Evidence map›Paper›PMID 28152215›Full record

ArticlePharmacotherapy2017

Comparison of Generic-to-Brand Switchback Rates Between Generic and Authorized Generic Drugs.

Richard A Hansen, Jingjing Qian, Richard Berg, James Linneman, Enrique Seoane-Vazquez, Sarah K Dutcher, Saeid Raofi, C David Page, Peggy Peissig

Open access · greenAbstract readComparative Study
In one paragraph

Article in Pharmacotherapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
11.9field-weighted citation impact, top 2% 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

10 citing papers in PubMed, 21 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Utilization of Generic Cardiovascular Drugs in Medicare's Part D Program.Circulation. Cardiovascular quality and outcomes · 2021
    Article
  5. Generic Drug Usage in Dentistry across Japan: Analysis Using a Japanese National Database.International journal of environmental research and public health · 2021
    Article
  6. Article
  7. 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
  8. Article
  9. Observational
  10. 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.

Richard A HansenDepartment of Health Outcomes Research and Policy, Auburn University, Harrison School of Pharmacy, Auburn, Alabama.
Jingjing QianDepartment of Health Outcomes Research and Policy, Auburn University, Harrison School of Pharmacy, Auburn, Alabama.
Richard BergMarshfield Clinic Research Foundation, Biomedical Informatics Research Center, Marshfield, Wisconsin.
James LinnemanMarshfield Clinic Research Foundation, Biomedical Informatics Research Center, Marshfield, Wisconsin.
Enrique Seoane-VazquezMassachusetts College of Pharmacy and Health Sciences, International Center for Pharmaceutical Economics and Policy, Boston, Massachusetts.
Sarah K DutcherU.S. Food and Drug Administration, Office of Generic Drugs, Silver Spring, Maryland.
Saeid RaofiU.S. Food and Drug Administration, Office of Generic Drugs, Silver Spring, Maryland.
C David PageDepartment of Biostatistics and Medical Informatics, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.
Peggy PeissigMarshfield Clinic Research Foundation, Biomedical Informatics Research Center, Marshfield, Wisconsin.
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

STUDY

objectiveGeneric drugs contain identical active ingredients as their corresponding brand drugs and are pharmaceutically equivalent and bioequivalent, whereas authorized generic drugs (AGs) contain both identical active and inactive ingredients as their corresponding brand drugs but are marketed as generics. This study compares generic-to-brand switchback rates between generic and AGs.

designRetrospective cohort study. DATA SOURCE: Claims and electronic health record data from a regional U.S. health care system. PATIENTS: The full cohort consisted of 5542 unique patients who received select branded drugs during the 6 months prior to their generic drug market availability (between 1999 and 2014) and then were switched to an AG or generic drug within 30 months of generic drug entry. For these patients, 5929 unique patient-drug combinations (867 with AGs and 5062 with generic drugs) were evaluated. MEASUREMENTS AND MAIN

resultsTen drugs with AGs and generics marketed between 1999 and 2014 were evaluated. The date of the first generic prescription was considered the index date for each drug, and it marked the beginning of follow-up to evaluate the occurrence of generic-to-brand switchback patterns over the subsequent 30 months. Switchback rates were compared between patients receiving AGs versus those receiving generics using multivariable Cox proportional hazards models, controlling for individual drug effects, age, sex, Charlson Comorbidity Score, pre-index drug use characteristics, and pre-index health care utilization. Among the 5542 unique patients who switched from brand to generic or brand to AG, 264 (4.8%) switched back to the brand drug. Overall switchback rates were similar for AGs compared with generics (hazard ratio [HR] 0.86, 95% confidence interval [CI] 0.65-1.15). The likelihood of switchback was higher for alendronate (HR 1.64, 95% CI 1.20-2.23) and simvastatin (HR 1.81, 95% CI 1.30-2.54) and lower for amlodipine (HR 0.27, 95% CI 0.17-0.42) compared with the other drugs evaluated.

conclusionOverall switchback rates were similar between AG and generic drug users, indirectly supporting similar efficacy and tolerability profiles for brand and generic drugs. Reasons for differences in switchback rates among specific products need to be explored further.

Indexed as

AdultAgedAged, 80 and overCohort StudiesDrugs, GenericDrug SubstitutionElectronic Health RecordsFemaleHumansMaleMiddle AgedProportional Hazards ModelsRetrospective StudiesTherapeutic EquivalencyTime FactorsUnited StatesDrugs, Genericauthorized genericgenericswitchbackutilization

Identifiers

PMID28152215
PMCPMC5835402
OpenAlexW2585448320

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.