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Clinical Breast and Pelvic Examination Requirements for Hormonal Contraception: Current Practice vs Evidence

Clinical Breast and Pelvic Examination Requirements for Hormonal Contraception: Current Practice... Abstract Clinical breast and pelvic examinations are commonly accepted practices prior to provision of hormonal contraception. Such examinations, however, may reduce access to highly effective contraceptive methods, and may therefore increase women's overall health risks. These unnecessary requirements also involve ethical considerations and unwittingly reinforce the widely held but incorrect perception that hormonal contraceptive methods are dangerous. This article reviews and summarizes the relevant medical literature and policy statements from major organizations active in the field of contraception. Consensus developed during the last decade supports a change in practice: hormonal contraception can safely be provided based on careful review of medical history and blood pressure measurement. For most women, no further evaluation is necessary. Pelvic and breast examinations and screening for cervical neoplasia and sexually transmitted infection, while important in their own right, do not provide information necessary for identifying women who should avoid hormonal contraceptives or who need further evaluation before making a decision about their use. Unintended pregnancy in the United States is a widely recognized public health problem that entails adverse personal, health, economic, and social consequences.1 Although many factors influence unintended pregnancy, medical requirements for tests and procedures prior to initiation of hormonal contraceptives are of particular significance. Each requirement involves both personal and financial costs that need to be weighed carefully against their purported benefits. The possible intermediate and long-term health risks were unknown when hormonal methods were first introduced in 1960. A thorough medical evaluation prior to prescribing these drugs, and periodically thereafter, was a prudent care standard. Evidence accumulated in the interim, however, has shown that some of these practices are not necessary. For provision of hormonal contraception, breast and pelvic examinations have been customarily required. The examination visit provides an opportunity for education and counseling about preventive health care, contraceptive options, and sexually transmitted infection (STI) risk reduction. Counseling and education, however, can be provided without a physical examination, as can STI screening using methods that require only a urine or blood sample. For the early detection of cervical neoplasia, periodic Papanicolaou tests continue to be an important preventive health measure, but their utility is unrelated to the initiation of hormonal contraception. We have reviewed and summarized the published literature and recommendations from relevant professional organizations regarding the role of clinical breast and pelvic examinations in the provision of hormonal contraceptives. We considered all combined oral contraceptive and combined injectable contraceptive products containing both estrogen and progestin, oral contraceptive products containing only progestin, and injectable and implantable progestin contraceptives currently used in the United States. Together, these products account for most options for hormonal contraceptives. We excluded progestin-releasing intrauterine devices because the pelvic examination is part of the insertion process. To identify appropriate published articles for inclusion, we searched for several topics in MEDLINE, POPLINE, PubMed, and the Cochrane Library from January 1965 through January 2000. The following search terms were used: "hormonal contraception," "oral contraception," "pelvic examination," "physical examination," "clinical breast examination," "Pap smear," "breast cancer," "cervical cancer," and "chlamydia." Consensus statements, policy statements, and reviews were identified through the search process and by contacting major organizations in this field, including the World Health Organization (WHO), the International Planned Parenthood Federation, the American College of Obstetricians and Gynecologists, and Planned Parenthood Federation of America. Also reviewed were recommendations of the US Preventive Services Task Force, drug-labeling language approved by the US Food and Drug Administration (FDA), and statements from the US Agency for International Development. Additional papers of historical significance or that were helpful for interpreting more recent publications were identified from the reference lists of papers reviewed. Background Over the last 7 years, several international and US professional organizations have formulated revised recommendations for hormonal contraception users (Table 1).2-17 In general, expert medical opinion has shifted from requiring breast and pelvic examinations prior to initiation of hormonal contraception to encouraging these examinations and Papanicolaou screening as a part of routine care not directly tied to hormonal contraceptive provision. Several demonstration projects have evaluated the impact of revised approaches to service delivery of hormonal contraceptives. Overall, demonstration projects have found that many women choose to defer the pelvic examination and appreciate the opportunity to begin hormonal contraception more quickly. Providing hormonal contraception outside the clinic also has been explored as a way to reduce access barriers and improve outreach to underserved women. The Family Planning Council of Southeastern Pennsylvania, Philadelphia, established a program to offer oral contraception for up to 6 months to nonpregnant teenagers younger than age 18 years at their first clinic visit, while delaying the previously required pelvic examination.18 An evaluation of the project showed that of the 151 teenagers who completed follow-up, 26% chose to delay the pelvic examination at the time they initiated hormonal contraceptive use. The teenagers who delayed the pelvic examination were significantly more likely to fear that the examination would be embarrassing (50% compared with 38%); almost 40% of all teenagers worried that it would be painful. Teenagers who did delay the pelvic examination reported higher condom use, had fewer pregnancies, and had similar STI rates when compared with teenagers who did not delay the examination. Almost 80% of the teenagers returned to the clinic within 6 months for follow-up. The California Office of Family Planning, Sacramento, established a project in 1996-1998 to provide oral and injectable hormonal contraception without a mandatory pelvic examination.19 Women could obtain hormonal contraception after a detailed medical history and blood pressure screening. If indicated, women also received pregnancy tests and breast examinations. These services were provided in nonclinic locations. Clients in need of more extensive services were referred to affiliated family planning clinics. Women in the project reported improved contraceptive patterns: 38% adopted a more effective method, 47% remained with the same method, 12% switched to a less effective method, and 3% remained with no method (P<.001). Furthermore, 66% obtained condoms at their initial visit, while only 33% reported having used them at their last sexual encounter. In addition, 92% reported that they would recommend the services to others, and about 75% considered receiving pills or injections without a pelvic examination to be an important option. Approximately 50% were referred to an affiliated clinic for more extensive care, and the