Quality of MedDRA® Coding in a Sample of COVID-19 Vaccine Medication Error Data.

INTRODUCTION: In recent years, there has been increasing interest from regulatory agencies and scientific organisations into the recording, coding and reporting of medication errors. Accuracy and consistency in the handling of medication error reports ensure the safety and effectiveness of medicines and provide reliable information to both healthcare professionals and patients. OBJECTIVE: The authors have examined a sample of Medical Dictionary for Regulatory Activities (MedDRA®) coded reports that describe medication errors to assess the accuracy and consistency of MedDRA® coding, and to identify the main types of coding errors for the newly introduced COVID-19 vaccines. METHODS: The sample of coded terms was assessed by two MedDRA® experts applying the Four Eyes Principle. It included 1500 reported terms drawn from the Uppsala Monitoring Centre database reported up to 25 August, 2021, describing medication errors for COVID-19 vaccines with their assigned MedDRA® terms. RESULTS: One third of the records could not be assessed because of incomplete or unclear verbatims. In one third, MedDRA® term assignments were correct, but another third of the sample was not adequately coded. The most frequent coding errors corresponded to vague MedDRA® Preferred Term assignments despite more detailed information being available in the verbatim for a more precise coding. This observation is similar to findings in the EudraVigilance database, where some of the most frequently assigned MedDRA® terms for medication errors also represent vague concepts. CONCLUSIONS: The findings indicate that understanding of medication error documentation and of the importance of accurate extraction of information from case narratives, as well as knowledge of MedDRA® content and coding guidelines need to be reinforced. The authors provide useful references to training opportunities and to the applicable International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use-Endorsed Guides for MedDRA® users.

Potential of Nanonutraceuticals in Increasing Immunity.

Nutraceuticals are defined as foods or their extracts that have a demonstrably positive effect on human health. According to the decision of the European Food Safety Authority, this positive effect, the so-called health claim, must be clearly demonstrated best by performed tests. Nutraceuticals include dietary supplements and functional foods. These special foods thus affect human health and can positively affect the immune system and strengthen it even in these turbulent times, when the human population is exposed to the COVID-19 pandemic. Many of these special foods are supplemented with nanoparticles of active substances or processed into nanoformulations. The benefits of nanoparticles in this case include enhanced bioavailability, controlled release, and increased stability. Lipid-based delivery systems and the encapsulation of nutraceuticals are mainly used for the enrichment of food products with these health-promoting compounds. This contribution summarizes the current state of the research and development of effective nanonutraceuticals influencing the body's immune responses, such as vitamins (C, D, E, B12, folic acid), minerals (Zn, Fe, Se), antioxidants (carotenoids, coenzyme Q10, polyphenols, curcumin), omega-3 fatty acids, and probiotics.