-
BMC Health Services Research Oct 2021New medicines have become available for the treatment of drug-resistant tuberculosis (DR-TB) and are introduced in sub-Saharan Africa (SSA) by the national TB programs...
BACKGROUND
New medicines have become available for the treatment of drug-resistant tuberculosis (DR-TB) and are introduced in sub-Saharan Africa (SSA) by the national TB programs (NTPs) through special access schemes. Pharmacovigilance is typically the task of national medicines regulatory agencies (NMRAs), but the active drug safety monitoring and management (aDSM) recommended for the new TB medicines and regimens was introduced through the NTPs. We assessed the strengths and challenges of pharmacovigilance systems in Eswatini, Ethiopia, Nigeria and Tanzania, focusing on their capacity to monitor safety of medicines registered and not registered by the NMRAs for the treatment of DR-TB.
METHODS
Assessment visits were conducted to all four countries by a multidisciplinary team. We used a pharmacovigilance indicator tool derived from existing tools, interviewed key stakeholders, and visited health facilities where DR-TB patients were treated with new medicines. Assessment results were verified with the local NMRAs and NTPs.
RESULTS
Most countries have enabling laws, regulations and guidelines for the conduct of pharmacovigilance by the NMRAs. The relative success of NTP-NMRA collaboration is much influenced by interpersonal relationships between staff. Division of roles and responsibilities is not always clear and leads to duplication and unfulfilled tasks (e.g. causality assessment). The introduction of aDSM has increased awareness among DR-TB healthcare providers.
CONCLUSION
aDSM has created awareness about the importance of pharmacovigilance among NTPs. In the future, a push for conducting pharmacovigilance through public health programs seems useful, but this needs to coincide with increased collaboration with between public health programs and NMRAs with clear formulation of roles and responsibilities.
Topics: Ethiopia; Health Facilities; Health Personnel; Humans; Pharmacovigilance; Tuberculosis, Multidrug-Resistant
PubMed: 34625085
DOI: 10.1186/s12913-021-07043-6 -
PloS One 2020The objective of this review is to evaluate the existing evidence about the knowledge, attitude, and perceptions (KAP) of healthcare students towards pharmacovigilance...
OBJECTIVE
The objective of this review is to evaluate the existing evidence about the knowledge, attitude, and perceptions (KAP) of healthcare students towards pharmacovigilance and adverse drug reactions reporting (ADRs).
METHODS
A systematic literature search was conducted using MEDLINE, CINAHL, EMBASE, ERIC, and Cochrane Database of Systematic Reviews via OVID. This review restricted the search to studies published in English from inception until December 2019.
PRIMARY AND SECONDARY OUTCOME MEASURES
The primary outcome was healthcare students' knowledge, attitude, and perceptions of pharmacovigilance.
RESULTS
Of the 664 articles identified, twenty-nine studies were included in the review. Overall, healthcare students vary in their knowledge and attitude towards pharmacovigilance and ADRs reporting. There was inconsistency in measuring KAP between the studies and the main drawback in the literature is lacking validated KAP measures.
CONCLUSIONS
In summation, optimal KAP assessment can be achieved through developing a standard validated measure. Our future healthcare providers should have basics pharmacovigilance knowledge in order to rationally reporting ADRs and preventing serious health problems.
Topics: Adverse Drug Reaction Reporting Systems; Health Knowledge, Attitudes, Practice; Health Personnel; Humans; Pharmacovigilance; Students, Health Occupations
PubMed: 32433649
DOI: 10.1371/journal.pone.0233393 -
Pharmacoepidemiology and Drug Safety Jan 2023Spontaneous notification systems are essential in a post-marketing safety context. However, using this method, only about 6% of all adverse drug reactions are notified.... (Review)
Review
PURPOSE
Spontaneous notification systems are essential in a post-marketing safety context. However, using this method, only about 6% of all adverse drug reactions are notified. To overcome this sub-notification problem, new methods need to be developed to improve and facilitate reporting. In this sense, the use of digital media, mainly medical mobile apps, has been presented as a powerful tool, including in pharmacovigilance. We performed a scope review to identify the available apps used to report adverse drug reactions around the world to eventually identify which of them best fits the Portuguese pharmacovigilance system.
METHODS
The Joanna Briggs Institute guidelines were considered, and the framework proposed by Arksey and O'Malley was followed. All the articles that met the inclusion criteria were examined for this review. When the studies lacked in information about the app, Google was used to enhance the search for further information.
