New approaches in drug safety assessment based on information provided by doctors and patients in the register “PROFILE”

Abstract

The aim to compare various sources of the pharmacotherapy safety information in the outpatient register.Materials and methods. The original questionnaire included several questions for assessing information about patients’ knowledge of the concept of AEs of drug therapy, awareness of the possibility of drugs’ AEs, how often patients read the instructions for drugs and actions of patients in cases of AEs occurrence. Adverse events appearance were noted by the patients themselves in questionnaire and by doctors when completing the IRCs for the period from September 1. 2017 to May 31. 2018 are compared.Results. Of the 162 patients who answered the questions in the original questionnaire, there were 80 women and 82 men. 112 patients were observed by doctors regularly (at least 1 time per year), 16 people visited doctors 1 time in 1–2 years, 14 people were with a doctor more than 2 years ago, in 18 patients information on the regularity of observation by doctors is not indicated were. According to the questionnaire, the majority of patients (145 (89.5 %)) were familiar with information about the possibility of developing side effects of drugs, and 125 (86.2 %) people received this information from their doctor, 19 (13.1 %) noted that the doctor did not inform them about this. Only 6 patients did not know anything about AE pharmacotherapy. As the questionnaire showed, most patients get acquainted with the instructions for the prescribed medications. Comparison of data from the IRCs and questionnaires revealed more frequent registration of AE by doctors; however, there was an incomplete coincidence of information about the presence of AE from different sources.Conclusion. Using data from the retrospective-prospective registry with obtaining information about adverse events from doctors in combination with simultaneous patients questionare could get more complete information about safety of pharmacotherapy. At the same time solution to the problem of farmacotherapy safety lives in optimizing the doctor–patient relationship.

Keywords

• register
• questionnaire
• safety of pharmacotherapy
• adverse events
• side effects
• adverse drug interactions
• adverse drug reactions
• clinical trials
• individual registration cards
• questionnaire