accidental exposure (with or without an AE) to study drug (non-marketed) by a non-subject

I would like to share with you this interesting topic.

Susanna Flores, Manager of Drug Safety at SuperGen asked the question and among the answers Bruce Graves Owner, Pharma GCP Support Services, Inc, Dr. Yeshpal Mathangi Clinical Data Reviewer at Clinnovo and Anuj Kapoor Medical Writer at Novartis provided great answers.

In a nutshell, this is a very rare situation, hence it won't require a SOP.

Without an AE, you should get as much as possible from the patient and supporting the investigator to make sure you collect the sequence of the event and save it into your database.

With an AE, you should report it as you'll do for events occuring during the study, making sure you clearly separate this single report from the rest of the study.

In the US, Poison Prevention Packaging Act (PPPA) administered by US Consumer Product Safety Commission is providing guidance on the situation.

CIOMS is working on the question too and Classify accidental exposure as an reportable event: Inadvertent or accidental exposure to study product with or without an ADR http://www.cioms.ch/march2008_pv_in_rpc_final_14dec2005.pdf.