The Alliance for Pharmacy Compounding
(APC) reacted to the release of two FDA-commissioned studies concerning
compounded medications by the National Academies of Science, Engineering and
Medicine (NASEM).
Reacting to the release of the first study,
Compounded Topical Pain Creams: Review of Select Ingredients for Safety,
Effectiveness, and Use, APC’s
statement said that “There’s not much new here. It gets some things right
but misses some essential nuance, too.” APC noted that “One substantive
shortcoming of the study is its failure to look at the relative risks of topical
pain gels comparing them to other treatment options, particularly narcotic
medications. While compounded pain gels are not without risks, we note that
deaths related to topical pain gels are almost negligible by comparison to those
from many FDA-approved oral narcotic products.”
In
its announcement of the second study,
The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of
Safety, Effectiveness, and Use, NASEM concluded that “prescribers should
restrict the use of non-FDA-approved compounded bioidentical hormones, except
for specific medical circumstances.” APC’s
statement said the NASEM study “feels a lot like the movie Groundhog Day,
only without Bill Murray for laughs. Which is to say: We’ve seen this sort of
thing before.” The statement noted that “NASEM’s recommendations on cBHT hew
conveniently close to FDA’s stated concerns about cBHT … but that doesn’t mean
all of [the] recommendations … are reasonable or based on a thorough exploration
of evidence and outcomes.”