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British Journal of Clinical Pharmacology Oct 2015Adverse drug reactions come at a considerable cost on society. Social media are a potentially invaluable reservoir of information for pharmacovigilance, yet their true... (Review)
Review
Adverse drug reactions come at a considerable cost on society. Social media are a potentially invaluable reservoir of information for pharmacovigilance, yet their true value remains to be fully understood. In order to realize the benefits social media holds, a number of technical, regulatory and ethical challenges remain to be addressed. We outline these key challenges identifying relevant current research and present possible solutions.
Topics: Data Mining; Drug Industry; Drug-Related Side Effects and Adverse Reactions; Humans; Pharmacovigilance; Social Media
PubMed: 26147850
DOI: 10.1111/bcp.12717 -
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 -
Clinical Pharmacology and Therapeutics May 2021Adverse drug reactions (ADRs) are a major concern for patients, clinicians, and regulatory agencies. The discovery of serious ADRs leading to substantial morbidity and... (Review)
Review
Adverse drug reactions (ADRs) are a major concern for patients, clinicians, and regulatory agencies. The discovery of serious ADRs leading to substantial morbidity and mortality has resulted in mandatory phase IV clinical trials, black box warnings, and withdrawal of drugs from the market. Real-world data, data collected during routine clinical care, is being adopted by innovators, regulators, payors, and providers to inform decision making throughout the product life cycle. We outline several different approaches to modern pharmacovigilance, including spontaneous reporting databases, electronic health record monitoring and research frameworks, social media surveillance, and the use of digital devices. Some of these platforms are well-established while others are still emerging or experimental. We highlight both the potential opportunity, as well as the existing challenges within these pharmacovigilance systems that have already begun to impact the drug development process, as well as the landscape of postmarket drug safety monitoring. Further research and investment into different and complementary pharmacovigilance systems is needed to ensure the continued safety of pharmacotherapy.
Topics: Adverse Drug Reaction Reporting Systems; Databases, Pharmaceutical; Electronic Health Records; Humans; Pharmacovigilance; Social Media; United States; United States Food and Drug Administration
PubMed: 33492663
DOI: 10.1002/cpt.2172 -
F1000Research 2019Considering that marketed drugs are not free from side effects, many countries have initiated pharmacovigilance programs. These initiatives have provided countries with... (Review)
Review
Considering that marketed drugs are not free from side effects, many countries have initiated pharmacovigilance programs. These initiatives have provided countries with methods of detection and prevention of adverse drug reactions at an earlier stage, thus preventing harm occurring in the larger population. In this review, examples of drug withdrawals due to effective pharmacovigilance programs have been provided with details. In addition, information concerning data mining in pharmacovigilance, an effective method to assess pharmacoepidemiologic data and detecting signals for rare and uncommon side effects, is also examined, which is a method synchronized with information technology and advanced electronic tools. The importance of policy framework in relation to pharmacovigilance is discussed in detail, and country experiences upon implementation of pharmacovigilance policies is highlighted.
Topics: Adverse Drug Reaction Reporting Systems; Data Mining; Drug-Related Side Effects and Adverse Reactions; Humans; Pharmacovigilance
PubMed: 32161643
DOI: 10.12688/f1000research.21402.1 -
Eastern Mediterranean Health Journal =... Jul 2021The concept of pharmacovigilance is not well known in Libya and its practice is still in the early stages.
BACKGROUND
The concept of pharmacovigilance is not well known in Libya and its practice is still in the early stages.
AIMS
This study aimed to determine the knowledge, attitudes and practices of pharmacists in Tripoli, Libya about pharmacovigilance and the reporting of adverse drug reactions.
METHODS
A cross-sectional study was conducted from October 2019 to February 2020 of working pharmacists randomly selected from pharmacies in Tripoli. Participants were eligible for inclusion if they had a degree or diploma in pharmacy from a recognized university or institute. Data were collected using a validated self-administered questionnaire.
RESULTS
Of 500 pharmacists selected, 408 completed the questionnaire. The pharmacists' knowledge of pharmacovigilance and reporting of adverse drug reactions was poor overall: only 28.9% correctly defined pharmacovigilance and 14.7% knew about the existence of a centre for pharmacovigilance in Libya. The attitudes of the pharmacists to pharmacovigilance was positive: 77.2% believed that pharmacovigilance needed to be included in the pharmacy curriculum and 73.0% said that they would practice pharmacovigilance if trained. Pharmacists depended mostly on drug information leaflets to update their knowledge on adverse drug reactions.
CONCLUSION
Given the pharmacists' low level of knowledge about pharmacovigilance but their readiness to become involved if trained, training programmes should be introduced for practising pharmacists to improve their knowledge and encourage their active participation in pharmacovigilance. Regulators need to reinforce the importance of reporting adverse drug reactions and implement pharmacovigilance policies in the Libyan health care system.
Topics: Adverse Drug Reaction Reporting Systems; Attitude of Health Personnel; Cross-Sectional Studies; Drug-Related Side Effects and Adverse Reactions; Health Knowledge, Attitudes, Practice; Humans; Libya; Pharmacists; Pharmacovigilance; Surveys and Questionnaires
PubMed: 34369584
DOI: 10.26719/2021.27.7.693 -
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 Discovery Today Nov 2021The discovery and development of new medicines is expensive, time-consuming, and often inefficient, with many failures along the way. Powered by artificial intelligence... (Review)
Review
The discovery and development of new medicines is expensive, time-consuming, and often inefficient, with many failures along the way. Powered by artificial intelligence (AI), language models (LMs) have changed the landscape of natural language processing (NLP), offering possibilities to transform treatment development more effectively. Here, we summarize advances in AI-powered LMs and their potential to aid drug discovery and development. We highlight opportunities for AI-powered LMs in target identification, clinical design, regulatory decision-making, and pharmacovigilance. We specifically emphasize the potential role of AI-powered LMs for developing new treatments for Coronavirus 2019 (COVID-19) strategies, including drug repurposing, which can be extrapolated to other infectious diseases that have the potential to cause pandemics. Finally, we set out the remaining challenges and propose possible solutions for improvement.
