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Therapeutic Innovation & Regulatory... Mar 2021In this publication, the authors, having gained several decades of experience in Pharmacovigilance departments, both in pharmaceutical companies as well as in service... (Review)
Review
In this publication, the authors, having gained several decades of experience in Pharmacovigilance departments, both in pharmaceutical companies as well as in service providers companies, describe the reason why and the way how a guideline for outsourcing was created. While outsourcing in pharmacovigilance has become the rule rather than the exception in the last decade, a consensus guideline, based on best practice, appears to be missing. A group of committed professionals have given their time and knowledge to an iterative process of writing and reviewing drafts of such a guideline. One of the authors was closely involved with the writing as well as presenting the draft guidance at conferences. The other author was managing the process, including discussions, periodically reviewing the result, as well as responding to the reviewers' comments. In this publication, a high-level overview of the guideline is provided. The key message is that outsourcing in PV requires both a detailed preparation, including risk assessments of the various elements, as well as close contact with the service provider.
Topics: Outsourced Services; Pharmacovigilance
PubMed: 33118144
DOI: 10.1007/s43441-020-00229-w -
Sultan Qaboos University Medical Journal May 2021
Topics: Drug-Related Side Effects and Adverse Reactions; Humans; Oman; Pharmacovigilance
PubMed: 34221460
DOI: 10.18295/squmj.2021.21.02.001 -
Drug Safety May 2022Authors' views on the role of artificial intelligence and machine learning in pharmacovigilance. (MP4 139807 kb).
Authors' views on the role of artificial intelligence and machine learning in pharmacovigilance. (MP4 139807 kb).
Topics: Artificial Intelligence; Humans; Machine Learning; Pharmacovigilance
PubMed: 35579805
DOI: 10.1007/s40264-022-01177-0 -
Zhongguo Fei Ai Za Zhi = Chinese... Jul 2022In 2019, Drug Administration Law of China was first time proposed that the country should establish pharmacovigilance system. In 2021, the first Pharmacovigilance...
In 2019, Drug Administration Law of China was first time proposed that the country should establish pharmacovigilance system. In 2021, the first Pharmacovigilance Quality Management Standard of China was released. The proposal and implementation of pharmacovigilance were the initial stage in China, and it needed to improve the aspects of pharmacovigilance include institution, monitoring mechanism and database construction. The number of new diagnosed cancer patients in China ranked first in the world. In recent years, the marketing speed of novel antitumor drugs was accelerated, and there were many clinical trials. Therefore, antitumor pharmacovigilance was imperative. In this article, we summarized pharmacovigilance of the origin, clinical practice objectives, procedures, methods. We described the difficulties in antitumor pharmacovigilance and current characteristics of pharmacovigilance in China, aiming to provide reference for the development of antitumor pharmacovigilance. .
Topics: China; Humans; Lung Neoplasms; Pharmacovigilance
PubMed: 35899454
DOI: 10.3779/j.issn.1009-3419.2022.101.33 -
Drug Safety May 2022Monitoring adverse drug events or pharmacovigilance has been promoted by the World Health Organization to assure the safety of medicines through a timely and reliable... (Review)
Review
Monitoring adverse drug events or pharmacovigilance has been promoted by the World Health Organization to assure the safety of medicines through a timely and reliable information exchange regarding drug safety issues. We aim to discuss the application of machine learning methods as well as causal inference paradigms in pharmacovigilance. We first reviewed data sources for pharmacovigilance. Then, we examined traditional causal inference paradigms, their applications in pharmacovigilance, and how machine learning methods and causal inference paradigms were integrated to enhance the performance of traditional causal inference paradigms. Finally, we summarized issues with currently mainstream correlation-based machine learning models and how the machine learning community has tried to address these issues by incorporating causal inference paradigms. Our literature search revealed that most existing data sources and tasks for pharmacovigilance were not designed for causal inference. Additionally, pharmacovigilance was lagging in adopting machine learning-causal inference integrated models. We highlight several currently trending directions or gaps to integrate causal inference with machine learning in pharmacovigilance research. Finally, our literature search revealed that the adoption of causal paradigms can mitigate known issues with machine learning models. We foresee that the pharmacovigilance domain can benefit from the progress in the machine learning field.
Topics: Causality; Drug-Related Side Effects and Adverse Reactions; Humans; Machine Learning; Models, Theoretical; Pharmacovigilance
PubMed: 35579811
DOI: 10.1007/s40264-022-01155-6 -
Therapie Apr 2016Self-medication means resorting to one or more drugs in order to treat oneself without the help of a doctor. This phenomenon is developing fast. In this review, we will... (Review)
Review
Self-medication means resorting to one or more drugs in order to treat oneself without the help of a doctor. This phenomenon is developing fast. In this review, we will discuss the main definitions of self-medication; we will then present a few important characteristics of this therapeutic practice: prevalence, reasons, populations involved and drugs used. Whilst the theoretical risks of self-medication have been abundantly discussed in the literature (adverse effects, interactions, product, dosage or treatment duration errors, difficulty in self-diagnosis, risk of addiction or abuse…), there is in fact very little detailed pharmacovigilance data concerning the characteristics and the consequences of this usage in real life. This study therefore describes the all too rare data that is available: patients, clinical characteristics, "seriousness" and drugs involved in the adverse effects of self-medication. It also discusses leads to be followed in order to minimize medication risks, which are obviously not well known and clearly not sufficiently notified.
