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Drug Safety
Journal Prestige (SJR): 1.447
Citation Impact (citeScore): 3
Number of Followers: 83  
 
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ISSN (Print) 0114-5916 - ISSN (Online) 1179-1942
Published by Adis Homepage  [21 journals]
  • Signals of Adverse Drug Reactions Communicated by Pharmacovigilance
           Stakeholders: A Scoping Review of the Global Literature

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      Abstract: Introduction and Objective Signals of adverse drug reactions (ADRs) can be supported by reports of ADRs and by interventional and non-interventional studies. The evidence base and features of ADR reports that are used to support signals remain to be comprehensively described. To this end, we have undertaken a scoping review. Methods We searched the following databases: PubMed, EMBASE, PsycINFO, Web of Science, and Google Scholar, without language or time restrictions. We also hand searched the bibliographies of relevant studies. We included studies of any design if the results were described as signals. We assessed the levels of evidence using the Oxford Centre for Evidence-Based Medicine (OCEBM) criteria and coded features of reports of ADRs using the Bradford Hill guidelines. Results Overall, 1974 publications reported 2421 studies of signals; 1683/2421 were clinical assessments of anecdotal reports of ADRs, but only 225 (13%) of these included explicit judgments on which features of the ADR reports were supportive of a signal. These 225 studies yielded 228 signals; these were supported by features, which were: ‘experimental evidence’ (i.e., positive dechallenge or rechallenge, 154 instances [68%]), ‘temporality’ (i.e., time to onset, 130 [57%]), ‘exclusion of competing causes’ (49 [21%]), and others (40 [17%]). Positive dechallenge/rechallenge often co-occurred with temporality (77/228). OCEBM 4 (i.e., case series and case-control studies) was the most frequent level of evidence (2078 studies). Between 2013 and 2019, there was a three-fold increase in clinical assessments of reports of ADRs compared with a less than two-fold increase in studies supported by higher levels of evidence (i.e., OCEBM 1–3). We identified an increased rate between 2013 and 2019 in disproportionality analyses (about 15 studies per year), mostly from academia. Conclusions Most signals were supported by temporality and dechallenge/rechallenge, but clear reporting of judgments on causality remains infrequent. The number of studies supported only by anecdotal reports of ADRs increased from year to year. The impact of a growing number of signals of disproportionate reporting communicated without an accompanying clinical assessment should be evaluated.
      PubDate: 2022-12-05
       
  • The Food and Drug Administration’s (FDA’s) Drug Safety Surveillance
           During the COVID-19 Pandemic

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      Abstract: Introduction On 4 February, 2020, the Secretary of the Department of Health and Human Services declared a public health emergency related to coronavirus disease 2019 (COVID-19), and on 27 March, 2020 declared circumstances existed to justify the authorization of the emergency use of drug and biological products (hereafter, “drugs”) for COVID-19. At the outset of the pandemic with uncertainty relating to the virus, many drugs were being used to treat or prevent COVID-19, resulting in the US Food and Drug Administration’s (FDA’s) need to initiate heightened surveillance across these drugs. Objective We aimed to describe the FDA’s approach to monitoring the safety of drugs to treat or prevent COVID-19 across multiple data sources and the subsequent actions taken by the FDA to protect public health. Methods The FDA conducted surveillance of adverse event and medication error data using the FDA Adverse Event Reporting System, biomedical literature, FDA-American College of Medical Toxicology COVID-19 Toxicology Investigators Consortium Pharmacovigilance Project Sub-registry, and the American Association of Poison Control Centers National Poison Data System. Results From 4 February, 2020, through 31 January, 2022, we identified 22,944 unique adverse event cases worldwide and 1052 unique medication error cases domestically with drugs to treat or prevent COVID-19. These were from the FDA Adverse Event Reporting System (22,219), biomedical literature (1107), FDA-American College of Medical Toxicology COVID-19 Toxicology Investigator’s Consortium Sub-registry (638), and the National Poison Data System (32), resulting in the detection of several important safety issues. Conclusions Safety surveillance using near real-time data was critical during the COVID-19 pandemic because the FDA monitored an unprecedented number of drugs to treat or prevent COVID-19. Additionally, the pandemic prompted the FDA to accelerate innovation, forging new collaborations and leveraging data sources to conduct safety surveillance to respond to the pandemic.
      PubDate: 2022-12-02
       
