Bulgarian Experience with Adverse Drug Reaction Reports from Patients and Consumers – Retrospective Data-base Study

Abstract

Background: Since 2012, in compliance with the changes in the European legislation, the Bulgarian Drug Agency (BDA) has been receiving adverse drug reaction (ADR) reports directly from patients as well as from healthcare professionals and marketing authorization holders (MAH). Adverse reaction reports from patients and consumers have different characteristics from those sent by healthcare professionals. Moreover, they may require specific algorithm and assessment methods in order to be informative and beneficial to the pharmacovigilance system. Aim: The study aims to analyze the data-base of consumer reports in Bulgaria in order to distinguish and classify the main characteristics of the ADR reports from non-healthcare professionals. Materials and methods: In-depth analysis of the Bulgarian data-base of consumer ADR reports for 2012-2016 was conducted. The criteria include patient demographic characteristics, preferred method of reporting, seriousness and expectedness criteria and most frequently reported pharmacological groups. Results: The data showed the current trends in patient reporting in the country. It also marked new courses for development of the spontaneous reporting system and collection of safety data. The analysis of the data-base showed a rather stable level of patient reporting with a tendency for constant growth every year. Bulgaria follows the world tendencies for high number of reports for insufficiently studied ADRs which meet the seriousness criteria. The review of the most frequently reported ATC codes could lead to the conclusion that the current pharmacovigi-lance methods are not sensitive enough for specific groups of medicines. Conclusions: The results from the conducted study confirm the importance of patient reporting as a valuable source of information on adverse drug reactions. Moreover, it draws the attention to the lack of more sensitive methods for evaluation of drug safety in specific pharmacological groups. Maintenance of consumer-friendly ADR reporting system and innovative assessment algorithms should be the future directions for development in post-marketing surveillance.

A cross-sectional study: comparison of public perceptions of adverse drug reaction reporting and monitoring in eastern and western China

“…Our respondents mainly preferred reporting by telephone, as in other studies [25,43,54]. There were also more people who liked to report ADRs online.…”

“…There were also more people who liked to report ADRs online. Other studies [6,25,46,54] have also showed that some people have a tendency for reporting ADRs via SMS, email, completing a paper form, online, and other reporting methods. Thus, to improve the reporting rate and satisfy the needs and choices of different people, providing a variety of ADR reporting methods and channels is needed when establishing a public ADR reporting system.…”

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

“…The factors linked to investments in healthcare were recorded to correlate with elevated patient engagement in adverse reactions reporting whereas the aspects of pharmacovigilance did not correspond directly to the increase in patients participation in drug-safety monitoring [ 40 ]. Easily accessible and user-friendly systems for patient reporting as well as innovative assessment algorithms have been indicated as future directions for the changes and development of pharmacovigilance [ 41 ]. L. Rolfes et al investigated the level of satisfaction with the feedback received after providing the reports, and they demonstrated that the patients expected the feedback regardless of whether it was provided as a personalized letter or an automated response that confirmed the report submission [ 42 ].…”

The Evaluation of Dermatological Disease Profiles of Neurosurgery Inpatients: A Tertiary Clinic Experience

“…Drug eruptions, also known as toxidermia, are cutaneous symptoms that occur as a result of systemic drug administration. These reactions range from mild erythematous skin lesions to far more serious reactions like toxic epidermal necrosis [12]. Morbilliform or erythematous maculopapular eruptions account for around 40% of all drug eruptions.…”