Skip to main content
Top
Published in: BMC Health Services Research 1/2013

Open Access 01-12-2013 | Research article

Evaluating adverse drug event reporting in administrative data from emergency departments: a validation study

Authors: Corinne M Hohl, Lisa Kuramoto, Eugenia Yu, Basia Rogula, Jürgen Stausberg, Boris Sobolev

Published in: BMC Health Services Research | Issue 1/2013

Login to get access

Abstract

Background

Adverse drug events are a frequent cause of emergency department presentations. Administrative data could be used to identify patients presenting with adverse drug events for post-market surveillance, and to conduct research in patient safety and in drug safety and effectiveness. However, such data sources have not been evaluated for their completeness with regard to adverse drug event reporting. Our objective was to determine the proportion of adverse drug events to outpatient medications diagnosed at the point-of-care in emergency departments that were documented in administrative data.

Methods

We linked the records of patients enrolled in a prospective observational cohort study on adverse drug events conducted in two Canadian tertiary care emergency departments to their administrative data. We compared the number of adverse drug events diagnosed and recorded at the point-of-care in the prospective study with the number of adverse drug events recorded in the administrative data.

Results

Among 1574 emergency department visits, 221 were identified as adverse drug event-related in the prospective database. We found 15 adverse drug events documented in administrative records with ICD-10 codes clearly indicating an adverse drug event, indicating a sensitivity of 6.8% (95% CI 4.0–11.2%) of this code set. When the ICD-10 code categories were broadened to include codes indicating a very likely, likely or possible adverse event to a medication, 62 of 221 events were identifiable in administrative data, corresponding to a sensitivity of 28.1% (95% CI 22.3-34.6%).

