Skip to main content

Advertisement

SpringerLink
Log in

Preventability analysis of adverse drug reactions detected in two internal medicine departments in Romania

  • IM - ORIGINAL
  • Published:
Internal and Emergency Medicine Aims and scope Submit manuscript

Abstract

In order to improve patient safety, systematic analysis of common and repetitive patterns of preventable adverse drug reactions (pADRs) in the clinical setting should be performed regularly in order to propose adequate prevention strategies. Our aim is to evaluate the preventability of all ADRs collected in a drug information research center database, by spontaneous reporting and clinical surveillance in two internal medicine departments. One reviewer systematically reevaluated all the cases stored in the database. ADRs were deemed preventable if they were due to: a contraindication, an inadequate dose, a drug interaction, an inappropriate prescribing decision for the patient’s condition, inadequate monitoring, self-medication, or non-adherence to therapy. Out of 251 ADRs evaluated, 103 (41 %) were considered preventable. Out of the total pADRs, 86.4 % were serious. The most frequent adverse outcomes affected the gastrointestinal system (21.4 %), followed by the renal (11.6 %), metabolic (10.7 %), vascular (10.7 %) and hepatic (6.8 %) systems. Acenocoumarol (28 %), diclofenac (12.6 %), digoxin and furosemide accounted for more than 50 % of all preventable reports. One of up to three factors was involved in the preventability of the analyzed reports. Drug–drug interactions were the cause of 49.5 % of the pADRs. Inappropriate dose accounted for 17.5 % reports out of the total pADRs, inappropriate monitoring for 9.7 % reports, history of allergy to drug or drug class for 5.8 % reports and administration of a contraindicated drug for 4.8 % reports. Identifying prevalent pADRs in this study indicates a clear target for prevention strategies: drug prescription, with a special emphasis on drug interactions.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. van der Hooft CS, Sturkenboom CJM, van Groothest K, Kingma HJ, Stricker HC (2006) Adverse drug reactions-related hospitalizations. A nationwide study in The Netherlands. Drug Saf 29(2):161–168

    Article  PubMed  Google Scholar 

  2. Pouyanne P, Haramburu F, Imbs JL, Bégaud B (2000) Admissions to hospital caused by adverse drug reactions: cross sectional incidence study. BMJ 320:1036

    Article  CAS  PubMed  Google Scholar 

  3. Pirmohamed M, James S, Meakin S et al (2004) Adverse drug reaction as cause of admission to hospital: prospective analysis of 18,820 patients. BMJ 329:15–19

    Article  PubMed  Google Scholar 

  4. Alexpoulou A, Dourakis SY, Mantzoukis D et al (2008) Adverse drug reactions as a cause of hospital admissions: a 6-month experience in a single center in Greece. Eur J Int Med 19:505–510

    Article  Google Scholar 

  5. Beijer HJM, Blaey CJ (2002) Hospitalizations caused by adverse drug reactions: a meta-analysis of observational studies. Pharm World Sci 24(2):46–54

    Article  CAS  PubMed  Google Scholar 

  6. Lagnaoui R, Moore N, Fach J, Longy-Boursier M, Begaud B (2000) Adverse drug reactions in a department of systemic disease-oriented internal medicine: prevalence, incidence, direct costs and avoidability. Eur J Clin Pharmacol 55:181–186

    Article  Google Scholar 

  7. Davies EC, Green CF, Mottram DR, Pirmohamed M (2006) Adverse drug reactions in hospital in-patients: a pilot study. J Clin Pharm Ther 31:335–341

    Article  CAS  PubMed  Google Scholar 

  8. Farcas A, Sinpetrean A, Mogosan C, Palage M, Vostinaru O, Bojita M, Dumitrascu D (2010) Adverse drug reactions detected by stimulated spontaneous reporting in an internal medicine department in Romania. Eur J Intern Med 21(5):453–457

    Article  PubMed  Google Scholar 

  9. Moore N, Lecointre D, Noblet C, Mabille M (1998) Frequency and cost of serious adverse drug reactions in a department of general medicine. Br J Clin Pharmacol 45:301–308

