Prevalence, risk factors and main features of adverse drug reactions leading to hospital admission
- 1k Downloads
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.
KeywordsPharmacovigilance 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.
- 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. http://ec.europa.eu/health/files/eudralex/vol-1/dir_2010_84/dir_2010_84_en.pdf. Accessed 17 September 2013
- 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. http://www.boe.es/boe/dias/2007/11/01/pdfs/A44631-44640.pdf. Accessed 17 September 2013
- 9.WHO Collaborating Centre for Drug Statistics Methodology. Norwegian Institute of Public Health. The Anatomical Therapeutic Chemical (ATC) classification system. http://www.whocc.no. Accessed 17 September 2013
- 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
- 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
- 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.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
- 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