Improving Patient Care
18 May 2004

Clarifying Adverse Drug Events: A Clinician's Guide to Terminology, Documentation, and Reporting

Publication: Annals of Internal Medicine
Volume 140, Number 10

Abstract

Adverse drug events cause substantial morbidity and mortality, yet they remain underappreciated and misunderstood. The terminology to describe errors and patient harm associated with medications causes much confusion. This article uses the case study of a patient with multiple adverse drug events to clarify key terms, such as adverse event, adverse drug reaction, adverse drug event, medication error, and side effect. The case discussion illustrates clinical approaches to analyzing the causal connection between a suspect drug and an adverse event. Examples and rationale for meaningful documentation of adverse drug events are provided, along with an outline of the types of events that should be reported to regulatory agencies.

Get full access to this article

View all available purchase options and get full access to this article.

References

1.
Ross SD. Drug-related adverse events: a readers' guide to assessing literature reviews and meta-analyses. Arch Intern Med. 2001;161:1041-6. [PMID: 11322836]
2.
Shojania KGDuncan BWMcDonald KMWachter RM. Safe but sound: patient safety meets evidence-based medicine [Editorial]. JAMA. 2002;288:508-13. [PMID: 12132985]
3.
Kohn LTCorrigan JMDonaldson MS. To Err Is Human: Building a Safer Health System. Washington, DC: National Academy Pr; 1999.
4.
Bates DWCullen DJLaird NPetersen LASmall SDServi Det al . Incidence of adverse drug events and potential adverse drug events. Implications for prevention. ADE Prevention Study Group. JAMA. 1995;274:29-34. [PMID: 7791255]
5.
Gandhi TKWeingart SNBorus JSeger ACPeterson JBurdick Eet al . Adverse drug events in ambulatory care. N Engl J Med. 2003;348:1556-64. [PMID: 12700376]
6.
Fattinger KRoos MVergeres PHolenstein CKind BMasche Uet al . Epidemiology of drug exposure and adverse drug reactions in two swiss departments of internal medicine. Br J Clin Pharmacol. 2000;49:158-67. [PMID: 10671911]
7.
Classen DCPestotnik SLEvans RSBurke JP. Computerized surveillance of adverse drug events in hospital patients. JAMA. 1991;266:2847-51. [PMID: 1942452]
8.
Tegeder ILevy MMuth-Selbach UOelkers RNeumann FDormann Het al . Retrospective analysis of the frequency and recognition of adverse drug reactions by means of automatically recorded laboratory signals. Br J Clin Pharmacol. 1999;47:557-64. [PMID: 10336581]
9.
Nebeker JRHurdle JFHoffman JMRoth BWeir CRSamore MH. Developing a taxonomy for research in adverse drug events: potholes and signposts. J Am Med Inform Assoc. 2002;9 6 Suppl S80-5.
10.
Schlienger RGLuscher TFSchoenenberger RAHaefeli WE. Academic detailing improves identification and reporting of adverse drug events. Pharm World Sci. 1999;21:110-5. [PMID: 10427579]
11.
Johnstone DMKirking DMVinson BE. Comparison of adverse drug reactions detected by pharmacy and medical records departments. Am J Health Syst Pharm. 1995;52:297-301. [PMID: 7749958]
12.
Sivaram CAJohnson STirmizi SNRobertson VGarcia DSorrells E. Morning report: a forum for reporting adverse drug reactions. Jt Comm J Qual Improv. 1996;22:259-63. [PMID: 8743062]
13.
Thatcher C. ADR: reporting problems. Can Pharm J. 2002;134:11.
14.
Hofer TPKerr EAHayward RA. What is an error? Eff Clin Pract. 2000;3:261-9. [PMID: 11151522]
15.
Clinical Safety Data Management: Definitions and Standards for Expedited Reporting. London: European Agency for the Evaluation of Medicinal Products, Human Medicines Evaluation Unit; 1995. Accessed at www.emea.eu.int/pdfs/human/ich/037795en.pdf on 16 December 2003.
16.
