Symposium: The contraceptive patch: How will it impact your practice?

February 3, 2003

A group of leading clinicians who are familiar with the new transdermal contraceptive discuss how and why its use as a first-line option can make a dent in unintended pregnancy rates.

 

SYMPOSIUM

The contraceptive patch:
How will it impact your practice?

Despite the ready availability of safe, reliable, and effective contraception, the United States is still beset by an embarrassingly high rate of unintended pregnancy. Essentially one half of all pregnancies in America are unintended or unplanned.1 A complete discussion of the reasons is outside the realm of this roundtable. But whether we're talking about specific contraceptive-related or societal issues, there are things that we obstetrician/gynecologists can do to reduce that rate by improving the usage of available contraceptives and educating ourselves and our patients about new contraceptive options.

In my opinion, many patients lack a good contraceptive fit, a choice that suits their habits and lifestyles. Too many clinicians look to particular methods, primarily oral contraceptives, as the solution for the majority of their patients. OCs have been, are, and will continue to be the major form of contraception in the US.2 But they are subject to a high rate of misuse. More than a million pregnancies occur each year in women who are using OCs during the month in which they conceive.2

If we are to make a dent in this unintended pregnancy rate, we clinicians have to look to nondaily methods not just as "go-to" methods—those we resort to only when the Pill or the other options have failed—but as primary, first-line, mainstream options. That calls for an attitude change about how to start patients on contraception and how to manage them.

With that in mind, we have assembled a group of leading clinicians who are familiar with the recently introduced transdermal contraceptive to discuss its impact on clinical practice.

—Lee Shulman, MD, Moderator

Shulman: One of the new methods that recently became available in the US is a novel delivery of one of our standbys, combination hormonal contraception. Dr. Burkman, please describe the design and mode of action of the transdermal delivery.

Burkman: Certainly. The contraceptive patch is a flat, 20-cm square device using a matrix system. It consists of a top beige-colored protective layer over a second layer that contains the contraceptive steroids and glue. Beneath that is a transparent cover that is peeled off before being applied to the skin. The patch contains two hormones, norelgestromin (NGMN) (a major metabolite of norgestimate), and ethinyl estradiol (EE).

Patients can apply the patch to the buttocks, abdomen, upper arm, or torso, but not to the breast. They are instructed to avoid spots such as the waist, where the patch might be abraded by clothing or belts. A patch is worn for 1 week, then discarded, and a new patch put in place. The new patch should not be put on exactly the same spot, but can be placed on the same general area of the body. A patch-free week follows the conclusion of the third week, allowing for a withdrawal bleed.

The pharmacokinetic profile of the transdermal system is characterized by a continuous release of hormones. In contrast, the profile of a woman taking a pill containing the same components has large peaks and troughs that are typical of oral administration. Transdermal delivery also avoids the first pass through the liver because the drug is not being absorbed through the gut. This may ultimately have advantages for some patients.

Shulman: Let's move now to how and why transdermal delivery might improve pregnancy rates.

Unintended pregnancy

Williams: We've come a long way with availability of contraceptive methods, but best evidence shows us that 60% of the women who walk into our offices and clinics with an unintended pregnancy actually were using some form of contraception—maybe not using it appropriately or consistently or accurately. Issues of understanding and compliance go way beyond availability, and that may be our biggest challenge right now with the unintended pregnancy rate.

Burkman: Analyzing the gaps between typical-use pregnancy rates and perfect-use pregnancy rates, you see the biggest divergence with contraceptive methods that require action at the time of coitus or that require daily action. Methods with longer dosing frequencies or those that are largely out of the patient's control—such as injectables or implants—appear to demonstrate typical-use pregnancy rates that are much closer to perfect-use pregnancy rates. So a contraceptive used on a weekly basis may prove more effective than one used on a daily basis.

Archer: Certainly the efficacy of the transdermal system is equivalent to OCs, and at least in the clinical trials, typical-use rates indicate a positive effect. The clinical trial data suggest compliance is good, that most people can use this successfully. At least 90% of patients reported that they were using it appropriately and obviously successfully, judging by the very acceptable pregnancy rates.

Some unintended pregnancy seems motivationally driven. I sometimes wonder whether something inherent in human nature makes women deliberately put themselves in a position where they can become pregnant.

Shulman: You bring up an important point, Dr. Archer. Every day in our offices we deal with patients who exhibit risk-taking behaviors, whether it's with sexually transmitted disease, pregnancy, or cervical cancer. We see it more frequently in adolescents than in older women, but it touches on our patients' expectations and perceptions.