Conclusions

Adverse drug events to outpatient medications were underreported in emergency department administrative data compared to the number of adverse drug events diagnosed and recorded at the point-of-care.
Appendix
Available only for authorised users
Literature
1.
go back to reference Bates D: Drugs and adverse drug reactions. How worried should We Be?. JAMA. 1998, 279 (15): 1216-1217. 10.1001/jama.279.15.1216.CrossRefPubMed Bates D: Drugs and adverse drug reactions. How worried should We Be?. JAMA. 1998, 279 (15): 1216-1217. 10.1001/jama.279.15.1216.CrossRefPubMed
3.
go back to reference Gurwitz JH, Field TS, Harrold LR, Rothschild J, Debellis K, Seger AC, Cadoret C, Fish LS, Garber L, Kelleher M, et al: Incidence and preventability of adverse drug events among older persons in the ambulatory setting. JAMA. 2003, 289 (9): 1107-1016. 10.1001/jama.289.9.1107.CrossRefPubMed Gurwitz JH, Field TS, Harrold LR, Rothschild J, Debellis K, Seger AC, Cadoret C, Fish LS, Garber L, Kelleher M, et al: Incidence and preventability of adverse drug events among older persons in the ambulatory setting. JAMA. 2003, 289 (9): 1107-1016. 10.1001/jama.289.9.1107.CrossRefPubMed
4.
go back to reference Sorensen SV, Dewilde S, Singer DE, Goldhaber SZ, Monz BU, Plumb JM: Cost-effectiveness of warfarin: trial versus “real-world” stroke prevention in atrial fibrillation. Am Heart J. 2009, 157: 1064-1073. 10.1016/j.ahj.2009.03.022.CrossRefPubMed Sorensen SV, Dewilde S, Singer DE, Goldhaber SZ, Monz BU, Plumb JM: Cost-effectiveness of warfarin: trial versus “real-world” stroke prevention in atrial fibrillation. Am Heart J. 2009, 157: 1064-1073. 10.1016/j.ahj.2009.03.022.CrossRefPubMed
5.
go back to reference T-Pv S, Leufkens HG, Zhang B, Smeeth L: A comparison of cost effectiveness using data from randomized trials or actual clinical practice: selective Cox-2 inhibitors as an example. PLoS Med. 2009, 6 (12): e1000194-10.1371/journal.pmed.1000194.CrossRef T-Pv S, Leufkens HG, Zhang B, Smeeth L: A comparison of cost effectiveness using data from randomized trials or actual clinical practice: selective Cox-2 inhibitors as an example. PLoS Med. 2009, 6 (12): e1000194-10.1371/journal.pmed.1000194.CrossRef
6.
go back to reference Wiktorowicz M, Lexchin J, Paterson M, Mintzes B, Metge C, Light D, Morgan S, Holbrook A, Tamblyn R, Zaki E, et al: Research networks involved in post-market pharmacosurveillance in the United States, United Kingdom, France, New Zealand, Australia, Norway and European Union: Lessons for Canada. Edited by: the Canadian Institute for Patient Safety. 2008, Edmonton, Canada: The Canadian Institute for Patient Safety. Wiktorowicz M, Lexchin J, Paterson M, Mintzes B, Metge C, Light D, Morgan S, Holbrook A, Tamblyn R, Zaki E, et al: Research networks involved in post-market pharmacosurveillance in the United States, United Kingdom, France, New Zealand, Australia, Norway and European Union: Lessons for Canada. Edited by: the Canadian Institute for Patient Safety. 2008, Edmonton, Canada: The Canadian Institute for Patient Safety.
8.
go back to reference Suissa S, Garbe E: Primer: administrative health databases in observational studies of drug effects—advantages and disadvantages. Nat Clin Pract Rheum. 2007, 3 (12): 725-732. 10.1038/ncprheum0652.CrossRef Suissa S, Garbe E: Primer: administrative health databases in observational studies of drug effects—advantages and disadvantages. Nat Clin Pract Rheum. 2007, 3 (12): 725-732. 10.1038/ncprheum0652.CrossRef
9.
go back to reference Schuur JD, Venkatesh AK: The growing role of emergency departments in hospital admissions. N Engl J Med. 2012, 367: 391-393. 10.1056/NEJMp1204431.CrossRefPubMed Schuur JD, Venkatesh AK: The growing role of emergency departments in hospital admissions. N Engl J Med. 2012, 367: 391-393. 10.1056/NEJMp1204431.CrossRefPubMed
10.