Edwards IRAronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000;356:1255-9. [PMID: 11072960]
17.
Cobert BLBiron P. Pharmacovigilance from A to Z. Malden, MA: Blackwell Science; 2002.
18.
Gurwitz JHField TSAvorn JMcCormick DJain SEckler Met al . Incidence and preventability of adverse drug events in nursing homes. Am J Med. 2000;109:87-94. [PMID: 10967148]
19.
What Is a Medication Error? Rockville, MD: National Coordinating Council for Medication Error Reporting and Prevention; 1998. Accessed at www.nccmerp.org on 29 August 2003.
20.
Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting E2D. Geneva, Switzerland: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use; 2003. Accessed at www.ich.org/MediaServer.jser?@_ID=631&@_TYPE=MULTIMEDIA&@_TEMPLATE=616&@_MODE=GLB on 17 December 2003.
21.
Venulet Jten Ham M. Methods for monitoring and documenting adverse drug reactions. Int J Clin Pharmacol Ther. 1996;34:112-29. [PMID: 8705089]
22.
Meyboom RHHekster YAEgberts ACGribnau FWEdwards IR. Causal or casual? The role of causality assessment in pharmacovigilance. Drug Saf. 1997;17:374-89. [PMID: 9429837]
23.
Michel DJKnodel LC. Comparison of three algorithms used to evaluate adverse drug reactions. Am J Hosp Pharm. 1986;43:1709-14. [PMID: 3752106]
24.
Kramer MSLeventhal JMHutchinson TAFeinstein AR. An algorithm for the operational assessment of adverse drug reactions. I. Background, description, and instructions for use. JAMA. 1979;242:623-32. [PMID: 449002]
25.
Naranjo CABusto USellers EMSandor PRuiz IRoberts EAet al . A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30:239-45. [PMID: 7249508]
26.
Bates DW. Medication errors. How common are they and what can be done to prevent them? Drug Saf. 1996;15:303-10. [PMID: 8941492]
27.
Schaaf TVan der Lucas DAHale AReds. Near Miss Reporting as a Safety Tool. Oxford: Butterworth-Heinemann; 1991.
28.
Guideline for Postmarketing Reporting of Adverse Drug Experiences. Rockville, MD: U.S. Food and Drug Administration; 1992. Accessed at www.fda.gov/medwatch/safety/ade/t_cder.htm on 16 December 2003.
29.
Andrews LBStocking CKrizek TGottlieb LKrizek CVargish Tet al . An alternative strategy for studying adverse events in medical care. Lancet. 1997;349:309-13. [PMID: 9024373]
30.
Bates DWBoyle DLVander Vliet MBSchneider JLeape L. Relationship between medication errors and adverse drug events. J Gen Intern Med. 1995;10:199-205. [PMID: 7790981]
31.
Hurdle JFWeir CRRoth BHoffman JNebeker JR. Critical gaps in the world's largest electronic medical record: ad hoc nursing narratives and invisible adverse drug events. Proc AMIA Symp. 2003;:309-12. [PMID: 14728184]
32.
Hanlon JTSchmader KEKoronkowski MJWeinberger MLandsman PBSamsa GPet al . Adverse drug events in high risk older outpatients. J Am Geriatr Soc. 1997;45:945-8. [PMID: 9256846]
33.
Evans RSPestotnik SLClassen DCBass SBBurke JP. Prevention of adverse drug events through computerized surveillance. Proc Annu Symp Comput Appl Med Carem. 1992;:437-41. [PMID: 1482913]
34.
Lucas LMColley CA. Recognizing and reporting adverse drug reactions. West J Med. 1992;156:172-5. [PMID: 1536067]
35.
Wood AJStein CMWoosley R. Making medicines safer—the need for an independent drug safety board. N Engl J Med. 1998;339:1851-4. [PMID: 9854125]
36.
Ladewski LABelknap SMNebeker JRSartor OLyons EAKuzel TCet al . Dissemination of information on potentially fatal adverse drug reactions for cancer drugs from 2000 to 2002: first results from the research on adverse drug events and reports project. J Clin Oncol. 2003;21:3859-66. [PMID: 14551305]
37.
Ahmad SR. Adverse drug event monitoring at the Food and Drug Administration. J Gen Intern Med. 2003;18:57-60. [PMID: 12534765]

