Table 1.
Characteristics of studies that investigated adverse drug reaction-related hospitalizations
| Reference | Country | Setting | Population | Definition used | Duration (months) | Sample size (patients) | Prevalence rate (%) | Reported severe cases (%) | Reported preventability (%) |
|---|---|---|---|---|---|---|---|---|---|
| Retrospective studies | |||||||||
| Carrasco-Garrido et al. [15] | Spain | Hospital data maintained by Ministry of Health and Consumer Affairs | Whole population (mean age, 45 years); only adult population was considered, >18 years old | The WHO definition of ADR | 72 | 350 835 | 1.63 | 5.64* | NR |
| Van Der Hooft et al. [25] | The Netherlands | IPCI (Integrated Primary Care Information database) | Whole population; adults and elderly were considered | WHO definition | 12 | 2238 | 14.9 | NR | 30.4 |
| McDonnell and Jacobs [17] | USA | Temple University Hospital | Adults of mean age 57 years | WHO definition | 11 | 20 166 | 0.76 | 24 | 62.3 |
| Ruiter et al. [18] | The Netherlands | Dutch nationwide registry of hospital discharge (LMR) | Adults and elderly >55 years old | WHO definition | 72 | 2 127 133 | 1.3 | NR | NR |
| Wawruch et al. [20] | Slovak | Department of Internal Medicine of the Hospital in Povazska Bystrica | Adults and elderly >65 years old | A-type ADRs are dose dependant and are a consequence of the drug pharmacological action; B-type ADRs are dose independant and associated with drug pharmacodynamic activity | 16 | 600 | 7.8 | NR | NR |
| Wu et al. [19] | UK | Data from the hospital episode statistics database | Adults and elderly >65 years old | Undesirable effect of a drug beyond its anticipated therapeutic effects occurring during clinical use, and is one of the major causes of iatrogenic disease | 120 | 6 830 067 | 0.9 | NR | NR |
| Prospective and observational studies | |||||||||
| Ahren et al. [28] | Ireland | Cork University Hospital, Cork, Ireland | Whole population of mean age 68.8 years; adults and elderly were considered | WHO definition | 1 | 856 | 8.8 | NR | 5.3 |
| Franceschi et al. [56] | Italy | Geriatric Unit of the Casa Sollievo della Sofferenza Hospital, San Giovanni Rotondo in Italy | Adults and elderly >65 years; mean age, 76.5 (65–93 years) | An appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which predicts hazards from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen, or withdrawal of the product | 11 | 1756† | 5.8 | NR | 78 |
| Hopf et al. [22] | Scotland | Aberdeen Royal Infirmary (ARI) | Adults and elderly >16 years old | WHO definition | 0.5 | 1101 | 2.7 | NR | 13.3 |
| Pérez Menéndez-Conde et al. [50] | Spain | Hospital Ramón y Cajal, Madrid | Adult and elderly population of mean age 68.2 years (21–96 years) | Events which can affect the public health of people who consume drugs for therapeutic, diagnostic or prophylactic purposes | 12 | 252 | 19.4 | NR | 63.5 |
| Onder et al. [57] | Italy | 81 academic hospitals across Italy | Adults and elderly, mean age, 70 years (54–96 years) | Any noxious, unintended and undesired effect of a drug, excluding therapeutic failures, intentional and accidental poisoning, and abuse | 120 | 28 411 | 5.99 | 20 | NR |
| Thuermann et al. [29] | Germany | Two German pharmacovigilence centres | Adult population | A-type ADRs are dose dependent and are a consequence of the drug pharmacological action; B-type ADRs are dose independent and associated with drug pharmacodynamic activity | 48 | 41 375 | 2.4 | NR | NR |
| Mjörndal et al. [23] | Sweden | Swedish university hospital | Adult population of median age 74 years (21–92 years) | WHO definition | 9 | 681 | 14.5 | NR | NR |
| Gholami et al. [24] | Iran | Cardiovascular clinic at teaching hospital in Tehran | Whole population, but only adults and elderly were considered | WHO definition | 8 | 518 | 20.3 | 1.1 | 1.9 |
| Pirmohamed et al. [21] | UK | Two general hospitals in Merseyside, UK | Adults and elderly >16 years old; median age, 76 years (65–83 years) | An appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen, or withdrawal of the product | 6 | 18 825 | 6.5 | 0.15 | NR |
| Wasserfallen et al. [51] | Switzerland | University hospital at Lusanne | Adults and elderly >16 years old; mean age, 61.4 years (16–93 years) | WHO definition | 6 | 4840 | 7 | 9.2 | 67 |
| Mannesse et al. [52] | The Netherlands | University hospital in Rotterdam | Elderly >70 years old | An undesirable clinical manifestation consequent to and caused by the administration of a particular drug or interacting drugs, excluding intentional overdose, substance abuse and therapeutic failure | 4 | 106 | 12 | 24 | NR |
| Rodenburg et al. [41] | The Netherlands | Dutch National Medical Register | Adults and elderly | An ADR-related hospitalization was defined as a hospitalization with an E-code as secondary diagnosis, indicating an ADR as the mean reason for hospitalization | 72 | 14 207 | 54 | NR | NR |
| Van Der Hooft et al. [25] | The Netherlands | Nationwide computer database for hospital discharge records | Whole population of mean age 48.5 years; only adults and elderly >18 years old were considered | WHO definition | 12 | 668 714 | 2.03 | 1 | NR |
| Jayarama et al. [27] | India | Jalappa hospital, Kolar emergency department | Adults of mean age 49.5 years (20−79 years) | WHO definition | 12 | 133 | 37.6 | 18 | 18 |
| Varallo et al. [26] | Brazil | Private Hospital at São Paulo State | Adults and elderly >60 years old | WHO definition | 1 | 308 | 54.5 | NR | NR |
Abbreviations are as follows: ADR, adverse drug reaction; NR, not reported; WHO, World Health Organization.
*
Patients died.
†
Geriatric patients. The severity indicated the percentage of reported severe and/or fatal injuries. The WHO definition for an adverse drug reaction is as follows: any noxious, undesired and unattended drug effect that occurs at doses used in human for therapy, diagnosis or prophylaxis.