RESULTS
A final number of five articles were included, revealing seven implemented mobile apps for adverse drug reaction report (Medwatcher, VigiBIP, Yellow Card, Bijwerking, Halmed, Med Safety, and ADR PvPi). These apps are implemented in the United States, France, United Kingdom, The Netherlands, Croatia, and India. Med Safety was originally designed for multi-region use and is implemented in 12 low and middle-income countries.
CONCLUSIONS
Apps are easier and faster ways of reporting. The integration of such a tool in an individual care plan would allow to maintain a complete electronic health record at both individual and global level and could be eventually seen as an added value by both health professionals and patients. A country specific version of the WEB-RADR could be a solution for Portugal, in order to introduce an app to notify ADRs at the national level, due previous successful experiences in European countries.
Topics: Humans; Adverse Drug Reaction Reporting Systems; Mobile Applications; Internet; Pharmacovigilance; Drug-Related Side Effects and Adverse Reactions
PubMed: 36125022
DOI: 10.1002/pds.5542 -
Drug Safety Aug 2014Post-marketing drug surveillance for adverse drug events (ADEs) has typically relied on spontaneous reporting. Recently, regulatory agencies have turned their attention... (Comparative Study)
Comparative Study Review
Post-marketing drug surveillance for adverse drug events (ADEs) has typically relied on spontaneous reporting. Recently, regulatory agencies have turned their attention to more preemptive approaches that use existing data for surveillance. We conducted an environmental scan to identify active surveillance systems worldwide that use existing data for the detection of ADEs. We extracted data about the systems' structures, data, and functions. We synthesized the information across systems to identify common features of these systems. We identified nine active surveillance systems. Two systems are US based-the FDA Sentinel Initiative (including both the Mini-Sentinel Initiative and the Federal Partner Collaboration) and the Vaccine Safety Datalink (VSD); two are Canadian-the Canadian Network for Observational Drug Effect Studies (CNODES) and the Vaccine and Immunization Surveillance in Ontario (VISION); and two are European-the Exploring and Understanding Adverse Drug Reactions by Integrative Mining of Clinical Records and Biomedical Knowledge (EU-ADR) Alliance and the Vaccine Adverse Event Surveillance and Communication (VAESCO). Additionally, there is the Asian Pharmacoepidemiology Network (AsPEN) and the Shanghai Drug Monitoring and Evaluative System (SDMES). We identified two systems in the UK-the Vigilance and Risk Management of Medicines (VRMM) Division and the Drug Safety Research Unit (DSRU), an independent academic unit. These surveillance systems mostly use administrative claims or electronic medical records; most conduct pharmacovigilance on behalf of a regulatory agency. Either a common data model or a centralized model is used to access existing data. The systems have been built using national data alone or via partnership with other countries. However, active surveillance systems using existing data remain rare. North America and Europe have the most population coverage; with Asian countries making good advances.
Topics: Adverse Drug Reaction Reporting Systems; Databases, Pharmaceutical; Humans; Internationality; Pharmacovigilance
PubMed: 25022829
DOI: 10.1007/s40264-014-0194-3 -
British Journal of Clinical Pharmacology Feb 2022Adverse drugs effects (ADEs) in children are common and may result in disability and death. The current paediatric drug safety landscape, including clinical trials, is... (Review)
Review
Adverse drugs effects (ADEs) in children are common and may result in disability and death. The current paediatric drug safety landscape, including clinical trials, is limited as it rarely includes children and relies on extrapolation from adults. Children are not small adults but go through an evolutionarily conserved and physiologically dynamic process of growth and maturation. Novel quantitative approaches, integrating observations from clinical trials and drug safety databases with dynamic mechanisms, can be used to systematically identify ADEs unique to childhood. In this perspective, we discuss three critical research directions using systems biology methodologies and novel informatics to improve paediatric drug safety, namely child versus adult drug safety profiles, age-dependent drug toxicities and genetic susceptibility of ADEs across childhood. We argue that a data-driven framework that leverages observational data, biomedical knowledge and systems biology modelling will reveal previously unknown mechanisms of pediatric adverse drug events and lead to improved paediatric drug safety.
Topics: Adult; Adverse Drug Reaction Reporting Systems; Child; Databases, Factual; Drug-Related Side Effects and Adverse Reactions; Humans; Pharmacovigilance; Systems Biology
PubMed: 33332641
DOI: 10.1111/bcp.14705 -
BMC Medical Education Aug 2023To compare the pediatric neurologists' knowledge, practice, and barriers to the pharmacovigilance (PV) process in Poland and Germany.
OBJECTIVES
To compare the pediatric neurologists' knowledge, practice, and barriers to the pharmacovigilance (PV) process in Poland and Germany.
METHODS
The research tool was an online anonymous questionnaire on Google Forms e-mailed to pediatric neurologists from Poland and Germany.
