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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Main Authors: Sawalha AF, Sweileh WM, Zyoud SH, Jabi SW
Format: Article
Language:English
Published: Taylor & Francis Group 2008-01-01
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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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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AT jabisw comparativeanalysisofpatientpackageinsertsoflocalandimportedantiinfectiveagentsinpalestine