جستجوی مقالات مرتبط با کلیدواژه "drug labeling" در نشریات گروه "پزشکی"

Background The Patient package inserts are officially published by pharmaceutical companies and authorized by the food and drug administration. The purpose of the package inserts is to provide complete, reliable and safety information about the drug to the consumer. Drug catalogues are another drug information sheet that is made available to physicians due to time constraints and busy schedules to update their knowledge about the existing and novel drugs. Of course, today the digital world has faced tremendous changes in the provision and consumption of pharmaceutical services. Internet of things, artificial intelligence, block chain and cloud computing are new technologies that will revolutionize the future of drug therapy. Digital transformation will lead to accurate drug therapy, cost reduction, saving time and manpower, access to more flexibility and better efficiency in all processes. This review article was about the current situation, challenges and promotion of information provided in the patient package inserts, also the importance of new technologies in the field of medication information.

The Drug Package Insert (PI) is a written information provided by drug manufacturers to deliver essential information for the consumer. This study aimed to investigate quality of the labeling and content of PIs to identify if they meet the criteria of Iran’s Food and Drug Administration (FDA).

A cross-sectional descriptive study was used to evaluate the PPIs of top selling cardiac medications in Iran during March and September 2015 formed the population of this study. We used comparative and descriptive methods in conduction of the study. An evaluation checklist was built based on the regulations of PPI of Iranian Food and Drug Administration (FDA). The presence of criteria was considered as conformity and scored “1” and lacking the criteria was scored “zero”. The descriptive statistics parameters were used for data analysis using SPSS v.20.

A total of 66 PPIs of 13 cardiac drugs from top 33 selling medicines were evaluated using 27 criteria. None of the drug boxes included patient and professional package inserts separately, but the criteria of ‘general guidance to patients’ was observed in 59(89.39)of package inserts. About 64.59% of the information in PPI was consistent with the regulations of drug regulation of the FDA of Iran. All PPIs (100%) included brand name, contraindication, keeping conditions, and the name of the manufacturer. the revision date and resources observed in 4 (6.06%) and 19 (28.71%), respectively. Of total 64.59%.

PPIs need to be improved by both quantity and quality to be appropriate use of patients and consumers