EXECUTIVE SUMMARY

The American College of Obstetricians and Gynecologists has updated its guidance regarding over-the-counter (OTC) access to hormonal contraception, expanding its support for access to vaginal rings, the contraceptive patch, and contraceptive injections with no age restrictions.

• The new guidance updates and expands the organization’s 2012 recommendation that oral contraceptives be available OTC.

• Two companies are researching pills for OTC approval; however, such a pill is likely still years away.

• Until an OTC method is available, several states have passed laws designed to make it easier for women to obtain and use hormonal contraceptives through pharmacist provision.


The American College of Obstetricians and Gynecologists (ACOG) has updated its guidance regarding over-the-counter (OTC) access to hormonal contraception, expanding its support for access to vaginal rings, the contraceptive patch, and contraceptive injections with no age restrictions.1

The new guidance updates and expands the organization’s 2012 recommendation that oral contraceptives be available OTC.2 Regulatory action is needed to achieve OTC access, according to the guidance. While some states are implementing direct access to hormonal contraception at pharmacies or through online ordering, OTC access should be the ultimate goal.

A prescription is an “unnecessary obstacle” for some women to get their preferred contraceptive method, observed Rebecca Allen, MD, MPH, an ACOG committee member who helped update the opinion. OTC hormonal birth control would be a step toward greater access to an essential component of women’s healthcare and give adolescents and women more options to manage their reproductive health, she noted in a statement.3

While OTC access to hormonal contraception will improve availability, it should not be at the expense of affordability, said Allen, assistant professor of obstetrics and gynecology in the Warren Alpert Medical School at Brown University. Insurance coverage and other financial support for contraception still should apply, she stated.

“Each woman should be able to select the contraception that works best for her, including over-the-counter hormonal contraceptives, a long-acting reversible contraceptive provided by her healthcare provider, or other methods,” Allen said.

The need to consistently obtain a prescription, get a refill approval, or schedule an appointment can lead to inconsistent use of a preferred birth control method, said Michelle Isley, MD, MPH, who co-authored the opinion.

“Making more methods available over the counter would lead to reliable, equitable access for more women,” said Isley, assistant professor of obstetrics and gynecology at Ohio State University Wexner Medical Center in Columbus. “A move to over-the-counter status would complement, not replace, policies that ensure availability of the full range of contraceptive options and safeguard access to a robust network of qualified family planning providers.”3

Laying Groundwork for OTC Pill

Two companies are researching pills for OTC approval; however, such a pill likely is years away. Oakland, CA-based Cadence Health is working to bring an OTC pill to market, while HRA Pharma, a French firm, is working with Oakland, CA-based Ibis Reproductive Health on a progestin-only OTC pill. The hormone component in the Cadence Health pill is unknown.4 HRA Pharma is looking at norgestrel as the component for its progestin-only pill.

Lawmakers are laying groundwork to ensure that contraception is as accessible as possible. In June 2019, Sen. Patty Murray, D-WA, and Rep. Ayanna Pressley, D-MA, introduced the Affordability is Access Act in their respective chambers, which will require insurance companies to cover any OTC birth control pill without copay or prescription.

The new ACOG Committee Opinion says that any plan to make contraception available OTC should address the issue of cost, including for women whose insurance currently covers their preferred method. It also says there is no medical or scientific justification to limit access to OTC contraception based on age.

Until an OTC method is available, several states have passed laws designed to make it easier for women to obtain and use hormonal contraceptives. According to the Association of State and Territorial Health Officials, 11 states and the District of Columbia passed legislation to allow pharmacists to issue contraception without a prescription.

Almost all states with such legislation require pharmacists to assess patients before prescribing and dispensing contraceptives, most often by using a self-screening risk assessment. Most states also require pharmacists to provide patients with a standardized information sheet about contraceptives, a written summary of the consultation, advice about follow-up with a primary care provider, and a referral to a reproductive care provider or clinic if there is no established contact.

Age limits may restrict pharmacist provision. In Utah and Washington, pharmacists cannot prescribe contraceptives to those under age 18, while Oregon allows provision if a minor has previously had a prescription from a physician. (Oregon’s age limit is set to expire in 2020.) Pharmacists in Tennessee can prescribe to minors only if they are emancipated.

Some pharmacists may not participate in contraceptive provision due to lack of insurance reimbursement for counseling services. Medi-Cal, California’s Medicaid system, implemented reimbursement in April 2019. The Medi-Cal program covers more than 2.4 million reproductive-age women; the effect of reimbursement on the percentage of pharmacists who prescribe contraceptives is not yet known.4

REFERENCES

  1. Over-the-counter access to hormonal contraception: ACOG committee opinion, number 788. Obstet Gynecol 2019;134:e96-e105.
  2. Committee on Gynecologic Practice, American College of Obstetricians and Gynecologists. Committee Opinion No. 544: Over-the-counter access to oral contraceptives. Obstet Gynecol 2012;120:1527-1531.
  3. American College of Obstetricians and Gynecologists. ACOG updates guidance on over-the-counter access to hormonal contraception. Sept. 24, 2019. Available at: http://bit.ly/33AbXBL.
  4. Rubin R. High unintended pregnancy rate spurs efforts to ease contraceptive access. JAMA 2019;doi:10.1001/jama.2019.15237.