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  10. Queneau P, Bannwarth B, Carpentier F et al (2007) Emergency department visits caused by adverse drug events: results of a French survey. Drug Saf 30(1):81–88

    Article  PubMed  Google Scholar 

  11. Howard RL, Avery AJ, Howard PD, Partridge M (2003) Investigation into the reasons for preventable drug related admissions to a medical admissions unit: observational study. Qual Saf Health Care 12(4):280–285

    Article  CAS  PubMed  Google Scholar 

  12. Olivier P, Boulbes O, Tubery M, Lauque D, Montastruc JL, Lapeyre-Mestre M (2002) Assessing the feasibility of using an adverse drug reaction preventability scale in clinical practice. Drug Saf 25(14):1035–1044

    Article  PubMed  Google Scholar 

  13. Zed PJ, Abu-Laban RB, Balen RM et al (2008) Incidence, severity and preventability of medication-related visits to the emergency department: a prospective study. CMAJ 178(12):1563–1569

    Article  PubMed Central  PubMed  Google Scholar 

  14. Winterstein AG, Hatton RC, Gonzales-Rothi R, Johns TE, Segal R (2002) Identifying clinically significant preventable adverse drug events through a hospital’s database of adverse drug reactions reports. Am J Health Syst Pharm 59:1742–1749

    PubMed  Google Scholar 

  15. Forster AJ, Worthington JR, Hawken S et al (2011) Using prospective clinical surveillance to identify adverse events in hospital. BMJ Qual Saf 20(9):756–763

    Article  PubMed Central  PubMed  Google Scholar 

  16. Smits M, Zegers M, Groenewegen PP et al (2010) Exploring the causes of adverse events in hospitals and potential prevention strategies. Qual Saf Health Care 19(5):e5

    CAS  PubMed  Google Scholar 

  17. Kanjanarat P, Winterstein AG, Johns TE et al (2003) Nature of preventable adverse drug events in hospitals: a literature review. Am J Health Syst Pharm 60(17):1750–1759

    PubMed  Google Scholar 

  18. Jönsson AK, Hakkarainen KM, Spigset O, Druid H, Hiselius A, Hägg S (2010) Preventable drug related mortality in a Swedish population. Pharmacoepidemiol Drug Saf 19(2):211–215

    Article  PubMed  Google Scholar 

  19. Hoonhout LH, de Bruijne MC, Wagner C, Asscheman H, van der Wal G, van Tulder MW (2010) Nature, occurrence and consequences of medication-related adverse events during hospitalization: a retrospective chart review in The Netherlands. Drug Saf 33(10):853–864

    Article  PubMed  Google Scholar 

  20. Brennan TA, Leape LL, Laird NM et al (1991) Incidence of adverse events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I. N Engl J Med 324(6):370–376

    Article  CAS  PubMed  Google Scholar 

  21. Morimoto T, Gandhi TK, Seger AC, Hsieh TC, Bates DW (2004) Adverse drug events and medication errors: detection and classification methods. Qual Saf Health Care 13(4):306–314

    Article  CAS  PubMed  Google Scholar 

  22. Hug BL, Witkowski DJ, Sox CM et al (2010) Adverse drug event rates in six community hospitals and the potential impact of computerized physician order entry for prevention. J Gen Intern Med 25(1):31–38

    Article  PubMed Central  PubMed  Google Scholar 

  23. Bates DW (1999) Frequency, consequences and prevention of adverse drug events. J Qual Clin Pract 19(1):13–17

    Article  CAS  PubMed  Google Scholar 

  24. Howard RL, Avery AJ, Slavenburg S et al (2007) Which drugs cause preventable admissions to hospital? A systematic review. Br J Clin Pharmacol 63(2):136–147

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  25. International Conference on Harmonisation (ICH) (1994) ICH topic E2a: clinical safety data management: definitions and standards for expedited reporting. http://www.ich.org/LOB/media/MEDIA436.pdf

