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Dr Lee Shulman

Good afternoon, everyone.  Thank you, Ron.  These are truly exciting times for us in providing contraception and healthcare to women, but with that excitement comes some responsibility.  Responsibility on our part is to learn about these new methods and in a real sense to somewhat change our way of providing these methods, because in a real sense it has been the system, not so much the method, that has I think failed our patients and why we have one of the highest rates of unintended pregnancy in the United States.

In a real sense, our ability to provide contraception is not so much directly linked with the efficacy of a contraceptive method.  As Ron showed you, and I think all of you probably know very well, perfect use or efficacy of most of these sex steroid methods is similar.  Well over 98% to 99% effective when used properly, but there is an incredibly important phrase there:  when used properly, and that’s really where we come into play.  Obviously, in order for us to be effective clinicians, we have to have the knowledge to help our patients choose and use their methods properly.  But I think where the change has to come and it has to start with practitioners like yourselves, it has, the message has, in fact, to go out past this meeting.  It is, it is not our job or our responsibility to help patients make decisions.  It is our responsibility to empower those women to determine what methods they are most likely to use consistently and correctly.

This part of the presentation is going to give you in a sense the nuts and bolts of how to use or so ever, how to use the transdermal contraception system for those patients who choose to use this particular method.  But ultimately what our greatest responsibility is to be educators, in a sense to support our patients in helping them find out what ultimately is going to be successfully incorporated into their lifestyles.  So the counseling remains not just for the transdermal patch but also for all the new and not so new methods.

The most critical aspect of knowing how these methods work and being effective clinicians for our patients, as Ron showed you earlier, this is essentially not your grandmother’s patch.  This is not the reservoir patch that many of you may have used in the ‘70s and early ‘80s.  This is a matrix patch and essentially what the matrix patch is it has the drug in the glue.  The glue is rather adherent to the skin which, as you’ll see in a little bit and as you saw just before, results in very low rates of detachment, but it also provides a far more steady state pharmaco dynamic, as also you’ve seen, providing in a sense the capability of this particular delivery system to provide a steady state of sex, sex steroids and hopefully a far more beneficial efficacy as far as, well, as side effect profile.

Very simply, the transdermal system is placed on clean, dry skin, except in overlying the breast or genital areas.  It obviously should not be placed in an area of the body that undergoes a considerable amount of movement.  I have many patients, both had at the University of Tennessee in Memphis where I was before as well as now at the University of Illinois, that place this patch on the abdominal area, in the buttock or even on the shoulder.  But obviously should not be in the areas like the scapula or near the neck.  So anywhere where a patient, a woman can in fact obtain clean, dry skin, frequently after a shower, that doesn’t undergo a lot of movement, is going to be the ideal location for the placement of the patch.  One other note is that when a woman replaces the patch in the appropriate time period that the next patch should not be replaced on an area of skin under which a patch just recently was placed.  It should be moved somewhere away from the previous patch site.  It can stay on the same side of the body.  I have some patients who stay a particular month cycle on one side of the body and go to the other.  I have other women who, in fact, go from one side to another every week.  Whatever works for that particular woman is obviously appropriate, it just should not go back on the same skin site.

As Ron showed you with the pharmaco dynamics, there is, there are differences between the transdermal system and the oral system and one of the major differences is that we don’t get into that therapeutic range immediately as we do with an oral method or with an injectable method and, as a result, this particular method is optimally begun on the first day of a withdrawal bleed.  Now some women may not like that or may not choose to go that route.  For those women who choose not to go that route and want to do the Sunday start, that’s okay except the recommendation is that the woman uses a barrier method of contraception for the first week of the first cycle.  Once that first week of the first cycle has been completed, then the woman can in fact engage in, in intercourse without the need or, or the desire if she so wishes to use a barrier back-up method.  Again, it is a weekly cycle; it is removed and replaced every week.  At the end of the third week, the patch is removed and, in a conventional state, that particular method then is a patch-free week.  What we have during that patch-free week is the vast majority, well over 97% of women, actually, well over 99% of women, will in fact have some sort of withdrawal bleed in that patch-free week.  Once that patch-free week has been completed, then the next cycle, if you will, begins.  Obviously this method, as well as oral contraceptives and the vaginal ring, are potentially amenable to continuous use.  Obviously, the patch, the ring and most of these, have not been approved for that particular usage, but I would daresay that many of you in this room are using these particular methods in this regard, whether it’s to reduce the number of withdrawal bleeds or, in fact, to try to eliminate the number of withdrawal bleeds.  So this method is obviously amenable to conventional use, in a sense, a standard 21/7 modality, but also may be amenable to continuous use, as a continuous use regimen.

