Optimizing the Use of Oral Contraceptives

October 25 - 29, 2008, San Diego, California

Diana G. Foster, PhD


February 25, 2009


With 11.6 million people using them (31% of contracepting women), oral contraceptive pills (OCPs) are the most common contraceptive method used by American women.[1] They are particularly popular among young women and non-Hispanic white women. The safety and efficacy of oral contraceptives are well established, with most women having no medical contraindications to their use. The most common contraindications, experienced by approximately 5% of women under age 35 and 30% of women age 35 and older, include hypertension, smoking over age 35, history of cardiovascular disease or venous thromboembolism, migraine with aura, diabetes, and current or history of breast cancer.[2] Still, for all women except smokers over age 35, the risk for death from cardiovascular disease resulting from pregnancy exceeds the risk posed by OCP use.[3]

Oral contraceptives are highly effective when used properly. Only 3 in 1000 women using OCPs will become pregnant in a year of perfectly consistent use, ie, taking 1 pill at the same time every day.[2] Despite the high potential effectiveness of perfect use, OCPs as they are typically used are frequently associated with unintended pregnancy. In a year of typical use, 80 in 1000 OCP users will become pregnant. The relatively high failure rate of oral contraceptives is also reflected in the history of contraceptive use among women seeking abortions. One in 7 women seeking an abortion in the United States reported using oral contraceptives in the month in which they conceived.[4]

The reason for the large gap in OCP effectiveness under perfect use and typical use may be due primarily to missed pills. Nearly 1 in 2 pill users report missing 1 or more pills per cycle.[5] The most common reasons for missing pills are being away from home, forgetting to take the pill, and having no new pill pack on hand to start a new cycle.

Although many women become pregnant while using OCPs, the pregnancy rate would be 10 times higher (850) if these same women used no method of contraception.[2] Therefore, encouraging the adoption of oral contraceptive use among women who are sexually active but not using a method of contraception could result in a significant drop in rates of unintended pregnancy. In fact, the widespread use of OCPs, the effectiveness of OCPs, and the troublesome gap in pregnancy rates between typical use and perfect use in outcomes make improving OCP access and compliance a public health priority. Research presented at the 2008 American Public Health Association (APHA) meeting in San Diego, California, focused on methods to facilitate access to oral contraceptives and improve use and continuation.

Traditionally, women are told to wait until the first Sunday after their next menses before initiating use of oral contraceptives. It has been surmised that the resulting delay in initiating oral contraceptives may put women at risk for an unintended pregnancy. With that in mind, physicians recently proposed allowing women to begin OCP use immediately and back up the method with condoms for the first 7 days as a strategy to improve effectiveness, continuation, and acceptability of the method.

Researchers at Family Health International presented a review of recent studies on what is called "immediate start" or "quick start" of hormonal contraceptives at the APHA meeting.[6] In their review, the largest multisite randomized trial of immediate start of oral contraceptives showed that contraceptive continuation from the first pack to the second pack was higher among women who began use immediately. Women who began on a quick-start regimen were slightly less likely to become pregnant within 6 months from the time when they started the pill.[7] The differences in pregnancy rates and continuation between those who started pill use in the clinic and those who waited until their first menses were not significant beyond the short period following initiation of the method.

A study ongoing in California is examining the extent to which the number of cycles of pills dispensed at one time affects the pregnancy rate.[8] Nationally, almost three quarters of pill users are dispensed just 1 pack at a time, meaning that women must seek refills every month for continuous use. The California Family PACT Program allows some clinical providers to dispense up to a year's supply (13 pill packs) at once. Pharmacies in California are normally limited to a 100-day supply or 3 pill packs. This program provides researchers and public health planners the opportunity to look at the effects of the number of pill packs on use and unintended pregnancy.

Previous work has shown that dispensing a whole year's supply of OCPs at a family planning clinic visit can be cost-effective and result in fewer gaps in coverage and higher continuation than dispensing just 1 or 3 cycles at a time.[9] In the latest work,[8] researchers compared pregnancy rates in the year following the dispensing of oral contraceptives with 84,562 women in January 2006 through the California Family PACT Program. They found a significantly higher probability of pregnancy in 2006 among women who received 1 or 3 cycles (nearly 8%) than among women who received 13 (2.9%). Still, it is too early to draw any conclusions on the basis of these findings. The higher pregnancy rate among women receiving fewer cycles may well be the result of selection of more dedicated oral contraceptive users to receive a greater number of cycles. Conclusive findings about the effect of number of cycles on pregnancy rates are awaiting more complete data on abortions, and data for 2 natural experiments in which women were in effect randomized to receiving just 1 cycle or a year's supply due to stocking problems or a change in clinic policy.