go back to reference Hafner JW, Belknap SM, Squillante MD, Bucheit KA: Adverse drug events in emergency department patients. Ann Emerg Med. 2002, 39 (3): 258-267. 10.1067/mem.2002.121401.CrossRefPubMed Hafner JW, Belknap SM, Squillante MD, Bucheit KA: Adverse drug events in emergency department patients. Ann Emerg Med. 2002, 39 (3): 258-267. 10.1067/mem.2002.121401.CrossRefPubMed
11.
go back to reference Hohl CM, Dankoff J, Colacone A, Afilalo M: Polypharmacy, adverse drug-related events, and potential adverse drug interactions in elderly patients presenting to an emergency department. Ann Emerg Med. 2001, 38 (6): 666-671. 10.1067/mem.2001.119456.CrossRefPubMed Hohl CM, Dankoff J, Colacone A, Afilalo M: Polypharmacy, adverse drug-related events, and potential adverse drug interactions in elderly patients presenting to an emergency department. Ann Emerg Med. 2001, 38 (6): 666-671. 10.1067/mem.2001.119456.CrossRefPubMed
12.
go back to reference Zed PJ, Abu-Laban RB, Balen RM, Loewen PS, Hohl CM, Brubacher JR, Wilbur K, Wiens MO, Samoy LJ, Lacaria K, Pursell RA: Incidence, severity and preventability of medication-related visits to the emergency department: a prospective study. Can Med Ass J. 2008, 178 (12): 1563-1569. 10.1503/cmaj.071594.CrossRef Zed PJ, Abu-Laban RB, Balen RM, Loewen PS, Hohl CM, Brubacher JR, Wilbur K, Wiens MO, Samoy LJ, Lacaria K, Pursell RA: Incidence, severity and preventability of medication-related visits to the emergency department: a prospective study. Can Med Ass J. 2008, 178 (12): 1563-1569. 10.1503/cmaj.071594.CrossRef
13.
go back to reference Budnitz DS, Lovegrove MC, Shehab N, Richards CL: Emergency Hospitalizations for Adverse Drug Events in Older Americans. N Engl J Med. 2011, 365: 2002-2012. 10.1056/NEJMsa1103053.CrossRefPubMed Budnitz DS, Lovegrove MC, Shehab N, Richards CL: Emergency Hospitalizations for Adverse Drug Events in Older Americans. N Engl J Med. 2011, 365: 2002-2012. 10.1056/NEJMsa1103053.CrossRefPubMed
14.
go back to reference WHO: Nternational drug monitoring: the role of national centres. Report of a WHO meeting. 1972, Geneva: World Health Organization, 1-44. WHO: Nternational drug monitoring: the role of national centres. Report of a WHO meeting. 1972, Geneva: World Health Organization, 1-44.
15.
go back to reference Zed PJ: Drug-related visits to the emergency department. J Pharm Pract. 2005, 18: 329-335. 10.1177/0897190005280049.CrossRef Zed PJ: Drug-related visits to the emergency department. J Pharm Pract. 2005, 18: 329-335. 10.1177/0897190005280049.CrossRef
16.
go back to reference Budnitz DS, Pollock DA, Weidenbach KN, Mendelsohn AB, Schroeder TJ, Annest JL: National surveillance of emergency department visits for outpatient adverse drug events. JAMA. 2006, 296 (15): 1858-1866. 10.1001/jama.296.15.1858.CrossRefPubMed Budnitz DS, Pollock DA, Weidenbach KN, Mendelsohn AB, Schroeder TJ, Annest JL: National surveillance of emergency department visits for outpatient adverse drug events. JAMA. 2006, 296 (15): 1858-1866. 10.1001/jama.296.15.1858.CrossRefPubMed
17.
go back to reference Carleton B, Foerster V, Warren L, Smith A: Overview of novel drug plan and drug regulatory pharmacosurveillance initiatives in the United States, United Kingdom, and select other jurisdictions: A background paper prepared for the Working Conference on Strengthening the Evaluation of Real World Drug Safety and Effectiveness. September 13-15, 2005 Carleton B, Foerster V, Warren L, Smith A: Overview of novel drug plan and drug regulatory pharmacosurveillance initiatives in the United States, United Kingdom, and select other jurisdictions: A background paper prepared for the Working Conference on Strengthening the Evaluation of Real World Drug Safety and Effectiveness. September 13-15, 2005
19.
