Abstract
BackgroundPatient 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.MethodsEighteen 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.ResultsIn 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.ConclusionsSignificant 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.
Highlights
Patient package inserts (PPIs) should provide accurate, sufficient, and clear information for patients as well as health care professionals
Patient information leaflets The total number of anti-diabetic agents that were available in the Palestinian markets was 18
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
Summary
Patient package inserts (PPIs) should provide accurate, sufficient, and clear information for patients as well as health care professionals. Patient package inserts (PPIs) are probably the most accessible source of drug information for both patients and health care professionals, as PPIs always accompany prescription only and over the counter (OTC) drugs, this is true especially in areas with limited healthcare resources [1]. PPIs still reflect major drawbacks, as patients may feel frightened from the listed drug side effects in PPI and have confusion while reading medical jargon [5, 6]. This highlights the necessity for PPIs to be clear and comprehensible for the general public. The Palestinian law does not create strict guidelines that adjust the design and types of information included by PPIs [9]
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