Signal and noise: applying a laboratory trigger tool to identify adverse drug events among primary care patients

The international journal of healthcare improvement BMJ Qual Saf 2012;21:670-675 doi:10.1136/bmjqs-2011-000643 OPEN ACCESS Stacey Brenner1, Alissa Detz2, Andrea López1,3, Claire Horton1, Urmimala Sarkar1,3

1Division of General Internal Medicine, San Francisco General Hospital, University of California, San Francisco, California, USA

2Department of Medicine, California Pacific Medical Center, San Francisco, California, USA

3Department of Medicine, Center for Vulnerable Populations, San Francisco General Hospital, University of California, San Francisco, California, USA Correspondence to Dr Urmimala Sarkar, Medicine, University of California, San Francisco, 1001 Potrero Av, Ward 13, San Francisco, CA 94110, USA; usarkar{at}medsfgh.ucsf.eduContributors SB performed chart review of all triggers, and wrote the first draft of the manuscript. AD performed secondary chart review and provided intellectual contribution in editing the manuscript. AL conducted analysis and created tables and figures. CH oversaw data collection and provided intellectual contribution in editing the manuscript. US conceived the study, oversaw data collection and provided intellectual contribution in editing the manuscript.

Accepted 7 April 2012 Published Online First 23 May 2012 Background The extent of outpatient adverse drug events (ADEs) remains unclear. Trigger tools are used as a screening method to identify care episodes that may be ADEs, but their value in a population with high chronic-illness burden remains unclear.

Methods The authors used six abnormal laboratory triggers for detecting ADEs among adults in outpatient care. Eligible patients were included if they were >18 years, sought primary or urgent care between November 2008 and November 2009 and were prescribed at least one medication. The authors then used the clinical / administrative database to identity patients with these triggers. Two physicians conducted in-depth chart review of any medical records with identified triggers.

Results The authors reviewed 1342 triggers representing 622 unique episodes among 516 patients. The trigger tool identified 91 (15%) ADEs. Of the 91 ADEs included in the analysis, 49 (54%) occurred during medication monitoring, 41 (45%) during patient self-administration, and one could not be determined. 96% of abnormal international normalised ratio triggers were ADEs, followed by 12% of abnormal blood urea nitrogen triggers, 9% of abnormal alanine aminotransferase triggers, 8% of abnormal serum creatinine triggers and 3% of aspartate aminotransferase triggers.

Conclusions The findings imply that other tools such as text triggers or more complex automated screening rules, which combine data hierarchically are needed to effectively screen for ADEs in chronically ill adults seen in primary care.

Funding Funds were provided by the National Centre for Research Resources KL2RR024130 (to US) and Agency for Healthcare Research and Quality K08 HS017594 (to US). None of the funders had any role in study design; in the collection, analysis, and interpretation of data; in the writing of the manuscript; or in the decision to submit the manuscript for publication.

Competing interests None.

Ethics approval Ethics approval was granted by the University of California San Francisco Committee on Human Research.

Provenance and peer review Not commissioned; externally peer reviewed.

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Adverse drug events caused by serious medication administration errors

Adverse drug events caused by serious medication administration errors -- Kale et al. -- BMJ Quality and Safety Search the BMJ BMJ BMJ Journals BMJ Careers BMJ Learning Evidence Centre doc2doc BMJ Group Search this site

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The international journal of healthcare improvement Online First Current issue Archive About the journal Submit a paper Subscribe Help Online First Current issue Archive Supplements eLetters Topic collections RSS Home > Online First > Article BMJ Qual Saf doi:10.1136/bmjqs-2012-000946 Original research Adverse drug events caused by serious medication administration errors Abhivyakti Kale1,2, Carol A Keohane1, Saverio Maviglia1,3, Tejal K Gandhi1,2,3, Eric G Poon1,2,3

1Department of General Internal Medicine, Brigham & Women's Hospital, Boston, Massachusetts, USA

2Harvard Medical School, Boston, Massachusetts, USA

3Partners Healthcare, Boston, Massachusetts, USA Correspondence to Eric G Poon, Division of General Medicine and Primary Care, Brigham & Women's Hospital, 3/F 1620 Tremont St, Boston, MA 02120, USA; epoon{at}partners.org Contributors All authors contributed extensively to the research and the work presented in this paper. All authors discussed the results and implications and commented on the manuscript at all stages. AK: first author—data acquisition, data analysis, statistical analysis, ? analysis, result interpretation, manuscript design, manuscript writing and incorporating edits. EP: principal investigator and fifth author—conceived the research question, data analysis supervision, data analysis review, manuscript design, manuscript review and edits. CK: second author—data analysis second reviewer, ? analysis, result interpretation, manuscript review and edits. SM: third author—data analysis review, statistical analysis support, gave technical and conceptual advice, manuscript review and edits. TG: fourth author—jointly conceived the study with EP, gave conceptual advice, data analysis review, advice on results presentation, manuscript review and edits.

Accepted 10 June 2012 Published Online First 12 July 2012 Abstract Objective To determine how often serious or life-threatening medication administration errors with the potential to cause harm (potential adverse drug events) result in actual harm (adverse drug events (ADEs)) in the hospital setting.

Design Retrospective chart review of clinical events following observed medication administration errors.

Background Medication errors are common at the medication administration stage for inpatients. While many errors can cause harm, it is unclear exactly how often.

Methods In a previous study where 14 041 medication administrations were directly observed, 1271 medication administration errors were discovered, of which 133 had the potential to cause serious or life-threatening harm and were considered serious or life-threatening potential adverse drug events. As a follow-up, clinical reviewers conducted detailed chart review of serious or life-threatening potential ADEs to determine if they caused an ADE. Reviewers assessed severity of the ADE and attribution to the error.

Results Ten (7.5% (95% CI 6.98 to 8.01)) actual ADEs resulted from the 133 serious and life-threatening potential ADEs, of which 6 resulted in significant, three in serious, and one life threatening injury. Therefore 4 (3% (95% CI 2.12 to 3.6)) of serious or life threatening potential ADEs led to serious or life threatening ADEs. Half of the ADEs were caused by dosage or monitoring errors for anti-hypertensives.

Conclusions Unintercepted potential ADEs at the medication administration stage can cause serious patient harm. At hospitals where 6 million doses are administered per year, about 4000 preventable ADEs would be attributable to medication administration errors annually.

Adverse drug events patient safety clinical quality human factors medication errors Footnotes Funding Agency of Healthcare Research and Quality #HS14053-02. The funder played no role in the design and conduct of the study; collection, management, analysis and interpretation of the data; and preparation, review or approval of the manuscript.

Competing interests None.

Provenance and peer review Not commissioned; externally peer reviewed.

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