Evidence map›Paper›PMID 32008244›Full record

ArticleTherapeutic innovation & regulatory science2020

Determinants of Generic Drug Substitution in the United States.

Jodi B Segal, Oluwadamilola Onasanya, Matthew Daubresse, Chia-Ying Lee, Mischka Moechtar, Xia Pu, Sarah K Dutcher, Robert J Romanelli

Abstract read
In one paragraph

Article in Therapeutic innovation & regulatory science, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–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

7 citing papers in PubMed.

  1. Global Warming and the Elderly: A Socio-Ecological Framework.International journal of environmental research and public health · 2026
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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

8 authors.

Jodi B SegalDepartment of Medicine, Johns Hopkins School of Medicine, 624 N. Broadway Room 644, Baltimore, MD, 21205, USA. jsegal@jhmi.edu.ORCID 0000-0003-3978-9662
Oluwadamilola OnasanyaDepartment of Medicine, Johns Hopkins School of Medicine, 624 N. Broadway Room 644, Baltimore, MD, 21205, USA.
Matthew DaubresseDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Chia-Ying LeeDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Mischka MoechtarDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Xia PuOffice of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Sarah K DutcherOffice of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Robert J RomanelliPalo Alto Medical Foundation Research Institute, Palo Alto, CA, USA.

Funding

Effect of Therapeutic Class on Generic Drug SubstitutionsU01FD005267 · FDA · JOHNS HOPKINS UNIVERSITY · PI SEGAL, JODI B. · 2014 to 2015
$440k
FDA HHS U01 FD005267
6 · The paper itself

Abstract

backgroundSome classes of drugs have lower than optimal uptake of generic products. We aimed to understand the determinants of generic drug substitution across classes.

methodsWe conducted a cross-sectional analysis of data from the 2013 MarketScan Commercial Claims and Encounters Database from Truven Health Analytics. We quantified generic substitution rates (GSR) for 26 drug classes, choosing one representative week in November 2013. We used mixed-effects logistic regression to estimate the independent relationship between the determinants of interest and generic substitution for 8 classes with low generic utilization.

resultsThe GSRs for most classes exceeded 90%, although some were much lower including thyroid hormones (64%), androgens (74%), estrogens (71%), and hydantoin-type anticonvulsants (72%). The determinants of generic substitution varied across classes, albeit with important patterns. Patients using a mail order pharmacy had significantly less generic substitution than patients filling at retail pharmacies for 5 of the 8 studied classes; two additional classes showed no relationship between pharmacy type and generic use. Men relative to women and patients taking more medications were more likely to use generics for most classes. State substitution laws and patient consent laws were largely inconsequential regarding generic substitution.

conclusionsPolicies are needed to support the use of safe, effective and often lower cost generic drugs, when available. Mail order pharmacies, as often required by pharmacy benefits managers, lessen generic use for many classes. These pharmacies may require additional regulatory oversight if this adversely impacts patients.

Indexed as

Drugs, GenericDrug SubstitutionPharmaciesAdultCross-Sectional StudiesFemaleHumansMaleMiddle AgedPostal ServiceUnited StatesDrugs, Genericdrug utilizationgenericmail orderpharmacoepidemiology

Identifiers

PMID32008244
PMCPMC7261594

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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.