The pharmaceutical leaflet on the use of common Analgesics

Abstract

The pharmaceutical leaflet is a fundamental document for our health. It’s the information leaflet for the user that accompanies the medication, usually found on a small piece of paper inside the medicine box. It plays a key role in medication prescription, the user’s understanding of the treatment, and the doctor patient relationship, promoting informed decision-making. It is a right backed by international standards, allowing pharmaceutical sales to be authorized in each country, in the case of Mexico, the Official Mexican Standard NOM-072-SSA1-2012 establishes the requirements for its authorization. During the review of leaflets for non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin, paracetamol, ibuprofen, among others (the most commonly prescribed medications in Mexico). From 25 products analyzed, we observed that 100% formally comply with the secondary labeling required by the Mexican Health Services. However, this compliance was primarily identified as administrative because none of the analyzed medications have a physical package insert or leaflet; instead, they present a minimal summary of information on the secondary packaging, which lacks important information such as potential drug interactions. A lack of explanations in accessible language regarding serious adverse reactions was identified, as well as limited use of pictograms, which together constitute a deficiency in safety information. This demonstrates that the importance of package inserts is being underutilized, at least for the most commonly used medications in our country.