The appeal of novelty

And of course compliance is especially an issue with adolescents. New methods of contraception do not necessarily provide a better level of efficacy, safety, or reliability than conventional options. But new methods provide a different compliance regimen or different side-effect profile that may achieve a higher level of acceptance among women than has been demonstrated in the past. More options increase the chances that women will find a method that they can use consistently and correctly.

Zieman: I second your point, Dr. Shulman, that we should move away from that "new is better" concept, because historically when new methods come on the market, we've seen the boom followed by the bust. We think, "This method is going to answer the needs for so many people, let's put all our new patients on it." That is followed by a big disappointment and a bust. Again, we have to put these methods in the context of choice, and the more choices we have, the better fit we're going to make for individuals.

Shulman: Clearly, new methods in and of themselves don't solve problems, but better interaction with patients solves a whole lot of problems.

Williams: Just to play devil's advocate, occasionally "new" turns out to be better, but often not in the direction that we expected. We may have thought new was going to be better for one reason—like cycle control—yet it turns out that new is better because of compliance. New will have some advantages and disadvantages simply because new is different.

Zieman: And it's enough if new simply gives us something that women are happier with, making them more likely to be consistent and correct in their contraceptive use. Not everyone understands that user satisfaction is connected with contraceptive success. One of the most revealing questions during a talk I did last year came from a physician who asked, "Why would I bother counseling women on these new methods if the only advantage is compliance?" Formulary committees also have a hard time understanding why we would need so many different methods.

Side effects

Shulman: What can we say about the patch's side-effect profile?

Archer: All steroidal contraceptive methods are associated with side effects. These are low and limited, although they do account for some discontinuations. As long as a method is working and has an extended duration of action, there is less noncompliance, despite the side effects. Therefore I don't think compliance is so much side-effect driven as it is behaviorally driven by the patient.

Zieman: If we're proactive about counseling regarding side effects, women do much better and continuation rates are higher.

Archer: A lot of discontinuation for side effects, at least as I understand it from the Rosenberg paper, comes down to "I just don't like the method," or "I don't like how I feel."2 I don't know of any studies in which responses improve as the result of a method switch. Are side-effect profiles with hormonal contraceptives, particularly in the realm of "I just don't feel good," the same no matter which hormonal contraceptive you use?

Shulman: It depends on when you ask patients. I have a real problem with studies that say, "We looked at women 12 months after they began method X and 97% of them were happy with that method." Of course if they've been using it for 12 months and they're still using it, that means they're at least somewhat happy. I'm interested in what they say 3 or 4 months after initiation.

Of the "I don't like it" studies, the most enlightening response is from a University of Wisconsin study.3 They asked women, "Are you happy with your contraception?" Only about 65% said yes, but many of those women said that they would consider a new option. That's not a ringing endorsement, even for the majority of the satisfied women.

Williams: I've been very impressed that the women I've talked to define "better" simply as easier, regardless of side-effect profile.

Compliance

Archer: The compliance data for the transdermal delivery system show that younger women were much more compliant with the patch than with the oral method.4

Shulman: The information on the transdermal delivery system shows improvement in adolescent compliance up through 40-plus-year-olds—one of the first methods to show that. Compliance also improves with the monthly injectable, despite the issues of having to go to a clinic or office to get an injection.

We learned as second-year medical students that compliance and overall outcomes are going to be better when you have less interaction with the product—for most people, once-a-day dosing works better than four-times-a day dosing.

Zieman: For many women, convenience is an overriding factor in their initial choice. But I do see patients who experience side effects unique to a particular method. The hormonal side effects include headaches, breast tenderness, nausea, and, probably most importantly, bleeding. I do think that after the initial choice, side effects play a role in switching between methods. I find that women do respond differently to a different method.

Archer: The bleeding issue is the one that I see wherein delivery methods of hormonal contraceptives differ. I was really focusing more on the discontinuation rate for the generalized feeling of "I don't feel good." There may be subtle differences in the incidence of headaches between formulations and how you use them, but I was always impressed that even users of the progestin-only implants had a fairly high incidence of headaches, too. I'm not sure if either formula or delivery matter—it's just a general steroid effect.

Williams: About 10 years ago a study looked at reasons for OC discontinuation.5 The number one explanation by patients was that they didn't feel good or feel right, that they felt different. It was something totally subjective that they couldn't articulate precisely. Obviously, bleeding was second and the rest of it came down the line, but women were stopping their OCs because they just didn't feel well.

Shulman: And our OC discussion is a good place to make it clear that while our focus is on the transdermal system, we do not mean to disparage any other method. Clinicians need to understand the role of all methods in the overall contraceptive armamentarium, and know how to guide patients in proper and consistent use.

Assumptions about patients

Archer: How much does the physician's attitude toward a method drive acceptance by a patient? Or how much does physician attitude toward a patient affect what he or she will prescribe?

