On October 18, 2011, Health Canada conducted a follow-up inspection of the pharmacy for our planned Phase 2 Canadian study of MDMA-assisted psychotherapy for PTSD. We expect that Health Canada will report on the results of this inspection within four to six weeks. Frustratingly, even though we followed Health Canada’s exact written requirements, the requirements have now changed and additional security measures may be needed. This will delay the start of the study for several additional months. The pharmacy inspection is required under Canadian regulations to ensure that the facility used to store and label the MDMA to be used in the study is adequately secure, and that the proper accountability procedures are in place. Once we obtain clearance from Health Canada we will be able to import the MDMA for the study into Canada from Switzerland.
We’ve done everything Health Canada requested in their written communication but the inspector has now stated that new regulations have been created and that we may need to comply with them as well. The inspector said that she will submit her report to officials in Ottawa, and that we should hear back from Health Canada by the end of November. We have now been told we will receive the report the first or second week of December. Some of the changes that may be necessary could be to replace the glass door to the pharmacy with a solid wood or metal door and to replace the windows of the room with shatterproof/bulletproof glass. We haven’t heard back from Health Canada yet about their verdict, but the video certainly shows the lengths to which the pharmacy has gone to protect the MDMA supply.
The lead investigator for this study, Ingrid Pacey, M.D., will speak on the MDMA-Assisted Therapy for PTSD Research Panel at our 25th anniversary conference this December.
Watch this brief video made by Canadian documentary filmmaker Arwen Hunter featuring a personal interview with pharmacist Colin Holyk discussing the challenges of negotiating the strict security requirements required by Health Canada and for a look inside the Vancouver pharmacy where the MDMA will be stored.
Originally appearing here.