The Importance of Direct Patient Reporting of Adverse Drug Reactions in the Safety Monitoring Process

Sienkiewicz, Kamila; Burzyńska, Monika; Rydlewska-Liszkowska, Izabela; Sienkiewicz, Jacek; Gaszyńska, Ewelina

doi:10.3390/ijerph19010413

Cited by 21 publications

(18 citation statements)

References 36 publications

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“…Just consider that more than 40% of ChAdOx1-SARS-COV-2 -related ICSRs of our dataset were send by patients. According current pharmacovigilance legislation, patients are nowadays considered an important source of safety data ( 22 ). Although, ICSRs reported by patients could be considered maybe less reliable than those reported by a healthcare professional, we hypothesized that those still followed a CLS medical diagnosis.…”

Section: Discussionmentioning

confidence: 99%

Capillary leak syndrome following COVID-19 vaccination: Data from the European pharmacovigilance database Eudravigilance

et al. 2022

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Capillary leak syndrome (CLS) emerged as new adverse event after immunization (AEFI) associated to COVID-19 vaccination. CLS is a rare condition characterized by increased capillary permeability, resulting in hypoalbuminemia, hypotension, and edema mainly in the upper and lower limbs. Our pharmacovigilance study aims to evaluate the CLS onset following receipt of COVID-19 mRNA vaccines (mRNA-1273 and BNT162b2) compared to viral vector vaccines (Ad26.COV2-S and ChAdOx1-SARS-COV-2). We carried a cross-sectional study using all Individual Case Safety Reports (ICSRs) reporting a COVID-19 vaccine as suspected drug and CLS as AEFI, which were collected in the pharmacovigilance database EudraVigilance from January 1st, 2021, to January 14th, 2022. We applied the Reporting Odds Ratio (ROR) 95% CI for the disproportionality analysis. During our study period, CLS was described as AEFI in 84 out of 1,357,962 ICRs reporting a vaccine COVID-19 as suspected drug and collected in the EV database. Overall, the ICSR reported by CLS were mainly related to the viral vector COVID-19(ChAdOx1-SARS-COV-2 = 36; Ad26.COV2-S = 9). The mRNA COVID-19 vaccines were reported in 39 ICSRs (BNT162b2 =33; mRNA-1273 =6). Majority of ICSRs were reported by healthcare professionals (71.4%). Majority of the patients were adult (58.3%) and the female gender accounted in more than 65% of ICSRs referred both to classes vaccines. In particular, women were more represented in ICSRs referred to mRNA-1273 (83.3%) and to ChAdOx1-SARS-COV-2 (72.2%). The CLS outcome was more frequently favorable in mRNA ICSRs (33,3%) than the viral vector ones (13.3%). Among the ICSRs reporting CLS with unfavorable outcome, we found also 9 fatal cases (BNT162b2 = 1; ChAdOx1-SARS-COV-2 = 4; Ad26.COV2-S = 4). From disproportionality analysis emerged a lower CLS reporting probability after vaccination with mRNA vaccines compared to viral vector-based ones (ROR 0.5, 95% CI 0.3–0.7; p <0.001).Our findings, even if subject to the limitations of spontaneous reporting systems, suggest a small but statistically significant safety concern for CLS following receipt of COVID-19 viral vector vaccines, in particular with Ad26.COV2-S. Cytokine-release following T-cell activation could be involved in CLS occurrence, but a precise mechanism has been not yet identified. COVID-19 vaccines remain attentive as possible triggers of CLS.

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Section: Discussionmentioning

confidence: 99%

Capillary leak syndrome following COVID-19 vaccination: Data from the European pharmacovigilance database Eudravigilance

et al. 2022

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“…It is used for the management, collection, and analyses of individual case safety reports (ICSRs) related to both medicines or vaccines ( 23 ). The EV contains all ICSRs reported by a healthcare professional or a non-healthcare professional (e.g., citizen or other professional figures) ( 24 ). The ICSRs are aimed to inform the competent authorities or a marketing authorization holder regarding the suspected adverse drug reactions (ADRs) or the adverse events following immunization (AEFI) which, in the reporters’ opinion, may be related to assumption of the medicines (drug or vaccine, respectively).…”