Zieman: Niching is a big problem that we should tackle in examining our own practices and in educating providers and recognizing our biases. Providers may assume that their private patients or middle- and upper-class patients are going to be better pill takers, but we know that pill-taking success is not related to education level or economic status.

Shulman: Those assumptions can be dangerous. The best pill takers among my patients are not women with PhDs but rather single mothers who cannot afford another mouth to feed and understand the implications of not taking that pill every day at the same time.

Zieman: Women want to be informed about all these methods so they can make the best choice for themselves.

Shulman: I agree, Dr. Zieman. That is truly the issue. If we want to empower women to have better control over their lives, we're going to need to stop making assumptions. We need to offer these new methods, including the patch, as first-line, mainstream options.

Archer: Contraceptive clinics seem to have a much more even-handed counseling technique and the choice of options is different than in the practicing physician's office in suburban USA.

Transdermal pros and cons

Shulman: What aspect of this contraceptive delivery system do you think will play the biggest role in its acceptability in the American marketplace?

Burkman: I'd say the weekly dosing, so that a woman has to remember only three events per month, rather than 21 events per month.

Williams: Even with those three events per month, a patient has at least a 24-hour time period in which to change her patch. Women are told to take OCs not just once a day, but optimally at the same time every day. With the patch, being off by a few hours does not make a difference. Given this steady-state hormone level, basically any time within the change period patients can just take one off and put the next one on.

Archer: I agree with you, Dr. Williams. Relative to timing, the patch is more forgiving than the birth control pill. It has to do with the extended duration of the delivery in the pharmacokinetic profile of this particular transdermal system.

Shulman: I see potential promise in the pharmacokinetic profile of the patch, as well as the contraceptive vaginal ring, for those women who choose to reduce their number of menstrual withdrawal bleeds. The steady-state administration, without the peaks and troughs, may well result in better untimely bleeding rates than oral contraception when used in an extended use regimen.

Burkman: Some women don't want to go the extended-use route because the withdrawal bleeding reassures them that they are not pregnant, especially if they have trouble remembering whether they've taken their pills. With alternative systems, particularly the patch, they can see if it's still there and feel confident.

Williams: Yes, we shouldn't underestimate the importance of a patient's seeing her contraceptive method. I've had relative success suggesting to women that they don't need an artificial withdrawal bleed every month. But I'm always impressed at the number of women who still insist upon having that bleed. It comes down to admitting that they missed a pill or two and they need that reassurance. If women can see or touch their contraceptive method every day, they will have less need for that constant monthly reassurance.

Educating women that they need not have a withdrawal bleed every month when on a sex steroid further empowers them to choose what kind of lifestyle they want. It's important to ask patients what they want or expect from their menstrual pattern. Are they looking for once a month or twice a year?

Burkman: Of course, an extended-use regimen does constitute off-label use.

Shulman: Well, we've spoken about the positive aspects of the transdermal delivery system and pharmacokinetics. Do you see any negatives?

Zieman: A cautionary note: Do not assume—as some people do—that because a product is transdermal, it's safer. As we saw when the newer progestins came on the market, clinicians prescribed them differently assuming that they were somehow safer.

Shulman: With transdermal administration there is no gut metabolism and no first-pass effect, and there is potential improvement in the coagulopathic profile. We have good laboratory data but no clinical data regarding safety.

Zieman: The clinical data that we do have show the coagulopathic effects of the patch to be similar to OCs. We don't have enough numbers to say better or worse.

Williams: We have to be careful with sex steroids that are ultimately metabolized in the liver. We should definitely not jump to any conclusion that bypassing first-pass metabolism is going to make a profound clinical difference.

Shulman: Yes. I think it's unwise for us to give even subtle encouragement to use these formulations to patients who shouldn't use pills. Until we have reliable clinical data, we should consider the contraindications to OCs as the contraindications to the patch, the ring, or the combination injectable.

Archer: I absolutely agree. I think risk for adverse events like venous thromboembolism does not depend on the route of administration but rather on the impact of the sex hormone on the endothelial cell and whatever other clotting factor or factors that are involved.

Weight and efficacy

Limited trial data suggest that the pregnancy rates are somewhat higher in women who weigh more than 198 lb. This is probably not unique to this system; it's been shown with levonorgestrel implants6 and a recent OC study that also shows higher failure rates among heavier women.7 And this issue is being studied much more widely. While that does not mean that this method is contraindicated, it is a consideration with larger women. To put it into perspective, the typical-use failure rate with the Pill probably will be higher for lousy pill takers than the results that will be seen with the patch in that weight group. Patients who weigh more than 198 lb do require special counseling.

