Improve information on oral contraceptives
[Editor’s note: This article concludes a two-part series to help providers guide women in achieving proper use of oral contraceptives (OCs). Such guidance is needed, since a new report shows that more than 2 million women around the globe will become unintentionally pregnant this year due to improper Pill use. This month’s installment addresses effective counseling on missed pills and the promise of revised package information. The first article, included in December’s issue, addressed some of the clinical challenges and strategies to encourage compliance.]
How do you counsel women when it comes to helping them remember the need to take their oral contraceptives on a regular basis?
"We provide women with some standard tricks for remembering their pills, such as putting them by their toothbrush, but the truth for many women’s lives is that the standard tricks don’t work very well," says Susan Wysocki, RNC, NP, president and CEO of the Washington, DC-based National Association of Nurse Practitioners in Women’s Health. "For these women, recommending that they check their pack more than once a day to make sure they didn’t forget — or having them take the pills without a pill-free interval is useful."
Making up missed pills
Do you know when it is riskiest for women to miss pills?
Women become pregnant when they start a pill pack late or miss pills in the third week of the pill pack, thus extending the contraceptive-free interval. This concept is at the core of the "seven-day rule," developed by the Family Planning Associa-tion of the United Kingdom (U.K.) and John Guillebaud, MA, FRCS(Ed), FRCOG MFFP, professor of family planning and reproductive health at University College London and medical director of the Margaret Pyke Family Planning Centre, all in London.1
The guidance may be explained as follows: For full protection, women should not go more than seven days without taking hormonal pills. If two or more pills are missed, keep taking pills for at least seven days straight to remain protected.
The seven-day guidance stresses the importance of starting the next pill pack on time, no more than seven days after the last hormonal pill from the previous pack. If the pack is started late, a woman should incorporate a backup method or abstinence to protect her from pregnancy until she has taken pills for seven days.
If the patient extends the pill-free time to nine or more days, the ovulation risk is high, says Guillebaud. The U.K. recommendation is emergency contraception, then return to pill taking, still with backup, for seven days.
When one pill is missed, it should be taken as soon as it is remembered, even if it means taking two pills in one day. The remaining pills should be taken as usual, one per day.
Missing two or more consecutive pills in the first or second week of the pack can be remedied by following the seven-day guidance: taking a pill as soon as it is remembered, with the rest of the pills taken in normal sequence. By the time the last of the hormonal pills are taken, the woman will have taken pills for at least seven days straight.
The third week of the pill pack is the most important time to follow the seven-day guidance, according to Guillebaud. If a woman misses two or more pills in a row during the third week of the pack, she should be sure to take at least seven pills straight. For those who use 21-day packs, one pill should be taken as soon as it is remembered, with the rest of the hormonal pills taken, one per day. The next pack should be started the next day, without the seven-day wait. This stops the patient adding her last-week missed pills’ time to the regular pill-free time, since together, they exceed seven days and could lead to ovulation, he says.
Women using 28-day packs should skip the pills in the fourth week because they contain no hormones and thereby do not count toward seven straight days of pill taking. They should start a new pill pack after taking the last hormonal pill.
Package insert revised
Women may soon get some help in understanding how to take their pills with more user-friendly instructions included in their pill packages.
The Food and Drug Administration has published draft guidance for OC manufacturers that contains simpler language for package inserts.2 Except for the directions for use, which were simplified in 1992, the information in pill package inserts is written at a reading level ranging from 10th-12th grade, says Linda Potter, DrPH, of Family Health Research, a private family planning consulting firm in Princeton Junction, NJ.
Potter is working with the Family Planning Council in Philadelphia in pretesting the proposed inserts with women, a project co-funded by Wyeth-Ayerst Pharmaceuticals of Philadelphia, Ortho-McNeil Pharmaceuticals of Raritan, NJ, and Region III of the federal Department of Health and Human Services.
The insert has been presented to focus groups and is undergoing pilot testing, reports Potter. By the time it moves through the last phases of testing, project organizers hope that the insert will not only offer an easier level of reading, but will reflect the specific choices of words and phrases that help women fully understand the instructions, says Potter.
The new package insert language will be helpful to health care providers, because it can be used when counseling patients on proper pill use, states Potter. "Making the information easier to find, easier to read, and easier to understand and apply is the first step toward safe, effective use."
References
1. Guillebaud J. Contraception Today. 3rd ed. London: Martin Dunitz; 1998.
2. Food and Drug Administration, Department of Health and Human Services. Draft guidance for industry on combined oral contraceptives — labeling for health care providers and patients. 65 Fed Reg 42387 (July 10, 2000).
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