Table 3.
Characteristics of 28 studies looking at adverse drug events in general, that is, events that were not specific to any drug or disease category
| Study | Country | Setting | Design | Data source | Main objective | Main outcome and definition | No. codes | Methods to identify ICD-10 codes | Sample size | Frequency of outcome measure |
|---|---|---|---|---|---|---|---|---|---|---|
| Malpass et al53 | Australia | NR | Review | NR | To describe an ADE monitoring system | ADE: NR | 318i AM |
Mapped an adverse event classification system to ICD-10. | NR | NR |
| Cox et al26 | England | Hospital | RS | Admin and PV | To compare ADR reports in administrative and PV data | ADR: NR | 175 | NR | 21 635 records | 0.2% of admissions due to ADR |
| Runciman et al54 | Australia | Hospital | Review | Admin, trial, drug use, chart review and VS | To review information about ADE and medication errors in Australia | ADR: Noxious and unintended response to a drug used at doses for prophylaxis, diagnosis or therapy of disease or modification of function. ADE: ADR, harm from medication errors and underuse |
175 AM |
NR | NR | ▸ ADR: occur in 1% of admissions. ▸ ADE: occur in 2–4% of admissions |
| Waller et al35 | England | Hospital | RS | Admin | To describe records coded as drug-induced and assess their utility for research | ADR: NR | 243 | Codes containing ‘drug-induced’, diagnoses ‘due to’ a drug, ‘clearly implying’ an ADR and Y40–59 | 53.8M records | 0.4% of admissions due to ADR |
| CDC37 | USA | NR | RS | VS | To describe trends in poisoning deaths | Death from ingestion, inhalation or exposure to pharmaceuticals, illicit drugs and chemicals37 | 137 | NR | NR | 5.0–7.8 deaths/100 000 population |
| Wysowski43 | USA | NR | Letter | VS | To study deaths attributed to therapeutic drug use | Death attributed to drugs used therapeutically | 4 | NR | 604 records | NR |
| Moneret et al32 | NR | NR | Review | NR | To review the epidemio-logy of anaphylaxis | Anaphylaxis | 6 | NR | NR | NR |
| Burgess et al49 | Australia | Hospital | Case series | Admin data | To examine trends in ADR-related admissions in people ≥60 years | ADR: Noxious and unintended response to a drug that occurs at doses normally used in humans | 200 AM |
NR | NR | 0.8% of admissions associated with ADR |
| Barrow et al23 | England | Hospital | RS | Admin and PV | To compare ADR in admin data with PV reports | ADR: NR | 37 | Used codes identified by Waller et al35 | NR | NR |
| Lugardon et al29 | France | Hospital | RS | Admin and PV | To estimate the incidence of serious ADR in hospital | ADR: Noxious and unintended response to a drug used at doses for prophylaxis, diagnosis, or therapy of disease or modification of physiological function | 299 | NR | 261 records | 2.9% of admissions associated with ADR |
| Wysowski42 | USA | NR | RS | VS | To identify prescription drugs associated with >1000 deaths/year | Death due to a prescription drug | NRii | Seven disease manifestation codes and codes listing prescription drugs as cause | NR | NR |
| Zhang et al57 | Australia | Hospital | RS | Admin, VS and census | To examine trends in repeat ADR causing hospitalization in elderly | Hospitalization for ADR. ADR: Noxious and unintended response to a drug at doses normally used in humans |
175 AM |
NR | 37 296 records | 30.3% of ADR-related admissions were repeat events |
| Patel et al34 | England | Hospital | RS | Admin | To examine trends in hospital admissions associated with ADR | ADR: NR | 245 | Codes containing ‘drug-induced’, indicating a diagnosis ‘due to’ a drug, and codes Y40–59 | 88M records | 0.5% of admissions due to ADR |
| Phillips et al14 | USA | NA | RS | VS | To describe trends in fatal medication errors | ADE: Preventable deaths resulting from accidental overdose, wrong drug given or taken in error, and other accidents in the use of drugs | 180 | NR | 50M death records | 0.4% of deaths due to fatal medication errors |
| Hwang et al 58 | Korea | Hospital | RS | Chart review | To evaluate an electronic ADE monitoring system | ADE: Injury from a medical intervention related to a drug | 326 | Codes corresponded to ADE described in four previous studies on ADE monitoring systems73–76 | 598 patients | 31% of patients admitted to hospital |
| Benkhaial et al24 | Germany | Hospital | RS | Admin | To assess the value of ICD-10 codes to identify drug allergies | Drug allergy: NR | 35 GM |
NR | 200 records | 9% of records indicating an allergy |
| Hodgkin-son et al51 | Australia | Hospital | RS | Admin and PV | To compare ADR identification using coding surveillance with spontaneous reporting | ADR: Noxious and unintended response to a drug that occurs at doses used for prophylaxis, diagnosis, or therapy, or modification of physiological function | 175 AM |
NR | 12 414 records | 4.5% of admissions associated with ADR |