Williams: An NIH study published in May, ironically 2 days after the introduction of the transdermal system to the market, showed a 60% increase in failures in women who were in the fourth quartile of body weight.7 This was a huge retrospective cohort study.

Let's not fall into the trap of talking about relative risk versus absolute risk. If we take the accepted perfect-use failure rate with an OC to be around 1%, a relative risk of 1.6 (or a 60% increase) translates into an absolute risk of about 1 1/2%.

Archer: Interestingly, the typical-use failure rates that we've had in the past for hormonal contraceptives have never really addressed the weight issue. Clinical trials in general have restricted the upper limit of weight in participants. I wonder how much typical-use failure could be due to weight.

Shulman: Exactly. I frequently hear that there is no published weight-associated drop in efficacy with the vaginal ring contraceptive. That annoys me, because there was a weight cut-off in those studies, so there are no data. Absence of data doesn't indicate the absence of an effect.

That doesn't preclude your using hormonal contraceptive methods for a patient who weighs more than 198 pounds, but you do have to discuss it with her.

Williams: I can't say this strongly enough: If we are counseling women who weigh more than 198 lb about the decreased efficacy of these newer methods, we have to have that same discussion with our pill takers who are overweight, too.

Burkman: Actually the cut-off in the OC paper, if you look at the data, is much more like 155 lb, so we're going to have a lot of discussions.

Climate and patch adherence

Zieman: Patients may not be used to thinking about a patch as reliable contraception. It is a new concept for them that something worn on the skin can actually prevent pregnancy. We have to explain that it is a very effective method, in part by addressing fears about losing the patch.

Archer: If a patient isn't able to keep that patch on snugly, there could be a loss of efficacy. Skin adherence was a problem in about 2% of the population in studies of the patch.

Burkman: Regarding partial displacement of the patch, we should point out that the instructions given in the clinical trial stage were different from those now provided to patients. In the trials, when there was a recorded rate of 1.8% complete detachment and 2.8% partial detachment, the instructions were to remove the patch and replace it with a new one with any level of detachment. Now we counsel patients to see if they can re-stick the patch if it's come unglued. If you hold the loose edge down, it often can be reapplied successfully.

Archer: Yes, but I would caution against stretching a piece of adhesive tape over the patch to hold it in place.

Shulman: The manufacturer says you should not do that. You try applying pressure for 10 to 15 seconds; if it does not reapply at that point the patch is taken off and replaced. The procedure is different from that used with menopausal hormone therapy patches, which can be taped down until the regular time to change the patch (Figures 1 and 2).

 

 

 

Williams: I'm told there is a pharmacodynamic reason why you can't occlude the upper surface of the patch. According to people who helped design this product, the reattachment instructions reflect how this hormone penetrates the skin. In fact, the upper layer of the patch is porous. Heat and moisture from the skin evaporate up through that upper layer and somehow drive the drug through.

Shulman: Because of adhesion concerns, the patch was studied in hot, humid areas—Florida, Georgia, and Louisiana. There was also a small randomized, open-label study of 30 women who wore the patch for 7 days under various conditions of heat, humidity, and exercise (for example, sauna, whirlpool, treadmill, etc.), in order to evaluate patch adhesion under those conditions.8

Archer: With what results?

Shulman: The patch delivered effective concentrations of NGMN and EE and adhesion was reliable, with only 1.1% of 87 patches completely detaching spontaneously. However, I'm also concerned about patch adhesion in places like North Dakota when it's 240° and the humidity is 8%. We could use a short study looking at the detachment rate in a cold, dry climate.

Archer: Do you think that these products can become brittle?

Shulman: No, but the skin is definitely drier in a cold, dry climate.

Williams: I have heard that it's dry skin that doesn't hold the patch, not the other extreme—hot, sweaty skin—that had concerned us.

Shulman: There were Canadian study sites, but they haven't teased out those data, so we cannot definitely say that dry skin is problematic with the patch. Of course, a woman should not use a lotion or moisturizer under the patch.

The only skin type clinicians want to avoid is any skin with a lesion. As with any therapeutic patch, one doesn't put a contraceptive patch on any dermatologic lesion, such as eczema or seborrhea.

Williams: Skin condition aside, does it make a difference where on her body (which of the four approved locations) a woman wears her patch?

Shulman: Investigators consistently found less absorption through the abdomen than at other body sites. However, despite this pharmacokinetic difference, there is no alteration in efficacy based on patch placement.

Archer: It seems to me if a woman puts a transdermal system on her abdomen and bends forward, then the abdomen wrinkles and diminished contact could mean diminished absorption. If it's put anywhere else where the skin is tauter, there's less likelihood of wrinkling.