RESULTS
The questionnaires were handed out to 830 pediatric neurologists and 371 expressed their consent to participate in the study. Most of the neurologists were familiar with the definition of PV and adverse drug reactions (ADRs). Only 34.10% of pediatric neurologists from Poland, and 38.88% from Germany believe that many ADRs are preventable and almost most of them believe it is necessary to report ADRs from children with epilepsy. Unfortunately, in opposite to this knowledge, only 37.79% of respondents from Poland and 40.32% from Germany felt co-responsible for reporting ADRs. The main reason for the neurologists not to report ADRs was a conviction that reporting ADRs would be an additional burden generating extra work.
CONCLUSION
There is no big difference between the practice of PV by pediatric neurologists in Poland and Germany. System-regulated PV stabilization in the country translates into the practice of maintaining PV. Monitoring the safety of pharmacotherapy and knowledge of risks associated with ADRs should be included in the curricula of academic neurologics courses.
Topics: Child; Humans; Neurologists; Pharmacovigilance; Poland; Adverse Drug Reaction Reporting Systems; Health Knowledge, Attitudes, Practice; Drug-Related Side Effects and Adverse Reactions; Germany
PubMed: 37528387
DOI: 10.1186/s12909-023-04542-4 -
Drug Safety May 2022There is great interest in the application of 'artificial intelligence' (AI) to pharmacovigilance (PV). Although US FDA is broadly exploring the use of AI for PV, we...
There is great interest in the application of 'artificial intelligence' (AI) to pharmacovigilance (PV). Although US FDA is broadly exploring the use of AI for PV, we focus on the application of AI to the processing and evaluation of Individual Case Safety Reports (ICSRs) submitted to the FDA Adverse Event Reporting System (FAERS). We describe a general framework for considering the readiness of AI for PV, followed by some examples of the application of AI to ICSR processing and evaluation in industry and FDA. We conclude that AI can usefully be applied to some aspects of ICSR processing and evaluation, but the performance of current AI algorithms requires a 'human-in-the-loop' to ensure good quality. We identify outstanding scientific and policy issues to be addressed before the full potential of AI can be exploited for ICSR processing and evaluation, including approaches to quality assurance of 'human-in-the-loop' AI systems, large-scale, publicly available training datasets, a well-defined and computable 'cognitive framework', a formal sociotechnical framework for applying AI to PV, and development of best practices for applying AI to PV. Practical experience with stepwise implementation of AI for ICSR processing and evaluation will likely provide important lessons that will inform the necessary policy and regulatory framework to facilitate widespread adoption and provide a foundation for further development of AI approaches to other aspects of PV.
Topics: Adverse Drug Reaction Reporting Systems; Algorithms; Artificial Intelligence; Drug-Related Side Effects and Adverse Reactions; Humans; Pharmacovigilance
PubMed: 35579808
DOI: 10.1007/s40264-022-01157-4 -
Journal of Clinical Pharmacology Jun 2021The efficacy and safety of a drug is dose or exposure related, and both are used to assess the benefit-risk balance of a given drug and ultimately to decide on the... (Review)
Review
The efficacy and safety of a drug is dose or exposure related, and both are used to assess the benefit-risk balance of a given drug and ultimately to decide on the specific drug license, including its dose and indication(s). Unfortunately, both efficacy and safety are much more difficult to establish in neonates, resulting in very few drugs licensed for use in this vulnerable population. This review will focus on dose-related adverse events in neonates. Besides the regulatory classification on seriousness, adverse event assessment includes aspects related to signal detection, causality, and severity. Disentangling confounders from truly dose-related adverse drug events remains a major challenge, as illustrated for drug-induced renal impairment, drug-induced liver injury, and neurodevelopmental outcome. Causality assessment, using either routine tools (Naranjo algorithm, World Health Organization's Uppsala Monitoring Center causality tool) or a Naranjo algorithm tailored to neonates, still does not sufficiently and reliably document causality in neonates. Finally, very recently, a first neonatal severity-grading tool for neonates has been developed. Following the development of advanced pharmacokinetic approaches and techniques to predict and assess drug exposure, additional efforts are needed to truly and fully assess dose adverse drug events. To further operationalize the recently developed tools on causality and severity, reference databases on a palette of biomarkers and outcome variables and their covariates are an obvious next step. These databases should subsequently be integrated in modeling efforts to truly explore safety outcome, including aspects associated with or caused by drug dose or exposure.
