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      Calculating reading ease score of patient package inserts in Iran

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          Abstract

          Background

          The patient package inserts (PPIs), which contain the necessary information about medications intended for patients, need to be expressed in a clear language comprehensible to everyone.

          Objective

          This study aimed to evaluate the readability and understandability of the drug package inserts for the inexpert people.

          Methods

          The readability of the 158 PPIs of the 33 drugs, registered and manufactured in Iran, was calculated. The main criterion for selecting PPIs to include in this study was of those top-selling drugs during the year 2015 according to the Social Security Organization in Iran. The PPIs were collected from the pharmacies of the three major cities, namely, Tabriz, Ardabil and Meshgin Shahr. Then, using the Flesch–Dayani readability (FDR) tool adjusted for the Persian language, the average number of the words and syllables was counted to calculate and grade the readability score of the selected PPIs.

          Results

          This study showed that the average FDR readability score for all the 33 drugs is 52.52, which are graded 10th–11th. Of the PPIs, 70.89% were difficult to read, and on average, the readability of the PPIs was five times difficult than the standard ones. Only 13.92% PPIs were suitable for the 5th–7th grade, and 15.19% of the package inserts ranked in the 8th–9th reading grade.

          Conclusion

          A considerable number of the PPIs in Iran have low readability level and were not suitable for the inexpert readers. Since the treatment cost is very high, people tend to use medications arbitrarily or simply use old prescriptions. This study suggests the necessity of a major improvement in the readability level of the PPIs in order to ensure the usefulness of the PPIs to the majority of the consumers.

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          Most cited references23

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          Risk of acute myocardial infarction with NSAIDs in real world use: bayesian meta-analysis of individual patient data

          Objective To characterise the determinants, time course, and risks of acute myocardial infarction associated with use of oral non-steroidal anti-inflammatory drugs (NSAIDs). Design Systematic review followed by a one stage bayesian individual patient data meta-analysis. Data sources Studies from Canadian and European healthcare databases. Review methods Eligible studies were sourced from computerised drug prescription or medical databases, conducted in the general or an elderly population, documented acute myocardial infarction as specific outcome, studied selective cyclo-oxygenase-2 inhibitors (including rofecoxib) and traditional NSAIDs, compared risk of acute myocardial infarction in NSAID users with non-users, allowed for time dependent analyses, and minimised effects of confounding and misclassification bias. Exposure and outcomes Drug exposure was modelled as an indicator variable incorporating the specific NSAID, its recency, duration of use, and dose. The outcome measures were the summary adjusted odds ratios of first acute myocardial infarction after study entry for each category of NSAID use at index date (date of acute myocardial infarction for cases, matched date for controls) versus non-use in the preceding year and the posterior probability of acute myocardial infarction. Results A cohort of 446 763 individuals including 61 460 with acute myocardial infarction was acquired. Taking any dose of NSAIDs for one week, one month, or more than a month was associated with an increased risk of myocardial infarction. With use for one to seven days the probability of increased myocardial infarction risk (posterior probability of odds ratio >1.0) was 92% for celecoxib, 97% for ibuprofen, and 99% for diclofenac, naproxen, and rofecoxib. The corresponding odds ratios (95% credible intervals) were 1.24 (0.91 to 1.82) for celecoxib, 1.48 (1.00 to 2.26) for ibuprofen, 1.50 (1.06 to 2.04) for diclofenac, 1.53 (1.07 to 2.33) for naproxen, and 1.58 (1.07 to 2.17) for rofecoxib. Greater risk of myocardial infarction was documented for higher dose of NSAIDs. With use for longer than one month, risks did not appear to exceed those associated with shorter durations. Conclusions All NSAIDs, including naproxen, were found to be associated with an increased risk of acute myocardial infarction. Risk of myocardial infarction with celecoxib was comparable to that of traditional NSAIDS and was lower than for rofecoxib. Risk was greatest during the first month of NSAID use and with higher doses.
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            Risk of death among users of Proton Pump Inhibitors: a longitudinal observational cohort study of United States veterans

