Evaluation of medication package inserts in Iran

Khamas, Shahriyar Shahbazi; Jafari, Alireza; Zarif-Yeganeh, Morvarid; Taghvaye‐Masoumi, Hamidreza

doi:10.4103/jrpp.jrpp_18_32

Cited by 5 publications

(5 citation statements)

References 18 publications

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“…The limited availability of PIs in Iran was confirmed in another study of 100 commonly used medicines, 63% of which had a PI [ 126 ] and none of which met all local regulatory requirements, with the authors suggesting superior WMI accompanied imported products. Additional studies found missing information in 104 PIs for psychiatric drugs [ 125 ], that 92 PIs for neurological drugs failed to fully meet Iran’s local requirements [ 127 ] and that the readability of 71% of 33 PIs was graded as difficult [ 124 ].…”

Section: Resultsmentioning

confidence: 96%

Provision and Need for Medicine Information in Asia and Africa: A Scoping Review of the Literature

2021

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Published reviews of written medicine information (WMI) have mainly drawn on studies published in high-income countries, including very few Asian or African studies. We therefore set out to scope the research literature to determine the extent and type of studies concerning WMI for patients/consumers across these two continents. We sought empirical studies published between January 2004 and December 2019, conducted in any Asian or African country, as defined by the United Nations, in English or with an English abstract. The majority of the 923 papers identified were from high-income countries. We retained 26 papers from Africa and 99 from Asia. Most African studies (n = 20) involved patients in the development of PILs, in the assessment of the effectiveness of PILs or in surveys. In contrast, the highest proportion of Asian studies concerned the content of WMI (n = 42). WMI is desired, but needs to be in local languages, and there needs to be more use made of pre-tested pictograms. Existing WMI frequently does not meet local regulatory requirements, particularly locally manufactured products. A number of studies reported potentially positive impacts of providing WMI on knowledge and medicine use behaviours. Provision of medicine information is essential for safe use of medicines in all countries. Internationally agreed guidelines, incorporating good design principles, are needed to ensure the optimal content and design of WMI. The World Health Organization should support African and Asian regulatory bodies to share best practice in relation to WMI for patients/consumers and to develop and implement pan-continental guidelines that take into account consumer needs and preferences.

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Section: Resultsmentioning

confidence: 96%

Provision and Need for Medicine Information in Asia and Africa: A Scoping Review of the Literature

2021

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“…Examining the quality of the information provided in the DL is substantial, as the presence of obvious details in the leaflet will help the patient use the medication correctly (Gillies et al, 2014). Evaluation of the information content of the DLs was carried out in many previous studies (Al-Aqeel, 2012;Arandy et al, 2019;Chhaya, 2017;Eshtayeh et al, 2019;Khamas et al, 2019;Qatmosh et al, 2017;Rahim & Rafiq, 2013;Shivkar, 2009). Some of these depended on the presence of particular topics in the PIs (Al-Aqeel, 2012;Chhaya, 2017;Khamas et al, 2019;Rahim & Rafiq, 2013;Shivkar, 2009), while other studies built their assessment on both the presence of certain headings and the amount of information provided in the PIs (Arandy et al, 2019;Eshtayeh et al, 2019;Qatmosh et al, 2017;.…”

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

“…Sawalha et al, 2008; Shivkar, 2009). Some of these depended on the presence of particular topics in the PIs (Al-Aqeel, 2012; Chhaya, 2017; Khamas et al, 2019; Rahim & Rafiq, 2013; Shivkar, 2009), while other studies built their assessment on both the presence of certain headings and the amount of information provided in the PIs (Arandy et al, 2019; Eshtayeh et al, 2019; Qatmosh et al, 2017; A. Sawalha et al, 2008).…”