The question you may have is why is there no placebo patch.  I think many of us have spent a large part of our careers looking at the, at patients and trying to find for them a regimen that is easily inclusive into their particular lifestyles and I think, for many us, we have found that providing, in a sense, reinforcing pill-taking behavior or contraceptive use behavior has, in fact, improved overall compliance and yet for this particular method, we have no placebo patch.  The major reason was to try to avoid a potential confusion with a placebo patch which would obviously not provide sex steroids versus an active patch which would provide sex steroids and it regards both ways:  we don’t a woman who is in the middle of her three weeks of active sex steroid use to go ahead and use the placebo patch or vice versa.  Again, we, if you do apply a new patch which was a placebo you would ostensibly increase the risk of pregnancy.  In another sense, the patch change day is the same activity every week and we have some information that, in fact, this does not considerably improve compliance and, in fact, within clinical trials many, in fact, most of the participants expressed, did not express a need in fact for a placebo patch.  Once that patch-free week has completed, then she begins a next cycle, another four-week cycle.

Ron mentioned three, actually several issues.  I want to address three important counseling issues when you’re discussing this method with patients.  Number one is the patient.  I think most of your patients are going to be asking you, “does it fall off?”  The answer is obviously yes, but very, very infrequently.  We’ve assessed patch adhesion in multiple studies and multiple venues.  We now have information on more than 70,000 patches that have been worn.  The results, especially in cycle 6 to 13 when you have women who are experienced with this particular method shows that only 4.7% of patches were replaced, either because they fell off or were partly detached.  Now what’s interesting is that in these preliminary studies, the instructions given to women is that if, if the patch was to be partially detached, they were to remove and replace.  That is not in a sense the instructions that are given either on the package insert or what you should be telling your patients.  If the patch is partially detached, they should attempt to reattach it by applying some pressure on it for about ten to fifteen seconds.  If the patch reattaches, she continues on.  If it fails to reattach, then she needs to replace it.

So in the phase three trial, we had in a sense different instructions for patients that we, that in fact, we are to provide our patients with currently and then similarly in a small study of patch wear under, I would say extreme conditions of exercise and as Ron described earlier in the exercise study and warm, humid climate studies, again we found no increased risk of patch detachment, so you have a patient who runs, who swims, who showers two to three times a day, she is not going to increase the risk of detachment by her lifestyle.  Detachment in this situation and replacement for that, except that it is far more likely to be less than that with current appropriate usage of the transdermal patch.  When we take a look at warm, humid climates, again we find no increase, no real or even statistical increase, in detachment rates, either partial or complete and, in fact, in the exercise study again, little over 1% detachment rate in women who were undergoing considerable exercise during the weeks that they were in the study using the patch.

What do you do, however, how do you counsel your patients about partial or complete detachment?  This is a rather simple algorithm, but it really does provide all the answers that you and your patients are going to need.  If the detachment is noted to be less than 24 hours, you obviously, as I said, attempt reattachment.  If you’re successful, if the woman is successful, she continues on, no change.  If she is unsuccessful, she replaces the patch, but the change there remains the same, so you replace the patch and no change in the patch change day.  If the detachment, partial or complete, is more than 24 hours or if the woman is unsure, she stops the current cycle and starts a new cycle by applying a new patch and uses back-up contraception for a week.

What about the other issues?  Not detachment but forgetting to replace a patch.  Well, in week one, the patch is applied as soon as it’s remembered and she obviously then needs to go back to using barrier methods for back-up for the first week of that new cycle.  If it’s in week two or three, maybe she’s already had the first week in, if you will, and now she has forgotten to replace week two or week three, if it’s less than 48 hours, again remember Ron’s slide on the pharmacokinetics, that there is, in a sense, that window of forgiveness that most extended-use regimens, most non-daily use regimens, do in fact have, whether you’re looking at IUDs, implants or injectables.  In this situation, if she has forgotten she was supposed to remove and replace on a Sunday but she wakes up Monday morning remembering that she forgot to remove the current patch, she applies a new patch immediately, no barrier back-up method is needed, she goes ahead with the same regimen.  If it’s, however, more than 48 hours, then she removes the current patch, she applies a new patch and she uses, and in a sense starts a new cycle, and uses barrier methods for, in fact, that first week of that new cycle and if it’s in week four, in the ostensible patch-free week, then obviously she removes the patch when it’s remembered, no barrier method is required.  Well, we said that ultimately this particular method is begun by starting the patch on the first day of a withdrawal bleed.  If that woman does, in fact, start that Tuesday or Wednesday or whenever it does, but wishes to change that day, it’s rather easy.  She continues for that first four week cycle, starts it on, say, a Tuesday, removes and replaces the following week, removes and replaces the following week, removes and replaces that week and then removes at the end of the third week.  So, let’s say it’s Wednesday, she wants to go to a Sunday change day, she goes Wednesday, Thursday, Friday, Saturday, the new cycle is begun on Sunday.  The patch-free week is seven days or less but should never be more than seven days.

