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COMPOUNDING WOES
FDA Wants Control
Over Compounders
and failed to follow his directions. Meanwhile, I pointed out
that the tone of his voice made it
very difficult for the surgical
team to concentrate on proper
patient care.
Staff often approach me after
the role-playing exercises to let
me know how much it helped
them manage actual difficult situations in the OR. A staff member once told me that an anesthetist had yelled at her in front
of the patient during a pre-op
time out when she was asked
about the antibiotic administration. The nurse said she tried
some of the communication
tools she learned during roleplaying, and the anesthetist apologized after being approached
about the negative behavior.
Now the two actually have a
better working relationship.
T
hree more compounding pharmacies, one in New Jersey, one in
Georgia and one in Massachusetts,
were forced to recall all their compounded products last month as a result
of stepped-up FDA inspections. The FDA
wants Congress to expand its legal
powers over compounding pharmacies
and to perhaps charge fees for this
oversight.
FDA Commissioner Margaret A.
Hamburg, MD, believes the agency
could ensure that drugs produced by
sterile compounders would be compounded "without putting patients at
undue risk." To support these activities,
funding would be necessary, she says.
"[O]ur authorities are limited and not
the right fit for FDA to provide appropriate and efficient oversight of this growing industry," Dr. Hamburg writes on the
FDA blog. "There should be legislation
that establishes appropriate, minimum
federal standards for firms that compound sterile drug products in advance
of or without a prescription and ship
them interstate." The FDA's authority
must be made clear because, "[e]ven
during this time of heightened awareness, our inspectors are being delayed
in their work or denied full access to
records at some of the facilities we are
inspecting."
— Stephanie Wasek
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