go back to reference Budnitz DS, Pollock DA, Mendelsohn AB, Weidenbach KN, McDonald AK, Annest JL: Emergency department visits for outpatient adverse drug events: demonstration for a national surveillance system. Ann Emerg Med. 2005, 45 (2): 197-206. 10.1016/j.annemergmed.2004.09.020.CrossRefPubMed Budnitz DS, Pollock DA, Mendelsohn AB, Weidenbach KN, McDonald AK, Annest JL: Emergency department visits for outpatient adverse drug events: demonstration for a national surveillance system. Ann Emerg Med. 2005, 45 (2): 197-206. 10.1016/j.annemergmed.2004.09.020.CrossRefPubMed
20.
go back to reference Jhung MA, Budnitz DS, Mendelsohn AB, Weidenbach KN, Nelson TD, Pollock DA: Evaluation and Overview of the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance Project (NEISS-CADES). Med Care. 2007, 45 (10): S96-S102.CrossRefPubMed Jhung MA, Budnitz DS, Mendelsohn AB, Weidenbach KN, Nelson TD, Pollock DA: Evaluation and Overview of the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance Project (NEISS-CADES). Med Care. 2007, 45 (10): S96-S102.CrossRefPubMed
21.
go back to reference Hohl CM, Brubacher J, Hunte G, Wiens MO, Abu-Laban R, Singer J, Sheps S: Clinical Decision Rules to Improve the Detection of Adverse Drug Events in Emergency Department Patients. Acad Emerg Med. 2012, 19 (6): 640-649. 10.1111/j.1553-2712.2012.01379.x.CrossRefPubMed Hohl CM, Brubacher J, Hunte G, Wiens MO, Abu-Laban R, Singer J, Sheps S: Clinical Decision Rules to Improve the Detection of Adverse Drug Events in Emergency Department Patients. Acad Emerg Med. 2012, 19 (6): 640-649. 10.1111/j.1553-2712.2012.01379.x.CrossRefPubMed
22.
go back to reference Forster A, Asmis T, Clark H, Al Saied G, Code C, Caughey S, Baker K, Watters J, Worthington J, van Walraven C: Ottawa Hospital Patient Safety Study: incidence and timing of adverse events in patients admitted to a Canadian teaching hospital. Can Med Ass J. 2004, 170 (8): 1235-1240. 10.1503/cmaj.1030683.CrossRef Forster A, Asmis T, Clark H, Al Saied G, Code C, Caughey S, Baker K, Watters J, Worthington J, van Walraven C: Ottawa Hospital Patient Safety Study: incidence and timing of adverse events in patients admitted to a Canadian teaching hospital. Can Med Ass J. 2004, 170 (8): 1235-1240. 10.1503/cmaj.1030683.CrossRef
23.
go back to reference Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, Janecek E, Domecq C, Greenblatt DJ: A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981, 30 (2): 239-245. 10.1038/clpt.1981.154.CrossRefPubMed Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, Janecek E, Domecq C, Greenblatt DJ: A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981, 30 (2): 239-245. 10.1038/clpt.1981.154.CrossRefPubMed
24.
go back to reference World Health Organization: Letter MIO/372/2(A). 1991, Geneva, Switzerland: WHO World Health Organization: Letter MIO/372/2(A). 1991, Geneva, Switzerland: WHO
25.
go back to reference Hepler C, Strand L: Opportunities and responsibilities in pharmaceutical care. Am J Hosp Pharm. 1990, 47: 533-543.PubMed Hepler C, Strand L: Opportunities and responsibilities in pharmaceutical care. Am J Hosp Pharm. 1990, 47: 533-543.PubMed
26.
go back to reference Karpov A, Stausberg J, Doyle-Waters M, Hohl CM: Adverse drug event codes in ICD-10: a systematic review of the literature. In press Karpov A, Stausberg J, Doyle-Waters M, Hohl CM: Adverse drug event codes in ICD-10: a systematic review of the literature. In press
27.
go back to reference Stausberg J, Hasford J: Identification of adverse drug events: the use of ICD-10 coded diagnoses in routine hospital data. DtschArztebl Int. 2010, 107 (3): 23-29. Stausberg J, Hasford J: Identification of adverse drug events: the use of ICD-10 coded diagnoses in routine hospital data. DtschArztebl Int. 2010, 107 (3): 23-29.
28.