We have several slides here, the first one is actually from a package insert, the next one is in a sense to give you some information not because, primarily not everybody who is going to consider to use this method will be switching from an OC.  What do you do if a woman is switching from an OC?  Very simple.  Again, it is optimally associated with the first day of withdrawal bleed; whether that be a natural menses or a chemical withdrawal bleed.  If she starts the patch the first day of withdrawal bleed after the pill, she needs no barrier methods.  If she wishes to continue on her pill pack change day, if you will, say a Sunday start, a barrier method the first week of the first cycle.

What about if she’s switching from an IUD?  She’s counseled, either the IUD’s life is up, if you will, and she wants to go to the transdermal method.  Well, if in fact she comes in on or before the day she needs her new IUD or IUS, she can begin the patch any time at that point and the IUD/IUS is removed at her convenience.  If in fact patch commencement occurs after the IUD is removed or after the time at which the new IUD should have begun, then as with any other method, we rule out pregnancy and there’s no, in a sense, required thing to rule out pregnancy whether by history, exam or laboratory, that is again your decision, and you begin the transdermal system, again using the barrier method for the first week of the first cycle.

What about switching from injectables?  Again, the, you can apply that patch on any day prior to or on the scheduled re-injection day and whether you’re talking about Depo Provera, DMPA or lunel which is MPAE2C, either one of those worked in this regard.  If, however, the woman has missed that re-injection day or she’s coming in after that day for whatever reason, again you rule out pregnancy and begin the transdermal system using a barrier method again for the first week of the first cycle.  Now, I have here a third bullet.  Many of you have probably heard that there was, actually this past week, a recall and I want to clarify a few things.  It was not a recall of MPAE2C, it was a recall of the pre-filled syringes of MPAE2C, and so for those of you who are using this particular method, who are using it from a vial, there was no recall from the vial.  It was only a recall from the pre-filled MPAE2C syringe, the pre-filled lunel syringe.

What is the requirement of that recall or what are we supposed to do for that recall?  Regardless of what that patient is going through, chooses to go on after the recall, you need to contact the patient, as with any drug recall, you need to rule out pregnancy and encourage a barrier method.  If in that situation once you have accomplished that she wishes to go on the transdermal system after you counsel her about her options, she can in fact go on it, again using a barrier method for the first week that she’s on it.  You of course have ruled out pregnancy as is required and recommended by the recall and so, as a result, you can start this patient on the patch, on a pill, on a ring, on any method once you’ve ruled out pregnancy and proceeded to counsel her about what her options are.

What about the converse?  What if you’re switching a patient from the patch to another method?  Well, if the patient has used that, has used the patch properly, she can actually begin the new method without the need for pregnancy assessment unless she had signs and symptoms that would suggest something to the contrary.  Obviously, beginning a new method, pill, IUD, etc., will, in fact, depend specifically on the particular method and if the patch has not been used properly, she’s missed a week, she’s not placed it on the correct day, it, then obviously to consider evaluating that particular patient for pregnancy before starting a new method other than the patch.

Ron showed you this before and issue number two, issue number one was detachment, issue number two is breast tenderness and, in fact, if you are an aficionado, so the speak, of the transdermal HRT literature, you’ll recognize that in fact with transdermal sex steroids, we have a somewhat higher rate of breast discomfort in using transdermal versus oral regimen.  Your patient has to be cognizant of this before they leave your office.  If you, in fact, discuss this with your patients, you will have few problems concerning this, but if they find out about the breast discomfort on the third or fourth night that they’re wearing the patch as they’re rolling over in bed, you and your office will get a phone call, likely around 11:00 pm to midnight.  You don’t want a phone call at 11:00 pm to midnight; you don’t want a patient who’s upset, who is associating breast symptoms, which again have an issue whether we’re dealing with reproductive age women or menopausal women with a new method that they’re using.  Again, there’s no associated increased risk of adverse breast-related outcomes.  It is something your patients need to know about in the counseling before they leave your office.

