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Pharmacological Research Nov 2023Traditionally, clinical pharmacology has focused its activities on drug-organism interaction, from an individual or collective perspective. Drug efficacy assessment by... (Review)
Review
Traditionally, clinical pharmacology has focused its activities on drug-organism interaction, from an individual or collective perspective. Drug efficacy assessment by performing randomized clinical trials and analysis of drug use in clinical practice by carrying out drug utilization studies have also been other areas of interest. From now on, Clinical pharmacology should move from the analysis of the drug-individual interaction to the analysis of the drug-individual-society interaction. It should also analyze the clinical and economic consequences of the use of drugs in the conditions of normal clinical practice, beyond clinical trials. The current exponential technological development that facilitates the analysis of real-life data offers us a golden opportunity to move to all these other areas of interest. This review describes the role that clinical pharmacology has played at the beginning and during the evolution of pharmacovigilance, pharmacoepidemiology and economic drug evaluations in Spain. In addition, the challenges that clinical pharmacology is going to face in the following years in these three areas are going to be outlined too.
Topics: Cost-Benefit Analysis; Pharmacoepidemiology; Pharmacology, Clinical; Pharmacovigilance; Drug Utilization
PubMed: 37865127
DOI: 10.1016/j.phrs.2023.106967 -
Drug Safety May 2022Increasing availability of electronic health databases capturing real-world experiences with medical products has garnered much interest in their use for... (Review)
Review
Increasing availability of electronic health databases capturing real-world experiences with medical products has garnered much interest in their use for pharmacoepidemiologic and pharmacovigilance studies. The traditional practice of having numerous groups use single databases to accomplish similar tasks and address common questions about medical products can be made more efficient through well-coordinated multi-database studies, greatly facilitated through distributed data network (DDN) architectures. Access to larger amounts of electronic health data within DDNs has created a growing interest in using data-adaptive machine learning (ML) techniques that can automatically model complex associations in high-dimensional data with minimal human guidance. However, the siloed storage and diverse nature of the databases in DDNs create unique challenges for using ML. In this paper, we discuss opportunities, challenges, and considerations for applying ML in DDNs for pharmacoepidemiologic and pharmacovigilance studies. We first discuss major types of activities performed by DDNs and how ML may be used. Next, we discuss practical data-related factors influencing how DDNs work in practice. We then combine these discussions and jointly consider how opportunities for ML are affected by practical data-related factors for DDNs, leading to several challenges. We present different approaches for addressing these challenges and highlight efforts that real-world DDNs have taken or are currently taking to help mitigate them. Despite these challenges, the time is ripe for the emerging interest to use ML in DDNs, and the utility of these data-adaptive modeling techniques in pharmacoepidemiologic and pharmacovigilance studies will likely continue to increase in the coming years.
Topics: Databases, Factual; Humans; Machine Learning; Pharmacoepidemiology; Pharmacovigilance
PubMed: 35579813
DOI: 10.1007/s40264-022-01158-3 -
Zhongguo Zhong Yao Za Zhi = Zhongguo... Nov 2019Taking the Zeyao Materia Medica,Benjing Fengyuan,De Pei Materia Medica,Shiyi Materia Medica,Harmful Benefits of Materia Medica as representative works in Qing...
Taking the Zeyao Materia Medica,Benjing Fengyuan,De Pei Materia Medica,Shiyi Materia Medica,Harmful Benefits of Materia Medica as representative works in Qing Dynasty,this paper extracts text information from four aspects: drug identification,drug use,drug prevention and detoxification,constructs a drug pharmacovigilance information table of Qing Dynasty herbal works,and summarizes the drug pharmacovigilance of Qing Dynasty. Thought,in the Qing Dynasty,there were many recordings of drug pharmacovigilance. In the aspect of drug awareness,the main representative was Shi Yi Materia Medica which added many new drugs and introduced more new uses of drugs. In addition,in the aspect of drug use and prevention,the main representatives were Zeyao Materia Medica,Benjing Fengyuan,De Pei Materia Medica,and Harmful Benefits of Materia Medica. In the aspect of taboo of disease and syndrome,attention should be paid to the integration of medicine so as to make drugs closely related to clinical use. Although there is no special introduction on detoxification,it has been introduced in various medicines in the De Pei Materia Medica,Shiyi Materia Medica,which has a relatively systematic and complete drug warning ideology system of " drug identification-use-drug prevention-detoxification".This study found that the traditional pharmacovigilance thought of Qing Dynasty had the characteristics of attaching importance to the clinical application of toxic traditional Chinese medicine and the combination of medicine,which had certain guiding significance for modern clinical medication. This paper aims to explore the traditional drug pharmacovigilance knowledge in representative works of the Qing Dynasty,analyze the characteristics of the drug pharmacovigilance thought in the Qing Dynasty,and lay a foundation for clarifying the traditional drug pharmacovigilance system.
