Despite legal status, it is profoundly maintained
that all drugs pose the risk of adverse events, ranging from the rare
idiosyncratic effects to predictable ones that reflect the pharmacodynamic
activity, and therefore it is essential to be considered in benefit–risk
analyses (Brass et al. 2011).
According to the Brass et al model, a significant risk involves unintended misuse,
for example, before initiating use, some consumers may find safety labelling
too complex to understand and may disregard it as important (Brass et al 2001). As a
result, consumers may (i) decide to self-treat on the basis of incorrect
self-assessment of symptoms, thereby delaying treatment of a clinically
important condition, (ii) use the drug alongside other medications that induce
drug–drug interactions due to limited awareness and recognition (Indermitte et al. 2007), (iii) use the drug for indications other than
those specified on the label, (iv) use the drug when they have a medical
condition that increases the risk of developing toxicity, (v) exceed the recommended
dose (either by taking more per dose or shortening the dosing interval), or
(vi) take the drug for periods longer than indicated on the label (Brass et al. 2011).
Additionally, another key consideration highlighted
by the Brass et al model is the accidental ingestion of drugs by children, an
issue recognised as a public health concern with non-prescription drugs often having
an involvement in these events (Schillie
et al. 2009). Despite this, the
high prevalence of accidental poisonings in this context reflects the high popularity
in the household setting whereby a greater familiarity exists. Additional research
by Wilcox et al indicates that consumers may even gravitate towards the perception
that the risks of non-prescription medication are considered less hazardous compared
with prescription medication, therefore leading to a lack of attentiveness around
children (Wilcox et al. 2005).
Due to the high likelihood of provoked morbidity and mortality when taken in
overdose, particularly by children, it is essential that robust risk management
plans, labelling and package designs are prepared when undergoing scrutiny by health
authorities in order to gain reclassification approval. In parallel to the above
discussion, readily available non-prescription drugs augment the risk in
situations whereby they are taken intentionally for recreational purposes thereby
having the potential to result in exposures far exceeding the recommended dose.
As a result, any drugs with recreational capabilities must be clinically reviewed
and carefully regulated (Brass
et al. 2011).