  • Weight Gain During Antipsychotic Treatment in Children, Adolescents, and
           Adults: A Disproportionality Analysis in the Global Pharmacovigilance
           Database, Vigibase®

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      Abstract: Introduction While antipsychotic-induced weight gain has been widely described in adults, it has yet to be better characterized in children and adolescents. Objective The aim of this study was to assess antipsychotic-induced weight-gain reporting in children and adolescents as compared to adults, and according to the type of antipsychotic. Methods The study is an observational, case–non-case study using individual case safety reports from the WHO global pharmacovigilance database VigiBase® from 1 January 2000 to 2 June 2021. Disproportionality in antipsychotic-related weight-gain reporting in children and adolescents compared to adults was evaluated based on reporting odds ratios (RORs) with corresponding 95% confidence intervals (CIs) through multivariate logistic regression modeling. Analysis was adjusted for sex, region of reporting, year of notification, reporter qualification, concomitant use of antidepressants, and use of more than one antipsychotic. Results Among 282,224 antipsychotic-related spontaneous reports included in this analysis, we identified 16,881 (6.0%) weight-gain cases. Disproportionality in weight-gain reporting was found in children (adjusted ROR (aROR) 3.6; 95% CI 3.3–3.8) and in adolescents (aROR 2.3; 95% CI 2.2–2.4) compared to adults. Use of risperidone was associated with the highest increase in weight-gain reporting in children (aROR 4.9; 95% CI 3.9–6.1) and adolescents (aROR 3.6; 95% CI 3.1–4.1). Conclusions Compared to adults, weight-gain reporting with antipsychotics was disproportionally higher in the pediatric population, especially in children under 12 years of age. Considering the impact of weight gain on global morbidity and mortality, physicians should closely monitor weight gain in young patients, especially children on risperidone.
      PubDate: 2022-12-02
       
  • Authors’ Response to Yoshihiro Noguchi’s Comment on: “A
           Disproportionality Analysis of Drug-Drug Interactions of Tizanidine and
           CYP1A2 Inhibitors from the FDA Adverse Event Reporting System (FAERS)”

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      PubDate: 2022-12-01
       
  • Acknowledgement to Referees

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      PubDate: 2022-12-01
       
  • Comment on: "A Disproportionality Analysis of Drug–Drug
           Interactions of Tizanidine and CYP1A2 Inhibitors from the FDA Adverse
           Event Reporting System (FAERS)"

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      PubDate: 2022-12-01
       
  • Gastrointestinal Bleeding on Oral Anticoagulation: What is Currently Known

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      Abstract: Abstract Gastrointestinal bleeding (GIB) is the most common type of bleeding occurring in patients on oral anticoagulation. A meta-analysis of the landmark randomized controlled trials (RCTs) for patients with atrial fibrillation demonstrated that direct oral anticoagulants (DOACs) were associated with higher GIB rates compared to warfarin. However, significant heterogeneity existed between studies. While rivaroxaban, high-dose dabigatran, and high-dose edoxaban were associated with higher GIB rates than warfarin, GIB rates were similar between warfarin users and both apixaban and low-dose dabigatran users. Additionally, previous observational studies have yielded conflicting reports on whether GIB rates differ between warfarin and DOACs. Meta-analyses of observational studies demonstrated that warfarin is associated with lower rates of GIB compared to rivaroxaban, similar or lower rates compared to dabigatran, and higher rates compared to apixaban. Importantly, no RCT has compared individual DOACs directly and due to the different selection criteria of the initial RCTs, indirect comparisons between DOACs using these studies are unreliable. The best available information of comparisons between individual DOACs is therefore limited to observational studies. There is mounting evidence that suggests that rivaroxaban is associated with a higher risk of GIB compared to other DOACs. Finally, GIB induced by oral anticoagulation may have some positive aspects. Interestingly, there are studies that indicate oral anticoagulation facilitates colorectal cancer detection. Furthermore, results from RCTs and observational studies suggest that warfarin may even decrease the incidence of cancer.
      PubDate: 2022-12-01
       
