Regulatory Considerations Concerning Safety of OTC NSAIDs and Analgesics

Abstract

Self-medication worries the healing arts professions. By taking medicines without the ‘learned intermediary’, people avoid becoming patients (defined as persons consulting physicians, pharmacists, or other professionals for treatment, and, importantly, for diagnosis). This recourse contains several implications: the individual regards the symptom as minor or non-threatening and is willing to temporize to see if the problem can disappear on its own; the individual wishes to avoid further medical consultative charges and recognizes the OTC medicine as continuing what began as prescribed type of medication but at lower cost; or an attempt at self-diagnosis that obviates professional consultation. This holds true particularly in the United States; in some countries, even self-medication drugs must be obtained in a pharmacy, though without prescription, so someone to counsel is present. In the USA, such medications fill supermarket shelves and there is no one in the store to give advice. Packaging, shelf-space, and advertising influence choices. The labels, not always consulted, and the promotional materials dictate uses and comparisons. Thus, for example, a large ‘FOR FEVERS’ may send a more powerful message than the smaller print on cautious use in children, and a medication restricted to adult use may become a favourite for treating the more common childhood fevers Similar inappropriate uses cloud OTC marketing. As pain control remains a major reason for self-medication, the drugs positioned as options find a highly competitive and highly remunerative market. Leaving aside topically applied medications, OTC analgesics in the USA basically represent three groups: aspirin, acetaminophen (paracetamol), and non-steroidal anti-inflammatory drugs (NSAIDs).