutions
include Beth Israel Deaconess Medical Center, Brigham and Women's
Hospital, Cambridge Health Alliance, The CBR Institute for Biomedical
Research, Children's Hospital Boston, Dana-Farber Cancer Institute,
Forsyth Institute, Harvard Pilgrim Health Care, Joslin Diabetes Center,
Judge Baker Children's Center, Massachusetts Eye and Ear Infirmary,
Massachusetts General Hospital, Massachusetts Mental Health Center,
McLean Hospital, Mount Auburn Hospital, Schepens Eye Research Institute,
Spaulding Rehabilitation Hospital, and the VA Boston Healthcare System.
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