Breakthrough bleeding and spotting.  Again, counseling-related issues are important here.  Perception and expectations are vital.  Understand that, as with any sex steroid contraception, a good percentage of women will in fact experience some breakthrough bleeding and spotting in the first several cycles of use.  Very little difference here.  As we see when we compare with a 35mg pill as in this study from Audett, the study in JAMA of last year, we find similar rates of breakthrough bleeding and spotting.  But you know, the major issue with breakthrough bleeding and spotting isn’t the kind of, sort of cut up the pie in smaller pieces.  It isn’t saying well, this method has more breakthrough bleeding and less spotting, etc.  Let’s talk about what the ultimate issue is with breakthrough bleeding and spotting.  Our patients, yours, mine, doesn’t matter, do not want to be in a situation, in a social situation, where they’re not expecting to have vaginal bleeding.  That is the major issue.  They want to be in a sense as sure as possible that they are not in a situation that they are bleeding when they’re not supposed to, and so what we see with this particular study is a slight reduction in breakthrough bleeding and spotting.  Again, because of the system itself?  Yes and no.  Not from the sex steroids but from the compliance issue because this particular method, like the other methods that Ron mentioned earlier, the non-daily use methods, lend themselves to better compliance and more appropriate “perfect” use, we, in fact, have an improved adverse event profile with this as well as the other new non-daily use methods.  Very low rates of absence of withdrawal bleeds, very low rates of pregnancy and what I’ve been telling audiences, our residents, faculty members at U of I is this:  if you have a patient who’s using her method properly, although the package insert says to wait for a second missed cycle or missed period, if that woman has been using it properly, especially if she’s been on the method for several months and been having regular withdrawal bleeds and she’s using a 21/7 regimen, meaning three weeks, one week off, and she calls up and says she has had absolutely no vaginal bleeding, none, not even a smudge, I’m not waiting a second cycle, I’m bringing her in and evaluating her for pregnancy.  Now I have not had a pregnancy on this particular method as of yet and, again, we’ve used it somewhat considerably both within studies and now as a routine contraceptive option.  So, again, in a sense, when you hear hoof beats behind you, it’s usually not a zebra.  Make sure the patient is using the method properly.  Rule out pregnancy.  The one thing I will tell you, both with bleeding episodes, breakthrough bleeding, spotting or amenorrhea, is I’m going to encourage you not to start adding back other sex steroids.  Don’t give her a progestin pill or an oral contraceptive pill.  If, for whatever reason, the bleeding profile is not to her liking and she’s gone through several cycles, two to three, maybe four months, and she calls you and says, you know, I’m just not happy with the spotting, or whatever, find another method of contraception for her to use.  Don’t add back pills.  We have no data on that.  We’re talking about mixing metabolisms and other, and receptor dynamics.  Find another method of reversible contraception for her.

Again, as I said, the issues are your patient’s need to leave your office with the best available information.  If it’s, you’re talking about transdermal contraceptive systems, make sure they’re aware of how to manage detachment, make sure they’re aware about the weight issue that Ron spoke about, that’s going to be part of your counseling, make sure they’re aware of how to handle and what to expect as far as breast symptoms.  Again, when we take a look at this increase, we’re looking at about 18% of the overall population who reported breast symptoms, breast discomfort.  Of those 18%, 86% said it was mild to moderate.  Only 14% said it was marked or severe as we have here.  Now, was it an increase in limiting its use versus the comparative pill?  Yes, it was.  But I will tell you that now we have, in fact, started discussing in somewhat more detail what they can expect as far as breast symptoms, we have absolutely no phone calls after hours to our offices concerned about this and, in fact, some of the patients who have come back have actually said they were concerned that the method wasn’t working because they had no breast symptoms, so maybe we counseled a little too well in some, some patients.

