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A systematic comparison of patient information leaflets from local and multinational pharmaceutical companies: Assessing content quality and completeness

Ibrahim Alzarea A 1 , Athar Ishaqui A 2 , Zeeshan M 3 , Salah Alanazi A 1 , Awad Alsaidan A 4 , Hussain Mallhi T 5 Show all authors , Salman M 6 , Habib Khan Y 5 , Farooq J 7 , H Alhassan H 8 , I Alzarea S 9 , Awad Alsaidan O 10

Affiliations 

  • 1 Department of Clinical Pharmacy, College of Pharmacy, Jouf University, Sakaka, Saudi Arabia
  • 2 Department of Clinical Pharmacy, College of Pharmacy, King Khalid University, Abha, Saudi Arabia
  • 3 Department of Pharmacy, Iqra University, Karachi, Pakistan
  • 4 Department of Family and Community medicine, College of medicine, Jouf University, Sakaka, Saudi Arabia
  • 5 School of Pharmacy, Faculty of Health and Medical sciences, Taylors University, Selangor, Malaysia
  • 6 Institute of Pharmacy, Faculty of Pharmaceutical and Allied Health Sciences, Lahore College for Women University, Lahore, Pakistan
  • 7 Faculty of Pharmacy, University of Karachi, Karachi, Pakistan
  • 8 Department of Clinical Laboratory Sciences, College of Applied Medical Sciences, Jouf University, Sakaka, Saudi Arabia
  • 9 Department of Pharmacology, College of Pharmacy, Jouf University, Sakaka, Saudi Arabia
  • 10 Department of Pharmaceutics, College of Pharmacy, Jouf University, Sakaka, Saudi Arabia
PLoS One, 2025;20(11):e0335149.
PMID: 41202075 DOI: 10.1371/journal.pone.0335149

Abstract

BACKGROUND: It 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.

METHOD: A 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.

RESULT: Several 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).

CONCLUSION: Multinational 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.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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