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

BMC Public Health

Research Article

Amer A. Koni¹  Sandra A. Qatmosh¹  Bahaa M. Al-hroub¹  Dina A. Arandy¹  Maysa W. Abu-Hashia¹  Baraa G. Qeeno¹  Sa’ed H. Zyoud² 

[1] PharmD Program, College of Medicine and Health Sciences, An-Najah National University, 44839, Nablus, Palestine;Poison Control and Drug Information Center (PCDIC), College of Medicine and Health Sciences, An-Najah National University, 44839, Nablus, Palestine;Department of Clinical and Community Pharmacy, College of Medicine and Health Sciences, An-Najah National University, 44839, Nablus, Palestine;

关键词: Package inserts;    Antihypertensive medications;    Palestine;   

DOI  :  10.1186/s12889-017-4782-x

 received in 2017-04-07, accepted in 2017-09-21,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundPackage 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.MethodsThirty-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.ResultsNone 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.ConclusionsThe 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.

【 授权许可】

CC BY   
© The Author(s). 2017