Making OCs More User-friendly

July 14, 2011

This article examines issues surrounding noncompliance, and offers advice regarding effective patient counseling. It also highlights the importance of OC packaging: Market research studies suggest that more discreet and more convenient styles of packaging may promote consistent use.

When used consistently and correctly, oral contraceptives (OCs) are a highly effective method of reversible birth control. Unfortunately, studies show that many OC users--a sizable proportion of whom are teenagers--do not adhere to their regimens. Thus, clinicians and pharmacists, in concert with drug manufacturers, need to explore ways to enhance OC compliance in adolescent users.

This article examines issues surrounding noncompliance, and offers advice regarding effective patient counseling. It also highlights the importance of OC packaging: Market research studies suggest that more discreet and more convenient styles of packaging may promote consistent use.

POOR ComplianceSigns
Unintended pregnancy is the most obvious outcome of poor compliance with an OC regimen. In general, OC users who are young and impoverished have the highest rates of unintended pregnancy.1 The National Survey of Family Growth showed that unmarried or ever-married OC users younger than 20 and relatively poor (income less than twice the national poverty level) had rates of 13% to 29%. This contrasted with rates of 3% to 4% for women who were at least 30 and of higher socioeconomic status.

Other evidence of poor OC compliance includes reports of adolescent girls who miss an average of three pills per cycle;2 fail to keep clinic appointments or follow instructions for using the Pill;3 or use OCs sporadically because of sporadic sexual relationships.4 Teens should always be counseled that OCs do not protect them from sexually transmitted diseases and that condoms should be used for that purpose.

Contributory Factors
Teenage girls may fail to adhere to their OC regimens because of misperceptions about minor side effects, unawareness of noncontraceptive benefits of the Pill, lack of clear communication concerning proper use of the Pill, and unresolved psychosocial issues.

Minor side effects. Irregular menstrual bleeding patterns (amenorrhea, oligomenorrhea, spotting, and breakthrough bleeding [BTB]) can occur with OC use, particularly during the first three cycles. Although these bleeding changes are usually minor from a clinical standpoint, many adolescents cannot tolerate them. Some girls fear that they have a serious disease, such as a gynecologic cancer. Others become confused about the timing of their "real" period, and still others are disturbed by the interruption of previously "blood-free" spontaneous sexual activity. Finally, some girls fear that irregular bleeding means they are pregnant. Bleeding changes, particularly in adolescents, can prompt OC cessation or poor compliance. Poor compliance, in turn, can increase the risk for further episodes of inconsistent bleeding. Some clinicians fail to link improper OC use to spotting and BTB.4 Consequently, they may not reinforce consistent and proper OC use in girls plagued by irregular bleeding.

Other minor side effects attributed to OC use include nausea, headache, and

. With current low-dose OCs, nausea is rare and usually diminishes after the first few cycles. Attempts to establish a relationship between OC use and migraine induction/exacerbation have been inconclusive.5 Like nausea, headache often subsides after the first few cycles of OC use. Finally, studies of low-dose OCs have not demonstrated a significant link between weight gain and OC use.6,7

 1991 (%)1995 (%)
Ovarian cancer8077
8081
Ectopic pregnancy8891
Pelvic inflammatory disease8990
Benign breast disease9595

Unawareness of benefits. Despite a proliferation of studies over the past decade supporting the major health benefits of OCs, few college women seem to be aware of them (Table 1).8,9 A smaller proportion of respondents in 1995 than in 1991 knew that OC use eases dysmenorrhea (66% vs 75%).8,9 Many teens are still unaware that OC use can protect against ovarian and endometrial cancer, ectopic pregnancy, pelvic inflammatory disease, and benign breast disease.

Poor communication. One of the principal determinants of compliance with regimens is a satisfying clinician-patient interaction.10 The current health care system does not always afford clinicians sufficient time to establish such a relationship. Consequently, patients feel that they are not getting enough information and support. Ways to increase communication include effective use of ancillary personnel, distribution of written material, and clear instructions for addressing concerns that occur "after hours." Referral to a good contraception Web site (e.g., www.ARHP.org or www.managingcontraception.com) is helpful.

Psychosocial problems. Adolescents may seek prescriptions for OCs without knowledge or consent of an adult, thus limiting support of, and assistance with, their contraceptive choice. They may also be ambivalent about their sexual activity; feelings of shame may lead to poor OC compliance. Also, personal and/or cultural backgrounds may conflict with acceptance of contraception, resulting in a psychological barrier to consistent use. Finally, some teenagers may lack sufficient reading skills to interpret labels and instructions for OC use.

IMPROVING Compliance
Because of the many factors that jeopardize OC compliance, clinicians, patients, pharmacists, and OC manufacturers have varied opportunities to facilitate proper and consistent use of these agents.

