FDA Updates on Birth Control

There have been some notable changes with birth control products, including three new product approvals and one product exiting the market.

1. New yearly birth control vaginal ring approved. This birth control ring is very different from the existing vaginal ring product since it works for 1 year. It is a combined hormonal product and contains ethinyl estradiol and a new progestin — segesterone acetate. The ring is placed in the vagina for three weeks followed by one week out of the vagina, at which time women may experience a period (a withdrawal bleed). This schedule is repeated every four weeks for one year. The brand name is Annovera. One advantage of this product is that it does not require refrigeration. It is expected to be available in 2019. For more info, FDA News Release and Manufacturer Press Release.

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2.  First direct-to-consumer birth control digital app approved. This is the first app approved by the FDA as a safe and effective method of contraception.  It is indicated for use by adults aged 18 years and older. The app must be used with a thermometer — a two decimal basal thermometer, which is not the same as a normal fever thermometer.

Users will measure their temperature first thing in the morning before they get up and out of bed (at least five mornings a week) and enter it into the app.  For the algorithm to calculate daily fertility, users will also need to add their period data each month. The Natural Cycles algorithm analyses the information entered into the app to detect ovulation, thereby identifying green days, when no protection is needed, or red days, when you should use condoms or abstain from sex to prevent a pregnancy. For more info, FDA News Release and Company Website.

Natural Cycles Birth Control App

3. Another generic levonorgestrel emergency contraceptive pill approved. New generic emergency contraception (EC) pill approved. Preventeza is the brand name and it is made by the makers of Vagisil. This is another Levonorgestrel 1.5 mg single-pill EC product that may be sold without a prescription to consumers of all ages — women and men. It is available online only from the manufacturer’s website.

Preventeza Emergency Contraception

4. Essure to be discontinued. Essure is a permanent birth control method that doesn’t requires surgery and is placed in an office-based procedure. In this procedure, a soft, flexible insert is delivered through the vagina and uterus and permanently placed in each fallopian tube. No incision is required to deliver or place the inserts and general anesthesia is not required. Over time, a natural barrier forms around the inserts and prevents sperm from reaching the eggs by occluding the fallopian tubes. During this time, the patient must continue using another form of birth control to prevent pregnancy until the confirmation test at 3 months post-procedure.

The manufacturer is discontinuing production and it will no longer be available at the end of 2018.  This may be due to complaints from users due to adverse effects, restrictions by the FDA in April of this year, and/or low utilization. For more info, FDA Press Announcement.

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This has been a busy time for birth control product changes. We always welcome new birth control options to fit patient needs, given they are safe and effective.

More Birth Control Supplies Leads to Longer Use

More frequent trips to the pharmacy to pick up refills are bad for patients when it comes to birth control. Studies have shown that when patients are given more supplies at a time, they stick to their birth control method for longer and have fewer unintended pregnancies.

Pharmacists are used to the barriers imposed by insurers on quantities we can dispense. But that does little to ease the frustrations of patients who have to come in every four weeks to obtain more birth control or are forced into a mail order pharmacy. And beyond frustrations, frequent trips lead to worse outcomes in this case.

Let’s start with the good that happens when the need to obtain refills goes away.

Birth Control Yay

More supplies leads to fewer unintended pregnancies and abortions. One study evaluated oral contraceptive supplies and pregnancy events among Medicaid users in California. Patients who were dispensed a one year supply of oral contraceptives experienced a 30% reduction in the odds of an unintended pregnancy compared to those patients who received supplies for one or three months. The one-year supply was also associated with a 46% reduction in the odds of an abortion.

Unintended pregnancy is a costly outcome that can be mitigated in part by providing patients with a one-year supply of contraception. Contraception is generally cost effective and it would behoove health insurers and other payers to increase dispensing limits to allow for one-year supplies.

Six states have passed legislation requiring health plans to cover a 12-month supply of hormonal contraceptives. This applies to self-administered hormonal contraceptives including pills, patches, and rings. Patients may request these larger quantities to be dispensed from their pharmacy. Similar legislation has been introduced in 17 other states.

California’s legislation was passed in September 2016 and became effective January 2017, however it does not require health plans to adhere to the law until the plan renews. For many plans, the annual renewal period is in the fall or winter.

