Patient information leaflets of opioid analgesics — evaluation of their content from patient and other users perspectives

Abstract

Introduction. Patient information leaflet (PIL), enclosed to the drug, is the basic source of information provided for the patient, caregivers, physicians and pharmacists. The usage of opioid analgesics (because of safety of the treatment) requires education of the patient. Therefore, the information included in the PILs, as well as its presentation is essential.

Material and methods. The information included in PILs of 17 commonly used opioids has been the material of the study. The applied method based on an analysis of the contents of the PILs with a focus on patients’ and other people’s safety.

Results. The analysis has indicated that, in general, key messages provided in all PILs are similar and the content of PILs meets the minimal legal requirements. However, it has been found that the information in some PILs is incomplete, what in turn, may affect the safety of the patient and others, e.g. children. There is also apparent discrepancy between the density of information written in particular PILs and the details they include as well as the usage of medical terminology.

Conclusion. In general, the scope of information included in PILs of opioids registered in Poland is in accordance with legal regulations. The differences are visible in detailed information and it may influence patient’s and other people’s safety. Some of the PILs have extended information, while others include only short comments or do not contain the particular issues. Moreover, not all PILs explain in details medical terms, that are not understandable for the users. This inconsistent and incomplete information may lead to misunderstanding of the drug pharmacologic action by the patients, physicians or pharmacists.