Comparative evaluation of drug information leaflets for non-steroidal anti-inflammatory drugs in Palestine: local versus imported products

Abstract

BackgroundDrug information leaflets (DILs) are written for patients and health care providers to show how to use the medications safely and effectively, in order to reach the required therapeutics outcomes. This comparative study was conducted to evaluate various DILs of non-steroidal anti-inflammatory drugs (NSAIDs) that are produced in Palestine, along with their imported equivalents.MethodsThirty-five DILs of NSAIDs were analyzed and evaluated in a cross-sectional comparative study. Thirty-one statements were obtained from literature and used; evaluation was performed on basis of both any presence or absence of these statements in the leaflets. 23 of the 31 statements that were available in both local and imported DILs were also evaluated in terms of total word-counts: the median (interquartile range) word-count for each statement was determined separately for the two groups and then compared. For the remaining 8 statements, this was not performed,either because they were not present in any leaflet, or because counting the number of words would not be meaningful.ResultsA total of 35 DILs for nine different active ingredients of NSAIDs were analyzed. In 97% of leaflets, “Instructions to convert medication into liquid forms” were missing and 94% did not provide any information about “Pharmacokinetics”. 83% of DILs provided no information about “Mechanism of action” and 74% did not mention any reliable references. 66% of the analyzed inserts did not include any instruction about the possibility of a tablet splitting. And in 63%, the “Date of last revision” was missing. Further, “Duration of using” and “Inactive ingredients” were not found in 51% of leaflets. In terms of word-count, the related sections of the 23 selected criteria were expressed with more words by imported leaflets compared with the local ones, significant differences were found in 12 categories, the highest significance of > 42.4-fold difference was found in “Geriatric considerations” category whereas 1.4-fold difference was found in “Shelf life,” being the lowest one.ConclusionsThis study shows that local products provide less information than imported products, so we recommend that appropriate measurements be taken by both Palestinian authorities and manufacturers to improve both quantity and quality of local DILs.

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

“…The median word count [Q1–Q3] was 52.0 [42.0–71.3] and 160.0 [130.0–260.0] for the local and imported leaflets, respectively. Similar results were also found in many other Palestinian studies (Arandy et al, 2019; Eshtayeh et al, 2019; Qatmosh et al, 2017; A. Sawalha et al, 2008).…”

“…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;.…”

“…Sawalha et al, 2008). 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; A. Sawalha et al, 2008).…”

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

“…In Palestine, surveys involving 594 consumers found that 45–52% always read PIs [ 115 , 116 ]; one also noted that most consumers wanted information in Arabic [ 116 ] and that written information was sometimes vague or not useful. A study focusing on administration of oral drops noted inaccurate instructions [ 118 ], while four further studies assessed the content of PIs [ 117 , 119 – 121 ], consistently finding both incomplete information and PIs for locally manufactured products having greater deficiencies in content than those for imported products. Such differences were also reported regarding PIs available in Abu Dhabi [ 134 ], which concurs with findings from other countries [ 75 , 81 ].…”

Knowledge, Attitudes, and Practices of Pills Splitting in Malaysia: A Cross-Sectional Study

“…Therefore, patients will not know the divisibility of the tablet unless they ask health professionals more regarding that topic. 8 In Malaysia, there is no tablet-splitting guideline implemented by the government for health professionals. Under this circumstance, little is known about the tablet splitting practice in Malaysia.…”