Advancesin Contraception. 1992;8(Suppl1):1-3. (~) 1992KluwerAcademicPublishers. Printed in the Netherlands

Introduction Enhancing oral contraceptive compliance and efficacy G. BENAGIANO, M D

Professor and Director, First Institute of Obstetrics and Gynecology, University "la Sapienza", Rome, Italy

There is a widespread belief that proper compliance with the medication schedule is not an issue with oral contraceptives (OCs). Patients are led to believe that OC packages offer both clear guidance and a simple way to make the patient aware of the fact that she has missed a pill. Anecdotal evidence suggests that the latest generation of pills will not allow a pregnancy even if the patient forgets to take one or more pills. By and large, these beliefs are unsubstantiated. In fact, 30 years after the introduction of OCs, a major gap now exists between the lowest expected failure rates and the observed rates in typical users. Although we state the theoretical risk of OC failure as less than 1% for married women, 3% to 6% actually report failure. For special groups, such as US inner-city adolescents, 16% to 20% failure rates are observed. The unacceptably high OC failure rates worldwide have drawn attention to the importance of noncompliance as an issue that deserves closer examination by OB/GYN specialists, general practitioners, and family planning specialists. It is important that the issue of compliance in OC users be properly evaluated and reviewed in the light of existing data. It is also necessary to point out areas in which future research must focus in order to elucidate the many still unanswered questions on this topic. I recently chaired a symposium, "Enhancing Oral Contraceptive Compliance and Efficacy," at the European Society of Contraception Congress in Athens, Greece. An international group of eminent physicians convened to discuss the importance of patient compliance, identify physician and patient educational needs, and develop guidelines for identifying and addressing noncompliance in clinical practice. The following proceedings of that meeting address the main reasons for discontinuation of OCs. With the new low-dose OCs, we have taken further steps toward effective oral contraception with a minimum of side effects. With safety no longer a pressing issue, we can now concentrate on eliminating factors that contribute to noncompliance and, therefore, unplanned pregnancies. Only with correct and continued daily use will the promise of oral contraceptive efficacy be realized.

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Benagiano

In order to understand the importance of compliance, even with a method theoretically as effective as the pill, one must bear in mind that over an extended number of years even very low OC failure rates can produce a significant number of unwanted pregnancies, and with a method that is 99% effective, there will be almost 20% failures over a period of 10 years. Therefore, if lack of compliance causes effectiveness to decrease to 97.5% in a given group of women, this may result in as much as a doubling of the number of patients who become inadvertently pregnant over the 10-year period. Contraceptive compliance can be viewed in at least two different ways. It can be defined as "the willingness and ability of a woman to take the medication as prescribed," putting the emphasis on the woman's motivation and understanding of what she is supposed to do. It can also be defined as "the behavior directly affecting the likelihood of treatment success or failure." In this case the focus is on the consequences of a person's behavior, thereby discounting departures from the prescribed course that do not decrease efficacy or continuation. When one tries to analyze contraceptive compliance, three major components become immediately dear: The first is acceptability. Compliance will invariably be influenced by the overall perception of oral contraceptive safety that a woman has before she initiates the use of the pill. In other words, she may "accept" (acceptance) the pill even if the pill is - in theory - not "acceptable" to her (acceptability). The second component of compliance is continuation, because compliance will also depend on the ability of a women to stay with the treatment. Continuation is obviously influenced by medical, social, and psychological factors. The third component of compliance is the medication schedule. In this regard, motivation seems important, and indeed it has been proven that highly motivated subjects can comply more easily if they receive proper and complete information. This, however, does not seem to be the case with less motivated subjects. Still, questions remain unanswered about the role that lack of compliance plays in increasing discontinuation and decreasing efficacy of OCs. We need to learn how often pills are taken incorrectly by various groups differing in age, cultural setting, and socioeconomic status. Also, we need to know what are the most common errors made by users; we are not aware of whether differences exist among women in the kind of mistakes they make and why. An important area for research, as well as discussion, deals with factors affecting the ability of a woman to follow instructions or to stay with the same medication for long periods of time. Finally, in spite of all the clinical work carried out in the last three decades, we still do not know how serious under prevailing field conditions - is the risk of pregnancy in missing pills. Physicians are often not aware that patients are having a problem with OCs because when they experience concerns such as side effects, they may turn to friends, families, or the media for guidance. The success or failure of oral contraception, as Dr Elizabeth Connell discusses in this publication, depends heavily on the type and extent of counseling that patients receive. Clear and accurate instructions must be given and fears dispelled; patients should be encouraged to ask questions. To close the gap between the theoretical and everyday use of OCs, we must make certain that patients understand how to use them.

Introduction: Enhancing Oral Contraceptive Complianceand Efficacy

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Compliance, as Dr Killick will discuss, is influenced by many factors: age, socioeconomic group, and education of the patient; side effects of the OC; as well as packaging and the efficiency of the health care delivery system. It is the physician's responsibility, according to Dr Hillard, to dispel fears, provide education, and prescribe OCs with a minimum of side effects. Poor cycle control and side effects or fear of side effects are, according to Dr Serfaty, important medical aspects of OC discontinuation. In one study, as many as 50% of women taking OCs discontinued use because of side effects; 15% of these women had unintended pregnancies. Adolescents, especially, are concerned about nuisance side effects, such as weight gain, acne, nausea, and spotting - factors that affect body image. Irregular bleeding is the main reason for discontinuation in all patient groups. Dr Rosenberg advises that patients be informed that such bleeding decreases with continuous OC use, that the bleeding does not represent a loss of contraceptive protection, and that there are few problems when patients are compliant. New progestins are available that decrease the incidence of such bleeding and improve cycle control. More rigorous studies to address comparative bleeding problems and to emphasize the importance of counseling OC users about bleeding problems are needed. Increased physician/patient contact and thorough education of patients regarding side effects will, according to Dr Serfaty, encourage patients to discuss problems with their physicians rather than discontinue OCs without informing their providers. An important but often neglected area of patient education is the dissemination of information on the noncontraceptive benefits of the modern low-dose OCs. Significant noncontraceptive health benefits, as discussed by Dr Thorneycroft, have been observed in OC users and represent new directions for future research. When the risk/benefit ratio of OC use is evaluated today, it clearly favors benefits. But to realize these benefits, improved compliance is necessary. When physicians, providers, and women around the world begin to understand the true nature of the risks and benefits of oral contraceptives, compliance will improve and we will come closer to achieving the 99.6% efficacy that is possible with this method.