Evidence map›Paper›PMID 30120741›Full record

ArticleDrug safety2018

Evaluation of Switching Patterns in FDA's Sentinel System: A New Tool to Assess Generic Drugs.

Joshua J Gagne, Jennifer R Popovic, Michael Nguyen, Sukhminder K Sandhu, Patty Greene, Rima Izem, Wenlei Jiang, Zhong Wang, Yueqin Zhao, Andrew B Petrone and 2 more

Abstract readEvaluation Study
PubMed Publisher
In one paragraph

Article in Drug safety, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors.

Joshua J GagneDivision of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. jgagne@bwh.harvard.edu.ORCID http://orcid.org/0000-0001-5428-9733
Jennifer R PopovicDepartment of Population Medicine, Harvard Medical School, Harvard Pilgrim Health Care Institute, Boston, MA, USA.
Michael NguyenCenter for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Sukhminder K SandhuCenter for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Patty GreeneCenter for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Rima IzemCenter for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Wenlei JiangCenter for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Zhong WangCenter for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Yueqin ZhaoCenter for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Andrew B PetroneDepartment of Population Medicine, Harvard Medical School, Harvard Pilgrim Health Care Institute, Boston, MA, USA.
Anita K WagnerDepartment of Population Medicine, Harvard Medical School, Harvard Pilgrim Health Care Institute, Boston, MA, USA.
Sarah K DutcherCenter for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

Funding

U.S. Food and Drug Administration HHSF223201400030I
6 · The paper itself

Abstract

introductionNearly 90% of drugs dispensed in the US are generic products.

objectiveThe aim of this study was to develop and implement a tool for analyzing manufacturer-level drug utilization and switching patterns within the US Food and Drug Administration's Sentinel system.

methodsA descriptive tool was designed to analyze data in the Sentinel common data model and was tested with two case studies-metoprolol extended release (ER) and lamotrigine ER-using claims data from four Sentinel data partners. We plotted initiators of each brand and generic product over time. For metoprolol ER, we evaluated rates of switching from generics around the time of manufacturing issues. For lamotrigine ER, we examined rates of switching back to the brand among those who switched from brand to generic.

resultsWe identified 1,651,285 initiators of metoprolol ER products between July 2008 and September 2015. We observed a large decrease in monthly metoprolol ER initiators (from 25,465 in December 2008 to 13,128 in February 2009), corresponding to recalls by generic manufacturers. We observed simultaneous increases in utilization of the authorized generic and brand products. We identified 4266 initiators of lamotrigine ER with an epilepsy diagnosis between January 2012 and September 2015. Among those who switched from brand to generic, the cumulative incidence of switching back was close to 20% at 2 years. Switchback rates were higher for the first available generic products.

conclusionsThis developed tool was able to elucidate novel utilization and switching patterns in two case studies. Such information can be used to support surveillance of generic drugs and biosimilars.

Indexed as

Sentinel SurveillanceDrug ApprovalDrugs, GenericDrug SubstitutionHumansLamotrigineMetoprololUnited StatesDrugs, GenericLamotrigineMetoprolol

Identifiers

PMID30120741

What OpenQuestion holds

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Registered trials

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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.