Evidence map›Paper›PMID 33315251›Full record

ArticleThe Hastings Center report2020

Prescription Requirements and Patient Autonomy: Considering an Over-the-Counter Default.

Madison Kilbride, Steven Joffe, Holly Fernandez Lynch

Open access · greenAbstract read
In one paragraph

Article in The Hastings Center report, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.2field-weighted citation impact, top 43% 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

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Article
  2. 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

3 authors.

Madison Kilbride
Steven Joffe
Holly Fernandez Lynch

Funding

The Penn Postdoctoral Training Program in the Ethical, Legal and Social Implications of Genetics and GenomicsT32HG009496 · NHGRI · UNIVERSITY OF PENNSYLVANIA · PI Steven Joffe · 2017 to 2026
$3.4M
Greenwall FoundationNHGRI NIH HHS T32 HG009496PfizerT32 training HG009496
6 · The paper itself

Abstract

When new drugs are approved by the Food and Drug Administration, the default assumption is that they will be available by prescription only, safe for use exclusively under clinical supervision. The paternalism underlying this default must be interrogated in order to ensure appropriate respect for patient autonomy. Upon closer inspection, prescription requirements are justified when nonprescription status would risk harm to third parties and when a large segment of the population would struggle to exercise their autonomy in using a drug safely and effectively on their own. Although these justifications can support prescription status for many drugs, we propose that reversing the FDA's current default to instead begin with a presumption in favor of over-the-counter status is the best way to avoid interference with valid claims of patient autonomy. Under this approach, a range of drug products could be considered for an OTC switch, including oral contraceptives, statins, and HIV-prevention drugs.

Indexed as

Nonprescription DrugsPrescriptionsContraceptives, OralFemaleHumansPaternalismUnited StatesUnited States Food and Drug AdministrationContraceptives, OralNonprescription DrugsautonomyFDAgroup soft paternalismover-the-counterprescription

Identifiers

PMID33315251
PMCPMC7797306
OpenAlexW3111503586

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.