Prevention of Preterm Labor with 17α-Hydroxyprogesterone (17OHP) Caproate: A Comparison of Adverse Drug Reaction Rates between Compounded and Commercial Formulations

Rebecca H. Stone; Christina Bobowski; Nataliya Milikhiker; Rebekah H. Anguiano; Dimitrios Mastrogiannis

doi:10.1055/s-0037-1604195

American Journal of Perinatology, Table of Contents

Am J Perinatol 2017; 34(14): 1436-1441
DOI: 10.1055/s-0037-1604195

Original Article

Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Prevention of Preterm Labor with 17α-Hydroxyprogesterone (17OHP) Caproate: A Comparison of Adverse Drug Reaction Rates between Compounded and Commercial Formulations

Rebecca H. Stone

¹Department of Clinical and Administrative Pharmacy, University of Georgia, Athens, Georgia

,

Christina Bobowski

²Division of Pharmacy, CVS Pharmacy, Chicago, Illinois

,

Nataliya Milikhiker

³Department of Pharmacy Practice, University of Illinois at Chicago, Chicago, Illinois

,

Rebekah H. Anguiano

³Department of Pharmacy Practice, University of Illinois at Chicago, Chicago, Illinois

,

Dimitrios Mastrogiannis

⁴Division of Maternal–Fetal Medicine, Department of Obstetrics and Gynecology, University of Illinois at Chicago, Chicago, Illinois

› Author Affiliations

Abstract

Objective A commercial formulation of injectable 17α-hydroxyprogesterone (17OHP) for prevention of preterm birth was introduced in 2011; however, use of compounded formulations remains widespread. This study compared the frequency of adverse drug reactions (ADRs) associated with compounded versus commercial 17OHP formulations, aiding in provider assessment of 17OHP tolerability.

Study Design A retrospective cohort evaluation of data obtained from the electronic medical record (EMR) of patients prescribed weekly 17OHP injections at an obstetric clinic between 2009 and 2015 was performed. A descriptive analysis characterized the frequency and proportion of ADRs associated with 17OHP administration. Patient differences between 17OHP formulations were identified with t-test, chi-square, or Fischer's exact tests.

Results Of 175 patients included, 56% received commercial formulation and 44% received compounded formulation. ADRs occurred in 16 patients, all of whom received the compounded formulation (p < 0.001). The most common ADRs were injection site reaction (n = 7) and acute coughing following 17OHP administration (n = 6). Of patients with an ADR, 63% discontinued all medication therapy for prevention of preterm birth or changed to an alternative therapy.

Conclusion Comparison of ADR rates between compounded and commercial formulation differed significantly. In addition to food and drug administration (FDA) compliance, providers may consider preferential use of the commercial formulation, since 21% of women receiving compounded product experienced an ADR.

Keywords

preterm labor - preterm birth - compounding - 17OHP - Makena - hydroxyprogesterone

Full Text

References

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