Evidence map›Paper›PMID 27981563›Full record

ArticleClinical pharmacology and therapeutics2018

Comparison of Outcomes Following a Switch From a Brand to an Authorized Versus Independent Generic Drug.

R A Hansen, J Qian, R L Berg, J G Linneman, E Seoane-Vazquez, S Dutcher, S Raofi, C D Page, P L Peissig

Open access · greenAbstract readComparative Study
In one paragraph

Article in Clinical pharmacology and therapeutics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
16.3field-weighted citation impact, top 1% 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

11 citing papers in PubMed, 20 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Impact of brand drug discount cards on private insurer, government and patient expenditures.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2019
    Article
  6. Article
  7. Article
  8. Article
  9. Observational
  10. Article
  11. 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 6 institutions in 1 country.

R A HansenAuburn University, Harrison School of Pharmacy, Department of Health Outcomes Research and Policy, Auburn, Alabama, USA.
J QianAuburn University, Harrison School of Pharmacy, Department of Health Outcomes Research and Policy, Auburn, Alabama, USA.
R L BergMarshfield Clinic Research Foundation, Biomedical Informatics Research Center, Marshfield, Wisconsin, USA.
J G LinnemanMarshfield Clinic Research Foundation, Biomedical Informatics Research Center, Marshfield, Wisconsin, USA.
E Seoane-VazquezMassachusetts College of Pharmacy and Health Sciences, International Center for Pharmaceutical Economics and Policy, Boston, Massachusetts, USA.
S DutcherUS Food and Drug Administration, Office of Generic Drugs, Silver Spring, Maryland, USA.
S RaofiUS Food and Drug Administration, Office of Generic Drugs, Silver Spring, Maryland, USA.
C D PageUniversity of Wisconsin, School of Medicine and Public Health, Department of Biostatistics and Medical Informatics, and Department of Computer Science, Madison, Wisconsin, USA.
P L PeissigMarshfield Clinic Research Foundation, Biomedical Informatics Research Center, Marshfield, Wisconsin, USA.
Marshfield Clinic · USAuburn University · USCenter for Drug Evaluation and Research · USMCPHS University · USUnited States Food and Drug Administration · USUniversity of Wisconsin–Madison · US

Funding

Post-market Authorized Generic Evaluation (PAGE)U01FD005272 · FDA · AUBURN UNIVERSITY AT AUBURN · PI HANSEN, RICHARD A. · 2014 to 2015
$400k
FDA HHS U01 FD005272
6 · The paper itself

Abstract

Authorized generics are identical in formulation to brand drugs, manufactured by the brand company but marketed as a generic. Generics, marketed by generic manufacturers, are required to demonstrate pharmaceutical and bioequivalence to the brand drug, but repetition of clinical trials is not required. This retrospective cohort study compared outcomes for generics and authorized generics, which serves as a generic vs. brand proxy that minimizes bias against generics. For the seven drugs studied between 1999 and 2014, 5,234 unique patients were on brand drugs prior to generic entry and 4,900 (93.6%) switched to a generic. During the 12 months following the brand-to-generic switch, patients using generics vs. authorized generics were similar in terms of outpatient visits, urgent care visits, hospitalizations, and medication discontinuation. The likelihood of emergency department (ED) visits was slightly higher for authorized generics compared with generics. These data suggest that generics were clinically no worse than their proxy brand comparators.

Indexed as

Drug SubstitutionAdministrative Claims, HealthcareAdultAgedAmbulatory CareData MiningDrug-Related Side Effects and Adverse ReactionsDrugs, GenericElectronic Health RecordsEmergency Service, HospitalEvidence-Based MedicineFemaleHospitalizationHumansMaleMiddle AgedDrugs, Generic

Identifiers

PMID27981563
PMCPMC5860648
OpenAlexW2561346376

What OpenQuestion holds

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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.