• About Us
    • Contact Us
    • Login
    • ObGFirst
  • Alerts
  • OB
  • 2T US Atlas
  • The Genome
  • GYN
    • GYN
    • Sexual Health
  • Primary Care
  • Your Practice
  • GrandRounds
  • My Bookshelf
  • COVID-19
About Us Contact Us Login ObGFirst
  • Alerts
  • OB
  • 2T US Atlas
  • The Genome
  • GYN
    • GYN
    • Sexual Health
  • Primary Care
  • Your Practice
  • GrandRounds
  • My Bookshelf
  • COVID-19
Grand Rounds

How do Compounded vs. Commercial 170HP Formulations Compare?

image_pdfFavoriteLoadingFavorite

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

 

image_pdfFavoriteLoadingFavorite

< Previous
All Grand Rounds Posts
Next >

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?

Sections

  • Alerts
  • OB
  • GYN
    • GYN
    • Sexual Health
  • 2T US Atlas
  • The Genome
  • Primary Care
  • Your Practice
  • Grand Rounds
  • My Bookshelf
  • COVID-19

Are you an
ObG Insider?

Get specially curated clinical summaries delivered to your inbox every week for free

  • Site Map/
  • © ObG Project/
  • Terms and Conditions/
  • Privacy/
  • Contact Us/
© ObG Project
SSL Certificate


  • Already an ObGFirst Member?
    Welcome back

    Log In

    Want to sign up?
    Get guideline notifications
    CME Included

    Sign Up

Sign In

Lost your password?

Sign Up for ObGFirst and Stay Ahead

  • - Professional guideline notifications
  • - Daily summary of a clinically relevant
    research paper
  • - Includes 1 hour of CME every month

ObGFirst Free Trial

Already a Member of ObGFirst®?

Please log in to ObGFirst to access the 2T US Atlas

Password Trouble?

Not an ObGFirst® Member Yet?

  • - Access 2T US Atlas
  • - Guideline notifications
  • - Daily research paper summaries
  • - And lots more!
ObGFirst Free Trial

Media - Internet

Computer System Requirements

OBG Project CME requires a modern web browser (Internet Explorer 10+, Mozilla Firefox, Apple Safari, Google Chrome, Microsoft Edge). Certain educational activities may require additional software to view multimedia, presentation, or printable versions of their content. These activities will be marked as such and will provide links to the required software. That software may be: Adobe Flash, Apple QuickTime, Adobe Acrobat, Microsoft PowerPoint, Windows Media Player, or Real Networks Real One Player.

Disclosure of Unlabeled Use

This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.

The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Disclaimer

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information
presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

Jointly provided by

NOT ENOUGH CME HOURS

It appears you don't have enough CME Hours to take this Post-Test. Feel free to buy additional CME hours or upgrade your current CME subscription plan

Subscribe

JOIN OBGFIRST AND GET CME/CE CREDITS

One of the benefits of an ObGFirst subscription is the ability to earn CME/CE credits from the ObG entries you read. Tap the button to learn more about ObGFirst

Learn More
Leaving ObG Website

You are now leaving the ObG website and on your way to PRIORITY at UCSF, an independent website. Therefore, we are not responsible for the content or availability of this site