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BMC Medical Informatics and Decision... May 2020Medication errors have been identified as the most common preventable cause of adverse events. The lack of granularity in medication error terminology has led...
BACKGROUND
Medication errors have been identified as the most common preventable cause of adverse events. The lack of granularity in medication error terminology has led pharmacovigilance experts to rely on information in individual case safety reports' (ICSRs) codes and narratives for signal detection, which is both time consuming and labour intensive. Thus, there is a need for complementary methods for the detection of medication errors from ICSRs. The aim of this study is to evaluate the utility of two natural language processing text mining methods as complementary tools to the traditional approach followed by pharmacovigilance experts for medication error signal detection.
METHODS
The safety surveillance advisor (SSA) method, I2E text mining and University of Copenhagen Center for Protein Research (CPR) text mining, were evaluated for their ability to extract cases containing a type of medication error where patients extracted insulin from a prefilled pen or cartridge by a syringe. A total of 154,209 ICSRs were retrieved from Novo Nordisk's safety database from January 1987 to February 2018. Each method was evaluated by recall (sensitivity) and precision (positive predictive value).
RESULTS
We manually annotated 2533 ICSRs to investigate whether these contained the sought medication error. All these ICSRs were then analysed using the three methods. The recall was 90.4, 88.1 and 78.5% for the CPR text mining, the SSA method and the I2E text mining, respectively. Precision was low for all three methods ranging from 3.4% for the SSA method to 1.9 and 1.6% for the CPR and I2E text mining methods, respectively.
CONCLUSIONS
Text mining methods can, with advantage, be used for the detection of complex signals relying on information found in unstructured text (e.g., ICSR narratives) as standardised and both less labour-intensive and time-consuming methods compared to traditional pharmacovigilance methods. The employment of text mining in pharmacovigilance need not be limited to the surveillance of potential medication errors but can be used for the ongoing regulatory requests, e.g., obligations in risk management plans and may thus be utilised broadly for signal detection and ongoing surveillance activities.
Topics: Adverse Drug Reaction Reporting Systems; Data Mining; Drug-Related Side Effects and Adverse Reactions; Female; Humans; Male; Medication Errors; Pharmacovigilance; Reference Standards
PubMed: 32448248
DOI: 10.1186/s12911-020-1097-0 -
Drug Safety May 2022With the rapid development of artificial intelligence (AI) technologies, and the large amount of pharmacovigilance-related data stored in an electronic manner,... (Review)
Review
With the rapid development of artificial intelligence (AI) technologies, and the large amount of pharmacovigilance-related data stored in an electronic manner, data-driven automatic methods need to be urgently applied to all aspects of pharmacovigilance to assist healthcare professionals. However, the quantity and quality of data directly affect the performance of AI, and there are particular challenges to implementing AI in limited-resource settings. Analyzing challenges and solutions for AI-based pharmacovigilance in resource-limited settings can improve pharmacovigilance frameworks and capabilities in these settings. In this review, we summarize the challenges into four categories: establishing a database for an AI-based pharmacovigilance system, lack of human resources, weak AI technology and insufficient government support. This study also discusses possible solutions and future perspectives on AI-based pharmacovigilance in resource-limited settings.
Topics: Artificial Intelligence; Databases, Factual; Health Personnel; Humans; Pharmacovigilance; Technology
PubMed: 35579814
DOI: 10.1007/s40264-022-01170-7 -
BMJ Open Sep 2023The slow progress of pharmacovigilance (PV) in low-income and middle-income countries (LMIC) raises questions about core challenges on the growth of PV, and the... (Review)
Review
OBJECTIVES
The slow progress of pharmacovigilance (PV) in low-income and middle-income countries (LMIC) raises questions about core challenges on the growth of PV, and the appropriateness of strategies used so far to develop PV. Therefore, this scoping review aims to describe strategies and interventions to strengthen PV in LMIC and to propose recommendations for future investments in PV capacity building.
INCLUSION CRITERIA
Publications included were primary studies, articles, policy and guideline papers, describing interventions to strengthen PV in LMIC.
METHODS
The review was conducted following the Joanna Briggs Institute (JBI) guidelines on conducting scoping reviews. Literature searches were performed in MEDLINE, EMBASE, Web of Science, PDQ-evidence, CINAHL and other relevant websites from January 1990 to January 2021. Two reviewers independently screened titles, abstracts and full texts. One reviewer performed data extraction and descriptive analysis, which were reviewed by two other reviewers.
RESULTS
10 922 unique titles were screened and 152 were eligible for full text review. Of these, 57 and an additional 13 reports from grey literature fulfilled eligibility criteria for inclusion in the review. These were grouped into two categories: (1) Interventions aimed at increasing PV knowledge and adverse drug reactions (ADR) reporting (45 papers), primarily education of healthcare professionals (HCP), alone or in combination with other interventions such as mobile and electronic reporting and (2) Interventions aimed at strengthening various components of the national PV system (25 papers), describing strategies or mixed interventions implemented at the national level, targeting different components of the national PV system.
