BACKGROUND AND PURPOSE:

• Despite the 2011 release of a commercial formulation of injectable 17α-hydroxyprogesterone (17OHP) for prevention of preterm birth, compounded formulations remain widespread
• Cost remains a concern, but there are other differences as well, such as the suspending agent (e.g., castor vs. cottonseed or sesame oils)
• Rates of adverse drug reactions (ADRs) should be the same, but need to be rigorously assessed
• Stone et al. (American Journal of Perinatology, 2017) compared the frequency of ADRs associated with the compounded versus commercial 170HP formulations

METHODS:

• Retrospective cohort study (2009 – 2015)
• Evaluation of data, including ADRs, were obtained from the electronic medical record (EMR)
• Compounded 17OHP was used exclusively until March 2013 (cottonseed and sesame oil suspension)
• In April 2013, the switch was made to commercial 17OHP (castor oil suspension)
• Descriptive analysis characterized the frequency and proportion of ADRs associated with 170HP administration
• Potential ADR symptoms included swelling, rash, pruritus, pain, erythema, acute coughing, and shortness of breath
• Patients experiencing an ADR, regardless of number, were counted only once in he analysis
• Primary outcome
  • Proportion of patients who experienced a documented ADR within 8 days of 17OHP administration
• Secondary outcomes
  • Baseline characteristics, nature of the adverse reaction, number of 17OHP doses, changes in therapy, frequency of preterm birth

RESULTS:

• Data was collected from 175 patients
  • 56% received commercial formulation
  • 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 and acute coughing following administration
• 63% of ADR cases discontinued all medication therapy for prevention of preterm birth or changed to an alternative method compared to 26% of women who did not experience ADRs (P=0.007)
• There was no difference between women who did have ADRs compared to those who did not experience ADRs with respect to preterm delivery < 37 weeks

CONCLUSION:

• 20% of women receiving compounded 17OHP formulations experienced an ADR
• This study included compounded medications from two different, unrelated sources, therefore implying that the results of this study were not related to poor practices of a particular pharmacy
• More research is necessary to determine if there are any other detrimental maternal and/or fetal outcomes

Learn More – Primary Sources:

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

Related ObG Topics:

SMFM Statement: Choice of Progestogen for Preterm Birth Prevention

Vaginal Progesterone to Prevent Preterm Birth in Twins

Do Progestogens Prevent Preterm Birth in Symptomatic Pregnancies with a Short Cervix?