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Clinical Utility of Pharmacogenomic Data Collected by a Health-System Biobank to Predict and Prevent Adverse Drug Events

Introduction Medication-related harm represents a significant issue for patient safety and quality of care. One strategy to avoid preventable adverse drug events is to utilize patient-specific factors such as pharmacogenomics (PGx) to individualize therapy. Objective We measured the number of patien...

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Published in:Drug safety 2021-05, Vol.44 (5), p.601-607
Main Authors: Shah, Sonam N., Gammal, Roseann S., Amato, Mary G., Alobaidly, Maryam, Reyes, Dariel Delos, Hasan, Sarah, Seger, Diane L., Krier, Joel B., Bates, David W.
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container_title Drug safety
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creator Shah, Sonam N.
Gammal, Roseann S.
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Seger, Diane L.
Krier, Joel B.
Bates, David W.
description Introduction Medication-related harm represents a significant issue for patient safety and quality of care. One strategy to avoid preventable adverse drug events is to utilize patient-specific factors such as pharmacogenomics (PGx) to individualize therapy. Objective We measured the number of patients enrolled in a health-system biobank with actionable PGx results who received relevant medications and assessed the incidence of adverse drug events (ADEs) that might have been prevented had the PGx results been used to inform prescribing. Methods Patients with actionable PGx results in the following four genes with Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines were identified: HLA-A*31:01, HLA-B*15:02, TPMT, and VKORC1 . The patients who received interacting medications (carbamazepine, oxcarbazepine, thiopurines, or warfarin) were identified, and electronic health records were reviewed to determine the incidence of potentially preventable ADEs. Results Of 36,424 patients with PGx results, 2327 (6.4%) were HLA-A*31:01 positive; 3543 (9.7%) were HLA-B*15:02 positive; 2893 (7.9%) were TPMT intermediate metabolizers; and 4249 (11.7%) were homozygous for the VKORC1 c.1639 G>A variant. Among patients positive for one of the HLA variants who received carbamazepine or oxcarbazepine ( n  = 92), four (4.3%) experienced a rash that warranted drug discontinuation. Among the TPMT intermediate metabolizers who received a thiopurine ( n  = 56), 11 (19.6%) experienced severe myelosuppression that warranted drug discontinuation. Among patients homozygous for the VKORC1 c.1639 G>A variant who received warfarin ( n  = 379), 85 (22.4%) experienced active bleeding and/or international normalized ratio (INR) > 5 that warranted drug discontinuation or dose reduction. Conclusion Patients with actionable PGx results from a health-system biobank who received relevant medications experienced predictable ADEs. These ADEs may have been prevented if the patients’ PGx results were available in the electronic health record with clinical decision support prior to prescribing.
doi_str_mv 10.1007/s40264-021-01050-6
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One strategy to avoid preventable adverse drug events is to utilize patient-specific factors such as pharmacogenomics (PGx) to individualize therapy. Objective We measured the number of patients enrolled in a health-system biobank with actionable PGx results who received relevant medications and assessed the incidence of adverse drug events (ADEs) that might have been prevented had the PGx results been used to inform prescribing. Methods Patients with actionable PGx results in the following four genes with Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines were identified: HLA-A*31:01, HLA-B*15:02, TPMT, and VKORC1 . The patients who received interacting medications (carbamazepine, oxcarbazepine, thiopurines, or warfarin) were identified, and electronic health records were reviewed to determine the incidence of potentially preventable ADEs. Results Of 36,424 patients with PGx results, 2327 (6.4%) were HLA-A*31:01 positive; 3543 (9.7%) were HLA-B*15:02 positive; 2893 (7.9%) were TPMT intermediate metabolizers; and 4249 (11.7%) were homozygous for the VKORC1 c.1639 G&gt;A variant. Among patients positive for one of the HLA variants who received carbamazepine or oxcarbazepine ( n  = 92), four (4.3%) experienced a rash that warranted drug discontinuation. Among the TPMT intermediate metabolizers who received a thiopurine ( n  = 56), 11 (19.6%) experienced severe myelosuppression that warranted drug discontinuation. Among patients homozygous for the VKORC1 c.1639 G&gt;A variant who received warfarin ( n  = 379), 85 (22.4%) experienced active bleeding and/or international normalized ratio (INR) &gt; 5 that warranted drug discontinuation or dose reduction. Conclusion Patients with actionable PGx results from a health-system biobank who received relevant medications experienced predictable ADEs. These ADEs may have been prevented if the patients’ PGx results were available in the electronic health record with clinical decision support prior to prescribing.</description><identifier>ISSN: 0114-5916</identifier><identifier>EISSN: 1179-1942</identifier><identifier>DOI: 10.1007/s40264-021-01050-6</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Biobanks ; Carbamazepine ; Consortia ; Cost control ; Drug dosages ; Drug Safety and Pharmacovigilance ; Drug stores ; Drug therapy ; Electronic health records ; Electronic medical records ; Hospitals ; Medicine ; Medicine &amp; Public Health ; Morbidity ; Myelosuppression ; Original Research Article ; Oxcarbazepine ; Patient safety ; Pharmacogenetics ; Pharmacogenomics ; Pharmacology ; Pharmacology/Toxicology ; Pharmacy ; Warfarin</subject><ispartof>Drug safety, 2021-05, Vol.44 (5), p.601-607</ispartof><rights>The Author(s), under exclusive licence to Springer Nature Switzerland AG part of Springer Nature 2021</rights><rights>Copyright Springer Nature B.V. May 2021</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c375t-a5507f19cf3f51cc3511d58c5f7dd24ebad54f00324a5276652b5319affcaadd3</citedby><cites>FETCH-LOGICAL-c375t-a5507f19cf3f51cc3511d58c5f7dd24ebad54f00324a5276652b5319affcaadd3</cites><orcidid>0000-0002-2222-895X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids></links><search><creatorcontrib>Shah, Sonam N.