In principle, medical professionals are required to report all adverse effects related to a specific form of therapy. In practice, it is at the discretion of the professional to determine whether a medical event is at all related to the therapy. For example, a leg fracture in a skiing accident in a patient who years before took antibiotics for pneumonia is not likely to get reported.
As a result, routine adverse effects reporting may often not include long-term and subtle effects that may ultimately be attributed to a therapy.
Part of the difficulty is identifying the source of a complaint. A headache in a patient taking medication for influenza may be the underlying disease and may be an adverse effect. In patients with end-stage cancer, death is a very likely outcome and whether the drug is the cause or a bystander is often difficult to discern
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