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JCO Clinical Cancer Informatics May 2024This new editorial discusses the promise and challenges of successful integration of natural language processing methods into electronic health records for timely,...
This new editorial discusses the promise and challenges of successful integration of natural language processing methods into electronic health records for timely, robust, and fair oncology pharmacovigilance.
Topics: Pharmacovigilance; Humans; Artificial Intelligence; Electronic Health Records; Medical Oncology; Natural Language Processing; Data Collection; Neoplasms; Adverse Drug Reaction Reporting Systems
PubMed: 38713889
DOI: 10.1200/CCI.24.00051 -
Pharmaceuticals (Basel, Switzerland) Dec 2023The global impact of the COVID-19 pandemic has underscored the pivotal role of drug safety and effective communication within the realm of pharmacovigilance,...
The global impact of the COVID-19 pandemic has underscored the pivotal role of drug safety and effective communication within the realm of pharmacovigilance, particularly in times of unprecedented public health emergencies [...].
PubMed: 38139815
DOI: 10.3390/ph16121689 -
BMJ Open Apr 2024Pharmacovigilance databases play a critical role in monitoring drug safety. The duplication of reports in pharmacovigilance databases, however, undermines their data... (Review)
Review
OBJECTIVES
Pharmacovigilance databases play a critical role in monitoring drug safety. The duplication of reports in pharmacovigilance databases, however, undermines their data integrity. This scoping review sought to provide a comprehensive understanding of duplication in pharmacovigilance databases worldwide.
DESIGN
A scoping review.
DATA SOURCES
Reviewers comprehensively searched the literature in PubMed, Web of Science, Wiley Online Library, EBSCOhost, Google Scholar and other relevant websites.
ELIGIBILITY CRITERIA
Peer-reviewed publications and grey literature, without language restriction, describing duplication and/or methods relevant to duplication in pharmacovigilance databases from inception to 1 September 2023.
DATA EXTRACTION AND SYNTHESIS
We used the Joanna Briggs Institute guidelines for scoping reviews and conformed with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. Two reviewers independently screened titles, abstracts and full texts. One reviewer extracted the data and performed descriptive analysis, which the second reviewer assessed. Disagreements were resolved by discussion and consensus or in consultation with a third reviewer.
RESULTS
We screened 22 745 unique titles and 156 were eligible for full-text review. Of the 156 titles, 58 (47 peer-reviewed; 11 grey literature) fulfilled the inclusion criteria for the scoping review. Included titles addressed the extent (5 papers), prevention strategies (15 papers), causes (32 papers), detection methods (25 papers), management strategies (24 papers) and implications (14 papers) of duplication in pharmacovigilance databases. The papers overlapped, discussing more than one field. Advances in artificial intelligence, particularly natural language processing, hold promise in enhancing the efficiency and precision of deduplication of large and complex pharmacovigilance databases.
CONCLUSION
Duplication in pharmacovigilance databases compromises risk assessment and decision-making, potentially threatening patient safety. Therefore, efficient duplicate prevention, detection and management are essential for more reliable pharmacovigilance data. To minimise duplication, consistent use of worldwide unique identifiers as the key case identifiers is recommended alongside recent advances in artificial intelligence.
Topics: Pharmacovigilance; Humans; Databases, Factual; Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions
PubMed: 38684275
DOI: 10.1136/bmjopen-2023-081990 -
SAGE Open Medicine 2024Healthcare professionals' awareness of adverse drug reaction reporting and pharmacovigilance practices differ by country. The study assesses healthcare professionals'...
INTRODUCTION
Healthcare professionals' awareness of adverse drug reaction reporting and pharmacovigilance practices differ by country. The study assesses healthcare professionals' knowledge, practice, and potential barriers to pharmacovigilance-related practices and reporting adverse drug reaction.
METHODS
A cross-sectional investigation was conducted in government and private healthcare settings. The study included licensed physicians, pharmacists, and nurses. To examine knowledge, practice, and potential barriers to pharmacovigilance-related practices and adverse drug reaction reporting, a 22-item validated questionnaire was used.
