Special Access Programme - Drugs
The Special Access Programme (SAP) considers requests for access to drugs that are unavailable for sale in Canada. These requests:
- must be submitted by practitioners, and
- must be for access to drugs for treating patients with serious or life-threatening conditions when conventional treatments have failed, are unsuitable, or are unavailable.
Regulations and policies
- The SAP is supported by sections C.08.010 and C.08.011 of the Food and Drug Regulations.
- Additional information is provided in Health Canada's Guidance Document for Industry and Practitioners - Special Access Programme for Drugs (the Guidance).
- The SAP is not intended to be a mechanism to:
- promote or encourage the early use of drugs, or
- conduct research or to circumvent the clinical trial or drug review process.
Scope of Drugs
- The SAP may provide access to a drug (pharmaceuticals, radiopharmaceuticals, biologics, and genetic therapies) that cannot otherwise be sold or distributed in Canada.
- Drugs that are, or that contain, a “restricted drug” as defined in Part J of the Food and Drug Regulations are not eligible for authorization via the SAP.
- Veterinary products, medical devices, marijuana for medical purposes, and drugs for research are also outside the scope of the SAP but may be requested through other programs.
- There is currently no externally available list of products accessible through the SAP.
- Practitioners interested in the status of a particular drug may contact the SAP directly.
- An individual who is entitled, under the laws of a province or territory to treat patients with a prescription drug and is practising their profession in that province under the Food and Drug Regulations.
- In most cases, this would be a provincially licensed physician but can include other health professionals who have prescribing privileges.
- Health professionals should consult their professional college for information on their scope of practice.
- Responsible for initiating a request on behalf of patients.
- Ensure that the decision to prescribe the drug is supported by credible evidence available in the medical literature (generally no older than 10 years) or provided by the manufacturer.
- Ensure that patients are well informed of the possible risks and benefits of the drug being requested and its development status.
- Provide a report on the results of the use of the drug, including any adverse reactions to Health Canada.
- Maintain accurate and accessible records in the event that the SAP requests an accounting for quantities of the drug received.
SAP processing of requests
- Practitioners can submit requests using a Special Access Request (SAR) Form.
- The form consists of two pages containing five sections.
- Practitioners are required to complete all five sections of the form.
- Completed forms should be faxed without an accompanying cover sheet to (613) 941-3194.
- Telephone calls should be reserved for urgent requests requiring immediate attention.
- Most drugs accessed are for acute serious or life-threatening conditions that require short term treatment.
- For chronic conditions, quantities equivalent to a maximum of a six month supply may be considered per request.
- Special access requests are screened and reviewed upon receipt.
- The SAP employs a risk management process that takes into account the following criteria:
- known risks of the product;
- marketed alternatives;
- manufacturing standards;
- product information provided by the manufacturer;
- drug’s stage of development; and
- level of evidence for use in a condition.
- Following careful consideration, the SAP will issue one of the following decisions:
- Authorization: Information provided meets the criteria of the Programme.
- Incomplete: The SAR form is incomplete, missing information, or is illegible. The SAR is returned with an incomplete notification to the practitioner.
- Cancellation: Due to external or logistical factors, the requested drug is not accessed via the SAP. For example, the manufacturer is unable to provide access via the SAP.
- Withdrawal: The SAR is withdrawn by the requesting practitioner.
- Denial: The information provided by the practitioner does not meet the criteria of the Programme.
- If a request is authorized, a Letter of Authorization is sent by fax to the manufacturer and a copy sent to the practitioner.
- If a request is not authorized, a letter is sent by fax only to the practitioner and will include an explanation.
- The SAP may also contact the practitioner by telephone to discuss the reasons for the decision.
- Additional information on the consideration process is available in Section 4 of the Guidance.
- Every effort is made to process requests within 24 hours of receipt.
- The SAP adopts a triage system to ensure requests for drugs that require timely administration take precedence over less urgent matters.
- If a drug is new to the Programme, the total processing time will be extended, although every effort is made to contact the practitioner within 24 hours to discuss the process for handling new drugs.
- Drugs accessed via SAP are supplied directly by manufacturers to practitioners.
- The authorized drug supplies can only be sent to:
- the requesting practitioner's office,
- in-patient pharmacies,
- radiopharmacies, and
- blood banks.
- When an SAP authorization is issued, 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.
- Manufacturers are also responsible for providing all drug information to requesting practitioners.
- Additional information on roles and responsibilities is listed in Section 2 of the Guidance.
Cost of drugs
- There is no requirement for manufacturers to provide drugs released via the SAP free of charge, however many do.
- When manufacturers do charge, the cost is covered by hospitals, public or private insurance plans, or in some cases by patients or their families directly.
- The SAP can be reached 24 hours a day, 365 days a year.
- Regular business hours are from 8:30 am to 4:30 pm Eastern Standard Time on weekdays.
- On call service is available for emergency situations outside of business hours:
- weekdays from 4:30 pm to 8:30 am;
- weekends from 4:30 pm on Friday to 8:30 am on Monday; except:
- during statutory holidays when the on call service continues until 8:30 am on the first business day following the holiday.
Special Access Programme
Therapeutic Products Directorate
Address Locator 3105A
Ottawa, ON, K1A 0K9
Web Site: www.canada.ca/en/health-canada/services/drugs-health-products/special-access/drugs.html
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