The Value of Patient Reporting of Adverse Drug Reactions to Pharmacovigilance Systems

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Title: The Value of Patient Reporting of Adverse Drug Reactions to Pharmacovigilance Systems
Author: Inácio, Pedro
Contributor: University of Helsinki, Faculty of Pharmacy, Division of Pharmacology and Pharmacotherapy
Doctoral Programme in Drug Research
Publisher: Helsingin yliopisto
Date: 2018-09-28
Language: en
Thesis level: Doctoral dissertation (article-based)
Abstract: Patient reporting of adverse drug reactions (ADRs) has become an important element of pharmacovigilance. The aim of this thesis was to research the value of patient reporting of ADRs to pharmacovigilance systems. The study consists of 4 original studies, of which study I and II are interrelated. Study I identified which are the clinical and subjective aspects of adverse drug reactions (ADRs) that patients provide. A literature review covered peer-reviewed literature published in English until January 2015, in a total of 34 studies. Main results supported patient reporting having the advantages of bringing novel information about ADRs. Patients provide a more detailed description of ADRs and report about different medicines, system organ classes and effects when compared with health care providers (HCPs). In addition, patients describe the severity and impact of ADRs on daily life, complementing information derived from HCPs. Patient reporting is still relatively rare in most countries. This study concluded that patient reporting adds new information, and perspective about ADRs in a way otherwise unavailable. The opinions and experiences of different stakeholders on the role of direct patient reporting were explored through a series of qualitative interviews in selected countries (Study II). Participants from countries introducing patient reporting recently expressed a more negative attitude. All participants highlighted the need for additional resources, both human and financial, to address patient reporting and associated advantages. The findings identified perceived barriers and facilitators of patient reporting, such as the engagement of patients, use of information and dissemination of patient reporting. Study III analyzed the correlation between several sociodemographic and economic factors and direct patient reporting rate in diverse countries. The study was based on the hypothesis that a higher human development index is related with a higher reporting rate and patient involvement in their health status. Health investment indicators, such as per capita public health expenditure, hospital bed density and under-five mortality rate categories were the relevant factors to discriminate countries that have higher patient reporting rates. Although general, these results point that to reach better patient involvement in the pharmacovigilance system it is preferable to invest in public health education rather than to have more sophisticated pharmacovigilance systems designed to capture all patients’ inputs. Study IV aimed to assess the degree of variation of language used by HCPs when describing ADRs and to compare it with the corresponding Medical Dictionary of Regulatory Activities (MedDRA) codes. The study concluded that lexical and semantic distances between spontaneous reports and coded terms by MedDRA exist, as well as between different groups of HCPs. These differences may interfere with the strength of a generated safety signal, which places more value into having additional source of ADRs information e.g. from the patients. In this context, HCPs can be seen as bench-markers, while assessing the pharmacovigilance system maturity.
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