Among the possible mechanisms for improving oral contraceptive access and continuation is the idea of making OCPs available to women without a prescription. A discussion of the clinical and logistical considerations was mediated in an APHA panel entitled "Moving Oral Contraceptives Over the Counter.[10"] Panelists presented data on the safety and efficacy of OCPs under a possible switch to over-the-counter (OTC) availability.

The promise of OTC access to oral contraceptives is that it will make this contraceptive method available to women who are at risk for unintended pregnancy but not currently using a method of contraception, as well as make it easier for current users to resupply. Seeking and filling a prescription can be a barrier to use especially among women with no insurance. Long waits to get an appointment, inconvenient physician hours, the expense of the doctor's visit, and a lack of time are reasons women participating in a national survey gave in support of streamlined access to pills at pharmacies.[11] More than a third of women who were not currently using a method of contraception said that they would start if they had direct access through pharmacies.

The US Food and Drug Administration (FDA) sets out the following criteria for medications to gain OTC status[12]:

  • The benefits outweigh the risks;

  • The potential for misuse and abuse is low;

  • Consumers can use them for self-diagnosed conditions;

  • The medication can be adequately labeled; and

  • Health practitioners are not needed for the safe and effective use of the product.

In their presentation, Kelly Blanchard and Dan Grossman[13] of Ibis Reproductive Health outlined how oral contraceptives may meet the criteria. They found:

  • The benefits of oral contraception are primarily in the prevention of unintended pregnancy. The risk to women from oral contraceptive use, even among some women for whom OCPs are contraindicated, is lower than the risk for pregnancy. Some nonpregnancy prevention benefits include long-term protection against ovarian cancer and treatment of conditions that worsen during menses, such as epilepsy, endometriosis, and acne.

  • The need for oral contraceptives is clear: Women can identify when they are sexually active and at risk for unintended pregnancy. Whether women are able to screen for contraindications is a larger question. Dr. Grossman examined concerns raised by physicians about self-screening and found that self-screening for contraindications is accurate, particularly among younger women.[14] Also, even under clinical screening procedures, some women with contraindications use OCPs.

  • The information needed to safely take OCPs can be presented simply through instructions for use, contraindications, and how to recognize serious warning signs.

  • The need for health practitioners to counsel women on the correct use of OCPs is not known; there is little evidence about the benefits to counseling on prevention of unintended pregnancy.[15] Clinical screening tests often associated with the provision of contraceptives, such as cervical cancer or sexually transmitted infection tests, are not preconditions for OCP use: Women do not need these clinical services to safely use OCPs.

Although the FDA's requirements for OTC status appear to be met by oral contraceptives, two other concerns remain around OTC access for OCPs: access to other reproductive clinical services and coverage of costs.

If women can get oral contraceptives without a prescription, they may no longer seek clinical care, such as routine exams, cervical cancer screening, and sexually transmitted infections. Further, although women may still come in for an annual exam, the motivation to do so may be lower if they do not need refills for hormonal contraceptive prescriptions. Some data lessen this concern, as findings have shown that a large number of women who don't use contraception still get Papanicolaou (Pap) tests.[16] Dr. Grossman stated that access to OCPs should not be "held hostage" to other healthcare services. In other words, although the other screening tests are important, there is no medical reason to make OCP access contingent on these screening tests.

The remaining concern is a logistical one -- that if oral contraceptives were available without a prescription, health insurance companies and Medicaid might no longer cover them under their prescription drug benefits. The net result for women may be an increase in the costs of using oral contraceptives as the cost shifts from insurance plans to out-of-pocket expenses. One solution would be to have some formulations of oral contraceptives available with a prescription and others available OTC. This would allow women with insurance to continue accessing their medication through their healthcare provider and allow women without a healthcare provider to buy the medication alongside other OTC drugs.

Research presented at the APHA meeting showed several mechanisms by which oral contraceptive access and use can be improved. From the research at APHA, 4 policy and patient care recommendations stand out:

  • There is no need to wait until after the patient's next menses to begin use of oral contraceptives. The first pill can be taken in the clinician's office or pharmacy.

  • Dispensing a year's supply of oral contraceptives per visit may improve contraceptive continuation and prevent unintended pregnancy.

  • Making oral contraceptives available without a prescription may be a safe and effective way to increase access to this effective contraceptive method; however, if OTC access reduces insurance coverage of the medication, the net effect on access to care may be deleterious.

  • Routine reproductive healthcare concerns, such as annual exams, Pap tests, and sexually transmitted infection screening and treatment, are important but do not need to be preconditions to oral contraceptive provision.


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