  • mRNA (BNT162b2) and Inactivated (CoronaVac) COVID-19 Vaccination and Risk
           of Adverse Events and Acute Diabetic Complications in Patients with Type 2
           Diabetes Mellitus: A Population-Based Study

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      Abstract: Introduction In Hong Kong, CoronaVac and BNT162b2 have been approved for emergency use owing to the coronavirus disease 2019 (COVID-19) pandemic. Reactions towards the vaccine and the risk of post-vaccination adverse events may be different between recipients with and without type 2 diabetes mellitus (T2DM). Objective The aim of this study was to evaluate the risk of adverse events of special interest (AESI) and acute diabetic complications in the T2DM population after COVID-19 vaccination in Hong Kong. Research Design and Methods Self-controlled case-series analysis was conducted. Patients with T2DM who received at least one dose of BNT162b2 or CoronaVac between 23 February 2021 and 31 January 2022 from electronic health records in Hong Kong were included. The incidence rates of 29 AESIs and acute diabetic complications (any of severe hypoglycemia, diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome) requiring hospitalization within 21 days after the first or second dose of vaccination were reported. The risks of these outcomes were evaluated using conditional Poisson regression. Results Among 141,224 BNT162b2 recipients and 209,739 CoronaVac recipients with T2DM, the incidence per 100,000 doses and incidence per 100,000 person-years of individual AESIs and acute diabetic complications ranged from 0 to 24.4 and 0 to 438.6 in BNT162b2 group, and 0 to 19.5 and 0 to 351.6 in CoronaVac group. We did not observe any significantly increased risk of individual AESIs or acute diabetic complications after first or second doses of BNT162b2 or CoronaVac vaccine. Subgroup analysis based on HbA1c < 7% and ≥ 7% also did not show significantly excess risk after vaccination. Conclusions Patients with T2DM do not appear to have higher risks of AESI and acute diabetic complications after BNT162b2 or CoronaVac vaccination. Moreover, given the low incidence of AESIs and acute diabetic complications after vaccination, the absolute risk increment was likely minimal.
      PubDate: 2022-12-01
       
  • Comparison of the MOdified NARanjo Causality Scale (MONARCSi) for
           Individual Case Safety Reports vs. a Reference Standard

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      Abstract: Introduction In 2018, we published the MONARCSi algorithmic decision support tool showing high inter-rater agreement, moderate sensitivity, and high specificity compared with drug-event pairs (DEPs) previously reviewed using current, industry-established approaches. Following publication, MONARCSi was implemented as a prototype system to facilitate medical review of individual case safety reports (ICSRs). This paper presents subsequent evaluation of MONARCSi-supported causality assessments against an independent, best achievable reference standard. Objective This paper describes the development of an independent reference standard (i.e., reference comparator) using a sample of DEPs evaluated by Roche subject matter experts (SMEs) and subsequent performance analysis for both the reference standard and MONARCSi. Methods Roche collected a random sample of 131 DEPs evaluated by an external vendor using the MONARCSi prototype during 2020, and collectively referred to as the VMON (Vendor using the MONARCSi system for medical review) dataset. An internal group of causality SMEs (aka CAUSMET) were recruited and trained to assess the same DEPs independently using the MONARCSi structure with Global Introspection to determine their individual assessments of causality. The CAUSMET final causality was determined using a majority voting rule. Results Binary comparison of the aggregate results showed substantial agreement (Gwet kappa = 0.81) between the VMON and reference standard CAUSMET assessments. Bayesian latent class modeling showed that both the reference standard and VMON assessments exhibited similar high posterior mean sensitivity and specificity (CAUSMET: 89 and 93%, respectively; VMON: 87 and 94%, respectively). Finally, comparison of the sensitivity and specificity suggested no obvious difference across groups. Conclusion Analysis of causality results from the assessments by independent internal SMEs using MONARCSi shows there is no obvious difference in performance between the aggregate CAUSMET and VMON assessments based on the comparison of specificity and sensitivity. These results further support use of MONARCSi as a decision support tool for evaluating drug-event causality in a consistent and documentable manner.
      PubDate: 2022-12-01
       
