Q: Is it possible to transfer a special access drug from one facility to another?
The Special Access Program (SAP) was created by Health Canada (HC) to provide drugs not marketed in Canada to Canadian practitioners for treatment, diagnosis or prevention of serious or life-threatening conditions when conventional therapies have been considered and ruled out, have failed, are unsuitable, and/or unavailable. Drugs requested for access via the SAP will only be authorized to be shipped to hospital in-patient pharmacies, hospital blood banks, nuclear medicine departments or the requesting practitioner’s office.
HC advises that SAP drugs may be transferred to another location under certain circumstances:
1. For treatment of the same patient at a different facility:
- If the initial physician who has ordered the drug is comfortable shipping the drug to another facility for dispensing or treatment of the patient, and is comfortable retaining responsibility for care of that patient, no paperwork is required by HC. HC would ultimately seek any information regarding the drug from the responsible physician. This would be a professional judgment by the physician; i.e., taking responsibility of drug treatment in a patient, when the patient is in another facility and being treated through another physician.
- If the initial physician prefers to transfer responsibility of care for the patient to a second physician in another location, HC must be notified. In this case, the second physician must submit an SAP form to HC. However, in the quantity section of the form, the amount of drug to be transferred (i.e. vials/ tabs) must be specified, and it must be clearly marked that no additional supply is required ( i.e. by checking the box). If authorized by HC, the request is forwarded to the manufacturer for approval. Once confirmed, HC notifies the second physician that the transfer is authorized.
2. For treatment of a different patient at a different facility:
- If the original patient is no longer receiving the SAP drug, it can be transferred to another facility for a different patient. The physician ordering the drug for the new patient must submit an SAP form to HC. However, in the quantity section of the form, the amount of drug to be transferred (i.e., vials/ tabs) must be specified, and it must be clearly marked that no additional supply is required. If authorized by HC, the request is forwarded to the manufacturer for approval. Once confirmed, HC notifies the second physician that the transfer is authorized.
3. Future Use Drugs for more than one facility:
- SAP drugs are sometimes used in acute settings where their use is unpredictable. An example is hyaluronidase used for treatment of extravasation caused by chemotherapy. If HC determines that a drug is appropriate for future use access, they will allow one facility to order in stock of the drug for distribution to other facilities. For example, a buying group for a health authority can order hyaluronidase stock and distribute it to the hospitals located within the health region. The ordering practitioner will be required to account for all SAP drug requested and received. Each facility must keep track of the names of patients who receive hyaluronidase and this information must be submitted to the SAP with the subsequent order.
HC and/or the manufacturer can refuse the request to transfer SAP drugs to other facilities.
1. Health Canada Special Access Program (SAP). Guidance for Industry and Practitioners: Special Access Programme for Drugs. Available at: http://www.hc-sc.gc.ca/dhp-mps/acces/drugs-drogues/index-eng.php#factsheets. Accessed Jun 2, 2009.
2. Health Canada Special Access Program (SAP). Transfer of SAP drug from one facility to another: E-mail recieved May 21, 2009
Revised July 28, 2009