Assessment of the Quality of Saudi Patient Information Leaflets (PILs) Based on the Accuracy of Physical Description and Frequency of Solid Dosage Forms

The physical description of dosage forms is one of the most important considerations in avoiding patient confusion and minimizing medication errors. This study aimed to determine the quality and accuracy of the physical descriptions in patient information leaflets (PILs). This cross-sectional study...

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Main Authors: Turki Al Hagbani, Dareen Alrdaian, Reem Q. Alshammari, Ghaliah Alshammary, Mukhtar Ansari
Format: Article
Language:English
Published: MDPI AG 2022-03-01
Series:Healthcare
Subjects:
Online Access:https://www.mdpi.com/2227-9032/10/3/501
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author Turki Al Hagbani
Dareen Alrdaian
Reem Q. Alshammari
Ghaliah Alshammary
Mukhtar Ansari
author_facet Turki Al Hagbani
Dareen Alrdaian
Reem Q. Alshammari
Ghaliah Alshammary
Mukhtar Ansari
author_sort Turki Al Hagbani
collection DOAJ
description The physical description of dosage forms is one of the most important considerations in avoiding patient confusion and minimizing medication errors. This study aimed to determine the quality and accuracy of the physical descriptions in patient information leaflets (PILs). This cross-sectional study constituted a total of 200 drugs and PILs that were randomly selected, by pharmacy students, from Al-Dawaa community pharmacies in the Hail region of Saudi Arabia, from January 2021 to July 2021. The drugs and PILs were thoroughly evaluated in accordance with the Gulf Cooperation Council (GCC) guidelines for PILs. The accuracy screening of the total solid dosage forms (capsules + tablets) revealed that 45% showed complete accuracy and compliance, 1.5% showed poor accuracy and compliance, and 53% showed no accuracy and no compliance with the GCC guidelines and the Saudi Food and Drug Authority (SFDA) guidelines. In the frequency test, color, shape, and imprints accounted for 95.6%, 79.1%, and 73.6%, respectively. However, the size of the dosage form was the least (2.2%) used physical description feature. These findings recommend pharmaceutical companies to pay more attention to the written physical description in their PILs. Additionally, the process of PIL approval should be optimized, evaluated, and updated systematically to ensure that they contain the essential information.
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spelling doaj.art-e51abdba86bc440686d72a5ba28c08722023-11-24T01:22:33ZengMDPI AGHealthcare2227-90322022-03-0110350110.3390/healthcare10030501Assessment of the Quality of Saudi Patient Information Leaflets (PILs) Based on the Accuracy of Physical Description and Frequency of Solid Dosage FormsTurki Al Hagbani0Dareen Alrdaian1Reem Q. Alshammari2Ghaliah Alshammary3Mukhtar Ansari4Department of Pharmaceutics, College of Pharmacy, University of Hail, Hail 81442, Saudi ArabiaDepartment of Pharmaceutics, College of Pharmacy, University of Hail, Hail 81442, Saudi ArabiaDepartment of Pharmaceutics, College of Pharmacy, University of Hail, Hail 81442, Saudi ArabiaDepartment of Pharmaceutics, College of Pharmacy, University of Hail, Hail 81442, Saudi ArabiaDepartment of Clinical Pharmacy, College of Pharmacy, University of Hail, Hail 81442, Saudi ArabiaThe physical description of dosage forms is one of the most important considerations in avoiding patient confusion and minimizing medication errors. This study aimed to determine the quality and accuracy of the physical descriptions in patient information leaflets (PILs). This cross-sectional study constituted a total of 200 drugs and PILs that were randomly selected, by pharmacy students, from Al-Dawaa community pharmacies in the Hail region of Saudi Arabia, from January 2021 to July 2021. The drugs and PILs were thoroughly evaluated in accordance with the Gulf Cooperation Council (GCC) guidelines for PILs. The accuracy screening of the total solid dosage forms (capsules + tablets) revealed that 45% showed complete accuracy and compliance, 1.5% showed poor accuracy and compliance, and 53% showed no accuracy and no compliance with the GCC guidelines and the Saudi Food and Drug Authority (SFDA) guidelines. In the frequency test, color, shape, and imprints accounted for 95.6%, 79.1%, and 73.6%, respectively. However, the size of the dosage form was the least (2.2%) used physical description feature. These findings recommend pharmaceutical companies to pay more attention to the written physical description in their PILs. Additionally, the process of PIL approval should be optimized, evaluated, and updated systematically to ensure that they contain the essential information.https://www.mdpi.com/2227-9032/10/3/501colorcommunity pharmaciespatient information leafletsphysical descriptionquality
spellingShingle Turki Al Hagbani
Dareen Alrdaian
Reem Q. Alshammari
Ghaliah Alshammary
Mukhtar Ansari
Assessment of the Quality of Saudi Patient Information Leaflets (PILs) Based on the Accuracy of Physical Description and Frequency of Solid Dosage Forms
Healthcare
color
community pharmacies
patient information leaflets
physical description
quality
title Assessment of the Quality of Saudi Patient Information Leaflets (PILs) Based on the Accuracy of Physical Description and Frequency of Solid Dosage Forms
title_full Assessment of the Quality of Saudi Patient Information Leaflets (PILs) Based on the Accuracy of Physical Description and Frequency of Solid Dosage Forms
title_fullStr Assessment of the Quality of Saudi Patient Information Leaflets (PILs) Based on the Accuracy of Physical Description and Frequency of Solid Dosage Forms
title_full_unstemmed Assessment of the Quality of Saudi Patient Information Leaflets (PILs) Based on the Accuracy of Physical Description and Frequency of Solid Dosage Forms
title_short Assessment of the Quality of Saudi Patient Information Leaflets (PILs) Based on the Accuracy of Physical Description and Frequency of Solid Dosage Forms
title_sort assessment of the quality of saudi patient information leaflets pils based on the accuracy of physical description and frequency of solid dosage forms
topic color
community pharmacies
patient information leaflets
physical description
quality
url https://www.mdpi.com/2227-9032/10/3/501
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