Evidence map›Paper›PMID 29092097›Full record

ArticleJournal of clinical pharmacy and therapeutics2018

Brand vs generic adverse event reporting patterns: An authorized generic-controlled evaluation of cardiovascular medications.

Y Alatawi, Md M Rahman, N Cheng, J Qian, P L Peissig, R L Berg, C D Page, R A Hansen

Abstract readComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of clinical pharmacy and therapeutics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

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

  1. Pooled it
  2. Impact and implications of national centralized drug procurement in China.International journal of clinical pharmacy · 2024
    Article
  3. Article
  4. Observational
  5. 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

8 authors.

Y AlatawiDepartment of Health Outcomes Research and Policy, Harrison School of Pharmacy, Auburn University, Auburn, AL, USA.
Md M RahmanDepartment of Health Outcomes Research and Policy, Harrison School of Pharmacy, Auburn University, Auburn, AL, USA.
N ChengDepartment of Health Outcomes Research and Policy, Harrison School of Pharmacy, Auburn University, Auburn, AL, USA.
J QianDepartment of Health Outcomes Research and Policy, Harrison School of Pharmacy, Auburn University, Auburn, AL, USA.
P L PeissigBiomedical Informatics Research Center, Marshfield Clinic Research Foundation, Marshfield, WI, USA.
R L BergBiomedical Informatics Research Center, Marshfield Clinic Research Foundation, Marshfield, WI, USA.
C D PageDepartment of Biostatistics and Medical Informatics and Computer Science, School of Medicine and Public Health, University of Wisconsin, Madison, WI, USA.
R A HansenDepartment of Health Outcomes Research and Policy, Harrison School of Pharmacy, Auburn University, Auburn, AL, USA.

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

WHAT IS KNOWN AND

objectiveSome public scepticism exists about generics in terms of whether brand and generic drugs produce identical outcomes. This study explores whether adverse event (AE) reporting patterns are similar between brand and generic drugs, using authorized generics (AGs) as a control for possible generic drug perception biases.

methodsEvents reported to the FDA Adverse Event Reporting System from the years 2004-2015 were analysed. Drugs were classified as brand, AG or generic based on drug and manufacturer names. Reports were included if amlodipine, losartan, metoprolol extended release (ER) or simvastatin were listed as primary or secondary suspect drugs. Disproportionality analyses using the reporting odds ratio (ROR) assessed the relative rate of reporting labelled AEs compared to reporting these AEs with all other drugs. The Breslow-Day test compared RORs across brand, AG and generic. Interrupted time series analysis evaluated the impact of generic entry on reporting trends. RESULTS AND DISCUSSION: Generics accounted for significant percentages of total U.S. reports, but AGs accounted for smaller percentages of reports, including for amlodipine (14.26%), losartan (1.48%), metoprolol ER (0.35%) and simvastatin (0.70%). Whereas the RORs were significantly different for multiple brand vs generic comparisons, the AG vs generic comparisons yielded fewer statistically significant findings. Namely, only the ROR for AG differed from generic for amlodipine with peripheral oedema (P < .01). WHAT IS NEW AND

conclusionInconsistent reporting patterns were observed more between brand and generic compared with AG and generic. Use of AGs as a control for perception biases against generics is useful, but this approach can be limited by small AG report numbers. Requiring the manufacturer name to be printed on the prescription bottle or packaging could improve the accuracy of assignment for products being reported.

Indexed as

Adverse Drug Reaction Reporting SystemsCardiovascular AgentsDrug-Related Side Effects and Adverse ReactionsDrugs, GenericHumansInterrupted Time Series AnalysisUnited StatesUnited States Food and Drug AdministrationCardiovascular AgentsDrugs, Genericadverse eventauthorized genericgenericsurveillance

Identifiers

PMID29092097
PMCPMC5930131

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.