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Ethical Compliance of Pharmaceutical Promotional Brochures and Its Implications for Shared Decision- Making in South Korea

  • Korean Journal of Medical Ethics
  • Abbr : 의료윤리
  • 2026, 29(3), pp.147~161
  • Publisher : The Korean Society For Medical Ethics
  • Research Area : Medicine and Pharmacy > General Medicine
  • Received : June 24, 2026
  • Accepted : July 28, 2026
  • Published : September 30, 2026

민석환 1,  Hwang Seungsik ORD ID 2

1한국로슈
2서울대학교

Accredited

ABSTRACT

Shared decision-making depends not only on clinician–patient interactions, but also on the qualityof the evidence clinicians bring to the clinical process. Pharmaceutical promotional brochures areone upstream source of such evidence, yet are unmonitored and exempt from mandatory review. Weassessed their compliance with established ethical standards and evaluated variations by companytype. In 2022, we collected 108 of 263 eligible brochures for top-300 best-selling prescription drugs(41.1% coverage at 17 academic conferences); the 91 presenting clinical results were evaluated againstWorld Health Organization (WHO) and Food and Drug Administration (FDA) criteria. Only 15(16%) met all nine WHO criteria. Multinational company brochures more frequently included safetyinformation (81% vs. 43%), manufacturer details, and appropriate references, while citing strongerevidence. After adjustment, this association persisted for the FDA composite score but remainedborderline for the WHO score. No brochures reported the number needed to treat or harm, and onlythree presented absolute risk reduction. Of 725 references, 28 (4%) could not be retrieved. Becauseshared decision-making presupposes trustworthy evidence, deficiencies in this upstream sourcemay weaken the informational basis for patient autonomy and physicians’ professional duties beforedeliberation begins.

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