Comments

0 Comments
Sign In to Submit A Comment

Information & Authors

Information

Published In

cover image Annals of Internal Medicine
Annals of Internal Medicine
Volume 140Number 1018 May 2004
Pages: 795 - 801

History

Published online: 18 May 2004
Published in issue: 18 May 2004

Keywords

Authors

Affiliations

Jonathan R. Nebeker, MS, MD
From Veterans Affairs Salt Lake City Health Care System and University of Utah School of Medicine, Salt Lake City, Utah; and Jackson Memorial Hospital, University of Miami, Miami, Florida.
Paul Barach, MD, MPH
From Veterans Affairs Salt Lake City Health Care System and University of Utah School of Medicine, Salt Lake City, Utah; and Jackson Memorial Hospital, University of Miami, Miami, Florida.
Matthew H. Samore, MD
From Veterans Affairs Salt Lake City Health Care System and University of Utah School of Medicine, Salt Lake City, Utah; and Jackson Memorial Hospital, University of Miami, Miami, Florida.
Grant Support: By the Geriatric Education and Clinical Center (GRECC) of the Veterans Affairs Salt Lake City Health Care System and by Health Services Research & Development grants SAF 98-122, TRP 02-147, and RCD 02-176.
Acknowledgments: The authors thank Adam R. Nebeker, MD, and Seth R. Lewis, MD, for their critical reviews of the manuscript.
Disclosures: None disclosed.
Corresponding Author: Jonathan R. Nebeker, MS, MD, Salt Lake Informatics, Decision Enhancement And Surveillance (IDEAS) Center, GRECC 182, 500 Foothill Drive, Salt Lake City, UT 84148; e-mail, [email protected].
Current Author Addresses: Dr. Nebeker: Salt Lake Informatics, Decision Enhancement And Surveillance (IDEAS) Center, GRECC 182, 500 Foothill Drive, Salt Lake City, UT 84148.
Dr. Barach: Department of Anesthesiology, Jackson Memorial Hospital, University of Miami, North Wing 109, 1611 NW 12th Avenue, Miami, FL 33136.
Dr. Samore: Division of Clinical Epidemiology, Salt Lake Informatics, Decision Enhancement And Surveillance (IDEAS) Center, 50 North Medical Drive, Salt Lake City, UT 84132.

Metrics & Citations

Metrics

Citations

If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. For an editable text file, please select Medlars format which will download as a .txt file. Simply select your manager software from the list below and click Download.

For more information or tips please see 'Downloading to a citation manager' in the Help menu.

Format





Download article citation data for:
Jonathan R. Nebeker, Paul Barach, Matthew H. Samore. Clarifying Adverse Drug Events: A Clinician's Guide to Terminology, Documentation, and Reporting. Ann Intern Med.2004;140:795-801. [Epub 18 May 2004]. doi:10.7326/0003-4819-140-10-200405180-00009

View More

Login Options:
Purchase

You will be redirected to acponline.org to sign-in to Annals to complete your purchase.

Access to EPUBs and PDFs for FREE Annals content requires users to be registered and logged in. A subscription is not required. You can create a free account below or from the following link. You will be redirected to acponline.org to create an account that will provide access to Annals. If you are accessing the Free Annals content via your institution's access, registration is not required.

Create your Free Account

You will be redirected to acponline.org to create an account that will provide access to Annals.

View options

PDF/EPUB

View PDF/EPUB

Related in ACP Journals

Full Text

View Full Text

Figures

Tables

Media

Share

Share

Copy the content Link

Share on social media