Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2013 Aug;22(8):861-72.
doi: 10.1002/pds.3470. Epub 2013 Jun 25.

Validity of diagnostic codes to identify cases of severe acute liver injury in the US Food and Drug Administration's Mini-Sentinel Distributed Database

Vincent Lo Re 3rd  1 , Kevin Haynes, David Goldberg, Kimberly A Forde, Dena M Carbonari, Kimberly B F Leidl, Sean Hennessy, K Rajender Reddy, Pamala A Pawloski, Gregory W Daniel, T Craig Cheetham, Aarthi Iyer, Kara O Coughlin, Sengwee Toh, Denise M Boudreau, Nandini Selvam, William O Cooper, Mano S Selvan, Jeffrey J VanWormer, Mark I Avigan, Monika Houstoun, Gwen L Zornberg, Judith A Racoosin, Azadeh Shoaibi
Affiliations

Validity of diagnostic codes to identify cases of severe acute liver injury in the US Food and Drug Administration's Mini-Sentinel Distributed Database

Vincent Lo Re 3rd et al. Pharmacoepidemiol Drug Saf. 2013 Aug.

Abstract

Purpose: The validity of International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes to identify diagnoses of severe acute liver injury (SALI) is not well known. We examined the positive predictive values (PPVs) of hospital ICD-9-CM diagnoses in identifying SALI among health plan members in the Mini-Sentinel Distributed Database (MSDD) for patients without liver/biliary disease and for those with chronic liver disease (CLD).

Methods: We selected random samples of members (149 without liver/biliary disease; 75 with CLD) with a principal hospital diagnosis suggestive of SALI (ICD-9-CM 570, 572.2, 572.4, 572.8, 573.3, 573.8, or V42.7) in the MSDD (2009-2010). Medical records were reviewed by hepatologists to confirm SALI events. PPVs of codes and code combinations for confirmed SALI were determined by CLD status.

Results: Among 105 members with available records and no liver/biliary disease, SALI was confirmed in 26 (PPV, 24.7%; 95%CI, 16.9-34.1%). Combined hospital diagnoses of acute hepatic necrosis (570) and liver disease sequelae (572.8) had high PPV (100%; 95%CI, 59.0-100%) and identified 7/26 (26.9%) events. Among 46 CLD members with available records, SALI was confirmed in 19 (PPV, 41.3%; 95%CI, 27.0-56.8%). Acute hepatic necrosis (570) or hepatorenal syndrome (572.4) plus any other SALI code had a PPV of 83.3% (95%CI, 51.6-97.9%) and identified 10/19 (52.6%) events.

Conclusions: Most individual hospital ICD-9-CM diagnoses had low PPV for confirmed SALI events. Select code combinations had high PPV but did not capture all events.

Keywords: ICD-9 codes; hepatotoxicity; liver injury; pharmacoepidemiology; validity.

PubMed Disclaimer

Conflict of interest statement

POTENTIAL CONFLICTS OF INTEREST

All authors report no potential conflicts of interest related to this manuscript.

Figures

Figure 1
Figure 1
Flow chart of case retrieval results for health plan members without liver/biliary disease. All percentages are based on the number of records requested. SALI=severe acute liver injury; ALF=acute liver failure
Figure 2
Figure 2
Flow chart of case retrieval results for health plan members with chronic liver disease. All percentages are based on the number of records requested.
See this image and copyright information in PMC

References

    1. [Accessed February 7, 2009];PhRMA/FDA/AASLD Drug-Induced Hepatotoxicity White Paper Postmarketing Considerations. 2000 Nov; http://www.fda.gov/cder/livertox/postmarket.pdf.
    1. Kaplowitz N. Drug-induced liver disorders: implications for drug development and regulation. Drug Saf. 2001;24(7):483–490. - PubMed
    1. Lee WM. Drug-induced hepatotoxicity. N Engl J Med. 2003 Jul 31;349(5):474–485. - PubMed
    1. Navarro VJ, Senior JR. Drug-related hepatotoxicity. N Engl J Med. 2006 Feb 16;354(7):731–739. - PubMed
    1. Temple RJ, Himmel MH. Safety of newly approved drugs: implications for prescribing. JAMA. 2002 May 1;287(17):2273–2275. - PubMed

Publication types

MeSH terms