  • Prevalence, Causes and Severity of Medication Administration Errors in the
           Neonatal Intensive Care Unit: A Systematic Review and Meta-Analysis

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      Abstract: Introduction Neonates are at greater risk of preventable adverse drug events as compared to children and adults. Objective This study aimed to estimate and critically appraise the evidence on the prevalence, causes and severity of medication administration errors (MAEs) amongst neonates in Neonatal Intensive Care Units (NICUs). Methods A systematic review and meta-analysis was conducted by searching nine electronic databases and the grey literature for studies, without language and publication date restrictions. The pooled prevalence of MAEs was estimated using a random-effects model. Data on error causation were synthesised using Reason’s model of accident causation. Results Twenty unique studies were included. Amongst direct observation studies reporting total opportunity for errors as the denominator for MAEs, the pooled prevalence was 59.3% (95% confidence interval [CI] 35.4–81.3, I2 = 99.5%). Whereas, the non-direct observation studies reporting medication error reports as the denominator yielded a pooled prevalence of 64.8% (95% CI 46.6–81.1, I2 = 98.2%). The common reported causes were error-provoking environments (five studies), while active failures were reported by three studies. Only three studies examined the severity of MAEs, and each utilised a different method of assessment. Conclusions This is the first comprehensive systematic review and meta-analysis estimating the prevalence, causes and severity of MAEs amongst neonates. There is a need to improve the quality and reporting of studies to produce a better estimate of the prevalence of MAEs amongst neonates. Important targets such as wrong administration-technique, wrong drug-preparation and wrong time errors have been identified to guide the implementation of remedial measures.
      PubDate: 2022-12-01
       
  • Withdrawal Syndrome Following Discontinuation of 28 Antidepressants:
           Pharmacovigilance Analysis of 31,688 Reports from the WHO Spontaneous
           Reporting Database

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      Abstract: Introduction Evidence is lacking on withdrawal syndrome related to individual antidepressants and relevant risk factors for severe reactions. Objective To ascertain whether antidepressants are associated with an increased reporting of withdrawal syndrome as compared with other medications, and to investigate risk factors for severe reactions. Methods This is a case/non-case pharmacovigilance study, based on the VigiBase®, the WHO global database of individual case safety reports of suspected adverse drug reactions. We performed a disproportionality analysis of reports of antidepressant-related withdrawal syndrome (calculating reporting odds ratio [ROR] and Bayesian information component [IC]). We compared antidepressants to all other drugs, to buprenorphine (positive control), and to each other within each class of antidepressants (selective serotonin reuptake inhibitors [SSRIs], tricyclics and other antidepressants). Antidepressants with significant disproportionate reporting were ranked in terms of clinical priority. Serious versus non-serious reactions were compared. Results There were 31,688 reports of antidepressant-related withdrawal syndrome were found. A disproportionate reporting was detected for 23 antidepressants. The estimated ROR for antidepressants altogether, compared to all other drugs, was 14.26 (95% CI 14.08–14.45), 17.01 for other antidepressants (95% CI 16.73–17.29), 13.65 for SSRIs (95% CI 13.41–13.90) and 2.8 for tricyclics (95% CI 2.59–3.02). Based on clinical priority ranking, the strongest disproportionate reporting was found for paroxetine, duloxetine, venlafaxine and desvenlafaxine, being comparable to buprenorphine. Withdrawal syndrome was reported as severe more often in males, adolescents, persons in polypharmacy, and with a longer antidepressant treatment duration (p < 0.05). Conclusions Antidepressants are associated with an increased reporting of withdrawal syndrome compared with other drug classes. When prescribing and discontinuing antidepressants, clinicians should be aware of the potentially different proclivity of withdrawal syndrome across individual antidepressants, and the liability to experience more severe withdrawal symptoms in relation to specific patient characteristics.
      PubDate: 2022-11-18
       
