Despite those specified on the label, (iv) use the

Despite legal status, it is profoundly maintainedthat all drugs pose the risk of adverse events, ranging from the rareidiosyncratic effects to predictable ones that reflect the pharmacodynamicactivity, and therefore it is essential to be considered in benefit–riskanalyses (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 labellingtoo complex to understand and may disregard it as important (Brass et al 2001). As aresult, consumers may (i) decide to self-treat on the basis of incorrectself-assessment of symptoms, thereby delaying treatment of a clinicallyimportant condition, (ii) use the drug alongside other medications that inducedrug–drug interactions due to limited awareness and recognition (Indermitte et al. 2007), (iii) use the drug for indications other thanthose specified on the label, (iv) use the drug when they have a medicalcondition that increases the risk of developing toxicity, (v) exceed the recommendeddose (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 highlightedby the Brass et al model is the accidental ingestion of drugs by children, anissue recognised as a public health concern with non-prescription drugs often havingan involvement in these events (Schillieet al. 2009).  Despite this, thehigh prevalence of accidental poisonings in this context reflects the high popularityin the household setting whereby a greater familiarity exists. Additional researchby Wilcox et al indicates that consumers may even gravitate towards the perceptionthat the risks of non-prescription medication are considered less hazardous comparedwith prescription medication, therefore leading to a lack of attentiveness aroundchildren (Wilcox et al.

2005).Due to the high likelihood of provoked morbidity and mortality when taken inoverdose, particularly by children, it is essential that robust risk managementplans, labelling and package designs are prepared when undergoing scrutiny by healthauthorities in order to gain reclassification approval. In parallel to the abovediscussion, readily available non-prescription drugs augment the risk insituations whereby they are taken intentionally for recreational purposes therebyhaving the potential to result in exposures far exceeding the recommended dose.As a result, any drugs with recreational capabilities must be clinically reviewedand carefully regulated (Brasset al.