Burkman: Even on the buttocks.

Archer: Yes, anywhere else, it's less likely. Simplistically, you could say that peaks and valleys in the skin beneath your patch would affect delivery and therefore efficacy.

Burkman: And yet the data examining the forgiveness—when women wore patches for 2 days beyond the recommended week—was exclusively based on abdominal applications.

Williams: Is it reasonable to tell a patient who weighs more than 198 lb to refrain from wearing the patch on her abdomen, to wear it instead on one of the other three sites? That might maximize protection for heavier women.

Burkman: On the other hand, perhaps women who have excessive fat have more capillaries in their belly, so maybe abdominal application is better for heavier women.

Shulman: Different fat types may predispose to different delivery rates of sex steroids to the circulation. We don't know how a woman with brown fat differs from a woman with yellow fat or a mixed type of fat. Is weight an issue because the greater amount of blood volume and serum has a dilutional effect and, therefore, a lower concentration of the drug reaches the ovaries or CNS? We don't know.

Burkman: Or is it tied up in the fat? Steroids are fat-soluble.

Dose differences

Williams: Too often clinicians see the dose of estrogen in the patch or the ring and say, "Oh, the patch is just like a 20-µg pill or the ring is a 15-µg pill." It's very important that clinicians understand that there's no mathematical formula by which you can compare the dose of something given systemically at a steady state with the dose of a daily pill. There are very elegant studies showing the differences in actual serum levels with the two systems.9,10 So I would hope clinicians would not look at the patch or the ring as some form of ultra-ultra low-dose estrogen product.

Shulman: Although some people dismiss the importance of educating practicing doctors on pharmacokinetic issues, there are profound differences between transdermal administration and other routes of delivery. For instance, why do we see different rates of breast tenderness with ostensibly similar levels of sex steroids? With this transdermal system we have essentially a fivefold increase in reported breast discomfort. That increase is self-limited, and the patch is not associated with increased risk of adverse outcomes related to the breast, such as lesions that require biopsy. How should clinicians approach this issue?

Williams: The studies have shown that the breast tenderness problems were limited to the first two cycles of a 13-cycle study, which meant that no increased breast tenderness occurred in cycles 3 through 13. So obviously it occurs early on but dissipates over the first month or two.

Burkman: It's fascinating because that wasn't reported in the contraceptive ring trials (another system with continuous absorption). I would have predicted that OCs would produce that effect due to the resulting very high peaks of estrogen.

Shulman: Women do experience breast tenderness with OCs.

Burkman: But not at the same rate with initial use, so it's perplexing why this occurred. I have no real explanation for it. The bottom line is that while it obviously is not life-threatening, it's certainly a surprise to patients unless you counsel them about it. If roughly one in five will experience some degree of breast tenderness—at least enough to report it in a clinical trial—we need to reassure patients that this effect will probably dissipate within a couple of cycles. Only 1% of women in the clinical trials discontinued because of breast tenderness.

Shulman: What's even more fascinating is that we saw no difference between pill and patch users with regard to nausea, which again you would assume to be a sex steroid-related phenomenon.

Archer: The difference may have to do with clinical trial design. A woman starting on a new medication will initially be looking for problems and is going to report them. After she's been on a product a month or 2, what she's been reporting is often no longer a significant issue for her. And with a contraceptive trial, obviously there's no placebo comparator, so we have no idea what the background rate would have been in this group. I think it's just a blip of activity that is artifactual to clinical trials.

Williams: I want to ask, "breast tenderness compared to what?" Compared to the Pill they used to be on, or compared to not taking any form of hormonal contraception? Certainly, patients report breast tenderness with a normal physiologic menstrual cycle.

Shulman: A recent paper reported that 19 of 812 women complained of mastalgia.11 That to me is a high rate of breast discomfort.

Burkman: In placebo-controlled trials, in many instances the placebo group experienced many of the same side effects as the group taking the active drug. Headache, for example, is very common, and trying to decide how much is related to medication or just the luck of the draw is very difficult.

Archer: Women using a hormonal contraceptive are focused on where that hormone is acting. In terms of women's perception, the breast is obviously the major site, other than the vagina or uterus, and so they just pick on that. It's not relevant to the actual overall problem-related adverse effect; it's just a fluke.

Burkman: Assessing weight gain was one aspect of the patch studies where there was a placebo control. This is a spin-off of a lipid evaluation. Women were weighed over a 9-month period of time while using either the transdermal patch or a placebo patch. Weight gains and losses were the same between the placebo group and the patch users, so it appears that—at least during the first year—any change in weight is probably unrelated to the use of this particular system.

