BACKGROUND AND AIMS: Gastric restriction techniques have recently emerged as minimally invasive bariatric procedures. Endoscopic sutured gastroplasty (ESG) with the Endomina (Endo Tools Therapeutics, Gosselies, Belgium) triangulation platform proved to be safe and effective for the treatment of class I and II obesity in prospective studies. In this registry, we aimed to further assess on a larger scale the safety and efficacy of the procedure in routine practice with a dedicated device. METHODS: This was a multicenter, observational, prospective post-market study including patients with obesity undergoing Endomina ESG. The primary safety outcome was the occurrence of serious adverse device effects (SADEs) at 12 months. The primary efficacy outcome was the technical success defined by completing the procedure without premature abortion owing to technical issues. The rates of procedure-related adverse events, weight loss outcomes, and quality of life changes were collected. RESULTS: A total of 142 patients underwent ESG in 3 centers from July 2020 to March 2023. Of these, 67 (mean body mass index, 38.5 ± 6.3 kg/m2) reached at least 12 months of follow-up up to October 2022. Technical success was 100%. No SADEs occurred. Seven mild procedure-related adverse events were reported overall. Mean percentage of excess weight loss and total body weight loss at 12 months' follow-up were 48.5% ± 38.6 and 15.3% ± 10.6, respectively (n = 67). Improved quality of life was observed following ESG. CONCLUSIONS: ESG is safe and effective, thus offering a satisfactory therapeutic option for a wide range of obese patients on a large scale.
- MeSH
- dospělí MeSH
- gastroplastika * metody škodlivé účinky MeSH
- gastroskopie metody MeSH
- hmotnostní úbytek MeSH
- kvalita života MeSH
- lidé středního věku MeSH
- lidé MeSH
- morbidní obezita chirurgie MeSH
- obezita chirurgie komplikace MeSH
- pooperační komplikace MeSH
- postmarketingový dozor * MeSH
- prospektivní studie MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- pozorovací studie MeSH
PURPOSE: The purpose of this narrative review is to provide a comparison of several countries with different legislation and approaches to pharmacovigilance and to point out how these impact the number of adverse drug reactions (ADRs) that are reported to national competent authorities. METHODS: Legislative and statistical data regarding ADR reporting from various national competent authorities' websites, databases, and pharmacovigilance centers were used. In combination with the WHO pharmacovigilance quantitative indicator that was applied to evaluate the effectiveness of particular national pharmacovigilance systems in our scope. RESULTS: The study compared pharmacovigilance systems in six countries, focusing on ADR reporting from 2010 onwards. All countries required MAHs to report ADRs, while healthcare professionals' obligations varied. Per-capita ADR reports increased in all countries with available data, with the United States having a significantly higher reporting rate, possibly due to FDA campaigns. Despite starting later, China's per-capita reporting rate surpassed that of the Czech Republic and Japan. The study highlighted various measures taken by countries to enhance ADR reporting systems since the inception of their programs, contributing to the overall increase in reporting rates. CONCLUSIONS: ADR reporting is a global priority, with efforts made by different countries to strengthen their pharmacovigilance systems. Some success can be seen in gradually improving per-capita ADR reporting rates. The varying reporting rates and measures taken by each country may serve as a basis for further research and exchange of best practices to improve drug safety monitoring worldwide.
- Klíčová slova
- fremanezumab, studie PEARL,
- MeSH
- humanizované monoklonální protilátky farmakologie terapeutické užití MeSH
- klinické zkoušky, fáze IV jako téma metody MeSH
- lidé MeSH
- migréna * farmakoterapie prevence a kontrola MeSH
- peptid spojený s genem pro kalcitonin antagonisté a inhibitory MeSH
- prospektivní studie MeSH
- Check Tag
- lidé MeSH
OBJECTIVES: To compare the prevalence, regulations, and pharmacovigilance practices of clozapine use in Eastern European countries (except Russia). METHODS: Questionnaires and data from administrative databases (2016 and 2021), package inserts and national guidelines were collected from 21 co-authors from 21 countries. Reports of clozapine adverse drug reactions (ADRs) sent to the global pharmacovigilance database (VigiBaseTM) were analyzed from introduction to December 31, 2022. RESULTS: Clozapine prescription among antipsychotics in 2021 varied six-fold across countries, from 2.8 % in the Czech Republic to 15.8 % in Montenegro. The utilization of antipsychotics in both 2016 and 2021 was highest in Croatia, and lowest in Serbia in 2016, and Montenegro in 2021, which had half the defined daily dose (DDD)/1000/day compared to the Croatian data. From 2016 to 2021, the prevalence of antipsychotic use increased in almost all countries; the proportion of clozapine use mainly remained unchanged. Differences were detected in hematological monitoring requirements and clozapine approved indications. Only a few national schizophrenia guidelines mention clozapine-induced myocarditis or individual titration schemes. The VigiBase search indicated major underreporting regarding clozapine and its fatal outcomes. By comparison, the United Kingdom had less than half the population of these Eastern European countries but reported to VigiBase more clozapine ADRs by 89-fold and clozapine fatal outcomes by almost 300-fold. CONCLUSION: Clozapine is under-utilized in Eastern European countries. Introducing individualized clozapine treatment schedules may help to maximize clozapine benefits and safety. Major improvement is needed in reporting clozapine ADRs and fatal outcomes in Eastern European countries.