Topics: Drug-Related Side Effects and Adverse Reactions; Humans; Pharmacovigilance; Risk; Self Medication
PubMed: 27080848
DOI: 10.1016/j.therap.2016.02.012 -
Therapie Apr 2016This article reviews the main historical events before the 21st century and explained their consequences in the current pharmacovigilance legislation. (Review)
Review
This article reviews the main historical events before the 21st century and explained their consequences in the current pharmacovigilance legislation.
Topics: Drug-Related Side Effects and Adverse Reactions; History, 19th Century; History, 20th Century; History, 21st Century; Humans; Legislation, Drug; Pharmacovigilance
PubMed: 27080830
DOI: 10.1016/j.therap.2015.12.007 -
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 -
Drug Safety Jul 2019Pharmacovigilance has received much attention in Arab countries recently due to the development of new regulations. However, there are differences in the progression of... (Review)
Review
Pharmacovigilance has received much attention in Arab countries recently due to the development of new regulations. However, there are differences in the progression of pharmacovigilance systems by regulatory agencies in these countries because only some are able to meet the requirements for conducting pharmacovigilance activities. Only 45% of Arab countries are official members of the World Health Organization (WHO) Collaborating Centre for International Drug Monitoring. Countries such as Morocco, Tunisia, Saudi Arabia, Egypt, and Jordan are considered to be advanced pharmacovigilance countries, whereas other countries such as Libya, Yemen, and Palestine remain in the very early stages of implementing and developing pharmacovigilance systems. Countries such as Somalia, Djibouti, Mauritania, and Comoros Island have no pharmacovigilance system or culture. Asian Arab countries have some advantages over those in Africa because 50% of them are a part of the Gulf Cooperation Council (GCC), meaning that most of them can utilize similar approaches for the application of the majority of activities related to the healthcare system, including pharmacovigilance. Thus, participating in the GCC enables increased connections among these countries. However, one of the strengths in Africa is that Morocco is partnering with the WHO through the WHO Collaborating Center to enhance and strengthen pharmacovigilance across the Eastern Mediterranean Region and the Francophone and Arab countries. This partnership could have a role in enhancing the pharmacovigilance culture among African Arab countries. This review provides a general overview of the current situation regarding regulatory agencies related to pharmacovigilance in Arab countries.
Topics: Developing Countries; Drug-Related Side Effects and Adverse Reactions; Humans; Middle East; Pharmacovigilance; Population Surveillance
PubMed: 31006085
DOI: 10.1007/s40264-019-00807-4 -
European Journal of Clinical... Jul 2018The effectiveness of active pharmacovigilance depends on the specific methods adopted and the work patterns put into place. Over the past few years, much attention has... (Review)
Review
BACKGROUND
The effectiveness of active pharmacovigilance depends on the specific methods adopted and the work patterns put into place. Over the past few years, much attention has been paid to the importance of implementing such systems in China. However, less has been done to evaluate the state of implementation and future needs of such systems.
METHODS
This paper reviews China's recent approaches to active pharmacovigilance by examining: (1) information collected from scientific articles and the websites of the China Food and Drug Administration and the China National Center for Adverse Drug Reaction Monitoring, (2) information available on China's spontaneous reporting systems (SRS) and active pharmacovigilance system, and (3) annual reports and internal reports on this subject.
RESULTS
Areas that improved most meaningfully for China's active pharmacovigilance in recent years appear to include: (1) quicker reporting and more intelligent scanning methods for adverse drug reactions (ADRs), (2) the use of pharmacovigilance approaches to mine electronic hospital records, and (3) the development of integrated systems including the China Hospital Pharmacovigilance System and China Sentinel Hospital Alliance Program.
CONCLUSION
Not only has the national online SRS system provided a platform for passive pharmacovigilance, it has also become an important platform for various explorations of active pharmacovigilance in China. Quick reporting and intelligent scanning of ADRs, facilitated by automated ADR detection based on electronic hospital records, have accelerated to capabilities for active pharmacovigilance. The outcomes of the programs, such as the China Hospital Pharmacovigilance System and China Sentinel Hospital Alliance Program, usher in a new era for China's active pharmacovigilance. These are particularly important to bridge the information system of sentinel hospitals and ADR research centers, but gaps remain. Thus, much work needs to be done before a high-level active pharmacovigilance system is sufficiently mature to ensure drug safety in the country.
Topics: Adverse Drug Reaction Reporting Systems; China; Hospital Information Systems; Humans; Pharmacovigilance
PubMed: 29637279
DOI: 10.1007/s00228-018-2455-z