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[Audio] Special Access Program Medication Primer: How to Order and Obtain Drugs Not Marketed in Canada..
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[Audio] What Is the Special Access Program? "Health Canada's Special Access Program, or S‑A‑P, enables access to drugs that are not marketed in Canada, for both inpatients and outpatients. Eligibility requires that the patient has a serious or life‑threatening condition, and that standard or available therapies have failed, are unsuitable, or are unavailable." "Patient consent must be obtained and documented according to institutional policy. Adverse drug reactions must be reported to both the SAP and the manufacturer, following mandatory reporting procedures." "Importantly, SAP approval is tied to the quantity of drug, not the duration of therapy. For example, an approval might specify one hundred and twenty vials of cefiderocol. Any dose adjustments due to changes in renal or hepatic function require new submissions." "The program includes Patient‑Specific Requests, known as Form A, and Future‑Use Requests, known as Form B. Patient‑specific requests must include a detailed rationale, treatment justification, and supporting evidence. Future‑use requests apply to the prescriber and include anticipated clinical use, evidence, and projected volumes." "To prevent delays, submissions must be thorough and well‑supported. The SAP aims for a twenty‑four‑hour turnaround time, but this depends on urgency, volume, and does not include shipping time." "After SAP approval of a non‑formulary medication, an LHSC Non‑Formulary and High‑Cost Drug Request Form must still be completed before purchase or shipment." "SAP office hours are Monday to Friday from eight‑thirty to sixteen‑thirty, with emergency after‑hours access available by telephone and fax. Interim approvals require follow‑up within one to two business days..
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[Audio] "Step 1: Clinical and Eligibility Assessment. Clinicians assess the seriousness of the patient's condition and confirm that conventional therapies are insufficient, ensuring the case meets SAP eligibility." "Step 2: Health Canada Application Submission and Review. The SAP application is completed with full clinical justification and securely submitted for review." "Step 3: LHSC Approval and Procurement by Pharmacy. Pharmacy obtains required internal approvals and manages ordering logistics with the manufacturer. Non‑formulary medications also require the LHSC Non‑Formulary and High‑Cost Drug Request Form, which may undergo additional or escalated review." "Step 4: Documentation and Follow‑Up. Accurate documentation is essential to maintain regulatory compliance and ensure patient safety throughout treatment.".
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[Audio] "All non‑formulary medication orders at LHSC that do not meet drug‑specific restriction criteria must undergo internal review. The process includes assessing clinical justification, safety, cost, and alternative formulary options." "Including supporting evidence, such as primary literature or SAP approval documents, improves the efficiency and likelihood of approval." "Pharmacy leadership reviews requests and ensures appropriate resources, such as parenteral drug administration monographs, are developed when needed. Health Canada approval alone does not authorize procurement—LHSC internal approval is also required to proceed." "These internal reviews uphold patient safety, fiscal accountability, and adherence to medication policy.".
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[Audio] "Drug procurement can begin only after both Health Canada SAP approval and LHSC Non‑Formulary Medication approval have been obtained." "Procurement is limited to the approved quantity associated with the SAP application number. Medications may only be shipped to authorized locations, including the prescriber's office, hospital pharmacies, community pharmacies, radiopharmacies, and blood banks." "Shipments often require specialized transport, and delays may occur due to customs, supply shortages, or off‑label use considerations." "In emergencies, nearby hospitals may provide temporary supply, when available. If a patient is being transferred or discharged, any patient‑specific drug supply must be coordinated in advance, as receiving sites are unlikely to carry these medications." "Pharmacists should be contacted with at least twenty‑four hours' notice for assistance.".
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[Audio] "Accurate documentation is essential when managing SAP medications, including approval numbers, authorization letters, and patient consent." "To report outcomes or adverse reactions, the follow‑up form must be completed, signed, dated, and faxed to the designated SAP number." "The SAP operates twenty‑four hours a day, three hundred sixty‑five days a year. Regular business hours are eight‑thirty to four‑thirty Eastern, with after‑hours service available evenings, nights, weekends, and holidays." "For questions or support, the SAP can be contacted by phone, fax, or email.".