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Drug Safety May 2022Artificial intelligence based on machine learning has made large advancements in many fields of science and medicine but its impact on pharmacovigilance is yet unclear. (Review)
Review
INTRODUCTION
Artificial intelligence based on machine learning has made large advancements in many fields of science and medicine but its impact on pharmacovigilance is yet unclear.
OBJECTIVE
The present study conducted a scoping review of the use of artificial intelligence based on machine learning to understand how it is used for pharmacovigilance tasks, characterize differences with other fields, and identify opportunities to improve pharmacovigilance through the use of machine learning.
DESIGN
The PubMed, Embase, Web of Science, and IEEE Xplore databases were searched to identify articles pertaining to the use of machine learning in pharmacovigilance published from the year 2000 to September 2021. After manual screening of 7744 abstracts, a total of 393 papers met the inclusion criteria for further analysis. Extraction of key data on study design, data sources, sample size, and machine learning methodology was performed. Studies with the characteristics of good machine learning practice were defined and manual review focused on identifying studies that fulfilled these criteria and results that showed promise.
RESULTS
The majority of studies (53%) were focused on detecting safety signals using traditional statistical methods. Of the studies that used more recent machine learning methods, 61% used off-the-shelf techniques with minor modifications. Temporal analysis revealed that newer methods such as deep learning have shown increased use in recent years. We found only 42 studies (10%) that reflect current best practices and trends in machine learning. In the subset of 154 papers that focused on data intake and ingestion, 30 (19%) were found to incorporate the same best practices.
CONCLUSION
Advances from artificial intelligence have yet to fully penetrate pharmacovigilance, although recent studies show signs that this may be changing.
Topics: Artificial Intelligence; Humans; Machine Learning; Pharmacovigilance
PubMed: 35579812
DOI: 10.1007/s40264-022-01176-1 -
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 -
Annales Pharmaceutiques Francaises Sep 2022Globally, the use of drugs from traditional pharmacopoeias is a major subject. The confidence of the populations in these drugs is linked to their presumption of safety... (Review)
Review
Globally, the use of drugs from traditional pharmacopoeias is a major subject. The confidence of the populations in these drugs is linked to their presumption of safety and also to the fact that geographically and financially they are more accessible than synthetic drugs. In view of the high exposure of the world population to traditional medicines, they are subject to pharmacovigilance guaranteeing their safety in use. Thus, this review aims to take stock of the risks identified by the national pharmacovigilance systems. It is based on research referenced in PubMed, Embase, ScienceDirect and GoogleScholar. These studies indicate that the use of traditional drugs can involve risks including adverse effects, interactions with synthetic drugs, adulteration and contamination. The spontaneous notification system was the basis for their identification. Strengthening this system and making populations aware of these risks constitute the key levers for traditional medicines pharmacovigilance progress.
Topics: Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions; Humans; Pharmacovigilance; Synthetic Drugs
PubMed: 34914891
DOI: 10.1016/j.pharma.2021.11.008 -
Research in Social & Administrative... Jan 2019Pharmacovigilance is the pharmacological science associated with the detection, understanding and prevention of adverse effects, especially long-term and short-term... (Review)
Review
Pharmacovigilance is the pharmacological science associated with the detection, understanding and prevention of adverse effects, especially long-term and short-term adverse effects of medicines. In the present day pharmaceutical scenario, where the development and marketing of an ever-growing array of medicines has rendered their safety and therapeutic efficacy key to determining the success of a drug, pharmacovigilance has come about to play a critical and significant part. While pharmacovigilance, as a system, has witnessed considerable progress and evolution in the West, not as much has been accomplished in India. With India now being recognised as a hub of global clinical trials and with an increasing number of clinical trials and clinical research studies being conducted actively, the need for a dynamic pharmacovigilance network with an efficient and prudent operation methodology is felt, now more than ever. This article observes the evolution of the pharmacovigilance system in India, with a fundamental overview of the present system in place and also various schemes and proposals to establish and sustain the same. It also examines the challenges faced in the execution of an effective pharmacovigilance network as well as the future prospects with regards to the Indian market.
Topics: Adverse Drug Reaction Reporting Systems; Clinical Trials as Topic; Guidelines as Topic; Humans; India; Pharmacovigilance
PubMed: 29602659
DOI: 10.1016/j.sapharm.2018.03.061 -
Pharmacoepidemiology and Drug Safety Dec 2019
Topics: Drug-Related Side Effects and Adverse Reactions; Humans; Pharmaceutical Services; Pharmacies; Pharmacists; Pharmacovigilance
PubMed: 31714644
DOI: 10.1002/pds.4901 -
Current Drug Safety 2024Pharmacovigilance is important for generating accurate safety of herbal medications information. The present methods were designed for synthetic medications and will... (Review)
Review
Pharmacovigilance is important for generating accurate safety of herbal medications information. The present methods were designed for synthetic medications and will need to be modified to account for the unique characteristics of medicinal plants. The objective of pharmacovigilance is to identify, measure, and explain adverse effects or other potential drug-related issues associated with herbal, traditional, and complementary therapies, as well as to avoid them. Required data for pharmcovigilance of herbal drugs and formulation were obtained from electronic sources (google scholar, PubMed, Scopus, Web of Science), several textbooks. The keywords used to search for various journal publishers such as Willey Online Library, Springer, Wolters Kluwer and Elsevier were closely monitored. This review article covers all the relevant information on issues and challenges in pharmacovigilance of formulation covering Herbal drugs.
