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BMC Public Health
Published in: BMC Public Health 1/2017

Open Access 01-12-2017 | Research article

Comparative analysis of package inserts of local and imported antihypertensive medications in Palestine

Authors: Sandra A. Qatmosh, Amer A. Koni, Baraa G. Qeeno, Dina A. Arandy, Maysa W. Abu-Hashia, Bahaa M. Al-hroub, Sa’ed H. Zyoud

Published in: BMC Public Health | Issue 1/2017

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Abstract

Background

Package inserts (PIs) as a reliable reference for patients and health care providers should provide accurate, complete and up-to-date information. The purpose of the current study is to assess and compare the PIs of antihypertensive agents locally produced in Palestine and their imported counterparts.

Methods

Thirty-five PIs were assessed for the presence of 31 information statements using a scoring method. Word counting of 20 headings and subheadings was used to evaluate and compare local and imported PIs for information quantity.

Results

None of the analysed PIs fulfilled the criteria. All of them included the brand name, active ingredients, indications, directions for use, adverse drug reactions, drug–drug interactions, pregnancy and lactation considerations, and storage. Whereas none of them, either local or imported PIs, included the shelf life and instructions to convert tablets or capsules into liquid forms. Additionally, only one (5%) imported and no (0%) local PIs mentioned the duration of therapy. Moreover, 93.4% of local PIs were deficient in areas regarding the inactive ingredients and date of last revision, and 86.7% did not mention the drug dose and possibility of tablet splitting. Furthermore, the maximum dose was not indicated in 90% of imported and 86.7% of local PIs. In general, imported PIs contained more detailed information than their local counterparts, where the range of differences in medians between the local and imported PIs was from 1.5-fold for pregnancy considerations to >42.00-fold for the effect on the ability to drive and use machines.

Conclusions

The findings of this study revealed the superiority of imported over local PIs in both quality and quantity of information provided. This emphasises the need for appropriate measures to be taken by the Ministry of Health and local manufacturers to ensure efficiency of local PIs in providing accurate, complete and up-to-date information.
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Metadata
Title
Comparative analysis of package inserts of local and imported antihypertensive medications in Palestine
Authors
Sandra A. Qatmosh
Amer A. Koni
Baraa G. Qeeno
Dina A. Arandy
Maysa W. Abu-Hashia
Bahaa M. Al-hroub
Sa’ed H. Zyoud
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Public Health / Issue 1/2017
Electronic ISSN: 1471-2458
DOI
https://doi.org/10.1186/s12889-017-4782-x

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