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Extended effectiveness of the Etonogestrel-releasing contraceptive implant and the 20 ug Levonorgestrel-releasing intrauterine system for 2 years beyond U.S. Food and Drug Administration Product Labeling.
Global Health: Science and Practice. 2017 Dec; 5(4):534-539.Add to my documents.
CONTRACEPTION REPORT. 1993 Nov; 4(5):14.In 1993, the Food and Drug Administration (FDA) issued new labeling guidelines for oral contraceptives, intrauterine devices (IUDs), implantable and injectable contraceptives, and natural membrane condoms. The prevalence of sexually transmitted diseases (STDs) and the AIDS epidemic prompted the FDA to take this action as part of an on-going education effort to reduce the risk in sexually active individuals, particularly adolescents and young adults. In spite of strong educational efforts, many adolescents and young adults. In spite of strong educational efforts, many adolescents and young adults, are continuing to engage in high-risk sexual behavior. The required statement for oral contraceptives, subdermal implants, injectables, and IUDs is: "This product is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases." For latex condoms the message reads: "If used properly, latex condoms will help reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases." For female condoms the label reads: "If you are not going to use a male latex condom, you can use a female condom to help protect yourself and your partner." The message on latex condoms will appear on individual condom wrappers as well as on the outer package. Manufacturers will add a similar statement to patient and physician leaflets provided with the products. Other contraceptives that may be relabeled in the future include spermicides, cervical caps, diaphragms, and the contraceptive sponge. The new contraceptive labeling effort is part of a broader initiative of the US Public Health Service regarding women's health that focuses on health issues and diseases in women, including reproductive disorders, breast and other cancers, and substance abuse.
FDA MEDICAL BULLETIN. 1993 Jun; 23(2):4-5.The US Food and Drug Administration (FDA) has notified the manufacturers of oral contraceptives, IUDs implantable and injectable contraceptives, and natural membrane (lambskin) condoms that labeling accompanying their products must state in clear language displayed prominently that they do not provide protection from sexually transmitted diseases (STDs) including AIDS. FDA is taking this action as part of ongoing education efforts to reduce the risk of HIV infection and other STDs in sexually active individuals, particularly adolescents and young adults. Since 1987, FDA has strongly recommended that the labeling on latex condoms provide information regarding their effectiveness in preventing pregnancy and protecting users from STDs. Oral contraceptives, Norplant, Depo Provera, natural membrane (lambskin) condoms, and IUDs are intended to prevent pregnancy and do not protect against HIV infection (AIDS) and other STDs. If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other STDs. This message is to appear on individual condom wrappers, as well as on the outer package. FDA, is conjunction with the National Institutes of Health and the national Centers for Disease Control and Prevention, is currently reviewing the scientific literature to determine whether the labeling for other contraceptives, such as spermicides, cervical caps, diaphragms, and the newly approved female condom should be changed as well.