go back to reference Stausberg J, Hasford J: Drug-related admissions and hospital-acquired adverse drug events in Germany: a longitudinal analysis from 2003 to 2007 of ICD-10-coded routine data. BMC Health Serv Res. 2011, 11: 134-10.1186/1472-6963-11-134.CrossRefPubMedPubMedCentral Stausberg J, Hasford J: Drug-related admissions and hospital-acquired adverse drug events in Germany: a longitudinal analysis from 2003 to 2007 of ICD-10-coded routine data. BMC Health Serv Res. 2011, 11: 134-10.1186/1472-6963-11-134.CrossRefPubMedPubMedCentral
30.
go back to reference Edwards IR, Aronson JK: Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000, 356 (9237): 1255-1259. 10.1016/S0140-6736(00)02799-9.CrossRefPubMed Edwards IR, Aronson JK: Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000, 356 (9237): 1255-1259. 10.1016/S0140-6736(00)02799-9.CrossRefPubMed
31.
go back to reference Nebeker J, Barach P, Samore M: Clarifying adverse drug events: a clinician’s guide to terminology, documentation, and reporting. Ann Intern Med. 2004, 140: 795-801. 10.7326/0003-4819-140-10-200405180-00017.CrossRefPubMed Nebeker J, Barach P, Samore M: Clarifying adverse drug events: a clinician’s guide to terminology, documentation, and reporting. Ann Intern Med. 2004, 140: 795-801. 10.7326/0003-4819-140-10-200405180-00017.CrossRefPubMed
32.
go back to reference WHO: International drug monitoring: the role of the hospital. Report of a WHO meeting. WHO Technical Report Series. 1966, 425: 5-24. WHO: International drug monitoring: the role of the hospital. Report of a WHO meeting. WHO Technical Report Series. 1966, 425: 5-24.
33.
go back to reference Hohl CM, Robitaille C, Lord V, Dankoff J, Colacone A, Pham L, Berard A, Pepin J, Afilalo M: Emergency physician recognition of adverse drug-related events in elder patients presenting to an emergency department. Acad Emerg Med. 2005, 12 (3): 197-205. 10.1111/j.1553-2712.2005.tb00869.x.CrossRefPubMed Hohl CM, Robitaille C, Lord V, Dankoff J, Colacone A, Pham L, Berard A, Pepin J, Afilalo M: Emergency physician recognition of adverse drug-related events in elder patients presenting to an emergency department. Acad Emerg Med. 2005, 12 (3): 197-205. 10.1111/j.1553-2712.2005.tb00869.x.CrossRefPubMed
34.
go back to reference Glasgow RE, Magid DJ, Beck A, Ritzwoller D, Estabrooks PA: Practical clinical trials for translating research to practice design and measurement recommendations. Med Care. 2005, 43: 551-557. 10.1097/01.mlr.0000163645.41407.09.CrossRefPubMed Glasgow RE, Magid DJ, Beck A, Ritzwoller D, Estabrooks PA: Practical clinical trials for translating research to practice design and measurement recommendations. Med Care. 2005, 43: 551-557. 10.1097/01.mlr.0000163645.41407.09.CrossRefPubMed
35.
go back to reference Tunis SR, Stryer DB, Clancy CM: Practical clinical trials. Increasing the value of clinical research for decision making in clinical and health policy. JAMA. 2003, 290 (12): 1624-1632.CrossRefPubMed Tunis SR, Stryer DB, Clancy CM: Practical clinical trials. Increasing the value of clinical research for decision making in clinical and health policy. JAMA. 2003, 290 (12): 1624-1632.CrossRefPubMed
36.
go back to reference Verelst S, Jacques J, Heede KV, Gillet P, Kolh P, Vleugels A, Sermeus W: Validation of hospital administrative dataset for adverse event screening. Qual Saf Health Care. 2010, 19: e25.PubMed Verelst S, Jacques J, Heede KV, Gillet P, Kolh P, Vleugels A, Sermeus W: Validation of hospital administrative dataset for adverse event screening. Qual Saf Health Care. 2010, 19: e25.PubMed
37.
go back to reference Hougland P, Nebeker J, Pickard S, Tuinen MV, Masheter C, Elder S, Williams S, Xu W: Using ICD-9-CM codes in hospital claims data to detect adverse events in patient safety surveillance. 2008, Agency for Healthcare Research and Quality: Rockville (MD), Volume 1. Hougland P, Nebeker J, Pickard S, Tuinen MV, Masheter C, Elder S, Williams S, Xu W: Using ICD-9-CM codes in hospital claims data to detect adverse events in patient safety surveillance. 2008, Agency for Healthcare Research and Quality: Rockville (MD), Volume 1.