majority (73%) followed through on their referrals within 6 weeks. A comparison of the project participants with clients at clinic sites showed that participants were not at higher risk for cervical neoplasia.20 Potential Benefits Eliminating examination requirements prior to use of hormonal contraception has the potential to improve access to highly effective contraception. If this change helps women to replace no or less effective protection with more effective contraception, significant health benefits may result. Perpetuating unnecessary requirements also involves ethical considerations and may reinforce fears about the safety of hormonal contraceptive methods. Improving Access to Effective Contraception Young women often report an interval of many weeks or months between the time sexual intercourse begins and the time they first obtain medical care to acquire contraception. This interval carries a high risk for unintended pregnancy21: the very first family planning visit for many young women is for a pregnancy test.22 The same interval also delays the opportunity to receive counseling about STI prevention. For some, economic and practical factors in arranging medical care are primary reasons for this delay. Many, however, are delayed because of fears about coping with a medical examination. In particular, fear of pain and other anxieties about the pelvic examination concern adolescents.22-25 Ethical Considerations Perpetuating medically unnecessary requirements for examinations also raises important ethical questions. Using the hormonal contraception prescription to coerce compliance with routine screening involves unexamined premises. First, it assumes that policy makers rather than women are the appropriate decision makers. Second, it assumes that the health impact of missed screening for these women is more significant at that specific time than the health impact of delayed or less effective contraception. Women who are informed about the implications of a decision to defer screening should have the right to make the decision. Even if a change in requirements did result in decreased routine screening for unrelated conditions, would it be ethical to withhold hormonal contraceptives on this basis? In other areas of medical care, this would not be perceived as appropriate. Correcting Misperceptions Breast and pelvic examination requirements are likely to reinforce the incorrect belief that hormonal contraceptive methods are dangerous. This belief is widely held and may discourage use of these safe and highly effective options. Perceived danger also may play a role in early discontinuation and inconsistent use of hormonal methods.26 In the long term, public awareness based on the valid reasons for physical screening would be preferable to the current situation. Education to correct inaccurate information and beliefs and to "market" recommended screening on the basis of its own real value is an appropriate public health goal. Issues of Concern In contemplating a change in medical requirements, several issues emerge as important considerations. Screening to identify women who should not use hormonal contraception must be ensured, and the possible impact of hormonal contraceptive use on other health risks also should be considered. Identifying Women Who Should Not Use Hormonal Contraceptives For some women, hormonal contraceptives are not an appropriate choice. Consensus recommendations have been provided by several expert review panels as well as by the FDA as part of required labeling for the products sold in the United States. Among the most current and comprehensive recommendations is the 2000 review by the WHO presented in Table 2a.16 The WHO review concluded that hormonal contraceptive methods should not be recommended for women who have the following medical conditions: pregnancy, breast cancer, hypertension, certain heart and liver diseases, and diabetes mellitus, either long-standing or with end-organ involvement. Women with a history of thromboembolic disease, stroke, or migraine headaches with focal, neurologic symptoms also are advised to avoid these methods, as are women who are less than 6 weeks postpartum and breastfeeding and those older than age 35 years who smoke more than 15 cigarettes per day. Cautious use is suggested for women with hyperlipidemia, women less than 21 days postpartum, women breastfeeding from 6 weeks to 6 months postpartum, light smokers older than age 35 years, and those using medications that affect liver enzymes (eg, rifampin, griseofulvin, phenytoin, carbamezapine, barbiturates, and primadone). Additional cautions apply to women receiving estrogen-containing medications but not progestin-only medications; these include agents for biliary tract disease and use by women who are undergoing major surgery with prolonged immobilization. Unexplained vaginal bleeding requires special attention before any hormonal method is prescribed.14,16,17,27 For all of these conditions, a clinical breast or pelvic examination is unlikely to detect the condition. Medical history and blood pressure measurement are the most useful screening approaches. For example, to avoid providing hormonal methods to a woman who has an unrecognized, early pregnancy, recommended steps are a review of medical history regarding menses and instructions for initiating the first pill or injection in conjunction with a normal menstrual period. A pelvic examination during the first 14 days of pregnancy is not helpful for diagnosis of pregnancy because it cannot yet be detected by an examination. After 14 days, the possibility of pregnancy would be suspected because of the medical history—a late or abnormal period. Use of hormonal contraceptive methods during pregnancy is not recommended because they are ineffective; there is no evidence that hormonal contraceptives are harmful for either the woman or the fetus if inadvertent exposure occurs during early pregnancy.4 Failure to detect breast cancer prior to beginning hormonal contraceptive use is a particular concern. Recommendations for screening of asymptomatic women to detect unsuspected breast cancer are not clear cut. Breast cancer is rare in women younger than age 30 years, occurring in less than 4 per 100 000 annually in the United States. Among older women the risk is higher: for those aged 40 to 44 years, the annual incidence is 62 per 100 000; for women 45 to 49 years, it is 101 per 100 000.28 A recent review of clinical breast examination efficacy recommended annual clinical breast examination as a routine screening measure for women older than 40 years, although clear research evidence that such examinations can reduce breast cancer mortality is lacking.29 The US Preventive Services Task Force recommends screening every 1 to 2 years with mammography alone or in combination with clinical breast examination for women aged 50 to 69 years, but it finds insufficient evidence to recommend for or against these measures for younger women.30 Medical history (age and family history) identifies those women at increased risk for breast cancer who might benefit most from clinical breast examination prior to hormone use and for whom such examinations are recommended as a screening measure. Women older than age 40 years constitute a small minority of hormonal contraceptive users: less than 6% of women aged 40 to 44 years use such methods, and they represent less than 7% of all hormonal users.31,32 Whether or not a breast examination should be required for a woman in this group who wishes to defer the examination, however, is more problematic. Although breast cancer is a contraindication to use of exogenous hormones, the true effect of hormonal contraceptives on progression