Williams: One of our least successful educational campaigns is getting women to understand that—with very rare exceptions—hormonal contraception has nothing to do with weight gain. The placebo-controlled trial with the patch was useful, because if women believe the pills cause weight gain and the patch acts like the Pill, then they're going to believe the patch causes weight gain. So, in fact, what I thought scientifically an unnecessary trial is probably a very necessary trial, giving us this kind of evidence.

Zieman: A lot depends on how the questions are asked in these studies, that is, "Did you have any breast discomfort in the past month?" Well, maybe the subjects had it at baseline, too, but I don't think we have that information.

Shulman: I'm less concerned about quantification here than qualification. The degree of discomfort a woman had going into the study is a vital clinical issue, but if she perceived a difference in breast discomfort related to the drug she is using, it obviously needs to be addressed. If a patient is prepared for possible breast tenderness, she'll likely respond to it more reasonably than to an unexpected adverse event.

Williams: How is that any different than what you tell a new-start pill patient?

Shulman: Let's make that what hopefully our colleagues are going to start telling new-start contraceptive patients. How do we overcome misperceptions? What do we tell our colleagues so that they feel comfortable not just with this but also with the other relatively novel contraceptive methods?

Burkman: Well, we do studies to get information that we then can apply to practice. Misperceptions grow when clinicians don't counsel patients about expectations. Clinicians should neither over- or undersell any new drug or any new system. The bottom line is that patients need to be informed about potential problems they could face. I think education can overcome misperceptions, if clinicians clearly communicate available information to patients. If a woman has no surprises in the first few months of use, she's less likely to discontinue because she mistakenly interprets a side effect as a sign that either the medication isn't working or that some terrible event is about to occur.

Shulman: Dr. Zieman, what do you see as the major roadblock to getting the message out with the transdermal method?

Zieman: Clinicians have to want to take the time to learn about any new method or product and then counsel their patients.

Shulman: Now I'm going to be the devil's advocate. Dr. Zieman, has the patch been too well accepted for a new method? I'm alluding to the rather early direct-to-consumer campaign?

Zieman: It brings us back to the boom and bust. Let's hope that that doesn't happen.

Williams: If there's an unusual side-effect profile—things that no one anticipated going in—that's where the bust will come in. So I think the women themselves are going to determine the ultimate success of all of these delivery methods.

Burkman: It still comes back to communicating expectations. As long as patients understand that the patch is like a birth control pill in its side effects, then there are no surprises. Clinicians have a big role to play that can certainly avoid unnecessary busts.

Zieman: We need to be proactive in explaining the side effects that we discussed and that are common to many of the hormonal methods. Specific to the patch, we need to bring up the possibility of application site reactions and, more commonly, the grunge factor around the patch, because women are surprised when they see that. I let them know that the appearance of the patch can change and that they can expect to get a ring around it. By the way, baby oil on a cotton ball or pad can be used to clean it. Alcohol also works, but it can be dehydrating and irritating to the skin.

Counseling in a time crunch

Williams: What about the extra time it takes to counsel a patient about any of these new products, but specifically the patch? Take this familiar scenario: It's late in the afternoon, you're an hour behind schedule, with a full waiting room. The next patient is a 25-year-old pill taker, coming in for her annual visit, who has seen the patch sign in the waiting room, and you think, "Please don't ask me about the patch, because I just don't have an extra 3 minutes to spend."

Burkman: That pill taker could be someone who misses three pills a cycle and just by the luck of the draw has not gotten pregnant. And it may be the next month she'll be knocking on the door for a pregnancy test.

Shulman: So the ob/gyn can talk to her now or talk to her later.

Williams: I haven't found that it takes a great deal of time to counsel women about the patch.

Shulman: Perhaps the old paradigm for counseling no longer fits with the way we provide health care now. Whether for a discussion of genetics or new classes of contraceptive options, I agree with that clinician: I don't have 3 1/2 more minutes. Do we now look elsewhere? Planned Parenthood offers one model. In addition to health-care providers who do exams and clinical work, they have staff counselors working with patients. That formula won't work in most private offices, I understand, but in our societies or professional colleges, we're going to have to reevaluate and reformulate the way we counsel patients, particularly about contraception.

Burkman: Hiring counselors is not cost-effective for most practitioners.

Shulman: It is an increasingly difficult barrier for the average practicing clinician to navigate through the obstacles to effective counseling.

Burkman: What happens then is limiting. Let's say there's a patient with hot flushes who may benefit from hormone replacement therapy for a few months. The busy clinician is just going to say HRT is not an option for her because a full discussion is too time-consuming. The same thing can happen in contraception. "I'm too busy" becomes "That won't work for you. You're too heavy."

