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  1. 1
    Peer Reviewed

    One versus multiple packs for women starting oral contraceptive pills: a comparison of two distribution regimens.

    Chin-Quee D; Otterness C; Wedderburn M; McDonald O; Janowitz B

    Contraception. 2009 May; 79(5):369-74.

    BACKGROUND: Despite World Health Organization and International Planned Parenthood Federation recommendations to provide multiple pill cycles to new users, many programs in developing countries still give only one pill cycle to new acceptors. STUDY DESIGN: To compare provision of a single versus multiple packs of pills, new pill users in 20 matched public sector clinics in Jamaica were assigned to one of two pill regimens in which they received either one (then subsequently three) or four pill cycles at method initiation. The primary outcome was the proportion of women who used pills beyond 4 months. RESULTS: Among 655 women, those receiving one cycle of pills at initiation, followed by counseling and a three-pack resupply, were no more likely to be using pills after 4 months than women who received four packs at initiation (odds ratio=1.33; 95% confidence interval=0.88-2.0). In both pill regimen groups, returning late to the clinic for resupply was a problem. However, more women in the 1+3-pack regimen group returned late to study clinics to obtain their fifth cycle of pills than their counterparts in the 4-pack regimen group (53% vs. 28%). CONCLUSION: Our findings support the recommendation that pill users should be given more than one cycle to start, because an extra visit for resupply contributes to clinic and provider costs. Moreover, providing more pill cycles at initiation would decrease the likelihood that women experience a gap in pill use between cycles.
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  2. 2
    Peer Reviewed

    New labeling for the pill: will it change how you prescribe oral contraceptives?

    Contraceptive Technology Update. 2004 Sep; 25(9):[4] p..

    When it comes to using combined oral contraceptives (OCs), clinicians and patients look to drug package labeling for the most current information on how the Pill may be safely and effectively used. If new industry guidance for package labeling goes into effect, however, combined OC labels may not reflect the most current thinking in contraceptive provision. While the guidance offers a more simplified approach to the label and patient instructions, several women’s health groups have called for the directive to contain more updated medical information, a more thorough explanation about contraceptive method failure rates, and expanded information on the noncontraceptive benefits of the Pill. “My understanding is that package labeling is intended to provide accurate and up-to-date drug information for consumers and providers,” says David Grimes, MD, vice president of biomedical affairs at Family Health International in Research Triangle Park, NC. “The proposed labeling I reviewed was neither accurate nor up to date.” Groups such as the American College of Obstetricians and Gynecologists (ACOG), National Association of Nurse Practitioners in Women’s Health (NPWH), both based in Washington, DC; Planned Parenthood Federation of America (PPFA) in New York City; and drug manufacturers such as Raritan, NJ-based Ortho-McNeil Pharmaceutical and Philadelphia-based Wyeth Pharmaceuticals, have filed comments with the regulatory agency. The deadline for filing comments was May 4, 2004. The FDA is analyzing the comments, says Susan Cruzan, FDA spokeswoman. (excerpt)
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  3. 3

    Improve information on oral contraceptives. [Améliorer l'information sur les contraceptifs oraux]


    More than 2 million women around the world are expected to become unintentionally pregnant in the year 2001, due to improper use of OCs. Effective counseling on missed pills and revised package information are needed. Guidance can be structured around the “7-day rule,” which states that women should not go more than seven days without taking the hormonal pill. In the context of the revised OC package, the Food and Drug Administration is reviewing revisions that include simpler language for enhanced reading comprehension.
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  4. 4

    Labeling has caused "incredible confusion".


