After a practitioner uses a drug obtained through Health Canada's Special Access Program, the Food and Drug Regulations require a report on the results, including adverse reactions. Form C is that follow-up, used when a drug was requested for a patient only once. Health Canada uses these reports when processing requests and to help detect product-related safety issues.
The practitioner who requested and received the drug completes the whole form: practitioner details, patient initials, drug use, treatment response, adverse reactions and the signed attestation with licence or college number.
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Special Access Program (drugs) – Form C: Follow-up form
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Health Canada's guidance says Form C is used when a drug was requested for a patient only once, meaning no further requests will be made for that patient and drug. If treatment continues, the outcome is reported before more drug is requested through a repeat Form A.
It asks whether treatment started, the quantity given and dates of administration, any dose changes, the treatment goal, whether the response was none, partial or complete with a description, concomitant medications or therapies, and whether any serious or unexpected adverse reactions occurred.
The form defines it as a serious adverse drug reaction that is not identified in nature, severity or frequency in the risk information on the drug's label. If one occurred, the practitioner also completes a CIOMS adverse reaction form and should stay vigilant, since most SAP drugs are still in clinical development.