This has implications for pharmacies. Besides being aware of this law and honoring our patient requests for larger supplies, we also need to consider inventory adjustments to accommodate these requests. Keeping substantially larger quantities of birth control products will be challenging for many pharmacies as these come in bulky packaging and shelf space is limited. If this is a significant limitation for your pharmacy, consider dispensing an initial supply of about three months, ordering the remaining quantity, and mailing those supplies directly to the patient’s home when it arrives or whatever method the patient prefers.

All birth control methods dispensed at the pharmacy are stored at room temperature except for the vaginal ring (NuvaRing). Since the ring can only be stored at room temperature for up to four months, we will need to dispense appropriate quantities to ensure the medication remains effective. While patients may want to store their rings in their refrigerator at home, the temperature cannot be controlled and monitored as it is in the pharmacy. For this reason, it would be prudent to dispense up to four vaginal rings if the patient plans on inserting the first the same day or up to three vaginal rings in the patient plans on inserting the first within the next month. For patients to be satisfied with this plan, it will be critical to explain the storage requirements and concern for effectiveness with the patient.

This evidence-based change is good for patients. While it’s a change for pharmacies initially, hopefully they will benefit from improved patient satisfaction and outcomes.

 

References:

  • Foster DG, Hulett D, Bradsbetty M, Darney P, Policar M. Number of oral contraceptive pill packages dispensed and subsequent unintended pregnancies. Obstet Gyencol 2011;117:566-72.
  • Steenland MW Rodriguez M, Marchbanks PA, Curtis KM. How does the number of oral contraceptive pill packs dispensed or prescribed affect continuation and other measures of consistent and correct use? A systematic review. Contraception 2013;605-10.
  • McMenamin SB, Charles SA, Tabatabaeepour N, Shigekawa E, Corbett G. Implications of dispensing self-administered hormonal contraceptives in a 1-year supply: a California case study. Contraception 2017;449-51.

 

This article was originally published in Pharmacy Times.

The image was adapted with permission from Sarah Mirk via Flickr.

Colorado is Third State Allowing Pharmacists to Prescribe Birth Control

More good news about access to birth control is coming from the state level. Colorado has passed legislation authorizing pharmacists to prescribe birth control after obtaining additional training. They are the third state to follow California and Oregon with this statewide authority specific to birth control. There is a task force that is charged with implementing the new protocol in the coming months.

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Pharmacist Protocols

All state protocols to date require pharmacist training and patient screening with a questionnaire and blood pressure measurement. Colorado’s legislation most closely resembles Oregon’s in allowing initiation of birth control pills and patch to adult women for up to three years until she sees a physician. California’s protocol is more comprehensive in allowing initiation of birth control ring and injection as well, in addition to serving female patients of all ages without a duration limit.

Public Health Impact

In 2010, 45% of all pregnancies (43,000) in Colorado were unintended. This expanded pharmacist scope is great news for women in Colorado and affords them more choices in access points for birth control. Colorado pharmacists are also looking forward to providing this important public health service to their patients.

It is yet to be determined what types of patients utilize this service when offered by pharmacists. The service became available at participating pharmacies as of January 2016 in Oregon and April 2016 in California.

Colorado has had great success with other initiatives to address unintended pregnancies. The Colorado Department of Public Health and Environment Family Planning Initiative provided more than 30,000 intrauterine devices (IUDs) or implants at low or no cost to low-income women. This contributed to a 40% drop in the teen birth rate from 2009 through 2013. This project is among others in demonstrating that when cost and access barriers to long-acting, reversible contraceptive methods such as IUDs and implants are removed, women are likely to choose these more effective methods. By 2019, Colorado aims to reduce the unintended pregnancy rate to 30% or less as one of their “Winnable Battles.”

Safety

There have been concerns about the safety of providing hormonal contraception without physical exams and pap smears. Though hormonal contraceptives are not without risks, these are generally outweighed by the benefits and considered safe for most women. A pelvic examination and a pap smear are not necessary to initiate hormonal birth control.  They are important for other health reasons.  Women will need to complete a health history questionnaire and have their blood pressure taken at the pharmacy.  The pharmacist will use this information to determine which methods of birth control are safe.

This is another step forward in increasing access to birth control.  Hopefully more states will pass similar laws expanding access with pharmacist prescribing.

There is also growing support for over-the-counter birth control pills. That differs from pharmacist prescribing because consultation with a pharmacist would no longer be required.

This article was originally published in Pharmacy Times.

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.