of undiagnosed breast cancer is unknown. For young women, the risk of unsuspected breast cancer is remote, the efficacy of clinical breast examination is unclear, and the risk of pregnancy is high. Within 1 year, the likelihood of pregnancy is about 90% among women using no contraceptive method; this risk can be reduced to less than 10% with average pill use and to 1% with consistent and correct use.33 The benefits of contraceptive use for young women, as well as for older women, are likely to matter more than a small theoretical increased risk associated with hormone exposure in the rare case of unsuspected breast cancer that could have been detected through breast examination. Monitoring for Possible Effects of Hormonal Contraceptives on Other Health Risks Use of hormonal methods may have negative or positive effects on susceptibility or risk for future health problems. Users of combined oral contraceptives face increased risks for occurrence of several conditions, including benign liver tumors, biliary tract disease, and breast cancer.15 Informing patients of these risks is important for informed decision making. Fortunately, these health problems are not common, and apart from appropriate evaluation of any signs or symptoms that the patient may notice (such as a breast lump or gallbladder disease symptoms), no specific steps are currently recommended for predicting or detecting their occurrence among asymptomatic women. Concerns raised in the past about an increased risk for malignant liver tumors or stimulation of the growth of uterine leiomyomata have not been substantiated.15 Even if documented in advance, fibroids are not identified as a reason to avoid hormonal methods.34,35 The relationship between hormonal contraceptive use and risks for STIs is of special concern. Hormone use could have a direct effect on infection susceptibility. Women who use hormonal contraceptives are also less likely than other women to use condoms that protect against STIs.36 Several studies have documented higher risks for cervical chlamydia infection, human papillomavirus, and for human papillomavirus–related cervical dysplasia and cancer among combined oral contraceptive users.7,37-43 Available research on susceptibility to the human immunodeficiency virus and acquired immunodeficiency syndrome is not conclusive. It is critical that possible effects on risk of infection be included in information for an informed decision to use these methods. In addition, women who use hormonal methods should be counseled effectively about the importance of wise decisions, testing for chlamydia and gonorrhea, Papanicolaou screening, and consistent condom use if there is any question of possible STI exposure. Recommended annual screening for chlamydia and screening for gonorrhea if indicated are important for all sexually active young women who may be at risk for STIs, whether or not they use oral contraceptives. Routine annual screening for chlamydia can be provided through urine testing.43 Detection of gonorrhea or chlamydia are not reasons to withhold hormonal methods or discontinue their use. There is some theoretical concern that hormone use may affect cervical intraepithelial neoplasia progression or cancer prognosis. However, cervical intraepithelial neoplasia and cervical cancer awaiting treatment are not conditions that require avoiding hormonal methods or for which caution is recommended. Because the development of cervical cancer involves identifiable precursors that may progress to invasive disease over a period of many years, effective screening can be achieved with periodic Papanicolaou tests at least every 3 years.30 For most women, complying with effective Papanicolaou screening intervals is not a problem. For those women who do not comply, however, should hormonal methods be withheld to avoid their inadvertent use by someone with unsuspected cervical cancer? Young women gain relatively little from mandatory examination and Papanicolaou test requirements30,44,45 and gain a great deal from pregnancy prevention, since the disease rates are so low and unintended pregnancy rates are so high in this age group. In California, for example, the Cancer Registry reported in 1993 only 2 cases of cervical cancer for every 1 000 000 women aged 15 to 19 years.46 Among 1 000 000 similar women exposed to the risk of pregnancy for just 1 extra month, as many as 175 000 undesired pregnancies might be expected.33 Among older women, the risk for cervical neoplasia is somewhat higher, but nevertheless, a theoretical concern about precursor progression or cervical cancer prognosis must be balanced against the noncontraceptive health benefits of hormonal methods as well as the benefits of effective contraceptive protection. Weighing against these increased risks, use of combined oral contraceptives also is associated with a significantly reduced risk for both ovarian cancer and endometrial (uterine) cancer. Use of combined oral contraceptives also reduces risks for common conditions, including symptomatic pelvic inflammatory disease and benign breast lumps. Because these problems are common and often require medical or surgical intervention, their reduced incidence among oral contraceptive users constitutes a significant positive health benefit for users.47 It is true that a pelvic examination performed for a woman requesting hormonal contraception might lead to the serendipitous identification of a palpable, malignant ovarian tumor. Unfortunately, however, bimanual pelvic examination has not been found effective as a screening measure to reduce ovarian cancer mortality, and it is not recommended for this purpose.48-50 The US Preventive Services Task Force explicitly recommends that periodic bimanual pelvic examination not be performed for ovarian cancer screening because of the harm associated with evaluation of false-positive findings and the lack of evidence of benefit. Also, although treatment for ovarian cancer renders a woman infertile in most cases, ovarian cancer is not identified as a reason to withhold hormonal contraception for a woman awaiting treatment.30 Encouraging Important Preventive Services For many women, medical visits prompted by the decision to use hormonal contraception or for refills have served as an opportunity for obtaining preventive services. Historically, clinicians, and no doubt many patients, have considered such screening essential prior to hormone use and have not been aware of the independent reasons for them. It is possible, therefore, that streamlining medical requirements for provision of these methods could adversely affect adherence to important routine prevention screening recommendations. Steps to educate women about the importance of such screening and encourage them to seek care will be needed. In addition, recommendations for services that should comprise well-woman care should be updated periodically, based on sound scientific evidence. As policy changes are contemplated, several steps to protect nonmedical concerns also need to be addressed. These include the financial stability of family planning agencies and the need to ensure continued political support for public funding. These are significant problems that require financial and organizational considerations but lie outside the scope of this medical review. Summary Hormonal contraceptives are among the most thoroughly studied of all medications. For most women they are safe, effective, and well tolerated. For some women, however, they are not a wise choice, and for a rare few, their use should be avoided or special caution and monitoring may be indicated. The medical conditions that need to be considered have been carefully identified by researchers