  • Development and Evaluation of the Algorithm CErtaInty Tool (ACE-IT) to
           Assess Electronic Medical Record and Claims-based Algorithms’ Fit for
           Purpose for Safety Outcomes

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      Abstract: Introduction Electronic health record (EHR) or medical claims-based algorithms (i.e., operational definitions) can be used to define safety outcomes using real-world data. However, existing tools do not allow researchers and decision-makers to adequately appraise whether a particular algorithm is fit for purpose (FFP) to support regulatory decisions on drug safety surveillance. Our objective was to develop a tool to enable regulatory decision-makers and other stakeholders to appraise whether a given algorithm is FFP for a specific decision context. Methods We drafted a set of 77 generic items informed by regulatory guidance documents, existing instruments, and publications. The outcome of ischemic stroke served as an exemplar to inform the development of draft items. The items were designed to be outcome independent. We conducted a three-round online Delphi panel to develop and refine the tool and achieve consensus on items (> 70% agreement) among panel participants composed of regulators, researchers from pharmaceutical organizations, academic clinicians, methodologists, pharmacoepidemiologists, and cardiologists. We conducted a qualitative analysis of panel responses. Five pairs of reviewers independently evaluated two ischemic stroke algorithm validation studies to test its application. We developed a user guide, with explanation and elaboration for each item, guidance on essential and additional elements for user responses, and an illustrative example of a complete assessment. Furthermore, we conducted a 2-h online stakeholder panel of 16 participants from regulatory agencies, academic institutions, and industry. We solicited input on key factors for an FFP assessment, their general reaction to the Algorithm CErtaInty Tool (ACE-IT), limitations of the tool, and its potential use. Results The expert panel reviewed and made changes to the initial list of 77 items. The panel achieved consensus on 38 items, and the final version of the ACE-IT includes 34 items after removal of duplicate items. Applying the tool to two ischemic stroke algorithms demonstrated challenges in its application and identified shared concepts addressed by more than one item. The ACE-IT was viewed positively by the majority of stakeholders. They identified that the tool could serve as an educational resource as well as an information-sharing platform. The time required to complete the assessment was identified as an important limitation. We consolidated items with shared concepts and added a preliminary screen section and a summary assessment box based on their input. The final version of the ACE-IT is a 34-item tool for assessing whether algorithm validation studies on safety outcomes are FFP. It comprises the domains of internal validity (24 items), external validity (seven items), and ethical conduct and reporting of the validation study (three items). The internal validity domain includes sections on objectives, data sources, population, outcomes, design and setting, statistical methods, reference standard, accuracy, and strengths and limitations. The external validity domain includes items that assess the generalizability to a proposed target study. The domain on ethics and transparency includes items on ethical conduct and reporting of the validation study. Conclusion The ACE-IT supports a structured, transparent, and flexible approach for decision-makers to appraise whether electronic health record or medical claims-based algorithms for safety outcomes are FFP for a specific decision context. Reliability and validity testing using a larger sample of participants in other therapeutic areas and further modifications to reduce the time needed to complete the assessment are needed to fully evaluate its utility for regulatory decision-making.
      PubDate: 2022-11-17
       
  • Potential Risk Factors of Drug-Related Problems in Hospital-Based Mental
           Health Units: A Systematic Review

