Department of Medicine, College of Medicine and Health Sciences, An-Najah National University, Nablus, 44839, Palestine.
Poison Control and Drug Information Center (PCDIC), College of Medicine and Health Sciences, An-Najah National University, Nablus, 44839, Palestine.
BMC Public Health. 2019 Aug 2;19(1):1037. doi: 10.1186/s12889-019-7379-8.
Patient package inserts (PPIs) should provide accurate, sufficient, and clear information for patients as well as health care professionals. The goal of this study was to evaluate and compare the PPIs of local and imported anti-diabetic agents in the Palestinian market.
Eighteen leaflets were collected and analysed based on the completeness of 31 criteria using a scoring method, then the quantity of information was assessed by applying word counting of 17 headings and subheadings. Statistical comparisons of the word count for all products were performed using the Mann-Whitney U test with mean ranks. Then the mean ranks for differences in word counts were adjusted to calculate the fold-difference statistic by dividing the higher mean rank by the lower mean rank.
In general, the PPIs of imported agents scored better than local PPIs, but none of the inserts fulfilled the whole criteria. Thirteen out of thirty-one criteria were available in all products. None of these agents had provided any information about duration of use, instructions to convert tablets into liquids forms, pharmacokinetics, or shelf life. Moreover, mechanism of action and maximum dose were deficient in all local PPIs (0.0%), while they were included in 37.5 and 62.5% of imported PPIs, respectively. Furthermore, 90.0% of local PPIs lacked information about drug dose, 80.0% didn't mention any instructions regarding effects on ability to drive or possibility of tablet splitting, and 60.0% didn't involve orders about possibility of tablet crushing. Local PPIs provided inadequate and less detailed instructions regarding many aspects, since the estimated mean rank of local and imported PPIs demonstrated a range of difference from 1.04-fold for missing dose to 2.64-fold for warning and precautions.
Significant differences were being identified, with excellence being assigned to imported PPIs. So, it is worth suggesting some necessary modifications in PPI topography and sequence structure of local diabetic agents. Experts in Palestinian Ministry of Health should implement regulatory guidelines to improve the quality and quantity of information provided by local PPIs. This optimisation could become a step forward toward optimal health practice in our society.
患者用药指南（PPIs）应为患者和医疗保健专业人员提供准确、充分和清晰的信息。本研究的目的是评估和比较巴勒斯坦市场上本地和进口抗糖尿病药物的 PPI。
根据 31 项标准的完整性，使用评分法收集和分析了 18 份传单，然后通过对 17 个标题和副标题的字数进行评估来评估信息量。使用 Mann-Whitney U 检验和平均秩对所有产品的字数进行统计比较。然后，通过将较高的平均秩除以较低的平均秩，调整差异的平均秩以计算折叠差异统计量。
一般来说，进口药物的 PPI 评分优于本地 PPI，但没有一个插页符合所有标准。31 项标准中有 13 项在所有产品中都有提供。这些药物都没有提供任何关于使用期限、将片剂转化为液体形式的说明、药代动力学或保质期的信息。此外，所有本地 PPI 都缺乏作用机制和最大剂量的信息（0.0%），而这些信息分别包含在 37.5%和 62.5%的进口 PPI 中。此外，90.0%的本地 PPI 缺乏药物剂量信息，80.0%的药物没有提到任何关于对驾驶能力的影响或片剂分割的可能性的说明，60.0%的药物没有涉及片剂粉碎的可能性的说明。由于本地和进口 PPI 的估计平均秩显示出从缺失剂量的 1.04 倍到警告和预防措施的 2.64 倍的差异范围，因此本地 PPI 提供了不充分和不详细的说明。
确定了明显的差异，进口 PPI 表现出色。因此，值得对本地糖尿病药物的 PPI 外观和顺序结构进行一些必要的修改。巴勒斯坦卫生部的专家应执行监管准则，以提高本地 PPI 提供的信息量和质量。这种优化可以成为我们社会朝着最佳健康实践迈进的一步。
