Klin Farmakol Farm. 2006;20(4):223-225

EVALUATION OF ADVERSE DRUG REACTIONS

Roman Hudec1, Lýdia Božeková1, prof. MUDr. Milan Kriška DrSc2, doc. MUDr. Viera Kořínková CSc3, Tatiana Magálová4
1 Farmakologický ústav Lekárskej fakulty UK, Bratislava
2 Ústav farmakológie LF UK Bratislava
3 Psychiatrická klinika FN a LF UK Bratislava
4 Sekcia bezpečnosti a klinického skúšania liečiv, Štátny ústav pre kontrolu liečiv, Bratislava

Causality assessment is the process of further evaluation of adverse drug reaction in Slovak State Institute of Drug Control. We brought different views and classifications. According to Uppsala Monitoring Centre of the WHO, causality is divided into six categories. The most reports are classified as probable, or possible. Causality assessment is a part of pharmacovigilance and help us to estimate severity of spontaneus reports. This process is difficult and we have to remember that we cannot quantify or eliminate uncertainty, but can help to type several adverse drug reactions.

Keywords: Key words: causality, evaluation, adverse drug reaction.

Published: February 1, 2007  Show citation

ACS AIP APA ASA Harvard Chicago Chicago Notes IEEE ISO690 MLA NLM Turabian Vancouver
Hudec R, Božeková L, Kriška M, Kořínková V, Magálová T. EVALUATION OF ADVERSE DRUG REACTIONS. Klin Farmakol Farm. 2006;20(4):223-225.
Share...
Download citation
  • BibTeX (.bib)
  • Bookends (.ris)
  • EasyBib (.ris)
  • EndNote (.enw)
  • EndNote 8 (.xml)
  • ISI WoS (.isi)
  • Medlars (.medlars)
  • Mendeley (.ris)
  • MODS (.xml)
  • Papers (.ris)
  • RefWorks (.txt)
  • RefManager (.ris)
  • RIS (.ris)
  • MS Word (.xml)
  • Zotero (.ris)
    • Open full article

    References

    1. World Health Organisation: Safety of medicines. Geneva 2002. WHO/EDM/QSM/2002.2
    2. Lee B, Turner WM. Food and Drug Administration's adverse drug reaction monitoring program. Am J Hosp Pharm 1978; 35 (8): 929-932. Go to original source...
    3. Meyboom RHB, Lindquist M, Egberts ACG. An ABC of drug-related problems. Drug Saf 2000; 22 (6): 415-423. Go to original source... Go to PubMed...
    4. Meyboom RHB, Hekster YA, Egberts ACG et al. Causal or Casual? The role of causality assesment in pharmacovigilance. Drug Saf 1997; 17 (6): 374-89. Go to original source... Go to PubMed...
    5. Venulet J. Aspects of standardization as applied to the assessment of drug-event associations. Drug Inf J 1984; 18: 199-200. Go to original source... Go to PubMed...
    6. Stricker BH, Psaty BM. Detection, verification, and quantification of adverse drug reactions. Br Med J 2004; 329: 44-47. Go to original source... Go to PubMed...
    7. Arimone Y, Begaud B, Miremont-Salame G et al. A new method for assessing drug causation provided agreement with experts' judgment. J Clin Epidemiol. 2006; 59 (3): 308-314. Go to original source... Go to PubMed...
    8. Edwards IR, Hungman B. The challenge of effectively communicating risk-benefit information. Drug Saf 1997; 17: 216-227. Go to original source... Go to PubMed...
    9. Meyboom RHB, Egberts ACG, Gribnau FWJ, et al. Pharmacovigilance in perspective. Drug Saf 1999; 21: 429-447. Go to original source... Go to PubMed...
    10. Shakir SA, Layton D. Causal association in pharmacovigilance and pharmacoepidemiology: thoughts on the application of the Austin Bradford-Hill criteria. Drug Saf. 2002; 25 (6): 467-471. Go to original source... Go to PubMed...
    11. Nelson RC, Palsulich B, Gogolak V. Good pharmacovigilance practices: technology enabled. Drug Saf. 2002; 25 (6): 407-414. Go to original source... Go to PubMed...
    12. Karch F, Lasagna L. Toward the operational identification of adverse drug reactions. Clin Pharmacol Ther 1977; 21: 247-254. Go to original source... Go to PubMed...
    13. Kramer MS, Leventhal JM, Hutchinson TA et al. An algorithm for the operational assessment of adverse drug reactions. I. Background, description, and instructions for use. JAMA 1979; 242: 623-631. Go to original source... Go to PubMed...
    14. Venulet J, Berneker CG, Ciucci AG (editors). Assesing causes of adverse drug reactions. London, Academic Press 1982.
    15. Garcia-Cortes M, Lucena MI, Andrade RJ et al. Is the Naranjo probability scale accurate enough to ascertain causality in drug-induced hepatotoxicity? Ann Pharmacother. 2004; 38 (9): 1540-1541. Go to original source... Go to PubMed...
    16. Venulet J, Ciucci AG, Berneker CG. Updating of a method for causality assessment of adverse drug reactions. Int J Clin Pharmacol 1986; 24: 559-568.
    17. Meyboom RHB, Royer RR. Causality assessment in the European Community. Pharmacoepidemiol Drug Saf 1992; 1: 87-97. Go to original source...
    18. Olsson S. (editor): National pharmacovigilance systems. Country profiles and overview. Upssala, The Upssala Monitoring Centre 1997.
    19. Macedo AF, Marques FB, Ribeiro CF. Can Decisional Algorithms Replace Global Introspection in the Individual Causality Assessment of Spontaneously Reported ADRs? Drug Saf. 2006; 29 (8): 697-702. Go to original source... Go to PubMed...
    20. Kundi M. Causality and the interpretation of epidemiologic evidence. Environ Health Perspect. 2006; 114 (7): 969-974. Go to original source... Go to PubMed...

    Return to the content


    Clinical Pharmacology and Pharmacy

    Madam, Sir,
    please be aware that the website on which you intend to enter, not the general public because it contains technical information about medicines, including advertisements relating to medicinal products. This information and communication professionals are solely under §2 of the Act n.40/1995 Coll. Is active persons authorized to prescribe or supply (hereinafter expert).
    Take note that if you are not an expert, you run the risk of danger to their health or the health of other persons, if you the obtained information improperly understood or interpreted, and especially advertising which may be part of this site, or whether you used it for self-diagnosis or medical treatment, whether in relation to each other in person or in relation to others.

    I declare:

    1. that I have met the above instruction
    2. I'm an expert within the meaning of the Act n.40/1995 Coll. the regulation of advertising, as amended, and I am aware of the risks that would be a person other than the expert input to these sites exhibited

    No
    Yes

    If your statement is not true, please be aware
    that brings the risk of danger to their health or the health of others.