The consistency of information across the Carton Labelling (CL), Summary of Product Characteristics (SPC), and Package Leaflet (PL) of medications is critical for effective treatment and patient safety. This study aimed to evaluate the consistency of the “Do not swallow” warning on secondary packaging elements of specific pharmaceutical forms. This study included oropharyngeal medications, sublingual, effervescent, and chewable tablets, suppositories, and capsules for inhalation. Data were collected from July to December 2024 in a single community pharmacy. An evaluation was conducted of the CL, SPC and PL of these medications, with a specific focus on the presence of the “Do not swallow” warning. A total of 96 commercial medications were included. The “Do not swallow” warning was commonly present in SPC (58.3%) and PL (60.4%) but appeared less frequently on the CL (27.1%). The majority of capsules for inhalation group (94.4%) have this warning on their CL, whereas the sublingual, effervescent, and chewable tablets group had the lowest rate (2.6%). Notably, this warning was often lacking on the CL of recently licensed medications. Although the number of original medications in the study was limited (n = 14), this warning was present at a higher rate in generic medications than in original products. The “Do not swallow” warning should be consistently included across the CL, SPC, or PL. Oral ingestion of these dosage forms may lead to altered pharmacokinetics, therapeutic failure, toxicity and local gastrointestinal irritation. • Consistent information on the Carton Labelling (CL), Summary of Product Characteristics (SPC), and Package Leaflet (PL) is crucial for preventing medication errors and adverse drug events. Discrepancies between these sources can lead to confusion and medication administration errors. • In this study, the “Do not swallow” warning was frequently present in SPC and PL but was often absent from the CL. Furthermore, while almost all capsules for inhalation displayed this warning on their CL, the suppository/effervescent/chewable tablet group had the lowest rate of inclusion. • These inconsistencies and deficiencies in drug information sources can increase the medication administration errors, which may lead to altered pharmacokinetics, therapeutic failure, toxicity and local irritation.
Sekman et al. (Sat,) studied this question.