Ways to use the Pill: What’s your strategy?

While several protocols are available to start women on a combined oral contraceptive (OC), respondents to the 2012 Contraceptive Technology Update Contraception Survey are firmly behind the Quick Start method of pill initiation. One hundred percent of survey participants say they use Quick Start, an increase from 2011’s 93% response.

Also known as the Same-Day Start, the practice entails having the woman take the first pill in her pill pack on the day of her visit as long as it is reasonably certain that she is not pregnant and not in need of emergency contraception.1

Quick Start is so much simpler; most women choose to use it, says Debbie Wright, MSN, OGNP, nurse practitioner at the University of Wisconsin — Eau Claire Student Health Center. However, it requires more counseling on breakthrough bleeding, she notes.

Quick Start is preferred because other combined oral contraceptive initial protocols generally have a time gap between the time of prescription and the time the patient begins taking it. Research indicates as many as 25% of women who use other protocols fail to take the pills as instructed because they conceive in the interim, fail to fill the prescription, or worry about taking the Pill.2,3

In using the Quick Start protocol, advise the patient to take her first pill at the time of the office visit or within the next 12 hours. Unless she has started the pills within five days of starting her period, counsel her to use a backup method, such as condoms, for at least seven days, says Anita Nelson, MD, professor in the Obstetrics and Gynecology Department at the David Geffen School of Medicine at the University of California in Los Angeles. Nelson provided an OC update at the 2012 Contraceptive Technology: Quest for Excellence conference.4

Tara Cleary, MD, MPH, research assistant professor at the University of North Carolina — Chapel Hill and guest researcher at the Centers for Disease Control and Prevention in Atlanta, says a provider can be reasonably certain that a woman is not pregnant if she has no symptoms or signs of pregnancy and meets any of the following criteria:

  • has not had intercourse since last normal menses; OR
  • has been correctly and consistently using a reliable method of contraception; OR
  • is within seven days after normal menses; OR
  • is within four weeks postpartum (non-lactating); OR
  • is within the first seven days postabortion or miscarriage; OR
  • is fully or nearly fully breastfeeding, amenorrheic, and less than six months postpartum. This information comes from the Geneva, Switzerland-based World Health Organization’s Selected Practice Recommendations, which is being adapted to provide U.S. clinicians with practical applications for contraceptive management.5

New extended regimen OC?

Clinicians report that more women are choosing extended or continuous regimen pills. About 55% reported such use, compared to 2011’s 42% figure. (Need tips on how to talk with patients about extended or continuous regimen pills? See box, below.)

Menstrual Suppression Counseling Checklist

Introducing the Concept

  • Standard oral contraceptives (OCs) include placebo pills to mimic a woman’s natural menses, but when a woman is on OCs, she does not have a natural bleeding episode.
  • There is no medical or health reason to bleed while on hormonal contraceptives.
  • Menstrual blood does not build up when women are using hormonal birth control.

Safety

  • Safety appears comparable to that of conventional combined OC regimens.
  • Return to fertility after discontinuation is expected to be the same as for conventional combined OC use.

Advantages

  • Menstrual suppression can help alleviate menstruation-related conditions.
  • Such regimens are more convenient in general and during particular occasions, such as vacations and athletic activities.
  • Menstrual suppression eliminates the need to purchase and carry as many hygiene products.

Disadvantages

  • Unpredictable breakthrough bleeding is initially more common than with conventional combined OCs. Bleeding will lessen as the body adjusts to the new hormone balance.
  • It often takes a few months before the desired effect of reduced bleeding is achieved. If the method is being used to eliminate menstruation for a specific event, it should be initiated well in advance of the event.
  • It may be more difficult to detect pregnancy with a suppressive regimen. Patients should be advised to look for other signs of pregnancy besides a skipped menstrual period, such as breast tenderness, nausea, fatigue, and other signs, and to obtain a pregnancy test if unsure.
  • In some cases, the regimen may be more costly.

How to Follow an Extended-Use Regimen

  • Discuss when to have hormone-free days, if any.
  • Discuss the schedule of the method, such as taking combined OCs at the same time every day.

What to Expect

  • Spotting
  • Blood may be dark brown (oxidized due to remaining in vagina longer) rather than red (blood noted with active bleeding). Blood may have a different texture.

Source: Association of Reproductive Health Professionals. Menstrual Suppression. Accessed at http://bit.ly/14o4zyX.

