ArticlePloS one2025
A systematic comparison of patient information leaflets from local and multinational pharmaceutical companies: Assessing content quality and completeness.
Article in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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Who cites it
1 citing paper in PubMed.
- A comparative analysis of clinical quality and readability of neuropathic pain patient information leaflets: Türkiye versus the United States.Turkish journal of medical sciences · 2026Article
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Authors and funding
12 authors.
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No grant is acknowledged in the PubMed record.
Abstract
backgroundIt is necessary to provide essential information to patients regarding medication to ensure safe and effective use. Patient Information Leaflets (PILs) are vital to fulfil this purpose. However, disparities in quality between multinational and local pharmaceutical companies PILs have been observed. The study aimed to assess and compare the completeness and quality of PILs available in community pharmacies from multinational and local pharmaceutical companies.
methodA cross-sectional comparative study design was used for evaluating 695 PILs (312 multinational, 383 local) across various therapeutic classes (antibiotics, anti-hypertensives, anti-diabetics, NSAIDs, and antidepressants). PILs were assessed against 31 criteria encompassing general information, dosage, indications, administration, interactions, safety information, pharmacokinetics, toxicology, storage, adverse effects, and pregnancy/breastfeeding details. Descriptive statistics, t-tests, chi-square tests, and odds ratios were included in statistical analysis.
resultSeveral criteria results showed excelling of Multinational PILs over local PILs. Significant differences favouring multinational PILs were observed in providing information on inactive ingredients (p = 0.024), adult-specific dosing (p = 0.0001), renal and hepatic dose adjustments (p = 0.018, p = 0.007 respectively), dosing in haemodialysis patients (p = 0.036), drug-drug interactions (p = 0.029), black box warnings (p = 0.027), clinical effects of toxicity (p = 0.045), and reporting adverse drug reactions (p = 0.04).
conclusionMultinational and local PILs, both performed well in providing basic information on active ingredients, brand names, contraindications, pregnancy, and lactation details. However, disparities among various aspects including inactive ingredient, specific dosing, dose adjusments and drug interactions between PILS of multinational and local pharmaceutical companies in Pakistan highlights the necessity for regulatory measures and industry initiatives to standardize PIL content. For ensuring patient safety and enhancing the quality of medication use it is essential to improve the comprehensiveness and clarity of PILs.
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