RESULTS
The final analysis included 311 healthcare professionals. Most healthcare professionals, 59% ( = 182), mentioned encountering patients with adverse drug reactions during the last year. On the other hand, most healthcare professionals, 54% ( = 167), mentioned that they had not reported adverse drug reactions. A good proportion of respondents mentioned that it is essential to report adverse drug reactions ( = 288, 92.6%), availability of adverse drug reactions reporting forms in practice sites ( = 216, 69.5%), had awareness regarding how to report adverse drug reactions ( = 221, 71.1%), the necessity of reporting minor/less important adverse drug reactions ( = 265, 85.2%), and were trained on how to report adverse drug reactions ( = 201, 64.6%). Adverse drug reaction reporting program in the United Arab Emirates ( = 148, 47.6) was known to many healthcare professionals. Lack of time was the major impediment to reporting adverse drug reactions at 42.7% ( = 133). The predictor variable work experience does add to the model ( < 0.05) concerning association with filling of adverse drug reaction forms (Estimate = 0.380; SE = 0.452; = 0.400), professional role (Estimate = 0.454; SE = 0.673; = 0.500). In addition, the predictor variable practice setting adds to the model ( < 0.05) concerning the knowledge regarding the availability of adverse drug reaction reporting forms (Estimate = -1.229; SE = 0.298; = 0.000), training on how to report adverse drug reactions (Estimate = -0.660; SE = 0.294; = 0.025), and awareness regarding the adverse drug reaction reporting program in the United Arab Emirates (Estimate = -1.032; SE = 0.280; = 0.000).
CONCLUSION
Pharmacists had the most knowledge regarding adverse drug reaction reporting and pharmacovigilance. The underreporting of adverse drug reactions was documented among physicians and nurses. Lack of time was the most significant barrier to reporting adverse drug reactions, followed by uncertainty and complicated adverse drug reaction documentation forms.
PubMed: 38725923
DOI: 10.1177/20503121241249908 -
Human Vaccines & Immunotherapeutics Dec 2024The pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) led to urgent actions by innovators, vaccine developers, regulators, and other... (Review)
Review
The pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) led to urgent actions by innovators, vaccine developers, regulators, and other stakeholders to ensure public access to protective vaccines while maintaining regulatory agency standards. Although development timelines for vaccines against SARS-CoV-2 were much quicker than standard vaccine development timelines, regulatory requirements for efficacy and safety evaluations, including the volume and quality of data collected, were upheld. Rolling review processes supported by sponsors and regulatory authorities enabled rapid assessment of clinical data as well as emergency use authorization. Post-authorization and pharmacovigilance activities enabled the quantity and breadth of post-marketing safety information to quickly exceed that generated from clinical trials. This paper reviews safety and reactogenicity data for the BNT162 vaccine candidates, including BNT162b2 (Comirnaty, Pfizer/BioNTech COVID-19 vaccine) and bivalent variant-adapted BNT162b2 vaccines, from preclinical studies, clinical trials, post-marketing surveillance, and real-world studies, including an unprecedentedly large body of independent evidence.
Topics: Humans; BNT162 Vaccine; COVID-19; COVID-19 Vaccines; Marketing; Pharmacovigilance; SARS-CoV-2; Vaccines, Combined
PubMed: 38407186
DOI: 10.1080/21645515.2024.2315659 -
Bundesgesundheitsblatt,... Jul 2023The drug treatment of mental illness in childhood and adolescence poses a particular clinical and legal challenge. Reasons for this include the often necessary... (Review)
Review
The drug treatment of mental illness in childhood and adolescence poses a particular clinical and legal challenge. Reasons for this include the often necessary off-label use and existing knowledge gaps regarding the long-term effects of the neuro-/psychotropic drugs used. In this article, the prerequisites for therapy with neuro/psychotropic drugs, such as the need for age-appropriate inclusion of children and adolescents in the decision-making and education process, as well as the evaluation of medication, the consideration of biological age- and maturation-related factors, and the special measures for off-label use, are discussed. We further discuss general problems in the development and use of neuro-/psychotropic drugs, such as the difficulties in relation to proof of effectiveness, reimbursement and liability issues of off-label administration, and the problems of conducting clinical trials with children and adolescents.