- MeSH
- antipsychotika * škodlivé účinky MeSH
- databáze faktografické MeSH
- farmakovigilance * MeSH
- klozapin * škodlivé účinky MeSH
- lidé MeSH
- nežádoucí účinky léčiv epidemiologie MeSH
- schizofrenie farmakoterapie MeSH
- systémy pro sběr zpráv o nežádoucích účincích léků statistika a číselné údaje MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- východní Evropa MeSH
The recent reports of oral side effects (SEs) following COVID-19 vaccination warrant further investigation into their prevalence, severity, and aetiology. This study was conducted to synthesize the first-ever population-level evidence about oral SEs of COVID-19 vaccines in Europe. The European Union Drug Regulating Authorities Pharmacovigilance (EudraVigilance) database was accessed in August 2022 to extract summary data of all potential oral SEs reported after COVID-19 vaccination. The data were reported descriptively and cross-tabulated to facilitate sub-group analysis per vaccine type, sex, and age group. Dysgeusia was the most commonly reported oral SE (0.381 case per each 100 received reports), followed by oral paraesthesia (0.315%), ageusia (0.296%), lip swelling (0.243%), dry mouth (0.215%), oral hypoaesthesia (0.210%), swollen tongue (0.207%), and taste disorder (0.173%). Females had significantly (Sig. < 0.001) a higher prevalence of all most common (top 20) oral SEs, except for salivary hypersecretion, which was equally prevalent among females and males. The present study revealed a low prevalence of oral SEs, with taste-related, other sensory and anaphylactic SEs being the most common SEs in Europe, similar to what was found earlier among the US population. Future studies should explore the potential risk factors of oral sensory and anaphylactic SEs to verify whether they are causally linked to COVID-19 vaccines.
- MeSH
- anafylaxe * MeSH
- COVID-19 * epidemiologie prevence a kontrola MeSH
- lidé MeSH
- nežádoucí účinky léčiv MeSH
- systémy pro sběr zpráv o nežádoucích účincích léků MeSH
- vakcíny proti COVID-19 * škodlivé účinky MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- Geografické názvy
- Evropa MeSH
Cíl: Cílem tohoto sdělení je získat a analyzovat dostupné údaje o neuroleptickém maligním syndromu (NMS) v ČR, srovnat je s údaji z jiných zemí a zvážit jejich výpovědní hodnotu. Metoda: Použili jsme vyžádaná data farmakovigilančního oddělení SÚKL o NMS a celostátní statistické údaje ÚZIS o hospitalizacích. Výsledky: Od vzniku farmakovigilančního oddělení SÚKL v r. 2004 do poloviny roku 2020 bylo zaznamenáno 13 lékařsky ověřených hlášení NMS, u 4 z nich byl průběh fatální. S rozvojem NMS bylo spojeno podávání antipsychotik první i druhé generace, nebyly zjištěny rozdíly ve formě léku a rizikovější se jevily kombinace léků. Dle údajů ÚZIS za období 2010-2019 bylo v ČR hospitalizováno 214 nemocných s přijímací diagnózou NMS, z těchto došlo u 11 k úmrtí. V datech jsou zahrnuty hlavně demografické údaje, diagnózy a výkony. Závěr: Při nepřímém srovnání jsou zřejmé hlavně nesrovnalosti v počtu případů. Kromě účelů a metodiky obou zdrojů se na nesrovnalosti nepochybně podílí více faktorů. Jeden ovlivnitelný faktor spočívá v dodržování zákonem dané povinnosti hlásit závažné nežádoucí účinky.
