Adverse drug reaction reporting in the Czech Republic 2005-2009

International Journal of Clinical Pharmacy

Volumn 33, Issue 4, 2011, Pages 683-689

  Kopečná, Eva ^a   Deščíková, Veronika ^a,b   Vlček, Jiří ^a   Mladá, Jana ^b  

^a Charles University in Prague Faculty of Pharmacy   (Czech Republic)

^b State Institute for Drug Control   (Czech Republic)

Author keywords

Adverse drug reactions; Czech Republic; Pharmacovigilance; Spontaneous reporting; Under reporting

Indexed keywords

AMOXICILLIN; ATORVASTATIN; BEVACIZUMAB; ESTRADIOL; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; IBUPROFEN; INDINAVIR; INFLIXIMAB; IOMEPROL; KETOPROFEN; LAMOTRIGINE; NIMESULIDE; OLANZAPINE; OXALIPLATIN; PACLITAXEL; TERBINAFINE; VACCINE;

ADVERSE OUTCOME; ATTITUDE TO HEALTH; CAUSE OF DEATH; CLINICAL ASSESSMENT; CONTROLLED STUDY; CZECH REPUBLIC; DENMARK; DISEASE SEVERITY; DRUG EFFICACY; DRUG MARKETING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; HEALTH SURVEY; HUMAN; MAJOR CLINICAL STUDY; PATIENT EDUCATION; PRIORITY JOURNAL; REVIEW; SELF REPORT; SLOVAKIA; TREND STUDY; UNITED KINGDOM; UNSPECIFIED SIDE EFFECT;

EID: 80052395689     PISSN: 22107703     EISSN: None     Source Type: Journal    
DOI: 10.1007/s11096-011-9527-9     Document Type: Review

References (26)

