Healthy Skepticism Library item: 19150
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Publication type: Journal Article
Alexander GC, Gallagher SA, Mascola A, Moloney RM, Stafford RS
Increasing off-label use of antipsychotic medications in the United States, 1995-2008
Pharmacoepidemiol Drug Saf 2011 Jan 6;
http://onlinelibrary.wiley.com/doi/10.1002/pds.2082/abstract
Abstract:
OBJECTIVE: To evaluate patterns of
antipsychotic use. DESIGN, SETTING,
AND
MEASUREMENTS: We used nationally
representative data from the IMS
Health National Disease and
Therapeutic Index to describe
outpatient antipsychotic use. The
primary outcome was the volume of
visits where antipsychotics were
used for specific indications
(treatment visits). We also
quantified use without U.S. Food and
Drug Administration approval
(off-label use) and off-label use
with compendium data suggesting an
uncertain evidence base.
RESULTS: Antipsychotic use increased
from 6.2 million (M) treatment
visits (95% CI, 5.4-7.0) in 1995 to
16.7 M visits (15.5-18.2) in 2006,
then declined to 14.3 M visits
(13.0-15.6) by 2008. A shift
occurred from typical agents in 1995
(84% of all antipsychotic visits) to
atypical agents by 2008 (93%). As
they declined, typical medications
shifted toward use in schizophrenia
(30% in 1995 to 48% 2008). In
contrast, use of atypical agents
expanded for bipolar affective
disorder (10 to 34%), remained
stable for depression (12 to 14%),
and declined for schizophrenia (56
to 23%). Overall, antipsychotic use
for indications without FDA approval
increased from 4.4 M visits in 1995
to 9.0 M in 2008. The estimated cost
associated with off-label use in
2008 was US$6.0 billion.
CONCLUSIONS: Atypical use has grown
far beyond substitution for the now
infrequently used typical agents.
Antipsychotics are increasingly used
for conditions where FDA approval
and associated clinical evidence is
less certain. Despite the value of
innovation, the benefits of widening
atypical antipsychotic use should be
weighed against their cost,
regulatory status, and incomplete
nature of available evidence.