JOURNAL OF FAMILY PRACTICE. 1992 Sep; 35(3):249.Dr. Reynolds raises concerns regarding the Norplant packaging system. The surgical specialists in eastern North Carolina performing training programs for Wyeth did initially teach physicians to place the sterile Norplant capsules onto the nonsterile tray during insertion. Some of our faculty were trained in this technique, and at least 1 of the 3 insertions resulting in skin complications was performed in this manner. When the letter by Reynolds and Weber was published in JAMA in November of 1991, the wyeth surgical specialist wrote to 11 physicians in this area informing us to stop using the Norplant tray as part of the operative field. I am intrigued by Dr. Lawless's description of a recent skin complication following the insertion of the Norplant contraception system. She indicated that adequate depth of insertion and proper sterile technique were assured in the patient who developed the skin complication. After witnessing several superficial insertions recently performed by surgical specialists outside our University center, I am confident that we also correctly placed the subdermal implants. I emphasize that we do not know the cause of the reported skin complications. it is unclear whether epinephrine played a significant role. Darney reported in the May issue of the Journal that a large number of insertions performed with epinephrine failed to show any complications. We have recently performed 100 procedures without epinephrine and have failed to observe any skin problems. Dr. Lawless's patient was anesthetized with xylocaine that included epinephrine. Wyeth apparently has been aware of many reports of skin complications. It is unclear why these complications have not been more widely publicized to physicians. With increased physician reporting, it is hoped that the cause of these problems may be identified and corrected. (full text) (2 references cited in original document)
JOURNAL OF FAMILY PRACTICE. 1992 Sep; 35(3):249.Zuber, DeWitt, and Patton recently reported 3 cases of skin damage after implantation of Norplant. One plausible explanation for the skin damage would be infection or granulomatous foreign body reaction if unclean and nonsterile technique was during the insertion procedure. As I have previously reported, some manufacturer-sponsored hands-on training sessions for inserting Norplant have demonstrated improper use of the nonsterile white plastic packaging tray as a sterile field. As a result of discussions that I have had with the manufacturer and the FDA, a prominent "Nonsterile Tray" label has been placed on the clear plastic cover of the Norplant System. Under the cover and in the wells of the white plastic tray are 15 separate items that must be unwrapped and placed in a side table sterile field before the insertion can proceed. Despite widespread dissatisfaction with this inefficient packaging, Wyeth-Ayerst has refused to repackage the Norplant system in the fashion of an "open-it-once" sterile tray. (full text) (2 references cited in original document)
[Washington, D.C.], Futures Group, SOMARC, . iv, 147 p.This training manual in social marketing of contraceptives (CSM) in text format presents the elements of a program, summarizes marketing theory, and describes practical examples. It is based primarily on written material by marketing professionals and population communication experts. The elements of social marketing, elaborated in 10 chapters, include: marketing, products selection, pricing, promotion, distribution, market research, marketing plan, organization, management, and management information systems. CSM use commercial marketing techniques to expand availability of contraceptive products, information and services by existing or newly created outlets, thereby complementing private and public services. While commercial and social marketing share the same management process and the same activities planned around product, price, promotion and distribution, they differ in that the goal of commerce is profit, while that of social marketing is maximizing sales and contraceptive usage. Contraceptive products supplied by USAID are described. Types of promotion used in CSMs are advertising, point-of-purchase, personal selling, and sampling: local conditions determine which is most effective. Distribution may be by commercial distributors or by program distributors if needed. The section on market research is particularly detailed and broken down into types and steps, preparing for the annual marketing plan, itself divided into 15 sub-sections. 2 methods of forecasting contraceptive demand are given, a matrix projection model and logit analysis. Types of marketing organization suggested are by functional and product specialties, the latter modeled after pharmaceutical firm management and most commonly used in CSM. Suggestions on minimal software requirements for marketing information systems, covering commodity tracking, finances, and donor agency data requirements are briefly outlined, and a monthly report form is shown.
JAMA. 1991 Nov 6; 266(17):2373.We at Wyeth-Ayerst appreciate that Dr Reynolds has brought to our attention the fact that some healthcare providers are using the plastic tray in the Norplant system kit as a sterile field. As Dr Reynolds mentioned, an extra sterile drape is provided in the product kit for this purpose, and use of this drape as the sterile field is shown in all the audiovisual materials and in the package insert. As a result of this information, the instructors participating in the Norplant system instruction program have been notified of this unintended use of the plastic tray, and Wyeth-Ayerst has reemphasized the labeling recommendation to use the extra sterile drape provided as the sterile field. We have also contracted each healthcare provider who has participated in an instruction session where the plastic tray may have been incorrectly used as a sterile field. In addition, Wyeth-Ayerst is now placing high visibility stickers on the plastic tray, stating that the tray is not sterile. (full text)
JAMA. 1991 Nov 6; 266(17):2373.Evidence is presented of a potentially serious perception problem concerning the sterility of the Norplant packaging. The insertion kit consists of an outer cardboard box with an inner plastic tray that holds the individually wrapped, sterilized insertion materials. Also included is a sterile towel intended for use as a side table sterile field. At a physician training session conducted by Norplant's manufacturer, Wyeth-Ayerst Laboratories, the author observed the trainer to use the nonsterile plastic tray as a sterile field to lay out the insertion materials. The trainer reportedly had been taught this procedure at a seminar for trainers. The manufacturer's audiovisual materials and package insert outline the need to unwrap all insertion materials into a sterile field. All physicians, especially those who have attended trainings, should be aware of the nonsterile nature of the plastic tray. Both the Food and Drug Administration and the manufacturer have been informed of this perception problem.
