Download Scenario # 6

Reporting Scenario # 6
September 18, 2005
Scenario # 6
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A pt (M.E.) with pancreatic
carcinoma is undergoing
treatment with an FDA-licensed
DC tumor vaccine delivered
intranodally.
The vaccine is auto DC pulsed
with MUC-1 100-mer peptide.
Vaccine is released by the lab in
a syringe (labeled by 2 techs).
Scenario # 6
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Later that day, it is discovered that
the DC product issued to M.E. was a
different FDA-licensed autologous
DC product belonging to another
patient but which had been labeled
as M.E.’s autologous product. M.E.’s
autologous DC product was still in
the facility and had not yet been
labeled and issued.
M.E.’s physician is contacted, and
reports that the distributed
autologous DC product had already
been administered to M.E., but there
had been no reaction or symptoms.
Scenario # 6
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Is this an adverse event?
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No. There was a mixup of products
in the facility, and the mixup led to
the patient (M.E.) receiving the
wrong product, BUT the patient did
not have any signs or symptoms that
would be required to fulfill the
definition of an adverse reaction or
adverse event.
Scenario # 6
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Is this a deviation?
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Yes. The mixup was apparently
related to an error in following
product labeling procedures.
This occurrence meets the
definition of a biologic product
deviation.
Scenario # 6
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Is this reportable to the FDA? If so,
how should it be reported?
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Yes. Because the products involved
are both FDA-licensed products, this
should be reported as a Biologic
Product Deviation Report (BPDR) as
soon as possible, and no later than
within 45 days, to the OCBQ.
Scenario # 6
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What else should you do?
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Promptly investigate the deviation.
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Review SOPs, staff training, product
segregation procedures.
Implement corrective actions.
The patient, M.E., should be
informed about what happened by
his/her physician and followed up
with infectious disease testing.