Topics: China; Drug Delivery Systems; Drugs, Chinese Herbal; Materia Medica; Medicine, Chinese Traditional; Pharmacovigilance; Records
PubMed: 31872674
DOI: 10.19540/j.cnki.cjcmm.20190812.502 -
Research in Social & Administrative... Jul 2022The (prescription) sequence symmetry analysis (PSSA) design has been used to identify potential prescribing cascade signals by assessing the prescribing sequence of an... (Review)
Review
BACKGROUND
The (prescription) sequence symmetry analysis (PSSA) design has been used to identify potential prescribing cascade signals by assessing the prescribing sequence of an index drug relative to a marker drug presumed to treat an adverse drug event provoked by the index drug.
OBJECTIVES
This review aimed to explore the use of the PSSA design as a pharmacovigilance tool with a particular focus on the breadth of identified signals and advances in PSSA methodology.
METHODS
We searched Embase, PubMed/Medline, Google Scholar, Web of Science and grey literature to identify studies that used the PSSA methodology. Two reviewers independently extracted relevant data for each included article. Study characteristics including signals identified, exposure time window, stratified analyses, and use of controls were extracted.
RESULTS
We identified 53 studies which reported original results obtained using PSSA methodology or quantified the validity of components of the PSSA design. Of those, nine studies provided validation metrics showing reasonable sensitivity and high specificity of PSSA to identify prescribing cascade signals. We identified 340 unique index drug - marker drug signals published in the PSSA literature, representing 281 unique index - marker pharmacological class dyads (i.e., unique fourth-level Anatomical Therapeutic Chemical [ATC] classification dyads). Commonly observed signals were identified for index drugs acting upon the nervous system (34%), cardiovascular system (21%), and blood and blood-forming organs (15%), and many marker drugs were related to the nervous system (25%), alimentary tract and metabolism (23%), cardiovascular system (17%), and genitourinary system and sex hormones (14%). Negative controls and positive controls were utilized in 21% and 13% of studies, respectively.
CONCLUSIONS
The PSSA methodology has been used in 53 studies worldwide to detect and evaluate over 300 unique prescribing cascades signals. Researchers should consider sensitivity analyses incorporating negative and/or positive controls and additional time windows to evaluate time-varying biases when designing PSSA studies.
Topics: Drug-Related Side Effects and Adverse Reactions; Humans; Pharmacovigilance; Prescriptions
PubMed: 34376366
DOI: 10.1016/j.sapharm.2021.08.003 -
British Journal of Hospital Medicine... Mar 2021The European Medicines Agency's Pharmacovigilance Risk Assessment Committee has issued statements regarding limiting the use of high-dose oestradiol creams by women...
The European Medicines Agency's Pharmacovigilance Risk Assessment Committee has issued statements regarding limiting the use of high-dose oestradiol creams by women experiencing the genitourinary syndrome of menopause, and such statements carry much medicolegal weight. Although a low dose is most often used, some clinicians opt to use higher dose creams with close monitoring of the patient. The committee should publish the evidence behind these statements or amend its official position.