Topics: Causality; Chemical and Drug Induced Liver Injury; Drug-Related Side Effects and Adverse Reactions; Humans; Infant, Newborn; Kidney; Neurocognitive Disorders; Pharmacovigilance
PubMed: 34185907
DOI: 10.1002/jcph.1827 -
International Journal of Clinical... Jun 2024In the era of personalized medicine, pharmacovigilance faces new challenges and opportunities, demanding a shift from traditional approaches. This article delves into... (Review)
Review
In the era of personalized medicine, pharmacovigilance faces new challenges and opportunities, demanding a shift from traditional approaches. This article delves into the evolving landscape of drug safety monitoring in the context of personalized treatments. We aim to provide a succinct reflection on the intersection of tailored therapeutic strategies and vigilant pharmacovigilance practices. We discuss the integration of pharmacogenetics in enhancing drug safety, illustrating how genetic profiling aids in predicting drug responses and adverse reactions. Emphasizing the importance of phase IV-post-marketing surveillance, we explore the limitations of pre-marketing trials and the necessity for a comprehensive approach to drug safety. The article discusses the pivotal role of pharmacogenetics in pre-exposure risk management and the redefinition of pharmacoepidemiological methods for post-exposure surveillance. We highlight the significance of integrating patient-specific genetic profiles in creating personalized medication leaflets and the use of advanced computational methods in data analysis. Additionally, we examine the ethical, privacy, and data security challenges inherent in precision medicine, emphasizing their implications for patient consent and data management.
Topics: Precision Medicine; Humans; Pharmacovigilance; Drug-Related Side Effects and Adverse Reactions; Pharmacogenetics; Product Surveillance, Postmarketing
PubMed: 38416349
DOI: 10.1007/s11096-024-01709-x -
PloS One 2023Healthcare professionals' involvement and reporting of adverse drug reactions are essential for the success of a pharmacovigilance program. The aim of this study was to...
Evaluation of health care professionals' knowledge, attitudes, practices and barriers to pharmacovigilance and adverse drug reaction reporting: A cross-sectional multicentral study.
BACKGROUND
Healthcare professionals' involvement and reporting of adverse drug reactions are essential for the success of a pharmacovigilance program. The aim of this study was to assess healthcare professionals (medical doctors, pharmacists, nurses, dentists, midwives, and paramedics) current knowledge, attitude, practices, and barriers regarding pharmacovigilance and adverse drug reactions reporting in multicentral healthcare settings.
METHODS
A cross-sectional face-to-face survey was conducted among currently working healthcare professionals in various hospitals in ten districts of Adana province, Türkiye from March to October 2022. A self-administered, pretested questionnaire (Cronbach's alpha = 0.894 for knowledge, attitudes and practices variables) was used for data collection. The questionnaire's final draft included five sections (sociodemographic/general information, knowledge, attitude, practices, and barriers) with 58 questions. The collected data was analyzed in SPSS (version 25) using descriptive statistics, the chi-square test, and logistic regression.
RESULTS
Of the total 435 distributed questionnaires, 412 completed the entire questionnaire, yielding a 94% response rate. The majority of healthcare professionals (60.4%; n = 249) had never received pharmacovigilance training. Among healthcare professionals 51.9% (n = 214), 71.1% (n = 293) and 92.5% (n = 381) had poor knowledge, positive attitudes and poor practices, respectively. Only 32.5% of healthcare professionals kept the record of an adverse drug reaction and only 13.1% reported adverse drug reactions. The profession (medical doctors, pharmacists, nurses, dentists, midwives, and paramedics) of healthcare professionals and a lack of training were predictors of poor adverse drug reaction reporting (p < 0.05). A statistically significant difference in healthcare professionals and knowledge, attitude and practices scores was also observed (p < 0.05). The main barriers which were supposed to discourage adverse drug reactions reporting by the healthcare professionals were higher workload (63.8%) followed by thinking that a single adverse drug reaction report makes no impact (63.6%) and lack of a professional atmosphere (51.9%).
CONCLUSION
In the current study, most healthcare professionals had poor knowledge and practice, but they had a positive attitude toward pharmacovigilance and adverse drug reactions reporting. Barriers to under-reporting of adverse drug reactions were also highlighted. Periodic training programs, educational interventions, systematic follow-up of healthcare professionals by local healthcare authorities, interprofessional links between all healthcare professionals, and the implementation of mandatory reporting policies are critical for improving healthcare professionals knowledge, practices, patient safety and pharmacovigilance activities.
Topics: Humans; Cross-Sectional Studies; Health Knowledge, Attitudes, Practice; Pharmacovigilance; Health Personnel; Drug-Related Side Effects and Adverse Reactions
PubMed: 37224133
DOI: 10.1371/journal.pone.0285811