Structured Product Labeling Improves Detection of Drug-intolerance Issues
Journal of the American Medical Informatics AssociationPublished 24 October 2008Open access
Gunther Schadow
Citations14
SJR quartileQ1
SJR score2.04
SNIP1.95
Generate an AI Snapshot to get a quick, structured summary of this paper.
Study Snapshot
ObjectiveStudy objective
MethodsResearch methodology
PopulationPopulation studied
Sample sizeSample sizes
OutcomesStudy outcomes here
ResultsStudy results comes here
LimitationsResearch study limitations comes here
A concise AI-generated summary of the paper will appear here once you click Generate AI Snapshot.
TL;DR
The SPL-based approach is more sensitive and suggests that mapping local dictionaries to SPL, and enhancing the depth and breadth of coverage of SPL content are worth accelerating.
Abstract
OBJECTIVES: This study sought to assess the value of the Health Level 7/U.S. Food and Drug Administration Structured Product Labeling (SPL) drug knowledge representation standard and its associated terminology sources for drug-intolerance (allergy) decision support in computerized provider order entry (CPOE) systems. DESIGN: The Regenstrief Institute CPOE drug-intolerance issue detection system and its knowledge base was compared with a method based on existing SPL label content enriched with knowledge sources used with SPL (NDF-RT/MeSH). Both methods were applied to a large set of drug-intolerance (allergy) records, drug orders, and medication dispensing records covering >50,000 patients over 30 years. MEASUREMENTS: The number of drug-intolerance issues detected by both methods was counted, as well as the number of patients with issues, number of distinct drugs, and number of distinct intolerances. The difference between drug-intolerance issues detected or missed by either method was qualitatively analyzed. RESULTS: Although <70% of terms were mapped to SPL, the new approach detected four times as many drug-intolerance issues on twice as many patients. CONCLUSION: The SPL-based approach is more sensitive and suggests that mapping local dictionaries to SPL, and enhancing the depth and breadth of coverage of SPL content are worth accelerating. The study also highlights specificity problems known to trouble drug-intolerance decision support and suggests how terminology and methods of recording drug intolerances could be improved.
Keywords
Health ProfessionsBiochemistry, Genetics and Molecular BiologyPharmacology, Toxicology and Pharmaceutics
Cambridge University Press eBooksThe Description Logic Handbook
6,212 Citations2007Franz Baader, Franz Baader +17 more
Journal of the ACMA Theorem on Boolean Matrices
1,657 Citations1962Stephen Warshall
It is proved the validity of an algorithm whose running time goes up slightly faster than the square of d, the running times of which increase-other things being equal-as the cube of d.
Journal of the American Medical Informatics AssociationCharacteristics and Consequences of Drug Allergy Alert Overrides in a Computerized Physician Order Entry System
232 Citations2004Tyken C. Hsieh, Gilad J. Kuperman +6 more
Characteristics of drug allergy alert overrides are determined, how often they lead to preventable adverse drug events (ADEs), and methods for improving the allergy-alerting system are suggested.
Journal of the American Medical Informatics AssociationClinical Decision Support in Electronic Prescribing: Recommendations and an Action Plan
184 Citations2005Jonathan M. Teich, Jerome A. Osheroff +2 more
This consensus white paper sets forth recommendations and action plans in three critical domains: advances in system capabilities, uniform standards, vocabularies, and centralized knowledge structures and services that could reduce rework by vendors and care providers, improve dissemination of well-constructed CDS interventions, and accelerate the movement of new medical knowledge from research to practice.
The American Journal of MedicineThe Incidence of Stroke after Myocardial Infarction: A Meta-Analysis
169 Citations2006Brandi J. Witt, Karla V. Ballman +4 more
The public health implications of stroke among MI survivors, as well as the large number ofMI survivors, underscore the need to be aware of this devastating complication and determine the optimal stroke prevention strategies for MI survivors.
Journal of Allergy and Clinical Immunology10. Drug allergy
162 Citations2003Rebecca S. Gruchalla
After a drug-disease connection is established, it must be determined whether the reaction was immunologically mediated, and confirmatory tests, if available, should be used to determine the allergic status of the patient.
PubMedKnowledge resource preferences of family physicians.
158 Citations1990Donald P. Connelly, Eugene C. Rich +2 more
In deciding among a subset of knowledge resources for answering a clinical practice question, resource cost variables related to clinical availability and applicability of the information to the problem at hand appeared to be more influential in the minds of physicians than factors related to quality of the resource.
