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Obstacles to health care providers’ prescribing and women’s
use of extended regimen contraception include lack of third-party coverage,
concerns about safety, and off-label use of existing contraceptives.1 With
the availability of Seasonale®,
an extended oral contraceptive (OC) regimen, these obstacles are easier
to address. Other obstacles, including health care providers’
lack of time and skills to adequately counsel their patients, may be
alleviated with better counseling tools and consumer and provider education.1
“I
suggest this regimen to patients, especially those who have menstrual
migraines. In counseling patients, I make sure I tell them to
expect breakthrough bleeding. The key barriers to more widespread
use of this regimen are that women think they need to have a period
and that health [care] providers think that it builds up the endometrium.”
—Rosa, nurse practitioner,
age 44 |
Third-party Coverage
Coverage of OCs varies among third-party payers. With extended use
of OCs, four extra packs of pills per year (17 instead of 13) are needed.
These additional packs of OCs are more likely to be covered for medical
purposes, such as endometriosis and dysmenorrhea, than for convenience.
Coverage for Seasonale also varies; in some cases, insurance covers
it but requires three co-pays for one pack.
Medicaid coverage for OCs also differs from state to state. For example,
in Delaware, both public and private providers of hormonal contraceptives
can issue up to three cycles of pills at a time but can bill for only
one cycle per month. However, Medicaid pays by the tablet, so if an
OC prescription is written “daily for 63 days” and indicated
as a medical necessity, Medicaid will be more likely to cover it.
According to an expert at the American Association of Health Plans,
when a provider writes a prescription for more than one pack of pills
per month, the pharmacist can fill the prescription easily when the
woman pays out of pocket. However, when the insurance company pays,
the prescription needs to be justified by the consumer or sometimes
the provider. Approval varies according to the insurance company.
Safety
Patients and providers have expressed concerns about the safety of
extended regimen contraception in regard to long-term health effects,
side effects, and future fertility.2
Earlier studies of women taking an extended OC regimen have not shown
adverse health consequences. The 1-year trial of extended use of Seasonale3
and the 6-month trial of continuous use of a 20-mg ethinyl estradiol/100-mg
levonorgestrel OC conducted in Oregon4
offer reassurance that no untoward effects on the endometrium occur
with these regimens. In the Seasonale trial, some patients underwent
endometrial biopsy at the start and finish of therapy to assess the
effects of the extended regimen on the endometrium; no instances of
endometrial hyperplasia or carcinoma were observed. In the Oregon trial,
investigators conducted transvaginal ultrasound examinations to document
endometrial stripe thickness on 14 subjects using the continuous regimen.
All women with endometrial stripe thicknesses of >5 mm were to be
asked to consent to endometrial biopsy; this proved unnecessary, however,
as mean thickness ranged from 2 to 4 mm with a mean of 3.3 mm (standard
deviation = 0.73). The investigators suggested that “continuous
use of oral contraceptives results in an inactive endometrium, similar
to that obtained with combined continuous hormone replacement therapy.”
Concerns about breast cancer and thrombosis as a result of extended
or continuous use of OCs can be answered only by large postmarketing
observational studies. However, data on conventional use of pills—including
epidemiologic data on doses of OCs higher than are usually used—are
reassuring with respect to breast cancer.5
In regard to fertility, a German trial suggests that return to fertility
after discontinuation is rapid: Patients who switched from the extended
regimen to the conventional regimen experienced a rapid reversal of
amenorrhea, and those who desired pregnancy conceived soon after discontinuation.6
In addition, in the Oregon trial, one subject became pregnant the week
after discontinuation of continuous OCs.4
Depo-Provera® injections and the
Mirena® intrauterine system have
been used by millions of women and have excellent safety records. Nevertheless,
additional studies on long-term use of extended OCs and other extended
contraceptive methods would be welcome.
Women’s Beliefs and Cultural Myths
Many women want or feel that it is necessary to menstruate. Some believe
that menstruation cleans out toxins, is “natural,” makes
them feel feminine, or helps connects them to the “cycle of life.”
Some use menstruation as a way to determine whether they are pregnant,
as a reason to avoid sex, or to ascertain fertility; others continue
to menstruate because of pressure from family and friends, and still
others avoid contraceptives because of religious beliefs.7
Women’s customs, values, and beliefs about menstruation and contraception
differ among societies. According to Castaneda et al., researchers with
the National Institute of Public Health in Mexico, “every society
builds complex belief systems in relation to the reproductive system.”8
This concept is illuminated in the researchers’ study of fertility
and menstruation in rural Mexico. Here are some quotes from women in
the study:
“A period is like a wound which opens in the woman and
the womb has to vent itself.”
Menstrual blood “…collects in the belly, because
it no longer circulates in the body and it has to come out.”
Menstrual blood is “something which ripens and must be
thrown out.”
“Blood comes with menstruation because it is going into
heat.”
“Most girls with a strong nature were born under a full
moon and their first menstruation will come with a full moon, whereas
weak ones have their first menstruation when there is no moon or a
new moon.”
In a study of indigenous Alaskan women, researchers found that Eskimo
women were uninterested in tracking their periods to find out when their
next period was due, the usual interval between periods, or the average
duration of the period.9 Suha Kridli,
PhD, RN, reviewed studies of Arab women’s beliefs about menstruation
and family planning.10 Some Arab American
women think that they should not shower until the end of their menstrual
periods. The researcher said that women might have this belief because
according to Islamic religion, a menstruating woman is not considered
tahra, which is Arabic for clean. Many Kuwati women believe that OCs
cause obesity and twin pregnancies. Some Jordanian women think that
OCs cause serious side effects, such as cancer, hair loss, and back
pain.