during the past 40 years. Expert review panels convened by US and international regulatory and professional organizations have established recommendations that are comprehensive and consistent; these provide the basis for identifying clinical care steps needed to ensure appropriate screening without imposing unnecessary medical obstacles or procedures. Hormonal contraception can safely be provided on the basis of careful medical history and blood pressure measurement. Breast and pelvic examinations and screening for cervical cancer and STIs are important in their own right, but they are not necessary for identifying women who should avoid these methods or need further evaluation before a decision about hormone use is reached. All women should be advised about recommended screening for STIs and cervical and breast cancer; such services are essential components of family planning and reproductive health care. Women who are older, and therefore at greater risk for breast cancer and cervical cancer, should be advised strongly about the importance of periodic Papinocolaou tests and clinical breast examinations. Providing ongoing hormonal contraception to women in these groups without such screening involves the risk that a woman with unsuspected breast or cervical cancer may incur the possible (theoretical) adverse effects of hormone exposure. Because these conditions are uncommon, however, and the countervailing health benefits of effective contraceptive protection so powerful, hormonal methods should not be withheld from a woman who understands the implications of the potential risks involved and nevertheless wishes to defer recommended screening. In addition to being medically reasonable, this new approach also may better meet the needs of some women and should help women avoid delay in achieving effective contraceptive protection. For clinicians and health care organizations, it may also be an opportunity to develop innovative outreach approaches and to redirect resources to optimize their benefit for the reproductive health of the women they serve. The appropriate decision maker in determining when to have a pelvic examination should be the woman herself; decisions should not be made unacknowledged and by default because of historical beliefs perpetuated without scrutiny. As changes are undertaken, however, continued study will be important to characterize the impact such changes have on women's health and to identify education and referral approaches that are effective in sustaining important, though not directly related, routine health screening practices. References 1. Brown S, Eisenberg L. The Best Intentions: Unintended Pregnancy and the Well-Being of Children and Families. Washington, DC: National Academy Press; 1995. 2. American College of Obstetricians and Gynecologists. Guidelines for Women's Health Care. Washington, DC: ACOG; 1996. 3. American College of Obstetricians and Gynecologists. Oral Contraceptives for Adolescents: Benefits and Safety. Washington, DC: ACOG; 1999. 4. Food and Drug Administration. Labeling guidance text for combination oral contraceptives, prescribing information, physician labeling. 1994. 5. Food and Drug Administration. Labeling guidance text for progestin-only oral contraceptives, prescribing information, physician labeling. Available at: http://www.fda.gov/medwatch/safety/label/guidance.htm; revised 1995. Accessibility verified April 11, 2001. 6. Faculty of Family Planning and Reproductive Health Care, Royal College of Obstetricians and Gynaecologists. First prescription of combined oral contraception: recommendations for clinical practice. Br J Fam Plann.2000;26:27-38.Google Scholar 7. Hannaford PC, Webb AM. Evidence-guided prescribing of combined oral contraceptives: consensus statement, March 1996. Contraception.1996;54:125-129.Google Scholar 8. International Planned Parenthood Federation. IMAP statement on steroidal oral contraception. IPPF Med Bull.1995;29:1-6.Google Scholar 9. International Planned Parenthood Federation. IMAP statement on injectable contraception. IPPF Med Bull.1999;33:1-5.Google Scholar 10. Society of Obstetricians and Gynaecologists of Canada. The Canadian Consensus Conference on Contraception. Toronto: Society of Obstetricians and Gynaecologists of Canada; 1998. Available at: http://sogc.medical.org/SOGCnet/sogc_docs/common/guide/library_e.shtml. Reprinted from: J SOGC:1998:20. Accessibility verified April 6, 2001. 11. Physicians' Desk Reference, 53rd ed . Montvale, NJ: Medical Economics Co Inc; 1999. 12. Revised oral contraceptive labeling: FDA approves recommendation allowing delay of pelvic exam. Contracept Rep.1993;4:4-7.Google Scholar 13. New York: Planned Parenthood Federation of America. Manual of Medical Standards and Guidelines. New York, NY: PPFA, National Medical Committee; revised 1996. 14. New York: Planned Parenthood Federation of America. Manual of Medical Standards and Guidelines: Hormonal Contraceptive Use. New York, NY: PPFA National Medical Committee; revised August 1999. 15. World Health Organization. Improving Access to Quality Care in Family Planning: Medical Eligibility Criteria For Initiating and Continuing Use of Contraceptive Methods. Geneva, Switzerland: WHO; 1996. 16. World Health Organization. Medical Eligibility Criteria For Initiating and Continuing Use of Contraceptive Methods. Geneva, Switzerland: WHO; 2000. 17. World Health Organization and U.S. Agency for International Development. Recommendations for Updating Selected Practices in Contraceptive Use, Volume I. Washington, DC: WHO and USAID; 1994. 18. Armstrong KA, Stover MA. SMART START: an option for adolescents to delay the pelvic examination and blood work in family planning clinics. J Adolesc Health.1994;15:389-395.Google Scholar 19. Harper C, Balistreri L, Boggess J, Leon K, Darney P. Provision of hormonal contraceptives without a mandatory pelvic exam: the First Stop demonstration project. Fam Plann Perspect.2001;33:13-18.Google Scholar 20. Sawaya G, Harper C, Balistreri E, Boggess J, Darney P. Cervical neoplasia risk in women provided hormonal contraception without a Pap smear. Contraception.2001;63:57-60.Google Scholar 21. Finer LB, Zabin LS. Does the timing of the first family planning visit still matter? Fam Plann Perspect.1998;30:30-33, 42.Google Scholar 22. Zabin LS, Emerson MR, Ringers PA, Sedivy V. Adolescents with negative pregnancy test results: an accessible at-risk group. JAMA.1996;275:113-117.Google Scholar 23. Larsen SB, Kragstrup J. Experiences of the first pelvic examination in a random samples of Danish teenagers. Acta Obstet Gynecol Scand.1995;74:137-141.Google Scholar 24. Millstein SG, Adler NE, Irwin Jr CE. Sources of anxiety about pelvic examinations among adolescent females. J Adolesc Health Care.1984;5:105-111.Google Scholar 25. Frye CA, Weisberg RB. Increasing the incidence of routine pelvic examinations: behavioral medicine's contribution. Women Health.1994;21:33-55.Google Scholar 26. Kaunitz AM. Oral contraceptive health benefits: perception versus reality. Contraception.1999;59 (suppl 1):29S-33S.Google Scholar 27. International Planned Parenthood Federation. IMAP statement on steroidal oral contraception. IPPF Med Bull.1995;29:1-6.Google Scholar 28. Ries LAG, Kosary CL, Hankey BF, Miller BA, Harras A, Edwards BK. SEER Cancer Statistics Review, 1973-1994. Bethesda, Md: National Cancer Institute; 1997. 29. Barton MB, Harris R, Fletcher SW. Does this patient have breast cancer? JAMA.1999;282:1270-1280.Google Scholar 30. US Preventive Services Task Force, Guide to Clinical Preventive Services . 2nd ed. Baltimore, Md: Williams & Wilkins; 1996. 