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      Abstract: Introduction Reducing the occurrence of drug-related problems is a global health concern. In mental health hospitals, drug-related problems are common, leading to patient harm, and therefore understanding their potential risk factors is key for guiding future interventions designed to minimise their frequency. Objective The aim of this systematic review was to explore the potential risk factors of drug-related problems in mental health inpatient units. Methods Six databases were searched between 2000 and 2021 to identify studies that investigated the potential risk factors of drug-related problems in adults hospitalised in mental health inpatient units. Data extraction was performed by two authors independently and Allan and Barker’s criteria were used for study quality assessment. Studies were categorised based on drug-related problem types and potential risk factors were stratified as patient, medication, and hospital related. Results A total of 22 studies were included. Studies mostly originated in Europe (n = 19/22, 86.4%), and used a multivariable logistic regression to identify potential risk factors (n = 13, 59%). Frequently investigated factors were patient age (n = 14/22), sex (n = 14/22) and the number of prescribed medications (n = 14/22). Of these, increasing the number of prescribed medications was the only factor consistently reported to be significantly associated with the occurrence of most types of drug-related problems (n = 11/14). Conclusions A variety of patient, medication and hospital-related potential risk factors of drug-related problems in mental health inpatient units were identified. These factors could guide the development of interventions to reduce drug-related problems such as pharmaceutical screening tools to identify high-risk patients for timely interventions. Future studies could test a wider range of possible factors associated with drug-related problems using standardised approaches. Clinical Trial Registration PROSPERO: CRD42021279946.
      PubDate: 2022-11-11
       
  • Fully Liquid MenACWY-CRM Vaccine: Results from an Integrated Safety
           Analysis

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      Abstract: Introduction The currently licensed quadrivalent MenACWY-CRM conjugate vaccine presentation consists of two vials (lyophilized MenA and liquid MenCWY) to be reconstituted before injection. A new fully liquid, single-vial formulation has been developed to simplify administration and prevent reconstitution errors. We present pooled safety data from two randomized, controlled, observer-blind phase 2b clinical trials, in which the fully liquid presentation was compared with the licensed presentation. Methods This is a post hoc analysis of two studies, in which safety data from participants aged 10–40 years who received one dose of either liquid MenACWY-CRM (1337 participants; MenACWY liquid group) or licensed MenACWY-CRM (1332 participants; MenACWY licensed group) were pooled. Frequencies were calculated for solicited adverse events (AEs) during 7 days post-vaccination and unsolicited AEs, including medically attended AEs and serious AEs (SAEs), during the 6-month safety follow-up period. Analysis results are presented by vaccine group, overall and by age category (10–17 and 18–40 years). Results Overall, AEs solicited for collection during the first 7 days after vaccination were reported by similar percentages of participants (69.2%, MenACWY liquid; 68.2%, MenACWY licensed), and were generally mild/moderate in intensity. Solicited local AEs were reported by 46.0% of the MenACWY liquid group and 43.5% of the MenACWY licensed group and solicited systemic AEs by 55.2 and 54.1%, respectively. During the 6-month post-vaccination period, unsolicited AEs were reported by 32.2 and 31.2% of the MenACWY liquid group and MenACWY licensed group, respectively, and medically attended AEs by 18.6 and 17.3%, respectively. Overall, 14 participants in each group (1.0 and 1.1%, respectively) reported SAEs, none of which was considered vaccine-related by the investigator. The safety profiles of both MenACWY-CRM presentations were similar for each age group and overall. Conclusions This pooled analysis shows the safety profile of fully liquid MenACWY-CRM is comparable with that of the currently licensed vaccine presentation. Clinical Trial Registration ClinicalTrials.gov Identifiers: NCT03652610 (August 29, 2018), NCT03433482 (14 February 2018). Graphical abstract
      PubDate: 2022-11-11
       
  • Optimizing Safety Surveillance for COVID-19 Vaccines at the National
           Pharmacovigilance Centre Lareb: One Year of COVID-19 Vaccine Experience