Topics: Humans; Pharmacovigilance; Plants, Medicinal; Drug-Related Side Effects and Adverse Reactions
PubMed: 36757041
DOI: 10.2174/1574886318666230209110922 -
Therapeutic Innovation & Regulatory... Jul 2020There are significant challenges and opportunities in deploying and utilizing advanced information technology (IT) within pharmacovigilance (PV) systems and across the... (Review)
Review
There are significant challenges and opportunities in deploying and utilizing advanced information technology (IT) within pharmacovigilance (PV) systems and across the pharmaceutical industry. Various aspects of PV will benefit from automation (e.g., by improving standardization or increasing data quality). Several themes are developed, highlighting the challenges faced, exploring solutions, and assessing the potential for further research. Automation of the workflow for processing of individual case safety reports (ICSRs) is adopted as a use case. This involves a logical progression through a series of steps that when linked together comprise the complete work process required for the effective management of ICSRs. We recognize that the rapid development of new technologies will invariably outpace the regulations applicable to PV systems. Nevertheless, we believe that such systems may be improved by intelligent automation. It is incumbent on the owners of these systems to explore opportunities presented by new technologies with regulators in order to evaluate the applicability, design, deployment, performance, validation and maintenance of advanced technologies to ensure that the PV system continues to be fit for purpose. Proposed approaches to the validation of automated PV systems are presented. A series of definitions and a critical appraisal of important considerations are provided in the form of use cases. We summarize progress made and opportunities for the development of automation of future systems. The overall goal of automation is to provide high quality safety data in the correct format, in context, more quickly, and with less manual effort. This will improve the evidence available for scientific assessment and helps to inform and expedite decisions about the minimization of risks associated with medicines.
Topics: Drug Industry; Pharmacovigilance; Technology
PubMed: 32557311
DOI: 10.1007/s43441-019-00023-3 -
Drug Safety Apr 2016The world changes continuously and pharmacovigilance as a new discipline also must change. There are new fields opening with novel challenges whilst we are still...
The world changes continuously and pharmacovigilance as a new discipline also must change. There are new fields opening with novel challenges whilst we are still perfecting ways to manage and improve the basic challenges such as inadequate data for decision making and under-reporting. Traditional medicines, vaccines, poisoning and medication error are all aspects of the safety of medicines that we have monitored for decades, though without perhaps paying enough attention to their special aspects. There are many new stakeholders taking serious interest in pharmacovigilance outside the regulatory sphere and they often focus on improving individual patient care, rather than the more traditional concentration on broad public health. The same stakeholders are also drawing attention to other iatrogenic outcomes that should be recognised, evaluated and their outcomes compared and contrasted with medication, such as harm from medical devices. The vigilance methods used for medication are very much applicable to all these new fields, though more and different expertise will be needed to evaluate outcomes.
Topics: Drug Monitoring; Humans; International Cooperation; Medication Errors; Pharmacovigilance; Poisoning; Treatment Outcome
PubMed: 26692393
DOI: 10.1007/s40264-015-0373-x -
Clinical Therapeutics Jun 2020After nearly 12 decades of pharmaceutical catastrophes and the associated groundbreaking regulatory innovations, pharmacovigilance has come down to us in the present day... (Review)
Review
PURPOSE
After nearly 12 decades of pharmaceutical catastrophes and the associated groundbreaking regulatory innovations, pharmacovigilance has come down to us in the present day as 3 interlocking core disciplines: case management, signal management, and benefit-risk management. This review provides a state-of-the-art introduction to the great variety of sources of safety information, both dependent on and independent of the Individual Case Safety Report (ICSR), and explains how this content undergoes management-system processes with globally accepted definitions, standards, and structures that make possible the ongoing safe use of a pharmaceutical product throughout its lifecycle. This occurs in the context of: (1) new products coming to market with new risks for drug-drug interactions, and (2) new global threats to safe manufacturing and distribution.
METHODS
This narrative review, reflective of the author's experience, uses a large-frame system of signal management developed by the Council for International Organizations of Medical Sciences VIII Working Group and modified by the author to include governance. A key feature of the review is the regular inclusion of relevant case studies to provide a backdrop of the unexpected, with resulting tragic outcomes, to the ever-evolving regulatory landscape.
FINDINGS
Regarding content, beyond the commonly appreciated sources of safety information that find their way into ICSRs are non-ICSR-based sources, including preclinical data, manufacturing data, findings from subject-matter experts who participate on data-monitoring committees, outside expert panels, advocacy groups, and independent investigator studies. Regarding process, it is important to recognize that governance is crucial in the effective conduct of signal management, in that subject-matter experts are essential to the scientific and medical aspects of decision making, and business and policy executives are essential in determining the final courses of action, as these decisions have implications for the company.
IMPLICATIONS
Signal management is an integral part of pharmacovigilance practices that strive to obtain all of the information necessary for maintaining the safety profiles of a company's pharmaceutical and biological products, to support favorable benefit-risk balances, and to ensure safe use by health care providers and their patients.
Topics: Animals; Drug Development; Humans; Pharmacovigilance; Risk Assessment
PubMed: 32487428
DOI: 10.1016/j.clinthera.2020.03.018 -
The British Journal of Dermatology Nov 2020
Topics: Adverse Drug Reaction Reporting Systems; Databases, Factual; Drug-Related Side Effects and Adverse Reactions; Humans; Pharmacovigilance
PubMed: 33135791
DOI: 10.1111/bjd.19504