Again, the issue with regard to body weight needs to be very clear when you’re counseling patients.  We know that there is likely a slight immunition in efficacy.  That has led, not to a warning, not to a contraindication, but in fact to a statement in the package insert that this is something that your patients are likely to need to know in order in making a decision.  For women who are at or above 198 pounds, you need to help women consider what they’re contraceptive needs and expectations are.  I’ve heard a lot of people say, oops, she’s 220 pounds, and I’m not going to talk about the patch.  In a real sense, if she’s 220 pounds, are you still talking to her about the pill?  Because again, we have some very evocative data that shows its immunition and efficacy.  If you had a woman who was overweight, who was obese, who was looking for the most effective method of contraception, you really have two options to talk to her primarily about: that’s an intrauterine method or DMPA.  Those are the two methods that have demonstrated no reduction in efficacy with regards to patient weight.  But if the most effective method of contraception is not at the priority, the top priority of that patient’s medical, social or other reasons, then you’re going to talk to her about the pill, you’re going to talk to her about the patch, you’re going to talk to her about the ring, and again this is why counseling remains the most important part of the contraceptive decision process.   As Ron showed you, we have issues with pills, we have issues of, we had issues with the subdermal implant system, and we are likely to find more information out about other methods that we are currently using.   But again, this is part of the counseling, part of expectations and, again, part of the expecting, expectations and perceptions that our patients leave our office with.

Again, the decision about what contraceptive to use has to take into account lots of things, but the most important thing is that you are not making the decision for your patient.   We need to start thinking about these new methods, not as methods that we can go to when pills fail or when other methods fail, but to present these new methods, the patch, the ring, the new intrauterine methods, as first line, mainstream options.  We are only going to start reducing unintended pregnancy rates when our patients are getting unbiased, complete counseling about what their options are.  The concept that pills are, in fact, the right choice for the vast majority of women is unfortunately borne out by the concept that we are looking at close to one million pregnancies in the United States each year in women who are using oral contraceptives the month that they conceive.  Our job is not to get our patients on a particular method, our job is to help them find the best contraceptive fit.  Again, when we take a look at percentage of pregnancies with typical use, the issues are not so much the efficacy, meaning perfect use, which unfortunately we banter those numbers about in talking to patients, but the actual use.  None of us practice in a perfect world.  All of us have patients who don’t do well with particular methods.  Again, the challenge for you is to find out what method they are likely to incorporate into their lifestyle and it’s clear that non-daily use methods are associated with far better compliance, meaning appropriate and correct use, than daily or quarter-related methods.  Again, the challenge is to find who is likely to use a daily pill correctly and if those women who are not likely to use a daily pill correctly, find the other method, find those non-daily methods that they are likely to use correctly.

So when we look at precautions, the only difference between the patch as, from the pills is in fact the body weight greater than 198 pounds and a precaution, in a sense, the lowest approbation that is afforded by the FDA.  Again, there was no warning as we had with the Norplant system, there was no contraindication.  It is not that women over that weight should not be using that, it’s that you need to be counseling those patients appropriately.  With regard to drug interactions, we again have the same language that essentially we have with oral contraceptives about concerns with reduced contraceptive effectiveness but, again, remember what you’re dealing with.  You’re dealing with a transdermal method that, in fact, bypasses the whole gut metabolism.  So although the wording in the package insert is the same as you see with OCs, studies have shown that we, with, with concurrent or concomitant use of tetracycline, we have absolutely no significant or actual reduction in norlagesteronine levels and no significant or actual reductions in ethinyl estradiol levels.  So again, what the package insert said, it’s based on issues with sex steroids.  Understand that you’re using a non-oral sex steroid delivery system.

So, how do you choose a method for your patients and you already saw the punch line?  You don’t.  If we, again, are going to improve unintended pregnancy rates, we are going to have to empower patients to make choices.  We have to find out, and this is something that always gets to me.  When we talk about sex and sexuality, there is no more important time to discuss that than when we’re helping patients choose a contraceptive option.  That has to become an important part of the process.  We have to know about our patients’ lifestyle issues so that we can inform them about what methods are likely to become a successful part of that lifestyle.  We can’t make the decision for them.  We have to give them the education so that they, in fact, do make those decisions; those hopefully correct decisions, for themselves.

So, what’s our job?  Very simple.  Have a good understanding of these new methods.  Help our patients make the right choices for them.  Elicit and respect the patient’s choice.  What I tell my residents is very simple and straightforward.  You should not care what method they are using when they walk out of the office, just that they are using an effective method that is likely to work for them.  Don’t care about what their choice is.  Be passionate about the process, be non-directive about the ultimate choice and outcome, because it’s only then that a woman is likely to have the information and be empowered with that information to make that correct choice.