Sage Journals: Discover world-class research

Abstract

Objective:

To compare the evidence-of-risk and recommendation levels of new drugs' label information in pregnancy among US, UK, Japan, and Korea. Despite the importance of drug labels in guiding decisions, officially approved prescribing information in drug labels is often inconsistent across countries and contains misleading content. Women are unintentionally exposed to drugs during early stages of unplanned or unrecognized pregnancies when treated for medical conditions.

Methods:

We selected 81 drugs approved in all 4 countries mentioned above from 2008 to 2016. Evidence level was classified into five categories (“Definite,” “Probable,” “Possible,” “Unlikely,” and “Unclassified”), and recommendation level was classified into four categories (“Contraindicated,” “Cautious,” “Compatible,” and “Unclassified”). We calculated kappa coefficient with 95% confidence intervals (CIs) to estimate the agreement of each category.

Results:

For evidence level, “Unclassified” was the highest in Japan (33.3%), while representing a much smaller proportion in US (2.5%), UK (6.2%), and Korea (6.2%; p < 0.01). For recommendation level, “Contraindicated” was the lowest in US (9.9%), while it was greater in UK (50.6%), Japan (50.6%), and Korea (42.0%; p < 0.01). Korea-UK presented substantial agreement for both evidence-of-risk (kappa = 0.80, 95% CI: 0.67–0.94) and recommendation level (kappa = 0.64, 95% CI: 0.46–0.82), while Korea-Japan and Korea-US were in fair or moderate agreement.

Conclusions:

Label information in pregnancy was discrepant among the four countries. Discrepancies in labeling information among countries may cause confusion to patients and healthcare professionals alike. To better assist healthcare professionals and patients in the use of prescription drugs, global harmonization of safety information is needed to minimize confusion with potential risk.

Get full access to this article

View all access options for this article.

References

Daw

, Hanley

, Greyson

, Morgan

. Prescription drug use during pregnancy in developed countries: A systematic review. Pharmacoepidemiol Drug Saf, 2011; 20:895–902.

Glover

, Amonkar

, Rybeck

, Tracy

. Prescription, over-the-counter, and herbal medicine use in a rural, obstetric population. Am J Obstet Gynecol, 2003; 188:1039–1045.

Food and Drug Administration

HHS

. Content and format of labeling for human prescription drug and biological products; requirements for pregnancy and lactation labeling. Fed Regist, 2014; 79:72063–72103.

Feibus

. FDA's proposed rule for pregnancy and lactation labeling: Improving maternal child health through well-informed medicine use. J Med Toxicol, 2008; 4:284–288.

, Friedman

. Teratogenicity of recently introduced medications in human pregnancy. Obstet Gynecol, 2002; 100:465–473.

Pfistermeister

, Saß

, Criegee-Rieck

, Bürkle

, Fromm

, Maas

. Inconsistencies and misleading information in officially approved prescribing information from three major drug markets. Clin Pharmacol Ther, 2014; 96:616–624.

Garbe

, Andersohn

. Contraindication labelling changes in the United States and Germany. Eur J Clin Pharmacol, 2007; 63:87–93.

Drugs@FDA. FDA approved drug products. Available at: www.accessdata.fda.gov Accessed February 1, 2017 .

U.S. national library of medicine. Dailymed. Available at: http://dailymed.nlm.nih.gov Accessed February 1, 2017 .

10.

Electronic Medicines Compendium. Accessible information about medicines licensed for use in the UK. Available at: www.medicines.org.uk/emc Accessed February 1, 2017 .

11.

Weblio. English-Japanese dictionary. Available at: http://ejje.weblio.jp Accessed February 1, 2017 .

12.

Pharmaceuticals and Medical Devices Agency. Available at: www.info.pmda.go.jp Accessed February 1, 2017 .

13.

Korea Ministry of Food and Drug Safety. Available at: http://ezdrug.mfds.go.kr Accessed February 1, 2017 .

14.

Sackett

, Straus

, Richardson

, Rosenberg

. Haynes RB. Evidence-based medicine: How to practise and teach EBM. Edinburgh: Churchill Livingstone, 2000.

15.

Landis

, Koch

. The measurement of observer agreement for categorical data. Biometrics, 1977; 33:159–174.

16.

Moro

, Zheteyeva

, Lewis

, et al. Safety of quadrivalent human papillomavirus vaccine (Gardasil^®) in pregnancy: Adverse events among non-manufacturer reports in the Vaccine Adverse Event Reporting System, 2006–2013. Vaccine, 2015; 33:519–522.

17.

Pfistermeister

, Schenk

, Kornhuber

, Bürkle

, Fromm

, Maas

. Different indications, warnings and precautions, and contraindications for the same drug—An international comparison of prescribing information for commonly used psychiatric drugs. Pharmacoepidemiol Drug Saf, 2013; 22:329–333.

18.

Addis

, Sharabi

, Bonati

. Risk classification systems for drug use during pregnancy. Drug Saf, 2000; 23:245–253.

19.

Warrer

, Aagaard

, Hansen

. Comparison of pregnancy and lactation labeling for attention-deficit hyperactivity disorder drugs marketed in Australia, the USA, Denmark, and the UK. Drug Saf, 2014; 37:805–813.

20.

Arguello

, Salgado

, Fernandez-Llimos

. Assessing the information in the summaries of product characteristics for the use of medicines in pregnancy and lactation. Br J Clin Pharmacol, 2015; 79:537–544.

21.

Rajpal

, Reidenberg

. Drug labeling should be kept current. Clin Pharmacol Ther, 2003; 73:4–6.

22.

Lee

, Shin

J-Y

, Park

M-J

, Park

B-J

. Agreement of label information of cardiovascular drugs in pregnancy among Korea, the USA, the UK, and Japan. Regul Toxicol Pharmacol, 2014; 68:363–369.

23.

Kesselheim

, Franklin

, Avorn

, Duke

. Speaking the same language? International variations in the safety information accompanying top-selling prescription drugs. BMJ Qual Saf, 2013; 22:727–734.

Supplementary Material

Please find the following supplemental material available below.

For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.

For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article.

0.00 MB

0.02 MB

0.03 MB