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What Happened to Nattokinase? Is There Anything I Can Do?

The Special Access Program (SAP) provides access to nonmarketed drugs for practitioners treating patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable.  The SAP authorizes a manufacturer to sell a drug that cannot otherwise be sold or distributed in Canada.  Drugs considered for release by the SAP include pharmaceutical, biologic, and radio-pharmaceutical products not approved for sale in Canada.  If patient and practitioner are in agreement that a nonmarketed drug is the best choice for the patient’s treatment strategy, then the SAP is a viable option.

A maximum quantity equivalent to six month’s duration may be authorized for chronic treatments. Repeats must be re-ordered through the usual SAP request procedures.  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.

The Special Access Request (SAR) Form and associated instructions are available on the Health Canada web site (here http://www.hc-sc.gc.ca/dhp-mps/acces/drugs-drogues/index-eng.php).  The SAR Form consists of two pages containing five sections (practitioner information, drug and manufacturer information, patient information, clinical rationale, and practitioner attestation).  Practitioners are required to complete all five sections of the form.  Completed forms should be faxed to the SAP without an accompanying cover sheet.

Following careful consideration of the SAR Form, the SAP will either grant or deny authorization.  SAR Forms 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.

In all cases, the manufacturer has the final word on whether the drug will be supplied.  The manufacturer also 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 and request further patient information.  Manufacturers are also responsible for providing all drug information to requesting practitioners and/or patients.  SAP drugs may only be sent to practitioners’ offices or in-patient pharmacies.  Manufacturers are not permitted to send SAP drugs to retail pharmacies.

Visit your medical doctor and ask them about the Special Access Program!

AOR CA

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