Evaluation of the labelling adherence of the foodassociated effects of selected pharmacotherapy
Keywords:
food-associated effects, food-drug interactions, labelling adherence, medicinal package inserts, patient information leaflets, professional information, South African Health Products Regulatory AuthorityAbstract
Background: Pharmacotherapy and dietary interventions often work together to enhance patient treatment and outcomes. Yet, food-associated effects, including food-drug interactions, remain a significant challenge, especially for oral pharmacotherapy. These interactions can undermine the safety and efficacy of medications and negatively impact patients’ nutritional status. Despite medicinal package inserts being the primary source of such information, studies from other countries highlight inconsistencies and inadequacies in the labelling of food-drug interactions. In South Africa, this critical issue remains largely unexplored, leaving potential risks unaddressed. The study aimed to evaluate the adherence of professional and patient information leaflets to labelling regulations concerning food-associated effects, providing some insight on a crucial yet often overlooked aspect of patient safety.
Methods: The South African Health Products Regulatory Authority (SAHPRA) labelling guidelines were used to evaluate the adherence to labelling of food-associated effects in the professional and patient information leaflets of warfarin, statins, fluoroquinolone and tetracycline antibiotics.
Results: The leaflets showed partial adherence to SAHPRA labelling guidelines. Food-drug interaction information was either lacking or inadequately described, particularly in relation to the mechanism of interaction, clinical outcomes, or recommendations. Although the information was mostly presented under appropriate headings, it was not always available under recommended sections and rarely cross-referenced.
Conclusions: The labelling of food-associated effects in the evaluated professional and patient information leaflets was partially adherent to SAHPRA labelling guidelines, which may hinder effective guidance for healthcare professionals and patients. Although a small sample, non-adherence is evident and suggests bolstering is needed to mitigate potentially clinically significant interactions.
