Lupus Canada Advokit

Special Access Program

Website: http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/

The Special Access Program (SAP) is a federal program to provide access to non-marketed drugs for medical practitioners treating patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, are unavailable or offer limited options. The SAP provides the authority for a manufacturer to sell a specific quantity of a drug and therefore grant access to a drug which cannot be otherwise sold or distributed in Canada. The scope of drugs considered for release by SAP includes pharmaceutical, biologic, and radiopharmaceutical products that are not approved for sale in Canada. SAP does not grant authority to use or administer a drug - this authority is considered to be within the practice of medicine, which is regulated at the provincial level.

SAP authorization does not constitute an opinion or statement that a drug is safe, efficacious or of high quality. SAP does not conduct a comprehensive evaluation to ensure the validity of drug information or attestations of the manufacturer respecting safety, efficacy and quality. These are important factors for practitioners to consider when recommending the use of a drug and in making an appropriate risk/benefit decision in the best interests of the patient. SAP strongly encourages practitioners treating patients with drugs obtained through SAP to seek informed consent prior to treatment.

To initiate a request a practitioner may write, telephone, fax or e-mail the Special Access Program:

Special Access Program
Therapeutic Products Program
Finance Building 2nd Floor
Tunney's Pasture
Ottawa, ON K1A 1B9
(Office hours 8:30 am to 4:30 pm EST)
Fax (613) 941-3194
After hours:

Calls to this emergency service should be limited to requests for drugs or blood products requiring immediate or overnight drug delivery.

Websites: Main Health Canada site: http://www.hc-sc.gc.ca/english; Special Access Program (SAP) site: http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/

The Special Access Program is designed to help meet the needs of patients with serious or life-threatening conditions who require drugs that are not currently approved for use in Canada.

Under this program, the Drugs Directorate of the Health Protection Branch (Health Canada) can authorize the sale of certain medications to health care practitioners.

Responsibility for the Special Access Program is divided between two federal bureaus: the Bureau of Human Prescription Drugs and the Bureau of Biologics. Each bureau is responsible for authorizing the sale of drugs falling under its jurisdiction.

The Special Access Program does not deal directly with individual patients, it responds only to requests from health care practitioners. It is important to make sure that your doctor (or a delegated representative from a medical profession, such as a nurse or pharmacist) is familiar with the procedure for obtaining the release of drugs through the program. The person requesting the release of a drug should provide the following information with each request:

• Physician's name and telephone number;
• Address of physician's office or hospital pharmacy where the drug is to be distributed;
• Drug name and dosage form (i.e. tablet, capsule etc.);
• Name of manufacturer;
• Quantity of drug requested;
• Intended dosage;
• Patient information: initials, age, sex, condition;
• Medical indication for the use of the drug; and
• Whether it is a new request or a repeated request.

The procedure is for health care practitioners to telephone, fax or write a request for an emergency drug. Health Canada follows up any written request with telephone communication. Requests for emergency drugs are then considered and, if authorized, the manufacturer of the requested drug is notified by telephone by the EDRP.

This verbal notice is followed by a Letter of Authorization, with a copy sent to the health care professional making the initial request. The manufacturer has the final word on whether the drug requested will be supplied. The turn-around time from request to delivery is twenty-four hours, so it is crucial for the health care professional to have all of the above-mentioned information readily available.