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

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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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          Most cited references 41

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          2015 Annual Report of the American Association of Poison Control Centers' National Poison Data System (NPDS): 33rd Annual Report.

          This is the 33rd Annual Report of the American Association of Poison Control Centers' (AAPCC) National Poison Data System (NPDS). As of 1 January 2015, 55 of the nation's poison centers (PCs) uploaded case data automatically to NPDS. The upload interval was 9.52 [7.40, 13.6] (median [25%, 75%]) minutes, creating a near real-time national exposure and information database and surveillance system.
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            Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010.

            Postmarket safety events of novel pharmaceuticals and biologics occur when new safety risks are identified after initial regulatory approval of these therapeutics. These safety events can change how novel therapeutics are used in clinical practice and inform patient and clinician decision making.
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              Factors influencing consumer use of written drug information.

              To provide an overview of the use and impact of written drug information (WDI) on consumers, and to review the literature on the factors influencing the use of WDI by consumers. Relevant articles published in English since the late 1970s were identified based on searches of on-line databases, texts, and cited references in published articles. Articles reporting findings on the origin, use, and impact of WDI were included. Due to limited literature, articles reporting findings on factors influencing the use of written drug as well as disease information were included. Due to the lack of design consistency between studies and the comparatively small volume of work, subjective assessment rather than a criteria-based objective review was deemed more appropriate. To date, research on WDI has focused on its use and impact. WDI has the potential to increase patients' knowledge, compliance, and satisfaction. However, there is also the potential for anxiety or premature cessation of therapy due to fear of possible adverse effects. Multiple factors may potentially influence the use of WDI by consumers including those associated with the written information document (readability, presentation), the patient (health literacy, role of caregiver, demographic factors, health locus of control, coping style, health belief model), and the environment (timing of provision, experience). WDI has the potential to impact consumers positively and negatively. Although not widely investigated, a number of factors can potentially influence the use of WDI by consumers. The findings of this review can form the basis for much needed further research.
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                Author and article information

                Contributors
                sandra_q94@hotmail.com
                koni_amer@hotmail.com
                Baraa.qeeno@gmail.com
                dina-a-randy@hotmail.com
                Maysa_abuhashya@hotmail.com
                bahahroub@hotmail.com
                00970599833649 , saedzyoud@yahoo.com , saedzyoud@najah.edu
                Journal
                BMC Public Health
                BMC Public Health
                BMC Public Health
                BioMed Central (London )
                1471-2458
                25 September 2017
                25 September 2017
                2017
                : 17
                Affiliations
                [1 ]ISNI 0000 0004 0631 5695, GRID grid.11942.3f, PharmD Program, College of Medicine and Health Sciences, , An-Najah National University, ; Nablus, 44839 Palestine
                [2 ]ISNI 0000 0004 0631 5695, GRID grid.11942.3f, Poison Control and Drug Information Center (PCDIC), College of Medicine and Health Sciences, , An-Najah National University, ; Nablus, 44839 Palestine
                [3 ]ISNI 0000 0004 0631 5695, GRID grid.11942.3f, Department of Clinical and Community Pharmacy, College of Medicine and Health Sciences, , An-Najah National University, ; Nablus, 44839 Palestine
                Article
                4782
                10.1186/s12889-017-4782-x
                5613627
                28946858
                © The Author(s). 2017

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                Categories
                Research Article
                Custom metadata
                © The Author(s) 2017

                Public health

                package inserts, antihypertensive medications, palestine

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