Topics: Female; Humans; Pharmacovigilance; Risk Assessment
PubMed: 33792390
DOI: 10.12968/hmed.2020.0568 -
Journal of the American Academy of... Jun 2022
Topics: Eosinophilia; Fasciitis; Humans; Pharmacovigilance
PubMed: 34052335
DOI: 10.1016/j.jaad.2021.05.030 -
Indian Journal of Pharmacology 2021The primary care medical practitioners as well as common public must be made aware of the importance and benefits of reporting adverse drug reactions (ADRs). The... (Review)
Review
The primary care medical practitioners as well as common public must be made aware of the importance and benefits of reporting adverse drug reactions (ADRs). The reporting of ADRs through periodic safety update reports is a regulatory requirement in many countries including India, however, the importance of ADR reporting through spontaneous reporting system cannot be ignored. After the initiation of Programme for International Drug Monitoring, WHO-Uppsala Monitoring Centre (UMC), Sweden, succeeded in establishing a worldwide pharmacovigilance (PV) network in >150 countries. As a full member of this program, India also has developed a robust PV system through Pharmacovigilance Programme of India (PvPI) involving its various ADR Monitoring Centers and after due quality check of Individual Case Safety Reports (ICSRs), submits this information to UMC through a web-based tool VigiFlow. This information is then stored into VigiBase which is the repository of worldwide ICSRs. Based on the drug safety information collected, PvPI issues alerts, recommends label change (if any), and identifies signals thereby supporting National Regulatory Authority. At national level, PvPI has developed several tools for reporting of ADRs by the stakeholders. This article provides an overview of adverse events reporting tools in India vis-a-vis selected countries around the world, based on a comparative literature search. This article also throws light upon the regulatory aspects of PV in India, findings of PvPI and its recommendations to Central Drugs Standard Control Organization, collaboration of PvPI with Public Health Programmes, future prospects of reporting ADRs in India and how it will help enhance the quality of ADR-reporting by citizens of India.
Topics: Adverse Drug Reaction Reporting Systems; Drug and Narcotic Control; Humans; India; Pharmacovigilance; Public Health; World Health Organization
PubMed: 34100398
DOI: 10.4103/ijp.ijp_901_20 -
Indian Journal of Pharmacology 2023
Topics: Pharmacovigilance; Education, Medical; Curriculum; Education, Medical, Undergraduate
PubMed: 37737082
DOI: 10.4103/ijp.ijp_145_23 -
BMC Medical Informatics and Decision... Jun 2018A scoping review to characterize the literature on the use of conversations in social media as a potential source of data for detecting adverse events (AEs) related to... (Review)
Review
BACKGROUND
A scoping review to characterize the literature on the use of conversations in social media as a potential source of data for detecting adverse events (AEs) related to health products.
METHODS
Our specific research questions were (1) What social media listening platforms exist to detect adverse events related to health products, and what are their capabilities and characteristics? (2) What is the validity and reliability of data from social media for detecting these adverse events? MEDLINE, EMBASE, Cochrane Library, and relevant websites were searched from inception to May 2016. Any type of document (e.g., manuscripts, reports) that described the use of social media data for detecting health product AEs was included. Two reviewers independently screened citations and full-texts, and one reviewer and one verifier performed data abstraction. Descriptive synthesis was conducted.
RESULTS
After screening 3631 citations and 321 full-texts, 70 unique documents with 7 companion reports available from 2001 to 2016 were included. Forty-six documents (66%) described an automated or semi-automated information extraction system to detect health product AEs from social media conversations (in the developmental phase). Seven pre-existing information extraction systems to mine social media data were identified in eight documents. Nineteen documents compared AEs reported in social media data with validated data and found consistent AE discovery in all except two documents. None of the documents reported the validity and reliability of the overall system, but some reported on the performance of individual steps in processing the data. The validity and reliability results were found for the following steps in the data processing pipeline: data de-identification (n = 1), concept identification (n = 3), concept normalization (n = 2), and relation extraction (n = 8). The methods varied widely, and some approaches yielded better results than others.
CONCLUSIONS
Our results suggest that the use of social media conversations for pharmacovigilance is in its infancy. Although social media data has the potential to supplement data from regulatory agency databases; is able to capture less frequently reported AEs; and can identify AEs earlier than official alerts or regulatory changes, the utility and validity of the data source remains under-studied.
TRIAL REGISTRATION
Open Science Framework ( https://osf.io/kv9hu/ ).
Topics: Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions; Humans; Pharmacovigilance; Social Media
PubMed: 29898743
DOI: 10.1186/s12911-018-0621-y -
Pharmacovigilance through the development of text mining and natural language processing techniques.Journal of Biomedical Informatics Dec 2015
Topics: Data Mining; Natural Language Processing; Pharmacovigilance
PubMed: 26547007
DOI: 10.1016/j.jbi.2015.11.001