A Clinician-Driven Automated System for Integration of Pharmacogenetic Interpretations Into an Electronic Medical Record

Hicks, J. Kevin; Crews, Kristine R.; Hoffman, James M.; Kornegay, Nancy; Wilkinson, Mark R.; Lorier, Rachel; Stoddard, Alexander J.; Yang, Wenjian; Smith, Colton; Fernandez, Christian A.; Cross, Shane J; Haidar, Cyrine E.; Baker, Donald K.; Howard, Scott C.; Evans, William E.; Broeckel, Ulrich; Relling, Mary V.

doi:10.1038/clpt.2012.140

Cited by 91 publications

(83 citation statements)

References 5 publications

(9 reference statements)

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“…(Fig 2) and clinical decision support (CDS) alerts that are presented via the EHR. 40,41 For those patients who do not have a CYP2D6 result available through PG4KDS, a single gene test for CYP2D6 may be ordered as a routine clinical laboratory test to guide codeine prescribing, an option that has a turn-around time of ∼5 to 7 days. 42 St. Jude hematologists often order a CYP2D6 genotype before codeine is prescribed, anticipating the future use of codeine as a potential therapeutic option for patients with SCD.…”

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confidence: 99%

Pharmacogenetics for Safe Codeine Use in Sickle Cell Disease

et al. 2016

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After postoperative deaths in children who were prescribed codeine, several pediatric hospitals have removed it from their formularies. These deaths were attributed to atypical cytochrome P450 2D6 (CYP2D6) pharmacogenetics, which is also implicated in poor analgesic response. Because codeine is often prescribed to patients with sickle cell disease and is now the only Schedule III opioid analgesic in the United States, we implemented a precision medicine approach to safely maintain codeine as an option for pain control. Here we describe the implementation of pharmacogenetics-based codeine prescribing that accounts for CYP2D6 metabolizer status. Clinical decision support was implemented within the electronic health record to guide prescribing of codeine with the goal of preventing its use after tonsillectomy or adenoidectomy and in CYP2D6 ultra-rapid and poor metabolizer (high-risk) genotypes. As of June 2015, CYP2D6 genotype results had been reported for 2468 unique patients. Of the 830 patients with sickle cell disease, 621 (75%) had a CYP2D6 genotype result; 7.1% were ultra-rapid or possible ultra-rapid metabolizers, and 1.4% were poor metabolizers. Interruptive alerts recommended against codeine for patients with high-risk CYP2D6 status. None of the patients with an ultra-rapid or poor metabolizer genotype were prescribed codeine. Using genetics to tailor analgesic prescribing retained an important therapeutic option by limiting codeine use to patients who could safely receive and benefit from it. Our efforts represent an evidence-based, innovative medication safety strategy to prevent adverse drug events, which is a model for the use of pharmacogenetics to optimize drug therapy in specialized pediatric populations. abstractDepartments of a Pharmaceutical Sciences, b Hematology, and c Biostatistics, St. Jude Children's Research Hospital, Memphis, Tennessee; and d Department of Pediatrics, Medical College of Wisconsin, Milwaukee, Wisconsin Dr Gammal collected data, carried out the initial analyses, and drafted the initial manuscript; Drs Crews, Haidar, and Hoffman are coinvestigators on the PG4KDS study; they supervised the collection and analysis of data and critically reviewed and revised the manuscript; Dr Baker created the clinical decision support alerts, collected data, and critically reviewed the manuscript; Drs Barker, Estepp, Wang, and Weiss critically reviewed and revised the manuscript; Ms Pei designed and conducted the statistical analysis; Dr Broeckel supervises all PG4KDS-related genotyping; Dr Relling conceptualized and designed the PG4KDS study, supervised the collection and analysis of data, and critically reviewed and revised the manuscript; Dr Hankins conceptualized and designed the study and critically reviewed and revised the manuscript; and all authors approved the fi nal manuscript as submitted. The use of codeine in pediatric medicine has been questioned following reports of postoperative deaths in children who were prescribed codeine and the subsequent US Food and Drug Admin...

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confidence: 99%

Pharmacogenetics for Safe Codeine Use in Sickle Cell Disease

et al. 2016

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“…Various models for implementation of pharmacogenomic testing have been proposed in the US [44][45][46], and reviews into how pharmacogenomic information should be integrated into an electronic medical record (EMR) are available [47]. The RAPID GENE trial is the first study to show efficacy of a point-of-care pharmacogenomic test to determine antiplatelet treatment [48].…”

Section: Implementation Integration and Interpretationmentioning

confidence: 99%

The integration and interpretation of pharmacogenomics – a comparative study between the United States of America and Europe: towards better health care

Bartlett

Shephard

2016

Drug Metabolism and Personalized Therapy

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The study of pharmacogenomics has, by harnessing sequence information from human genomes, the potential to lead to novel approaches in drug discovery, an individualized application of drug therapy, and new insights into disease prevention. For this potential to be realized results need to be interpreted to the prescriber into a format which dictates an action. This mini review briefly describes the history, the regulatory environment, opinions towards, and implementation, integration and interpretation of pharmacogenomics in the United States of America and Europe. The article discusses also how interpretation of pharmacogenomics could move forward to better implementation in health care.

