Comparative Analysis of Patient Package Inserts of Local and Imported Anti-Infective Agents in Palestine
Background and Objective: The patient package insert is an important source of drug information. The aim of this study was to evaluate and compare the PPI of the anti-infective agents manufacturedin Palestine with the imported equivalents. Method: The selection criteria generated 15 different antiin...
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Format: | Article |
Language: | English |
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Taylor & Francis Group
2008-01-01
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Series: | Libyan Journal of Medicine |
Subjects: | |
Online Access: | http://www.ljm.org.ly/articles/AOP/AOP080907.pdf |
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author | Sawalha AF Sweileh WM Zyoud SH Jabi SW |
author_facet | Sawalha AF Sweileh WM Zyoud SH Jabi SW |
author_sort | Sawalha AF |
collection | DOAJ |
description | Background and Objective: The patient package insert is an important source of drug information. The aim of this study was to evaluate and compare the PPI of the anti-infective agents manufacturedin Palestine with the imported equivalents. Method: The selection criteria generated 15 different antiinfective agents available as 36 locally manufactured products and 15 imported equivalents. Thedesign of the patient package insert was evaluated in terms of the number of words used in eight main headings and the presence or absence of certain information regarding nine statements.Results: Inserts of locally manufactured products have significantly fewer words than those of imported products with respect to warnings, dosage and administration, and side effects. The mostsignificant difference was found in the warnings. Moreover, differences were found between inserts of local and imported products in terms of the presence of the nine informative statements. Locally manufactured products did not mention inactive ingredients, clinical pharmacology or date of lastrevision, but all of them provided information on the use of the drug during pregnancy and lactation and on the duration of therapy. However, in general they provided less information than the importedequivalents. Conclusion: Palestinian authorities and local manufacturers should implement appropriate measures to regulate the quality and quantity of information in the patient package insertof locally produced anti-infective agents. PPI improvement will better direct health practices to the benefit of the patients. |
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format | Article |
id | doaj.art-a2c380fd63bd498f8c10634f30024c2f |
institution | Directory Open Access Journal |
issn | 1819-6357 |
language | English |
last_indexed | 2024-12-12T10:10:23Z |
publishDate | 2008-01-01 |
publisher | Taylor & Francis Group |
record_format | Article |
series | Libyan Journal of Medicine |
spelling | doaj.art-a2c380fd63bd498f8c10634f30024c2f2022-12-22T00:27:49ZengTaylor & Francis GroupLibyan Journal of Medicine1819-63572008-01-0134AOP:080907Comparative Analysis of Patient Package Inserts of Local and Imported Anti-Infective Agents in PalestineSawalha AFSweileh WMZyoud SHJabi SWBackground and Objective: The patient package insert is an important source of drug information. The aim of this study was to evaluate and compare the PPI of the anti-infective agents manufacturedin Palestine with the imported equivalents. Method: The selection criteria generated 15 different antiinfective agents available as 36 locally manufactured products and 15 imported equivalents. Thedesign of the patient package insert was evaluated in terms of the number of words used in eight main headings and the presence or absence of certain information regarding nine statements.Results: Inserts of locally manufactured products have significantly fewer words than those of imported products with respect to warnings, dosage and administration, and side effects. The mostsignificant difference was found in the warnings. Moreover, differences were found between inserts of local and imported products in terms of the presence of the nine informative statements. Locally manufactured products did not mention inactive ingredients, clinical pharmacology or date of lastrevision, but all of them provided information on the use of the drug during pregnancy and lactation and on the duration of therapy. However, in general they provided less information than the importedequivalents. Conclusion: Palestinian authorities and local manufacturers should implement appropriate measures to regulate the quality and quantity of information in the patient package insertof locally produced anti-infective agents. PPI improvement will better direct health practices to the benefit of the patients.http://www.ljm.org.ly/articles/AOP/AOP080907.pdfpatient package insertevaluationPalestinedrug information |
spellingShingle | Sawalha AF Sweileh WM Zyoud SH Jabi SW Comparative Analysis of Patient Package Inserts of Local and Imported Anti-Infective Agents in Palestine Libyan Journal of Medicine patient package insert evaluation Palestine drug information |
title | Comparative Analysis of Patient Package Inserts of Local and Imported Anti-Infective Agents in Palestine |
title_full | Comparative Analysis of Patient Package Inserts of Local and Imported Anti-Infective Agents in Palestine |
title_fullStr | Comparative Analysis of Patient Package Inserts of Local and Imported Anti-Infective Agents in Palestine |
title_full_unstemmed | Comparative Analysis of Patient Package Inserts of Local and Imported Anti-Infective Agents in Palestine |
title_short | Comparative Analysis of Patient Package Inserts of Local and Imported Anti-Infective Agents in Palestine |
title_sort | comparative analysis of patient package inserts of local and imported anti infective agents in palestine |
topic | patient package insert evaluation Palestine drug information |
url | http://www.ljm.org.ly/articles/AOP/AOP080907.pdf |
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