Women like not having monthly cycles, says Donna Gray, CNM, WHNP, clinician at the Wyoming County Men’s and Women’s Reproductive Health Services in Silver Springs NY.

Women have requested continuous OC regimens for convenience purposes, including but not limited to not wanting menses while traveling or during their honeymoon, observes Dolores Conroy, ARNP, senior advanced nurse practitioner specialist and nurse practitioner supervisor at Gulf County Health Department in Port Saint Joe, FL.

Many women have medical indications for menstrual suppression or a personal preference to reduce or eliminate monthly bleeding, which can be achieved with extended and continuous regimens of combined estrogen and progestin contraceptives.6 For extended regimen pills, there are four 30 mcg ethinyl estradiol/150 mcg levonorgestrel pills, packaged as 84 active pills and seven placebo pills: Seasonale and Jolessa (Teva Pharmaceuticals, North Wales, PA), Quasense (Watson Pharmaceuticals, Morristown, NJ) and Introvale (Sandoz, Princeton, NJ). There are three 30 mcg ethinyl estradiol/150 mcg levonorgestrel and 10 mcg ethinyl estradiol pills, packaged as 84 active pills and seven low-dose estrogen pills: Seasonique and Camrese (Teva Pharmaceuticals), and Amethia (Watson Pharmaceuticals). There are three 20 mcg ethinyl estradiol/100 mcg levonorgestrel pills and 10 mcg pills, packaged as 84 active pills and seven low-dose estrogen pills: LoSeasonique and CamreseLo (Teva Pharmaceuticals) and Amethia Lo (Watson Pharmaceuticals). Two continuous regimen pills, containing 20 mcg ethinyl estradiol/90 mcg levonorgestrel, packed as 28-day packs with no hormone-free interval: Lybrel (Wyeth Pharmaceuticals, Philadelphia) and Amethyst (Watson Pharmaceuticals).6

There might be an addition to the extended regimen pill roster. Teva Women’s Health has completed Phase III studies and filed a New Drug Application with the Food and Drug Administration for regulatory approval of an investigational ascending-dose, extended-regimen oral contraceptive, Quartette, confirms Louise Strong, a Teva spokesperson.

Data on the Phase III, multicenter, open-label, single arm efficacy and safety study were presented at the 68th Annual Meeting of the American Society of Reproductive Medicine. A total of 3,701 women were enrolled; 2,144 completed the study. The Pearl Index (PI) was 2.92 (95% confidence interval [CI],2.26-3.72), based on 65 pregnancies that occurred after the onset of treatment and within seven days after the last combination tablet in women ages 18-35, and excluding cycles in which another method of birth control was used. Life-table pregnancy rate was 2.68% (95% CI, 2.11%-3.42%) for all users ages 18-35. The most common treatment-related adverse effects were metrorrhagia (5.9%) and headache (4.5%).7

References

  1. Nelson AL, Cwiak C. Combined oral contraceptives (COCs). In: Hatcher RA, Trussell J, Nelson AL, et al. Contraceptive Technology: 20th revised edition. New York: Ardent Media; 2011.
  2. Oakley D, Sereika S, Bogue EL. Oral contraceptive pill use after an initial visit to a family planning clinic. Fam Plann Perspect 1991; 23(4):150-154.
  3. Westhoff C, Kerns J, Morroni C, et al. Quick start: novel oral contraceptive initiation method. Contraception 2002; 66(3):141-145.
  4. Nelson AL. Combined oral contraceptives: update 2012. Presented at the Contraceptive Technology: Quest for Excellence conference. Atlanta; November 2012.
  5. Cleary TP. The new U.S. Selected Practice Recommendations: practical applications for contraceptive management. Presented at the Contraceptive Technology: Quest for Excellence conference. Atlanta; November 2012.
  6. Jacobson JC, Likis FE, Murphy PA. Extended and continuous combined contraceptive regimens for menstrual suppression. J Midwifery Womens Health 2012; 57(6):585-592.
  7. Portman DJ, Howard B, Weiss H, et al. Multicenter open-label study to evaluate efficacy and safety of an ascending-dose, extended-regimen ethinyl estradiol/levonorgestrel combination oral contraceptive for preventing pregnancy in women. Presented at the 68th Annual Meeting of the American Society of Reproductive Medicine. San Diego; October 2012.