Managing the risks of off-licence prescribing in pregnancy

Off-licence drugs are frequently given on grounds of cost, but cost constraints are not a defence to a claim of negligence. Sensible prescribing is key to managing the risks of using off-licence drugs. Whenever possible, licenced drugs supported by extensive clinical trial programs undertaken for regulatory approval should be used in preference to off-licence, unproven alternatives, particularly when both are equivalent in efficacy and no additional benefits are associated with use of the off-licence drug. Absence of evidence of harm is not the same as evidence of absence of harm.