No Restrictions: ACOG Supports Over-the-Counter Access to Hormonal Contraception
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. Discuss the risk/benefit analysis related to over-the-counter hormonal contraceptive access 2. List the examinations and tests that are required (by the CDC) prior to initiating combined hormonal contraception
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 1/15/2020 through 07/15/2022, 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.
Continuing Nursing Education
The maximum number of hours awarded for this Continuing Nursing Education activity is 0.2 contact hours.
Designated for 0.1 contact hours of pharmacotherapy credit for Advance Practice Registered Nurses.
ACOG supports over-the-counter availability of hormonal contraception as a way of reducing inconsistent use or nonuse. Data demonstrates that adherence rates are similar whether hormonal contraception is obtained via a prescriber or over-the-counter. In addition, the ACOG opinion is consistent with AAFP, AMA and APHA in its support of unrestricted access. ACOG does not call for age restrictions except that contraception should not be initiated before menarche.
Would incur only “a small increase in absolute numbers of thrombotic events at the population level”
Combined hormonal contraceptives (i.e., including estrogen such as ethinyl estradiol)
OCPs: 3 to 9 events per 10,000 woman-years of exposure
Nonoral (e.g., patch or ring): Evidence inconsistent and if risk present, “likely represents a small number of events on a population level”
Note: VTE risks lower than those associated with pregnancy and postpartum which can reach up to 40 to 60 per 10,000 women-years | Other CVD outcomes such as MI or stroke are rare and unclear if there is increased risk | Obesity may raise risk but still below pregnancy risk
Understood that DMPA will require self-administration via subQ
Women with certain disorders (e.g., diabetes) are taught how to self-inject and there are studies substantiating successful administration specific to DMPA with appropriate education and training
Self-Screening for Contraindications
Self-screening tools are available and are required to identify women who are not candidates for hormonal contraceptives (see Box 1 in ACOG Opinion with link in ‘Primary Sources – Learn More’ below)
Research indicates that women tend to be cautious and self-assessment in most studies did not result incorrect use of OCPs
Studies conducted to assess pharmacist screening for behind-the-counter access also demonstrated safety and appropriate use
However, ACOG states “Pharmacist-provided contraception may be a necessary intermediate step to increase access to contraception, but over-the-counter access to hormonal contraception should be the ultimate goal.”
DMPA and Progestin-only pills Exam and Lab Requirements (CDC – see ‘Learn More – Primary Sources’)
Combined Hormonal Contraception Exam and Lab Requirements (CDC – see ‘Learn More – Primary Sources’)
Blood pressure (Class A)
Essential and mandatory in all circumstances for safe and effective use of the contraceptive method
In instances in which blood pressure cannot be measured by a provider, blood pressure measured in other settings can be reported by the woman to her provider
Not needed to determine medical eligibility for any methods of contraception because all methods can be used (U.S. MEC 1) or generally can be used (U.S. MEC 2) among obese women
Measuring weight and calculating BMI at baseline might be helpful for monitoring any changes and counseling women who might be concerned about weight change perceived to be associated with their contraceptive method
The following all fall under ‘Class C’ which means they do not contribute substantially to safe and effective use of the contraceptive method and therefore would not be required prior to contraceptive use
Bimanual examination and cervical inspection
Laboratory tests (universal screening in asymptomatic women)
Glucose| Lipids | Liver enzymes | Hemoglobin | Thrombogenic mutations | Cervical cytology (Papanicolaou smear) | STD screening with laboratory tests | HIV screening with laboratory tests
Who Should Not Use Combined Hormonal Contraception
VTE WARNING – Category 3 or 4 (risks outweigh benefits or unacceptable risk for)
Smoking ≥35 years of age
Postpartum <21 days
Postpartum 21-42 days with additional risk factors
≥35 years of age | Previous VTE | Thrombophilia | Immobility | Transfusion at delivery | Peripartum Cardiomyopathy | BMI ≥30 | PPH | Postcesarean delivery | preeclampsia | smoking
Major surgery with immobilization
History of DVT or PE
Hereditary thrombophilia including antiphospholipid syndrome
Inflammatory Bowel Disease with
Active or extensive disease | Surgery | Immobilization | Steroid use | Vitamin deficiencies | Fluid depletion
SLE with positive or unknown antiphospholipid antibodies
Superficial DVT (acute or history)
Other Issues to Consider Prior To Obtaining Over-The-Counter Combined Hormonal Contraception (Related to Estrogen Component)
Aside from ensuring the patient is not a VTE risk (category 3 or 4) and is normotensive, ask about
Chance of current pregnancy
CVD history (heart attack or stroke)
Migraine headaches (with aura)
Liver disease or cancer | Gall bladder disease (acute cholecystitis/cholangitis)
Breast cancer and other estrogen dependent cancers
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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.
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