European Journal of Clinical Pharmacology

, Volume 70, Issue 3, pp 361–367 | Cite as

Prevalence, risk factors and main features of adverse drug reactions leading to hospital admission

  • Consuelo PedrósEmail author
  • Beatriz Quintana
  • Mireia Rebolledo
  • Núria Porta
  • Antoni Vallano
  • Josep Maria Arnau
Pharmacoepidemiology and Prescription



To assess the prevalence of hospital admission related to adverse drug reactions (ADRs) in a third-level hospital, to analyse the associated factors, and to describe the reactions and the drugs involved.


A cross-sectional study was conducted for a 120-day period. Patients that were urgently hospitalized entered the study. The primary endpoint was the ADR-related urgent admission. A descriptive analysis of demographic, clinical, and drug-related variables was performed. The association between the likelihood of urgent admission due to ADRs and age, gender, and number of drugs used was analysed. A descriptive analysis of the suspected drugs and the reactions in ADR-related admissions was performed.


Overall, 186 out of 4,403 hospital admissions were due to ADRs (prevalence: 4.2 % [95 % CI 3.7–4.8 %]). Age (≥65 years: OR 1.59 [95 % CI 1.10–2.29]) and number of drugs used at the time of admission (3–5 drugs: OR 5.07 [95 % CI 2.71–9.59]; 6–9 drugs: OR 5.90 [95 % CI 3.16–11.0]; ≥10 drugs: OR 8.94 [95 % CI 4.73–16.89]), but not gender, were identified as independent factors associated with ADR-related hospitalization. The overall in-hospital stay for patients admitted with ADRs amounted to 1,785 days. The ADRs were mainly type A reactions (92 %). Acute renal failure related to renin-angiotensin system inhibitors, haemorrhage due to anticoagulants, and upper gastrointestinal bleeding related to antiplatelet drugs and/or non-steroidal anti-inflammatory drugs were the most frequent.


Over 4 % of urgent hospitalizations are caused by ADRs, which are dose-related and predictable in more than 90 % of cases. The main risk factors are advanced age and polypharmacy.


Pharmacovigilance Adverse drug reaction reporting systems Drug toxicity Hospitalization Risk factors 



The authors would like to thank the staff of the Admissions Unit of Bellvitage University Hospital, who on a daily-basis, and always on time, provided us with the daily list of urgent admissions.

Conflict of interest

No sources of funding were used to assist in the development of this study. The authors declare that they have no conflicts of interest.

Supplementary material

228_2013_1630_MOESM1_ESM.doc (58 kb)
ESM 1 (DOC 57 kb)