Aim: The aim of this paper is to obtain and analyse available data about malignant neuroleptic syndrome (NMS), further, to compare these data with other countries and consider their representative value. Methods: We have used requested data from State Institute for Drug Control, Department of Pharmacovigilance and statistical data from the Institute of Health Information and Statistics of the Czech Republic. Results: Since the establishment of Pharmacovigilance Department in 2004 till the half of 2020 year there were recorded 13 medically verified NMS cases, 4 of them with fatal outcome. The NMS development has been associated with application of antipsychotics of both, the first and second generation. No differences have been found among drug formulations and drug combinations were associated with a greater risk of NMS. During the period 2010-2019 according to data from the Institute of Health Information and Statistics of the Czech Republic 214 patients with admission diagnosis of NMS were hospitalized in Czech Republic and out of them 11 patients died. The dataset includes mainly demographic data, diagnoses, and medical procedures. Conclusions: By indirect comparison of both sources, we can see discrepancies in the number of cases. Besides aims and methods, other factors may be involved in these inconsistences. An influenceable factor lies in respecting the law on reporting serious side effects.
- MeSH
- antipsychotika škodlivé účinky MeSH
- farmakovigilance MeSH
- komorbidita MeSH
- lidé MeSH
- maligní neuroleptický syndrom * etiologie patofyziologie MeSH
- nežádoucí účinky léčiv MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- práce podpořená grantem MeSH
- Geografické názvy
- Česká republika MeSH
- Klíčová slova
- selhání vakcinace, SÚKL, ISIN,
- MeSH
- analýza dat MeSH
- dítě MeSH
- gastroenteritida prevence a kontrola virologie MeSH
- hospitalizace statistika a číselné údaje MeSH
- kojenec MeSH
- lidé MeSH
- novorozenec MeSH
- rotavirové infekce * prevence a kontrola MeSH
- systémy pro sběr zpráv o nežádoucích účincích léků MeSH
- vakcína proti rotavirům farmakologie MeSH
- vakcinace * škodlivé účinky statistika a číselné údaje MeSH
- zdravotnické informační systémy MeSH
- Check Tag
- dítě MeSH
- kojenec MeSH
- lidé MeSH
- novorozenec MeSH
- Publikační typ
- práce podpořená grantem MeSH
BACKGROUND: The core motive of pharmacovigilance is the detection and prevention of adverse drug reactions (ADRs), to improve the risk-benefit balance of the drug. However, the causality assessment of ADRs remains a major challenge among clinicians, and none of the available tools of causality assessment used for assessing ADRs have been universally accepted. OBJECTIVE: To provide an up-to-date overview of the different causality assessment tools. METHODS: We conducted electronic searches in MEDLINE, EMBASE, and the Cochrane database. The eligibility of each tool was screened by three reviewers. Each eligible tool was then scrutinized for its domains (the reported specific set of questions/areas used for calculating the likelihood of cause-and-effect relation of an ADR) to discover the most comprehensive tool. Finally, we subjectively assessed the tool's ease-of-use in a Canadian, Indian, Hungarian, and Brazilian clinical context. RESULTS: Twenty-one eligible causality assessment tools were retrieved. Naranjo's tool and De Boer's tool appeared the most comprehensive among all the tools, covering 10 domains each. Regarding "ease-of-use" in a clinical setting, we judged that many tools were hard to implement in a clinical context because of their complexity and/or lengthiness. Naranjo's tool, Jones's tool, Danan and Benichou's tool, and Hsu and Stoll's tool appeared to be the easiest to implement into various clinical contexts. CONCLUSION: Among the many tools identified, 1981 Naranjo's scale remains the most comprehensive and easy to use for performing causality assessment of ADRs. Upcoming analysis should compare the performance of each ADR tool in clinical settings.
- MeSH
- farmakovigilance * MeSH
- hodnocení rizik MeSH
- lidé MeSH
- nežádoucí účinky léčiv * diagnóza epidemiologie prevence a kontrola MeSH
- pravděpodobnost MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- přehledy MeSH
- Geografické názvy
- Kanada MeSH
- MeSH
- Ambrosia imunologie MeSH
- desenzibilizace imunologická * metody MeSH
- klinické zkoušky, fáze IV jako téma MeSH
- kombinovaná protilátková terapie farmakologie terapeutické užití MeSH
- léková kontraindikace MeSH
- lidé MeSH
- Phleum imunologie MeSH
- pyl MeSH
- rostlinné extrakty aplikace a dávkování farmakologie terapeutické užití MeSH
- tolerance léku MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- přehledy MeSH