38.
go back to reference Hougland P, Xu W, Pickard S, Masheter C, Williams SD: Performance of international classification of diseases, 9th revision, clinical modification codes as an adverse drug event surveillance system. Med Care. 2006, 44: 629-636. 10.1097/01.mlr.0000215859.06051.77.CrossRefPubMed Hougland P, Xu W, Pickard S, Masheter C, Williams SD: Performance of international classification of diseases, 9th revision, clinical modification codes as an adverse drug event surveillance system. Med Care. 2006, 44: 629-636. 10.1097/01.mlr.0000215859.06051.77.CrossRefPubMed
39.
go back to reference Leonard CE, Haynes K, Localio R, Hennessy S, Tjia J, Cohen A, Kimmel SE, Feldman HI, Metlay JP: Diagnostic E-codes for commonly used, narrow therapeutic index medications poorly predict adverse drug events. J Clin Epidemiolog. 2008, 61: 561-571. 10.1016/j.jclinepi.2007.08.003.CrossRef Leonard CE, Haynes K, Localio R, Hennessy S, Tjia J, Cohen A, Kimmel SE, Feldman HI, Metlay JP: Diagnostic E-codes for commonly used, narrow therapeutic index medications poorly predict adverse drug events. J Clin Epidemiolog. 2008, 61: 561-571. 10.1016/j.jclinepi.2007.08.003.CrossRef
40.
go back to reference Drösler S, Romano P, Wei L: Health Care Quality Indicators Project: Patient Safety Indicators Report 2009. Organization for Economic Co-operation and Development (OECD) Health Working Papers No 47. Edited by: Head of Publications Service, OECD. 2009, Paris, France: Head of Publications Service, OECD, 1-47. Drösler S, Romano P, Wei L: Health Care Quality Indicators Project: Patient Safety Indicators Report 2009. Organization for Economic Co-operation and Development (OECD) Health Working Papers No 47. Edited by: Head of Publications Service, OECD. 2009, Paris, France: Head of Publications Service, OECD, 1-47.
41.
go back to reference Wu C: Adverse Drug Reactions in the Emergency Department Population in Ontario: Analysis of National Ambulatory Care Reporting System and Discharge Abstract Database 2003–2007. 2009, Toronto: University of Toronto Wu C: Adverse Drug Reactions in the Emergency Department Population in Ontario: Analysis of National Ambulatory Care Reporting System and Discharge Abstract Database 2003–2007. 2009, Toronto: University of Toronto
42.
go back to reference Hohl CM, Zed PJ, Brubacher JR, Abu-Laban RB, Loewen PS, Purssell R: Do emergency physicians attribute drug-related emergency department visits to medication-related problems?. Ann Emerg Med. 2010, 55 (6): 493-502. 10.1016/j.annemergmed.2009.10.008.CrossRefPubMed Hohl CM, Zed PJ, Brubacher JR, Abu-Laban RB, Loewen PS, Purssell R: Do emergency physicians attribute drug-related emergency department visits to medication-related problems?. Ann Emerg Med. 2010, 55 (6): 493-502. 10.1016/j.annemergmed.2009.10.008.CrossRefPubMed
43.
go back to reference Hohl CM, Nosyk B, Zed P, Kuramoto L, Sobolev B, Brubacher J, Abu-Laban R, Loewen PS, Sheps S: Outcomes of emergency department patients presenting with adverse drug events. Ann Emerg Med. 2011, 58 (3): 270-279. 10.1016/j.annemergmed.2011.01.003.CrossRefPubMed Hohl CM, Nosyk B, Zed P, Kuramoto L, Sobolev B, Brubacher J, Abu-Laban R, Loewen PS, Sheps S: Outcomes of emergency department patients presenting with adverse drug events. Ann Emerg Med. 2011, 58 (3): 270-279. 10.1016/j.annemergmed.2011.01.003.CrossRefPubMed
Metadata
Title
Evaluating adverse drug event reporting in administrative data from emergency departments: a validation study
Authors
Corinne M Hohl
Lisa Kuramoto
Eugenia Yu
Basia Rogula
Jürgen Stausberg
Boris Sobolev
Publication date
01-12-2013
Publisher
BioMed Central
Published in
BMC Health Services Research / Issue 1/2013
Electronic ISSN: 1472-6963
DOI
https://doi.org/10.1186/1472-6963-13-473

Other articles of this Issue 1/2013

BMC Health Services Research 1/2013 Go to the issue