  1. 1.
    Lazarou J, Pomeranz BH, Corey PN (1998) Incidence of adverse drug reactions in hospitalized patients. A meta-analysis of prospective studies. JAMA 279:1200–1205PubMedCrossRefGoogle Scholar
  2. 2.
    Beijer HJM, de Blaey CJ (2002) Hospitalisations caused by adverse drug reactions (ADR): a meta-analysis of observational studies. Pharm World Sci 24:46–54PubMedCrossRefGoogle Scholar
  3. 3.
    Kongkaew C, Noyce PR, Ashcroft DM (2008) Hospital admissions associated with adverse drug reactions: a systematic review of prospective observational studies. Ann Pharmacother 42:1017–1025PubMedCrossRefGoogle Scholar
  4. 4.
    Leendertse AJ, Visser D, Egberts ACG, van den Bemt PMLA (2010) The relationship between study characteristics and the prevalence of medication-related hospitalizations. Drug Saf 33:233–244PubMedCrossRefGoogle Scholar
  5. 5.
    Edwards IR, Aronson JK (2000) Adverse drug reactions: definitions, diagnosis, and management. Lancet 356:1255–1259PubMedCrossRefGoogle Scholar
  6. 6.
    Commission Directive 2010/84/EU of the European Parliament and 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. Official Journal of the European Union 31.12.2010: L348/74-L348/99. Accessed 17 September 2013
  7. 7.
    Real Decreto 1344/2007, de 11 de octubre, por el que se regula la farmacovigilancia de medicamentos de uso humano. Boletín Oficial de Estado 1/11/2007: 44631-4460. Accessed 17 September 2013
  8. 8.
    Meyboom RHB, Royer RJ (1992) Causality classification at pharmacovigilance centres in the European Community. Pharmacoepidemiol Drug Saf 1:87–97CrossRefGoogle Scholar
  9. 9.
    WHO Collaborating Centre for Drug Statistics Methodology. Norwegian Institute of Public Health. The Anatomical Therapeutic Chemical (ATC) classification system. Accessed 17 September 2013
  10. 10.
    Gruchalla RS (2000) Clinical assessment of drug-induced disease. Lancet 356:1505–1511PubMedCrossRefGoogle Scholar
  11. 11.
    Ibañez L, Laporte J-R, Carné X (1991) Adverse drug reactions leading to hospital admissions. Drug Saf 6:450–459PubMedCrossRefGoogle Scholar
  12. 12.
    Garijo B, de Abajo FJ, Castro MA, Lopo CR, Carcas A, Frías J (1991) Hospitalizaciones motivadas por fármacos: un estudio prospectivo. Rev Clin Esp 188:7–12PubMedGoogle Scholar
  13. 13.
    Martín MT, Codina C, Tuset M, Carné X, Nogué S, Ribas J (2002) Problemas relacionados con la medicación como causa de ingreso hospitalario. Med Clin (Barc) 118:205–210CrossRefGoogle Scholar
  14. 14.
    Routledge PA, O’Mahony MS, Woodhouse KW (2003) Adverse drug reactions in elderly patients. Br J Clin Pharmacol 57:121–126CrossRefGoogle Scholar
  15. 15.
    Davies EC, Green CF, Mottram DR et al (2007) Adverse drug reactions in hospitals: a narrative review. Curr Drug Saf 2:79–87PubMedCrossRefGoogle Scholar
  16. 16.
    Ruiter R, Visser LE, Rodenburg EM, Trifirò G, Ziere G, Stricker BH (2012) Adverse drug reaction-related hospitalizations in persons aged 55 years and over. A population-based study in the Netherlands. Drugs Aging 29:225–232PubMedCrossRefGoogle Scholar
  17. 17.
    Pouyanne P, Haramburu F, Imbs JL, Bégaud B, for the French Pharmacovigilance Centres (2000) Admissions to hospital caused by adverse drug reactions: cross sectional incidence study. Br Med J 320:1036CrossRefGoogle Scholar
  18. 18.
    Van der Hooft CS, Dieleman JP, Siemes C, Aarnoudse AJLHJ, Verhamme KMC, Stricker BHCH, Sturkenboom MCJM (2008) Adverse drug reaction-related hospitalisations: a population-based cohort study. Pharmacoepidemiol Drug Saf 17:365–371PubMedCrossRefGoogle Scholar
  19. 19.
    Alexopoulou A, Dourakis SP, Mantzoukis D, Pitsariotis T, Kandyli A, Deutsch M, Archimandritis AJ (2008) Adverse drug reactions as a cause of hospital admission: a 6-month experience in a single center in Greece. Eur J Intern Med 19:505–510PubMedCrossRefGoogle Scholar
  20. 20.