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      Abstract: Introduction Due to the COVID-19 vaccination campaign, national pharmacovigilance (PV) centres had to deal with high volumes of Individual Case Safety Reports (ICSRs) that needed to be processed and assessed in a short time span. This necessitated the development of a dedicated system to enable near real-time vaccine safety monitoring at the Dutch PV Centre Lareb. Objectives To describe infrastructure, processes and Adverse Events Following Immunisation (AEFIs) reported for vaccine safety monitoring of COVID-19 vaccines during a large-scale vaccination campaign in the Netherlands. Methods A COVID-19 tailored vaccine web-based reporting form collected information on the vaccine administered, AEFIs and other (medical) information. A fully automated process for ICSRs enabled the handling of the majority of common and known reported AEFIs. All other ICSRs were triaged daily and processed separately. There were daily signal detection meetings and weekly reports for batch analysis. Results In 2021, Lareb received 184,411 ICSRs, a reporting rate of 0.67% for vaccines given in the Netherlands. 887,954 AEFIs were reported, mostly well-known, nonserious AEFIs; 2.4% were serious and 0.3% were fatal. 33.1% of all ICSRs were processed fully automatically. Based on the daily triage, 4.2% were flagged as ‘high priority’; 62.7% as ‘low-priority’. Twenty-seven signals and news stories about the COVID-19 vaccines were disseminated. Conclusions Due to automatic processing of well-known AEFIs, daily triage and signal detection meetings, 99.9% of the ICSRs were processed within the compliance timeframe to Eudravigilance, and signal detection was performed during a large-scale vaccination campaign. These experiences may serve as a blueprint for future mass vaccination programs.
      PubDate: 2022-11-09
       
  • Detectability of Medication Errors With a STOPP/START-Based Medication
           Review in Older People Prior to a Potentially Preventable Drug-Related
           Hospital Admission

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      Abstract: Introduction Multimorbidity and polypharmacy are risk factors for drug-related hospital admissions (DRAs) in the ageing population. DRAs caused by medication errors (MEs) are considered potentially preventable. The STOPP/START criteria were developed to detect potential MEs in older people. Objective The aim of this study was to assess the detectability of MEs with a STOPP/START-based in-hospital medication review in older people with polypharmacy and multimorbidity prior to a potentially preventable DRA. Methods Hospitalised older patients (n = 963) with polypharmacy and multimorbidity from the intervention arm of the OPERAM trial received a STOPP/START-based in-hospital medication review by a pharmacotherapy team. Readmissions within 1 year after the in-hospital medication review were adjudicated for drug-relatedness. A retrospective assessment was performed to determine whether MEs identified at the first DRA were detectable during the in-hospital medication review. Results In total, 84 of 963 OPERAM intervention patients (8.7%) were readmitted with a potentially preventable DRA, of which 72 patients (n = 77 MEs) were eligible for analysis. About half (48%, n = 37/77) of the MEs were not present during the in-hospital medication review and therefore were not detectable at that time. The pharmacotherapy team recommended a change in medication regimen in 50% (n = 20/40) of present MEs, which corresponds to 26% (n = 20/77) of the total identified MEs at readmission. However, these recommendations were not implemented. Conclusion MEs identified at readmission were not addressed by a prior single in-hospital medication review because either these MEs occurred after the medication review (~50%), or no recommendation was given during the medication review (~25%), or the recommendation was not implemented (~25%). Future research should focus on optimisation of the timing and frequency of medication review and the implementation of proposed medication recommendations. Registration ClinicalTrials.gov identifier: NCT02986425. December 8, 2016. Funding European Union HORIZON 2020, Swiss State Secretariat for Education, Research and Innovation (SERI), Swiss National Science Foundation (SNSF) Graphical abstract
      PubDate: 2022-11-01
       
  • Topiramate Utilization After Phentermine/Topiramate Approval for Obesity
           Management: Risk Minimization in the Era of Drug Repurposing