Clinician Initiatives
One of the main responsibilities of clinicians who take care of sexually active teenage girls is providing contraceptive counseling. Such counseling--a process that includes solicitation of the patient's needs, preferences, and involvement in decision making--can enhance satisfaction and compliance with the proposed regimen.11 One easy way to facilitate the counseling process is to have patients view and handle an OC package. Table 2 shows key aspects of successful interactive counseling regarding OC use.

At the very least, clinicians should provide instruction about correct and consistent OC use for optimal prevention of pregnancy. They should also review the Pill's noncontraceptive benefits, excellent safety profile, and possible minor side effects. Information should be conveyed in language that patients understand. It is better to translate study data into absolute risk, attributable risk, or conferred protection rather than discussing relative risk--a concept that may be misinterpreted. (Because most OC-associated adverse events are rare, data concerning absolute/attributable risk give patients a better perspective than does citation of, say, two-fold or greater increases in relative risk.) Clinicians should also provide counseling that is age-specific: Adolescents' incentives to reduce the risk of contraceptive failure may differ from those of married women. By gearing counseling to individual needs, clinicians increase the likelihood that patients will adhere to the prescribed regimen.

During these sessions, clinicians should follow the "1-minute rule": After no more than a minute of talking, they should ask patients a question to promote interaction. To solicit more substantive information, clinicians should phrase questions in such a way that patients cannot answer with a simple yes or no. For example, clinicians might ask: "What are your concerns about taking the Pill?" In addition, providing instructions in written form, or having patients repeat key phrases, may improve recall later on.

Aside from providing basic information about OCs, clinicians should provide anticipatory guidance as part of the counseling process. Although many OC users never experience adverse events related to the Pill, others may have episodes of BTB or may skip an entire period. For those adolescents who are destined to experience mild effects, knowing about them in advance and that these events are usually transitory may assuage fears and enhance compliance. As many teenage OC users tend to skip pills, even two or three in a row once in a while, anticipatory counseling should also include emergency contraception methods, use of backup contraceptives, and alternatives to sexual intercourse.

To maintain optimal clinician- patient interaction, a process for ongoing involvement and flexible contact arrangements should be established, particularly if patients may need emergency contraception (see "Contraceptive Compliance" article). Routine follow-up appointments should be scheduled and patients contacted if appointments are missed. For questions between visits, a ready telephone information access line may alleviate patient concerns and avoid OC misuse.

Patient Initiatives
After undergoing counseling, adolescent OC users must take responsibility for their contraceptive needs. They should establish a regular pill-taking regimen, which may be cued to daily activities such as putting on earrings, brushing teeth, or showering. They should promptly refill prescriptions, and make sure that they understand any changes to their dosing instructions. They should continue taking their pills in the presence of minor side effects, and immediately contact their clinician with any concerns.

All OC users should choose (and have available) a backup contraceptive method for unexpected episodes of OC noncompliance. If they are experiencing vomiting or diarrhea that may affect OC absorption, they should use a backup contraceptive. They should also know what to do if pills are missed: If they skip one pill, they should take the missed pill as soon as possible and proceed with the next daily dose; if they miss two or more pills, they should continue taking pills, use a backup contraceptive method, and consider emergency contraception if unprotected intercourse has occurred. This should be clearly explained in written materials provided by clinicians, and clinicians, office staff, and pharmacists should be able to answer any questions that may arise.

Pharmacist Initiatives
Pharmacists can assist with patient education and reinforce a regular pill-taking regimen. They should be familiar with available OC formulations and inform patients of any prescribing information changes. If patients require an OC prescription refill and contact with their clinician is not feasible (e.g., on a Sunday), pharmacists should encourage patients to return the next day. If pills are missed, the pharmacists should refer patients to the prescribing information and explain the instructions for missed pills.

Manufacturer Initiatives
Drug manufacturers encourage, and have responded to, studies that define predictors for unsuccessful OC use. They have refined OC formulations to enhance safety while preserving efficacy (e.g., by developing products with low estrogen and progestin doses). As studies have linked OC side effects with OC discontinuation, these improved side-effect profiles should result in higher compliance rates.12 Although most women can use any OC, the host of OC formulations available allows clinicians to tailor a regimen to each patient's unique needs.

OC packaging also has evolved over time, becoming more "user-friendly." Early OCs were dispensed from a conventional pill bottle. In contrast, current OCs come in several different prepackaged color-coded pills. Table 3 shows the numerous OC packaging styles available, including flat foil rectangle packs and thin oval foil packs. In addition, circular packs have been introduced to initiate an OC cycle on any day, giving clinicians and users increased flexibility. Manufacturers have also provided a variety of cases to hold the foil packages.