    Leendertse AJ, Egberts ACG, Stoker LJ, van den Bemt PMLA, for the HARM Study Group (2008) Frequency of and risk factors for presentable medication-related hospital admissions in the Netherlands. Arch Intern Med 168:1890–1896PubMedGoogle Scholar
  21. 21.
    Onder G, Pedone C, Landi F, Cesari M, Della Vedova C, Bernabei R, Gambassi G (2002) Adverse drug reactions as cause of hospital admissions: results from the Italian Group of Pharmacoepidemiology in the Elderly (GIFA). J Am Geriatr Soc 50:1962–1968PubMedCrossRefGoogle Scholar
  22. 22.
    Caamaño F, Pedone C, Zuccalà G, Carbonin P (2005) Socio-demographic factors related to the prevalence of adverse drug reaction at hospital admission in elderly population. Arch Gerontol Geriatr 40:45–52PubMedCrossRefGoogle Scholar
  23. 23.
    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 45:301–308PubMedCentralPubMedCrossRefGoogle Scholar
  24. 24.
    Von Euler M, Eliasson E, Öhlén G, Bergman U (2006) Adverse drug reactions causing hospitalization can be monitored from computerized medical records and thereby indicate the quality of drug utilization. Pharmacoepidemiol Drug Saf 15:179–184CrossRefGoogle Scholar
  25. 25.
    Brvar M, Fokter N, Bunc M, Mozina M (2009) The frequency of adverse drug reaction related admissions according to method of detection, admission urgency and medical department speciality. BMC Clin Pharmacol 9:8PubMedCentralPubMedCrossRefGoogle Scholar
  26. 26.
    Ahern F, Sahm LJ, Lynch D, McCarthy S (2013) Determining the frequency and preventability of adverse drug reaction-related admissions to an Irish University Hospital: a cross-sectional study. Emerg Med J. doi: 10.1136/emermed-2012-201945 PubMedGoogle Scholar
  27. 27.
    Pirmohamed M, James S, Meakin S, Green C, Scott AK, Walley TJ, Farrar K, Park BK, Breckenridge AM (2004) Adverse drug reactions as cause of admission to hospital: prospective analysis of 18,820 patients. Br Med J 329:15–19CrossRefGoogle Scholar
  28. 28.
    Mjörndal T, Boman MD, Hägg S, Bäckström M, Wiholm B-E, Wahlin A, Dahlqvuist R (2002) Adverse drug reactions as a cause for admissions to a department of internal medicine. Pharmacoepidemiol Drug Saf 11:65–72PubMedCrossRefGoogle Scholar
  29. 29.
    Olivier P, Boulbés O, Tubery M, Lauque D, Montastruc J-L, Lapeyre-Mestre M (2002) Assessing the feasibility of using and adverse drug reaction preventability scale in clinical practice. A study in a French emergency department. Drug Saf 25:1036–1044CrossRefGoogle Scholar
  30. 30.
    Hopf Y, Watson M, Williams D (2008) Adverse-drug-reaction related admissions to a hospital in Scotland. Pharm World Sci 30:854–862PubMedCrossRefGoogle Scholar
  31. 31.
    Lagnaoui R, Moore N, Fach J, Longy-Boursier M, Bégaud B (2000) Adverse drug reactions in a department of systemic diseases-oriented internal medicine: prevalence, incidence, direct costs and avoidability. Eur J Clin Pharmacol 56:181–186PubMedCrossRefGoogle Scholar
  32. 32.
    Fattinger K, Roos M, Vergères P, Holenstein C, Kind B, Masche U, Stocker DN, Braunschweig S, Kullak-Ublick GA, Galeazzsi RL, Follath F, Gasser T, Meier PJ (2000) Epidemiology of drug exposure and adverse drug reactions in two Swiss departments of internal medicine. Br J Clin Pharmacol 49:158–167PubMedCentralPubMedCrossRefGoogle Scholar
  33. 33.
    Zopf Y, Rabe C, Neubert A, Gabmann KG, Rascher W, Hahn EG, Brune K, Dormann H (2008) Women encounter ADRs more often than do men. Eur J Clin Pharmacol 64:999–1004PubMedCrossRefGoogle Scholar
  34. 34.
    Rodenburg EM, Stricker BHC, Visser LE (2011) Sex-related differences in hospital admissions attributed to adverse drug reactions in Netherlands. Br J Clin Pharmacol 71:95–104PubMedCentralPubMedCrossRefGoogle Scholar
  35. 35.
    Budnitz DS, Loovegrove MC, Shehab N, Richards CL (2011) Emergency hospitalizations for adverse drug events in older Americans. N Engl J Med 365:2002–2012PubMedCrossRefGoogle Scholar
  36. 36.