31. Abma J, Chandra A, Mosher W, Peterson L, Piccinino L. Fertility, family planning, and women's health: new data from the 1995 National Survey of Family Growth. Vital Health Stat.Series 23: Data from the National Survey of Family Growth. 1997:19:1-114. ID/PMID:97345568.Google Scholar 32. Hatcher R, Trussell J, Stewart F. et al. Contraceptive Technology. 17th ed. New York, NY: Ardent Media; 1998. 33. Trussell J, Koenig J, Stewart F, Darroch JE. Medical care cost savings from adolescent contraceptive use. Fam Plann Perspect.1997;29:248-255, 295.Google Scholar 34. Chiaffarino F, Parazzini F, La Vecchia C, Ricci E, Crosignani PG. Oral contraceptive use and benign gynecologic conditions: a review. Contraception.1998;57:11-18.Google Scholar 35. Chiaffarino F, Parazzini F, La Vecchia C, Marsico S, Surace M, Ricci E. Use of oral contraceptives and uterine fibroids: results from a case-control study. Br J Obstet Gynaecol.1999;106:857-860.Google Scholar 36. Darney P, Callegari L, Swift A, Atkinson E, Robert A. Condom practices of urban teens using Norplant contraceptive implants, oral contraceptives, and condoms for contraception. Am J Obstet Gynecol.1999;180:929-937.Google Scholar 37. Brinton LA, Reeves WC, Brenes MM. et al. Oral contraceptive use and risk of invasive cervical cancer. Int J Epidemiol.1990;19:4-11.Google Scholar 38. Brinton LA. Oral contraceptives and cervical neoplasia. Contraception.1991;43:581-595.Google Scholar 39. Jones CJ, Brinton LA, Hamman RF. et al. Risk factors for in situ cervical cancer: results from a case-control study. Cancer Res.1990;50:3657-3662.Google Scholar 40. Kjaer SK, Engholm G, Dahl C, Bock JE, Lynge E, Jensen OM. Case-control study of risk factors for cervical squamous-cell neoplasia in Denmark: role of oral contraceptive use. Cancer Causes Control.1993;4:513-519.Google Scholar 41. Hildesheim A, Reeves WC, Brinton LA. et al. Association of oral contraceptive use and human papillomaviruses in invasive cervical cancers. Int J Cancer.1990;45:860-864.Google Scholar 42. Negrini BP, Schiffman MH, Kurman RJ. et al. Oral contraceptive use, human papillomavirus infection, and risk of early cytological abnormalities of the cervix. Cancer Res.1990;50:4670-4675.Google Scholar 43. Ursin G, Peters RK, Henderson BE, d'Ablaing III G, Monroe KR, Pike MC. Oral contraceptive use and adenocarcinoma of cervix. Lancet.1994;344:1390-1394.Google Scholar 44. Shafer MA. Annual pelvic examination in the sexually active adolescent female: what are we doing and why are we doing it? J Adolesc Health.1998;23:68-73.Google Scholar 45. Schachter J, Shafer MA, Young M, Ott M. Routine pelvic examinations in asymptomatic young women. N Engl J Med.1996;335:1847-1848.Google Scholar 46. Perkins C, Morris C, Wright E. Cancer incidence and mortality in California by race/ethnicity, 1988-1993. Sacramento, Calif: Cancer Registry; March 1996. 47. American College of Obstetricians and Gynecologists. Technical Bulletin 198 on Hormonal Contraception. Washington, DC: ACOG; 1994. 48. Bombard AT, Fields AL, Aufox S, Ben-Yishay M. The genetics of ovarian cancer: an assessment of current screening protocols and recommendations for counseling families at risk. Clin Obstet Gynecol.1996;39:860-872.Google Scholar 49. Grover SR, Quinn M. Is there any value in bimanual pelvic examination as a screening test? Med J Aust.1995;162:408-410.Google Scholar 50. Thompson S. Ovarian cancer screening: a primary care guide. Lippincotts Primary Care Pract.1998;2:244-250.Google Scholar http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

Clinical Breast and Pelvic Examination Requirements for Hormonal Contraception: Current Practice vs Evidence

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Copyright © 2001 American Medical Association. All Rights Reserved.
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Abstract

Abstract Clinical breast and pelvic examinations are commonly accepted practices prior to provision of hormonal contraception. Such examinations, however, may reduce access to highly effective contraceptive methods, and may therefore increase women's overall health risks. These unnecessary requirements also involve ethical considerations and unwittingly reinforce the widely held but incorrect perception that hormonal contraceptive methods are dangerous. This article reviews and summarizes the relevant medical literature and policy statements from major organizations active in the field of contraception. Consensus developed during the last decade supports a change in practice: hormonal contraception can safely be provided based on careful review of medical history and blood pressure measurement. For most women, no further evaluation is necessary. Pelvic and breast examinations and screening for cervical neoplasia and sexually transmitted infection, while important in their own right, do not provide information necessary for identifying women who should avoid hormonal contraceptives or who need further evaluation before making a decision about their use. Unintended pregnancy in the United States is a widely recognized public health problem that entails adverse personal, health, economic, and social consequences.1 Although many factors influence unintended pregnancy, medical requirements for tests and procedures prior to initiation of hormonal contraceptives are of particular significance. Each requirement involves both personal and financial costs that need to be weighed carefully against their purported benefits. The possible intermediate and long-term health risks were unknown when hormonal methods were first introduced in 1960. A thorough medical evaluation prior to prescribing these drugs, and periodically thereafter, was a prudent care standard. Evidence accumulated in the interim, however, has shown that some of these practices are not necessary. For provision of hormonal contraception, breast and pelvic examinations have been customarily required. The examination visit provides an opportunity for education and counseling about preventive health care, contraceptive options, and sexually transmitted infection (STI) risk reduction. Counseling and education, however, can be provided without a physical examination, as can STI screening using methods that require only a urine or blood sample. For the early detection of cervical neoplasia, periodic Papanicolaou tests continue to be an important preventive health measure, but their utility is unrelated to the initiation of hormonal contraception. We have reviewed and summarized the published literature and recommendations from relevant professional organizations regarding the role of clinical breast and pelvic examinations in the provision of hormonal contraceptives. We considered all combined oral contraceptive and combined injectable contraceptive products containing both estrogen and progestin, oral contraceptive products containing only progestin, and injectable and implantable progestin contraceptives currently used in the United States. Together, these products account for most options for hormonal contraceptives. We excluded progestin-releasing intrauterine devices because the pelvic examination is part of the insertion process. To identify appropriate published articles for inclusion, we searched for several topics in MEDLINE, POPLINE, PubMed, and the Cochrane Library from January 1965 through January 2000. The following search terms were used: "hormonal contraception," "oral contraception," "pelvic examination," "physical examination," "clinical breast examination," "Pap smear," "breast cancer," "cervical cancer," and "chlamydia." Consensus statements, policy statements, and reviews were identified through the search process and by contacting major organizations in this field, including the World Health Organization (WHO), the International Planned Parenthood