The American Journal of MedicineIs There Cross-Reactivity Between Penicillins and Cephalosporins?
108 Citations2006Andrea J. Apter, Judith L. Kinman +6 more
Patients with allergic-like events after penicillin had a markedly increased risk of events after either subsequent cephalosporins or sulfonamide antibiotics, and the risk of anaphylaxis is very low.
PubMedThe Medical Gopher--a microcomputer system to help find, organize and decide about patient data.
92 Citations1986Clement J. McDonald, William M. Tierney
A microcomputer-based medical workstation that does some of physicians' "gopher" work of fetching, organizing, reviewing and recording and is linked to a central hospital information system through a high-speed network link.
Annals of PharmacotherapySulfonamide Cross-Reactivity: Fact or Fiction?
87 Citations2005Kelly K Johnson, David L. Green +2 more
The dogma of sulfonylarylamine cross-reactivity with non-sulfonylARYlamines is not supported by the data, and the level of evidence does not conclusively support either a connection or an association between the observed cause and effect.
PubMedVA National Drug File Reference Terminology: a cross-institutional content coverage study.
84 Citations2004Steven H. Brown, Peter L. Elkin +7 more
Journal of the American Medical Informatics AssociationUsing Commercial Knowledge Bases for Clinical Decision Support: Opportunities, Hurdles, and Recommendations
78 Citations2006Gilad J. Kuperman, Richard M. Reichley +1 more
The quality and safety of health care leaves much to be desired and automated clinical decision support tools embedded in clinical information systems (CISs) such as computer provider order entry and EHR applications have the potential to improve care and should be part of any comprehensive approach to improve quality.
Canadian Journal of Anesthesia/Journal canadien d anesthésieDrug allergies in the surgical population
54 Citations1994Orlando Hung, Colin Bands +4 more
A serious problem is suggested in the “labelling” of patients as having drug allergies in a surgical population and patients and health care personnel should be educated in the differentiation between predictable adverse drug reactions and true allergic drug reactions.
PubMedPart-whole reasoning in medical ontologies revisited--introducing SEP triplets into classification-based description logics.
47 Citations1998S Schulz, Martin Romacker +1 more
The approach this work takes emulates part-whole reasoning via classification-based reasoning using SEP triplets, a special data structure for encoding part-Whole relations that is fully embedded in the formal framework of standard description logics.
PubMedRequirements on content and format of labeling for human prescription drug and biological products. Final rule.
41 Citations2006
The final rule revises current regulations to require that the labeling of new and recently approved products include highlights of prescribing information and a table of contents, which will make it easier for health care practitioners to access, read, and use information in prescription drug labeling.
International Journal of Medical InformaticsConceptual alignment of electronic health record data with guideline and workflow knowledge
32 Citations2001Gunther Schadow, Daniel C. Russler +1 more
The Unified Service Action Model (USAM) that has been developed for the HL7 Reference Information Model and that conceptually integrates guidelines and WfM in the EHR is presented, suggesting that guidelines and EHR reuse the same information structures.
PubMedA semantic normal form for clinical drugs in the UMLS: early experiences with the VANDF.
30 Citations2002Stuart J. Nelson, Steven H. Brown +7 more
A semantic normal form (SNF) for a clinical drug, designed to represent the meaning of an expression typically seen in a practitioner's medication order, has been developed and is being created in the UMLS Metathesaurus.
PubMedAssessing the impact of HL7/FDA Structured Product Label (SPL) content for medication knowledge management.
15 Citations2007Gunther Schadow
Journal of Oncology Pharmacy PracticeInappropriate labelling of patients as opioid allergic
15 Citations2004Peter J Gilbar, Alison M Ridge
Opioid prescribing did not appear to be influenced by a reported allergy, but staff must be educated regarding the importance of recording accurately and thoroughly the specifics of patients’ medication allergies and its importance in future safe prescribing.
Journal of Oncology Pharmacy PracticeHistory of opioid allergy: what significance?
7 Citations2004Peter J Gilbar, Alison M Ridge
Many health care staff either missed or ignored the allergy or assumed it was really an adverse effect and not significant, potentially placing the patient at risk of serious consequences, including anaphylaxis, despite the low incidence of true opioid allergy.
PubMedRequirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs. Final rule.
3 Citations2016
The Food and Drug Administration is amending its regulations governing drug establishment registration and drug listing, which reorganize, modify, and clarify current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products, and animal drugs.