Ethical, Legal, and Regulatory Issues Regarding the Study and Use of Medications in Pregnant Women

Authors

  • Diana Pham Johns Hopkins University

DOI:

https://doi.org/10.5912/jcb665

Keywords:

regulation, ethics, legal, pregnancy

Abstract

Despite the prevalence of off-label drug prescriptions for pregnant women, little attention is paid to the ethical, legal, and regulatory issues regarding this practice. This paper discusses some of these key issues relevant to the practice of off-label medication use by women during pregnancy.

Author Biography

  • Diana Pham, Johns Hopkins University

    Diana Pham received a Master’s in Biotechnology from the Krieger School of Arts & Sciences at Johns Hopkins University.  She has worked in healthcare,  research, and currently is teaching healthcare at the college level. She is  a certified practitioner in several complementary and integrative modalities and has spent the last 12 years intertwining these topics. These experiences allow her to combine her passion for science and holistic health and enable her to offer a unique perspective on the intersection of biotechnology, healthcare, and integrative medicine.

References

Doering, P. (2002). Review of pregnancy labeling of prescription drugs:is the current system adequate to inform of risks?. Am J Obstet Gynecol, 187(2), 333-339. doi: 10.1067/mob.2002.125740

Kim, J., & Scialli, A. (2011). Thalidomide: The tragedy of birth defects and the effective treatment of disease.Toxicological Sciences, 122(1), 1-6. doi: 10.1093/toxsci/kfr088

PDR.net - The Most Trusted Source for FDA-Approved Full .... (2014, January 1). The Physicians' Desk Reference. Retrieved , from http://www.pdr.net/

Duke Medicine News and Communications. (2010, July 15). An ethical argument: Include pregnant women in research. Duke Medicine, pp. 1-2.

Centers for disease control and prevention, (2013). Data & statistics: Uses of medications in pregnant women

Peters , S et al. (2013). Safe lists for medications in pregnancy: Inadequate evidence base and inconsistent guidance from web-based information, 2011.Pharmacoepidemiology and Drug Safety, 22, 324-328. doi: 10.1002/pds.3410

Lyerly, A et al (2001). The second wave: Toward responsible inclusion of pregnant women in research.International Journal of Feminist Approaches to Bioethics, 1(2), 5-22.

Piper, J et al. (1992). Pregnancy outcome following exposure to angiotensin-converting enzyme inhibitors. Obstetrics & Gynecology, 80(3), 429-432.

Ornoy, A. (2009). Valproic Acid In Pregnancy: How Much Are We Endangering The Embryo And Fetus?. Reproductive Toxicology, 28, 1-10.

Yang Q et al (1997). The return of thalidomide: Are birth defect surveillance systems ready? American Journal of Medical Genetics, 73, 251-258.

Boothby LA & Doering PL (2001). FDA labeling system for drugs in pregnancy. The Annals of Pharmacotherapy. 35, 1485-1489.

Food and Drug Administration, Consumer Health Information. (2008). Pregnant women to benefit from better information. Retrieved from website: http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM143746.pdf

Food and Drug Administration, Consumer Health Information. (2011). Pregnancy and lactation labeling. Retrieved from website: http://www.fda.gov/drugs/developmentapprovalprocess/developmentresources/labeling/ucm093307.htm

Charo, R. (1993). Protecting us to death: Women, pregnancy, and clinical research trials. Saint Louis University Law Journal, 38(135), 135187.

Merkatz, R. (1993). Women in clinical trials of new drugs: A change in food and drug administration policy. The New England Journal of Medicine, 329(4), 292-296.

Feibus, K et al (2011). Pregnant women & clinical trials: Scientific, regulatory, and ethical considerations. Presentation. PMHS. FDA Office of Women’s Symposium. 17 May 2011.

Kessler, D. (1993). Introducing medwatch. JAMA, 269(21), 2765-1768.

Beard K (1992). Adverse reactions as a cause of hospital admission in the aged. Drugs Aging. 1992:2

Faden, R. (2010). Justice in health research: Beyond protection from risks. Enrolling Pregnant Women in Research, 20-23.

Jackson, J. (1992). Pharmaceutical product liability may be hazardous to your health: A no-fault alternative to concurrent regulation. The American University Law Review, 42, 199-237. P. 204

Brody, J. (1983, June 19). Shadow of doubt wipes out bendectin. The new york times. Retrieved from http://www.nytimes.com/1983/06/19/weekinreview/shadow-of-doubt-wipes-out-bendectin.html?pagewanted=print

Sindell v. Abbott Laboratories et al (1980). 26 Cal 3d 588

Walsh CJ and Klein MS (1986). The conflicting objectives of federal and state tort law drug regulation. Food Drug Cosmetic Law Journal 41, 171-194

Henry, V. (1999). Off-label prescribing: Legal implications.The Journal of Legal Medicine, 20, 365-383.

Get Whooping Cough Vaccine While You Are Pregnant. (2014, January 17). Centers for Disease Control and Prevention. Retrieved , from http://www.cdc.gov/vaccines/adults/rec-vac/pregnant/whooping-cough/get-vaccinated.html

Whooping Cough Vaccines are Safe but Side Effects Can Occur. (2014, January 17). Centers for Disease Control and Prevention. Retrieved , from http://www.cdc.gov/vaccines/adults/rec-vac/pregnant/whooping-cough/safety-side-effects.html

Lori B et al (2004). Risks of untreated depression during pregnancy. Canadian Family Physician, 50, 37-39

Downloads

Published

2014-07-01

Issue

Section

Article