Topics: Child; Humans; Adolescent; Psychopharmacology; Off-Label Use; Germany; Psychotropic Drugs; Mental Disorders
PubMed: 37277511
DOI: 10.1007/s00103-023-03718-z -
Frontiers in Pharmacology 2023To investigate adverse events (AEs) associated with denosumab (Dmab) and zoledronic acid (ZA), compare their association strengths, and explore potential applications...
To investigate adverse events (AEs) associated with denosumab (Dmab) and zoledronic acid (ZA), compare their association strengths, and explore potential applications to provide clinical reference. We collected data from FAERS from January 2004 to November 2022 and mined AE signals for Dmab and ZA using ROR values. We compared signal intensity for same AEs and investigated off-label use. We also examined their AEs in adjuvant therapy for breast and prostate cancer. 154,735 reports of primary suspect drugs were analyzed in the FAERS database (Dmab: 117,857; ZA: 36,878). Dmab and ZA had 333 and 1,379 AE signals, with 189 overlaps. The AEs of Dmab included death (ROR:3.478), osteonecrosis of jaw (ROR:53.025), back pain (ROR:2.432), tooth disorder (ROR:16.18), bone pain (ROR:6.523). For ZA, the AEs included osteonecrosis (ROR:104.866), death (ROR: 3.645), pain (ROR:3.963), osteonecrosis of jaw (ROR: 91.744), tooth extraction (ROR: 142.143). Among overlap signals, Dmab showed higher strength in exostosis of the jaw (ROR: 182.66 vs. 5.769), atypical fractures (ROR: 55.589 vs. 9.123), and atypical femur fractures (ROR:49.824 vs. 4.968). And ZA exhibited stronger associations in abscess jaw (ROR: 84.119 vs. 11.12), gingival ulceration (ROR: 74.125 vs. 4.827), increased bone formation (ROR: 69.344 vs. 3.218). Additionally, we identified 528 off-label uses for Dmab and 206 for ZA, with Dmab mainly used in prostate cancer (1.04%), breast cancer (1.03%), and arthritis (0.42%), while ZA in breast cancer (3.21%), prostate cancer (2.48%), and neoplasm malignant (0.52%). For Dmab in breast cancer treatment, AEs included death (11.6%), disease progression (3.3%), and neutropenia (2.7%), while for ZA included death (19.8%), emotional disorder (12.9%), osteomyelitis (11.7%). For prostate cancer treatment, Dmab`s AEs were death (8.9%), prostate cancer metastatic (1.6%), renal impairment (1.7%), while ZA`s included death (34.4%), general physical health deterioration (19.9%), and hemoglobin decreased (18.9%). Our analysis of FAERS database provided postmarketing surveillance data and revealed different strengths of reported AE signals between Dmab and ZA in some of their common AEs. It's also worth noting that both drugs have potential off-label applications, which could introduce new AEs. This highlights the necessity for safety monitoring when using Dmab and ZA off-label.
PubMed: 38027014
DOI: 10.3389/fphar.2023.1225919 -
Frontiers in Reproductive Health 2023The risk of HIV acquisition is higher during pregnancy and postpartum than other times. Newly acquired maternal HIV infection associated with high primary viraemia,... (Review)
Review
The risk of HIV acquisition is higher during pregnancy and postpartum than other times. Newly acquired maternal HIV infection associated with high primary viraemia, substantially increases the risk of vertical HIV transmission. Pre-exposure prophylaxis (PrEP) reduces the risk of HIV acquisition. Currently available products include oral tenofovir/emtricitabine (TDF/FTC) and tenofovir alafenamide (TAF)/FTC), long-acting cabotegravir (CAB-LA) and the dapivirine ring (DVR). All except oral TDF/FTC have limited safety data available for use in pregnant and breastfeeding women. The safety of new PrEP agents for pregnant women and the fetus, infant and child, either exposed or during breastfeeding is an ongoing concern for health care workers and pregnant and breastfeeding women, particularly as the safety risk appetite for antiretroviral (ARV) agents used as PrEP is lower in pregnant and breastfeeding women who are HIV-uninfected, compared to women living with HIV taking ARVs as treatment. With the widespread rollout of TDF/FTC among pregnant women in South Africa and other low-middle income countries (LMIC) and the potential introduction of new PrEP agents for pregnant women, there is a need for safety surveillance systems to identify potential signals of risk to either the mother or fetus, measure the burden of such a risk, and where appropriate, provide specific reassurance to PrEP users. Safety data needs to be collected across the continuum of the product life cycle from pre-licensure into the post-marketing period, building a safety profile through both passive and active surveillance systems, recognising the strengths and limitations of each, and the potential for bias and confounding. Pharmacovigilance systems that aim to assess the risk of adverse birth outcomes in pregnant women exposed to PrEP and other agents need to consider the special requirements of pregnancy epidemiology to ensure that the data derived from surveillance are sufficiently robust to inform treatment policies. Here we review the known safety profiles of currently available PrEP candidates in women of child-bearing potential, pregnancy and breastfeeding and discuss pragmatic approaches for such surveillance in HIV-endemic LMICs.