| Wu40 | Canada | ED | RS | Admin data | To estimate the incidence of ADR-related ED visits and admissions for patients >65 years | ADR: Injury resulting from a medical intervention relating to a drug. | 245 CA |
Used codes identified by Patel et al34 | 966 232 records | 0.8% of ED visits were ADR-related |
| Zhang et al56 | Australia | Hospital | RS | Admin, VS and census | To identify factors that predict repeat hospital admission for ADR in older adults | ADR: Harmful or unpleasant reaction related to a drug that predicts hazard from future use and warrants prevention, treatment, dose change or withdrawal | 175 AM |
NR | 28 548 patients | 17.7% of ADR-related admissions were repeat events |
| Jackson et al52 61 | Australia | Hospital | RS | Admin | To develop a tool to monitor hospital-acquired diagnoses | Hospital acquired diagnosis. ADE: NR |
279iii AM |
Codes Y40–59 and codes with a C prefix, indicating a hospital acquired condition | 126 940 records | NR |
| Wu et al36 | England | Hospital | RS | Admin | To examine trends in hospital admissions associated with ADR | ADR: Undesirable effect of a drug beyond its anticipated therapeutic effects | 260 | Codes containing ‘ADR’, ‘drug-induced’, ‘due to drug’, ‘due to medication’, ‘drug allergy’ and Y40–59 | 59.7M records | 0.9% admissions associated with an ADR |
| Bergman et al25 | Sweden | Hospital | RS | Admin and PV | To examine trends in the use of the Y57.9 code for ADR reporting | ADR: Unintended effect of therapeutic use of drugs | 1 | NR | NR | 500 ADR reports/million in population |
| Stausberg and Hasford21, Stausberg77 | Germany | Hospital | RS | Admin | To examine the utility of ICD-10 coded diagnoses in admin data to identify ADE among inpatients | ADE: Unfavorable medical event that occurred in association with the use of a medication, and that may be causally related to the medication | 502*> GM |
Literature search for ADE, identified previously used codes,78 and applied screening criteria of and data from a PV center. Mapped ADE to ICD-10 | 12M records | ▸ 0.7% admissions due to an ADE ▸ 5.3% admissions possibly due to ADE |
| Stausberg and Hasford22 | Germany | Hospital | RS | Admin | To examine the frequency of ADE-related admissions and hospital-acquired ADE | ADE: Injury resulting from a medical intervention related to a drug including errors and ADR | 505iv GM |
Literature search for ADE, identified previously used codes,78 and applied screening criteria of and data from a PV center. Mapped ADE to ICD-10 | 48M records | ▸ 0.5–0.7% of admissions due to ADE ▸ 5% of admissions possibly due to ADE |
| Osmont et al33 | France | Hospital | RS | Admin | To evaluate ICD-10 queries to identify serious ADR | ADR: NR | NR | NR | NR | NR |
| Hauck and Zhao50 | Australia | Hospital | RS | Admin | To examine the association between ADR and hospital length of stay | ADR: NR | 206 AM |
NR | 206 489 records |
3.4% risk of ADR for 2-day admission |
| Shepherd et al39 | USA | NA | RS | VS | To examine trends in mortality attributed to ADR using US VS data | ADR: Noxious and unintended response to a medication used at doses administered for diagnosis, prophylaxis or treatment | 175 | NR | NR | 0.1 deaths from ADR/100 000 in population |
| Hohl et al submitted38 | Canada | ED | RS | Admin and prospect data | To measure proportion of ADE-related ED visits identifiable in admin data | ADE: Untoward and unintended symptoms, signs or abnormal laboratory values from medication use | 650 | Adapted previously established code set21 22 with others found through literature review | 1574 records | 14.0% of ED visits ADE related |
iUse of the AM modification likely, although unable to verify with authors.
iiOnly codes associated with >1000 deaths and/or >1000 total mentions per year were listed.
iiiJackson et al describe the CHADx algorithms to identify hospital acquired diagnoses, including adverse drug events (ADE). The CHADx code set and algorithms are published on the Australian Commission on Quality and Safety in Healthcare website. Jackson et al. recommend searching for ADE using disease manifestation codes clustered with external injury cause codes (Y40–59). C-prefixes are codes that were introduced in the Victorian addition of the Australian Modification of ICD-10.
ivThe difference in the number of codes used by Stausberg et al. has to do with the splitting of code E66.1 (in ICD-10-German Modification 2006) into the four codes: E66.10, E66.11, E66.12 and E66.19 (in ICD-10-German Modification 2008).
ADE, adverse drug event; Admin, administrative; ADR, adverse drug reaction; AM, Australian modification; CDC, Centers for Disease Control and Prevention; ED, emergency department; GM, German modification; ICD, International Classification of Diseases; M, million; NR, not reported; pros, prospective; PV, pharmacovigilance; RS, retrospective; VS, vital statistics.