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

Abstract

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.