Section: Introductionmentioning

confidence: 99%

“…Evaluation of the information content of the DLs was carried out in many previous studies (Al-Aqeel, 2012;Arandy et al, 2019;Chhaya, 2017;Eshtayeh et al, 2019;Khamas et al, 2019;Qatmosh et al, 2017;Rahim & Rafiq, 2013;Shivkar, 2009). Some of these depended on the presence of particular topics in the PIs (Al-Aqeel, 2012;Chhaya, 2017;Khamas et al, 2019;Rahim & Rafiq, 2013;Shivkar, 2009), while other studies built their assessment on both the presence of certain headings and the amount of information provided in the PIs (Arandy et al, 2019;Eshtayeh et al, 2019;Qatmosh et al, 2017;. In Palestine, many studies were conducted using similar principles to assess the quality and quantity of information provided in the PIs (Arandy et al, 2019;Eshtayeh et al, 2019;Qatmosh et al, 2017;.…”

Section: Introductionmentioning

confidence: 99%

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A Comparative Evaluation of Drug Information Leaflets of Over-the-Counter Medicines in Palestine

Koni,

Snobar,

Ahmed

et al. 2023

Sage Open

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Our study aims to conduct an evaluation and comparison between the leaflets of local and imported oral solid over-the-counter medications (OTC) found in the Palestinian markets. Forty-nine leaflets were evaluated using a scoring method and depending on the appearance of 31 headings, along with the use of manual word counting to assess the amount of information within 23 topics of all 31. None of the evaluated PIs, local or imported, completed all 31 criteria. Remarkably, the imported product leaflets achieved higher scores than their local leaflets in 19 out of 31 topics, whereas the local products achieved better scores than the imported agents in only 2 items, and 10 criteria were equally scored between them. None of the PIs mentioned pharmacokinetic information, instructions for converting tablets or capsules into liquid forms, or shelf life. In general, imported leaflets give more detailed information than their local counterparts. The lowest value of the fold difference in mean rank was 0.85 times for the direction of use, and the highest value was 2.43-fold for adverse drug reactions. The results showed a deficiency in the information provided in the local package inserts compared to the imported versions of oral solid OTC medications available in Palestine. These findings encourage the Palestinian Ministry of Health to provide full criteria for pharmaceutical companies to ensure that the leaflets contain sufficient and updated information and ensure that the patients use their drugs safely and effectively.

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Utility of information in package inserts by pharmacists and pharmacy clients in a metropolitan city in Southwest Nigeria

Showande

Victor

2020

Journal of Pharmaceutical Health Services Research

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Objective Package inserts provide relevant information to patients and health care professionals on the safety and rational use of drugs. This study evaluated the utility of package inserts by pharmacy clients for information, and by pharmacists during consultation and counselling with patients. Methods This cross-sectional self-administered questionnaire-based study was conducted in Ibadan, Nigeria among 705 pharmacy clients and 344 community and hospital pharmacists. The questionnaire had a 12-item and a 14-item package insert utility scale for pharmacists and pharmacy clients, respectively. The level of utility and association between demographic variables and package insert utility scores were determined with Mann–Whitney U and Kruskal–Wallis tests at P < 0.05. Key findings The response rate was 88.2% for pharmacy clients and 67.2% for pharmacists. Most of the pharmacy clients, 459 (73.8%), check for package inserts in drug packs. The most assessed information in package inserts was dose 432 (69.5%). Some of the pharmacy clients, 276 (44.4%), considered information from health professionals more reliable than that in package inserts. The pharmacy clients’ level of education was associated with package insert utility score (P = 0.001). Most of the pharmacists, 137 (59.3%), read package inserts but only 36 (15.6%) consulted package inserts during counselling with patients. The pharmacists’ age and the number of years spent in practice were significantly associated with package insert utility scores (P < 0.05). The level of utility of the information in package inserts by the pharmacy clients and the pharmacists was moderate – 66.8 and 60.0%, respectively. Conclusion Both pharmacists and pharmacy clients use package insert content moderately. Pharmacy clients rely more on information provided by health professionals than the information in package inserts but pharmacists seldom consult package inserts during counselling process.

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Evaluation of medication package inserts in Iran

Cited by 5 publications

References 18 publications

Provision and Need for Medicine Information in Asia and Africa: A Scoping Review of the Literature

Provision and Need for Medicine Information in Asia and Africa: A Scoping Review of the Literature

A Comparative Evaluation of Drug Information Leaflets of Over-the-Counter Medicines in Palestine

Utility of information in package inserts by pharmacists and pharmacy clients in a metropolitan city in Southwest Nigeria

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