An expert review of clozapine in Eastern European countries: Use, regulations and pharmacovigilance.

HOME
>
論文・技術情報
>
An expert review of clozapine in Eastern European countries: Use, regulations and pharmacovigilance.

An expert review of clozapine in Eastern European countries: Use, regulations and pharmacovigilance.

アブストラクト	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 (VigiBase) 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.
ジャーナル名	Schizophrenia research
Pubmed追加日	2023/10/3
投稿者	Sagud, Marina; Breznoscakova, Dagmar; Celofiga, Andreja; Chihai, Jana; Chkonia, Eka; Ristic Ignjatovic, Dragana; Injac Stevovic, Lidija; Kopecek, Miloslav; Kurvits, Katrin; Kuzo, Nazar; Lazary, Judit; Mazaliauskiene, Ramune; Mladina Perisa, Djurdjica; Novotni, Antoni; Panov, Georgi; Pikirenia, Uladzimir; Radulescu, Flavian Stefan; Sukiasyan, Samvel Grant; Taube, Maris; Tomori, Sonila; Wilkowska, Alina; De Las Cuevas, Carlos; Sanz, Emilio J; de Leon, Jose
組織名	School of Medicine, University of Zagreb, Zagreb, Croatia; University Hospital;Centre Zagreb, Zagreb, Croatia. Electronic address: marinasagud@mail.com.;Department of Social and Behavioural Medicine, Faculty of Medicine, Pavol Jozef;Safarik University, Kosice, Slovakia. Electronic address:;dbreznoscakova@gmail.com.;Department of Psychiatry, University Medical Centre, Maribor, Maribor, Slovenia.;Electronic address: Andreja.CELOFIGA@ukc-mb.si.;State University of Medicine and Pharmacy Nicolae Testemitanu, Chisinau, Republic;of Moldova. Electronic address: jana.chihai@usmf.md.;Tbilisi State Medical University, Department of Psychiatry, Tbilisi, Georgia.;Electronic address: e.chkonia@tsmu.edu.;University of Kragujevac, Faculty of Medical Sciences, Department of Psychiatry,;Kragujevac, Serbia. Electronic address: draganaristic4@gmail.com.;Medical Faculty, University of Montenegro, Psychiatric Clinic, Clinical Centre of;Montenegro, Podgorica, Montenegro. Electronic address: injacl19@gmail.com.;National Institute of Mental Health, Klecany, Czech Republic; Department of;Psychiatry, Charles University, Third Faculty of Medicine, Prague, Czech;Republic. Electronic address: Miloslav.Kopecek@nudz.cz.;Bureau of Pharmacovigilance, Department of Post-authorisation Safety, State;Agency of Medicines, Estonia. Electronic address: Katrin.Kurvits@ravimiamet.ee.;Department of Psychiatry, Psychotherapy and Psychosomatics, Hospital of;Psychiatry, University of Zurich, Zurich, Switzerland. Electronic address:;kuzonazar@gmail.com.;National Institute of Mental Health, Neurology and Neurosurgery, Budapest,;Hungary. Electronic address: lazaryjudit@gmail.com.;Psychiatric Clinic, Lithuanian Health Sciences University Kaunas Hospital,;Lithuanian Health Sciences University, Kaunas, Lithuania. Electronic address:;mazaliauskiene@gmail.com.;County Hospital "Dr. Fra Mihovil Sucic" Livno, Svetog Ive 2, Livno 80101, Bosnia;and Herzegovina. Electronic address: djurdjica.perisa07@gmail.com.;University Clinic of Psychiatry Medical Faculty, University Ss. Cyril and;Methodius-Skopje, North Macedonia. Electronic address: prof.novotni@gmail.com.;Psychiatric Clinic, University Hospital "Prof Dr Stoyan Kirkovich" Trakia;University, Stara Zagora, Bulgaria. Electronic address: gpanov@dir.bg.;Department of Psychiatry and Medical Psychology, Belarusian State Medical;University, Minsk, Belarus. Electronic address: pikireniauladzimir@gmail.com.;Center for Drug Sciences, Faculty of Pharmacy, University of Medicine and;Pharmacy Carol Davila, Bucharest, Romania. Electronic address:;flavian.radulescu@umfcd.ro.;Psychiatric Services of Center of Psychosocial Recovery, Yerevan, Armenia;;Department of Applied Psychology of the Armenian State Pedagogical University;named after Kh. Abovyan, Yerevan, Armenia. Electronic address: samsu57@yahoo.com.;Department of Psychiatry and Narcology, Riga Stradins University, Riga, Latvia;;Department for Depression and Crisis, Riga Center of Psychiatry and Narcology,;Riga, Latvia. Electronic address: Maris.Taube@rsu.lv.;University Hospital Center "Mother Teresa", Tirana, Albania. Electronic address:;sonila.tomori@gmail.com.;Department of Psychiatry, Medical University of Gdansk, Gdansk, Poland.;Electronic address: alinawilkowska@gumed.edu.pl.;Department of Internal Medicine, Dermatology and Psychiatry, School of Medicine,;University of La Laguna, Canary Islands, Spain; Instituto Universitario de;Neurociencia (IUNE), Universidad de La Laguna, San Cristobal de La Laguna, Spain.;Electronic address: cdelascuevas@gmail.com.;Department of Physical Medicine and Pharmacology, School of Medicine, Universidad;de La Laguna, Canary Islands, Spain; Hospital Universitario de Canarias,;Tenerife, Spain. Electronic address: ejsanz@gmail.com.;Mental Health Research Center at Eastern State Hospital, Lexington, KY, United;States of America; Biomedical Research Centre in Mental Health Net (CIBERSAM),;Santiago Apostol Hospital, University of the Basque Country, Vitoria, Spain.;Electronic address: jdeleon@uky.edu.
Pubmed リンク	https://www.ncbi.nlm.nih.gov/pubmed/37783650/