Topics: Artificial Intelligence; Drug Development; Drug Discovery; Humans; Natural Language Processing; Pharmacovigilance; SARS-CoV-2; COVID-19 Drug Treatment
PubMed: 34216835
DOI: 10.1016/j.drudis.2021.06.009 -
British Journal of Clinical Pharmacology Dec 2022Children frequently respond differently to therapies compared to adults. Differences also exist between paediatric age groups for pharmacokinetics and pharmacodynamics... (Review)
Review
Children frequently respond differently to therapies compared to adults. Differences also exist between paediatric age groups for pharmacokinetics and pharmacodynamics in both efficacy and safety. Paediatric pharmacovigilance requires an understanding of the unique aspects of children with regard to, for example, drug response, growth and development, clinical presentation of adverse drug reactions (ADRs), how they can be detected and population-specific factors (e.g., more frequent use of off-label/unlicensed drugs). In recognition of these challenges, a group of experts has been formed in the context of the conect4children (c4c) project to support paediatric drug development. This expert group collaborated to develop methodological considerations for paediatric drug safety and pharmacovigilance throughout the life-cycle of medicinal products which are described in this article. These considerations include practical points to consider for the development of the paediatric section of the risk management plan (RMP), safety in paediatric protocol development, safety data collection and analysis. Furthermore, they describe the specific details of post-marketing pharmacovigilance in children using, for example, spontaneous reports, electronic health care records, registries and record-linkage, as well as the use of paediatric pharmacoepidemiology studies for risk characterisation. Next the details of the assessment of benefit-risk and challenges related to medicinal product formulation in the context of a Paediatric Investigation Plan (PIP) are presented. Finally, practical issues in paediatric signal detection and evaluation are included. This paper provides practical points to consider for paediatric pharmacovigilance throughout the life-cycle of medicinal products for RMPs, protocol development, safety data collection and analysis and PIPs.
Topics: Humans; Child; Adult; Pharmacovigilance; Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions; Pharmacoepidemiology; Research Design
PubMed: 34699077
DOI: 10.1111/bcp.15119 -
Drug Safety Dec 2020This review summarizes current evidence on the abuse and misuse of the gabapentinoids pregabalin and gabapentin. Pharmacovigilance studies, register-based studies,... (Review)
Review
This review summarizes current evidence on the abuse and misuse of the gabapentinoids pregabalin and gabapentin. Pharmacovigilance studies, register-based studies, surveys, clinical toxicology studies, and forensic toxicology studies were identified and scrutinized with the goal to define the problem, identify risk factors, and discuss possible methods to reduce the potential for abuse and misuse. Studies found that gabapentinoids are abused and misused and that individuals with a history of psychiatric disorders or substance use disorder seem to be at high risk. Moreover, some evidence supports the notion that patients with opioid use disorders may be at an increased risk of abusing gabapentinoids. Available evidence also suggests that abuse and misuse are more frequent in users of pregabalin compared with users of gabapentin. Health professionals and prescribers should be aware of the risk for misuse of pregabalin and gabapentin, which eventually could lead to abuse, substance dependence, and intoxications. Prescribing to patients belonging to risk populations such as those with psychiatric disorders or substance use disorder should be avoided if possible and, if prescribed, signs of misuse and abuse should be monitored.
Topics: Gabapentin; Humans; Pharmacovigilance; Prescription Drug Misuse; Risk Factors; Substance-Related Disorders
PubMed: 32857333
DOI: 10.1007/s40264-020-00985-6 -
BioMed Research International 2021To describe and synthesize aspects of knowledge, attitudes, and practice regarding pharmacovigilance and adverse drug reaction (ADR) reporting and to explore associated...
AIM
To describe and synthesize aspects of knowledge, attitudes, and practice regarding pharmacovigilance and adverse drug reaction (ADR) reporting and to explore associated barriers from a nurse perspective.
METHODS
A systematic review was conducted. Electronic databases including MEDLINE, Embase, Scopus, and Web of Knowledge from January 2010 to October 2020 were searched. Original observational studies that were written in English and which focused on nurses' knowledge, attitudes, practice, and perceived barriers regarding pharmacovigilance and ADR reporting in various healthcare settings were included.
RESULTS
Twenty-three studies published in English from 2010 to 2020 were retrieved during the search process. Overall, in the knowledge domain, the median percentages of nurses who were aware of the definitions of ADRs were 74.1%, while only 26.3% were aware of the adverse drug reaction reporting form. In the attitude domain, 84.6% of nurses believed ADR reporting to be important for patient/medicine safety and 37.1% had a fear of legal liability following ADR reporting. Although 67.1% of nurses encountered ADRs during their professional life, only 21.2% had a history of ADR reporting. In addition, lack of knowledge/training (median: 47.1%) was identified as the most common barrier in ADR reporting from a nursing viewpoint.
CONCLUSION
Despite positive nurse attitudes, knowledge and practice in relation to pharmacovigilance activities and ADR reporting did not occur regularly or often. Improving nurses' knowledge through in-service training and degree-level education and addressing the main barriers of ADR reporting may help to achieve an improved level of reporting.
Topics: Adverse Drug Reaction Reporting Systems; Attitude of Health Personnel; Health Knowledge, Attitudes, Practice; Humans; Nurses; Pharmacovigilance
PubMed: 33937402
DOI: 10.1155/2021/6630404