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“…4 Other academic medical centers are now implementing pharmacogenetics into clinical practice, and others are expected to follow. [29][30][31][32] Thus, it is more important now than ever for pharmacy graduates to possess the knowledge and skill to manage genotype-guided therapy. Elective and advanced pharmacy practice experiences in pharmacogenetics, such as those we describe, are expected to better prepare students, residents, and fellows to manage genotype-guided drug therapy.…”

Section: Discussionmentioning

confidence: 99%

“…While the service is one of the first examples of a comprehensive warfarin pharmacogenetic service, other academic centers are beginning to implement pharmacogenetic programs for other medications. [29][30][31] Broader implementation efforts are expected as further data supporting personalized medicine emerge. The experiential and research opportunities described in this paper may thus serve as models for other institutions as they establish clinical pharmacogenetics programs of their own.…”

Section: Discussionmentioning

confidence: 99%

A Pharmacogenetics Service Experience for Pharmacy Students, Residents, and Fellows

Drozda

Labinov

Jiang

et al. 2013

American Journal of Pharmaceutical Education

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Objective. To utilize a comprehensive, pharmacist-led warfarin pharmacogenetics service to provide pharmacy students, residents, and fellows with clinical and research experiences involving genotypeguided therapy. Design. First-year (P1) through fourth-year (P4) pharmacy students, pharmacy residents, and pharmacy fellows participated in a newly implemented warfarin pharmacogenetics service in a hospital setting. Students, residents, and fellows provided genotype-guided dosing recommendations as part of clinical care, or analyzed samples and data collected from patients on the service for research purposes. Assessment. Students', residents', and fellows' achievement of learning objectives was assessed using a checklist based on established core competencies in pharmacogenetics. The mean competency score of the students, residents, and fellows who completed a clinical and/or research experience with the service was 97% 63%. Conclusion. A comprehensive warfarin pharmacogenetics service provided unique experiential and research opportunities for pharmacy students, residents, and fellows and sufficiently addressed a number of core competencies in pharmacogenetics.Keywords: pharmacogenetics, warfarin, pharmacy service, research INTRODUCTIONPharmacogenetics was recognized as an important component of the doctor of pharmacy (PharmD) curriculum with the 2007 revision of the standards and guidelines for the professional program of pharmacy by the Accreditation Council for Pharmacy Education (ACPE).1 Curricular content considered essential includes the genetic basis for drug action, alteration of drug metabolism, and individualizing drug doses. The report from the 2007-2008 American Association of Colleges of Pharmacy (AACP) Argus Commission identified advances in personalized medicine as one of the top challenges of academic pharmacy and posed that the pharmacy curricula must adequately address issues related to the topic. While pharmacogenetic content is included in the PharmD curriculum of most colleges, whether this content is sufficient to prepare pharmacy graduates to manage personalized therapy is questionable. 3,4 The majority of pharmacists agree that pharmacists should be capable of applying pharmacogenetic data to drug therapy decisions; however, few feel prepared to do so.5 An intensive educational effort would probably be necessary to improve pharmacists' knowledge and comfort level with pharmacogenetics, and a continuing education program alone, without hands-on experience probably would be insufficient. 6 Similarly, some pharmacy students feel that exercises involving the direct application of genetic data to drug therapy would increase their comfort level with interpreting and applying pharmacogenetic test results. 4 Participation on a clinical pharmacogenetics service would provide pharmacy students, residents, and fellows with firsthand experience with interpreting and applying genetic information to drug management. In addition, a pharmacogenetics service could serve as a platform for unique research opp...

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A Clinician-Driven Automated System for Integration of Pharmacogenetic Interpretations Into an Electronic Medical Record

Cited by 91 publications

References 5 publications

Pharmacogenetics for Safe Codeine Use in Sickle Cell Disease

Pharmacogenetics for Safe Codeine Use in Sickle Cell Disease

The integration and interpretation of pharmacogenomics – a comparative study between the United States of America and Europe: towards better health care

A Pharmacogenetics Service Experience for Pharmacy Students, Residents, and Fellows

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