Federation, the American College of Obstetricians and Gynecologists, and Planned Parenthood Federation of America. Also reviewed were recommendations of the US Preventive Services Task Force, drug-labeling language approved by the US Food and Drug Administration (FDA), and statements from the US Agency for International Development. Additional papers of historical significance or that were helpful for interpreting more recent publications were identified from the reference lists of papers reviewed. Background Over the last 7 years, several international and US professional organizations have formulated revised recommendations for hormonal contraception users (Table 1).2-17 In general, expert medical opinion has shifted from requiring breast and pelvic examinations prior to initiation of hormonal contraception to encouraging these examinations and Papanicolaou screening as a part of routine care not directly tied to hormonal contraceptive provision. Several demonstration projects have evaluated the impact of revised approaches to service delivery of hormonal contraceptives. Overall, demonstration projects have found that many women choose to defer the pelvic examination and appreciate the opportunity to begin hormonal contraception more quickly. Providing hormonal contraception outside the clinic also has been explored as a way to reduce access barriers and improve outreach to underserved women. The Family Planning Council of Southeastern Pennsylvania, Philadelphia, established a program to offer oral contraception for up to 6 months to nonpregnant teenagers younger than age 18 years at their first clinic visit, while delaying the previously required pelvic examination.18 An evaluation of the project showed that of the 151 teenagers who completed follow-up, 26% chose to delay the pelvic examination at the time they initiated hormonal contraceptive use. The teenagers who delayed the pelvic examination were significantly more likely to fear that the examination would be embarrassing (50% compared with 38%); almost 40% of all teenagers worried that it would be painful. Teenagers who did delay the pelvic examination reported higher condom use, had fewer pregnancies, and had similar STI rates when compared with teenagers who did not delay the examination. Almost 80% of the teenagers returned to the clinic within 6 months for follow-up. The California Office of Family Planning, Sacramento, established a project in 1996-1998 to provide oral and injectable hormonal contraception without a mandatory pelvic examination.19 Women could obtain hormonal contraception after a detailed medical history and blood pressure screening. If indicated, women also received pregnancy tests and breast examinations. These services were provided in nonclinic locations. Clients in need of more extensive services were referred to affiliated family planning clinics. Women in the project reported improved contraceptive patterns: 38% adopted a more effective method, 47% remained with the same method, 12% switched to a less effective method, and 3% remained with no method (P<.001). Furthermore, 66% obtained condoms at their initial visit, while only 33% reported having used them at their last sexual encounter. In addition, 92% reported that they would recommend the services to others, and about 75% considered receiving pills or injections without a pelvic examination to be an important option. Approximately 50% were referred to an affiliated clinic for more extensive care, and the majority (73%) followed through on their referrals within 6 weeks. A comparison of the project participants with clients at clinic sites showed that participants were not at higher risk for cervical neoplasia.20 Potential Benefits Eliminating examination requirements prior to use of hormonal contraception has the potential to improve access to highly effective contraception. If this change helps women to replace no or less effective protection with more effective contraception, significant health benefits may result. Perpetuating unnecessary requirements also involves ethical considerations and may reinforce fears about the safety of hormonal contraceptive methods. Improving Access to Effective Contraception Young women often report an interval of many weeks or months between the time sexual intercourse begins and the time they first obtain medical care to acquire contraception. This interval carries a high risk for unintended pregnancy21: the very first family planning visit for many young women is for a pregnancy test.22 The same interval also delays the opportunity to receive counseling about STI prevention. For some, economic and practical factors in arranging medical care are primary reasons for this delay. Many, however, are delayed because of fears about coping with a medical examination. In particular, fear of pain and other anxieties about the pelvic examination concern adolescents.22-25 Ethical Considerations Perpetuating medically unnecessary requirements for examinations also raises important ethical questions. Using the hormonal contraception prescription to coerce compliance with routine screening involves unexamined premises. First, it assumes that policy makers rather than women are the appropriate decision makers. Second, it assumes that the health impact of missed screening for these women is more significant at that specific time than the health impact of delayed or less effective contraception. Women who are informed about the implications of a decision to defer screening should have the right to make the decision. Even if a change in requirements did result in decreased routine screening for unrelated conditions, would it be ethical to withhold hormonal contraceptives on this basis? In other areas of medical care, this would not be perceived as appropriate. Correcting Misperceptions Breast and pelvic examination requirements are likely to reinforce the incorrect belief that hormonal contraceptive methods are dangerous. This belief is widely held and may discourage use of these safe and highly effective options. Perceived danger also may play a role in early discontinuation and inconsistent use of hormonal methods.26 In the long term, public awareness based on the valid reasons for physical screening would be preferable to the current situation. Education to correct inaccurate information and beliefs and to "market" recommended screening on the basis of its own real value is an appropriate public health goal. Issues of Concern In contemplating a change in medical requirements, several issues emerge as important considerations. Screening to identify women who should not use hormonal contraception must be ensured, and the possible impact of hormonal contraceptive use on other health risks also should be considered. Identifying Women Who Should Not Use Hormonal Contraceptives For some women, hormonal contraceptives are not an appropriate choice. Consensus recommendations have been provided by several expert review panels as well as by the FDA as part of required labeling for the products sold in the United States. Among the most current and comprehensive recommendations is the 2000 review by the WHO presented in Table 2a.16 The WHO review concluded that hormonal contraceptive methods should not be recommended for women who have the following medical conditions: pregnancy, breast cancer, hypertension, certain heart and liver diseases, and diabetes mellitus, either long-standing or with end-organ involvement. Women with a history of thromboembolic disease, stroke, or migraine headaches with focal, neurologic symptoms also are advised to avoid these methods, as are women who are less than 6 weeks postpartum and breastfeeding and those older than age 35 years who smoke