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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 -
The European Respiratory Journal Jul 2021https://bit.ly/3n4vaXe
https://bit.ly/3n4vaXe
Topics: COVID-19; Humans; Pharmacovigilance; Public Policy; SARS-CoV-2; Vaccination
PubMed: 33888525
DOI: 10.1183/13993003.01111-2021 -
Drug Discovery Today Mar 2018The objective of this paper is to identify the extent to which real world data (RWD) is being utilized, or could be utilized, at scale in drug development. Through... (Review)
Review
The objective of this paper is to identify the extent to which real world data (RWD) is being utilized, or could be utilized, at scale in drug development. Through screening peer-reviewed literature, we have cited specific examples where RWD can be used for biomarker discovery or validation, gaining a new understanding of a disease or disease associations, discovering new markers for patient stratification and targeted therapies, new markers for identifying persons with a disease, and pharmacovigilance. None of the papers meeting our criteria was specifically geared toward novel targets or indications in the biopharmaceutical sector; the majority were focused on the area of public health, often sponsored by universities, insurance providers or in combination with public health bodies such as national insurers. The field is still in an early phase of practical application, and is being harnessed broadly where it serves the most direct need in public health applications in early, rare and novel disease incidents. However, these exemplars provide a valuable contribution to insights on the use of RWD to create novel, faster and less invasive approaches to advance disease understanding and biomarker discovery. We believe that pharma needs to invest in making better use of Electronic Health Records and the need for more precompetitive collaboration to grow the scale of this 'big denominator' capability, especially given the needs of precision medicine research.
Topics: Biomarkers; Drug Discovery; Electronic Health Records; Humans; Pharmaceutical Preparations; Pharmacovigilance; Public Health
PubMed: 29294362
DOI: 10.1016/j.drudis.2017.12.002 -
CPT: Pharmacometrics & Systems... May 2022Promising drug development efforts may frequently fail due to unintended adverse reactions. Several methods have been developed to analyze such data, aiming to improve... (Review)
Review
Promising drug development efforts may frequently fail due to unintended adverse reactions. Several methods have been developed to analyze such data, aiming to improve pharmacovigilance and drug safety. In this work, we provide a brief review of key directions to quantitatively analyzing adverse events and explore the potential of augmenting these methods using additional molecular data descriptors. We argue that molecular expansion of adverse event data may provide a path to improving the insights gained through more traditional pharmacovigilance approaches. Examples include the ability to assess statistical relevance with respect to underlying biomolecular mechanisms, the ability to generate plausible causative hypotheses and/or confirmation where possible, the ability to computationally study potential clinical trial designs and/or results, as well as the further provision of advanced features incorporated in innovative methods, such as machine learning. In summary, molecular data expansion provides an elegant way to extend mechanistic modeling, systems pharmacology, and patient-centered approaches for the assessment of drug safety. We anticipate that such advances in real-world data informatics and outcome analytics will help to better inform public health, via the improved ability to prospectively understand and predict various types of drug-induced molecular perturbations and adverse events.
Topics: Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions; Humans; Machine Learning; Marketing; Pharmacovigilance
PubMed: 35143713
DOI: 10.1002/psp4.12765 -
British Journal of Clinical Pharmacology Feb 2023To identify and characterize ocular adverse events (oAEs) that are significantly associated with proprotein convertase subtilisin-like/kexin type 9 (PCSK9) inhibitors...
AIMS
To identify and characterize ocular adverse events (oAEs) that are significantly associated with proprotein convertase subtilisin-like/kexin type 9 (PCSK9) inhibitors using the US Food and Drug Administration Adverse Event Reporting System (FAERS).
METHODS
We conducted a disproportionality analysis of PCSK9 inhibitors in the FAERS (01/2004-12/2021). The association between PCSK9 inhibitors and oAEs was evaluated using the information component (IC) and the reporting odds ratio (ROR), and the difference in oAEs between evolocumab and alirocumab was compared using the ROR. Different sensitivity analyses were conducted to evaluate the robustness of results.
RESULTS
A total of 103 531 reports involving at least 1 PCSK9 inhibitor were found in the FAERS. PCSK9 inhibitors were associated with higher reporting of increased lacrimation (IC 0.27 [95% confidence interval {CI} 0.02-0.45]; ROR 1.21 [95% CI 1.04-1.40]), seasonal allergy (IC 0.39 [95% CI 0.04-0.64]; ROR 1.32 [95% CI 1.07-1.62]) and eye operation (IC 0.66 [95% CI 0.04-1.10]; ROR 1.60 [95% CI 1.11-2.30]) compared with the full database, and there was no difference between evolocumab and alirocumab. Sensitivity analyses showed that the disproportionate signals of increased lacrimation disappeared after excluding cases with other lipid-lowering agents in the combined drugs. Except for eye operations, most of these adverse events occurred within 30 days of the first dose, and all 3 oAEs were mostly reported in women and individuals >65 years.