    Olivier P, Bertrand L, Tubery M, Lauque D, Montastruc J-L, Lapeyre-Mestre M (2009) Hospitalizations because of adverse drug reactions in elderly patients admitted though the emergency department. A prospective study. Drugs Aging 26:475–482PubMedCrossRefGoogle Scholar
  37. 37.
    McDonnell J, Jacobs MR (2002) Hospital admissions resulting from preventable adverse drug reactions. Ann Pharmacother 36:1331–1336PubMedCrossRefGoogle Scholar
  38. 38.
    Wu WK, Pantaleo N (2003) Evaluation of outpatient adverse drug reactions leading to hospitalization. Am J Health Syst Pharm 60:253–259PubMedGoogle Scholar
  39. 39.
    Rottenkolber D, Schmiedl S, Rottenkolber M, Farker K, Saljé K, Mueller S, Hippius N, Thuermann PA, Hasford J, for the Net of Regional Pharmacovigilance Centers (2011) Adverse drug reactions in Germany: direct costs of internal medicine hospitalizations. Pharmacoepidemiol Drug Saf 20:626–634PubMedCrossRefGoogle Scholar
  40. 40.
    Hofer-Dueckelmann C, Prinz E, Beindi W, Szymanski J, Fellhofer G, Pichler M, Schuler J (2011) Adverse drug reactions (ADRs) associated with hospital admissions—elderly female patients are at higher risk. Int J Clin Pharmacol Ther 49:577–586PubMedCrossRefGoogle Scholar
  41. 41.
    Franceschi M, Scarcelli C, Niro V, Seripa D, Pazienza AM, Pepe G, Colusso AM, Pacilli L, Pilotto A (2008) Prevalence, clinical features and avoidability of adverse drug reactions as cause of admission to a geriatric unit. A prospective study of 1756 patients. Drug Saf 31:545–556PubMedCrossRefGoogle Scholar
  42. 42.
    Hartholt KA, van der Velde N, Looman CWN, Panneman MJM, van Beek EF, Patka P, van der Cammen TJM (2010) Adverse drug reactions related hospital admissions in persons aged 60 years and over, The Netherlands, 1981-2007: less rapid increase, different drugs. PLoS ONE 5:e13977PubMedCentralPubMedCrossRefGoogle Scholar
  43. 43.
    Howard RL, Avery AJ, Slavenburg S, Royal S, Pipe G, Licassen P, Pirmohamed M (2007) Which drugs cause presentable admissions to hospital? A systematic review. Br J Clin Pharmacol 63:136–147PubMedCentralPubMedCrossRefGoogle Scholar
  44. 44.
    Schneeweiss S, Hasford J, Göttler M, Hoffmann A, Riethling A-K, Avorn J (2002) Admissions caused by adverse drug events to internal medicine and emergency departments in hospitals: a longitudinal population-based study. Eur J Clin Pharmacol 58:258–291CrossRefGoogle Scholar
  45. 45.
    Conforti A, Constantini D, Zanetti F, Moretti U, Grezzana M, Leone R (2012) Adverse drug reactions in older patients: an Italian observational prospective hospital study. Drug Healthc Patient Saf 4:75–80PubMedCentralPubMedCrossRefGoogle Scholar
  46. 46.
    Patel KJ, Media MS, Bajpai D, Mehta SS, Kshirsagar NA, Gogtay NJ (2007) Evaluation of the prevalence and economic burden of adverse drug reactions presenting to the medical emergency department of a tertiary referral centre: a prospective study. BMC Clin Pharmacol 7:8PubMedCentralPubMedCrossRefGoogle Scholar
  47. 47.
    Hakkarainen KM, Hedna K, Petzold M, Hägg S (2012) Percentage of patients with preventable adverse drug reactions and preventability of adverse drug reactions—A meta-analysis. PLoS ONE 7:e33236PubMedCentralPubMedCrossRefGoogle Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 2013

Authors and Affiliations

  • Consuelo Pedrós
    • 1
    • 2
    Email author
  • Beatriz Quintana
    • 1
    • 2
  • Mireia Rebolledo
    • 1
    • 2
  • Núria Porta
    • 2
    • 3
  • Antoni Vallano
    • 1
    • 2
    • 4
  • Josep Maria Arnau
    • 1
    • 2
    • 3
    • 4
  1. 1.Clinical Pharmacology ServiceBellvitge University HospitalBarcelonaSpain
  2. 2.Bellvitge Biomedical Research Institute (IDIBELL)BarcelonaSpain
  3. 3.Clinical Trials Unit (UCICEC-CAIBER)Bellvitge Biomedical Research Institute (IDIBELL)BarcelonaSpain
  4. 4.Department of Pathology and Experimental TherapeuticsUniversity of BarcelonaBarcelonaSpain

Personalised recommendations