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Advice on Drug Safety in Pregnancy

Are there Differences between Commonly Used Sources of Information?

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Abstract

Background and Objective: Safety regarding use in pregnancy is not established for many drugs. Inconsistencies between sources providing drug information can give rise to confusion with possible therapeutic consequences. Therefore, it is important to measure clinically important differences between drug information sources. The objective of this study was to compare two easily accessible Norwegian sources providing advice on drug safety in pregnancy — the product monographs in the Felleskatalog (FK), published by the pharmaceutical companies, and the five regional Drug Information Centres (DICs) in Norway — in addition to assessing the frequency of questions regarding drug safety in pregnancy made to the DICs according to the Anatomical Therapeutic Chemical (ATC) classification system.

Methods: Advice on drug use in pregnancy provided by the DICs in 2003 and 2005 were compared with advice in the product monographs for the respective drugs in the FK. Comparison of advice was based on categorization to one of four categories: can be used, benefit-risk assessment, should not be used, or no available information.

Results: A total of 443 drug advice were categorized. Seven out of ten of drugs frequently enquired about, according to the ATC system, were drugs acting on the nervous system (group N). For 208 (47%) of the drugs, advice differed between the DICs and FK. Advice from the FK was significantly (p < 0.01) more restrictive than advice from the DICs. There were no differences in the level of consistency of advice between drugs that were newly introduced and those that had been on the market for a longer time, advice regarding use of drugs in the first trimester and advice regarding use of drugs in the second or third trimester, or between advice provided during 2003 and during 2005.

Conclusions: The results of this study show considerable differences between two Norwegian sources providing advice on the use of drugs in pregnancy. Based on the knowledge that healthcare providers choose sources of information in a random manner, our results may be of clinical importance. We believe that the problem with heterogeneous drug information on this subject is not confined to Norway and that our results should be of international interest.

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References

  1. Mitchell AA. Systematic identification of drugs that cause birth defects: a new opportunity. N Engl J Med 2003 Dec 25; 349(26): 2556–9

    Article  PubMed  CAS  Google Scholar 

  2. Irl C, Hasford J. Assessing the safety of drugs in pregnancy: the role of prospective cohort studies. Drug Saf 2000 Mar; 22(3): 169–77

    Article  PubMed  CAS  Google Scholar 

  3. Webster WS, Freeman JA. Prescription drugs and pregnancy. Expert Opin Pharmacother 2003 Jun; 4(6): 949–61

    Article  PubMed  Google Scholar 

  4. Hancock RL, Koren G, Einarson A, et al. The effectiveness of Teratology Information Services (TIS). Reprod Toxicol 2007 Feb; 23(2): 125–32

    Article  PubMed  CAS  Google Scholar 

  5. Koren G. Maternal-fetal toxicology: a clinician’s guide. 3rd ed. New York: Dekker, 2001

    Google Scholar 

  6. Della-Giustina K, Chow G. Medications in pregnancy and lactation. Emerg Med Clin North Am 2003 Aug; 21(3): 585–613

    Article  PubMed  Google Scholar 

  7. Bjerrum L, Foged A. Patient information leaflets: helpful guidance or a source of confusion? Pharmacoepidemiol Drug Saf 2003 Jan–Feb; 12(1): 55–9

    Article  PubMed  Google Scholar 

  8. Ronning M, Blix HS, Harbo BT, et al. Different versions of the anatomical therapeutic chemical classification system and the defined daily dose: are drug utilisation data comparable? Eur J Clin Pharmacol 2000 Dec; 56(9-10): 723–7

    Article  PubMed  CAS  Google Scholar 

  9. Goodwin J, Rieder S, Rieder MJ, et al. Counseling regarding pregnancy: related drug exposures by family physicians in Ontario. Can J Clin Pharmacol 2007 Winter; 14(1): e58–69

    PubMed  Google Scholar 

  10. Addis A, Sharabi S, Bonati M. Risk classification systems for drug use during pregnancy: are they a reliable source of information? Drug Saf 2000 Sep; 23(3): 245–53

    Article  PubMed  CAS  Google Scholar 

  11. Sannerstedt R, Lundborg P, Danielsson BR, et al. Drugs during pregnancy: an issue of risk classification and information to prescribes. Drug Saf 1996 Feb; 14(2): 69–77

