Loading…
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...
Saved in:
Published in: | Drug safety 2021-05, Vol.44 (5), p.601-607 |
---|---|
Main Authors: | , , , , , , , , |
Format: | Article |
Language: | English |
Subjects: | |
Citations: | Items that this one cites Items that cite this one |
Online Access: | Get full text |
Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
cited_by | cdi_FETCH-LOGICAL-c375t-a5507f19cf3f51cc3511d58c5f7dd24ebad54f00324a5276652b5319affcaadd3 |
---|---|
cites | cdi_FETCH-LOGICAL-c375t-a5507f19cf3f51cc3511d58c5f7dd24ebad54f00324a5276652b5319affcaadd3 |
container_end_page | 607 |
container_issue | 5 |
container_start_page | 601 |
container_title | Drug safety |
container_volume | 44 |
creator | 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. |
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 |
format | article |
fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_journals_2517259585</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2517259585</sourcerecordid><originalsourceid>FETCH-LOGICAL-c375t-a5507f19cf3f51cc3511d58c5f7dd24ebad54f00324a5276652b5319affcaadd3</originalsourceid><addsrcrecordid>eNp9kE1LAzEQhoMoWD_-gKeA52gmu7PbPWr9BEFBew7TfLSr240mqdh_79YK3jzNMDzvO_AwdgLyDKSsz1MpVVUKqUBIkChFtcNGAHUjoCnVLhtJgFJgA9U-O0jpVUo5VtV4xL4mXdu3hjo-zW3X5jUPnj8tKC7JhLnrw7I1_Ioy8UnoOmeys3y25sTvHHV5IZ7XKbslv2zDjPo3ngN_is62JnPq7Wb_dH3mF_bTxeT4VVzN-fXmlI7YnqcuuePfecimN9cvkzvx8Hh7P7l4EKaoMQtClLWHxvjCIxhTIIDFsUFfW6tKNyOLpZeyUCWhqqsK1QwLaMh7Q2RtcchOt73vMXysXMr6NaxiP7zUCqFW2OAYB0ptKRNDStF5_R7bJcW1Bqk3hvXWsB4M6x_DuhpCxTaUBrifu_hX_U_qGzO_fwQ</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2517259585</pqid></control><display><type>article</type><title>Clinical Utility of Pharmacogenomic Data Collected by a Health-System Biobank to Predict and Prevent Adverse Drug Events</title><source>Nexis UK</source><source>Springer Nature</source><creator>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.</creator><creatorcontrib>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.</creatorcontrib><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.</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 & 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>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.</description><subject>Biobanks</subject><subject>Carbamazepine</subject><subject>Consortia</subject><subject>Cost control</subject><subject>Drug dosages</subject><subject>Drug Safety and Pharmacovigilance</subject><subject>Drug stores</subject><subject>Drug therapy</subject><subject>Electronic health records</subject><subject>Electronic medical records</subject><subject>Hospitals</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Morbidity</subject><subject>Myelosuppression</subject><subject>Original Research Article</subject><subject>Oxcarbazepine</subject><subject>Patient safety</subject><subject>Pharmacogenetics</subject><subject>Pharmacogenomics</subject><subject>Pharmacology</subject><subject>Pharmacology/Toxicology</subject><subject>Pharmacy</subject><subject>Warfarin</subject><issn>0114-5916</issn><issn>1179-1942</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><recordid>eNp9kE1LAzEQhoMoWD_-gKeA52gmu7PbPWr9BEFBew7TfLSr240mqdh_79YK3jzNMDzvO_AwdgLyDKSsz1MpVVUKqUBIkChFtcNGAHUjoCnVLhtJgFJgA9U-O0jpVUo5VtV4xL4mXdu3hjo-zW3X5jUPnj8tKC7JhLnrw7I1_Ioy8UnoOmeys3y25sTvHHV5IZ7XKbslv2zDjPo3ngN_is62JnPq7Wb_dH3mF_bTxeT4VVzN-fXmlI7YnqcuuePfecimN9cvkzvx8Hh7P7l4EKaoMQtClLWHxvjCIxhTIIDFsUFfW6tKNyOLpZeyUCWhqqsK1QwLaMh7Q2RtcchOt73vMXysXMr6NaxiP7zUCqFW2OAYB0ptKRNDStF5_R7bJcW1Bqk3hvXWsB4M6x_DuhpCxTaUBrifu_hX_U_qGzO_fwQ</recordid><startdate>20210501</startdate><enddate>20210501</enddate><creator>Shah, Sonam N.</creator><creator>Gammal, Roseann S.</creator><creator>Amato, Mary G.</creator><creator>Alobaidly, Maryam</creator><creator>Reyes, Dariel Delos</creator><creator>Hasan, Sarah</creator><creator>Seger, Diane L.</creator><creator>Krier, Joel B.