An OTC Birth Control Pill Could Become a Reality

over-the-counter-birth-control-pillsAn over-the-counter (OTC) birth control pill is finally on the horizon. HRA Pharma, a French pharmaceutical company, has recently formed a partnership with the nonprofit research organization Ibis Reproductive Health to conduct the research needed to prepare and submit a new drug application for an OTC progestin-only pill to the FDA. While the approval may be several years away, at least we are on the way. More than 70% of women support OTC access to birth control.1

This is an exciting prospect that could make birth control pills more widely available and easier for people to access and use. Ultimately, it may make a dent in our high rate of unintended pregnancies (45% of all pregnancies in the United States).2

All birth control pills – combined and progestin-only – are currently available by prescription only. Some states, such as California and Oregon, have enacted state laws allowing pharmacists to prescribe hormonal birth control. The more resources and options people have to obtain their birth control, the more likely they are to use it to effectively control if and when they have a pregnancy.

The birth control options currently available OTC are spermicides, condoms, and levonorgestrel emergency contraception. Progestin-only pills are much more effective at preventing pregnancy than any of these other methods. The pill—including progestin-only and combined—is one of the most effective birth control methods available. Both pill types are about 99% effective when used exactly as directed and 91% effective with typical use.3 Progestin- only pills have about the same effectiveness as combination estrogen and progestin pills, rings, and patches.

While combined hormonal birth control pills are generally more popular, the estrogen component results in some serious contraindications and precautions.3 Women with high blood pressure, migraines with aura, and other medical conditions should be avoiding estrogen. On the other hand, the progestin-only pill does not have the same concerns and can be safely used by most women. An OTC progestin-only pill is expected to follow in the footsteps of levonorgestrel – a progestin-only emergency contraceptive pill.

Many professional medical associations have expressed support for OTC birth control pills, including the American Medical Association, American College of Obstetricians and Gynecologists, American Academy of Family Physicians, and the American College of Clinical Pharmacy Women’s Health Practice and Research Network.4-7 It’s even a bipartisan issue, although there are disagreements on who should pay for an OTC birth control pill among different political parties.

Pharmacists and other providers have expressed concerns about expanding access to birth control and how that might impact other necessary health services.8,9 We must trust women to continue to seek and obtain related preventive health care and health maintenance from their primary care physicians, obstetricians/gynecologists, or other health care providers. There is no evidence to suggest that birth control pills should be held hostage to make women go to the doctor. Pap smears and other preventive health care procedures are important, and access to birth control pills is important, but the 2 are independents and do not need to be linked.3

For more information, see the Oral Contraceptives Over-the-Counter (OCs OTC) Working Group websites: http://ocsotc.org/ and http://freethepill.org/.

References:

  1. Grossman D, Grindlay K, Li R, Potter JE, et al. Interest in over-the-counter access to oral contraceptives among women in the United States. Contraception. 2013;88(4):544-52.
  2. Finer LB, Zolna MR. Declines in unintended pregnancy in the United States, 2008–2011. N Engl J Med. 2016; 374(9): 843-52
  3. US Centers for Disease Control and Prevention. US selected practice recommendations for contraceptive use, 2016. MMWR. 2016;65(4):1-66.
  4. American Academy of Family Physicians (AAFP) Resolution No 501: Endorse access without age restriction to over-the-counter oral contraceptive pills. April 2016.
  5. American College of Obstetricians and Gynecologists Committee Opinion No 615: Access to contraception. Obstetrics and Gynecology. 2015; 125(1):250–5.
  6. American Medical Association Resolution D-75.995 (Sub. Res. 507, A-13): Over-the-counter access to oral contraceptives. American Medical Association. 2013.
  7. McIntosh J, Rafie S, Wasik M, McBane S, Lodise NM, El-Ibiary SY, et al. Changing oral contraceptives from prescription to over-the-counter status: An opinion statement of the Women’s Health Practice and Research Network of the American College of Clinical Pharmacy. Pharmacotherapy. 2011;31(4):424-37.
  8. Rafie S, Kelly S, Gray EK, et al. Provider opinions regarding expanding access to hormonal contraception in pharmacies. Womens Health Issues. 2016;26(2):153-60.
  9. Rafie S, Haycock M, Rafie S, Yen S, Harper CC. Direct pharmacy access to hormonal contraception: California physician and advanced practice clinician views. Contraception. 2012;86(6):687-93.

This article was originally published in Pharmacy Times.

MPR Ask the Experts Interview

mpr-cover

A few months ago, I was interviewed by the team at Monthly Prescribing Reference (MPR) regarding pharmacist prescribing of oral contraceptives. The newsletter has just been published and I want to share with you all as it is a great reference if you are interested in prescribing oral contraceptives.

In the 16-page newsletter dedicated to this topic, you will see both my responses as well as responses from Dr. Lorinda Anderson of Oregon to the following questions:

In your opinion, what are the implications of legislation allowing qualified pharmacists in California and Oregon to prescribe and dispense certain types of contraceptives? What is your take on how women perceive these new laws?

Under the Affordable Care Act, insurance plans are permitted to use cost sharing to encourage or discourage use of specific contraceptive products. In your opinion, how much does cost sharing influence the decision of which OC to prescribe? Are there any concerns that cost sharing could prevent a patient from receiving the OC that is optimal for her?

When choosing from among the many combination OCs available, how do the doses of estrogen factor into your decision (if at all) regarding which OC to prescribe?