PubMed: 37854936
DOI: 10.3389/frph.2023.1221101 -
The Journal of Dermatological Treatment Dec 2024Topical clindamycin, a lincosamide antibiotic, is commonly combined with benzoyl peroxide or a retinoid for acne vulgaris (AV) treatment. While oral and topical... (Review)
Review
Topical clindamycin, a lincosamide antibiotic, is commonly combined with benzoyl peroxide or a retinoid for acne vulgaris (AV) treatment. While oral and topical clindamycin carry warnings/contraindications regarding gastrointestinal (GI) adverse events (AEs), real-world incidence of GI AEs with topical clindamycin is unknown. This review provides background information and an overview of safety data of topical clindamycin for treating AV. Available safety data from published literature, previously unpublished worldwide pharmacovigilance data, and two retrospective cohort studies were reviewed. According to pharmacovigilance data, the rate of GI adverse drug reactions with topical clindamycin-containing products was 0.000045% (64/141,084,533). Results from two retrospective medical record studies of patients with AV indicated that physicians prescribe topical clindamycin equally to patients with or without inflammatory bowel disease history, and that rates of pseudomembranous colitis in these patients were low. In 8 published pivotal clinical trials of topical clindamycin for AV, GI AEs were reported in 1.4% of participants. Limitations include under/inaccurate reporting of AEs or prescription data and limited generalizability. This review of published case reports, worldwide pharmacovigilance data, retrospective US prescription data, and clinical trials safety data demonstrates that the incidence of colitis in patients exposed to topical clindamycin is extremely low.
Topics: Humans; Clindamycin; Retrospective Studies; Acne Vulgaris; Anti-Bacterial Agents; Benzoyl Peroxide
PubMed: 38568005
DOI: 10.1080/09546634.2024.2325603 -
Medicine and Pharmacy Reports Oct 2023To determine the knowledge regarding various aspects of pharmacovigilance among doctors and nurses of a tertiary care teaching hospital and to evaluate the effect of an...
AIM
To determine the knowledge regarding various aspects of pharmacovigilance among doctors and nurses of a tertiary care teaching hospital and to evaluate the effect of an educational intervention.
METHODS
A cross-sectional study was conducted among doctors and nurses of a tertiary care teaching hospital. The participants attended a one-hour educational session during which the concept of pharmacovigilance, the Pharmacovigilance Program of India, the need for reporting ADRs, and the method of reporting were explained by a subject expert. A 20-item questionnaire was used to assess their knowledge regarding pharmacovigilance before and after an educational session. The pre-post comparisons were done using Wilcoxon's signed-rank test. A p-value less than 0.05 was considered statistically significant.
RESULTS
Forty-two doctors and 115 nurses participated in the study. A significant improvement in the participant scores was seen following the educational intervention in both doctors (Z = -5.344, p < 0.001) and nurses (Z = -8.808, p < 0.001). Lack of knowledge/awareness was perceived as the major barrier for ADR reporting among nurses as well as doctors.
CONCLUSION
There is need for education and training among doctors and nurses to enhance their knowledge about drug safety and reporting practices. Educational intervention is likely to improve the knowledge regarding pharmacovigilance, and thereby enhance reporting by healthcare professionals.
PubMed: 37970197
DOI: 10.15386/mpr-2076