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  1. 1
    084619
    Peer Reviewed

    Should oral contraceptives be available without prescription?

    Trussell J; Stewart F; Potts M; Guest F; Ellertson C

    AMERICAN JOURNAL OF PUBLIC HEALTH. 1993 Aug; 83(8):1094-9.

    More is known about the safety of oral contraceptives (OCs) than any other drug. 30 years of OC use show that they are safe. Some reproductive health specialists propose that OCs be available without a prescription. Obtaining a prescription keeps women from using this effective contraceptive because they need to make a costly initial clinic visit, undergo a pelvic examination, and periodic visits or telephone calls for refills, all of which are barriers to OC use. Women themselves can determine their need for OCs. They consider their risk of pregnancy and sexually transmitted diseases (STDs) and the costs and benefits of pregnancy and other contraceptives. Some people argue that OC users are more likely to receive preventive care services, such as STD screening, than are nonusers. Yet, men do not need an annual prescription for condoms to promote early detection of prostate and testicular cancer. This carrot (i.e., coercion) policy assumes that women cannot make their own decisions. Family planning clinics fear losing revenue if OCs were available without a prescription, but family planning providers need to be reimbursed for the primary prevention services they already provide and not for providing prescriptions to OCs. Improper compliance already exists even though women need a prescription to use OCs, so making OCs available over-the-counter will not effect user compliance. Some options to make OCs more accessible include a 28-day format packaging of OCs with comprehensible and legible labels including guidelines on compliance and key danger signals, an initial examination only, elimination of the pelvic examination, and counseling only for first-time users. Over-the-counter options could be a self-administered knowledge inventory maintained by pharmacists, a toll-free telephone authorization process a fax or mail-in order form, over-the-counter purchases for experienced users, and over-the-counter purchase with no restrictions.
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  2. 2
    035665

    CUP: contraceptive users pamphlet.

    Advances in Contraceptive Delivery Systems. 1986 Feb; 2(1):84-103.

    This pamphlet, edited by an ad hoc committee of several consultants, scientists, theologians, public health and family planning directors, and an international attorney, covers the following topics: contra-conception; choices of contraceptives; contraceptive package information; copper IUDs; pelvic inflammatory disease (PID); sexually transmitted diseases; and acquired immunodeficiency syndrome. It includes a questionnaire for sexually transmitted diseases (STDs). Professor Joseph Goldzieher describes the "Contra-Conception" database as "a synthesis of up-to-date literature and contemporary guidelines, designed to provide ready access for practicing physicians and medical students." It contains data on several types of hormonal contraception. "Contra-Conceptions" is designed to allow the physician to set his or her own pace when working with the computer, and no previous computer experience is required. 1 of the program's many innovative features is the patient-profiling/decisionmaking section which can be used in the doctor's office to help decide what type of hormonal contraceptive is appropriate for a particular patient. The program permits the doctor to evaluate the significance of patient variables such as parity, smoking, menstrual difficulties and helps the doctor to identify the risks and benefits of the various methods and, ultimately, to make a balanced decision in the context of the most recent data. Contraceptive drugs and devices should include detailed information on the following: description of formula or device; indication, usage, and contraindications, clinical pharmacology and toxicology; dose-related risk; pregnancies per 100 women year; and detailed warning. The sequence of major pathophysiological reactions associated with copper IUDs is identified as are special problems of pelvic infections in users of copper IUDs. Those women who use oral contraceptives (OCs) or a barrier method of contraception or whose partners use a condom have a lower frequency of PID than women not employing any protection. It is well established that copper IUDs cause different types and different degrees of PID. Women using copper IUDs are more at risk for pelvic infection. There is a higher frequency of salpingitis and PID when copper IUDs are employed especially when the population is nulligravidas under the age of 25. The pamphlet lists criteria for the diagnosis of salpingo-oophoritis and actue salpingitis.
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  3. 3
    784223

    The ideal vaginal barrier contraceptive. (Staff memorandum).

    SHELTON JD

    Washington, D.C., U.S. Agency for International Development, March 2, 1978. 2 p.

    The ideal vaginal contraceptive is described in terms of the requirements of any other contraceptive method, i.e., that it be effective, acceptable, deliverable, and safe. In terms of effectiveness, the spermicidal action should be powerful, long lasting, and ideally instantaneous in action. Overkill should be overwhelming. Some type of active dispersal (such as foaming) is probably mandatory. Regarding acceptability, the contraceptive should be easy and convenient to insert into the vagina, and messiness, running, odor, itching, irritation, residue and probably sensation of heat should be minimized. The aspect of deliverability is a positive feature of this method, since it easily lends itself to household distribution. It would be useful for the product to be conveniently packaged in multiple dose packaging as well as in unit dose packaging suitable for vending machines. Stability of the product with respect to heat, humidity, and other physical forces is very important, and cost should be comparable to condoms. The potential toxicity of these kinds of methods is favorable, since they compare favorably with the alternatives. Preparations ought not to contain heavy metals nor be detrimental to the normal vaginal flora. These products should potentially offer considerable protection from venereal disease.
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  4. 4
    774763

    King condom.