1. J Tisoňová A Szalayová M Kriška P Gibala V Foltán 2004 Factors influencing the spontaneous reporting of adverse drug reactions-the experience of the Slovak Republic Pharmacoepidemiol Drug Saf 13 333 337 15133786 10.1002/pds.889 (Pubitemid 38697056)
2. F Perlík O Slanař M Šmíd J Petráček 2002 Attitude of Czech physicians to adverse drug reaction reporting Eur J Clin Pharmacol 58 367 369 12418475 10.1007/s00228-002- 0476-z (Pubitemid 34983928)
3. Volume 9A of the rules governing medicinal products in the European Union: pharmacovigilance for medicinal products for human use (version September 2008). [Online]. 2008; Available from: URL: http://ec.europa.eu/enterprise/ sectors/pharmaceuticals/documents/eudralex/vol-9/index-en.htm. Accessed 13 Mar 2010.
4. Act on pharmaceuticals 378, 2007 (Zákon č.378/2007Sb.o léčivech.) [Online]. Available from: http://aplikace.mvcr.cz/ archiv2008/sbirka/2007/sb115-07.pdf. Accessed 3 Nov 2010. [Czech].
5. CA Osborne 2010 Adverse drug reactions: investigating to reporting J Can Acad Child Adolesc Psychiatry 19 46 47 20119567
6. L Hazell SA Shakir 2006 Under-reporting of adverse drug reactions: a systematic review Drug Saf 29 385 396 16689555 10.2165/00002018-200629050-00003
7. Vlček J, Dalecká R, Koblihová H, Kučera Z, Macek K, Matoulková P, et al. Základy farmakoepidemiologie, farmakoekonomiky a farmakoinformatiky (Basic pharmacoepidemiology, pharmaeconomics and pharmacoinformatics). 2nd ed. Prague: Remedia; 2005. p. 6-41. ISBN 80-903555-0-1 [Czech].
8. Health care workers as of 31.12.2009. Available from: URL: http://www.uzis.cz/. Accessed 30 Oct 2010 [Czech].
9. J Ulfvarson S Mejyr U Bergman 2007 Nurses are increasingly involved in pharmacovigilance in Sweden Pharmacoepidemiol Drug Saf 16 532 537 17072915 10.1002/pds.1336 (Pubitemid 46824274)
10. A Blenkinsopp P Wilkie M Wang PA Routledge 2007 Patient reporting of suspected adverse drug reactions: a review of published literature and international experience Br J Clin Pharmacol 63 148 156 17274788 10.1111/j.1365-2125.2006.02746.x 1:STN:280:DC%2BD2s%2Fns1yhsQ%3D%3D (Pubitemid 46072099)
11. J de Langen F van Hunsel A Passier L den Berg K van Grootheest 2008 Adverse drug reaction reporting by patients in the Netherlands: three years of experience Drug Saf 31 515 524 18484785 10.2165/00002018-200831060-00006 (Pubitemid 351693684)
12. J Lazarou BH Pomeranz PN Corey 1998 Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies JAMA 279 1200 1205 9555760 10.1001/jama.279.15.1200 1:STN:280:DyaK1c3hsFSnsQ%3D%3D (Pubitemid 28193431)
13. H Patel D Bell M Molokhia J Srishanmuganathan M Patel J Car A Majeed 2007 Trends in hospital admissions for adverse drug reactions in England: analysis of national hospital episode statistics 1998-2005 BMC Clin Pharmacol 7 9 17894876 10.1186/1472-6904-7-9 (Pubitemid 350177224)
14. M Brvar N Fokter M Bunc M Mozina 2009 The frequency of adverse drug reaction related admissions according to method of detection, admission urgency and medical department speciality BMC Clin Pharmacol 9 8 19409112 10.1186/1472-6904-9-8
15. CS van der Hooft JP Dieleman C Siemes AJ Aarnoudse KM Verhamme BH Stricker, et al. 2008 Adverse drug reaction-related hospitalisations:a population-based cohort study Pharmacoepidemiol Drug Saf 17 365 371 18302300 10.1002/pds.1565 (Pubitemid 351566352)
16. Hospitalisations in hospitals in the Czech Republic in 2008. [Online]. 2010; Prague: Institute of Health Information and Statistics of the Czech Republic. Available from: URL: http://www.uzis.cz. ISBN 978-80-7280-851-9. Accessed 7 Mar 2010 [Czech].
17. M Pirmohamed S James S Meakin C Green AK Scott TJ Walley, et al. 2004 Adverse drug reactions as cause of admission to hospital: prospective analysis of 18,820 patients BMJ 329 15 19 15231615 10.1136/bmj.329.7456.15 (Pubitemid 38869995)
18. PA Chyka 2000 How many deaths occur annually from adverse drug reactions in the United States? Am J Med 109 122 130 10967153 10.1016/S0002-9343(00)00460- 5 1:STN:280:DC%2BD3cvosV2htg%3D%3D
19. K Wester A Jönsson O Spigset S Hägg 2007 Spontaneously reported fatal suspected adverse drug reactions: a 10-year survey from Sweden Pharmacoepidemiol Drug Saf 16 173 180 16739241 10.1002/pds.1263 (Pubitemid 46291169)
20. M Zhang J Holman DB Preen K Brameld 2007 Repeat adverse drug reactions causing hospitalization in older Australians: a population-based longitudinal study 1980-2003 Br J Clin Pharmacol 63 163 170 17274789 10.1111/j.1365-2125. 2006.02839.x (Pubitemid 46072102)
21. CK Mannesse FH Derkx MA de Ridder AJ Man in't Veld TJ van der Cammen 1997 Adverse drug reactions in elderly patients as contributing factors for hospital admission: cross-sectional study BMJ. 315 1057 1058 9366733 1:STN:280:DyaK1c%2FjtlGhug%3D%3D (Pubitemid 27458397)
22. E Kimland A Rane M Ufer G Panagiotidis 2005 Paediatric adverse drug reactions reported in Sweden from 1987 to 2001 Pharmacoepidemiol Drug Saf 14 493 499 15918163 10.1002/pds.1121 (Pubitemid 40990744)
23. State Institute for Drug Control. Annual Report 2004 State Institute for Drug Control. [Online]; Available from: URL: http://www.sukl.cz/vyrocni-zprava- o-cinnosti-sukl. Accessed 18 Aug 2009. [Czech/English].
24. Beneš M, Mladá J. Bezpečnost léč ivých přípravků v České republice aneb 5 minut pro bezpečnější farmakoterapii. (Safety of human medicinal products in CZ alias 5 minutes for safer pharmacotherapy) [Online]. 2010; Available from: URL: http://www.sukl.cz/sukl-zahajuje-kampan-o- bezpecnosti-lecivych-pripravku. Accessed 17 Feb 2010. [Czech].
25. Pelcová D. Nejčastější otravy a jejich terapie (The most frequent intoxications and their treatment) Prague: Galén; 2009. ISBN 9788072626038 [Czech].
26. Directive 2010/84/EU of the European Parliament and of the council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the community code relating to medicinal products for human use. OJ L 348/74 31.12.2010.