Evidence map›Paper›PMID 33620701›Full record

ArticleDrug safety2021

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

Sonam N Shah, Roseann S Gammal, Mary G Amato, Maryam Alobaidly, Dariel Delos Reyes, Sarah Hasan, Diane L Seger, Joel B Krier, David W Bates

Abstract read
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In one paragraph

Article in Drug safety, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 1 country.

Sonam N ShahDepartment of Internal Medicine, Brigham and Women's Hospital, 41 Avenue of Louis Pasteur, Office 103, Boston, MA, 02115, USA. sonamnshah@gmail.com.ORCID 0000-0002-2222-895X
Roseann S GammalDepartment of Pharmacy Practice, MCPHS University School of Pharmacy, Boston, MA, USA.
Mary G AmatoDepartment of Internal Medicine, Brigham and Women's Hospital, 41 Avenue of Louis Pasteur, Office 103, Boston, MA, 02115, USA.
Maryam AlobaidlyDepartment of Pharmacy Practice, MCPHS University School of Pharmacy, Boston, MA, USA.
Dariel Delos ReyesDepartment of Pharmacy Practice, MCPHS University School of Pharmacy, Boston, MA, USA.
Sarah HasanDepartment of Pharmacy Practice, MCPHS University School of Pharmacy, Boston, MA, USA.
Diane L SegerClinical Quality Analysis, Partners Healthcare, Somerville, MA, USA.
Joel B KrierDivision of Genetics, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.
David W BatesDepartment of Internal Medicine, Brigham and Women's Hospital, 41 Avenue of Louis Pasteur, Office 103, Boston, MA, 02115, USA.
Brigham and Women's Hospital · USMassachusetts College of Pharmacy and Health Sciences · USMass General Brigham · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionMedication-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.

objectiveWe 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.

methodsPatients 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.

resultsOf 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.

conclusionPatients 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.

Indexed as

Drug-Related Side Effects and Adverse ReactionsPharmacogeneticsBiological Specimen BanksHLA-A AntigensHLA-B AntigensHumansOxcarbazepineVitamin K Epoxide ReductasesWarfarinHLA-A AntigensHLA-B AntigensOxcarbazepineVitamin K Epoxide ReductasesVKORC1 protein, humanWarfarin

Identifiers

PMID33620701
OpenAlexW3130926028

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.