</creator><creator>Bates, David W.</creator><general>Springer International Publishing</general><general>Springer Nature B.V</general><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>4T-</scope><scope>7RV</scope><scope>7T2</scope><scope>7TK</scope><scope>7U7</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>C1K</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><orcidid>https://orcid.org/0000-0002-2222-895X</orcidid></search><sort><creationdate>20210501</creationdate><title>Clinical Utility of Pharmacogenomic Data Collected by a Health-System Biobank to Predict and Prevent Adverse Drug Events</title><author>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.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c375t-a5507f19cf3f51cc3511d58c5f7dd24ebad54f00324a5276652b5319affcaadd3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Biobanks</topic><topic>Carbamazepine</topic><topic>Consortia</topic><topic>Cost control</topic><topic>Drug dosages</topic><topic>Drug Safety and Pharmacovigilance</topic><topic>Drug stores</topic><topic>Drug therapy</topic><topic>Electronic health records</topic><topic>Electronic medical records</topic><topic>Hospitals</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Morbidity</topic><topic>Myelosuppression</topic><topic>Original Research Article</topic><topic>Oxcarbazepine</topic><topic>Patient safety</topic><topic>Pharmacogenetics</topic><topic>Pharmacogenomics</topic><topic>Pharmacology</topic><topic>Pharmacology/Toxicology</topic><topic>Pharmacy</topic><topic>Warfarin</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><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><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Docstoc</collection><collection>ProQuest Nursing and Allied Health Journals</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Proquest Health & Medical Complete</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>AUTh Library subscriptions: ProQuest Central</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><jtitle>Drug safety</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Shah, Sonam N.</au><au>Gammal, Roseann S.</au><au>Amato, Mary G.</au><au>Alobaidly, Maryam</au><au>Reyes, Dariel Delos</au><au>Hasan, Sarah</au><au>Seger, Diane L.</au><au>Krier, Joel B.</au><au>Bates, David W.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Clinical Utility of Pharmacogenomic Data Collected by a Health-System Biobank to Predict and Prevent Adverse Drug Events</atitle><jtitle>Drug safety</jtitle><stitle>Drug Saf</stitle><date>2021-05-01</date><risdate>2021</risdate><volume>44</volume><issue>5</issue><spage>601</spage><epage>607</epage><pages>601-607</pages><issn>0114-5916</issn><eissn>1179-1942</eissn><abstract>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.</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> |
fulltext | fulltext |
identifier | ISSN: 0114-5916 |
ispartof | Drug safety, 2021-05, Vol.44 (5), p.601-607 |
issn | 0114-5916 1179-1942 |
language | eng |
recordid | cdi_proquest_journals_2517259585 |
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 |
url | http://sfxeu10.hosted.exlibrisgroup.com/loughborough?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-07T23%3A50%3A35IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Clinical%20Utility%20of%20Pharmacogenomic%20Data%20Collected%20by%20a%20Health-System%20Biobank%20to%20Predict%20and%20Prevent%20Adverse%20Drug%20Events&rft.jtitle=Drug%20safety&rft.au=Shah,%20Sonam%20N.&rft.date=2021-05-01&rft.volume=44&rft.issue=5&rft.spage=601&rft.epage=607&rft.pages=601-607&rft.issn=0114-5916&rft.eissn=1179-1942&rft_id=info:doi/10.1007/s40264-021-01050-6&rft_dat=%3Cproquest_cross%3E2517259585%3C/proquest_cross%3E%3Cgrp_id%3Ecdi_FETCH-LOGICAL-c375t-a5507f19cf3f51cc3511d58c5f7dd24ebad54f00324a5276652b5319affcaadd3%3C/grp_id%3E%3Coa%3E%3C/oa%3E%3Curl%3E%3C/url%3E&rft_id=info:oai/&rft_pqid=2517259585&rft_id=info:pmid/&rfr_iscdi=true |