Off-Label in New Zealand
I was pleased to be asked to contribute to the recent ABC documentary on the use of the antipsychotic medication quetiapine in Australia. I am a practicing forensic psychiatrist, with a research interest in the patterns and characteristics of off-label prescribing of antipsychotic medications. Off-label prescribing refers to the use of a medication outside the indications approved by the licensing authority; the approval process requires robust scientific evidence of efficacy and safety for specific clinical situations. Licensing for specific indications was in part designed to rationalize and limit the marketing claims made by the pharmaceutical industry in their thirst for profit and to prevent further disasters such as those that followed the excessive use of thalidomide in the 1960s, in which up to 10,000 infants across the US and Europe were born with malformation of the limbs and where only 50% of those affected survived.
Before the early 1990’s the use of antipsychotic medications was largely reserved for adults with severe psychotic disorders; unpleasant involuntary movement disorders (extrapyramidal side-effects) and cardiovascular risks appear to have largely limited their use outside these disorders. The introduction and intense marketing of what seemed to be better tolerated and safer (now proven not to be), second generation atypical antipsychotics (AAPs) such as risperidone, olanzapine, quetiapine, ziprasidone and aripiprazole from the mid 1990’s led to a rapid expansion of antipsychotic medication use for a wide variety of unlicensed conditions and in more diverse clinical populations. Part of the rapid diffusion of AAPs has been achieved by large increases in the rate of use in certain sub-populations, most notably children and youths for whom long term data on safety and efficacy are still lacking, and due to persisting use of AAPs over long periods of time (Crystal et al, 2009, Monasterio and McKean, 2013). This unlicensed use has predominantly not been supported by scientific evidence (McKean and Monasterio, 2012). At the same time the diagnosis of serious mental illness, particularly bipolar affective disorder and the use of antipsychotic medications in children and youth increased between 5-40 times in the US and parts of Europe (Moreno et al, 2007, Monasterio and McKean, 2013).