    Article  PubMed  CAS  Google Scholar 

  12. Myhr K. Can we rely on drug information [in Norwegian]? Tidsskr Nor Laegeforen 2002 Nov 10; 122(27): 2644–6

    PubMed  Google Scholar 

  13. Fusier I, Tollier C, Husson MC. Infovigilance: reporting errors in official drug information sources. Pharm World Sci 2005 Jun; 27(3): 166–9

    Article  PubMed  Google Scholar 

  14. Petersen MN, Christensen HR, Kristensen MB. Lack of consensus on drug interactions: a descriptive analysis of information on interactions in the Laegemiddelkatalog, Medicinfortegnelse and product descriptions [in Danish]. Ugeskr Laeger 2005 Aug 29; 167(35): 3286–90

    PubMed  Google Scholar 

  15. Bergk V, Haefeli WE, Gasse C, et al. Information deficits in the summary of product characteristics preclude an optimal management of drug interactions: a comparison with evidence from the literature. Eur J Clin Pharmacol 2005 Jul; 61(5–6): 327–35

    Article  PubMed  Google Scholar 

  16. Kimland E, Bergman U, Lindemalm S, et al. Drug related problems and off-label drug treatment in children as seen at a drug information centre. Eur J Pediatr 2007 Jun; 166(6): 527–32 806

    Article  PubMed  Google Scholar 

  17. Pandolfini C, Bonati M. A literature review on off-label drug use in children. Eur J Pediatr 2005 Sep; 164(9): 552–8

    Article  PubMed  Google Scholar 

  18. The Norwegian Pharmaceutical Products Compendium (Felleskatalogen). 2007 edition. Oslo, Norway: Norwegian Medicine Agency, 2007

  19. European Commission. EudraLex: the rules governing medicinal products in the European Union. Volume 2A: procedures for marketing authorization. Chapter 2: mutual recognition. Brussels: European Commission, 2005

    Google Scholar 

  20. Lagoy CT, Joshi N, Cragan JD, et al. Medication use during pregnancy and lactation: an urgent call for public health action. J Womens Health (Larchmt) 2005 Mar; 14(2): 104–9

    Article  Google Scholar 

  21. Kasilo O, Romero M, Bonati M, et al. Information on drug use in pregnancy from the Viewpoint Regional Drug Information Centre. Eur J Clin Pharmacol 1988; 35(5): 447–53

    Article  PubMed  CAS  Google Scholar 

  22. Guilhem D, Castex V, Soubrie C. Possible exploitation of a pharmacovigilance center concerning the risk of teratogenesis [in French]. Therapie 1993 Jan–Feb; 48(1): 47–9

    PubMed  CAS  Google Scholar 

  23. Schjott J, Pomp E, Gedde-Dahl A. Quality and impact of problem-oriented drug information: a method to change clinical practice among physicians? Eur J Clin Pharmacol 2002 Feb; 57(12): 897–902

    Article  PubMed  Google Scholar 

  24. Schjott J, Pomp E, Gedde-Dahl A, et al. What do health professionals ask RELIS Vest service and how satisfied are they with the answers [in Norwegian]? Tidsskr Nor Laegeforen 2000 Jan 20; 120(2): 204–7

    PubMed  CAS  Google Scholar 

  25. Addis A, Impicciatore P, Miglio D, et al. Drug use in pregnancy and lactation: the work of a regional drug information center. Ann Pharmacother 1995 Jun; 29(6): 632–3

    PubMed  CAS  Google Scholar 

  26. Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics 1977 Mar; 33(1): 159–74

    Article  PubMed  CAS  Google Scholar 

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Acknowledgements

No sources of funding were used to assist in the preparation of this study. The authors have no conflicts of interest that are directly relevant to the content of this study.

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Authors and Affiliations

  1. Regional Drug Information Centre (RELIS Vest), Haukeland University Hospital, Bergen, N-5021, Norway

    Sofia K. Frost Widnes

  2. Section of Clinical Pharmacology, Laboratory of Clinical Biochemistry, Haukeland University Hospital, Bergen, Norway

    Jan Schjott

  3. Section of Pharmacology, Institute of Medicine, Faculty of Medicine, University of Bergen, Bergen, Norway

    Jan Schjott

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  1. Sofia K. Frost Widnes
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  2. Jan Schjott
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Correspondence to Sofia K. Frost Widnes.

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Widnes, S.K.F., Schjott, J. Advice on Drug Safety in Pregnancy. Drug-Safety 31, 799–806 (2008). https://doi.org/10.2165/00002018-200831090-00008

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  • DOI: https://doi.org/10.2165/00002018-200831090-00008

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