Zieman: That brings us back to the provider bias that occurred with levonorgestrel implants. It was just too time-consuming.

Archer: Yes, I've heard the same thing about intrauterine contraception, that insertion is too time-consuming. It can take 5 to 6 minutes to get everything ready to put in an IUD. There's no getting around it.

Burkman: That's where the doctor becomes paternalistic. "Let me decide what I think is best for you," which really means what is better for the doctor.

Conclusions

Zieman: We hope that new contraceptive options will be considered as useful mainstream options. We've discussed these newer hormonal options and focused on the patch, but let's be sure to mention that for many women it's appropriate to use dual methods and to add condoms for prevention of sexually transmitted infections. We also need to be proactive about offering emergency contraceptive for the times women fail to use these methods consistently.

Williams: It's interesting how medication delivery systems change through the generations. My mother used to feel when she took me to a pediatrician, that if I didn't get an injection, she wasn't getting her money's worth, because no worthwhile medicine could possibly come in pill form. We've since evolved into a pill-taking culture and I think now we're ready to take the next step: that new delivery systems in medicine are what we're going to see. Contraception is leading the way with new delivery systems of medications to be used on a long-term basis.

Burkman: We still have a significant unplanned, unintended pregnancy rate in this country. If new contraceptive methods are going to reduce this rate, we need to move toward an era in which the patient takes an active role in choosing a method that fits her lifestyle. The more choice, the more we interact with the patients, the increased likelihood is that we'll be able to do something about what is a significant public health problem.

Archer: My biggest problem is figuring out what a patient wants, so she has to tell me. But I think it's up to the physician to explain to a woman the variety of available options—as if offering a menu to a customer entering a restaurant—and have her decide what she likes best in her lifestyle.

Shulman: When we recognize that the most important part of the contraceptive process is the initial patient counseling, we will have happier patients, far fewer unintended pregnancies, and will have achieved a greater positive impact on our patients' lives. And that is ultimately what we all want. How we get there will depend primarily on our patients. We and our colleagues, physicians as well as nurses and other health-care professionals, have to learn about these options, to be nonjudgmental in our counseling, and to support patients in their choices. And if those choices don't work out, for whatever reason, again we should be nonjudgmental and go back to the armamentarium to help patients find another method. As you said, Dr. Archer, if we do not look at these methods as first-line, mainstream options we are going to maintain an embarrassingly high unintended pregnancy rate in the US. With that, I thank you all for your participation.

REFERENCES:

1. Henshaw SK. Unintended pregnancy in the United States. Fam Plann Perspect. 1998;30:24-29,46.

2. Rosenberg MJ, Waugh MS, Long S. Unintended pregnancies and use, misuse, and discontinuation of oral contraceptives. J Reprod Med. 1995;40:355-360.

3. Eilers GM, Swanson TK. Women's satisfaction with Norplant as compared with oral contraceptive. J Fam Pract. 1994;38:596-600.

4. Archer D, Bigrigg A, Smallwood G, et al. An integrated assessment of patient compliance with a weekly contraceptive patch (ORTHO EVRA/EVRA). Abstract 50. Presented at the ASRM, Orlando Fla., September 2001.

5. Ortho Annual Birth Control Study (1991), Ortho Pharmaceutical Corporation, Raritan, NJ.

6. Sivin I, Mishell DR Jr, Diaz S, et al. Prolonged effectiveness of Norplant capsule implants: a 7-year study. Contraception. 2000;61:187-194.

7. Holt VL, Cushing-Haugen KL, Daling JR. Body weight and risk of oral contraceptive failure. Obstet Gynecol. 2002;99(5 Pt 1):820-827.

8. Abrams LS, Skee DM, Natarajan J, et al. Pharmacokinetics of norelgestromin and ethinyl estradiol delivered by a contraceptive patch (Ortho Evra/Evra) under conditions of heat, humidity, and exercise. J Clin Pharmacol. 2001;41:1301-1309.

9. Dittrich R, Parker L, Rosen JB, et al. Transdermal contraception: evaluation of three transdermal norelgestromin/ethinyl estradiol doses in a randomized, multicenter, dose-response study. Am J Obstet Gynecol. 2002;186:15-20.

10. Timmer CJ, Mulders TM. Pharmacokinetics of etonogestrel and ethinylestradiol released from a combined contraceptive vaginal ring. Clin Pharmacokinet. 2000;39:233-242.

11. Sibai BM, Odlind V, Meador ML, et al. A comparative and pooled analysis of the safety and tolerability of the contraceptive patch (Ortho Evra/Evra). Fertil Steril. 2002;77(2 suppl 2):S19-S26.

SUGGESTED READING

Burkman RT. Compliance and other issues in contraception. Int J Fertil Womens Med. 1999;44:234-240.