For which patients and under what circumstances might one opt to prescribe a progestin-only OC or a combination OC?

What questions/concerns should pharmacists expect to address when counseling a patient who is being prescribed an OC?

In your experience, what are some common side effects that may occur with OC use? In the event that a patient finds specific side effects persistent and/or bothersome, what do you recommend in terms of next steps?

In what type of situation should a pharmacist refer patients to a women’s healthcare professional or other healthcare provider for contraception?

What would you like to communicate to your colleagues regarding the appropriate training and knowledge that should be acquired in order to begin prescribing contraceptives? Can you recommend any relevant resources that your colleagues could consult if needed?

Do you have any concluding remarks that you would like to share with our readers?

Please see the full newsletter here.

Thank you to MPR and Teva Generics for supporting this important content for pharmacists.  

CDC Updates Guidelines for Contraceptive Use

The CDC has just released the second editions of both guidelines related to contraception.

The 2016 U.S. Medical Eligibility Criteria for Contraceptive Use (U.S. MEC) comprises recommendations for the use of specific contraceptive methods by women and men who have certain characteristics or medical conditions. The information in this report updates the 2010 U.S. MEC.

Notable updates include:

  • the addition of recommendations for women with cystic fibrosis, women with multiple sclerosis, and women receiving certain psychotropic drugs or St. John’s wort;
  • revisions to the recommendations for emergency contraception, including the addition of ulipristal acetate; and
  • revisions to the recommendations for postpartum women; women who are breastfeeding; women with known dyslipidemias, migraine headaches, superficial venous disease, gestational trophoblastic disease, sexually transmitted diseases, and human immunodeficiency virus; and women who are receiving antiretroviral therapy.

The 2016 U.S. Selected Practice Recommendations for Contraceptive Use (U.S. SPR) addresses a select group of common, yet sometimes controversial or complex, issues regarding initiation and use of specific contraceptive methods. The information in this report updates the 2013 U.S. SPR. Major updates include:

  • Revised recommendations for starting regular contraception after the use of emergency contraceptive pills.
  • New recommendations for the use of medications to ease insertion of intrauterine devices.

Download the 2016 US MEC and US SPR app in the iTunes App Store, an easy to use reference that combines information from the both CDC family planning guidance. It features a streamlined interface so providers can access the guidance quickly and easily.

Birth Control and Population Issues

With more women and men empowered to control their fertility with planning and birth control use, some populations are seeing drops in childbearing.  Some countries are concerned about population declines and are promoting childbearing.  The “baby bonus” programs of Australia and Singapore may ring a bell.

Other countries are considering policies that restrict access to reproductive health services, such as contraception and abortion, and actually making them illegal in some situations.  If these policies are implemented, there are serious concerns it could lead to more unsafe abortions.

Others question whether forcing women into the domestic sphere roles may backfire.  Research from Harvard’s sociology department found that declining fertility may not be linked to birth control use, but rather to gender role stereotypes placed on women.  Other countries experiencing similar drops in birth rates are working to improve conditions so that couples want to plan to have children.  An example of improving conditions is more maternity and paternity leave.

We live in an interesting time where most populations are struggling to reduce unintended pregnancies but a few are now working to promote more pregnancies.

Women’s Life Plans Have Changed

The average American woman’s life plan has changed drastically over the last few decades.  It’s no longer start having sex, get married, and have a kid…all within 4 years.  It’s now start having sex…continue having sex for about 9 years…then get married and have a kid in the year after that.

This means young women will need effective birth control for many years until their plans change.

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Reference:  Infographic from Guttmacher Institute’s Media Center.  Based on data from: Finer LB and Philbin JM, Trends in ages at key reproductive transitions in the United States, 1951–2010, Women’s Health Issues 2014, 23:e1–e9.

Other Uses for The Pill

While millions of women use birth control pills for pregnancy prevention, more than 1.5 million women (that’s 14% of pill users) are using it solely for another heath reason.

Many women using the pills for birth control also rely on the pills for other purposes, mainly menstrual cramps/pain, menstrual regulation, and acne.  Some pill users are either not currently sexually active or have never had sex.

So you can see there are lots of health benefits to birth control pills!

otherbenefitsofbcps birth control pharmacist

Why I Started “Birth Control Pharmacist”

My ultimate goal is to help women and men who do not want to start or expand their families right now with their family planning needs.  Seems simple.  Despite a lot of valiant efforts, nearly half of all pregnancies…45% to be exact…are unintended (i.e., mistimed or unwanted).  That’s millions of unintended pregnancies in the United States each year.  For more stats, check out the Guttmacher Institute’s fact sheet.

Now you’re beginning to understand my passion for this issue.

The good news is that policymakers and consumers alike are starting to realize the contributions of pharmacists to the field of family planning, particular direct patient care services. Some states have enacted legislation to expand the pharmacists scope of practice to include prescribing hormonal contraception and emergency contraception, with more states following suit.

Most pharmacists who will be providing contraceptive services are not experts in the field of family planning nor are they expected to be.  As a pharmacist specializing in family planning, I’d like to support my colleagues in providing competent and evidence-based contraceptive care.  The Birth Control Pharmacist project aims to provide the education and training, resources, and clinical updates to pharmacists prescribing contraception. Relevant information and news on research, public policy, and products will be shared too.

In closing, I hope pharmacists and pharmacy students will find the Birth Control Pharmacist’s content useful.  I look forward to your comments, suggestions, and questions!

Sincerely,
Sally