Section: Methodsmentioning

confidence: 99%

Neurological Manifestations Related to Immune Checkpoint Inhibitors: Reverse Translational Research by Using the European Real-World Safety Data

et al. 2022

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Immune checkpoint inhibitors (ICIs) are widely used improving clinical outcomes in many cancer patients. However, they can induce serious consequences, like neurological immune-related adverse drug reactions (NirADRs). Although these are rare complications, they can be serious with important impact on patients’ quality of life. Our purpose is to describe these adverse events observed in the European clinical practice context. We carried out a descriptive analysis of individual case safety reports (ICSRs) related to ICIs collected until February 7, 2020, in the European spontaneous reporting database, EudraVigilance, and reported nervous disorders as suspect adverse drug reactions (ADRs). NirADRs were classified according to the Medical Dictionary for Regulatory Activities (MedDRA). In order to identify a hypothetical different reporting probability of the NirADR types between the ICI classes, we carried out a disproportionality analysis. The reporting odds ratio (ROR) with 95% CI was computed comparing the different ICI classes to each other based on their pharmacological target [the cytotoxic T-lymphocyte antigen-4 (CTLA-4), the programmed death-1 (PD-1) or its ligand (PD-L1)]. Finally, we researched in the literature the hypothesized mechanisms, which could explain the onset of these ICI-related neurological complications. Overall, we found 4,875 cases describing 6,429 ICI-related suspected NirADRs. ICI-related neurotoxicities include a wide range of central and peripheral events. These were mainly related to anti-PD-1 agents and occurred in male patients (59%). Our analysis confirmed a gender difference of NirADRs. Twenty-three percent of the events (comprising myasthenia gravis, neuropathy peripheral, and cerebral infarction) had unfavorable fallouts, including fatal outcome (7%). Majority of the NirADRs were categorized as “Neurological disorders NEC” HLGTs MedDRA (2,076; 32%). In 1,094 cases (22%), more NirADRs overlapped with other neurologic complications. An interesting overlapping of myasthenia gravis with myositis or myocarditis emerged. From our disproportionality analysis, an increased reporting probability of peripheral neuropathies and headaches emerged with ipilimumab when compared to anti-PD-1 and anti-PD-L1 agents. However, neuromuscular disorders were more probably reported with anti-PD-1. Several pathogenic mechanisms, including neuronal damage by T cells and autoantibodies and/or cytokine-mediated inflammation processes, have been hypothesized. However, the pathogenesis of these ICI-related complications is not completely understood. Considering the recent marketing authorizations of ICIs, further studies are strongly needed to monitor their neurologic safety profile.

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“…26 These additional data from patient and consumer reporting provides complementary information to healthcare professional data, such as the effects on quality of life. 26 VigiBase provides an opportunity for greater participation by patients and consumers in haemovigilance reporting, and the inclusion of their voices can help improve haemovigilance processes. It is important to note that when using data from patients or consumers, it must be verified or analyzed further by healthcare professionals.…”

Section: Patient and Consumer Reportingmentioning

confidence: 99%

“…It is important to note that when using data from patients or consumers, it must be verified or analyzed further by healthcare professionals. 26…”

Section: Patient and Consumer Reportingmentioning

confidence: 99%

Suspected adverse reactions reported for blood, blood components, and blood products in VigiBase

Samukange

Souverein

et al. 2023

Transfusion

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Introduction Since being designated as medicines by World Health Organization (WHO), blood components are subject to pharmacovigilance reporting. Using VigiBase, the WHO global database of individual case safety reports (ICSRs), we characterized reports of adverse reactions for all blood products. Study Design and Methods ICSRs involving blood products as the suspected medicine in VigiBase between 1968 and 2021 were extracted. MedDRA preferred terms and the International Society of Blood Transfusion haemovigilance definitions were used to stratify adverse reactions. Descriptive statistics were used to characterize ICSR demographics. Results A total of 111,033 ICSRs containing 577,577 suspected adverse reactions with 6152 MedDRA preferred terms were reported for 34 blood products. There were 12,153 (10.9%) reports for blood components, 98,135 (88.4%) reports for plasma‐derived medicines, and 745 (0.7%) reports for recombinant products. The majority of reports (21.0% and 19.7%, respectively) were from patients aged 45–64 and over 65 years. The Americas contributed the most ICSRs (49.7%). Top reported suspected adverse reactions were for the following MedDRA preferred terms: headache (3.5%), pyrexia (2.8%), chills (2.8%), dyspnoea (1.8%), and nausea (1.8%). Conclusion VigiBase already has a large number of reports on blood products. When compared to other existing haemovigilance databases, our study found reports from a broader range of countries and reporters. This may provide us with new perspectives, but for VigiBase to reach its full potential in haemovigilance some alterations in what is captured in reports are required.

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The Importance of Direct Patient Reporting of Adverse Drug Reactions in the Safety Monitoring Process

Cited by 21 publications

References 36 publications

Capillary leak syndrome following COVID-19 vaccination: Data from the European pharmacovigilance database Eudravigilance

Capillary leak syndrome following COVID-19 vaccination: Data from the European pharmacovigilance database Eudravigilance

Neurological Manifestations Related to Immune Checkpoint Inhibitors: Reverse Translational Research by Using the European Real-World Safety Data

Suspected adverse reactions reported for blood, blood components, and blood products in VigiBase

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