Indirect and Direct 65+ Patient Reporting of Non-Steroidal Anti-Inflammatory Drug-Induced Adverse Drug Reactions as a Source of Information on Polypharmacy and Polypharmacy-Related Risk.

Background and Objectives: Non-steroidal anti-inflammatory drugs (NSAIDs), which have anti-inflammatory and analgesic properties, are commonly used in the treatment of various, particularly frequent, as well as chronic, conditions in older patients. Due to common polypragmasia in these patients and a high risk of adverse drug reactions (ADRs) and drug interactions, pain management poses a therapeutic challenge. This study describes the importance of ADR reports in the identification of polypharmacy and the ensuing interactions. Materials and Methods: Both healthcare professionals (HPs) and non-healthcare professionals (non-HPs) reports collected in the EudraVigilance database of NSAIDs, including most commonly co-reported medications and reported reactions, were analysed and differences between HPs and non-HPs reports were identified. Results: In the analysed period and group, non-HPs reported more reactions but indicated fewer drugs as suspect or concomitant. The outcomes of our analysis indicate more HP engagement and more detailed reports of serious ADRs when compared to non-serious individual case safety reports (ICSRs) by non-HPs, which appeared more detailed. Such reactions as kidney failure and increased risk of bleeding are known adverse reactions to NSAIDs and common symptoms of their interactions, which were described in the available literature. They were much more frequently reported by HPs than by non-HPs. Non-HPs more frequently reported reactions that may have been considered less significant by HPs. Conclusions: The differences between healthcare professionals' (HPs) and non-healthcare professionals' (non-HPs) reports may result from the fact that the reports from patients and their caregivers require a professional medical diagnosis based on symptoms described by the patient or additional diagnostic tests. This means that when appropriately classified, medically verified, and statistically analysed, the data may provide new evidence for the risks of medication use or drug interactions.

[Phytotherapy threats with emphasis on St. John's wort medicines]. / Zagrozenia fitoterapii ze szczególnym uwzglednieniem preparatów dziurawca.

Plant medicines used by patients in self-treatment contain powerfully acting active substances which can be a source of adverse events including interactions with synthetic medicines. Usage of St. John's wort causes high risk of various complications. St. John's wort preparations shouldn't be combined with antidepressants without physician's consultation. Long-term intake of medicines which contain Hypericum perforatum extracts can be a reason of undesirable interactions with isoenzymes CYP3A4, CYP1A2, CYP2C9, CYP2C19 and P-glycoprotein (P-gp) for which St John's wort is a substrate. Compounds present in the St. John's wort, especially hyperforin, increase the activity of cytochrome P450 in the liver and intestinal mucosa as well as P-gp, which can accelerate their elimination from the body, decrease their concentrations and reduce the effect. Effective and safe phytotherapy requires a lot of knowledge about the properties and toxicity of preparations used and accurate monitoring of the consequences of their actions.

The Importance of Direct Patient Reporting of Adverse Drug Reactions in the Safety Monitoring Process.

All medicinal products authorized in the European Union are subjects of constant drug-safety monitoring processes. It is organized in a pharmacovigilance system that is designed to protect human health and life by the detection, analysis and prevention of adverse drug reactions (ADRs) and other drug-related problems. The main role of the aforementioned system is to collect and analyze adverse drug reaction reports. Legislation introduced several years ago allowed patients, their legal representatives and caregivers to report adverse drug reactions, which caused them to be an additional source of safety data. This paper presents the analysis of EudraVigilance data related to adverse drug reactions provided by patients, their representatives, as well as those obtained from healthcare professionals related to medicines which belong to M01A anti-inflammatory and antirheumatic products, a non-steroid group. The objective of the study was to identify the changes in the number and structure of adverse reaction reporting after the introduction of pharmacovigilance (PV) obligations in EU. A review of scientific literature was also conducted to assess the differences in adverse reactions reported by patients or their representatives and by healthcare professionals. We also identified other factors which, according to literature review, influenced the number of adverse reaction reports provided by patients. Analysis of data collected from the EudraVigilance showed that from 2011 to 2013 the number of reports made by patients and their caregivers increased by approx. 24 percentage points, and then, from 2014, it constituted around 30% of the total of reported reactions every year, so patient reporting is an important part of pharmacovigilance system and a source of drugs' safety information throughout their use in healthcare practice. Additionally, there was no interrelationship between the seriousness of reported adverse reactions and the overall number of patient reports when compared to reports form healthcare professionals.