more than 15 cigarettes per day. Cautious use is suggested for women with hyperlipidemia, women less than 21 days postpartum, women breastfeeding from 6 weeks to 6 months postpartum, light smokers older than age 35 years, and those using medications that affect liver enzymes (eg, rifampin, griseofulvin, phenytoin, carbamezapine, barbiturates, and primadone). Additional cautions apply to women receiving estrogen-containing medications but not progestin-only medications; these include agents for biliary tract disease and use by women who are undergoing major surgery with prolonged immobilization. Unexplained vaginal bleeding requires special attention before any hormonal method is prescribed.14,16,17,27 For all of these conditions, a clinical breast or pelvic examination is unlikely to detect the condition. Medical history and blood pressure measurement are the most useful screening approaches. For example, to avoid providing hormonal methods to a woman who has an unrecognized, early pregnancy, recommended steps are a review of medical history regarding menses and instructions for initiating the first pill or injection in conjunction with a normal menstrual period. A pelvic examination during the first 14 days of pregnancy is not helpful for diagnosis of pregnancy because it cannot yet be detected by an examination. After 14 days, the possibility of pregnancy would be suspected because of the medical history—a late or abnormal period. Use of hormonal contraceptive methods during pregnancy is not recommended because they are ineffective; there is no evidence that hormonal contraceptives are harmful for either the woman or the fetus if inadvertent exposure occurs during early pregnancy.4 Failure to detect breast cancer prior to beginning hormonal contraceptive use is a particular concern. Recommendations for screening of asymptomatic women to detect unsuspected breast cancer are not clear cut. Breast cancer is rare in women younger than age 30 years, occurring in less than 4 per 100 000 annually in the United States. Among older women the risk is higher: for those aged 40 to 44 years, the annual incidence is 62 per 100 000; for women 45 to 49 years, it is 101 per 100 000.28 A recent review of clinical breast examination efficacy recommended annual clinical breast examination as a routine screening measure for women older than 40 years, although clear research evidence that such examinations can reduce breast cancer mortality is lacking.29 The US Preventive Services Task Force recommends screening every 1 to 2 years with mammography alone or in combination with clinical breast examination for women aged 50 to 69 years, but it finds insufficient evidence to recommend for or against these measures for younger women.30 Medical history (age and family history) identifies those women at increased risk for breast cancer who might benefit most from clinical breast examination prior to hormone use and for whom such examinations are recommended as a screening measure. Women older than age 40 years constitute a small minority of hormonal contraceptive users: less than 6% of women aged 40 to 44 years use such methods, and they represent less than 7% of all hormonal users.31,32 Whether or not a breast examination should be required for a woman in this group who wishes to defer the examination, however, is more problematic. Although breast cancer is a contraindication to use of exogenous hormones, the true effect of hormonal contraceptives on progression of undiagnosed breast cancer is unknown. For young women, the risk of unsuspected breast cancer is remote, the efficacy of clinical breast examination is unclear, and the risk of pregnancy is high. Within 1 year, the likelihood of pregnancy is about 90% among women using no contraceptive method; this risk can be reduced to less than 10% with average pill use and to 1% with consistent and correct use.33 The benefits of contraceptive use for young women, as well as for older women, are likely to matter more than a small theoretical increased risk associated with hormone exposure in the rare case of unsuspected breast cancer that could have been detected through breast examination. Monitoring for Possible Effects of Hormonal Contraceptives on Other Health Risks Use of hormonal methods may have negative or positive effects on susceptibility or risk for future health problems. Users of combined oral contraceptives face increased risks for occurrence of several conditions, including benign liver tumors, biliary tract disease, and breast cancer.15 Informing patients of these risks is important for informed decision making. Fortunately, these health problems are not common, and apart from appropriate evaluation of any signs or symptoms that the patient may notice (such as a breast lump or gallbladder disease symptoms), no specific steps are currently recommended for predicting or detecting their occurrence among asymptomatic women. Concerns raised in the past about an increased risk for malignant liver tumors or stimulation of the growth of uterine leiomyomata have not been substantiated.15 Even if documented in advance, fibroids are not identified as a reason to avoid hormonal methods.34,35 The relationship between hormonal contraceptive use and risks for STIs is of special concern. Hormone use could have a direct effect on infection susceptibility. Women who use hormonal contraceptives are also less likely than other women to use condoms that protect against STIs.36 Several studies have documented higher risks for cervical chlamydia infection, human papillomavirus, and for human papillomavirus–related cervical dysplasia and cancer among combined oral contraceptive users.7,37-43 Available research on susceptibility to the human immunodeficiency virus and acquired immunodeficiency syndrome is not conclusive. It is critical that possible effects on risk of infection be included in information for an informed decision to use these methods. In addition, women who use hormonal methods should be counseled effectively about the importance of wise decisions, testing for chlamydia and gonorrhea, Papanicolaou screening, and consistent condom use if there is any question of possible STI exposure. Recommended annual screening for chlamydia and screening for gonorrhea if indicated are important for all sexually active young women who may be at risk for STIs, whether or not they use oral contraceptives. Routine annual screening for chlamydia can be provided through urine testing.43 Detection of gonorrhea or chlamydia are not reasons to withhold hormonal methods or discontinue their use. There is some theoretical concern that hormone use may affect cervical intraepithelial neoplasia progression or cancer prognosis. However, cervical intraepithelial neoplasia and cervical cancer awaiting treatment are not conditions that require avoiding hormonal methods or for which caution is recommended. Because the development of cervical cancer involves identifiable precursors that may progress to invasive disease over a period of many years, effective screening can be achieved with periodic Papanicolaou tests at least every 3 years.30 For most women, complying with effective Papanicolaou screening intervals is not a problem. For those women who do not comply, however, should hormonal methods be withheld to avoid their inadvertent use by someone with unsuspected cervical cancer? Young women gain relatively little from mandatory examination and Papanicolaou test requirements30,44,45 and gain a great deal from pregnancy prevention, since the disease rates are so low and unintended pregnancy rates are so high in this age group. In California, for example, the Cancer Registry reported in 1993 only 2 cases of cervical