Jakarta, Indonesia, Survey Research Indonesia, 1988 Sep. 40,  p. (SRI - 737)This report of a survey of awareness, usage and attitudes of 2106 men from Jakarta, Surabaya, Medan and Bandung, Indonesia, featuring condoms and the Duo Lima condom in particular, by Survey Research Indonesia, comparing 1988 to 1987, consists of 27 tables and 2 conceptual maps. Many of the data compare location or economic class. Unaided awareness of condoms had decreased from 20 to 16% overall between 1987-1988, while knowledge of vasectomy and Norplant had increased. Use of condoms as the main method fell from 7 to 5%. 10% have ever tried condoms. The main source of purchase was the Apotik (50%), drug store (195) and puskesmas (12%). The most common condom pack size purchased was 12, followed by 3 and 6. Men described condoms' "messiness" as their worst drawback. Most users tried condoms for <1 year, indicating falling off of use. Awareness of the Duo Lima brand has increased to 48%, up from 43% in 1987. It was the 1st brand mentioned by all men; 69% recalled Duo Lima advertising, primarily on radio, on billboards, and in newspapers. Duo Lima was the leading brand with 39% of subjects using it. Perceptual maps placed Duo Lima as an attractive, modestly priced, well advertised brand, the right size, and best suited for family planning.
American Pharmacy. 1981 Jun; 21(6):38-41.There are an estimated 8.4 million women today in the U.S. using combined OCs (oral contraceptives). The estrogen component of OCs can either be mestranol or ethinylestradiol. Formulations with high doses of estrogen are thought to be responsible for most of the side effects related to OCs, i.e. myocardial infarction, venous thrombosis, and thrombotic or hemorrhagic stroke. OC users are 3 times more likely than nonusers to have a fatal heart attack. In women who smoke or who are hypertensive, who have diabetes or high cholesterol levels, or who are in advanced age, the risk increases. High-dose estrogen formulations also seem to increase cholesterol and triglycerides levels, and suppress insulin after about 2 years of use. The use of ampicillin, rifampin or tetracycline may interfere with the contraceptive effect of the formulation. A recent longitudinal study conducted in Walnut Creek, California, concluded that OCs are safe for young, white, middle-class American women. It also noted an increased incidence among users of lung cancer, cervical cancer and malignant melanoma, and attributed these findings to higher rates of smoking, sexual activity, and sun exposure. There are not any postcoital drugs on the market today which are approved by the FDA. DES (diethylstilbestrol) is widely used as an antidote to unprotected intercourse; 25 mg are taken twice a day for 5 days, starting within 72 hours of coitus. The FDA has never been able to induce manufacturers to label the drug noting the severe side effects it can cause. High dosage ethinyl estradiol and conjugated estrogen are also used as postcoital contraceptives. ERT (estrogen replacement therapy) has been proven to increase risk of endometrial cancer, and it does alleviate vasomotor sequelae and vaginal atrophy and dryness. The value of ERT in retarding osteoporosis is still a controversial matter. The FDA and most gynecologists recommend prescribing the lowest dose of estrogen for the shortest time possible in patients for whom alleviation of postmenopausal symptoms by ERT seem warranted. The use of subcutaneous implant of estradiol pellets in the treatment of menopause-related vasomotor symptoms and for contraceptive purposes is currently being investigated.