    SEAMAN B; SEAMAN G

    In: Seaman, B. and Seaman, G. Women and the crisis in sex hormones. New York, Rawson, 1977. p. 251-261

    Despite the simple technical nature of the condom, it remains the preferred method in such low birthrate, sexually sophisticated countries as Japan, Sweden, and England. Yet in the U.S. restrictions still exist which prevent open television and newspaper advertisment, which emphasizes the venereal disease preventative nature of condoms. American condoms remain much thicker, by 1/2 to 1/3, than most foreign brands, such as the Japanese. Condoms are considered by some users to interfere with sensation. Their effectiveness approaches that of the diaphragm and the pill. Significant barriers also exist in obtainability for young people. Some problems of packaging and size still persist. Directions for the proper use of condoms are provided, as well as a review of American brands. Vaseline should not be used for lubrication, as it can deteriorate the material. They can be used in conjunction with spermicidal foams.
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  5. 5
    764234

    Oral contraceptive patient labeling. Part 310 (new drugs) of Subchapter D (drugs for human use) of Chapter 1 (Food and Drug Administration, Department of Health, Education, and Welfare) of Title 21 (Food and Drugs) of the United States Code of Federal Regulations.

    United States

    International Digest of Health Legislation 27(3): 689. 1976

    Under the terms of this text, manufacturers of oral contraceptives are henceforth required to include in the mandatory patient labelling and the patient brochure a statement that oral contraceptives are of no value in the prevention or treatment of venereal disease. (Full text)
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  6. 6
    746676

    Summary minutes of the second meeting September 28-29, 1973.

    United States. Food and Drug Administration [FDA]. OTC Panel on Contraceptive and Other Vaginal Drug Products

    Adopted. 1973 October 20; 10.

    The panel members decided that their major goals were 1) the establishment of safety and effectiveness standards to be used in reviewing ingredients; 2) the development of labeling standards for over the counter products; and 3) the compilation of a pertinent bibliography. The members divided themselves into 3 review teams, and each team was made responsible for specific tasks. The members decided to ask a number of experts, knowledgeable about the ingredients under review, to lecture to the panel during the following month. The members decided to review ingredients one by one instead of reviewing product by product. The members decided to arrange all ingredients by their mode of action into sulfactants, antiseptics, aromatics, astringents, and chelating agents. Areas of future study were also determined. These areas included 1) the storage potential of the products; 2) venereal disease prevention and vaginal products; 3) the relationship between cervical cancer and vaginal contraceptive products; 4) hygiene vaginal sprays; and 5) the possibility of selling low dose estrogen pills over the counter. The panel was notified about consumer concern regarding the use of phenylmercuric acetate in vaginal products. A recent study found that phenylmercuric acetate was vaginally absorbed in rat tests. The panel will carefully consider this matter at a later date.
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  7. 7
    746473

    The condom: increasing utilization in the United States.

    Redford MH; Duncan GW; Prager DJ

    San Francisco, San Francisco Press, 1974. 292 p.

    Despite its high effectiveness, lack of side effects, ease of use, and low cost, condom utilization has declined in the U.S. from 30% of contracepting couples in 1955 to 15% in 1970. The present status of the condom, actions needed to facilitate its increased availability and acceptance, and research required to improve understanding of factors affecting its use are reviewed in the proceedings of a conference on the condom sponsored by the Battelle Population Study Center in 1973. It is concluded that condom use in the U.S. is not meeting its potential. Factors affecting its underutilization include negative attitudes among the medical and family planning professions; state laws restricting sales outlets, display, and advertising; inapplicable testing standards; the National Association of Broadcasters' ban on contraceptive advertising; media's reluctance to carry condom ads; manufacturer's hesitancy to widen the range of products and use aggressive marketing techniques; and physical properties of the condom itself. Further, the condom has an image problem, tending to be associated with venereal disease and prostitution and regarded as a hassle to use and an impediment to sexual sensation. Innovative, broad-based marketing and sales through a variety of outlets have been key to effective widespread condom usage in England, Japan, and Sweden. Such campaigns could be directed toward couples who cannot or will not use other methods and teenagers whose unplanned, sporadic sexual activity lends itself to condom use. Other means of increasing U.S. condom utilization include repealing state and local laws restricting condom sales to pharmacies and limiting open display; removing the ban on contraceptive advertising and changing the attitude of the media; using educational programs to correct erroneous images; and developing support for condom distribution in family planning programs. Also possible is modifying the extreme stringency of condom standards. Thinner condoms could increase usage without significantly affecting failure rates. More research is needed on condom use-effectiveness in potential user populations and in preventing venereal disease transmission; the effects of condom shape, thickness, and lubrication on consumer acceptance; reactions to condom advertising; and the point at which an acceptable level of utilization has been achieved.
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