Prescribing Ospemifene for Postmenopausal Vaginal Atrophy
Learning Objectives and CME/Disclosure Information
This activity is intended for healthcare providers delivering care to women and their families.
After completing this activity, the participant should be better able to:
1. Recall the correct dose for ospemefine 2. Identify those patients for whom the use of ospemefine is appropriate and safe
Estimated time to complete activity: 0.25 hours
Susan J. Gross, MD, FRCSC, FACOG, FACMG President and CEO, The ObG Project
Disclosure of Conflicts of Interest
Postgraduate Institute for Medicine (PIM) requires faculty, planners, and others in control of educational content to disclose all their financial relationships with ineligible companies. All identified conflicts of interest (COI) are thoroughly vetted and mitigated according to PIM policy. PIM is committed to providing its learners with high quality accredited continuing education activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of an ineligible company.
The PIM planners and others have nothing to disclose. The OBG Project planners and others have nothing to disclose.
Faculty: Susan J. Gross, MD, receives consulting fees from Cradle Genomics, and has financial interest in The ObG Project, Inc.
Planners and Managers: The PIM planners and managers, Trace Hutchison, PharmD, Samantha Mattiucci, PharmD, CHCP, Judi Smelker-Mitchek, MBA, MSN, RN, and Jan Schultz, MSN, RN, CHCP have nothing to disclose.
Method of Participation and Request for Credit
Fees for participating and receiving CME credit for this activity are as posted on The ObG Project website. During the period from Dec 31 2017 through Dec 31 2021, participants must read the learning objectives and faculty disclosures and study the educational activity.
If you wish to receive acknowledgment for completing this activity, please complete the post-test and evaluation. Upon registering and successfully completing the post-test with a score of 100% and the activity evaluation, your certificate will be made available immediately.
For Pharmacists: Upon successfully completing the post-test with a score of 100% and the activity evaluation form, transcript information will be sent to the NABP CPE Monitor Service within 4 weeks.
Joint Accreditation Statement
In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and The ObG Project. Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.
Physician Continuing Medical Education
Postgraduate Institute for Medicine designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Continuing Pharmacy Education
Postgraduate Institute for Medicine designates this continuing education activity for 0.25 contact hour(s) (0.25 CEUs) of the Accreditation Council for Pharmacy Education. (Universal Activity Number – 0809-9999-17-779-H01-P)
Type of Activity: Knowledge
Continuing Nursing Education
The maximum number of hours awarded for this Continuing Nursing Education activity is 0.2 contact hours.
Designated for 0.2 contact hours of pharmacotherapy credit for Advance Practice Registered Nurses.
Ospemifene is an oral medication that is indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.
Confirm the diagnosis of post-menopausal atrophy with physical exam
Dosage of ospemifene is 60 milligrams daily
Expect improvement after 6 weeks of continued use
Maximum efficacy is reached at 12 weeks
Consider discontinuation if no improvement
Topical estrogen is considered a first line therapy for post-menopausal atrophy. However, there are situations where some women in consultation with their provider may choose not to use local estrogen. According to the FDA, there is insufficient data to use ospemifene in women with breast cancer. While there do not appear to be any cases of ospemifene causing endometrial cancer, a potential risk for this particular malignancy is mentioned in a boxed warning, and surveillance for any signs of endometrial hyperplasia such as irregular uterine bleeding is recommended.
Ospemifene is a SERM and therefore may have estrogen agonist (endometrium) or antagonist effects depending on the tissue
Ospemifene should not be used with estrogen or another SERM
Ospemifene is FDA approved, with a boxed warning regarding risk of endometrial cancer, DVT and stroke
Contraindications include but are not limited to
Undiagnosed abnormal genital bleeding
Known or suspected estrogen-dependent neoplasia
Active or history of DVT, pulmonary embolism
Active or history of arterial thromboembolic disease (e.g., stroke or myocardial infarction)
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.
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
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