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Off-label prescribing

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Prescribing medications “off label” in some settings is appropriate as long as it is evidence-based

Many medication prescriptions are written for approved indications, as listed in the product information (PI) for the drug. “Off-label” prescribing is the term used when a drug is prescribed for an indication, a route of administration, or a patient group that is not included in the approved PI. There are groups of patients who are not included in the clinical trials undertaken for drug registration, and these groups may not be included in the PI. They typically include children, pregnant women, older men and women, and patients with terminal illness. Prescribing the medication for patients in these categories would be off label if they are not listed in the PI.

Based on a drug’s mechanism of action in an approved indication, it may be hypothesised that the drug may be efficacious in treating a medical disorder that is not listed in the PI. It is acceptable to prescribe off label, provided that there is sufficient evidence of efficacy and safety. This situation can arise for medications that have been available for many years, during which well conducted studies in patients with an off-label indication have shown acceptable efficacy and safety. If the drug’s…