CONCLUSIONS
Results of this review suggest that educating HCP on ADR reporting is the most common approach to build PV capacity in LMIC. Though important, education alone is insufficient and should ideally be organised within the holistic framework of strengthening national PV systems, with a focus on also building capacity for advanced activities such as signal detection.
Topics: Humans; Developing Countries; Pharmacovigilance; Educational Status; Academies and Institutes; Capacity Building; Drug-Related Side Effects and Adverse Reactions
PubMed: 37709326
DOI: 10.1136/bmjopen-2022-071079 -
International Journal of Health Policy... Jul 2022Evaluating a pharmacovigilance system helps identify its deficiencies and could facilitate measures to remedy and improve the quantity and quality of adverse drug...
BACKGROUND
Evaluating a pharmacovigilance system helps identify its deficiencies and could facilitate measures to remedy and improve the quantity and quality of adverse drug reaction (ADR) reports and other opportunities for pharmacovigilance systems strengthening. This study aimed to evaluate the status of pharmacovigilance in Iran using the World Health Organization (WHO) pharmacovigilance indicators with the prospect of identifying the gaps and areas for improvement.
METHODS
This study was conducted in 2 parts. The first part included a secondary analysis of the national data obtained from the Iranian National Pharmacovigilance Center (PVC) using a structured data collection form based on WHO core pharmacovigilance indicators. In the second part, a 3-month prospective study was carried out to investigate 2 outcome indicators, ie, length of stay and costs of medicine-related hospitalization in all patients of 2 main referral hospitals in the southeast and north of Iran.
RESULTS
Iran has a PVC with national policy, trained staff, and a statutory budget. In 2017, the number of ADR reports was 15.0 per 100 000 population, and 262 signals were detected during the preceding 5 years. The average length of stay and costs of medicine-related hospitalization were 5 days and US$817.2 in Afzalipour hospital and 6.6 days and US$306.7 in Razi hospital, respectively. The status of pharmacovigilance in the Iranian public health programs (PHPs) is unknown, and most of the indicators could not be assessed.
CONCLUSION
A robust pharmacovigilance system is a pivotal part of the overall medicines regulatory system. The Iranian pharmacovigilance system has relatively the proper structural condition. Though the underreporting of ADRs, especially medicine-related deaths, is an important issue, and some indicators' status was unclear. The Iranian pharmacovigilance program requires a higher prioritization, particularly in the PHPs, a greater allocation of resources, and cross-sectoral cooperation to bolster and achieve the pharmacovigilance objectives.
Topics: Humans; Iran; Pharmacovigilance; Prospective Studies; Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions
PubMed: 33590736
DOI: 10.34172/ijhpm.2020.243 -
Drug Safety Jan 2021Pharmaceutical legislation provides a legal framework to ensure the safe and effective use of medicines. This framework requires national regulatory authorities (NRAs)... (Review)
Review
Pharmaceutical legislation provides a legal framework to ensure the safe and effective use of medicines. This framework requires national regulatory authorities (NRAs) to establish and maintain a pharmacovigilance system (PV system) stating and enforcing the regulatory commitments that key stakeholders, including marketing authorisation holders (MAHs), are required to fulfil. In recent years, national legislative bodies and NRAs across the world have issued a significant amount of legislation and guidance enforcing the obligation to perform pharmacovigilance activities. In countries where the NRA is a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), safety management requirements are generally consistent with ICH guidelines. In a number of countries beyond this scope, requirements may deviate from internationally agreed standards, adding a substantial complexity and increasing burden on the stakeholders involved, whilst the benefit for patients' safety may not be evident. Committed to fulfilling safety-regulatory obligations in any country where a product licence is held, global pharmaceutical companies have accumulated a broad and deep experience acquired whilst meeting the expectations of a large array of diverse PV systems across the world. These range from sub-optimal frameworks, according to the World Health Organization (WHO) Global Benchmarking Tool, to highly effective resource-optimised PV systems. In order to support countries creating or further developing their PV systems, especially where infrastructure and resources are limited, the European Federation of Pharmaceutical Industries and Associations (EFPIA) International Pharmacovigilance Group (IPVG) has developed consensus recommendations consistent with harmonised standards for the development and step-wise implementation of key PV system components. These recommendations endorsed by the EFPIA membership constitute the focus of this review article.
Topics: Consensus; Drug Industry; Humans; Patient Safety; Pharmacovigilance; World Health Organization
PubMed: 33289904
DOI: 10.1007/s40264-020-01008-0 -
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 -
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 -
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 -
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 -
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