Piccinino LJ, Mosher WD. Trends in contraceptive use in the United States: 1982-1995. Fam Plann Perspect. 1998;30:4-10, 46.

Shulman LT. Advances in female contraception: current alternatives to oral regimens. Trends in Endocrinol. 2003. In Press.

Zieman M, Guillebaud J, Weisberg E, et al. Contraceptive efficacy and cycle control with the Orth Evra/Evra transdermal system: the analysis of endometrial bleeding. Fertil Steril. 2001;75:1080-1087.

 

Acknowledgment

The panel would like to thank Deborah M. Smith, MD, MPH, of Howard University College of Medicine for her work in creating Figures 1 and 2.

 

DISCLOSURES

Dr. Shulman receives grants and research support from Berlex Laboratories, Pharmacia, and Ortho-McNeil Pharmaceuticals, and is a consultant for Berlex Labs, Pharmacia, Ortho-McNeil, and Pfizer. He serves on the Speakers Bureaus for Berlex Labs, Pharmacia, and Ortho-McNeil.

Dr. Archer is a consultant for Wyeth-Ayerst Labs, Organon, Inc., Rhone-Poulenc-Rorer, Solvay Pharmaceuticals, Berlex, Eli Lilly & Co., TAP Pharmaceutical Products, Inc., and BioSante Pharmaceuticals, Inc., and has received grants from Schering-Plough, Berlex, Ortho (RW Johnson), Wyeth-Ayerst Labs, Organon, Inc., UpJohn Pharmaceuticals, Novo Nordisk Pharmaceuticals, Alza Pharmaceuticals, and Parke Davis. He is on the Speakers Bureaus of Novo Nordisk, Ortho, Wyeth-Ayerst Labs, UpJohn Pharmaceuticals, Eli Lilly & Co., and Solvay Pharmaceuticals.

Dr. Burkman receives grants from NICHD and Ortho-McNeil, is a consultant for Pharmacia, and is on the Speakers Bureaus of Ortho-McNeil, Berlex, and Wyeth.

Dr. Williams is a consultant for Eli Lilly and Ortho-McNeil. He serves on the Speakers Bureaus of Ortho-McNeil, Organon, and Pharmacia.

Dr. Zieman is a consultant for Berlex Laboratories and Ortho-McNeil. She serves on the Speakers Bureaus for Berlex Labs, Pharmacia, Ortho-McNeil, and Wyeth, and receives research support from Berlex Labs, Pharmacia, and Ortho-McNeil.

 

Dr. Shulman is Professor of Obstetrics and Gynecology and Molecular Genetics, Director of the Division of Reproductive Genetics, and Deputy Head of the Department of Obstetrics and Gynecology at the University of Illinois at Chicago.
David F. Archer, MD, is Professor, Department of Ob/Gyn, at Eastern Virginia Medical School, and Director of the Contraceptive Research and Development Program, Clinical Research Center, Norfolk, Va.
Ronald T. Burkman, MD, is Chairman, Department of Ob/Gyn, Baystate Medical Center, Springfield, Mass., and Professor and Deputy Chairman, Department of Ob/Gyn, Tufts University School of Medicine, Western Campus, Springfield, Mass.
J. Kell Williams, MD, is Associate Professor and Director, Division of Gynecology, University of South Florida College of Medicine, Tampa, Fla.
Miriam Zieman, MD, is Associate Professor, Department of Ob/Gyn, Emory University School of Medicine, Atlanta, Ga.

Key points

  • Anticipating patients' expectations about new contraceptive options and providing adequate counseling can help curb the high rate of unintended pregnancy in the US. So can having patients take a more active role in choosing a birth control method that fits their lifestyles.

  • Lowering the pregnancy rate may call for an attitude change on the part of ob/gyns who haven't considered novel delivery methods like progestin-releasing IUDs, the combination injectable, rings, and transdermal contraception as first-line mainstream options when starting patients on birth control.

  • The transdermal approach avoids the first-pass metabolism through the liver. Because the patch continuously releases its hormones for 1 week—in contrast to the high peaks and low troughs that are typical of oral administration—daily timing is not an issue.

  • Until reliable clinical data accrue, clinicians should consider the contraindications to OCs as the contraindications to the patch, the ring, or the combination injectable.

  • New methods of contraception might not be any more effective, more reliable, or safer than conventional options—but may be better accepted and, therefore, used more consistently and correctly.

 

David Archer, Lee Shulman, Miriam Zieman, J Williams, Ronald Burkman. Symposium: The contraceptive patch: How will it impact your practice?. Contemporary Ob/Gyn 2003;2:67-90.