    The US Food and Drug Administration is considering changing the package labeling for the mini-pill to eliminate confusion about when to prescribe it. However, differing opinions about some related issues are hard to reconcile, to wit: whether breast feeding women should use progestin-only pills (POPs) or combined oral contraceptives (COCs). Less than 1% of American pill users rely on POPs, therefore manufacturers did not think it worthwhile to produce a separate insert for them. However, the shared insert has caused confusion. First-year failure rates for POPs range from 1.1% to 13.2%, but for lactating women they are nearly 100% effective if taken 3 weeks after delivery every day as a backup method. The consensus seems to be that POPs are used during lactation, and that at weaning or when menstruation returns women should switch to COCs. This should be done even if women were doing fine on POPs during breastfeeding, because POPs are less effective, cause irregular bleeding, and are implicated in a higher rate of ectopic pregnancies. In contrast to this opinion, another view is that prescribing COCs to breastfeeding women is acceptable, although lower-dose cyclic pills are preferred. Either pill would be acceptable for breastfeeding women according to a committee chair of the American Association of Pediatricians. Another option is to let the women decide themselves, especially if they have high blood pressure and do not like implants and injectables. For clients who choose POPs providers should assume that they comply with pill use; they should get feedback from them about the effectiveness of the pills; and they should allow them to have time to make a decision that would serve them in the long run.
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  5. 5

    Revised oral contraceptive labeling: FDA approves recommendation allowing delay of pelvic exam.

    CONTRACEPTION REPORT. 1993 Nov; 4(5):4-7.

    In May 1993, a Food and Drug Administration (FDA) committee voted to allow women seeking oral contraceptives (OCs) the option of deferring physical examination without denial of the prescription. The ruling came as a result of weighing the risks and benefits of OCs and finding that benefits exceeded the risks. Various opinions were voiced at the committee meeting. Among the reasons for deferral were the apprehension of teenagers who wish to get OCs and the inconvenience of the menstrual period. Planned Parenthood (PP) revised its own medical standards in August 1992 to allow a 3-month deferral based on a nationwide survey done in 1986 that revealed a 60% rate among teenagers who considered the exam a barrier to family planning service use. Data were obtained from 151 teenagers under 18, and 40 teens wished to delay the pelvic exam. The PP-revised standard was endorsed by the American College of Obstetricians and Gynecologists (ACOG). Contraindications to prescribing can be obtained by taking a history, measuring blood pressure, and by a pregnancy test. The most pressing reason for the pelvic exam is to diagnose and treat sexually transmitted diseases. Some were concerned that the change might prompt women not to come back for medical exams and Pap smears. Another element considered was whether deferral of breast examination might also follow, the postponement of which could delay the diagnosis of a malignancy. PP's policy requires women over 30 to have a breast examination prior to receiving an OC prescription. Appropriate counselling and health education is also necessary for women to avoid sexually transmitted diseases and ensure correct use of OCs. However, the follow-up of teenagers may be difficult because of confidentiality. The change of OC labeling and choice of deferral will increase the access of women to safe and effective contraception.
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  6. 6

    Patient education and understanding: a critical review.

    Killick SR

    ADVANCES IN CONTRACEPTION. 1992 Oct; 8 Suppl 1:57-65.

    All women in the UK have access to family planning (FP) services via general practitioners (GPs), fee paying clinics, and National Health Service FP clinics. FP services are adequately publicized and open late in the evening. They consider patient education as high priority. Nevertheless recent studies indicate that patient knowledge of oral contraceptives (OCs) is lower than expected. Most large clinical trials reveal OC failure rates are about 3% yet subjects tend to be married women who have the lowest failure rates. Rates from clinics are up to 6%. Among US adolescents and women from developing countries, failure rates may reach 13-20%. Despite comparable rates of sexual activity among adolescents, pregnancy rates among European adolescents are much lower than those among US adolescents (50% lower in Sweden and 85% in the Netherlands). Research in family planning clinics in London show that many women do not even have basic knowledge about OCs, but they had greater knowledge than women who received counseling at GPs offices. Adolescents of lower socioeconomic status who fear real or perceived side effects, use the low dose OCs, and served by a poor quality delivery system which provides little or no educational counseling are at highest risk of poor OC compliance and OC failure. Manufactures should include start days an sequence and package OCs in a small package. After identifying what patients are at risk of OC failure, physicians must realize that people learn in a safe and calm environment and by doing. They can only remember 3 messages/session. Physicians need to pay attention to the patient, to assume nothing, and to hand the patient written facts about OCs. Education comes down to teaching facts, teaching skills, and answering questions. The most powerful means of patient education is the mass media.
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  7. 7

    Recommendations for improving instructions for taking oral contraceptives.

