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Clinical Summary

Planning for OTC medical abortion: labels matter

Takeaway

  • Development of an over-the-counter (OTC) medical abortion product will require improvements in labeling to increase comprehension, especially for lower literacy populations.

Why this matters

  • Evidence exists that women can safely self-administer the combination of mifepristone and misoprostol for medication abortion.
  • Allowing OTC medical abortion will require that package information is understandable and promotes its safe and effective use.

Study design

  • Nonrandomized pilot study with a convenience sample of 100 participants.
  • Participants were recruited at malls and shopping centers.
  • Interviews were conducted to determine the comprehension of a label prototype for a medical abortion product.
  • The primary objective was understanding information on a prototype package label.
  • Funding: Ipas, Chapel Hill.

Key results

  • Overall, the scores for comprehension of key concepts were "moderate" (number of correct responses to interview questions ranged from 60% to 79%).
  • There was some confusion over whether the product was for prevention or was an abortifacient (21%).
  • Women with low literacy were more likely to answer incorrectly; this included questions on the method of action and assessing for correct gestational age.

Limitations

  • Participants were from 1 country; results may not be generalizable to the United States.

References


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