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Trends in Pharmacological Sciences Jun 2022Researchers, regulatory agencies, and the pharmaceutical industry are moving towards precision pharmacovigilance as a comprehensive framework for drug safety assessment,... (Review)
Review
Researchers, regulatory agencies, and the pharmaceutical industry are moving towards precision pharmacovigilance as a comprehensive framework for drug safety assessment, at the service of the individual patient, by clustering specific risk groups in different databases. This article explores its implementation by focusing on: (i) designing a new data collection infrastructure, (ii) exploring new computational methods suitable for drug safety data, and (iii) providing a computer-aided framework for distributed clinical decisions with the aim of compiling a personalized information leaflet with specific reference to a drug's risks and adverse drug reactions. These goals can be achieved by using 'smart hospitals' as the principal data sources and by employing methods of precision medicine and medical statistics to supplement current public health decisions.
Topics: Adverse Drug Reaction Reporting Systems; Data Collection; Drug Industry; Drug-Related Side Effects and Adverse Reactions; Hospitals; Humans; Pharmacovigilance
PubMed: 35490032
DOI: 10.1016/j.tips.2022.03.009 -
British Journal of Clinical Pharmacology Sep 2023Pharmacovigilance studies based on spontaneous reporting systems use disproportionality analysis methods to identify drug-event combinations with higher-than-expected... (Review)
Review
Pharmacovigilance studies based on spontaneous reporting systems use disproportionality analysis methods to identify drug-event combinations with higher-than-expected reporting. Enhanced reporting is deemed as a proxy for a detected signal and is used to generate drug safety hypotheses, which can then be tested in pharmacoepidemiologic studies or randomized controlled trials. Higher-than-expected reporting means that the reporting rate of a drug-event combination of interest is disproportionately higher than the rate in a specific comparator or reference set. Currently, it is unclear which comparator is the most appropriate for use in pharmacovigilance. Moreover, it is also unclear how the selection of a comparator may affect the directionality of the various reporting and other biases. This paper reviews commonly used comparators chosen for signal detection studies (active comparator, class-exclusion comparator, and full data reference set). We give an overview of the advantages and disadvantages of each method based on examples from the literature. We also touch upon the challenges related to the derivation of general recommendations for the selection of comparators when mining spontaneous reports for pharmacovigilance.
Topics: Humans; Pharmacovigilance; Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions; Databases, Factual
PubMed: 37226576
DOI: 10.1111/bcp.15802 -
Clinical Therapeutics Dec 2016The discipline of pharmacovigilance is rooted in the aftermath of the thalidomide tragedy of 1961. It has evolved as a result of collaborative efforts by many... (Review)
Review
PURPOSE
The discipline of pharmacovigilance is rooted in the aftermath of the thalidomide tragedy of 1961. It has evolved as a result of collaborative efforts by many individuals and organizations, including physicians, patients, Health Authorities, universities, industry, the World Health Organization, the Council for International Organizations of Medical Sciences, and the International Conference on Harmonisation. Biomedical informatics is rooted in technologically based methodologies and has evolved at the speed of computer technology. The purpose of this review is to bring a novel lens to pharmacovigilance, looking at the evolution and development of the field of pharmacovigilance from the perspective of biomedical informatics, with the explicit goal of providing a foundation for discussion of the future direction of pharmacovigilance as a discipline.
METHODS
For this review, we searched [publication trend for the log value of the numbers of publications identified in PubMed] using the key words [informatics (INF), pharmacovigilance (PV), phar-macovigilance þ informatics (PV þ INF)], for [study types] articles published between [1994-2015]. We manually searched the reference lists of identified articles for additional information.
IMPLICATIONS
Biomedical informatics has made significant contributions to the infrastructural development of pharmacovigilance. However, there has not otherwise been a systematic assessment of the role of biomedical informatics in enhancing the field of pharmacovigilance, and there has been little cross-discipline scholarship. Rapidly developing innovations in biomedical informatics pose a challenge to pharmacovigilance in finding ways to include new sources of safety information, including social media, massively linked databases, and mobile and wearable wellness applications and sensors. With biomedical informatics as a lens, it is evident that certain aspects of pharmacovigilance are evolving more slowly. However, the high levels of mutual interest in both fields and intense global and economic external pressures offer opportunities for a future of closer collaboration.
