Reporting Scenario # 1 September 18, 2005. Scenario # 1 A pancreas is used to prepare islets under IND. The donor was a victim in a motor vehicle accident.

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Presentation transcript:

Reporting Scenario # 1 September 18, 2005

Scenario # 1 A pancreas is used to prepare islets under IND. The donor was a victim in a motor vehicle accident. A pancreas is used to prepare islets under IND. The donor was a victim in a motor vehicle accident. The accompanying records (including donor eligibility determination) are complete. The accompanying records (including donor eligibility determination) are complete. The pancreas appears in good condition. The pancreas appears in good condition. This islet product meets release criteria. This islet product meets release criteria. The islet product is administered the next day. The islet product is administered the next day.

Scenario # 1 48 hrs after receipt of the pancreas, the OPO notifies the lab that drug paraphernalia was found in the donor’s car. 48 hrs after receipt of the pancreas, the OPO notifies the lab that drug paraphernalia was found in the donor’s car. The donor’s mother denied knowledge of drug use. The donor’s mother denied knowledge of drug use. Assessment of the cadaver did not reveal evidence of drug use. Assessment of the cadaver did not reveal evidence of drug use. The drug screen is pending. The drug screen is pending. The clinical protocol requires that the donors meet FDA HCT/P donor eliqibility criteria. The clinical protocol requires that the donors meet FDA HCT/P donor eliqibility criteria.

Scenario # 1 Is this an adverse event? Is this an adverse event? No (but after the product is licensed, this would be considered a reportable biological product deviation). No (but after the product is licensed, this would be considered a reportable biological product deviation).

Scenario # 1 If an adverse event, is the event serious? If an adverse event, is the event serious? Not applicable, no AE occurred. Not applicable, no AE occurred.

Scenario # 1 Is this reportable to the FDA? If so, how should it be reported? Is this reportable to the FDA? If so, how should it be reported? This is not reportable as an IND safety report. However, it should be documented in your records and included in IND annual report. This is not reportable as an IND safety report. However, it should be documented in your records and included in IND annual report.

Scenario # 1 What else should you do? What else should you do? Follow up with the OPO to obtain results of the drug screen. Follow up with the OPO to obtain results of the drug screen. It would be prudent to It would be prudent to Notify the recipient’s physician Notify the recipient’s physician Follow the patient for seroconversion Follow the patient for seroconversion

Scenario # 1 If the information was available before the islets were infused, could the physician use the product? Could he/she invoke Urgent Medical Need? If the information was available before the islets were infused, could the physician use the product? Could he/she invoke Urgent Medical Need? Use of the product depends on whether you interpret the donor screening results as meeting the Donor Eligibility criteria, and this depends on trying to get more information before the product needs to be released. While you have a report of drug paraphernalia in the car, you don’t have any hard evidence that the donor actually engaged in risk behavior– so this is a very difficult judgment call. Use of the product depends on whether you interpret the donor screening results as meeting the Donor Eligibility criteria, and this depends on trying to get more information before the product needs to be released. While you have a report of drug paraphernalia in the car, you don’t have any hard evidence that the donor actually engaged in risk behavior– so this is a very difficult judgment call. Urgent medical need should only be invoked when the patient has extremely limited clinical treatment options and other products are not available. Urgent medical need should only be invoked when the patient has extremely limited clinical treatment options and other products are not available.