Background <p>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.</p> Objective <p>This study aimed to evaluate the consistency of the “Do not swallow” warning on secondary packaging elements of specific pharmaceutical forms.</p> Methods <p>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.</p> Results <p>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 (<i>n</i> = 14), this warning was present at a higher rate in generic medications than in original products.</p> Conclusions <p>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.</p> Graphical Abstract <p></p>

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The Consistency of “Do Not Swallow” Warning in Pharmaceutical Information Leaflets and Carton Labelling: A Cross-Sectional Study in Türkiye

  • Muhammetcan Sekman,
  • Zinnet Şevval Aksoyalp

摘要

Background

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.

Objective

This study aimed to evaluate the consistency of the “Do not swallow” warning on secondary packaging elements of specific pharmaceutical forms.

Methods

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.

Results

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.

Conclusions

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.

Graphical Abstract