Reporting Scenario # 6

1. Reporting Scenario # 6 September 18, 2005

2. Scenario # 6 • 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).

3. Scenario # 6 • 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.

4. Scenario # 6 • Is this an adverse event? • 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.

5. Scenario # 6 • Is this a deviation? • Yes. The mixup was apparently related to an error in following product labeling procedures. This occurrence meets the definition of a biologic product deviation.

6. Scenario # 6 • Is this reportable to the FDA? If so, how should it be reported? • 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.

7. Scenario # 6 • What else should you do? • Promptly investigate the deviation. • 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.