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      Abstract: Introduction The US FDA required a Risk Evaluation and Mitigation Strategy (REMS) for phentermine/topiramate, an anti-obesity medication, to prevent congenital malformations. No REMS is required for single-ingredient topiramate, which may be used off-label for the same purpose. Objective The aim of this study was to evaluate the impact of phentermine/topiramate approval in 2012 on subsequent topiramate use among patients with obesity. Methods We used a national insurance claims database to conduct an interrupted time-series study (2009–2015). Enrollees aged 18–65 years in each examined calendar quarter had full insurance benefits during that quarter and the preceding 6 months. We required patients to have an obesity diagnosis and no other conditions warranting topiramate use. We calculated topiramate or comparator drug (atorvastatin, metformin) initiation rates and evaluated changes in trends before and after 2012 (transition period). Results Among topiramate users, 80% were female, and demographic characteristics remained consistent during the study period. Between 2009 and 2011, the topiramate initiation rate (95% confidence interval) among patients with obesity was 0.85 (0.73–0.98) per 1000 patients, with no significant upward or downward trend. In the first quarter of 2013, this rate had increased more than 2.5-fold (change: + 1.36 [1.19–1.52]). Metformin and atorvastatin initiation rates did not change. Topiramate initiation rates were threefold higher than phentermine/topiramate rates during the post-approval period. Conclusion Phentermine/topiramate approval was associated with increased topiramate use among patients with obesity. Prescribers are encouraged to enhance patient education and monitoring in such clinical use since topiramate prescribing information, compared with REMS for phentermine/topiramate, has less emphasis on preventing prenatal exposure.
      PubDate: 2022-11-01
       
  • Correction to: Assessing Case Fatality on Cases of Thrombosis with
           Concurrent Thrombocytopenia Following COVID-19 Vaccine AstraZeneca
           (Vaxzevria) in the United Kingdom: A Review of Spontaneously Reported Data
           

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      PubDate: 2022-11-01
       
  • Characterization of Serous Retinopathy Associated with Cobimetinib:
           Integrated Safety Analysis of Four Studies

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      Abstract: Introduction and Objective Serous retinopathy can be associated with MEK inhibitors, including cobimetinib. We present results of an integrated safety analysis to further characterize ocular functional and structural changes due to serous retinopathy. Methods Four studies evaluating cobimetinib at the approved dose and schedule in combination with other oncology drugs were included. Study CO39721 incorporated standardized ophthalmologic assessments to fully characterize serous retinopathy events over time and was the primary study for analysis. Supporting information was provided by studies GO28141, WO29479, and GO30182. Results In total, 655 patients received one or more doses of cobimetinib and comprised the safety-evaluable population. Overall, 117 patients (17.9%) had one or more serous retinopathy events, 24 (3.7%) had two or more events, and four (0.6%) had three or more events. Grade 3 events occurred in < 2.5% of patients. In CO39721, the median time to onset was 15 days (range 7–111); median time to resolution of first occurrence was 26 days (range 6–591 + days). Twelve of 25 patients (48.0%) recovered without a dose modification and 4/25 (16.0%) were recovered/recovering following a dose modification. The most frequent presentation of serous retinopathy was focal subretinal fluid on optical coherence tomography (62.8% of cases); in some instances (25.7% of cases), subretinal fluid was multifocal. There was no loss of visual function or visual acuity at serous retinopathy onset or resolution. Conclusions Results from this integrated safety analysis indicate that cobimetinib-associated serous retinopathy can be managed with or without a dose modification of cobimetinib at the discretion of the treating physician. No visual loss or permanent retinal damage was identified on comprehensive ophthalmologic assessments. Clinical Trial Registration ClinicalTrials.gov identifiers: NCT03178851, NCT01689519, NCT02322814, and NCT02788279.
      PubDate: 2022-10-30
       
  • Correction to: 21st ISoP Annual Meeting “A New Era of Pharmacovigilance:
           Challenges and Opportunities” 20–23 September 2022 Verona, Italy

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      PubDate: 2022-09-22
       
 
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