CONCLUSION
This pharmacovigilance study identified a possible signal of ocular disorders associated with PCSK9 inhibitors and encourages paying attention to at-risk populations in PCSK9 inhibitors medication.
Topics: Humans; Female; PCSK9 Inhibitors; Pharmacovigilance; Proprotein Convertase 9; Hypolipidemic Agents; Eye Diseases; Adverse Drug Reaction Reporting Systems
PubMed: 35973681
DOI: 10.1111/bcp.15494 -
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 -
Therapeutic Innovation & Regulatory... Jul 2023Materiovigilance (Mv) has the same purpose and approach in ensuring patient safety as pharmacovigilance but deals with medical devices associated with adverse events... (Review)
Review
Materiovigilance (Mv) has the same purpose and approach in ensuring patient safety as pharmacovigilance but deals with medical devices associated with adverse events (MDAEs) and their monitoring. Mv has been instrumental in recalling many defective or malfunctioning devices based on their safety data. All MDAEs, such as critical or non-critical, known, or unknown, those with inadequate or incomplete specifications, and frequent or rare events should be reported and evaluated. Mv helps to improve medical devices' design and efficiency profile and avoid device-related complications and associated failures. It alerts consumers and health professionals regarding counterfeit or substandard devices. Common events reported through Mv are device breakage and malfunction, entry- and exit-site infections, organ perforations or injuries, need for surgery and even death, and life cycle assessment of devices. Health authorities globally have developed reporting frameworks with timeframes for MDAEs, such as MedWatch in the USA, MedSafe in New Zealand, and others. Health professionals and consumers need to be made aware of the significance of Mv in ensuring the safe use of medical devices and getting familiar with the reporting procedures and action plans in case of a device-induced adverse event.
Topics: Humans; Pharmacovigilance; Health Personnel; Patient Safety; Delivery of Health Care
PubMed: 37106236
DOI: 10.1007/s43441-023-00514-4 -
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 -
Cadernos de Saude Publica 2020National Pharmacovigilance Systems (PVS) manage health risks and identify, assess, and act to minimize them, contributing to adequate use of medicines, patient safety,...
National Pharmacovigilance Systems (PVS) manage health risks and identify, assess, and act to minimize them, contributing to adequate use of medicines, patient safety, and improved quality of care. Fast-track drug registration, which has become increasingly frequent, hinders assessment of the efficacy and safety of new drugs, adding difficulties to current regulation and health protection. The article applies indicators proposed by the World Health Organization to analyze the National PVS of Portugal and Brazil. Brazil's PVS was established later than that of Portugal, generates fewer safety signals, has a lower notification rate for suspected adverse drug events (ADEs), and displays difficulty in producing and disseminating information to health professionals and the population. Portugal has the advantage of being a member state of the European Medicines Agency. The article also suggests that the differences are related to the political and social context that hinders the implementation of public policies and compromises the effectiveness of the Brazilian PVS. Challenges for PVS include awareness-raising of health professionals, the adoption of methods to complement voluntary notification, pharmacovigilance of biological and genetic drugs, and assessment of the system's impact. An additional challenge for the Brazilian PVS is to improve the notifications' uptake and quality, including from industry, generate safety signals in the national context, and communicate risk in timely fashion to health professionals and the population.
Topics: Adverse Drug Reaction Reporting Systems; Brazil; Drug-Related Side Effects and Adverse Reactions; Humans; Patient Safety; Pharmacovigilance; Portugal
PubMed: 32696826
DOI: 10.1590/0102-311x00043019 -
International Journal of Environmental... Apr 2022Patients are recognized as important players in the pharmacovigilance system. This study aims to describe and compare the characteristics of patient reporting systems,... (Review)
Review
Patients are recognized as important players in the pharmacovigilance system. This study aims to describe and compare the characteristics of patient reporting systems, reporting forms, awareness raising-activities, and the statistics related to patient reporting in the selected countries. Fifteen countries (eight Western countries and seven Asian countries) were purposively selected. A questionnaire survey was distributed to national pharmacovigilance authorities in those countries. Nine countries (five Western countries and four Asian countries) returned the questionnaire. A review of the websites of national pharmacovigilance centres was conducted. The proportion of patient reports in the selected Western countries ranged from 57.83% to 14.37%, while it was accounted for less than 1% in the selected Asian countries. Currently, patients in all nine countries can report adverse drug reactions online via a website. The number of clicks from the national pharmacovigilance website to reach the online reporting form range from one to five clicks. Countries with higher patient reporting rates seemed to share the following characteristics; provision of feedback, engagement with patient organizations, and implementation of several activities to raise the awareness of the general public on the importance of pharmacovigilance. To increase the number of patient reports, the strengths of each country's system should be adopted.
Topics: Adverse Drug Reaction Reporting Systems; Asia; Drug-Related Side Effects and Adverse Reactions; Humans; Pharmacovigilance; Surveys and Questionnaires
PubMed: 35457318
DOI: 10.3390/ijerph19084447