Health Care Provider Awareness and Beliefs
Some health care providers believe that women need to have regular
menstrual periods for medical reasons and that safety issues concerning
the extended use of contraceptives have not been adequately researched.2,11,12
Many health care providers have never questioned the reasons for the
21/7 regimen and may have assumed that there was a scientific rationale
for scheduling OCs in this manner. Some providers also mistakenly confuse
amenorrhea that normally accompanies hormonal methods—particularly
Depo-Provera, Mirena, and extended regimen OCs—with amenorrhea
associated with endometrial pathology (i.e., hyperplasia). Once they
learn about the physiological differences between amenorrhea induced
by hormonal methods versus that associated with pathology, they should
be reassured.
Some providers are concerned with the long-term effect of menstrual
suppression for extended periods. Although long-term use of extended
regimens has not been studied, it is reassuring that there have been
no reports of harm among thousands of patients who have used extended
regimens to treat endometriosis and other menstrual-related problems.
It is also reassuring that recent studies have shown that concern about
endometrial proliferation from extended use is unfounded.3,4
“For
5 years, I took oral contraceptives, continuously. I stop taking
them about every 3 months for about 5 days because my doctor suggested
this pattern. It seems to me that nurse practitioners know more
about continuous oral contraceptives than physicians. They learn
about and discuss this regimen at conferences and then go back
and talk to the physicians they work with. But there does seem
to be confusion about how often you should have a pill-free interval.
Some say twice a year, others every 3 months. I would like to
know even more about this regimen to gain confidence in prescribing
it. It’s difficult convincing women that they don’t
need to bleed.”
—Kate, nurse practitioner
in physician’s office, age 41
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Perception that Extra Counseling is Required
Women need counseling on how to take and what to expect with extended
regimen contraception. Health care providers often have little time
to counsel their patients adequately for conventional-use methods. They
also do not have the patient education tools to assist them in counseling
about changes in bleeding patterns with hormonal methods.1
Because all women initiating a contraceptive hormonal method experience
changes in menstrual patterns, counseling women on continuous use may
not take much more time than counseling on conventional use.
Correct Use of Contraceptive Method
The regimen for any contraceptive method—whether it is conventional
or extended use—must be followed closely to lessen side effects
and prevent pregnancy. Many contraceptive methods rely on the woman’s
memory and willingness to follow the contraceptive schedule. For example,
with OCs, women should take the pill at the same time every day, yet
it is difficult for many people to remember consistently to do so.
Side Effects
In a study of 1,675 women, the most common reason cited for discontinuing
OCs was bleeding irregularities.13
Unscheduled bleeding is initially more common with an extended OC regimen
than with a conventional OC regimen. However, after 3–4 months,
the number of days of unscheduled bleeding or spotting with extended
OCs is comparable to that with conventional OCs. With both regimens,
the bleeding decreases over time.
Off-Label Use
Some providers are uncomfortable with prescribing conventional contraceptives
for extended use because these formulations have not been approved by
the US Food and Drug Administration for that purpose.1
Public clinics often use the labeling on contraceptives to prepare practice
protocols. It is noteworthy, however, that most clinicians prescribe
OCs for women with dysfunctional uterine bleeding, menorrhagia, and
dysmenorrhea, even though OCs are not approved for these indications.
As mentioned previously, third-party payers are reluctant to cover extended
contraceptives because of this “off-label” use. The current
availability of Seasonale, a dedicated extended OC regimen, addresses
some of these off-label concerns.
References
1. Association of Reproductive Health Professionals. Continuous use
of oral contraceptives. A supplement to The Female Patient®,
April 2002.
2. Andrist LC, Arias RD, Nucatola D, et al. Women’s and providers’
attitudes toward menstrual suppression. Contraception; in press.
3. Anderson FD, Hait H, Seasonale-301 Study Group. A multicenter, randomized
study of an extended cycle oral contraceptive. Contraception
2003;68:89-96.
4. Kwiecien M, Edelman A, Nichols MD, Jensen JT. Bleeding patterns
and patient acceptability of standard or continuous dosing regimens
of a low-dose oral contraceptive: a randomized trial. Contraception
2003;67:9-13.
5. Marchbanks PA, McDonald JA, Wilson HG, et al. Oral contraceptives
and the risk of breast cancer. N Engl J Med 2002;346:2025-2032.
6. Wiegratz I, Hommel HH, Zimmermann T, Kuhl H. Attitude of German
women and gynecologists towards long-cycle treatment with oral contraceptives.
Contraception 2004;69:37-42.
7. Andrist LC, Hoyt A, Weinstein D, McGibbon C. The need to bleed:
women’s attitudes and beliefs about menstrual suppression. J
Am Acad Nurse Pract 2004;16:31-37.
8. Castenada X, Garcia C, Langer A. Ethnography of fertility and menstruation
in rural Mexico. Soc Sci Med 1996;42:133-140.
9. Boyle JS, Gramling LF, Voda AM. Eskimo women and a menstrual cycle
study: some ethnographic notes. Health Care Women Int 1996;17(4):331-342.
10. Kridli SA. Health beliefs and practices among Arab women. MCN
Am J Matern Child Nurs 2002;27(3):178-182.
11. Chollar S. Are monthly periods obsolete? WebMD Health, June 23,
2000.
12. Association of Reproductive Health Professionals and National Association
of Nurse Practitioners in Women’s Health. Annual meeting registrant
survey. August- September 2002.
13. Rosenberg MJ, Waugh MS. Oral contraceptive discontinuation: a prospective
evaluation of frequency and reasons. Am J Obstet Gynecol 1998;179:577-582.
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