Topics: Biomedical Research; Humans; Medical Informatics; Pharmacovigilance
PubMed: 27913029
DOI: 10.1016/j.clinthera.2016.11.006 -
Therapie 2022
Topics: Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions; Humans; Pharmacovigilance
PubMed: 35581019
DOI: 10.1016/j.therap.2022.03.001 -
Drug Safety Aug 2021This review is intended to present perspectives from the US experience in enhancing pharmacovigilance on current practices and future opportunities. Best practices... (Review)
Review
This review is intended to present perspectives from the US experience in enhancing pharmacovigilance on current practices and future opportunities. Best practices concepts could be applied worldwide through the presentation of how three pillars of pharmacovigilance: (1) medical and scientific excellence, (2) operational and compliance excellence, and (3) knowledge sharing and experts development in the field could serve as a framework for the establishment of an efficient and successful global pharmacovigilance system.
Topics: Humans; Pharmacovigilance
PubMed: 33993430
DOI: 10.1007/s40264-021-01078-8 -
Journal of Clinical Psychopharmacology Aug 2015
Topics: Drug-Related Side Effects and Adverse Reactions; Humans; Pharmacovigilance; Serotonin Syndrome; Syndrome
PubMed: 26066340
DOI: 10.1097/JCP.0000000000000367 -
Current Medical Research and Opinion Dec 2017This review outlines current issues of the pharmacovigilance (PV) system in the Russian Federation, namely the present state of regulatory aspects, regulatory... (Review)
Review
This review outlines current issues of the pharmacovigilance (PV) system in the Russian Federation, namely the present state of regulatory aspects, regulatory requirements in both Russia and the Eurasian Economic Union, and review of causes of under-reporting of adverse drug reactions. Specific attention will be focused on how the system is designed to monitor drug safety functions, reporting and accountability of pharmaceutical products, their manufacturers and medical staff, the role played by regional centers for drug-safety monitoring, and insufficient understanding of the part taken by patients in the system of PV. The prospects of the Russian PV system and its harmonization with global practice will also be discussed.
Topics: Adverse Drug Reaction Reporting Systems; Drug Monitoring; Drug-Related Side Effects and Adverse Reactions; Humans; Pharmacovigilance; Russia
PubMed: 28562116
DOI: 10.1080/03007995.2017.1336082 -
Pharmacological Research Feb 2015Vaccines have peculiar characteristics as well as their surveillance. Specific requirements, needs and challenges for the vaccine vigilance are discussed in the... (Review)
Review
Vaccines have peculiar characteristics as well as their surveillance. Specific requirements, needs and challenges for the vaccine vigilance are discussed in the perspective to improve the whole system in order to guarantee a safer vaccine use and the keeping of the public confidence in vaccinations. Key elements for the routine safety monitoring, new regulations and some available tools are taken into account. Finally, the Italian experience is shortly described.
Topics: Humans; Italy; Legislation, Drug; Pharmacovigilance; Vaccines
PubMed: 25447592
DOI: 10.1016/j.phrs.2014.10.011 -
Clinical Therapeutics Feb 2023
Topics: Humans; Pharmacovigilance; Drug-Related Side Effects and Adverse Reactions; Drug Interactions; Adverse Drug Reaction Reporting Systems
PubMed: 36641261
DOI: 10.1016/j.clinthera.2022.12.005 -
European Journal of Clinical... Mar 2024The purpose of this narrative review is to provide a comparison of several countries with different legislation and approaches to pharmacovigilance and to point out how... (Review)
Review
PURPOSE
The purpose of this narrative review is to provide a comparison of several countries with different legislation and approaches to pharmacovigilance and to point out how these impact the number of adverse drug reactions (ADRs) that are reported to national competent authorities.
METHODS
Legislative and statistical data regarding ADR reporting from various national competent authorities' websites, databases, and pharmacovigilance centers were used. In combination with the WHO pharmacovigilance quantitative indicator that was applied to evaluate the effectiveness of particular national pharmacovigilance systems in our scope.
RESULTS
The study compared pharmacovigilance systems in six countries, focusing on ADR reporting from 2010 onwards. All countries required MAHs to report ADRs, while healthcare professionals' obligations varied. Per-capita ADR reports increased in all countries with available data, with the United States having a significantly higher reporting rate, possibly due to FDA campaigns. Despite starting later, China's per-capita reporting rate surpassed that of the Czech Republic and Japan. The study highlighted various measures taken by countries to enhance ADR reporting systems since the inception of their programs, contributing to the overall increase in reporting rates.
CONCLUSIONS
ADR reporting is a global priority, with efforts made by different countries to strengthen their pharmacovigilance systems. Some success can be seen in gradually improving per-capita ADR reporting rates. The varying reporting rates and measures taken by each country may serve as a basis for further research and exchange of best practices to improve drug safety monitoring worldwide.
Topics: Humans; Pharmacovigilance; Adverse Drug Reaction Reporting Systems; Health Personnel; Drug-Related Side Effects and Adverse Reactions; Databases, Factual
PubMed: 38135821
DOI: 10.1007/s00228-023-03608-y