Canadian Study: Health Canada Requests Additional Changes to Canadian MDMA/PTSD Study Pharmacy

On December 2, 2011, Health Canada sent a report of the results of their second security inspection to the manager of the pharmacy where the MDMA will be stored for our planned Canadian study of MDMA-assisted psychotherapy for PTSD. The report summarizes several changes that will be needed at the pharmacy before Health Canada grants it the license to store the study MDMA. These include (1) the installation of an additional alarm system for the area surrounding the safe, (2) the reinforcement of the windows, door, and lock to the room containing the safe, and (3) the addition of the words “Restricted Drug” to the MDMA label. Health Canada requested additional information after their initial May 10 inspection, after which a follow-up took place on October 18. A third security inspection will be scheduled once we have made the required changes to the pharmacy site. The creation of additional security regulations following the initial inspection has delayed the security clearance, and therefore the study initiation, by almost six months.

The process of meeting the security requirements of Health Canada is exceedingly frustrating. At times, the amount of security required for about $1500 of MDMA seems absurd, as compared to security for other items at the pharmacy worth much more. Nevertheless, our policy is still to comply with whatever is required and to continue to persevere until we are able to start this study.