Evidence map›Paper›PMID 28855012›Full record

ArticleThe Consultant pharmacist : the journal of the American Society of Consultant Pharmacists2017

Tamoxifen Pharmacovigilance: Implications for Safe Use in the Future.

Demetra Antimisiaris, Ki-Hwan Gabriel Bae, Laura Morton, Zahara Gully

Abstract read
In one paragraph

Article in The Consultant pharmacist : the journal of the American Society of Consultant Pharmacists, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

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1citing papers in PubMed
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1 · What the graph read from it

What it found

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2 · The registry

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3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

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5 · Who and what money

Authors and funding

4 authors.

Demetra Antimisiaris
Ki-Hwan Gabriel Bae
Laura Morton
Zahara Gully

Funding

University of Louisville Cancer Education ProgramR25CA134283 · NCI · UNIVERSITY OF LOUISVILLE · PI HEIN, DAVID W, KIDD, LA CREIS RENEE · 2011 to 2022
$3.1M
NCI NIH HHS R25 CA134283
6 · The paper itself

Abstract

objectiveTo survey the status of current tamoxifen pharmacovigilance documentation reflecting tamoxifen use in an academic outpatient multispecialty practice in older adults. This data will help provide information to develop improved pharmacovigilance for a growing cohort of older adult users. The data will be utilized by an interdisciplinary team developing new methods of identifying factors for individualized pharmacovigilance in older adults.

designRetrospective chart review to gather descriptive and quantitative data on tamoxifen pharmacovigilance.

settingMulti-specialty clinic. PATIENTS: Ninety-three patients 60 years of age and older.

main outcome measuresQuantitative report of tamoxifen monitoring as well as descriptive analysis of individual cases.

resultsWe found 19 cases of serious adverse events possibly related to tamoxifen (thrombi, uterine malignancies). There were 15 cases with no documentation of pharmacovigilance. All cases had incomplete pharmacovigilance documented. There were two cases of hypercalcemia. There was one case of tamoxifen discontinuation resulting from muscle pain and with chronic muscle pain complaints while receiving tamoxifen. We observed a correlation in older age or high comorbidity burden patients and adverse events patients.

conclusionSome studies direct the important pharmacovigilance toward prevention of thrombi, uterine malignancies, and hypercalcemia; however, it is not easy to identify recommendations for frequency or focus of monitoring to prevent adverse events for individual older adults based on existing recommendations. The data collected and presented in this study serve to heighten awareness of tamoxifen pharmacovigilance and as a starting point for the application of machine learning techniques and modeling to identify high-risk patients and individualized pharmacovigilance recommendations.

Indexed as

PharmacovigilanceAgedAged, 80 and overFemaleHumansHypercalcemiaMaleMiddle AgedRetrospective StudiesTamoxifenThrombosisUterine NeoplasmsTamoxifen

Identifiers

PMID28855012
PMCPMC5812281

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