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If you have experienced any adverse side effects from a medication or therapy -
Health Canada - Special Access Programmes SAP (Jan 2007)
The Special Access Programme (SAP) allows practitioners to request access to drugs
that are unavailable for sale in Canada. This access is limited to patients with
serious or life-threatening conditions on a compassionate or emergency basis when
conventional therapies have failed, are unsuitable, or are unavailable.
Can SAP be considered a fast-track approval process for drugs? No!
SAP is not intended to be a mechanism to promote or encourage the early use of drugs or to circumvent the clinical trials review and approval process or the new drug approval process, but rather to provide compassionate access to drugs on a patient by patient basis.
Are there any SAP regulations or policies -
The SAP is supported by sections C.08.010 and C.08.011 of the Food and Drug Regulations. In the future, a guidance document will be available on the SAP website which provides more detail on the day to day operations of the SAP.
What types of drugs could be authorized under the SAP?
These range from pharmaceutical, biologic, and radio pharmaceutical products that are not approved for sale in Canada. Most of these drugs treat patients with life threatening diseases or serious conditions such as intractable depression, epilepsy, transplant rejection, haemophilia and other blood disorders, terminal cancer, and AIDS. The SAP can also respond to specific health crises, such as an outbreak of a communicable disease, by providing access to non marketed drugs.
Is there a list naming the drugs that can be released through the SAP?
The Special Access Management System (SAMS) is an internal database that lists all drugs eligible through the SAP. This list changes continuously making a current publication difficult to maintain. Practitioners interested in the status of a particular drug may contact the manufacturer or the SAP.
What is the processing time for a SAP request?
Every effort is made to process requests within 24 hours of receipt. However, given
the mandate of the Programme and the volume of SARs received, the SAP adopts a triage
system to ensure that requests for drugs for life-
What is the practitioner's role in the SAP?
The practitioner is responsible for initiating a request on behalf of a patient and ensuring that the decision to prescribe the drug is supported by credible evidence available in the medical literature or provided by the manufacturer. It is also the practitioner's responsibility to ensure that patients are well informed of the possible risks and benefits of the drug being requested.
How do practitioners request access to a SAP drug?
A Special Access Request (SAR) Form and associated instructions are available on the Health Canada web site (see contact information below). The SAR Form consists of two pages containing five sections. Practitioners are required to complete all five sections of the form. Completed forms should be faxed to the SAP without an accompanying cover sheet. Telephone calls should be reserved for urgent requests requiring immediate attention.
Are there any restrictions on the amount a practitioner can request?
A maximum quantity equivalent to a six month duration may be authorized for chronic
treatments. Repeats must be re-
What assurance does the SAP give that the drug is safe?
The SAP authorization does not constitute an opinion or statement that a drug is safe, efficacious or of high quality. We consider these important factors for practitioners to consider when recommending the use of a drug and in making an appropriate risk/benefit decisions for their patients.
How are requests processed?
Authorized SARs are sent by facsimile to manufacturers and entered into the SAMS database from which formal Letters of Authorization are issued. These formal letters are signed and sent by surface mail to the manufacturer and copied to the practitioner.
Are all requests authorized?
Following careful consideration of the SAR, the SAP will either grant or deny authorization. SAR's that are denied authorization are returned by fax to the practitioner with an explanation. SAP may also contact the practitioner by telephone to discuss the reasons for the denial and what, if any, recourse the practitioner may consider.
What is the manufacturer's role in SAP?
In all cases, the manufacturer has the final word on whether the drug will be supplied. The manufacturer has the right to impose certain restrictions or conditions on the release of the drug to ensure that it is used in accordance with the latest information available. For instance, they may restrict the amount of product released, request further patient information, determine payment requirements and place conditions on shipping arrangements. Manufacturers are also responsible for providing all drug information to requesting practitioners and/or patients.
Are there any restrictions on where the drug can be shipped?
SAP drugs may only be sent to the practitioner's office or in-
Are there reporting requirements for a drug released through the SAP?
The practitioner must agree to provide a report on the result of the use of the drug, including any adverse reactions.
What are the SAP Operational Hours?
SAP operates 24 hours a day 365 days a year. Regular business hours are from 8.30 to 4.30 Eastern Standard Time. Plus an after hours emergency help line is available.
Contact.
Special Access Programme
Therapeutic Products Directorate
2nd Floor, Holland Cross Tower A
11 Holland Avenue, A.L. 3002C
Ottawa
ON.K1A 0K9
Tel (613) 941-
Fax (613) 941-