BRA Day is an initiative designed to promote education, awareness and access for women who may wish to consider post-mastectomy breast reconstruction.
Notes on Health Canada Special Access Program
Application for authorization to use leeches
Dr Don Lalonde, MD, FRCSC (Saint John, NB)
Since the fall of 2010, all legal Canadian leech purchases need to be authorized by Health Canada’s Special Access Program (SAP). You (the doctor) must fill out a form from Health Canada whether you order leeches on an emergency basis or on an elective basis in case of emergency. The purpose of these notes is to help in filling out the form. Click here to find a properly filled out application with all of the information needed by Health Canada. You will still need to fill out Section A (your demographics), how many leeches you want in section C (we put in 60 which you can change), and section E where you sign the form and put in your license number as a doctor. You then send the MSWord document by fax to 613.941.2108 or email to .
Health Canada will call, email, or fax the authorization to purchase the leeches to you, and you can purchase leeches from LeechesUSA.
More detailed notes on how to fill out the form from Health Canada are included at the bottom of form B: Future Use Request.
You do not need to fill out patient initials if this is the first time you are getting approval for leeches from Health Canada, but you do if it is the second time you are getting their approval (see below).
Ordering leeches electively
We recommend that all hospitals where leeches may be needed on an emergency basis keep a stock on hand to avoid delays should they be required, and you may consider ordering them before you have an emergency. You can go online to Health Canada Special Access Program at http://www.hc-sc.gc.ca/dhp-mps/acces/drugs-drogues/sapf2_pasf2-eng.php and download an empty form B Future Use Request, to fill it out, or you can use the one we are providing you here. Send in the filled out form and Health Canada will authorize the leeches.
Call 613.941.2108 for help.
Ordering leeches as an emergency
Should you require leeches as an emergency, Health Canada officials are available 24 hours a day, 365 days a year to remove any road blocks you may encounter at 613.941.2108 and then press 0. It is important that you do not listen to the menu and leave a message. You must just press 0 to get to the human and avoid delays.
Is this the first time or the second time you are getting authorization for leeches from Health Canada? If this is the first time you are getting special access from Health Canada’s Special Access Program, you are not required to fill out the patient initials. Just ignore this part as we have ticked off “Yes” in the first future use box. However, you do need to fill out the patient initials on the second request from Health Canada. They want to know who you gave leeches to with your previous batch approved by them. You need to keep track of these from now on until Leeches USA gets market approval. Once they get market approval, you can go back to ordering leeches from them as before.
On your second request to the Health Canada Special Access Program, you will need to click the “No” box, and you will need to fill out the initials of patients you treated with the leeches obtained from your first request: 1st Future Use Request: YES ☐ NO ☐