    Family Health International [FHI]

    Research Triangle Park, North Carolina, FHI, 1991 Feb 8. [262] p.

    A special notebook for use at a U.S. Food and Drug Administration meeting held February 8, 1991, for the Advisory Committee on Fertility and Maternal Health Drugs, contains draft instructions for oral contraceptive users to be included in the Patient's Package Insert (PPI). There are 9 manufacturers of 56 types of oral contraceptives in the U.S., as well as 26 family planning organizations, with many different sets of directions for use. Particular discrepancies exist in start date, what to do if 1, 2 or more pills are missed, and in related factors such as the design of the package. The suggested instructions are readable by a person with 5-6th grade reading level, are the same for all pills, and resemble those issued by the IPPF and WHO. THe only exception is the difference between 21- and 28-day pill packages. This draft has been pre-tested on a limited basis on 70 users. The rest of the notebook contains sections on advantages and disadvantages of the proposed instructions, a review of relevant biomedical and social literature on pill-taking with excerpted readings, list of manufacturers, types of instructions by manufacturer, bibliography, and contributors. With a 1st-year failure rate as high as 10%, leading to a 10-year failure rate of 40%, it is assumed that if compliance could be improved, the current estimated 250,000 pill failures annually in the U.S. would decrease.
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  8. 8

    Counseling on contraceptives: an unfilled need.

    Steadman S

    American Pharmacy. 1985 Sep; NS25(9):42-6.

    The dictum that pharmacists have a fundamental responsibility to provide health care information for their patients includes the need to furnish complete and accurate information on all of the contraceptive products that currently are on the market. To help accomplish this, many different resources are available that provide guidance for comprehensive patient education on all the different products and devices. If one agrees to the principle that an individual's sexuality is an accepted element of his or her life, then promoting sexual well-being should be an important part of health care. Yet, it seems that pharmacists and other health care professionals in general have not been particularly liberated about talking about and making objective assessments on sexual matters. Health care professionals seem to need more education to enable them to provide accurate information, to augment their own knowledge bases, and to reduce their inhibitions and possible misconceptions about sexual matters. Pharmacists do not want to appear as if they are encouraging or promoting sexual activity, but, given the consequences of nonuse of contraception, socially responsible pharmacists need to disseminate basic information about the use of contraceptive products. At some level, too, objective guidelines should be established to help pharmacists in handling contraceptive information. Pharmacists can play a key role in counseling on both prescription and nonprescription methods. In fact, pharmacists may be the only health care professionals with whom a sexually active person can speak about nonprescription contraceptive methods. Some pharmacists have been reluctant to provide patient information because of the risk of possible liability. But this attitude seems to be changing. The recent emphasis on clinical functions in pharmacy practice has led to speculation that, as pharmacists come to assume new roles, they may become liable for not providing some of this information. At present, at least 22 states already have guidelines or regulations requiring pharmacists to counsel patients. To provide the most effective learning experience, active participation is the key ingredient. It is necessary to elicit active participation in the counseling process. It is not possible to give complete guidance on the subject of contraceptives to every patient that comes in the store. Nor is every person going to be receptive, at least initially, to the idea of talking about contraception with a pharmacist. Yet, the role of the pharmacist takes on greater significance now because of the controversy that continues to surround some of the safety and efficacy issues of oral contraceptives and IUDs. Brochures and other materials are available to help pharmacists counsel patients on all of the different contraceptive methods.
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