  26. Karch FE, Lasagna E (1977) Towards the operational identification of adverse drug reactions. Clin Pharmacol Ther 21(3):247–254

    CAS  PubMed  Google Scholar 

  27. World Health Organization. Programme and projects: classifications [online]. http://www.who.int/classifications/icd/en/index.htm

  28. Anatomical therapeutic chemical (ATC) classification index (1992) Geneva: WHO Collaborating Center for Drug Statistics Methodology

  29. Micromedex® Healthcare Series [Internet database]. Greenwood Village, Thomson Reuters (Healthcare) Inc., Colo (Updated periodically)

  30. Schumock GT, Thornton JP (1992) Focusing on the preventability of adverse drug reactions. Hosp Pharm 27(6):538

    CAS  PubMed  Google Scholar 

  31. Imbs JL, Pletan Y, Spriet A (1998) Evaluation de la iatrogénèse médicamenteuse évitable: méthodologie. Therapie 53:365–370

    CAS  PubMed  Google Scholar 

  32. Ducharme MM, Boothby LA (2007) Analysis of adverse drug reactions for preventability. Int J Clin Pract 61(1):157–161

    Article  CAS  PubMed  Google Scholar 

  33. Jonville-Béra AP, Béra F, Autret-Leca E (2005) Are incorrectly used drugs more frequently involved in adverse drug reactions? A prospective study. Eur J Clin Pharmacol 61(3):231–236

    Article  PubMed  Google Scholar 

  34. Olivier P, Bertrand L, Tubery M, Lauque D, Montastruc JL, Lapeyre-Mestre M (2009) Hospitalizations because of adverse drug reactions in elderly patients admitted through the emergency department. Drugs Aging 26(6):475–482

    Article  PubMed  Google Scholar 

  35. Becker ML, Kallewaard M, Caspers PW et al (2007) Hospitalisations and emergency department visits due to drug–drug interactions: a literature review. Pharmacoepidemiol Drug Saf 16:641–651

    Article  PubMed  Google Scholar 

  36. Bartlett G, Blais R, Tamblyn R, Clermont RJ, MacGibbon B (2008) Impact of patient communication problems on the risk of preventable adverse events in acute care settings. CMAJ 178(12):1555–1562

    Article  PubMed Central  PubMed  Google Scholar 

Download references

Acknowledgments

This study was supported by a research grant financed by the Romanian Ministry of Education, Research and Innovation—PNII 12-102/2008.

Conflict of interest

There are no conflicts of interest to declare.

Author information

Authors and Affiliations

  1. Drug Information Research Center, School of Pharmacy, “Iuliu Hatieganu” University of Medicine and Pharmacy, Pasteur 6, 400349, Cluj-Napoca, Romania

    Andreea Farcas, Camelia Bucsa, Cristina Mogosan & Marius Bojita

  2. Second Medical Department, “Iuliu Hatieganu” University of Medicine and Pharmacy, Cluj-Napoca, Romania

    Aura Sinpetrean & Dan Dumitrascu

  3. Medical Informatics and Biostatistics Department, “Iuliu Hatieganu” University of Medicine and Pharmacy, Cluj-Napoca, Romania

    Daniel Leucuta

  4. Forth Medical Department, “Iuliu Hatieganu” University of Medicine and Pharmacy, Cluj-Napoca, Romania

    Andrei Cadariu Achimas

Authors
  1. Andreea Farcas
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Camelia Bucsa
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Aura Sinpetrean
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Daniel Leucuta
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Cristina Mogosan
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Dan Dumitrascu
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Andrei Cadariu Achimas
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Marius Bojita
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Andreea Farcas.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Farcas, A., Bucsa, C., Sinpetrean, A. et al. Preventability analysis of adverse drug reactions detected in two internal medicine departments in Romania. Intern Emerg Med 9, 187–193 (2014). https://doi.org/10.1007/s11739-012-0843-4

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11739-012-0843-4

Keywords

Search

Navigation