cancer for every 1 000 000 women aged 15 to 19 years.46 Among 1 000 000 similar women exposed to the risk of pregnancy for just 1 extra month, as many as 175 000 undesired pregnancies might be expected.33 Among older women, the risk for cervical neoplasia is somewhat higher, but nevertheless, a theoretical concern about precursor progression or cervical cancer prognosis must be balanced against the noncontraceptive health benefits of hormonal methods as well as the benefits of effective contraceptive protection. Weighing against these increased risks, use of combined oral contraceptives also is associated with a significantly reduced risk for both ovarian cancer and endometrial (uterine) cancer. Use of combined oral contraceptives also reduces risks for common conditions, including symptomatic pelvic inflammatory disease and benign breast lumps. Because these problems are common and often require medical or surgical intervention, their reduced incidence among oral contraceptive users constitutes a significant positive health benefit for users.47 It is true that a pelvic examination performed for a woman requesting hormonal contraception might lead to the serendipitous identification of a palpable, malignant ovarian tumor. Unfortunately, however, bimanual pelvic examination has not been found effective as a screening measure to reduce ovarian cancer mortality, and it is not recommended for this purpose.48-50 The US Preventive Services Task Force explicitly recommends that periodic bimanual pelvic examination not be performed for ovarian cancer screening because of the harm associated with evaluation of false-positive findings and the lack of evidence of benefit. Also, although treatment for ovarian cancer renders a woman infertile in most cases, ovarian cancer is not identified as a reason to withhold hormonal contraception for a woman awaiting treatment.30 Encouraging Important Preventive Services For many women, medical visits prompted by the decision to use hormonal contraception or for refills have served as an opportunity for obtaining preventive services. Historically, clinicians, and no doubt many patients, have considered such screening essential prior to hormone use and have not been aware of the independent reasons for them. It is possible, therefore, that streamlining medical requirements for provision of these methods could adversely affect adherence to important routine prevention screening recommendations. Steps to educate women about the importance of such screening and encourage them to seek care will be needed. In addition, recommendations for services that should comprise well-woman care should be updated periodically, based on sound scientific evidence. As policy changes are contemplated, several steps to protect nonmedical concerns also need to be addressed. These include the financial stability of family planning agencies and the need to ensure continued political support for public funding. These are significant problems that require financial and organizational considerations but lie outside the scope of this medical review. Summary Hormonal contraceptives are among the most thoroughly studied of all medications. For most women they are safe, effective, and well tolerated. For some women, however, they are not a wise choice, and for a rare few, their use should be avoided or special caution and monitoring may be indicated. The medical conditions that need to be considered have been carefully identified by researchers during the past 40 years. Expert review panels convened by US and international regulatory and professional organizations have established recommendations that are comprehensive and consistent; these provide the basis for identifying clinical care steps needed to ensure appropriate screening without imposing unnecessary medical obstacles or procedures. Hormonal contraception can safely be provided on the basis of careful medical history and blood pressure measurement. Breast and pelvic examinations and screening for cervical cancer and STIs are important in their own right, but they are not necessary for identifying women who should avoid these methods or need further evaluation before a decision about hormone use is reached. All women should be advised about recommended screening for STIs and cervical and breast cancer; such services are essential components of family planning and reproductive health care. Women who are older, and therefore at greater risk for breast cancer and cervical cancer, should be advised strongly about the importance of periodic Papinocolaou tests and clinical breast examinations. Providing ongoing hormonal contraception to women in these groups without such screening involves the risk that a woman with unsuspected breast or cervical cancer may incur the possible (theoretical) adverse effects of hormone exposure. Because these conditions are uncommon, however, and the countervailing health benefits of effective contraceptive protection so powerful, hormonal methods should not be withheld from a woman who understands the implications of the potential risks involved and nevertheless wishes to defer recommended screening. In addition to being medically reasonable, this new approach also may better meet the needs of some women and should help women avoid delay in achieving effective contraceptive protection. For clinicians and health care organizations, it may also be an opportunity to develop innovative outreach approaches and to redirect resources to optimize their benefit for the reproductive health of the women they serve. The appropriate decision maker in determining when to have a pelvic examination should be the woman herself; decisions should not be made unacknowledged and by default because of historical beliefs perpetuated without scrutiny. As changes are undertaken, however, continued study will be important to characterize the impact such changes have on women's health and to identify education and referral approaches that are effective in sustaining important, though not directly related, routine health screening practices. References 1. Brown S, Eisenberg L. The Best Intentions: Unintended Pregnancy and the Well-Being of Children and Families. Washington, DC: National Academy Press; 1995. 2. American College of Obstetricians and Gynecologists. 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Contraception.1996;54:125-129.Google Scholar 8. International Planned Parenthood Federation. IMAP statement on steroidal oral contraception. IPPF Med Bull.1995;29:1-6.Google Scholar 9. International Planned Parenthood Federation. IMAP statement on injectable contraception. IPPF Med Bull.1999;33:1-5.Google Scholar 10. Society of Obstetricians and Gynaecologists of Canada. The Canadian Consensus Conference on Contraception. Toronto: Society of Obstetricians and Gynaecologists of Canada; 1998. Available at: http://sogc.medical.org/SOGCnet/sogc_docs/common/guide/library_e.shtml. Reprinted from: J SOGC:1998:20. Accessibility verified April 6, 2001. 11. Physicians' Desk Reference, 53rd ed . Montvale, NJ: Medical Economics Co Inc; 1999. 12. Revised oral contraceptive labeling: FDA approves recommendation allowing delay of pelvic exam. Contracept Rep.1993;4:4-7.Google Scholar 13. New York: Planned Parenthood Federation of America. Manual of Medical Standards and Guidelines. 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Journal

JAMAAmerican Medical Association

Published: May 2, 2001

Keywords: contraceptive methods,breast,manual pelvic examination,screening,contraceptives, oral, hormonal,sexually transmitted diseases,neoplasms,medical history,blood pressure determination,breast examination

References

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