</creatorcontrib><creatorcontrib>Gammal, Roseann S.</creatorcontrib><creatorcontrib>Amato, Mary G.</creatorcontrib><creatorcontrib>Alobaidly, Maryam</creatorcontrib><creatorcontrib>Reyes, Dariel Delos</creatorcontrib><creatorcontrib>Hasan, Sarah</creatorcontrib><creatorcontrib>Seger, Diane L.</creatorcontrib><creatorcontrib>Krier, Joel B.</creatorcontrib><creatorcontrib>Bates, David W.</creatorcontrib><title>Clinical Utility of Pharmacogenomic Data Collected by a Health-System Biobank to Predict and Prevent Adverse Drug Events</title><title>Drug safety</title><addtitle>Drug Saf</addtitle><description>Introduction Medication-related harm represents a significant issue for patient safety and quality of care. One strategy to avoid preventable adverse drug events is to utilize patient-specific factors such as pharmacogenomics (PGx) to individualize therapy. Objective We measured the number of patients enrolled in a health-system biobank with actionable PGx results who received relevant medications and assessed the incidence of adverse drug events (ADEs) that might have been prevented had the PGx results been used to inform prescribing. Methods Patients with actionable PGx results in the following four genes with Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines were identified: HLA-A*31:01, HLA-B*15:02, TPMT, and VKORC1 . The patients who received interacting medications (carbamazepine, oxcarbazepine, thiopurines, or warfarin) were identified, and electronic health records were reviewed to determine the incidence of potentially preventable ADEs. Results Of 36,424 patients with PGx results, 2327 (6.4%) were HLA-A*31:01 positive; 3543 (9.7%) were HLA-B*15:02 positive; 2893 (7.9%) were TPMT intermediate metabolizers; and 4249 (11.7%) were homozygous for the VKORC1 c.1639 G&gt;A variant. Among patients positive for one of the HLA variants who received carbamazepine or oxcarbazepine ( n  = 92), four (4.3%) experienced a rash that warranted drug discontinuation. Among the TPMT intermediate metabolizers who received a thiopurine ( n  = 56), 11 (19.6%) experienced severe myelosuppression that warranted drug discontinuation. Among patients homozygous for the VKORC1 c.1639 G&gt;A variant who received warfarin ( n  = 379), 85 (22.4%) experienced active bleeding and/or international normalized ratio (INR) &gt; 5 that warranted drug discontinuation or dose reduction. Conclusion Patients with actionable PGx results from a health-system biobank who received relevant medications experienced predictable ADEs. 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One strategy to avoid preventable adverse drug events is to utilize patient-specific factors such as pharmacogenomics (PGx) to individualize therapy. Objective We measured the number of patients enrolled in a health-system biobank with actionable PGx results who received relevant medications and assessed the incidence of adverse drug events (ADEs) that might have been prevented had the PGx results been used to inform prescribing. Methods Patients with actionable PGx results in the following four genes with Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines were identified: HLA-A*31:01, HLA-B*15:02, TPMT, and VKORC1 . The patients who received interacting medications (carbamazepine, oxcarbazepine, thiopurines, or warfarin) were identified, and electronic health records were reviewed to determine the incidence of potentially preventable ADEs. Results Of 36,424 patients with PGx results, 2327 (6.4%) were HLA-A*31:01 positive; 3543 (9.7%) were HLA-B*15:02 positive; 2893 (7.9%) were TPMT intermediate metabolizers; and 4249 (11.7%) were homozygous for the VKORC1 c.1639 G&gt;A variant. Among patients positive for one of the HLA variants who received carbamazepine or oxcarbazepine ( n  = 92), four (4.3%) experienced a rash that warranted drug discontinuation. Among the TPMT intermediate metabolizers who received a thiopurine ( n  = 56), 11 (19.6%) experienced severe myelosuppression that warranted drug discontinuation. Among patients homozygous for the VKORC1 c.1639 G&gt;A variant who received warfarin ( n  = 379), 85 (22.4%) experienced active bleeding and/or international normalized ratio (INR) &gt; 5 that warranted drug discontinuation or dose reduction. Conclusion Patients with actionable PGx results from a health-system biobank who received relevant medications experienced predictable ADEs. These ADEs may have been prevented if the patients’ PGx results were available in the electronic health record with clinical decision support prior to prescribing.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><doi>10.1007/s40264-021-01050-6</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0002-2222-895X</orcidid></addata></record>
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source Nexis UK; Springer Nature
subjects Biobanks
Carbamazepine
Consortia
Cost control
Drug dosages
Drug Safety and Pharmacovigilance
Drug stores
Drug therapy
Electronic health records
Electronic medical records
Hospitals
Medicine
Medicine & Public Health
Morbidity
Myelosuppression
Original Research Article
Oxcarbazepine
Patient safety
Pharmacogenetics
Pharmacogenomics
Pharmacology
Pharmacology/Toxicology
Pharmacy
Warfarin
title Clinical Utility of Pharmacogenomic Data Collected by a Health-System Biobank to Predict and Prevent Adverse Drug Events
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