OC FormulationTrade Name, ManufacturerFoil Packaging (28-Day Regimen) Outer Plastic Case
Norgestimate/EEOrtho Tri-Cyclen, Ortho-McNeilPills lay on side in a circle. Pack can turn with a dial for dispensing daily pill. Can set first pill for any-day start regimen.
Desogestrel/EEMircette, OrganonPills lay flat in four rows.
Desogestrel/EEDesogen, OrganonPills lay flat in four rows.
Norethindrone acetate/EEEstrostep, Parke-DavisPills lay flat in four rows.
Levonorgestrel/EETriphasil, Wyeth-AyerstPills lay on side in a circle. Pack can turn with a coin for dispensing daily pill. Can set first pill for any-day start regimen.
Levonorgestrel/EEAlesse, Wyeth-AyerstPills lay on side in a circle. Can use coin to set first pill for any-day start regimen.
Levonorgestrel/EENordette, Wyeth-AyerstPills lay flat in a long, thin oval.

To provide discreet, easy-to-use packaging, one manufacturer introduced an OC container that is not easily recognized as packaging for pills (Table 3). Market research studies conducted on past/present OC users, nurses, and OB/GYNs suggest that such packaging might increase compliance.13 Key findings from the studies include the following observations:

Among 284 OC users, more than 40% said that they would carry a discreet OC package in their purses (a significant increase over the current OC storage practices of those surveyed) and 32% said that they would feel better about taking their OCs, and would be reminded to take their OCs, if the pills were packaged in a discreet containerWhen nurses were asked to assess a discreet, round OC package with dial capability on a scale of 0-10, with 10 being the most favorable, 88% (15/17) of nurses rated the package.8 Reasons for the high rating included preference for a round shape (over an oblong shape), dial capability, and the option to choose any-day startSixty physicians who were interviewed had favorable impressions of the discreet packaging because of the potential for compliance enhancement and because of patients' confidentiality needs. They noted, for example, that a male who did not know that his partner was using OCs might be more inclined to use a condom, which might serve to protect the female from contracting a sexually transmitted disease. Further, they surmised that compliance might increase if adolescents carried their pill packages with them.

In addition to discreet packaging, manufacturers can facilitate compliance with the prescribed regimen by offering standardized written materials that are comprehensible for the typical patient. Packaging instructions required by the Food and Drug Administration may be too difficult for many patients to understand. Providing clear and concise instructions in list format (i.e., step 1, step 2, etc.), including instructions for dosing when one or more pills are missed, might increase compliance through improved knowledge of proper OC use (Figure).

Conclusion
Consistent adherence to an OC regimen results in a contraceptive failure rate of less than 1%. Poor compliance reduces this high level of efficacy. Typical OC use, which includes missed pills and taking pills out of order, can result in unintended pregnancy, minor side effects, unnecessary calls to clinicians, and higher health costs. Minor side effects can further jeopardize compliance, creating a pattern of behavior that increases the risk for unintended pregnancy. Clinicians should improve their relationships with patients through interactive and anticipatory counseling. Patients should be responsible for taking their pills consistently and pharmacists should reinforce a regular pill-taking regimen. Manufacturers should continue to improve and monitor OC safety. They should also heed surveys and studies showing that OC users prefer discreet packaging and are more likely to follow instructions presented in list format. With everyone's increased efforts to improve OC compliance, more adolescent girls can successfully use OCs.

References:

REFERENCES

1. Jones EF, Forrest JD. Contraceptive failure rates based on the 1998 NSFG. Fam Plann Perspect. 1992;24:12-19.

2. Balassone ML. Risk of contraceptive discontinuation among adolescents. J Adolesc Health Care. 1989;10:527-533.

3. Emans SJ, Grace E, Woods S, et al. Adolescent's compliance with the use of oral contraceptives. JAMA. 1987;257: 3377-3381.

4. Rosenberg MJ, Burnhill MS, Waugh MS, et al. Compliance and oral contraceptives: a review. Contraception. 1995;52: 137-141.

5. Mattson RH, Rebar RW. Contraceptive methods for women with neurologic disorders. Am J Obstet Gynecol. 1993;168: 2027-2032.

6. Redmond G, Godwin AJ, Olson W, et al. Use of placebo controls in an oral contraceptive trial: methodological issues and adverse event incidence. Contraception. 1999;60:81-85.

7. Moore LL, Valuck R, McDougall C, et al. A comparative study of one-year weight gain among users of medroxyprogesterone acetate, levonorgestrel implants, and oral contraceptives. Contraception. 1995;52: 215-220.

8. Tessler SL, Peipert JF. Perception of contraceptive effectiveness and health effects of oral contraception. Women's Health Issues. 1997;7:400-406.

9. Peipert JF, Gutmann J. Oral contraceptive risk assessment: a survey of 247 educated women. Obstet Gynecol. 1993;82: 112-117.

10. Lipkin M Jr. Physician-patient interaction in reproductive counseling. Obstet Gynecol. 1996;88:31S-40S.

11. Delbanco TL, Daley J. Through the patient's eyes: strategies toward more successful contraception. Obstet Gynecol. 1996;88:41S-47S.

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

13. Ortho-McNeil Pharmaceutical, Inc. Data on file.

14. Miriam Zieman, MD, is an Assistant Professor, Department of Gynecology and Obstetrics, Emory University, Atlanta, GA.

Originally published in The Female Patient -- November, 2000

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