            Objective Proton pump inhibitors (PPIs) are widely used, and their use is associated with increased risk of adverse events. However, whether PPI use is associated with excess risk of death is unknown. We aimed to examine the association between PPI use and risk of all-cause mortality. Design Longitudinal observational cohort study. Setting US Department of Veterans Affairs. Participants Primary cohort of new users of PPI or histamine H2 receptor antagonists (H2 blockers) (n=349 312); additional cohorts included PPI versus no PPI (n=3 288 092) and PPI versus no PPI and no H2 blockers (n=2 887 030). Main outcome measures Risk of death. Results Over a median follow-up of 5.71 years (IQR 5.11–6.37), PPI use was associated with increased risk of death compared with H2 blockers use (HR 1.25, CI 1.23 to 1.28). Risk of death associated with PPI use was higher in analyses adjusted for high-dimensional propensity score (HR 1.16, CI 1.13 to 1.18), in two-stage residual inclusion estimation (HR 1.21, CI 1.16 to 1.26) and in 1:1 time-dependent propensity score-matched cohort (HR 1.34, CI 1.29 to 1.39). The risk of death was increased when considering PPI use versus no PPI (HR 1.15, CI 1.14 to 1.15), and PPI use versus no PPI and no H2 blockers (HR 1.23, CI 1.22 to 1.24). Risk of death associated with PPI use was increased among participants without gastrointestinal conditions: PPI versus H2 blockers (HR 1.24, CI 1.21 to 1.27), PPI use versus no PPI (HR 1.19, CI 1.18 to 1.20) and PPI use versus no PPI and no H2 blockers (HR 1.22, CI 1.21 to 1.23). Among new PPI users, there was a graded association between the duration of exposure and the risk of death. Conclusions The results suggest excess risk of death among PPI users; risk is also increased among those without gastrointestinal conditions and with prolonged duration of use. Limiting PPI use and duration to instances where it is medically indicated may be warranted.
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              Epidemiology of NSAID induced gastrointestinal complications.

              Nonsteroidal antiinflammatory drugs (NSAID) are one of the most commonly used classes of medications worldwide. It is estimated that more than 30 million people take NSAID daily. Gastrointestinal (GI) complications related to NSAID therapy are the most prevalent category of adverse drug reactions. Patients with arthritis are among the most frequent users of NSAID and are therefore particularly at risk for these side effects. To evaluate the nature of NSAID-related GI complications and to determine how their frequency can be reduced, a series of studies of such complications in patients with rheumatic disease have been carried out based on data from the Arthritis, Rheumatism, and Aging Medical Information System (ARAMIS). This report briefly reviews the literature and presents recent findings from the ARAMIS studies, which provide an update on published information. It addresses whether GI side effects such as dyspepsia can serve as warning symptoms for life-threatening GI complications and describes the risk factors for these events. It also summarizes a study that investigated whether H2-receptor antagonists and antacids affect the development of serious GI complications. In addition, ongoing research and topics to be addressed in future studies are described.
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                Author and article information

                Journal
                Drug Healthc Patient Saf
                Drug Healthc Patient Saf
                Drug, Healthcare and Patient Safety
                Drug, Healthcare and Patient Safety
                Dove Medical Press
                1179-1365
                2018
                19 March 2018
                : 10
                : 9-19
                Affiliations
                [1 ]Department of Medical Library and Information Sciences, School of Management and Medical Informatics, Tabriz University of Medical Sciences, Tabriz, Iran
                [2 ]Tabriz Health Service Management Research Center, Tabriz University of Medical Sciences, Tabriz, Iran
                [3 ]Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran
                [4 ]Faculty of Pharmacy, Near East University, Nicosia, Cyprus
                [5 ]Department of Clinical Pharmacy, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran
                Author notes
                Correspondence: Sedigheh Mirzadeh Qasabeh, Department of Medical Library and Information Sciences, Room Number 210, School of Management and Medical Informatics, Tabriz University of Medical Science, Behind the Shahid Madani Heart Hospital, Tabriz, Iran, Tel +98 91 4197 3248, Email se.mqas@ 123456gmail.com
                Article
                dhps-10-009
                10.2147/DHPS.S150428
                5863713
                29593437
                95a8a8cd-a757-4400-b338-cd6848d23830
                © 2018 Zarea Gavgani et al. This work is published and licensed by Dove Medical Press Limited

                The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

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                Public health
                flesch–dayani indicator,drug package insert,patient package inserts,readability,pharmaceutical brochures,leaflet,drug guide,flesch–dayani readability

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